US20140336754A1 - Multiple Component Prosthetic Heart Valve Assemblies and Methods for Delivering Them - Google Patents

Abstract

Multiple component heart valves and apparatus and methods for implanting them are provided. The heart valve generally includes a first annular prosthesis and a second valve prosthesis. The first prosthesis includes an annular member compressible from a relaxed condition to a contracted condition to facilitate delivery into a biological annulus, the annular member being resiliently expandable towards the relaxed condition. The first prosthesis also includes guide rails extending therefrom. The second prosthesis includes an annular frame, valve elements, and receptacles for receiving respective guide rails therethrough when the second prosthesis is directed towards the first prosthesis. In addition, a valve holder may releasably carry the valve prosthesis that includes channels for receiving respective guide rails therethrough when the guide rails are received through the valve prosthesis. A delivery tool is also provided that includes an actuator for selectively compressing the annular member into the contracted condition.

Description

RELATED APPLICATION DATA
• This application claims benefit of co-pending provisional application Ser. No. 60/746,038, filed Apr. 29, 2006, and 60/914,742, filed Apr. 29, 2007, the entire disclosures of which are expressly incorporated by reference herein.
FIELD OF THE INVENTION
• The present invention relates generally to heart valves that may be implanted within a patient, and, more particularly, to multiple component heart valve assemblies that may be assembled together, and to apparatus and methods for using them.
BACKGROUND
• Prosthetic heart valves can replace defective human valves in patients. For example, one piece valves have been suggested that include sewing rings or suture cuffs that are attached to and extend around the outer circumference of a prosthetic valve. In addition, multiple component valves have also been suggested that include a sewing ring that is separate from a valve component. The sewing rings of either type of prosthetic valve can be tedious and time consuming to secure within a target site, i.e., within an annulus of a heart where a natural heart valve has been removed.
• For example, to implant a sewing ring within an annulus of a heart, between twelve and twenty sutures may be secured initially to tissue surrounding the annulus. The sewing ring and/or the entire prosthetic valve may then be advanced or “parachuted” down the sutures into the annulus. Knots may then be tied with the sutures to secure the sewing ring within the annulus, whereupon the sutures may be cut. Consequently, this procedure can be very complicated, requiring management and manipulation of many sutures. The complexity of the procedure also provides a greater opportunity for mistakes and requires a patient to be on cardiopulmonary bypass for a lengthy period of time.
• Because the annulus of the heart may not match the circular cross-section of the sewing ring and/or prosthetic valve, the prosthetic valve may not fit optimally within the annulus. As a result, natural blood hemodynamics through and around the valve may be impaired, resulting in clotting, possible emboli production, and eventual calcification of the valve structure.
• To address this concern, flexible sewing rings have been suggested for use with multiple component valves. The sewing ring may be implanted within the annulus, e.g., using the procedure described above, i.e., parachuted down an arrangement of sutures. The sewing ring may conform at least partially to the anatomy of the annulus. Alternatively, instead of using sutures, it has also been suggested to drive staples through the sewing ring into the surrounding tissue to secure the sewing ring.
• When a mechanical or prosthetic valve is then attached to the sewing ring, however, the valve and sewing ring may not mate together effectively, e.g., if the shape of the sewing ring has been distorted to conform to the annulus, which may also impair natural blood hemodynamics, create leaks, and/or otherwise impair performance of the prosthetic valve.
• In addition, less invasive or minimally invasive procedures are often desirable, because they may reduce stress on the patient's body and/or accelerate recovery after a procedure. Such procedures may involve creating smaller access sites and/or even using ports to access a procedure site. During valve replacement, in order to introduce a prosthetic heart valve and/or sewing ring into a patient's heart, the heart must be accessed, e.g., by sternotomy or thoracotomy. The resulting opening must be sufficiently large to permit passage of the prosthetic heart valve and still allow the physician to access and/or observe the site of implantation. Thus, conventional procedures for implanting prosthetic heart valves may not be compatible with less invasive or minimally invasive procedures.
SUMMARY OF THE INVENTION
• The present invention is directed to prosthetic heart valves that may be implanted within a patient, and, more particularly, to multiple component heart valve assemblies that may be assembled together, and to tools, apparatus, systems, and methods for making and implanting them.
• In accordance with one embodiment, a prosthesis is provided for receiving a valve prosthesis to replace a natural or prosthetic heart valve within a biological annulus. The prosthesis may include an annular member implantable within the biological annulus for contacting tissue surrounding the biological annulus, a sewing cuff extending from the annular member, and a plurality of elongate guide rails or other leaders extending from one of the annular member and the sewing cuff for guiding a valve prosthesis towards the prosthesis. Optionally, the annular member may be resiliently compressible, expandable, and/or otherwise biased, and/or may include a collar extending upwardly therefrom, a skirt, one or more guide shields, and/or other components.
• In accordance with another embodiment, a prosthesis is provided for receiving a valve prosthesis to replace a natural or prosthetic heart valve within a biological annulus. The prosthesis may include an annular member that is compressible radially inwardly from a relaxed or expanded condition to a contracted condition to facilitate delivery into a biological annulus. When the annular member is released from the contracted condition, the annular member may resiliently expand towards the expanded condition, e.g., to dilate tissue surrounding the biological annulus. Optionally, the prosthesis may include a sewing cuff extending from the annular member, a collar extending upwardly therefrom, a skirt, a plurality of elongate guide rails or other leaders extending from the prosthesis for guiding a valve prosthesis member towards the prosthesis, and/or other components.
• In accordance with yet another embodiment, a prosthesis is provided for receiving a valve prosthesis to replace a natural or prosthetic heart valve within a biological annulus. The prosthesis may include an annular member, and a plurality of guide rails or other leaders extending from the annular member. Each of the leaders may include a proximal end, a distal end secured to the annular member, and one or more ratchets, clasps, locking tabs, or other retention elements or connectors, e.g., configured to allow a valve member to be directed distally but not proximally over the connectors. In an exemplary embodiment, each of the connectors may include a tapered proximal surface and a blunt distal surface. The connectors may be spaced a predetermined distance from the annular member to secure the valve member against or immediately adjacent the annular member. Optionally, the annular member may be compressible radially inwardly from a relaxed or expanded condition to a contracted condition to facilitate delivery into a biological annulus, resiliently expandable towards the expanded condition, and/or otherwise biased.
• In accordance with still another embodiment, a heart valve assembly is provided that includes a first annular prosthesis implantable within a biological annulus, a second valve prosthesis, and a plurality of elongate guide rails or other leaders extending from the first prosthesis for guiding the second prosthesis into engagement with the first prosthesis. In exemplary embodiments, the second prosthesis may be a mechanical valve or a bioprosthetic valve, e.g., including multiple tissue leaflets carried by a frame.
• Optionally, the second prosthesis may include a plurality of receptacles or other features for receiving respective leaders. For example, the features may be ports or other receivers fixed to a frame or wall of the second prosthesis, a plurality of tubular members that may be removable from a frame, fabric covering, or other portion of the second prosthesis, and the like.
• In one embodiment, one or more connectors may be provided on at least one of the first and second prostheses for securing the second prosthesis to the first prosthesis. For example, the one or more connectors may include one or more cooperating clips, detents, and the like that self-engage one another when the second prosthesis is directed towards the first prosthesis. In addition, or alternatively, the leaders may include one or more ratchets, clasps, locking tabs, or other retention elements or connectors for securing the second prosthesis against or immediately adjacent the first prosthesis.
• In addition or alternatively, the first prosthesis may include an annular member, a sewing cuff extending radially from the annular member, and/or a skirt to enhance scaling between the first prosthesis and surrounding tissue. In one embodiment, the first prosthesis may also include a collar extending upwardly from the annular member for receiving the valve member. The sewing cuff and/or collar may be formed from resiliently flexible material, e.g., silicone or polyester film, covered with a fabric covering.
• In accordance with yet another embodiment, a prosthetic heart valve system is provided that includes a first annular prosthesis, a second valve prosthesis, and one or more delivery tools for introducing the first and/or second prostheses. The first prosthesis may include an annular member implantable within a biological annulus for contacting tissue surrounding the biological annulus, a sewing cuff extending radially outwardly from the annular member, and a plurality of elongate guide rails or other leaders extending from one of the annular member and the sewing cuff for guiding the valve prosthesis towards the sewing cuff.
• The one or more delivery tools may include an elongate member including a proximal end, a distal end sized for introduction into a biological annulus, and an actuator for directing the first prosthesis between an expanded or relaxed condition and a contracted condition that facilitates introduction into a biological annulus. In one embodiment, the tool may include a groove or lumen extending between the proximal and distal ends thereof for receiving portions of the leaders therethrough. The actuator may include a handle at the proximal end and one or more mechanisms for locking, tightening, and/or releasing the leaders received in the groove or lumen, e.g., to facilitate tightening and/or loosening the leaders. Thus, the first prosthesis may be releasably engaged with the distal end of the delivery tool when the leaders are secured to the delivery tool. For example, the first prosthesis may be compressible from an expanded or relaxed condition to a contracted condition when the leaders are tensioned, thereby drawing portions of the first prosthesis inwardly towards the distal end of the delivery tool.
• In another embodiment, the tool may include a central hub or support and a plurality of movable arms for capturing the first prosthesis between the support and arms. The actuator may direct the arms inwardly and outwardly for directing the first prosthesis to the contracted condition and releasing the first prosthesis from the tool. In an exemplary embodiment, in the contracted condition, the first prosthesis may assume a clover or other multiple lobular shape, while, in the expanded condition, the first prosthesis may have a substantially circular shape. The first prosthesis may be resiliently compressible such that, when the first prosthesis is released, the first prosthesis may resiliently expand towards the expanded condition.
• In accordance with still another embodiment, a prosthetic heart valve system is provided that includes a first annular prosthesis and a delivery tool. The first prosthesis may be resiliently compressible from a relaxed or expanded condition to a contracted condition. The delivery tool may include one or more constraints for maintaining the first prosthesis in the contracted condition. For example, the delivery tool may include a plurality of movable arms surrounding a central hub or set of supports, the arms being movable towards and away from the hub for capturing and/or compressing the first prosthesis between the arms and the hub. The first prosthesis may be resiliently compressible such that, when released from the one or more constraints, the first prosthesis may resiliently expand towards the expanded condition.
