Prosthetic heart valve assembly

Abstract

A transcatheter heart valve delivery assembly is provided for delivering a heart valve prosthesis to a treatment site. The transcatheter heart valve delivery assembly includes a handle defining an elongated opening, and an actuator that rotates relative to the handle. A rotation member is positioned within the elongated opening and is attached to the actuator. The rotation member rotates with the actuator. An outer member is attached to the rotation member and extends from the handle toward the treatment site. The outer member rotates with the rotation member. A capsule is attached to the outer member. The capsule rotates with the outer member such that the heart valve prosthesis is rotatable. Methods of implanting a heart valve prosthesis are provided.

Description

PROSTHETIC HEART VALVE ASSEMBLYCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 527,666, filed July 19, 2023 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 rotating a heart valve prosthesis to avoid obstruction of the coronary arteries.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, aligning the heart valve prosthesis to avoid obstructing 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 transcatheter heart valve delivery assembly is provided for delivering a heart valve prosthesis to a treatment site . The transcatheter heart valve delivery assembly comprises a handle defining an elongated opening. The transcatheter heart valve delivery assembly comprises an actuator attached to the handle and configured to rotate relative to the handle. The transcatheter heart valve delivery assembly comprises a rotation member positioned within the elongated opening and attached to the actuator such that the actuator circumferentially surrounds the rotation member. The rotation member is configured to rotate with the actuator. The transcatheter heart valve delivery assemblycomprises an outer member attached to the rotation member and extending from the handle toward the treatment site. The outer member is configured to rotate with the rotation member. The transcatheter heart valve delivery assembly comprises a capsule attached to the outer member and in frictional engagement with the heart valve prosthesis. The capsule is configured to rotate with the outer member such that the heart valve prosthesis is rotatable relative to the treatment site between a first rotational position and a second rotational position that is angularly offset from the first rotational position.

[0006] In aspects, the rotation member is received within an actuator channel of the actuator.

[0007] In aspects, the actuator comprises an attachment tab projecting radially inwardly toward the rotation member and received within a tab opening of the rotation member. The tab opening is defined at an outer radial side of the rotation member. The attachment tab is configured to transmit rotation to the rotation member.

[0008] In aspects, the rotation member circumferentially surrounds the outer member such that the outer member is received within a rotation channel of the rotation member.

[0009] In aspects, an attachment member is positioned circumferentially between the rotation member and the outer member. The attachment member is attached at an outer radial side to the rotation member and attached at an inner radial side to the outer member. The attachment member is configured to transmit rotation to the outer member.

[0010] In aspects, a middle member is circumferentially surrounded by the outer member such that the middle member extends coaxially with the outer member. The middle member is maintained at a fixed rotational position while the outer member is configured to rotate relative to the middle member.

[0011] In aspects, an engagement member is attached to the handle and configured to move between a first position, in which the rotation member is rotatable, and a second position, in which the rotation member is maintained at a fixed position relative to the handle.

[0012] In aspects, a stationary member is circumferentially surrounded by the actuator. The stationary member is maintained at a fixed rotational position while the actuator is configured to rotate relative to the stationary member.

[0013] In aspects, the actuator comprises an extension portion that extends radially inward from the actuator toward the stationary member. The stationary member comprises a detent portion extending radially outward from the stationary member toward the actuator. The extension portion is configured to contact the detent portion to limit a maximum rotation of the actuator relative to the handle.

[0014] In aspects, a transcatheter heart valve delivery assembly is provided for delivering a heart valve prosthesis to a treatment site . The transcatheter heart valve delivery assembly comprises a handle defining an elongated opening. The transcatheter heart valve delivery assembly comprises an actuator attached to the handle and configured to rotate relative to the handle. The actuator comprises an extension portion that extends radially from the actuator and is configured to limit a maximum rotation of the actuator relative to the handle. The transcatheter heart valve delivery assembly comprises a rotation member positioned within the elongated opening and attached to the actuator such that the actuator circumferentially surrounds the rotation member. The rotation member is configured to rotate with the actuator. The transcatheter heart valve delivery assembly comprises an engagement member attached to the handle and configured to move between a first position, in which the rotation member is rotatable, and a second position, in which the rotation member is maintained at a fixed position relative to the handle. The transcatheter heart valve delivery assembly comprises an outer member attached to the rotation member and extending from the handle toward the treatment site. The outer member is configured to rotate with the rotation member. The transcatheter heart valve delivery assembly comprises a capsule attached to the outer member and in frictional engagement with the heart valve prosthesis. The capsule is configured to rotate with the outer member such that the heart valve prosthesis is rotatable relative to the treatment site between a first rotational position and a second rotational position that is angularly offset from the first rotational position.

[0015] In aspects, the transcatheter heart valve delivery assembly comprises further comprising a stationary member that is circumferentially surrounded by the actuator. The stationary member is maintained at a fixed rotational position while the actuator is configured to rotate relative to the stationary member.

[0016] In aspects, the stationary member comprises a detent portion extending radially outward from the stationary member toward the actuator. The extension portion is configured to contact the detent portion to limit the maximum rotation of the actuator.

[0017] In aspects, the maximum rotation of the actuator is within a range from about 90 degrees to about 150 degrees.

[0018] In aspects, the engagement member contacts the actuator when the engagement member is in the second position, and the engagement member is spaced apart from the actuator when the engagement member is in the first position.

[0019] In aspects, the handle circumferentially surrounds the actuator.

[0020] In aspects, methods of implanting a heart valve prosthesis comprise delivering the heart valve prosthesis to a treatment site. The heart valve prosthesis is in frictional engagement with a capsule that is attached to an outer member. Methods comprise maintaining the outer member at a first rotational position as the heart valve prosthesis is delivered to the treatment site. Methods comprise, upon reaching the treatment site, rotating the outer member and the heart valve prosthesis by rotating an actuator that is attached to a handle such that the outer member is rotated from the first rotational position to a second rotational position. Methods comprise deploying the heart valve prosthesis at the treatment site such that the heart valve prosthesis is at a desired rotational position relative to an ostia.

[0021] In aspects, the actuator, the outer member, the capsule, and the heart valve prosthesis are rotated unitarily from the first rotational position to the second rotational position relative to the handle.

