Transcatheter devices

Abstract

A heart valve prosthesis including an expandable stent frame having an interior area extending along an axis of the expandable stent frame between an atrial portion of the expandable stent frame and a ventricular portion of the expandable stent frame. A prosthetic valve structure is mounted within the interior area of the expandable stent frame. An expandable anchoring frame at least partially circumscribes the expandable stent frame. The expandable anchoring frame includes an atrial portion of the expandable anchoring frame and a ventricular portion of the expandable anchoring frame. The atrial portion of the expandable anchoring frame includes a circumferential segment that extends radially outward from an axis of the expandable stent frame. The circumferential segment is configured to deflect upon contact with native anatomy of a patient. The circumferential segment only partially circumscribes the axis of the expandable stent frame.

Description

TRANSCATHETER DEVICESCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 711,658, filed October 24, 2024, the entire content of which is incorporated herein by reference.FIELD

[0002] The present disclosure relates generally to a prosthetic heart valve, and more particularly, to a prosthetic heart valve including an expandable stent frame and an expandable anchoring frame circumscribing the expandable stent frame.BACKGROUND

[0003] A human heart includes four heart valves that determine the path that blood flows through the heart: the mitral valve, the tricuspid valve, the aortic valve, and the pulmonary valve. The mitral and tricuspid valves are atrio-ventricular valves, which are between the atria and the ventricles, while the aortic and pulmonary valves are semilunar valves, which are in the arteries leaving the heart. Ideally, native leaflets of a heart valve move apart from each other when the valve is in an open position and meet or “coapf ’ when the valve is in a closed position. Problems that may develop with valves include stenosis in which a valve does not open properly, and / or insufficiency or regurgitation in which a valve does not close properly. Stenosis and insufficiency may occur concomitantly in the same valve. The effects of valvular dysfunction vary, with regurgitation or backflow typically having relatively severe physiological consequences to the patient.

[0004] Diseased or otherwise deficient heart valves can be repaired or replaced using a variety of different types of heart valve surgeries. One conventional technique involves an open-heart surgical approach that is conducted under general anesthesia, during which the heart is stopped, and blood flow is controlled by a heart-lung bypass machine.

[0005] More recently, minimally invasive approaches have been developed to facilitate catheter-based implantation of a prosthetic heart valve or prosthesis on the beating heart, intending to obviate the need for the use of classical sternotomy and cardiopulmonary bypass. In general terms, an expandable prosthetic valve is compressed about or within acatheter, inserted inside a body lumen of the patient, such as the femoral artery, and delivered to a desired location in the heart. In catheter-based implantations of a prosthetic heart valve or prosthesis, it is important that the heart valve is accurately located relative to the native annulus prior to full deployment to prevent serious complications, such as for example, where the prosthetic heart valve or prosthesis leaks or dislodges from the native heart valve implantation site.

[0006] In light of the above, a need exists for a prosthetic heart valve that can minimize or prevent leakage and avoid dislodging when implanted into a native heart valve.SUMMARY

[0007] The following presents a simplified summary of the disclosure to provide a basic understanding of some aspects described in the detailed description.

[0008] In an example, a heart valve prosthesis comprising an expandable stent frame comprising an interior area extending along an axis of the expandable stent frame between an atrial portion of the expandable stent frame and a ventricular portion of the expandable stent frame. A prosthetic valve structure is mounted within the interior area of the expandable stent frame. An expandable anchoring frame at least partially circumscribes the expandable stent frame. The expandable anchoring frame comprises an atrial portion of the expandable anchoring frame and a ventricular portion of the expandable anchoring frame. The atrial portion of the expandable anchoring frame comprises a circumferential segment that extends radially outward from an axis of the expandable stent frame. The circumferential segment is configured to deflect upon contact with native anatomy of a patient. The circumferential segment only partially circumscribes the axis of the expandable stent frame.

[0009] In an example, a method of implanting the heart valve prosthesis within a target site of the patient comprising: delivering the heart valve prosthesis to a heart valve of the patient while the heart valve prosthesis is in a collapsed orientation within a capsule of a transcatheter delivery device; aligning the heart valve prosthesis with at least a portion of an atrium of the patient and / or with at least a portion of a ventricle of the patient; and deploying the heart valve prosthesis from the capsule and allowing the heart valve prosthesis to expand such that the atrial portion of the expandable anchoring frame engages the atrium of the patient and the ventricular portion of the expandable anchoring frame engages the ventricle of the patient.

[0010] In an example, a heart valve prosthesis comprising an expandable stent frame comprising an interior area extending along an axis of the expandable stent frame between an atrial portion of the expandable stent frame and a ventricular portion of the expandable stent frame. A prosthetic valve structure is mounted to the expandable stent frame within the interior area of the expandable stent frame. An expandable anchoring frame at least partially circumscribes the expandable stent frame. The expandable anchoring frame comprises an atrial portion of the expandable anchoring frame and a ventricular portion of the expandable anchoring frame. A notch is formed in an end of the ventricular portion of the expandable anchoring frame to form a skirt that extends circumferentially about the end of the ventricular portion of the expandable anchoring frame.

[0011] In an example, a method of implanting the heart valve prosthesis within a target site of a patient comprising: delivering the heart valve prosthesis to a heart valve of a patient while the heart valve prosthesis is in a collapsed orientation within a capsule of a transcatheter delivery device; aligning the heart valve prosthesis with at least a portion of an atrium of the patient and / or with at least a portion of a ventricle of the patient; and deploying the heart valve prosthesis from the capsule and allowing the heart valve prosthesis to expand such that the atrial portion of the expandable anchoring frame engages the atrium of the patient and the ventricular portion of the expandable anchoring frame engages the ventricle of the patient.

[0012] Additional features and advantages of the aspects disclosed herein will be set forth in the detailed description that follows, and in part will be clear to those skilled in the art from that description or recognized by practicing the aspects described herein, including the detailed description which follows, the claims, as well as the appended drawings. It is to be understood that both the foregoing general description and the following detailed description present aspects intended to provide an overview or framework for understanding the nature and character of the aspects disclosed herein. The accompanying drawings are included to provide further understanding and are incorporated into and constitute a part of this specification. The drawings illustrate various aspects of the disclosure, and together with the description explain the principles and operations thereof.BRIEF DESCRIPTION OF THE DRAWINGS

[0013] These and other features, aspects and advantages are better understood when the following detailed description is read with reference to the accompanying drawings, in which:

[0014] FIG. 1 illustrates a perspective view of a transcatheter heart valve prosthesis including an exemplary stented prosthesis positioned inside of an exemplary anchoring frame, in accordance with aspects of the disclosure;

[0015] FIG. 2 illustrates a simplified section view of the transcatheter heart valve prosthesis taken along line 2-2 of FIG. 1;

[0016] FIG. 3 illustrates a simplified section view of the transcatheter heart valve prosthesis taken along line 2-2 of FIG. 1 showing a first attachment arrangement for securing an atrial portion of the anchoring frame and a ventricular portion of the anchoring frame to the stented prosthesis, according to one aspect of the disclosure;