• In accordance with yet another embodiment, a method is provided for implanting a prosthetic heart valve assembly to replace a natural or prosthetic heart valve within a biological annulus below a sinus cavity. A first annular prosthesis may be inserted into the biological annulus while in a contracted condition. In one embodiment, the first prosthesis may include a plurality of guide rails or other leaders extending from the prosthesis. At least a first portion of the first prosthesis may be deployed in the annulus so that the first prosthesis expands to an enlarged state therein, e.g., to at least partially dilate tissue surrounding the biological annulus. In addition or alternatively, the first prosthesis may include a flexible sewing cuff and/or skirt extending around the first prosthesis, which may be disposed supra-annularly and/or sub-annularly when the first portion is deployed in the biological annulus. One or more connectors, e.g., sutures, clips, and the like, may be directed through the first prosthesis, e.g., through the sewing cuff, and adjacent tissue, to secure the first prosthesis relative to the annulus.
• A second valve prosthesis, e.g., a mechanical or bioprosthetic valve, may be directed into the annulus adjacent the first prosthesis. For example, the valve prosthesis may be advanced along guide rails or other leaders extending from the first prosthesis until the second prosthesis engages or otherwise contacts the implanted first prosthesis. In one embodiment, the valve prosthesis may be secured to the first prosthesis using one or more connectors, e.g., one or more sutures, clips detents, and/or other cooperating connectors, e.g., on the first prosthesis and a frame of the valve prosthesis. In addition or alternatively, the second prosthesis may be secured to the first prosthesis by ratcheting, locking, or other retention elements or connectors on the leaders.
• In accordance with yet another embodiment, a method is provided for implanting a prosthetic heart valve assembly to replace a natural or prosthetic heart valve within a biological annulus below a sinus cavity. A gasket member and delivery tool may be provided with a plurality of elongate guide rails or other leaders extending from the gasket member into a distal end of the delivery tool. The leaders may be secured relative to the delivery tool, e.g., by a locking mechanism. A tightening mechanism on the delivery tool may be actuated to tension the leaders to compress the gasket member to a contracted condition. Alternatively, the delivery tool and gasket member may be initially provided with the leaders already tensioned.
• The distal end of the delivery tool may be introduced into the sinus cavity, thereby carrying the gasket member in the contracted state at least partially into the biological annulus. The gasket member may be at least partially released from the delivery tool, e.g., to at least partially dilate tissue surrounding the biological annulus. For example, the locking mechanism on the delivery tool may be released, unlocked, or otherwise actuated to release the gasket member, allowing the gasket member to expand resiliently towards an enlarged condition. The gasket member may be attached to the biological annulus, e.g., using one or more fasteners, such as sutures, clips, and the like.
• A valve member may then be introduced into the sinus cavity and secured to the first prosthesis. Optionally, the valve member may be carried by the same delivery tool used to introduce the gasket member or by a separate tool. The valve member may be secured to the gasket member by one or more connectors, e.g., sutures, clips, detents, ratcheting or other retention elements, and the like. In one embodiment, the valve member may be introduced into the sinus cavity along the leaders and/or may be secured to the gasket member by one or more connectors on the leaders.
• In accordance with still another embodiment, a valve holder device may be provided for delivering a valve prosthesis into a biological annulus for connection to an annular prosthesis previously introduced into the biological annulus and including one or more guide rails or other leaders extending therefrom. For example, the valve holder device may include one or more elements, e.g., a head, for releasably carrying the valve prosthesis on a distal end of the valve holder device. In addition, the valve holder device may include one or more channels or other receivers for receiving respective leaders, the receivers slidably receiving the leaders while the valve holder device and valve prosthesis are directed towards the annular prosthesis. Optionally, the valve holder device may include one or actuators that may be manipulated to sever the leaders after the valve prosthesis is secured relative to the annular prosthesis.
• Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• The drawings illustrate exemplary embodiments of the invention, in which:
• FIG. 1 is a perspective view of a two piece heart valve assembly including a gasket member having elongate leaders extending therefrom and a valve member.
• FIG. 2 is a perspective view of an apparatus for delivering the gasket member ofFIG. 1 into a biological annulus that includes a delivery tool for receiving the elongate leaders from the gasket member.
• FIG. 3A is a perspective view of the apparatus ofFIG. 2, showing the gasket member in a relaxed condition, when the leaders are free from external forces.
• FIG. 3B is a perspective view of the apparatus ofFIGS. 2 and 3A, showing the gasket member in a contracted condition, when tension is applied to pull the leaders further into the delivery tool.
• FIG. 4 is a perspective view of another embodiment of a heart valve assembly, including a gasket member having elongate leaders extending therefrom that include retention elements, and a valve member.
• FIGS. 5A-5C are cross-sectional views of a biological annulus, showing a method for implanting the heart valve assembly ofFIG. 4.
• FIG. 6 is a cross-sectional view of a biological annulus showing an alternate embodiment of a valve member that may be provided for a heart valve assembly implanted within the biological annulus.
• FIG. 7 is a perspective view of another alternate embodiment of a valve member.
• FIGS. 8A and 8B are perspective and top views, respectively, of another embodiment of a gasket member including a plurality of guide rails and guide shields.
• FIG. 8C is a perspective view of an alternative embodiment of a gasket member, including a collar extending upwardly for receiving a valve member therein.
• FIGS. 9A-9C are side, perspective, and end views, respectively, of a tool for delivering the gasket member ofFIGS. 8A and 8B.
• FIGS. 10A and 10B are end and side views, respectively, of a distal end of the tool ofFIGS. 9A-9C, showing the gasket ofFIGS. 8A and 8B secured thereto in a folded or contracted condition.
• FIGS. 11A-11E show the gasket member ofFIGS. 10A and 10B being delivered into a biological annulus (FIG. 11B) in a contracted condition (FIGS. 11A,11C,11D), aligned with commissures of the annulus (FIGS. 11B,11C), and released from the tool (FIG. 11E).
• FIG. 12 is an end view of an alternate contracted configuration for the gasket member ofFIGS. 8A and 8B, e.g., having a folded shape.
• FIG. 13A is a perspective detail of a biological annulus including the gasket member ofFIGS. 8A and 8B delivered therein, showing a guide shield of the gasket member.
• FIG. 13B is a perspective detail of the biological annulus ofFIG. 13A, showing tools being used to deliver a fastener through the gasket member into surrounding tissue.
• FIGS. 14A-14C are details of the biological annulus ofFIGS. 13A and 13B, showing the gasket member being secured to the annulus.
• FIGS. 15A and 15B are side and end views, respectively, of a valve holder tool for delivering a valve prosthesis into a biological annulus.
• FIG. 15C is a longitudinal cross-section of the valve holder tool ofFIGS. 15A and 15B, taken along line15C-15C.
• FIG. 15D is a perspective view of a distal end of the valve holder tool ofFIGS. 15A-15C.
• FIGS. 16A and 16B are perspective views of the valve holder tool ofFIGS. 15A-15D, showing an actuator on the valve holder in distal and proximal positions, respectively.
• FIG. 17A is a side view of the valve holder tool ofFIGS. 15A-15D carrying a valve prosthesis.
• FIG. 17B is a detail of a distal end of the valve holder tool ofFIG. 17A, showing a plurality of sutures securing the valve prosthesis to the valve holder tool.
• FIG. 17C is a detail of the distal end of the valve holder tool ofFIGS. 17A and 17B, showing passages for receiving respective guide rails of a gasket member, such as that shown inFIGS. 8A and 8B.
• FIGS. 18A and 18B show the valve holder tool ofFIG. 17A being used to deliver the valve prosthesis into a biological annulus along guide rails of a gasket member already delivered into the annulus.
• FIG. 18C is a detail showing the passages on the valve holder tool ofFIG. 17C with guide rails from a gasket member extending through the passages.
• FIG. 19A is a detail showing a method for removing guide shields from a gasket member after a valve prosthesis has been engaged with the gasket member.
• FIG. 19B is a detail showing a method for removing a valve prosthesis from the valve holder tool ofFIGS. 17A and 17B by cutting the sutures securing the valve prosthesis to the valve holder tool.
• FIGS. 19C and 19D show a distal end of the valve holder tool ofFIG. 19B being withdrawn after releasing the valve prosthesis from the valve holder tool.
• FIGS. 20A and 20B are details of a frame of a valve prosthesis that includes a receptacle including a cantilever spring, showing a track and locking elements being formed therein.
• FIGS. 20C and 20D are perspective and side details, respectively, of the receptacle ofFIGS. 20A and 20B receiving a guide rail therethrough, the locking elements on the cantilever spring causing the cantilever spring to defect outwardly to accommodate locking tabs on the guide rail passing through the receptacle.
• FIG. 20E is a side detail of the frame ofFIGS. 20A-20D with the locking tabs of a guide rails engaged with the locking elements of the receptacle and a top portion of the guide rails severed and removed.
• FIGS. 21A-21D are perspective views of a biological annulus with a valve assembly including a gasket member and a valve prosthesis (with leaflets omitted for clarity) implanted therein.
• FIGS. 22A and 22B are side views of another embodiment of a valve holder tool for delivering a valve prosthesis into a biological annulus.
• FIGS. 23A and 23B are details showing a free end of a guide rail being received within an actuator of the valve holder tool ofFIGS. 22A and 22B.
• FIGS. 24A and 24B are front and back views, respectively, of a receptacle that may be attached to a valve prosthesis.
• FIGS. 25A and 25B are perspective views of a frame for a valve prosthesis including the receptacle ofFIGS. 24A and 24B attached thereto.
• FIG. 26 is a detail showing a guide rail being received within the receptacle ofFIGS. 25A and 25B.
DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
• Turning to the drawings,FIGS. 1 and 2 show an exemplary embodiment of aheart valve assembly10 that generally includes agasket member12 and avalve member14. Thegasket member12 is an annular shaped body generally defining aplane16 and a centrallongitudinal axis17 extending substantially perpendicular to theplane16. As shown, thegasket member12 includes anannular ring18, asewing cuff20, and a plurality of elongate leaders, guide rails, orother elements50 extending from thesewing cuff20 or other portion of thegasket member12, as described further below. Optionally, thegasket member12 may also include a flexible skirt and/or baleen elements (not shown), e.g., surrounding theannular ring18, a collar, and/or a plurality of guide shields (also not shown), similar to other embodiments described herein. A fabric covering21 may be provided on one or more components of thegasket member12, e.g., over theannular ring18 and over a core of thesewing cuff20, as described further below.
• In one embodiment, theannular ring18 may have a generally circular shape. Alternatively, theannular ring18 may have a multi-lobular shape about the circumference, e.g., including three lobes separated by scallops or cusps (not shown) depending upon the anatomy within which theannular ring18 is to be introduced. Theannular ring18 may be formed from an elastic or superelastic material, for example, metal, such as Nitinol, stainless steel, and the like, a polymer, or a composite material. Such material may facilitate compression and/or expansion of theannular ring18, as described further below.