[0022] In aspects, a maximum rotation of the actuator is within a range from about 90 degrees to about 150 degrees.

[0023] In aspects, methods further comprise circumferentially surrounding the outer member with a stability member that is at a fixed rotational position. The stability member extends from the handle toward the capsule.

[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 ofthis 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 the transcatheter heart valve prosthesis positioned at a treatment site in accordance with aspects of the disclosure;

[0033] FIG. 8 illustrates a top-down view of the treatment site in accordance with aspects of the disclosure;

[0034] FIG. 9 illustrates a top-down view similar to FIG. 8 with the heart valve prosthesis deployed at the treatment site in accordance with aspects of the disclosure;

[0035] FIG. 10 illustrates a portion of a handle in accordance with aspects of the disclosure;

[0036] FIG. 11 illustrates a cross-sectional view of the handle along lines 11-11 of FIG. 10 in accordance with aspects of the disclosure;

[0037] FIG. 12 illustrates a cross-sectional view of the handle along lines 12-12 of FIG. 11 in accordance with aspects of the disclosure;

[0038] FIG. 13 illustrates a cross-sectional view of the handle along lines 13-13 of FIG. 11 in accordance with aspects of the disclosure; and

[0039] FIG. 14 illustrates a side view of the delivery assembly in accordance with aspects of the disclosure.DETAILED DESCRIPTION

[0040] 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.

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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 notrecited, 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] Unless otherwise indicated, the terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction toward the clinician. In addition, the term “self-expanding” may be used in the following description with reference to one or more valve or stent structures of the prostheses hereof and is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration or vice versa. Non-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.

[0051] 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 canincrease the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and / or life threatening.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] 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 valve 20 includes exactly three leaflets 21, as shown in FIG. 2. However, this is not meant to belimiting, as the prosthetic valve 20 may include more or fewer leaflets 21. The valve leaflets 21 open and close to regulate flow through the transcatheter heart valve prosthesis 10.

[0056] 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.

[0057] 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 the plurality of crowns 17, the plurality of nodes 19, and the plurality of struts 16. The frame15, and, thus, the plurality of struts 16, can be adjustable between a radially-collapsed position and a radially-expanded position.

[0058] 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. Although not shown, 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.

[0059] 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.

[0060] 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 coupledto 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.

[0061] 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 self-expansion at the treatment site and release from the retainer 38, as shown in FIG. 4 (without showing the transcatheter heart valve prosthesis 10).

[0062] 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 upsizethe 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.

[0063] 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 predilatation or post-dilatation.

[0064] 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.

[0065] 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.

[0066] 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.

[0067] 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.

[0068] 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.

[0069] 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 armulus of a patient’s left ventricle. The treatment site 701 can comprise one or more native valve leaflets 705 and corresponding native sinuses 707. Although disclosed with respect to placement of the heart valve prosthesis 10 within a native anatomy of the patient, in aspects, the heart valve prosthesis 10 can be implanted within a previously implanted prosthetic valve (e.g., a surgical or transcatheter index valve) to facilitate a valve-in-valve (e.g., TAV- in-SAV or TAV-in-TAV) procedure, without departing from the scope of the disclosure. 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 13 of the heart valve prosthesis 10. The frame 15 of the heart valve prosthesis 10 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, as discussed above, 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. Thus, features of the disclosure may be employed alone or in combination with a heart valve prosthesis 10 having an outer skirt or other external sealing member (not shown) or a heart valve prosthesis 10 having no outer skirt.

[0070] FIG. 8 illustrates atop-down view of the treatment site 701 without the heart valve prosthesis 10, wherein the treatment site 701 comprises an aortic valve in a view from the aorta. The native aortic valve can comprise three leaflets or cusps, for example, a first native leaflet 801, a second native leaflet 803, and a third native leaflet 805. The treatment site 701 comprises a first coronary artery 809 (e.g., right coronary artery), which comprises a first ostia 810 or opening in the sinus of Valsalva, and a second coronary artery 811, which comprises a second ostia 812 or opening in the sinus of Valsalva. The native leaflets 801, 803, 805 can be joined at native commissures 815, 817, 819. For example, the first native commissure 815 is where the first native leaflet 801 and the second native leaflet 803 are joined. The second native commissure 817 is where the second native leaflet 803 and the third native leaflet 805 are joined. The third native commissure 819 is where the first native leaflet 801 and the third native leaflet 805 are joined. It will be appreciated that the native commissures 815, 817, 819 may not be in the same location for all patients, and, in aspects, a patient-specific variation of 10-20 degrees is possible. In this way, the native commissures 815, 817, 819 may not be exactly 120 degrees apart. Rather, in aspects, the first native commissure 815 and the second native commissure 817 can be closer, for example, about 108 degrees apart. Likewise, the location of the ostia 810, 812 may vary approximately 15- 20 degrees depending on patient anatomy.

[0071] FIG. 9 illustrates the treatment site 701 of FIG. 8 after the delivery and deployment of the valve prosthesis 10 at the treatment site 701. For example, the valve prosthesis 10 can comprise a first commissure 901, a second commissure 903, and a third commissure 905 attached to the frame 15, with the commissures 901, 903, 905 substantially identical to the commissures 25 of FIG. 2. In aspects, the valve prosthesis 10 can be positioned such that the first commissure 901 is placed at a substantially identical position as the first native commissure 815, the second commissure 903 is placed at a substantially identical position as the second native commissure 817, and the third commissure 905 is placed at a substantially identical position as the third native commissure 819. The valve prosthesis 10 can comprise one or more leaflets, for example, a first leaflet 907, a second leaflet 909, and a third leaflet 911, with the first leaflet 907 placed at a substantially identical position as the first native leaflet 801, the second leaflet 909 placed at a substantially identical position as the second native leaflet 803, and the third leaflet 911 placed at a substantially identical position as the third native leaflet 805. In this way, the firstcommissure 901 is where a first pair of the leaflets 907, 909 are attached, with the first commissure 901 attached to the frame 15. The second commissure 903 is where a second pair of the leaflets 909, 911 are attached, with the second commissure 903 attached to the frame 15. The third commissure 905 is where a third pair of the leaflets 907, 911 are attached, with the third commissure 905 attached to the frame 15.

