US20140324164A1 - Techniques for percutaneous mitral valve replacement and sealing - Google Patents

Abstract

Apparatus is provided for use with a native valve of a heart of a subject, the apparatus including (1) an annular upstream support portion, configured to be transluminally placed against an atrial surface of the native valve; (2) a tissue-engaging element that includes a coupling portion configured to be transluminally coupled to tissue in a ventricle of the heart; (3) an elastically-stretchable holding element, configured to secure the upstream support portion against the atrial surface by elastically coupling the coupling portion to the upstream support portion; and (4) a prosthetic valve, configured to be transluminally delivered to the native valve and intracorporeally coupled to the upstream support portion subsequently to the securing of the upstream support portion against the atrial surface. Other embodiments are also described.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS
• This application claims priority from:
• U.S. 61/515,372 to Gross, filed Aug. 5, 2011;
• U.S. 61/525,281 to Gross, filed Aug. 19, 2011;
• U.S. 61/537,276 to Gross, filed Sep. 21, 2011;
• U.S. 61/555,160 to Gross, filed Nov. 3, 2011;
• U.S. 61/588,892 to Gross, filed Jan. 20, 2012; and
• U.S. Ser. No. 13/412,814 to Gross, filed Mar. 6, 2012, all of which are incorporated herein by reference; and
• this application is a Continuation-In-Part of U.S. Ser. No. 13/412,814 to Gross, filed Mar. 6, 2012.
• This application is related to a PCT application to Gross, entitled, “Percutaneous mitral valve replacement and sealing,” filed on even date herewith.
FIELD OF THE INVENTION
• Some applications of the present invention relate in general to valve replacement. More specifically, some applications of the present invention relate to prosthetic valves for replacement of a cardiac valve.
BACKGROUND
• Ischemic heart disease causes regurgitation of a heart valve by the combination of ischemic dysfunction of the papillary muscles, and the dilatation of the ventricle that is present in ischemic heart disease, with the subsequent displacement of the papillary muscles and the dilatation of the valve annulus.
• Dilation of the annulus of the valve prevents the valve leaflets from fully coapting when the valve is closed. Regurgitation of blood from the ventricle into the atrium results in increased total stroke volume and decreased cardiac output, and ultimate weakening of the ventricle secondary to a volume overload and a pressure overload of the atrium.
SUMMARY OF THE INVENTION
• For some applications of the invention, a prosthetic valve support is provided for facilitating transluminal implantation of a prosthetic valve at a native valve (e.g., a native heart valve) of a subject. The prosthetic valve support is configured to be placed at the native valve, such as by placing an upstream support portion (e.g., an annular portion) of the prosthetic valve support against an upstream surface of the native valve (e.g., against a native valve annulus). The prosthetic valve is subsequently implanted at the native valve by coupling the prosthetic valve to the prosthetic valve support, such as by expanding the prosthetic valve in an opening defined by the prosthetic valve support. For some applications, the prosthetic valve support is couplable to the native valve, independently of the prosthetic valve. The implantation of the prosthetic valve at the native valve replaces native check valve functionality of the native valve with substitute check valve functionality of the prosthetic valve. For some applications, the prosthetic valve support and/or the prosthetic valve comprise tissue-engaging elements (e.g., support-anchoring elements, and valve-anchoring elements, respectively), such as anchors or clips.
• Typically, the prosthetic valve is expanded within one or more openings defined by the prosthetic valve support, and coupling of the prosthetic valve to the prosthetic valve support is facilitated by radially-expansive force applied by the prosthetic valve against the prosthetic valve support. For some applications, additional coupling techniques, such as support-engaging elements, coupling leads, ratchet mechanisms, protrusions, and/or pockets are used.
• For some applications, the prosthetic valve support is configured to receive, at different periods, more than one prosthetic valve. For example, a first prosthetic valve may be removed from the prosthetic valve support, and replaced with a second prosthetic valve. Alternatively, the first prosthetic valve may be left in place when the second prosthetic valve is implanted. For example, the prosthetic valve support may define more than one lumen, each lumen configured to receive a respective prosthetic valve. Alternatively, the prosthetic valve support may define a lumen that is configured (e.g., shaped) to receive a first valve at a first period, and a second valve at a second period.
• For some applications, the prosthetic valve support comprises support-anchoring elements that are flexibly-coupled to the upstream support portion. For some such applications, the support-anchoring elements are configured to anchor the prosthetic valve support to the native valve, while allowing the leaflets of the native valve to continue to function, at least in part. For some applications, the prosthetic valve support comprises support-anchoring elements whose length is variable (e.g., adjustable).
• For some applications of the invention, a cross-sectional area of the opening defined by the prosthetic valve support is adjustable.
• For some applications of the invention, delivery apparatus for implantation of a medical device (e.g., a prosthetic valve and/or a prosthetic valve support) is provided, the delivery apparatus and/or the medical device being configured to allow retrievability of the medical device during one or more stages of delivery and/or deployment of the medical device.
• There is therefore provided, in accordance with an application of the present invention, apparatus for use with a first prosthetic valve and a second prosthetic valve at a native heart valve of a subject, the apparatus including:
• a prosthetic valve support, shaped to define at least one lumen, and configured:
• • to be implanted at the native valve,
  • to facilitate, at a first period, implantation at the native valve of the first prosthetic valve, and
  • to facilitate, at a second period, implantation at the native valve of the second prosthetic valve without removal of the first valve.
• In an application, the prosthetic valve support is configured to facilitate the implantation of the first prosthetic valve by being configured to receive the first prosthetic valve in the at least one lumen.
• In an application, the prosthetic valve support includes a seal, which:
• • does not cover at least a first region of the at least one lumen,
  • covers at least a second region of the at least one lumen, and
  • is configured to be openable at at least the second region,
    and the prosthetic valve support is configured:
• to facilitate the implantation of the first prosthetic valve by being configured to receive the first prosthetic valve in the first region, and
• to facilitate the implantation of the second prosthetic valve by being configurable, by opening of the seal, to receive the second prosthetic valve in the second region.
• In an application, the at least one lumen is shaped to define at least a first lumen and a second lumen, and the seal covers the second lumen.
• In an application, the first region and the second region are defined by the same lumen.
• In an application, the apparatus includes a covering that covers the prosthetic valve support, and the seal is defined by a portion of the covering.
• In an application, the prosthetic valve support is configured to receive the first prosthetic valve in the lumen, and is configured to facilitate the implantation of the second prosthetic valve by being configured to receive the second prosthetic valve in the same lumen.
• In an application, the apparatus further includes the first and second prosthetic valves, the first prosthetic valve defines a lumen therethrough, and the second prosthetic valve is configured to be implanted in the lumen of the first prosthetic valve.
• In an application:
• the second prosthetic valve defines a lumen therethrough,
• after the first period, and before the second period, the lumen of the first prosthetic valve has a first diameter, and
• the prosthetic valve support is configured such that, after the second period, the lumen of the second prosthetic valve has a diameter that is at least as great as the first diameter.
• In an application, the prosthetic valve support is configured such that, after the second period, the lumen of the second prosthetic valve has a diameter that is greater than the first diameter.
• In an application, the prosthetic valve support includes a weak zone that circumscribes and defines the lumen, and is configured to facilitate enlarging of the lumen.
• In an application, the prosthetic valve support is configured to facilitate enlarging of the lumen by being configured to be deformed by a radially-expansive force applied from within the lumen.
• In an application, the prosthetic valve support includes a cylindrical element:
• shaped to define the lumen,
• configured to receive the first prosthetic valve at a first portion of the lumen, and
• configured to receive the second prosthetic valve support at a second portion of the lumen.
• In an application, the cylindrical element is configured to receive the first prosthetic valve at a first longitudinal portion of the lumen, and to receive the second prosthetic valve at a second longitudinal portion of the lumen.
• There is further provided, in accordance with an application of the present invention, apparatus for use with a prosthetic heart valve for implantation at a native heart valve of a subject, the apparatus including:
• a core, shaped to define at least one conduit therethrough; and
• one or more control filaments, slidable through the conduit, and reversibly couplable to the prosthetic valve,
• the apparatus being configured such that sliding the control filaments in a first direction through the conduit facilitates expansion of the prosthetic valve, and sliding the control filaments in a second direction through the conduit facilitates compression of the prosthetic valve.
• In an application, the apparatus is configured such that sliding the control filaments in the first direction through the conduit facilitates radial expansion of the prosthetic valve away from the core.
• In an application, the apparatus further includes the prosthetic valve, a delivery tube and a pushing member, and:
• the prosthetic valve has an expanded configuration and a compressed configuration,
• the delivery tube is configured to be transluminally delivered to the native valve,
• the pushing member includes the core,
• the pushing member is configured:
• • to be disposed within the delivery tube,
  • to be fixedly coupled, within the delivery tube, to the prosthetic valve in the compressed configuration thereof,
  • when fixedly coupled to the prosthetic valve, to facilitate movement of the prosthetic valve with respect to the delivery tube, and
  • to be decouplable from the prosthetic valve.
• In an application, the apparatus further includes one or more release wires, configured to facilitate decoupling of the control filaments from the prosthetic valve.
• In an application, the apparatus further includes one or more guide elements, radially extendable from the core, and configured to guide expansion of the prosthetic valve away from the core.
• In an application, the guide elements are configured to automatically radially retract when the control filaments are decoupled from the prosthetic valve.
• There is further provided, in accordance with an application of the present invention, apparatus for use at a native heart valve of a subject, the apparatus including:
• a prosthetic valve, configured to be transluminally delivered to, and implantable at, the native valve of the subject;
• a prosthetic valve support, configured to be transluminally delivered to the native valve of the subject, and to facilitate implantation of the prosthetic valve;
• at least one coupling lead, extending between the prosthetic valve and the prosthetic valve support; and
• a ratchet housing, slidably coupled to the coupling lead, and configured to be slidable over the coupling lead in a first direction, and inhibited from sliding over the coupling lead in an opposite direction,
• the apparatus being configured such that sliding of the ratchet housing over the coupling lead in the first direction facilitates coupling of the prosthetic valve to the prosthetic valve support.
• In an application, the coupling lead extends between a proximal portion of the prosthetic valve, and the prosthetic valve support.
• In an application, the prosthetic valve support includes one or more support-anchoring elements, configured to couple the prosthetic valve support to the native valve, and the coupling lead extends between the prosthetic valve and the support-anchoring elements.
• There is further provided, in accordance with an application of the present invention, apparatus for use with a native heart valve of a subject, the apparatus including:
• a first expandable prosthetic valve component, including a crimpable frame, and configured to be transcatheterally advanceable toward the native valve while the first prosthetic valve component is in a crimped state thereof;
• a second expandable prosthetic valve component, including a crimpable frame, and configured to be transcatheterally advanceable toward the native valve, placeable in the native valve while the second prosthetic valve component is in a crimped state thereof, and couplable to the first prosthetic valve component, expansion of the second prosthetic valve component facilitating coupling of the second prosthetic valve component to the first prosthetic valve component; and
• one or more tissue-engagement elements, coupled to at least one of the prosthetic valve components, the tissue-engagement elements configured, when the prosthetic valve component is in an expanded state thereof, to extend from the prosthetic valve component, and to inhibit a proximal movement of the prosthetic valve component.
• There is further provided, in accordance with an application of the present invention, apparatus for use with a prosthetic valve for implantation at a native valve of a subject, the native valve (1) defining an orifice, (2) including at least one native leaflet, having a native beating, and (3) having a native blood flow regulation functionality, the apparatus including:
• • a prosthetic valve support, including:
  • an upstream support portion, configured to be placed against an upstream side of the native valve, to have an inner perimeter that defines an opening that is configured to receive the prosthetic valve, and
    • at least one clip, configured to be coupled to a native leaflet of the native valve, the clip including a plurality of clip arms, at least one clip arm coupled to a clip-controller interface; and
  • a clip controller, couplable to the clip-controller interface, and configured to control a relative angular disposition between the clip arms.
• For some applications, techniques described herein are practiced in combination with techniques described in one or more of the references cited in the Background section and Cross-references section of the present patent application.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIGS. 1A-H are schematic illustrations of sequential steps in the implantation of an implant comprising a prosthetic valve and a prosthetic valve support, in accordance with some applications of the present invention;
• FIG. 2 is a schematic illustration of a prosthetic valve support, comprising adjustable prosthetic valve support, in accordance with some applications of the invention;
• FIG. 3 is a schematic illustration of a prosthetic valve support, comprising an adjustable prosthetic valve support, in accordance with some applications of the invention;
• FIG. 4 is a schematic illustration of a prosthetic valve support, comprising an adjustable prosthetic valve support, in accordance with some applications of the invention;
• FIG. 5 is a schematic illustration of a prosthetic valve support, comprising a graduated prosthetic valve support, in accordance with some applications of the invention;
• FIG. 6 is a schematic illustration of a prosthetic valve support, comprising a flexibly-anchored prosthetic valve support, in accordance with some applications of the invention;
• FIG. 7 is a schematic illustration of a prosthetic valve support, comprising a flexibly-anchored prosthetic valve support, in accordance with some applications of the invention;
• FIGS. 8A-B are schematic illustrations of a prosthetic valve support, and a prosthetic valve, the prosthetic valve comprising an integrally-anchoring prosthetic valve, in accordance with some applications of the invention;
• FIGS. 9A-E are schematic illustrations of delivery apparatus, used to deploy a medical device, in accordance with some applications of the invention;
• FIG. 10 is a schematic illustration of a prosthetic valve support, comprising a multi-lumen prosthetic valve support, in accordance with some applications of the invention;
• FIG. 11 is a schematic illustration of a prosthetic valve, comprising an extended-lumen prosthetic valve support, in accordance with some applications of the invention;
• FIGS. 12A-B are schematic illustrations of a prosthetic valve support, comprising an adjustable-lumen prosthetic valve support, in accordance with some applications of the invention;
• FIGS. 13A-D are schematic illustrations of a prosthetic valve support, comprising an asymmetric prosthetic valve support, in accordance with an application of the invention;
• FIG. 14 is a schematic illustration of a prosthetic valve support, in accordance with some applications of the invention;
• FIGS. 15A-E are schematic illustrations of the implantation of a prosthetic valve support and a prosthetic valve, in accordance with some applications of the invention;
• FIG. 16 is a schematic illustration of a prosthetic valve support being deployed in a native heart valve, in accordance with some applications of the invention;
• FIGS. 17A-D are schematic illustrations of prosthetic valve supports, comprising tissue-engaging elements, which comprise support-anchoring elements, comprising length-adjustable holding elements, in accordance with some applications of the invention;
• FIGS. 18A-B are schematic illustrations of prosthetic valve supports, comprising tissue-engaging elements, which comprise support-anchoring elements, comprising length-adjustable holding elements, in accordance with some applications of the invention;
• FIG. 19 is a schematic illustration of a prosthetic valve support, comprising tissue-engaging elements, which comprise support-anchoring elements, comprising length-adjustable holding elements, in accordance with some applications of the invention;
• FIGS. 20A-F are schematic illustrations of prosthetic valve supports, comprising tissue-engaging elements, which comp support-anchoring elements, comprising flexible support-anchoring elements, in accordance with some applications of the invention;
• FIGS. 21A-C are schematic illustrations of a prosthetic valve support, comprising an inflatable support-engaging element, in accordance with some applications of the invention;
• FIGS. 22A-C are schematic illustrations of sequential steps in the implantation of an implant, comprising a prosthetic valve and a prosthetic valve support, coupled via coupling leads;
• FIGS. 23A-B are schematic illustrations of a prosthetic valve support, shaped to define at least one pocket, and the coupling thereto of a prosthetic valve, in accordance with some applications of the invention;
• FIG. 24 is a schematic illustration of a prosthetic valve support, shaped to define at least one pocket, and the coupling thereto of a prosthetic valve, in accordance with some applications of the invention;
• FIGS. 25A-E are schematic illustrations of a retrieval device, and sequential steps in the use thereof, in accordance with some applications of the invention;
• FIGS. 26A-C are schematic illustrations of a prosthetic valve support comprising a braided structure, and the deployment thereof, in accordance with some applications of the invention;
• FIGS. 27A-D are schematic illustrations of delivery apparatus, in accordance with some applications of the invention;
• FIGS. 28A-D are schematic illustrations of the deployment of a prosthetic valve in the lumen of another prosthetic valve, in accordance with some applications of the invention;
• FIGS. 29A-F are schematic illustrations of the deployment of a prosthetic valve in the lumen of another prosthetic valve, and of a prosthetic valve support configured to facilitate such deployment, in accordance with some applications of the invention;
• FIGS. 30A-B are schematic illustrations of the deployment of a second prosthetic valve in the lumen of a prosthetic valve support, in which a first prosthetic valve is already disposed, in accordance with some applications of the invention;
• FIGS. 31A-C are schematic illustrations of a flexible delivery tube, configured to facilitate removal thereof from a subject, in accordance with some applications of the invention;
• FIGS. 32A-C are schematic illustrations of a compressible delivery tube, configured to facilitate removal thereof from a subject, in accordance with some applications of the invention;
• FIGS. 33A-C are schematic illustrations of a dismantling delivery tube, configured to facilitate removal thereof from a subject, in accordance with some applications of the invention;
• FIG. 34 is an schematic illustration of a prosthetic valve, comprising a leaflet-engaging element, in accordance with some applications of the invention;
• FIGS. 35A-C are schematic illustrations of a prosthetic valve support comprising temporary valve components, and sequential steps in the coupling of a prosthetic valve to the support, in accordance with some applications of the invention;
• FIGS. 36A-D are schematic illustrations of a prosthetic valve support, comprising support-anchoring elements and stabilizing legs, in accordance with some applications of the invention;
• FIGS. 37A-H are schematic illustrations of a prosthetic valve support, comprising support-anchoring elements and stabilizing legs, and sequential steps in the implantation thereof, in accordance with some applications of the invention;
• FIGS. 38A-H are schematic illustrations of a prosthetic valve support, comprising support-anchoring elements and stabilizing legs, and sequential steps in the implantation thereof, in accordance with some applications of the invention;
• FIGS. 39A-D are schematic illustrations of a medical device, comprising one or more coupling tabs, in accordance with some applications of the invention;
• FIGS. 40A-C are schematic illustrations of a prosthetic valve, comprising tissue-engaging elements, in accordance with some applications of the invention;
• FIGS. 41A-B are schematic illustrations of a prosthetic valve, and a prosthetic valve support, comprising support-anchoring elements that are couplable to the prosthetic valve, in accordance with some applications of the invention;
• FIGS. 42A-B are schematic illustrations of a prosthetic valve, and a prosthetic valve support, comprising support-anchoring elements that are couplable to the prosthetic valve, in accordance with some applications of the invention;
• FIGS. 43A-C are schematic illustrations of a prosthetic valve, and a prosthetic valve support, comprising support-anchoring elements that are couplable to the prosthetic valve, in accordance with some applications of the invention;
• FIGS. 44A-B are schematic illustrations of a prosthetic valve support, comprising support-anchoring elements, and a prosthetic valve, comprising valve-anchoring elements that are couplable to the tissue-engaging elements of the prosthetic valve support, in accordance with some applications of the invention;
• FIGS. 45A-C are schematic illustrations of a lock for facilitating delivery of a medical device, in accordance with some applications of the invention;
• FIGS. 46A-B are schematic illustrations of a prosthetic valve support, comprising one or more support-anchoring elements, coupled to a stabilizing strip, in accordance with some applications of the invention;
• FIGS. 47A-C are schematic illustrations of sequential steps in the implantation of an implant, comprising a prosthetic valve and a prosthetic valve support, in accordance with some applications of the invention;
• FIGS. 48A-C are schematic illustrations of sequential steps in the implantation of an implant, comprising a prosthetic valve and a prosthetic valve support, in accordance with some applications of the invention;
• FIG. 49 is a schematic illustration of the prosthetic valve support, in accordance with some applications of the invention;
• FIG. 50 is a schematic illustration of a step in the implantation of the implant, in accordance with some applications of the invention;
• FIGS. 51A-B are schematic illustrations of the prosthetic valve support, in accordance with some applications of the invention;
• FIG. 52 is a schematic illustration of the prosthetic valve, in accordance with some applications of the invention;
• FIGS. 53A-C are schematic illustrations of the prosthetic valve, comprising tissue-engaging elements, in accordance with some applications of the invention;
• FIGS. 54A-D are schematic illustrations of the prosthetic valve, comprising tissue-engaging elements, in accordance with some applications of the invention;
• FIGS. 55A-E are schematic illustrations of the prosthetic valve, comprising tissue-engaging elements, in accordance with some applications of the invention;
• FIGS. 56A-D are schematic illustrations of the prosthetic valve, comprising tissue-engaging elements, in accordance with some applications of the invention;
• FIGS. 57A-D are schematic illustrations of the prosthetic valve, comprising tissue-engaging elements, in accordance with some applications of the invention;
• FIGS. 58A-D are schematic illustrations of the prosthetic valve support, comprising tissue-engaging elements, in accordance with some applications of the invention;
• FIGS. 59A-B are schematic illustrations of the prosthetic valve support, comprising tissue-engaging elements, in accordance with some applications of the invention;
• FIGS. 60A-B are schematic illustrations of the prosthetic valve support, comprising tissue-engaging elements, in accordance with some applications of the invention;
• FIGS. 61A-C are schematic illustrations of the prosthetic valve support, comprising tissue-engaging elements, in accordance with some applications of the invention;
• FIGS. 62A-D are schematic illustrations of a delivery device for the delivery and deployment of an expandable medical device, in accordance with some applications of the invention;
• FIGS. 63A-B are schematic illustrations of the delivery device for the delivery and deployment of an expandable medical device, in accordance with some applications of the invention;
• FIGS. 64A-C,65A-B,66A-B, and67A-B are schematic illustrations of a locking mechanism for delivery of an expandable medical device, in accordance with some applications of the invention;
• FIGS. 68A-B and69A-E are schematic illustrations of a retrievable prosthetic valve support, and sequential steps in the retrieval of the retrievable prosthetic valve support, in accordance with some applications of the invention;
• FIGS. 70A-C are schematic illustrations of the prosthetic valve, comprising tissue engaging elements, in accordance with some applications of the invention;
• FIG. 71 is a schematic illustration of an implant comprising a prosthetic valve and a prosthetic valve support, in accordance with some applications of the present invention;
• FIGS. 72A-D are schematic illustrations of an implant, comprising a prosthetic valve support and a prosthetic valve, in accordance with some applications of the invention;
• FIG. 73 is a schematic illustration of a prosthetic valve support, for use with a prosthetic valve, in accordance with some applications of the invention;
• FIGS. 74A-L are schematic illustrations of steps in the implantation of an implant, comprising a prosthetic valve and a prosthetic valve support, in a native valve of a subject, in accordance with some applications of the invention;
• FIGS. 75A-D are schematic illustrations of an implant, comprising a prosthetic valve support and a prosthetic valve, and steps in the implantation thereof, in accordance with some applications of the invention;
• FIGS. 76A-F are schematic illustrations of steps in the implantation of an implant, comprising a prosthetic valve and a prosthetic valve support, in a native valve of a subject, in accordance with some applications of the invention;
• FIG. 77 is a schematic illustration of an implant, implanted at the mitral valve of a subject, in accordance with some applications of the invention;
• FIG. 78 is a schematic illustration of an implant, implanted at the tricuspid valve of a subject, in accordance with some applications of the invention;
• FIG. 79 is a schematic illustration of an implant, implanted at the pulmonary valve of a subject, in accordance with some applications of the invention; and
• FIG. 80 is a schematic illustration of an implant, implanted at the aortic valve of a subject, in accordance with some applications of the invention.
DETAILED DESCRIPTION OF EMBODIMENTS
• Reference is made toFIGS. 1A-H, which are schematic illustrations of sequential steps in the implantation in a native heart valve23 of theheart22 of a subject20 of animplant30, comprising (1) a first prosthetic valve component, i.e.,prosthetic valve support40, and (2) a second prosthetic valve component, i.e., aprosthetic valve42, in accordance with some applications of the present invention. For such applications of the present invention, native valve23 includes a nativemitral valve24 by way of illustration and not limitation; the scope of the present invention includes implantingimplant30 in other valves of the heart (e.g., the tricuspid valve, the pulmonary valve, or the aortic valve).FIG. 1A illustrates a cross-section throughheart22 of the subject which is used throughoutFIGS. 1B-G to illustrate the implantation procedure. As shown in the cross-sectional illustration, nativemitral valve24 includesnative leaflets82, which are supported bynative chordae tendineae80.
• FIG. 1B showsprosthetic valve support40 being deployed in aleft atrium26. Prior to deployment,support40 is percutaneously (e.g., transcatheterally) advanced intoleft atrium26, typically viaovertube44. In some applications of the present invention, the advancement ofovertube44 toward heart valve23 is preceded by advancement of aguidewire45 through vasculature of the subject. Typically, guidewire45 is used to guide overtube44 through the vasculature. During its deployment,support40 is moved distally (e.g., by a pushing coupling element, not shown for clarity of illustration and described hereinbelow), such thatsupport40 emerges from the distal end ofovertube44.Support40 is typically expandable, and typically comprises a wire frame which comprises a shape-memory material such as, but not limited to, nickel titanium (nitinol). For some applications of the invention,support40 comprises nickel cobalt, stainless steel and/or titanium. Assupport40 gradually emerges fromovertube44, it gradually expands to assume an expanded configuration.
• FIG. 1C showssupport40 reversibly coupled to one ormore holding members46, which exert a distal pushing force that causessupport40 to emerge from withinovertube44. Once fully exposed from withinovertube44,support40 expands to assume the expanded configuration, as shown. In its expanded state,support40 is annular and is shaped so as to define a lumen therethrough. Typically,prosthetic valve support40 is shaped to define anouter edge69 and an inner edge68 (seeFIG. 1H).Outer edge69 typically defines the diameter of the annular prosthetic valve support, andinner edge68 typically defines the diameter of the lumen in whichprosthetic valve42 is typically disposed. As shown inFIG. 1C, oncesupport40 is fully exposed from withinovertube44, holdingmembers46 continue to pushsupport40 distally (i.e., in the direction as indicated by the arrows) untilsupport40 is positioned against an annulus of native heart valve23.
• Support40 is held against the annulus of native valve23 (e.g., by holding members46) such that the lumen ofsupport40 aligns with the lumen of the native valve, and such thatatrium26 andventricle28 remain in fluid communication.
• Following the positioning ofsupport40 against the annulus of the native valve,prosthetic valve42 is percutaneously (e.g., transcatheterally) advanced and delivered toward the native valve, typically alongguidewire45, as shown inFIG. 1D.
• Prosthetic valve42 is typically expandable, and typically comprises a wire frame which comprises a shape-memory material such as, but not limited to, nickel titanium (nitinol). For some applications of the invention,prosthetic valve42 comprises nickel cobalt, stainless steel and/or titanium. During the advancing,prosthetic valve42 is disposed in a distal portion of adelivery tube60, which holds the prosthetic valve in a compressed (e.g., crimped) configuration.Delivery tube60 is slidably advanceable withintube44.Prosthetic valve42 is typically delivered through the native valve and intoventricle28, as shown inFIG. 1D. Typically,prosthetic valve42 is delivered to the native valve whilesupport40 is held against the annulus of native valve23 by holdingmembers46.
• FIG. 1E showsprosthetic valve42 being partially deployed from withindelivery tube60. Asprosthetic valve42 expands,prosthetic valve42 expands toward assuming an expanded configuration.Prosthetic valve42 comprises a primarystructural element130, which is typically cylindrical, prismatic, or any other suitable shape, and is shaped so to define a lumen. Prosthetic valve components (e.g., leaflets; not shown for clarity of illustration) are typically disposed within the lumen of the prosthetic valve, are coupled to a surface ofstructural element130 defining the lumen, and regulate blood flow therethrough.
• Typically, a plurality of tissue-engaging elements62 are disposed at a distal portion of the primarystructural element130 ofprosthetic valve42. For applications in whichprosthetic valve42 comprises tissue-engaging elements62, tissue-engaging elements62 comprise valve-anchoring elements64. For such applications of the present invention, primarystructural element130 ofprosthetic valve42 is generally cylindrical (e.g., shaped so as to define a right circular cylinder), and anchoring elements64 protrude radially from a surface of the cylinder. It is to be noted that althoughprosthetic valve42 is shown comprising tissue-engaging elements62, the scope of the present application includes prosthetic valves with no tissue-engaging elements62.
• FIG. 1F showsprosthetic valve42 being moved proximally, such that at least part of primarystructural element130 is disposed in the respective lumens of native valve23 andprosthetic valve support40, and such that valve-anchoring elements64 contact the ventricular side of the native valve. Such contacting of elements64 with the ventricular side of the native valve restricts further undesired atrial (i.e., proximal) movement of the prosthetic valve. Typically, the contact between valve-anchoring elements64 and the ventricular side of the native valve occurs by valve-anchoring elements64 protruding betweenchordae tendineae80 and capturingleaflets82 of the native valve. Responsively to the capturing by valve-anchoring elements64,leaflets82 are typically pushed proximally and/or outward by the prosthetic valve. In some applications of the invention,leaflets82 are held against the outer surface of primarystructural element130 by valve-anchoring elements64, so as to reduce blood flow betweennative leaflets82 andprosthetic valve42. In an alternative application of the invention, rather than being partially deployed in the ventricle and subsequently moved proximally (as described with reference toFIGS. 1E-F),prosthetic valve42 is deployed directly in the lumen of the native valve.
• Following the capturing ofnative leaflets82,prosthetic valve42 is then fully exposed from within delivery tube60 (by pushingvalve42 relative todelivery tube60 or by retractingdelivery tube60 with respect to valve42) and is allowed to expand further.FIG. 1G showsprosthetic valve42 in a deployed and expanded configuration after being fully exposed from withindelivery tube60. The expansion ofprosthetic valve42 exerts a radial force againstsupport40, thereby facilitating coupling ofprosthetic valve42 to support40.Implant30, comprisingprosthetic valve42 andsupport40, is secured in place by sandwiching the native valve by the components ofimplant30. That is, (1)implant30 is inhibited from ventricular (i.e., distal) movement bysupport40 and the radial force ofprosthetic valve42 exerted onsupport40, and (2)implant30 is inhibited from atrial (i.e., proximal) movement by valve-anchoring elements64.
• For some applications of the present invention,support40 preventsvalve42 from expanding to assume a fully-expanded configuration (i.e., a configuration to whichvalve42 would otherwise expand without being impeded bysupport40 or tissue). In such applications, the radial force exerted bysupport40 onvalve42 facilitates coupling and sealing betweensupport40 and valve42 (for example, by increasing friction betweensupport40 and valve42), and facilitates implantation ofimplant30 at native valve23.
• FIG. 1H showsimplant30 following implantation in the mitral valve of the subject. This figure is a transverse atrial cross-section, showingprosthetic valve support40 in contact with the atrial side of the native valve.Prosthetic valve42 is expanded, and is disposed in, and coupled to,prosthetic valve support40. Tissue-engaging elements62, comprising valve-anchoring elements64, are disposed on the ventricular side of the native valve (as described hereinabove with reference toFIGS. 1F-G), and are therefore illustrated in phantom. Valve-anchoring elements64 are typically arranged in two clusters, each cluster being disposed on opposite sides ofprosthetic valve42.
• Typically, when deployed as shown,prosthetic valve42 is configured to be aligned with the native valve such that valve-anchoring elements64 protrude toward, and engageleaflets82 of the native valve. In some applications of the present invention, valve-anchoring elements64 protrude toward, and engage,commissures84 of the native valve. In some applications of the invention, a single valve-anchoring element64 is disposed on each side of the prosthetic valve. It is to be noted that the scope of the present application includes any other suitable arrangement of valve-anchoring elements64 with respect to valve64. Typically, valve-anchoring elements64capture leaflets82 of the native valve, holding them clear of the flow of blood through the prosthetic valve and the left ventricular outflow tract (LVOT).
• For clarity of illustration, the lumen defined byprosthetic valve42 is shown as being empty, such thatventricle28 is visible. However, as described hereinabove,prosthetic valve42 typically comprises valve components (e.g., prosthetic valve leaflets, not shown inFIG. 1H), that are disposed in the lumen ofprosthetic valve42, coupled tostructural element130, and configured to regulate blood flow throughprosthetic valve42.
• Reference is again made toFIGS. 1A-H. For some applications, as described hereinabove, valve-anchoring elements64 function so as to (1) prevent proximal migration ofprosthetic valve42 into the subject's atrium, while (2) creating a seal between the native valve23 andprosthetic valve42 by generally clampingnative leaflets82 between valve-anchoring elements64 and primarystructural element130,valve support40, and/or native valve annulus.
• For other applications, prevention of proximal migration ofvalve42 is maintained, while movement ofnative leaflets82 with respect toprosthetic valve42 is allowed. For example, valve-anchoring elements64 may have the aforementioned functionalities by having lengths of less than 5 mm, and/or by having a total width of each cluster of valve-anchoring elements (corresponding to respective leaflets of the native valve) being less than 5 mm. For example, the valve may include a single valve-anchoring element64 corresponding to each leaflet of the native valve, the width of each of the single valve-anchoring elements being less than 1 mm. Thus, the valve may be stopped from proximally migrating into the atrium by the valve-coupling elements preventing the distal end of the valve from migrating further proximally than edges of native leaflets of the valve. Furthermore, the valve-anchoring elements may allow movement of the native leaflets with respect to the prosthetic valve by not generally squeezing the native leaflets between the valve-coupling elements and primarystructural element130 of the prosthetic valve. In other applications of the invention,prosthetic valve support40 comprises support-anchoring elements (such as clips), and is directly coupled to the native valve. For some such applications, no valve-anchoring elements are used; rather, implant30 is coupled to the native valve via prosthetic valve support40 (e.g., as described hereinbelow, such as with reference toFIGS. 37A-H and38A-H). For some applications, both valve-anchoring elements and support-anchoring elements are used. For some applications, by allowing movement of the native leaflets with respect to the prosthetic valve, sealing of the native leaflets against the outer surface of the primary structural element of the prosthetic valve is facilitated, in accordance with the techniques described herein.
• For some applications of the invention, the implantation ofimplant30 follows an alternative order to that described with reference toFIGS. 1A-H. For these applications of the invention,prosthetic valve42 is initially delivered toventricle28. Subsequently,prosthetic valve support40 is deployed withinatrium26. In these applications of the invention, following deployment and positioning ofprosthetic valve support40 against the annulus of native valve23,prosthetic valve42 is moved atrially (i.e., proximally) into the respective lumens of the native valve andprosthetic valve support40, and is deployed, as described hereinabove.
• For some applications of the invention, valve-anchoring elements64 anchorprosthetic valve42 to the native valve in a manner that restricts both proximal and distal movement of the prosthetic valve. For such applications of the invention, deployment ofprosthetic valve42 may occur in the reverse orientation, such that, following positioning in the native valve ofprosthetic valve42 compressed indelivery tube60, the delivery tube is moved distally (i.e., ventricularly) asprosthetic valve42 is deployed from the delivery tube.Delivery tube60 is then removed from the subject via the lumen of the deployed prosthetic valve. It is hypothesized that this approach facilitates maneuvering of implant components and delivery apparatus, both for delivery ofimplant30 and for withdrawal of delivery apparatus. For example, this approach is hypothesized to require less space on the proximal side of the native valve (e.g., in the atrium), compared to techniques whereby the prosthetic valve is deployed from the proximal side of the native valve. An example of this approach is described with reference toFIGS. 15A-E.
• For some applications of the invention, surfaces of one or more components ofimplant30 are covered at least in part with a covering (not shown). For example, surfaces ofprosthetic valve support40 andprosthetic valve42 may be covered so as to direct substantially all blood flowing through the valve, to flow through the lumen ofprosthetic valve42. For some applications, the surface of prosthetic valve support40 (or another component) that is placed in contact with the native valve is covered; the covering is configured to facilitate coupling ofsupport40 to the native valve, by enhancing fibrosis at the interface between the prosthetic valve support and the native valve.
• The covering may comprise polyethylene terephthalate (e.g., polyester), polytetrafluoroethylene (e.g., Teflon, ePTFE), or pericardial tissue. Typically, a thickness of the covering is less than 0.2 mm, e.g., less than 0.1 mm, or less than 0.05 mm.
• For some applications, one or more dimensions of native valve23 (e.g., ofleaflets82, and/or of the annulus of the native valve) is measured (e.g., by using imaging techniques) prior to deployment ofvalve42. Taking this measuring into account, a suitably-sized prosthetic valve is chosen to be placed in the annulus, in a manner in which a cross-sectional area of the prosthetic valve in its deployed state is less than 90% (e.g., less than 80%, or less than 60%) of the area defined by the annulus.
• For some applications, the cross-sectional area of the prosthetic valve in its deployed state has a longest length of less than 25 mm, e.g., less than 20 mm, and/or more than 15 mm, e.g., 15-25 mm. For some applications, placing a prosthetic valve inside the native valve, with the dimensions of the native valve annulus and the prosthetic valve as described, facilitates sealing of the prosthetic valve with respect to the native valve, by the native valve leaflets closing around the outer surface of the prosthetic valve. In such applications,prosthetic valve42 is implanted directly within native valve23 (i.e., without support40).
• For some applications,prosthetic valve support40, that is shaped to define a lumen, is placed against the annulus of native valve23 (e.g., as described with reference toFIGS. 1A-H). The lumen ofsupport40 has a cross-sectional area that is less than 90% (e.g., less than 80%, or less than 60%) of an area defined by native valve23 (e.g., area A1,FIG. 71). As described hereinabove,prosthetic valve42 is typically coupled toprosthetic valve support40 and, thereby, to native valve23, at least in part by expansion of the prosthetic valve such that primarystructural element130 exerts a radial force againstinner edge68 ofprosthetic valve support40. The cross-sectional area defined by the primarystructural element130 of the prosthetic valve, upon expansion of the prosthetic valve, is limited by the cross-sectional area of the lumen of theprosthetic valve support40 to less than 90% (e.g., less than 80%, or less than 60%) of the area defined by the annulus of the native valve. For some applications, placing aprosthetic valve support40 at the native valve, as described, facilitates sealing of the prosthetic valve with respect to the native valve, by the native valve leaflets closing around the outer surface of the prosthetic valve.
• Typically, placing a prosthetic valve inside the native valve with the dimensions of the native valve annulus, theprosthetic valve42, and/orvalve support40 as described in the above paragraphs, facilitates sealing of the prosthetic valve with respect to the native valve. For some applications, the sealing is facilitated by the native leaflets being pushed against, and closing against, the outer surface of the frame of the valve during systole, in a similar manner to the manner in which native valve leaflets coapt during systole, in a healthy mitral valve.
• Typically, as the diameter of the prosthetic valve is increased, the proportion of the native leaflets that is pushed against the outer surface of the valve during systole is increased, thereby enhancing the sealing of the native leaflets with respect to the frame of the prosthetic valve. However, beyond a given diameter, as the diameter of the prosthetic valve is increased, the native valve leaflets are pushed apart at the commissures, thereby causing retrograde leakage of blood through the commissures. Therefore, in accordance with some applications of the present invention,prosthetic valve42, and/orvalve support40 are chosen such that the cross-sectional area of the prosthetic valve (when expanded inside the valve support) is less than 90% (e.g., less than 80%, or less than 60%) of the area defined by the annulus of native vale23. Thus the valve support facilitates additional sealing of the prosthetic valve with respect to the native valve, by the native valve leaflets closing around the outer surface of the prosthetic valve, while not causing retrograde leakage of blood through the commissures.
• For some applications, in order to facilitate the sealing of the native valve around the outer surface of the prosthetic valve, a material is placed on the outer surface of the prosthetic valve in order to provide a sealing interface between the prosthetic valve and the native valve. For example, a smooth material that prevents tissue growth (e.g., polytetrafluoroethylene (PTFE), and/or pericardium) may be placed on the outer surface of the prosthetic valve. Alternatively or additionally, a material that facilitates tissue growth (such as polyethylene terephthalate; PET) may be placed on the outer surface of the prosthetic valve, in order to (a) act as a sealing interface between the native valve and the prosthetic valve, and (b) facilitate tissue growth around the prosthetic valve to facilitate anchoring and/or sealing of the prosthetic valve.
• For some applications, one or more dimensions of native valve23 (e.g., ofleaflets82, and/or of the annulus of the native valve) are measured (e.g., by using imaging techniques) prior to deployment ofprosthetic valve42 and/orprosthetic valve support40. Taking this measuring into account, a suitably-sized and/or suitably-configured prosthetic valve and/or prosthetic valve support is selected for implantation. For example, a prosthetic valve or prosthetic valve support comprising tissue-engaging elements62 with appropriate configurations and/or dimensions may be selected.
• Reference is made toFIG. 2, which is a schematic illustration ofprosthetic valve support40, comprising adjustable prosthetic valve support40e, which comprises tissue-engaging elements62, comprising support-anchoring elements66e, in accordance with some applications of the invention. Each support anchoring element66ecomprises, or is coupled to, aholding wire522, which is slidably coupled to an upstream support portion41 (e.g., an annular portion) of support40e. During implantation, support40eis anchored to native valve23 via support-anchoring elements66e. For example, elements66emay engagecommissures84 orleaflets82 of the native valve, as described hereinabove. The distance betweenupstream support portion41 of support40eand acoupling portion70 of anchoring element66e, is adjustable by adjusting the length of the portion of holdingwire522 that couples the upstream support portion to the coupling portion. Some examples of techniques for adjusting this length are described hereinbelow, with reference toFIGS. 3 and 4.
• For some applications of the invention, at least part of holdingwire522 is disposed in aconnector540, which furthercouples coupling portion70 toupstream support portion41.Holding wire522 may be slidable throughconnector540. For some applications,connector540 is more rigid than holdingwire522.
• Reference is made toFIG. 3, which is a schematic illustration ofprosthetic valve support40, comprising adjustable prosthetic valve support40f, which comprises tissue-engaging elements62, comprising support-anchoring elements66f, in accordance with some applications of the invention. Each support anchoring element66fcomprises, or is coupled to, a holding wire522f, which is slidably coupled toupstream support portion41 of support40f. During implantation, support40fis anchored to native valve23 via support-anchoring elements66f. For example, elements66fmay engagecommissures84 orleaflets82 of the native valve, as described herein. The distance betweenupstream support portion41 of support40fand a coupling portion of anchoring element66f, is adjustable by adjusting the length of holding wire522f. Typically, holding wire522fis slidably coupled toupstream support portion41 of support40fvia aratchet526, wherein holding wire522fis slidable through aratchet housing524, and comprises a plurality ofteeth523 which allow the holding wire to slide through the ratchet housing in one direction, and restrict such sliding in another direction. Such adjustment of holding wire522fmay be performed while support40fis partially deployed, or after the support has been fully deployed.
• FIG. 3 shows ratchethousing524 being slidable over holding wire522f, such that the ratchet housing is movable with respect toupstream support portion41 of support40f. For this application of the invention, acontroller tube528 is typically used to slide (e.g., push)ratchet housing524 over holding wire522f, so as to adjust the distance betweenupstream support portion41 of support40fand the coupling portion. For other applications of the invention, ratchethousing524 is substantially stationary with respect to upstream support portion41 (e.g., ratchethousing524 is attached to and/or embedded in portion41), and holdingwire522 is slid (e.g., pulled) throughhousing524, so as to adjust the distance betweenupstream support portion41 of support40fandcoupling portion70.
• As described with reference toFIG. 2, for some applications of the invention, at least part of holding wire522 (e.g., wire522f) is disposed in a connector540 (e.g., connector540f), which furthercouples coupling portion70 toupstream support portion41 of support40f. Holding wire522fmay be slidable through connector540f. Connector540fis typically more rigid that holding wire522f.
• It is hypothesized that adjusting the position ofcoupling portion70 of support-anchoring elements66f, with respect toupstream support portion41 of prosthetic valve support40f, allows prosthetic valve support40fto be adapted to the anatomy of the subject during and/or subsequent to the implantation procedure.
• Reference is made toFIG. 4, which is a schematic illustration ofprosthetic valve support40, comprising adjustable prosthetic valve support40g, which comprises tissue-engaging elements62, comprising support-anchoring elements66g, in accordance with some applications of the invention. Each support anchoring element66gcomprises, or is coupled to, aholding wire522, which is slidably coupled toupstream support portion41 of support40g. During implantation, support40gis anchored to native valve23 via support-anchoring elements66g. For example, elements66gmay engagecommissures84 orleaflets82 of the native valve, as described herein. The distance betweenupstream support portion41 of support40gand a coupling portion70 (not shown) of anchoring element66g, is adjustable by adjusting the length of holding wire522g. Holding wire522gis coupled to aspool460, such that operation (e.g., turning) ofspool460 withdraws and/or ejects portions of the holding wire, thereby adjusting the length of holding wire522gthat couples the upstream support portion to the coupling portion, thereby adjusting the distance betweenupstream support portion41 andcoupling portion70. Such adjustment of holding wire522gmay be performed while support40gis partially deployed, or after the support has been fully deployed.
• As described with reference toFIG. 2, for some applications of the invention, at least part of holding wire522 (e.g., wire522g) is disposed in a connector540 (e.g., connector540), which furthercouples coupling portion70 toupstream support portion41 of support40g. Holding wire522gmay be slidable through connector540g. In some applications, connector540gis more rigid that holding wire522g.
• It is hypothesized that adjusting the position ofcoupling portion70 of support-anchoring elements66g, with respect toupstream support portion41 of prosthetic valve support40g, allows prosthetic valve support40gto be adapted to the anatomy of the subject during and/or subsequent to the implantation procedure.
• Reference is made toFIG. 5, which is a schematic illustration ofprosthetic valve support40, comprising graduated prosthetic valve support40h, which comprises tissue-engaging elements62, comprising support-anchoring elements66h, in accordance with some applications of the invention. Each support-anchoring element66his coupled toupstream support portion41 of support40hvia a graduatedconnector542. Graduatedconnector542 comprises a plurality of coupling points543, to whichcoupling portion70 of element66his couplable. Prior to implantation of prosthetic valve support40h, the distance betweenupstream support portion41 of support40handcoupling portion70 is adjustable, by selecting thecoupling point543 to which eachcoupling portion70 is coupled.
• It is hypothesized that adjusting the position ofcoupling portion70 of support-anchoring elements66h, with respect toupstream support portion41 of prosthetic valve support40h, allows prosthetic valve support40hto be adapted to the anatomy of the subject during and/or subsequent to the implantation procedure.
