US20160235525A1 - Integrated valve assembly and method of delivering and deploying an integrated valve assembly - Google Patents

Abstract

An integrated valve prosthesis includes an anchor stent, a tether component, and a valve component. The anchor stent includes a self-expanding tubular frame member configured to be deployed in the annulus of an aortic valve or the aorta. The valve component includes a valve frame and a prosthetic valve coupled to the valve frame, and is configured to be deployed within the anchor stent. The tether component includes a first end coupled to the anchor stent and a second end coupled to the valve frame. In the delivery configuration, the tether component extends in a first direction from the anchor stent to the valve component, and in the deployed configuration, the tether component extends in a second direction from the anchor stent to the valve component. The second direction is generally opposite the first direction. The tether component may set the location of the valve component relative to the anchor stent.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application claims priority under 35 U.S.C. 119(e) to the benefit of the filing date of U.S. Provisional Application No. 62/115,464 filed Feb. 12, 2015, the contents of which are incorporated herein by reference in their entirety.
FIELD OF THE INVENTION
• Embodiments hereof relate to heart valve prostheses and methods for intraluminally deploying heart valve prostheses, and in particular, to an integrated heart valve prosthesis including an anchor stent connected to a valve component and methods of intraluminally delivering and deploying the integrated valve prosthesis.
BACKGROUND OF THE INVENTION
• Heart valves, such as the mitral, tricuspid, aortic, and pulmonary valves, are sometimes damaged by disease or by aging, resulting in problems with the proper functioning of the valve. Heart valve problems generally take one of two forms: stenosis in which a valve does not open completely or the opening is too small, resulting in restricted blood flow; or insufficiency in which blood leaks backward across a valve when it should be closed.
• Heart valve replacement has become a routine surgical procedure for patients suffering from valve regurgitation or stenotic calcification of the leaflets. Conventionally, the vast majority of valve replacements entail full sternotomy in placing the patient on cardiopulmonary bypass. Traditional open surgery inflicts significant patient trauma and discomfort, requires extensive recuperation times, and may result in life-threatening complications.
• To address these concerns, efforts have been made to perform cardiac valve replacements using minimally-invasive techniques. In these methods, laparascopic instruments are employed to make small openings through the patient's ribs to provide access to the heart. While considerable effort has been devoted to such techniques, widespread acceptance has been limited by the clinician's ability to access only certain regions of the heart using laparascopic instruments.
• Still other efforts have been focused upon percutaneous transcatheter (or transluminal) delivery of replacement cardiac valves to solve the problems presented by traditional open surgery and minimally-invasive surgical methods. In such methods, a valve prosthesis is compacted for delivery in a catheter and then advanced, for example through an opening in the femoral artery and through the descending aorta to the heart, where the prosthesis is then deployed in the valve annulus (e.g., the aortic valve annulus).
• Various types and configurations of prosthetic heart valves are used in percutaneous valve procedures to replace diseased natural human heart valves. The actual shape and configuration of any particular prosthetic heart valve is dependent to some extent upon the valve being replaced (i.e., mitral valve, tricuspid valve, aortic valve, or pulmonary valve). In general, prosthetic heart valve designs attempt to replicate the function of the valve being replaced and thus will include valve leaflet-like structures used with either bioprostheses or mechanical heart valve prostheses. If bioprostheses are selected, the replacement valves may include a valved vein segment or pericardial manufactured tissue valve that is mounted in some manner within an expandable stent frame to make a valved stent. In order to prepare such a valve for percutaneous implantation, one type of valved stent can be initially provided in an expanded or uncrimped condition, then crimped or compressed around a balloon portion of a catheter until it is close to the diameter of the catheter. In other percutaneous implantation systems, the stent frame of the valved stent can be made of a self-expanding material. With these systems, the valved stent is crimped down to a desired size and held in that compressed state within a sheath, for example. Retracting the sheath from this valved stent allows the stent to expand to a larger diameter, such as when the valved stent is in a desired position within a patient.
• While some problems of traditional open-heart surgery are overcome by percutaneous transcatheter (transluminal) methods, there are still risks associated with the method including patient prosthetic mismatch (PPM), para-valvular leakage, and conductance disorders. Many of these potential risks are thought to be aggravated by improper valve placement.
• Patient prosthetic mismatch (PPM) is when an effective prosthetic valve area is less than that of a normal human valve. Despite technical efforts to optimize valve prostheses, their rheological properties are not comparable with those of native human valves and aortic stenosis will occur in a normally functioning prosthesis that is too small for the patient. Patient prosthetic mismatch is associated with decreased regression of left ventricular hypertrophy, reduced coronary flow reserve, increased incidence of congestive heart failure, diminished functional capacity, and increased risk of early and late mortality. Implantation of a prosthetic heart valve at an inaccurate depth is thought to increase the incidence and severity of patient prosthetic mismatch.
• Para-valvular leakage (PVL) is leakage around an implanted prosthetic valve. The effects of para-valvular leakage on patients range from small PVL resulting in valve inefficiency and intravascular hemolysis causing anemia, to large PVL resulting in risk of heart failure and endocarditis. Often, sealing material is secured to the inside or outside of the stent frame to reduce the incidence of PVL, but the sealing material increases overall diameter (crossing profile) of the radially collapsed stent which limits crimping and may limit access through some vessels. Implantation of a prosthetic heart valve at an inaccurate depth is also thought to increase the incidence and severity of para-valvular leakage.
• Conductance disorder is the abnormal progression of electrical impulses through the heart causing the heart to beat in an irregular fashion. The abnormal impulses may exhibit themselves as a mismatch of the electrical signals between sides or top to bottom and may cause symptoms from headaches, dizziness, and arrhythmia to cardiac arrest. Valve prostheses implanted too deep are thought to be more prone to inducing conduction disorders.