[0072] In aspects, subsequent to the delivery and deployment in situ of the valve prosthesis 10 at the treatment site 701, access to one or both of the first coronary artery 809 or the second coronary artery 811 through the first ostia 810 and / or the second ostia 812 may be necessary. For example, a physician may need to access the first coronary artery 809 and / or the second coronary artery 811 with a coronary guide catheter 915. To limit the likelihood of obstructing the first coronary artery 809 and / or the second coronary artery 811 and, thus, blocking the coronary guide catheter 915 from passing through the first ostia 810 and / or the second ostia 812, the valve prosthesis 10 can be positioned such that the struts 16 of the frame 15, the commissures 901, 903, 905, and the prosthetic valve 20 do not obstruct the first ostia 810 and the second ostia 812. For example, a first radial axis 921 can intersect the longitudinal axis LA and pass through the first ostia 810 and the first coronary artery 809. The first radial axis 921 may be perpendicular to the longitudinal axis LA, and the first radial axis 921 may not intersect or pass through the struts 16 of the frame 15, the commissures 901, 903, 905, or the prosthetic valve 20. Likewise, a second radial axis 923 can intersect the longitudinal axis LA and pass through the second ostia 812 and the second coronary artery 811. The second radial axis 923 may be perpendicular to the longitudinal axis LA, and the second radial axis 923 may not intersect or pass through the struts 16 of the frame 15, the commissures 901, 903, 905, or the prosthetic valve 20. Accordingly, in this way, the valve prosthesis 10 can be positioned to rotationally align the prosthetic commissures and leaflets with the native commissures and leaflets, while also not blocking or obstructing the ostia 810, 812, thus allowing subsequent access to the coronary arteries 809, 811 via the coronary guide catheter 915. In aspects, the valve prosthesis 10 can be rotationally aligned such that the larger access cells (e.g., access cell(s) 23) can be aligned with the ostia 810, 812 to facilitate subsequent access. In aspects, the valve prosthesis 10 can be rotated during the delivery and deployment of the valve prosthesis 10 to further facilitate rotational alignment of the valve prosthesis 10 relative to the native commissures and leaflets while not blocking or obstructing the ostia 810, 812.

[0073] FIG. 10 illustrates a portion of the handle 33 for use with the delivery assembly 30 of FIGS. 3-4. In aspects, the handle 33 can comprise a channel 1001 (e.g., opening, slot, window, etc.) through which access to an interior of the handle 33 is provided. In aspects, the channel 1001 can extend through a wall of the handle 33 such that an axis can extend through the channel 1001 and into an interior of the handle 33 without passing through or intersecting a wall of the handle 33. The delivery assembly 30 can comprise an actuator 1003 that is attached to the handle 33 and can rotate relative to the handle 33. For example, by being attached to the handle 33, the actuator 1003 can be received within the interior of the handle 33, with the actuator 1003 configured to rotate relative to the handle 33. In aspects, access to the actuator 1003 can be provided through the channel 1001. For example, a physician can access the actuator 1003 through the channel 1001 and apply a rotational force to the actuator 1003 (e.g., using finger(s) and / or a thumb), thus causing the actuator 1003 to rotate relative to the handle 33.

[0074] FIG. 11 illustrates a sectional view of the handle 33 along lines 11-11 of FIG. 10. As illustrated, the handle 33 can define an elongated opening 1101 that extends along the handle 33 and is surrounded by a wall of the handle 33. In aspects, one or more structures (e.g., shafts, members, etc.) can be positioned within the elongated opening 1101 and, thus, may be circumferentially surrounded by the handle 33. For example, the actuator 1003 can be positioned within the elongated opening 1101 such that a diameter of the actuator 1003 may be less than a diameter of the handle 33. In aspects, the handle 33 and the actuator 1003 may comprise a substantially circular cross-sectional shape, with the actuator 1003 extending coaxially with the handle 33 along an axis 1103. The actuator 1003 can move, for example, rotate about the axis 1103, relative to the handle 33 such that the handle 33 may remain relatively stationary while the actuator 1003 rotates.

[0075] In aspects, the delivery assembly 30 can comprise an engagement member 1107 that can selectively permit the actuator 1003 to move relative to the handle 33 or that can lock (e.g., fix, secure, etc.) the actuator 1003 relative to the handle 33. For example, the engagement member 1107 can be attached to the handle 33 and can move between a first position (e.g., illustrated with solid lines 1109), in which the actuator 1003 (e.g., and a rotation member 1117) is rotatable relative to the handle 33, and a second position (e.g., illustrated with dashed lines 1111) in which the actuator 1003 (e.g., and the rotation member 1117) are locked and maintained at a fixed and non-rotatable position relative to the handle33. For example, in aspects, the actuator 1003 can comprise a recess 1113 defined at an outer radial side of the actuator 1003. The recess 1113 can be positioned in alignment with the engagement member 1107, and may be sized to receive the engagement member 1107.

[0076] When the engagement member 1107 is in the first position 1109, the engagement member 1107 may be spaced apart from the actuator 1003 such that the engagement member 1107 may not be in contact with the actuator 1003. As such, the actuator 1003 can freely rotate with the engagement member 1107 in the first position. Conversely, the engagement member 1107 can contact the actuator 1003 when the engagement member 1107 is in the second position 1111. For example, in the second position 1111, the engagement member 1107 can be moved radially inward toward the axis 1103 such that the engagement member 1107 can be received within the recess 1113 of the actuator 1003. While received within the recess 1113, the engagement member 1107 can contact the actuator 1003 and, in aspects, may be surrounded by one or more walls of the actuator 1003 that border the recess 1113. Accordingly, in the second position 1111, the engagement member 1107 can limit or stop the actuator 1003 from rotating. In aspects, the engagement member 1107 can be biased toward one of the first position 1109 or the second position 1111, for example, by being spring-biased. The physician can selectively apply a radial force to the engagement member 1107, such as an inward radial force toward the axis 1103 to move the engagement member 1107 from the first position 1109 to the second position 1111 or an outward radial force away from the axis 1103 to move the engagement member 1107 from the second position 1111 to the first position 1109. As such, the physician can control whether the actuator 1003 is permitted to rotate. By moving the engagement member 1107 to the second position, the heart valve prosthesis 10 can be delivered to the treatment site 701 without being rotated, thus allowing for the heart valve prosthesis 10 to be maintained at a predetermined rotational alignment during delivery. However, upon reaching the treatment site 701, or prior thereto, the engagement member 1107 can move to the first position 1109, whereupon the heart valve prosthesis 10 can be rotated.