• Reference is made toFIG. 6, which is a schematic illustration ofprosthetic valve support40, comprising flexibly-anchored prosthetic valve support40i, which comprises tissue-engaging elements62, comprising support-anchoring elements66i, in accordance with some applications of the invention. Each support-anchoring element66iis coupled toupstream support portion41 of support40ivia aconnector540, such as flexible connector544. Flexible connector544 typically comprises a flexible material which typically, but not necessarily, comprises polyethylene terephthalate (e.g., polyester), polytetrafluoroethylene (e.g., Teflon, ePTFE), silicone (e.g., silicone rubber), and/or or pericardial tissue. Flexible connector544 facilitates movement ofcoupling portion70 of elements66ito move with respect toupstream support portion41 of support40i. It is hypothesized that this flexibility allows elements66ito anchor prosthetic valve support40ito the native valve (e.g., by coupling to leaflets82), whilst allowingleaflets82 to continue to function, at least in part.
• Reference is made toFIG. 7, which is a schematic illustration ofprosthetic valve support40, comprising flexibly-anchored prosthetic valve support40j, which comprises tissue-engaging elements62, comprising support-anchoring elements66j, in accordance with some applications of the invention. Couplingportion70 of each element66jis coupled toupstream support portion41 of support40jvia at least oneconnector ring548.Connector ring548 typically facilitates movement ofcoupling portion70 with respect toupstream support portion41. Each support-anchoring element66jtypically comprises aconnector540, such as flexible connector546. Flexible connector546 typically comprises a flexible material which typically, but not necessarily, comprises polyethylene terephthalate (e.g., polyester), polytetrafluoroethylene (e.g., Teflon, ePTFE), silicone (e.g., silicone rubber), and/or or pericardial tissue. Flexible connector546 typically further facilitates couplingportion70 to move with respect toupstream support portion41 of support40j. It is hypothesized that this flexibility allows elements66jto anchor prosthetic valve support40jto the native valve (e.g., by coupling to leaflets82), whilst allowingleaflets82 to continue to function, at least in part.
• Reference is made toFIGS. 8A-B, which are schematic illustrations ofprosthetic valve support40, andprosthetic valve42, the prosthetic valve comprising an integrally-anchoring prosthetic valve42a, which comprises support-engagingelements422 comprising a plurality of integral support-engaging elements424, in accordance with some applications of the invention. For some applications of the invention, support-engagingelements422 comprise other valve-anchoring elements described herein, such as valve-anchoring elements64.
• Reference is now made toFIG. 8A. Prosthetic valve42acomprises a lattice structure, comprising a plurality of struts which typically collectively define a tessellation of shapes and voids. In some regions of the prosthetic valve, there is a separation between adjacent shapes. This separation allows a portion of the shape to move or be moved out of the plane of the lattice, thereby protruding from primarystructural element130 of prosthetic valve42awhen the prosthetic valve is expanded. The protruding portion of the shapes thereby form integral support-engaging elements424, which are typically configured to anchor prosthetic valve42ato the distal side ofprosthetic valve support40.
• Reference is made toFIG. 8B, which showsimplant30, comprising prosthetic valve42aandprosthetic valve support40, implanted in native valve23.FIG. 8B showsimplant30, comprisingprosthetic valve support40 and prosthetic valve42a, implanted in native valve23, comprisingmitral valve24.Prosthetic valve support40 typically comprises a plurality of tissue-engaging elements62, comprising support-anchoring elements66, which engageleaflets82 and/orchordae tendineae80, and/orcommissures84, thereby anchoringsupport40 to the native valve. Prosthetic valve42ais compressible (e.g., crimpable) and expandable, and typically comprises a shape-memory material, as described hereinabove with reference toprosthetic valve42. Prosthetic valve42ais configured (e.g., shape-set) such that support-engagingelements422, comprising integral support-engaging elements424, are biased to protrude from the surface of primarystructural element130. In this application of the present invention, primarystructural element130 of prosthetic valve42ais generally cylindrical, and integral support-engaging elements424 protrude radially from the surface of the cylinder. Because integral support-engaging elements424 are formed from the regular repeating structure of the lattice that forms prosthetic valve42a, support-engaging elements424 fit back into the plane ofstructural element130 when valve42ais crimped intodelivery tube60, prior to and even during implantation. Integral support-engaging elements424, thereby typically do not increase the length nor the transverse cross-sectional longest dimension of the crimped configuration ofprosthetic valve42, as compared to those of any other prosthetic valves that do not comprise support-engagingelements422, or that compriseelements422 at a proximal end thereof.
• As described hereinabove,prosthetic valve42 is deployed by distal movement out ofdelivery tube60.FIG. 8B shows prosthetic valve42ain a fully-deployed state, such that integral support-engaging elements424 have emerged fromdelivery tube60, and have assumed an unconstrained, expanded, resting configuration in which the integral support-engaging elements424 protrude radially from the surface of primarystructural element130 of the prosthetic valve. In an expanded state of at least the proximal portion of valve42a, as shown inFIG. 8B, integral support-engaging elements424 typically protrude up to and including 110 degrees (e.g., between 10 and 60 degrees, such as between 15 and 30 degrees) from the surface of primarystructural element130, in a resting state of support-engaging elements424. That is, in the protruded state, the proximal portions of support-engaging elements424 are distanced further fromstructural element130 than the distal portions of support-engaging elements424 which function as the pivot joints74 between support-engaging elements424 andstructural element130, as shown inFIG. 8A.
• In the expanded state of support-engaging elements424, the radially-protruding proximal portions thereof typically define a cross-sectional area, the longest dimension of which is typically longer than a transverse cross-sectional longest dimension of the lumen defined byprosthetic valve support40. That is, in the expanded state, support-engaging elements424 increase a longest transverse cross-sectional length of prosthetic valve42a, such that the longest transverse cross-sectional length is longer than a longest transverse cross-sectional length of the lumen defined byprosthetic valve support40. Thereby, the radially-protruding support-engaging elements424 restrict proximal movement of prosthetic valve42awith respect toprosthetic valve support40, thereby anchoring prosthetic valve42ato the distal side ofprosthetic valve support40, and to native valve23.
• Reference is made toFIGS. 9A-E, which are schematic illustrations ofdelivery apparatus438, used to deploy a medical device150, in accordance with some applications of the invention.Delivery apparatus438 comprises adelivery tube154 and a pushingmember140. Pushingmember140 comprises asupport142 and one ormore coupling tabs146, extending from the support. In the application of the invention shown inFIG. 9A,support142 comprises acore144, andcoupling tabs146 extend radially from the core.
• In some applications of the invention,support142 is shaped to define aplate148 at the proximal end ofsupport142. The dimensions and relative positions ofsupport142,tabs146, andplate148 may be adjusted for the specific medical device150 to be deployed usingdelivery apparatus438.Support142 is shaped to define a plurality of conduits492 (e.g., holes).Delivery apparatus438 further comprises one or more control filaments, such asretrieval wires490, slidably disposed inconduits492. Typically,conduits492 provide communication between a proximal side ofsupport142 and a circumference of the support, such that a proximal end of eachretrieval wire490 is disposed at a site proximal todelivery tube154, and a distal end of each wire is reversibly coupled to medical device150,retrieval wires490 extending throughconduits492.
• For some applications of the invention,retrieval wires490 are coupled to medical device150 by being looped around parts of the medical device (e.g., looped around a strut of the lattice structure, as shown inFIG. 9D), and are uncouplable from the medical device by being unlooped. For some applications of the invention,retrieval wires490 are coupled to medical device150 via a lock, such as a lock comprising a plug disposed in a tubular member (e.g., as described with reference toFIGS. 45A-C and/or64A-C, mutatis mutandis). It is to be noted that the scope of the present application includes other techniques forcoupling retrieval wires490 to medical device150, and decoupling the retrieval wires. In the application of the invention described with reference toFIGS. 9A-E, medical device150 comprisesprosthetic valve42.
• FIG. 9B showsprosthetic valve42 in a compressed (i.e., crimped) configuration for delivery and deployment usingdelivery apparatus438.Prosthetic valve42 typically has a lattice structure that defines a plurality of shapes, and respective voids126 (FIG. 9C), and has shape memory (described in more detail hereinbelow, such as with reference toFIGS. 53A-C and62A-D, mutatis mutandis).Prosthetic valve42 is shown in a compressed (e.g., crimped) configuration, and as shown in the enlarged image, a proximal portion ofvalve42 is disposed around (e.g., against)core144 of pushingmember140 such that each ofcoupling tabs146 is disposed within arespective void126 defined by the lattice structure of the prosthetic valve.
• Prosthetic valve42 and pushingmember140 are disposed within the lumen ofdelivery tube154.Delivery tube154 restricts expansion ofprosthetic valve42, thereby holding the proximal portion ofprosthetic valve42 aroundcore144 of pushingmember140, in the configuration described herein. Couplingtabs146 restrict movement ofprosthetic valve42 with respect to pushingmember140.Delivery tube154 therefore facilitates coupling ofprosthetic valve42 to pushingmember140 viacoupling tabs146. In applications of the invention where pushingmember140 is shaped to defineplate148, the plate typically further facilitates this coupling by restricting proximal movement ofprosthetic valve42 with respect to the pushing member (i.e., by functioning as a cap). Thereby, in the compressed configuration thereof,prosthetic valve42 is configured to be fixedly coupled to pushingmember140.
• Acontrol tube152 is typically coupled at a distal end thereof to pushing member140 (e.g.,control tube152 is coupled to support142).Control tube152 is shaped so as to define a lumen through which aguidewire tube153 passes, andcontrol tube152 is slidable with respect to and alongguidewire tube153.Guidewire tube153 houses guidewire45 described hereinabove.Control tube152 is slidably disposed within a lumen of anovertube155.
• FIG. 9C showsprosthetic valve42 partially deployed fromdelivery tube154. Pushingmember140, and, thereby,prosthetic valve42, are moved distally throughdelivery tube154.
• Reference is again made toFIG. 9C. Pushingmember140 is pushed distally by pushingcontrol tube152 alongguidewire tube153 such that pushingmember140 pushesprosthetic valve42. As pushingmember140 pushesvalve42 distally, distal portions of the prosthetic valve expand toward the expanded configuration as they become exposed fromdelivery tube154, while the proximal end ofvalve42 remains coupled to pushingmember140 viatabs146.
• FIG. 9D showsprosthetic valve42 having been fully deployed from withindelivery tube154. Pushingmember140 andprosthetic valve42 are moved further distally throughdelivery tube154 bycontrol tube152. When the proximal portion ofprosthetic valve42 emerges from withindelivery tube154, expansion of the proximal portion ofprosthetic valve42 uncouples the prosthetic valve from couplingtabs146 by expandingvoids126 away fromtabs146, thereby releasing the prosthetic valve from pushingmember140. For some applications,retrieval wires490 are generally loose, such that expansion ofprosthetic valve42 pulls the wires throughconduits492, and radially outward fromcore144. For some applications,retrieval wires490 are under tension, and are released gradually, so as to control expansion ofprosthetic valve42. That is, for some applications, the expansion ofprosthetic valve42 is restricted (e.g., controlled) by the distal advancement ofretrieval wires490.
• Should it be necessary and/or desirable during deployment, until medical device150 (e.g., prosthetic valve42) is released from pushing member140 (i.e., while the proximal portion of medical device150 is crimped within delivery tube154), the deployed, expanded portions of medical device150 (i.e., the portions of medical device150 that are exposed from delivery tube154) may be drawn back into delivery tube154 (e.g., for repositioning or withdrawal of the medical device).
• Subsequent to deployment ofprosthetic valve42, should it be necessary and/or desirable, the prosthetic valve may be drawn back against support142 (e.g., radially inward) by proximally pullingretrieval wires490. Subsequently,prosthetic valve42 may be drawn back, along with pushingmember140, intodelivery tube154. That is, for some applications,prosthetic valve42 is recompressible (i.e., the expansion ofprosthetic valve42 is at least in part reversible) by proximal retraction ofretrieval wires490.
• FIG. 9E showsretrieval wires490 having been pulled proximally (e.g., by a user), such thatwires490 pull at least part ofprosthetic valve42 into a compressed configuration around and againstsupport142.Prosthetic valve42 is thereby recoupled to pushingmember140. Pushingmember140 andprosthetic valve42 are moved proximally and drawn intodelivery tube154.Prosthetic valve42 may subsequently redeployed, or removed from the subject along withdelivery tube154.
• That is, (1)retrieval wires490 are slidable throughconduits492 ofcore144, and reversibly couplable toprosthetic valve42, and (2)delivery apparatus438 is configured to control and/or facilitate (a) expansion ofprosthetic valve42, by the retrieval wires being advanced distally through the conduits, and (b) recompression ofprosthetic valve42, by the retrieval wires being retracted proximally through the conduits.
• Reference is now made toFIGS. 9A-E and1D-F. It is to be noted thatdelivery tube154 ofFIGS. 9A-E is similar to, and/or may comprise,delivery tube60 ofFIGS. 1D-F.
• Reference is made toFIG. 10, which is a schematic illustration ofprosthetic valve support40, comprising multi-lumen prosthetic valve support40a, in accordance with some applications of the invention. As described hereinabove,prosthetic valve support40 is generally annular and shaped to define a lumen, in whichprosthetic valve42 is deployed and expanded. In the application of the invention illustrated inFIG. 10,prosthetic valve support40, comprising multi-lumen prosthetic valve support40a, is shaped to define two or more lumens. That is, the wire frame of support40adefines two or more lumens. Prosthetic valve support40ais typically couplable to the native valve using techniques described herein for coupling other prosthetic valve supports to the native valve. For example, prosthetic valve support40amay comprise tissue-engaging elements (e.g., support-anchoring elements). Similarly, other prosthetic valve supports described herein may comprise prosthetic valve support40a.
• Prosthetic valve support40ais typically covered with a covering440, such as a fabric. Covering440 may comprise polyethylene terephthalate (e.g., polyester), polytetrafluoroethylene (e.g., Teflon, ePTFE), or pericardial tissue. Typically, a thickness of covering440 is less than 0.2 mm, e.g., less than 0.1 mm, or less than 0.05 mm. When support40ais supplied and/or implanted, covering440 typically covers support40asuch that only afirst lumen444 is open and configured to receive a prosthetic valve, and thesecond lumen446 is closed. That is, the wire frame of support40adefines two or more lumens but the covering defines only one lumen, thereby covering440 functions as aseal442.
• In some applications of the invention, covering440 is not disposed oversecond lumen446; rather a different element functions asseal442. For example, a weaker and/or softer material (e.g., pericardial tissue) or a removable plug may be coupled to prosthetic valve support40a, and disposed oversecond lumen446 to function asseal442.
• Implant30, comprisingprosthetic valve42 and prosthetic valve support40a, is implanted in native valve23 (e.g., as described with reference toFIGS. 1A-H, mutatis mutandis), whereby prosthetic valveprosthetic valve42 is deployed infirst lumen444 of the support. At a later time, a second prosthetic valve may be introduced by deploying the second prosthetic valve insecond lumen446. That is, at a first period, prosthetic valve support40afacilitates implantation of a first prosthetic valve at the native valve, and at a second period, the prosthetic valve support facilitates implantation of a second prosthetic valve at the native valve. In some applications of the invention,seal442 is opened, and thereby configured to receive a prosthetic valve (e.g., by being broken, cut and/or torn) by the introduction of the second prosthetic valve. In other applications,seal442 is opened with a cutting tool (not shown) prior to deployment of the second prosthetic valve. In some applications of the invention,seal442 is uncoupled from support40a, prior to deployment of the second prosthetic valve.
• For some applications of the invention, following the deployment of the second prosthetic valve, the first prosthetic valve (i.e., prosthetic valve42) is disabled (e.g., sealed). For example, an expandable plug may be expanded in the lumen of the first prosthetic valve.
• Prosthetic cardiac valves typically require replacement after several years (e.g., after 2-20 years, such as after 5-10 years). For example, the condition of the subject may change and/or components of the prosthetic valve (e.g., prosthetic valve leaflets) may suffer fatigue. It is hypothesized that multi-lumen prosthetic valve support40aallows a second prosthetic valve to be implanted in the native valve, the second prosthetic valve being supported by the originally-implanted prosthetic valve support40a. The first prosthetic valve may be sealed, for example, if the original prosthetic valve allows, or is predicted to allow, retrograde leakage. Implantation of a second prosthetic valve is hypothesized to increase the lifespan ofimplant30.
• Reference is made toFIG. 11, which is a schematic illustration ofprosthetic valve40, comprising extended-lumen prosthetic valve support40e, in accordance with some applications of the invention. As described hereinabove,prosthetic valve support40 is generally annular and shaped to define a lumen, in whichprosthetic valve42 is deployed and expanded. Extended-lumen prosthetic valve support40eis shaped to define alumen448, which has an extended dimension. That is, the wire frame of support40etypically defineslumen448, which has (1) aprimary region447, and (2) asecondary region449 that is generally not filled by expansion ofprosthetic valve42 in the lumen. Typically,lumen448 has a first length that is longer than, and generally orthogonal to, a second length, and has one or more concave portions. For example,lumen448 may be generally shaped to define an oval or ellipse with one or more concave portions generally midway along the first length (e.g., a Cassini oval or a hippopede). Prosthetic valve support40eis typically couplable to the native valve using techniques described herein for coupling other prosthetic valve supports to the native valve. For example, prosthetic valve support40emay comprise tissue-engaging elements (e.g., support-anchoring elements). Similarly, other prosthetic valve supports described herein may comprise prosthetic valve support40e.
• Prosthetic valve support40eis typically covered with a covering440, such as a fabric. Covering440 may comprise polyethylene terephthalate (e.g., polyester), polytetrafluoroethylene (e.g., Teflon, ePTFE), or pericardial tissue. Typically, a thickness of covering440 is less than 0.2 mm, e.g., less than 0.1 mm, or less than 0.05 mm. When support40eis supplied and/or implanted, covering440 typically covers support40esuch thatsecondary region449 is closed. That is, the wire frame of support40edefines a generally elongatedlumen448, whilst covering440 defines a generally roundprimary region447. In this manner, covering440 functions as aseal442 oversecondary region449.
• In some applications of the invention, covering440 is not disposed oversecondary region449; rather a different element functions asseal442. For example, a weaker and/or softer material (e.g., pericardial tissue) or a removable plug may be coupled to prosthetic valve support40e, and disposed oversecondary region449, so as to function asseal442.
• Implant30, comprisingprosthetic valve42 and prosthetic valve support40e, is implanted in native valve23 (e.g., as described with reference toFIGS. 1A-H), wherebyprosthetic valve42 is deployed inprimary region447 of the support. At a later time, a second prosthetic valve may be introduced by deploying the second prosthetic valve insecondary region449. That is, at a first period, prosthetic valve support40efacilitates implantation of a first prosthetic valve at the native valve, and at a second period, the prosthetic valve support facilitates implantation of a second prosthetic valve at the native valve. In some applications of the invention,seal442 is opened (e.g., broken, cut and/or torn) by the introduction of the second prosthetic valve. In other applications,seal442 is opened with a cutting tool (not shown) prior to deployment of the second prosthetic valve. In some applications of the invention,seal442 is uncoupled from support40e, prior to deployment of the second prosthetic valve.
• Typically, expansion of the second prosthetic valve during deployment deforms the first prosthetic valve (i.e., a radially-expansive force of the second prosthetic valve is stronger than that of the first prosthetic valve). For example, following deployment of the second valve, the first valve may assume a lune shape or a generally semicircular shape. In some applications of the invention, the second prosthetic valve is shaped to fit intosecondary region449 without deforming the first prosthetic valve.
• Prosthetic cardiac valves typically require replacement after several years (e.g., after 2-20 years, such as after 5-10 years). For example, the condition of the subject may change and/or components of the prosthetic valve (e.g., prosthetic valve leaflets) may suffer fatigue. It is hypothesized that extended-lumenprosthetic valve support40 allows a second prosthetic valve to be implanted in the native valve, the second prosthetic valve being supported by the originally-implantedprosthetic valve support40. The first prosthetic valve may be sealed, as described hereinabove, for example, if the original prosthetic valve allows, or is predicted to allow, retrograde leakage. Implantation of a second prosthetic valve is hypothesized to increase the lifespan ofimplant30.
• Reference is made toFIGS. 12A-B, which are schematic illustrations ofprosthetic valve support40, comprising adjustable-lumen prosthetic valve support40b, in accordance with some applications of the invention. As described hereinabove, expansion ofprosthetic valve42 is restricted by the lumen ofprosthetic valve support40. As further described hereinabove, the optimum lumen size may depend on the individual subject and/or condition being treated. Adjusting the size of the lumen ofprosthetic valve42 is hypothesized to alter the flow of blood through the prosthetic valve, and the sealing ofleaflets82 of the native valve against the outer surface of the prosthetic valve. In some applications of the invention, the size of the area defined by the annulus of the native valve is measured (e.g., using a measuring ring and/or using imaging techniques), and appropriately-sizedprosthetic valve42 andprosthetic valve support40 are selected for implantation.FIGS. 12A-B show adjustable-lumen prosthetic valve support40b, which comprises aspool461 and atightening wire462. Tighteningwire462 typically forms a loop around a central portion of support40b(e.g., threadedly coupled around an inner edge68), and is coupled tospool461 such that the tightening wire can be tightened (i.e., shortened) viaspool461.FIG. 12A shows support40bwith a larger lumen (i.e., when tighteningwire462 is relatively loose) andFIG. 12B shows support40bwith a smaller lumen, following tightening of tighteningwire462 with atightening tool464.
• For some applications, prosthetic valve support40bandprosthetic valve42 are implanted as described herein (e.g., with reference toFIGS. 1A-H), and tighteningwire462 is subsequently tightened. For some applications, the annulus of the native valve is measured, and tighteningwire462 is responsively adjusted, prior to implantation. For some applications, following measurement of the native valve, and prior to implantation, a support40bof appropriate size is selected from a range.
• Reference is made toFIGS. 13A-D, which are schematic illustrations ofprosthetic valve support40, comprising asymmetric prosthetic valve support40c, in accordance with an application of the invention. As described hereinabove,support40 is generally annular, and shaped to define a lumen.FIG. 13A shows that the lumen defined by support40c(i.e., oblique lumen480) is typically not central with respect to the support. That is, support40cis typically rotationally asymmetric. Support40ctypically defines a total cross-sectional area of between 16 cm̂2 and 38 cm̂2 (e.g., between 22 cm̂2 and 28 cm̂2). Typically, the cross-sectional area oflumen480 is less than 70% (e.g., less than 60%, or less than 40%) of the cross-sectional area of area of support40c. For example, for some applications, the cross-sectional area oflumen480 has a longest length of less than 25 mm, e.g., less than 20 mm, and/or more than 15 mm, e.g., 15-25 mm. As described hereinabove, for some applications, surfaces ofprosthetic valve support40 are covered with a covering so as to direct substantially all blood to flow through the lumen ofprosthetic valve42. Asymmetric prosthetic valve support40cis typically not covered, i.e., the lattice structure of which the support is comprised, is exposed.
• FIG. 13B shows prosthetic valve support40chaving been deployed to the annulus of native valve23, as described herein (e.g., with reference toFIGS. 1A-H). For the applications of the invention described with reference toFIGS. 13A-D, prosthetic valve support typically comprises a plurality of tissue-engaging elements (e.g., support-anchoring elements), such as those described herein (not shown inFIGS. 13A-D). Support-anchoring elements66 are typically configured and oriented to engagecommissures84 of the native valve, so as to anchorsupport40 to the native valve whilst allowingleaflets82 to continue to function. Prosthetic valve support40cis typically deployed to native valve23 such thatlumen480 is positioned over (i.e., proximal to) a place of coaptation of the twoleaflets82 of the native valve. Subsequently,prosthetic valve42 is deployed in lumen480 (as described hereinabove; e.g., with reference toFIGS. 1A-H), such that, in the expanded state,prosthetic valve42 is disposed betweenleaflets82.
• FIG. 13C showsimplant30, comprising prosthetic valve support40candprosthetic valve42, implanted in native valve23, in accordance with an application of the invention. Typically, but not necessarily,prosthetic valve42 does not comprise valve-anchoring elements64. Rather,prosthetic valve42 is typically anchored to native valve23 by being coupled to support40c, which is, itself, anchored to the native valve, as described hereinabove.Prosthetic valve42 is positioned betweenleaflets82 of the native valve, due to the oblique position oflumen480 of support40c. Typically,leaflets82 are generally free to move with respect to the prosthetic valve, and move proximally and distally with the beating of the heart, coapting and sealing aroundprosthetic valve42. This movement ofleaflets82 is facilitated by support40cbeing uncovered and fluid communication being maintained betweenatrium26 andventricle28 through the lattice structure of support40c. For example, when native valve23 comprisesmitral valve24, during diastole,leaflets82 open, and left atrial blood moves into the left ventricle, both through and around prosthetic valve42 (i.e., through the lumen ofprosthetic valve42 and through the exposed lattice structure of support40c). During systole,leaflets82 close, i.e., coapt together, and seal aroundprosthetic valve42, restricting retrograde movement of blood.
• It is hypothesized that over a period of time (e.g., a week, e.g., a month, e.g., a year) following implantation ofimplant30 comprising support40c, movement ofleaflets82 is reduced (e.g., due to tissue growth and/or calciferous deposits), such that the functionality of native valve23 is gradually reduced, and the proportion of blood that flow throughprosthetic valve42, relative to that which flows around the prosthetic valve, is increased. That is, over time,prosthetic valve42 takes over the function of native valve23.
• Reference is made toFIG. 14, which is a schematic illustration ofprosthetic valve support40, comprising prosthetic valve support40d, which comprises tissue-engaging elements62, comprising a plurality of support-anchoring elements66a, in accordance with some applications of the invention. Typically, support40dcomprises two elements66a, typically coupled toinner edge68, and positioned generally opposite each other. Elements66atypically comprise two or more (e.g., three)coupling portions70, which extend radially from astructural component71.FIG. 14 shows elements66acomprising threecoupling portions70, arranged in a T-shape. Support40dis typically deployed in the native valve such that elements66aare oriented towardcommissures84 of the native valve, and engage both the commissures and the closest regions ofleaflets82. It is hypothesized that this structure and positioning of elements66aanchor support40dto the native valve, whilst allowingleaflets82 to move, thereby allowing native valve23 to continue to function, at least partly, untilprosthetic valve42 is deployed.
• Reference is made toFIGS. 15A-E, which are schematic illustrations of the implantation ofprosthetic valve support40 andprosthetic valve42, in accordance with some applications of the invention.Prosthetic valve42 is compressible (e.g., crimpable) and expandable, and typically comprises a shape-memory material, as described hereinabove.FIG. 15A showsprosthetic valve support40 having been deployed to the annulus of native valve23, andprosthetic valve42 having been delivered, in the crimped configuration thereof, withindelivery tube60a, to the native valve.Prosthetic valve42 anddelivery tube60aare disposed in the lumen of native valve23.Leaflets82 of the native valve typically coapt and seal arounddelivery tube60a. The proximal end ofdelivery tube60ais shown open.
• FIG. 15B showsdelivery tube60abeing moved distally whileprosthetic valve42 remains relatively stationary, thereby exposing the prosthetic valve from the delivery tube. As portions ofprosthetic valve42 are exposed, they expand from the crimped configuration to an expanded configuration. Typically, expansion of the proximal portion ofprosthetic valve42 facilitates coupling of the prosthetic valve toprosthetic valve support40. In the application of the invention illustrated byFIGS. 15A-E,prosthetic valve42 is shaped to define a widened proximal end, which facilitates coupling ofprosthetic valve42 toprosthetic valve support40. It is to be noted that the scope of the present application includes other configurations ofprosthetic valve42, such as those included herein.
• FIG. 15C showsdelivery tube60ahaving been removed entirely fromprosthetic valve42, andprosthetic valve42 having expanded to its expanded configuration, the expansion facilitating coupling of the prosthetic valve to support40 and, thereby, native valve23.Delivery tube60ais shown inleft ventricle28 of the heart.
• FIGS. 15D and 15E showdelivery tube60abeing withdrawn proximally, through the lumen ofprosthetic valve42.Delivery tube60ais subsequently removed from the subject. Typically,delivery tube60ais withdrawn between leaflets of prosthetic valve42 (not shown), which are typically disposed in the lumen of the prosthetic valve. Typically,delivery tube60ais withdrawn intoovertube44 prior to removal from the subject. It is to be noted that the scope of the present application includes deployment of the prosthetic valve from the distal (i.e., ventricular) side of native valve23, and the withdrawal of the delivery tube via the lumen of the prosthetic valve. It is hypothesized that this approach facilitates maneuvering of implant components and delivery apparatus, both for delivery ofimplant30 and for withdrawal of delivery apparatus. For example, this approach is hypothesized to require less space on the proximal side of the native valve (e.g., in atrium26), compared to techniques whereby the prosthetic valve is deployed from the proximal side of the native valve.
• Reference is made toFIG. 16, which is a schematic illustration ofprosthetic valve support40 being deployed in native valve23, comprisingmitral valve24, in accordance with some applications of the invention.Support40 is typically delivered to the native valve in a compressed (e.g., crimped) configuration, withinovertube44. In the compressed configuration,support40 typically assumes a tubular shape, having a proximal end and a distal end. Typically, the distal end is defined by inner edge68 (described hereinabove), and tissue-engaging elements62, comprising support-anchoring elements66, extend distally from the distal end. To deploysupport40, the support is moved (e.g., pushed) throughovertube44, such that support-anchoring elements66 emerge from the overtube. Support-anchoring elements66 engage native valve23, typically by graspingleaflets82,commissures84, and/orchordae80 of the native valve. Subsequently, the remaining portions of support40 (e.g., upstream support portion41) are moved out ofovertube44, andsupport40 expands to assume its expanded, generally annular, shape.Prosthetic valve support40 is thereby anchored to the native valve, typically withupstream support portion41 held against the annulus of the native valve, by support-anchoring elements66 (e.g., as described hereinabove).
• In some applications of the invention, support-anchoring elements66 are configured and/or arranged so as to anchorprosthetic valve support40 to the native valve (e.g., by engagingleaflets82, and/orcommissures84, and/or chordae tendineae80), whilst allowingleaflets82 to continue to function, at least in part.
• In some applications of the invention, should it be necessary and/or desirable,support40 is retrievable before it is fully deployed, by withdrawing the support proximally, back intoovertube44.
• In some applications, should it be necessary and/or desirable,support40 is retrievable after it has been fully deployed. For example,support40 may be drawn back around and against a pushing member of delivery apparatus,recompressing support40 for withdrawal into a delivery tube, in a similar way to the technique described with reference toFIGS. 9A-E, mutatis mutandis.Prosthetic valve support40 may subsequently be removed from the subject, and/or repositioned, and/or redeployed.
• Reference is made toFIGS. 17A-D, which are schematic illustrations ofsupport40, comprising tissue-engaging elements62, which comprise support-anchoring elements66, comprising length-adjustable holding elements600, in accordance with some applications of the invention. Native heart valves vary naturally in various dimensions, such as, but not limited to, the length, width and/or thickness ofleaflets82, the distance betweencommissures84, and/or the distance between fibrous trigones. In this context, in the specification and in the claims, these varying parameters are referred to as “dimensions.” Length-adjustable holding elements600 are configured such that the distance betweencoupling portion70 andupstream support portion41 ofprosthetic valve support40 is adjustable. This adjustability typically facilitates placement (i.e., implantation) of the prosthetic valve support at native valves of different dimensions, such that (1)upstream support portion41 is placeable against the proximal (i.e., atrial) side of the prosthetic valve, and (2)coupling portion70 is placeable on the distal (i.e., ventricular) side of the native valve (e.g., to engage the native leaflets and/or commissures, as described hereinabove).
• For some applications,coupling portions70 engage (e.g., are coupled to)leaflets82 and/orcommissures84 of native valve23 whileprosthetic valve support40 is still in a partially-deployed configuration (e.g., as described with reference toFIGS. 1B and 16). For some applications,support40 is first expanded,upstream support portion41 is then placed against the annulus of the native valve, andcoupling portions70 subsequently engage (e.g., are coupled to) the leaflets and/or commissures.
• In the applications of the invention described with reference toFIGS. 17A-D, holding elements600 are typically biased to assume a contracted configuration, and are typically expanded (e.g., stretched) so as to coupleportions70 to the native valve. This bias thereby provides a pulling force, which is hypothesized to facilitate coupling ofprosthetic valve support40 to native valve23 by sandwiching the native valve betweenupstream support portion41 andcoupling portion70, in some applications of the invention.
• Typically, adjustment and/or other manipulation of support-anchoring elements66, comprising length-adjustable holding elements600, may be performed prior to the implantation procedure, e.g., following imaging-based sizing of one or more dimensions of native valve23 (e.g., ofleaflets82, and/or of the annulus of the native valve), and/or during the implantation procedure (e.g., when the prosthetic valve support is at the site of implantation).
• FIG. 17A showsprosthetic valve support40, comprising prosthetic valve support40n, which comprises support-anchoring elements66, comprising support-anchoring elements66n. Each support-anchoring element66ncomprises acoupling portion70, coupled toupstream support portion41 of support40nvia a length-adjustable holding element600, comprising a stretchable holding element600n. Stretchable holding element600ncomprises a tension spring, typically comprising a coil spring. Stretchable holding element600nfacilitates adjusting the distance betweencoupling portion70 andupstream support portion41 such that, for native valves of different dimensions, (1)upstream support portion41 is placeable against the proximal (i.e., atrial) side of the prosthetic valve, and (2)coupling portion70 is placeable on the distal (i.e., ventricular) side of the native valve (e.g., to engage the native leaflets and/or commissures, as described hereinabove).
• FIG. 17B showsprosthetic valve support40, comprising prosthetic valve support40p, which comprises support-anchoring elements66, comprising support-anchoring elements66p. Each support-anchoring element66pcomprises acoupling portion70, coupled toupstream support portion41 of support40pvia length-adjustable holding element600, comprising a stretchable holding element600p. Stretchable holding element600pcomprises a tension spring, typically comprising a zigzag-shaped piece of material, such as a shape-memory material, e.g., nitinol. Stretchable holding element600pfacilitates adjusting the distance betweencoupling portion70 andupstream support portion41 such that, for native valves of different dimensions, (1)upstream support portion41 is placeable against the proximal (i.e., atrial) side of the prosthetic valve, and (2)coupling portion70 is placeable on the distal (i.e., ventricular) side of the native valve (e.g., to engage the native leaflets and/or commissures, as described hereinabove).
• FIG. 17C showsprosthetic valve support40, comprising prosthetic valve support40q, which comprises support-anchoring elements66, comprising support-anchoring elements66q. Each support-anchoring element66qcomprises acoupling portion70, coupled toupstream support portion41 of support40qvia length-adjustable holding element600, comprising astretchable holding element600q.Stretchable holding element600qcomprises a tension spring, typically comprising anelastic tube602, such as a tube of elastic silicone.Stretchable holding element600qfacilitates adjusting the distance betweencoupling portion70 andupstream support portion41 such that, for native valves of different dimensions, (1)upstream support portion41 is placeable against the proximal (i.e., atrial) side of the prosthetic valve, and (2)coupling portion70 is placeable on the distal (i.e., ventricular) side of the native valve (e.g., to engage the native leaflets and/or commissures, as described hereinabove).
• For some applications of the invention,stretchable holding element600qfurther comprises a limitingwire604, typically coupled toupstream support portion41 andcoupling portion70. Limitingwire604 is generally non-elastic, and is configured to limit the expansion (i.e., stretching) of holdingelement600q. For example, limiting wire may be configured to prevent overstretching of holdingelement600q, e.g., to prevent failure of the holding element. Typically, limitingwire604 is longer than the length ofelastic tube602 in the relaxed (i.e., contracted) configuration thereof, and is shorter than the length ofelastic tube602 in a maximally-expanded (i.e., maximally-stretched) configuration thereof. In the relaxed (i.e., contracted) configuration ofelastic tube602, limitingwire604 is typically loose (e.g., generally bent, crumpled, flexed). Whenelastic tube602 is expanded (i.e., stretched), limitingwire604 typically becomes taut (e.g., generally straight), thereby limiting the expansion ofelastic tube602 to generally the length of limitingwire604.
• It is to be noted that the scope of the present invention includes the use of limitingwire604 in combination with other length-adjustable holding elements including, but not limited to, stretchable holding element600n, described with reference toFIG. 17A.
• FIG. 17D showsprosthetic valve support40, comprising prosthetic valve support40u, which comprises support-anchoring elements66, comprising support-anchoring elements66u. Each support-anchoring element66ucomprises acoupling portion70, coupled toupstream support portion41 of support40uvia a length-adjustable holding element600, comprising a stretchable holding element600u. Stretchable holding element600ufacilitates adjusting the distance betweencoupling portion70 andupstream support portion41 such that, for native valves of different dimensions, (1)upstream support portion41 is placeable against the proximal (i.e., atrial) side of the prosthetic valve, and (2)coupling portion70 is placeable on the distal (i.e., ventricular) side of the native valve (e.g., to engage the native leaflets and/or commissures, as described hereinabove). Stretchable holding element600ucomprises a tension spring, typically comprising acoil spring610. For some applications of the invention,coil spring610 is generally similar to the coil spring of stretchable holding element600n, as described hereinabove. Stretchable holding element600ufurther comprises, or is coupled to, arestrictor612. Restrictor612 typically holdsspring610 in an expanded (i.e., stretched) configuration. Typically, restrictor612 is decouplable fromspring610. For some applications,restrictor612 may be mechanically removed by the user. For some applications,restrictor612 may comprise a material that disintegrates in the body (e.g., a material that is at least in part soluble and/or biodegradable and/or bioresorbable). For these applications,restrictor612 typically disintegrates over a predictable period of time e.g., between 15 minutes and 1 week, such as between 30 minutes and 3 days, for example, between 1 h and 1 day. For some applications,restrictor612 is configured to decouple from (i.e., release)spring610 gradually, e.g., in stages. For some applications,restrictor612 is coupled tospring610 and/or another part of prosthetic valve support40u, such that, following the release ofspring610, the restrictor is retained so as not to enter the vasculature of the subject.
• Whenspring610 is released fromrestrictor612, the spring relaxes (i.e., contracts), and provides a pulling force that sandwiches the native valve between support40uandcoupling elements70, e.g., as described hereinabove, mutatis mutandis.
• Reference is made toFIGS. 18A-B, which are schematic illustrations ofprosthetic valve support40, which comprises support-anchoring elements66, comprising length-adjustable holding elements600, in accordance with some applications of the invention.
• FIG. 18A showsprosthetic valve support40, comprising prosthetic valve support40r, which comprises support-anchoring elements66, comprising support-anchoring elements66r. Each support-anchoring element66rcomprises acoupling portion70, coupled toupstream support portion41 of support40rvia length-adjustable holding element600, comprising a telescopic holding element600r. Telescopic holding element600rcomprises a plurality of portions, typically cylinders, which are slidable over and/or through each other.FIG. 18A shows telescopic holding element600rcomprising two externally-threaded cylinders connected by an internally-threaded cylinder, and configured such that rotation of the internally-threaded cylinder with respect to the externally-threaded cylinders adjusts the distance between the externally-threaded cylinders. Thereby, rotation of the internally-threaded cylinder adjusts the distance betweencoupling portion70 andupstream support portion41. Adjustment of this distance may be performed prior to implantation of prosthetic valve support40r, and/or during the implantation procedure (e.g., after deployment of support40r).
• Reference is again made toFIGS. 17A-D, and18A-B. The applications of the invention described with reference toFIGS. 17A-D, comprise support-anchoring elements66 that comprise length-adjustable holding elements600, such asstretchable holding elements600n,600p, and600q. In addition to being axially stretchable, these holding elements are typically laterally flexible. This flexibility is hypothesized to be advantageous in some applications of the invention. For example, in some applications,leaflets82 of the native valve may continue to function, at least in part, after support-anchoring elements66 are coupled to the leaflets. In contrast, the adjustable holding elements600 described with reference toFIGS. 18A-B (i.e.,elements600rand600t) are typically laterally rigid.
• Reference is again made toFIG. 18B, which showsprosthetic valve support40, comprising prosthetic valve support40t, which comprises support-anchoring elements66, comprising support-anchoring elements66t, in accordance with some applications of the invention. Each support-anchoring element66tcomprises acoupling portion70, coupled toupstream support portion41 of support40tvia length-adjustable holding element600, comprising atelescopic holding element600t. Telescopic holding element600rcomprises a plurality of portions, typically cylinders, which are slidable over and/or through each other.FIG. 18B shows telescopic holdingelement600tcomprising two overlapping cylinders. Sliding of the cylinders over each other adjusts the distance betweencoupling portion70 andupstream support portion41. Adjustment of this distance may be performed prior to implantation of prosthetic valve support40t, and/or during the implantation procedure (e.g., after deployment of support40t).
• Typically, telescopic holdingelement600tfurther comprises another element (not shown), which controls and/or adjusts the sliding of the cylinders described hereinabove. For example,element600tmay comprise a tension spring, such as those described with reference toFIGS. 17A-D, typically disposed inside the lumen defined by the overlapping cylinders. The combination of the tension spring with the overlapping cylinders combines the stretchability described with reference toFIGS. 17A-D, with the rigidity described with reference toFIGS. 18A-B.
• Reference is made toFIG. 19, which is a schematic illustration ofprosthetic valve support40, comprising prosthetic valve support40v, which comprises support-anchoring elements66, comprising support-anchoring elements66v, in accordance with some applications of the invention. Each support-anchoring element66vcomprises acoupling portion70, coupled toupstream support portion41 of support40vvia length-adjustable holding element600, comprising length-adjustable holding element600v. Element600vcomprises astrap630 and a strap adjuster632 (e.g., a buckle, a ladder lock, a tri-glide).Strap630 andadjuster632 are configured and arranged such that the distance betweencoupling portion70 andupstream support portion41 is adjustable by slidingadjuster632 alongstrap630, and/or by sliding at least part ofstrap630 throughadjuster632. That is,strap630 andstrap adjuster632 are generally similar to the strap and adjustor of a bag, such as a backpack. Adjustment of element600vmay be performed prior to implantation of prosthetic valve support40v, and/or during the implantation procedure (e.g., after deployment of support40v).
• Non-limiting examples of materials which strap630 and/orstrap adjuster632 may comprise, include polyester, PTFE (e.g., ePTFE), nylon, cotton, nitinol, stainless steel, nickel cobalt, and cobalt chrome.
• Reference is made toFIGS. 20A-F, which are schematic illustrations ofprosthetic valve support40, comprising support-anchoring elements66, comprising flexible support-anchoring elements720, in accordance with some applications of the invention. Elements720 comprise acoupling portion70 and aconnector540, which comprises (1) aflexible material722, such as a fabric (e.g., covering440), pericardial tissue, and/or a polymer, and (2) one ormore stiffening filaments724.Filaments724 typically comprise a material that is stiffer and/or more resilient thanflexible material722. For example,filaments724 may comprise a metallic or plastic wire.Filaments724 are coupled tomaterial722, such as by weaving and/or by gluing. The absolute and relative quantities and configurations ofmaterial722 andfilaments724, may be generated and/or selected so as to provide a desired stiffness of an element720. For example, an element720 that comprises more and/or more densely-wovenfilaments724 may be selected for applications that require a stiffer element720. Conversely, an element720 that comprises fewer and/or less densely-wovenfilaments724 may be selected for applications that require a more flexible element720.FIGS. 20A-F show elements720 comprising flexible support-anchoring elements720a-f, comprising various relative quantities ofmaterial722 andfilaments724, in accordance with respective applications of the invention. These figures are not intended to limit the scope of the invention but, rather, to illustrate the variability of the invention as a whole, and of elements720 in particular.
• For some applications, a kit is provided, containing a plurality of prosthetic valve supports40, each prosthetic valve support comprising a flexible support-anchoring element720 having a different configuration ofmaterial722 andfilaments724, and thereby a different flexibility (e.g., elements720a-720f). A user typically selects asupport40 that comprises a support-anchoring element720 of a desired configuration for a particular application.
• For some applications, a kit is provided, containing (1) at least one prosthetic valve support40 (i.e., upstream support portion41), and (2) a plurality of flexible support-anchoring elements720, each element720 having a different configuration ofmaterial722 andfilaments724, and thereby a different flexibility. A user typically (1) selects a support-anchoring element720 of a desired configuration for a particular application, and (2) couples the selected element720 to theupstream support portion41.
• For some applications, a kit is provided, containing (1) at least one prosthetic valve support40 (i.e., upstream support portion41), (2) at least onecoupling portion70, and (3) a plurality ofconnectors540, eachconnector540 having a different configuration ofmaterial722 andfilaments724, and thereby a different flexibility. A user typically (1) selects aconnector540 of a desired configuration for a particular application, and (2) couples the selectedconnector540 to thecoupling portion70, and to theupstream support portion41.
• Reference is made toFIGS. 21A-C, which are schematic illustrations ofprosthetic valve42, comprising prosthetic valve42j, in accordance with some applications of the invention. Prosthetic valve42jcomprises at least one support-engagingelement422, comprising inflatable support-engaging element426, disposed on the outer surface of primarystructural element130 of prosthetic valve42j.FIGS. 21A-B show prosthetic valve42jcomprising one annular inflatable support-engaging element426, disposed circumferentially around primarystructural element130. Typically,prosthetic valve support40 comprises one or more support-anchoring elements (not shown; e.g., support-anchoring elements66, as described herein) which anchor the prosthetic valve support to native valve23.
• FIG. 21A shows prosthetic valve42jandprosthetic valve support40. Following the deployment ofprosthetic valve support40 against the annulus of native valve23, prosthetic valve42jis passed through the lumen of the prosthetic valve support as described hereinabove (e.g., with reference toFIGS. 1A-H). As described hereinabove, prosthetic valve42jis typically less than fully expanded (e.g., prosthetic valve42jis partially expanded) when it is passed through the lumen of the prosthetic valve. Accordingly,FIG. 21A shows prosthetic valve42jin a partially-expanded configuration.
• FIG. 21B shows prosthetic valve42jhaving been expanded in the lumen ofprosthetic valve support40, such that inflatable support-engaging element426 is disposed distal (e.g., ventricularly) toprosthetic valve support40. Element426 is inflated (e.g., with saline) and thereby expands, thereby increasing a longest transverse cross-sectional length of prosthetic valve42j, such that the transverse cross-sectional length is longer than a longest transverse cross-sectional length of the lumen defined byprosthetic valve support40. Thereby, inflatable support-engaging element426 restricts proximal movement of prosthetic valve42jwith respect toprosthetic valve support40, thereby anchoring prosthetic valve42jto the distal side ofprosthetic valve support40, and to native valve23.
• Inflatable support-engaging element426 is typically coupled toprosthetic valve42 such that the prosthetic valve is compressible (i.e., crimpable) for delivery, as described hereinabove. For some applications, inflatable support-engaging element426 is coupled to the prosthetic valve using sutures. Typically, such sutures are arranged in a single circumferential suture line, so as to facilitate deformation (e.g., flattening) of element426 during crimping of the prosthetic valve for delivery. For some applications, element426 is coupled to the prosthetic valve using an adhesive.
• FIG. 21C showsimplant30, comprisingprosthetic valve support40 and prosthetic valve42j, implanted at native valve23, comprisingmitral valve24.Support40 is deployed against the proximal (i.e., atrial) surface of the annulus of the native valve, and is typically coupled to the valve via support-anchoring elements66 (not shown). Prosthetic valve42jis deployed in the lumen ofsupport40 such that, when inflated, element426 restricts proximal movement of the prosthetic valve with respect to support40. This restriction, combined with the coupling ofsupport40 to the native valve, couples implant30 to the native valve.
• For some applications of the invention, prosthetic valve42jis deployed in the lumen ofsupport40, such that element426 is disposed on the proximal side ofsupport40. It is hypothesized that, when in this position and inflated, element426 restricts distal movement of the prosthetic valve with respect to the support.
• For some applications of the invention, prosthetic valve42jis deployed in the lumen ofsupport40, such that element426 is planar withupstream support portion41 of the support, and such that at least part of element426 is disposed proximal toportion41, and at least part of element426 is disposed distal toportion41. It is hypothesized that, when in this position and inflated, element426: (1) applies a radially-expansive force on support40 (i.e., supplements radially-expansive forces applied byprosthetic valve42 on support40), and (2) restricts proximal and distal movement of the prosthetic valve with respect to the support.
• Reference is made toFIGS. 22A-C, which are schematic illustrations of the implantation ofimplant30, comprisingprosthetic valve support40 andprosthetic valve42, coupled by one or more (e.g., 2 or more, such as 4) coupling leads840 (e.g., coupling wires), in accordance with some applications of the invention. For delivery, coupling leads840 are coupled toprosthetic valve support40 andprosthetic valve42. For some applications, coupling leads840 are slidably coupled to support40 and/orprosthetic valve42. For example, withinovertube44,prosthetic valve42 may be disposed proximally to support40, and coupled to support40 by being slidably coupled to coupling leads840.
