Prosthetic heart valve implant

Abstract

A heart valve prosthesis is positioned within an index valve prosthesis. The heart valve prosthesis includes an annular frame extending along a valve axis between a first valve end and a second valve end. The annular frame includes a plurality of frame members and is adjustable between a radially-collapsed configuration and a radially- expanded configuration. The annular frame includes a central region including a folded segment that moves between a first configuration and a second configuration. The folded segment is biased toward the second configuration. The folded segment defines a channel on an outer radial side of the folded segment when the folded segment is in the second configuration. The channel receives at least one lacerated leaflet of the index valve prosthesis. Methods of implanting a heart valve prosthesis are provided.

Description

PROSTHETIC HEART VALVE IMPLANTCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 625,799, filed January 26, 2024, the entire content of which is incorporated herein by reference.FIELD

[0002] The present disclosure relates generally to a prosthetic heart valve assembly and, more particularly, to a heart valve prosthesis configured to be positioned within an index valve prosthesis.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 while avoiding obstruction of the coronary arteries 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 heart valve prosthesis is configured to be positioned within an index valve prosthesis. The heart valve prosthesis comprises 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. The annular frame comprises a central region extending circumferentially around the valve axis and located axially between the first valve end and the second valve end. The central region comprises a folded segment that is configured to move between a first configuration in which the annular frame comprises a first length along the valve axis between the first valve end and the second valve end, and a secondconfiguration in which the annular frame comprises a second length along the valve axis between the first valve end and the second valve end. The second length is less than the first length and the folded segment is biased toward the second configuration. The folded segment defines a channel on an outer radial side of the folded segment when the folded segment is in the second configuration. The channel is configured to receive at least one lacerated leaflet of the index valve prosthesis.

[0006] In aspects, in the second configuration, a radial axis extends substantially perpendicular to, and intersecting, the valve axis intersects a first segment portion of the folded segment and a second segment portion of the folded segment.

[0007] In aspects, the second segment portion is located radially exterior from the first segment portion such that the second segment portion circumferentially surrounds the first segment portion.

[0008] In aspects, the folded segment comprises a depth along the radial axis that is within a range from about 2 millimeters to about 15 millimeters.

[0009] In aspects, the folded segment comprises a length along the valve axis that is within a range from about 5 millimeters to about 15 millimeters.

[0010] In aspects, an outer radial side of the annular frame is configured to contact the at least one lacerated leaflet and move the at least one lacerated leaflet into the channel as the folded segment moves from the first configuration to the second configuration.

[0011] In aspects, the outer radial side of the central region is in contact with the at least one lacerated leaflet and is configured to guide the at least one lacerated leaflet toward the first valve end and into the channel.

[0012] In aspects, a heart valve prosthesis is configured to be positioned within an index valve prosthesis. The heart valve prosthesis comprises 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. The annular frame comprises a central region extending circumferentially around the valve axis and located axially between the first valve end and the second valve end. The central region comprises a folded segment that is configured to move between a first configuration in which the annular frame comprises a first length along the valve axis between the first valve end and the second valve end, and a secondconfiguration in which the annular frame comprises a second length along the valve axis between the first valve end and the second valve end. The second length is less than the first length and the folded segment is biased toward the second configuration. When the folded segment is in the second configuration, the folded segment defines a channel on an outer radial side of the folded segment. The channel is configured to receive a lacerated index leaflet of the index valve prosthesis. The folded segment comprises a segment portion that extends along a radial axis that intersects, and is substantially perpendicular to, the valve axis.

[0013] In aspects, the folded segment comprises a first segment portion and a second segment portion. The second segment portion is located radially exterior from the first segment portion such that the second segment portion circumferentially surrounds the first segment portion.

[0014] In aspects, an outer radial side of the annular frame is configured to contact the at least one lacerated leaflet and move the at least one lacerated leaflet into the channel as the folded segment moves from the first configuration to the second configuration.

[0015] In aspects, methods of implanting a heart valve prosthesis comprise lacerating index leaflets of an index valve prosthesis that is positioned in a native aortic annulus. Methods comprise delivering the heart valve prosthesis to an interior index lumen of the index valve prosthesis. Methods comprise deploying the heart valve prosthesis within the interior index lumen such that the heart valve prosthesis moves from a radially-compressed configuration to a radially-expanded configuration. Methods comprise, as the heart valve prosthesis moves to the radially-expanded configuration, contacting the lacerated index leaflets of the index valve with an outer radial side of the heart valve prosthesis while the heart valve prosthesis moves to an axially-compressed configuration such that the lacerated index leaflets are held within a channel on the outer radial side of a folded segment of the heart valve prosthesis.

[0016] In aspects, the heart valve prosthesis comprises an annular frame comprising a first portion that is formed by wire-forming, and a second portion that is formed by laser cutting.

[0017] In aspects, the first portion is attached to the second portion by one or more attachment structures, the attachment structures comprising one or more of sutures, rivets, or crimp fittings.

[0018] In aspects, the folded segment comprises a segment portion that extends along a radial axis that intersects, and is substantially perpendicular to, the valve axis.

[0019] In aspects, the folded segment comprises a first segment portion and a second segment portion. The second segment portion is located radially exterior from the first segment portion such that the second segment portion circumferentially surrounds the first segment portion.

[0020] In aspects, delivering the heart valve prosthesis comprises holding the heart valve prosthesis in the radially-compressed configuration within a capsule as the heart valve prosthesis is moved to the interior index lumen.