[0077] It will be appreciated that the delivery assembly 30 is not limited to the design or structure of the engagement member 1107 illustrated in FIG. 11. Rather, in aspects, the delivery assembly 30 may comprise variations of the engagement member 1107 that may be structurally different than the illustrated engagement member 1107 whilefunctioning in a similar manner. That is, variations of the engagement member 1107 are envisioned that can selectively lock or fix the actuator 1003 to the handle 33, while also allowing for rotation of the actuator 1003 relative to the handle 33.

[0078] In aspects, the delivery assembly 30 can comprise the rotation member 1117 that can be received within an actuator channel 1119 of the actuator 1003. In aspects, the rotation member 1117 may comprise a substantially circular cross-sectional shape, with the rotation member 1117 extending coaxially with the handle 33 and the actuator 1003 along the axis 1103. The rotation member 1117 can move, for example, rotate about the axis 1103, relative to the handle 33 such that the handle 33 may remain relatively stationary while the rotation member 1117 rotates. The rotation member 1117 can be positioned within the elongated opening 1101 and may be attached to the actuator 1003 such that the actuator 1003 circumferentially surrounds the rotation member 1117. In this way, the rotation member 1117 can rotate with the actuator 1003. That is, as the actuator 1003 is rotated (e.g., by a physician), the rotation of the actuator 1003 can likewise cause corresponding rotation of the rotation member 1117. As will be described below relative to FIG. 13, the actuator 1003 can comprise an attachment tab 1123 projecting radially inwardly toward the rotation member 1117 and the axis 1103. The rotation member 1117 can comprise a tab opening 1125 defined at an outer radial side of the rotation member 1117, with the attachment tab 1123 received within the tab opening 1125 of the rotation member 1117. The mating between the attachment tab 1123 and the tab opening 1125 is such that the attachment tab 1123 can transmit rotation (e.g., rotation of the actuator 1003) to the rotation member 1117.

[0079] The rotation member 1117 can extend along the axis 1103 through the handle 33, with the rotation member 1117 comprising a longer length than the actuator 1003. In aspects, the rotation member 1117 can extend through the actuator 1003 and a stationary member 1131, with the actuator 1003 and the stationary member 1131 positioned in contact with one another while surrounding, the axis 1103. For example, the stationary member 1131 may be circumferentially surrounded by the actuator 1003, with the stationary member 1131 maintained at a fixed rotational position while the actuator 1003 can rotate relative to the stationary member 1131. In aspects, a radial axis 1135 that is perpendicular to the axis 1103 can intersect the handle 33, the actuator 1003, the stationary member 1131, the rotation member 1117, and the axis 1103. In this way, the stationary member 1131 may be surrounded by the actuator 1003 while being positioned radially between the rotationmember 1117 and the actuator 1003. The stationary member 1131 can be attached to the handle 33 such that zero relative movement between the stationary member 1131 and the handle 33 may occur. In aspects, the stationary member 1131 can be directly attached to the handle 33 (e.g., by being in contact with the handle 33, by being attached via mechanical fasteners or adhesives, etc.) or may be indirectly attached to the handle 33 with one or more intervening structures between the stationary member 1131 and the handle 33. In this way, by not moving relative to the handle 33, the stationary member 1131 may be maintained at the fixed rotational position (e.g., relative to the handle 33).

[0080] To facilitate rotation of the actuator 1003 and allow for more precise incremental rotational adjustment of the actuator 1003 relative to the handle 33 and the stationary member 1131, the actuator 1003 and the stationary member 1131 can comprise one or more mating features. For example, the actuator 1003 can comprise a first mating feature 1141 positioned on an actuator wall 1143, with the first mating feature 1141 facing the stationary member 1131. In aspects, the actuator wall 1143 may lie within a plane that intersects, and is perpendicular to, the axis 1103, with the actuator wall 1143 circumferentially surrounding the axis 1103. The first mating feature 1141 can comprise one or more teeth (e.g., serrated or jagged edge) that extend around the actuator wall 1143. The stationary member 1131 can comprise a second mating feature 1145 positioned on a stationary wall 1147, with the second mating feature 1145 facing the first mating feature 1141. In aspects, the stationary wall 1147 may he within a plane that intersects, and is perpendicular to, the axis 1103, with the stationary wall 1147 circumferentially surrounding the axis 1103. The second mating feature 1145 can comprise a size and shape that substantially matches the size and shape of the first mating feature 1141. For example, the second mating feature 1145 can comprise one or more teeth (e.g., serrated or jagged edge) that extend around the stationary wall 1147.

[0081] The first mating feature 1141 can engage and mate with the second mating feature 1145. For example, the teeth of the mating features 1141, 1145 can be separated by valleys, with a tooth and a valley in alternating positions . As such, a tooth of the first mating feature 1141 can be received within a valley of the second mating feature 1145. Likewise, a tooth of the second mating feature 1145 can be received within a valley of the first mating feature 1141. Each tooth can be separated by a predetermined angular amount, for example, 1°, 2°, or the like. Accordingly, as the actuator 1003 is rotated relative to the handle 33 andthe stationary member 1131, the first mating feature 1141 can continuously disengage and re-engage with the second mating feature 1145 as the stationary member 1131 remains in the fixed rotational position. A physician may be able to feel or sense the engagement and disengagement between the mating features 1141, 1145 during rotation of the actuator 1003 (e.g., tactile or haptic feedback). Further, upon reaching a desired rotational position, the actuator 1003 may be more likely to remain in that position relative to the stationary member 1131 (e.g., due to the engagement between the mating features 1141, 1145), such that unintended and / or undesirable movement of the actuator 1003 relative to the stationary member 1131 may be avoided. In further, aspects, the mating features 1141, 1145 can be angled in a way to function as a one-way clutch or ratcheting mechanism. In this way, the mating features 1141, 1145 can be angled to allow continuous rotary motion in one direction, while stopping motion in an opposing direction. By being angled, the mating features 1141, 1145 can, in aspects, be uniform but asymmetrical, with each tooth comprising a moderate slope on one edge and a steeper slope on the other edge. As such, the actuator 1003 can be rotated in a first direction relative to the stationary member 1131, but may be stopped from inadvertently rotating in an opposing second direction. The benefit of such a one-way clutch or ratcheting mechanism is that the physician can rotate the actuator 1003, with the actuator 1003 limited from inadvertently rotating in an unintended opposing direction.