• FIG. 22A showsprosthetic valve support40, having been coupled to native valve23, comprisingmitral valve24. For example,support40 may be coupled to the native valve using techniques described herein (e.g., via support-anchoring elements66).Support40 is coupled to coupling leads840, which extend fromsupport40 to at leastprosthetic valve42, which remains disposed withinovertube44.
• FIG. 22B showsprosthetic valve42 having been deployed in the lumen ofsupport40, and in the lumen of native valve23, as described herein, mutatis mutandis. Coupling leads840 extend fromsupport40, through a proximal portion (e.g., an upstream portion and/or proximal portion110) ofprosthetic valve42, and intoovertube44. Typically,coupling lead840 comprises a plurality ofteeth846, typically disposed at a distal end of the coupling lead. Acontroller tube844 is typically used to slide (e.g., push)ratchet housing842 overcoupling lead840, and overteeth846, such that the proximal portion ofprosthetic valve42 is pushed againstsupport40.Teeth846 allowratchet housing842 to slide overcoupling lead840 in one direction, and inhibit (e.g., restrict) such sliding in another (e.g., the opposite) direction. Pushingprosthetic valve42 againstsupport40 usingcontroller tube844 and ratchethousing842, thereby facilitates coupling ofprosthetic valve42 to support40. Thereby, sliding ofratchet housing842 overcoupling lead840 facilitates coupling of the prosthetic valve to the prosthetic valve support.
• Reference is made toFIG. 22C. Following the coupling ofprosthetic valve42 toprosthetic valve support40, and thereby the implantation ofimplant30 in native valve23, coupling leads are typically cut at a point proximal to ratchethousing842, and overtube44 is withdrawn from the subject.
• Reference is made toFIGS. 23A-24, which are schematic illustrations ofprosthetic valve support40, comprising prosthetic valve support40w, which is shaped to define at least onepocket640, in accordance with some applications of the invention. Prosthetic valve support40 (i.e., support40w) typically comprises a wire frame, such as an expandable wire frame. For some applications, the wire frame of support40wis shaped to definepocket640. For some applications, the wire frame of prosthetic valve support40 (i.e., support40w) is generally covered with a covering (such as a fabric, e.g., as described herein). For some applications, the covering may form at least one wall ofpocket640.
• FIG. 23A shows an application of support40w, comprisingupstream support portion41 that comprises awire frame642, generally covered with acovering644. In this application,pocket640 is generally annular, and circumscribes the lumen defined by support40w(i.e., the lumen defined byupstream support portion41 of support40w). That is, the lumen defined by support40wcan be considered to be defined by two holes: (1) a proximal (i.e., upper) hole defined by a proximal (i.e., upper) wall ofpocket640, and (2) a distal (i.e., lower) hole defined by a distal (i.e., lower) wall ofpocket640.FIGS. 23A-24 show both walls ofpocket640 as having a generally similar depth. That is, a longest dimension of the distal hole is generally equal to the longest dimension of the proximal hole. For some applications, the two holes are generally not equally dimensioned. For example, to facilitate deployment ofprosthetic valve42 and/or coupling ofprosthetic valve42 to support40w, one of the holes that defines the lumen of support40wmay have a smaller longest dimension than the other hole.
• FIG. 23B showsprosthetic valve42 comprising support-engaging elements422 (e.g., prosthetic valve42acomprising integral support-engaging elements424, as described with reference toFIG. 8A), coupled to prosthetic valve support40w.Elements422 typically define a cross-sectional area, the longest dimension of which is typically longer than a transverse cross-sectional longest dimension of the lumen defined by prosthetic valve support40w(i.e., of the upper and/or lower holes described with reference toFIG. 23A). During deployment,elements422 are placed withinpocket640. Thereby, in addition to the radially-expansive force that typically couplesprosthetic valve42 to support40, the radially-protruding support-engagingelements422 restrict axial (i.e., proximal and distal) movement ofprosthetic valve42 with respect to support40w, thereby anchoringprosthetic valve42 to support40w, and to native valve23.
• For some applications, prosthetic valve is provisionally expanded (1) sufficiently such thatelements422 protrude into pocket420 and prevent axial movement ofprosthetic valve42, but (2) insufficiently for radially-expansive forces to fixedly couple the prosthetic valve to prosthetic valve support40w. In this configuration, a user may rotate the prosthetic valve to a desired orientation, before finally allowing the prosthetic valve to expand and become coupled to support40w.
• FIG. 24 showsprosthetic valve42, configured to comprise an expandedproximal portion110 of primarystructural element130.Proximal portion110 defines a cross-sectional area with a longest length that is longer than a transverse cross-sectional longest dimension of the lumen defined by prosthetic valve support40w(i.e., of the upper and/or lower holes described with reference toFIG. 23A). During deployment,portion110 is placed withinpocket640. Thereby, in addition to the radially-expansive force that typically couplesprosthetic valve42 to support40,portion110 restricts axial (i.e., proximal and distal) movement ofprosthetic valve42 with respect to support40w, thereby anchoringprosthetic valve42 to support40w, and to native valve23.
• Reference is made toFIGS. 25A-E, which are schematic illustrations of sequential steps in the use of aretrieval device800, in accordance with some applications of the invention.Retrieval device800 comprises a plurality ofstruts804, and typically comprises ashaft802, with which struts804 are axially aligned, and around which the struts are circumferentially disposed. A coupling element805, such as a hook806, is coupled to a middle portion of each strut.
• Reference is made toFIGS. 25A-B. At some time subsequent to implantation of a prosthetic valve (i.e., prosthetic valve42), it may be necessary and/or desirable to retrieve the prosthetic valve (i.e., to remove the prosthetic valve from the subject). Typically,retrieval device800 is delivered to the site of the prosthetic valve (i.e., to the native valve) in and/or using anovertube808.Retrieval device800 is advanced towardprosthetic valve42, and into the lumen defined by the prosthetic valve.
• FIG. 25C shows middle portions ofstruts804 being extended radially outward fromshaft802. Typically, one or more middle portions ofstruts804 are extended radially outward by reducing the distance between the proximal end and the distal end of each strut. For example, struts804 may be bent and/or folded. In the application of the invention shown inFIGS. 25A-E, retrieval device further comprises acuff810, coupled to the proximal ends ofstruts804, and slidably coupled toshaft802. Movement ofcuff810 distally, reduces the distance between the proximal and distal ends ofstruts804, thereby extending the middle portions ofstruts808 radially outward.
• FIG. 25D shows two, respectively orthogonal, cross-sectional views ofretrieval apparatus800 in the lumen ofprosthetic valve42. The middle portions ofstruts804 have been extended radially outward, and typically make contact withprosthetic valve42.Prosthetic valve42 is typically covered with a covering, which facilitates the desired flow of blood through the prosthetic valve. The covering may comprise polyethylene terephthalate (e.g., polyester), polytetrafluoroethylene (e.g., Teflon, ePTFE), pericardial tissue, or any other suitable material. Hooks806 protrude throughwire frame812 ofprosthetic valve42, and typically do not extend through covering814. Following the extension of the middle portions ofstruts804, coupling element805 is coupled to (e.g., hooks806 are hooked around)wire frame812 ofprosthetic valve42. For example, hooks806 are arranged to point in the same direction as each other (e.g., such that all hooks point clockwise, or all hooks point anticlockwise). Following extension of the middle portions ofstruts804,retrieval apparatus800 is rotated, such that hooks806 hook aroundwire frame812, between the wire frame and covering814.
• Reference is made toFIG. 25E. Following coupling of coupling elements805 (i.e., hooks806) towire frame812 ofprosthetic valve42, the middle portions ofstruts804 are retracted radially inward, i.e., towardshaft802. For example, the distance between proximal and distal ends ofstruts804 is increased, e.g., by slidingcuff810 proximally. Becausestruts804 are coupled to the wire frame,prosthetic valve42 is drawn radially inward. That is,prosthetic valve42 is compressed (i.e., re-crimped).Retrieval apparatus800 andprosthetic valve42 are drawn intoovertube808, and subsequently removed from the subject.
• FIGS. 25A-E illustrate eachstrut804 having two outwardly-extendable middle portions, in order to couple to, and compressprosthetic valve42 at/from two sites (i.e., a proximal site and a distal site). It is hypothesized that the use ofapparatus800 comprisingstruts804 with different numbers and/or configurations of outwardly-extendable middle portions, allows the compression and/or retrieval of prosthetic valve of different dimensions and/or configurations.
• Reference is again made toFIGS. 25A-E. For some applications, ahem820 is disposed within, and slidable throughovertube808.Hem820 is advanced out of the overtube during or after the advancement of retrieval apparatus, and expands, such that a distal portion of the hem defines a lumen that has a longer transverse cross-sectional area than that of overtube808 (e.g., as shown inFIGS. 25B-C). Whenretrieval apparatus800 andprosthetic valve42 are drawn intoovertube808, at least proximal portions of the retrieval apparatus and prosthetic valve are first drawn intohem820.Hem820 facilitates the drawing in of the retrieval apparatus and prosthetic valve, by widening the effective open end of the overtube, and/or by reducing resistance between theprosthetic valve42 andovertube808. Althoughhem820 is described herein with respect to the use ofretrieval apparatus800, it is to be noted that the scope of the present invention includes the use ofhem820 in combination with any retrieval apparatus.
• Reference is made toFIGS. 26A-C, which are schematic illustrations ofprosthetic valve support40, comprising a braided prosthetic valve support860, in accordance with some applications of the invention. As described hereinabove,support40 is typically expandable, and typically comprises a shape-memory material. Support860 typically further comprises a braided structure, comprising a plurality of intertwiningstrands862. At least some regions ofstrands862 are slidable past (e.g., over, under) each other. Typically,strands862 comprise a shape-memory material such as, but not limited to, nitinol. In an expanded state (i.e., uncompressed),support40 is annular, and is shaped to define a lumen therethrough. For delivery, support860 is typically advanced through the vasculature of the subject in a compressed configuration, e.g., within anovertube44.FIG. 26A shows support860 being deployed from overtube44 at native valve23 (i.e., proximal to the native valve). Typically, support860 is deployed proximal to the native valve.
• FIG. 26B shows sequential illustrations of the expansion of support860 as it is deployed fromovertube44. Support860 is typically coupled to a restricting element, such asdrawstring864, in a manner that at least partly restricts expansion of the support.FIG. 26B showsdrawstring864 threaded through a plurality ofrings866, disposed at the proximal end of support860, whereby both ends ofdrawstring864 are disposed proximal to the open distal end of overtube44 (e.g., withinovertube44, and/or outside the body of the subject).Drawstring864 thereby forms a closed loop that is coupled torings866 and, thereby, to support860. Once support860 has been fully ejected fromovertube44, tension ondrawstring864 typically restricts expansion of support860. Subsequently, at least one end ofdrawstring864 is moved distally (i.e., the drawstring is at least partially loosened), such that support860 moves toward its uncompressed, expanded shape. When support860 is successfully positioned (i.e., when a user determines that the support is in the desired position), one end ofdrawstring864 is released, typically in combination with drawing (i.e., retracting) the other end ofdrawstring864 proximally, thereby releasing support860 from the drawstring.
• FIG. 26C shows prosthetic valve support860 in its fully-expanded configuration, against the proximal (i.e., atrial) side of the annulus of native valve23. One end ofdrawstring864 has been released, and the drawstring is shown being retracted proximally.
• Throughout the deployment of prosthetic valve support860, until the release of one end ofdrawstring864, support860 may be retrieved by movingdrawstring864 proximally (i.e., pulling the drawstring). Pulling the drawstring (1) tightens the loop formed by the drawstring, thereby bringingrings866 closer to each other, and compressing the proximal portion of support860, and (2) draws support860 intoovertube44. Thus, a user can determine if and/or when to release support860, throughout the deployment procedure.
• Reference is made toFIGS. 27A-D, which are schematic illustrations ofdelivery apparatus880, and the use thereof, in accordance with some applications of the invention.FIGS. 27A-D show apparatus880 being used to deliver and deploy a medical device150, comprisingprosthetic valve42, to native valve23.Apparatus880 comprises a plurality ofcontrol filaments882, disposed and slidable within respective guide elements, such as rail-pairs884 (e.g., between individual rails thereof). Rail-pairs884 are typically extendable. For example, rail-pairs884 may comprise sections that are slidable over and/or through each other, such that the rail-pairs are telescopically extendable.Apparatus880 typically comprises acore886, from which rail-pairs884 typically protrude radially, such that extension of rail-pairs884 comprises outwardly-radial extension of the rail-pairs fromcore886.
• Apparatus880 has a contracted configuration and an extended configuration, is typically reversibly movable between these two configurations, and is further typically movable into continuous configurations between the contracted and extended configurations.FIG. 27A showsapparatus880 in the contracted configuration. In the contracted configuration, rail-pairs884 are typically telescopically retracted, such thatapparatus880 is disposable indelivery tube60. That is, in the contracted configuration, a longest length of a transverse cross-section ofapparatus880 is smaller than a longest length of a transverse cross-section ofdelivery tube60.
• FIG. 27B shows medical device150, comprisingprosthetic valve42, being deployed fromdelivery tube60, at native valve23, usingapparatus880.Apparatus880 is coupled to a portion (e.g., a proximal portion) ofprosthetic valve42, and is disposed withindelivery tube60.Apparatus880 is thereby not visible inFIG. 27B. A distal portion ofprosthetic valve42 has been exposed fromdelivery tube60, and has begun to expand toward its expanded configuration. Typically,prosthetic valve42 is moved with respect to delivery tube60 (e.g., is pushed out of the delivery tube) bycore886, which thereby acts as a pushing member.
• As described hereinabove,prosthetic valve42 typically comprises a shape-memory material, and expands toward its expanded configuration as it is exposed fromdelivery tube60. In the application of the invention described with reference toFIGS. 27A-D,apparatus880 typically controls this expansion.Control filaments882 are typically coupled (e.g., slidably coupled) toprosthetic valve42, e.g., via respective coupling pins888, which are couplable toprosthetic valve42, and slidably couplable to controlfilaments882.Release wires892 facilitate the coupling ofcontrol filaments882 toprosthetic valve42, e.g., by facilitating the coupling of coupling pins888 toprosthetic valve42.
• Control filaments882 (e.g., proximal portions thereof) are distally advanceable, and proximally retractable, through acontrol tube890, e.g., using a control unit external to the subject.Control filaments882 are slidably couplable tocore886 and/orcontrol tube890, such as being slidable through respective conduits (e.g., holes) in the core or the control tube. The expansion ofapparatus880, and thereby that ofprosthetic valve42, is restricted and/or facilitated (e.g., controlled) by the distal advancement and/or proximal retraction ofcontrol filaments882. In the application of the invention illustrated inFIGS. 27A-D,control filaments882 form respective loops. The size of the loops is increased when the control filaments are distally advanced, and reduced when the control filaments are proximally retracted. When the loops are small,control filaments882 restrict expansion ofprosthetic valve42. Distal advancement ofcontrol filaments882, and the resulting enlargement of the loops formed thereof, facilitates the expansion ofprosthetic valve42.
• FIG. 27C showsapparatus880 in its expanded configuration.FIG. 27D showsapparatus880 in its expanded configuration, coupled toprosthetic valve42, during the deployment of the prosthetic valve. Rail-pairs884 protrude radially fromcore886, and controlfilaments882 remain coupled to the prosthetic valve, facilitated byrelease wires892, as described hereinabove. Rail-pairs884 typically facilitate (e.g., guide) the expansion ofprosthetic valve42.
• Whenprosthetic valve42 is successfully positioned (i.e., when a user determines that the prosthetic valve is in the desired position),prosthetic valve42 is released fromcontrol filaments882, e.g., by pullingrelease wires892 proximally. Release ofprosthetic valve42 allows (1) the prosthetic valve to expand further (e.g., until it couples to, and is restricted by, support40), and/or (2)control filaments882 to be retracted, and rail-pairs884 to be telescopically retracted, such thatapparatus880 is retractable intodelivery tube60.
• For some applications, rail-pairs884 are biased toward moving into the contracted configuration thereof, are pulled radially outward by the expansion ofprosthetic valve42, and automatically return to the contracted configuration upon release of the prosthetic valve. For example, the rail-pairs may provide a contractive force, and the prosthetic valve may provide an expansive force that is sufficient to overcome the contractive force, and thereby to pull the rail-pairs radially outward. Upon release of the prosthetic valve, the contractive force automatically returns the rail-pairs to the contracted configuration thereof. Alternatively or additionally, rail-pairs884 may be actively controllable (e.g., extracorporeally) by a user.
• For some applications of the invention, proximal portions ofcontrol filaments882 are coupled to each other (e.g., fixedly coupled to each other, such as adhered and/or welded to each other), such that the plurality of control filaments are synchronously distally advanceable, and synchronously proximally retractable, e.g., via a control rod and/or control unit.
• For some applications of the invention, proximal portions ofrelease wires892 are coupled to each other (e.g., fixedly coupled to each other, such as adhered and/or welded to each other), such that the plurality of release wires are pullable synchronously, e.g., via a control rod and/or control unit, thereby facilitating synchronous release ofcontrol filaments882.
• Throughout the deployment ofprosthetic valve42 usingapparatus880, until the release of the prosthetic valve fromcontrol filaments882,prosthetic valve42 may be re-compressed (e.g., for repositioning and/or retrieval into delivery tube60) by proximally retractingcontrol filaments880. Thus, a user can determine if and/or when to releaseprosthetic valve42, throughout the deployment procedure. That is,prosthetic valve42 is recompressible (i.e., the expansion ofprosthetic valve42 is at least in part reversible) by proximal retraction ofcontrol filaments882.
• That is, (1)control filaments882 are slidable through conduits ofcore886, and reversibly couplable toprosthetic valve42, and (2)delivery apparatus880 is configured to control and/or facilitate (a) expansion ofprosthetic valve42, by the control filaments being advanced distally through the conduits, and (b) recompression ofprosthetic valve42, by the control filaments being retracted proximally through the conduits.
• Reference is made toFIGS. 28A-30B, which are schematic illustrations of techniques for replacement of a prosthetic valve, in accordance with some applications of the invention. It is noted that in the context of the present patent application, the term “replacement” with respect to a prosthetic valve includes both (a) placement at a valve site of a new prosthetic valve while removing or disabling a prosthetic valve that was already at the valve site, as well as (b) placement of a new prosthetic valve at the valve site without removing or disabling a prosthetic valve that was already at the site.
• Prosthetic cardiac valves typically require replacement after a duration (e.g., after between 1 month and 10 years, such as after between 1 and 5 years). For example, the condition of the subject may change, components of the prosthetic valve (e.g., prosthetic valve leaflets, sutures, frame) may suffer fatigue, and/or tissue growth may block blood flow or otherwise interfere with prosthetic valve function.
• The prosthetic valve supports described with reference toFIGS. 28A-30B are typically couplable to the native valve using techniques described herein for coupling other prosthetic valve supports to the native valve. For example, the prosthetic valve supports described with reference toFIGS. 28A-30B may comprise tissue-engaging elements (e.g., support-anchoring elements), such as those described herein. Similarly, other prosthetic valve supports described herein may comprise the upstream support portions and/or the cylindrical elements of the prosthetic valve supports described with reference toFIGS. 28A-30B.
• Reference is now made toFIGS. 28A-D.FIGS. 28A-B show implant30, comprisingprosthetic valve42 coupled toprosthetic valve support40, such as described hereinabove with reference to the implantation of implant30 (e.g., with reference toFIGS. 1A-H).FIG. 28A shows a side view andFIG. 28B shows a top view. At such a time that it is deemed necessary and/or desirable to replaceprosthetic valve42, a secondprosthetic valve42′ is delivered to the lumen of the first prosthetic valve, and deployed therein. Generally, delivery and deployment ofprosthetic valve42′ is performed using similar techniques to those used to deployprosthetic valve42.
• FIGS. 28C-D show secondprosthetic valve42′ in an expanded configuration within the lumen ofprosthetic valve42.FIG. 28C shows a side view andFIG. 28D shows a top view. Bothprosthetic valve42 andprosthetic valve42′ comprise valve components, typicallyvalve leaflets660, disposed in the lumen of the prosthetic valve. As it expands,prosthetic valve42′ typically pushes asideleaflets660 ofprosthetic valve42.Prosthetic valve42′ exerts radially-expansive forces against the inner surface ofprosthetic valve42, thereby couplingprosthetic valve42′ toprosthetic valve42. In some applications,leaflets660 are sandwiched betweenprosthetic valve42 andprosthetic valve42′ (i.e., between the primarystructural elements130 of the prosthetic valves). In some applications,leaflets660 facilitate sealing between the two prosthetic valves. Following the deployment ofprosthetic valve42′,leaflets660′ ofprosthetic valve42′ begin to function, thereby replacing the function ofleaflets660. Typically, diameter d2 of deployedprosthetic valve42′ is smaller than diameter d1 of deployedprosthetic valve42. Typically, the difference in diameter is caused at least in part byprosthetic valve42 restricting the expansion ofprosthetic valve42′.
• Reference is now made toFIGS. 29A-F.FIGS. 29A-B show implant30, comprisingprosthetic valve42 coupled toprosthetic valve support40, comprising prosthetic valve support40x.FIG. 29A shows a side view andFIG. 29B shows a top view. As described hereinabove,prosthetic valve support40 is generally annular, and typically comprises a wire frame and/or a shape-memory material. For some applications, the wire frame of prosthetic valve support40 (i.e.,wire frame672 of support40x) is generally covered with covering440 (such as a fabric, e.g., as described herein). Support40xtypically comprises aweak zone670 that circumscribes the lumen defined by the support (i.e., the lumen defined byupstream support portion41 of support40x).
• For some applications,wire frame672 does not extend intoweak zone670; rather the weak zone only comprises covering440. For some applications, a stretchable and/or breakable reinforcing-wire674 is disposed at or nearinner edge68 ofupstream support portion41 of support40x. For some applications,wire frame672 has a different structure inweak zone670 than in other regions ofupstream support portion41 of support40x. For example,wire frame672 may comprise fewer struts inweak zone670.
• FIG. 29C shows an expanding device, such as aballoon678, having been delivered to the lumen ofprosthetic valve42, and being used to expand (e.g., to enlarge) the lumen of the prosthetic valve and the lumen of prosthetic valve support40x.FIG. 29D shows a transverse cross-sectional view of support40xandprosthetic valve42, following the expansion of the lumen of the prosthetic valve withballoon678. At such a time that it is deemed necessary and/or desirable to replaceprosthetic valve42,balloon678 is delivered to the prosthetic valve and inflated (e.g., using saline), such that it applies a radially-expansive force, from within the lumen ofprosthetic valve42, to the prosthetic valve and support40x. Typically, the radially-expansive force applied by the balloon is greater than the radially-expansive force applied byprosthetic valve42 on support40 (i.e., support40x), that typically couplesprosthetic valve42 to support40. For some applications,balloon678 is shaped to define a lumen, so that blood can continue to flow while the balloon is expanded. For some such applications,balloon678 comprises a temporary prosthetic valve (i.e., one or more temporary prosthetic valve leaflets), disposed in the lumen of the balloon, and configured to further facilitate continued blood flow while the balloon is expanded.
• The radially-expansive force applied byballoon678 increases the lumen ofprosthetic valve42, typically by increasing the lumen of support40xby deforming (e.g., crushing)weak zone670. For example, a material whichweak zone670 comprises may be compressed, broken, bent, stretched and/or torn (e.g., reinforcing wire674 may be broken and/or covering440 may be stretched and/or torn).Balloon678 is subsequently removed from the subject. Typically,leaflets660 continue to function at least in part until secondprosthetic valve42′ is deployed.
• For some applications,leaflets660 are disposed in a portion ofprosthetic valve42 that is distal (i.e., ventricular) to the portion ofprosthetic valve42 that is coupled to prosthetic valve support40x. For these applications,balloon678 is typically disposable in a proximal portion ofvalve42, and thereby may be used to increase the lumen ofprosthetic valve42, without damaging (e.g., crushing)leaflets660.
• FIGS. 29E-F show secondprosthetic valve42′ in an expanded configuration within the lumen ofprosthetic valve42.FIG. 29E shows a side view andFIG. 29F shows a top view.Prosthetic valve42′ exerts radially-expansive forces against the inner surface ofprosthetic valve42, thereby couplingprosthetic valve42′ toprosthetic valve42. Because the lumen ofprosthetic valve42 is initially expanded, as described hereinabove, a diameter d3 of the lumen defined byprosthetic valve42′ may not be smaller than the diameter d1 of the lumen originally defined by prosthetic valve42 (i.e., d3 may be at least as great as d1). For example, diameter d3 may be equal to, or larger than, diameter d1.
• Reference is again made toFIGS. 28A-29F. For some applications of the invention,prosthetic valve42′ comprises a secondprosthetic valve42. That is, a second (i.e., new)prosthetic valve42 is used to replace a firstprosthetic valve42. Alternatively,prosthetic valve42′ may be different toprosthetic valve42. For some applications,prosthetic valve42′ may comprise a sealing element, such as a circumferential seal (e.g., a soft material and/or a balloon), that facilitates sealing and/or coupling betweenprosthetic valve42′ andprosthetic valve42. For some applications,prosthetic valve42′ comprises protruding barbs, which facilitate coupling between the two prosthetic valves.
• For some applications, a distal portion ofprosthetic valve42′ defines a cross-sectional area with a longest length that is longer than a transverse cross-sectional longest dimension of the lumen defined by prosthetic valve42 (i.e., defined by primarystructural element130 of prosthetic valve42). During deployment ofprosthetic valve42′, the distal portion is placed distal to the open distal end of prosthetic valve42 (i.e., in the ventricle). Thereby, in addition to the radially-expansive force that typically couplesprosthetic valve42′ toprosthetic valve42, the distal portion restricts proximal movement ofprosthetic valve42′ with respect toprosthetic valve42, thereby anchoringprosthetic valve42′ toprosthetic valve42, and to native valve23.
• Reference is made toFIGS. 30A-B, which are schematic illustrations ofimplant30, comprisingprosthetic valve42 andprosthetic valve support40y, being restored by the addition of a secondprosthetic valve42′, in accordance with some applications of the invention.Prosthetic valve support40ycomprisesupstream support portion41 coupled to acylindrical element690 that is typically configured to extend distally through native valve23. Alternatively,cylindrical element690 may be configured to extend away from the native valve.Prosthetic valve support40yis typically couplable to the native valve using techniques described herein for coupling other prosthetic valve supports to the native valve. For example,prosthetic valve support40ymay comprise tissue-engaging elements (e.g., support-anchoring elements).Cylindrical element690 is typically configured to (1) facilitate coupling ofprosthetic valve support40yto the native valve, and/or sealing therebetween, (2) to facilitate coupling of prosthetic valves toprosthetic valve support40y, and/or sealing therebetween, and/or (3) to push asidenative leaflets82 of native valve23.
• FIG. 30A showsprosthetic valve42 having been deployed in the lumen ofprosthetic valve support40y. Typically,prosthetic valve42 is deployed in a distal (i.e., more ventricular and/or downstream) portion of the lumen.
• FIG. 30B showsprosthetic valve42′ having been deployed in the lumen ofprosthetic valve support40y. At such a time that it is deemed necessary and/or desirable to perform a replacement ofprosthetic valve42,prosthetic valve42′ is delivered to, and deployed in, another portion ofprosthetic valve support40y. Typically,prosthetic valve42′ is deployed in a portion of the lumen that is proximal to (e.g., upstream of)prosthetic valve42. That is,prosthetic valve support40yis configured to receive, at a first period, a first prosthetic valve at a first longitudinal portion of the lumen ofcylindrical element690, and to receive, at a second period, a second prosthetic valve at a second longitudinal portion of the lumen.
• For some applications,prosthetic valve42 continues to function at least in part, and at least temporarily. That is,prosthetic valve42 andprosthetic valve42′ operate generally simultaneously. For some applications,prosthetic valve42 is disabled in conjunction with deployment ofprosthetic valve42′. For example,leaflets660 ofprosthetic valve42 may be disabled, removed and/or restrained, by using a separate device (not shown) and/or by using a part (e.g., an extending element; not shown) ofprosthetic valve42′.
• For some applications, the primarystructural element130 ofprosthetic valve42′ is longer than the primary structural element ofprosthetic valve42, and the leaflets ofprosthetic valve42′ are disposed in a proximal portion of the primary structural element thereof. A distal portion of the primary structural element ofprosthetic valve42′ is deployed in the lumen ofprosthetic valve42, such that the leaflets ofprosthetic valve42 are crushed upon expansion ofprosthetic valve42′.
• Reference is made toFIGS. 31A-33C, which are schematic illustrations ofdelivery tube60, in accordance with some applications of the invention. Deployment of a medical device150, such asprosthetic valve42, as described with reference toFIGS. 1A-H, typically comprises proximal movement ofdelivery tube60 relative toprosthetic valve42, as described hereinabove. Immediately prior to the release ofprosthetic valve42 from the delivery tube, the length of the delivery tube-plus-prosthetic valve may be double or more than that of the delivery tube or prosthetic valve alone. For some applications, this extra length can hinder the movement of, and removal of, the delivery tube from the body. A delivery tube that takes up less room during and/or following deployment ofprosthetic valve42 would thereby be advantageous.
• FIGS. 31A-Cshow delivery tube60, comprising a flexible delivery tube60bbeing used to deliverprosthetic valve42, in accordance with some applications of the invention. Delivery tube60bcomprises a flexible material, such as a fabric or polymer.FIG. 31A showsprosthetic valve42 in a compressed (i.e., crimped) configuration within delivery tube60b.Prosthetic valve42 exerts an expansive force on tube60b, and tube60bprovides a reciprocal compressive force onprosthetic valve42. Delivery tube60bis typically not rigid; ratherprosthetic valve42 provides (i.e., dictates) the shape to which the delivery tube conforms. That is,prosthetic valve42 functions as a scaffold on which delivery tube60bis disposed.
• FIG. 31B showsprosthetic valve42 partially deployed from delivery tube60b. For example,prosthetic valve42 may be pushed distally out of the delivery tube using a pushing member (e.g., pushing member140).FIG. 31C showsprosthetic valve42 fully deployed from delivery tube60b.Prosthetic valve42 has expanded toward its expanded configuration. The reciprocal expansive and compressive forces are thereby no longer exerted, and delivery tube60bno longer conforms to a rigid shape. That is, delivery tube60bbecomes flaccid, facilitating its removal from the subject. For example delivery tube60bmay be moved around corners and/or into an overtube such as a catheter.
• FIGS. 32A-Cshow delivery tube60, comprising a compressible delivery tube60cbeing used to deliverprosthetic valve42, in accordance with some applications of the invention. Delivery tube60ccomprises a flexible material, such as a fabric or polymer, and one or more pullingwires740. Delivery tube60ctypically further comprises anaperture ring742.FIG. 32A showsprosthetic valve42 in a compressed (i.e., crimped) configuration within delivery tube60c.Prosthetic valve42 exerts an expansive force on tube60c, and tube60cprovides a reciprocal compressive force onprosthetic valve42. Delivery tube60cis typically not rigid; ratherprosthetic valve42 provides (i.e., dictates) the shape to which the delivery tube conforms. That is,prosthetic valve42 functions as a scaffold on which delivery tube60cis disposed. Pullingwires740 extend from a proximal site (e.g., outside the subject) and are coupled to a distal portion of delivery tube60c(e.g., to aperture ring742).
• FIG. 32B showsprosthetic valve42 partially deployed from delivery tube60c. Typically, following placement of delivery tube60c(and thereby prosthetic valve42) in the lumen of native valve23, pullingwires740 are pulled, drawing the distal portion of the delivery tube (e.g., aperture ring742) proximally. Delivery tube60cis thereby compressed (i.e., shortened) and a distal portion ofprosthetic valve42 is exposed, and typically expands at least in part responsively. For example, a proximal end of delivery tube60cmay be generally closed, such that compressing (i.e., shortening) of the delivery tube, exposes the distal portion ofprosthetic valve42 from the distal end of the delivery tube.FIG. 32C showsprosthetic valve42 fully deployed from delivery tube60c.Prosthetic valve42 has expanded toward its expanded configuration. Delivery tube60cis generally compressed such that it has a length of less than 50% (e.g., less than 30%, such as less than 10%) of its length when containingprosthetic valve42, thereby facilitating its removal from the subject. For example delivery tube60cmay be moved around corners and/or into an overtube such as a catheter.
• FIGS. 33A-Cshow delivery tube60, comprising a dismantling delivery tube60dbeing used to deliverprosthetic valve42, in accordance with some applications of the invention. Delivery tube60dcomprises a flexible material, such as a fabric or polymer, and apullstring750.FIG. 33A showsprosthetic valve42 in a compressed (i.e., crimped) configuration within delivery tube60d.Prosthetic valve42 exerts an expansive force on tube60d, and tube60dprovides a reciprocal compressive force onprosthetic valve42. Delivery tube60dis typically not rigid; ratherprosthetic valve42 provides (i.e., dictates) the shape to which the delivery tube conforms. That is,prosthetic valve42 functions as a scaffold on which delivery tube60dis disposed.Pullstring750 is coupled to the flexible material of delivery tube60d, typically along the length of the delivery tube. Typically, delivery tube60dcomprises a sheet of the flexible material, held in a generally cylindrical shape bypullstring750. For example,pullstring750 may weave between two parts of the flexible material, stitching them together. Alternatively,pullstring750 may be coupled to the two parts of the flexible material via a weakened (e.g., perforated) join.
• FIG. 33B showsprosthetic valve42 partially deployed from delivery tube60d. Typically, following placement of delivery tube60d(and thereby prosthetic valve42) in the lumen of native valve23,pullstring750 is pulled, decoupling the two parts of the flexible material, and thereby opening delivery tube60d. Typically, regions ofprosthetic valve42 expand as regions of delivery tube60dare opened.FIG. 33C showsprosthetic valve42 fully deployed from delivery tube60d.Prosthetic valve42 has expanded toward its expanded configuration.Pullstring750 has been pulled sufficiently, such that the flexible material of delivery tube60dbecomes a generally open sheet. That is, delivery tube60dtypically loses its cylindrical shape and becomes flaccid, thereby facilitating its removal from the subject. For example delivery tube60dmay be moved around corners and/or into an overtube such as a catheter.
• Reference is made toFIG. 34, which is a schematic illustration ofprosthetic valve42, comprising a tissue-engaging element62, comprising a leaflet-engaging element760, coupled to a distal portion of primarystructural element130 of the prosthetic valve, in accordance with some applications of the invention. For some applications, leaflet-engaging760 is similar in structure to a valve-anchoring element64, such as a loop-shaped valve-anchoringelement200. Element760 is positioned and configured so as to engage a single leaflet, typically the anterior leaflet, of native valve23. The engagement of the leaflet is hypothesized to reduce undesired interference with blood flow. Specifically, holding the anterior leaflet clear of the LVOT is hypothesized to reduce interference with blood flowing from the left ventricle into the aorta.
• Although element760 is described with reference toFIG. 34 as being coupled to the primary structural element ofprosthetic valve42, it is to be noted that the scope of the present invention includes an element760 being additionally or alternatively coupled toprosthetic valve support40.
• Reference is made toFIGS. 35A-C, which are schematic illustrations of sequential steps in the implantation ofprosthetic valve42, andprosthetic valve support40, comprising prosthetic valve support40z, in accordance with some applications of the invention. As described hereinabove,support40 comprises anupstream support portion41 which is shaped to define a lumen. During implantation ofimplant30,prosthetic valve42 is deployed in this lumen. As described herein, for some applications of the invention,support40 is coupled to native valve23 prior to delivery and/or deployment ofprosthetic valve42. For example,support40 may comprise tissue-engaging elements62, comprising support-anchoring elements66 (not shown inFIGS. 35A-C). In some applications,support40 and/or the coupling thereof to native valve23, interferes with the functioning ofleaflets82 of the native valve. For example, in some applications,support40 is coupled to the native valve via support-anchoring elements66 engaging (i.e., coupling to)leaflets82, thereby disrupting native valve function. For further example, in some applications, elements66move leaflets82, so as to sandwich the leaflets againstprosthetic valve42. For applications such as these, there is typically a period after the coupling ofsupport40 to the native valve, and before deployment ofprosthetic valve42, that the native valve has significantly reduced functionality. Prosthetic valve support40zcomprises one or more temporary valve components, such astemporary leaflets700, and advantageously provides temporary valve functionality during this period.
• FIG. 35A shows prosthetic valve support40z, which comprises one or more temporary valve components, such astemporary leaflets700, typically disposed in the lumen defined by support40z.Leaflets700 provide temporary valve functionality to support40z, thereby facilitating pumping of blood by the heart in the absence of native valve function.Temporary leaflets700 may comprise a biological material, such as pericardial tissue, and/or a synthetic material, such as silicone, polyethylene terephthalate (e.g., polyester), and/or polytetrafluoroethylene (e.g., Teflon). Temporary leaflets are typically coupled toupstream support portion41 using sutures. It is noted that, although prosthetic valve40zis illustrated inFIGS. 35A-C as not comprising tissue-engaging elements such as support-anchoring elements66, prosthetic valve40ztypically does comprise support-anchoring elements66, such as those described elsewhere herein.
• FIG. 35B showsprosthetic valve42 being deployed in the lumen of support40z. For some applications,prosthetic valve42 is deployed as described with reference toFIGS. 1A-H, mutatis mutandis. For some applications,prosthetic valve42 is deployed as described with reference toFIGS. 15A-L, mutatis mutandis. As it expands,prosthetic valve42 typically pushes asidetemporary leaflets700.
• FIG. 35C showsprosthetic valve42 having been fully deployed (i.e., expanded) in the lumen of support40z. In some applications,leaflets700 are sandwiched betweenprosthetic valve42 and support40z. In some applications,leaflets700 facilitate sealing betweenprosthetic valve42 and support40z. Asprosthetic valve42 is deployed, it begins to function, thereby replacing the temporary valve functionality ofleaflets700. Thereby, the techniques described with reference toFIGS. 35A-C provide ongoing valve functionality throughout the implantation of a prosthetic valve.
• Reference is made toFIGS. 36A-D, which are schematic illustrations ofprosthetic valve support40, comprising a prosthetic valve support1040, in accordance with some applications of the invention. For some applications of the invention, prosthetic valve support1040 is analogous to other prosthetic valve supports described herein. For some applications of the invention, prosthetic valve support1040 comprisesprosthetic valve support40. Support1040 comprisesupstream support portion41, which is shaped to define a lumen. Support1040 comprises one or more support-anchoringelements900 and one or more stabilizinglegs910. Typically, support1040 comprises two support-anchoringelements900 and two stabilizinglegs910. Typically, support-anchoringelements900 and stabilizinglegs910 are coupled toinner edge68 ofupstream support portion41. For some applications of the invention, support-anchoringelements900 are embodiments of support-anchoring elements66, which are embodiments of tissue-engaging elements62, as described hereinabove. For some applications of the invention, stabilizinglegs910 are embodiments of support-anchoring elements and/or of tissue-engaging elements62, as described hereinabove.
• FIG. 36A shows a lower side view of support1040. Typically, support-anchoringelements900 comprise clips and/or clip functionality.Elements900 are illustrated inFIG. 36A as generic clips, and may comprise any of the clips described herein, and/or any other clips that are couplable to the leaflets of the native valve (e.g., support-anchoringelements900aand900band the clip functionalities thereof, described hereinbelow with reference toFIGS. 37A-H, and38A-H). For some applications of the invention, support-anchoringelement900 comprises two clip elements, (1) coupled at a coupling point, and (2) between which, during implantation,leaflets82 of the native valve are typically clamped. Clamping of a leaflet between the two clip elements coupleselement900 to the leaflet. Typically, one clip element is substantially immobile, and the other clip element is (1) biased to assume a first configuration, and (2) movable between the first configuration and another configuration.
• Element900 typically has (1) an open configuration, in whichleaflets82 of the native valve may be moved between the two clip elements, and (2) a closed configuration, in which the clip elements typically clamp (i.e., couple to) the leaflets.Element900 is typically moved between the open and closed configurations thereof (i.e., is opened and closed) by moving at least one clip element between the first configuration thereof, and the other configuration thereof.
• Typically, the clip elements are disposed at a distal portion of each support-anchoringelement900, and a proximal portion (e.g., a proximal end) of eachelement900 is coupled toupstream support portion41. Typically, support-anchoringelements900 have a length (i.e., a distance from (1) the point of coupling of theelement900 toupstream support portion41, to (2) a distal end of the element900) of between 3 and 20 mm, (e.g., between 5 and 12 mm). Typically, the proximal portion has a length (i.e., a distance between (1) the point of coupling ofelement900 toupstream support portion41, and (2) a clip element) of between 2 and 10 mm, (e.g., between 2 and 8 mm)
• Support1040 typically comprises two support-anchoringelements900 and two stabilizinglegs910. Typically,elements900 andlegs910 are disposed atinner edge68 in an alternating manner, i.e., such that eachleg910 is between twoelements900, and eachelement900 is between twolegs910.
• Typically, stabilizingleg910 is longer than support-anchoringelement900. That is, a distance between (1) acoupling point911 ofupstream support portion41 and a stabilizingleg910 and (2) a distal end of the stabilizing leg, is typically greater than a distance between (1) a coupling point ofupstream support portion41 and anelement900 and (2) a distal end of theelement900. Typically, stabilizingleg910 has a length of between 5 mm and 30 mm (e.g., between 5 mm and 20 mm), and a width of between 0.4 mm and 5.0 mm.
• For some applications of the invention, each stabilizingleg910 comprises a proximal portion912 and adistal portion914, whereby the proximal portion is coupled atcoupling point913 between the stabilizing leg and the distal portion. For some such applications, stabilizingleg910 comprises a bend, such that an axis defined bydistal portion914 is divergent to an axis defined by the proximal portion. Typically, proximal portion912 has a length of between 5 mm and 20 mm.
• Typically, stabilizinglegs910 have a stabilizing configuration, in which they stabilize prosthetic valve support1040 at the native valve. Typically, in the stabilizing configuration, the proximal portion912 of eachleg910 is disposed on a plane between (1) a plane that is orthogonal to a plane defined byupstream support portion41, and (2) a position in which the leg touches a part ofupstream support portion41 that is peripheral toinner edge68. That is, in the stabilizing configuration, proximal portion912 typically forms an acute angle with a portion ofupstream support portion41.
• Stabilizinglegs910 are hypothesized to increase the stability of prosthetic valve support1040 at the native valve. For example,legs910 are hypothesized to at least partly inhibit (1) lateral rotation (i.e., rotation around an atrial-ventricular axis) of the prosthetic valve support, and/or (2) movement of the parts ofupstream support portion41 that are disposed against the proximal (e.g., atrial) side of the native valve, from moving away from, or through, the native valve. Following deployment (e.g., implantation) ofprosthetic valve42,legs910 are further hypothesized to reduce rolling movement (e.g., movement around a lateral axis, e.g., an axis between twoelements900, such as an axis that is generally orthogonal to an axis between the stabilizing legs) of the prosthetic valve and/orimplant30, including inversion (e.g., ‘flipping’) of the implant.
• For some applications of the invention, support1040 is configured such thatlegs910 and/orelements900 are biased to reside in a particular (e.g., a pre-selected) configuration. For example,legs910 and/orelements900 and/or a coupling point (e.g., coupling point911) may comprise a shape-memory material (e.g., nitinol, stainless steel, nickel cobalt, cobalt chrome, and/or titanium) or a spring mechanism. For some applications of the invention, the pre-selected configuration oflegs910 comprises the stabilizing configuration oflegs910.
• For some applications of the invention,legs910 and/orelements900 are rotatable aroundcoupling point911. For example,legs910 and/orelements900 may be coupled toupstream support portion41 via a hinge point (e.g., a hinge element), which may comprise a flexible material and/or moving components. For some applications of the invention,legs910 and/orelements900 rotate freely aroundcoupling point911 as far as their shape and juxtaposition allows.
• For some applications whereelements900 rotate freely, following the coupling ofelements900 toleaflets82 of the native valve, the leaflets continue to function, at least in part.
• For some applications where stabilizinglegs910 rotate freely, the stabilizing legs have (1) a floating configuration, in which the stabilizing legs rotate freely, and (2) a stabilizing configuration, in which the stabilizing legs assume the pre-selected configuration, and are movable from the floating configuration to the pre-selected configuration. For some such applications, stabilizing legs assume the floating configuration when support1040 is implanted, and are moved to the stabilizing configuration when the prosthetic valve is deployed in the lumen of the support.
• FIG. 36B shows a top (i.e., atrial side) view ofimplant30, comprising support1040 andprosthetic valve42, following implantation in native valve23, comprisingmitral valve24, in accordance with some applications of the invention. Zones (scallops) P1, P2 and P3 of posterior leaflet82p, and zones A1 and A3 of anterior leaflet82aare labeled. As described hereinabove,elements900 andlegs910 are disposed atinner edge68 in an alternating manner. For the applications of the invention illustrated inFIG. 36B,elements900 andlegs910 are typically arranged such that (1) the twoelements900 are disposed opposite each other, (2) the twolegs910 are disposed opposite each other, and (3) eachleg910 is generally midway between the twoelements900. That is,inner edge68 is typically elliptical (e.g., circular), and eachleg910 is disposed atedge68 generally between 80 degrees and 100 degrees (e.g., 90 degrees) to anelement900.
• Typically, support-anchoringelements900 are coupled toleaflets82, i.e., oneelement900 is coupled to anterior leaflet82a, and oneelement900 is coupled to posterior leaflet82p. Typically, stabilizinglegs910 are oriented toward zones (scallops) P1 and P3 of the posterior leaflet. This configuration and orientation ofelements900 andlegs910 with respect to each other, and with respect to the native valve, is hypothesized to facilitate the stable placement and coupling (i.e., implantation) of prosthetic valve support1040 at/to the native valve, and thereby is hypothesized to facilitate the stable implantation ofimplant30 at the native valve.
• FIG. 36C shows a top (i.e., atrial side) view ofimplant30, comprising support1040 andprosthetic valve42, following implantation in native valve23, comprisingmitral valve24, in accordance with some applications of the invention. Zones (scallops) P1, P2 and P3 of posterior leaflet82p, and zones A1 and A3 of anterior leaflet82aare labeled. As described hereinabove,elements900 andlegs910 are disposed atinner edge68 in an alternating manner. For the applications of the invention illustrated inFIG. 36C, support-anchoringelements900 are coupled toleaflets82, i.e., oneelement900 is coupled to anterior leaflet82a, and oneelement900 is coupled to posterior leaflet82p.Elements900 andlegs910 are typically arranged such that (1) the twoelements900 are disposed opposite each other, and (2) eachleg910 is disposed between 30 degrees and 120 degrees (e.g., between 60 degrees and 120 degrees) from theelement900 that is coupled to the posterior leaflet.
• Stabilizinglegs910 are thereby typically oriented toward parts of posterior leaflet82p. This configuration and orientation ofelements900 andlegs910 with respect to each other, and with respect to the native valve, is hypothesized to facilitate the stable placement and coupling (i.e., implantation) of prosthetic valve support1040 at/to the native valve, and thereby is hypothesized to facilitate the stable implantation ofimplant30 at the native valve.
• FIG. 36D shows a top (i.e., atrial side) view ofimplant30, comprising support1040 andprosthetic valve42, following implantation in native valve23, comprisingmitral valve24, in accordance with some applications of the invention. Zones (scallops) P1, P2 and P3 of posterior leaflet82p, and zones A1 and A3 of anterior leaflet82aare labeled. As described hereinabove,elements900 andlegs910 are disposed atinner edge68 in an alternating manner. For the applications of the invention illustrated inFIG. 36D, support-anchoringelements900 are coupled toleaflets82, i.e., oneelement900 is coupled to anterior leaflet82a, and oneelement900 is coupled to posterior leaflet82p.Elements900 andlegs910 are typically arranged such that (1) the twoelements900 are disposed opposite each other, and (2) eachleg910 is disposed between 30 degrees and 120 degrees (e.g., between 60 degrees and 120 degrees) from theelement900 that is coupled to the anterior leaflet.
• Stabilizinglegs910 are thereby typically oriented toward parts of anterior leaflet82a. This configuration and orientation ofelements900 andlegs910 with respect to each other, and with respect to the native valve, is hypothesized to facilitate the stable placement and coupling (i.e., implantation) of prosthetic valve support1040 at/to the native valve, and thereby is hypothesized to facilitate the stable implantation ofimplant30 at the native valve.
• Reference is made toFIGS. 37A-H, which are schematic illustrations of prosthetic valve support1040, comprising aprosthetic valve support1040a, and the implantation thereof in a native valve, in accordance with some applications of the invention. For some applications of the invention,support1040ais an embodiment ofprosthetic valve support40, described hereinabove.FIG. 37A shows a lower side view, and some detailed views, ofsupport1040a.Support1040acomprises two support-anchoringelements900, comprising support-anchoringelements900a, and two stabilizinglegs910. Typically,elements900aandlegs910 are disposed atinner edge68 such that (1) the twoelements900aare disposed opposite each other, (2) the twolegs910 are disposed opposite each other, and (3) eachleg910 is generally midway between the twoelements900a. That is,inner edge68 is typically elliptical (e.g., circular), and eachleg910 is disposed atedge68 generally at a right angle (e.g., between 80 degrees and 100 degrees, such as 90 degrees) to anelement900a.
• Support-anchoringelement900acomprises two clip elements, such asplate920 andplate922, (1) coupled at a coupling point, and (2) between which, during implantation,leaflets82 of the native valve are clamped. Typically,plate920 is substantially immobile, andplate922 is (1) biased to assume a first configuration, and (2) movable between the first configuration and another configuration. Typically, the first configuration ofplate922 is a closed configuration. Typically, the other configuration ofplate922 is an open configuration, whereby a portion ofplate922 that is furthest from the coupling point is disposed (1) further fromplate920 than is the same portion in the first, closed configuration, and (2) further fromplate920 than a portion ofplate922 that is closest to the coupling point. Whenplate922 is in the closed configuration thereof,element900ais in a closed configuration thereof. Whenplate922 is in the open configuration thereof,element900ais in an open configuration thereof. That is,element900ais movable between open and closed configurations thereof, byplate922 moving between open and closed configurations thereof.FIG. 37A shows detailed illustrations of support-anchoringelement900ain the open and closed configurations, and further shows an exploded view of the components ofelement900a.