[0017] FIG. 4A illustrates an enlarged view taken from FIG. 3 showing the first attachment arrangement for securing an atrial portion of the anchoring frame and a ventricular portion of the anchoring frame to the stented prosthesis, according to one aspect of the disclosure;

[0018] FIG. 4B illustrates a second attachment arrangement for securing an atrial portion of the anchoring frame and a ventricular portion of the anchoring frame to the stented prosthesis, according to one aspect of the disclosure;

[0019] FIG. 4C illustrates a third attachment arrangement for securing an atrial portion of the anchoring frame and a ventricular portion of the anchoring frame to the stented prosthesis, according to one aspect of the disclosure;

[0020] FIG. 5 illustrates an end view of the stented prosthesis of FIG. 1;

[0021] FIG. 6 illustrates a simplified section view of the transcatheter heart valve prosthesis taken along line 2-2 of FIG. 1 showing a single body anchoring frame secured to the stented prosthesis, according to one aspect of the disclosure;

[0022] FIG. 7 illustrates a simplified section view of the transcatheter heart valve prosthesis taken along line 2-2 of FIG. 1 showing a single body anchoring frame secured to the stented prosthesis, according to one aspect of the disclosure;

[0023] FIG. 8 illustrates a side view of a transcatheter delivery assembly for delivering the transcatheter heart valve prosthesis, in accordance with aspects of the disclosure;

[0024] FIG. 9 illustrates an enlarged side view of a distal portion of the transcatheter delivery assembly of FIG. 8, in accordance with aspects of the disclosure;

[0025] FIG. 10 illustrates the transcatheter delivery assembly of FIG. 8 extending through a mitral valve of a heart, according to one aspect of the disclosure;

[0026] FIG. 11 illustrates the transcatheter delivery assembly of FIG. 8 extending through a mitral valve of a heart with a ventricular portion of the anchoring frame of FIG. 1 partially expanded and extending out of the transcatheter delivery assembly;

[0027] FIG. 12 illustrates the transcatheter delivery assembly of FIG. 8 extending through a mitral valve of a heart with the stented frame and the anchoring frame of FIG. 1 partially expanded and positioned outside of the transcatheter delivery assembly, according to one aspect of the disclosure;

[0028] FIG. 13 illustrates the stented frame and anchoring frame of FIG. 1 fully expanded and positioned in a mitral valve of a heart, according to one aspect of the disclosure;

[0029] FIG. 14 illustrates a transcatheter delivery assembly, according to an aspect, extending through a mitral valve of a heart, showing a ventricular portion of the anchoring frame in a first capsule portion of the transcatheter delivery assembly and an atrial portion of the anchoring frame in a second capsule portion of the transcatheter delivery assembly;

[0030] FIG. 15 illustrates the transcatheter delivery assembly of FIG. 14 extending through the mitral valve of the heart with the ventricular portion of the anchoring frame of FIG. 1 out of the first capsule portion and partially expanded; and

[0031] FIG. 16 illustrates the transcatheter delivery assembly of FIG. 14 extending through the mitral valve of the heart with the transcatheter heart valve prosthesis of FIG. 1 partially expanded and positioned outside of the first capsule portion and the second capsule portion of the transcatheter delivery assembly, according to one aspect of the disclosure.DETAILED DESCRIPTION

[0032] Aspects will now be described more fully hereinafter with reference to the accompanying drawings in which example aspects are shown. Whenever possible, the same reference numerals are used throughout the drawings to refer to the same or like parts. However, this disclosure may be embodied in many different forms and should not be construed as limited to the aspects set forth herein.

[0033] As used herein, the term “about” means that amounts, sizes, formulations, parameters, and other quantities and characteristics are not, and need not be, exact, but may be approximate and / or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art.

[0034] Ranges can be expressed herein as from “about” one value, and / or to “about” another value. When such a range is expressed, aspects include from the one value to the other value. Similarly, when values are expressed as approximations by use of the antecedent “about,” it will be understood that the value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.

[0035] Directional terms as used herein - for example up, down, right, left, front, back, top, bottom, upper, lower, etc. - are made only with reference to the figures as drawn and are not intended to imply absolute orientation.

[0036] Unless otherwise expressly stated, it is in no way intended that any methods set forth herein be construed as requiring that its steps be performed in a specific order, nor that with any apparatus, specific orientations be required. Accordingly, where a method claim does not actually recite an order to be followed by its steps, or that any apparatus claim does not actually recite an order or orientation to individual components, or it is not otherwise specifically stated in the claims or description that the steps are to be limited to a specific order, or that a specific order or orientation to components of an apparatus is not recited, it is in no way intended that an order or orientation be inferred in any respect. This holds for any possible non-express basis for interpretation, including matters of logic relative to arrangement of steps, operational flow, order of components, or orientation of components; plain meaning derived from grammatical organization or punctuation, and; the number or type of aspects described in the specification.

[0037] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Thus, for example, reference to “a” component includes aspects having two or more such components, unless the context clearly indicates otherwise.

[0038] The word “exemplary,” “example,” or various forms thereof are used herein to mean serving as an example, instance, or illustration. Any aspect or design described hereinas “exemplary” or as an “example” should not be construed as preferred or advantageous over other aspects or designs. Furthermore, examples are provided solely for purposes of clarity and understanding and are not meant to limit or restrict the disclosed subject matter or relevant portions of this disclosure in any manner. It can be appreciated that a myriad of additional or alternate examples of varying scope could have been presented but have been omitted for purposes of brevity.

[0039] As used herein, the terms “comprising,” “including,” and variations thereof shall be construed as synonymous and open-ended, unless otherwise indicated. A list of elements following the transitional phrases comprising or including is a non-exclusive list, such that elements in addition to those specifically recited in the list may also be present.

[0040] The terms “substantial,” “substantially,” and variations thereof as used herein are intended to represent that a described feature is equal or approximately equal to a value or description. For example, a “substantially planar” surface is intended to denote a surface that is planar or approximately planar. Moreover, “substantially” is intended to denote that two values are equal or approximately equal. The term “substantially” may denote values within about 10% of each other, for example, within about 5% of each other, or within about 2% of each other.

[0041] Modifications may be made to the instant disclosure without departing from the scope or spirit of the claimed subject matter. Unless specified otherwise, “first,” “second,” or the like are not intended to imply a temporal aspect, a spatial aspect, an ordering, etc. Rather, such terms are merely used as identifiers, names, etc. for features, elements, items, etc. For example, a first end and a second end generally correspond to end A and end B or two different ends.

[0042] Unless otherwise indicated, the terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction toward the clinician. In addition, the term “self-expanding” may be used in the following description with reference to one or more valve or stent structures of the prostheses hereof and is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration or vice versa. Non-exhaustiveexemplary self-expanding materials include stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal. Mechanical memory may be imparted to a wire or stent structure by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol. Various polymers that can be made to have shape memory characteristics may also be suitable for use in aspects hereof to include polymers such as polynorborene, transpolyisoprene, styrene-butadiene, and polyurethane. As well poly L-D lactic copolymer, oligo caprylactone copolymer and poly cyclo-octine can be used separately or in conjunction with other shape memory polymers.