[0082] In aspects, the delivery assembly 30 can comprise an outer member 1151 that is attached to the rotation member 1117 and can extend from the handle 33 toward the treatment site 701 (e.g., illustrated in FIG. 7). The outer member 1151 can rotate with the rotation member 1117, for example, with the actuator 1003, the rotation member 1117, and the outer member 1151 rotating unitarily about the axis 1103. The rotation member 1117 can circumferentially surround the outer member 1151 such that the outer member 1151 can be received within a rotation channel 1153 of the rotation member 1117. The outer member 1151 can be attached to the rotation member 1117 in several ways. For example, the outer member 1151 can be attached (e.g., directly) by an adhesive or similar fastener to the rotation member 1117. Alternatively, as illustrated in FIG. 11, an attachment member 1155 can be positioned circumferentially between the rotation member 1117 and the outer member 1151, with the attachment member 1155 attached at an outer radial side 1157 (e.g., outer radial side 1157 of the attachment member 1155) to the rotation member 1117 andattached at an inner radial side 1159 (e.g., inner radial size 1159 of the attachment member 1155) to the outer member 1151. That is, the outer radial side 1157 of the attachment member 1155 is attached to the rotation member 1117, and the inner radial side 1159 of the attachment member 1155 is attached to the outer member 1151. In this way, the attachment member 1155 can transmit rotation of the rotation member 1117 to the outer member 1151, thus causing the outer member 1151 to rotate. The outer member 1151 can extend between a proximal end 1163 and a distal end, wherein the proximal end 1163 is attached to the rotation member 1117 (e.g., via the attachment member 1155, for example), and the distal end may be operatively attached to the heart valve prosthesis 10 at the treatment site 701. Accordingly, rotation of the outer member 1151 can likewise cause rotation of the heart valve prosthesis 10 at the treatment site 701.

[0083] In aspects, the delivery assembly 30 can comprise a middle member 1169 that extends along the axis 1103 and through the outer member 1151. The middle member 1169 may be circumferentially surrounded by the outer member 1151 such that the middle member 1169 can extend substantially coaxially with the outer member 1151. The middle member 1169 can be maintained at a fixed rotational position while the outer member 1151 can rotate relative to the middle member 1169. As described below, a distal end of the middle member 1169 can be attached to the spindle 38, with the spindle 38 configured to rotate relative to the middle member 1169. The middle member 1169 can extend from the handle 33 at a proximal end to the treatment site 701 at a distal end.

[0084] FIG. 12 illustrates a sectional view of the handle 33 along lines 12-12 of FIG. 11. In aspects, the actuator 1003 can comprise one or more extension portions that can engage one or more detent portions of the stationary member 1131 to limit the maximum rotation of the actuator 1003 relative to the stationary member 1131 and, thus, the handle 33. For example, the actuator 1003 can comprise a first extension portion 1201 and a second extension portion 1203 that extend radially inward from the actuator 1003 and toward the stationary member 1131 and the axis 1103. In aspects, the first extension portion 1201 and the second extension portion 1203 may be spaced circumferentially apart from one another, for example, within a range from about 160 degrees to about 200 degrees apart, or about 180 degrees apart. As illustrated in FIG. 12, the first extension portion 1201 and the second extension portion 1203 may be positioned at opposing sides of the actuator 1003.

[0085] The stationary member 1131 can comprise one or more detent portions that extend radially outward from the stationary member 1131 toward the actuator 1003. For example, the stationary member 1131 can comprise a first detent portion 1205, a second detent portion 1207, a third detent portion 1209, and a fourth detent portion 1211. In aspects, the extension portions 1201, 1203 and the detent portions 1205, 1207, 1209, 1211 can lie in a plane that is perpendicular to the axis 1103. The first extension portion 1201 can be positioned between the first detent portion 1205 and the second detent portion 1207. The second extension portion 1203 can be positioned between the third detent portion 1209 and the fourth detent portion 1211. In aspects, the angular spacing between the first detent portion 1205 and the second detent portion 1207 may substantially match the angular spacing between the third detent portion 1209 and the fourth detent portion 1211. For example, the first detent portion 1205 and the fourth detent portion 1211 may be spaced circumferentially apart from one another, for example, within a range from about 160 degrees to about 200 degrees apart, or about 180 degrees apart. The second detent portion 1207 and the third detent portion 1209 may be spaced circumferentially apart from one another, for example, within a range from about 160 degrees to about 200 degrees apart, or about 180 degrees apart.

[0086] In aspects, the extension portions 1201, 1203 can contact the detent portions 1205, 1207, 1209, 1211 to limit a maximum rotation of the actuator 1003 relative to the handle 33 and the stationary member 1131. For example, an angle 1213 between the first detent portion 1205 and the second detent portion 1207 may be within a range from about 90 degrees to about 150 degrees, or within a range from about 110 degrees to about 130 degrees, or about 120 degrees. Likewise, the angle 1213 between the third detent portion 1209 and the fourth detent portion 1211 may be within a range from about 90 degrees to about 150 degrees, or within a range from about 110 degrees to about 130 degrees, or about 120 degrees. The actuator 1003 can rotate such that the first extension portion 1201 can move between a first position 1215 and a second position 1217. In the first position 1215, the first extension portion 1201 may be adjacent to, or in contact with, the first detent portion 1205, such that additional rotation (e.g., in a counter-clockwise direction) is limited. In the second position 1217, the first extension portion 1201 may be adjacent to, or in contact with, the second detent portion 1207, such that additional rotation (e.g., in a clockwise direction) is limited. Similarly, as the actuator 1003 rotates, the second extension portion 1203 canmove between a first position 1219 and a second position 1221. In the first position 1219, the second extension portion 1203 may be adjacent to, or in contact with, the fourth detent portion 1211, such that additional rotation (e.g., in a counter-clockwise direction) is limited. When the first extension portion 1201 is in the first position 1215, the second extension portion 1203 may likewise be in the first position 1219. In the second position 1221, the second extension portion 1203 may be adjacent to, or in contact with, the third detent portion 1209, such that additional rotation (e.g., in a clockwise direction) is limited. When the first extension portion 1201 is in the second position 1217, the second extension portion 1203 may likewise be in the second position 1221. Accordingly, the detent portions 1205, 1207, 1209, 1211 of the stationary member 1131 can limit the maximum rotation of the actuator 1003 (e.g., due to the angle 1213 separating the detent portions 1205, 1207, 1209, 1211).