• Support-anchoringelement900afurther comprises, or is coupled to, an actuator, typically comprising a pull-wire924, which facilitates movement ofplate922 between the closed and open configurations. Pull-wire924 is typically coupled toplate922, and controlled from outside the subject. For example, pull-wire924 may be coupled toplate922, and extend to a control unit outside the body of the subject, for use by a physician. Typically, pull-wire924 is coupled to the portion ofplate922 that is furthest from the coupling point, such that movement of the pull-wire proximally (e.g., by pulling) movesplate922 toward the open configuration. For some applications of the invention, pull-wire924 is slidably coupled to another part ofelement900a, such asplate920, and/or to another part ofsupport1040a, and/or to a part of delivery apparatus, such ascore926, as shown inFIGS. 37C-E. That is,plate922, and therebyelement900a, are configured to be biased toward assuming a closed configuration, such that the user (1) actively openselement900ato envelop aleaflet82, and (2) releaseselement900ato couple the element to the leaflet (i.e., to clamp the leaflet betweenplates920 and922).
• For some applications of the invention, both support-coupling elements900aare controlled simultaneously by a user (e.g., support-coupling elements900aare configured to operate simultaneously). For some applications, eachelement900ais controllable independently. For some applications,element900afurther comprises one or more grips, such asteeth928, which facilitate the clamping ofleaflets82 whenelement900ais closed.
• FIG. 37B shows a top side view ofprosthetic valve support1040a. Support-coupling elements900aare shown in their closed configuration.
• FIG. 37C showsprosthetic valve support1040abeing delivered to native valve23, comprisingmitral valve24.Support1040ais shown in a partially deployed configuration, wherebyupstream support portion41 is compressed within anovertube1044, and support-anchoringelements900aand stabilizinglegs910 are exposed from the distal end of the overtube. Support-anchoringelements900aare shown in the closed configuration thereof. Typically, prior to deployment, at least part ofsupport1040ais coupled to (e.g., disposed around) a scaffold, such as acore926. For some applications of the invention,core926 is configured to facilitate the opening ofelements900a(i.e., movement ofelements900aand/orplate922 to the open configuration), and/or to facilitate the enveloping ofleaflets82 of the native valve byelements900a. For example, and as shown inFIG. 37C,core926 may supportelements900aat an angle that facilitates the movement ofplate922 by pull-wire924.
• FIG. 37D shows, in cross-section,support1040ain a partially-deployed configuration within native valve23.Annular portion41 ofsupport1040ais in a compressed configuration thereof, and is partially disposed withinovertube1044. Support-anchoringelements900aand stabilizinglegs910 are exposed from the distal end of the overtube (i.e., have been deployed from the overtube). Arrows indicate the movement of pull-wire924, caused by proximally pulling the pull-wire. Support-anchoringelements900aare shown having been moved to the open configuration thereof, by the movement of pull-wire924. A part of eachleaflet82 is shown within the ‘dip’ of arespective element900a(i.e., enveloped by and/or disposed betweenplate920 andplate922 of arespective element900a). For some applications, the entry ofleaflets82 between the plates is facilitated by the movement of the leaflets caused by the beating ofheart22. For some applications, the entry ofleaflets82 between the plates is facilitated by movement ofsupport1040a, and/or iterative opening and closing ofelements900a.
• FIG. 37E shows support-anchoringelements900ahaving moved to the closed configuration thereof, following the release of pull-wire924. Arrows indicate the movement of pull-wire924 following the release thereof. The part of eachleaflet82 that was previously disposed betweenplate920 andplate922 is thereby clamped between the two plates. That is,elements900aare coupled toleaflets82 of the native valve. Onceelements900ahave been successfully coupled to leaflets82 (e.g., once a physician is satisfied with the position and coupling ofsupport1040a), the remainder of the support (e.g., upstream support portion41) is typically deployed.
• FIG. 37F showsprosthetic valve support1040ain a fully-deployed configuration thereof. Following coupling ofelements900atoleaflets82, overtube1044 is retracted proximally, and/orsupport1040ais moved distally, such that the support emerges from the overtube, and expands to its expanded configuration. For some applications, the expansion ofsupport1040aautomatically decouples the support from the scaffold (e.g., core926), which is subsequently removed from the subject.Annular portion41 ofsupport1040ais shown disposed against the proximal side (e.g., the atrial surface) of the native valve, as described hereinabove with respect toupstream support portion41 of other prosthetic valve supports.FIG. 37D shows native valve23 in an open configuration thereof, wherebyleaflets82 generally extend intoventricle28. As described hereinabove, mutatis mutandis, with reference toelements900, illustrated inFIGS. 36A-D, for some applications,elements900aare configured to allowleaflets82 to continue to function, at least in part. For such applications,FIG. 37F illustrates a snapshot of the position ofleaflets82 during diastole. As also described hereinabove, mutatis mutandis, with reference toelements900, illustrated inFIGS. 36A-D, for some applications,elements900aare configured to be biased to assume a pre-selected position with respect toupstream support portion41. For such applications,FIG. 37F illustratesleaflets82 being held in the open configuration thereof, byelements900athat are configured to be biased to assume the position shown.
• For some applications, following deployment ofsupport1040a, pull-wire924, or a portion thereof, is decoupled from the support, or a portion thereof, (e.g., fromelement900a). For example, the pull-wire may be coupled toelement900ausing a lock described herein (e.g., with reference toFIGS. 45A-C and/or64A-C, mutatis mutandis), and decoupled fromelement900aby moving the lock to the open configuration. Alternatively, the pull-wire may be coupled toelement900aby being looped around the element, and decoupled from the element by being unlooped from the element, e.g., by subsequent to a portion of the pull-wire being cut and/or released.
• FIG. 37G showsprosthetic valve42, having been deployed (e.g., delivered and expanded) in the lumen ofprosthetic valve support1040a, and coupled thereto, as described herein (e.g., with reference to other prosthetic valve supports).
• FIG. 37H is a top (e.g., atrial) view ofprosthetic valve42, having been deployed (e.g., delivered and expanded) in the lumen ofprosthetic valve support1040a, and coupled thereto, as described herein (e.g., with reference to other prosthetic valve supports). Support-anchoringelements900aare coupled toleaflets82, i.e., oneelement900ais coupled to anterior leaflet82a, and oneelement900ais coupled to posterior leaflet82p.Elements900aandlegs910 are typically arranged such that (1) the twoelements900aare disposed opposite each other, and (2) eachleg910 is disposed between 60 degrees and 120 degrees from theelement900athat is coupled to the posterior leaflet.
• Reference is made toFIGS. 38A-H, which are schematic illustrations of prosthetic valve support1040, comprising aprosthetic valve support1040b, and the implantation thereof in a native valve, in accordance with some applications of the invention. For some applications of the invention,support1040bis an embodiment ofprosthetic valve support40, described hereinabove.FIG. 38A shows a lower side view, and some detailed views, ofsupport1040b.Support1040bcomprises two support-anchoringelements900, comprising support-anchoringelements900b, and two stabilizinglegs910. Typically,elements900bandlegs910 are disposed atinner edge68 such that (1) the twoelements900bare disposed opposite each other, (2) the twolegs910 are disposed opposite each other, and (3) eachleg910 is generally midway between the twoelements900b.
• Support-anchoringelement900bcomprises two clip elements, such asplate940 andplate942, (1) coupled at a coupling point, and (2) between which, during implantation,leaflets82 of the native valve are clamped. Typically,plate940 is substantially immobile, andplate942 is (1) biased to assume a first configuration, and (2) movable between the first configuration and another configuration. Typically, the first configuration ofplate942 is an open configuration, whereby a portion ofplate942 that is furthest from the coupling point is disposed further fromplate940 than a portion ofplate942 that is closest to the coupling point. Typically, the other configuration ofplate942 is a closed configuration, whereby a portion ofplate942 that is furthest from the coupling point is disposed closer to plate940 than is the same portion in the first, open configuration. Whenplate942 is in the closed configuration thereof,element900bis in a closed configuration thereof. Whenplate942 is in the open configuration thereof,element900bis in an open configuration thereof. That is,element900bis movable between open and closed configurations thereof, byplate942 moving between open and closed configurations thereof.
• FIG. 38A shows detailed illustrations of support-anchoringelement900bin the open and closed configurations, and further shows an exploded view of the components ofelement900b. As shown in the exploded view, for some applications,plate942 comprises more than one element, including aspring element942a, and aface element942b.Spring element942atypically comprises a strip of shape-memory material (e.g., nitinol, stainless steel, nickel cobalt, cobalt chrome, and/or titanium), that is configured such thatplate942 is biased to assume the open configuration.Spring element942ais typically configured to provide a force that is (1) sufficiently strong to provide this bias, but (2) sufficiently weak so as to facilitate (e.g., to not inhibit) sliding ofcuff944 overplate942. Typically, this configuration is provided by selecting an appropriate thickness of the strip of shape-memory material ofspring element942a.Face element942bis typically configured to increase the rigidity of at least part ofplate942, thereby facilitating clamping of the native leaflets whencuff944 is slid overplate942.
• Support-anchoringelement900bfurther comprises an actuator, typically comprising a restraint, such ascuff944, which facilitates movement ofplate922 between the closed and open configurations.Cuff944 is typically coupled toplate940 and/orplate942, and controlled from outside the subject (e.g., controlled from outside the body of the subject by a physician, such as via a control unit). Typically,cuff944 is coupled toplate940 via aspring950, and is slidable over (e.g., onto and off of) at least a portion ofplate942. Support-anchoringelement900bis configured such that (1)spring950 applies a force (i.e., a first force) tocuff944, that slidescuff944 overplate942, and (2) sliding ofcuff944 overplate942 moves the portion ofplate942 that is furthest from the coupling point closer to plate950 (i.e., movesplate942, and therebyelement900b, into the closed configuration). A user typically openselement900b(e.g., so as to clamp leaflets of the native valve, e.g., as described hereinbelow with reference toFIGS. 38D-E) by slidingcuff944 off ofplate942. For example, acontrol rod952 may be used to slidecuff944 off of plate942 (e.g., by distal movement of the control rod), and may be controlled, by a physician, via a control unit outside the body of the subject. That is, (1)plate942 itself is configured to be biased toward assuming an open configuration, (2)cuff944 andspring950 are configured to moveplate942 toward a closed configuration, and (3) the user (a) actively openselement900bby slidingcuff944 off ofplate942, so as to envelop aleaflet82, and (b) releasescuff944 to couple the element to the leaflet (i.e., to clamp the leaflet betweenplates940 and942).
• For some applications of the invention, both support-coupling elements900bare controlled simultaneously by a user (e.g., support-coupling elements900bare configured to operate simultaneously). For some applications, eachelement900bis controllable independently. For some applications,element900bfurther comprises one or more grips, such asteeth948, which facilitate the clamping ofleaflets82 whenelement900bis closed. For some applications,control rod952 is moved distally using a pusher (not shown), disposed within delivery apparatus (e.g., overtube1044), and typically not fixedly coupled to the control rod.
• FIG. 38B shows a top side view ofprosthetic valve support1040b. Support-coupling elements900bare shown in their open configuration.
• FIG. 38C showsprosthetic valve support1040bbeing delivered to native valve23, comprisingmitral valve24.Support1040bis shown in a partially deployed configuration, wherebyupstream support portion41 is compressed withinovertube1044, and support-anchoringelements900band stabilizinglegs910 are exposed from the distal end of the overtube. Support-anchoringelements900bare shown in the closed configuration thereof. Typically, prior to deployment, at least part ofsupport1040bis coupled to (e.g., disposed around) a scaffold, such as acore946. For some applications of the invention,core946 is configured to facilitate the opening ofelements900b(i.e., movement ofelements900band/orplate942 to the open configuration), and/or to facilitate the enveloping ofleaflets82 of the native valve byelements900b. For example, and as shown inFIG. 38C,core946 may supportelements900bat a pre-selected angle.
• FIG. 38D showssupport1040bin a partially-deployed configuration within native valve23.Annular portion41 ofsupport1040bis in a compressed configuration thereof, and is partially disposed withinovertube1044. Support-anchoringelements900band stabilizinglegs910 are exposed from the distal end of the overtube (i.e., have been deployed from the overtube). Arrows indicate the movement ofcuff944, caused by distal movement (e.g., pushing) ofcontrol rod952. Support-anchoringelements900bare shown having been moved to the open configuration thereof, by the movement ofcuff944. A part of eachleaflet82 is shown within the ‘clip’ of arespective element900b(i.e., enveloped by and/or disposed betweenplate940 andplate942 of arespective element900b). For some applications, the entry ofleaflets82 between the plates is facilitated by the movement of the leaflets caused by the beating ofheart22. For some applications, the entry ofleaflets82 between the plates is facilitated by movement ofsupport1040b, and/or iterative opening and closing ofelements900b.
• FIG. 38E shows support-anchoringelements900bhaving moved to the closed configuration thereof, following the release of cuff944 (e.g., caused by the release of control rod952). Arrows indicate the movement ofcuff944 following the release thereof. The part of eachleaflet82 that was previously enveloped by (i.e., disposed between)plate940 andplate942 is thereby clamped between the two plates. That is,elements900bare coupled toleaflets82 of the native valve. Onceelements900bhave been successfully coupled to leaflets82 (e.g., once a physician is satisfied with the position and coupling ofsupport1040b), the remainder ofprosthetic valve support1040b(e.g., upstream support portion41) is typically deployed.
• FIG. 38F showsprosthetic valve support1040bin a fully-deployed configuration thereof. Following coupling ofelements900btoleaflets82, overtube1044 is retracted proximally, and/orsupport1040bis moved distally, such that the support emerges from the overtube, and expands to its expanded configuration. For some applications, the expansion ofsupport1040bautomatically decouples the support from the scaffold (e.g., core946), which is subsequently removed from the subject.Annular portion41 ofsupport1040bis shown disposed against the proximal side (e.g., the atrial surface) of the native valve, as described hereinabove with respect toupstream support portion41 of other prosthetic valve supports.FIG. 38D shows native valve23 in an open configuration thereof, wherebyleaflets82 generally extend intoventricle28. As described hereinabove, mutatis mutandis, with reference toelements900, illustrated inFIGS. 36A-D, for some applications,elements900bare configured to allowleaflets82 to continue to function, at least in part. For such applications,FIG. 38F illustrates a snapshot of the position ofleaflets82 during diastole. As also described hereinabove, mutatis mutandis, with reference toelements900, illustrated inFIGS. 36A-D, for some applications,elements900bare configured to be biased to assume a pre-selected position with respect toupstream support portion41. For such applications,FIG. 38F illustratesleaflets82 being held in the open configuration thereof, byelements900bthat are configured to be biased to assume the position shown.
• As described hereinabove, for some applications,control rod952 is moved distally using a pusher, disposed within delivery apparatus (e.g., overtube1044), and typically not fixedly coupled to the control rod. For such applications, the pusher remains within the delivery apparatus, and is removed with the delivery apparatus, following full deployment ofprosthetic valve support1040b.FIG. 38F thus shows aproximal end953 of eachcontrol rod952, previously disposed withinovertube1044, now exposed and not in contact with the pusher, following removal of the overtube.
• FIG. 38G showsprosthetic valve42, having been deployed (e.g., delivered and expanded) in the lumen ofprosthetic valve support1040b, and coupled thereto, as described herein (e.g., with reference to other prosthetic valve supports).
• FIG. 38H is a top (e.g., atrial) view ofprosthetic valve42, having been deployed (e.g., delivered and expanded) in the lumen ofprosthetic valve support1040b, and coupled thereto, as described herein (e.g., with reference to other prosthetic valve supports). Support-anchoringelements900bare coupled toleaflets82, i.e., oneelement900bis coupled to anterior leaflet82a, and oneelement900bis coupled to posterior leaflet82p.Elements900bandlegs910 are typically arranged such that (1) the twoelements900bare disposed opposite each other, and (2) eachleg910 is disposed between 60 degrees and 120 degrees from theelement900bthat is coupled to the posterior leaflet.
• Reference is again made toFIGS. 36A-38H. Typically, support-anchoring elements900 (e.g.,elements900aand900b) and stabilizinglegs910 are configured to be movable independently from each other, and to be at least in part flexible and/or movable with respect toannular element41. That is,elements900 andlegs910 are typically positionable according to the individual anatomy of the subject in which the implant is implanted. For some applications of the invention, this is conferred at least in part by the connection between (1) theelement900 and/orleg910, and (2)upstream support portion41. For some applications of the invention, this is conferred at least in part by the composition of theelement900 and/orleg910 itself. For example, for some applications, techniques and/or elements described with reference toFIGS. 2-7 and17A-20F, may be used in combination with those described with reference toFIGS. 36A-37H (e.g., in combination with support-anchoringelements900,900a, and/or900b, and stabilizing legs910).
• For some applications of the invention, during the deployment (e.g., implantation) of prosthetic valve support1040 (e.g.,support1040a, and/orsupport1040b), the user (e.g., physician) may determine the quality (e.g., strength) of coupling of support-anchoring elements900 (e.g.,elements900a, and/or900b) by applying a force (e.g., pushing, pulling, twisting) to the device, and/or using imaging techniques to visualize the device in situ.
• Typically, support-anchoring elements900 (e.g.,elements900aand/or900b) are operable (i.e., openable, and/or closable) repeatedly. Should coupling ofelements900 toleaflets82 be determined to be suboptimal,elements900 may be opened (e.g., decoupled from the leaflets) and reclosed (e.g., re-coupled to the leaflets), until optimal coupling has been achieved.
• Should it be necessary and/or desirable during deployment, until prosthetic valve support1040 (e.g.,support1040a, and/orsupport1040b) is fully deployed (e.g., from overtube1044), the deployed, expanded portions of the support (i.e., the portions of the support, including elements900) that are exposed from the overtube may be drawn back into the overtube (e.g., for repositioning, or for withdrawal from the body of the subject).
• It is to be noted that, although the support-anchoring elements described with reference toFIGS. 36A-38H (e.g.,elements900,900aand900b) are described and/or illustrated in the context of prosthetic valve supports that comprise two support-anchoring elements and two stabilizing legs (e.g., as described with reference toFIGS. 36A-D), the scope of the invention includes other contexts for these support-anchoring elements, and the clip functionality thereof. For example, for some applications of the invention, a prosthetic valve support comprises two support-anchoringelements900aand/or support-anchoringelements900b, and does not comprise stabilizinglegs910. For some applications of the invention, a prosthetic valve support comprises greater or fewer than two such support-anchoring elements. Furthermore, for some applications of the invention, the structure and/or function ofelement900aand/or900 may be incorporated in a valve-anchoring element (e.g., valve-anchoring element64). That is, for some applications of the invention, a prosthetic valve comprises at least one valve-anchoring element, which is described as a support-anchoring element with reference to one or more ofFIGS. 36A-38H, mutatis mutandis.
• Reference is made toFIGS. 39A-D, which are schematic illustrations of a medical device150, comprising one or more coupling tabs1100, in accordance with some applications of the invention. Coupling tabs1100 facilitate delivery of medical device150, by facilitating reversible coupling of the medical device to a delivery apparatus, such as, but not limited to, delivery apparatus880 (described with reference toFIGS. 27A-D).FIGS. 39A-D illustrate medical device150 as comprisingprosthetic valve42. However, it should be noted that the scope of the invention includes coupling tabs1100 that facilitate delivery of other medical devices (e.g., expandable medical devices).FIGS. 39A-B show coupling tabs1100 comprising T-shaped coupling tabs1100a, andFIG. 39C-D show coupling tabs1100 comprising box-shaped coupling tabs1100b. Tabs1100aand1100bare configured, respectively, to be reversibly couplable to delivery apparatus of a respective, complimentary configuration.
• As described hereinabove,prosthetic valve42 has (1) a compressed configuration, in which it is typically delivered, within a delivery tube (e.g., tube60), to the implantation site (e.g., native valve23), and (2) an expanded configuration, toward which the prosthetic valve moves during deployment. Coupling tabs1100 are configured such that (1) in the compressed configuration of the prosthetic valve, the tabs assume a restrained configuration (FIGS. 39A and 39C), and (2) in the expanded configuration of the prosthetic valve, the tabs assume an unconstrained configuration, e.g., a pre-selected configuration (FIGS. 39B and 39D). Typically, in the restrained configuration, coupling tabs1100 extend collinearly from an end ofprosthetic valve42. For example, and as illustrated inFIGS. 39A and 39C, coupling tabs1100 extend proximally from the proximal end of the prosthetic valve. Typically, in the unconstrained configuration, at least part of each coupling tab1100 protrudes radially from primarystructural element130 of the prosthetic valve. For some applications, and as illustrated inFIGS. 39B and 39D, in the unconstrained configuration, coupling tabs1100 extend radially outward from primarystructural element130 of the prosthetic valve. The arrows indicate the direction of the movement of coupling tabs1100 from the constrained to the unconstrained configuration. This movement is typically between 5 degrees and 180 degrees (e.g., between 80 degrees and 180 degrees). For some applications, this movement is greater than 180 degrees, whereby coupling tabs1100 protrude into voids defined byprosthetic valve42.
• Typically, coupling tabs1100 comprise a shape-memory material (e.g., nitinol, stainless steel, nickel cobalt, cobalt chrome, and/or titanium), and the unconstrained configuration is pre-selected by shape-setting the material.
• It is hypothesized that, whenprosthetic valve42 is implanted in the native valve, coupling tabs1100 (e.g., tabs1100aand tabs1100b), advantageously, disturb blood flow less than some coupling tabs that do not move into a configuration in which at least part of the tabs protrude radially from the prosthetic valve. For example, for some applications, coupling tabs1100 protrude less far proximally into the atrium from the proximal part of primarystructural element130, and/or are disposed further peripherally to a flow of blood through the prosthetic valve. It is hypothesized that this reduced blood flow disturbance of tabs1100 reduces the likelihood of inducing hemodynamic disorders such as thrombus formation. It is further hypothesized that this reduced proximal protrusion into the atrium, increases the available space in the atrium, thereby facilitating the delivery, removal and/or other movement of medical devices and/or delivery apparatus in the vicinity of the prosthetic valve.
• For some applications of the invention, coupling tabs1100 (e.g., coupling tabs1100a, and/or coupling tabs1100b) further facilitate coupling of the prosthetic valve to the prosthetic valve support (e.g., prosthetic valve support40). As described herein, the size of the lumen ofsupport40 typically determines the size to whichprosthetic valve42 expands, when implanted in this lumen. Thus, when implanted and expanded in the lumen ofprosthetic valve support40, the primary structural element ofprosthetic valve42 typically has a longest transverse cross-sectional length that generally corresponds to a longest transverse cross-sectional length of the lumen ofsupport40. A transverse cross section ofprosthetic valve42 at the position of radially-protruding coupling tabs1100, typically has a longest length that is greater than the longest transverse cross-sectional length of the lumen ofsupport40. That is, in the region of coupling tabs1100,prosthetic valve42 is typically wider than in other (e.g., more distal) regions of the prosthetic valve. This extra width provides axial resistance against undesired distal (e.g., ventricular) movement ofprosthetic valve42 with respect to support40, in addition to the resistance typically provided by radially expansive forces of prosthetic valve against the support.
• For some applications of the invention, coupling tabs1100 (e.g., coupling tabs1100a, and/or coupling tabs1100b) increase the rigidity of prosthetic valve42 (e.g., the rigidity of primarystructural element130 of the prosthetic valve). For example, for some applications, when primarystructural element130 is generally cylindrical, coupling tabs1100 inhibit deformation ofelement130.
• Reference is made toFIGS. 40A-C, which are schematic illustrations ofprosthetic valve42, comprisingprosthetic valve2000, which comprises one or more tissue-engagingelements2002. For some applications,elements2002 are embodiments of tissue-engaging elements62. For some applications,elements2002 are embodiments of valve-anchoring elements64. Tissue-engagingelements2002 protrude laterally from primarystructural element130 ofprosthetic valve2000.
• Tissue-engagingelements2002 are configured to couple toleaflets82 of the native valve, subsequent to the deployment (e.g., implantation) ofprosthetic valve2000. Typically,elements2002 are configured to couple to the leaflets by piercing the leaflets, at least in part.
• For some applications,prosthetic valve2000 comprises twoelements2002, that are disposed at sites on the circumference of primarystructural element130 that are generally opposite each other. For some applications of the invention,prosthetic valve2000 comprises more than two (e.g., four or more, such as six or more)elements2002, that are disposed circumferentially around primarystructural element130.
• For some applications, tissue-engagingelements2002 protrude generally orthogonally to the outer surface of primary structural element130 (i.e., generally straight outward laterally from element130). For some applications,elements2002 protrude at an acute angle from the outer surface of primarystructural element130. For example, and as illustrated inFIGS. 40A-C,elements2002 may protrude proximally, such that a portion (e.g., a tip) ofelements2002 that is further from a point of coupling between theelement2002 and primarystructural element130, is closer to the proximal end ofelement130 than is a portion ofelements2002 that is closer to that point of coupling.
• FIG. 40A showsprosthetic valve2010, comprising a plurality of tissue-engagingelements2012.Prosthetic valve2010 is an embodiment ofprosthetic valve2000, andelements2012 are embodiments of tissue-engagingelements2002.Elements2012 are typically configured to protrude at an acute angle from the outer surface of primarystructural element130 ofprosthetic valve2010.Tip2014 is the portion ofelement2012 that is furthest from a point of coupling between theelement2012 andelement130. For some applications of the invention,tip2014 is sharp (e.g., pointed) so as to facilitate piercing of the native leaflets.
• FIG. 40B showsprosthetic valve2020, comprising a plurality of tissue-engaging elements2022.Prosthetic valve2020 is an embodiment ofprosthetic valve2000, and elements2022 are embodiments of tissue-engagingelements2002. For some applications of the invention,prosthetic valve2020 and elements2022 are analogous to, and/or comprise,prosthetic valve2010 andelements2012, respectively. Elements2022 are typically configured to protrude at an acute angle from the outer surface of primarystructural element130 ofprosthetic valve2020. For some applications of the invention, elements2022 are formed from a lattice structure that the prosthetic valve comprises. For example, a separation in the structure may allow a portion of the structure to be moved out of the plane of the structure, thereby protruding fromelement130. Element2022 thereby comprises the protruding portion of the structure.Tip2024 is the portion of element2022 that is furthest from a point of coupling between the element2022 andelement130. For some applications of the invention,tip2024 is sharp (e.g., pointed) so as to facilitate piercing of the native leaflets.
• FIG. 40C showsimplant30, comprisingprosthetic valve support2030 andprosthetic valve2000, following implantation thereof in native valve23.Prosthetic valve support2030 typically comprises support-anchoringelements2032. For some applications of the invention,prosthetic valve support2030 and/or support-anchoringelements2032 are analogous, respectively, to other prosthetic valve supports and support-anchoring elements described herein. For some applications of the invention,prosthetic valve support2030 comprisesprosthetic valve support40.
• Immediately following the implantation ofsupport2030 andprosthetic valve2000,leaflets82 of the native valve typically continue to function, at least in part. For example, support-anchoringelements2032 may be configured to rotate around a coupling point withupstream support portion41 of the prosthetic valve, so as to allow the leaflets to continue to function, at least in part (e.g., as described herein for several support-anchoring elements). Whenleaflets82 move against prosthetic valve2000 (e.g., during systole), tissue-engagingelements2002 couple to (e.g., by piercing) the leaflets.
• For some applications of the invention, tissue-engagingelements2032 are configured to moveleaflets82 againstprosthetic valve2000, and thereby onto tissue-engagingelements2002. For example,elements2032 may be configured to move toward each other, such that following implantation ofprosthetic valve support2030 and coupling ofelements2032 toleaflets82, whenprosthetic valve2000 is deployed in the lumen ofsupport2030,elements2032push leaflets82 against the prosthetic valve.
• It is hypothesized that such coupling ofleaflets82 toelements2002, and thereby toprosthetic valve2000, facilitates (1) stable implantation ofimplant30 in the native valve, and/or (2) sealing ofleaflets82 around the prosthetic valve, thereby inhibiting retrograde leakage of blood between the leaflets and the implant.
• FIG. 40C shows, by way of illustration and not limitation,prosthetic valve2000 being used in combination with a prosthetic valve support that comprises support-anchoring elements. It is to be noted that, for some applications,prosthetic valve2000 is used in combination with other prosthetic valve supports that comprise support-anchoring elements, and/or with prosthetic valve supports that do not comprise support-anchoring elements.
• Reference is made toFIGS. 41A-B,42A-B,43A-C, and44A-B, which are schematic illustrations of prosthetic valves and prosthetic valve supports, comprising a coupling functionality for coupling support-anchoring elements of the prosthetic valve support to the prosthetic valve.
• Reference is now made toFIGS. 41A-B, which are schematic illustrations ofprosthetic valve support40, comprising a prosthetic valve support1122, which comprises one or more support-anchoringelements1124, in accordance with some applications of the invention.FIG. 41A shows support1122, andFIG. 41B shows, implanted in a native valve23, animplant30, which comprises support1122 andprosthetic valve42, comprising a prosthetic valve1120. For some applications of the invention, support-anchoringelements1124 comprise (1) other support-anchoring elements described herein (e.g., support-anchoring elements66), and/or (tissue-engaging elements62). Support-anchoringelements1124 comprise one ormore barbs1126, which comprise the coupling functionality for coupling the support-anchoring elements of the prosthetic valve support to the prosthetic valve. Typically, eachbarb1126 protrudes from another part ofelement1124 at between 10 degrees and 80 degrees (e.g., between 15 degrees and 60 degrees). Typically, a tip of each barb is thereby disposed more distally (e.g., ventricularly) than a base of that barb. Typically, eachbarb1136 has a length of between 0.5 and 5 mm.
• Prosthetic valve support1122 is typically delivered to, and deployed at, native valve23, as described herein for other prosthetic valve supports. Support-anchoringelements1124 are typically coupled toleaflets82 of the native valve, as described herein for other support-anchoring elements. Subsequent to the deployment and coupling of support1122 to the native valve, prosthetic valve1120 is deployed in the lumen of the prosthetic valve support, as described herein for other prosthetic valves. As prosthetic valve1120 expands,barbs1126 engage and couple to the prosthetic valve, typically by protruding into voids defined by the prosthetic valve. For some applications of the invention,elements1124 are configured to assume a pre-selected configuration, such as that shown inFIG. 41A, and to restrainleaflets82. For some applications of the invention,elements1124 are configured to allowleaflets82 to continue to function, at least in part. For some such applications, movement ofleaflets82 andelements1124, caused by the beating of the heart, is hypothesized to facilitate engagement of the prosthetic valve bybarbs1126.
• Typically,barbs1126 are configured to protrude into the voids defined by prosthetic valve1120, but to not protrude further into the prosthetic valve, e.g., into the lumen defined by the prosthetic valve. Typically, prosthetic valve1120 comprises a wire frame, and acovering1128, which covers at least part of the inner surface of the prosthetic valve (i.e., the walls of the lumen), so as to facilitate blood flow through the prosthetic valve. Typically,barbs1126 are dimensioned so as to protrude into the voids defined by the prosthetic valve, but to not protrude into and/or through covering1128. That is, prosthetic valve1120 and prosthetic valve support1122 are configured so as to be couplable to each other usingbarbs1126, without the barbs contacting (and possibly damaging) covering1128.
• For some applications of the invention, and as illustrated inFIG. 41B, the prosthetic valve is coupled to prosthetic valve support only by (1) a radially-expansive force exerted by the prosthetic valve on the prosthetic valve support, and (2)barbs1126 protruding into the voids defined by the prosthetic valve. For such applications of the invention, the prosthetic valve (e.g., prosthetic valve1120) is typically couplable to the prosthetic valve support at a plurality of relative positions. That is, the prosthetic valve is typically implantable in the native valve at a plurality of depths i.e., a physician may decide on the depth at which the prosthetic valve is implanted in the native valve.
• Reference is now made toFIGS. 42A-B, which are schematic illustrations ofprosthetic valve support40, comprising a prosthetic valve support1132, which comprises one or more support-anchoringelements1134, in accordance with some applications of the invention.FIG. 42A shows support1132, andFIG. 42B shows, implanted in a native valve23, animplant30, which comprises support1132 andprosthetic valve42, comprising a prosthetic valve1130. For some applications of the invention, support-anchoringelements1134 comprise (1) other support-anchoring elements described herein (e.g., support-anchoring elements66), and/or (2) tissue-engaging elements62. Support-anchoringelements1134 comprise one ormore barbs1136, which comprise the coupling functionality for coupling the support-anchoring elements of the prosthetic valve support to the prosthetic valve. Typically, eachbarb1136 protrudes from another part ofelement1134 at between 10 degrees and 80 degrees (e.g., between 15 degrees and 60 degrees). Typically, a tip of each barb is thereby disposed more distally (e.g., ventricularly) than a base of that barb. Typically, eachbarb1136 has a length of between 0.5 and 5 mm.
• The structure, function and implantation method of prosthetic valve support1132 and prosthetic valve1130, are typically similar to those of prosthetic valve support1122 and prosthetic valve1120. However, each support-anchoringelement1134 of prosthetic valve support1132 typically comprises no more than 4 barbs1136 (e.g., 2 barbs1136). Prosthetic valve1130 comprises a wire frame, and acovering1138, which covers at least part of the inner surface of the prosthetic valve (i.e., the walls of the lumen), so as to facilitate blood flow through the prosthetic valve. Typically, the inner surface of a portion (e.g., a distal portion1139) of prosthetic valve1130 is not covered with covering1138. Typically,barbs1136 are positioned and/or configured to engage and coupledistal portion1139. That is, prosthetic valve1130 and prosthetic valve support1132 are configured so as to be couplable to each other usingbarbs1136, without the barbs contacting (and possibly damaging) covering1138.
• Reference is now made toFIGS. 43A-C, which are schematic illustrations of a prosthetic valve support1142, comprising one or more support-anchoringelements1144, which are couplable to aprosthetic valve1140, in accordance with some applications of the invention. For some applications of the invention, prosthetic valve support1142 comprises, and/or is analogous to, another prosthetic valve support described herein (e.g., prosthetic valve support40). For some applications of the invention,prosthetic valve1140 comprises, and/or is analogous to, another prosthetic valve described herein (e.g., prosthetic valve42).
• Prosthetic valve support1142 comprises one or more support-anchoringelements1144, which, for some applications of the invention, comprise, and/or are analogous to, (1) other support-anchoring elements described herein (e.g., support-anchoring elements66), and/or (2) tissue-engaging elements62. Support-anchoringelements1144 comprise a coupling lead1146 (e.g., a coupling wire) and astopper1147, which is slidably coupled to the coupling lead. Coupling lead114 andstopper1147 comprise the coupling functionality for coupling the support-anchoring elements of the prosthetic valve support to the prosthetic valve. One end (e.g., a distal end) ofcoupling lead1146 is typically coupled toelement1144, and portion (e.g., a proximal portion) of the coupling lead is slidably coupled toprosthetic valve1140. For some applications of the invention,prosthetic valve1140 is shaped to define an eyelet (not shown), through which coupling lead is slidable.
• FIG. 43A shows prosthetic valve support1142 having been deployed (e.g., implanted) in native valve23, andprosthetic valve1140 in a compressed configuration withindelivery tube60, prior to deployment. Acoupling lead1146 is coupled to each support-anchoringelement1144, and extends proximally, throughprosthetic valve1140.
• FIG. 43B showsprosthetic valve1140 following deployment thereof in the lumen defined by prosthetic valve support1142.Prosthetic valve1140 has been slid over coupling leads1146. That is, the length of each coupling lead that is disposed between anelement1144 and a closest portion of the prosthetic valve, has been shortened. Eachstopper1147 has been slid distally over coupling lead1146 (e.g., using a pusher; not shown), thereby sandwiching a portion of the prosthetic valve between each stopper and arespective element1144. Typically,coupling lead1146 andstopper1147 are configured to inhibit movement of the stopper in the opposite direction. For example,stopper1147 may comprise a ratchet housing (e.g., may contain a ratchet mechanism), andcoupling lead1146 may comprise ratchet teeth. Thereby, sliding ofstopper1147 overcoupling lead1146 facilitates coupling of the prosthetic valve to the prosthetic valve support.
• For some applications of the invention, coupling leads1146 facilitate rotational orientation ofprosthetic valve1140 with respect to support1142 during deployment of the prosthetic valve in the lumen of the support. For example, coupling leads1146 may act as guidewires, along which the prosthetic valve is slid during deployment thereof.
• For some applications of the invention,prosthetic valve1140 is coupled to prosthetic valve support1142 using coupling leads1146 and stoppers1147 (i.e.,stoppers1147 are slid distally, sandwiching the portions of the prosthetic valve between the stoppers and elements1144) before the prosthetic valve is fully deployed. For example, this coupling may be performed when the prosthetic valve is semi-deployed fromdelivery tube60, i.e., when a proximal portion of the prosthetic valve is still compressed within the delivery tube.
• Coupling ofprosthetic valve1140 toelements1144 withcoupling lead1146 is hypothesized to inhibit lateral rotation (e.g., rotation around an atrial-ventricular axis), and/or axial movement, of the prosthetic valve, with respect to the support.
• Following coupling ofprosthetic valve1140 to support-anchoringelements1144, a proximal portion ofcoupling lead1146 is typically subsequently removed from the subject.FIG. 43C shows a distal portion ofcoupling lead1146 having been decoupled from a proximal portion of the coupling lead. For some applications of the invention,coupling lead1146 is cut. For some applications of the invention, the proximal portion of the coupling lead comprises a loop, which is (1) coupled to the distal portion of the coupling lead by being looped around an element of the distal portion of the coupling lead, and (2) decoupled from the distal portion of the coupling lead by being unlooped from the distal portion of the coupling lead. For some applications, the proximal portion of the coupling lead is (1) coupled to the distal portion of the guidewire using a lock described herein (e.g., with reference toFIGS. 45A-C and/or64A-C, mutatis mutandis), and (2) decoupled from the distal portion of the coupling lead by moving the lock to the open configuration.
• Reference is made toFIGS. 44A-B, which are schematic illustrations of (1) a prosthetic valve support1162, comprising one or more support-anchoringelements1164, and (2) a prosthetic valve1160, comprising one or more valve-anchoringelements1146, which are couplable to prosthetic valve support1162, in accordance with some applications of the invention. Typically, valve-anchoringelements1146 are couplable to the prosthetic valve support by being couplable to support-anchoringelements1164. For some applications of the invention, prosthetic valve support1142 comprises, and/or is analogous to, another prosthetic valve support described herein (e.g., prosthetic valve support40). For some applications of the invention, prosthetic valve1160 comprises, and/or is analogous to, another prosthetic valve described herein (e.g., prosthetic valve42). For some applications of the invention, support-anchoringelements1164 comprise, and/or are analogous to, (1) other support-anchoring elements described herein (e.g., support-anchoring elements66), and/or (2) tissue-engaging elements62. For some applications of the invention, valve-anchoringelements1146 comprise, and/or are analogous to, other valve-anchoring elements described herein (e.g., valve-anchoring elements64). For some applications of the invention, valve-anchoringelements1146 comprise, and/or are analogous to, support-engaging elements, such as support-engagingelements422.
• FIG. 44A shows prosthetic valve support1162 having been deployed (e.g., implanted) in native valve23, and at least part of prosthetic valve1160 in a compressed configuration withindelivery tube60, prior to deployment. Valve-anchoringelements1166 are typically coupled to a distal portion (e.g., a distal end) of the primary structural element of prosthetic valve1160, and, in the compressed configuration of the prosthetic valve,elements1166 extending distally from the prosthetic valve.Elements1166 are shown emerging fromdelivery tube60. For some applications of the invention, valve-anchoringelements1166 are formed from the regular repeating structure of the lattice that forms the prosthetic valve, e.g., as described with reference to support-engaging elements424 (FIGS. 8A-B), mutatis mutandis.
• FIG. 44B shows prosthetic valve1160 following deployment thereof in the lumen defined by prosthetic valve support1162. Valve-anchoringelements1166 are deployed on the distal (e.g., ventricular) side of the native valve, and are coupled to support-anchoringelements1164. Typically, support-anchoringelements1164 are configured to facilitate coupling (1) ofelements1164 to the native valve (e.g., to leaflets82), and (2) of valve-anchoringelements1166 to support-anchoringelements1164. Valve-anchoringelements1166 thereby restrict proximal movement of prosthetic valve1160, i.e.,elements1166 couple the prosthetic valve to support1162, and to the native valve.
• Reference is made toFIGS. 45A-C, which are schematic illustrations of alock1170 for facilitating delivery of a medical device, in accordance with some applications of the invention.
• Reference is now made toFIG. 45A.Lock1170 comprises atubular member1172 and aplug1174.Plug1174 is dimensioned such that it is disposable in, and slidable through (e.g., into and out of) the lumen oftubular member1172.Plug1174 comprises a restrictingportion1190 and asecond portion1192.Lock1170 has a locking configuration, in which (1) at least part of restrictingportion1190 is disposed inside the lumen oftubular member1172, and (2) a coupling lead1180 (e.g., a coupling wire) that is coupled to the lock, is generally not decouplable from the lock.Lock1170 further has an open configuration, in which (1) at least restrictingportion1190 is disposed outside the lumen oftubular member1172, and (2)coupling lead1180 is decouplable from the lock. Typically, at least part of plug1174 (e.g., restricting portion1190) is dimensioned so as to fit tightly in the lumen oftubular member1172, in a manner in which an outer surface of plug1174 (e.g., an outer surface of portion1190) is disposed very close to an inner surface oftubular member1172, i.e., such that little space exists between the at least part of the plug and the tubular member. Typically, a surface ofsecond portion1192 is disposed further from the inner surface oftubular member1172, than is the surface of the at least part ofportion1190.
• For some applications of the invention,second portion1192 is shaped to define at least part of a trough, and the surface of the second portion that is disposed further from the inner surface of the tubular member, comprises a surface of the trough.
• FIG. 45A showscoupling lead1180 comprising a loop, and coupled to lock1170 by at least part of the loop being disposed againstsecond portion1192 when the lock is in the locking configuration. Restrictingportion1190 inhibits axial movement of the coupling lead, andtubular member1172 inhibits lateral movement of the coupling lead (e.g., the inner surface of tubular member holds the coupling lead against second portion1192). Tubular member172 thereby facilitates coupling ofcoupling lead1180 to plug1174, and thereby to lock1170.
• As is described hereinbelow,coupling lead1180 is typically coupled to a medical device150 and facilitates (1) coupling of medical device150 to delivery apparatus during delivery of the medical device and (2) decoupling of medical device150 from the delivery apparatus following implantation of device150.
• Reference is now made toFIG. 45B.Plug1174 is slid distally throughtubular member1172, such thatlock1170 is in an open configuration. Typically,plug1174 is moved usingcontrol wire1175. In this open configuration, restrictingportion1190, and typically at least part ofsecond portion1192, are exposed from the tubular member (i.e., are outside the lumen of the tubular member).Coupling lead1180 is shown inFIG. 45B as being disposed against a surface ofsecond portion1192, by way of illustration and not limitation, as a temporary configuration prior to disengagement ofcoupling lead1180 from plug1174 (i.e., decoupling of the coupling lead fromlock1170; disengagement ofcoupling lead1180 is described hereinbelow).
• FIG. 45C showslock1170 in the open configuration, andcoupling lead1180 decoupled from the lock. In the open configuration of the lock,coupling lead1180 is allowed to move away from plug1174 (e.g.,tubular member1172 does not restrict lateral movement of the coupling lead away from second portion1192). That is, in the open configuration of the lock,coupling lead1180 is decouplable from the lock. Typically,coupling lead1180 is moved away fromplug1174 by moving the former with respect to the latter (e.g., by applying a moving force tocoupling lead1180 and/or to plug1174). In some applications of the invention, at least a portion ofcoupling lead1180 is configured such that it automatically moves out of the trough upon being exposed from the tubular member (i.e., whenlock1170 moves to the open configuration). For example, the coupling lead may comprise a shape-memory material such as nitinol, stainless steel, nickel cobalt, cobalt chrome, and/or titanium. In some applications of the invention,portions1190 and1192 are shaped to facilitate the decoupling ofcoupling lead1180 from the lock. For example, a boundary betweenportions1190 and1192 may be sloped.
• Reference is made toFIGS. 46A-B, which are schematic illustrations ofprosthetic valve support40, comprising prosthetic valve support1060, which comprises one or more support-anchoring elements, such as support-anchoringelements900, coupled to a stabilizing element1062 (e.g., a stabilizing strip or a stabilizing element), in accordance with some applications of the invention.FIG. 46A shows a lower side view of support1060. As described hereinabove, the support-anchoring elements are typically coupled toinner edge68, which defines the lumen ofupstream support portion41. That is, a first portion (e.g., a proximal end) of each support-anchoring element is typically coupled toinner edge68. A second portion of each support-anchoring element is typically coupled to stabilizingelement1062. Typically, stabilizingelement1062 comprises an annular band. Further typically, a distal portion of each support-anchoring elements is coupled to the stabilizing element. Stabilizingelement1062 defines an opening (e.g., an aperture), and is typically inelastic and at least partly flexible. Non-limiting examples of materials that stabilizingelement1062 may comprise include polyester, PTFE (e.g., ePTFE), nylon, cotton, nitinol, stainless steel, nickel cobalt, cobalt chrome, titanium, tantalum and palladium. The flexibility ofelement1062 typically facilitates the compressibility of the prosthetic valve support (e.g., for transvascular delivery). For some applications of the invention, the support-anchoring elements are configured to rotate freely around the point at which they couple toupstream support portion41, e.g., so as to allow leaflets of the native valve to continue to function (i.e., to move), at least in part. For some such applications, the flexibility of stabilizingelement1062 typically allows (i.e., does not generally inhibit) this movement of the support-anchoring elements and the leaflets.
• Stabilizingelement1062 is hypothesized to increase the stability of prosthetic valve support1060 at the native valve. For example, stabilizingelement1062 is hypothesized to at least partly inhibit lateral rotation (e.g., rotation around an atrial-ventricular axis, e.g., ‘yaw’) of the support and/or support-anchoring elements. Following deployment (e.g., implantation) of the prosthetic valve, stabilizingelement1062 is further hypothesized to reduce rolling movement (e.g., movement around a lateral axis, e.g., an axis between twoelements900, e.g., ‘pitch’ and ‘roll’) of the prosthetic valve and/orimplant30, including inversion (e.g., ‘flipping’) of the implant.
• For some applications of the invention, stabilizingelement1062 is further hypothesized to stabilizeelements900 during deployment of the elements, e.g., by facilitating coupling thereof to delivery apparatus.
• FIG. 46B showsimplant30, comprising prosthetic valve support1060 andprosthetic valve42, following implantation in native valve23. The prosthetic valve support and the prosthetic valve are typically implanted as described hereinabove, mutatis mutandis.Prosthetic valve42 is deployed (e.g., delivered and expanded) in the lumen of support1060, and in the opening defined by stabilizingelement1062. That is, whenprosthetic valve42 is deployed at the native valve, it is expanded such that (1) a proximal portion of the prosthetic valve couples toinner edge68 of support1060, and (2) a distal portion of the prosthetic valve is disposed within the opening of the stabilizing element. For some applications of the invention, and as illustrated inFIG. 46B, the distal portion of the prosthetic valve makes contact with the stabilizing element.
• For some applications of the invention, stabilizingelement1062 is configured (e.g., dimensioned) such that, when the prosthetic valve is expanded within the opening of the stabilizing element, the stabilizing element limits the expansion of the distal portion of primarystructural element130 of the prosthetic valve. That is, for some applications, the cross-sectional area defined by the primarystructural element130 of the prosthetic valve, upon expansion of the prosthetic valve, is determined by the cross-sectional area of the opening of the stabilizing element. For some applications, the cross-sectional area of the opening of the stabilizing element is substantially equal to the cross-sectional area of the lumen defined byupstream support portion41, thereby the expansion of both the distal and proximal portions of the primary structural element are limited to the same diameter, thereby facilitating the primary structural element to assume a cylindrical shape.
• For applications where stabilizingelement1062 limits the expansion ofprosthetic valve42, a radially-expansive force is thereby applied byprosthetic valve42 to stabilizingelement1062. The radially-expansive force typically couples the prosthetic valve to the stabilizing element. That is, for some applications,prosthetic valve42 is couplable to the stabilizing element. For some applications, the prosthetic valve is coupled to the stabilizing element by alternative or additional means. For example, the stabilizing element may comprise barbs and/or hooks, which facilitate coupling to the prosthetic valve.
• For some applications of the invention, at least part (e.g., an inner surface) of stabilizingelement1062 comprises a friction coating, that is configured to increase friction, and thereby coupling, between the stabilizing element and the prosthetic valve.