[0021] In aspects, deploying the heart valve prosthesis comprises separating the capsule from a distal tip to release the heart valve prosthesis from the capsule. A first valve end of the heart valve prosthesis remains attached to the distal tip as a second valve end of the heart valve prosthesis moves to the radially-expanded configuration.

[0022] In aspects, the first valve end remains attached to the distal tip as the heart valve prosthesis moves to the axially-compressed configuration and the second valve end moves toward the first valve end.

[0023] In aspects, the heart valve prosthesis comprises an annular frame that is formed by laser cutting.

[0024] Additional features and advantages of the aspects disclosed herein will be set forth in the detailed description that follows, and in part will be clear to those skilled in the art from that description or recognized by practicing the aspects described herein, including the detailed description which follows, the claims, as well as the appended drawings. It is to be understood that both the foregoing general description and the following detailed description present aspects intended to provide an overview or framework for understanding the nature and character of the aspects disclosed herein. The accompanying drawings are included to provide further understanding and are incorporated into and constitute a part of this specification. The drawings illustrate various aspects of the disclosure, and together with the description explain the principles and operations thereof.Brief Description Of The Drawings

[0025] 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:

[0026] FIG. 1 schematically illustrates example aspects of a transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0027] FIG. 2 illustrates a top-down view of the transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0028] FIG. 3 illustrates a side view of a delivery assembly for delivering the transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0029] FIG. 4 illustrates a side view of the delivery assembly for delivering the transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0030] FIG. 5 illustrates an introducer sheath in accordance with aspects of the disclosure;

[0031] FIG. 6 illustrates an introducer sheath in accordance with aspects of the disclosure;

[0032] FIG. 7 schematically illustrates a side view of an index transcatheter heart valve prosthesis positioned at a treatment site in accordance with aspects of the disclosure;

[0033] FIG. 8 illustrates an example of transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0034] FIG. 9 illustrates an example of transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0035] FIG. 10 illustrates an example of deploying the transcatheter heart valve prosthesis within the index transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0036] FIG. 11 illustrates an example of deploying the transcatheter heart valve prosthesis within the index transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0037] FIG. 12 illustrates an example of deploying the transcatheter heart valve prosthesis within the index transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0038] FIG. 13 illustrates an example of deploying the transcatheter heart valve prosthesis within the index transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0039] FIG. 14 illustrates an example of deploying the transcatheter heart valve prosthesis within the index transcatheter heart valve prosthesis in accordance with aspects of the disclosure; and

[0040] FIG. 15 illustrates an example of transcatheter heart valve prosthesis in accordance with aspects of the disclosure.Detailed Description

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 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 specificorder, 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.

[0046] 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.

[0047] The word “exemplary,” “example,” or various forms thereof are used herein to mean serving as an example, instance, or illustration. Any aspect or design described 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.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] Unless otherwise indicated, the terms “distaf’and “proximal” are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction toward the clinician. In addition, the term “self-expanding” may be used in the following description with reference to one or more valve or stent structures of the prostheses hereof and is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration or vice versa. Non-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, or other metal. Mechanical memory may be imparted to a wire or stent structure by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol. Various polymers that can be made to have shape memory characteristics may also be suitable for use in aspects hereof to include polymers such as polynorborene, transpolyisoprene, styrene-butadiene, and polyurethane. As well poly L-D lactic copolymer, oligo caprylactone copolymer and poly cyclo-octine can be used separately or in conjunction with other shape memory polymers.

[0052] 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 ofbreath, dizziness, fainting, palpitations, anemia and edema, and blood clots which can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and / or life threatening.

[0053] Heart valve prostheses have been developed for repair and replacement of diseased and / or damaged heart valves. Such heart valve prostheses can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based delivery systems. Such heart valve prostheses generally include a frame or stent and a prosthetic valve mounted within the frame. Such heart valve prostheses are delivered in a radially compressed or crimped configuration so that the heart valve prosthesis can be advanced through the patient’s vasculature. Once positioned at the treatment site, the heart valve prosthesis is expanded to engage tissue at the diseased heart valve region to, for instance, hold the heart valve prosthesis in position.

[0054] 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.

[0055] 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 of 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, and 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.

[0056] 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.

[0057] As shown in FIG. 1, the transcatheter heart valve prosthesis 10 includes an inflow end 11 and an outflow end 12. The prosthetic leaflets 21 are attached to the frame 15 at commissures 25 such that when pressure at the inflow end 11 exceeds pressure at the outflow end 12, the prosthetic leaflets 21 open to allow blood flow through the heart valve prosthesis 10 from the inflow end 11 to the outflow end 12. When the pressure at the outflow end 12 exceeds pressure at the inflow end 11, the prosthetic leaflets 21 close to prevent blood flow from the outflow end 12 to the inflow 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. 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 outflow 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.

[0058] 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 inflow end 11 and the outflow 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 theplurality 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.

[0059] 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 include 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 inflow end 11 to prevent paravalvular leakage of blood around the outside of the transcatheter heart valve prosthesis 10 once implanted in the patient.

[0060] 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.

[0061] 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 infrictional 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.

[0062] 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 36 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).

[0063] 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 theprocedure 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.

[0064] 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.

[0065] 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.

[0066] 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.

[0067] 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.

[0068] 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. The 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.

[0069] 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-limitingexample, 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.

[0070] 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 aortic annulus (hereinafter “annulus”) 703 of a native heart valve, for example, the annulus of a patient’s left ventricle. 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 or 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 inflow end 11, a second section 715 at the outflow 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. 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 inflow end 11 to prevent paravalvular leakage of blood around the outside of the transcatheter heart valve prosthesis 10 once implanted in the patient.

