Prosthetic heart valve implant

Abstract

A prosthetic heart valve assembly includes a heart valve prosthesis including an annular frame extending along a valve axis between a first valve end of the heart valve prosthesis and a second valve end of the heart valve prosthesis. The annular frame includes a plurality of frame members and is adjustable between a radially-collapsed configuration and a radially-expanded configuration. The heart valve prosthesis includes a plurality of prosthetic leaflets attached to the annular frame. The prosthetic heart valve assembly includes an anchoring element positioned within the heart valve prosthesis. The anchoring element includes a support frame that contacts the annular frame and applies an outward radial force to the annular frame in a radial direction away from the valve axis. Methods of implanting a heart valve prosthesis are provided.

Description

ATTORNEY DOCKET No. A0012587W001PROSTHETIC HEART VALVE IMPLANTCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 733,894, filed December 13, 2024, and U.S. Provisional Patent Application Serial No. 63 / 932,347, filed December 5, 2025, the entire contents of which are incorporated herein by reference.FIELD

[0002] The present disclosure relates generally to a prosthetic heart valve assembly and, more particularly, to an anchoring protrusion that assists in positioning the heart valve prosthesis at a patient’s aortic annulus.BACKGROUND

[0003] It is known to provide a prosthetic heart valve assembly for implanting a heart valve prosthesis within a target site of the vasculature of a patient. The heart valve prosthesis can be moved from a radially-contracted position to a radially-expanded position. However, positioning the heart valve prosthesis in native leaflets with no or minimal calcification for anchoring can be difficult.SUMMARY

[0004] The following presents a simplified summary of the disclosure to provide a basic understanding of some aspects described in the detailed description.

[0005] In aspects, a prosthetic heart valve assembly comprises a heart valve prosthesis comprising an annular frame extending along a valve axis between a first valve end of the heart valve prosthesis and a second valve end of the heart valve prosthesis. The annular frame comprises a plurality of frame members and is configured to be adjustable between a radially-collapsed configuration and a radially-expanded configuration. A plurality of prosthetic leaflets are attached to the annular frame. An anchoring element is positioned within the heart valve prosthesis. The anchoring element comprises a support frame that is configured to contact the annular frame and apply an outward radial force to the annular frame in a radial direction away from the valve axis.ATTORNEY DOCKET No. A0012587W001

[0006] In aspects, a transcatheter heart valve delivery assembly comprises a heart valve prosthesis comprising an annular frame extending along a valve axis between a first valve end of the heart valve prosthesis and a second valve end of the heart valve prosthesis. The annular frame comprises a plurality of frame members and configured to be adjustable between a radially-collapsed configuration and a radially-expanded configuration. A plurality of prosthetic leaflets are attached to the annular frame. An anchoring element comprises a support frame that is configured to contact the annular frame and apply an outward radial force to the annular frame in a radial direction away from the valve axis. The anchoring element is configured to be adjustable between a radially-collapsed configuration and a radially-expanded configuration. A capsule is configured to circumferentially surround at least one of the heart valve prosthesis and the anchoring element when the heart valve prosthesis and the anchoring element are in the radially-collapsed configuration. The capsule, the heart valve prosthesis, and the anchoring element are configured to be advanced through a patient’s vasculature to a treatment site.

[0007] In aspects, methods for implanting a heart valve prosthesis are provided. Methods comprise providing a heart valve prosthesis comprising a frame and leaflets, the frame extending between a first valve end and a second end. Methods comprise providing an anchoring element comprising a support frame. Methods comprise advancing a delivery assembly through a heart valve to deliver the heart valve prosthesis and the anchoring element. Methods comprise partially expanding the heart valve prosthesis. Methods comprise deploying the anchoring element inside of the partially-expanded heart valve prosthesis at the first valve end. Methods comprise fully-expanding the heart valve prosthesis and releasing the heart valve prosthesis from the delivery assembly.

[0008] In aspects, an expandable stent frame comprises a stent structure extending along an elongated axis of the expandable stent frame between a proximal end portion of the stent structure and a distal end portion of the stent structure. The stent structure is configured to expand from a radially-collapsed configuration to a radially-expanded configuration. The expandable stent frame comprises a plurality of anchors coupled to the distal end portion of the stent structure and spaced around the elongated axis. Each anchor of the plurality of anchors extends distally from a distal end of the distal end portion of the stent structure and is configured to transition from a straightened orientation to a radially flared orientation.ATTORNEY DOCKET No. A0012587W001

[0009] In aspects, an expandable stent frame comprises a stent structure extending along an elongated axis between a proximal end portion of the stent structure and a distal end portion of the stent structure. The stent structure is configured to expand from a radially- collapsed configuration to a radially-expanded configuration. The expandable stent frame comprises an expandable ring coupled to the distal end portion of the stent structure and circumscribing the elongated axis. The expandable ring extending distally from a distal end of the distal end portion of the stent structure along the elongated axis. The expandable ring comprises a plurality of anchors configured move from a retracted orientation to a radially projected orientation when the expandable ring is expanded from a radially-contracted orientation to a radially-expanded orientation.

[0010] In aspects, methods of expanding an expandable stent frame comprise expanding a stent structure of the expandable stent frame from a radially-collapsed configuration to a radially-expanded configuration. The methods comprise transitioning a plurality of anchors coupled to a distal end portion of the stent structure from a straightened orientation to a radially flared orientation.

[0011] In aspects, methods of expanding an expandable stent frame comprise at least partially expanding a stent structure of the expandable stent frame from a radially-collapsed configuration to a radially-expanded configuration. The methods comprise expanding an expandable ring coupled to a distal end portion of the stent structure. The method further comprising moving a plurality of anchors of the expandable ring from a retracted orientation to a radially projected orientation.

[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.ATTORNEY DOCKET No. A0012587W001BRIEF 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 schematically illustrates example aspects of a transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0015] FIG. 2 illustrates a top-down view of the transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0016] FIG. 3 illustrates a side view of a delivery assembly for delivering the transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0017] FIG. 4 illustrates a side view of the delivery assembly for delivering the transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0018] FIG. 5 illustrates an introducer sheath in accordance with aspects of the disclosure;

[0019] FIG. 6 illustrates an introducer sheath in accordance with aspects of the disclosure;

[0020] FIG. 7 schematically illustrates a side view of a transcatheter heart valve prosthesis positioned at a treatment site in accordance with aspects of the disclosure;

[0021] FIG. 8 illustrates an example of a transcatheter heart valve prosthesis and an anchoring element in accordance with aspects of the disclosure;

[0022] FIG. 9 illustrates the anchoring element in a radially-expanded position in accordance with aspects of the disclosure;

[0023] FIG. 10 illustrates an example of a transcatheter heart valve prosthesis and an anchoring element in accordance with aspects of the disclosure;

[0024] FIG. 11 illustrates the anchoring element in a radially-expanded position in accordance with aspects of the disclosure;

[0025] FIG. 12 illustrates an example of anchoring protrusions in accordance with aspects of the disclosure;

[0026] FIG. 13 illustrates the anchoring element in a radially-contracted position in accordance with aspects of the disclosure;

[0027] FIG. 14 illustrates the anchoring element in a radially-expanded position in accordance with aspects of the disclosure;ATTORNEY DOCKET No. A0012587W001

[0028] FIG. 15 illustrates an example of anchoring protrusions in accordance with aspects of the disclosure;

[0029] FIG. 16 illustrates an example of anchoring protrusions in accordance with aspects of the disclosure;

[0030] FIG. 17 illustrates an example of deploying the transcatheter heart valve prosthesis and the anchoring element in accordance with aspects of the disclosure;

[0031] FIG. 18 illustrates an example of deploying the transcatheter heart valve prosthesis and the anchoring element in accordance with aspects of the disclosure;

[0032] FIG. 19 illustrates an example of deploying the transcatheter heart valve prosthesis and the anchoring element in accordance with aspects of the disclosure;

[0033] FIG. 20 illustrates an example of deploying the transcatheter heart valve prosthesis and the anchoring element in accordance with aspects of the disclosure;

[0034] FIG. 21 illustrates an example of deploying the transcatheter heart valve prosthesis and the anchoring element in accordance with aspects of the disclosure;

[0035] FIG. 22 illustrates an example of deploying the transcatheter heart valve prosthesis and the anchoring element in accordance with aspects of the disclosure;

[0036] FIG. 23 illustrates an example of an anchoring element in a radially-contracted position in accordance with aspects of the disclosure;

[0037] FIG. 24 illustrates an example of the anchoring element in a radially-expanded position in accordance with aspects of the disclosure;

[0038] FIG. 25 illustrates a side view of an embodiment of an expandable stent frame in a radially-collapsed configuration in accordance with aspects of the disclosure;

[0039] FIG. 26 illustrates a side view of the expandable stent frame of FIG. 25 in a radially-expanded configuration in accordance with aspects of the present disclosure;

[0040] FIG. 27 illustrates a top-down view taken along line 27-27 of FIG. 26 illustrating leaflets coupled to the expandable frame of FIGS. 25 and 26 in accordance with aspects of the present disclosure;

[0041] FIG. 28 illustrates a side view of the expandable stent frame of FIG. 27 with a plurality of anchors in a radially flared orientation in accordance with aspects of the present disclosure;ATTORNEY DOCKET No. A0012587W001

[0042] FIG. 29 illustrates a schematic enlarged view taken at view 29 of FIG. 26 illustrating the plurality of anchors in a straightened orientation in accordance with aspects of the present disclosure;

[0043] FIG. 30 illustrates a schematic enlarged view taken at view 30 of FIG. 28 illustrating the plurality of anchors in the radially flared orientation in accordance with aspects of the present disclosure;

[0044] FIG. 31 is a schematic flow chart illustrating an exemplary method of expanding the expandable frame of FIGS. 25-30 in accordance with aspects of the present disclosure;

[0045] FIG. 32 illustrates a side view of another embodiment of an expandable stent frame in a radially-collapsed configuration in accordance with aspects of the disclosure;

[0046] FIG. 33 illustrates a side view of an expandable ring of the expandable stent frame of FIG. 32 in accordance with aspects of the present disclosure;

[0047] FIG. 34 illustrates a top-down view of the expandable ring taken along line 34-34 of FIG. 33 in accordance with aspects of the present disclosure;

[0048] FIG. 35 illustrates a top-down view of the expandable ring taken along line 34- 34 of FIG. 33 showing a plurality of anchors in a radially projected orientation in accordance with aspects of the present disclosure;

[0049] FIG. 36 illustrates a schematic perspective view of the expandable ring showing the plurality of anchors in the radially projected orientation in accordance with aspects of the present disclosure;

[0050] FIG. 37 illustrates a side view of the expandable stent frame of FIG. 32 in a radially-expanded configuration with the plurality of anchors in the radially flared orientation in accordance with aspects of the present disclosure;

[0051] FIG. 38 illustrates a top-down view taken along line 38-38 of FIG. 37 illustrating leaflets coupled to the expandable frame of FIGS. 32 and 37 in accordance with aspects of the present disclosure; and

[0052] FIG. 39 is a schematic flow chart illustrating an exemplary method of expanding the expandable frame of FIGS. 32-38 in accordance with aspects of the present disclosure.ATTORNEY DOCKET No. A0012587W001DETAILED DESCRIPTION

[0053] 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.

[0054] 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.

[0055] 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.

[0056] 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.

[0057] 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.ATTORNEY DOCKET No. A0012587W001

[0058] 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.

[0059] The words “exemplary,” “example,” or various forms thereof are used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein as “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.

[0060] 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.

[0061] 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.

[0062] 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.

[0063] 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,ATTORNEY DOCKET No. A0012587W001 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-exhaustive exemplary 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, rhenium, 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, trans-polyisoprene, 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. The present application is not intended to be limiting to self-expanding valve or stent structures of the prostheses hereof, and, can comprise mechanically-expanding valve or stent structures or balloonexpanding valve or stent structures. As used herein, a mechanically-expanding valve (or stent) can be deployed and expanded by a mechanical structure, while a balloon-expandable valve (or stent) can be deployed and expanded by a balloon (e.g., as described below).

[0064] 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 canATTORNEY DOCKET No. A0012587W001 increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and / or life threatening. In aspects, aortic regurgitation (AR) may occur when a native aortic valve does not close properly due to damage to native leaflets, or as a result of dilation of the aortic annulus, which may occur with non-calcified native leaflets. In this way, aortic regurgitation can pose challenges when implanting a valve prosthesis at a treatment site. As described below, in a situation when aortic regurgitation occurs, anchoring protrusions (e.g., described relative to FIGS. 8-24) can be provided as additional means to anchor into native leaflets and / or annulus. Accordingly, methods of implanting a heart valve prosthesis described herein can be for treating aortic regurgitation wherein native valve leaflets are non-calcified. Alternatively, if the native valve leaflets are calcified to some degree (e.g., for mild amount of calcification), the methods described herein can be for treating aortic regurgitation and replacing a native heart valve.

[0065] 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 (e.g. self-expanding, balloon-expanding, mechanically expanding) to engage tissue at the diseased heart valve region to, for instance, hold the heart valve prosthesis in position.

[0066] FIGS. 1 and 2 illustrate an example transcatheter heart valve prosthesis 10. The delivery assemblies described herein may be used with the transcatheter heart valve prosthesis 10 and / or other transcatheter heart valve prostheses. The transcatheter heart valve prosthesis 10 is illustrated to facilitate description of the disclosure. The following description of the transcatheter heart valve prosthesis 10 is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention.

[0067] FIGS. 1 and 2 illustrate a side view and a top / end view, respectively, of the transcatheter heart valve prosthesis 10. The transcatheter heart valve prosthesis 10 includes a radially-expandable frame or stent 15 and a prosthetic valve 20. The frame 15 of the transcatheter heart valve prosthesis 10 supports the prosthetic valve 20 within an interior ofATTORNEY DOCKET No. A0012587W001 the frame 15. In the example transcatheter heart valve prosthesis 10 shown in FIGS. 1 and 2, the frame 15 is self-expandable. However, this is not meant to be limiting, and the frame 15 can be balloon-expandable or mechanically expandable in other embodiments. In some embodiments, the transcatheter heart valve prosthesis 10 may be delivered to and implanted at a treatment site within a patient to replace any of an aortic valve, a pulmonic valve, a mitral valve, or a tricuspid valve. The valve to be replaced may be a native valve or a previously-implanted prosthetic valve, such as a failed surgical replacement valve or a failed transcatheter valve.

[0068] The prosthetic valve 20 includes at least one leaflet 21 disposed within and secured to the frame 15. In the embodiment shown in FIGS. 1 and 2, the prosthetic valve20 includes exactly three leaflets 21, as shown in FIG. 2. However, this is not meant to be limiting, as the prosthetic valve 20 may include more or fewer leaflets 21. The valve leaflets21 open and close to regulate flow through the transcatheter heart valve prosthesis 10. As shown in FIG. 1, the transcatheter heart valve prosthesis 10 includes an inflow end (e.g., first valve end 11) and an outflow end (e.g., second valve end 12). The prosthetic leaflets 21 are attached to the frame 15 at commissures 25 such that when pressure at the first valve end 11 exceeds pressure at the second valve end 12, the prosthetic leaflets 21 open to allow blood flow through the heart valve prosthesis 10 from the first valve end 11 to the second valve end 12. When the pressure at the second valve end 12 exceeds pressure at the first valve end 11, the prosthetic leaflets 21 close to prevent blood flow from the second valve end 12 to the first valve end 11. Accordingly, the at least one leaflet (e.g., the prosthetic leaflets 21) can be attached to the plurality of struts 16, for example, by being directly attached to the plurality of struts 16 at the commissures 25, or by being indirectly attached to the plurality of struts 16, for example, by being attached to a skirt, a commissure bracket, or other structure (e.g., mechanical actuator) that is attached to the plurality of struts 16.