• For some applications of the invention, at least part of stabilizingelement1062 is shaped to define ridges, which are configured (e.g., dimensioned) to protrude between struts of the lattice structure of the prosthetic valve (i.e., into voids defined by the lattice structure). The protruding parts facilitate coupling of the stabilizing element to the prosthetic valve, e.g., by inhibiting axial movement of the prosthetic valve through the opening defined by the stabilizing element.
• For some applications of the invention, a soft (e.g., crushable) material is disposed on the inner surface of stabilizing element1062 (e.g., the stabilizing element comprises the soft material). Whenprosthetic valve42 expands, and applies radially-expansive force to the stabilizing element, (1) the struts of the lattice structure of the prosthetic valve compress (e.g., crush) the parts of the soft material against which the struts apply the force, and (2) the parts of the soft material that are disposed between the struts (i.e., that are disposed at voids defined by the lattice structure), form ridges that protrude between the struts (i.e., protrude into the voids). The protruding parts of the soft material facilitate coupling of the stabilizing element to the prosthetic valve, e.g., by inhibiting axial movement of the prosthetic valve through the opening defined by the band, such as by increasing friction.
• For some applications of the invention, prosthetic valve42 (e.g., the primary structural element of prosthetic valve42) is shaped to define a circumferential groove that is configured (e.g., dimensioned) to receive stabilizingelement1062. That is, for some applications of the invention, stabilizingelement1062 is configured (e.g., dimensioned) to be placeable in a circumferential groove defined byprosthetic valve42. Whenprosthetic valve42 is deployed, and expands in the opening defined by stabilizingelement1062, stabilizingelement1062 is disposed in the groove, thereby further facilitating coupling of the stabilizing element to the prosthetic valve, e.g., by inhibiting axial movement of the prosthetic valve through the opening defined by the stabilizing element.
• It is to be noted that, although stabilizingelement1062 is described with reference toFIGS. 46A-B as being coupled to support-anchoringelements900, the scope of the present invention includes stabilizing elements coupled to other support-anchoring elements described herein, such as support-anchoring elements66.
• Reference is made toFIGS. 47A-C, which are schematic illustrations of sequential steps in the implantation ofimplant30, comprisingprosthetic valve42 and prosthetic valve support1040, which comprises prosthetic valve support1080, in accordance with some applications of the invention. Prosthetic valve support1080 comprises two stabilizinglegs910, which comprise stabilizinglegs910a. Support1080 and/orlegs910aare configured such that, during deployment of support1080 (e.g., from an overtube),legs910aautomatically move toward a pre-defined stabilizing configuration thereof. For example,legs910amay comprise a shape-memory material that is biased (e.g., shape-set) to move the legs toward the stabilizing configuration thereof.
• FIG. 47A shows support1080 during deployment thereof.Annular portion41 is disposed against the proximal (e.g., atrial) side of native valve23, and stabilizinglegs910aare moving toward the stabilizing configuration thereof. That is,FIG. 47A is a ‘snapshot’ of support1080 immediately following the release thereof from a delivery tube.
• FIG. 47B shows support1080 following deployment thereof at native valve23. Stabilizinglegs910ahave moved into the stabilizing configuration thereof. As described hereinabove, mutatis mutandis, for stabilizinglegs910, with reference toFIG. 36A, proximal portion912 of each leg is disposed on a plane between (1) aplane999 that is orthogonal to a plane defined byupstream support portion41, and (2) a position in which the leg touches a part ofupstream support portion41 that is peripheral toinner edge68.
• FIG. 47C showsprosthetic valve42 following deployment thereof in the lumen of support1080. Typically, and as shown inFIG. 47C, the primary structural element ofprosthetic valve42 definesplane999, that is orthogonal to the plane defined byupstream support portion41. That is, in the stabilizing configuration thereof, stabilizinglegs910aare typically disposed on a plane between (1) a plane defined by the primary structural element ofprosthetic valve42, and (2) a plane defined byupstream support portion41.
• Reference is made toFIGS. 48A-C, which are schematic illustrations of sequential steps in the implantation ofimplant30, comprisingprosthetic valve42 and prosthetic valve support1040, which comprises prosthetic valve support1090, in accordance with some applications of the invention. Prosthetic valve support1090 comprises two stabilizinglegs910, which comprise stabilizinglegs910b.
• FIG. 48A shows prosthetic valve support1090 in an at-rest configuration thereof, subsequent to deployment of the support at prosthetic valve23. Support1090 and/orlegs910bare configured such that, subsequent to deployment of support1090 (e.g., from an overtube),legs910bare disposed proximal to upstream support portion41 (e.g., atrially). For example,legs910bmay comprise a shape-memory material that is biased (e.g., shape-set) to move the legs toward the at-rest configuration.
• FIG. 48B showsprosthetic valve42, in a compressed configuration thereof, disposed within adelivery tube60, being delivered to native valve23.Prosthetic valve42 is moved distally into the lumen defined byupstream support portion41. Stabilizinglegs910bmove (e.g., rotate) through the lumen, responsively to the movement of the prosthetic valve. For example, distal movement of the prosthetic valve may directly push the stabilizing legs through the lumen. Alternatively or additionally,prosthetic valve42 and/or stabilizinglegs910bmay comprise engaging elements (e.g., barbs and/or levers) which facilitate the movement of the stabilizing legs in response to the movement of the prosthetic valve.
• FIG. 48C showsprosthetic valve42 following deployment thereof in the lumen of support1090. Stabilizinglegs910bhave moved into the stabilizing configuration thereof. Typically, and as shown inFIG. 48C, the primary structural element ofprosthetic valve42 definesplane999, that is orthogonal to the plane defined byupstream support portion41. That is, in the stabilizing configuration thereof, stabilizinglegs910bare typically disposed on a plane between (1) a plane defined by the primary structural element ofprosthetic valve42, and (2) a plane defined byupstream support portion41.
• Reference is made toFIG. 49, which is a schematic illustration ofprosthetic valve support40, embodied as aprosthetic valve support4040a, in accordance with some applications of the invention.Prosthetic valve support4040acomprises acylindrical element90 that is configured to extend distally through native valve23.Cylindrical element90 is typically configured to (1) facilitate coupling ofprosthetic valve support4040ato the native valve, and/or sealing therebetween, (2) to facilitate coupling ofprosthetic valve support4040ato prosthetic valve42 (or any other prosthetic valve described herein), and/or sealing therebetween, and/or (3) to push asidenative leaflets82 of native valve23. For such applications of the present invention in which prosthetic valve support40 (i.e.,prosthetic valve support4040a) comprisescylindrical element90,support40 andprosthetic valve42 may be implanted in a manner as described hereinabove with reference toFIGS. 1A-H.
• Reference is made toFIG. 50, which is a schematic illustration of an alternative technique for the implantation ofimplant30, in accordance with some applications of the invention.FIG. 50 shows a technique in which prosthetic valve42 (shown crimped within delivery tube60) is advanced withinventricle28 prior to and/or in conjunction with the deployment ofsupport40.
• Reference is now made toFIGS. 1A-H and50.FIGS. 1A-H illustrate the implantation ofimplant30, wherebyprosthetic valve support40 is initially delivered and placed against the annulus of the native valve, and subsequently,prosthetic valve42 is delivered to the native valve. In some applications of the invention, as shown inFIG. 50, these two components ofimplant30 are delivered in reverse order.FIG. 50 illustrates (1) the undeployedprosthetic valve42, having been initially delivered toventricle28, and (2)prosthetic valve support40 being subsequently and/or in conjunction, delivered and deployed withinatrium26. In these applications of the invention, following deployment and positioning ofprosthetic valve support40 against the annulus of native valve23,prosthetic valve42 is moved atrially (i.e., proximally) into the respective lumens of the native valve andprosthetic valve support40, and is deployed, as described hereinabove with reference toFIGS. 1G-H.
• It is to be noted thatimplants30 described herein may be implanted using the method described hereinabove with reference toFIGS. 1A-H, or using the method described hereinabove with reference toFIG. 50.
• Reference is made toFIGS. 51A-B, which are schematic illustrations ofprosthetic valve support40, comprising respective prosthetic valve supports4040band4040cwhich each comprise one ormore wings100, in accordance with respective applications of the invention.Prosthetic valve support40 is generally annular and is shaped to define a lumen.Wings100 are configured and positioned with respect to prosthetic valve supports4040band4040cso as to provide one or more of the following advantages: (1) Increasing the stability of the support on the atrial surface of the native valve annulus during the implantation procedure and/or post-implantation. (2) Distributing forces more evenly across the annulus of the native valve. (3) Restricting movement of native valve leaflets. (4) Preventing tilting ofsupport40 and subsequent interference with the LVOT.
• Wings100 typically increase a ratio of surface area of the support to annular tissue.Wings100 typically protrude between 5 mm and 40 mm (e.g., between 10 mm and 30 mm) fromouter edge69 of the support. Prosthetic valve support4040bcomprises two wings, as shown inFIG. 51A, typically positioned spaced apart from each other by 80-150 degrees, as shown.Prosthetic valve support4040ccomprises three wings, as shown inFIG. 51B, typically positioned spaced apart from each other by 80-150 degrees (e.g., by 120 degrees, as shown). Other quantities and configurations ofwings100 may be used in order to optimize the positioning and/or stability ofprosthetic valve support40.
• In some applications of the invention, prosthetic valve support40 (e.g., prosthetic valve supports4040a,4040b,4040c) comprisesbarbs102, which protrude into the lumen defined bysupport40. During the expansion ofprosthetic valve42 within the lumen ofsupport40, as described hereinabove,barbs102 protrude into and engageprosthetic valve42.Barbs102 thereby facilitate coupling betweensupport40 andprosthetic valve42 in addition to the radial forces betweensupport40 andprosthetic valve42. In some applications of the invention, some or all ofbarbs102 may be curved, as shown in the enlarged images ofFIGS. 51A-B. Typically, the curved barbs curve away from the transverse plane ofprosthetic valve support40, such that, when implanted,barbs102 point proximally (i.e., into atrium26). The applications of the invention described with reference toFIGS. 51A-B may be used in combination with other applications of the invention described herein (i.e., applications described herein in whichprosthetic valve support40 is used).
• Reference is made toFIG. 52, which is a schematic illustration ofprosthetic valve42 which comprises a variable-dimensionedvalve4042a, in accordance with some applications of the present invention. As described hereinabove, expansion ofprosthetic valve42 in the lumen ofprosthetic valve support40 creates radial force betweenprosthetic valve support40 andprosthetic valve42, which facilitates coupling ofprosthetic valve42 toprosthetic valve support40. In some applications of the present invention, a proximal portion110 (e.g., the atrial end) ofstructural element130 ofprosthetic valve4042aexpands such that it assumes a dimension larger than the lumen defined by support40 (i.e., such thatportion110 has a longest length measured from a first point ofportion110 to a second point ofportion110 opposite the first point ofportion110 at a transverse cross-section ofportion110, which is larger than a longest length of the lumen ofsupport40 measured from a first point onsupport40 to a second point ofsupport40 opposite the first point ofsupport40 at the transverse cross-section). Typically,proximal portion110 expands more than distal portions ofprosthetic valve4042a. For example,portion110 expands more than at least the portion ofprosthetic valve4042athat is disposed within the lumen ofsupport40. For some applications of the present invention,portion110 expands more than at least the distal end ofvalve4042a(e.g., the portion ofvalve42 designated for positioning within ventricle28).
• As illustrated inFIG. 52,proximal portion110 may be trumpet-shaped. Alternatively,proximal portion110 may be frustoconical, or may be any other configuration that has a dimension larger than the lumen defined byprosthetic valve support40. The extra expansion ofproximal portion110 described hereinabove provides axial resistance against undesired distal (i.e., ventricular) movement ofprosthetic valve4042awith respect to support40, in addition to the resistance provided by the radially expansive forces between prosthetic valve42 (i.e.,prosthetic valve4042a) andprosthetic valve support40, as described hereinabove. The extra expansion ofproximal portion110 is further hypothesized to facilitate release ofproximal portion110 from delivery apparatus (e.g., from a pushing member, fromcoupling tabs4146, and/or fromtroughs222, described hereinbelow with reference toFIGS. 62A-D and63A-B) thereby facilitating deployment ofprosthetic valve4042a. Furthermore, the shape ofprosthetic valve4042ais hypothesized to facilitate its alignment with respect toprosthetic valve support40 and/or native valve23 (e.g., to be at least in part self-righting, at least during deployment).
• InFIG. 52,prosthetic valve4042ais illustrated by a solid surface for clarity of illustration. It is to be noted that, typically,prosthetic valve42 comprises a lattice structure as described hereinabove. The application of the present invention described with reference toFIG. 52 may be used in combination with applications of the present invention described herein (i.e., applications for whichprosthetic valve42 is used).
• Reference is made toFIGS. 53A-C, which are schematic illustrations ofprosthetic valve42 comprising an integrally-anchoringprosthetic valve42b, which comprises valve-anchoring elements64 comprising a plurality ofintegral anchors300, in accordance with some applications of the present invention.
• Reference is now made toFIG. 53A, which is a schematic illustration ofprosthetic valve42b, in planar/flattened view in whichprosthetic valve42bis cut longitudinally and flattened, for clarity of illustration. It is to be noted, however, that the configuration shown inFIG. 53B defines the configuration ofvalve42bin an assembled, crimped state.Prosthetic valve42bcomprises a lattice structure, comprising a plurality of struts which typically collectively define a tessellation of shapes128, e.g., generally-quadrilateral shapes, as shown. In the application of the present invention illustrated inFIGS. 53A-C, the shapes128 that form the lattice structure include crude diamonds120 or crude kite-shapes (i.e., deltoids)122, or a combination thereof. It is to be noted that the scope of the present invention includes prosthetic valves having a tessellation of one or a combination of other shapes.
• The lattice structure ofprosthetic valve42bfurther defines a plurality ofvoids126. Shapes128 are typically arranged incolumns118, each shape connected to the next in each column. In some regions of the prosthetic valve, there is aseparation124 between a distal shape and an adjacent shape (e.g., between the final shape in a column and a respective penultimate shape in the column that is longitudinally proximal to the distal quadrilateral). Thisseparation124 allows a portion of the shape to move or be moved out of the plane of the lattice, thereby protruding from primarystructural element130 ofprosthetic valve42bwhen the distal portion ofprosthetic valve42bis expanded. The protruding portion of shapes128 thereby formintegral anchors300, which are typically configured to anchorprosthetic valve42bto native valve23. Valve-anchoring elements64 are thereby formed from integral parts of the lattice structure that formsprosthetic valve42b, and are disposed between aproximal end251 and adistal end252 of primarystructural element130 ofprosthetic valve42b. That is,prosthetic valve42bhas a functional length (i.e., a length selected so as to facilitate prosthetic valve function), andintegral anchors300 typically do not increase the length ofprosthetic valve42bto be greater than the functional length.
• Reference is made toFIGS. 53B-C, which are schematic illustrations of sequential steps ofprosthetic valve42bbeing implanted.
• Reference is now made toFIG. 53B.Prosthetic valve42bis compressible (e.g., crimpable) and expandable, and typically comprises a shape-memory material (e.g., nitinol).Prosthetic valve42bis configured (e.g., shape-set) such that valve-anchoring elements64, embodied asintegral anchors300, are biased to protrude from the surface of primarystructural element130. In this application of the present invention, primarystructural element130 ofprosthetic valve42bis generally cylindrical, andintegral anchors300 protrude radially from the surface of the cylinder. Becauseintegral anchors300 are formed from the regular repeating structure of the lattice that formsprosthetic valve42b, anchors300 fit back into the plane ofstructural element130 whenvalve42bis crimped intodelivery tube60, prior to and even during implantation. Integral anchors300, thereby typically do not increase the length nor the transverse cross-sectional longest dimension of the crimped configuration ofprosthetic valve42, as compared to those of any other prosthetic valves that do not comprise valve-anchoring elements64 or that comprise elements64 at a distal end thereof.
• As described hereinabove,prosthetic valve42 is deployed by distal movement out ofdelivery tube60.FIG. 53B showsprosthetic valve42bin a partially-deployed state, such thatintegral anchors300 have emerged fromdelivery tube60, and have assumed an unconstrained, expanded, resting configuration in which theintegral anchors300 protrude from the surface of primarystructural element130 of the prosthetic valve. In an expanded state of at least the distal portion ofvalve42b, as shown inFIG. 53B,integral anchors300 typically protrude up to and including 110 degrees (e.g., between 45 and 90, such as between 45 and 60 degrees) from the surface of primarystructural element130, in a resting state ofanchors300. That is, in the protruded state, the proximal portions ofanchors300 are distanced further from structural element than the distal portions ofanchors300 which function as thepivot joints4074 betweenanchors300 andstructural element130, as shown in the enlarged image ofFIG. 53B. Typically, this partial deployment ofprosthetic valve42 is performed on the distal side of native heart valve23 (e.g., the ventricular side of mitral valve24).
• Reference is now made toFIG. 53C. Following the movement ofintegral anchors300 into their unconstrained, protruding, configuration,prosthetic valve42bis pulled proximally (i.e., toward atrium26), along withdelivery tube60. This proximal movement causesintegral anchors300 to abut against and captureleaflets82 of the native valve in order to anchorprosthetic valve42bto the ventricular side of the native valve. Typically,integral anchors300capture leaflets82 of the native valve by sandwichingleaflets82 against primarystructural element130 ofprosthetic valve42band/or against the wall ofventricle28. Typically, but not necessarily,integral anchors300 protrude betweenchordae tendineae80 of the native valve.
• Typically, the anchoring of the prosthetic valve and/or the capturing of leaflets of the native valve are performed whileprosthetic valve42bis partially deployed fromdelivery tube60, as shown inFIG. 53C.Prosthetic valve42bis then fully deployed by movingdelivery tube60 proximally with respect tovalve42b, thereby sliding the delivery tube off of the prosthetic valve and allowing the prosthetic valve to expand. Such expanding ofprosthetic valve42bfacilitates coupling of the prosthetic valve to support40, as described with reference toFIG. 1G.
• Reference is made toFIGS. 54A-D, which are schematic illustrations ofprosthetic valve42 comprising an integrally-anchoringprosthetic valve42c, which comprises valve-anchoring elements64 comprising a plurality ofintegral anchors310, in accordance with some applications of the present invention.
• Integral anchors310 are similar in form and function tointegral anchors300, and are typically formed byseparations124 in the lattice structure ofstructural element130, as described with reference toFIGS. 53A-C. Integral anchors310 are configured (e.g., shape-set) so as protrude from primarystructural element130 ofprosthetic valve42c, typically at a more acute angle thanintegral anchors300 ofFIGS. 53A-C protrude fromprosthetic valve42b. For example,integral anchors310 may have an unconstrained, expanded, resting configuration in an expanded state of at least the distal portion ofprosthetic valve42c, in which anchors310 protrude up to and including 110 degrees (e.g., up to an including 60 degrees, or between 5 and 80 degrees, or between 5 and 40 degrees) from the surface of primarystructural element130 in a resting state ofanchors310. Integral anchors310 can be deformed by a deforming force (e.g., by pushingtube60 distally againstpivot joints4074 betweenanchors310 andstructural element130, as described hereinbelow) into a further-expanded configuration, in which anchors310 protrude at a greater angle from the surface of primarystructural element130 than the angle of the resting configuration ofanchors310; thus,integral anchors310 may be considered more open in this configuration than they are in their resting configuration. In this further-expanded, open configuration,integral anchors310 typically are made to protrude up to and including 160 degrees (e.g., between 30 and 110 degrees, such as between 60 and 110 degrees) from the surface ofstructural element130 ofprosthetic valve42c. Sinceanchors310 have a shape memory of assuming the resting state in the absence of force applied thereto,integral anchors310 return toward the resting state upon removal of the deforming force (e.g., oncetube60 is not pushed distally against pivot joints4074).
• As described hereinabove,prosthetic valve42 is deployed by distal movement out ofdelivery tube60.FIG. 54A showsprosthetic valve42cin a partially-deployed state, such thatintegral anchors310 have emerged fromdelivery tube60, and have assumed the unconstrained, expanded resting configuration described hereinabove. Typically, this partial deployment ofprosthetic valve42 is performed on the distal side of native heart valve23 (e.g., the ventricular side of mitral valve24).
• Reference is now made toFIG. 54B. Following partial deployment ofprosthetic valve42c, the prosthetic valve is moved proximally with respect to delivery tube60 (e.g.,prosthetic valve42cis moved proximally whiledelivery tube60 remains stationary, orprosthetic valve42cremains stationary whiledelivery tube60 is moved distally, orprosthetic valve42cis moved proximally whiledelivery tube60 is moved distally). The distal end ofdelivery tube60 is thereby pushed between primarystructural element130 andintegral anchors310, and provides the deforming force that pushes the integral anchors toward their further-expanded open configuration, described hereinabove.
• Reference is now made toFIG. 54C.Delivery tube60 andprosthetic valve42care pulled proximally (i.e., toward atrium26). This proximal movement causes the openintegral anchors310 to engageleaflets82 of the native valve, as described hereinabove.
• Reference is now made toFIG. 54D.Delivery tube60 is moved proximally with respect toprosthetic valve42c(e.g., by withdrawingdelivery tube60 proximally), thereby removing the deforming force onanchors310. As described hereinabove, this removal of the deforming force releasesintegral anchors310, which are thereby allowed to return toward their resting state, to (1) clamp thechordae tendineae80 and/orleaflets82 of native valve23 against primarystructural element130 ofprosthetic valve42c, and (2) anchor the prosthetic valve to the ventricular side of the native valve. Typically,prosthetic valve42 is then fully deployed from delivery tube60 (e.g., by retractingtube60 with respect to valve42), thereby allowing radial expansion of the prosthetic valve to coupleprosthetic valve42 toprosthetic valve support40, as described hereinabove.
• Reference is now made toFIGS. 53A-C and54A-C. For such applications of the present invention in which prosthetic valve42 (i.e.,prosthetic valves42band/or42c) comprisesintegral anchors300 and/or310,prosthetic valve support40 andprosthetic valve42 may be implanted in a manner as described hereinabove with reference toFIGS. 1A-H. The scope of the present invention includes implantation ofimplant30 in a manner wherebyprosthetic valve42 is delivered to native valve23 and/or at least partially deployed, prior to the deployment of support40 (e.g., as described hereinabove with reference toFIG. 50).
• Reference is made toFIGS. 55A-E, which are schematic illustrations ofprosthetic valve42 comprising a twisted-anchor-based prosthetic valve42d, which comprises valve-anchoring elements64 comprisingtwisted anchors320, in accordance with some application of the invention.
• FIGS. 55A-B show valve-anchoring elements64, comprisingtwisted anchors320, in their constrained and unconstrained configurations, respectively. Prosthetic valve42dtypically comprises a shape-memory material (e.g., nitinol), shaped to define a lattice structure. The lattice structure comprises a plurality of struts which typically collectively define a tessellation of shapes128 (e.g., crude diamonds120). Prosthetic valve42dcomprises one or moretwisted anchors320, disposed at the distal end of prosthetic valve42d.
• As described hereinabove, valve-anchoring elements64 typically have a constrained configuration for delivery, and an unconstrained configuration whereby they protrude radially from primarystructural element130 ofprosthetic valve42. For some applications, in the constrained configuration of elements64, during delivery, elements64 are typically but not necessarily disposed distal to the generally-cylindrical structure ofvalve42 at an angle that is between 165 and 180 degrees with respect to the generally-cylindrical structure. In order to achieve these constrained and unconstrained configurations for prosthetic valve42d, comprisingtwisted anchors320, a distal portion of prosthetic valve42dis typically torsionally bent to definetwisted anchors320. For some applications of the present invention, in order to achieve these configurations for prosthetic valve42dcomprisingtwisted anchors320, a distal portion of prosthetic valve42dis typically bent to definetwisted anchors320.
• The material comprising the lattice structure ofprosthetic valve42 has adepth242 and each strut of the lattice structure has a width244 (shown inFIG. 55B). Typically,depth242 is greater thanwidth244.Depth242 is typically between 0.15 mm and 1.1 mm (e.g., between 0.3 mm and 0.6 mm) andwidth244 is typically between 0.05 mm and 0.9 mm, (e.g., between 0.1 mm and 0.4 mm). In this application of the invention, the bending comprises twisting in the vicinity of abending region240, such that a bend axis246 (shown inFIG. 55B) is substantially parallel todepth242 in a vicinity of a distal portion of bendingregion240. That is, abend radius248 lies on a plane that is substantially parallel to the relativelysmaller width244, thereby allowing a smaller thickness of material to be bent, compared to ifbend radius248 were parallel with the relativelygreater depth242.
• It is hypothesized that this configuration allows a greater bend angle to be imparted, such thattwisted anchors320 can (1) be disposed distal to (e.g., planar with) primarystructural element130 of prosthetic valve42dwhen the twisted anchors are in their constrained configuration (i.e., when compressed indelivery tube60 for delivery) as shown inFIG. 55A, and (2) pivot greater than 90 degrees (e.g., greater than 110 degrees, greater than 120 degrees, or greater than 150 degrees), to protrude radially from primarystructural element130 when in their unconstrained configuration (i.e., following deployment of at least the distal portion of prosthetic valve42d).
• It is to be noted, that during delivery of prosthetic valve42dtowardmitral valve24, valve42dis crimped withindelivery tube60 such that anchors320 assume a constrained and compressed state withintube60.
• Reference is now made toFIGS. 55C-E, which are schematic illustrations of sequential steps in the deployment and retrieval of prosthetic valve42dthat comprises twisted anchors320.FIG. 55C showsdelivery tube60 being moved proximally with respect to prosthetic valve42d(e.g., prosthetic valve42dis moved distally whiledelivery tube60 remains stationary, or prosthetic valve42dremains stationary whiledelivery tube60 is moved proximally, or prosthetic valve42dis moved distally whiledelivery tube60 is moved proximally). Twisted anchors320 (disposed at a distal portion of valve42), emerge first from withintube60 and begin to move from their constrained and compressed configuration toward their unconstrained and expanded configuration once exposed from withintube60.
• Reference is now made toFIG. 55D.Delivery tube60 is moved further proximally, such that prosthetic valve42dis partially deployed toward its expanded configuration. Becausedelivery tube60 clearsanchors320,twisted anchors320 typically assume their resting unconstrained configuration. The physician may proceed to couple prosthetic valve42dto the native valve and/or toprosthetic valve support40, as described with reference toFIGS. 1F-G.
• Reference is now made toFIG. 55E. Valve-anchoring elements64 comprisingtwisted anchors320, facilitate retrieval of prosthetic valve42dintodelivery tube60. Should it be necessary and/or desirable, while a proximal portion of valve42dis still crimped withintube60,delivery tube60 may be moved distally with respect to prosthetic valve42d(e.g., prosthetic valve42dis moved proximally whiledelivery tube60 remains stationary, prosthetic valve42dremains stationary whiledelivery tube60 is moved distally, or prosthetic valve42dis moved proximally whiledelivery tube60 is moved distally), thereby recompressing prosthetic valve42dinto the delivery tube.Twisted anchors320 are pushed distally bydelivery tube60, such that they may also by straightened, as shown, and subsequently enter the delivery tube. Prosthetic valve42dmay then be repositioned and redeployed, or may be removed from the subject.
• In some applications of the invention,twisted anchors320 comprise more than one bendingregion240. For such applications, the material comprising prosthetic valve42dis bent and twisted in each respective bending region, as described with reference toFIGS. 55A-B. For example, one bending region may be longitudinally proximal (i.e., coaxial) with respect to another bending region.Twisted anchors320 that comprise more than one bending region are hypothesized to have enhanced pivoting ability compared to valve-anchoring elements that comprise one bending region. That is,twisted anchors320 having more than one bending region enableanchors320 to move more than 90 degrees, e.g., more than 160 degrees, with respect to a surface ofstructural element130. For example,twisted anchors320 may pivot such that they clampleaflets82 of the native valve against primarystructural element130 ofprosthetic valve42, thereby anchoring the prosthetic valve to the native valve.
• Reference is made toFIGS. 56A-D, which are schematic illustrations ofprosthetic valve42 comprising a clip-onprosthetic valve42e, which comprises valve-anchoring elements64 that comprise loop-shaped valve-anchoringelements200 arranged inpairs132 to form clips65a, in accordance with some applications of the invention.
• Reference is now made toFIG. 56A. As described hereinabove,prosthetic valve42 is compressible (e.g., crimpable) and expandable, and typically comprises a shape-memory material (e.g., nitinol). In this application of the invention,prosthetic valve42ecomprises loop-shaped valve-anchoringelements200, arranged inpairs132. Typically, a first loop-shaped valve-anchoringelement200ain each pair is smaller than a second loop-shaped element valve-anchoring200b, such that first loop-shapedelement200ais disposable within and/or passable through a space defined by the larger loop shape of second loop-shaped valve-anchoringelement200b. It is to be noted that the scope of the present invention includes other configurations and arrangements ofelements200.
• It is to be noted that the scope of the present invention includes a first loop-shaped valve-anchoringelement200abeing larger than second loop-shaped element valve-anchoring200b, such that second loop-shapedelement200bis disposable within and/or passable through a space defined by the larger loop shape of first loop-shaped valve-anchoringelement200a.
• As described hereinabove, valve-anchoring elements64 have a constrained and compressed configuration for delivery ofprosthetic valve42e(as shown inFIG. 56A), and an unconstrained, expanded configuration whenprosthetic valve42eis deployed (as shown inFIG. 56B).
• Loop-shaped valve-anchoringelements200 are shown inFIG. 56A in their constrained configuration in which second loop-shaped valve-anchoringelement200bof eachpair132 is typically disposed distal to primarystructural element130, and first loop-shaped valve-anchoringelement200aof eachpair132 is typically disposed against the surface of primarystructural element130. That is, in their constrained configuration, loop-shaped valve-anchoringelements200 are typically longitudinally aligned.
• FIG. 56B shows loop-shaped valve-anchoringelements200 in their unconstrained, expanded configuration. Movement from the constrained configuration to the unconstrained configuration ofelements200 typically comprises (1) pivoting proximally of second valve-anchoringelement200bof eachpair132, and (2) pivoting distally of first valve-anchoringelement200aof eachpair132. In some applications of the invention, in the unconstrained configuration, the planes defined by the two valve-anchoringelements200 of eachpair132 are generally aligned (e.g., within 20 degrees of each other).
• In some applications of the invention, in the unconstrained configuration, a rounded end of second valve-anchoringelement200bof eachpair132 is disposed more proximally than a rounded end of first valve-anchoringelement200a. In such applications, movement of valve-anchoringelements200 from the constrained configuration to the unconstrained configuration comprises movement of the rounded ends of the second valve-anchoringelements200bof eachpair132 proximally past the respective rounded ends of the firstvalve anchoring elements200aof eachpair132.
• In either application, movement of valve-anchoringelements200 from the constrained configuration to the unconstrained configuration allowselements200aand200bto capture material (e.g.,leaflets82 of the native valve) between them, i.e., in a manner in whichelements200aand200bfunction together as a clip65a.
• FIGS. 56C-D show sequential steps in the implantation ofprosthetic valve42e.FIG. 56C showsprosthetic valve42edisposed in a crimped configuration indelivery tube60.Delivery tube60 is moved proximally with respect toprosthetic valve42e, such that only loop-shaped valve-anchoringelements200b(i.e., the first-deployed anchoring elements) of eachpair132 are released and move toward their unconstrained configuration, typically by pivoting in a proximal direction and in a direction toward the ventricular surface ofrespective leaflets82.
• Typically, following the deployment ofelements200bat the respective ventricular surfaces ofleaflets82,elements200aare positioned withintube60 in a manner in which during their expansion from withintube60,elements200amove toward respective atrial surfaces ofleaflets82. For some applications, following the deploying ofelements200b,valve42eis pulled proximally (e.g., by pulling proximally on bothvalve42eand tube60) in order to adjust the positioning ofvalve42ewith respect toleaflets82 and so as to ensure that, once deployed from withintube60,elements200awill press against respective atrial surfaces ofleaflets82.
• FIG. 56D showsdelivery tube60 having been removed (i.e., by being retracted) from the body of the subject. During the retracting oftube60 loop-shaped valve-anchoringelements200a(i.e., the second-deployed anchoring elements) of each pair are deployed such thatelements200amove toward their unconstrained configuration, typically by pivoting in a distal direction and in a direction toward the atrial surfaces ofrespective leaflets82.Leaflets82 of the native valve are thereby clamped between the two loop-shaped valve-anchoringelements200aand200bof eachpair132, thereby anchoringprosthetic valve42eto native valve23. Thus, pairs132 of loop-shaped valve-anchoringelements200 function as clips65a.
• Reference is made toFIGS. 57A-D, which are schematic illustrations ofprosthetic valve42 comprising a clip-onprosthetic valve42f, which comprises valve-anchoring elements64 that comprise clips65b, in accordance with some applications of the invention.
• FIG. 57A showsclips65bbeing typically coupled to the distal end of primarystructural element130 ofprosthetic valve42f. Typically, clips65bare flexibly coupled toprosthetic valve42f, i.e., valve-coupling elements64 are configured such that clips65bare able to move with respect toprosthetic valve42f. During the implantation ofprosthetic valve42f, clips65bare clipped toleaflets82 and/orchordae80 of the native valve, thereby anchoring the prosthetic valve to the native valve.FIG. 57A shows two valve-anchoring elements64 comprisingrespective clips65b, disposed on opposite sides of the distal end ofprosthetic valve42f. It is to be noted that the scope of the present invention includesprosthetic valves42fhaving any suitable quantity and arrangement ofclips65b, depending on the technique used and the individual anatomy of the subject.
• Typically, during advancement ofvalve42f,valve42fis crimped withindelivery tube60.
• FIG. 57B showsprosthetic valve42fbeing partially deployed fromdelivery tube60, such thatclips65bare disposed outside of the delivery tube.Clips65bare coupled toleaflets82 of the native valve, holding the leaflets and drawing them close to the primarystructural element130 ofprosthetic valve42f. For some applications, clips65bhave a tendency to close, and are held open during delivery ofvalve42fby a force applied toclips65b(e.g., by a pull wire). In the absence of the force applied toclips65b, clips65bclose aroundrespective leaflets82. For other applications, the opening and closing ofclips65bare remotely controlled by the operating physician. Typically, clips65bmay be opened and closed repeatedly until a firm grasping ofleaflets82 is achieved.Clips65bare typically configured such that they do not cause substantial damage toleaflets82.
• FIG. 57C is a top-view schematic illustration ofprosthetic valve42fin the partially-deployed state, as described hereinabove with reference toFIG. 57B. Whileprosthetic valve42fis in a compressed configuration withindelivery tube60, it has a cross-sectional diameter smaller than that of the lumen defined byprosthetic valve support40. Typically, clips65bcouple parts of leaflets82 (e.g., central parts, or part ofleaflets82 adjacent one another) toprosthetic valve42f, the remaining potions ofleaflets82 remain relatively free. This arrangement typically results in a double-orifice configuration of native valve23, whereby native valve23 (comprising a pair of leaflets82) can be considered to be divided into twoorifices86, on opposite sides ofprosthetic valve42f, eachorifice86 being surrounded by respective pairs of remaining portions ofleaflets82. It is hypothesized that, in this arrangement, the native valve can continue to function untilprosthetic valve42fis fully deployed. It is further hypothesized that this double-orifice state provides even greater advantage in applications of the invention where the prosthetic valve is delivered before prosthetic valve support40 (such as the application of the invention described with reference toFIG. 50). In such applications in which the prosthetic valve is delivered beforesupport40, the interval between delivery and full deployment of the prosthetic valve is typically longer than in applications whereprosthetic valve support40 is delivered and deployed before delivery of the prosthetic valve. Thus, for these applications, the double orifice created by the prosthetic valve facilitates blood flow from the atrium to the ventricle during the implantation procedure.
• FIG. 57D is a side-view schematic illustration ofprosthetic valve42f, fully deployed in the annulus of the native valve. Valve-anchoring elements64, comprisingclips65b,couple leaflets82 of the native valve to the primarystructural element130 ofprosthetic valve42, thereby anchoring the prosthetic valve to the native valve.
• It is to be noted that the technique described with reference toFIGS. 57A-D, in particular the ‘double-orifice’ configuration described with reference toFIG. 57C, may be used in combination with other prosthetic valves comprising tissue-engagement elements62. In particular, the technique may be used where valve-anchoring elements64 comprise clips65 or clip functionality, such asintegral anchors310, described with reference toFIGS. 54A-D, and/ortwisted anchors320, described with reference toFIGS. 55A-E, and/or pairs132 loop-shaped valve-anchoringelements200, described with reference toFIGS. 56A-D.
• Reference is now made toFIGS. 52,53A-C,54A-C,55A-E,56A-D, and57A-D. It is to be noted that the scope of the present invention includes implanting the respectiveprosthetic valves42 disclosed herein at native valve23 prior to implantingsupport40. In such applications of the present invention, anchoring elements64 enableprosthetic valves42 described herein to remain coupled to native valve23 untilsupport40 is positioned at the annulus of native valve23. In such applications,leaflets82 are brought closer together, temporarily in a manner which forms a double orifice in native valve23 for blood to pass from the atrium to the ventricle during the implantation procedure (as described hereinabove with reference toFIG. 57C). Following the coupling ofprosthetic valve42 toleaflets42,support40 is then positioned around the proximal portion ofprosthetic valve42 in order to facilitate coupling ofsupport40 tovalve42 and provide the radial force againstvalve42 in order to maintain implanting ofprosthetic valve42 at native valve23, as described hereinabove. In such applications,support40 is positioned around the proximal portion ofprosthetic valve42 when the proximal portion ofprosthetic valve42 is crimped and compressed within tube60 (for ease ofpositioning support40 around the proximal portion of valve42).
• Reference is made toFIGS. 58A-61C, which are schematic illustrations ofprosthetic valve support40, embodied as anchoring prosthetic valve supports4040d,4040e, and4040f, comprising tissue-engaging elements62, in accordance with respective applications of the invention. In these applications of the invention, tissue-engaging elements62 comprise support-anchoring elements66, which anchorprosthetic valve support40 to native valve23. As described hereinabove,prosthetic valve support40 is typically used in combination withprosthetic valve42. The anchoring ofprosthetic valve support40 to the native valve provides one or more of the following advantages: (1) The delivery apparatus used to deploy the prosthetic valve support (e.g., holdingmembers46, described with reference toFIGS. 1C-F) may be removed following implantation ofsupport40 and prior to delivering and/or deployingprosthetic valve42, thereby providing more space inatrium26 for the delivery and/or deployment of the prosthetic valve; (2)Implant30, comprisingprosthetic valve42 andprosthetic valve support40, is anchored more securely to the native valve; and (3) Support-anchoring elements66 contribute toward the capture ofleaflets82 of the native valve.
• For some applications of the invention, it is hypothesized that the anchoring ofsupport40 to the native valve by support-anchoring elements66 may be sufficient to anchorimplant30 to the native valve, thereby minimizing or even eliminating the need for supplemental anchoring ofimplant30 by valve-securing elements64. Therefore, for such applications of the invention,prosthetic valve42 does not comprise valve-anchoring elements64. In some such applications of the invention,leaflets82 of the native valve are allowed to function, at least in part, following implantation of the prosthetic valve.
• Reference is now made toFIGS. 58A-D, which are schematic illustrations ofprosthetic valve support40 comprising anchoringprosthetic valve support4040d, which comprises support-anchoring elements66 comprising fixedanchors330, in accordance with some applications of the invention.
• During delivery ofsupport4040dto the native valve,support4040dis crimped withintube44, as described hereinabove with reference to support40 ofFIGS. 1B-C.FIG. 58A showsprosthetic valve support4040din its expanded configuration, as described hereinabove with reference to support40 inFIG. 1B. Typically,prosthetic valve support4040dis annular and is shaped to define anouter edge69 and aninner edge68.Outer edge69 typically defines the diameter of the annular prosthetic valve support, andinner edge68 typically defines the diameter of the lumen in whichprosthetic valve42 is typically disposed, as described hereinabove. Support-anchoring elements66 comprising fixedanchors330, are typically coupled toinner edge68.
• In some applications of the invention, fixedanchors330 comprise coupling-portion70 configured to engage tissue of the native valve. Coupling-portion70 is illustrated as an extension of fixedanchors330 such that fixedanchors330 assume a generally L-shape. In other applications of the invention, coupling-portion70 may be disposed differently (e.g., at an angle other than the angle as shown), or may compriseclips65aor65b, or another means for engaging native valve23. In some applications of the invention, fixedanchors330 do not comprise a coupling-portion.
• FIG. 58B showsprosthetic valve support4040d, partially deployed proximal to native valve23 (i.e., in atrium26), as described hereinabove (e.g., with reference toFIG. 1B).Fixed anchors330 extend distally from the semi-deployed prosthetic valve support, and are moved distally, between the leaflets of the native valve.
• Reference is now made toFIG. 58C.Fixed anchors330 move apart asprosthetic valve support4040dexpands to its fully-deployed, expanded configuration at native valve23. That is, asinner edge68 expands to assume its expanded state, the lumen ofsupport4040dexpands thereby moving apart anchors330.Fixed anchors330 engageleaflets82 of the native valve, thereby anchoringprosthetic valve support4040dto the native valve. In some applications of the invention, fixedanchors330 are configured such thatnative leaflets82 continue to function, at least in part whensupport4040dis implanted. For example, in some applications, the dimensions and relative positions of fixedanchors330 do not substantially restrict the movement ofleaflets82. For example, the total width of each of the fixedanchors330 elements may be less than 1 mm. Furthermore, in some applications of the invention, the forces exerted onleaflets82 by the flow of blood are hypothesized to overcome at least some of the force applied toleaflets82 by the rigidity of fixedanchors330, i.e., in order to cause fixedanchors330 to flex asleaflets82 move.
• FIG. 58D is a schematic illustration of a transverse atrial cross-section of the fully-deployed prosthetic valve support described with reference toFIG. 58C.Fixed anchors330 engageleaflets82 of the native valve, thereby anchoringprosthetic valve support4040dto the native valve. Coupling-portions70 are disposed on the distal (i.e., ventricular) side of the native valve, and are therefore illustrated in phantom.
• Reference is now made toFIGS. 59A-B, which are schematic illustrations of anchoringprosthetic valve support4040dcomprising support-anchoring elements66 comprising fixedanchors330, in accordance with some applications of the invention.
• Anchoringprosthetic valve support4040dis anchored to native valve23 in a different orientation to that described with reference toFIGS. 58A-D.FIG. 59A showsprosthetic valve support40 fully deployed and anchored to native valve23.Fixed anchors330 extend toward, and engage,commissures84 of the native valve, thereby anchoringprosthetic valve support4040dto the native valve.
• FIG. 59B is a schematic illustration of a transverse atrial cross-section of the fully-deployedprosthetic valve support4040ddescribed with reference toFIG. 59A.Fixed anchors330 engagecommissures84 of the native valve, holding the leaflets apart atcommissures84 and anchoringprosthetic valve support4040dto the native valve. Coupling-portions70 are disposed on the distal (i.e., ventricular) side of the native valve, and are therefore illustrated in phantom. It is hypothesized that the orientation ofprosthetic valve support4040dand positioning of fixedanchors330, described with reference toFIGS. 59A-B, interferes less withleaflets82, as compared to the orientation and positioning of fixedanchors330 described with reference toFIGS. 58C-D (i.e., fixedanchors330 engaging respective portions of leaflets82). This positioning ofanchors330 atcommissures84, thereby allows the native valve to continue to function, at least in part, untilprosthetic valve42 is deployed.
• Reference is made toFIGS. 60A-B and61A-C, which are schematic illustrations ofprosthetic valve support40 comprisingprosthetic valve support4040eand4040f, respectively, in accordance with some applications of the invention. Support-anchoring elements66 in such applications comprise hingedanchors340 that are typically coupled toinner edge68 ofsupport40. In some applications of the invention, hingedanchors340 comprise a coupling-portion70, configured to engage tissue of the native valve. Coupling-portion70 is illustrated as an extension of hingedanchors340, thereby forming the hinged anchors into generally L-shapes. In other applications of the invention, coupling-portion70 may be disposed differently (e.g., at an angle different to that as shown inFIGS. 60A-B and61A-C), or may compriseclips65aor65b, or another means for engaging native valve23. In some applications of the invention, hingedanchors340 do not comprise a coupling-portion.
• Hinged anchors340 are typically coupled toprosthetic valve support40 via ahinge point72.Hinge point72 may comprise a flexible material and/or moving components. For some applications of the invention, hingedanchors340 rotate freely aroundhinge point72 as far as their shape and juxtaposition allows. For some applications of the invention, hingedanchors340 are biased to reside in a particular configuration. For example, hingedanchors340 and/or hingepoint72 and/orprosthetic valve support40 may comprise a shape-memory material (e.g., nitinol) or a spring mechanism, configured to push hingedanchors340 radially outward.
• The use of hinge points72 for coupling support-anchoring elements66 toprosthetic valve support40 is hypothesized to provide one or more of the following advantages: (1) Improving compressibility ofprosthetic valve support40, for transcatheter delivery. (2) Improving movement ofnative leaflets82 following deployment ofprosthetic valve support40 to the native valve. (3) Increasing adjustability of the dimensions and configuration of support-anchoring elements66.
• Reference is now made toFIGS. 60A-B, which are schematic illustrations ofprosthetic valve support40 comprising hingedprosthetic valve support4040e, comprising hingedanchors340, in accordance with some applications of the invention.FIG. 60A showsprosthetic valve support4040ein a fully-expanded configuration.Prosthetic valve4040eis configured such that hingedanchors340 are biased to extend radially outward.
• FIG. 60B showsprosthetic valve support4040efully deployed at native valve23. As described with reference toFIGS. 58C-D and59A-B, support-anchoring elements66 may be positioned to engage commissures84 (FIGS. 59A-B) and/orleaflets82 of the native valve (FIGS. 58C-D). In the application of the invention illustrated inFIG. 60B,prosthetic valve support4040eand hingedanchors340 are configured such that the hinged anchors extend radially to engage thecommissures84 of the native valve. For other applications, hingedanchors340 are freely rotatable, and are coupled toleaflets82 such thatsupport40 is anchored to the native valve whilst allowingleaflets82 to move.
• Reference is made toFIGS. 61A-C, which are schematic illustrations ofprosthetic valve support40 comprising free-hinged prosthetic valve support40f, comprising hingedanchors340 comprising clamping-hinged-anchors350, in accordance with some applications of the invention.
• FIG. 61A showsprosthetic valve support4040f, comprising hinged anchors350, in a fully-expanded configuration and a resting state thereof. Clamping-hinged-anchors350 are coupled toprosthetic valve support4040fviahinge point72 and are typically free to pivot around the hinge point as far as their shape and juxtaposition allows. Coupling-portion70 is shown in an unconstrained clamped configuration, in which it is typically configured to extend fromstructural component71 of clamping-hinged-anchor350, at an acute angle (e.g., less than 80 degrees, less than 45 degrees, or less than 20 degrees). In some applications of the invention, coupling-portion70 may be configured to extend at less than 1 degree, i.e., to touch thestructural component71 of clamping-hinged-anchor350. Clamping-hinged-anchors350 typically comprise a shape-memory material (e.g., nitinol), such that they are compressible into a compressed (e.g., crimped) configuration for delivery, and are deformable and expandable at the site of implantation.
• FIG. 61B shows clamping-hinged anchors350 ofprosthetic valve support4040f, in a compressed configuration, e.g., for delivery toward the native valve within overtube44 (e.g., as described hereinabove with reference to support40 inFIG. 1B). It is to be noted thatovertube44 is not shown for clarity of illustration. Clamping-hinged-anchors350 are disposed distally to other parts ofprosthetic valve support4040f. Prior to delivery, coupling-portions70 are typically in an unclamped configuration, in which they extend further distally fromprosthetic valve support4040fand fromstructural component71 of clamping-hinged-anchor350. During deployment ofprosthetic valve support4040ffrom overtube44, clamping-hinged-anchors350 are extended from within tube44 (coupling-portion70 first followed by structural component71) and betweenleaflets82 of native valve23. As clamping-hinged-anchors350 are fully exposed from withinovertube44, they move toward their clamped configuration, and are allowed to assume their resting state (as shown inFIG. 61A) in which coupling-portion70 moves towardstructural component71 in order to clamp a portion ofleaflet82 therebetween and to thereby anchorprosthetic valve support4040fto the native valve.
• FIG. 61C showsprosthetic valve support4040ffully deployed at native valve23. Coupling-portions70clamp leaflets82 against respectivestructural components71 of clamping-hinged-anchors350, as described hereinabove. Thus, clamping-hinged-anchors350 function asclips65c. As described hereinabove, clamping-hinged-anchors350 are typically able to rotate freely abouthinge point72 as far as their shape and juxtaposition allows.Leaflets82 are thereby able to move proximally and distally (i.e., atrially and ventricularly), as illustrated by the upper and lower panels ofFIG. 61C. Clamping-hinged-anchors350 thereby allow native valve23 to continue to function untilprosthetic valve42 is deployed, as described hereinabove.
• For some applications of the invention,prosthetic valve support4040fis configured such that clamping hinged anchors350 are biased to extend radially inward (i.e., toward each other). This configuration is illustrated by the upper panel ofFIG. 61C. In such applications of the invention,leaflets82 of the native valve are held together, forming a double-orifice configuration, as described herein (e.g., with reference toFIG. 57C). Clamping hinged anchors350 thereby allow native valve23 to continue to function, at least in part, untilprosthetic valve42 is deployed.
• Reference is again made toFIGS. 58A-D,59A-B,60A-B and61A-C. It is to be noted that supports40 described herein comprise two support-anchoring elements66 by way of illustration and not limitation. That is, the scope of the present invention includes thesupports40 comprising any suitable number and configuration of anchoring elements66. For example,valve support40 may comprise four support-anchoring elements66 configured such that a pair of elements66 are anchored tocommissures84 and a pair of elements66 are anchored toleaflets82 of the native valve.