[0087] In aspects, while FIG. 12 illustrates detent portions 1205, 1207, 1209, 1211 and extension portions 1201, 1203 that can limit the maximum rotation of the actuator 1003, other possible structures and mechanisms can be provided in addition to, or in the alternative to, the illustrated detent portions and extension portions. That is, in aspects, less than all of the extension portions 1201, 1203 and less than all of the detent portions 1205, 1207, 1209, 1211 could be provided, such as, for example, the first extension portion 1201 provided with the detent portions 1205, 1207, while the second extension portion 1203 and the other detent portions 1209, 1211 may be omitted. Further, other possible structures or mechanisms could be provided to limit maximum rotation, such that none of the detent portions or extension portions may be provided.

[0088] FIG. 13 illustrates a sectional view of the handle 33 along lines 13-13 of FIG. 11. In aspects, the actuator 1003 can comprise the attachment tab 1123 and a second attachment tab 1301. The attachment tab 1123 and the second attachment tab 1301 can be spaced apart about 180 degrees and may project radially inwardly toward the rotation member 1117. The rotation member 1117 can comprise the tab opening 1125 and a second tab opening 1303. The tab opening 1125 and the second tab opening 1303 can be spaced apart about 180 degrees and may be defined at the outer radial side of the rotation member 1117. In this way, the attachment tab 1123 can be received within the tab opening 1125, and the second attachment tab 1301 can be received within the second tab opening 1303. Rotation of the actuator 1003 allows for the attachment tabs 1123, 1301 to transmit rotation to the rotation member 1117. For example, as the actuator 1003 rotates, the attachment tabs1123, 1301 may likewise rotate. Due to the attachment tabs 1123, 1301 being received within the tab openings 1125, 1303, the attachment tabs 1123, 1301 can cause the rotation member 1117 to likewise rotate. While two attachment tabs and tab openings are illustrated, there may be only a single tab and tab opening or there may be more than two tabs and tab openings. Alternatively, other mechanisms of connecting or interlocking the actuator 1003 and the rotation member 1117 may be used, such as interlocking teeth, adhesives, etc.

[0089] FIG. 14 illustrates a side view of the delivery assembly 30. In aspects, the delivery assembly 30 comprises a stability member 1401 that is circumferentially surrounding the outer member 1151. The stability member 1401 may, in aspects, be attached to the handle 33 and may extend outwardly from the handle 33 toward the capsule 35 while extending along the axis 1103. In this way, the stability member 1401 may be at a fixed rotational position and may not rotate relative to the handle 33. The outer member 1151 is received within the stability member 1401 and can rotate relative to the stability member 1401. The stability member 1401 can, in aspects, provide protection to the patient’s vasculature as the outer member 1151 is rotated, thus shielding the patient’s vasculature from the rotating outer member 1151.

[0090] In aspects, and with reference to FIGS. 3, 4, and 14, the inner member 36, the distal tip 37, and the spindle 38 may be free to rotate relative to the stationary middle member 1169. For example, a distal end of the middle member 1169 may be attached to the spindle 38, with the spindle 38 configured to rotate relative to the middle member 1169. In aspects, by being attached, the middle member 1169 can transmit axial movement to the spindle 38 (e.g., and, thus, the inner member 36 and the distal tip 37 due to the attachment of the spindle 38 to the inner member 36 and the distal tip 37), with the middle member 1169 configured to move the spindle 38 axially in a proximal or distal direction. However, in aspects, while being attached to the distal end of the middle member 1169, the spindle 38 is capable of rotating relative to the middle member 1169, such that the rotation of the spindle 38 may be decoupled from the middle member 1169, which can remain stationary and non-rotating. In aspects, one side of the spindle 38 can be attached to the distal end of the middle member 1169, and another side of the spindle 38 can be attached to the inner member 36. In aspects, the inner member 36 is capable of extending to the handle 33 or, alternatively, can be attached to the middle member 1169 and may not extend entirely to the handle 33. The heart valve prosthesis 10 can be held in place relative to the spindle 38 viapaddles (e.g., atachment members 24 the protrude or extend from the heart valve prosthesis 10). The paddles of the heart valve prosthesis 10 can be received within pockets (e.g., channels, openings, slots, etc.) of the spindle 38, such that when the paddles of the heart valve prosthesis 10 are received within the pockets of the spindle 38, the heart valve prosthesis 10 can be temporarily atached to the spindle 38, with the capsule 35 circumferentially surrounding, and in frictional engagement with, the heart valve prosthesis 10.

[0091] The capsule 35 may be atached to the outer member 1151 and can be in frictional engagement with the heart valve prosthesis 10. By being in frictional engagement with the heart valve prosthesis 10, the capsule 35 may be in direct or indirect contact with the heart valve prosthesis 10, for example, by friction or with one or more intervening structures (e.g., spindle 38, paddles, etc.) atached between the capsule 35 and the heart valve prosthesis 10. Further, by being in frictional engagement, the heart valve prosthesis 10 may be held or maintained in an attached state during movement of the heart valve prosthesis 10 through the patient’s vasculature to the treatment site 701. Upon reaching the treatment site, the heart valve prosthesis 10 may be rotated and / or deployed. In aspects, the outer member 1151 may be atached to the capsule 35 such that the capsule 35 can rotate with the outer member 1151. Due to the spindle 38 being capable of rotating relative to the middle member 1169, as the outer member 1151 rotates, the capsule 35 can likewise rotate . The rotation of the capsule 35 can likewise cause the spindle 38 and the heart valve prosthesis 10 to rotate, for example, rotating relative to the distal end of the middle member 1169. In this way, the capsule 35 can cause the heart valve prosthesis 10 to rotate relative to the treatment site 701 between a first rotational position and a second rotational position that is angularly offset from the first rotational position. Accordingly, methods of implanting the heart valve prosthesis 10 can comprise delivering (e.g., also illustrated in FIGS. 5-6) the heart valve prosthesis 10 to the treatment site 701, wherein the heart valve prosthesis 10 is engaged with the capsule 35 that is atached to the outer member 1151. In aspects, upon reaching the treatment site 701, or prior to reaching the treatment site 701, methods can comprise rotating the outer member 1151 and the heart valve prosthesis 10 by rotating the actuator 1003 (e.g., illustrated in FIGS. 10-14) that is atached to the handle 33 such that the outer member 1151 can be rotated from the first rotational position to the second rotational position. In aspects, methods can further comprise deploying the heartvalve prosthesis 10 at the treatment site 701 such that the heart valve prosthesis 10 is at a desired rotational position relative to an ostia 810, 812.