[0069] In aspects, the heart valve prosthesis 10 can comprise one or more attachment members 24 (e.g., paddles) positioned at an end, for example, the first valve end 11 or the second valve end 12. The attachment members 24 can be received within pockets of a spindle 38 (e.g., illustrated in FIG. 4), such that the spindle 38 and the attachment members 24 can interact to facilitate loading of the transcatheter heart valve prosthesis 10 and, in aspects, allow for possible recapture of the transcatheter heart valve prosthesis 10 during the deployment process. In aspects, and as described below, the attachment members 24ATTORNEY DOCKET No. A0012587W001 can be attached to either of the first valve end 11 or the second valve end 12. As such, the spindle 38 is configured to be positioned to receive the attachment members 24 either (1) adjacent to the first valve end 11 when the attachment members 24 are attached to the first valve end 11, or (2) adjacent to the second valve end 12 when the attachment members 24 are attached to the second valve end 12. Accordingly, the position of the attachment members 24 illustrated in FIG. 1 is merely exemplary.

[0070] The frame 15 of the transcatheter heart valve prosthesis 10 further includes a plurality of struts 16 that are arranged to form a plurality of openings or cells 18 arranged circumferentially around a longitudinal axis LA of the transcatheter heart valve prosthesis 10 and longitudinally to form a tubular structure defining a central lumen of the transcatheter heart valve prosthesis 10. For example, the frame 15 can extend along the longitudinal axis LA between the first valve end 11 and the second valve end 12. The frame 15 is configured to secure the prosthetic valve 20 within the central lumen of the frame 15 and to secure the transcatheter heart valve prosthesis 10 in place in the vasculature of the patient. The struts 16 are defined herein as the elongated wire segments of the frame 15. Struts 16 come together to form crowns 17 or nodes 19, as can be seen in FIG. 1. The frame 15 of the heart valve prosthesis 10 includes a plurality of cells 18 defined as the spaces between the plurality of crowns 17, the plurality of nodes 19, and the plurality of struts 16. The frame 15, and, thus, the plurality of struts 16, can be adjustable between a radially-collapsed position and a radially-expanded position.

[0071] In the example embodiment shown in FIG. 1, the plurality of cells 18 may be diamond-shaped. In the example embodiment shown, the plurality of cells includes a plurality of first cells 18 and, in aspects, access cells (e.g., an access cell 23). In particular, the access cells may be larger than the first cells 18 and can provide access to one or more coronary arteries when the transcatheter heart valve prosthesis 10 is implanted in the patient. FIG. 1 illustrates an example of an access cell 23, with the struts 16 at the access cell 23 illustrated with dashed lines to show that the struts 16 may not be present at the access cell 23, thus allowing for the access cell 23 to be larger than the first cells 18. The access cells can have an enlarged area relative or compared to the first cells 18. In some embodiments the transcatheter heart valve prosthesis 10 may include an outer skirt extending circumferentially around an outer circumference of the stent 15 at or near the first valve endATTORNEY DOCKET No. A0012587W00111 to prevent paravalvular leakage of blood around the outside of the transcatheter heart valve prosthesis 10 once implanted in the patient.

[0072] FIGS. 3 and 4 show schematically side views of a transcatheter heart valve delivery assembly 30 (e.g., “delivery assembly”) for delivering and deploying a transcatheter heart valve prosthesis (e.g., transcatheter heart valve prosthesis 10) according to embodiments hereof. One skilled in the art will realize that FIGS. 3 and 4 illustrate one example of a delivery assembly 30 and that components illustrated in FIGS. 3 and 4 may be removed and / or additional components may be added. The delivery assembly 30 includes a distal end 31, a proximal end 32, and a handle 33. The handle 33 enables a physician to manipulate a distal portion of the delivery assembly 30 and includes actuators for moving parts of the delivery assembly 30 relative to other parts. In the delivery assembly 30, an outer shaft 34 is coupled to an actuator 39 of the handle 33 for moving the outer shaft 34 relative to an inner shaft 36.

[0073] A distal portion of the outer shaft 34, referred to as a capsule 35, is configured to surround a transcatheter heart valve prosthesis (e.g., transcatheter heart valve prosthesis 10) during delivery to the treatment site (e.g., a native heart valve) and is retracted from the transcatheter heart valve prosthesis to expose the transcatheter heart valve prosthesis such that it self-expands (in self-expanding embodiments). In this way, the capsule 35 is in frictional engagement with the heart valve prosthesis 10. The inner shaft 36 can be coupled to the handle 33 (e.g., by being directly connected and in contact with the handle 33, or by being indirectly connected to the handle 33 with intermediate structures between the inner shaft 36 and the handle 33) and movement of the handle 33 can translate to movement of the inner shaft 36 and a distal tip or nosecone 37 coupled to a distal end of the inner shaft 36. The inner shaft 36 and distal tip or nosecone 37 may also be translated relative to the outer shaft 34 and the handle 33 via a tip retractor. In the embodiment shown, the inner shaft 36 includes a retainer or spindle 38 for receiving the paddles (e.g., attachment members 24) of the transcatheter heart valve prosthesis 10.

[0074] When the actuator 39 is actuated, the actuator 39 moves the outer shaft 34 and the capsule 35 relative to the inner shaft 36, as shown in FIG. 4. As known to those skilled in the art, when the delivery assembly 30 is in position such that the transcatheter heart valve prosthesis 10 is at the desired position at the treatment site in the patient’s vasculature, the actuator 39 is actuated (e.g., rotated) to move the capsule 35 relative to the inner shaft 36ATTORNEY DOCKET No. A0012587W001 and the transcatheter heart valve prosthesis 10 disposed between the inner shaft 36 and the capsule 35, thereby enabling the transcatheter heart valve prosthesis 10 to deploy via selfexpansion at the treatment site and release from the retainer 38, as shown in FIG. 4 (without showing the transcatheter heart valve prosthesis 10).

[0075] Minimally invasive percutaneous interventional procedures, including endovascular procedures, require access to the venous or arterial system. In general, it is desirable to make the smallest incision point with the shortest tissue contact time when entering the body. Small incisions and short tissue contact time generally lead to improved patient outcomes, less complications, and less trauma to the vessels or organs being accessed, as well as less trauma to the skin and tissue through which the access point is created. Access is required for various medical procedures that deliver or implant structural elements (such as heart valves, heart valve repair devices, occluders, grafts, electrical stimulators, leads, etc.) percutaneously. Some procedures employ relatively large devices that require relatively large sheaths to deliver the devices to the intended site within the body. With such procedures, access site trauma can occur, often resulting in vessel damage, excessive bleeding, increased case time, increased risk of infection, and increased hospitalization time. To reduce access trauma, physicians try to use the smallest devices possible and place the smallest sheath size. This can be problematic, however, if during the procedure the physician discovers a larger device is needed. This leads to a need to upsize the sheath, which is a lengthy procedure and leads to increased risk to the patient. Expandable sheaths can be expanded within the body and thus do not require removal to upsize.

[0076] Expandable sheath designs may be regionally or locally expansive to selectively and temporarily expand when the device is passing through a region of the sheath and to retract or recover when the device is not passing or has already passed through the sheath. Embodiments disclosed herein may be employed with an expandable introducer sheath that may solve these and other issues that contribute to vascular trauma. The expandable introducer sheath is described with respect to percutaneous access for transcatheter heart valve repair or replacement, and it should be understood that one or more features of the expandable introducer sheath may be employed alone or in combination for other medical procedures requiring percutaneous access, including but not limited to placement of stents, angioplasty, removal of arterial or venous calcification, and pre-dilatation or post-dilatation.ATTORNEY DOCKET No. A0012587W001

[0077] Various embodiments disclosed herein may include an introducer sheath that has a selectively expandable diameter to allow for the passage of a relatively larger device therethrough and further is configured to return to its original diameter upon passage of the device. The various embodiments may reduce damage to surrounding tissues by reducing contact with those tissues and by eliminating the need to exchange sheaths of different sizes. As a result, these embodiments can reduce procedure time, vascular trauma, bleeding, and the resulting risk of infection and other complications. In other embodiments, a nonexpandable sheath maybe used, of which, might either be assembled on the transcatheter heart valve delivery assembly 30 - i.e. inline sheath, or be a separate component.

[0078] FIGS. 5 and 6 depict one embodiment of an introducer sheath 50 positioned through an incision 60 in the skin 65 of a patient and into a vessel 40 of a patient. The sheath 50 has a tubular shaft 55 and a proximal hub 56 with a hemostatic seal and a luer lock 57. FIG. 5 shows the sheath 50 positioned in the vessel 40 in its normal, unexpanded state, while FIG. 6 shows the sheath 50 positioned in the vessel 40 with a delivery device 75 delivering another device 70 that is being advanced through the sheath 50 such that the tubular shaft 55 expands or deforms at the location where the device 70 is passing through. The shaft 55 expands at expanded region 58 when the device 70 passes through and then retracts or recovers to its original diameter after the device 70 moves past or is removed from the shaft 55. Thus, the tubular shaft 55 is configured to be expandable and retractable.

[0079] In certain embodiments, the expandability of the shaft 55 (and any shaft described according to any embodiment set forth herein) is achieved via the elasticity of the shaft 55, which can result in the shaft 55 being either self-expandable or self-expanding or mechanically expandable or mechanically expanding. For purposes of this application, selfexpandable means that the shaft 55 is configured to expand to a predetermined or nominal diameter automatically (without any type of actuation, mechanical or otherwise). Further, for purposes of this application, mechanically expandable means that the shaft 55 is configured to expand when a positionable medical device is positioned through the shaft 55. That is, the device itself that is being passed through the shaft 55 causes the expansion of the shaft 55, as depicted in FIG. 6. Alternatively, the expandable characteristics of the shaft 55 can be caused by something other than elasticity.

[0080] After passage of the device, the shaft 55 is configured to be contractable, retractable, or recoverable to its original, unexpanded state as depicted in FIG. 5. TheATTORNEY DOCKET No. A0012587W001 retractability can be, in certain embodiments, achieved by the elasticity of the shaft 55, which can result in the shaft 55 being either self-retractable or self-retracting, self- recoverable, or self-contractable, or mechanically retractable or mechanically retracting, mechanically recoverable, or mechanically contractable. For purposes of this application, self-retractable means that the shaft 55 is configured to retract to a predetermined or nominal diameter automatically (without any type of actuation, mechanical or otherwise). Further, for purposes of this application, mechanically retractable means that the shaft 55 is configured to retract when a device or component is used to cause the shaft 55 to retract or recover. Alternatively, the retractable characteristics of the shaft 55 can be caused by something other than elasticity.

[0081] For purposes of this application, any device that can be positioned through an introducer sheath according to any embodiment disclosed or contemplated herein can be referred to as a positionable medical device or insertable medical device. Such devices include guidewires, dilators, delivery devices (for delivery and / or placement of structural elements such as heart valves, heart valve repair devices, occluders, grafts, electrical stimulators, leads, etc.), guide catheters, guiding sheaths, diagnostic catheters, stent delivery systems, balloon catheters, and other known vascular devices. Other devices can include non-vascular devices such as scopes and other common surgical instruments. Further, the introducer sheath is configured to receive tissues or organs. Thus, as one non-limiting example, the introducer sheath 50 is described as being an expandable introducer sheath 50 for introduction of a delivery assembly 30 including a transcatheter heart valve prosthesis 10.

[0082] FIG. 7 illustrates the heart valve prosthesis 10 at a treatment site 701 within a patient’s vasculature. In aspects, the treatment site 701 can comprise a location of a native annulus (hereinafter “annulus”) 703 of a native heart valve, for example, the annulus of a patient’s aortic valve. The treatment site 701 can comprise one or more native valve leaflets 705 and corresponding native sinuses 707. In some instances, paravalvular leakage can occur when blood travels through a gap 709 around the outside of the transcatheter heart valve prosthesis 10, with the gap 709 formed between the transcatheter heart valve prosthesis 10 and the annulus 703. To avoid paravalvular leakage, the heart valve prosthesis 10 can be radially expanded such that an outer radial surface of the heart valve prosthesis 10 can contact the annulus 703 and / or the native valve leaflets 705, thus reducing orATTORNEY DOCKET No. A0012587W001 eliminating the gap 709 and causing the blood to flow through the central lumen of the heart valve prosthesis 10. The heart valve prosthesis 10 can comprise the frame 15, which can comprise an asymmetric hourglass shape with a first section 713 at the first valve end 11, a second section 715 at the second valve end 12, and a waist section 717 positioned between the first section 713 and the second section 715. In aspects, the first section 713 can comprise a first diameter 721 and the second section 715 can comprise a second diameter 723, with the second diameter 723 greater than the first diameter 721. In some embodiments, both the first section 713 at the first valve end 11 and waist section 717 positioned between the first section 713 and the second section 715, comprise a first diameter 721; while in other embodiments, the waist section 717 positioned between the first section 713 and the second section 715, comprises a diameter less than a first diameter 721. Additionally, in some embodiments the transcatheter heart valve prosthesis 10 may include an outer skirt extending circumferentially around an outer circumference of the frame 15 at or near the first valve end 11 to prevent paravalvular leakage of blood around the outside of the transcatheter heart valve prosthesis 10 once implanted in the patient.

[0083] FIG. 8 illustrates a side view of an example of the heart valve prosthesis 10. In aspects, one or more anchoring protrusions 801 can be attached to the annular frame 15. The anchoring protrusions 801 can move between a retracted position (e.g., as illustrated in FIG. 8) and an extended position (e.g., as illustrated in FIG. 9). In this way, when the anchoring protrusions 801 are in the retracted position, the anchoring protrusions 801 do not extend radially outwardly from the frame 15 and may be located within the interior lumen of the frame 15. Alternatively, when the anchoring protrusions 801 are in the extended position, the anchoring protrusions 801 extend radially outwardly from the frame 15, and may be at least partially located radially outside of the frame 15. As will be described herein, when the anchoring protrusions 801 are in the extended position, the anchoring protrusions 801 can function to secure the heart valve prosthesis 10 within the native aortic annulus 703 by engaging structures (e.g., native valve leaflets 705 of FIG. 7, for example) adjacent to the native aortic annulus 703. The anchoring protrusions 801 may be biased toward the retracted position in which the anchoring protrusions 801 are disposed within the annular frame 15. That is, in the absence of a force acting upon the anchoring protrusions 801, the anchoring protrusions 801 may be biased to remain in the retracted position illustrated in FIG. 8. To bias the anchoring protrusions 801 toward the retracted position,ATTORNEY DOCKET No. A0012587W001 the anchoring protrusions 801 may be shape-set inward, such that the anchoring protrusions 801 may not engage the native valve leaflets 705 until the anchoring protrusions 801 have been moved to the extended position.

[0084] Each anchoring protrusion 801 can comprise an arm 803 that extends between a first arm end 805 and a second arm end 807. The first arm end 805 is attached to the frame 15, and the second arm end 807 extends away from the first arm end 805 and away from the frame 15 (e.g., and is not attached to the frame 15). In this way, when the anchoring protrusion 801 is in the extended position, the second arm end 807 can contact and engage the native valve leaflets 705. By moving from the retracted position to the extended position, the first arm end 805 can move (e.g., pivot) relative to the frame 15 to allow for the second arm end 807 to extend radially outwardly from the frame 15 toward the native valve leaflets 705. In aspects, the arm 803 can extend linearly or non-linearly between the first arm end 805 and the second arm end 807. By extending non-linearly, the arm 803 can comprise a bend, curve, corner, right angle, or other shape between the first arm end 805 and the second arm end 807. As illustrated in FIG. 8, the arm 803 can extend from the first arm end 805 toward the second arm end 807 in a direction toward the first valve end 11 when the arm 803 is in the retracted position. In this way, a distance separating the second arm end 807 and the first valve end 11 may be less than a distance separating the first arm end 805 and the first valve end 11. However, as explained below relative to FIG. 10, such a configuration is not intended to be limiting, and the positions of the first arm end 805 and the second arm end 807 can be reversed. Furthermore, such configurations for each arm 803 within select cells along the frame 15 could be in the same position / direction, could be in alternating positions / directions, and / or could be in any combination of positions / directions. Further, any of the anchoring protrusions described herein can comprise one or more of the following materials: 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, rhenium, or other metal.