• Reference is now made toFIGS. 1,49-61. It is to be noted that applications of tissue-engaging elements62 described herein are interchangeable as valve-anchoring elements64, and/or as support-anchoring elements66. For example, pairs132 of loop-shapedanchoring elements200, described with reference toFIGS. 56A-D as valve-anchoring elements64, may be coupled toprosthetic valve support40 to the native valve (i.e., so as to function as support-anchoring elements66). Similarly, clamping-hinged-anchors-350, for example, described with reference toFIGS. 61A-C as support-anchoring elements66, may be employed to coupleprosthetic valve42 to the native valve (i.e., and function as valve-anchoring elements64).
• Reference is made toFIGS. 62A-D, which are schematic illustrations ofdelivery apparatus4138a, used to deploy a medical device150, in accordance with some applications of the invention. As shown inFIG. 62A,delivery apparatus4138acomprises adelivery tube154 and a pushingmember140a. Pushingmember140acomprises asupport4142aand one ormore coupling tabs4146, extending from the support. In the application of the invention shown inFIG. 62A,support4142acomprises acore144, andcoupling tabs4146 extend radially from the core. In some applications of the invention,support4142ais shaped to define aplate4148 at the proximal end ofsupport4142a. The dimensions and relative positions ofsupport4142a,tabs4146, andplate4148 may be adjusted for the specific medical device150 to be deployed usingdelivery apparatus4138a.
• In the application of the invention described with respect toFIGS. 62A-D, medical device150 comprises prosthetic valve42 (e.g., any one ofprosthetic valves42 described herein).
• FIG. 62B showsprosthetic valve42 in a compressed (i.e., crimped) configuration for delivery and deployment usingdelivery apparatus4138a. As described hereinabove,prosthetic valve42 typically has a lattice structure that defines a plurality of shapes, and voids4126, and has elastic memory.Prosthetic valve42 is shown in a compressed (e.g., crimped) configuration, and as shown in the enlarged image, a proximal portion ofvalve42 is disposed aroundcore144 of pushingmember140asuch that each ofcoupling tabs4146 is disposed within arespective void4126 defined by the lattice structure of the prosthetic valve.
• Prosthetic valve42 and pushingmember140aare disposed within the lumen ofdelivery tube154.Delivery tube154 restricts expansion ofprosthetic valve42, thereby holding the proximal portion ofprosthetic valve42 aroundcore144 of pushingmember140a, in the configuration described herein. Couplingtabs4146 restrict movement ofprosthetic valve42 with respect to pushingmember140a.Delivery tube154 therefore facilitates coupling ofprosthetic valve42 to pushingmember140aviacoupling tabs4146. In applications of the invention where pushingmember140ais shaped to defineplate4148, the plate typically further facilitates this coupling by restricting proximal movement ofprosthetic valve42 with respect to the pushing member (e.g., by functioning as a cap).
• FIG. 62C showsprosthetic valve42 partially deployed fromdelivery tube154. Pushingmember140a, and, thereby,prosthetic valve42, are moved distally throughdelivery tube154.
• Acontrol tube4152 is coupled at a distal end thereof to pushingmember140a(e.g.,control tube4152 is coupled to support4142a).Control tube4152 is shaped so as to define a lumen through which aguidewire tube4153 passes, andcontrol tube4152 is slidable with respect to and alongguidewire tube4153.Guidewire tube4153 houses guidewire45 described hereinabove.Control tube4152 is slidably disposed within a lumen of anovertube4155.
• Reference is again made toFIG. 62C. Pushingmember140ais pushed distally by pushingcontrol tube4152 alongguidewire tube4153 such that pushingmember140apushesprosthetic valve42. As pushingmember140apushes valve42 distally, distal portions of the prosthetic valve expand toward the expanded configuration as they become exposed fromdelivery tube154, while the proximal end ofvalve42 remains coupled to pushingmember140aviatabs4146.
• FIG. 62D showsprosthetic valve42 having been fully deployed from withindelivery tube154. Pushingmember140aandprosthetic valve42 are moved further distally throughdelivery tube154 bycontrol tube4152. When the proximal portion ofprosthetic valve42 emerges from withindelivery tube154, expansion of the proximal portion ofprosthetic valve42 uncouples the prosthetic valve fromcoupling tabs4146 by expandingvoids4126 away fromtabs4146, thereby releasing the prosthetic valve from pushingmember140a.
• Should it be necessary and/or desirable during the procedure, until medical device150 (e.g., prosthetic valve42) is released from pushingmember140a(i.e., while the proximal portion of medical device150 is crimped within delivery tube154), the remaining portions of medical device150 may be drawn back into delivery tube154 (e.g., for repositioning or withdrawal of the medical device).
• Reference is now made toFIGS. 54A-D and62A-D. It is to be noted that for some applications, withdrawing of a portion ofprosthetic valve42 withindelivery tube42 facilitates deforming ofintegral anchors310 toward their constrained, further-expanded open configuration. This occurs when a distal end oftube154 pushes against pivot joint4074 betweenanchor310 andstructural element130 as the portion ofprosthetic valve42 is withdrawn.
• In the application of the invention described with reference toFIGS. 62A-D, voids4126 are defined by the lattice structure of medical device150 (i.e., prosthetic valve42). In other applications of the invention, voids in medical device150 may be defined by other structural features of the medical device and not necessarily by a lattice structure. Typically, as described herein,coupling tabs4146 couple medical device150 to pushingelement140aat a proximal portion of the medical device, thereby retaining coupling of the medical device to pushingmember140auntil the medical device is fully deployed fromdelivery tube154. It is to be noted that the scope of the present invention includes tabs which alternatively or additionally couple medical device150 to pushingelement140aat portions of the medical device other than the proximal portion thereof.
• It is hypothesized that utilization of pushingmember140a, comprisingcoupling tabs4146 that are disposable invoids4126 defined by an expandable medical device150, (1) reduces the overall length of the apparatus (i.e., the combined lengths of medical device150 and delivery device154) being advanced into the subject, and/or (2) reduces the requirement for additional components of medical device150 which function as coupling structures of medical device150. That is, medical device150 has an integral coupling system by which voids4126 are coupled totabs4146. The applications of the invention described with reference toFIGS. 62A-D may be used in combination with applications of the invention described hereinabove, as well as for the delivery of other expandable medical devices.
• Reference is again made toFIGS. 1A-H,9A-E, and62A-D. It is to be noted thatdelivery tube154 ofFIGS. 9A-E and62A-D may be similar to, may act as, and/or may comprise, overtube44 and/ordelivery tube60 ofFIGS. 1A-H.
• Reference is made toFIGS. 63A-B, which are schematic illustrations ofdelivery apparatus4138b, used to deploy an expandable medical device150, in accordance with some applications of the invention. Reference is now made toFIG. 63A.Delivery apparatus4138bcomprisesdelivery tube154 and a pushingmember140b, which comprises asupport4142b. In this application of the invention, pushingmember140bis shaped to define a plurality oftroughs222. Typically,troughs222 run along the surface of pushingmember140b, from one end of the pushing member (e.g., a distal end) to a point along the length of the pushing member. Typically,troughs222 are shaped so as to define a respective widened part224 (e.g., at a proximal end of the trough) or is configured to open into a larger widened part224 (as shown). In the application of the invention described with reference toFIGS. 63A-B, widenedpart224 comprises a single circumferential groove surrounding the circumference of pushingmember140b, into which alltroughs222 open. Alternatively, eachtrough222 may be shaped so as to define a respective widened part.
• Reference is now made toFIG. 63B. Medical device150, embodied in this application of the invention as expandableprosthetic valve42, comprises a plurality ofcoupling tabs220. Couplingtabs220 are configured to be disposable inrespective troughs222 of pushingmember140b, such thattroughs222 restrict distal movement of medical device150. In the application of the invention described with reference toFIGS. 63A-B,coupling tabs220 are T-shaped, so as to be disposable inrespective troughs222 and in the circumferential groove that forms widenedpart224. The disposition ofcoupling tabs220 introughs222 couplesprosthetic valve42 to pushingmember140b. Couplingtabs220,troughs222, and widenedpart224 may assume any shape that allows such coupling.
• Prior to delivery,prosthetic valve42 is compressed (e.g., crimped) such that allcoupling tabs200 are disposed inrespective troughs222.Prosthetic valve42 and pushingmember140bare disposed within the lumen ofdelivery tube154.Delivery tube154 restricts expansion ofprosthetic valve42, thereby holdingcoupling tabs220 introughs222, in the configuration described herein. Couplingtabs220 restrict movement ofprosthetic valve42 with respect to pushingmember140b.Delivery tube154 therefore facilitates coupling ofprosthetic valve42 to pushingmember140bviacoupling tabs220. As described with reference toFIGS. 62C-D, prosthetic valve42 (or another medical device150) is advanced to the site of implantation, where pushingmember140bpushesprosthetic valve42 out ofdelivery tube154. When couplingtabs220 emerge fromdelivery tube154, expansion ofprosthetic valve42releases coupling tabs220 fromtroughs222, thereby releasingprosthetic valve42 from the pushing member.
• Reference is made toFIGS. 64A-C, which are schematic illustrations of alock170 for facilitating delivery of a medical device, in accordance with some applications of the invention.
• Reference is now made toFIG. 64A.Lock170 comprises atubular member4172 and aplug174.Plug174 is dimensioned such that it is disposable in, and slidable through the lumen oftubular member4172. Typically, plug174 is dimensioned so as to fit tightly in the lumen oftubular member4172 in a manner in which an outer surface ofplug174 is disposed very close to an inner surface totubular member4172, i.e., such that little space exists between the plug and the tubular member.Plug174 is shaped to define atrough176.Trough176 typically runs along the surface of the plug from one end of the plug to a point along the length of the plug. Typically,trough176 is shaped so as to define awidened part178.
• A coupling lead4180 (e.g., a coupling wire) is disposable intrough176, and is reversibly couplable thereto (and thereby to lock170), as described hereinbelow. As is described hereinbelow,coupling lead4180 is coupled to a medical device150 and facilitates (1) coupling of medical device150 to a delivery mechanism during delivery of the medical device and (2) decoupling of medical device150 from the delivery mechanism following implantation of device150. Typically, a region at an end ofcoupling lead4180 is shaped to define astopper182, which is thicker than other regions of the coupling lead, and is configured to be disposable inwidened part178 oftrough176, typically whentubular member4172 surroundsplug174. Alternatively,stopper182 may comprise a distinct component that is coupled tocoupling lead4180.Trough176,coupling lead4180, widenedpart178, andstopper182 are dimensioned such that when the coupling lead and the stopper are disposed intrough176, plug174 remains disposable in, and slidable through,tubular member4172.FIG. 64A showstrough176 disposed within the lumen oftubular member4172 such thatlock170 assumes a locking configuration. In this locking configuration,coupling lead4180 is held in the trough by the inner surface of the tubular member.Tubular member4172 therefore facilitates coupling ofcoupling lead4180 to plug174.
• Reference is now made toFIG. 64B.Plug174 is slid distally throughtubular member4172, such thatlock170 is in an open configuration. Typically, plug174 is moved usingcontrol wire175. In this open configuration,trough176 andstopper182 are exposed from the tubular member (i.e., are outside the tubular member).Coupling lead4180 andstopper182 are shown inFIG. 64B as being disposed withintrough176, by way of illustration and not limitation, as a temporary configuration prior todisengaging wire4180 andstopper182 from trough176 (disengaging ofwire4180 andstopper182 are described hereinbelow).
• Reference is now made toFIG. 64C. In the open configuration, coupling lead4180 (and stopper182) are allowed to leavetrough176. Typically,coupling lead4180 is released fromtrough176 by moving the former with respect to the latter (e.g., by applying a moving force to eithercoupling lead4180, directly or indirectly, or by applying a moving force to plug174 away from wire4180). In some applications of the invention, at least a portion ofcoupling lead4180 is configured such that it automatically moves out of the trough upon being exposed from the tubular member (e.g., the coupling lead comprises a shape-memory material such as nitinol). In some applications of the invention,trough176 and widenedpart178 are shaped to facilitate release ofcoupling lead4180 fromtrough176. For example, a distal edge ofwidened part178 may be sloped such that distal movement ofcoupling lead4180 facilitates the release.
• Reference is made toFIGS. 65A-B, which are schematic illustrations of sequential steps inlock170 being used to facilitate the delivery of a medical device150, the medical device embodied byprosthetic valve support40, in accordance with some applications of the invention.FIG. 65A shows a coupling lead4180 (e.g., a coupling wire) extending from a holding member4046 (e.g., a holdingmember4046a) to another holding member4046 (e.g., a holdingmember4046b). For some applications, holdingmembers4046 comprise holdingmembers46, described hereinabove with reference toFIGS. 1C-F.Coupling lead4180 is coupled to medical device150. For example,coupling lead4180 may loop around a part of medical device150. Alternatively,coupling lead4180 may weave through at least a portion of medical device150, as shown inFIG. 65A. At least one holding member4046 (e.g., holdingmember4046a) compriseslock170 at a distal end of holdingmember4046.Holding member4046 is shaped to define a lumen and definestubular member4172 oflock170.Holding member4046ais reversibly coupled to a first portion of coupling lead4180 (e.g., an end portion ofwire4180, as shown) vialock170. The remaining portions ofwire4180 are threaded throughsupport40, as shown, and extend through a lumen, of holdingmember4046b, as shown. Alternatively, a second portion ofcoupling lead4180 is coupled to a portion of holdingmember4046b.
• In the application of the invention illustrated inFIG. 65A, two holdingmembers4046aare coupled tocoupling lead4180 viarespective locks170, and one holdingmember4046bis coupled tocoupling lead4180 without alock170. That is, afirst holding member4046aholds a first end ofwire4180, and asecond holding member4046aholds a second end ofwire4180. Portions ofwire4180 extending from the first and second ends thereof are threaded through respective portions ofsupport40 and extend through a lumen of holdingmember4046b, as shown. Alternatively, each holdingmember4046ais coupled to respective first ends of respective first and second coupling leads4180. Respective portions of the first and second coupling leads4180 extending from the respective first ends thereof are threaded through respective portions ofsupport40, and extend through a lumen of holdingmember4046b. Alternatively, respective second portions of the first and second coupling leads4180 are coupled to a portion of holdingmember4046b.
• Reference is now made toFIG. 65B. At the site of implantation,lock170 is moved into its open configuration, thereby releasingcoupling lead4180 from holdingmember4046a.Coupling lead4180 is then decoupled (e.g., unthreaded or unlooped) from medical device150 (e.g., by pulling on a portion of coupling lead4180). In some applications of the invention, holdingmember4046bis slidably coupled tocoupling lead4180, and the decoupling ofcoupling lead4180 from medical device150 is performed by withdrawingcoupling lead4180 proximally, through holdingmember4046b. In other applications of the invention, holdingmember4046bis substantially attached tocoupling lead4180, and the decoupling ofcoupling lead4180 from medical device150 is performed by withdrawing holdingmembers4046 proximally following the decoupling of holdingmembers4042afromcoupling lead4180. Medical device150 is typically left at the site of implantation following the decoupling.
• Reference is made toFIGS. 66A-B, which are schematic illustrations of sequential steps inlock170 facilitating the delivery of a medical device150, the medical device embodied byprosthetic valve support40, in accordance with some applications of the invention. Reference is now made toFIG. 66A. In this application of the invention, both ends of eachcoupling lead4180 are coupled to onerespective holding member4046. Each one of holdingmembers4046 comprises arespective lock170. Arespective coupling lead4180 is coupled to each holdingmember4046. For each holdingmember4046, one end of coupling lead4180 (i.e., the end ofwire4180 comprising stopper182) is reversibly coupled to the holding member vialock170, as described hereinabove with reference toFIG. 65A. The other end of the coupling lead is coupled to the holding member in a substantially fixed manner (e.g., attached to the holding member, or attached to a second part of lock, such as a second part of plug174). In such a manner, eachcoupling lead4180 forms a loop around a part of medical device150 (as shown in the enlarged image ofFIG. 66A), thereby coupling eachcoupling lead4180, and thereby coupling each holdingmember4046, to medical device150.
• Reference is now made toFIG. 66B. At the site of implantation, eachlock170 is moved into its open configuration (described hereinabove), thereby releasing one end of each coupling lead4180 (i.e., the end ofwire4180 comprising stopper182), and thereby opening the loop formed bycoupling lead4180. Eachcoupling lead4180 is withdrawn proximally (i.e., by pulling proximally on each holdingmember4046, as shown), thereby uncoupling (e.g., unthreading or unlooping)coupling lead4180 from medical device150.
• For some applications of the present invention, the other end ofcoupling lead4180 is attached to a portion of holdingmember4046. In such applications, withdrawal ofcoupling lead4180 typically comprises withdrawing holdingmember4046 proximally.
• For some applications of the invention, the other end ofcoupling lead4180 is attached to a portion (e.g., an outer surface of) ofplug174. For such applications, withdrawal ofcoupling lead4180 may comprise withdrawing the plug into tubular member4172 (i.e., holding member4046).
• In either application, following the decoupling of holdingmembers4046 andwires4180 from device150, medical device150 is typically left at the site of implantation.
• Reference is made toFIGS. 67A-B, which are schematic illustrations of sequential steps inlock170 facilitating the delivery of a medical device150, the medical device embodied byprosthetic valve support40, in accordance with some applications of the invention. Reference is now made toFIG. 67A. One end of coupling lead4180 (i.e., the end ofwire4180 comprising stopper182) is reversibly coupled to holdingmember4046 vialock170, as described hereinabove with reference toFIG. 65A. The other end of the coupling lead is coupled to medical device150 in a substantially fixed manner. Typically, but not necessarily,coupling lead4180 is short in comparison to the coupling lead described with reference toFIGS. 65A-B and66A-B.
• Reference is now made toFIG. 67B. At the site of implantation,lock170 is moved into its open configuration, releasing one end of coupling lead4180 (i.e., the end ofwire4180 comprising stopper182). Holdingmembers4046 are withdrawn proximally, releasingcoupling lead4180 and medical device150 from holdingmembers4046. Following the decoupling of holdingmembers4046 from device150, medical device150 is typically left at the site of implantation. In this application of the invention, coupling leads4180 typically remain coupled to medical device150.
• The applications of the invention described with reference toFIGS. 64A-C,65A-B,66A-B, and67A-B may be used in combination with each other, and/or in combination with applications of the invention described herein, including those comprising delivery and/or deployment ofprosthetic valve42,prosthetic valve support40, and/or medical device150. These applications of the invention may also be used to deliver and/or deploy medical devices not described herein.
• Reference is made toFIGS. 68A-B and69A-E, which are schematic illustrations ofprosthetic valve support40 comprising a retrievability functionality, in accordance with some applications of the invention.
• FIGS. 68A-B showprosthetic valve support40 is coupled to one ormore holding members4046 via one or morecoupling retrieving wires4180, in accordance with respective applications of the invention. Typically,prosthetic valve support40 is coupled to 2 or more (e.g., 3) holdingmembers4046 via 2 or more (e.g., 3) coupling leads4180. Typically, the ends of eachcoupling lead4180 are disposed within holdingmembers4046, or more proximally (e.g., outside a body of the subject). A portion (e.g., a middle portion) of each coupling lead is disposed through respective portions of prosthetic valve support40 (e.g., threaded through support40), thereby coupling the prosthetic valve support to holdingmembers4046. Since (1) the respective ends of coupling leads4180 are coupled to or extend beyond a proximal end of holdingmembers4046, and (2) respective middle portions ofwires4180 are threaded through respective portions ofsupport40, each coupling lead forms a loop. Typically, this middle portion of each coupling lead is disposed through a peripheral region (e.g., close to an outer edge69) of the prosthetic valve support.
• FIGS. 68A-B show two configurations of coupling leads4180, coupling holdingmembers4046 toprosthetic valve support40, in accordance with respective applications of the invention. For these applications of the invention, three coupling leads4180 (e.g., coupling wires) are used, and are illustrated as coupling leads4180a,4180b, and4180c, for clarity.Prosthetic valve support40 is typically deployed in theatrium26 of the subject, e.g., as described with reference toFIGS. 1B-D.
• FIG. 68A shows the middle portions ofwires4180a-cforming respective pulling loops (e.g., closed loops) around and threaded throughsupport40. That is, a respective pulling force is applied annularly to theentire support40 by each one ofwires4180a-c.
• FIG. 68B shows the middle portions ofwires4180a-cthreaded through portions ofsupport40 in a manner in which the respective middle portions ofwires4180a-ccollectively form a pulling loop. That is, a respective pulling force is applied to respective portions of support40 (i.e., to respective thirds of support40) corresponding to the portions ofsupport40 through which the respective middle portions ofwires4180a-care threaded.
• Reference is now made toFIGS. 69A-E, which are schematic illustrations of sequential steps in the retrieval ofprosthetic valve support40 described hereinabove with reference toFIGS. 68A-B, in accordance with some applications of the invention. Should it be required (e.g., for repositioning of the prosthetic valve support, or abortion of the procedure), the deployed prosthetic valve support may be retrieved intoovertube44.FIG. 69A showsprosthetic valve support40 in a fully deployed configuration, still coupled to holdingmembers4046 via coupling leads4180. In this configuration,prosthetic valve support40 is typically flat, but may have a different shape (e.g., a saddle shape).
• Reference is now made toFIG. 69B. A user moves coupling leads4180 proximally with respect to holdingmembers4046 and prosthetic valve support40 (e.g., the user pulls coupling leads4180 through holding members4046). Due to the configuration of coupling leads4180 (as described with reference toFIGS. 68A-B) the portion of each coupling lead that passes through the prosthetic valve support becomes shortened, thereby reducing a perimeter of the peripheral region (e.g. of outer edge69) ofprosthetic valve support40, through which coupling leads4180 are disposed.
• FIG. 69C shows the perimeter ofouter edge69 ofprosthetic valve support40 having been reduced further, thereby deforming prosthetic valve support toward a cylindrical shape, withouter edge69 defining a proximal end of the further-reducedsupport40.FIG. 69D shows the diameter ofouter edge69 having been reduced, such that the proximal end comprisingouter edge69 ofprosthetic valve support40 is slidable and disposable inovertube44. As the user pulls coupling leads4180, he/she pushes overtube44 distally over successive portions ofsupport40.FIG. 69E shows holdingmembers4046 andprosthetic valve support40 being moved proximally with respect to overtube44 (e.g., the prosthetic valve support is moved proximally and/or the overtube is moved distally). As overtube44 slides overprosthetic valve support40, it compresses more distal portions of the prosthetic valve support, until the prosthetic valve support has been entirely retrieved intoovertube44.Prosthetic valve support40 may be redeployed or may be removed from the subject. Retrieval and/or deployment may be halted and/or reversed at any stage in the process described with reference toFIGS. 69A-E.
• The applications of the invention described with reference toFIGS. 68A-B and69A-E may be used in combination with each other, and/or in combination with applications of the invention described herein, including those which includeprosthetic valve support40.
• Reference is made toFIGS. 70A-C, which are schematic illustrations ofprosthetic valve42, comprising tissue-engagement elements62, in accordance with some applications of the invention. In these applications of the invention, tissue-engagement elements62 comprise valve-anchoring elements64, disposed at the distal end ofprosthetic valve42. Each valve-anchoring element64 may comprise a loop-shaped valve-anchoringelement200 or a stick-shaped valve-anchoringelement202. Loop-shaped valve-anchoringelements200 have a larger surface area with which to graspleaflets82, and are hypothesized to be facilitate more atraumatic advancement with respect to tissue than are stick-shaped valve-anchoringelements202. Stick-shaped valve-anchoringelements202 are hypothesized to more easily, be insertable between chordae tendineae80 (e.g., comb between chordae tendineae), than are loop-shaped valve-anchoringelements200.
• Prosthetic valve42 may be coupled to one or more valve-anchoring elements64, comprising loop-shaped valve-anchoringelements200, stick-shaped valve-anchoringelements202, or a combination thereof, in order to facilitate deployment ofprosthetic valve42 and coupling of the prosthetic valve to native heart valve23. For example, stick-shaped valve-anchoringelements202 may be used in areas of heart valve23 in whichchordae tendineae80 are disposed more densely, whereas loop-shaped valve-anchoringelements200 may be used to capture relatively exposed regions ofleaflets82. Loop-shaped valve-anchoringelements200 and stick-shaped valve-anchoringelements202 are illustrated here as fixed anchors. In some applications of the invention,elements200 and202 may be alternatively or additionally used as hinged anchors (e.g., hinged anchors340) and/or clamping hinged anchors (e.g., clamping hinged anchors350), as described hereinabove.
• Reference is now made toFIG. 71, which is a schematic illustration ofprosthetic valve42, for placing inside native heart valve23 of the patient, in accordance with some applications of the present invention. For this application of the invention, native valve23 includesmitral valve24. The primarystructural element130 of the prosthetic valve has a diameter d, and a corresponding cross-sectional area. The annulus of the native valve, which is typically saddle-shaped, defines an area A1, as shown. For some applications, area A1 is measured, e.g., using a measuring ring prior to deployment ofvalve42. Taking this measuring into account, a suitably-sized prosthetic valve is chosen to be placed in the annulus, in a manner in which the cross-sectional area of the prosthetic valve in its deployed state is less than 90% (e.g., less than 80%, or less than 60%) of area A1.
• For some applications, diameter d of the prosthetic valve is less than 25 mm, e.g., less than 20 mm, and/or more than 15 mm, e.g., 15-25 mm. For some applications, placing a prosthetic valve inside the native valve, with the dimensions of the native valve annulus and the prosthetic valve as described, facilitates sealing of the prosthetic valve with respect to the native valve, by the native valve leaflets closing around the outer surface of the prosthetic valve. In such applications,prosthetic valve42 is implanted directly within native valve23 (i.e., without support40).
• For some applications, aprosthetic valve support40, that is shaped to define a lumen, is placed against the annulus of native valve23 (e.g., as described with reference toFIGS. 1A-H). The lumen ofsupport40 has a cross-sectional area A2 that is less than 90% (e.g., less than 80%, or less than 60%) of area A1 of native valve23. As described hereinabove,prosthetic valve42 is typically coupled toprosthetic valve support40 and, thereby, to native valve23, at least in part by expansion of the prosthetic valve such that primarystructural element130 exerts a radial force againstinner edge68 ofprosthetic valve support40. The cross-sectional area defined by the primarystructural element130 of the prosthetic valve, upon expansion of the prosthetic valve, is limited by the cross-sectional area A2 of the lumen of theprosthetic valve support40 to less than 90% (e.g., less than 80%, or less than 60%) of area A1 of native valve23. For some applications, placing aprosthetic valve support40 at the native valve, as described, facilitates sealing of the prosthetic valve with respect to the native valve, by the native valve leaflets closing around the outer surface of the prosthetic valve.
• Typically, placing a prosthetic valve inside the native valve with the dimensions of the native valve annulus, theprosthetic valve42, and/orvalve support40 as described in the above paragraphs, facilitates sealing of the prosthetic valve with respect to the native valve. For some applications, the sealing is facilitated by the native leaflets being pushed against, and closing against, the outer surface of the frame of the valve during systole, in a similar manner to the manner in which native valve leaflets coapt during systole, in a healthy mitral valve.
• Typically, as the diameter d of the prosthetic valve is increased, the proportion of the native leaflets that is pushed against the outer surface of the valve during systole is increased, thereby enhancing the sealing of the native leaflets with respect to the frame of the prosthetic valve. However, beyond a given diameter, as the diameter d of the prosthetic valve is increased, the native valve leaflets are pushed apart at the commissures, thereby causing retrograde leakage of blood through the commissures. Therefore, in accordance with some applications of the present invention,prosthetic valve42, and/orvalve support40 are chosen such that the cross-sectional area of the prosthetic valve (when expanded inside the valve support) is less than 90% (e.g., less than 80%, or less than 60%) of area A1 of native vale23. Thus the valve support facilitates additional sealing of the prosthetic valve with respect to the native valve, by the native valve leaflets closing around the outer surface of the prosthetic valve, while not causing retrograde leakage of blood through the commissures.
• For some applications, in order to facilitate the sealing of the native valve around the outer surface of the prosthetic valve, a material is placed on the outer surface of the prosthetic valve in order to provide a sealing interface between the prosthetic valve and the native valve. For example, a smooth material that prevents tissue growth (e.g., polytetrafluoroethylene (PTFE), and/or pericardium) may be placed on the outer surface of the prosthetic valve. Alternatively or additionally, a material that facilitates tissue growth (such as polyethylene terephthalate; PET) may be placed on the outer surface of the prosthetic valve, in order to (a) act as a sealing interface between the native valve and the prosthetic valve, and (b) facilitate tissue growth around the prosthetic valve to facilitate anchoring and/or sealing of the prosthetic valve.
• Reference is made toFIGS. 72A-D, which are schematic illustrations of animplant2030, comprising aprosthetic valve support2040, and aprosthetic valve2042, in accordance with some applications of the invention.Implant2030 is configured to be implanted at a native heart valve of a subject, such as themitral valve2024 of the subject.
• FIG. 72A showssupport2040 andprosthetic valve2042 ofimplant2030 in respective fully uncompressed configurations thereof.Support2040 comprises anupstream support portion2041, which is shaped to define anopening2045, and configured to be placed against an upstream side of the native valve of the subject (e.g., against an atrial side of the mitral valve of the subject, such as against the annulus of the mitral valve of the subject). Typically,upstream support portion2041 is configured to be placed against the upstream side of the native valve such that the entire of opening2045 is disposed above (i.e., upstream and within a periphery defined by) the orifice of the native valve. Typically,upstream support portion2041 is configured and/or selected such thatopening2045 has a greatest diameter that is less than 90% (e.g., less than 80%, e.g., as less than 60%, such as less than 50%) of a greatest diameter of the orifice of the native valve. Typically,upstream support portion2041 is generally annular (e.g.,portion2041 andopening2045 are generally elliptical, circular, and/or oval).
• In the fully uncompressed configuration thereof,upstream support portion2041 typically has anouter perimeter2069 of length between 125 and 190 mm (e.g., between 140 and 170 mm, such as between 140 and 150 mm), and an inner perimeter2068 (that defines opening2045) of length between 62 and 105 mm (e.g., between 65 and 80 mm, such as between 75 and 80 mm). Whenupstream support portion2041 is annular, the upstream support portion, in the fully uncompressed configuration thereof, typically has an outer diameter d10 (e.g., a greatest outer diameter) of between 40 and 80 mm (e.g., between 40 and 70 mm, such as between 40 and 60 mm), and an inner diameter d11 (e.g., a greatest inner diameter) of between 20 and 35 mm (e.g., between 23 and 32 mm, such as between 25 and 30 mm) That is, opening2045 typically has a diameter of between 20 and 35 mm (e.g., between 23 and 32 mm, such as between 25 and 30 mm). Typically,outer perimeter2069 has a length that is at least 10% (e.g., at least 50%, such as at least 80%) greater thaninner perimeter2068.
• In the fully uncompressed configuration thereof,upstream support portion2041 is typically (but not necessarily) generally flat (e.g., laminar, and/or planar). For some applications, in the fully uncompressed configuration,portion2041 assumes a frustoconical shape, typically arranged from the generally flat composition of the portion.Portion2041 has a thickness of less than 5 mm, such as less than 2 mm.Opening2045 has a depth (e.g., a height) d12 from anupstream side2047 of the upstream support portion to adownstream side2049 of the upstream support portion. Depth d12 ofopening2045 is less than 5 mm, such as less than 2 mm. Typically, therefore, inner diameter d11 is more than 4 times (e.g., more than 6 times, such as more than 10 times) greater than depth d12. That is, opening2045 is more than 4 times (e.g., more than 6 times, such as more than 10 times) wider than it is deep. Typically, in the fully uncompressed configuration,upstream support portion2041 has a total height of less than 10 mm (e.g., less than 5 mm, such as less than 2 mm)
• Typically,inner perimeter2068 comprises, or is defined by, a free inner edge ofupstream support portion2041. That is, opening2045 resembles a hole cut out of a lamina (e.g., out of a disc). For some applications,inner perimeter2068 comprises, or is defined by, a curved and/or folded inner edge ofupstream support portion2041. If the inner perimeter ofupstream support portion2041 comprises, or is defined by, a curved or folded edge, then a radius of curvature of the curved or folded edge is typically less than 2.5 mm, such as less than 1 mm. That is, the curve or fold of the edge is generally sharp, such that when viewed from withinopening2045, the curved or folded edge looks generally like a free edge.
• It is to be noted that, for simplicity,upstream support portion2041 is generally described herein in terms of symmetrical geometric shapes (e.g., ellipse and frustum), but that the upstream support portion may assume a symmetrical or an unsymmetrical shape.
• Prosthetic valve2042 comprises a generally tubular (e.g., cylindrical) primarystructural element2130, shaped to define alumen2043 therethrough, and at least one check valve element (not shown), configured to regulate blood flow through the prosthetic valve. Typically, the check valve element comprises one or more prosthetic valve leaflets, disposed inlumen2043, and coupled (e.g., sutured) to the primary structural element. For some applications of the invention, the check valve element comprises a ball, disc, or other check valve component. For some applications of the invention,prosthetic valve2042 comprises a commercially-available stent-based prosthetic valve.
• Prosthetic valve2042 is configured to be placeable inopening2045 ofsupport2040, and couplable to the support by being expandable within this opening, e.g., as described in more detail hereinbelow. Typically,support2040 comprises tissue-engaging elements (e.g., support-anchoring elements), such as those described herein (not shown inFIGS. 72A-D), and is couplable to the native valve, such that coupling ofprosthetic valve2042 to the support, couples the prosthetic valve to the native valve. For some applications,prosthetic valve2042 comprises tissue-engaging elements (e.g., valve-anchoring elements), such as those described herein (not shown inFIGS. 72A-D), and is alternatively or additionally directly couplable to the native valve.
• In the fully uncompressed configuration thereof,prosthetic valve2042 typically has aperimeter2051 of length between 62 and 110 mm (e.g., between 70 and 90 mm, such as between 80 and 90 mm), and a height d14, (i.e., a length from an upstream end to a downstream end) of between 15 and 40 mm (e.g., between 20 and 35 mm, such as between 25 and 25 mm). Whenstructural element2130 is cylindrical,prosthetic valve2042, in the fully uncompressed configuration thereof, typically has a diameter d13 of between 20 and 35 mm (e.g., between 25 and 35 mm, such as between 25 and 30 mm). Typically,support2040 andprosthetic valve2042 are configured and/or selected (e.g., paired), such thatperimeter2051 is slightly (e.g., between 1 and 15 mm, such as between 1 and 7 mm) greater thanperimeter2068, and/or that diameter d13 is slightly (e.g., between 1 and 5 mm, such as between 1 and 3 mm) greater than diameter d11.
• In the respective fully uncompressed configurations thereof, height d14 ofprosthetic valve2042 is typically at least 1.5 times greater (e.g., at least 3 times greater, such as at least 5 times greater) than the total height ofupstream support portion2041.
• Typically,support2040 comprises a lattice structure which defines a plurality ofstruts2120, typically in a repeating arrangement, and a plurality of voids between the struts. Typically,upstream support portion2041 comprises the lattice structure ofsupport2040. Typically,prosthetic valve2042 comprises a lattice structure which defines a plurality ofstruts2124, and a plurality of voids between the struts.Support2040 andprosthetic valve2042 typically have shape-memory (e.g., resilient, pseudoelastic and/or superelastic) properties. Typically, struts2120 and/or struts2124 comprise a shape-memory (e.g., resilient, pseudoelastic and/or superelastic) material, such thatsupport2040 and/orprosthetic valve2042 are compressible when a compressive force is applied (e.g., prior to implantation), and re-expandable when the compressive force is removed (e.g., during implantation), as described hereinbelow. Non-limiting examples of materials that the support (e.g., struts2120) and/or prosthetic valve (e.g., struts2124) may comprise include nickel-titanium (Nitinol), stainless steel, nickel cobalt, cobalt chrome, titanium, tantalum, and palladium.
• Typically,support2040 and/orprosthetic valve2042 are at least in part covered with a covering2440 (for clarity, covering2440 is only shown on support2040). Non-limiting examples of materials that covering2440 may comprise include polyethylene terephthalate (e.g., polyester), polytetrafluoroethylene (e.g., Teflon, ePTFE), and pericardial tissue. For some applications, covering2440 comprises a fabric. Typically, a thickness of the covering is less than 0.5 mm, such as less than 0.2 mm, e.g., less than 0.1 mm, or less than 0.05 mm. InFIG. 72A, struts2120 are shown in phantom, as they are covered by covering2440.
• For some applications of the invention, covering2440 is configured to facilitate blood flow through the prosthetic valve, e.g., to channel blood throughlumen2043 defined byprosthetic valve2042, and/or to prevent leakage (1) between the prosthetic valve andsupport2040, and/or (2) betweenimplant2030 and the native valve. For some applications of the invention, the covering is configured to mask sharp and/or hard surfaces (e.g., metal surfaces, such as surfaces ofstruts2120 and/or2124), and thereby to protect native tissues from being damaged by such surfaces. For some applications of the invention, the covering is configured to facilitate (e.g., to enhance) coupling betweensupport2040 and prosthetic valve2042 (e.g., as described hereinbelow), such as by increasing friction. For some applications of the invention, the covering is configured to facilitate (e.g., to encourage) growth of tissue (e.g., fibrosis) over one or more components ofimplant2030.
• FIG. 72B showssupport2040 andprosthetic valve2042 ofimplant2030 in respective compressed configurations thereof, typically for delivery to the native valve. Typically,support2040 andprosthetic valve2042 are delivered percutaneously (e.g., transcatheterally). Typically, the support and the valve component are delivered to the native valve transluminally (e.g., transfemorally). For some applications,support2040 andprosthetic valve2042 are delivered to the native valve transatrially. For some applications,support2040 andprosthetic valve2042 are delivered to the native valve transapically. In the compressed configuration thereof,upstream support portion2041 is typically generally cylindrical, and is typically delivered to a site that is upstream of the native valve of the subject (e.g., the left atrium, upstream of the mitral valve of the subject), such that a downstream (e.g., distal)end2053 of the support has aperimeter2068b, which is a compressedinner perimeter2068, and anupstream end2055 of the support comprisesperimeter2069b, which is a compressedouter perimeter2069.
• In the compressed configuration thereof,upstream support portion2041 typically has (e.g.,perimeters2068band2069bhave) a perimeter of length between 9 and 30 mm (e.g., between 15 and 25 mm, such as between 18 and 22 mm), and a height d15 of between 11 and 30 mm (e.g., between 15 and 30 mm, such as between 15 and 25 mm). Whenupstream support portion2041, in the compressed configuration thereof, is cylindrical,portion2041 typically has a diameter of between 3 and 9 mm (e.g., between 5 and 8 mm, such as between 6 and 7 mm).
• In the compressed configuration thereof,prosthetic valve2042 is typically generally cylindrical. Compression of the prosthetic valve typically comprises inwardly-radial compression, such that the component is narrower and taller in the compressed configuration than in the fully uncompressed configuration thereof. In the compressed configuration thereof,prosthetic valve2042 typically has aperimeter2051b(a compressed perimeter2051) of between 9 and 30 mm (e.g., between 10 and 20 mm, such as between 15 and 20 mm), and a height d16 of between 16 and 41 mm (e.g., between 20 and 35 mm, such as between 20 and 30 mm). Whenprosthetic valve2042, in the compressed configuration thereof, is cylindrical,prosthetic valve2042 typically has a diameter of between 2 and 9 mm (e.g., between 3 and 8 mm, such as between 3 and 6 mm).
• Support2040 (e.g., portion2041) andprosthetic valve2042 typically have shape-memory properties, and are compressed (e.g., crimped) into their respective compressed configurations prior to (e.g., immediately prior to) the implantation procedure. Typically, the support and prosthetic valve are retained (e.g., ‘constrained’) in this configuration by a constraining member, such as an overtube, a delivery tube, and/or other delivery apparatus.Support2040 andprosthetic valve2042 are typically subsequently expanded (e.g., ‘deployed’) close to the site of implantation by releasing the constraining (e.g., compressive) force (e.g., by removing the constraining member). That is, the compressed configurations of prosthetic valve support2040 (e.g., of upstream support portion2041) andprosthetic valve2042, described with reference toFIG. 72B, typically comprise constrained compressed configurations, and the fully uncompressed configurations, described with reference toFIG. 72A, are unconstrained uncompressed configurations.
• FIG. 72C shows an end-view ofimplant2030, withprosthetic valve2042 coupled toprosthetic valve support2040 by being disposed and expanded within opening2045 (not shown inFIG. 72C) defined byportion2041.FIG. 72C showsdownstream side2049 ofsupport2040, therefore struts2120 are shown in solid form. Typically,prosthetic valve2042 is delivered toopening2045 in a constrained compressed configuration thereof (e.g., as described with reference toFIG. 72B), and expanded (e.g., released) in the opening, such thatprosthetic valve2042 applies a radially-expansive force againstinner perimeter2068 ofportion2041. Typically, this radially-expansive force facilitates coupling ofprosthetic valve2042 toportion2041.
• So as to provide the radially-expansive force, and as described hereinabove,prosthetic valve2042 and support2040 (e.g., portion2041) are typically configured and/or selected (e.g., paired) such thatperimeter2051 ofprosthetic valve2042, in the fully uncompressed configuration thereof, is slightly greater thaninner perimeter2068 ofportion2041. Whenprosthetic valve2042 is expanded withinopening2045, portion2041 (e.g., inner perimeter2068) thereby restricts the full expansion ofprosthetic valve2042. Therefore, in the coupled configuration shown inFIG. 72C, aperimeter2051cofprosthetic valve2042 is typically smaller thanperimeter2051 of the prosthetic valve in the fully uncompressed configuration thereof.
• As described hereinabove (e.g., with reference toFIG. 72A),upstream support portion2041 is configured to be placed against an upstream side of the native valve. As further discussed hereinbelow (e.g., with reference toFIG. 72K), it should be noted, that radial expansion ofprosthetic valve2042 againstinner perimeter2068 ofupstream support portion2041, thereby typically does not cause the prosthetic valve support to apply a radially-expansive force to the native valve.
• For some applications, the prosthetic valve is couplable to the upstream support portion at a continuum of positions along the axial length of the prosthetic valve. That is, a physician can couple the prosthetic valve to the support at a continuum of depths within the support. For example, in applications in which the prosthetic valve is configured to be coupled to the upstream support portion solely by the radially-expansive force, the prosthetic valve may be coupled to the upstream support portion at a continuum of positions along the length of the prosthetic valve.
• As described hereinabove, the lattice structures ofprosthetic valve2042 andportion2041 typically define a repeating arrangement of struts, e.g., a repeating arrangement of shapes. For some applications, and as shown inFIG. 72C,prosthetic valve2042 andportion2041 comprise the same number of arrangement repeats. For some such applications, this matching number of repeats facilitates coupling ofprosthetic valve2042 andportion2041. For example, and as shown inFIG. 72C, a number of inwardly-protrudingridges2057 ofportion2041 protrude (e.g., interpose) within an equal number of corresponding circumferential voids defined by the lattice structure ofprosthetic valve2042. These ridges facilitate coupling ofsupport2040 andprosthetic valve2042, e.g., by inhibiting axial movement of the prosthetic valve throughopening2045 ofupstream support portion2041.
• Typically, the arrangement of repeating circumferential voids defined by the lattice structure of the prosthetic valve is repeated axially, thereby defining a prismatic (e.g., cylindrical) shape of the prosthetic valve. For some applications, the prosthetic valve is thereby couplable to the upstream support portion at a plurality of positions along the axial length of the prosthetic valve. That is, a physician can couple the prosthetic valve is couplable to the upstream support portion at a plurality of depths within the support. For example, in applications in which when a circumferential arrangement of voids is repeated four times along the axial length of the prosthetic valve, the prosthetic valve is typically couplable to the upstream support portion at four positions along the axial length of the prosthetic valve.
• It is noted that, for some applications, the above descriptions ofprosthetic valve2042 andsupport2040 are applicable to (e.g., the applications described above are combinable with) other embodiments of prosthetic valves and prosthetic valve supports described herein.
• FIG. 72D shows an end view of animplant2030a, comprisingprosthetic valve2042 coupled to aprosthetic valve support2040a. For some applications of the invention,prosthetic valve support2040acomprises, and/or is analogous to, another prosthetic valve support (e.g., prosthetic valve support2040) described herein, andimplant2030acomprises, and/or is analogous to, other implants (e.g., implant2030) described herein.Prosthetic valve2040acomprises anupstream support portion2041a. For some applications of the invention,upstream support portion2041acomprises, and/or is analogous to, other upstream support portions described herein.Upstream support portion2041acomprises a plurality of inwardly-protrudingbarbs2102, protruding frominner perimeter2068 intoopening2045, such that, whenprosthetic valve2042 is expanded withinopening2045,barbs2102 protrude (e.g., interpose) into voids defined by the lattice structure ofprosthetic valve2042. Similarly to the protrusion of ridges2057 (described with reference toFIG. 72C) the protrusion ofbarbs2102 further facilitates coupling ofprosthetic valve support2040aandprosthetic valve2042. For some applications,barbs2102 are disposed on (e.g., protrude from)ridges2057. For some applications,barbs2102 are disposed between ridges2057 (e.g., protrude from sites between ridges2057).
• Reference is made toFIG. 73, which is a schematic illustration of aprosthetic valve support2040b, in accordance with some applications of the invention. For some applications of the invention,prosthetic valve support2040bcomprises, and/or is analogous to, other prosthetic valve supports described herein. For some applications,prosthetic valve support2040bcomprisesprosthetic valve support2040, described hereinabove.Support2040bcomprisesupstream support portion2041, coupled to one ormore clips2900, configured to be couplable to one or morenative leaflets2082 of the native valve. For some applications of the invention, clips2900 comprise tissue-engaging elements and/or support-anchoring elements (e.g., as described hereinabove). For some applications,prosthetic valve support2040balternatively or additionally comprises other tissue-engaging elements. Typically,support2040bcomprises twoclips2900, coupled toportion2041 at or nearinner perimeter2068. Typically, clips2900 are disposed opposite each other.
• Typically, clips2900 are articulatably coupled toportion2041. That is, typically, clips2900 can move, at least in part, with respect toportion2041. Typically, eachclip2900 is coupled toportion2041 via aconnector2540, which facilitates this movement. Typically, but not necessarily,connector2540 comprises a flexible material, such as a fabric and/or polymer. For some applications,connector2540 comprises one or more hinge points, to facilitate the movement of the clips.
• Eachclip2900 typically comprises two or more clip elements, such as aclip arm2920 and aclip arm2922, movable with respect to each other. Typically, the clip arms are articulatably-coupled at anarticulation point2921, and are movable with respect to each other by the relative angular disposition of the clip arms being controllable. Typically,clip2900 is configured to be biased (e.g., pre-set, such as shape-set) to be in a closed configuration, such thatarms2920 and2922 are relatively disposed at a generally small angle (e.g., less than 45 degrees, such as less than 20 degrees, such as less than 5 degrees) to each other. For some applications, in the closed configuration ofclip2900,arms2920 and2922 touch each other at a site that other than the articulation point. Eachclip2900 is configured to be couplable to anative leaflet2082 of the native valve by enveloping the native leaflet when the clip is in the open configuration thereof, and clipping the leaflet between the clip arms when the clip subsequently moves toward the closed configuration thereof.
• Typically,arm2920 is substantially immobile, andarm2922 is (1) biased to assume a first configuration, and (2) movable between the first configuration and another configuration. Typically, the first configuration ofarm2922 is a closed configuration. Typically, the other configuration ofarm2922 is an open configuration, whereby a portion ofarm2922 that is furthest fromarticulation point2921 is disposed (1) further fromarm2920 than is the same portion in the first, closed configuration, and (2) further fromarm2920 than a portion ofarm2922 that is closest to the articulation point. That is, an angular disposition ofarm2922 toarm2920 is greater whenarm2922 is in the open configuration thereof, than whenarm2922 is in the closed configuration thereof. Whenarm2922 is in the closed configuration thereof,clip2900 is in the closed configuration thereof. Whenarm2922 is in the open configuration thereof,clip2900 is in the open configuration thereof. That is,clip2900 is movable between open and closed configurations thereof, byarm2922 moving between open and closed configurations thereof.FIG. 73 shows detailed illustrations ofclip900 in the open and closed configurations, and further shows an exploded view of the components ofclip2900.
• Clip2900 further comprises a clip-controller interface, typically comprising a pull-wire2924, which facilitates movement ofarm2922 between the closed and open configurations, i.e., relative angular movement ofarms2920 and2922. Pull-wire2924 is typically coupled toplate2922, and controlled from outside the body of the subject. For example, pull-wire2924 may be coupled toarm2922, and extend to a clip controller (e.g.,clip controller2930, described with reference toFIGS. 74A-L) disposed within delivery apparatus, and ultimately controlled by a physician. Typically, pull-wire2924 is coupled toarm2922 such that (1) placing the pull-wire under tension (e.g., by pulling) movesarm2922 toward the open configuration, and (2) releasing the tension, at least in part, allows the arm to return toward the closed configuration.
• For some applications of the invention, bothclips2900 are controlled simultaneously by a user (e.g., clips2900 are configured to operate simultaneously). For some applications, eachclip2900 is controllable independently. For some applications,clip2900 further comprises one or more grips, such asteeth2928, which facilitate the clamping ofleaflets2082 whenclip2900 is closed. For some applications, clips2900 may alternatively or additionally be directly coupled to the prosthetic valve, and configured to couple the prosthetic valve directly to the native valve.
• Reference is made toFIGS. 74A-L, which are schematic illustrations of steps in the implantation ofimplant2030b, comprisingprosthetic valve2042 andprosthetic valve support2040b, in a native heart valve, such asmitral valve2024 of a subject, in accordance with some applications of the invention.
