WO2025088490A1

WO2025088490A1 - Prosthetic heart valve assembly

Info

Publication number: WO2025088490A1
Application number: PCT/IB2024/060376
Authority: WO
Inventors: Declan P. COSTELLO
Original assignee: Medtronic Inc
Current assignee: Medtronic Inc
Priority date: 2023-10-25
Filing date: 2024-10-22
Publication date: 2025-05-01
Anticipated expiration: 2026-04-25

Abstract

A delivery assembly is provided for delivering a heart valve prosthesis to a treatment site. The delivery assembly includes a hub including a first locking component and a shaft apparatus extending along a central axis. The shaft apparatus includes a shaft portion terminating at a distal end and a second locking component attached to the shaft portion. When the distal end is located a first distance from the hub, the shaft apparatus rotates relative to the hub about the central axis and the first locking component is spaced apart from the second locking component. When the distal end is located a second distance from the hub, the first locking component engages the second locking component such that the shaft apparatus is prevented from rotating. Methods of delivering a heart valve prosthesis are provided.

Description

PROSTHETIC HEART VALVE ASSEMBLY

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63/592,985, filed October 25, 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 a delivery assembly for delivering a heart 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.

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 delivery assembly is provided for delivering a heart valve prosthesis to a treatment site. The delivery assembly comprises a hub comprising a first locking component and a shaft apparatus extending along a central axis. The shaft apparatus comprises a shaft portion that terminates at a distal end and a second locking component attached to the shaft portion. The shaft apparatus is configured to move axially relative to the hub in a distal direction along the central axis. When the distal end is located a first distance from the hub, the shaft apparatus is configured to rotate relative to the hub about the central axis, and the first locking component is spaced apart from the second locking component. When the distal end is located a second distance from the hub, the first locking component is configured to engage the second locking component such that the shaft apparatus is prevented from rotating relative to the hub about the central axis, and the second distance is greater than the first distance.

[0006] In aspects, the first locking component comprises an outer wall surrounding an elongated slot. The first locking component comprises a first radial wall spaced apart from a second radial wall such that a first slot portion of the slot is defined between the first radial wall and the second radial wall. [0007] In aspects, the second locking component extends radially outwardly from the central axis. The second locking component is positioned within the first slot portion when the first locking component engages the second locking component such that the second locking component is between the first radial wall and the second radial wall.

[0008] In aspects, the first locking component comprises a radially-extending second slot portion spaced circumferentially apart from the radially-extending first slot portion. The first locking component comprises a third radial wall spaced apart from the second radial wall such that the second slot portion is defined between the second radial wall and the third radial wall.

[0009] In aspects, the first locking component comprises an outer wall surrounding an elongated slot. The slot comprises a substantially constant slot diameter.

[0010] In aspects, the shaft apparatus comprises a shaft portion attached to the second locking component such that the shaft portion and the second locking component extend along the central axis. The shaft portion comprises a first diameter, and the second locking component comprises a second diameter that is larger than the first diameter.

[0011] In aspects, the shaft apparatus is received with the slot, and the first diameter is less than the slot diameter. The second diameter is greater than or equal to the slot diameter. [0012] In aspects, the second locking component extends radially outwardly from the central axis.

[0013] In aspects, the second locking component contacts an actuator of the first locking component such that the first locking component contacts the second locking component.

[0014] In aspects, a delivery assembly is provided for delivering a heart valve prosthesis to a treatment site. The delivery assembly comprises a hub comprising a first locking component that defines an elongated slot and a shaft extending along a central axis. The shaft apparatus comprises a shaft portion extending through the elongated slot and terminating at a distal end. The shaft apparatus comprises a second locking component attached to the shaft portion. The shaft apparatus is configured to move axially relative to the hub in a distal direction along the central axis. The first locking component is configured to contact the second locking component such that the shaft apparatus is selectively prevented from rotating relative to the hub about the central axis.

[0015] In aspects, the elongated slot extends along a slot axis and comprises a nonconstant diameter about the slot axis. [0016] In aspects, the second locking component extends radially outwardly from the shaft portion. The second locking component comprises a radial size that is larger than a minimum slot radius of the slot and smaller than a maximum slot radius of the slot.

[0017] In aspects, the shaft portion is attached to the second locking component such that the shaft portion and the second locking component extend along the central axis. The shaft portion comprises a first diameter, and the second locking component comprises a second diameter that is larger than the first diameter. The shaft apparatus is configured to move axially relative to the hub along the central axis while the shaft apparatus is prevented from rotating relative to the hub about the central axis.

[0018] In aspects, the second locking component contacts an inner radial surface of the outer wall when the first locking component engages the second locking component.