[0085] The heart valve delivery assembly 30 can comprise an anchoring element 811 to increase radial stiffness of the frame 15, at the native aortic annulus 703 and surrounding structures (e.g. leaflets, left ventricular outflow tract, aorta). Additionally, in aspects where one or more anchoring protrusions 801 are included in the annular frame 15, the anchoring element 811 can facilitate movement of the anchoring protrusion 801 from the retractedATTORNEY DOCKET No. A0012587W001 position to the extended position. In this way, the anchoring element 811 (e.g., and any other anchoring elements described herein) can provide multiple benefits, at least some of which relate to increasing radial stiffness of the frame 15, and other benefits related to moving anchoring protrusions from the radially-retracted to the radially-extended position. The anchoring element 811 can be moved to be positioned within the heart valve prosthesis 10 during delivery and deployment of the heart valve prosthesis 10. The anchoring element 811 can comprise a support frame 813 that is radially expandable between a compressed position and an expanded position. FIG. 8 illustrates the anchoring element 811 in the compressed position, while FIG. 9 illustrates the anchoring element 811 in the expanded position. In the compressed position, the anchoring element 811 can comprise a smaller radius than in the expanded position, such that, in the compressed position, the anchoring element 811 may not contact an interior of the frame 15 of the heart valve prosthesis 10. As will be described herein, the anchoring element 811 can be expanded in several ways, such as, for example, by being balloon expandable. In additional embodiments, the anchoring element 811 can comprise a pleated or fabric skirt that is attached to the support frame 813 to reduce the likelihood of paravalvular leak (PVL). This skirt may also reduce or eliminate the need for a skirt at the bottom of the heart valve prosthesis 10, while allowing for the heart valve prosthesis 10 to be deployed higher within the native aortic annulus.

[0086] Referring to FIGS. 8-9, the anchoring element 811 can be radially-expanded from the compressed position (e.g., illustrated in FIG. 8) to the expanded position (e.g., illustrated in FIG. 9). Initially, the anchoring element 811 can be positioned at or adjacent to the first valve end 11 of the frame 15, with the anchoring element 811 extending coaxially within the frame 15 about and along a valve axis 817 (e.g., equivalent to axis LA of FIG. 7) of the heart valve prosthesis 10. By being positioned at or adjacent to the first valve end 11, the anchoring element 811 can be positioned in proximity to the anchoring protrusions 801, for example, with a radial axis extending perpendicular to the valve axis 817 and intersecting the anchoring element 811 and at least one of the anchoring protrusions 801. In aspects, a balloon can be inserted into an interior lumen of the anchoring element 811, such that upon inflation of the balloon, the balloon can cause the anchoring element 811 to radially-expand to the expanded position. In aspects, the support frame 813 can comprise a diameter in the expanded position that is at least equal to a diameter of the expanded heart valve prosthesis 10. As such, when the anchoring element 811 moves to the expanded position, the supportATTORNEY DOCKET No. A0012587W001 frame 813 can contact the annular frame 15 and apply an outward radial force to the annual frame 15 in a radial direction 815 away from the valve axis 817 of the heart valve prosthesis 10.

[0087] As the anchoring element 811 moves to the expanded position and contacts the annular frame 15, the anchoring element 811 is configured to contact the anchoring protrusions 801 (if present) and move the anchoring protrusions 801 from the retracted position to the extended position. For example, while the anchoring protrusions 801 can be biased to remain in the retracted position in the absence of a force acting upon the anchoring protrusions 801, the anchoring element 811 can contact the anchoring protrusions 801 and apply a radial force to the anchoring protrusions 801. This radial force is enough to cause the anchoring protrusions 801 to move radially outwardly to the extended position. Accordingly, the anchoring protrusions 801 can extend radially outwardly from the annular frame 15 in the radial direction 815 away from the valve axis 817, with the anchoring protrusions 801 configured to engage the native valve leaflets 705. As such, the anchoring element 811 applies the outward radial force to the annular frame 15 to radially expand the heart valve prosthesis 10 and / or to radially expand the anchoring protrusions 801, thus biasing the heart valve prosthesis 10 into contact with the native valve leaflets 705, native aortic annulus 703, and / or surrounding structures (e.g. left ventricular outflow tract, aorta, surrounding myocardium). When the anchoring protrusions 801 are in the extended position, the first arm end 805 may be spaced a first radial distance from the valve axis 817, and the second arm end 807 may be spaced a second radial distance from the valve axis 817, with the first radial distance less than the second radial distance.

[0088] The anchoring element 811 can comprise an anchoring length and anchoring diameter that changes based on whether the anchoring element 811 is in the compressed position or the expanded position. For example, with reference to FIG. 8, the anchoring element 811 can comprise a first anchoring length 823 and a first anchoring diameter 825 when the anchoring element 811 is in the compressed position. In this way, the first anchoring diameter 825 is less than a diameter of the heart valve prosthesis 10. The first anchoring length 823 may be less than an annular frame length 827 of the heart valve prosthesis 10. The first anchoring length 823 may be measured between a first anchoring end 831 and an opposing second anchoring end 833 of the anchoring element 811. As illustrated in FIG. 9, when the anchoring element 811 is in the expanded position, theATTORNEY DOCKET No. A0012587W001 anchoring element 811 may comprise a second anchoring length 901 and a second anchoring diameter 903. The second anchoring length 901 may be less than the first anchoring length 823, and the second anchoring diameter 903 may be greater than the first anchoring diameter 825, with the second anchoring diameter 903 substantially equal to, slightly more than, or slightly less than, the first diameter 721 (e.g., illustrated in FIG. 7).

[0089] In aspects, and with reference to FIG. 9, when the anchoring element 811 is in the expanded position, the anchoring element 811 may be at an axial location that substantially matches an axial location of the anchoring protrusions 801 (if present) along the valve axis 817. That is, a radial axis that extends radially outwardly from, and intersects, the valve axis 817 can intersect the anchoring protrusions 801 and may also intersect the anchoring element 811 adjacent to the first anchoring end 831. In this way, the anchoring element 811 can extend an extension length 911 into the heart valve prosthesis 10, wherein the extension length 911 is the length of the anchoring element 811 that is within the heart valve prosthesis 10. In aspects, the extension length 911 may be less than about 50% of the annular frame length 827 (e.g., when the heart valve prosthesis 10 and the anchoring element 811 are in the expanded position), or less than about 30% of the annular frame length 827, or less than about 25% of the annular frame length 827. In aspects, the length 911 of the anchoring element 811 may be 50% less than the annular frame length 827. In aspects, the length 911 of the anchoring element 811 may be 37.5% less than the annular frame length 827. The second anchoring end 833 may be at a substantially similar or identical axial location (e.g., along the valve axis 817) as the first valve end 11. Alternatively, the second anchoring end 833 may be at an axial location (e.g., along the valve axis 817) below or above the first valve end 11. To ensure optimal axial location, both the heart valve prosthesis 10 and the anchoring element 811 can have radiopaque markers to allow for relative positioning using fluoroscopy. In aspects, other portions of the delivery assembly 30 (e.g., catheter, etc.) can comprise radiopaque markers to facilitate positioning under fluoroscopy and when positioning a balloon inside of the frame 15. In other examples, the present application is not limited to radiopaque markers, and other positioning technologies (e.g., electronic sensors) can be provided to assist in positioning the anchoring element 811, relative to the heart valve prosthesis 10, the heart valve prosthesis 10 relative to the annulus 703, etc.ATTORNEY DOCKET No. A0012587W001

[0090] Upon being radially expanded, the anchoring element 811 may remain in the radially-expanded position and may remain in contact with the anchoring protrusions 801. For example, in the expanded position, the anchoring element 811 may be partially or completely within the heart valve prosthesis 10. As illustrated in FIG. 9, an entirety of the anchoring element 811 is within an interior of the heart valve prosthesis 10 when the anchoring element 811 is in the expanded position. That is, both the first anchoring end 831 and the second anchoring end 833 may be within the heart valve prosthesis 10. By remaining in contact with the anchoring protrusions 801, the anchoring element 811 can force the anchoring protrusions 801 to the extended position (e.g., such that the anchoring protrusions 801 are retained in the extended position) while not impeding blood flow through the heart valve prosthesis 10 and, thus, not impacting the functionality of the heart valve prosthesis 10. Further, the anchoring element 811 is positioned at an axial location relative to the heart valve prosthesis 10 that does not obstruct or interfere with the function of the valve leaflets 21 (e.g., illustrated in FIGS. 1-2). That is, the anchoring element 811 can be below the valve leaflets 21 (e.g., in close proximity to the first valve end 11) such that the anchoring element 811 is not in a position to obstruct or interfere with the valve leaflets 21.

[0091] FIGS. 10-11 illustrate additional aspects of anchoring protrusions 801. For example, the heart valve prosthesis 10 and the anchoring element 811 may be substantially identical in structure and function to the heart valve prosthesis 10 and the anchoring element 811 described relative to FIGS. 8-9. However, as illustrated in FIG. 10, the anchoring protrusions 801 in FIG. 10 can comprise a different orientation than the anchoring protrusions 801 in FIGS. 8-9. For example, as illustrated in FIG. 10, the anchoring protrusions 801 can comprise arms 803 that extend between the first arm end 805 and the second arm end 807. In this example, the second arm end 807 is attached to the frame 15, and the first arm end 805 extends away from the second arm end 807 and away from the frame 15 (e.g., and is not attached to the frame 15). In this way, when the anchoring protrusion 801 is in the extended position, the first arm end 805 can contact and engage the native leaflets. By moving from the retracted position to the extended position, the second arm end 807 can move relative to the frame 15 to allow for the first arm end 805 to extend radially outwardly from the frame 15 toward the native leaflets.ATTORNEY DOCKET No. A0012587W001

[0092] In aspects, the arm 803 can extend linearly or non-linearly between the first arm end 805 and the second arm end 807. By extending non-linearly, the arm 803 can comprise a bend, curve, corner, right angle, or other shape between the first arm end 805 and the second arm end 807. As illustrated in FIG. 10, the arm 803 can extend from the second arm end 807 toward the first arm end 805 in a direction toward the second valve end 12 when the arm 803 is in the retracted position. In this way, a distance separating the second arm end 807 and the first valve end 11 may be less than a distance separating the first arm end 805 and the first valve end 11. As illustrated in FIG. 11, the anchoring element 811 can function in a substantially identical manner as described relative to FIGS. 8-9 to cause the anchoring protrusions 801 of FIG. 10 to move from the retracted position (e.g., illustrated in FIG. 10) to the extended position (e.g., illustrated in FIG. 11). That is, as illustrated in FIG. 11, when the anchoring protrusions 801 are in the extended position, the first arm end 805 may be spaced a first radial distance from the valve axis 817, and the second arm end 807 may be spaced a second radial distance from the valve axis 817, with the first radial distance greater than the second radial distance.

[0093] FIG. 12 illustrates additional embodiments of one of the anchoring protrusions 801. For example, each anchoring protrusion 801 illustrated in FIGS. 8-11 comprises a single arm (e.g., arm 803) that extends between the first arm end 805 and the second arm end 807. FIG. 12 illustrates a portion of the frame 15 and possible examples of the anchoring protrusions 801. As illustrated in FIG. 12, however, the anchoring protrusions are not so limited to comprising a single arm. Rather, in aspects, the anchoring protrusions 801 can comprise a first arm 1201, a second arm 1203, and an engagement portion 1205 attached to the first arm 1201 and the second arm 1203. For example, the first arm 1201 can extend between a first end and an opposing second end, with the first end attached to the frame 15. The second arm 1203 can extend between a first end and an opposing second end, with the first end attached to the frame 15. In aspects, the first arm 1201 and the second arm 1203 can be attached to different frame members or struts, for example, with the first arm 1201 attached to one frame member or strut, and the second arm 1203 attached to a different frame member or strut. The first arm 1201 may extend non-parallel to the second arm 1203, for example, with an angle defined between the first arm 1201 and the second arm 1203. In aspects, the angle may be within a range from about 30 degrees to about 150 degrees, or about 60 degrees to about 120 degrees, or about 90 degrees. In aspects, the first arm 1201ATTORNEY DOCKET No. A0012587W001 and the second arm 1203 may move toward one another and converge in a direction away from the first arm ends and toward the second arm ends. That is, the first arm ends of the first arm 1201 and the second arm 1203 can represent a maximum separating distance between the first arm 1201 and the second arm 1203, while the second arm ends of the first arm 1201 and the second arm 1203 can represent a minimum separating distance between the first arm 1201 and the second arm 1203.

[0094] The second ends of the first arm 1201 and the second arm 1203 may be attached to the engagement portion 1205. The engagement portion 1205 can comprise a pair of outwardly protruding ends that can engage the native leaflets. The outwardly protruding ends of the engagement portion 1205 can form a cornered, curved, rounded, or semi-oval shape. In operation, the anchoring protrusion 801 illustrated in FIG. 12 can be biased to remain in the retracted position in the absence of a force acting upon the anchoring protrusion 801. The anchoring element 811 can contact the anchoring protrusions 801 in a substantially identical manner as described in FIGS. 8-11. As such, the anchoring element 811 can contact the anchoring protrusion 801 and apply a radial force to the anchoring protrusions 801, thus causing the anchoring protrusion to move to the extended position, whereupon the engagement portion 1205 can engage the native leaflets.

[0095] While FIGS. 8-12 illustrate the anchoring protrusion 801 as being attached to the frame 15 of the heart valve prosthesis 10, such a position is not intended to be limiting. Rather, in aspects, the anchoring protrusion 801 can be attached to one of the annular frame 15, or the support frame 813 of the anchoring element 811. For example, FIGS. 13-14 illustrate anchoring protrusions 1301 attached to the support frame 813. The anchoring protrusions 1301 can comprise an arm 1303 that extends between a first arm end 1305 and a second arm end 1307. The first arm end 1305 is attached to the support frame 813, and the second arm end 1307 extends away from the first arm end 1305 and away from the support frame 813. In this way, when the anchoring protrusion 1301 is in the extended position, the second arm end 1307 can contact and engage the native valve leaflets 705 (and / or native annulus 703 and / or surrounding structures). By moving from the retracted position to the extended position, the first arm end 1305 can move relative to the support frame 813 to allow for the second arm end 1307 to extend radially outwardly from the support frame 813 toward the native valve leaflets 705. In aspects, the arm 1303 can extend linearly or non-linearly between the first arm end 1305 and the second arm end 1307. ByATTORNEY DOCKET No. A0012587W001 extending non-linearly, the arm 1303 can comprise a bend, curve, comer, right angle, or other shape between the first arm end 1305 and the second arm end 1307. When the arm 1303 is in the retracted position (e.g., as illustrated in FIG. 13), the second arm end 1307 can be positioned within the support frame 813 and may not extend radially outwardly from the support frame 813. While FIG. 13 illustrates the arm 1303 as comprising a substantially 90-degree bend (e.g., between the first arm end 1305 and the second arm end 1307), such a shape is not intended to be limiting. Rather, the arm 1303 can comprise a shape that is similar or identical to any of the shapes illustrated and described relative to FIGS. 8-12.