• There is a need for devices and methods that allow for reduced crossing profile of a percutaneous transcatheter (transluminal) delivery of replacement heart valves while also providing sealing material to reduce para-valvular leakage (PVL). There is also a need for devices and methods to accurately locate and deploy valve prostheses to minimize para-valvular leakage (PVL), patient prosthesis mismatch (PPM), and conductance disorders in patients undergoing transcatheter valve implantation procedures.
BRIEF SUMMARY OF THE INVENTION
• Embodiments hereof are related to an integrated valve assembly including an anchor stent, a tether component, and a valve component sequentially arranged within a delivery device. The anchor stent includes a self-expanding tubular frame member configured to be deployed in the annulus of an aortic valve. The valve component includes a valve frame configured to be deployed within the tubular frame member of the anchor stent such that the valve frame engages with the attachment members of the tubular frame member and a prosthetic valve coupled to the valve frame. The tether component is a plurality of tethers with a first end of the tether component coupled to the anchor frame and a second end of the tether component coupled to the valve frame. In the delivery configuration, the tether component extends in a first direction from the anchor stent to the valve component, and in the deployed configuration, the tether component extends in a second direction from the anchor stent to the valve component. The second direction is generally opposite the first direction.
• Embodiments hereof are also directed to a method of implanting an integrated valve assembly at a location of a native heart valve. In an embodiment, the integrated valve assembly including an anchor stent, a valve component, and a tether component having a first end coupled to the anchor stent and a second end coupled to the valve component, is advanced in a delivery system in a radially compressed configuration into the annulus of a heart valve. The anchor stent includes a tubular frame member. The anchor stent is deployed in the annulus of the heart valve such that the tubular frame member expands from the radially compressed configuration to a radially expanded configuration engaging an inner wall surface of the annulus. Next, the tether component is exposed from the delivery system. The delivery system is advanced through the lumen of the anchor stent, effectively flipping the direction of the tether component. Accordingly, whereas the tether component in the delivery system initially extends in a first direction from the anchor stent towards the valve component, once flipped, the tether component extends in a second direction generally opposite from the first direction from the anchor stent towards the valve component. The delivery device is advanced until the tether component is taut. Tautness of the tether component correctly positions the valve component for deployment within the anchor stent. The valve component is then deployed. The valve component includes a valve frame and a prosthetic valve coupled to the valve frame. The valve component is deployed at the native aortic valve such that the valve frame expands from a radially compressed configuration to a radially expanded configuration with a proximal portion of the valve frame engaging an inner surface of the anchor stent.
• In another embodiment, an integrated valve assembly includes an anchor stent, a valve component, a tether component, and a skirt. The tether component includes a first end coupled to the anchor stent, and a second end coupled to the skirt. The skirt has a first end coupled to the tether component and a second end coupled to the valve component. The integrated valve assembly is advanced in a radially compressed configuration into the aorta. The anchor stent includes a tubular frame member and a proximal arm component extending from a proximal end of the tubular frame member. The proximal arm component is deployed such that the proximal arm component expands from a radially compressed configuration to the radially expanded configuration engaging the inner wall surface of the aortic sinuses. The anchor stent is advanced until the proximal arm component bottoms at the nadir of the aortic valve leaflets. The anchor stent is deployed in the aorta near the sinotubular junction such that the tubular frame member expands from the radially compressed configuration to a radially expanded configuration engaging an inner wall surface of the ascending aorta. The tether component and skirt are released from the delivery system. The delivery system with the valve component disposed therein is advanced through the lumen of the anchor stent, effectively flipping the direction of the tethers and skirt. Accordingly, whereas the tether component and the skirt initially extend in a first direction from the anchor stent towards the valve component, once flipped, the tethers and skirt extend in a second, and generally opposite direction from the anchor stent towards the valve component. The delivery system is advanced until the tether component and the skirt are taut. Tautness of the tether component and the skirt correctly positions the valve component for deployment within the annulus of the native valve. The valve component includes a valve frame and a prosthetic valve coupled to the valve frame. The valve component is deployed at the native aortic valve such that the valve frame expands from a radially compressed configuration to a radially expanded configuration with a proximal portion of the valve frame engaging the native aortic annulus and a distal portion of the valve frame engaging an inner surface of the anchor stent.
BRIEF DESCRIPTION OF DRAWINGS
• The foregoing and other features and advantages of the invention will be apparent from the following description of embodiments hereof as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the invention and to enable a person skilled in the pertinent art to make and use the invention. The drawings are not to scale.
• FIG. 1 is a schematic illustration of a prior art stented valve prosthesis.
• FIG. 2 is a schematic illustration of the prior art stented valve prosthesis ofFIG. 1.
• FIG. 3 is a schematic illustration of an integrated prosthesis assembly in accordance with an embodiment hereof.
• FIGS. 3A and 3B are a schematic cross-sectional illustrations of embodiments of an anchor stent with filler material on an inside surface or outside surface thereof.
• FIG. 4 is a schematic illustration of an integrated prosthesis assembly in accordance with another embodiment hereof.
• FIGS. 5-11, and 11A are schematic illustrations of an embodiment of a method for delivering and deploying the integrated prosthesis assembly ofFIG. 3 at an aortic valve with the anchor stent deployed in the annulus.
• FIG. 12 is a schematic illustration of the integrated valve prosthesis assembly ofFIG. 4 deployed at an aortic valve according to the method ofFIGS. 5-11A.