• In an exemplary embodiment, theannular ring18 may be cut from a flat sheet of base material having a desired thickness for theannular ring18, for example, by laser cutting, mechanical cutting, and the like. Thus, theannular ring18 may be initially formed as a long band of material, having a width corresponding to the desired width of theannular ring18 and a length corresponding to the desired circumference of theannular ring18. The band may be wrapped around a mandrel or otherwise restrained in a generally cylindrical shape with the ends adjacent, to one another, and the band may be heat treated or otherwise processed to program the generally cylindrical shape into the material to create theannular ring18. The generally cylindrical shape may include the ends overlapping one another, spaced apart from one another to provide an open “C” shape, or attached to one another. In another exemplary embodiment, theannular ring18 may be manufactured from a solid rod of material, e.g. Nitinol, stainless steel, a polymer, or composite material, e.g., by machining, electrical discharge machining (“EDM”), laser cutting, or other processes.
• Optionally, theannular ring18 may be heat treated to program a shape memory into the band material, e.g., when the material is in an austentic state. For example, the programmed shape may be an enlarged or relaxed condition, e.g., having a substantially circular shape. The composition of the material may be such that theannular ring18 transforms to a substantially martensitic state substantially below body temperature, e.g., at or below ambient temperatures (e.g., 20° C. or less). Thus, in the martensitic state (before delivery), theannular ring18 may be relatively soft such that theannular ring18 may be plastically compressed or otherwise deformed, e.g., into a contracted condition to facilitate delivery, as described below. A transition temperature of the material may be set such that theannular ring18 transforms substantially back to an austenitic state close to or at about body temperature (e.g., at 37° C. or more). Thus, once theannular ring18 is exposed within a patient's body, theannular ring18 may automatically become biased towards the enlarged condition due the shape memory of the austenitic state.
• Alternatively, the material may be programmed to assume an austenitic state at both ambient and body temperatures, but within the elastic or superelastic range of the material. Thus, theannular ring18 may be elastically compressed into the contracted condition, but may resiliently expand towards the enlarged condition when released from any constraints maintaining theannular ring18 in the contracted condition.
• Theannular ring18 may be at least partially covered with fabric, e.g., for tissue ingrowth, by wrapping fabric around theannular ring18, while accommodating expansion and contraction of theannular ring18. For example, at least near the ends of the band forming theannular ring18, the fabric may not be secured to theannular ring18, allowing the ends to slide circumferentially relative to the fabric. Optionally, sutures and the like (not shown) may be used to secure the fabric to theannular ring18 at locations removed from the ends, e.g., at an intermediate location about the circumference of theannular ring18. Alternatively, the entireannular ring18 may be free to slide within the fabric wrapped around theannular ring18.
• With continued reference toFIGS. 1 and 2, thesewing cuff20 may be attached to or otherwise extend around theannular ring18. Thesewing cuff20 may simply be one or more layers of fabric or other material covering at least a portion of theannular ring18. For example, a layer offabric21 may cover all of the annular ring18 (other than any connectors and/or bearing surfaces, if any) and/or may include a section of material extending radially outwardly from theannular ring18 to at least partially define thesewing cuff20.
• Optionally, thesewing cuff20 may include flexible core material (not shown) that may be attached to or otherwise extend around theannular ring18. For example, the core may be secured around theannular ring18 by an interference fit, bonding, fusing a portion of the core to theannular ring18, e.g., along an upper edge thereof, and the like. The core may be substantially covered with fabric, similar to theannular ring18.
• In an exemplary embodiment, the core may include a lattice (not shown) extending around a circumference of the core, e.g., including at least two spaced apart circumferential elements and a plurality of ribs or transverse elements extending between the circumferential elements, thereby defining openings through the lattice. The openings may be completely open, i.e., free from any material. Alternatively, the openings may be recesses including a relatively thin wall of core material, i.e., that is substantially thinner than the circumferential elements and/or ribs. In other embodiments, the core may include a base or web and a plurality of fins or ribs extending from the web to provide a flexible structure, e.g., which may facilitate sealing between thesewing cuff20 andvalve member14.
• Exemplary materials for the core include silicone or other elastomeric materials, foam, fabric, felt, polymers, and the like. In addition or alternatively, the core may include swellable material, e.g., foam or sponge materials that may expand when exposed to fluid, such as blood. The materials may be molded or otherwise formed into the core, e.g., using known molding, extrusion, cutting, or other manufacturing procedures. For example, the core may be injection molded or otherwise formed in its annular shape.
• Alternatively, the core may be molded or otherwise formed as a flat sheet, and rolled into the annular shape. In this alternative, the ends of the sheet may be attached to one another, e.g., using sutures, adhesives, ultrasonic welding, and the like. Optionally, to provide a tapered shape, one or more wedges (not shown) may be cut out of the band to provide a desired tapered but, annular shape. In another option, portions of the core may be disconnected from other portions, e.g., to prevent puckering. For example, if the core is formed from a rolled sheet (not shown), ends of the sheet (also not shown) may remain loose to allow the ends to move relative to one another.
• In a relaxed state (free from external forces), thesewing cuff20 may adopt an undulating annular shape or a generally planar annular shape. Thesewing cuff20 may also be tapered, as shown inFIGS. 1 and 2, e.g., having a larger diameter or circumference about an upper edge than about an edge adjacent theannular ring18. The tapered shape of thesewing cuff20 may define an angle relative to thelongitudinal axis17, e.g., between about twenty and forty five degrees (20-45°).
• The material of the core may be substantially flexible, e.g., manufactured in a desired annular shape, yet easily deformed, e.g., deflected, stretched, and/or compressed. The core may be sufficiently flexible to be “floppy,” i.e., such that the core conforms easily to the particular anatomy and/or implantation arrangements encountered during implantation. Thus, when thesewing cuff20 is placed above or within a biological annulus within a patient's heart, the core may conform to the surrounding anatomy and/or may deform when thevalve member14 is secured to thegasket member12, e.g. to enhance sealing between thevalve member14 and thegasket member12, as described further below. Additional information on flexible cores or other constructions of thesewing cuff20 may be found in U.S. Publication No. US 2006/0195184, filed as Ser. No. 11/069,081, the entire disclosure of which is expressly incorporate by reference herein.
• With continued reference toFIGS. 1 and 2, theleaders50 may include elongate rails, fibers, or filaments including a first ordistal end51 attached or otherwise secured to thegasket member12 and a second orproximal end52. Optionally, theleaders50 may include one or more markers or other elements (not shown) spaced apart along at least a portion of their lengths, e.g., immediately adjacent thefirst end51. In addition or alternatively, as shown inFIG. 4, theleaders50 may include one or more unidirectional orbidirectional retention elements54, e.g., locking beads, tabs, ratchets, detents, and the like. As explained further elsewhere herein, these leaders may also provide connectors for attaching and/or securing thevalve member14 to or adjacent thegasket member12.
• Theleaders50 may be threads, filaments, wires, rails, or other tethers that extend from thegasket member12. For example, theleaders50 may be monofilaments or multifilament structures, e.g., braided, spun, or otherwise formed into a unitary member. Theleaders50 may be formed from wire or suture materials, e.g., plastic, such as polyethylene, metal, such as stainless steel, cat gut, or composite materials, using known methods. Theleaders50 may be stiff or flexible, and/or may be resiliently bendable or plastically pliable. Theretention elements54 may be integrally formed on theleaders50, e.g., at the time theleaders50 are formed, or may be separate elements (made from the same or different materials than the leaders50) that are bonded, fused, or otherwise attached to theleaders50 at predetermined locations. Alternatively, theleaders50 may be flat bands, e.g., formed from plastic or other material, and may have theretention elements54 formed therein or attached thereto, as described elsewhere herein.
• With continued reference toFIG. 4, theretention elements54 may include tapered proximal edges54aand substantially blunt distal edges54b. The proximal edges54amay provide a substantially smooth transition allowing thevalve member14 to be passed distally over theretention elements54. The distal edges54bmay provide locks that prevent thevalve member14 from being passed proximally back over theretention elements54, similar to a ratchet or detent, as described further below. In alternative embodiments, the retention elements on theleaders50 may include knots (not shown) tied onto theleaders50 and/or beads (also not shown) formed on theleaders50 at predetermined locations. Although only oneretention element54 is shown on eachleader50, optionally,multiple retention elements54 may be provided spaced apart from one another along eachleader50.
• Eachleader50 may be attached to, pre-threaded through, or otherwise placed on thegasket member12, e.g., at spaced apart intervals from one another. For example,leaders50 may be provided on thegasket member12 that are aligned with the commissures (not shown) on thevalve member14 and/or a biological annulus into which thegasket member12 is to be implanted. Thus, for example, for a prosthesis for an aortic valve having three commissures, threeleaders50 may be provided, as shown.
• Eachleader50 may be attached to thegasket member12 by directing thefirst end51 through a predetermined location in thegasket member12 and melting or otherwise expanding the first end51 (e.g., similar to a rivet or nail head) to prevent subsequent removal. Alternatively, thefirst end51 may be looped back around theleader50 and bonded, fused, tied, or otherwise secured to theleader50. In another alternative, thefirst end51 may be pulled and secured or disposed adjacent the second end52 (not shown), e.g., similar to a double-arm suture. Theleaders50 may be attached to the fabric of thesewing cuff20 immediately adjacent theannular ring18, or to other portions of thegasket member12, e.g., to theannular ring18, the core of the sewing cuff (not shown), or other portions of the fabric covering ofgasket member12.
• Optionally, thegasket member12 may include one or more additional components. For example, thegasket member12 may include a collar or stand-off58 that extends upwardly from thesewing cuff20 for receiving thevalve member14, such as that shown inFIG. 8C. In addition or alternatively, a skirt or a plurality of baleen elements (not shown) may be provided around or adjacent theannular ring18, e.g., that may bias a portion of the fabric covering outwardly (also not shown). Additional information on materials, construction, and/or components of thegasket member112 may be found in U.S. Publication Nos. US 2004/0122516, filed as Ser. No. 10/327,821, US 2005/0165479, filed as Ser. No. 10/765,725, US 2006/0195184, filed as Ser. No. 11/069,081, and US 2007/0016285, filed as Ser. No. 11/420,720, and in co-pending application Ser. No. 11/567,735, filed Dec. 6, 2006. The entire disclosures of these references are expressly incorporated by reference herein.