[0043] Diseases associated with heart valves, such as those caused by damage or a defect, can include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis causes the valve to become narrowed and hardened which can prevent blood flow to a downstream heart chamber from occurring at the proper flow rate and may cause the heart to work harder to pump the blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backwards, thereby causing the heart to be less efficient. A diseased or damaged valve, which can be congenital, age-related, drug-induced, or in some instances, caused by infection, can result in an enlarged, thickened heart that loses elasticity and efficiency. Some symptoms of heart valve diseases can include weakness, shortness of breath, dizziness, fainting, palpitations, anemia and edema, and blood clots which can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and / or life threatening.

[0044] Heart valve prostheses have been developed for repair and replacement of diseased and / or damaged heart valves. Such heart valve prostheses can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based delivery systems. Such heart valve prostheses generally include a frame or stent and a prosthetic valve mounted within the frame. Such heart valve prostheses are delivered in a radially compressed or crimped configuration so that the heart valve prosthesis can be advanced through the patient’s vasculature. Once positioned at the treatment site, the heart valve prosthesis is expanded to engage tissue at the diseased heart valve region to, for instance, hold the heart valve prosthesis in position.

[0045] FIGS. 1 and 2 illustrate an exemplary transcatheter heart valve prosthesis 100 that may include an exemplary stented prosthesis 130 positioned inside of an exemplary expandable anchoring frame 160, in accordance with aspects of the disclosure. The stented prosthesis 130 may include an expandable stent frame 132 and a prosthetic valve structure 210 (FIG. 2) that may comprise a plurality of leaflets 212 (e.g. two or three leaflets). The expandable stent frame 132 of the stented prosthesis 130 may have a substantially cylindrical shape and support the prosthetic valve structure 210 within a lumen 134 defined by the expandable stent frame 132. A plurality of sutures (not shown) may mount the prosthetic valve structure 210 to the expandable stent frame 132 wherein the prosthetic valve structure 210 can be collapsed within the expandable stent frame 132. Furthermore, as shown in FIG. 2, the valve structure can be deployed to operate as a valve (e.g., heart valve) when the stented prosthesis 130 radially expands to the expanded orientation.

[0046] As shown in FIG. 2, the stented prosthesis 130 may include an inflow end 136 (see also FIG. 1) and an outflow end 224. The leaflets 212 may be attached to the expandable stent frame 132 such that when pressure at the inflow end 136 exceeds pressure at the outflow end 224, the leaflets 212 may open to allow blood flow through the stented prosthesis 130 from the inflow end 136 to the outflow end 224. When pressure at the outflow end 224 exceeds pressure at the inflow end 136, the leaflets 212 may close to prevent blood flow from the outflow end 224 to the inflow end 136.

[0047] The expandable anchoring frame 160 may be a tubular stent structure that at least partially circumferentially surrounds the stented prosthesis 130. The expandable anchoring frame 160 may function as an anchor for mounting the transcatheter heart valve prosthesis 100 in a heart 1002 (FIG. 10). The expandable anchoring frame 160 may include an atrial portion 162 and a ventricular portion 172. The atrial portion 162 defines an inflow end of the expandable anchoring frame 160 and the ventricular portion 172 defines an outflow end of the expandable anchoring frame 160. The atrial portion 162 of the expandable anchoring frame 160 may be contoured and dimensioned to be received into an atrium 1006 of the heart 1002 (see, FIG. 10). The ventricular portion 172 of the expandable anchoring frame 160 may be contoured and dimensioned to be received into a ventricle 1004 of the heart 1002 (see, FIG. 10).

[0048] Referring to FIGS. 1 and 2, the atrial portion 162 may include a segment 164 that extends radially outward from an end of the atrial portion 162. In aspects, the segment164 may partially circumscribe an axis A of the expandable anchoring frame 160. In other aspects (not shown), the segment 164 may fully circumscribe the axis A of the expandable anchoring frame 160. A plurality of cleats 166 may extend outwardly from a lower surface of the segment 164. The plurality of cleats 166 may be positioned and dimensioned to engage a neighboring anatomy of the heart 1002. In aspects, the plurality of cleats 166 may be arranged in at least one row. The segment 164 may be configured to deflect upon insertion of the transcatheter heart valve prosthesis 100 into the heart 1002, as described in detail below.

[0049] The ventricular portion 172 of the expandable anchoring frame 160 may include a notch 174 that may be formed in an end 176 of the ventricular portion 172. The portion of the ventricular portion 172 adjacent the notch 174 may define a skirt 178 that circumferentially extends about the end 176 of the ventricular portion 172. In aspects, the skirt 178 circumferentially may extend about the end 176 of the ventricular portion 172 of the expandable anchoring frame 160, as represented by angle B in FIG. 1. In aspects, the angle B may be between about 120 degrees and about 180 degrees. The skirt 178 of the ventricular portion 172 of the expandable anchoring frame 160 may be designed to deflect and conform to a neighboring anatomy of the heart 1002 (FIG. 10) when the transcatheter heart valve prosthesis 100 may be placed in the heart 1002 (FIG. 10), as described in detail below.

[0050] A plurality of cleats 182 may extend outwardly from a surface of the ventricular portion 172. The plurality of cleats 182 may be positioned and dimensioned to engage the neighboring anatomy of the heart when the transcatheter heart valve prosthesis 100 may be placed in the heart 1002 (see, FIGS. 10-16).

[0051] Referring to FIGS. 1 and 2, an outer surface of the stented prosthesis 130 and an inner surface of the expandable anchoring frame 160 may be spaced apart by a gap “G ” In one aspect (see, FIG. 2), a plurality of connector arms 232 may be used to secure the expandable anchoring frame 160 to the stented prosthesis 130. The connector arms 232 may be spaced circumferentially about the inner surface of the expandable anchoring frame 160 and the outer surface of the stented prosthesis 130. In aspects, the connector arms 232 may be integral with the expandable anchoring frame 160 and rivets 234 may be used to secure the connector arms 232 to the stented prosthesis 130.

[0052] Referring to FIGS. 3-4C, in aspects, a transcatheter heart valve prosthesis 300 may include an expandable anchoring frame 360 wherein an atrial portion 362 and a ventricular portion 372 may be separate components. In aspects, the expandable stent frame 132 of the stented prosthesis 130 may include holes 334 that align with holes 364 in the atrial portion 362 and / or with holes 374 in the ventricular portion 372 of the expandable anchoring frame 360. Referring to FIG. 4A, in one aspect, the hole 334 in the expandable stent frame 132 may align with the hole 364 in the atrial portion 362 and the hole 374 in the ventricular portion 372 such that the rivet 234 can secure the expandable stent frame 132, the atrial portion 362 and the ventricular portion 372 together. Referring to FIG. 4B, in one aspect, the hole 334 in the expandable stent frame 132 may align with the hole 374 in the ventricular portion 372 such that the rivet 234 can secures the expandable stent frame 132 and the ventricular portion 372 together. Referring to FIG. 4C, in one aspect, the hole 334 in the expandable stent frame 132 may align with the hole 364 in the atrial portion 362 such that the rivet 234 can secure the expandable stent frame 132 and the atrial portion 362 together.