• FIG. 13 is a schematic illustration of the integrated valve prosthesis assembly ofFIG. 4 deployed at an aortic valve with the skirt component everted.
• FIG. 14 is a schematic illustration of an integrated valve assembly in accordance with another embodiment hereof.
• FIG. 14A is a schematic illustration of an anchor stent of the integrated valve assembly ofFIG. 14.
• FIG. 15 is a schematic illustration of a distal portion of a delivery device with the integrated valve assembly ofFIG. 14 disposed therein.
• FIGS. 16-23 are schematic illustrations of an embodiment of a method for delivering and deploying the integrated valve assembly ofFIG. 14 at an aortic valve with the anchor stent deployed in the aorta.
DETAILED DESCRIPTION OF THE INVENTION
• Specific embodiments of the present invention are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. The terms “distal” and “proximal” when used in the following description to refer to a catheter or delivery system are with respect to a position or direction relative to the treating clinician. Thus, “distal” and “distally” refer to positions distant from or in a direction away from the clinician and “proximal” and “proximally” refer to positions near or in a direction toward the clinician. When the terms “distal” and “proximal” are used in the following description to refer to a device to be implanted into a vessel, such as an anchor stent or valve component, they are used with reference to the direction of blood flow from the heart. Thus, “distal” and “distally” refer to positions in a downstream direction with respect to the direction of blood flow and “proximal” and “proximally” refer to positions in an upstream direction with respect to the direction of blood flow.
• FIGS. 1 and 2 show an exemplary conventional valve prosthesis similar to the Medtronic CoreValve® transcatheter aortic valve replacement valve prosthesis and as described in U.S. Patent Application Publication No. 2011/0172765 to Nguyen et al. (hereinafter “the '765 publication”), which is incorporated by reference herein in its entirety. As shown inFIGS. 1 and 2,valve prosthesis100 includes anexpandable frame102 having avalve body104 affixed to its interior surface, e.g., by sutures.Frame102 preferably comprises a self-expanding structure formed by laser cutting or etching a metal alloy tube comprising, for example, stainless steel or a shape memory material such as nickel titanium. The frame has an expanded deployed configuration which is impressed upon the metal alloy tube using techniques known in the art.Valve body104 preferably comprises individual leaflets assembled to a skirt, where all of the components are formed from a natural or man-made material, including but not limited to, mammalian tissue, such as porcine, equine or bovine pericardium, or a synthetic or polymeric material.
• Frame102 in the exemplary embodiment includes anoutflow section106, aninflow section110, and aconstriction region108 between the inflow and outflow sections.Frame102 may comprise a plurality of cells having sizes that vary along the length of the prosthesis. When configured as a replacement for an aortic valve,inflow section110 extends into and anchors within the aortic annulus of a patient's left ventricle andoutflow section106 is positioned in the patient's ascending aorta.Frame102 also may includeeyelets130 for use in loading theheart valve prosthesis100 into a delivery catheter.
• Valve body104 may include askirt121 affixed to frame102, andleaflets112,114,116.Leaflets112,114,116 may be attached along their bases to skirt121, for example, using sutures or a suitable biocompatible adhesive. Adjoining pairs of leaflets are attached to one another at their lateral ends to formcommissures124,126,128, withfree edges118,120,122 of the leaflets forming coaptation edges that meet in an area of coaptation, as described in the '765 application and shown inFIG. 2 hereof.
• The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Although the description of the invention is in the context of transcatheter aortic valve implantation, the invention may also be used in any other body passageways where it is deemed useful. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description.
• Embodiments hereof are related to an integrated valve assembly including an anchor stent, a tether component, and a valve component assembled and connected together outside the human body. The tether component may be a plurality of tethers, a cylindrical skirt or a combination of thereof.
• In an embodiment shown inFIG. 3, anintegrated valve assembly300 includes ananchor stent210, atether component301 and avalve component240.Valve component240 is sized and shaped to fit within a lumen ofanchor stent210, andanchor stent210 is designed to deploy within the annulus of a heart valve, as described in more detail below.
• Anchor stent210 includes aframe212 having aproximal end216 and adistal end214, as shown inFIG. 3.Frame212 is a generally tubular configuration having alumen213.Frame212 is a stent structure as is known in the art.Frame212 may be self expanding or may be balloon expandable. Generally,frame212 includes a first, radially compressed configuration for delivery and a second, radially expanded or deployed configuration when deployed at the desired site. In the radially expanded configuration,frame212 may have a diameter in the range of 23 to 29 millimeters for use in the aortic annulus. However, it is recognized thatframe212 may have a smaller or larger expanded diameter depending on the application. Further, the unrestrained expanded diameter of self-expanding frames, such asframe212, is generally about 2-5 millimeters larger than the diameter of the location in which the frame is to be installed, in order to create opposing radial forces between the outward radial force of the frame against an inward resisting force of the vessel.
• Anchor stent210 may include afiller material211 on an outside213 surface ofanchor stent210, as shown inFIG. 3A, or the inside surface215 ofanchor stent210, as shown inFIG. 3B, or both surfaces (not shown).Filler material211 may be any anti-para-valvular leakage material suitable for the purposes described herein, such as, but not limited to, polyethylene terephthalate (PET), tissue (including porcine or bovine pericardium), or other biocompatible materials. The material may be woven or knitted.Filler material211 may be secured to anchorstent210 by methods such as, but not limited to, adhesives, sutures, laser or ultrasonic welding, or any other methods suitable for the purposes described herein.
• Tether component301 includes a plurality oftethers302 as shown inFIG. 3. The embodiment ofFIG. 3 shows three (3) tethers302, however, it is understood that more orfewer tethers302 may be provided depending on the specific requirements of the components, devices, and procedures being utilized.Tether component301 has afirst end304 coupled toanchor stent210, asecond end306 coupled tovalve component240, and a length that provides proper location placement ofvalve component240 at the implantation site, as described in greater detail below.Tethers302 are elongated members such as wires or sutures and may be constructed of materials such as, but not limited to, stainless steel, Nitinol, nylon, polybutester, polypropylene, silk, and polyester or other materials suitable for the purposes described herein.Tethers302 may be connected to anchorframe212 andvalve frame242 by methods such as, but not limited to fusing, welding, sutures or otherwise tied.