[0071] In aspects, the heart valve prosthesis 10 can function as an index valve prosthesis (e.g., a previously-implanted heart valve prosthesis), such that another heart valve prosthesis can be delivered and deployed within the heart valve prosthesis 10. As illustrated in FIG. 7, the delivery assembly 30 can deliver a heart valve prosthesis 751 (e.g., or 901) to an interior of the heart valve prosthesis 10. The delivery assembly 30 can comprise the capsule 35 and the distal tip 37, with the heart valve prosthesis 751 in a radially-compressed position and loaded within the capsule 35. In aspects, the heart valve prosthesis 751 can have some similarities in structure to the heart valve prosthesis 10 described herein, though the heartvalve prosthesis 751 can function as a new or redo heart valve prosthesis that is deployed within the index, or previously-implanted, heart valve prosthesis 10.

[0072] FIG. 8 illustrates a side view of an example of the heart valve prosthesis 751 that can be delivered to the interior of the index heart valve prosthesis 10. For example, the heart valve prosthesis 751 can comprise an annular frame 801 comprising a plurality of frame members or struts 803, with the annular frame 801 configured to be adjustable between a radially-collapsed configuration (e.g., illustrated in FIG. 7) and a radially-expanded configuration (e.g., illustrated in FIG. 8). The frame 801 can be similar to the frame 15 described herein, with the frame 801 supporting a prosthetic valve (e.g., substantially identical to the prosthetic valve 20 comprising at least one leaflet 21 disposed within and secured to the frame 801) within an interior of the frame 801. In aspects, the frame 801 can comprise a nitinol material. The frame 801 can be self-expandable, balloon-expandable, or mechanically expandable in other embodiments. The frame 801 can extend along a valve axis 809 between a first valve end 811 and a second valve end 813. The first valve end 811 forms the inflow end (e.g., substantially identical to the inflow end 11 of the heart valve prosthesis 10) and the second valve end 813 forms the outflow end (e.g., substantially identical to the outflow end 12 of the heart valve prosthesis 10).

[0073] The heart valve prosthesis 751 can comprise a central region 817 extending circumferentially around the valve axis 809 and located axially between the first valve end 811 and the second valve end 813. The central region 817 may be located at a similar location as the waist section 717 of the heart valve prosthesis 10. In aspects, the central region 817 can comprise a folded segment 819 that can move between a first configuration and a second configuration. The first configuration can correspond to the configuration when the heart valve prosthesis 751 is in the radially-compressed state (e.g., illustrated in FIG. 7) and loaded within the capsule 35. The second configuration can correspond to the configuration when the heart valve prosthesis 751 is in the radially-expanded state, as illustrated in FIG. 8. In the first configuration, the annular frame 801 can comprise a first length (e.g., when the prosthesis 751 is in the compressed position illustrated in FIG. 7) along the valve axis 809 between the first valve end 811 and the second valve end 813. In the second configuration, the annular frame 801 can comprise a second length 823 along the valve axis 809 between the first valve end 811 and the second valve end 813, with the second length 823 being less than the first length 753.

[0074] The folded segment 819 may be biased toward the second configuration such that when the heart valve prosthesis 751 is released from the capsule 35, the folded segment 819 may take the shape that is illustrated in FIG. 8. By being biased toward the second configuration, the folded segment 819, which may comprise a nitinol material, may be heatset to a predetermined shape (e.g., the shape illustrated in FIG. 8) such that, in the absence of forces acting upon the heart valve prosthesis 751, the folded segment 819 will move to the shape illustrated in FIG. 8. The folded segment 819 can define a channel 825 on an outer radial side 827 of the folded segment 819 when the folded segment 819 is in the second configuration. For example, the channel 825 can define a region of the heart valve prosthesis 751 that is at a reduced or minimum diameter as compared to a part of the heart valve prosthesis 751 that is closer to the first valve end 811 or the second valve end 813 (e.g., on opposing axial sides of the folded segment 819). In aspects, the channel 825 can define a minimum diameter of the heart valve prosthesis 751 along the valve axis 809. The folded segment 819 can comprise a segment portion 831 that extends along a radial segment axis 833 that intersects, and is substantially perpendicular to, the valve axis 809. In this way, the folded segment 819 can project radially inwardly toward the valve axis 809. The radial segment axis 833 is not limited to being substantially perpendicular to the valve axis 809. Rather, in aspects, the folded segment 819 can be angled such that the radial segment axis 833, while extending through the folded segment 819, intersects the valve axis 809 and forms an angle relative to the valve axis 809 that is within a range from about 45 degrees to about 90 degrees, or about 60 degrees to about 90 degrees, or about 75 degrees to about 90 degrees. It will be appreciated that the numerical ranges disclosed and discussed herein are merely exemplary, and that values outside of the ranges (e.g., 44 degrees which is outside of the stated range of about 45 degrees to about 90 degrees) are possible.