[0053] Referring to FIG. 5, in aspects, the securing of the expandable stent frame 132 of the stented prosthesis 130 to the ventricular portion 372 and the atrial portion 362 of the expandable anchoring frame 360 (FIG. 3) may be done in an alternating pattern wherein a first connection arrangement 502 can comprise the arrangement of FIG. 4B, wherein the rivet 234 can extend through the hole 334 in the expandable stent frame 132 and the hole 374 in the ventricular portion 372 and a second connection arrangement 504 can comprise the arrangement of FIG. 4C, wherein the rivet 234 can extend through the hole 334 in the expandable stent frame 132 and the hole 364 in the atrial portion 362. The first connection arrangement 502 and the second connection arrangement 504 may be placed alternately about the circumference of the expandable stent frame 132, as illustrated in FIG. 5. In another aspect, the securing of the expandable stent frame 132 of the stented prosthesis 130 to the ventricular portion 372 and the atrial portion 362 of the expandable anchoring frame 360 (FIG. 3) may comprise the arrangement of FIG. 4A, wherein the rivet 234 can extend through the hole 334 in the expandable stent frame 132, the hole 364 in the atrial portion 362 and the hole 374 in the ventricular portion 372. In other aspects, the securing of the expandable stent frame 132 of the stented prosthesis 130 to the ventricular portion 372 andthe atrial portion 362 of the expandable anchoring frame 360 (FIG. 3) may comprise any combination of the arrangements illustrated in FIGS. 4A-4C.

[0054] Referring to FIG. 6, in aspects, a transcatheter heart valve prosthesis 600 may include an expandable anchoring frame 660 having a ventricular portion 672 and an atrial portion 662 that may be formed as a single body. In this embodiment, a wall 674 of the ventricular portion 672 extends from a side surface of a wall 664 of the atrial portion 662. In this embodiment, the rivets 234 may connect the wall 664 of the atrial portion 662 to the expandable stent frame 132 of the stented prosthesis 130.

[0055] Referring to FIG. 7, in one aspect, a transcatheter heart valve prosthesis 700 may include an expandable anchoring frame 760 having a ventricular portion 772 and an atrial portion 762 that may be formed as a single body. In this embodiment, a wall 774 of the ventricular portion 772 and a wall 764 of the atrial portion 762 form one continuous wall. In this embodiment, the rivets 234 may connect the continuous wall of the atrial portion 762 and the ventricular portion 772 to the expandable stent frame 132 of the stented prosthesis 130.

[0056] FIG. 8 illustrates an example transcatheter delivery assembly 800 for a transcatheter heart valve implant apparatus having and extending between a distal end 802 and a proximal end 804. The transcatheter delivery assembly 800 may be provided for delivering and / or retrieving the transcatheter heart valve prosthesis 100, 300, 600, 700, as described in detail below.

[0057] The distal end 802 can be used to load and deliver the transcatheter heart valve prosthesis 100, 300, 600, 700 (e.g., illustrated in FIG. 6). The proximal end 804 can comprise components, for example, those found in other catheter delivery systems for controlling transcatheter delivery of the transcatheter heart valve prosthesis 100, 300, 600, 700 through the vasculature of the patient and for controlling deployment of the transcatheter heart valve prosthesis 100, 300, 600, 700 at the target site. In aspects, the components at the proximal end 804 may comprise, for example, a first rotating homeostasis valve 806, a side access port 808, a second rotating homeostasis valve 810, and a guide member 812.

[0058] The first rotating homeostasis valve 806 can comprise latex and can form a fluid seal to limit blood or other fluid from leaking out of the transcatheter delivery assembly 800 at the proximal end 804 or entry site into a patient. The side access port 808 may be providedto inject contrast media or saline, for example, into the transcatheter delivery assembly 800. The second rotating homeostasis valve 810 may be similar to the first rotating homeostasis valve 806 and can limit blood or other fluid from leaking back through the transcatheter delivery assembly 800. In addition, the second rotating homeostasis valve 810 can allow wires, devices, and fluid to pass through to aid in the preparation, delivery, and deployment of the transcatheter heart valve prosthesis 100, 300, 600, 700. Furthermore, the second rotating homeostasis valve 810 can control the components of the distal end 802. For example, by manipulating (e.g., rotating) a portion of the second rotating homeostasis valve 810, a physician can control components of the distal end 802. The first and second rotating homeostasis valves 806, 810 can be compatible with catheter-laboratory components and, unless otherwise noted, the transcatheter delivery assembly 800 may not be intended to be limited to the specific components and features disclosed.

[0059] The transcatheter delivery assembly 800 can be inserted into a vessel or artery of a patient. The proximal end 804 can extend outside of the patient while the distal end 802 may be delivered intravascularly to an area at or near a valve, for example, a mitral valve 1010 (FIG. 10), inside the body. The transcatheter delivery assembly 800 can include one or more axial lumens to pass items (e.g., guidewires, valve prosthesis, contrast media, other catheters, etc.) through the transcatheter delivery assembly 800.

[0060] The transcatheter delivery assembly 800 can comprise an inner shaft member 836 comprising at least one guidewire lumen 1022 (see, FIG. 10). As used herein, a lumen can comprise a cavity or hollow bore that extends through a structure, for example, the inner shaft member 836. The guide member 812 can be attached to a proximal shaft portion 814 of the inner shaft member 836 at the proximal end 804. In aspects, the inner shaft member 836 can extend partially or completely along an entire length of the transcatheter delivery assembly 800 and may be slid or moved through other components of the transcatheter delivery assembly 800. As explained herein, a plurality of guidewires (e.g., the guidewire lumen 1022 in FIG. 10) can extend through the inner shaft member 836 and can be used to guide the transcatheter heart valve prosthesis 100 to a desired location. The transcatheter delivery assembly 800 can comprise an outer shaft 816 that is located between the distal end 802 and the proximal end 804, with the inner shaft member 836 extending through the outer shaft 816. The outer shaft 816 can limit blood from leaking around the transcatheter deliveryassembly 800 and can provide a relatively smooth, flexible length to enable the transcatheter delivery assembly 800 to traverse through the vasculature of the patient.

[0061] A tapered tip 837 can be attached to the inner shaft member 836 at the distal end 802. The tip 837 comprises a tapered shape to ease the passage of the transcatheter delivery assembly 800 into and through the vasculature. A holding catheter 834 can be attached to the transcatheter heart valve prosthesis 100. The holding catheter 834 can comprise a centrally located lumen surrounding the inner shaft member 836. The holding catheter 834 can slide relative to the inner shaft member 836 and may be controlled by the second rotating homeostasis valve 810 at the proximal end 804 of the transcatheter delivery assembly 800. A portion of the second rotating homeostasis valve 810 can be rotated or otherwise manipulated in order to rotate the holding catheter 834 or move the holding catheter 834 proximally and distally as desired.