[0096] The anchoring element 811 can be radially-expanded by a balloon 1311. The process of radially-expanding the anchoring element 811 with the balloon 1311 is described relative to FIGS. 17-22. However, in general, the balloon 1311 can be delivered to an interior of the anchoring element 811, with the balloon 1311 and the anchoring element 811 initially in a radially-contracted, or non-expanded, position. The balloon 1311 can then be inflated by delivering a fluid to an internal chamber of the balloon 1311, thus causing the balloon 1311 to radially-expand. This radial expansion can cause the balloon 1311 to contact the anchoring element 811 and move the anchoring element 811 from a radially- contracted or retracted position (e.g., illustrated in FIG. 13) to a radially-expanded position (e.g., illustrated in FIG. 14).

[0097] In aspects, the balloon 1311 can comprise at least one channel 1313 within which the arms 1303 can be received. For example, the channel 1313 is a groove, recessed area, folds of the balloon, or other region of reduced cross-sectional size of the balloon 1311 as compared to areas that are upstream and / or downstream from the channel 1313 along the valve axis 817. The channel 1313 can extend circumferentially around the balloon 1311, or, the balloon 1311 can comprise a plurality of separate channels. The channel 1313 may be sized to receive the arms 1303 when the anchoring element 811 and the balloon 1311 are in the radially-contracted position (e.g., illustrated in FIG. 13). That is, the channel 1313 is at an axial location along the valve axis 817 that matches an axial location of the arms 1303, such that the arms 1303 can project radially inwardly toward the valve axis 817 and may extend into the channel 1313. As illustrated in FIG. 13, the balloon 1311 can comprise a waist region 1315 at the channel 1313, wherein the waist region 1315 is an area of reduced cross-sectional size (e.g., as compared to regions of the balloon 1311 that are upstream and downstream from the waist region 1315 along the valve axis 817). Alternatively, an entiretyATTORNEY DOCKET No. A0012587W001 of the balloon 1311 can comprise a cross-sectional size that substantially matches the cross- sectional size of the waist region 1315. In either of these embodiments, the balloon 1311 is sized to accommodate the arms 1303 that project radially inwardly, such that the balloon 1311 can allow for the arms 1303 to remain in the retracted position at least until the balloon 1311 is inflated and radially-expanded.

[0098] Referring to FIG. 14, the balloon 1311 can be inflated by delivering a fluid to the internal chamber of the balloon 1311. Inflation of the balloon 1311 can cause the balloon 1311 to radially-expand, thus causing the balloon 1311 to contact the anchoring element 811 and apply an outward radial force to the anchoring element 811. In this way, the anchoring element 811 can radially expand, while the anchoring protrusion 1301 can also move radially outwardly. That is, the waist region 1315 of the balloon 1311 can radially expand, which can apply the outward radial force to the anchoring protrusion 1301 and move the anchoring protrusion 1301 radially outwardly. The plurality of frame members of the frame 15 can be arranged to form a plurality of openings, such as, for example, a first opening 1321, a second opening 1323, etc. The anchoring protrusion 1301 is configured to extend through the openings of the plurality of openings 1321, 1323. For example, the anchoring protrusion 1301 can extend through the first opening 1321, with the second arm end 1307 extending through the first opening 1321 and protruding radially outwardly from the frame 15. Likewise, additional anchoring protrusions can extend through other openings of the frame 15, such as the second opening 1323, for example. In this way, when the anchoring protrusion 1301 is in the extended position, the second arm end 1307 can contact and engage the native valve leaflets 705.

[0099] While FIG. 14 illustrates the balloon 1311 as comprising a substantially constant cross-sectional size along the valve axis 817 upon being inflated, such a design is not intended to be limiting. Rather, the balloon 1311 can comprise a non-constant cross- sectional size. For example, at an axial location (e.g., along the valve axis 817) that matches the location of the arms 1303, the balloon 1311 can protrude radially outwardly to control outward radial expansion and penetration of the arms 1303. In this way, the balloon 1311 can comprise a larger cross-sectional size at the axial location (e.g., along the valve axis 817) that matches the location of the arms 1303, and a smaller cross-sectional size at locations upstream and downstream from this axial location. In aspects, the balloon 1311 can comprise a compliant material or a non-compliant material.ATTORNEY DOCKET No. A0012587W001

[0100] FIG. 15 illustrates examples of anchoring protrusions 1501 that can be attached to a frame 1502. The frame 1502 can be equivalent to the annular frame 15 or the support frame 813, such that the anchoring protrusions 1501 can be attached to the frame 15 or the support frame 813. The anchoring protrusions 1501 can comprise a first arm 1503 extending between a first arm end 1505 and a second arm end 1507. The first arm end 1505 is attached to the frame 1502, and the second arm end 1507 extends away from the first arm end 1505 and away from the frame 1502. The anchoring protrusions 1501 can move between the retracted position and the extended position in a substantially identical manner as described relative to FIGS. 8-14. In this way, when the anchoring protrusion 1501 is in the extended position, the second arm end 1507 can contact and engage the native valve leaflets 705 (and / or native annulus 703 and / or surrounding structures). By moving from the retracted position to the extended position, the first arm end 1505 can move relative to the frame 1502 to allow for the second arm end 1507 to extend radially outwardly from the frame 1502 toward the native valve leaflets 705. In aspects, the first arm 1503 can extend linearly or non-linearly between the first arm end 1505 and the second arm end 1507. By extending non-linearly, the arm 803 can comprise a bent region 1509 between the first arm end 1505 and the second arm end 1507. The bent region 1509 comprises a bend, curve, comer, right angle, or other non-linear shape. As illustrated in FIG. 15, the bent region 1509 can define an angle between segments of the first arm 1503, with the angle within a range from about 30 degrees to about 90 degrees.

[0101] In aspects, the anchoring protrusions 1501 can comprise a single arm (e.g., the first arm 1503), or a plurality of arms, such as, for example, the first arm 1503 and a second arm 1513. Accordingly, while FIG. 15 illustrates the anchoring protrusions 1501 as comprising a plurality of arms 1503, 1513, in alternative embodiments, the anchoring protrusions 1501 may comprise the first arm 1503 and not the second arm 1513, or the second arm 1513 and not the first arm 1503. The first arm 1503 and the second arm 1513 may be substantially identical in structure, but with the first arm 1503 and the second arm 1513 attached to the frame 1502 at different locations. For example, the first arm 1503 and the second arm 1513 can be positioned within the same cell 18, but with the first arm 1503 located on an opposite side of the cell 18 from the second arm 1513. The second arm 1513 can be substantially identical in structure to the first arm 1503. For example, the second arm 1513 can extend between a first arm end 1515 and a second arm end 1517. The firstATTORNEY DOCKET No. A0012587W001 arm end 1515 may be substantially identical to the first arm end 1505 of the first arm 1503, and the second arm end 1517 may be substantially identical to the second arm end 1507 of the first arm 1503. Likewise, the second arm 1513 can comprise a bent region 1519 that is substantially identical to the bent region 1509 of the first arm 1503. In operation, the first arm 1503 and the second arm 1513 can be moved from the retracted position to the extended position similar to the examples described relative to FIGS. 8-14. That is, a balloon (e.g., balloon 1311) can be inflated, which can cause the arms 1503, 1513 to move radially outwardly to the extended position, such that the second arm ends 1507, 1517 can contact and engage the native valve leaflets 705.

[0102] FIG. 16 illustrates yet another example of an anchoring protrusion 1601. In aspects, the anchoring protrusion 1601 is not limited to comprising an arm (e.g., any of arms 803, 1201, 1203, 1303, 1503, 1513). Rather, the anchoring protrusion 1601 can comprise a portion of the anchoring element 811 that extends through the opening 1321 of the frame 15. For example, the anchoring protrusion 1601 can comprise one or more frame members or struts of the support frame 813 of the anchoring element 811. That is, as the anchoring element 811 is radially expanded, the one or more frame members or struts (e.g., the anchoring protrusions 1601) can move radially outwardly and may extend through the opening 1321 in the frame 15. In aspects, the anchoring protrusion 1601 can comprise a pointed end 1603 that is located on a radially exterior side of the frame 15. The pointed end 1603 can contact and engage the native valve leaflets 705. As illustrated in FIG. 16, the anchoring protrusion 1601 may be in a retracted or non-radially expanded position (e.g., illustrated with dashed lines 1609) prior to radial expansion of the anchoring protrusion 1601. The anchoring protrusion 1601 may move from the retracted position (e.g., 1609) to the extended or radially-expanded position (e.g., illustrated with solid lines in FIG. 16), wherein the pointed end 1603 can extend through the opening 1321 of the frame 15. In aspects, the anchoring element 811 can be axially and circumferentially aligned with the opening 1321 to allow for the anchoring protrusion 1601 to extend through the opening 1321 during radial expansion.

[0103] While embodiments above have been described with an anchoring element 811 and anchoring protrusions 801, it is to be understood that in some embodiments anchoring protrusions 801 may be omitted. The anchoring element 811 may provide sufficient radial force to anchor the prosthesis that the protrusions are not necessary.ATTORNEY DOCKET No. A0012587W001

[0104] FIGS. 17-22 illustrate example aspects of implanting and deploying the heart valve prosthesis 10 and radial expansion of the anchoring element 811. Initially, methods can comprise providing the heart valve prosthesis 10 comprising the frame 15 and the leaflets 21, with the frame 15 extending between the first valve end 11 and the second valve end 12. Methods can further comprise providing the anchoring element 811 comprising the support frame 813.

[0105] Methods can comprise delivering the heart valve prosthesis 10 to the native aortic annulus 703, for example, by advancing the delivery assembly 30 (e.g., comprising the capsule 35, shaft 36, tip 37, heart valve prosthesis 10, anchoring element 811, balloon 1311, etc.) through a patient’s vasculature and heart valve to deliver the heart valve prosthesis 10 and the anchoring element 811. In aspects, the heart valve prosthesis 10 can be delivered in a similar manner as described relative to FIGS. 3-7. For example, the heart valve prosthesis 10 can be radially-compressed and loaded into the capsule 35. That is, the heart valve prosthesis 10 is in the radially-compressed configuration in FIG. 17. When the heart valve prosthesis 10 is in the radially-compressed position, the anchoring element 811 may likewise be radially-compressed and may be received within the capsule 35 or may not be within the capsule, such as crimped around the balloon 1311 proximal or distal to the prosthesis and / or capsule. In this way, the capsule 35 can circumferentially surround the heart valve prosthesis 10, the anchoring element 811, and the balloon 1311. In aspects, the capsule 35 can comprise a single capsule, or it can comprise multiple capsules (i.e. split capsule) that can move relative to each other, where for instance, a proximal capsule covers the heart valve prosthesis 10 and a distal capsule covers the anchoring element 811 to allow for expansion of each to be controlled and done in any order. Alternatively, it should be understood that the heart valve prosthesis 10 can be radially-compressed and loaded into the capsule 35, while the anchoring element 811 is radially compressed proximal or distal to the capsule (i.e. radially-compressed onto a balloon and not covered by the capsule). The capsule 35 can be moved through a patient’s vasculature to the native aortic annulus 703. In this way, delivering the heart valve prosthesis 10 can comprise holding the heart valve prosthesis 10 and the anchoring element 811 in the radially-compressed configuration within the capsule 35 as the heart valve prosthesis 10 is moved to the native aortic annulus 703. The balloon 1311 can be located within the anchoring element 811, with the balloon 1311 in a deflated or non-radially expanded position as the heart valve prosthesis 10, theATTORNEY DOCKET No. A0012587W001 anchoring element 811, and the balloon 1311 are moved through the patient’s vasculature to the native aortic annulus 703.

[0106] With reference to FIG. 17, to deploy the heart valve prosthesis 10, the capsule 35 can be moved in a retraction direction 1701. That is, the capsule 35 can be moved proximally in the retraction direction 1701, which is away from the distal tip 37 to initially expose an inflow portion of the prosthesis 10. Retraction of the capsule 35 in the retraction direction 1701 can allow for the heart valve prosthesis 10 to move from the radially- collapsed configuration to the radially-expanded configuration. As illustrated in FIG. 18, methods can comprise partially-expanding the heart valve prosthesis 10. For example, continued movement of the capsule 35 in the retraction direction 1701 can partially expose the heart valve prosthesis 10 by releasing the heart valve prosthesis 10 from the capsule 35, thus allowing the first valve end 11 of the heart valve prosthesis 10 to be removed from the capsule 35. The first valve end 11 of the heart valve prosthesis 10 can begin to radially- expand upon being removed from the capsule 35, while a remaining portion of the heart valve prosthesis 10 may remain in the capsule 35 in the radially-compressed configuration. As illustrated in FIG. 19, the capsule 35 can continue to move in the retraction direction 1701 at least until enough of the heart valve prosthesis 10 has been removed from the capsule 35 to allow for the prosthetic valve 20 to function (e.g. allow blood to flow through it and maintain adequate hemodynamics), which could be about when 50% to 100% of the heart valve prosthesis 10 has been removed from the capsule 35, for example, 70% to 90% or about 80%. That is, for example, about 80% of the heart valve prosthesis 10 may be located outside of the capsule 35, while the remaining 20% of the heart valve prosthesis 10 may remain within the capsule 35. In aspects, these percentages are not intended to be limiting, and, instead other lengths of the heart valve prosthesis 10 can be been removed from the capsule 35 prior to the capsule 35 stopping movement in the retraction direction 1701. However, the capsule 35 can stop moving in the retraction direction 1701 while at least a portion of the heart valve prosthesis 10 is within the capsule 35. By allowing a portion of the heart valve prosthesis 10 to radially expand, beginning at the first valve end 11, the expanded portion of the heart valve prosthesis 10 is sized to receive the anchoring element 811 and the balloon 1311, since the anchoring element 811 and the balloon 1311 may initially remain in a radially-contracted (e.g., non-expanded) position.ATTORNEY DOCKET No. A0012587W001

[0107] Referring to FIG. 20, with the second valve end 12 and portion of the heart valve prosthesis 10 remaining within the capsule 35, the anchoring element 811 and the balloon 1311 can be moved in the retraction direction 1701 toward the heart valve prosthesis 10. For example, the anchoring element 811 and / or the balloon 1311 can be attached to the inner shaft 36. The inner shaft 36 can be moved in the retraction direction 1701 relative to the heart valve prosthesis 10, which can cause the anchoring element 811, the balloon 1311, and the distal tip 37 to also move in the retraction direction 1701 toward the heart valve prosthesis 10. As described below, the handle 33 can comprise a tip retraction structure that can assist in moving and controlling the inner shaft 36, for example, by controlling movement of the inner shaft 36 in the retraction direction 1701. In aspects, distal markers (e.g., radiopaque markers) can be provided on one or more of the heart valve prosthesis 10 or the anchoring element 811 to improve implant visibility and placement accuracy of the anchoring element 811 relative to the heart valve prosthesis 10. Once the anchoring element 811 is in place relative to the heart valve prosthesis 10 (e.g., illustrated in FIG. 20 and also in FIGS. 8 and 10), the anchoring element 811 can be radially-expanded.