• Turning toFIGS. 3A and 3B, thegasket member12 may be expandable and/or compressible such that the cross-section of thegasket member12 may be adjusted, e.g., to accommodate introduction into a patient's body during a procedure, as described further elsewhere herein. In one embodiment, theannular ring18 may be biased to a relaxed or expanded condition, e.g., defining a predetermined diameter “D1” (as shown inFIG. 3A). At least a portion of theannular ring18 may be contracted radially inwardly to define a smaller diameter or cross-section “D2” (as shown inFIG. 3B), e.g., to facilitate delivery into a biological annulus. As described above, thesewing cuff20 may be substantially flexible such that thesewing cuff20 is also compressed radially inwardly as theannular ring18 is compressed. Thus, the gasket member may be compressible, yet may be resiliently expandable to dilate tissue surrounding the annulus and/or to facilitate securing thegasket member12 within a biological annulus.
• To contract thegasket member12, tension may be applied to the leaders50 (e.g., usingdelivery tool60, described further below), e.g., to draw one or more portions of thegasket member12 inwardly towards thecentral axis17. For example, inward and/or proximal tension may be applied to theleaders50, e.g., by pulling theleaders50 at least partially into thedelivery tool60, as described further below, which may pull the ends of theleaders50 inwardly towards thecentral axis17. As theleaders50 are tensioned, theannular ring18 may contract inwardly to assume a multiple lobular shape, e.g., as shown inFIG. 3B, such that thegasket member12 assumes the contracted condition.
• Theannular ring18 may deform elastically towards the contracted condition. Alternatively, as described elsewhere herein, theannular ring18 may be cooled to a martensitic state, e.g., by immersing thegasket member12 in ice, ice water, or other fluid maintained at a temperature below the final martensitic temperature of theannular ring18. In this alternative, theannular ring18 may be plastically deformed while theannular ring18 is in the relatively soft, martensitic state.
• When tension of theleaders50 is released, e.g. by releasing theleaders50 at least partially from thedelivery tool60, theannular ring18 may resiliently expand outwardly, e.g., to a shape having a generally circular cross-section, thereby returning thegasket member12 towards the expanded condition, e.g., a, shown inFIG. 3A. For example, if theannular ring18 is deformed elastically to the contracted condition, theannular ring18 may simply expand resiliently towards the expanded condition. Alternatively, if deformed in a martensitic state, thegasket member12 may be heated such that theannular ring18 resumes an austenitic state, e.g., when theannular ring18 is exposed to ambient temperatures or body temperature. In this alternative, theannular ring18 may “remember” the expanded condition and become biased to expand upon being released.
• Turning toFIG. 2, an exemplary embodiment of an apparatus orsystem30 is shown for delivering a prosthesis into a biological annulus that includes agasket member12 and adelivery tool60. Thegasket member12 may be any of the embodiments described herein, e.g., including anannular ring18, asewing cuff20, and a plurality ofelongate leaders50. Thedelivery tool60 generally includes ashaft62 having aproximal end61, adistal end63 sized and/or shaped for introduction into an opening in a patient's body, and ahandle65 on theproximal end61. Thedelivery tool60 may also include one or more lumens67 (one shown in phantom) extending between the proximal and distal ends61,63, e.g., for receiving portions of theleaders50 therein. Alternatively, theshaft62 may include other configurations, e.g., a “U” shaped cross-section defining a channel for receiving theleaders50 therein. Such a cross-section may facilitate loading the leaders onto thedelivery tool60.
• Thehandle65 may also include one ormore actuators66,68, e.g., one or more locking, tightening, and/or loosing mechanisms for manipulating theleaders50. For example, thedelivery tool60 may include alocking mechanism64 for releasably securing the second ends of theleaders50, e.g., one or more clamping structures, detents, and the like. In addition or alternatively, theactuators66,68 may allow the second ends of theleaders50 to be directed proximally or distally, e.g., to apply or release tension, as described further below. As shown, thelocking mechanism64 includes a lever66 that may be actuated to release the second ends of theleaders50, and alatch68 that may be actuated to increase and/or decrease tension applied to theleaders50.
• For example, theleaders50 may be loaded into thedistal end63 of thedelivery tool60 and through thelumen67 until the second ends are engaged or otherwise received by thelocking mechanism64. Optionally, theleaders50 may be loaded by a user shortly before a procedure, e.g., allowing agasket member12 of a desired size “D1” to be selected and loaded onto thedelivery tool60. Alternatively, theleaders50 may be preloaded into adelivery tool60 during manufacturing, although this may require providingmultiple delivery tools60 before a procedure, each carrying a differentsize gasket member12.
• When it is desired to compress thegasket member12, thelatch68 may be actuated to pull theleaders50 proximally a predetermined distance within thedelivery tool60. This action may pull thegasket member12 proximally against thedistal end63 of thedelivery tool60 and/or radially inwardly, as shown inFIG. 3B. The tension may be selected to compress thegasket member12 to a predetermined size and/or shape. As shown inFIG. 3B, thegasket member12 has been compressed into a three lobe clover-like shape having a cross-section “D2.” The tension may be applied by a user shortly before introducing thegasket member12 into a patient or the tension may be preloaded, e.g., during manufacturing.
• When it is desired to deploy thegasket member12, the lever66 may be actuated, thereby releasing theleaders50 from thedelivery tool60. Alternatively, the tension on theleaders50 may be released by actuating thelatch68, e.g., in the opposite direction, from that used to apply the tension, without releasing theleaders50 entirely from thedelivery tool60. In a further alternative, the lever66 andlatch68 may be combined into a single actuator having multiple settings or positions, depending upon the action desired (e.g., tension, tension release, fully release).
• It will be appreciated that other constraints and/or delivery tools may be provided to compress and/or maintain thegasket member12 in a contracted condition. For example, a delivery tool (not shown) may be provided that includes a tubular body or other structure into which theentire gasket member12 may be loaded, e.g., after compressing thegasket member12 to the contracted condition. The delivery tool may include a plunger or other device (not shown) within the tubular body that may be used to deploy thegasket member12 from the tubular body. In an exemplary embodiment, thegasket member12 may be compressed by flattening theannular ring18 along theplane16 and then folding or rolling the resulting flattenedannular ring18. For example, after flattening theannular ring18, theannular ring18 may be rolled into a spiral, folded in half, e.g., into a “C” shape, such as that shown inFIG. 12, or otherwise compressed. When thegasket member18 is deployed from the delivery tool, theannular ring18 may resiliently return to its expanded condition, similar to the other embodiments described elsewhere herein. Additional information regarding apparatus and methods for using such as gasket member and/or heart valve assembly may be found in U.S. Publication No. 2007/0016288, filed as Ser. No. 11/457,437, the entire disclosure of which is expressly incorporated by reference herein.
• Returning toFIGS. 1 and 2, thevalve member14 generally includes an annular shaped body orframe32 and one ormore valve elements33. Thevalve member14 may include a fabric covering35, similar to thegasket member12, e.g., covering theframe32 and/or other components of thevalve member14. Theframe32 may have a noncircular, e.g., multiple lobular shape corresponding to a shape of the biological annulus within which thevalve member14 is to be implanted. For example, thevalve member14 may have a tri-lobular shape, including three lobes separated by cusps or scallops, e.g., corresponding to a sinus of Valsalva above an aortic valve site. In one embodiment, thevalve member14 may be a bioprosthetic valve member, e.g., anannular frame32 carrying a plurality oftissue leaflets33. Theframe32 may include a plurality of struts (also not shown for clarity) that may be attached to and/or otherwise carry theleaflets33. For example, the struts may include a laminate structure, including two or more sheets of flexible material, similar to the valves disclosed in U.S. Pat. No. 6,371,983, and U.S. Publication No. US 2006/0276888, filed as Ser. No. 11/144,254, the entire disclosures of which are expressly incorporated by reference herein.
• Alternatively, thevalve member14 may be a connecting device to which a valve (not shown) may be connected or that may otherwise receive a valve component, such as the connection adapter elements shown in U.S. Publication No. US as 2005/0043760, filed as Ser. No. 10/646,639, the entire disclosure of which is expressly incorporated by reference herein. In another alternative, thevalve14 may include a mechanical valve or other valve (not shown), such as those disclosed in US 2005/0165479 and US 2007/0016285725, incorporated by reference above.
• Turning toFIGS. 6 and 7, optionally, thevalve member14 may include one or more introducers orreceivers76 through whichleaders50 may be received. For example, as shown inFIG. 6, a first embodiment of anintroducer76 is shown that includes atubular member76 received through a portion of thevalve member14. For example, thetubular members76 may simply be removably inserted through predetermined regions of a fabric covering on theframe32, e.g., such that thetubular members76 extend substantially parallel to thelongitudinal axis17. As shown, thetubular members76 are located atcommissures34 of theframe32, although alternatively, thetubular members76 may be located at other desired angular locations around theframe32 corresponding to the locations of theleaders50 on the gasket member12 (not shown inFIG. 6; see, e.g.,FIG. 1).
• Thetubular members76 may be formed from a variety of materials, e.g., a section of hypotube, made from metal, such as stainless steel, plastic, or composite materials. Thetubular members76 may be preloaded onto theframe32, e.g., during manufacturing, or loaded onto theframe32 shortly before a procedure. As described further below, thetubular members76 may be removed from theframe32 at any time, e.g., immediately before or after securing thevalve member14 to thegasket member12.
• FIG. 7 shows another embodiment ofintroducers76′ that may be provided directly on thevalve member14. As shown, for example, theintroducers76′ are formed from a piece of fabric orother material78′ attached to the fabric covering thevalve member14, thereby defining a pocket orpassage79′ therethrough. Theintroducers76′ may be a rectangular section of material whose side edges are stitched, bonded, or otherwise attached to the fabric covering or other portion of thevalve member14, or a separate tubular structure. In yet another embodiment, theleaders50 may be introduced through the fabric itself ofvalve member14, e.g., using a needle or other tool (not shown) on the second ends of theleaders50 to “pick up” one or more threads of the fabric. Additional information on introducers or receivers may be found in US 2005/0165479, incorporated by reference herein.
• Turning toFIGS. 5A-5C, during use, theheart valve assembly10 may be implanted within a patient's body, e.g., within or adjacent to abiological annulus90. Thebiological annulus90 may be the site for replacing an existing natural or previously implanted heart valve, such as a tricuspid, mitral, aortic, or pulmonary valve within a patient's heart (not shown).
• Before implanting theheart valve assembly10, the patient may be prepared for the procedure using known methods. For example, the patient may be placed on cardiopulmonary bypass (CPB), and the patient's heart may be exposed, e.g., by sternotomy, thoracotomy, or other open or minimally invasive procedure. An incision may be created in the blood vessel above the valve being replaced (not shown), e.g., the aorta for an aortic valve replacement, in order to access theannulus90. The existing natural or prosthetic heart valve and/or leaflets (also not shown) may be removed from theannulus90 using known methods.