[0075] As will be described herein, for example, relative to FIGS. 10-13), when the folded segment 819 is in the second configuration, the channel 825 can receive at least one lacerated leaflet of the index valve prosthesis 10. For example, prior to the deployment of the heart valve prosthesis 751, the leaflets 21 of the prosthetic valve 20 (e.g., illustrated in FIG. 1) of the index valve prosthesis 10 may be lacerated to reduce the likelihood of the leaflets 21 blocking a coronary artery. Laceration may be performed via a mechanical cutting tool (e.g., blade), an energetic cutting tool (e.g., RF electrode), by heated cutting tool, or any other suitable mechanism. In some aspects, laceration may comprise cutting theleaflet along a midline of the leaflet to substantially bifurcate the leaflet into two flaps. The movement of the central region 817 from the first configuration to the second configuration (e.g., and, thus, the radial-expansion of the heart valve prosthesis 751) can cause the outer radial side 827 of the heart valve prosthesis 751 to contact the lacerated leaflets 21. With the outer radial side 827 is in contact with the lacerated leaflets 21, the folded segment 819 can axially compress (e.g., shorten in length) along the axis 809, which can guide the lacerated leaflets 21 toward the channel 825, whereupon the lacerated leaflets 21 may be held within the channel 825. In aspects, the degree to which the central region 817 axially compresses while moving from the first configuration to the second configuration may be greater than the degree to which other portions of the heart valve prosthesis 751 axially compress. In this way, the outer radial side 827 can contact the at least one lacerated leaflet and guide the at least one lacerated leaflet toward the first valve end 811 and into the channel 825.

[0076] FIG. 9 illustrates a side view of another example of a heart valve prosthesis 901. The heart valve prosthesis 901 can be delivered to the interior of the heart valve prosthesis 10 in a substantially identical manner as the heart valve prosthesis 751. The heart valve prosthesis 751 can comprise the annular frame 801 comprising the plurality of frame members or struts 803, with the annular frame 801 configured to be adjustable between a radially-collapsed configuration (e.g., illustrated in FIG. 7) and a radially-expanded configuration (e.g., illustrated in FIG. 9). The frame 801 can extend between the first valve end 811 and the second valve end 813 along the valve axis 809. The heart valve prosthesis 901 can comprise a central region 903 extending circumferentially around the valve axis 809 and located axially between the first valve end 811 and the second valve end 813. The central region 903 may be located at a similar location as the central region 817 of the heart valve prosthesis 751. In aspects, the central region 903 can comprise a folded segment 905 that can move between a first configuration and a second configuration. The first configuration can correspond to the configuration when the heart valve prosthesis 901 is in the radially-compressed state (e.g., illustrated in FIG. 7) and loaded within the capsule 35. The second configuration can correspond to the configuration when the heart valve prosthesis 901 is in the radially-expanded state, as illustrated in FIG. 9. It will be appreciated that FIG. 9 illustrates the heart valve prosthesis 901 comprising the frame 801, with the frame 801 illustrated generically / schematically without the frame members (e.g., struts 16)to avoid obstructing the view of the central region 903, namely, the folded segment 905. In operation, however, the frame 801 will comprise the frame members (or struts 16) similar to the embodiments of FIGS. 1, 7, and 8.

[0077] The folded segment 905 may be biased toward the second configuration such that when the heart valve prosthesis 901 is released from the capsule 35, the folded segment 905 may take the shape that is illustrated in FIG. 9. For example, the folded segment 905 can define a channel 909 on an outer radial side 911 of the folded segment 905 when the folded segment 905 is in the second configuration. For example, the channel 909 can define a region of the heart valve prosthesis 901 that is at a reduced or minimum diameter as compared to a part of the heart valve prosthesis 901 that is closer to the first valve end 811 or the second valve end 813. In aspects, the channel 909 can define a minimum diameter of the heart valve prosthesis 901 along the valve axis 809.

[0078] The folded segment 905 can comprise a plurality of segment portions that are rounded and overlapping. For example, the folded segment 905 can comprise a first segment portion 915, a second segment portion 917, and a third segment portion 919. The segment portions 915, 917, 919 can be attached to one another and may extend circumferentially around the valve axis 809 while overlapping. For example, when the folded segment 905 is in the second configuration, a radial axis 923 can extend substantially perpendicular to, and intersecting, the valve axis 809. The radial axis 923 may intersect the first segment portion 915 and the second segment portion 917. In this way, the second segment portion 917 may be located radially exterior from the first segment portion 915 such that the second segment portion 917 circumferentially surrounds the first segment portion 915. In aspects, the third segment portion 919 can extend along a second radial axis 925 that is substantially parallel to the radial axis 923. The second radial axis 925 may intersect the valve axis 809 while being substantially perpendicular to the valve axis 809. Accordingly, the third segment portion 919 can be attached to the first segment portion 915 and the second segment portion 917, with the third segment portion 919 comprising a rounded shape while extending in a radial direction. In aspects, the first segment portion 915 can comprise a rounded shape.

[0079] The folded segment 905 can comprise a depth 931 along the radial axes 923, 925 that is within a range from about 2 millimeters to about 15 millimeters. For example, the depth 931 can comprise the distance between the second segment portion 917 and theinnermost portion of the frame 801 in a radial direction (e.g., along the radial axes 923, 925). The following dimensions are merely exemplary and are not intended to be limiting, for example, the folded segment 905 may comprise dimensions that are outside of the stated ranges. In aspects, the folded segment 905 can comprise a length 933 along the valve axis 809 that is within a range from about 5 millimeters to about 15 millimeters. In aspects, the length 933 is the distance between opposing ends of the first segment portion 915, for example, the distance between the third segment portion 919 at one end of the first segment portion 915, and a fourth segment portion 920 at an opposing end of the first segment portion 915. The third segment portion 919 and the fourth segment portion 920 may be rounded and spaced apart from one another with the first segment portion 915 extending therebetween. In aspects, the third segment portion 919 and the fourth segment portion 920 may each comprise a radius of curvature, for example, with the radius of curvature within a range from about 1 millimeter to about 10 millimeters. In aspects, a total length of the heart valve prosthesis 901, as measured between the valve ends 811, 813, may be within a range from about 20 millimeters to about 45 millimeters. In aspects, a difference between an end radius at the second valve end 813 and a central radius at the central region 903 (e.g., radial distance between a center of the heart valve prosthesis 901 and the second segment portion 917) may be within a range from about 2 millimeters to about 15 millimeters. In aspects, a diameter at the second valve end 813 may be within a range from about 20 millimeters to about 37 millimeters.