[0108] Referring to FIG. 21, methods can comprise deploying the anchoring element 811 inside of the partially-expanded heart valve prosthesis 10 at the first valve end 11. For example, the balloon 1311 can be inflated to cause the balloon 1311 to radially expand. As the balloon 1311 expands, the balloon 1311 can contact the anchoring element 811 and cause the anchoring element 811 to radially expand in a similar manner as described relative to FIGS. 8-16. In aspects, radial expansion of the anchoring element 811 can cause the anchoring protrusions 801 (e.g., and / or 1301, 1501, 1601) (if present) to move radially outwardly and contact the native valve leaflets 705 (and / or native annulus 703 and / or surrounding structures, such as the left ventricular outflow tract), thus anchoring the heart valve prosthesis 10 in place at the native aortic annulus 703. To expand the balloon 1311, the inner shaft 36 can comprise one or more openings that are in fluid communication with the balloon 1311. For example, in some embodiments, the inner shaft 36 can be surrounded by an inflation lumen shaft that is hollow, with a central lumen extending along the length of the inner shaft 36. In operation, a fluid can be delivered through the central lumen of the inflation lumen shaft and through the openings of the inflation lumen shaft, whereupon the fluid can flow into the balloon 1311. In this way, the balloon 1311 can be inflated. In this way, deploying the anchoring element 811 can comprise radially-expanding the anchoringATTORNEY DOCKET No. A0012587W001 protrusion. In aspects, the balloon 1311 can be moved (e.g. via an additional shaft, wires, etc) relative to the inner shaft 36 and / or distal tip or nosecone 37, so in cases where a guidewire is in place through the inner shaft 36 and out the distal tip or nosecone 37, that movement of the balloon 1311 does not affect positioning of the guidewire and thus positioning of the delivery assembly 30. Accordingly, inflation of the balloon 1311 can allow for the anchoring element 811 to move from the radially-collapsed configuration to the radially-expanded configuration.

[0109] As illustrated in FIG. 22, methods can comprise fully-expanding the heart valve prosthesis 10 and releasing the heart valve prosthesis 10 from the capsule 35 of the delivery assembly 30. For example, once the anchoring element 811 is radially expanded and the heart valve prosthesis 10 is in place, the balloon 1311 can be deflated (e.g., by removing fluid from the internal chamber of the balloon 1311) and the balloon 1311 can be removed from the interior of the heart valve prosthesis 10. For example, the inner shaft 36 can be moved relative to the heart valve prosthesis 10, thus allowing for the inner shaft 36 and the balloon 1311 to be removed. The anchoring protrusions (e.g., 801) in FIGS. 21-22, are illustrated schematically due to the anchoring protrusions comprising several different constructions described relative to FIGS. 8-16. Accordingly, the anchoring protrusions in FIGS. 21-22 are not intended to be limiting, as the deployment method described relative to FIGS. 17-22 can be used to radially-expand any of the anchoring protrusions (e.g., 801, 1301, 1501, 1601) described herein or there may only be anchoring element 811 and no anchoring protrusions.

[0110] FIGS. 23-24 illustrate an example of the anchoring element 811 moving from the radially-collapsed position (e.g., illustrated in FIG. 23) to the radially-expanded position (e.g., illustrated in FIG. 24). For the purposes of illustration, FIGS. 23-24 illustrate the second anchoring end 833 of the anchoring element 811, however, in operation, the anchoring element 811 may extend a length (e.g., 823 and 911) between the opposing anchoring ends 831, 833 as illustrated in FIGS. 10-11. Initially, the anchoring element 811 is in the radially-collapsed position as the anchoring element 811 (e.g., along with the heart valve prosthesis 10 and the balloon 1311) is moved through the patient’s vasculature to the native annulus 703. Upon reaching the native annulus 703, the anchoring element 811 can be radially-expanded (e.g., illustrated with movement in the radial direction 815) as described relative to FIGS. 17-22. While being radially-expanded, the anchoring elementATTORNEY DOCKET No. A0012587W001811 can contact the heart valve prosthesis 10 and facilitate radial expansion of the heart valve prosthesis 10. In addition, or in the alternative, the anchoring element 811 can cause the anchoring protrusions described herein to move radially outwardly.

[0111] Although not shown in the figures, it should be understood that the anchoring element 811 could be radially expanded first to contact and engage the native valve leaflets 705 (and / or native annulus 703 and / or surrounding structures), followed by radially expanding the heart valve prosthesis 10 within the interior of the anchoring element 811.

[0112] Additionally, it should be understood that rather than delivering an anchoring element 811, upon partially expanding the heart valve prosthesis 10 within the native valve leaflets 705 (and / or native annulus 703 and / or surrounding structures), the balloon 1311 (with no anchoring element crimped on it ) on the delivery assembly 30 could be inflated inside of the partially-expanded heart valve prosthesis 10 to provide temporary anchoring support at the first valve end 11, while the heart valve prosthesis 10 is fully-expanded and then released from the delivery assembly 30. The balloon 1311 could then be deflated and removed with the delivery assembly 30. In aspects, the frame 15 of the heart valve prosthesis 10 can be self-expanding while the anchoring element 811 can be balloonexpandable.

[0113] It will be appreciated that the present application is not limited to the aforementioned features, and additional features can be provided to facilitate improved functionality of the heart valve prosthesis 10, the anchoring element 811, and / or the delivery / deployment of the heart valve prosthesis 10 and the anchoring element 811. For example, as described above relative to FIG. 21, the inner shaft 36 can be surrounded by an inflation lumen shaft, with the inflation lumen shaft comprising a hollow chamber within which the inner shaft 36 can extend. The inflation lumen shaft can comprise one or more openings that are in fluid communication with the balloon 1311, such that the balloon 1311 can be inflated by delivering a fluid through the central lumen of the inflation lumen shaft. In aspects, the one or more openings of the inflation lumen shaft can be located at one or both of the proximal end or distal end of the balloon 1311 to selectively inflate these areas of the balloon 1311 first. The inflation lumen shaft can move (e.g., slide, translate, etc.) relative to the spindle 38 (e.g., illustrated in FIG. 4), and the outer shaft 34 can comprise an increased diameter to accommodate for the size of the inflation lumen shaft. In aspects, to further facilitate control and positioning of the heart valve prosthesis 10 and the anchoringATTORNEY DOCKET No. A0012587W001 element 811, the actuator 39 of the handle 33 can comprise one or more retraction structures that can be operatively attached to the inner shaft 36 to assist in positioning the balloon 1311 and the anchoring element 811. In addition, or in the alternative, a knob can be attached to the handle 33, wherein the knob can be moved (e.g., rotated, pushed, pulled, etc.) to allow for actuation of the inflation lumen shaft and the inner shaft 36 to further assist in positioning of the balloon 1311 and the anchoring element 811.

[0114] Referring to FIGS. 25-30 and 32-38, embodiments of an expandable stent frame 2500 (FIGS. 25-30) and 3200 (FIGS. 32-38) are illustrated. In some aspects, such as where the expandable stent frame 2500, 3200 is implanted within a heart valve (e.g., a native or previously implanted prosthetic heart valve), one or more features of the expandable stent frame 2500, 3200 can be beneficial to facilitate anchoring the expandable stent frame 2500, 3200 (e.g., prevent migration) within the heart valve while also minimizing conductive disturbances to the heart valve. In aspects, the expandable stent frame 2500, 3200 can be deployed utilizing the transcatheter heart valve delivery assembly 30 discussed above with reference to FIGS. 3 and 4. The expandable stent frame 2500, 3200 can comprise a stent structure 2502, 3202 extending along an elongated axis 2504, 3204 of the expandable stent frame 2500, 3200 between a proximal end portion 2506, 3206 (e.g., outflow end portion) of the stent structure 2502, 3202 and a distal end portion 2508, 3208 (e.g., inflow end portion) of the stent structure 2502, 3202. In aspects, the stent structure 2502, 3202 can comprise a plurality of struts that are arranged to form a plurality of openings or cells arranged circumferentially around the elongated axis 2504, 3204 of the expandable stent frame 2500, 3200 and longitudinally to form a tubular structure defining a central lumen of the expandable stent frame 2500, 3200.

[0115] The plurality of struts is shown as the elongated wire segments of the stent structure 2502, 3202. The plurality of struts can come together to form crowns 2510, 3210 (e.g., proximal crowns and distal crowns) or nodes 2512, 3212 as can be seen in FIGS. 25- 26 and FIGS. 32 and 37. The stent structure 2502, 3202 can further include a plurality of cells 2514, 3214 defined as the spaces between the plurality of crowns 2510, 3210, the plurality of nodes 2512, 3212, and the plurality of struts. In the example embodiments shown in FIGS. 25-26 (showing the expandable stent frame 2500) and FIGS. 32 and 37 (showing the expandable stent frame 3200), the plurality of cells 2514, 3214 may be diamond-shaped. However, the plurality of cells 2514, 3214 can be any other suitable shape.ATTORNEY DOCKET No. A0012587W001The stent structure 2502, 3202 can be configured to expand from a radially-collapsed configuration (shown in FIGS. 25 and 32) to a radially-expanded configuration (shown in FIGS. 26 and 37). For example, the expandable stent frame 2500, 3200 can be disposed within the capsule 35 of the transcatheter heart valve delivery assembly 30 to maintain the stent structure 2502, 3202 in the radially-collapsed configuration. When the capsule 35 is proximally retracted and / or the expandable stent frame 2500, 3200 is distally advanced to position the expandable stent frame 2500, 3200 outside the capsule 35, the stent structure 2502, 3202 can expand to the radially-expanded configuration.

[0116] In some examples, the stent structure 2502, 3202 can comprise a self-expanding stent structure. For example, the stent structure 2502, 3202 can be formed from a shape memory material, such as a shape memory alloy or polymer. The shape memory material can impart a natural tendency to the stent structure 2502, 3202 to naturally transition the stent structure 2502, 3202 from the radially-collapsed configuration to the radially- expanded configuration. In one non-limiting example, the stent structure 2502, 3202 can comprise Nitinol. In other examples, however, the stent structure 2502, 3202 can be a balloon expandable stent structure.

[0117] In aspects, the expandable stent frame 2500, 3200 can comprise one or more attachment members 2516, 3216 (e.g., paddles) positioned at the proximal end portion 2506, 3206 as shown. The one or more attachment members 2516, 3216 can function similar to the one or more attachment members 24, and thus reference can be made above for further details.

[0118] Now referring specifically to the expandable stent frame 2500 illustrated in FIGS. 25-30, in further aspects, the expandable stent frame 2500 can comprise a plurality of anchors 2518 coupled to the distal end portion 2508 of the stent structure 2502 and spaced around the elongated axis 2504. In some examples (as shown), an anchor can be coupled to each crown of the distal end portion 2508 of the stent structure 2502. However, in other examples, only some crowns or one crown of the distal end portion 2508 of the stent structure 2502 can include the anchor. In some aspects, best shown in FIGS. 29-30, each anchor of the plurality of anchors 2518 can be coupled to the distal end portion 2508 with a rivet 2902. For example, the crowns and anchors can both include an aperture through which the rivet 2902 can be inserted in order to couple the anchors to the crowns. However, theATTORNEY DOCKET No. A0012587W001 plurality of anchors 2518 can be coupled to the distal end portion 2508 any other suitable way, such as for example, by welding, fasteners, fixtures, etc.

[0119] In aspects, each anchor of the plurality of anchors 2518 can extend distally from a distal end 2520 of the distal end portion 2508 of the stent structure 2502 and is configured to transition from a straightened orientation (FIGS. 26 and 29) to a radially flared orientation (FIGS. 28 and 30). For example, FIG. 29 is a schematic enlarged view taken at view 29 of FIG. 26, and illustrates the straightened orientation of each anchor of the plurality of anchors 2518. In contrast, FIG. 30 is a schematic enlarged view taken at view 30 of FIG. 28, and illustrates the radially flared orientation of each anchor of the plurality of anchors 2518.

[0120] As best illustrated in FIGS. 26 and 29, the straightened orientation of each anchor of the plurality of anchors 2518 can comprise each anchor extending substantially along the elongated axis 2504 of the expandable stent frame 2500. As best shown in FIGS. 28 and 30, the radially flared orientation can comprise each anchor of the plurality of anchors 2518 flared radially outward relative to the stent structure 2502 in the radially-expanded configuration.

[0121] In aspects, as best shown in FIGS. 29 and 30, each anchor of the plurality of anchors 2518 can comprise a pair of spaced apart protrusions 2904, 2906. In some examples the pair of spaced apart protrusions 2904, 2906 can comprise cleats, barbs, spines, spikes, points, penetrating tips, tapered microprotusions, needle-like spines, and / or the like. The pair of spaced apart protrusions 2904, 2906 can be beneficial to anchor the expandable stent frame 2500 to an existing heart valve. While referred to herein as a pair of protrusions, there may be only a single protrusion or there may be three or more protrusions. In one example, the pair of spaced apart protrusions 2904, 2906 can anchor to a native heart valve. For example, when the expandable stent frame 2500 is implanted within native heart valve, the pair of spaced apart protrusions 2904, 2906 can anchor to the native heart valve (e.g., a native aortic, mitral, tricuspid, or pulmonary valve). In other examples, the pair of spaced apart protrusions 2904, 2906 can anchor to a previously implanted prosthetic heart valve. For example, when the expandable stent frame 2500 is implanted within the previously implanted prosthetic heart valve, the pair of spaced apart protrusions 2904, 2906 can anchor to implanted prosthetic heart valve (e.g., a previously implanted prosthetic aortic, mitral, tricuspid, or pulmonary valve). In another more particular example, such as where the expandable stent frame 2500 is implanted within the previously implanted prosthetic heartATTORNEY DOCKET No. A0012587W001 valve, the pair of spaced apart protrusions 2904, 2906 can anchor into both the previously implanted prosthetic heart valve and the native heart valve, such as for example the protrusions can pierce through the native heart valve and engage the previously implanted prosthetic heart valve. In yet another more particular example, the expandable stent frame 2500 can be implanted within the previously implanted prosthetic heart valve, but the pair of spaced apart protrusions 2904, 2906 can anchor into the native heart valve without engaging the previously implanted prosthetic heart valve (e.g., the protrusions can extend through cells of the previously implanted prosthetic heart valve or below the previously implanted prosthetic heart valve).

[0122] In some aspects, as best shown in FIG. 29, when each anchor of the plurality of anchors 2518 is in the straightened orientation, a distal end of each pair of spaced apart protrusions 2904, 2906 can be spaced apart by a first maximum width 2908. The first maximum width 2908 can be defined by a greatest distance between each protrusion 2904, 2906. In further aspects, as best shown in FIG. 30, when each anchor of the plurality of anchors 2518 is in the radially flared orientation, the distal end of each pair of spaced apart protrusions 2904, 2906 can be spaced apart by a second maximum width 3002. The second maximum width 3002 can be defined by a greatest distance between each protrusion 2904, 2906. As shown between FIGS. 29 and 30 the second maximum width 3002 can be greater than the first maximum width 2908. If there are more than two protrusions, the width between adjacent protrusions may be greater in the flared orientation than in the straightened orientation. For example, if there are three protrusions - a center and two outer protrusions - then the center protrusion may not flare but the two outer protrusions may flare to increase the width.