[0062] A coil 801 can be attached to the distal end of the holding catheter 834. In this way, movement of the holding catheter 834, as controlled by the second rotating homeostasis valve 810, can control movement or rotation of the coil 801. The holding catheter 834 can be surrounded by a reinforcement layer 824, which can be attached or otherwise bonded to the holding catheter 834 and can serve to reinforce the holding catheter 834. The coil 801 can be removably attached to the transcatheter heart valve prosthesis 100, 300, 600, 700. As such, the coil 801 can allow for loading of the transcatheter heart valve prosthesis 100, 300, 600, 700, holding of the transcatheter heart valve prosthesis 100, 300, 600, 700 during delivery, and release of the transcatheter heart valve prosthesis 100, 300, 600, 700 upon reaching a treatment site. In aspects, rotation of the coil 801 can cause the transcatheter heart valve prosthesis 100, 300, 600, 700 to detach from the coil 801. The transcatheter delivery assembly 800 can further comprise a capsule 826 that may comprise a low friction and flexible material, such as polytetrafluoroethylene (PTFE), polyurethane, silicone, or polyethylene. The capsule 826 can be sized and shaped to receive components near the distal end 802, for example, the inner shaft member 836, the coil 801 and the transcatheter heart valve prosthesis 100, 300, 600, 700.

[0063] FIG. 9 illustrates the distal end 802 of the transcatheter delivery assembly 800. In aspects, the transcatheter heart valve prosthesis 100, 300, 600, 700 can be in a radially-compressed position during intraluminal delivery to a treatment site. In the radially-compressed position, the transcatheter heart valve prosthesis 100, 300, 600, 700 can beremovably attached to the coil 801 and circumferentially surrounded by the capsule 826. The transcatheter heart valve prosthesis 100, 300, 600, 700 can extend coaxially with the inner shaft member 836, for example, with the inner shaft member 836 extending through a center of the transcatheter heart valve prosthesis 100, 300, 600, 700. capsule 826 can comprise a cross-sectional size (e.g., diameter) that is less than a cross-sectional size of the transcatheter heart valve prosthesis 100, 300, 600, 700 when the transcatheter heart valve prosthesis 100, 300, 600, 700 is in a radially-expanded position (e.g., illustrated in FIG. 1). As such, the capsule 826, along with the coil 801, can maintain the transcatheter heart valve prosthesis 100, 300, 600, 700 in the radially-compressed position during delivery.

[0064] The capsule 826 may be configured to surround the transcatheter heart valve prosthesis 100, 300, 600, 700 during deliver of the transcatheter heart valve prosthesis 100, 300, 600, 700 by the transcatheter delivery assembly 800 to a treatment site. In some embodiments, a distal portion of the capsule 826 may engage a proximal portion of the tip 837 such that the capsule 826 can be retracted with an actuator (e.g., the first rotating homeostasis valve 806 or the second rotating homeostasis valve 810) to allow the transcatheter heart valve prosthesis 100, 300, 600, 700 to expand within the patient’s vasculature. In some aspects, a transcatheter deliver assembly 1400 can include a first capsule portion 1410 (FIG. 14) and a second capsule portion 1420 (FIG. 14). In this embodiment, a distal end of the first capsule portion 1410 can be attached to a proximal end of the distal tip 837 and a proximal end of first capsule portion 1410 can engage a distal end of the second capsule portion 1420. As described in detail below, in this embodiment, the ventricular portion 172, 372, 672, 772 of the expandable anchoring frame 160, 360, 660, 760 can be disposed in the first capsule portion 1410 (FIG. 14) and the atrial portion 162, 362, 662, 762 of the expandable anchoring frame 160, 360, 660, 760 can be disposed in the second capsule portion 1420 (FIG. 14). While various features are illustrated as example components of the transcatheter delivery assembly 800, 1400, in some embodiments, more or less components may be provided.

[0065] Methods of implanting the transcatheter heart valve prosthesis 100, 300, 600, 700 of FIGS. 1, 3, 6 and 7 will now be described with reference to FIGS. 10-16. Methods of implanting the transcatheter heart valve prosthesis 100, 300, 600, 700 can include any embodiment of the transcatheter delivery assembly 800, 1400 described above.

[0066] Referring to FIG. 10, in this embodiment the transcatheter heart valve prosthesis 100, 300, 600, 700 (in the radially-compressed position) may be placed in the transcatheter delivery assembly 800 which, in turn, may be inserted into the heart 1002. In the embodiment illustrated, the transcatheter delivery assembly 800 is inserted through leaflets 1012 of the mitral valve 1010. The guidewire lumen 1022 may be used by the surgeon in inserting the distal end 802 of the transcatheter delivery assembly 800 through the mitral valve 1010. In aspects, the transcatheter delivery assembly 800 may be inserted through other valves of the heart 1002.

[0067] The transcatheter delivery assembly 800 is advanced distally until the ventricular portion 172, 372, 672, 772 of the expandable anchoring frame 160, 360, 660, 760 of the transcatheter heart valve prosthesis 100, 300, 600, 700 may be positioned in the ventricle 1004. Referring to FIG. 11, the capsule 826 of the transcatheter delivery assembly 800 may be withdrawn proximally (see arrow B) to allow the ventricular portion 172, 372, 672, 772 of the expandable anchoring frame 160, 360, 660, 760 of the transcatheter heart valve prosthesis 100, 300, 600, 700 to be deployed from the capsule 826 (see arrows C). As the ventricular portion 172, 372, 672, 772 is deployed, the surgeon may reposition the transcatheter heart valve prosthesis 100, 300, 600, 700 so that the continued deployment of the transcatheter heart valve prosthesis 100, 300, 600, 700 expands against the leaflets 1012 of the mitral valve 1010 to compress the leaflets 1012 against a wall of the ventricle 1004 (see FIG. 12). The cleats 182 on the ventricular portion 172, 372, 672, 772 may aid in fixing the ventricular portion 172, 372, 672, 772 to the leaflets 1012.

[0068] Once the ventricular portion 172, 372, 672, 772 is positioned, the surgeon may control the deployment of the atrial portion 162, 362, 662, 762 of the expandable anchoring frame 160, 360, 660, 760 (e.g., move the transcatheter delivery assembly 800 in the distal or proximal direction) such that the atrial portion 162, 362, 662, 762 deploys into the atrium 1006 of the heart 1002. See, arrow D in FIG. 12. In aspects, the surgeon may draw the transcatheter heart valve prosthesis 100, 300, 600, 700 back in to the capsule 826, as needed to adjust the position of the transcatheter heart valve prosthesis 100, 300, 600, 700 in the heart 1002 so the transcatheter heart valve prosthesis 100, 300, 600, 700 is placed in a target site (e.g., in the mitral valve 1010). In some embodiments, aligning the transcatheter heart valve prosthesis 100, 300, 600, 700 with the atrium 1006 and the ventricle 1004 may be aided by at least one radiopaque marker (not shown) engaged with the expandable anchoringframe 160, 360, 660, 760. In further embodiments, aligning the transcatheter heart valve prosthesis 100, 300, 600, 700 can include utilizing the guidewire lumen 1022. The cleats 166 on the atrial portion 162, 362, 662, 762 may aid in fixing the atrial portion 162, 362, 662, 762 to adjacent anatomy of the atrium 1006.