• Valve component240 includes aframe242 and aprosthetic valve250.Frame242 is a generally tubular configuration having aproximal end246, adistal end244, and alumen243 there between.Frame242 is a stent structure as is known in the art, and may be self-expanding or balloon expandable. Generally,frame242 includes a first, radially compressed configuration for delivery and a second, radially expanded or deployed configuration when deployed at the desired site. In the radially expanded configuration,frame242 may have a diameter in the range of 23 to 31 millimeters. However, it is recognized thatframe242 may have a smaller or larger expanded diameter depending on the application. Further, the unrestrained expanded diameter of self-expanding frames, such asframe242, is generally about 2-5 millimeters larger than the diameter of the location in which the frame is to be installed, in order to create opposing radial forces between the outward radial force of the frame against an inward resisting force of the vessel. In the embodiment shown,distal end244 has a larger expanded diameter thanproximal end246, similar tovalve prosthesis100 shown inFIGS. 1-2. However,frame242 is not limited to such a configuration, and instead may have proximal and distal ends with similar expanded diameters. Further,frame242 may have a smaller or larger expanded diameter depending on the application.Valve component240 is configured to be disposed such thatprosthetic valve250 is disposed approximately at the location of the native aortic valve.
• As explained briefly above and in more detail below,integrated valve assembly300 includesanchor stent210,tether component301, andvalve component240.Anchor stent210 is configured to be disposed in the annulus of the aortic valve.Valve component240 is configured to be disposed such thatprosthetic valve250 is disposed approximately at the location of the native aortic valve withproximal end246 offrame242 separating the valve leaflets of the native aortic valve.Proximal end246 offrame242 extends intolumen213 offrame212 ofanchor stent210 and is held in place by the outward radial force offrame242 and frictional forces betweenframe242 ofvalve component240 and frame212 ofanchor stent210. Further, an inner surface offrame212 and/or an outer surface offrame242 may include locking features such as barbs, anti-migration tabs or other devices known to those skilled in the art to interconnect withanchor frame212 and/orfiller material211
• FIG. 4 shows another embodiment of anintegrated valve assembly320 includinganchor stent210, atether component321 comprising acylindrical skirt322, and avalve component240.Anchor stent210 andvalve component240 may be as described above with respect to the embodiment ofFIG. 3.Skirt322 has afirst end324 coupled toanchor stent210, asecond end326 coupled tovalve component240, and a length that provides proper placement ofvalve component240 at the implantation site, as described in greater detail below.Skirt322 is a cylindrical tube constructed of cloth or fabric material. The fabric may comprise any suitable material including, but not limited to, woven polyester such as polyethylene terephthalate, polytetrafluoroethylene (PTFE), tissue (such as porcine or bovine pericardium, or other biocompatible materials.Skirt322 is secured to anchorframe212 andvalve frame242 in a manner such as, but not limited to sutures, laser or ultrasonic welding, or other methods suitable for the purposes disclosed herein.
• While embodiments ofFIGS. 3 and 4 provide possible configurations for a tether component, they are not meant to limit the component to these configurations, and other materials, shapes, and combinations of skirts and/or tethers may be utilized. For example, and not by way of limitation, a skirt may be attached to an inside surface or outside surface of the tethers, or the tethers and the skirt may be connected sequentially. For example, and not by way of limitation, the tethers may be attached to the anchor stent and to the skirt with the skirt attached to the tethers and to the valve component.
• FIGS. 5-11 and 11A schematically represent a method of delivering and deploying an integrated valve assembly in accordance with an embodiment hereof.FIGS. 5-11A describe the method with respect tointegrated valve assembly300 ofFIG. 3.FIGS. 5-11A are not drawn to scale regarding relative lengths ofanchor stent210 andvalve component240.
• FIG. 5 shows aguidewire502 advanced distally, i.e., away from the clinician, through theaorta400 into theaortic sinuses412 in the region of theaortic valve414.Guidewire502 may be introduced through an opening or arteriotomy through the wall of femoral artery in the groin region of the patient by methods known to those skilled in the art, such as, but not limited to, the Seldinger technique.Guidewire502 is advanced into the descending (or abdominal)aorta406, theaortic arch404, and the ascendingaorta402, as shown inFIG. 5.FIG. 5 also shows three branch arteries emanating fromaortic arch404. In particular, the innominate orbrachiocephalic artery416, the left commoncarotid artery418, and the leftsubclavian artery420 emanate fromaortic arch404. Thebrachiocephalic artery416 branches into the right common carotid artery and the right subclavian artery. AlthoughFIGS. 5-11A show a retrograde percutaneous femoral procedure, it is not meant to limit the method of use and other procedural methods may be used. For example, and not by way of limitation, retrograde percutaneous implantation via subclavian/axillary routes, direct apical puncture, and the use of direct aortic access via either ministernotomy or right anterior thoracotomy may also be used.
• FIG. 6 shows adelivery system500 for deliveringintegrated valve assembly300 being advanced distally, i.e., away from the clinician, overguidewire502 to a location in theannulus415 ofaortic valve414.Delivery system500 may be any suitable delivery system for delivering stents and/or stent grafts. In the embodiment shown schematically,anchor stent210 is a self-expanding stent,tether component301 is a plurality of tethers, andvalve frame242 ofvalve component240 is a self-expanding stent. Accordingly,delivery system500 generally includes an inner orguidewire shaft508 which includes a guidewire lumen for receivingguidewire502. A proximal end ofguidewire502 may be backloaded into the guidewire lumen ofinner shaft508 through a distal opening ininner shaft508.Delivery system500 may be an over-the-wire type catheter, or a rapid exchange catheter, or other catheter devices.Delivery system500 further generally may include adistal tip501, anouter sheath504 that maintainsanchor stent210 andvalve component240 in the radially compressed or delivery configuration during intraluminal delivery through the vasculature, as shown inFIG. 6 and may also include a pusher orstopper506, and other features.Delivery system500 and/oranchor stent210 may also include, for example, radiopaque markers such that the clinician may determine whendelivery system500 and/oranchor stent210 is in the proper location for deployment.