[0019] In aspects, methods of implanting a heart valve prosthesis comprise distally advancing the heart valve prosthesis attached to a shaft in a distal direction of a delivery path extending from a point of entry into a vasculature to the treatment site. Methods comprise rotating the heart valve prosthesis about a central axis of the shaft apparatus while the heart valve prosthesis is positioned within a proximal segment of the delivery path. Methods comprise continuing to distally advance the heart valve prosthesis through a distal segment of the delivery path toward the treatment site. Methods comprise preventing the heart valve prosthesis from rotating about the central axis while the heart valve prosthesis is positioned with the distal segment of the delivery path.

[0020] In aspects, preventing the heart valve prosthesis from rotating comprises positioning a second locking component of the shaft apparatus within a first locking component such that the second locking component contacts the first locking component.

[0021] In aspects, the first locking component comprises an outer wall surrounding an elongated slot defined between a first radial wall and a second radial wall. The second locking component is received within the slot between the first radial wall and the second radial wall.

[0022] In aspects, the shaft apparatus comprises a non-constant diameter with the second locking component comprising a segment with a larger diameter than a diameter of the first locking component.

[0023] In aspects, the second locking component projects radially outwardly from the shaft apparatus. [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 the transcatheter heart valve prosthesis positioned at a treatment site in accordance with aspects of the disclosure;

[0033] FIG. 8 illustrates a side view of a delivery assembly with the heart valve prosthesis in a proximal segment, in accordance with aspects of the disclosure;

[0034] FIG. 9 illustrates a side view of a delivery assembly with the heart valve prosthesis in a distal segment, in accordance with aspects of the disclosure; [0035] FIG. 10 illustrates a perspective view of a first locking component and a second locking component, in accordance with aspects of the disclosure;

[0036] FIG. 11 illustrates a side view along lines 11-11 of FIG. 10 of a first locking component and a second locking component, in accordance with aspects of the disclosure;

[0037] FIG. 12 illustrates a side view similar to FIG. 11 of the first locking component and the second locking component, in accordance with aspects of the disclosure;

[0038] FIG. 13 illustrates an end view along lines 13-13 of FIG. 12 of the first locking component and the second locking component, in accordance with aspects of the disclosure; [0039] FIG. 14 illustrates a perspective view of a first locking component and a second locking component, in accordance with aspects of the disclosure;

[0040] FIG. 15 illustrates a side view along lines 15-15 of FIG. 14 of a first locking component and a second locking component, in accordance with aspects of the disclosure;

[0041] FIG. 16 illustrates a side view similar to FIG. 15 of the first locking component and the second locking component, in accordance with aspects of the disclosure;

[0042] FIG. 17 illustrates a perspective view of a first locking component and a second locking component, in accordance with aspects of the disclosure;

[0043] FIG. 18 illustrates a side view along lines 18-18 of FIG. 17 of a first locking component and a second locking component, in accordance with aspects of the disclosure; and

[0044] FIG. 19 illustrates a side view similar to FIG. 18 of the first locking component and the second locking component, in accordance with aspects of the disclosure.

DETAILED DESCRIPTION

[0045] 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.

[0046] 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. [0047] 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.

[0048] 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.

[0049] Unless otherwise expressly stated, it is in no way intended that any methods set forth herein be construed as requiring that its steps be performed in a specific order, nor that with any apparatus, specific orientations be required. Accordingly, where a method claim does not actually recite an order to be followed by its steps, or that any apparatus claim does not actually recite an order or orientation to individual components, or it is not otherwise specifically stated in the claims or description that the steps are to be limited to a specific order, or that a specific order or orientation to components of an apparatus is not recited, it is in no way intended that an order or orientation be inferred in any respect. This holds for any possible non-express basis for interpretation, including matters of logic relative to arrangement of steps, operational flow, order of components, or orientation of components; plain meaning derived from grammatical organization or punctuation, and; the number or type of aspects described in the specification.

[0050] 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.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] 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 hub 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.

[0056] Diseases associated with heart valves, such as those caused by damage or a defect, can include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis causes the valve to become narrowed and hardened which can prevent blood flow to a downstream heart chamber from occurring at the proper flow rate and may cause the heart to work harder to pump the blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backwards, thereby causing the heart to be less efficient. A diseased or damaged valve, which can be congenital, age-related, drug-induced, or in some instances, caused by infection, can result in an enlarged, thickened heart that loses elasticity and efficiency. Some symptoms of heart valve diseases can include weakness, shortness of breath, dizziness, fainting, palpitations, anemia and edema, and blood clots which can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and/or life threatening.

[0057] 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-hub 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.

[0058] 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.

[0059] 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.

[0060] 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 be limiting, 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.

[0061] 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 atachment 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.