[0092] Aspect 1. A transcatheter heart valve delivery assembly is provided for delivering a heart valve prosthesis to a treatment site . The transcatheter heart valve delivery assembly comprises a handle defining an elongated opening. The transcatheter heart valve delivery assembly comprises an actuator attached to the handle and configured to rotate relative to the handle. The transcatheter heart valve delivery assembly comprises a rotation member positioned within the elongated opening and attached to the actuator such that the actuator circumferentially surrounds the rotation member. The rotation member is configured to rotate with the actuator. The transcatheter heart valve delivery assembly comprises an outer member attached to the rotation member and extending from the handle toward the treatment site. The outer member is configured to rotate with the rotation member. The transcatheter heart valve delivery assembly comprises a capsule attached to the outer member and in frictional engagement with the heart valve prosthesis. The capsule is configured to rotate with the outer member such that the heart valve prosthesis is rotatable relative to the treatment site between a first rotational position and a second rotational position that is angularly offset from the first rotational position.

[0093] Aspect 2. The transcatheter heart valve delivery assembly of aspect 1, wherein the rotation member is received within an actuator channel of the actuator.

[0094] Aspect 3. The transcatheter heart valve delivery assembly of any one of aspects 1-2, wherein the actuator comprises an attachment tab projecting radially inwardly toward the rotation member and received within a tab opening of the rotation member, the tab opening defined at an outer radial side of the rotation member, the attachment tab configured to transmit rotation to the rotation member.

[0095] Aspect 4. The transcatheter heart valve delivery assembly of any one of aspects 1-3, wherein the rotation member circumferentially surrounds the outer member such that the outer member is received within a rotation channel of the rotation member.

[0096] Aspect 5. The transcatheter heart valve delivery assembly of any one of aspects 1 -4, further comprising an attachment member positioned circumferentially between the rotation member and the outer member, the attachment member attached at an outer radial side to the rotation member and attached at an inner radial side to the outer member, the attachment member configured to transmit rotation to the outer member.

[0097] Aspect 6. The transcatheter heart valve delivery assembly of any one of aspects 1-5, further comprising a middle member circumferentially surrounded by the outer member such that the middle member extends coaxially with the outer member, the middle member maintained at a fixed rotational position while the outer member is configured to rotate relative to the middle member.

[0098] Aspect 7. The transcatheter heart valve delivery assembly of any one of aspects 1-6, further comprising an engagement member attached to the handle and configured to move between a first position, in which the rotation member is rotatable, and a second position, in which the rotation member is maintained at a fixed position relative to the handle.

[0099] Aspect 8. The transcatheter heart valve delivery assembly of any one of aspects 1-7, further comprising a stationary member that is circumferentially surrounded by the actuator, the stationary member maintained at a fixed rotational position while the actuator is configured to rotate relative to the stationary member.

[0100] Aspect 9. The transcatheter heart valve delivery assembly of any one of aspects 1-8, wherein the actuator comprises an extension portion that extends radially inward from the actuator toward the stationary member, the stationary member comprising a detent portion extending radially outward from the stationary member toward the actuator, the extension portion configured to contact the detent portion to limit a maximum rotation of the actuator relative to the handle.

[0101] Aspect 10. A transcatheter heart valve delivery assembly is provided for delivering a heart valve prosthesis to a treatment site . The transcatheter heart valve delivery assembly comprises a handle defining an elongated opening. The transcatheter heart valve delivery assembly comprises an actuator attached to the handle and configured to rotate relative to the handle. The actuator comprises an extension portion that extends radially from the actuator and is configured to limit a maximum rotation of the actuator relative to the handle. The transcatheter heart valve delivery assembly comprises a rotation member positioned within the elongated opening and attached to the actuator such that the actuator circumferentially surrounds the rotation member. The rotation member is configured to rotate with the actuator. The transcatheter heart valve delivery assembly comprises an engagement member attached to the handle and configured to move between a first position, in which the rotation member is rotatable, and a second position, in which the rotationmember is maintained at a fixed position relative to the handle. The transcatheter heart valve delivery assembly comprises an outer member attached to the rotation member and extending from the handle toward the treatment site. The outer member is configured to rotate with the rotation member. The transcatheter heart valve delivery assembly comprises a capsule attached to the outer member and in frictional engagement with the heart valve prosthesis. The capsule is configured to rotate with the outer member such that the heart valve prosthesis is rotatable relative to the treatment site between a first rotational position and a second rotational position that is angularly offset from the first rotational position.

[0102] Aspect 11. The transcatheter heart valve delivery assembly of aspect 10, further comprising a stationary member that is circumferentially surrounded by the actuator, the stationary member maintained at a fixed rotational position while the actuator is configured to rotate relative to the stationary member.

[0103] Aspect 12. The transcatheter heart valve delivery assembly of any one of aspects 10-11, wherein the stationary member comprises a detent portion extending radially outward from the stationary member toward the actuator, the extension portion configured to contact the detent portion to limit the maximum rotation of the actuator.

[0104] Aspect 13. The transcatheter heart valve delivery assembly of any one of aspects 10-12, wherein the maximum rotation of the actuator is within a range from about 90 degrees to about 150 degrees.

[0105] Aspect 14. The transcatheter heart valve delivery assembly of any one of aspects 10-13, wherein the engagement member contacts the actuator when the engagement member is in the second position, and the engagement member is spaced apart from the actuator when the engagement member is in the first position.