• Oncedelivery system500 has been advanced to the desired location, such as whenproximal end216 of anchor stent is generally aligned withannulus415,outer sheath504 is retracted proximally, i.e., towards the clinician, as shown inFIG. 7. Asouter sheath504 is retracted,anchor frame212 ofanchor stent210 expands radially outward, engaging the inner wall ofannulus415 ofaortic valve414, as shown inFIG. 7.
• Outer sheath504 is further retracted proximally, i.e., towards the clinician, to deploytether component301 fromouter sheath504. In other words,sheath504 is retracted such thattether component301 is no longer constrained bysheath504.FIG. 7 showstethers302 deployed distal ofanchor stent210 and extending in a first direction520 fromanchor stent210 towardvalve frame242.
• Withouter sheath504 retracted such thatanchor stent210 is deployed at theannulus415 andtethers302 are released fromouter sheath504,delivery system500 is advanced distally, i.e., away from the clinician, throughlumen213 ofanchor frame212, pullingtethers302 intolumen213, effectively flipping the direction oftethers302. Accordingly, whereastethers302 inFIG. 7 extend in a first direction520 fromanchor stent210 towardsvalve component240,tethers302 inFIGS. 8-9 extend in a second direction522 fromanchor stent210 towardsvalve component240. Second direction522 is generally opposite first direction520. The term “generally opposite” with respect to directions described herein and terms similar thereto, as used herein, is not so narrow as to mean 180 degrees difference in direction. Instead, the term “generally opposite” with respect to direction means that a component includes a vector component in the first direction, the direction which is generally opposite includes a vector component in the opposite direction. Thus, thetethers302 in the first direction520 may be within 45 degrees of the first direction520 and the second, generally opposite direction may be within 135 degrees to 225 degrees of the first direction520. Withdelivery system500 advanced intolumen213 ofanchor stent210,tethers302 reside withinlumen213 ofanchor frame212.Delivery system500 is advanced untiltethers302 are taut. Tautness oftethers302 correctly positionsvalve component240 for deployment withinanchor stent210, as shown inFIGS. 8-9.Anchor stent210 is shown with dotted lines for clarity of illustration inFIGS. 8-11A.
• Withtethers302 taut andvalve component240 in proper alignment withanchor stent210,sheath504 is further retracted proximally, i.e., towards the clinician, andvalve component240 is deployed and expands radially outward, engaging the inner wall of theanchor frame212 andsinotubular junction413, as shown inFIGS. 10-11A. With integratedvalve prosthesis assembly300 fully deployed,delivery system500 and guidewire502 may be retracted proximally, i.e., towards the clinician, and removed in a manner consistent with current procedures know to those in the art.Integrated valve prosthesis300 remains in the fully deployed configuration as shown in a close-up view ofFIG. 11A.
• WhileFIGS. 7-11A show the embodiment ofFIG. 3 withtether component301 as a plurality oftethers302, the method above would be equally applicable to the embodiment ofFIG. 4 withskirt322.FIG. 12 shows integratedvalve prosthesis320 includingskirt322 deployed by the method as described with respect toFIGS. 5-11A.
• In another embodiment,integrated valve prosthesis320 ofFIG. 4 may be deployed such thatskirt322 everts and is folded proximal ofanchor stent210, as shown inFIG. 13. In such an embodiment, rather than the tautness ofskirt322 locatingvalve component240,valve component240 may be located by conventional methods such as, but not limited to, x-ray fluoroscopy, ultrasound imaging, electromagnetic tracking, or other methods suitable for the purposes disclosed herein. In order to deployskirt322 as shown inFIG. 13, the steps shown inFIGS. 5-7 are as described with respect to those figures. Afterskirt322 is deployed as shown inFIG. 7 with respect totethers302,delivery system500 is advanced distally. However, due to the length ofskirt322,delivery system500 andskirt322 extend through and beyondanchor stent210.Delivery system500 is then retracted such thatproximal end246 ofvalve component240 is disposed withinanchor stent210 andskirt322 folds as shown inFIG. 13. The remaining steps for deployingvalve component240 are as described with respect toFIGS. 10-11.
• The close-up views described above show lateral gaps between the different parts which are disposed adjacent to each other. These gaps are shown for clarity such that the different parts of the integrated valve prosthesis and the heart valve may be seen. It is understood than many of these parts will abut directly against each other due to the radially outward forces ofanchor stent210 andvalve frame242.
• FIG. 14 shows schematically another embodiment of anintegrated valve assembly600 including ananchor stent610, a plurality oftethers602, askirt608, and avalve component640.Valve component640 is sized and shaped to fit within a lumen ofanchor stent610, andanchor stent610 is designed to deploy in the aorta, as described in more detail below.
• Anchor stent610 includes aframe612 having aproximal end616 and adistal end614, and aproximal arm component620 extending proximally fromproximal end616 offrame612, as shown inFIG. 14.Frame612 is a generally tubular stent structure having alumen613, as described previously.Frame612 may be self-expanding or may be balloon expandable. Generally,frame612 includes a first, radially compressed configuration for delivery and a second, radially expanded or deployed configuration when deployed at the desired site. In the radially expanded configuration,frame612 may have a diameter in the range of 23 to 31 millimeters. However, the expanded diameter may be a smaller or larger depending on the application. Further, as known those skilled in the art, the unrestrained expanded diameter of self-expanding frames, such asframe612, is generally about 2-5 millimeters larger than the diameter of the vessel in which the frame is to be installed, in order to create opposing radial forces between the outward radial force of the frame against an inward resisting force of the vessel.