[0062] 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 frame 15, and, thus, the plurality of struts 16, can be adjustable between a radially-collapsed position and a radially-expanded position.

[0063] 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. [0064] 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.

[0065] A distal portion of the outer shaft 34, referred to as a capsule 35, is configured to surround a transcatheter heart valve prosthesis (e.g., transcatheter heart valve prosthesis 10) during delivery to the treatment site (e.g., a native heart valve) and is retracted from the transcatheter heart valve prosthesis to expose the transcatheter heart valve prosthesis such that it self-expands (in self-expanding embodiments). In this way, the capsule 35 is in frictional engagement with the heart valve prosthesis 10. The inner shaft 36 can be coupled to the handle 33 (e.g., by being directly connected and in contact with the handle 33, or by being indirectly connected to the handle 33 with intermediate structures between the inner shaft 36 and the handle 33) and movement of the handle 33 can translate to movement of the inner shaft 36 and a distal tip or nosecone 37 coupled to a distal end of the inner shaft 36. The inner shaft 36 and distal tip or nosecone 37 may also be translated relative to the outer shaft 34 and the handle 33 via a tip retractor. In the embodiment shown, the inner shaft 36 includes a retainer or spindle 38 for receiving the paddles (e.g., attachment members 24) of the transcatheter heart valve prosthesis 10.

[0066] 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).

[0067] Minimally invasive percutaneous interventional procedures, including endovascular procedures, require access to the venous or arterial system. In general, it is desirable to make the smallest incision point with the shortest tissue contact time when entering the body. Small incisions and short tissue contact time generally lead to improved patient outcomes, less complications, and less trauma to the vessels or organs being accessed, as well as less trauma to the skin and tissue through which the access point is created. Access is required for various medical procedures that deliver or implant structural elements (such as heart valves, heart valve repair devices, occluders, grafts, electrical stimulators, leads, etc.) percutaneously. Some procedures employ relatively large devices that require relatively large sheaths to deliver the devices to the intended site within the body. With such procedures, access site trauma can occur, often resulting in vessel damage, excessive bleeding, increased case time, increased risk of infection, and increased hospitalization time. To reduce access trauma, physicians try to use the smallest devices possible and place the smallest sheath size. This can be problematic, however, if during the procedure the physician discovers a larger device is needed. This leads to a need to upsize the sheath, which is a lengthy procedure and leads to increased risk to the patient. In aspects, expandable sheaths can be expanded within the body and thus do not require removal to upsize.

[0068] Though not required, in aspects, 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. [0069] 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.

[0070] 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.

[0071] 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.

[0072] 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.

[0073] For purposes of this application, any device that can be positioned through an introducer sheath according to any embodiment disclosed or contemplated herein can be referred to as a positionable medical device or insertable medical device. Such devices include guidewires, dilators, delivery devices (for delivery and/or placement of structural elements such as heart valves, heart valve repair devices, occluders, grafts, electrical stimulators, leads, etc.), guide catheters, guiding sheaths, diagnostic catheters, stent delivery systems, balloon catheters, and other known vascular devices. Other devices can include non-vascular devices such as scopes and other common surgical instruments. Further, the introducer sheath is configured to receive tissues or organs. Thus, as one non-limiting example, the introducer sheath 50 is described as being an expandable introducer sheath 50 for introduction of a delivery assembly 30 including a transcatheter heart valve prosthesis 10.

[0074] 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 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, 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.

[0075] FIG. 8 illustrates a side view of the hub 56 and the delivery device 75 (e.g., catheter, etc.) that extends through the vessel 40 of a patient. The delivery device 75 can support the heart valve prosthesis 10 at a distal end of the delivery device 75. As illustrated in FIG. 8, the delivery device 75 can comprise a shaft apparatus 803 that passes through the hub 56 and may be moved in a distal direction 801 toward the treatment site 701 (e.g., illustrated in FIG. 7). The shaft apparatus 803 can extend along a delivery path 805 from an exterior of the vessel 40, through the vessel 40, and to the treatment site 701. In aspects, the delivery path 805 can comprise a plurality of segments, for example, a proximal segment 807, a distal segment 809, etc. The proximal segment 807 can comprise a region of the delivery path 805 within the vessel 40 where rotation of the shaft apparatus 803 is permitted, for example, at a location within the vessel 40 when the heart valve prosthesis 10 is proximal to an aortic arch 811 of a patient. The distal segment 809 can comprise a region of the delivery path 805 within the vessel 40 where rotation of the shaft apparatus 803 is to be avoided, for example, near or at the aortic arch 811 of the patient and/or when the heart valve prosthesis 10 is near the aortic annulus 703 (e.g., illustrated in FIG. 7). Accordingly, methods can comprise distally advancing the heart valve prosthesis 10, which is attached to the shaft apparatus 803, in the distal direction 801 of the delivery path 805 extending from a point of entry into the vasculature 40 to the treatment site 701.