[0069] Referring to FIG. 13, upon proper alignment of the transcatheter heart valve prosthesis 100, 300, 600, 700 with the atrium 1006 and the ventricle 1004 of the heart 1002, the transcatheter heart valve prosthesis 100, 300, 600, 700 may be positioned such that the atrial portion 162, 362, 662, 762 is positioned in the atrium 1006 and the ventricular portion 172, 372, 672, 772 is positioned in the ventricle 1004. In this position (i.e., the target site), the cleats 166 on the atrial portion 162, 362, 662, 762 of the expandable anchoring frame 160, 360, 660, 760 can engage the neighboring anatomy of the atrium 1006, and the cleats 182 on the ventricular portion 172, 372, 672, 772 of the expandable anchoring frame 160, 360,660, 760 can engage the neighboring anatomy of the ventricle 1004. As illustrated in FIG. 13, the segment 164 on the atrial portion 162, 362, 662, 762 engages the neighboring anatomy of the atrium 1006 and may be deflected from an original position (see broken lines in FIG. 13) to a deflected position (see solid lines for the segment 164 in FIG. 13). The skirt 178, 378, 678,778 of the ventricular portion 172, 372, 672, 772 of the expandable anchoring frame 160, 360,660, 760 can engage the neighboring anatomy of the ventricle 1004. In aspects, the ventricular portion 172, 372, 672, 772 is contoured and dimensioned to have a first fixation distance X above the notch 174 that is about 7 millimeters. In aspects, the ventricular portion 172, 372, 672, 772 is contoured and dimensioned to have a second fixation distance Y in the area of the skirt 178, 378, 678, 778 that is about 14 millimeters. In aspects, the first fixation distance X and the second fixation distance Y may be selected based on the anatomy of the surround target area to aid in the proper fixation of the transcatheter heart valve prosthesis 100, 300, 600, 700 in the heart 1002. As noted above, the skirt 178, 378, 678, 778 may be extend between about 180 degrees and 120 degrees about the end of the ventricular portion 172, 372, 672, 772. Based on the anatomy of the surrounding ventricle 1004, the surgeon may select the most suitable angular length for the skirt 178, 378, 678, 778 to aid in the proper fixation of the transcatheter heart valve prosthesis 100, 300, 600, 700 in the heart 1002.

[0070] FIGS. 14-16 illustrate another method of implanting the transcatheter heart valve prosthesis 100, 300, 600, 700 in the heart 1002, in accordance with aspects of the disclosure.As shown in FIG. 14, the transcatheter delivery assembly 1400 can include the first capsule portion 1410 and the second capsule portion 1420. A distal end of the first capsule portion is attached to a proximal end of a distal tip 1437 as further illustrated in FIG. 14. A proximal end of the first capsule portion 1410 engages a distal end of the second capsule portion 1420. The transcatheter heart valve prosthesis 100, 300, 600, 700 can be aligned in accordance with the aspects mentioned previously in regard to FIGS. 11-13.

[0071] Referring to FIG. 14, in this embodiment the transcatheter heart valve prosthesis 100, 300, 600, 700 (in the radially-compressed position) may be placed in the transcatheter delivery assembly 1400 which, in turn, may be inserted into the heart 1002. In the embodiment illustrated, the transcatheter delivery assembly 1400 is inserted through leaflets 1012 of the mitral valve 1010. The guidewire lumen 1022 may be used by the surgeon in inserting a distal end 1402 of the transcatheter delivery assembly 1400 through the mitral valve 1010. In aspects, the transcatheter delivery assembly 1400 may be inserted through other valves of the heart 1002.

[0072] The transcatheter delivery assembly 1400 is advanced distally until the ventricular portion 172, 372, 672, 772 of the expandable anchoring frame 160, 360, 660, 760 (FIGS. 1, 3, 6 and 7) of the transcatheter heart valve prosthesis 100, 300, 600, 700 may be positioned in the ventricle 1004. Referring to FIG. 15, the first capsule portion 1410 of the transcatheter delivery assembly 1400 may be withdrawn distally (see arrow E) away from the second capsule portion 1420 (e.g., via actuation of second rotating homeostasis valve 810) to allow the ventricular portion 172, 372, 672, 772 of the expandable anchoring frame 160, 360, 660, 760 (FIGS. 1, 3, 6 and 7) of the transcatheter heart valve prosthesis 100, 300, 600, 700 to be deployed from the first capsule portion 1410 (see arrows F). As the ventricular portion 172, 372, 672, 772 is deployed, the surgeon may reposition the transcatheter heart valve prosthesis 100, 300, 600, 700 so that the continued deployment of the transcatheter heart valve prosthesis 100, 300, 600, 700 expands against the leaflets 1012 of the mitral valve 1010 to compress the leaflets 1012 against the wall of the ventricle 1004 (see FIG. 16). The cleats 182 on the ventricular portion 172, 372, 672, 772 may aid in fixing the ventricular portion 172, 372, 672, 772 to the leaflets 1012. Sutures 1502 may connect the ventricular portion 172, 372, 672, 772 to the first capsule portion 1410 so that the surgeon may draw the ventricular portion 172, 372, 672, 772 back into the first capsule portion 1410, as needed. In aspects, the surgeon may draw the ventricular portion 172, 372,672, 772 back into the first capsule portion 1410 to aid in the proper positioning of the ventricular portion 172, 372, 672, 772 in the ventricle 1004.

[0073] Once the ventricular portion 172, 372, 672, 772 is positioned, the surgeon may control the deployment of the atrial portion 162, 362, 662, 762 of the expandable anchoring frame 160, 360, 660, 760 (e.g., move the transcatheter delivery assembly 1400 in the distal or proximal direction) such that the atrial portion 162, 362, 662, 762 deploys into the atrium 1006 of the heart 1002. See, arrow H in FIG. 16. Sutures 1604 (FIG. 16) may connect the atrial portion 162, 362, 662, 762 to the second capsule portion 1420 so that the surgeon may draw the atrial portion 162, 362, 662, 762 back into the second capsule portion 1420, as needed. In aspects, the surgeon may draw the transcatheter heart valve prosthesis 100, 300, 600, 700 back in to the first capsule portion 1410 or the second capsule portion 1420, as needed to adjust the position of the transcatheter heart valve prosthesis 100, 300, 600, 700 in the heart 1002 so the transcatheter heart valve prosthesis 100, 300, 600, 700 is placed in a target site (e.g., in the mitral valve 1010). In some embodiments, aligning the transcatheter heart valve prosthesis 100, 300, 600, 700 with the atrium 1006 and the ventricle 1004 may be aided by at least one radiopaque marker (not shown) engaged with the expandable anchoring frame 160, 360, 660, 760. In further embodiments, aligning the transcatheter heart valve prosthesis 100, 300, 600, 700 can include utilizing the guidewire lumen 1022. The cleats 166 on the atrial portion 162, 362, 662, 762 may aid in fixing the atrial portion 162, 362, 662, 762 to adjacent anatomy of the atrium 1006.