• Aheart valve assembly10, e.g., including agasket member12 and avalve member14, may be selected based upon the anatomy encountered, e.g., having a plurality of lobes, matching the lobes of thebiological annulus90 and/or having a cross-sectional dimension corresponding to the interior cross-section of thebiological annulus90. Optionally, agasket member12 and/orvalve member14 may be selected having a size that is larger than thebiological annulus90. For example, thegasket member12 may have a diameter in its relaxed condition that is slightly larger than thebiological annulus90, e.g., such that thegasket member12 may at least partially dilate thebiological annulus90 upon implantation. In addition or alternatively, thevalve member14 may have a diameter or other cross-section that is substantially larger than thebiological annulus90, e.g., for supra-annular or intra-sinus implantation, which may accommodate the larger size.
• With reference toFIG. 5A, initially thegasket member12 may be restrained in the contracted condition, e.g., by thedelivery tool60. For example, as described above, thegasket member12 may includeleaders50 and thedelivery tool60 may be provided with theleaders50 preloaded into thedelivery tool60. Theleaders50 may be provided initially in a relaxed state, i.e., without subjecting thegasket member12 to any tension or other stress, e.g., to prevent fatigue of components and/or materials of thegasket member12. Immediately before use, the user (e.g., a physician, physician's assistant, nurse, or other medical professional) may actuate thelatch68 to apply tension to theleaders50, e.g., to compress thegasket member12 inwardly to the contracted condition shown inFIG. 5A. Optionally, before compressing thegasket member12, thegasket member12 may be placed in ice water or otherwise chilled, e.g., to “soften” or place theannular ring18 in a martensitic state, as described elsewhere herein. In addition or alternatively, the predetermined tension may pull thegasket member12 onto or around thedistal end63 of thedelivery tool60, thereby stabilizing and/or securing thegasket member12 relative to thedistal end63, e.g., to facilitate introduction into the patient's body. Alternatively, theleaders50 may be pre-tensioned by thedelivery tool60 before use, e.g., during manufacturing, as described above.
• In an alternative embodiment, the user may load theleaders50 into the delivertool60 immediately before the procedure, and then apply the desired tension to compress and/or stabilize thegasket member14. This alternative may be particularly desirable when asingle delivery tool60 is used to deliver one of various sized gasket members available to the user. Thus, once the implantation site is exposed, the physician may measure the size of thebiological annulus90 and select an appropriate gasket member12 (and/or valve member14) based upon the specific anatomy encountered.
• Once constrained in the contracted condition, thegasket member12 may be introduced into the patient's body and advanced into thebiological annulus90, e.g., by directing thedistal end63 of thedelivery tool60 into the patient's body. Thegasket member12 may be advanced until theannular ring18 extends at least partially into thebiological annulus90. In one embodiment, theannular ring18 may extend through thebiological annulus90, i.e., with a lower edge of theannular ring18 disposed within the sub-annular space below thebiological annulus90. Optionally, thegasket member12 may include a flexible skirt (not shown) that may surround and/or extend from theannular ring18 through thebiological annulus90. The skirt may be biased to extend outwardly to provide a smooth transition and/or enhance a seal between thegasket member12 and thebiological annulus90.
• Turning toFIG. 5B, thegasket member12 may then be expanded or at least partially released within thebiological annulus90, e.g., to dilate thebiological annulus90 or otherwise direct the surroundingtissue98 outwardly. For example, thelatch68 on the delivery tool60 (not shown, seeFIG. 2) may be actuated to remove the tension on theleaders50, whereupon theannular ring18 may resiliently expand against the tissue surrounding thebiological annulus90. This may substantially stabilize or secure thegasket member12 relative to thebiological annulus90. Once stabilized, theleaders50 may be released entirely from thedelivery tool60, e.g., by actuating lever66 (not shown, seeFIG. 2). In an alternative embodiment, a dilation tool (not shown) may be advanced into thegasket member12 and expanded to forcibly (e.g., plastically) expand theannular ring18 within thebiological annulus90.
• With theannular ring18 deployed within thebiological annulus90, thesewing cuff20 may contact the tissue surrounding the supra-annular space above thebiological annulus90, as shown inFIG. 5B. One ormore fasteners96, e.g., clips, staples, sutures, and the like, may be directed through thegasket member12 into thetissue98 above and/or surrounding thebiological annulus90. For example, as shown, a plurality ofclips96 may be driven through thesewing cuff20 into the surroundingtissue98, similar to the method shown inFIGS. 14A-14C and described elsewhere herein. Exemplary fasteners and methods for using them to secure thegasket member112 may be found in U.S. Publication Nos. US 2004/0122516, filed as Ser. No. 10/327,821, US 2005/0043760, filed as Ser. No. 10/646,639, US 2005/0080454, filed as Ser. No. 10/681,700, and US 2006/0122634, filed as Ser. No. 11/004,445, the entire disclosures of which are incorporated by reference herein.
• Turning toFIG. 5B, with thegasket member12 within thebiological annulus90, thevalve member14 may then be advanced into the patient's body towards thebiological annulus90. In the embodiment shown, thevalve member14 may be advanced along theleaders50 toward thegasket member12. Before advancing thevalve member14, the second or free ends52 of theleaders50 may be directed through respective portions of thevalve member14. Thus, before advancing thevalve member14, theleaders50 need to be released and/or removed completely from thedelivery tool60, as described above.
• In the exemplary embodiment shown inFIG. 5B, theleaders50 may be directed through respective portions of the fabric covering35, e.g., adjacent thecommissures34. For example, the second ends52 of theleaders50 may include needles (not shown) that may be directed through desired portions of the fabric covering35 to pick up one or more threads. Optionally, thevalve member14 may include receptacles (not shown) attached to theframe32 and/or fabric covering35, and the fabric covering35 may include slits or other openings through which theleaders50 may be introduced to pass theleaders50 through the receptacles, e.g., similar to the embodiments shown inFIGS. 20A-20E andFIGS. 24A-26 and described elsewhere herein.
• Alternatively, as shown inFIG. 6, if thevalve member14 includesintroducers76, the second ends52 of theleaders50 may be backloaded throughrespective introducers76. In a further alternative, shown inFIG. 7, the valve may includereceivers76′ through which theleaders50 may be directed.
• With theleaders50 received through thevalve member14, thevalve member14 may be advanced distally over theleaders50 towards thegasket member12, i.e., in the direction of arrow94, until thevalve member14 engages or otherwise contacts thegasket member12. As shown inFIG. 5B, theleaders50 may include ratcheting orother retention elements54 over which thevalve member14 may pass. For example, theretention elements54 may include tapered proximal edges54a, which may provide a smooth transition that allows theretention elements54 to pass freely through the fabric covering35, receptacles (not shown), orintroducers76,76.′ Because of the blunt distal edges54b, however, thevalve member14 may not be withdrawn back over theretention elements54. Thus, theretention elements54 may allow unidirectional advancement of thevalve member14, i.e., towards thegasket member12.
• In an exemplary embodiment, theretention elements54 may be disposed a predetermined distance from the first ends51 of theleaders50, thereby securing thevalve member14 against or immediately adjacent thegasket member12. The predetermined distance may be set such that theframe32 of thevalve member14 substantially contacts thesewing cuff20, e.g., to at least partially compress the core, which may enhance sealing between thevalve member14 and thegasket member14.
• In addition or alternatively, one or more knots may be directed down theleaders50 after thevalve member14 engages or contacts thegasket member12. In another alternative, if thegasket member12 includes a collar (not shown, see, e.g.,FIG. 8C) extending above thesewing cuff20, the collar may include a drawstring or other connector(s) (also not shown) that may be tightened around theframe32 of thevalve member14 to secure thevalve member14 relative to thegasket member12. In further alternatives, thevalve member14 and/orgasket member12 may include one or more cooperating connectors, e.g., clips, detents, and the like, that may self-engage when thevalve member14 is docked to thegasket member12, similar to the embodiments described in the references incorporated by reference above.
• Turning toFIG. 5C, once thevalve member14 is secured to thegasket member12, theleaders50 may be cut or otherwise severed, thereby providing aheart valve assembly10 implanted within thebiological annulus90. As shown, theleaders50 are severed above theretention elements54 used to secure thevalve member14 to thegasket member12. If theleaders50 are knotted to secure thevalve member14 to thegasket member12, theleaders50 may be severed above the knots. Optionally, theleaders50 may include weakened regions (not shown) above theretention elements54 or otherwise disposed a predetermined distance from the first ends51. When a predetermined tension is applied to the leaders50 (greater than that used to compress and/or secure the gasket member to the delivery tool60), the weakened regions may automatically fail, thereby separating the first ends51 from the remainder of theleaders50, which may then be removed from the patient's body. This alternative may eliminate the need to introduce scissors or other cutting tools into the patient to cut theleaders50. If desired, e.g., in an acute emergency situation or if thevalve member14 is being replaced, the remaining leaders may be cut below theretention elements54 to release thevalve member14, allowing thevalve member14 to be removed from thegasket member12 and/or patient's body.
• With additional reference toFIG. 6, if thevalve member14 includesremovable introducers76, theintroducers76 may be removed from thevalve member14 immediately before, while, or immediately after thevalve member14 is secured to thegasket member12. For example, theintroducers76 may be removed simply by directing theintroducers76 proximally over theleaders50, i.e., out of the fabric or frame of thevalve member14 and over the second ends52 of theleaders50. Alternatively, as shown inFIG. 7, theintroducers76′ may be pockets formed from fabric, metal, or polymeric material, separately attached or integrated with theframe32 and/or fabric covering35 of thevalve member14. In this alternative, theintroducers76′ may interact with theretention elements54 on theleaders50 to prevent removal of thevalve member14 away from thegasket member12.
• Turning toFIGS. 8A and 8B, another embodiment of agasket member112 is shown that includes anannular ring118, asewing cuff120, and a plurality of elongate guide rails orother leaders150 extending from thesewing cuff120 or other portion of thegasket member12, e.g., similar to other embodiments herein. Optionally, thegasket member112 may also include a flexible skirt and/or baleen elements (not shown), e.g., surrounding theannular ring118. A fabric covering may be provided on one or more components of thegasket member112, e.g., over theannular ring118 and over a core of thesewing cuff120, also as described elsewhere herein.
• In addition, thegasket member112 includes a plurality ofguide shields156 removably attached to thegasket member112, e.g., by one or more sutures to thesewing cuff120. The guide shields156 may extend upwardly and/or outwardly from thesewing cuff120, e.g., to at least partially define apassage124 for guiding a valve prosthesis (not shown) downwardly towards thegasket member112, as described further below. In a relaxed condition, the guide shields156 may extend diagonally outwardly from thegasket member112, but may be deflectable radially inwardly towards acentral axis117 of thegasket member112, e.g., during delivery.
• The guide shields156 may be formed from a relatively thin and/or transparent sheet, e.g., a plastic such as polyester or Mylar or any other polymeric film or material, such as high-density or low-density polyethylene, polystyrene, and the like. The sheet may be cut or otherwise formed to include one or more bands, e.g., defining a relatively wide base that may be attached to thegasket member112 and a relatively narrow loose upper end. For example, as shown inFIG. 8A, the guide shields156 may have a generally triangular shape, e.g., with awider base156aand a narrowerupper end156b. Optionally, as shown, a center of the guide shields may be removed to provide diagonal or inverted “V” bands extending from theupper end156bdown to the base156a. Alternatively, the guide shields156 may have a substantially continuous “mandolin” or inverted “Y” shape, as shown inFIG. 8B, and described further in co-pending application Ser. No. 60/914,742, incorporated by reference herein.