[0076] As illustrated in FIG. 8, the hub 56 can comprise a first locking component 815 that can selectively prevent rotation of the shaft apparatus 803. Selectively preventing rotation of the shaft apparatus 803 is beneficial due, in part, to the relatively large forces generated by rotation of the shaft apparatus 803, and the tortuosity of the aortic arch 811. The shaft apparatus 803 can extend through the first locking component 815. As such, depending on the position of the shaft apparatus 803 relative to the first locking component 815, the shaft apparatus 803 can be permitted to rotate relative to the hub 56, or the first locking component 815 can prevent rotation of the shaft apparatus 803. The shaft apparatus 803 can extend along a central axis 819 along the delivery path 805. In aspects, the central axis 819 may extend from the hub 56, through the vessel 40 of the patient, and to the treatment site 701. In this way, the central axis 819 may extend non-linearly between the hub 56 and the treatment site 701. As used herein, by extending non-linearly, the central axis 819 can extend through the tortuous anatomy (e.g., vessel 40) of the patient, which may not be in a straight line. The shaft apparatus 803 can comprise a shaft portion 821 that extends along the central axis 819 and terminates at a distal end 823. The heart valve prosthesis 10 can be removably attached to the distal end 823 of the shaft portion 821 as the shaft portion 821 moves in the distal direction 801 toward the treatment site 701.

[0077] In aspects, the shaft apparatus 803 can comprise a second locking component 827 attached to the shaft portion 821. The second locking component 827 is illustrated schematically in FIGS. 8-9 due to the second locking component 827 comprising several different embodiments illustrated in FIGS. 10-19. As such, FIG. 8 generally illustrates a position of the second locking component 827 relative to the first locking component 815 when the distal end 823 of the shaft portion 821 is in the proximal segment 807 of the delivery path 805. That is, when the second locking component 827 is spaced a separating distance 833 from the first locking component 815, the second locking component 827 is not in contact with the first locking component 815, and the shaft apparatus 803 is free to rotate about the central axis 819. In this way, when the distal end 823 is located a first distance 835 from the hub 56, the shaft apparatus 803 can rotate relative to the hub 56 about the central axis 819 and the first locking component 815 can be spaced apart from the second locking component 827. Methods can therefore comprise rotating (e.g., illustrated schematically with arrowhead 841) the heart valve prosthesis 10 about the central axis 819 of the shaft apparatus 803 while the heart valve prosthesis 10 is positioned within the proximal segment 807 of the delivery path 805. [0078] Referring to FIG. 9, the shaft apparatus 803 can move axially relative to the hub 56 in the distal direction 801 along the central axis 819. As such, the heart valve prosthesis 10 can be moved axially along the central axis 819 from the position illustrated in FIG. 8, wherein the heart valve prosthesis 10 is located in the proximal segment 807 of the delivery path 805, to the position illustrated in FIG. 9, wherein the heart valve prosthesis 10 is located in the distal segment 809 of the delivery path 805 (e.g., at the aortic arch 811). In this way, the shaft apparatus 803 can move in the distal direction 801 along the delivery path 805 such that the distal end 823 may be located a second distance 901 from the hub 56. Methods can therefore comprise continuing to distally advance the heart valve prosthesis 10 through the distal segment 809 of the delivery path 805 toward the treatment site 701. The first distance 835 and the second distance 901 are not linear distances, but, rather, distances along the tortuous delivery path 805 between the distal end 823 and the hub 56. When the distal end 823 is located the second distance 901 from the hub 56, the first locking component 815 can engage the second locking component 827 such that the shaft apparatus 803 may be prevented from rotating relative to the hub 56 about the central axis 819. In aspects, when the distal end 823 is located the second distance 901 from the hub 56, the heart valve prosthesis 10 and/or a portion of the shaft portion 821 is within the distal segment 809 of the delivery path 805 and within the aortic arch 811. The second distance 901 may be greater than the first distance 835.

[0079] As will be illustrated and described relative to the embodiments of FIGS. 10-19, the second locking component 827 can engage and contact the first locking component 815 in several ways, depending on the structure of the locking components 815, 827. However, the engagement between the first locking component 815 and the second locking component 827 can prevent rotation of the heart valve prosthesis 10. Methods can therefore comprise preventing the heart valve prosthesis 10 from rotating about the central axis 819 while the heart valve prosthesis 10 is positioned within the distal segment 809 of the delivery path 805. In aspects, preventing the heart valve prosthesis 10 from rotating can comprise positioning the second locking component 827 of the shaft apparatus 803 within the first locking component 815 such that the second locking component 827 contacts the first locking component 815.