[0074] As discussed above for the prior embodiment, referring to FIG. 13, upon proper alignment of the transcatheter heart valve prosthesis 100, 300, 600, 700 into the atrium 1006 and the ventricle 1004 of the heart 1002, the transcatheter heart valve prosthesis 100, 300, 600, 700 may be positioned such that the atrial portion 162, 362, 662, 762 is positioned in the atrium 1006 and the ventricular portion 172, 372, 672, 772 is positioned in the ventricle 1004. In this position, the cleats 166 on the atrial portion 162, 362, 662, 762 of the expandable anchoring frame 160, 360, 660, 760 can engage the neighboring anatomy of the atrium 1006, and the cleats 182 on the ventricular portion 172, 372, 672, 772 of the expandable anchoring frame 160, 360,660, 760 can engage the neighboring anatomy of the ventricle 1004. As discussed in detail above, the segment 164 on the atrial portion 162, 362, 662, 762 engages the neighboring anatomy of the atrium 1006 and may be deflected from an original position (see broken lines in FIG. 13) to a deflected position (see solid lines forthe segment 164 in FIG. 13) and the skirt 178, 378, 678,778 of the ventricular portion 172, 372, 672, 772 of the expandable anchoring frame 160, 360,660, 760 can engage the neighboring anatomy of the ventricle 1004.

[0075] In accordance with the disclosure, non-limiting aspects of the disclosure will now be described. Various combinations of the aspects can be provided in accordance with the disclosure.

[0076] Example 1: A heart valve prosthesis comprising: an expandable stent frame comprising an interior area extending along an axis of the expandable stent frame between an atrial portion of the expandable stent frame and a ventricular portion of the expandable stent frame. A prosthetic valve structure is mounted within the interior area of the expandable stent frame. An expandable anchoring frame at least partially circumscribes the expandable stent frame. The expandable anchoring frame comprises an atrial portion of the expandable anchoring frame and a ventricular portion of the expandable anchoring frame. The atrial portion of the expandable anchoring frame comprises a circumferential segment that extends radially outward from an axis of the expandable stent frame. The circumferential segment is configured to deflect upon contact with native anatomy of a patient. The circumferential segment only partially circumscribes the axis of the expandable stent frame.

[0077] Example 2: The heart valve prosthesis of Example 1, wherein an outer surface of the expandable anchoring frame comprises at least one row of cleats.

[0078] Example 3: The heart valve prosthesis of Example 2, wherein the at least one row of cleats is configured to secure the expandable anchoring frame to a target site of the patient.

[0079] Example 4: The heart valve prosthesis of any one of Examples 1-3, wherein a notch is formed in an end of the ventricular portion of the expandable anchoring frame to form a skirt that extends circumferentially about the end of the ventricular portion of the expandable anchoring frame.

[0080] Example 5: The heart valve prosthesis of Example 4, wherein the skirt circumferentially extends between 120 degrees and 180 degrees about the end of the ventricular portion of the expandable anchoring frame.

[0081] Example 6: The heart valve prosthesis of Example 1, wherein fasteners secure the expandable anchoring frame and the expandable stent frame together.

[0082] Example 7: The heart valve prosthesis of Example 6, wherein the ventricular portion of the expandable anchoring frame and the atrial portion of the expandable anchoring frame are separate bodies that are independently secured to the expandable stent frame.

[0083] Example 8: The heart valve prosthesis of Example 6, wherein the ventricular portion of the expandable anchoring frame and the atrial portion of the expandable anchoring frame are separate bodies and at least one fastener secures both the ventricular portion of the expandable anchoring frame and the atrial portion of the expandable anchoring frame to the expandable stent frame.

[0084] Example 9: A method of implanting the heart valve prosthesis of Example 1 within a target site of the patient comprising: delivering the heart valve prosthesis to a heart valve of the patient while the heart valve prosthesis is in a collapsed orientation within a capsule of a transcatheter delivery device; aligning the heart valve prosthesis with at least a portion of an atrium of the patient and / or with at least a portion of a ventricle of the patient; and deploying the heart valve prosthesis from the capsule and allowing the heart valve prosthesis to expand such that the atrial portion of the expandable anchoring frame engages the atrium of the patient and the ventricular portion of the expandable anchoring frame engages the ventricle of the patient.

[0085] Example 10: The method of Example 9, wherein the step of aligning the heart valve prosthesis is aided by at least one radiopaque marker.

[0086] Example 11 : The method of Example 10, wherein the step of deploying the heart valve prosthesis includes proximally retracting the capsule relative to the heart valve prosthesis to open a distal end of the capsule and deploying at least a portion of the heart valve prosthesis from the interior of the capsule.

[0087] Example 12: The method of any one of Examples 9 or 10 wherein the capsule comprises a first capsule portion and a second capsule portion, wherein the ventricular portion of the expandable anchoring frame is disposed in the first capsule portion and the atrial portion of the expandable anchoring frame is disposed in the second capsule portion and wherein a proximal end of the first capsule portion is attached to a distal end of the second capsule portion.

[0088] Example 13 : The method of Example 12, wherein the step of deploying the heart valve prosthesis includes distally advancing the first capsule portion relative to the secondcapsule portion to deploy the ventricular portion of the expandable anchoring frame from the first capsule portion and to deploy the atrial portion of the expandable anchoring frame from the second capsule portion.

[0089] Example 14: A heart valve prosthesis comprising an expandable stent frame comprising an interior area extending along an axis of the expandable stent frame between an atrial portion of the expandable stent frame and a ventricular portion of the expandable stent frame. A prosthetic valve structure is mounted to the expandable stent frame within the interior area of the expandable stent frame. An expandable anchoring frame at least partially circumscribes the expandable stent frame. The expandable anchoring frame comprises an atrial portion of the expandable anchoring frame and a ventricular portion of the expandable anchoring frame. A notch is formed in an end of the ventricular portion of the expandable anchoring frame to form a skirt that extends circumferentially about the end of the ventricular portion of the expandable anchoring frame.

[0090] Example 15: The heart valve prosthesis of Example 14, wherein the skirt circumferentially extends between 120 degrees and 180 degrees about the end of the ventricular portion of the expandable anchoring frame

[0091] Example 16: The heart valve prosthesis of any one of Examples 14 or 15, wherein an outer surface of the expandable anchoring frame comprises at least one row of cleats.

[0092] Example 17: The heart valve prosthesis of Example 16, wherein the at least one row of cleats are configured to secure the expandable anchoring frame to a target site of a patient.

[0093] Example 18: A method of implanting the heart valve prosthesis of Example 14 within a target site of a patient comprising: delivering the heart valve prosthesis to a heart valve of a patient while the heart valve prosthesis is in a collapsed orientation within a capsule of a transcatheter delivery device; aligning the heart valve prosthesis with at least a portion of an atrium of the patient and / or with at least a portion of a ventricle of the patient; and deploying the heart valve prosthesis from the capsule and allowing the heart valve prosthesis to expand such that the atrial portion of the expandable anchoring frame engages the atrium of the patient and the ventricular portion of the expandable anchoring frame engages the ventricle of the patient.