[0106] Aspect 15. The transcatheter heart valve delivery assembly of any one of aspects 10-14, wherein the handle circumferentially surrounds the actuator.

[0107] Aspect 16. Methods of implanting a heart valve prosthesis comprise delivering the heart valve prosthesis to a treatment site. The heart valve prosthesis is in frictional engagement with a capsule that is attached to an outer member. Methods comprise maintaining the outer member at a first rotational position as the heart valve prosthesis is delivered to the treatment site. Methods comprise, upon reaching the treatment site, rotating the outer member and the heart valve prosthesis by rotating an actuator that is attached to a handle such that the outer member is rotated from the first rotational position to a secondrotational position. Methods comprise deploying the heart valve prosthesis at the treatment site such that the heart valve prosthesis is at a desired rotational position relative to an ostia.

[0108] Aspect 17. The method of claim 16, wherein the actuator, the outer member, the capsule, and the heart valve prosthesis are rotated unitarily from the first rotational position to the second rotational position relative to the handle.

[0109] Aspect 18. The method of any one of aspects 16-17, wherein a maximum rotation of the actuator is within a range from about 90 degrees to about 150 degrees.

[0110] Aspect 19. The method of any one of aspects 16-18, further comprising circumferentially surrounding the outer member with a stability member that is at a fixed rotational position, the stability member extending from the handle toward the capsule.

[0111] It should be understood that while various aspects have been described in detail relative to certain illustrative and specific examples thereof, the present disclosure should not be considered limited to such, as numerous modifications and combinations of the disclosed features are possible without departing from the scope of the following claims.

Claims

What is claimed is:

1. A transcatheter heart valve delivery assembly (30) for delivering a heart valve prosthesis (10) to a treatment site (701), the transcatheter heart valve delivery assembly (30) comprising: a handle (33) defining an elongated opening (1101); an actuator (1003) attached to the handle (33) and configured to rotate relative to the handle (33); a rotation member (1117) positioned within the elongated opening (1101) and attached to the actuator (1003) such that the actuator (1003) circumferentially surrounds the rotation member (1117), the rotation member (1117) configured to rotate with the actuator (1003); an outer member (1151) attached to the rotation member (1117) and extending from the handle (33) toward the treatment site (701), the outer member (11 1) configured to rotate with the rotation member (1117); and a capsule (35) attached to the outer member (1151) and in frictional engagement with the heart valve prosthesis (10), the capsule (35) configured to rotate with the outer member (1151) such that the heart valve prosthesis (10) is rotatable relative to the treatment site (701) between a first rotational position and a second rotational position that is angularly offset from the first rotational position.

2. The transcatheter heart valve delivery assembly (30) of claim 1, wherein the rotation member (1117) is received within an actuator channel (1119) of the actuator (1003).

3. The transcatheter heart valve delivery assembly (30) of claim 2, wherein the actuator (1003) comprises an attachment tab (1123) projecting radially inwardly toward the rotation member (1117) and received within a tab opening (1125) of the rotation member (1117), the tab opening (1125) defined at an outer radial side of the rotation member (1117), the attachment tab (1123) configured to transmit rotation to the rotation member (1117).

4. The transcatheter heart valve delivery assembly (30) of any one of claims 1-3, wherein the rotation member (1117) circumferentially surrounds the outer member (1151) such that the outer member (1151) is received within a rotation channel (1153) of the rotation member (1117).

5. The transcatheter heart valve delivery assembly (30) of claim 4, further comprising an attachment member (1155) positioned circumferentially between the rotation member (1117) and the outer member (1151), the attachment member (1155) attached at an outer radial side to the rotation member (1117) and attached at an inner radial side to the outer member (1151), the attachment member (1155) configured to transmit rotation to the outer member (1151).

6. The transcatheter heart valve delivery assembly (30) of claim 4, further comprising a middle member (1169) circumferentially surrounded by the outer member (1151) such that the middle member (1169) extends coaxially with the outer member (1151), the middle member (1169) maintained at a fixed rotational position while the outer member (1151) is configured to rotate relative to the middle member (1169).

7. The transcatheter heart valve delivery assembly (30) of any one of claims 1-6, further comprising an engagement member (1107) attached to the handle (33) and configured to move between a first position, in which the rotation member (1117) is rotatable, and a second position, in which the rotation member (1117) is maintained at a fixed position relative to the handle (33).

8. The transcatheter heart valve delivery assembly (30) of any one of claims 1-7, further comprising a stationary member (1131) that is circumferentially surrounded by the actuator (1003), the stationary member (1131) maintained at a fixed rotational position while the actuator (1003) is configured to rotate relative to the stationary member (1131).

9. The transcatheter heart valve delivery assembly (30) of claim 8, wherein the actuator (1003) comprises an extension portion (1201) that extends radially inward from the actuator (1003) toward the stationary member (1131), the stationary member (1131)comprising a detent portion (1205) extending radially outward from the stationary member (1131) toward the actuator (1003), the extension portion (1201) configured to contact the detent portion (1205) to limit a maximum rotation of the actuator (1003) relative to the handle (33).

10. A method of implanting a heart valve prosthesis (10) comprising: delivering the heart valve prosthesis (10) to a treatment site (701), the heart valve prosthesis (10) in frictional engagement with a capsule (35) that is attached to an outer member (1151); maintaining the outer member (1151) at a first rotational position as the heart valve prosthesis (10) is delivered to the treatment site (701); upon reaching the treatment site (701), rotating the outer member (1151) and the heart valve prosthesis (10) by rotating an actuator (1003) that is attached to a handle (33) such that the outer member (1151) is rotated from the first rotational position to a second rotational position; and deploying the heart valve prosthesis (10) at the treatment site (701) such that the heart valve prosthesis (10) is at a desired rotational position relative to an ostia.

11. The method of claim 10, wherein the actuator (1003), the outer member (1151), the capsule (35), and the heart valve prosthesis (10) are rotated unitarily from the first rotational position to the second rotational position relative to the handle (33).

12. The method of any one of claims 10-11, wherein a maximum rotation of the actuator (1003) is within a range from about 90 degrees to about 150 degrees.

13. The method of any one of claims 10-12, further comprising circumferentially surrounding the outer member (1151) with a stability member (1401) that is at a fixed rotational position, the stability member (1401) extending from the handle (33) toward the capsule (35).

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