[0123] As described above, the stent structure 2502 can move from the radially- collapsed configuration (FIG. 25) to the radially-expanded configuration (FIG. 26). For example, stent structure 2502 can be self-expanded or balloon expanded to reach the radially-expanded configuration. As shown in FIG. 28, a balloon 2802, which can be crimped around the inner shaft 36 of the transcatheter heart valve delivery assembly 30 for example, can then be expanded to transition each anchor of the plurality of anchors 2518 from the straightened orientation (FIGS. 26 and 29) to the radially flared orientation (FIGS. 28 and 30). When the balloon 2802 is expanded, the balloon 2802 can fill the space defining the first maximum width 2908 of the spaced apart protrusions 2904, 2906. As the balloonATTORNEY DOCKET No. A0012587W0012802 continues to expand, the balloon 2802 can begin to push the spaced apart protrusions 2904, 2906 further away from one another until the spaced apart protrusions 2904, 2906 are spaced apart by the second maximum width 3002. In some examples, the balloon 2802 can be utilized to expand the expandable stent frame 2500. In this example, the balloon 2802 can be configured such that a distal end portion of the balloon 2802 is configured to radially expand to a greater extend than a proximal end portion of the balloon 2802, for example, a diameter of the distal end portion of the balloon 2802 can be greater than a diameter of the proximal end portion of the balloon 2802 when the balloon 2802 is fully expanded. In this way, the distal end portion of the balloon 2802 can continue to expand to transition each anchor of the plurality of anchors 2518 from the straightened orientation to the radially flared orientation, without continuing to apply a radial expansion force to the stent structure 2502. However, in other examples, as shown in FIG. 28, the balloon 2802 can be disposed only at the distal end portion 2508 of the stent structure 2502 and may remain deflated until stent structure 2502 is expanded (e.g., self-expanded). In yet another example, the balloon 2802 need not part of the transcatheter heart valve delivery assembly 30. For example, the balloon 2802 can be delivered via a separate transcatheter device (not shown).

[0124] In some aspects, the distal end portion of each protrusion of the pair of spaced apart protrusions 2904, 2906 can comprise a curved segment 3004 (e.g., a hooked segment), as shown generally in FIG. 30. In one example, the curved segment 3004 of the distal end portion of each protrusion of the pair of spaced apart protrusions 2904, 2906 can be formed as part of the structure of each protrusion. For example, each protrusion can include the curved segment when in the straightened orientation and the flared orientation. However, in other embodiments, the curved segment 3004 can be formed as a result of the expansion of the balloon 2802. For example, as the balloon 2802 expands (as described above), the balloon 2802 can deform the distal end portions of each protrusion to form the curved segment 3004. In one example (not shown), the balloon 2802 can be configured to inflate to a greater extent within the region of the distal end portion of each protrusion of the pair of spaced apart protrusions 2904, 2906 than other regions of the balloon 2802.

[0125] The term “anchor,” as utilized for the embodiment of the expandable stent frame 2500, is intended to mean that the pair of spaced apart protrusions 2904, 2906 can engage, attach to, secure to, interlock with, penetrate, pierce, contact, or otherwise mechanically or frictionally interact with a native heart valve and / or prosthetic heart valve to secure,ATTORNEY DOCKET No. A0012587W001 stabilize, or prevent movement of the expandable stent frame 2500 within the native heart valve and / or the prosthetic heart valve (e.g., to prevent migration of the expandable stent frame 2500 after implantation). In one example, the pair of spaced apart protrusions 2904, 2906 can anchor to a native heart valve by piercing through the patient’s tissue. In another example, the pair of spaced apart protrusions 2904, 2906 can anchor to a previously implanted prosthetic heart valve by hooking onto a strut of the frame and / or by piercing through a feature of the previously implanted prosthetic heart valve (e.g., such as piercing through a skirt of the previously implanted prosthetic heart valve). In the example of anchoring to the previously implanted prosthetic heart valve, the pair of spaced apart protrusions 2904, 2906 may also pierce through the native tissue of the patient while engaging the previously implanted prosthetic heart valve.

[0126] As shown in FIGS. 25-30, the plurality of anchors 2518 are shown coupled to the distal end portion 2508 of the stent structure 2502 and spaced around the elongated axis 2504. Although not shown, in addition or alternatively, the anchors 2518 can be located in other locations of the stent structure. For example, in addition or alternatively, the anchors 2518 can be coupled to the proximal end portion 2506 of the stent structure 2502 and spaced around the elongated axis 2504 and / or at an intermediate location between the proximal end portion 2506 and the distal end portion 2508 of the stent structure 2502.

[0127] In aspects, the plurality of anchors 2518 can comprise any suitable material, such as for example, metals, metal alloys, etc. In some non-limiting examples, the plurality of anchors 2518 can comprise cobalt chromium or stainless steel. In this way, the plurality of anchors 2518 can comprise a different material than the stent structure 2502 (e.g., the stent structure 2502 can comprise Nitinol while the plurality of anchors 2518 can comprise cobalt chromium or stainless steel). However, in other examples, the plurality of anchors 2518 and the stent structure 2502 can comprise the same material (e.g., both can comprise cobalt chromium or stainless steel).

[0128] As best shown in FIGS. 26 and 27, in aspects, a prosthetic heart valve 2522 can comprise the expandable stent frame 2500 (described above). In aspects, a plurality of leaflets 2700 (see FIG. 27) can be coupled to the stent structure 2502 and configured to move between an opened configuration and a closed configuration to permit unidirectional blood flow when the stent frame 2500 is in the radially-expanded configuration. For example, the plurality of leaflets 2700 can be disposed within the central lumen of the stentATTORNEY DOCKET No. A0012587W001 structure 2502 and the stent structure can secure the prosthetic heart valve 2522 in place in the vasculature of the patient. While three leaflets are illustrated in FIG. 27, the prosthetic heart valve 2522 may include any other suitable number of leaflets (e.g., two leaflets). In some examples, the prosthetic heart valve 2522 can comprise a prosthetic mitral, tricuspid, pulmonary, or aortic valve. In some embodiments (not specifically shown), the prosthetic heart valve 2522 may include an outer skirt extending circumferentially around an outer circumference of the stent structure 2502, such as for example, around the distal end portion 2508. The outer skirt can be configured to prevent paravalvular leakage of blood around the outside of the prosthetic heart valve 2522 once implanted in the patient.

[0129] FIG. 31 will now describe a method of expanding the expandable stent frame 2500 with initial reference to FIGS. 3-6 and 25-30 with the understanding that similar or identical methods may be provided in the other embodiments of the disclosure.

[0130] Referring to FIG. 31, at step 3100, the method can comprise positioning the capsule 35 of the transcatheter heart valve delivery assembly 30 within a vasculature of a patient. In aspects, the expandable stent frame 2500 can be disposed within the capsule 35 in the radially-collapsed configuration (see FIG. 25). In some examples, the expandable stent frame 2500 can form part of the prosthetic heart valve 2522 (see FIGS. 26 and 27). In some examples, the prosthetic heart valve 2522 can comprise a prosthetic aortic, mitral, pulmonary, or tricuspid valve.

[0131] In some examples, positioning the capsule 35 within the vasculature of the patient can comprise making an incision at an anatomical location of the patient’s vessel and inserting the capsule 35 through the incision. For example, in a transfemoral approach, the incision can be made in the patient’s groin and can operate as a passageway for guiding the capsule 35 through the patient’s vasculature. In some examples, positioning the capsule 35 within the vasculature of a patient can comprise advancing the capsule 35 through the introducer sheath 50.

[0132] In some aspects, at step 3100, the method can comprise advancing the capsule 35 within the vasculature towards a target location within the patient. In some aspects, the target location can comprise a heart valve. In some examples, the heart valve can comprise a native heart valve (e.g., a failing native heart valve requiring replacement), such as for example, a tricuspid valve, a pulmonary valve, a mitral valve, and / or an aortic valve. In another example, the heart valve can comprise a previously implanted prosthetic heart valveATTORNEY DOCKET No. A0012587W001(e.g., a failing implanted prosthetic heart valve requiring replacement), such as for example, a failing prosthetic tricuspid, pulmonary, mitral, or aortic valve. In some aspects, advancing the capsule 35 within the vasculature towards the target location within the patient can further comprise advancing the capsule 35 along a guidewire.

[0133] In aspects, at step 3102, the method can comprise expanding the stent structure 2502 of the expandable stent frame 2500 from the radially-collapsed configuration (see FIG. 25) to the radially-expanded configuration (see FIG. 26). In aspects, expanding the stent structure 2502 from the radially-collapsed configuration to the radially-expanded configuration can comprise positioning the stent structure 2502 outside of the capsule 35 of the transcatheter heart valve delivery assembly 30. For example, expanding the stent structure 2502 can comprise providing relative movement between the capsule 35 and the stent structure 2502. In some examples, the relative movement can include at least one of proximally retracting the capsule 35, distally advancing the stent structure 2502, or proximally retracting the capsule 35 and distally advancing the stent structure 2502 simultaneously. In some examples, such as where the stent structure 2502 is selfexpandable, the stent structure 2502 can self-expand when positioned outside of the capsule 35. In other examples, such as where the stent structure 2502 is balloon expandable, the method can comprise inflating a balloon to expand the stent structure 2502 from the radially- collapsed configuration to the radially-expanded configuration after positioning the stent structure 2502 outside of the capsule 35.

[0134] In further aspects, at step 3104, the method can comprise transitioning the plurality of anchors 2518 coupled to the distal end portion 2508 of the stent structure 2502 from the straightened orientation (see FIG 29) to the radially flared orientation (see FIG. 30). In some aspects, transitioning the plurality of anchors 2518 coupled to the distal end portion 2508 of the stent structure 2502 from the straightened orientation to the radially flared orientation can comprise radially expanding the balloon 2802 (see FIG. 28). In some examples, the stent structure 2502 can be expanded from the radially-collapsed configuration to the radially-expanded configuration prior to transitioning the plurality of anchors 2518 from the straightened orientation to the radially flared orientation. However, in other examples, the method can comprise simultaneously expanding the stent structure 2502 from the radially-collapsed configuration to the radially-expanded configuration andATTORNEY DOCKET No. A0012587W001 transitioning the plurality of anchors 2518 from the straightened orientation to the radially flared orientation.

[0135] In some aspects, transitioning the plurality of anchors 2518 from the straightened orientation to the radially flared orientation can further comprise anchoring the plurality of anchors 2518 to an existing heart valve. In some examples, the existing heart valve can comprise a native heart valve (e.g., a native tricuspid, pulmonary, mitral, or aortic valve). In some examples, anchoring the plurality of anchors 2518 to the native heart valve can comprise engaging the native valve tissue with the plurality of anchors 2518 (e.g., such as engaging the native valve tissue of the left ventricle with the anchors). In some examples, the expandable stent frame 2500 can be implanted into a previously implanted prosthetic heart valve, but the plurality of anchors 2518 can be anchored to the native heart valve. For example, each of the plurality of anchors 2518 can extend through a cell of the previously implanted prosthetic heart valve or below the previously implanted prosthetic heart valve, but not engage the previously implanted prosthetic heart valve.

[0136] In other examples, the existing heart valve can comprise a previously implanted prosthetic heart valve (e.g., a prosthetic tricuspid, pulmonary, mitral, or aortic valve). In some examples, anchoring the plurality of anchors 2518 to the previously implanted prosthetic heart valve can comprise engaging the previously implanted prosthetic heart valve with the plurality of anchors 2518 (e.g., such as engaging a ventricular portion of the previously implanted prosthetic heart valve with the anchors). In some further examples, anchoring the plurality of anchors 2518 to the previously implanted prosthetic heart valve can comprise engaging the previously implanted prosthetic heart valve with the plurality of anchors 2518 and also engaging native valve tissue of a native heart valve with the plurality of anchors 2518. For example, the native valve tissue that the previously implanted prosthetic heart valve was implanted into can be engaged.

[0137] Lastly, at step 3106 of FIG. 31, the method can comprise removing the transcatheter heart valve delivery assembly 30 from the patient. For example, the capsule 35 and / or any other component can be distally retracted to remove the transcatheter heart valve delivery assembly 30 from the patient.

[0138] The expandable stent frame 3200 will now be discussed in further detail with reference to FIGS. 32-38. In aspects, the expandable stent frame 3200 can comprise an expandable ring 3300 coupled to the distal end (e.g., inflow) portion 3208 of the stentATTORNEY DOCKET No. A0012587W001 structure 3202. The expandable ring 3300 can circumscribe the elongated axis 3204. As illustrated best in FIGS. 32 and 37, the expandable ring 3300 can extend distally from a distal end 3218 of the distal end portion 3208 of the stent structure 3202 along the elongated axis 3204. Although not shown, in addition or alternatively, the expandable ring 3300 can be located in other locations of the stent structure 3202. For example, in addition or alternatively, the expandable ring 3300 can be coupled to the proximal end (e.g., outflow) portion 3206 of the stent structure 3202 and / or at an intermediate location between the proximal end portion 3206 and the distal end portion 3208 of the stent structure 3202.

[0139] Throughout the disclosure, “coupling” the expandable ring 3300 to the stent structure 3202 (e.g., to the distal end 3208) can comprise an integral coupling or an attached coupling. As shown in FIGS. 32-37, the attached coupling could provide the expandable ring 3300 being a separate component that is attached (e.g., by suturing, stapling, riveting or otherwise mechanically fastening) to the stent structure 3202. Providing the ring as a separate component can allow flexibility in the material selection, thereby enabling the ring to have different mechanical characteristics or configurations than the main frame. Alternatively, the expandable ring could be integrally coupled to the stent structure 3202 by being formed as an integral part of the stent structure. For instance, the expandable ring could be laser-cut into the stent structure during fabrication of the stent structure.

[0140] In further aspects, as shown in FIGS. 32 and 37, the expandable ring 3300 can be coupled to the distal end portion 3208 of the stent structure 3202 by stitching. In one example, as generally shown in FIG. 32, the expandable ring 3300 can overlap a portion of the distal end portion 3208 of the stent structure 3202. In this way, the overlapping portions can be stitched together. In another example, shown in FIG. 37, the expandable ring 3300 need not overlap the portion of the distal end portion 3208 of the stent structure 3202. For example, as shown, a proximal end of the expandable ring 3300 can abut (e.g., but not overlap) the distal end 3218 of the stent structure 3202. The distal end 3218 of the stent structure 3202 and the proximal end of the expandable ring 3300 can then be stitched together.

[0141] In aspects (best shown in FIGS. 33, 35, and 36), the expandable ring 3300 can comprise a plurality of anchors 3302. The plurality of anchors 3302 can be spaced (e.g., equally spaced) around the elongated axis 3204. The plurality of anchors 3302 can be configured to move from a retracted orientation (FIGS. 32-34) to a radially projectedATTORNEY DOCKET No. A0012587W001 orientation (FIGS. 35-37) when the expandable ring 3300 is expanded from a radially- contracted orientation (FIGS. 32-34) to a radially-expanded orientation (FIGS. 35-37). FIGS. 33-36 illustrate the expandable ring 3300 without the expandable stent frame 3200, for clarity. As shown in FIGS. 33 and 34, in aspects when the expandable ring 3300 is in the radially-contracted orientation, each anchor of the plurality of anchors 3302 can be in the retracted orientation.

[0142] In aspects, the retracted orientation can comprise of each anchor of the plurality of anchors 3302 disposed within a respective aperture 3602 (see FIG. 36 generally) of the expandable ring 3300. In this way, as shown in FIG. 34, when each anchor of the plurality of anchors 3302 are disposed within the respective aperture 3602 in the retracted orientation, an outer diameter 3402 of the expandable ring 3300 can define a generally uniform radial profile (e.g., none of the anchors are protruding radially outward). In one example, each anchor of the plurality of anchors can comprise an arcuate shape such that when each anchor of the plurality of anchors 3302 are disposed within the respective aperture 3602 the generally uniform radial profile shown in FIG. 34 can be achieved.