[0080] In operation, when the folded segment 905 is in the second configuration, the channel 909 can receive at least one lacerated leaflet of the index valve prosthesis 10. For example, following the laceration of the leaflets 21, the movement of the central region 903 from the first configuration to the second configuration can cause the outer radial side 911 of the heart valve prosthesis 901 to contact the lacerated leaflets 21 and guide the lacerated leaflets 21 toward the channel 909, whereupon the lacerated leaflets 21 may be held within the channel 909. In aspects, the degree to which the central region 903 axially compresses while moving from the first configuration to the second configuration may be greater than the degree to which other portions of the heart valve prosthesis 901 axially compress. In this way, the outer radial side 911 can contact the at least one lacerated leaflet and guide the at least one lacerated leaflet toward the first valve end 811 and into the channel 909. In aspects, due to the folded and overlapping configuration of the central region 903 of theheart valve prosthesis 901, the heart valve prosthesis 901 may exhibit a greater degree of axial compression than the heart valve prosthesis 751. This is due, at least in part, to the folded segment 905 comprising a larger surface area than the folded segment 819 of the heart valve prosthesis 751.

[0081] The heart valve prosthesis 751, 901 illustrated and described in FIGS. 8-9 can comprise the prosthetic valve 20 comprising the at least one leaflet 21, with the valve 20 and leaflets 21 being substantially identical to the valve 20 and leaflets 21 illustrated and described relative to FIGS. 1-2. In aspects, the valve 20 and leaflets 21 of the heart valve prosthesis 751, 901 can be attached to the non-folding portions of the frame, for example, by not being attached to the folded segments 819, 905. In this way, the folded segments 819, 905 can axially compress without interacting with the valve 20 and leaflets 21. In aspects, a fabric skirt can be attached adjacent to a valve end of the heart valve prosthesis 751, 901 to provide sealing at or near the leaflets. In aspects, and for the purposes of illustration, the valve 20 and leaflets 21 are not illustrated in some of the figures of the heart valve prosthesis 751, 901 so as to more clearly show the design and structure of the frame of the heart valve prosthesis 751, 901. However, in operation, the heart valve prosthesis 751, 901 comprises the valve 20 and leaflets 21.

[0082] FIGS. 10-12 illustrate example aspects of deploying the heart valve prosthesis (e.g., heart valve prosthesis 751 or heart valve prosthesis 901) within the interior index lumen of the index heart valve prosthesis 10. It will be appreciated that the method of deployment in FIGS. 10-12 is illustrated with the heart valve prosthesis 751, however, the method of deployment may be substantially identical for the heart valve prosthesis 901. With reference to FIGS. 7 and 10, initially, methods can comprise lacerating index leaflets 21 of the index valve prosthesis 10 that is positioned in the native aortic annulus 703. The leaflets 21 are lacerated prior to the deployment of the heart valve prosthesis 751. Following the laceration of the leaflets 21, methods can comprise delivering the heart valve prosthesis 751 to the interior index lumen of the heart valve prosthesis 10. In aspects, the heart valve prosthesis 751 can be delivered in a similar manner as described relative to FIGS. 3-7. For example, and as illustrated in FIG. 7, the heart valve prosthesis 751 can be radially- compressed and loaded into the capsule 35. When the heart valve prosthesis 751 is in the radially-compressed position, the central region 817 (e.g., the folded segment 819) may be elongated and may extend in a substantially linear direction. The capsule 35 can be movedthrough a patient’s vasculature to the native aortic annulus 703. In this way, delivering the heart valve prosthesis 751 can comprise holding the heart valve prosthesis 751 in the radially-compressed configuration within the capsule 35 as the heart valve prosthesis 751 is moved to the interior index lumen of the index heart valve prosthesis 10.

[0083] As illustrated in FIG. 10, upon reaching the heart valve prosthesis 10, methods can comprise deploying the heart valve prosthesis 751 within the interior index lumen such that the heart valve prosthesis 751 can move from the radially -compressed configuration to the radially-expanded configuration. For example, deploying the heart valve prosthesis 751 can comprise separating the capsule 35 from the distal tip 37 to release the heart valve prosthesis 751 from the capsule 35. For example, the capsule 35 can be moved in a direction away from the distal tip 37 and / or the distal tip 37 can be moved in a direction away from the capsule 35. In this way, the heart valve prosthesis 751 can be removed from the capsule 35. In aspects, the first valve end 811 may remain attached to the distal tip 37, such that the first valve end 811 is limited from moving axially (e.g., along the valve axis 809) and limited from moving to the fully radially-expanded position.