• Proximal arm component620 extends proximally fromproximal end616 offrame612. In the embodiment shown inFIG. 14,proximal arm component620 includes afirst arm622, asecond arm624, and athird arm626. In the embodiment shown inFIG. 14, eacharm622,624,626 is in the form of a wire loop with first and second ends of the wire attached to frame612. In particular,first arm622 includes first and second ends attached to frame612 atconnections632,633 respectively, as shown inFIG. 14A. Similarly,second arm624 includes first and second ends attached to frame612 atconnections628,629, respectively, andthird arm626 includes first and second ends attached to frame612 atconnections630,631, respectively.Connections628,629,630,631,632,633 may be formed by the material of the arms and frame612 fused or welded together. Alternatively, the connections may be mechanical connections such as, but not limited to, sutured or otherwise tied, a crimp connector to crimp ends of the arms to frame612, or other suitable connections.Proximal arm component620 includes a radially compressed configuration for delivery to the treatment site and a radially expanded or deployed configuration. In the radially expanded configuration, proximal arm component has a diameter in the range of 29 to 39 mm. However, the diameter may be smaller or larger depending on the application. As shown inFIG. 14, in the radially expanded configuration,arms622,624, and626 flare outwardly fromproximal end616 offrame612. Althoughproximal arm component620 has been shown as having three arms with connections approximately equally spaced around the circumference offrame612, more or fewer arms may be utilized, and the arms need not be equally spaced around the circumference offrame612.
• The embodiment ofFIG. 14 shows three (3) tethers602, however, it is understood that more orfewer tethers602 may be provided depending on the specific requirements of the components, devices and procedures being utilized.Tethers602 have afirst end604 coupled toanchor stent610, asecond end606 coupled toskirt608, and a length that provides proper location placement ofvalve component640 at the implantation site, as described in greater detail below.Tethers602 are elongated members such as wires or sutures and may be constructed of materials such as, but not limited to, stainless steel, Nitinol, nylon, polybutester, polypropylene, silk, and polyester or other materials suitable for the purposes described herein.Skirt608 includes afirst end609 connected totethers602 and asecond end607 connected tovalve component640. In the embodiment shown,skirt608 is a cylindrical tube constructed of cloth or fabric material. The fabric may comprise any suitable material including, but not limited to, woven polyester such as polyethylene terephthalate, polytetrafluoroethylene (PTFE), or other biocompatible material.Tethers602 may be connected to anchorstent610 by tying, fusion, or other connectors that permittethers602 to move as described below. Similarly,skirt608 may be attached tovalve component640 using sutures or other connectors that permitskirt608 to move relative tovalve component640, as described below.Tethers602 may be attached to skirt608 be tying or suturingtethers602 to skirt608, or by other connectors suitable for the purposes described herein. Additionally, thetethers602 may be tied at afirst end604 coupled toanchor stent610, tied to a second point on theend606 of theskirt608, and tied to athird point607 onvalve component640.
• While the embodiment ofFIG. 14 provides a possible configuration fortethers602 andskirt608, it is not meant to limit the component to this configuration, and other materials, shapes and combinations of skirts and/or tethers may be utilized depending on the application.
• Valve component640 includes aframe642 and aprosthetic valve650.Frame642 is a generally tubular configuration having aproximal end646, adistal end644, and a lumen643 there between.Frame642 may be a stent structure as is known in the art.Frame642 may be self-expanding or may be balloon expandable. Generally,frame642 includes a first, radially compressed configuration for delivery and a second, radially expanded or deployed configuration when deployed at the desired site. In the radially expanded configuration,frame642 may have a diameter in the range of 23 to 31 millimeters. In the embodiment shown inFIG. 14,distal end644 andproximal end646 offrame642 have different diameters, similar tovalve prosthesis100 shown inFIG. 1. However,distal end644 andproximal end646 may instead have similar expanded diameters. Further, the diameter may be larger or smaller than the range provided above depending on the application.Valve component640 is configured to be disposed such thatprosthetic valve650 is disposed approximately at the location of the native aortic valve.
• As explained briefly above and in more detail below,integrated valve assembly600 includesanchor stent610,tethers602,skirt608, andvalve component640.Anchor stent610 is configured to be disposed in the aorta, withproximal arm component620 extending into the aortic root or aortic sinuses.Valve component640 is configured to be disposed such thatprosthetic valve650 is disposed approximately at the location of the native aortic valve withproximal end646 offrame642 separating the valve leaflets of the native aortic valve.Distal end644 offrame642 extends intolumen613 offrame612 ofanchor stent610 and is held in place by the outward radial force offrame642 and frictional forces betweenframe642 of valve component and frame612 ofanchor stent610. Further, an inner surface offrame612 and/or an outer surface offrame642 may include locking features such as barbs, anti-migration tabs or other devices known to the art to interconnect withanchor frame612. For example, and not by way of limitation,barbs611 shown inFIG. 14A may extend from an inner surface ofanchor stent610. Further,proximal arm component620 provides support foranchor stent610 within the aortic sinuses, as described in more detail below.
• FIGS. 15-23 schematically represent a method of delivering and deployingintegrated valve assembly600 in accordance with an embodiment hereof.FIGS. 15-23 are not drawn to scale.
• FIG. 15 shows a distal portion of anexemplary delivery system700 to deliver and deployintegrated valve prosthesis600.Delivery system700 may be similar to other delivery devices for delivery and deployment of valve prostheses. Accordingly, the proximal portion ofdelivery system700 is not described herein, but may included features such as handles and knobs to advancedelivery system700, retractsheath704, andrelease valve component640 fromhub705.Delivery system700 may include, among other features, an inner orguidewire shaft708 which includes a guidewire lumen for receiving aguidewire702, adistal tip701, anouter sheath704 defining acapsule703, and ahub705. A proximal end ofguidewire702 may be backloaded into the guidewire lumen ofinner shaft708 through adistal opening tip701.Delivery system700 may be an over-the-wire type catheter, or a rapid exchange catheter, or other known catheter devices.Outer sheath704 maintainsanchor stent610 andvalve component640 in the radially compressed or delivery configuration during intraluminal delivery through the vasculature, as shown inFIG. 15.Hub705 may include grooves or other features to mate withtabs641 disposed at a distal end ofvalve component640.Hub705 andtabs641 may be features as described, for example and not by way of limitation, in U.S. Patent Application Publication Nos. 2011/0264203; 201/0251675; 2011/0098805; 2010/0049313; and 2009/0287290; and in U.S. Pat. Nos. 8,398,708; 8,052,732; and 6,267,783, each of which is incorporated by reference herein in its entirety. However,delivery system700 may include different features to retain and subsequently releasevalve component640. Further,delivery system700 may alternatively include a pusher or stopper as described above with respect todelivery system500.Delivery system700 may also include other features known to those skilled in the art.Delivery system700 and/oranchor stent610 may also include, for example, radiopaque markers such that the clinician may determine whendelivery system700 and/oranchor stent610 is in the proper location for deployment.