[0080] FIGS. 10-13 illustrate an embodiment of the first locking component 815 and the second locking component 827. For example, FIG. 10 illustrates a perspective view of the shaft apparatus 803 (e.g., comprising the second locking component 827) in engagement with the hub 56 (e.g., comprising the first locking component 815). The hub 56 can be fixed in a rotational position such that the hub 56 may not rotate about the central axis 819. In aspects, the hub 56 can be a part of a handle or other structure that a physician can grip to prevent rotation of the hub 56. In addition, or in the alternative, an outer surface of the hub 56 can be attached to a non-rotating structure (e.g., a sleeve, shaft, etc.) such that the hub 56 may be rotationally fixed in place. In this way, the hub 56 may not rotate while the shaft apparatus 803 is permitted to selectively rotate.

[0081] The first locking component 815 can define an elongated slot 1001 that extends through a length of the first locking component 815 such that the shaft portion 821 can be received within the elongated slot 1001 and can extend through the hub 56 (e.g., from one side of the hub 56 to an opposing side of the hub 56). The slot 1001 can extend along a slot axis 1003 that, in aspects, may be co-axial with the central axis 819. The first locking component 815 can comprise an outer wall 1005 that circumferentially surrounds the slot 1001, with the outer wall 1005 extending along the slot axis 1003. The outer wall 1005 is illustrated as comprising a substantially circular cross-sectional shape, though, in aspects, other shapes are possible (e.g., oval, quadrilateral such as square or rectangular, etc.).

[0082] The first locking component 815 can comprise one or more radial walls that are attached to, or formed with (e.g., one-piece formed as a single, unitary structure), the outer wall 1005. For example, the one or more radial walls can comprise a first radial wall 1007, a second radial wall 1009, etc. The first radial wall 1007 and the second radial wall 1009 may extend from the outer wall 1005 radially inwardly toward the slot axis 1003, with the first radial wall 1007 spaced apart from the second radial wall 1009. In this way, the slot 1001 can comprise a first slot portion 1013 that is defined between the first radial wall 1007 and the second radial wall 1009. The first slot portion 1013 may extend from the slot axis 1003 radially outwardly toward the outer wall 1005. As such, the first slot portion 1013 may be bounded on an outer radial side by the outer wall 1005, and may be bounded on opposing circumferential sides by the first radial wall 1007 and the second radial wall 1009. FIG. 10 illustrates the first slot portion 1013 as comprising a substantially rectangular shape, though, other shapes are possible.

[0083] In aspects, the first locking component 815 is not limited to one slot portion, but, rather, may comprise any number (e.g., one or more slot portions) of slot portions. As such, while FIG. 10 illustrates a total of four slot portions, greater than four or less than four slot portions are possible. For example, the slot 1001 can comprise a second slot portion 1017 that is spaced circumferentially apart from the first slot portion 1013. The first locking component 815 can comprise a third radial wall 1019 that is spaced apart from the second radial wall 1009 such that the second slot portion 1017 may be defined between the second radial wall 1009 and the third radial wall 1019. The third radial wall 1019 may be substantially identical to the first radial wall 1007 and the second radial wall 1009, but for being spaced circumferentially apart. For example, the third radial wall 1019 can extend from the outer wall 1005 radially inwardly toward the slot axis 1003, with the third radial wall 1019 spaced apart from the second radial wall 1009. The second slot portion 1017 may be substantially identical in size, shape, and structure to the first slot portion 1013. For example, the second slot portion 1017 may extend from the slot axis 1003 radially outwardly toward the outer wall 1005. As such, the second slot portion 1017 may be bounded on an outer radial side by the outer wall 1005, and may be bounded on opposing circumferential sides by the second radial wall 1009 and the third radial wall 1019. FIG. 10 illustrates the second slot portion 1017 as comprising a substantially rectangular shape, though, other shapes are possible. As illustrated in FIG. 10, the slot portions 1013, 1017 may be spaced circumferentially apart such that an angle may be defined between the slot portions 1013, 1017 about the slot axis 1003. In the illustrated example, the angle may be from about 70 degrees to about 110 degrees, or from about 80 degrees to about 100 degrees, or about 90 degrees. Likewise, the other slot portions 1013, 1017 may be spaced circumferentially apart at the same angle about the slot axis 1003. However, since the locking component 815 may comprise additional slot portions, the angle between neighboring slot portions may change. For example, when the locking component 815 comprises six slot portions, the angle between neighboring slot portions may be about 60 degrees. Though not required, in aspects, neighboring slot portions may be spaced a constant angle apart. However, in other embodiments, neighboring slot portions may be spaced a non-constant angle apart, for example, with a first angle between two neighboring slot portions different than a second angle between two different neighboring slot portions.