[0084] FIG. 11 illustrates a position of the lacerated leaflets 21 relative to the heart valve prosthesis 751 as the heart valve prosthesis 751 is being deployed. For example, as illustrated in FIG. 11, the capsule 35 may continue to move in a direction away from the distal tip 37, which can allow for the second valve end 813 to continue to radially expand. As the heart valve prosthesis 751 radially expands, the outer radial side 827 of the heart valve prosthesis 751 may contact the lacerated leaflets 21. For example, in aspects, the central region 817 may radially-expand into contact with the lacerated leaflets 21. At this point, the central region 817 may not yet be in the second configuration (e.g., illustrated in FIG. 8) yet, due to the axial force (e.g., tension) applied to the heart valve prosthesis 751 by the capsule 35 and the distal tip 37. That is, the first valve end 811 may remain attached to the distal tip 37 and the heart valve prosthesis 751 may remain attached to the capsule 35. The ends of the prosthesis may be attached at either end by any suitable mechanism, such as a crown capture mechanism. One example of a crown capture mechanism may include paddles or projections extending from the inflow or outflow end of the prosthesis which are configured to be held in pockets of a spindle attached to an inner member of the catheter. The paddles may be held in the pockets until uncovered by removal of a sheath. Other capture mechanisms can include constricting sutures that may hold the crowns to thedelivery system until cut or otherwise released. Due to this tension applied to the heart valve prosthesis 751, the central region 817 has not fully moved from the first configuration to the second configuration yet. Rather, the radial expansion of the heart valve prosthesis 751 may first allow the central region 817 to contact the lacerated leaflets 21.

[0085] FIG. 12 illustrates the release of the second valve end 813 from the capsule 35. For example, in aspects, the first valve end 811 may remain attached to the distal tip 37 to provide stability to the heart valve prosthesis 751. However, the second valve end 813 may be released and separated from the capsule 35, such that the first valve end 811 of the heart valve prosthesis 751 remains attached to the distal tip 37 as the second valve end 813 moves to the radially-expanded configuration. With the second valve end 813 released, and while the outer radial side 827 of the heart valve prosthesis 751 remains in contact with the lacerated leaflets 21 , the folded segment 819 of the central region 817 may infold and axially compress, thus reducing the axial length of the central region 817. The folded segment 819 may axially compress due to the central region 817 being biased toward the second configuration. The effect of the axial compression of the central region 817 may cause the second valve end 813 to move toward the first valve end 811, thus reducing an overall length of the heart valve prosthesis 751 along the valve axis 809. Due to the second valve end 813 moving toward the first valve end 811, the folded segment 819 can likewise move the lacerated leaflets 21 toward the first valve end 811. For example, with the folded segment 819 remaining in contact with the lacerated leaflets 21 , the radial force exerted by the folded segment 819 to the lacerated leaflets 21 is such that relative movement between the folded segment 819 and the lacerated leaflets 21 is limited.

[0086] FIG. 13 illustrates a side view of a position of the lacerated leaflets 21 relative to the folded segment 819. For example, the axial compression of the folded segment 819 can cause the lacerated leaflets 21 to move toward the first valve end 811 and into the channel 825. In aspects, the lacerated leaflets 21 may be folded while being received within the channel 825. As such, the lacerated leaflets 21 are limited from inadvertently exiting the channel 825 and may remain within the channel 825. The position of the heart valve prosthesis 751 relative to the native aortic annulus 703 is such that the channel 825 is axially offset from the coronary arteries. In this way, with the lacerated leaflets 21 held and maintained within the channel 825, the lacerated leaflets 21 will not block the coronary arteries, such that access to the coronary arteries is possible even after deployment of theheart valve prosthesis 751 within the index heart valve prosthesis 10. Accordingly, as the heart valve prosthesis 751 moves to the radially-expanded configuration, methods can comprise contacting the lacerated index leaflets 21 of the index valve 10 with the outer radial side 827 of the heart valve prosthesis 751 while the heart valve prosthesis 751 moves to an axially-compressed configuration such that the lacerated index leaflets 21 can be held within the channel 825 on the outer radial side 827 of the folded segment 819.

[0087] FIG. 14 illustrates a side view of the sides of the heart valve prosthesis 901 of FIG. 9 positioned within the index heart valve prosthesis 10 and engaging the lacerated leaflets 21. FIG. 14 illustrates the sides of the heart valve prosthesis 901 that are in contact with the leaflets 21 and index heart valve prosthesis 10, but, for illustrative purposes, the center of the heart valve prosthesis 901 is omitted from view so as to not obstruct the view of the central region 903 and the channel 909. The heart valve prosthesis 901 can be inserted and deployed within the index heart valve prosthesis 10 in a substantially identical manner as described relative to the heart valve prosthesis 751 of FIGS. 10-13. Accordingly, FIG. 14 illustrates the position of the heart valve prosthesis 901 after deployment. Similar to the example of the heart valve prosthesis 751 in FIGS. 12-13, the heart valve prosthesis 901 can move the lacerated index leaflets 21 into the channel 909 and may hold the lacerated index leaflets 21 within the channel 909. As such, the lacerated leaflets 21 are held and maintained within the channel 909 while not blocking the coronary arteries, such that access to the coronary arteries is possible even after deployment of the heart valve prosthesis 901 within the index heart valve prosthesis 10. The heart valve prosthesis 751, 901 is not limited to the methods of deployment and / or structure illustrated in FIGS. 10-14. For example, in aspects, the heart valve prosthesis 751, 901 can be deployed in an inverted position (e.g., 180 degrees offset from the position illustrated in FIGS. 10-14. In this way, the leaflets of the heart valve prosthesis 751 , 901 may be attached adj acent to the second valve end 813.