• As described previously with respect toFIG. 5, aguidewire702 is advanced distally, i.e., away from the clinician, through theaorta400 into theaortic sinuses412 in the region of theaortic valve414.Guidewire702 may be introduced through an opening or arteriotomy through the wall of femoral artery in the groin region of the patient by methods known to those skilled in the art, such as, but not limited to, the Seldinger technique.Guidewire702 is advanced into the descending (or abdominal)aorta406, theaortic arch404, and the ascendingaorta402. AlthoughFIGS. 15-23 show a retrograde percutaneous femoral procedure, it is not meant to limit the method of use and other procedural methods may be used. For example, and not by way of limitation, retrograde percutaneous implantation via subclavian/axillary routes, direct apical puncture, and the use of direct aortic access via either ministernotomy or right anterior thoracotomy may also be used.
• Delivery system700 is advanced overguidewire702, as shown inFIG. 16. Oncedelivery system700 has been advanced to the desired location, such as whenproximal end616 of anchor stent is generally aligned with thesinotubular junction413,outer sheath704 is retracted proximally, i.e., towards the clinician, as shown inFIG. 17. Asouter sheath704 is retracted,proximal arm component620 expands radially outward, as shown inFIG. 17.Delivery system700 is then advanced distally, i.e., away from clinician, untilproximal arm component620 bottoms at the nadir of the aortic valve leaflets117, as shown inFIG. 18.
• Next,anchor stent610 is deployed in the aorta near thesinotubular junction413 by further retracting proximally, i.e., towards the clinician,outer sheath704 such thattubular frame member612 expands from the radially compressed configuration to a radially expanded configuration engaging an inner wall surface of the ascending aorta, as shown inFIG. 19.
• Althoughproximal arm component620 is shown inFIGS. 18-23 as havingarms622,624,626 extending to an area near the base ofleaflets414, those skilled in the art would recognize thatarms622,624,626 may be shorter such that they engage thesinuses412 at a location nearer tosinotubular junction413 than shown inFIGS. 18-23.
• As can be seen inFIG. 19,proximal arm component620 is in the radially expanded configuration such that it flares outwardly fromframe612 and engages theaortic sinuses412, andframe612 is in the radially expanded configuration such that it engages the inner wall of the ascendingaorta402.
• Outer sheath704 is further retracted proximally, i.e., towards the clinician, to deploytethers602 and skirt608 fromouter sheath704, as shown inFIG. 20. As shown inFIG. 20,tethers602 andskirt608 are disposed distal ofanchor stent610 and are not constrained bysheath704.Tip701 may then be retracted to near the distal end ofsheath704, as shown inFIG. 20.
• Withouter sheath704 retracted such thatanchor stent610 is deployed in theaorta400 andtethers602 andskirt608 are released fromouter sheath704,delivery system700 is advanced distally, i.e., away from the clinician, throughlumen613 ofanchor frame612, pullingskirt608 andtethers602 throughlumen613, effectively flipping the direction oftethers602 andskirt608. Accordingly, whereastethers602 andskirt608 inFIGS. 19-20 extend in afirst direction720 fromanchor stent610 towardsvalve component640,tethers602 andskirt608 inFIGS. 21-23 extend in asecond direction722 fromanchor stent610 towardsvalve component640.Second direction722 is generally oppositefirst direction720. The term “generally opposite” with respect to directions described herein and terms similar thereto, as used herein, is not so narrow as to mean 180 degrees difference in direction. Instead, the term “generally opposite” with respect to direction means that a component includes a vector component in the first direction, the direction which is generally opposite includes a vector component in the opposite direction. Thus, thetethers602 andskirt608 in thefirst direction720 may be within 45 degrees of thefirst direction720 and the second, generallyopposite direction722 may be within 135 degrees to 225 degrees of thefirst direction720.Delivery system700 is advanced distally, i.e., away from the clinician, untiltethers602 andskirt608 are taut. Tautness oftethers602 andskirt608 correctly positionsvalve component640 for deployment at desired location, such as near the nativeaortic valve leaflets414 andproximal end646 offrame642 being generally aligned with theaortic annulus415, as shown inFIG. 21
• Sheath704 is then further retracted proximally, i.e., towards the clinician, to deployframe642 ofvalve component640.Frame642 expands radially outward to the radially expanded or deployed configuration, as shown inFIGS. 22-23. Asframe642 expands,frame642 separates the leaflets ofnative valve414, as shown inFIGS. 22-23.Proximal end646 offrame642 engages the inner wall of theannulus415, withskirt608 disposed betweenframe642 and theannulus415.Dist end644 offrame642 engages an inner surface ofanchor frame612, as shown inFIGS. 22-23.
• Withintegrated valve prosthesis600 fully deployed,delivery system700 and guidewire702 may be retracted proximally, i.e., towards the clinician, and removed in a manner consistent with current procedures know to those knowledgeable in the art.Integrated valve prosthesis600 remains in the fully deployed configuration as shown inFIG. 23.FIGS. 16-23 show lateral gaps between the different parts which are disposed adjacent to each other. These gaps are shown for clarity such that the different parts of the integrated valve prosthesis and the heart valve may be seen. It is understood than many of these parts will abut directly against each other due to the radially outward forces ofanchor stent610 andvalve frame642.
• Although some examples of advantages have been described above, these are non-limiting in that other advantages of theintegrated valve assembly300/320/600 would be apparent to those skilled in the art.
• It will also be understood that each feature of each embodiment discussed herein, and of each reference cited herein, can be used in combination with the features of any other embodiment. All patents and publications discussed herein are incorporated by reference herein in their entirety.
• While various embodiments according to the present invention have been described above, it should be understood that they have been presented by way of illustration and example only, and not limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the invention. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the appended claims and their equivalents. It will also be understood that each feature of each embodiment discussed herein, and of each reference cited herein, can be used in combination with the features of any other embodiment