• Prosthetic valve support2040bis implanted using support-delivery apparatus, such as support-delivery apparatus2960. As described hereinabove with reference toFIG. 73, eachclip2900 comprises a clip-controller interface, typically pull-wire2924, which is configured to open the clip when pulled (i.e., placed under tension). For some applications of the invention, and as shown inFIG. 74A, support-delivery apparatus2960 comprises at least oneclip controller2930, one end of pull-wire2924 is coupled to cliparm922, and another end of the pull-wire is coupled tocontroller2930.Controller2930 comprises atubular member2172, shaped to define a lumen, and aplug2174.Plug2174 is dimensioned such that it is disposable in, and slidable through (e.g., within, into, and out of) the lumen oftubular member2172.Plug2174 comprises a restrictingportion2190 and asecond portion2192.
• Typically, at least part of plug2174 (e.g., restricting portion2190) is dimensioned so as to fit tightly in the lumen oftubular member2172, in a manner in which an outer surface of plug2174 (e.g., an outer surface of portion2190) is disposed very close to an inner surface oftubular member2172, i.e., such that little space exists between the at least part of the plug and the tubular member. For example, the widest space betweenportion2190 andmember2172 may be smaller than a thickness of pull-wire2924. Typically, a surface ofsecond portion2192 is disposed further from the inner surface oftubular member2172, than is the surface of the at least part ofportion2190.
• Controller2930 typically has at least three controller configurations, each configuration having a different relative disposition ofplug2174 withintubular member2172. In a first controller configuration,plug2174 is disposed at a first longitudinal position withintubular member2172. In a second controller configuration, the plug is disposed at a second longitudinal position within the tubular member, the second position being more proximal (e.g., closer to a position outside the body; typically upstream) than the first longitudinal position. In a third controller configuration, the plug is disposed at a third longitudinal position, distal (e.g., downstream) to the first longitudinal position, such that at least restrictingportion2190 is disposed outside of (e.g., distal to) the tubular member.
• Controller2930 has at least one locking configuration, in which (1) at least part of restrictingportion2190 is disposed inside the lumen oftubular member2172, and (2) pull-wire2924, when coupled to the controller, is generally not decouplable from the controller. Typically, the first and second controller configurations, described hereinabove, are locking configurations.Controller2930 further has at least one open configuration, in which (1) at least restrictingportion2190 is disposed outside the lumen oftubular member2172, and (2) pull-wire2924 is decouplable from the controller. Typically, the third controller configuration, described hereinabove, is an open configuration.
• Typically, and as shown inFIG. 74A, pull-wire2924 comprises, and/or is shaped to define, a loop, and is coupled tocontroller2930 by at least part of the loop being disposed againstsecond portion2192 when the lock is in, or moves into, a locking configuration thereof. For some applications, pull-wire2924 is generally flat (e.g., has an elongate transverse cross-section, e.g., is a strip), is shaped to define a hole, and is coupled tocontroller2930 by at least part of restrictingportion2190 being disposed within the hole when the lock is in, or moves into, a locking configuration thereof. Restrictingportion2190 inhibits distal axial movement of the coupling lead, andtubular member2172 inhibits lateral movement of the coupling lead (e.g., the inner surface of the tubular member holds the coupling lead against second portion1192).Tubular member2172 thereby facilitates coupling of pull-wire2924 to plug2174, and thereby tocontroller2930.
• Controller2930 is typically controlled (e.g., the configurations of the controller, such as the disposition ofplug2174 withintubular member2172, are typically selected), via acontrol rod2175, using an extracorporeal controller, such as acontrol handle2932, typically disposed at a proximal end of support-delivery apparatus2960.Control handle2932 comprises at least oneadjuster2934, each adjuster configured to control at least oneclip2900 ofprosthetic valve support2040b. Typically, control handle2932 comprises twoadjusters2934, each adjuster configured to independently control oneclip2900. For clarity, however,adjusters2934 are shown operating simultaneously. Typically, but not necessarily,adjuster2934 has pre-defined positions in which it can reside, each pre-defined position of the adjuster corresponding to a respective configuration ofcontroller2930. That is, movingadjuster2934 between the pre-defined positions thereof, movescontroller2930 between the configurations thereof. For illustrative purposes only, example pre-defined positions (A), (B) and (C) are indicated.
• FIG. 74A showssupport2040bhaving been delivered, using support-delivery apparatus2960, to leftatrium2026 of the heart of a subject (i.e., to a site upstream of nativemitral valve2024 of the subject).Support2040bis typically delivered transcatheterally (e.g., transvascularly, such as transfemorally), while in a compressed configuration thereof (e.g., as described with reference toFIG. 72B for support2040). Typically,support2040bis delivered within anovertube2044, which provides a constraining (e.g., compressive) force, to constrain the support in the compressed configuration thereof. Typically,upstream support portion2041 ofsupport2040bis coupled to a scaffold, such as acore2946, and constrained in the compressed configuration by being disposed within anovertube2044 of the delivery apparatus. In the compressed configuration ofsupport2040b, clips2900 are typically disposed downstream (e.g., distal) to the cylinder ofupstream support portion2041, and coupled tocore2946.
• During delivery ofsupport2040b, and as shown inFIG. 74A, clips2900 are typically in the closed configuration thereof.FIG. 74A showsclips2900 exposed from the distal end ofovertube2044, overtube2044 having been retracted (e.g., overtube2044 having been moved proximally, and/orsupport2040bhaving been moved distally).Adjuster2934 of control handle2932 is in a first position (A) (typically a middle position) thereof, andcontroller2930 is in the first configuration thereof, whereby pull-wire2924 is coupled to plug2174, which is disposed withintubular member2172.
• FIG. 74B showssupport2040bandcore2946 having been moved closer to the native valve, and clips2900enveloping leaflets2082 of the native valve.Adjuster2934 of control handle2932 is in a second position (B) thereof (typically more proximal than the first position), andcontroller2930 is in the second configuration thereof. Movement ofcontroller2930 into the second configuration thereof (i.e., movingplug2174 proximally) places pull-wire2924 under tension (i.e., pulls the pull-wire), thereby pullingclip arm2922, andopening clip2900. Using support-delivery apparatus2960, the position ofprosthetic valve support2040bis adjusted, so as to envelopenative leaflets2082 between the clip arms ofclips2900.
• FIG. 74C showsclips2900, coupled (i.e., clipped) tonative leaflets2082. The user (e.g., the physician) couples the clips to the native leaflets by closing the clips while the leaflets are enveloped by the arms of the clips. Adjuster2394 of control handle2932 is in first position (A) thereof (i.e., has been returned to first position (A)), andcontroller2930 is in the first configuration thereof (i.e., has been returned to the first configuration thereof). For some applications of the invention, control handle2932 comprises a spring, which facilitates the return of adjuster2394 to first position (A). For example, a user may apply a force to adjuster2394 so as to move the adjuster to second position (B), and remove the force (e.g., release the adjuster) so as to return the adjuster to first position (A). Movement ofcontroller2930 into the first configuration thereof (i.e., movingplug2174 distally) at least partly releases the tension on pull-wire2924, allowing the bias of clip2900 (e.g., of clip arm2922) to return the clip toward the closed configuration. If anative leaflet2082 is enveloped by the clip arms, the leaflet is sandwiched between the arms, thereby coupling the clip to the leaflet.
• For some applications, visualization (e.g., imaging) techniques such as ultrasound are used to facilitate and/or confirm the coupling ofclips2900 toleaflets2082. For example, an echocardiogram may be used to observenative leaflets2082, and movement thereof. For some applications, coupling of both native leaflets byclips2900 is accompanied by a generally lemniscate (e.g., ‘FIG.8’) arrangement of the native leaflets, as shown in View A ofFIG. 74C.Clips2900 may be repeatedly opened and closed until coupling of the clips toleaflets2082 has been achieved.
• For some applications of the invention, clips2900 further comprise a securing element (not shown), configured to secure the clips in the closed configuration, following coupling of the clips to the native leaflets. For some applications of the invention, the securing element is configured to secure the clips in one or a pre-defined selection of closed configurations (e.g., in a partially-closed configuration).
• Reference is made toFIG. 74D. Following coupling ofclips2900 tonative leaflets2082, the clips are released (e.g., decoupled) from support-delivery apparatus2960 (e.g., from core2946) by decoupling pull-wire2924 fromcontroller2930. To decouple the pull-wire from the controller, the user moves adjuster2394 of control handle2932 to third position (C) thereof (typically a distal position), thereby movingcontroller2930 in the third configuration thereof, whereby at least restrictingportion2190 ofplug2174 is disposed outside oftubular member2172. For some applications of the invention, control handle2932 comprises a safety device, such as asafety lock2936, configured to prevent inadvertent movement of adjuster2394 into position (C), and thereby inadvertent release ofclips2900. For such applications, safety lock is disabled (e.g., removed) prior to releasingclips2900.
• Movement ofcontroller2930 into the third position thereof (i.e., moving at least part ofplug2174 outside of tubular member2172) allows pull-wire2924 to decouple from the controller. For some applications, pull-wire2924 is configured to automatically decoupled from the controller when the controller moves into the third position. For example, the pull-wire may comprise a shape-memory (e.g., resilient, pseudoelastic and/or superelastic) material configured to lift the loop of the pull-wire away (e.g., laterally away) fromplug2174 when restrictingportion2190 moves outside of the tubular member. Non-limiting examples of materials that pull-wire2924 may comprise include nickel-titanium (Nitinol), stainless steel, nickel cobalt, cobalt chrome, titanium, tantalum, palladium, polyester, PTFE, nylon, and cotton. For some applications of the invention, pull-wire2924 is biodegradable (e.g., bioabsorbent).
• Reference is now made toFIG. 74E. Following the decoupling ofclips2900 fromcontroller2930,upstream support portion2041 ofprosthetic valve support2040bis deployed (e.g., released from overtube2044). Typically, overtube2044 is withdrawn proximally, exposing successively more proximal (e.g., upstream) parts ofportion2041. As described hereinabove (e.g., with reference toFIG. 72A),portion2041 typically comprises a shape-memory material, and is compressed prior to implantation.Portion2041 thereby automatically expands upon removal of the constraining (e.g., compressive) force, i.e., when overtube2044 is withdrawn.
• Immediately prior to the release ofprosthetic valve support2040bfrom the overtube, the total length ofovertube2044 andsupport2040bmay be double or more than that of the overtube or support alone. For some applications, this extra length can hinder the movement and/or removal of the overtube from the body of the subject. For some applications, overtube2044 comprises a flexible and/or soft material, such as a fabric or polymer, thereby becoming flexible assupport2040bis removed from within the overtube. It is hypothesized that this composition/configuration ofovertube2044 facilitates deployment ofsupport2040b, and removal of the overtube from the body of the subject.
• FIG. 74F showsprosthetic valve support2040bduring full deployment thereof. Typically, and as described hereinabove, whenupstream support portion2041 is delivered to the native valve in the cylindrical, compressed configuration, downstream (e.g., distal)end2053 of the cylinder hasperimeter2068b, which is a compressedinner perimeter2068.Distal end2053, and therefore the inner perimeter ofportion2041, is thereby coupled to the native valve before deploying (e.g., expanding) upstream (e.g., proximal)end2055, and therefore the outer perimeter ofportion2041. That is, the inner perimeter ofportion2041 typically engages the native valve before the outer perimeter.
• The two phases illustrated inFIG. 74F illustrate typical behavior ofupstream support portion2041 during deployment thereof. Asdownstream end2053, moves out ofovertube2044, it expands toward becoming and/or defininginner perimeter2068 ofportion2041. Asupstream end2055 moves out ofovertube2044, it expands to becomeouter perimeter2069. Due to this arrangement, during deployment,upstream end2055 typically expands more than doesdownstream end2053. For some applications,upstream end2055 expands more than 1.5 times (e.g., more than twice) as much as doesdownstream end2053.
• Reference is now made toFIGS. 74G-H, which showsupport2040bin the implanted configuration thereof.Upstream support portion2041 is described hereinabove (e.g., with reference toFIG. 72A) as being generally flat when in its fully uncompressed configuration. However,portion2041 is typically at least partly resilient. For example, as described hereinabove,portion2041 typically comprises a shape-memory material. Implantingsupport2040b, as described with reference toFIGS. 74A-F, disposesportion2041 against the upstream side of the native valve (e.g., the upstream side of the native valve annulus). Typically,portion2041 is held tightly against the upstream side of the native valve byclips2900, and deforms responsively to the contours of the native tissue (e.g., conforms to the native annulus), thereby assuming an implanted configuration. For some applications,portion2041 repeatedly deforms responsively to the contours of the native tissue, as the native tissue repeatedly changes shape with the cardiac cycle.
• Upstream support portion2041 andclips2900 are typically configured such that, whensupport2040bis implanted at the native valve, upstream support portion inhibits downstream (e.g., ventricular) movement ofsupport2040b, and clips2900 inhibit upstream (e.g., atrial) movement of the support. Typically, clips2900 are configured to couple the prosthetic valve support to the native valve such thatupstream support portion2041 is in contact with the upstream side of the native valve (e.g., with the upstream side of the native annulus). For some applications, clips2900 are the only component ofprosthetic valve support2040bthat inhibits upstream movement of prosthetic valve support.
• The dimensions ofupstream support portion2041 in the implanted configuration thereof are typically similar to those of the same portion in the fully uncompressed configuration thereof, with any difference between the configurations typically due to the portion being implanted. For example, in some applications in whichupstream support portion2041 is generally flat in the fully uncompressed (e.g., unconstrained uncompressed) configuration thereof, whensupport2040bis implanted at the native valve, clips2900 apply a downstream force toinner perimeter2068 ofupstream support portion2041, thereby inducingportion2041 to assume a frustoconical shape in the implanted configuration thereof. Whenupstream support portion2041 is generally frustoconical in the implanted configuration thereof, a surface ofportion2041 typically has an angle of less than 60 degrees (e.g., less than 45 degrees) from a plane of the smaller base of the frustum. (As shown inFIG. 74G, for example, this angle is approximately 10 degrees.) That is, whenupstream support portion2041 is generally frustoconical in the implanted configuration thereof,portion2041 is closer to being planar than it is to being cylindrical. Alternatively, the surface ofportion2041 has an angle of greater than 60 degrees from the smaller base of the frustum. It is to be noted that, althoughupstream support portion2041 is generally described herein in terms of symmetrical geometric shapes (e.g., ellipse and frustum), when conforming to native tissue, the upstream support portion may assume a symmetrical or an unsymmetrical shape.
• Thus, in general, as shown in and described with reference toFIGS. 72A-74L, (1) the fully uncompressed configurations ofupstream support portion2041 described with reference toFIG. 72A are typically unconstrained uncompressed configurations, (2) the compressed configurations ofportion2041 described with reference toFIG. 72B are typically constrained compressed configurations, and (3) the implanted configurations ofportion2041 described with reference toFIG. 74F are typically constrained uncompressed configurations.
• When implanted at the native valve, and thereby in the implanted configuration thereof, no part ofupstream support portion2041 is disposed downstream of native leaflets2082 (e.g., no part ofportion2041 is disposed in ventricle2028). Typically, whenprosthetic valve support2040bis implanted at the native valve, no part ofsupport2040bthat circumscribes a space (e.g., opening2045) is disposed downstream of the native leaflets. For some applications, whenprosthetic valve support2040bis implanted at the native valve, no part ofsupport2040bthat circumscribes a space is disposed downstream of the native annulus.
• When implanted at the native valve, and thereby in the implanted configuration thereof, a height (i.e., a length along an upstream-to-downstream axis ax1 from a most upstream end to a most downstream end) ofupstream support portion2041, is typically less than 20 mm (e.g., less than 10 mm, such as less than 5 mm) Typically, whenprosthetic valve support2040bis implanted at the native valve, no part of the support that circumscribes a space has a height of more than 20 mm. For some applications, whenprosthetic valve support2040bis implanted at the native valve, no part of the support that circumscribes a space has a height of more than 10 mm. For some applications, whenprosthetic valve support2040bis implanted at the native valve, no part of the support that circumscribes a space has a height of more than 5 mm.
• As described hereinabove with reference toFIG. 73,clips2900 are articulatably-coupled toupstream support portion41 ofprosthetic valve support2040b. Following the implantation (e.g., delivery, coupling and deployment) ofprosthetic valve support2040b, clips2900 can move, at least in part, with respect toportion2041, thereby allowingnative leaflets2082 to continue to function, at least in part. That is, implantation ofprosthetic valve support2040bat a native valve, does not eliminate the native blood flow regulation functionality of the native valve.FIGS. 74G-H show such movement ofnative leaflets2082, and clips2900.FIG. 74G showssupport2040bimplanted atmitral valve2024, withnative leaflets2082 open (e.g., during ventricular diastole), clips2900 having moved away from each other.FIG. 74H showssupport2040bimplanted atmitral valve2024, withnative leaflets2082 closed (e.g., during ventricular systole), clips2900 having moved toward each other. Typically, each clip moves through an arc of greater than 45 degrees (e.g., greater than 60 degrees, such as greater than 80 degrees) during each cardiac cycle.
• FIGS. 74I-L show steps in the implantation ofprosthetic valve2042 in opening2045 ofprosthetic valve support2040b. As described hereinabove,prosthetic valve2042 is typically delivered transcatheterally. Typically,prosthetic valve2042 is delivered to the native valve from an upstream side (e.g., the atrial side of the mitral valve), in a compressed configuration, and constrained within adelivery tube2060, as shown in3I. The prosthetic valve and delivery tube are typically placed withinopening2045.Delivery tube2060 is then withdrawn from the prosthetic valve. Typically, the delivery tube is withdrawn in a downstream direction (e.g., distally and/or ventricularly), as shown inFIG. 74J. For some applications, the delivery tube is withdrawn in an upstream direction (e.g., proximally and/or atrially).
• As regions ofprosthetic valve2042 are successively exposed as they exitdelivery tube2060, they expand (e.g., radially). Whendelivery tube2060 is withdrawn in the downstream direction, the upstream end of the prosthetic valve is exposed, and expands, thereby coupling the prosthetic valve to the upstream support portion ofprosthetic valve support2040b, as shown inFIG. 74K (in whichprosthetic valve2042 is represented by a trapezoid/frustum). As described hereinabove (e.g., with reference toFIG. 72C), for some applications, the prosthetic valve is couplable to the upstream support portion at a plurality of positions along the axial length of the prosthetic valve. For such applications, a physician can typically implant (e.g., couple to support2040b) the prosthetic valve at a plurality of depths with respect toupstream support portion2041 and/or the native valve. For some such applications, the physician can implant the prosthetic valve prosthetic valve is implantable at a continuum of depths with respect toupstream support portion2041 and/or the native valve.
• As shown inFIG. 74K,upstream support portion2041 is placed against the upstream side of the native valve, andprosthetic valve2042 is radially expanded withinopening2045 defined by the upstream support portion. Radially-expansive force applied byprosthetic valve2042 to upstream support portion2041 (and which typically couples the prosthetic valve to the upstream support portion), is typically not transferred to the native valve via the prosthetic valve support. That is, and as described hereinabove (e.g., with reference toFIGS. 72A and 72C), radial expansion ofprosthetic valve2042 againstinner perimeter2068 ofupstream support portion2041, typically does not cause the prosthetic valve support to apply a radially-expansive force to the native valve.
• Oncedelivery tube2060 is fully withdrawn fromprosthetic valve2042, and the prosthetic valve is fully deployed (e.g., in the implanted configuration thereof),delivery tube2060 is removed from the body of the subject. For some applications, when the delivery tube is withdrawn in the downstream direction (e.g., ventricularly), it is removed from the body via the lumen of the prosthetic valve, as shown inFIG. 74L.
• As described hereinabove (e.g., with reference toFIGS. 73, and74G-H), following the implantation (e.g., delivery, coupling and deployment) ofprosthetic valve support2040b, clips2900 andnative leaflets2082 can move, at least in part, thereby not eliminating the native blood flow regulation functionality of the native valve. In experiments conducted by the inventors,prosthetic valve support2040bhas been implanted in two pigs. Both animals remained alive and stable (e.g., had stable blood pressure, pulse, breathing rate and oxygen saturation) for a duration of sufficient length to withdraw the support-delivery apparatus, introduce a valve-delivery system (e.g., delivery tube2060), and deploy (e.g., implant)prosthetic valve2042 in opening2045 of the support. The period between implantingsupport2040band implantingprosthetic valve2042 was between 5 and 10 minutes.
• It is thereby hypothesized that, following implantation ofprosthetic valve support2040b, the heart of the subject is able to continue pumping blood sufficiently to support the subject for longer than a minute, e.g., longer than 2 minutes, e.g., longer than 5 minutes, such as longer than an hour. It is thereby hypothesized that a period of generally normal physiological activity of the subject of up to a minute, e.g., up to 2 minutes, e.g., up to 5 minutes, such as up to an hour, between implantation ofsupport2040band implantation of prosthetic valve2042 (e.g., as described with reference toFIGS. 74I-L and/or76D-E), is supported byprosthetic valve support2040b. It is thereby hypothesized that the implantation ofimplant2030b, comprisingsupport2040bandprosthetic valve2042, may be performed without the use of cardiopulmonary bypass. It is thereby hypothesized that replacement of a native valve withimplant2030b, may be performed in a human, ‘off-pump,’ as was performed in the pig experiments.
• Reference is again made to FIGS.73 and74A-L. It should be noted thatclips2900, clip-controller interface (e.g., pull-wire2924), clip controller2930), and/or the support-delivery apparatus (e.g., support-delivery apparatus2930) are typically configured such that the clips are controllable independently of the deployment (e.g., expansion) of the prosthetic valve support (e.g., the withdrawal ofovertube2044 from upstream support portion2041). That is, clips2900 are typically configured to be controllable independently of a state of deployment of the prosthetic valve support (e.g.,prosthetic valve support2040b. Thus, a physician may independently control (1) the coupling (e.g., ‘clipping’) ofclips2900 to the leaflets of the native valve, and (2) the deployment of the prosthetic valve support (e.g., expansion of the upstream support portion).
• Reference is made toFIGS. 75A-E, which are schematic illustrations ofimplant2030c, comprisingprosthetic valve2042 andprosthetic valve support2040c, and the implantation thereof, in accordance with some applications of the invention. For some applications of the invention,prosthetic valve support2040ccomprises, and/or is analogous to, other prosthetic valve supports (e.g., prosthetic valve support2040), andimplant2030ccomprises, and/or is analogous to, other implants (e.g., implant2030) described herein.Support2040ccomprisesupstream support portion2041, coupled to one ormore clips2900, described hereinabove (e.g., with reference to FIGS.73 and74A-L), and configured to be couplable to one or morenative leaflets2082 of the native valve. Typically,support2040ccomprises twoclips2900, coupled toportion2041 at or nearinner perimeter2068. Typically, clips2900 are disposed opposite each other.Support2040cfurther comprises a stabilizing element3062 (e.g., a stabilizing strip or a stabilizing band), coupled to clips2900.
• Reference is now made toFIG. 75A, which shows a lower side view ofsupport2040c. Typically, stabilizingelement3062 is coupled to a downstream (e.g., distal) portion ofclips2900, and forms a ring shape downstream (e.g., distal) toupstream support portion2041. Stabilizingelement3062 defines an opening3064 (e.g., an aperture), and is typically inelastic and at least partly flexible. Non-limiting examples of materials thatelement3062 may comprise include polyester, PTFE (e.g., ePTFE), nylon, cotton, nitinol, stainless steel, nickel cobalt, cobalt chrome, titanium, tantalum and palladium. The flexibility ofelement3062 typically facilitates the compressibility of the prosthetic valve support (e.g., for delivery) and/or movement (e.g., articulation) ofclips2900 with respect toupstream support portion2041.
• Stabilizingelement3062 is hypothesized to increase the stability ofprosthetic valve support2040cat the native valve. For example,element3062 is hypothesized to at least partly inhibit lateral movement (e.g., rotation around an atrial-ventricular axis, e.g., ‘yaw’) of the support and/or clips, when the support is implanted at the native valve.Element3062 is further hypothesized to reduce rolling movement (e.g., movement around a lateral axis, e.g., an axis between twoclips2900, e.g., ‘pitch’ and ‘roll’) ofimplant2030c, including inversion (e.g., ‘flipping’) of the implant, following deployment (e.g., implantation) ofprosthetic valve2042.
• For some applications of the invention, stabilizingelement3062 is further hypothesized to stabilizeclips2900 during deployment of the elements, e.g., by facilitating coupling thereof to delivery apparatus, such asapparatus2960.
• FIGS. 75B-C showprosthetic valve support2040c, following implantation thereof atmitral valve2024. As described hereinabove, the upstream support portion is disposed upstream of the native valve. Stabilizing element is disposed downstream of the native valve (i.e., in ventricle2028).Prosthetic valve support2040cis typically implanted as described elsewhere herein for other prosthetic valve supports, mutatis mutandis. As described hereinabove, stabilizingelement3062 is typically at least partly flexible, such thatclips2900 are movable with respect toupstream support portion2041. Typically,element3062 is sufficiently flexible to allownative leaflets2082 to continue to function, at least in part.FIG. 75B showssupport2040cimplanted atmitral valve2024, withnative leaflets2082 open (e.g., during ventricular diastole).FIG. 75C showssupport2040cimplanted atmitral valve2024, withnative leaflets2082 closed (e.g., during ventricular systole). For some applications, when the native leaflets close, stabilizingelement3062 deforms toward a generally lemniscate (e.g., ‘figure-8’ or ‘butterfly’) configuration (e.g., as shown inFIG. 75C).
• For some applications of the invention, a similar generally lemniscate configuration is formed byelement3062 whenprosthetic valve support2040cis coupled to delivery apparatus, during delivery to the native valve (e.g., as described forsupport2040bwith reference toFIGS. 74A-B). For some such applications, stabilizingelement3062 protrudes from the compressed prosthetic valve support, and facilitates positioning and/or orientation of the support. For example, the ‘limbs’ of the lemniscate are typically oriented at right angles toclips2900, and protrude from the compressed support. When the clips are in close proximity to the native leaflets, the ‘limbs’ are typically downstream of the leaflets, and interact (e.g., touch) chordae tendineae of the native valve. By orienting the prosthetic valve support such that the ‘limbs’ have the least interaction with chordae tendineae (typically when the ‘limbs are oriented toward commissures of the native valve), a user automatically orientsclips2900 towardleaflets2082 of the native valve.
• Similarly to support2040b(described with reference toFIGS. 74A-L), implantation ofprosthetic valve support2040cat a native valve does not eliminate the native blood flow regulation functionality of the native valve. It is thereby hypothesized that, following implantation ofprosthetic valve support2040c, the heart of the subject is able to continue pumping blood sufficiently well to support the physiological systems of the subject for longer than a minute, e.g., longer than 2 minutes, e.g., longer than 5 minutes, such as longer than an hour. It is thereby hypothesized that a period of up to a minute, e.g., up to 2 minutes, e.g., up to 5 minutes, such as up to an hour, between implantation ofsupport2040cand implantation of a prosthetic valve (e.g., prosthetic valve2042), is supported byprosthetic valve support2040c. It is thereby hypothesized that the implantation ofimplant2030c, comprisingsupport2040candprosthetic valve2042, may be performed without the use of cardiopulmonary bypass. That is, it is hypothesized that replacement of a native valve withimplant2030c, may be performed ‘off-pump’.
• When implanted at the native valve, and thereby in the implanted configuration thereof, no part of stabilizingelement3062 is disposed upstream of native leaflets2082 (e.g., no part ofelement3062 is disposed in atrium2026). Typically, whenprosthetic valve support2040cis implanted at the native valve, no part ofsupport2040cthat circumscribes a space (e.g.,portion2041, which circumscribesopening2045 and/orelement3062, which circumscribes opening3064) traverses (e.g., fully traverses) the native annulus.
• When implanted at the native valve, and thereby in the implanted configuration thereof, a height (i.e., a length along an upstream-to-downstream axis ax2 from a most upstream part to a most downstream part) of stabilizingelement3062, is typically less than 20 mm (e.g., less than 10 mm, such as less than 5 mm) For example, stabilizingelement3062 typically has a thickness of less than 20 mm (e.g., less than 10 mm, e.g., less than 5 mm, such as less than 1 mm). Typically, whenprosthetic valve support2040cis implanted at the native valve, no part of the support that circumscribes a space has a height of more than 20 mm. For some applications, whenprosthetic valve support2040cis implanted at the native valve, no part of the support that circumscribes a space has a height of more than 10 mm. For some applications, whenprosthetic valve support2040cis implanted at the native valve, no part of the support that circumscribes a space has a height of more than 5 mm.
• FIG. 75D showsimplant2030, comprisingprosthetic valve support2040candprosthetic valve2042, following implantation atmitral valve2024. The prosthetic valve is typically implanted as described elsewhere herein (e.g., with reference toFIGS. 74I-L), mutatis mutandis.Prosthetic valve2042 is deployed (e.g., delivered and expanded) inopening2045, defined byupstream support portion2041, and inopening3064, defined by stabilizingelement3062. That is, whenprosthetic valve2042 is deployed at the native valve, it is expanded such that (1) an upstream (e.g., proximal) portion of the prosthetic valve engages (e.g., couples to)inner perimeter2068 ofsupport2040c, and (2) a downstream (e.g., distal) portion of the prosthetic valve is disposed within the opening of the stabilizing element. For some applications of the invention, and as illustrated inFIG. 75D, the distal portion of the prosthetic valve engages (e.g., couples to) the stabilizing element.
• For some applications of the invention, stabilizingelement3062 is configured (e.g., dimensioned) such that, when the prosthetic valve is expanded within the opening of the stabilizing element, the stabilizing element restricts the full expansion of the downstream portion of the prosthetic valve. That is, for some applications, upon expansion of the prosthetic valve, a transverse cross-sectional dimension (e.g., area) defined by a downstream portion of the prosthetic valve is determined (e.g., restricted) by a transverse cross-sectional dimension (e.g., area) ofopening3064 of the stabilizing element. For some applications, one or more dimensions ofopening3064, defined by stabilizingelement3062, are substantially equal to one or more dimensions ofopening2045, defined byupstream support portion2041. For some such applications, the expansion of both the downstream and upstream portions of the prosthetic valve are restricted to substantially the same transverse cross-sectional dimensions, thereby facilitating the primary structural element of the prosthetic valve to assume a generally prismatic (e.g., generally cylindrical) shape.
• For applications where stabilizingelement3062 limits the expansion ofprosthetic valve2042, a radially-expansive force is thereby applied byprosthetic valve2042 to stabilizingelement3062. The radially-expansive force typically couples the prosthetic valve to the stabilizing element. That is, for some applications,prosthetic valve2042 is couplable to the stabilizing element. For some applications, the prosthetic valve is coupled to the stabilizing element by alternative or additional means. For example, the stabilizing element may comprise barbs and/or hooks, which facilitate coupling to the prosthetic valve.
• For some applications of the invention, at least part (e.g., an inner surface) of stabilizingelement3062 comprises a friction coating that is configured to increase friction and, thereby, coupling between the stabilizing element and the prosthetic valve.
• For some applications of the invention, at least part of stabilizingelement3062 is shaped to define ridges, which are configured (e.g., dimensioned) to protrude (e.g., interpose) within corresponding voids defined by the lattice structure of the prosthetic valve. The ridges facilitate coupling of the stabilizing element to the prosthetic valve, e.g., by inhibiting axial movement of the prosthetic valve throughopening3064.
• For some applications of the invention, a soft (e.g., crushable) material is disposed on the inner surface of stabilizing element3062 (e.g., the stabilizing element comprises the soft material). Whenprosthetic valve2042 expands, and applies radially-expansive force to the stabilizing element, (1) the struts of the lattice structure of the prosthetic valve compress (e.g., crush) the parts of the soft material against which the struts apply the force, and (2) the parts of the soft material that are disposed between the struts (i.e., that are disposed at voids defined by the lattice structure), form ridges that protrude between the struts (i.e., protrude into the voids). The protruding parts of the soft material facilitate coupling of the stabilizing element to the prosthetic valve, e.g., by inhibiting axial movement of the prosthetic valve throughopening3064, such as by increasing friction.
• For some applications of the invention, prosthetic valve2042 (e.g., the primary structural element of prosthetic valve2042) is shaped to define a circumferential groove that is configured (e.g., dimensioned) to receive stabilizingelement3062. That is, for some applications of the invention, stabilizingelement3062 is configured (e.g., dimensioned) to be placeable in a circumferential groove defined byprosthetic valve2042. Whenprosthetic valve2042 is deployed, and expands withinopening3064,element3062 is disposed in the groove, thereby further facilitating coupling of the stabilizing element to the prosthetic valve, e.g., by inhibiting axial movement of the prosthetic valve through theopening3064.
• Reference is made toFIGS. 76A-E, which are schematic illustrations of steps in the implantation ofimplant2030h, comprisingprosthetic valve2042 andprosthetic valve support2040h, in a native heart valve, such asmitral valve2024 of a subject, in accordance with some applications of the invention. For some applications of the invention,prosthetic valve support2040hcomprises, and/or is analogous to, other prosthetic valve supports described herein.Prosthetic valve2040hcomprisesupstream support portion2041 andclips2900, and typically comprises, and/or is analogous toprosthetic valve2040b.FIGS. 76A-E show steps in the transapical implantation ofimplant2030h.
• FIG. 76A showssupport2040hbeing delivered, using support-delivery apparatus2970, via the apex of the heart, to leftventricle2028 of the subject. During delivery,portion2041 is disposed, in the compressed configuration thereof, within anovertube2972 of the delivery apparatus. Typically,portion2041 is disposed within adelivery tube2976, which itself is disposed within the overtube.
• FIG. 76B showsclips2900 in the open configuration thereof, and coupled to a scaffold, such ascore2974.Clips2900 are typically operated and coupled tonative leaflets2082 as described hereinabove, mutatis mutandis.Upstream support portion2041 is advanced, in the compressed configuration thereof, such thatupstream end2055 is upstream ofdownstream end2053.Upstream end2055 ofportion2041 is advanced betweennative leaflets2082. Typically,coupling clips2900 toleaflets2082 automatically advances at least part of portion2041 (e.g., upstream end2055) between the native leaflets.FIG. 76C showsclips2900 in the closed configuration thereof, coupled tonative leaflets2900.
• Afterclips2900 have been coupled tonative leaflets2082,delivery tube2976 is withdrawn distally (e.g., atrially) fromupstream support portion2041, such thatdownstream end2053 ofportion2041 is exposed, and expands to defineinner perimeter2068 as described hereinabove, mutatis mutandis. As successively more distal (e.g., upstream) parts ofportion2041 are exposed as they exitdelivery tube2976, they expand (e.g., radially). Whenportion2041 is sufficiently exposed from the delivery tube (e.g., whenupstream end2055 is exposed from the delivery tube),upstream end2055 expands to defineouter perimeter2068, as described hereinabove, mutatis mutandis. As shown inFIG. 76D,support2040hthereby assumes its implanted configuration, as described hereinabove, wherebyclips2900 are coupled to the native leaflets, andupstream support portion2041 is disposed against the upstream side of the native valve (e.g., the upstream side of the native valve annulus).Delivery tube2976 is subsequently withdrawn fromatrium2026 via opening2045 ofupstream support portion2041, and support-delivery apparatus2970 (including delivery tube2976) is withdrawn from the body of the subject.
• FIG. 76E showsprosthetic valve2042 being coupled to support2040h(i.e., implanted).Prosthetic valve2042 is delivered transapically, toventricle2028 of the subject. During delivery,prosthetic valve2042 is disposed, in a compressed configuration thereof, within adelivery tube2986 of the delivery apparatus. The delivery tube containing the prosthetic valve is disposed in opening2045 ofupstream support portion2041. The delivery tube is subsequently withdrawn proximally (e.g., ventricularly) fromprosthetic valve2042, such that the upstream end of the prosthetic valve is exposed. As successively more proximal (e.g., downstream) parts ofprosthetic valve2042 are exposed as they exitdelivery tube2986, they expand (e.g., radially). Whenprosthetic valve2042 is sufficiently exposed from the delivery tube, the prosthetic valve engagesinner perimeter2068 ofupstream support portion2041 ofsupport2040h, and couples the prosthetic valve thereto, as described hereinabove, mutatis mutandis.
• Onceprosthetic valve2042 is completely exposed (e.g., deployed), the prosthetic valve thereby assumes its implanted configuration, as described hereinabove. Support-delivery apparatus2980 (including delivery tube2986) is subsequently withdrawn from the body of the subject.
• Reference is made toFIGS. 77-80, which are schematic illustrations of implants, each comprising a prosthetic valve support and a prosthetic valve, implanted at native valves of aheart2020 of a subject, in accordance with some applications of the invention.FIGS. 77-80 are not intended to limit the scope of the invention, but to indicate some placements of the implants with respect to the anatomy of the heart and/or native valve, and to illustrate commonalities between such placements. Other prosthetic valves and prosthetic valve supports described herein may be implanted at the native valves, as described with reference toFIGS. 77-80, mutatis mutandis.
• FIG. 77 shows implant2030d, comprising aprosthetic valve support2040dand aprosthetic valve2042d, implanted atmitral valve2024 ofheart2020 of a subject, in accordance with some applications of the invention. For some applications of the invention,prosthetic valve support2040dcomprises, and/or is analogous to, other prosthetic valve supports described herein, andimplant2030dcomprises, and/or is analogous to, other implants described herein.Implant2030d(e.g.,support2040dandprosthetic valve2042d) are configured (e.g., dimensioned) to be implanted atmitral valve2024.Implant2030dis typically implanted atmitral valve2024 as described elsewhere herein (e.g., with reference toFIGS. 74A-L and/or76A-E). Anupstream support portion2041dofsupport2040dis disposed against the upstream (i.e., atrial) side ofmitral valve2024, and is coupled to the native valve, e.g., using clips or another support-anchoring element.Prosthetic valve2042dis disposed and expanded in the opening defined byportion2041d, thereby traversing the annulus of the native valve.
• FIG. 78 shows implant2030e, comprising aprosthetic valve support2040eand aprosthetic valve2042e, implanted attricuspid valve2010 ofheart2020 of a subject, in accordance with some applications of the invention. For some applications of the invention,prosthetic valve support2040ecomprise, and/or is analogous to, other prosthetic valve supports described herein, andimplant2030ecomprises, and/or is analogous to, other implants described herein.Implant2030e(e.g.,support2040eandprosthetic valve2042e) are configured (e.g., dimensioned) to be implanted attricuspid valve2010. For example, and as shown inFIG. 78, anupstream support portion2041eofsupport2040etypically defines a concavity2121, configured to be oriented toward the atrioventricular (AV) node, so as to reduce a likelihood ofsupport2040einterfering with electrical activity of the heart.Upstream support portion2041eofsupport2040eis disposed against the upstream (i.e., atrial) side oftricuspid valve2010, and is coupled to the native valve, e.g., using clips or another support-anchoring element.Prosthetic valve2042eis disposed and expanded in the opening defined byportion2041e, thereby traversing the annulus of the native valve.
• FIG. 79 shows implant2030f, comprising aprosthetic valve support2040fand aprosthetic valve2042f, implanted atpulmonary valve2012 ofheart2020 of a subject, in accordance with some applications of the invention. For some applications of the invention,prosthetic valve support2040fcomprises, and/or is analogous to, other prosthetic valve supports described herein, andimplant2030fcomprises, and/or is analogous to, other implants described herein.Implant2030f(e.g.,support2040fandprosthetic valve2042f) are configured (e.g., dimensioned) to be implanted atpulmonary valve2012. For example, and as shown inFIG. 79, an outer perimeter ofupstream support portion2041fofsupport2040fmay be dimensioned to be small enough to fit within the downstream portion ofright ventricle2013, but large enough to inhibit movement ofimplant2030fdownstream through the pulmonary valve.Upstream support portion2041fofsupport2040fis disposed against the upstream (i.e., ventricular) side ofpulmonary valve2012, and is coupled to the native valve, e.g., using clips or another support-anchoring element.Prosthetic valve2042fis disposed and expanded in the opening defined byportion2041f, thereby traversing the annulus of the native valve.
• FIG. 80 shows implant2030g, comprising aprosthetic valve support2040gand aprosthetic valve2042g, implanted ataortic valve2014 ofheart2020 of a subject, in accordance with some applications of the invention. For some applications of the invention,prosthetic valve support2040gcomprises, and/or is analogous to, other prosthetic valve supports described herein, and implant2030gcomprises, and/or is analogous to, other implants described herein.Implant2030g(e.g.,support2040gandprosthetic valve2042g) are configured (e.g., dimensioned) to be implanted ataortic valve2014. For example, and as shown inFIG. 80, an outer perimeter ofupstream support portion2041gofsupport2040gmay be dimensioned to be sufficiently large to inhibit movement ofimplant2030gdownstream through the aortic valve, and/orprosthetic valve2042g, andprosthetic valve2042gmay be dimensioned to reduce a likelihood of interference with (e.g., reduction of) blood flow into the coronary arteries of the subject.Upstream support portion2041gofsupport2040gis disposed against the upstream (i.e., ventricular) side ofaortic valve2014, and is coupled to the native valve, e.g., using clips or another support-anchoring element.Prosthetic valve2042gis disposed and expanded in the opening defined byportion2041g, thereby traversing the annulus of the native valve.
• Reference is again made toFIGS. 77-80. It is thereby to be noted that although some apparatus and methods are described herein to facilitate replacement of a native mitral valve of the subject, apparatus (and subcomponents thereof) and methods described herein may also be used to replace a native cardiac valve other than the native mitral valve, such as the tricuspid valve, the aortic valve, and the pulmonary valve.
• Reference is again made toFIGS. 1A-80. For each of the prosthetic valve supports described, at least a part of the prosthetic valve support circumscribes (e.g., encloses on all lateral sides) a space. For example, the upstream support portions and stabilizing elements described hereinabove, define respective openings (e.g., apertures). These openings are thereby spaces that the upstream support portions and stabilizing elements circumscribe.
• For some applications of the invention, following implantation at the native valve, no part of the prosthetic valve support that circumscribes a space, traverses the native leaflets and/or annulus. For example, following implantation, the upstream support portions described hereinabove (e.g.,upstream support portions41 and2041) are typically disposed only upstream of the native leaflets and/or annulus. Similarly, for applications in which the prosthetic valve support comprises a stabilizing element (e.g., stabilizingelement1062 or3062), following implantation, the stabilizing element is typically disposed only downstream to the native leaflets and/or annulus. It is hypothesized that this advantageously facilitates continued function of the native leaflets following implantation of the prosthetic valve support, and prior to the implantation of a prosthetic valve, as described hereinabove.
• Typically, the perimeter (e.g., the circumference) of the spaces defined by the upstream support portions and stabilizing elements described hereinabove, is greater than 60 mm Typically, the upstream support portions and stabilizing elements have respective heights of less than 10 mm. For some applications of the invention, no part of the prosthetic valve support that circumscribes a space that has a perimeter that is greater than 60 mm, has a height (e.g., a depth) that is greater than 10 mm. For example, prosthetic valve supports that do not comprise a cylindrical element (e.g.,cylindrical element90 or690), do not comprise a part that (1) circumscribes a space that has a perimeter that is greater than 60 mm, and (2) has a height (e.g., a depth) that is greater than 10 mm.
• Reference is again made toFIGS. 1A-80. It is to be noted that the apparatus and techniques described hereinabove are not limited to the combinations described hereinabove. For example:
• (1) Any of the prosthetic valves described hereinabove (including features and/or components thereof) may be used in combination with any of the prosthetic valve supports (including features and/or components thereof) described hereinabove (e.g., any of the prosthetic valve supports described hereinabove may be used to facilitate implantation of any of the prosthetic valves described hereinabove), mutatis mutandis;
• (2) any of the prosthetic valve supports described hereinabove may comprise any of the upstream support portions, tissue-engaging elements (e.g., support-anchoring elements and/or clips), connectors (e.g., flexible and/or length-adjustable connectors), holding wires and/or stabilizing elements described hereinabove, mutatis mutandis;
• (3) any of the prosthetic valves or prosthetic valve supports described hereinabove may comprise any of the coupling functionalities (e.g., barbs, coupling leads and/or support-engaging elements) described hereinabove, for coupling a prosthetic valve support (e.g., support-anchoring elements thereof) to a prosthetic valve, mutatis mutandis;
• (4) any of the tissue-engaging elements, and/or elements thereof, described hereinabove may be used in combination with any one of prosthetic valve supports or prosthetic valves described herein, mutatis mutandis. For example, tissue-engaging elements (e.g., support-anchoring elements) that are described hereinabove for coupling a prosthetic valve support to the native valve, may be alternatively or additionally used to couple a prosthetic valve to the native valve (the tissue-engaging element thereby acting as a valve-anchoring element), mutatis mutandis. Similarly, tissue-engaging elements (e.g., valve-anchoring elements) that are described hereinabove for coupling a prosthetic valve to the native valve, may be alternatively or additionally used to couple a prosthetic valve support to the native valve (the tissue-engaging element thereby acting as a support-anchoring element), mutatis mutandis;
• (5) any of the implantation techniques described hereinabove (e.g., those described with reference toFIGS. 1A-H,15A-E,16,28A-30B,37A-H,38A-H,50,74A-L,75A-D and76A-F) may be used in combination with any of the implants (e.g., any of the prosthetic valves and/or prosthetic valve supports) described hereinabove, mutatis mutandis;
• (6) any of the delivery apparatus described hereinabove (e.g., those described with reference toFIGS. 9A-E,27A-D,31A-33C,37A-H,38A-H,62A-D,63A-B,64A-67B and74A-L) may be used to facilitate delivery of any of the implants (e.g., any of the prosthetic valves and/or prosthetic valve supports) described hereinabove, mutatis mutandis; and
• (7) any of the techniques and apparatus described hereinabove (e.g., those described with reference toFIGS. 9A-F,25A-E,27A-D, and68A-69E), for retrieval of a prosthetic valve or prosthetic valve support, may be used in combination with (e.g., may be used to retrieve) any of the prosthetic valves and/or prosthetic valve supports described hereinabove, mutatis mutandis.
• Reference is again made toFIGS. 1A-80. It is to be noted that for some applications of the present invention that comprise tissue-engaging elements62, movement of tissue-engaging elements62 from their constrained configuration to their unconstrained configuration during deployment, comprises movement of over 180 degrees. For some applications, tissue-engaging elements, comprising valve-anchoring elements, move from a constrained configuration distal to the primary structural element of the prosthetic valve, to an unconstrained configuration wherein a portion of each valve-anchoring element is disposed inside the generally-cylindrical structure of the primary structural element of the prosthetic valve (e.g., valve-anchoring elements protrude through voids defined by the lattice structure of the primary structural element).
• Reference is again made toFIGS. 1A-80. For some applications of the invention, apparatus such as the prosthetic valves and/or prosthetic valve supports described hereinabove (e.g., the primary structural elements, upstream support portions, and tissue-engaging elements thereof), are covered at least in part with a covering. The covering may comprise polyethylene terephthalate (e.g., polyester), polytetrafluoroethylene (e.g., Teflon, ePTFE), a fabric, and/or or pericardial tissue. Typically, a thickness of the covering is less than 0.2 mm, e.g., less than 0.1 mm, or less than 0.05 mm. The covering may be selected according to requirements. For example, for some applications, a surface of the apparatus that is placed in contact with the native valve is covered; the covering being configured to facilitate coupling of the prosthetic valve support to the native valve, by enhancing tissue growth at the interface between the prosthetic valve support and the native valve. Conversely, for some applications, the covering may be configured to inhibit tissue growth thereon. For some applications, a surface of the apparatus is covered with the covering so as to inhibit (e.g., prevent) leakage of blood between the prosthetic valve and the native valve, and/or between the prosthetic valve and the prosthetic valve support.
• For some applications, the prosthetic valve support (e.g., the upstream support portion thereof) is not covered with the covering, and is configured to allow flow of blood therethrough. For example, the prosthetic valve support may be configured to allow flow of blood through the interface between the valve support and the prosthetic valve, in order to accommodate antegrade flow of blood between the subject's atrium and the subject's ventricle that is greater than can be accommodated by blood flowing through the prosthetic valve alone. For some such application of the invention, the prosthetic valve support is not covered with the covering and is configured to support prosthetic valve, such that the leaflets of the native valve (1) move in response to the beating of the heart, (2) coapt with each other and/or with the primary structural element of the prosthetic valve, and (3) inhibit (e.g., prevent) retrograde flow of blood through the prosthetic valve support.
• Reference is yet again made toFIGS. 1A-80. It is to be noted that although some apparatus and methods are described herein to replace a native heart valve (e.g., a native mitral valve) of the subject, apparatus (and subcomponents thereof) and methods described herein may also be used at any other site in the body of the subject. For example, delivery apparatus and/or locks described herein may be used to facilitate implantation and/or adjustment of any suitable implant at a given implantation site of a body of the subject, e.g., the stomach.
• Reference is made toFIGS. 1A-80. It is to be noted that for some applications of the present invention, medical device150 comprises an implant that comprises a prosthetic valve support and a prosthetic valve. For other applications, medical device150 comprises a prosthetic valve support. For yet other applications, medical device150 comprises a prosthetic valve.
• Reference is again made toFIGS. 1A-80. It is to be noted that at least some of the tissue-engaging elements that are described herein as adjustable (e.g., length-adjustable), may be adjusted prior to implantation, during the implantation procedure, or following implantation.
• It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.