[0088] FIG. 15 illustrates another example of the heart valve prosthesis 751 wherein the annular frame 801 can be formed in a variety of ways. For example, the heart valve prosthesis 751, 901 illustrated in FIGS. 8-14 can comprise a frame that is formed by lasercutting, and may comprise a self-expanding material, such as a nickel titanium alloy or nitinol. In other embodiments, the heart valve prosthesis 751, 901 is not limited to being formed by laser-cutting, but rather, one region of the frame of the heart valve prosthesis 751, 901 can be formed by a first forming method (e.g., laser-cutting) while another region ofthe frame of the heart valve prosthesis 751 , 901 can be formed by a different forming method (e.g., wire-forming). For example, the heart valve prosthesis 751 can comprise a first region 1501 and a second region 1503. The first region 1501 can comprise a wire-formed frame, while the second region 1503 can comprise a laser-cut frame. The two regions 1501, 1503, which may be formed in different ways, may be attached to one another. For example, the heart valve prosthesis 751 can comprise one or more attachment structures 1505 that can attach the first region 1501 and the second region 1503. The attachment structures 1505 can comprise, for example, sutures and fabric, rivets, or crimp fittings. In aspects, the first region 1501 can comprise the first valve end 811 and the central region 817, while the second region 1503 can comprise the area of the annular frame 801 that extends from the second valve end 813 to the central region 817. It will be appreciated that the heart valve prosthesis 901 of FIG. 9 could also be formed in a similar manner, with a first region 1501 comprising a wire-formed frame, and a second region 1503 comprising a laser-cut frame. A benefit of providing two regions that are formed in different ways is that the heart valve prosthesis 751, 901 may have greater durability and an increased capacity to withstand bending strain due, at least in part, to the material damage that may occur during a laser-cut process. Accordingly, these issues may be avoided by having the central region 817, 903 formed by a wire-forming process.

[0089] 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.

[0090] The following examples are illustrative of the techniques described herein.

[0091] Example 1. A heart valve prosthesis configured to be positioned within an index valve prosthesis, the 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 comprising a plurality of frame members and configured to be adjustable between a radially-collapsed configuration and a radially- expanded configuration, the annular frame comprising: a central region extending circumferentially around the valve axis and located axially between the first valve end and the second valve end, the central region comprising a folded segment that is configured to move between: a first configuration in which the annular frame comprises a first lengthalong the valve axis between the first valve end and the second valve end; and a second configuration in which the annular frame comprises a second length along the valve axis between the first valve end and the second valve end, wherein the second length is less than the first length and the folded segment is biased toward the second configuration, the folded segment defining a channel on an outer radial side of the folded segment when the folded segment is in the second configuration, the channel configured to receive at least one lacerated leaflet of the index valve prosthesis.

[0092] Example 2. The heart valve prosthesis of Example 1, wherein, in the second configuration, a radial axis extending substantially perpendicular to, and intersecting, the valve axis intersects a first segment portion of the folded segment and a second segment portion of the folded segment.

[0093] Example 3. The heart valve prosthesis of Example 2, wherein the second segment portion is located radially exterior from the first segment portion such that the second segment portion circumferentially surrounds the first segment portion.

[0094] Example 4. The heart valve prosthesis of Example 3, wherein the folded segment comprises a depth along the radial axis that is within a range from about 2 millimeters to about 15 millimeters.

[0095] Example 5. The heart valve prosthesis of Example 4, wherein the folded segment comprises a length along the valve axis that is within a range from about 5 millimeters to about 15 millimeters.

[0096] Example 6. The heart valve prosthesis of Example 1, wherein an outer radial side of the annular frame is configured to contact the at least one lacerated leaflet and move the at least one lacerated leaflet into the channel as the folded segment moves from the first configuration to the second configuration.

[0097] Example 7. The heart valve prosthesis of Example 1, wherein the outer radial side of the central region is in contact with the at least one lacerated leaflet and is configured to guide the at least one lacerated leaflet toward the first valve end and into the channel.

[0098] Example 8. A heart valve prosthesis configured to be positioned within an index valve prosthesis, the 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 comprising a plurality of frame membersand configured to be adjustable between a radially-collapsed configuration and a radially- expanded configuration, the annular frame comprising: a central region extending circumferentially around the valve axis and located axially between the first valve end and the second valve end, the central region comprising a folded segment that is configured to move between: a first configuration in which the annular frame comprises a first length along the valve axis between the first valve end and the second valve end; and a second configuration in which the annular frame comprises a second length along the valve axis between the first valve end and the second valve end, wherein the second length less than the first length and the folded segment is biased toward the second configuration, and when the folded segment is in the second configuration: the folded segment defines a channel on an outer radial side of the folded segment, the channel configured to receive a lacerated index leaflet of the index valve prosthesis; and the folded segment comprises a segment portion that extends along a radial axis that intersects, and is substantially perpendicular to, the valve axis.

[0099] Example 9. The heart valve prosthesis of Example 8, wherein the folded segment comprises a first segment portion and a second segment portion, the second segment portion is located radially exterior from the first segment portion such that the second segment portion circumferentially surrounds the first segment portion.

[0100] Example 10. The heart valve prosthesis of Example 8, wherein an outer radial side of the annular frame is configured to contact the at least one lacerated leaflet and move the at least one lacerated leaflet into the channel as the folded segment moves from the first configuration to the second configuration.

[0101] Example 11. A method of implanting a heart valve prosthesis comprising: lacerating index leaflets of an index valve prosthesis that is positioned in a native aortic annulus; delivering the heart valve prosthesis to an interior index lumen of the index valve prosthesis; deploying the heart valve prosthesis within the interior index lumen such that the heart valve prosthesis moves from a radially-compressed configuration to a radially- expanded configuration; and as the heart valve prosthesis moves to the radially-expanded configuration, contacting the lacerated index leaflets of the index valve with an outer radial side of the heart valve prosthesis while the heart valve prosthesis moves to an axially- compressed configuration such that the lacerated index leaflets are held within a channel on the outer radial side of a folded segment of the heart valve prosthesis.