• Optionally, the upper ends156bmay include one or more features that partially restrain theguide rails150 away from thepassage124 or otherwise out of the operator's field of view during a procedure. For example, as shown inFIG. 8A, the upper ends156bmay include one ormore bands159 that may be wrapped around theguide rails150 to releasably constrain theguide rails150 to the guide shields156. In addition or alternatively, as shown inFIG. 8B, the upper ends156bmay includeopenings158 that may receive the guide rails150. Optionally, the upper ends156bof the guide shields156 may be split, e.g., at158adown to theopenings158 or diagonally from the openings158 (not shown), to facilitate inserting and/or removing the guide rails into/from theopenings158, as shown inFIG. 8B.
• The guide shields156 may be attached to thesewing cuff120, e.g., by one or more sutures (not shown) sewn through fabric of the sewing cuff120 (and/or other portion of the gasket member12) and holes (also not shown) in the base156a. Optionally, a chain stitch or other stitch may be used, e.g., that may unravel upon being cut at a single location, which may facilitate removing the sutures and, consequently, the guide shields156 after implantation. Additional information on methods for removably attaching the guide shields156 to the gasket member and/or methods for using the guide shields156 may be found in co-pending application Ser. No. 60/914,742, incorporated by reference herein.
• Turning toFIGS. 9A-9C, an exemplary embodiment of agasket delivery tool160 is shown that generally includes anelongate shaft162 including aproximal end161, adistal end163, and anactuator165 on theproximal end161. With additional reference toFIGS. 10A and 10B, thedelivery tool160 includes a plurality ofsupports166 on the distal end, e.g., spaced apart around alongitudinal axis167 of thetool160. Thesupports166 may be substantially rigid cylindrical hubs for receiving a gasket member112 (such as any of those described herein) around thesupports166. Thesupports166 may generally define a diameter that is smaller than thegasket member112, e.g., smaller than the radius of theannular ring118. Thesupports166 may be formed as a single piece, e.g., integrally molded, machined, and the like, or may be separate shafts and/or other components attached to one another and/or thedistal end163 of thegasket delivery tool160. Alternatively, a hub or base having a circular or other multiple lobed shape may be provided instead of thesupports166, if desired.
• In addition, thetool160 includes a plurality ofarms168 movably mounted to thedistal end163. For example, oneend168aof thearms168 may be attached to thedistal end163 of thetool160, e.g., proximal to thesupports166, and the other free end may includetips168bdisposed adjacent thesupports166. As shown, thearms168 may be offset radially relative to thesupports166 such that eacharm168 is disposed betweenadjacent supports166. Thearms168 may be movable from an outer position, e.g., as shown inFIGS. 9A and 9B, defining a radius larger than thegasket member112 to an inner position, e.g., as shown inFIGS. 10A and 10B, wherein thetips168bare disposed between and/or within thesupports166.
• Theactuator165 may include a lever or other mechanism that may selectively move thetips168bof thearms168 between the outer and inner positions. For example, as shown inFIGS. 9A and 9B, theactuator165 may include ahandle165acoupled to asleeve165bvia alinkage165c. Thehandle165amay be biased outwardly, e.g., by aspring165dor other biasing mechanism, thereby maintaining thearms168 in the outer position. Thehandle165amay be directed towards theshaft162, e.g., about pivot point165e, thereby directinglinkage165candsleeve165bdistally, i.e., towards thedistal end163. This action causes thetips168bof thearms168 to move inwardly towards the inner position.
• For example, thearms168 may be deflectable radially inwardly by an inward force applied to thearms168 as thesleeve165bpasses over the first ends168a. Thearms168 may be sufficiently resilient to return outwardly when thesleeve165bis retracted from over the first ends168a. Alternatively, thearms168 may include hinges or other components coupled to thesleeve165band/orlinkage165csuch that thearms168 are movable inwardly and outwardly.
• Thehandle165amay be temporarily locked against theshaft162 with thearms168 in the inner position, e.g., by a lock or other interlocking features (not shown) on thehandle165a,linkage165c, and/orshaft162. For example, thelinkage165cmay include a slot165fand thehandle165amay include a sliding button, switch or other control165gthat includes across pin165hthat may be received in the slot165fwhen thehandle165ais directed against theshaft162. The control165gmay be manually moved to engage and/or disengage thecross pin165hand the slot165f. Optionally, the control165gmay be biased, e.g., towards or away from the end of thehandle165a, for example by a spring (not shown), such that when thehandle165ais directed against theshaft162, thecross pin165hslides into the slot165f, preventing subsequent movement of thehandle165a. The control165gmay be directed against the bias of the spring, e.g., distally or proximally, to release thecross pin165hfrom the slot165f, whereupon thespring165dmay then bias thehandle165aoutwardly. Thus, the slot165fmay be oriented to engage with thecross pin165has the control165gis translated along thehandle165ain a distal or proximal direction, and to release thecross pin165has the control165gis translated in an opposite proximal or distal direction. When it is desired to release thehandle165aandarms168 back to the outer position, the control165gmay be released, whereupon thespring165dmay then bias thehandle165aoutwardly, thereby automatically opening thearms168 towards the outer position. Alternatively, the levers involved may be designed such that the bias of thespring165dis removed when thehandle165ais directed against theshaft162, thereby maintaining thearms168 in the inner position. In this alternative, thehandle165amay simply be pulled away from theshaft162 such that thespring165dagain biases thehandle165ato move outwardly, directing thearms168 to the outer position.
• During use, with thearms168 in the outer position, agasket member112 may be placed between thesupports166 and thearms168, e.g., with the nadir regions of thesewing cuff120 aligned radially with thearms168 and the commissure regions of thesewing cuff120 aligned radially with thesupports166. Thearms168 may then be directed to the inner position, thereby securing thegasket member112 between thesupports166 and thearms168. As shown inFIGS. 10A and 10B, thegasket member112 may be deformed from a generally circular expanded condition to a multiple lobed, e.g., “shamrock” shaped contracted condition defining lobes, similar to the other embodiments and tools described above. Thegasket member112 may be elastically deformed into the contracted condition or plastically deformed, e.g., in a martensitic state, similar to the previous embodiments.
• Turning toFIGS. 11A-11E, during use, thetool160 may be loaded with thegasket member112, as shown inFIG. 11A, and then directed into abiological annulus90, e.g., as best seen inFIG. 11B. As shown inFIG. 11C, thetool160 may be rotated about itslongitudinal axis167 to align the lobes or “ears” of thegasket member112 with the commissures91 of thebiological annulus90. Turning toFIGS. 11D and 11E, thearms168 may then be directed to the outer position, thereby releasing thegasket member112.
• As shown inFIG. 11E, thegasket member112 may resiliently expand towards its original expanded condition when released, thereby contacting tissue surrounding thebiological annulus90. Thetool160 may be removed, leaving thegasket member112 in place within thebiological annulus90. As shown, the annular ring of thegasket member112 may be located within a native valve annulus, while thesewing cuff120 may be located in a supra-annular position relative to the native valve annulus. If thegasket member112 includesguide rails150 and/or guideshields156, theguide rails150 and/or guideshields156 may extend upwardly from thebiological annulus90, e.g., to a location above the biological annulus and/or outside the patient's body, as described elsewhere herein.
• FIG. 12 shows an alternate contracted configuration for thegasket member112, which may be used instead of the multiple lobed or “shamrock” contracted condition shown inFIG. 10A. As shown inFIG. 12, thegasket member112 may be folded into a generally “C” shaped or rolled shape in the contracted condition, rather than the multiple lobed condition. Such a folded condition may be maintained by a tool (not shown), e.g., including one or more arms or other actuatable members (also not shown), similar to thearms168 of thetool160. Alternatively, thegasket member112 may simply held by a needle driver, clamp, or other surgical instrument. Optionally, the folded ends of thegasket member112 may be temporarily secured to one another, e.g., using one or more sutures, a band, and the like (not shown), which may be removed once thegasket member112 is introduced into thebiological annulus90. Upon being released by the tool, thegasket member112 ofFIG. 12 may resiliently unfold or otherwise return back to its original annular shape, similar to when thegasket member112 is released from the multiple lobed condition. The folded condition may allow thegasket member112 to achieve a smaller cross-section than the multiple lobed condition, which may be useful when access is limited into the biological annulus.
• Turning toFIG. 13A, thegasket member112 is shown delivered into thebiological annulus90, e.g., using any of the tools and/or methods described elsewhere herein. The guide shields156 extend upwardly and/or outwardly from thegasket member112, thereby contacting surrounding tissue. The guide shields156 may be sufficiently long such that upper ends of the guide shields156 are disposed outside the patient's body and/or outside thebiological annulus90. Optionally, the upper ends156bof the guide shields156 may be folded outwardly, e.g. against the patient's chest or other anatomy, to maintain a passage through the guide shields156 open and/or move the uppers ends156bout of the field of view. In addition or alternatively, the upper ends156bmay also be held by sutures, clips, clamps, and the like (not shown), e.g., to help tension or retract the guide shields156 in order to maintain the field of view open. The guide shields156 may at least partially define a passage communicating with thebiological annulus90, the inner surfaces of the guide shields156 providing a smooth and/or lubricious surface to facilitate advancing a valve prosthesis (not shown) into thebiological annulus90 towards thegasket member112, as described further elsewhere herein.
• Turning toFIG. 13B, after releasing thegasket member112 within thebiological annulus90, thegasket member112 may be secured to the surrounding tissue. For example, as shown, atool170 may be used to deliver a plurality of fasteners96 (not shown) through thesewing cuff120 and into the surrounding tissue, as described elsewhere herein. Forceps, tweezers, orother tool172 may be used, if desired, to manipulate components of thegasket member112 during delivery of thefasteners96. For example, thetool172 may be used to hold thesewing cuff120 and/or to move theguide rails150 and/or guideshields156 out of the way. Because of the orientation, configuration, and/or transparency of the guide shields156, the guide shields156 may not obscure observation and/or access into the biological annulus to deliver the fasteners.FIGS. 14A-14C show additional details of securing thegasket member112 to the surroundingtissue using fasteners96.
• Turning toFIGS. 15A-17B, avalve holder tool210 is shown that may be used to deliver avalve member14, which may be any valve prosthesis described elsewhere herein or in the references incorporated by reference. For simplicity, only a frame of avalve member14 is shown without leaflets or fabric covering. Generally, thevalve holder210 includes anelongate shaft212 including aproximal end214 and adistal end216 defining alongitudinal axis218 therebetween. As best seen inFIGS. 15B and 17B, thevalve holder210 may include an enlarged head orsupport220 on thedistal end216, which may have a size and/or shape similar to thevalve member14 carried on thedistal end216. For example, thehead220 may have a partial dome shape, e.g., defining a cavity (not shown) under thehead220, which may protect or otherwise cover leaflets (not shown) of thevalve member14. Thehead220 may include one or more openings221 therethrough, e.g., for receiving one ormore sutures13, e.g., as shown inFIG. 17B. As shown, asuture13 may be directed through a respective opening221 and through fabric of thevalve member14, and then tied off and cut, thereby securing thevalve member14 to thehead220. Thereafter, during use, e.g., after implantation, the suture(s)13 may be cut, thereby releasing thevalve member14 from thehead220, as described further below.