Claims (23)

1-25. (canceled)

26. Apparatus for use with a native valve of a heart of a subject, the apparatus comprising:

an annular upstream support portion, configured to be transluminally placed against an atrial surface of the native valve;

a tissue-engaging element, comprising a coupling portion configured to be transluminally coupled to tissue in a ventricle of the heart;

an elastically-stretchable holding element, configured to secure the upstream support portion against the atrial surface by elastically coupling the coupling portion to the upstream support portion; and

a prosthetic valve, configured to be transluminally delivered to the native valve and intracorporeally coupled to the upstream support portion subsequently to the securing of the upstream support portion against the atrial surface.

27. The apparatus according toclaim 26, wherein the upstream support portion is configured to be transluminally advanced to the heart while coupled to the tissue-engaging element via the holding element.

28. The apparatus according toclaim 26, wherein the holding element has a contracted configuration in which the holding element has a length, and wherein the holding element is configured to couple the coupling portion to the upstream support portion such that a distance between the coupling portion and the upstream support portion is reversibly increasable to be greater than the length, by stretching of the holding element.

29. The apparatus according toclaim 26, wherein the holding element comprises nitinol.

30. The apparatus according toclaim 26, wherein the holding element comprises a spring.

31. The apparatus according toclaim 30, wherein the spring comprises a tension spring.

32. The apparatus according toclaim 30, wherein the spring is shaped to define a coil.

33. The apparatus according toclaim 30, wherein the spring is shaped to define a zigzag.

34. The apparatus according toclaim 26, wherein the holding element comprises a plurality of telescopically-slidable cylinders.

35. The apparatus according toclaim 26, wherein the holding element comprises a limiting wire, configured to limit stretching of the holding element.

36. A method, comprising:

securing an annular upstream support portion against an atrial surface of a native valve of a heart of a subject by:

transluminally placing the upstream support portion against the atrial surface of the native valve of the heart, and

anchoring a coupling portion of a tissue-engaging element to tissue in a ventricle of the heart, the tissue-engaging element being elastically couplable to the upstream support portion via an elastically-stretchable holding element;

transluminally delivering a prosthetic valve to the native valve; and

intracorporeally coupling the prosthetic valve to the upstream support portion subsequently to the securing of the upstream support portion against the atrial surface.

37. The method according toclaim 36, further comprising advancing the upstream support portion to the native valve while the upstream support portion is coupled to the tissue-engaging element via the holding element.

38. The method according toclaim 36, wherein anchoring the coupling portion of the tissue-engaging element comprises anchoring a coupling portion of a tissue-engaging element that is elastically couplable to the upstream support portion via an elastically-stretchable holding element that includes nitinol.

39. The method according toclaim 36, wherein anchoring the coupling portion of the tissue-engaging element comprises anchoring a coupling portion of a tissue-engaging element that is elastically couplable to the upstream support portion via an elastically-stretchable holding element that includes a spring.

40. The method according toclaim 39, wherein anchoring the coupling portion of the tissue-engaging element comprises anchoring a coupling portion of a tissue-engaging element that is elastically couplable to the upstream support portion via an elastically-stretchable holding element that includes a spring that is shaped to define a coil.

41. Apparatus for use at a heart of a subject, the apparatus comprising:

a self-expanding prosthetic valve having a compressed state in which the prosthetic valve is transluminally advanceable, and an expanded state; and

a delivery tube:

comprising a flexible material, and

configured to house the prosthetic valve in a manner in which the tube (1) retains the prosthetic valve in the compressed state, and (2) conforms to a shape of the prosthetic valve in the compressed state.

42. The apparatus according toclaim 41, wherein the flexible material is a fabric.

43. The apparatus according toclaim 41, wherein the delivery tube is flaccid without the prosthetic valve housed therewithin.

44. The apparatus according toclaim 41, wherein the delivery tube is configured to release the prosthetic valve by at least part of the delivery tube being intracorporeally opened into a sheet of the flexible material.

45. The apparatus according toclaim 44, further comprising a pullstring, wherein the delivery tube comprises the sheet of the flexible material held in a generally cylindrical shape by the pullstring, and is configured to be opened by the pullstring being pulled out of the delivery tube.

46. The apparatus according toclaim 45, wherein the pullstring holds the flexible material in the generally cylindrical shape by being woven between parts of the flexible material.

47. The apparatus according toclaim 45, wherein the pullstring holds the flexible material in the generally cylindrical shape by being coupled to the flexible material via a weakened join.

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