[0102] Example 12. The method of Example 11, wherein the heart valve prosthesis comprises an annular frame comprising a first portion that is formed by wireforming, and a second portion that is formed by laser cutting.

[0103] Example 13. The method of Example 12, wherein the first portion is attached to the second portion by one or more attachment structures, the attachment structures comprising one or more of sutures, rivets, or crimp fittings.

[0104] Example 14. The method of Example 11, wherein the folded segment comprises a segment portion that extends along a radial axis that intersects, and is substantially perpendicular to, the valve axis.

[0105] Example 15. The method of Example 14, wherein the folded segment comprises a first segment portion and a second segment portion, the second segment portion located radially exterior from the first segment portion such that the second segment portion circumferentially surrounds the first segment portion.

[0106] Example 16. The method of Example 11, wherein delivering the heart valve prosthesis comprises holding the heart valve prosthesis in the radially-compressed configuration within a capsule as the heart valve prosthesis is moved to the interior index lumen.

[0107] Example 17. The method of Example 16, wherein deploying the heart valve prosthesis comprises separating the capsule from a distal tip to release the heart valve prosthesis from the capsule, a first valve end of the heart valve prosthesis remaining attached to the distal tip as a second valve end of the heart valve prosthesis moves to the radially- expanded configuration.

[0108] Example 18. The method of Example 17, wherein the first valve end remains attached to the distal tip as the heart valve prosthesis moves to the axially- compressed configuration and the second valve end moves toward the first valve end.

[0109] Example 19. The method of Example 11, wherein the heart valve prosthesis comprises an annular frame that is formed by laser cutting.

Claims

What is claimed is:

1. A heart valve prosthesis configured to be positioned within an index valve prosthesis, the 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 comprising a plurality of frame members and configured to be adjustable between a radially-collapsed configuration and a radially-expanded configuration, the annular frame comprising: a central region extending circumferentially around the valve axis and located axially between the first valve end and the second valve end, the central region comprising a folded segment that is configured to move between: a first configuration in which the annular frame comprises a first length along the valve axis between the first valve end and the second valve end; and a second configuration in which the annular frame comprises a second length along the valve axis between the first valve end and the second valve end, wherein the second length is less than the first length and the folded segment is biased toward the second configuration, the folded segment defining a channel on an outer radial side of the folded segment when the folded segment is in the second configuration, the channel configured to receive at least one lacerated leaflet of the index valve prosthesis.

2. The heart valve prosthesis of claim 1, wherein, in the second configuration, a radial axis extending substantially perpendicular to, and intersecting, the valve axis intersects a first segment portion of the folded segment and a second segment portion of the folded segment.

3. The heart valve prosthesis of claim 2, wherein the second segment portion is located radially exterior from the first segment portion such that the second segment portion circumferentially surrounds the first segment portion.

4. The heart valve prosthesis of claim 3, wherein the folded segment comprises a depth along the radial axis that is within a range from about 2 millimeters to about 15 millimeters.

5. The heart valve prosthesis of claim 4, wherein the folded segment comprises a length along the valve axis that is within a range from about 5 millimeters to about 15 millimeters.

6. The heart valve prosthesis of claim 1, wherein an outer radial side of the annular frame is configured to contact the at least one lacerated leaflet and move the at least one lacerated leaflet into the channel as the folded segment moves from the first configuration to the second configuration.

7. The heart valve prosthesis of claim 1, wherein the outer radial side of the central region is in contact with the at least one lacerated leaflet and is configured to guide the at least one lacerated leaflet toward the first valve end and into the channel.

8. A method of implanting a heart valve prosthesis comprising: lacerating index leaflets of an index valve prosthesis that is positioned in a native aortic annulus; delivering the heart valve prosthesis to an interior index lumen of the index valve prosthesis; deploying the heart valve prosthesis within the interior index lumen such that the heart valve prosthesis moves from a radially-compressed configuration to a radially- expanded configuration; and as the heart valve prosthesis moves to the radially-expanded configuration, contacting the lacerated index leaflets of the index valve with an outer radial side of the heart valve prosthesis while the heart valve prosthesis moves to an axially-compressed configuration such that the lacerated index leaflets are held within a channel on the outer radial side of a folded segment of the heart valve prosthesis.

9. The method of claim 8, wherein the heart valve prosthesis comprises an annular frame comprising a first portion that is formed by wire-forming, and a second portion that is formed by laser cutting.

10. The method of claim 9, wherein the first portion is attached to the second portion by one or more attachment structures, the attachment structures comprising one or more of sutures, rivets, or crimp fittings.

11. The method of claim 8, wherein the folded segment comprises a segment portion that extends along a radial axis that intersects, and is substantially perpendicular to, the valve axis.

12. The method of claim 11, wherein the folded segment comprises a first segment portion and a second segment portion, the second segment portion located radially exterior from the first segment portion such that the second segment portion circumferentially surrounds the first segment portion.

13. The method of claim 8, wherein delivering the heart valve prosthesis comprises holding the heart valve prosthesis in the radially-compressed configuration within a capsule as the heart valve prosthesis is moved to the interior index lumen.

14. The method of claim 13, wherein deploying the heart valve prosthesis comprises separating the capsule from a distal tip to release the heart valve prosthesis from the capsule, a first valve end of the heart valve prosthesis remaining attached to the distal tip as a second valve end of the heart valve prosthesis moves to the radially-expanded configuration.

15. The method of claim 8, wherein the heart valve prosthesis comprises an annular frame that is formed by laser cutting.

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