[0143] More specifically, when each of the plurality of anchors 3302 are in the retracted orientation (e.g., each anchor is received within the respective aperture 3602), an inner surface 3604 (see FIG. 36 showing the inner surface, where the inner surface is the surface that faces the elongated axis 3204 in the retracted orientation) of each anchor of the plurality of anchors 3302 can at least partially encircle the elongated axis 3204 to collectively define a generally tubular profile. In some aspects, best shown in FIG. 36, the respective aperture 3602 can be shaped to correspond to the profile of the respective anchor. For instance, the perimeter or contour of the respective aperture 3602 may include one or more features that match or complement the geometry of the respective anchor. This allows the respective anchor to be received within the respective aperture with a mating or conforming fit. Although not shown, in some embodiments, additional material may be removed from the ring, creating holes or spaces to create other patterns or relief areas. Such modifications can help reduce resistance to expansion of the anchors and / or allow the ring to exhibit different mechanical properties or behaviors. In addition, localized areas or weakness or hinge points can also be created to further assist in helping reduce resistance in expansion of the anchors. For instance, fabrication techniques such as crimping or laser cutting can be used to remove material or emboss material to create thin areas to create a line of weakness that will act asATTORNEY DOCKET No. A0012587W001 a hinge to encourage pivoting outward of the anchor as desired. Such design features would allow controlled deformation and hinging at predetermined locations, thereby improving adaptability during deployment and anchoring.

[0144] In aspects, as illustrated in FIGS. 35-37, the radially projected orientation can comprise each anchor of the plurality of anchors 3302 projecting radially outward relative to the expandable ring 3300. As shown, each anchor of the plurality of anchors 3302 can be disposed outside of the respective aperture 3602. Thus, in the radially projected orientation, the inner surface 3604 of each anchor of the plurality of anchors 3302 will not encircle the elongated axis 3204 to collectively define the generally tubular profile. In some aspects, each anchor of the plurality of anchors 3302 can extend perpendicular (e.g., ninety degrees) to the elongated axis 3204 in the radially projected orientation. However, in other examples, each anchor of the plurality of anchors 3302 can extend at an angle less than 90 degrees relative to the elongated axis 3204. The angle can be measured between the elongated axis 3204 and the inner surface 3604 of each anchor of the plurality of anchors 3302.

[0145] Referring to FIGS. 32-33 and 35-37, in aspects, each anchor of the plurality of anchors 3302 can comprise a pair of spaced apart protrusions 3304, 3306 (see FIG. 33). In some examples the pair of spaced apart protrusions 3304, 3306 can comprise cleats, barbs, spines, spikes, points, penetrating tips, tapered microprotusions, needle-like spines, and / or the like. The pair of spaced apart protrusions 3304, 3306 can be beneficial to anchor the expandable stent frame 3200 to an existing heart valve. In one example, the pair of spaced apart protrusions 3304, 3306 can anchor to a native heart valve. For example, when the expandable stent frame 3200 is implanted within native heart valve, the pair of spaced apart protrusions 3304, 3306 can anchor to the native heart valve (e.g., a native aortic, mitral, tricuspid, or pulmonary valve). In other examples, the pair of spaced apart protrusions 3304, 3306 can anchor to a previously implanted prosthetic heart valve. For example, when the expandable stent frame 3200 is implanted within the previously implanted prosthetic heart valve, the pair of spaced apart protrusions 3304, 3306 can anchor to implanted prosthetic heart valve (e.g., a previously implanted prosthetic aortic, mitral, tricuspid, or pulmonary valve). In another more particular example, such as where the expandable stent frame 3200 is implanted within the previously implanted prosthetic heart valve, the pair of spaced apart protrusions 3304, 3306 can anchor into both the previously implanted prosthetic heart valve and the native heart valve, such as for example the protrusions can pierce through the nativeATTORNEY DOCKET No. A0012587W001 heart valve and engage the previously implanted prosthetic heart valve. In yet another more particular example, the expandable stent frame 3200 can be implanted within the previously implanted prosthetic heart valve, but the pair of spaced apart protrusions 3304, 3306 can anchor into the native heart valve without engaging the previously implanted prosthetic heart valve (e.g., the protrusions can extend through cells of the previously implanted prosthetic heart valve or below the previously implanted prosthetic heart valve). Similar to above, while a pair of protrusions are shown, there may be only a single protrusion or three or more protrusions.

[0146] The term “anchor,” as utilized for the embodiment of the expandable stent frame 3200, is intended to mean that the pair of spaced apart protrusions 3304, 3306 can engage, attach to, secure to, interlock with, penetrate, pierce, contact, or otherwise mechanically or frictionally interact with a native heart valve and / or prosthetic heart valve to secure, stabilize, or prevent movement of the expandable stent frame 3200 within the native heart valve and / or the prosthetic heart valve (e.g., to prevent migration of the expandable stent frame 3200 after implantation). In one example, the pair of spaced apart protrusions 3304, 3306 can anchor to a native heart valve by piercing through the patient’s tissue. In another example, the pair of spaced apart protrusions 3304, 3306 can anchor to a previously implanted prosthetic heart valve by hooking onto a strut of the frame and / or by piercing through a feature of the previously implanted prosthetic heart valve (e.g., such as piercing through a skirt of the previously implanted prosthetic heart valve). In the example of anchoring to the previously implanted prosthetic heart valve, the pair of spaced apart protrusions 3304, 3306 may also pierce through the native tissue of the patient while engaging the previously implanted prosthetic heart valve.

[0147] In aspects, with specific reference to FIG. 36, The expandable ring 3300 can further comprise a plurality of arms 3606 (e.g., lever arm) (see FIG. 36) and a plurality of segments 3608. Each segment can include at least one anchor of the plurality of anchors 3302. A first end 3610 of each arm of the plurality of arms 3606 can be connected to a respective anchor 3302 of a corresponding segment 3608 while a second end 3612 (e.g., opposite the first end 3610) of each arm of the plurality of arms 3606 can be connected to a portion of an adjacent segment 3608.

[0148] The function of the expandable stent frame 3200 will now be described by way of example to illustrate certain features. As described above, the stent structure 3202 canATTORNEY DOCKET No. A0012587W001 expand from the radially-collapsed configuration (FIG. 32) to the radially-expanded orientation (FIG. 37). In one example, the expandable stent frame 3200 can be selfexpanded, where at least the proximal end portion 3206 can self-expand towards the radially-expanded orientation and the distal end portion 3208 can remain in the radially- collapsed configuration (e.g., due to the expandable ring 3300 being in the radially- contracted orientation). A balloon (not specifically shown, but can be similar to the balloon 2802) extending within (or later inserted within) an interior of the expandable ring 3300 can then be radially expanded to expand the expandable ring 3300 from the radially-contracted orientation (FIGS. 32-34) to the radially-expanded orientation (FIGS. 35-37). The distal end portion 3208 of the stent structure 3202 can expand with the expansion of the expandable ring 3300. However, in another example, the expandable stent frame 3200 can be balloon expandable. In this example, the balloon can expand both the expandable stent frame 3200 and the expandable ring 3300 simultaneously.

[0149] In either case, as best shown in FIGS. 36 and 37, as the expandable ring 3300 is expanded, the plurality of anchors can be moved from the retracted orientation to the radially projected orientation. For example, as the balloon expands each arm of the plurality of arms 3606 will allow the expandable ring 3300 to increase in diameter by pulling the corresponding anchor 3302 in a first circumferential direction 3614 or a second circumferential direction 3616 to remove the corresponding anchor 3302 from the respective aperture 3602. As each anchor of the plurality of anchors 3302 is removed from the respective aperture 3602, the plurality of segments 3608 will begin to separate from one another, as shown. In this regard, the angle at which each anchor of the plurality of anchors 3302 extends can be determined by how much the balloon is expanded. For example, as the expandable ring 3300 increases in diameter, each anchor of the plurality of anchors 3302 will extend at a greater angle relative to the elongated axis 3204. The angle should be measured from the elongated axis 3204 to the inner surface 3604 of each anchor in the direction at which each anchor moves from the retracted orientation to the radially projected orientation (e.g., the first circumferential direction 3614 or the second circumferential direction 3616). While each anchor of the plurality of anchors 3302 is illustrated as moving from the retracted orientation to the radially projected orientation in the second circumferential direction 3616, the plurality of anchors 3302 can move from the retracted orientation to the radially projected orientation in the first circumferential direction 3614.ATTORNEY DOCKET No. A0012587W001

[0150] In some aspects, as best shown in FIG. 33, each anchor of the plurality of anchors 3302 can be defined by a laser-cut pattern formed through a circumferential wall of the expandable ring 3300 and extending at least partially around the elongated axis 3204. In some examples (as illustrated), the laser-cut pattern can extend around the entire elongated axis 3204 (e.g., 360 degrees). In this way, the expandable ring 3300, the plurality of arms 3606, the plurality of segments 3608, and the plurality of anchors 3302 can be a unitary body (e.g., monolithic structures). However, in other embodiments, the plurality of arms 3606, and / or the plurality of anchors 3302 can be attached separately to form the expandable ring 3300 (e.g., via welding, fasteners, etc.).

[0151] In aspects, the expandable ring 3300 can comprise any suitable material, such as for example, metals, metal alloys, etc. In some non-limiting examples, the expandable ring 3300 can comprise cobalt chromium or stainless steel. In further examples, such as with a self-expanding stent structure, the stent structure 3202 can comprise a different material than the expandable ring 3300 (e.g., the stent structure 3202 can comprise Nitinol while the expandable ring 3300 can comprise cobalt chromium or stainless steel). However, in other examples, such as with a balloon expandable stent frame, the stent structure 3202 can comprise the same material as the expandable ring 3300 (e.g., the stent structure 3202 and the expandable ring 3300 can both comprise cobalt chromium or stainless steel).

[0152] As best shown in FIGS. 32 and 37-38, in aspects, a prosthetic heart valve 3220 can comprise the expandable stent frame 3200 (described above). In aspects, a plurality of leaflets 3800 (see FIG. 38) can be coupled to the stent structure 3202 and configured to move between an opened configuration and a closed configuration to permit unidirectional blood flow when the stent frame 3200 is in the radially-expanded configuration. For example, the plurality of leaflets 3800 can be disposed within the central lumen of the stent structure 3202 and the stent structure can secure the prosthetic heart valve 3220 in place in the vasculature of the patient. While three leaflets are illustrated in FIG. 38, the prosthetic heart valve 3220 may include any other suitable number of leaflets (e.g., two leaflets). In some examples, the prosthetic heart valve 3220 can comprise a prosthetic mitral, tricuspid, pulmonary, or aortic valve. In some embodiments, shown in FIGS. 32 and 37, the prosthetic heart valve 3220 may include an outer skirt 3222 (illustrated as transparent in FIG. 32 for clarity) extending circumferentially around an outer circumference of the stent structure 3202, such as for example, around the distal end portion 3208. The outer skirt 3222 can beATTORNEY DOCKET No. A0012587W001 configured to prevent paravalvular leakage of blood around the outside of the prosthetic heart valve 3220 once implanted in the patient.

[0153] FIG. 39 will now describe a method of expanding the expandable stent frame 3200 with initial reference to FIGS. 3-6 and 32-38 with the understanding that similar or identical methods may be provided in the other embodiments of the disclosure.

[0154] Referring to FIG. 39, at step 3900, the method can comprise positioning the capsule 35 of the transcatheter heart valve delivery assembly 30 within a vasculature of a patient. In aspects, the expandable stent frame 3200 can be disposed within the capsule 35 in the radially-collapsed configuration (see FIG. 32). In some examples, the expandable stent frame 3200 can form part of the prosthetic heart valve 3220 (see FIGS. 32 and 37-38). In some examples, the prosthetic heart valve 3220 can comprise a prosthetic aortic, mitral, pulmonary, or tricuspid valve. In some aspects, at step 3900, the method can comprise advancing the capsule 35 within the vasculature towards a target location within the patient. Step 3900 can be substantially similar to step 3100, and thus reference can be made above for further details.

[0155] In aspects, at step 3902, the method can comprise at least partially expanding the stent structure 3202 of the expandable stent frame 3200 from the radially-collapsed configuration (see FIG. 32) to the radially-expanded configuration (see FIG. 37). In aspects, expanding the stent structure 3202 from the radially-collapsed configuration to the radially- expanded configuration can comprise positioning the stent structure 3202 outside of the capsule 35 of the transcatheter heart valve delivery assembly 30. For example, expanding the stent structure 3202 can comprise providing relative movement between the capsule 35 and the stent structure 3202. In some examples, the relative movement can include at least one of proximally retracting the capsule 35, distally advancing the stent structure 3202, or proximally retracting the capsule 35 and distally advancing the stent structure 3202 simultaneously. In some examples, such as where the stent structure 3202 is selfexpandable, at least the proximal end portion 3206 of the stent structure 3202 can partially self-expand when positioned outside of the capsule 35. In this example, the method can comprise inflating a balloon (e.g., similar to the balloon 2802 of FIG. 28) to radially expand the distal end portion 3208 of the stent structure 3202. In other examples, such as where the stent structure 3202 is balloon expandable, the method can comprise inflating a balloon toATTORNEY DOCKET No. A0012587W001 expand the stent structure 3202 from the radially-collapsed configuration to the radially- expanded configuration after positioning the stent structure 3202 outside of the capsule 35.

[0156] In further aspects, at step 3904, the method can comprise expanding the expandable ring 3300 coupled to the distal end portion 3208 of the stent structure 3202. In some examples, expanding the stent structure 3202 can comprise inflating a balloon (e.g., similar to the balloon 2802 of FIG. 28). In some embodiments, the balloon can simultaneously inflate the stent structure 3202 and the expandable ring 3300. In other embodiments, the proximal end portion 3206 of the stent structure 3202 can already be at least partially radially expanded and the balloon can simultaneously inflate the distal end portion 3208 of the stent structure 3202 and the expandable ring 3300. In further aspects, at step 3904, the method can comprise moving the plurality of anchors 3302 of the expandable ring 3300 from the retracted orientation (FIGS. 32-34) to the radially projected orientation (FIGS. 35-38). For example, when the balloon is inflated, the plurality of anchors 3302 of the expandable ring 3300 can move from the retracted orientation to the radially projected orientation.

[0157] In some aspects, moving the plurality of anchors 3302 of the expandable ring 3300 from the retracted orientation to the radially projected orientation can further comprise anchoring the plurality of anchors 3302 to an existing heart valve. In some examples, the existing heart valve can comprise a native heart valve (e.g., a native tricuspid, pulmonary, mitral, or aortic valve). In some examples, anchoring the plurality of anchors 3302 to the native heart valve can comprise engaging the native valve tissue with the plurality of anchors 3302 (e.g., such as engaging the native valve tissue of the left ventricle with the anchors). In some examples, the expandable stent frame 3200 can be implanted into a previously implanted prosthetic heart valve, but the plurality of anchors 3302 can be anchored to the native heart valve. For example, each of the plurality of anchors 3302 can extend through a cell of the previously implanted prosthetic heart valve or below the previously implanted prosthetic heart valve but not engage the previously implanted prosthetic heart valve.

[0158] In other examples, the existing heart valve can comprise a previously implanted prosthetic heart valve (e.g., a prosthetic tricuspid, pulmonary, mitral, or aortic valve). In some examples, anchoring the plurality of anchors 2518 to the previously implanted prosthetic heart valve can comprise engaging the previously implanted prosthetic heart valve with the plurality of anchors 2518 (e.g., such as engaging a ventricular portion of theATTORNEY DOCKET No. A0012587W001 previously implanted prosthetic heart valve with the anchors). In some further examples, anchoring the plurality of anchors 2518 to the previously implanted prosthetic heart valve can comprise engaging the previously implanted prosthetic heart valve with the plurality of anchors 2518 and also engaging native valve tissue of a native heart valve with the plurality of anchors 2518. For example, the native valve tissue that the previously implanted prosthetic heart valve was implanted into can be engaged.

[0159] Lastly, at step 3906 of FIG. 39, the method can comprise removing the transcatheter heart valve delivery assembly 30 from the patient. For example, the capsule 35 and / or any other component can be distally retracted to remove the transcatheter heart valve delivery assembly 30 from the patient.