[0094] Example 19: The method of Example 18, wherein the step of aligning the heart valve prosthesis is aided by at least one radiopaque marker.

[0095] Example 20: The method of Example 19, wherein the step of deploying the heart valve prosthesis includes proximally retracting the capsule relative to the heart valve prosthesis to open a distal end of the capsule and deploying at least a portion of the heart valve prosthesis from the interior of the capsule.

[0096] Example 21 : The method of any one of Examples 18 or 19 wherein the capsule comprises a first capsule portion and a second capsule portion, wherein the ventricular portion of the expandable anchoring frame is disposed in the first capsule portion and the atrial portion of the expandable anchoring frame is disposed in the second capsule portion and wherein a proximal end of the first capsule portion is attached to a distal end of the second capsule portion.

[0097] Example 22: The method of Example 21, wherein the step of deploying the heart valve prosthesis includes distally advancing the first capsule portion relative to the second capsule portion to deploy the ventricular portion of the expandable anchoring frame from the first capsule portion and to deploy the atrial portion of the expandable anchoring frame from the second capsule portion.

[0098] It should be understood that while various aspects have been described in detail relative to certain illustrative and specific examples thereof, the present disclosure should not be considered limited to such, as numerous modifications and combinations of the disclosed features are possible without departing from the scope of the following claims.

Claims

What is claimed is:

1. A heart valve prosthesis (100, 300, 600, 700) comprising:an expandable stent frame (132) comprising an interior area extending along an axis of the expandable stent frame (132) between an inflow end (136) and an outflow end (224);a prosthetic valve structure (210) mounted within the interior area of the expandable stent frame (132); andan expandable anchoring frame (160, 360, 660, 760) at least partially circumscribing the expandable stent frame (132), the expandable anchoring frame (160, 360, 660, 760) comprising an atrial portion (162, 362, 662, 762) of the expandable anchoring frame (160, 360, 660, 760) and a ventricular portion (172, 372, 672, 772) of the expandable anchoring frame (160, 360, 660, 760),wherein the atrial portion (162, 362, 662, 762) of the expandable anchoring frame (160, 360, 660, 760) comprises a circumferential segment (164, 664, 764) that extends radially outward from an axis of the expandable anchoring frame (160, 360, 660760), wherein the circumferential segment (164, 664, 764) is configured to deflect upon contact with native anatomy of a patient, andwherein the circumferential segment (164, 664, 764) only partially circumscribes the axis of the expandable anchoring frame (160, 360, 660, 760).

2. The heart valve prosthesis (100, 300, 600, 700) of claim 1, wherein an outer surface of the expandable anchoring frame (160, 360, 660, 760) comprises at least one row of cleats (166).

3. The heart valve prosthesis (100, 300, 600, 700) of claim 2, wherein the at least one row of cleats (166) is configured to secure the expandable anchoring frame (160, 360, 660, 760) to a target site of the patient.

4. The heart valve prosthesis (100, 300, 600, 700) of any one of claims 1-3, wherein a notch (174) is formed in an end (176) of the ventricular portion (172, 372, 672, 772) of the expandable anchoring frame (160, 360, 660, 760) to form a skirt (178, 378, 678, 778) thatextends circumferentially about the end (176) of the ventricular portion (172, 372, 672, 772) of the expandable anchoring frame (160, 360, 660, 760).

5. The heart valve prosthesis (100, 300, 600, 700) of claim 4, wherein the skirt (178, 378, 678, 778) circumferentially extends between 120 degrees and 180 degrees about the end (176) of the ventricular portion (172, 372, 672, 772) of the expandable anchoring frame (160, 360, 660, 760).

6. The heart valve prosthesis (100, 300, 600, 700) of claim 1, wherein fasteners (234) secure the expandable anchoring frame (160) and the expandable stent frame (132) together.

7. The heart valve prosthesis (300) of claim 6, wherein the ventricular portion (372) of the expandable anchoring frame (360) and the atrial portion (362) of the expandable anchoring frame (360) are separate bodies that are independently secured to the expandable stent frame (132).

8. The heart valve prosthesis (300) of claim 6, wherein the ventricular portion (372) of the expandable anchoring frame (360) and the atrial portion (362) of the expandable anchoring frame (360) are separate bodies and at least one fastener (234) secures both the ventricular portion (372) of the expandable anchoring frame (360) and the atrial portion (362) of the expandable anchoring frame (360) to the expandable stent frame (132).

9. A method of implanting the heart valve prosthesis (100, 300, 600, 700) of claim 1 within a target site of the patient comprising:delivering the heart valve prosthesis (100, 300, 600, 700) to a heart valve (1010) of the patient while the heart valve prosthesis (100, 300, 600, 700) is in a collapsed orientation within a capsule (826) of a transcatheter delivery device;aligning the heart valve prosthesis (100, 300, 600, 700) with at least a portion of an atrium (1006) of the patient and / or with at least a portion of a ventricle (1004) of the patient; anddeploying the heart valve prosthesis (100, 300, 600, 700) from the capsule (826) and allowing the heart valve prosthesis (100, 300, 600, 700) to expand such that the atrial portion (162, 362, 662, 762) of the expandable anchoring frame (160, 360, 660, 760) engages the atrium (1006) of the patient and the ventricular portion (172, 372, 672, 772) of the expandable anchoring frame (160, 360, 660, 760) engages the ventricle (1004) of the patient.

10. The method of claim 9, wherein the step of aligning the heart valve prosthesis (100, 300, 600, 700) is aided by at least one radiopaque marker.

11. The method of claim 10, wherein the step of deploying the heart valve prosthesis (100, 300, 600, 700) includes proximally retracting the capsule (826) relative to the heart valve prosthesis (100, 300, 600, 700) to open a distal end (802) of the capsule (826) and deploying at least a portion of the heart valve prosthesis (100, 300, 600, 700) from the interior of the capsule (826).

12. The method of any one of claims 9 or 10 wherein the capsule (826) comprises a first capsule portion (1410) and a second capsule portion (1420), wherein the ventricular portion (172, 372, 672, 772) of the expandable anchoring frame (160, 360, 660,760) is disposed in the first capsule portion (1410) and the atrial portion (162, 362, 662, 762) of the expandable anchoring frame (160, 360, 660,760) is disposed in the second capsule portion (1420) and wherein a proximal end of the first capsule portion (1410) is attached to a distal end of the second capsule portion (1420).

13. The method of claim 12, wherein the step of deploying the heart valve prosthesis (100, 300, 600, 700) includes distally advancing the first capsule portion (1410) relative to the second capsule portion (1420) to deploy the ventricular portion (172, 372, 672, 772) of the expandable anchoring frame (160, 360, 660,760) from the first capsule portion (1410) and to deploy the atrial portion (162, 362, 662, 762) of the expandable anchoring frame (160, 360, 660,760) from the second capsule portion (1420).

Images