• Returning toFIGS. 15A and 15D, thevalve holder210 also includes a plurality oftubular members230 including open upper and lower ends232,233. Thetubular members230 may provide guidepassages230afor receiving guide rails150 (not shown) of a gasket member112 (also not shown), as described further below. Thetubular members230 may be attached to theshaft212 of thevalve holder210, e.g., byhubs234,236, such that thetubular members230 extend generally parallel to thelongitudinal axis218. As shown, thetubular members230 includeupper ends232 that are disposed closer to thelongitudinal axis218 than lower ends233, which may facilitate visually monitoring beyond thetubular members230. Alternatively, thetubular members230 may extend parallel to thelongitudinal axis218. In addition or alternatively, thetubular members230 may be disposed against or otherwise closer to theshaft212, although the distal ends233 may then curve outwardly, e.g., in an “S” shape to dispose the distal ends233 outside thehead220, e.g., as shown inFIG. 15B.
• In addition, thevalve holder210 may include one or more actuators for causing separation of at least a portion of theguide rails150 from thegasket member112, as described further below. For example, in one embodiment, each of thetubular members230 may be rotatable about an individualcentral axis231, as shown inFIG. 15D. Thepassages230athrough thetubular members230 may have a cross-section similar to theguide rails150, e.g., having an oblong or rectangular cross-section, which may receive theguide rails150 in a fixed angular orientation, while accommodating relative axial movement. When thetubular members230 are rotated about, theaxes231, the portion of theguide rails150 in the passages may also rotate, thereby causing theguide rails150 to plastically deform and break, e.g., adjacent thedistal end233 of thetubular members230. Optionally, similar to previous embodiments, theguide rails150 may include weakened regions that may preferentially break upon rotation of thetubular members230. The weakened regions may include a notch, slit, groove, cut, necking, thinning, score mark, and/or narrowing on either or both edges of theguide rails150, across the entire width of theguide rails150, and/or axially or diagonally along the length of the guide rails150. Optionally, a preload force or stress may be applied on theguide rails150 when received within thetubular members230 that is less than the tensile breaking strength of theguide rails150, or, more specifically, less than the tensile breaking strength at the weakened region(s) of the guide rails150. Such a preload may reduce the number of turns of thetubular members230 necessary to break or separate theguide rails150, e.g., by preventing theguide rails150 from twisting, binding, and/or bunching excessively during rotation of thetubular members230. Thus, eachguide rail150 may be separated by rotating the respectivetubular member230.
• Alternatively, theentire hub234 may be rotatable around theshaft210, which may cause all of theguide rails150 to separate substantially simultaneously at the weakened regions or other locations adjacent the distal ends263. In a further alternative, shown inFIGS. 16A and 16B, thevalve holder210 may include anactuator250 that is movable axially relative to theshaft212, e.g., from a distal position (shown inFIG. 16A) to a proximal position (shown inFIG. 16B) for breaking the guide rails.
• For example, as best seen inFIG. 15C, theactuator250 may include anouter housing252 and aninner member256 disposed adjacent thehub234 in the distal position. Theinner member256 may be coupled to ahandle254, e.g., such that axial movement of the handle causes the inner member to move axially. Theouter housing252 may be rotatable relative to theinner member256, e.g., for capturing ends of the guide rails150. The proximal ends232 of thetubular members230 may extend into thehub234 and communicate with one or more recesses or other features, e.g., recess253abetween theouter housing252 and theinner member256. Theouter housing252 and/orinner member256 may include one or more locking features, e.g., hooks, catches, ratchets, and the like, such ascatch253bwithin the recess253athat may receive and/or engage the ends of the guide rails150.
• With theouter housing252 open relative to the inner member, ends of theguide rails150 may be received within the recess253a, e.g., when theguide rails150 are loaded through thetubular members230. Theouter housing252 may then be rotated to engage the ends of theguide rails150, e.g., with the catch(es)253band/or by at least partially closing the recess253ato clamp the ends of theguide rails150, thereby preventing theguide rails150 from being separated from theactuator250. Optionally, similar to the embodiment shown inFIGS. 23A and 23B, the ends of theguide rails150 may include aslot153 that may receive or otherwise engage corresponding hooks, catches, ratchets and the like (not shown) within the recess253aor otherwise provided on theouter housing252 and/orinner member256.
• During use, a portion of theguide rails150 may be received in or otherwise engaged with theactuator250, e.g., when theguide rails150 are loaded through thetubular members230. When theactuator250 is moved from the distal position, shown inFIG. 16A, towards the proximal position, shown inFIG. 16B, e.g., by pulling thehandle254, theguide rails150 may be pulled by thehousing252, thereby causing theguide rails150 to separate at weakened regions or otherwise break, e.g. adjacent the distal ends263 of thetubular members230. Optionally, theactuator250 may include a lock (not shown) to prevent proximal movement of theactuator250 until the lock is released. For example, theactuator250 may be rotated about theshaft212 to engage or disengage a lock between the actuator250 and theshaft212.
• This configuration of thevalve holder tool210 may allow theactuator250 to be located at a distance proximally from thehead220. For example, this may facilitate actuation, allowing the user to actuate thevalve holder210 without having to reach into the biological annulus. In addition, this configuration of thevalve holder tool210 may also allow theactuator250 to be moved a substantial distance away from thehead220 and the implantation site. For example, if theshaft212 were replaced with a flexible catheter, and theguide rails150 were sufficiently long and/or flexible, thevalve holder210 may be used in a percutaneous implantation or other procedure wherein the actuator is located outside the patient's body, while the head220 (andvalve14 thereon) are located within the body at the implantation site, e.g., as disclosed in US 2007/0016288, incorporated by reference herein.
• In another alternative, shown inFIGS. 22A and 22B, avalve holder tool210′ may include a set of cam-lock features258 for securing ends of guide rails150 (not shown, seeFIGS. 23A and 23B) to an actuator250.′ Thevalve holder tool210′ includes anelongate shaft212′ including proximal anddistal ends214,′216,′ a support orhead220′ on thedistal end216,′ and a plurality oftubular members230,′ similar to the previous embodiments. An actuator250′ is slidable on theshaft212,′ e.g., for severing ends ofguide rails150, similar to the previous embodiment. Theactuator250 includes aninner member256′ includingguide channels257a′ that communicate with tracks257b.′ Openings257c′ aboverespective tracks257b′ provide access into thetracks257b,′ if desired. Eachtrack257b′ includes a tab, detent, catch, orother feature257d′ as best seen inFIGS. 23A and 23B that may be received in ahole153 in an end of aguide rail150.
• Each cam-lock258′ includes acap258a′ pivotally mounted to theactuator250′ by a hinge or element, such that thecap258a′ may be moved between an open position, e.g., extending away from theinner member256′ as shown, and a closed position covering arespective track257b′ and/or opening257c′. In addition, each cam-lock258′ includes atab258b′ or other feature that is received in thetrack257b′ when thecap258a′ is moved to the closed position. Thus, aguide rail150 may be directed from atubular member230′ along theguide channel257a′ into thetrack257b,′ e.g., until the catch257c′ is received in thehole153, as shown inFIGS. 23A and 23B. Thecap258a′ may then be closed, thetab258b′ contacting the guide rail to prevent the catch257c′ from being removed from thehole153, thereby securing the end of theguide rail150 to the actuator250.′ Optionally, the hole may be omitted from theguide rail150 and the catch257c′ may have a pointed and/or barbed tip that may embed or penetrate through the end of theguide rail150, e.g., when thecap258a′ is moved to the closed position. Once theguide rails150 are captured in thetracks257b′ by thecaps258a′, theactuator250′ may be subsequently moved proximally or otherwise manipulated to pull the guide rails, e.g., to break the guide rails at weakened regions or elsewhere, similar to the other embodiments described herein.
• Turning toFIGS. 18A-19D, a method is shown for using thevalve holder210 ofFIGS. 15A-17C to deliver avalve14 into a biological annulus. The desired valve14 (which may be any of the embodiments disclosed herein or in the references incorporated by reference herein) may be preloaded onto thehead220 of thevalve holder210 by the manufacturer or the user. Alternatively, a desired size valve (if multiple sizes are available) may be selected and loaded onto thehead220 by the user immediately before or during the procedure, e.g., using one ormore sutures13, as described above. For example, a valve sizer (or a series of progressively larger valve sizers) may be directed into the biological annulus to determine the appropriate size valve prosthesis to be delivered into the biological annulus.
• Before introducing thehead220 andvalve14 into the biological annulus, a gasket member (not shown) may be delivered and/or secured within the biological annulus, e.g., as described above. As can be seen inFIGS. 18A and 18B,guide rails150 and guideshields156 extend out of the biological annulus from the gasket member, which cannot be seen.
• Turning toFIG. 18A, thehead220 of thevalve holder210, carrying thevalve14, may be directed into the biological annulus. Before doing so, theguide rails150 may be loaded into thetubular members230 of thevalve holder210. Eachguide rail150 may be loaded through a feature (not shown) of the valve14 (e.g., as described elsewhere herein) and into thelower end233 of the respectivetubular member230, e.g., until theguide rail150 exits theupper end232 of thetubular member230.
• For example, as shown inFIGS. 20A-20E, thevalve14 may include aframe32 including a plurality of receptacles orother features130 configured to receive theguide rails150 therethrough. Eachreceptacle130 may include acantilever spring132 including a first end supported by thevalve frame32 and a second free end including one ormore detents134. As shown inFIGS. 20A and 20B, thedetents134 may be bent or otherwise formed to at least partially define a track, slot, or other passage136 for receiving aguide rail150 therethrough. Thereceptacle130 may be formed integrally with thevalve frame32, e.g., laser cut or otherwise formed from a Nitinol or other sheet used to make theframe32. Alternatively, other receptacles or connectors may be provided on thevalve14, such as those disclosed in the references incorporated by reference above.
• Returning toFIGS. 18A and 18B, thereceptacles130 of thevalve14 may be aligned with the lower ends233 of respectivetubular members230 on thevalve holder210. Thus, to insert theguide rails150, the ends of theguide rails150 may be passed upwards through thereceptacles130, into the lower ends233 and out the upper ends232 of thetubular members230. Optionally, thevalve14 may include guides or other features (not shown) to facilitate loaded the ends of theguide rails150 into thereceptacles130. For example, the fabric covering thevalve14 may include a slot or other opening that may receive the ends of theguide rails150, and direct theguide rails150 into thereceptacles130. In addition or alternatively, visual markers may be provided on thevalve14, e.g., above or around thereceptacles130, to facilitate inserting theguide rails150 through thevalve14 and intotubular members230.
• Turning toFIG. 18B, as thehead220 andvalve14 are directed into the biological annulus, thevalve14 may slidably contact the guide shields156 extending from the gasket member (not shown). The guide shields156 may thereby provide a substantially smooth and/or lubricious surface, which may facilitate advancing thevalve14 into a narrow or partially obstructed biological annulus.