[0160] Example 1. A prosthetic heart valve assembly comprises a heart valve prosthesis comprising an annular frame extending along a valve axis between a first valve end of the heart valve prosthesis and a second valve end of the heart valve prosthesis. The annular frame comprises a plurality of frame members and is configured to be adjustable between a radially-collapsed configuration and a radially-expanded configuration. A plurality of prosthetic leaflets are attached to the annular frame. An anchoring element is positioned within the heart valve prosthesis. The anchoring element comprises a support frame that is configured to contact the annular frame and apply an outward radial force to the annular frame in a radial direction away from the valve axis.

[0161] Example 2. The prosthetic heart valve assembly of example 1, wherein the anchoring element is positioned adjacent to the first valve end of the annular frame, the anchoring element extending coaxially within the annular frame about the valve axis.

[0162] Example 3. The prosthetic heart valve assembly of example 2, wherein the anchoring element comprises an anchoring length that is less than an annular frame length of the heart valve prosthesis between the first valve end and the second valve end.

[0163] Example 4. The prosthetic heart valve assembly of example 3, wherein the anchoring length is 50% less than the annular frame length.

[0164] Example 5. The prosthetic heart valve assembly of example 4, wherein the anchoring length is 37.5% less than the annular frame length.

[0165] Example 6. The prosthetic heart valve assembly of example 3, wherein the anchoring element applies the outward radial force to the annular frame to radially expandATTORNEY DOCKET No. A0012587W001 the heart valve prosthesis and bias the heart valve prosthesis into contact with a native leaflet, annulus, and / or surrounding myocardium.

[0166] Example 7. The prosthetic heart valve assembly of example 1, wherein the plurality of frame members are arranged to form a plurality of openings, the anchoring element comprising an anchoring protrusion that extends through an opening of the plurality of openings.

[0167] Example 8. The prosthetic heart valve assembly of example 7, wherein the anchoring protrusion is configured to engage a native leaflet, annulus, and / or surrounding myocardium.

[0168] Example 9. A transcatheter heart valve delivery assembly comprising a heart valve prosthesis comprising an annular frame extending along a valve axis between a first valve end of the heart valve prosthesis and a second valve end of the heart valve prosthesis. The annular frame comprises a plurality of frame members and configured to be adjustable between a radially-collapsed configuration and a radially-expanded configuration. A plurality of prosthetic leaflets are attached to the annular frame. An anchoring element comprises a support frame that is configured to contact the annular frame and apply an outward radial force to the annular frame in a radial direction away from the valve axis. The anchoring element is configured to be adjustable between a radially-collapsed configuration and a radially-expanded configuration. A capsule is configured to circumferentially surround at least one of the heart valve prosthesis and the anchoring element when the heart valve prosthesis and the anchoring element are in the radially-collapsed configuration. The capsule, the heart valve prosthesis, and the anchoring element are configured to be advanced through a patient’s vasculature to a treatment site.

[0169] Example 10. The transcatheter heart valve delivery assembly of example 9, further comprising a balloon positioned within the anchoring element, the balloon configured to be in a deflated configuration when the capsule, the heart valve prosthesis, the anchoring element and the balloon are advanced through the patient’s vasculature, and configured to be moved to an inflated configuration upon reaching the treatment site.

[0170] Example 11. The transcatheter heart valve delivery assembly of example 9, further comprising an anchoring protrusion attached to one of the annular frame or the anchoring element, the anchoring protrusion in a retracted position when the capsule, the heart valve prosthesis, and the anchoring element are advanced through the patient’sATTORNEY DOCKET No. A0012587W001 vasculature, and configured to be moved to an extended position upon reaching the treatment site.

[0171] Example 12. Methods for implanting a heart valve prosthesis are provided. Methods comprise providing a heart valve prosthesis comprising a frame and leaflets, the frame extending between a first valve end and a second end. Methods comprise providing an anchoring element comprising a support frame. Methods comprise advancing a delivery assembly through a heart valve to deliver the heart valve prosthesis and the anchoring element. Methods comprise partially expanding the heart valve prosthesis. Methods comprise deploying the anchoring element inside of the partially-expanded heart valve prosthesis at the first valve end. Methods comprise fully-expanding the heart valve prosthesis and releasing the heart valve prosthesis from the delivery assembly.

[0172] Example 13. The method of example 12, wherein deploying the anchoring element comprises radially-expanding an anchoring protrusion to extend radially outwardly from the frame, the anchoring protrusion engaging a native valve leaflet, annulus, and / or surrounding myocardium.

[0173] Example 14. The method of example 13, wherein the anchoring protrusion is attached to the frame of the heart valve prosthesis.

[0174] Example 15. The method of example 13, wherein the anchoring protrusion is attached to the support frame of the anchoring element.

[0175] Example 16. The method of example 12, wherein the frame of the heart valve prosthesis is self-expanding and the support frame of the anchoring element is balloon-expanding.

[0176] Example 17. The method of example 12, wherein the delivery assembly comprises a capsule and a balloon, wherein retraction of the capsule allows for the heart valve prosthesis to move from a radially-collapsed configuration to a radially-expanded configuration; and inflation of the balloon allows for the anchoring element to move from a radially-collapsed configuration to a radially-expanded configuration.

[0177] Example 18. The method of example 12, wherein the implanting of the heart valve prosthesis is for treating aortic regurgitation and native valve leaflets are noncalcified.

[0178] Example 19. The method of example 12, wherein the implanting of the heart valve prosthesis is for treating aortic regurgitation by replacing a native heart valve.ATTORNEY DOCKET No. A0012587W001

[0179] Example 20. An expandable stent frame comprises a stent structure extending along an elongated axis of the expandable stent frame between a proximal end portion of the stent structure and a distal end portion of the stent structure. The stent structure is configured to expand from a radially-collapsed configuration to a radially- expanded configuration. The expandable stent frame further comprises a plurality of anchors coupled to the stent structure and spaced around the elongated axis. Each each anchor of the plurality of anchors is configured to transition from a straightened orientation to a radially flared orientation.

[0180] Example 21. The expandable stent frame of example 20, wherein each anchor of the plurality of anchors is coupled to the distal end portion of the stent structure.

[0181] Example 22. The expandable stent frame of claim 21, wherein each anchor of the plurality of anchors extends distally from a distal end of the distal end portion of the stent structure.

[0182] Example 23. The expandable stent frame of any one of examples 20-22, wherein each anchor of the plurality of anchors comprises a pair of spaced apart protrusions.

[0183] Example 24. The expandable stent frame of any one of examples 20-23, wherein the radially flared orientation comprises each anchor of the plurality of anchors flared radially outward relative to the stent structure in the radially-expanded configuration.

[0184] Example 25. The expandable stent frame of any one of examples 20-24, wherein the stent structure comprises a self-expanding stent structure.

[0185] Example 26. A prosthetic heart valve comprises the expandable stent frame of any one of examples 20-25. The prosthetic heart valve further comprises a plurality of leaflets coupled to the stent structure and configured to move between an opened configuration and a closed configuration to permit unidirectional blood flow when the stent structure is in the radially-expanded configuration.

[0186] Example 27. An expandable stent frame comprises a stent structure extending along an elongated axis between a proximal end portion of the stent structure and a distal end portion of the stent structure. The stent structure is configured to expand from a radially-collapsed configuration to a radially-expanded configuration. An expandable ring is coupled to the stent structure and circumscribes the elongated axis. The expandable ring comprises a plurality of anchors configured move from a retracted orientation to a radiallyATTORNEY DOCKET No. A0012587W001 projected orientation when the expandable ring is expanded from a radially-contracted orientation to a radially-expanded orientation.

[0187] Example 28. The expandable stent frame of example 27, wherein the expandable ring is coalbed to the distal end portion of the stent structure.

[0188] Example 29. The expandable stent frame of example 28, wherein the expandable ring extends distally from a distal end of the distal end portion of the stent structure along the elongated axis.

[0189] Example 30. The expandable stent frame of any one of examples 27-29, wherein each anchor of the plurality of anchors is defined by a laser-cut pattern formed through a circumferential wall of the expandable ring and extending at least partially around the elongated axis.

[0190] Example 31. The expandable stent frame of any one of examples 27-30, wherein each anchor of the plurality of anchors comprises a pair of spaced apart protrusions.

[0191] Example 32. The expandable stent frame of any one of examples 27-31, wherein the stent structure comprises a balloon-expandable stent structure.

[0192] Example 33. A prosthetic heart valve comprises the expandable stent frame of any one of examples 27-32. The prosthetic heart valve further comprises a plurality of leaflets coupled to the expandable stent frame and configured to move between an opened configuration and a closed configuration to permit unidirectional blood flow when the stent structure is in the radially-expanded configuration.

[0193] Example 34. A method of expanding an expandable stent frame comprises expanding a stent structure of the expandable stent frame from a radially-collapsed configuration to a radially-expanded configuration. The method further comprises transitioning a plurality of anchors coupled to the stent structure from a straightened orientation to a radially flared orientation.

[0194] Example 35. The method of example 34, wherein transitioning the plurality of anchors from the straightened orientation to the radially flared orientation further comprises anchoring the plurality of anchors to an existing heart valve.

[0195] Example 36. The expandable stent frame of example 35, wherein the existing heart valve comprises a native heart valve.

[0196] Example 37. The expandable stent frame of example 35, wherein the existing heart valve comprises a previously implanted prosthetic heart valve.ATTORNEY DOCKET No. A0012587W001

[0197] Example 38. A method of expanding an expandable stent frame comprises at least partially expanding a stent structure of the expandable stent frame from a radially- collapsed configuration to a radially-expanded configuration. The method further comprises expanding an expandable ring coupled to the stent structure, and moving a plurality of anchors of the expandable ring from a retracted orientation to a radially projected orientation.

[0198] Example 39. The method of example 38, wherein moving the plurality of anchors of the expandable ring from the retracted orientation to the radially projected orientation comprises anchoring the plurality of anchors to an existing heart valve.

[0199] Example 40. The expandable stent frame of example 39, wherein the existing heart valve comprises a native heart valve.

[0200] Example 41. The expandable stent frame of example 39, wherein the existing heart valve comprises a previously implanted prosthetic heart valve.

[0201] 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

ATTORNEY DOCKET No. A0012587W001What is claimed is:

1. A prosthetic heart valve assembly comprising: a heart valve prosthesis (10) comprising: an annular frame (15) extending along a valve axis (817) between a first valve end (11) of the heart valve prosthesis (10) and a second valve end (12) of the heart valve prosthesis (10), the annular frame (15) comprising a plurality of frame members and configured to be adjustable between a radially-collapsed configuration and a radially-expanded configuration; a plurality of prosthetic leaflets (21) attached to the annular frame (15); and an anchoring element (811) positioned within the heart valve prosthesis (10), the anchoring element (811) comprising a support frame (813) that is configured to contact the annular frame (15) and apply an outward radial force to the annular frame (15) in a radial direction (815) away from the valve axis (817).

2. The prosthetic heart valve assembly of claim 1, wherein the anchoring element (811) applies the outward radial force to the annular frame (15) to radially expand the heart valve prosthesis (10) and bias the heart valve prosthesis (10) into contact with a native leaflet, annulus (703), and / or surrounding myocardium.

3. The prosthetic heart valve assembly of any one of claims 1-2, wherein the plurality of frame (15) members are arranged to form a plurality of openings (1321), the anchoring element (811) comprising an anchoring protrusion (1301) that extends through an opening (1321) of the plurality of openings (1321).

4. A method for implanting a heart valve prosthesis (10), comprising: providing a heart valve prosthesis (10) comprising a frame (15) and leaflets (21), the frame (15) extending between a first valve end (11) and a second end (12); providing an anchoring element (811) comprising a support frame (813); advancing a delivery assembly (30) through a heart valve to deliver the heart valve prosthesis (10) and the anchoring element (811); partially expanding the heart valve prosthesis (10);ATTORNEY DOCKET No. A0012587W001 deploying the anchoring element (811) inside of the partially-expanded heart valve prosthesis (10) at the first valve end (11); and fully-expanding the heart valve prosthesis (10) and releasing the heart valve prosthesis (10) from the delivery assembly (30).

5. The method of claim 4, wherein deploying the anchoring element (811) comprises radially-expanding an anchoring protrusion (801, 1301) to extend radially outwardly from the frame (15), the anchoring protrusion (801, 1301, 1501, 1601) engaging a native valve leaflet, annulus (703), and / or surrounding myocardium.

6. The method of any one of claims 4-5, wherein the frame (15) of the heart valve prosthesis (10) is self-expanding and the support frame (813) of the anchoring element (811) is balloon (1311)-expanding.

7. The method of any one of claims 4-6, wherein the delivery assembly (30) comprises a capsule (35) and a balloon (1311), wherein: retraction of the capsule (35) allows for the heart valve prosthesis (10) to move from a radially-collapsed configuration to a radially-expanded configuration; and inflation of the balloon (1311) allows for the anchoring element (811) to move from a radially-collapsed configuration to a radially-expanded configuration.

8. An expandable stent frame (2500) comprising: a stent structure (2502) extending along an elongated axis (2504) of the expandable stent frame (2500) between a proximal end portion (2506) of the stent structure (2502) and a distal end portion (2508) of the stent structure (2502), wherein the stent structure (2502) is configured to expand from a radially-collapsed configuration to a radially-expanded configuration; and a plurality of anchors (2518) coupled to the stent structure (2502) and spaced around the elongated axis (2504), wherein each anchor (3302) of the plurality of anchors (2518) is configured to transition from a straightened orientation to a radially flared orientation.ATTORNEY DOCKET No. A0012587W0019. The expandable stent frame (2500) of claim 8, wherein the radially flared orientation comprises each anchor (3302) of the plurality of anchors (2518) flared radially outward relative to the stent structure (2502) in the radially-expanded configuration.

10. An expandable stent frame (3200) comprising: a stent structure (3202) extending along an elongated axis (3204) between a proximal end portion (3206) of the stent structure (3202) and a distal end portion (3208) of the stent structure (3202), wherein the stent structure (3202) is configured to expand from a radially-collapsed configuration to a radially-expanded configuration; and an expandable ring (3300) coupled to the stent structure (3202) and circumscribing the elongated axis (3204), wherein the expandable ring (3300) comprises a plurality of anchors (3302) configured move from a retracted orientation to a radially projected orientation when the expandable ring (3300) is expanded from a radially-contracted orientation to a radially-expanded orientation.

11. The expandable stent frame (3200) of claim 10, wherein each anchor (3302) of the plurality of anchors (3302) is defined by a laser-cut pattern formed through a circumferential wall of the expandable ring (3300) and extending at least partially around the elongated axis (3204).

12. A method of expanding an expandable stent frame (2500) comprising: expanding a stent structure (2502) of the expandable stent frame (2500) from a radially-collapsed configuration to a radially-expanded configuration; and transitioning a plurality of anchors (2518) coupled to the stent structure (2502) from a straightened orientation to a radially flared orientation.

13. The method of claim 12, wherein transitioning the plurality of anchors (2518) from the straightened orientation to the radially flared orientation further comprises anchoring the plurality of anchors (2518) to an existing heart valve.ATTORNEY DOCKET No. A0012587W00114. A method of expanding an expandable stent frame (3200) comprising: at least partially expanding a stent structure (3202) of the expandable stent frame (3200) from a radially-collapsed configuration to a radially-expanded configuration; expanding an expandable ring (3300) coupled to the stent structure (3202); and moving a plurality of anchors (3302) of the expandable ring (3300) from a retracted orientation to a radially projected orientation.

15. The method of claim 14, wherein moving the plurality of anchors (3302) of the expandable ring (3300) from the retracted orientation to the radially projected orientation comprises anchoring the plurality of anchors (3302) to an existing heart valve.

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