Claims (28)

What is claimed is:

1. An integrated valve assembly having a radially compressed delivery configuration and a radially expanded deployed configuration, the valve prosthesis comprising:

an anchor stent; and

a valve component including a valve frame and a prosthetic valve coupled to the valve frame; and

a tether component having a first end coupled to the anchor stent and a second end coupled to the valve component, wherein in the delivery configuration the tether component extends in a first direction from the anchor stent to the valve component, and in the deployed configuration the tether component extends in a second direction from the anchor stent to the valve component, wherein the second direction is generally opposite the first direction.

2. The integrated valve assembly ofclaim 1, wherein the anchor stent is configured to be deployed within the annulus of an aortic valve.

3. The integrated valve assembly ofclaim 2, wherein in the radially expanded deployed configuration, a proximal portion of the valve frame is deployed within the anchor stent.

4. The integrated valve assembly ofclaim 2, wherein the tether component is configured such that in the deployed configuration the tether component is taut to set the location of the valve component within the anchor stent.

5. The integrated valve assembly ofclaim 2, wherein the tether component comprises a plurality of tethers, and wherein each tether is an elongate element.

6. The integrated valve assembly ofclaim 5, further comprising a tubular skirt coupled to an inner surface or outer surface of the tethers.

7. The integrated valve assembly ofclaim 2, wherein the tether component comprises a tubular skirt.

8. The integrated valve assembly ofclaim 7, wherein in the deployed configuration, a portion of the tubular skirt is configured to extend proximal of the anchor stent.

9. The integrated valve assembly ofclaim 8, wherein in the deployed configuration, the portion of the tubular skirt extending proximal of the anchor stent is configured to extend radially outward to seal against tissue of the heart.

10. The integrated valve assembly ofclaim 1, wherein the anchor stent is configured to be deployed in the aorta, and wherein a proximal portion of the valve frame is configured to be deployed in the annulus of the aortic valve.

11. The integrated valve assembly ofclaim 10, wherein the tether component is configured such that in the deployed configuration the tether is taut to set the location of the valve component within the annulus of the aortic valve.

12. The integrated valve assembly ofclaim 11, wherein the tether component comprises a plurality of tethers, further comprising a tubular skirt coupling the tethers to the valve component.

13. The integrated valve assembly ofclaim 12, wherein in the deployed configuration, the tubular skirt is configured to be disposed between the valve frame and the annulus of the aortic valve.

14. The integrated valve assembly ofclaim 11, wherein the anchor stent further comprises a proximal arm component, extending from a proximal end of the anchor stent, the proximal arm component configured to be deployed in the sinuses of the aortic valve.

15. The integrated valve assembly ofclaim 14, wherein the proximal arm component comprises three proximal arms with each proximal arm configured to be deployed in one of the three aortic sinuses.

16. The integrated valve assembly ofclaim 14, wherein the proximal arm component comprises a plurality of proximal arms and each proximal arm comprises a wire loop with a first end of the wire coupled to the proximal end of the anchor stent, the wire extending proximally from the first end and bending back distally to a second end of the wire coupled to the proximal end of the anchor stent spaced from the first end.

17. The integrated valve assembly ofclaim 16, wherein the proximal arm component comprises three proximal arms with each proximal arm configured to be deployed in one of the three aortic sinuses.

18. A method of implanting an integrated valve assembly at a location of a native valve comprising the steps of:

advancing the integrated valve assembly in a radially compressed delivery configuration to the location of the native valve, wherein the integrated valve assembly comprises an anchor stent, a valve component including a valve frame and a prosthetic valve, and a tether component having a first end coupled to the anchor stent and a second end coupled to the valve component, wherein in the radially compressed delivery configuration the tether component extends in a first direction from the anchor stent to the valve component;

deploying the anchor stent from the radially compressed configuration to a radially expanded configuration at a location within an annulus of the native valve;

advancing the valve component in the delivery configuration in a second direction opposite the first direction through at least a portion of the anchor stent such that the tether component extends in the second direction from the anchor stent to the valve component; and

deploying the valve component such that the valve frame expands from the radially compressed delivery configuration to a radially expanded configuration with a proximal portion of the valve frame engaging an inner surface of the anchor stent.

19. The method ofclaim 18, wherein the step of advancing the valve component in the delivery configuration through at least a portion of the anchor stent comprises advancing the valve component until the tether component becomes taught such that a length of the tether sets a location for the deployed valve component.

20. The method ofclaim 18, wherein the tether component comprises a plurality of tethers.

21. The method ofclaim 18, wherein the tether component comprises a tubular skirt, the tubular skirt being configured such that the step of advancing the valve component disposes the tubular skirt between the anchor stent and the valve frame.

22. The method ofclaim 21, wherein the step of advancing the valve component causes the tubular skirt to fold such that a portion of the skirt extends proximal of the anchor stent and wherein the step of deploying the valve component causes the portion of the tubular skirt extending proximal of the anchor stent to extend radially outward to seal the skirt against tissue of the heart.

23. A method of implanting an integrated valve assembly at a location of a native valve comprising the steps of:

advancing the integrated valve assembly in a radially compressed configuration into the aorta, wherein the integrated valve assembly comprises an anchor stent, a valve component including a valve frame and a prosthetic valve, and a tether component having a first end coupled to the anchor stent and a second end coupled to the valve component, wherein in the delivery configuration the tether component extends in a first direction from the anchor stent to the valve component;

deploying the anchor stent from the radially compressed configuration to a radially expanded configuration at a location within the aorta;

advancing the valve component in the delivery configuration in a second direction opposite the first direction through the anchor stent until the tether component becomes taut;

deploying the valve component such that the valve frame expands from the radially compressed configuration to a radially expanded deployed configuration with a first portion of the valve frame engaging the aortic valve.

24. The method ofclaim 23, wherein the tether component comprises a plurality of tethers.

25. The method ofclaim 23, wherein a length of the tether component is configured such that the step advancing the valve component until the tether becomes taut causes at least a portion of the valve component to be disposed within an annulus of the aortic valve.

26. The method ofclaim 24, wherein the tether component comprises a tubular skirt disposed adjacent the valve component such that the step of advancing the valve component and deploying the anchor component disposes the tubular skirt between the valve component and the annulus of the aortic valve.

27. The method ofclaim 23, wherein the anchor stent further comprises a proximal arm component extending from a proximal end of the anchor stent, wherein the step of deploying the anchor stent comprises deploying the proximal arm component in a sinus of the aortic valve.

28. The method ofclaim 27, wherein the proximal arm component comprises a plurality of proximal arms and the step of deploying the anchor stent comprises deploying each proximal arm in one of the three aortic sinuses.

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