[0084] The slot 1001 can comprise a non-constant diameter or radius about the slot axis 1003. For example, the first slot portion 1013 can comprise a first radius 1023 that is measured between the slot axis 1003 (e.g., at a center or midpoint of the slot 1001) and a radial end ofthe first slot portion 1013 (e.g., at the outerwall 1005). The second slot portion 1017 can also comprise the first radius 1023. However, at a location between the first slot portion 1013 and the second slot portion 1017, the slot 1001 can comprise a minimum radius 1025. For example, the minimum radius 1025 at the location between the first slot portion 1013 and the second slot portion 1017 can be measured between the slot axis 1003 and the second radial wall 1009. The minimum radius 1025 may be less than the first radius 1023, with the first radius 1023 representing a maximum radius ofthe slot 1001. As such, the slot 1001 can comprise a non-constant radius or diameter about the slot axis 1003.

[0085] The shaft portion 821 can be received by the slot 1001 and can pass through the hub 56. FIG. 10 illustrates a portion of the shaft portion 821 (e.g., less than all of the shaft portion 821) for illustrative purposes so as to not obscure portions of the first locking component 815 from view. However, in operation, a position 1031 ofthe shaft portion 821 passing through slot 1001 is illustrated with dashed lines. The shaft apparatus 803 can comprise the second locking component 827 that projects radially outwardly from the central axis 819. For example, the second locking component 827 can be attached to the shaft portion 821 and may extend radially outwardly from an outer surface of the shaft portion 821. In aspects, the second locking component 827 can extend along the central axis 819, for example, by extending substantially parallel to the central axis 819.

[0086] The second locking component 827 can comprise a shape that may match a shape of the slot portions 1013, 1017 of the slot 1013, such that the second locking component 827 can be received within one of the slot portions 1013, 1017. For example, when the slot portions 1013, 1017 comprise the substantially rectangular shape, the second locking component 827 may comprise a substantially matching rectangular shape. In aspects, the second locking component 827 can comprise a radial size 1033 that is larger than the minimum slot radius 1025 of the slot 1001 and smaller than the maximum slot radius (e.g., the first radius 1023) of the slot 1001. Likewise, the second locking component 827 can comprise a width that is less than a width of the slot portions 1013, 1017, wherein the width of the slot portions 1013, 1017 is the distance between neighboring radial walls that border the slot portions. For example, the width ofthe first slot portion 1013 is the distance between the first radial wall 1007 and the second radial wall 1009. In this way, the second locking component 827 can be positioned within the slot 1001 (e.g., within one of the slot portions 1013, 1017) when the first locking component 815 engages the second locking component 827. As such, the second locking component 827 can be between radial walls when the second locking component 827 is positioned within one of the slot portions 1013, 1017. For example, when the second locking component 827 is received within the first slot portion 1013, the second locking component 827 is between the first radial wall 1007 and the second radial wall 1009.

[0087] FIG. 11 illustrates a side view of the hub 56 and the shaft apparatus 803 along lines 11-11 of FIG. 10 when the second locking component 827 is not received within the first locking component 815. FIG. 11 illustrates a position of the shaft apparatus 803 relative to the hub 56 that substantially matches the position illustrated in FIG. 8. In this way, the second locking component 827 is spaced the separating distance 833 from the first locking component 815. Accordingly, with the second locking component 827 not engaging the first locking component 815, the shaft apparatus 803 can freely rotate 841 about the central axis 819 relative to the hub 56.

[0088] FIG. 12 illustrates a side view of the hub 56 and the shaft apparatus 803 when the second locking component 827 is received within the first locking component 815. FIG. 12 illustrates a position of the shaft apparatus 803 relative to the hub 56 that substantially matches the position illustrated in FIG. 9. In this way, the second locking component 827 engages the first locking component 815, for example, by being received within the first slot portion 1013. Accordingly, with the second locking component 827 engaging the first locking component 815, the shaft apparatus 803 is prevented from rotating about the central axis 819 relative to the hub 56.

[0089] FIG. 13 illustrates an end view of the hub 56 and the shaft apparatus 803 as viewed along lines 13-13 of FIG. 12. As illustrated, when the second locking component 827 engages the first locking component 815, the second locking component 827 is received within one of the slot portions 1013, 1017 (e.g., the first slot portion 1013 in FIG. 13). The second locking component 827, when positioned within the first slot portion 1013, is bounded on opposing circumferential sides by the first radial wall 1007 and the second radial wall 1009. In this way, the second locking component 827 is limited from rotating, due to the second locking component 827 contacting the adjacent radial walls 1007, 1009. Accordingly, due to the second locking component 827 being prevented from rotating, the shaft portion 821 can likewise be prevented from rotating. As such, rotation of the shaft apparatus 803, for example, when the distal end 823 of the shaft portion 821 is within the aortic arch 811, can be prevented.