• As shown inFIG. 18C, theguide rails150 may includemarkers151 at predetermined locations, i.e., known lengths from the gasket member. Themarkers151 may exit the upper ends232 of thetubular members230 when thevalve14 is located immediately adjacent the gasket member. This may provide the user confirmation of the relative location and that thevalve14 may then be secured to the gasket member.
• For example, turning toFIGS. 20C-20E, when thevalve14 is disposed immediately adjacent, the gasket member, theretention elements154 on theguide rails150 may encounter thedetents134 on thecantilever spring132. As shown, theretention elements154 may include tapered upper edges and thedetents134 may include tapered lower edges. Thus, as thevalve14 is directed downwardly, the tapered edges may slide relative to one another, causing thecantilever spring132 to deflect resiliently outward, as shown inFIG. 20D. Once thedetents134 pass below theretention elements154, thecantilever spring132 may return inwardly, thereby capturing thedetents134 below the lockingtabs154. Thedetents134 may include substantially blunt upper edges and theretention elements154 may include substantially blunt lower edges, thereby preventing thevalve14 from being moved subsequently away from the gasket member, similar to the embodiment disclosed in the references incorporated by reference above.
• Turning toFIG. 20E, theguide rails150 may include a weakened region above the lockingtabs154 or may be otherwise severable above the lockingtabs154. For example, theguide rails150 may include one or more holes, thinned regions, and the like (not shown), which may allow theguide rails150 to preferential break at the weakened regions, similar to other embodiments described elsewhere herein.
• With additional reference toFIGS. 18B and 18C, once themarkers151 on theguide rails150 appear from the upper ends232 of thetubular members230, thevalve holder210, andvalve14, may be advanced further distally to secure thevalve14 to the gasket member. As just described with reference toFIGS. 20A-20E, thevalve14 may be advanced to engage thedetents134 with theretention element154. To facilitate this, the user may pull or otherwise subject theguide rails150 to proximal tension, while advancing thevalve holder210 andvalve14 until a “click.” or other audible and/or tactile feedback is provided that confirms that thedetents134 andretention elements154 are engaged. Each set ofdetents134 andretention elements154 may be engaged sequentially or simultaneously.
• Optionally, the valve holder tool may include one or more safety features that prevent final engagement of thevalve14 with the gasket member until the user makes an affirmative decision to complete this step. For example, as shown inFIGS. 22A and 22B, thevalve holder tool210′ includes ahandle270′ and cap274′ that may facilitate manipulation of thevalve holder tool270′ during a procedure. Thecap274′ may be disposed above ahub272′ coupled to theshaft212′ such that thecap274′ may be movable towards thehub272′ to complete deployment of the valve14 (not shown). However, features276′ on thecap274′ may be keyed with an opening (not shown) through thehub272′ such that the user must rotate thecap274′ to align thefeatures276′ with the opening before thecap274′ may be directed towards the hub272.′ In addition, theshaft213′ may include an axial marker or other visual feature that may be used to confirm the orientation of thehead220′ andvalve14 relative to surrounding anatomy.
• After securing thevalve14 to the gasket member, theguide rails150 may then be severed or otherwise separated from the gasket member, e.g., above theretention elements154, as shown inFIG. 20E. Methods for breaking or otherwise severing theretention elements154 are described above. For example, in one embodiment, eachtubular member230 may be rotated to twist theguide rail150 received therein until theguide rail150 breaks at the weakened region. Alternatively, thehub234 may be twisted to break theguide rails150, e.g., substantially simultaneously. In a further alternative, shown inFIGS. 16A and 16B, theactuator250 engaging the ends of theguide rails150 may be pulled proximally, thereby breaking theguide rails150 at their respective weakened regions. In a further alternative, theguide rails150 may be cut or otherwise severed using a tool introduced into the biological annulus.
• Turning toFIG. 19A, the guide shields156 may be removed from thegasket member112 before or after severing the guide rails150. As shown,sutures157 may be looped through individual portions of the sewing cuff (not shown) and guideshields156 that may be cut or otherwise severed. Thesutures157 may then simply unravel or otherwise loosen, allowing the guide shields156 andsutures157 to be removed from the gasket member. Additional information on methods for attaching and removing the guide shields may be found in the references incorporated by reference above.
• Turning toFIG. 19B, thevalve14 may be released from thevalve holder210, e.g., before or after severing theguide rails150 and/or removing the guide shields156. As shown, sutures13 may be cut, thereby releasing thevalve14 from thehead220, and allowing thehead220,valve holder210, and sutures13 to be removed.FIGS. 19C and 19D show thevalve holder210 being separated from thevalve14. As best seen inFIG. 19D, the severed ends of theguide rails150 may extend from the lower ends233 of thetubular members232 when thevalve holder210 is removed, thereby ensuring that theguide rails150 are removed from the patient. In addition or alternatively, thesutures13 may be anchored to a portion of thehead220 orvalve holder210, e.g., when thevalve14 is secured to thehead220. Thus, when thesutures13 are cut to allow thevalve14 to be separated from thehead220, thesutures13 may be remain anchored to thevalve holder210 to avoid having to retrieve individual pieces of thesutures13.
• FIGS. 21A-21D show various views of the implantedvalve14 andgasket member12 with the leaflets of thevalve14 omitted for clarity.
• Turning toFIGS. 24A-26, another exemplary embodiment of avalve member314 is shown that generally includes an annular shaped body orframe332, a plurality ofreceptacles380 attached to theframe332, and one or more valve elements (not shown for simplicity). Thevalve member14 may include a fabric covering (also not shown) covering theframe332,receptacles380, and/or other components of thevalve member14. Thevalve member314 may be included in any of the systems and methods described herein and/or in the references incorporated by reference herein.
• As shown inFIGS. 25A and 25B, theframe332 is an annularhand including commissures334, e.g., at the cusps, andspring tabs370, e.g., at the lobes, similar to other embodiments described herein. Thespring tabs370 may be supported by extensions of theframe332 definingwindows375, e.g., receiving thereceptacles380, as described further below. As shown, eachspring tab370 includes alower end370asubstantially fixed relative to theframe332 and a freeupper end370b, e.g., having a “T” shape. Thus, thefree end370bof thespring tabs370 may be deflectable radially inwardly, but may be resiliently biased to return to the position shown inFIGS. 25A and 2513.
• Turning toFIGS. 24A and 24B, thereceptacle380 may be a unitary body, e.g., injection molded, cast, machined, or otherwise formed from plastic, metal, or composite material. Generally, thereceptacle380 includes amain body382 defining a substantially smoothfront surface382a, as shown inFIG. 24A, and include a plurality of lips orflanges384,385 extending from themain body382. For example, a first set offlanges384 may extend laterally from themain body382 but offset away from thefront surface382, and a second set offlanges385 may extend up and down from themain body382. Thus, the first set offlanges384 may be offset from the second set offlanges385, e.g., for capturing a portion of theframe332 therebetween, as described further below.
• Thereceptacle380 includes achannel386 along a back surface of themain body382 and a pair of lockingtabs388 within thechannel386, as shown inFIG. 24B. Thechannel386 may have sufficient width to receive a guide rail150 (seeFIG. 26) therethrough, e.g., between thetabs388. The lockingtabs388 may include ramped or tapered lower surfaces388aand bluntupper surfaces388b. Optionally, as shown, raised ridges orlips389 may be provided that extends upwardly from theupper surfaces388b, thereby defining pocket behind thelips389 and above theupper surfaces388b.
• Thereceptacle380 may include one or more additional features formed therein, e.g., holes383 for receivingsutures390 or other fasteners therethrough.
• Turning toFIGS. 25A and 25B, areceptacle380 may be attached to theframe332 over each of thespring tabs370, e.g., such that thereceptacle380 is disposed on an outer surface of theframe332. For example, themain body382 of eachreceptacle380 may be compressed to direct the first set offlanges384 closer together and thereceptacle380 may be inserted through thewindow375 around one of thespring tabs370. As themain body382 is inserted through thewindow375, the second set offlanges385 may abut the outer surface of theframe332 while the first set offlanges384 pass through behind theframe332. Themain body382 may then be released, thereby capturing theframe332 between the first and second set offlanges384,385. Optionally,sutures390 may be directed throughholes383 in thereceptacles380 and around the portion of theframe332 defining thewindows375, thereby further securing thereceptacles380 to theframe332.
• Theframe332 may then be covered with fabric, e.g., over thereceptacles380, using similar procedures for assembling valves described elsewhere herein and in the references incorporated by reference herein. Slits or other openings (not shown) may be formed in the fabric covering above and below thereceptacles380, e.g., to provide access to thereceptacles380 during use.
• With thereceptacles380 attached to theframe332, thechannel386 may be spaced apart from theframe332, thereby defining a vertical passage between thereceptacles380 and theframe332, similar to other embodiments described herein.
• Turning toFIG. 26, during use, aguide rail150 may be passed through the passage, i.e., between thereceptacle380 andframe332, e.g., from below. The free of theguide rail150 may pass freely through thechannel386 of thereceptacle380, e.g., exiting out the top of thereceptacle380 andframe332. Asretention elements154 on theguide rails150 enter thechannel386, theretention elements154 may slide along the ramped lower surfaces388aof the lockingtabs388, thereby directing thespring tab370 away from thechannel386 to accommodate theretention elements154 passing over the lockingtabs388. Once theretention elements154 pass over the lockingtabs388, thespring tab370 may resiliently return inwardly, thereby directing theretention elements154 into the pockets defined by thelips389 andupper surfaces388bof the lockingtabs388. Thus, if theguide rail150 is pulled back down out of thereceptacle380, the blunt lower edges of theretention elements154 may engage theupper surfaces388b, thereby preventing removal of theguide rail150. The free end of theguide rail150 above thereceptacle380 may be severed, similar to previous embodiments, e.g., including one or more weakened regions (not shown) above theretention elements154.
• It will be appreciated that elements or components shown with any embodiment herein are exemplary for the specific embodiment and may be used on or in combination with other embodiments disclosed herein.
• While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the scope of the appended claims.

Claims (7)

1-5. (canceled)

6. A method for delivering an annular first prosthesis into a biological annulus, the first prosthesis comprising a plurality of leaders extending therefrom, the method comprising: securing the leaders to a delivery tool such that the first prosthesis is disposed adjacent a distal end of the delivery tool;

applying axial tension to the leaders to compress the first prosthesis inwardly to a contracted condition;

introducing the distal end of the delivery tool into a biological annulus with the first prosthesis in the contracted condition; and

deploying the first prosthesis in the biological annulus such that the prosthesis expands to an enlarged condition.

7. The method ofclaim 6, further comprising securing the first prosthesis to tissue surrounding the biological annulus.

8. The method ofclaim 7, further comprising securing a second valve prosthesis to the first prosthesis after deploying the first prosthesis in the biological annulus.

9. The method ofclaim 7, further comprising advancing the second prosthesis over the leaders towards the first prosthesis before securing the second prosthesis to the first prosthesis.

10. The method ofclaim 6, wherein tissue surrounding the biological annulus is dilated when the first prosthesis is deployed.

11-22. (canceled)

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