[0090] FIG. 13 illustrates an alternative position 1301 of the second locking component 827 with dashed lines. In aspects, for the first locking component 815 to receive the second locking component 827 within the slot 1001, the second locking component 827 is first aligned with one of the slot portions 1013, 1017. The alternative position 1301 illustrates a position of the second locking component 827 in which the second locking component 827 is not aligned with one of the slot portions 1013, 1017. Rather, the second locking component 827, when in the position 1301, would contact or engage one of the radial walls of the hub 56, thus preventing further axial movement (e.g., in the distal direction 801) of the shaft apparatus 803 and preventing the second locking component 827 from being received within the slot 1001. To resolve this, the shaft apparatus 803 must first be rotated (e.g., rotation 841 illustrated in FIGS. 8 and 11) at least until the second locking component 827 is aligned with one of the slot portions 1013, 1017. Once aligned, the shaft apparatus 803 can be moved axially (e.g., in the distal direction 801) such that the second locking component 827 can be received within one of the slot portions 1013, 1017.

[0091] As illustrated in FIG. 13, the shape of the slot 1001 (e.g., with four slot portions) allows for four separate rotational positions of the shaft apparatus 803, with the four separate rotational positions spaced about 90 degrees apart. However, additional slot portions can be provided, such that additional rotational positions of the shaft apparatus 803 are possible. In aspects, the slot 1001 and slot portions 1013, 1017 can be used for alignment purposes, for example, to facilitate proper alignment of the heart valve prosthesis 10 at the annulus 703. For example, in aspects, one of the slot portions 1013, 1017 may correspond to a desired rotational alignment of the heart valve prosthesis 10 at the annulus 703. In this way, when the second locking component 827 is received within the desired slot portion, the heart valve prosthesis 10 will be at the desired rotational alignment relative to the annulus 703. This desired slot portion can be marked or otherwise comprises a visual indicator to a physician to indicate that the desired slot portion will produce the desired rotational alignment of the heart valve prosthesis 10. Alternatively, the slot 1001 may comprise a single slot portion (e.g., first slot portion 1013, for example), with the single slot portion corresponding to the desired rotational alignment of the heart valve prosthesis 10. In these examples, the physician can rotationally orient the hub 56 based on imaging and/or a prediction of a rotational position of the heart valve prosthesis 10 within the annulus 703. Accordingly, the slot 1001 can function to not only limit undesired rotation of the distal end 823, but also to assist in rotationally aligning the heart valve prosthesis 10 within the annulus 703.

[0092] With reference to FIG. 12, a locking length of the second locking component 827 and a hub length of the hub 56 can be selected based on the length of the distal segment 809 (e.g., illustrated in FIGS. 8-9) to limit the second locking component 827 from passing through and exiting the hub 56 and, upon exiting, rotating while the distal end 823 is in the distal segment 809. For example, the locking length of the second locking component 827 can be longer than the hub length of the hub 56 to limit the second locking component 827 from exiting the hub 56 and rotating when rotation is undesirable. Alternatively, the hub length of the hub 56 can be longer than the locking length of the second locking component 827 to limit the second locking component 827 from exiting the hub 56 and rotating when rotation is undesirable. In either of these examples, the length along which the second locking component 827 is within the first slot portion 1013 is greater than or equal to the length of the distal segment 809, such that rotation while the heart valve prosthesis 10 is within the distal segment 809 can be prevented.

[0093] FIGS. 14-16 illustrate another embodiment of the hub 56 and the shaft apparatus 803. For example, FIG. 14 illustrates a perspective view of the shaft apparatus 803 (e.g., comprising a second locking component 1401) in engagement with the hub 56 (e.g., comprising a first locking component 1403). The first locking component 1403 can define an elongated slot 1405 that extends through a length of the first locking component 1403 such that the shaft portion 821 can be received within the elongated slot 1405 and can extend through the hub 56 (e.g., from one side of the hub 56 to an opposing side of the hub 56). The slot 1405 can extend along a slot axis 1407 that, in aspects, may be co-axial with the central axis 819. The first locking component 1403 can comprise an outer wall 1409 that circumferentially surrounds the slot 1405, with the outer wall 1409 extending along the slot axis 1407. The outer wall 1409 is illustrated as comprising a substantially circular cross- sectional shape, though, in aspects, other shapes are possible (e.g., oval, quadrilateral such as square or rectangular, etc.). In aspects, the slot 1405 can comprise a substantially constant slot diameter about the slot axis 1407, such that the slot 1405 comprises a substantially circular cross-sectional shape. [0094] The shaft portion 821 can be received by the slot 1405 and can pass through the hub 56. FIG. 14 illustrates a portion of the shaft portion 821 (e.g., less than all of the shaft portion 821) for illustrative purposes so as to not obscure portions of the first locking component 1403 from view. However, in operation, a position 1411 of the shaft portion 821 passing through slot 1405 is illustrated with dashed lines.

[0095] The shaft apparatus 803 can comprise the second locking component 1401 that is attached to the shaft portion 821. In this way, with the shaft portion 821 and the second locking component 1401 attached to one another, the shaft portion 821 and the second locking component 1401 can extend along the central axis 819. As used herein, by being attached, the second locking component 1401 and the shaft portion 821 can be a one-piece formed, single, unitary structure . Alternatively, the shaft portion 821 and the second locking component 1401 can be attached by one or more attachment structures/methods (adhesives, a forming process that uses heat to melt and attach the two structures together, etc.). Regardless of the attachment method, the shaft portion 821 and the second locking component 1401 can be attached in an end-to-end manner with the shaft portion 821 and the second locking component 1401 extending coaxially along the central axis 819.

[0096] The shaft portion 821 and the second locking component 1401 can comprise different diameters. For example, the shaft portion 821 can comprise a first diameter 1419. In aspects, the shaft portion 821 can comprise a substantially constant diameter (e.g., first diameter 1419) along a length of the shaft portion 821 from the second locking component 1401. The second locking component 1401 can comprise a second diameter 1421 that is different than the first diameter 1419, for example, by being larger than the first diameter 1419. For example, the second locking component 1401 can comprise an end that is attached to the shaft portion 821, wherein the end can comprise the first diameter 1419. The second locking component 1401 can comprise an increasing diameter away from the shaft portion 821, for example, with the second locking component 1401 comprising a frustoconical shape (e.g., a truncated cone shape). That is, the second locking component 1401 can comprise a minimum diameter at the shaft portion 821 , and may gradually increase in diameter away from the shaft portion 821. Accordingly, the second locking component 1401 can comprise a non-constant diameter along a length of the second locking component 1401. The second locking component 1401 may continue to increase in diameter until reaching the second diameter 1421, which is the maximum diameter of the second locking component 1401. The second locking component 1401 may then remain at the second diameter 1421 (e.g., in a direction away from the shaft portion 821). In this way, the second locking component 1401 comprises a first segment 1451 and a second segment 1453, with the first segment 1451 positioned between the shaft portion 821 and the second segment 1453. For example, the first segment 1451 is attached to the shaft portion 821, with the first segment 1451 comprising the frustoconical shape and increasing in diameter from the first diameter 1419 (e.g., at one end of the first segment 1451) to the second diameter 1421 (e.g., at an opposing end of the first segment 1451). The second segment 1453 is attached to the first segment 1451, with the second segment 1453 comprising a cylindrical shape with the constant second diameter 1421.

[0097] FIG. 15 illustrates a side view of the hub 56 and the shaft apparatus 803 along lines 15-15 of FIG. 14 when the second locking component 1401 is not received within the first locking component 1403. FIG. 15 illustrates a position of the shaft apparatus 803 relative to the hub 56 that substantially matches the position illustrated in FIG. 8. In this way, the second locking component 1401 is spaced the separating distance 833 from the first locking component 1403. Accordingly, with the second locking component 1401 not engaging the first locking component 1403, the shaft apparatus 803 can freely rotate 841 about the central axis 819 relative to the hub 56.

[0098] FIG. 16 illustrates a side view of the hub 56 and the shaft apparatus 803 when the second locking component 1401 is received within the first locking component 1403. FIG. 16 illustrates a position of the shaft apparatus 803 relative to the hub 56 that substantially matches the position illustrated in FIG. 9. In this way, the second locking component 1401 engages the first locking component 1403, for example, by being received within the slot 1405. As used herein, by engaging the first locking component 1403, at least a portion of the second locking component 1401 can be received within the slot 1405. That is, some, or all, of the length of the second locking component 1401 can be received within the slot 1405.

[0099] In aspects, the second locking component 1401 can be received within the slot 1405 such that the second segment 1453 (e.g., comprising the second diameter 1421) of the second locking component 1401 contacts the outer wall 1409 of the first locking component 1403. For example, the slot 1405 can comprise a substantially constant slot diameter 1601. The slot diameter 1601 may be greater than the first diameter 1419 of the shaft portion 821, and the slot diameter 1601 may be substantially equal to, or slightly less than the second diameter 1421 of the second locking component 1401. Accordingly, and as illustrated in FIG. 16, the shaft portion 821 can be received within the slot 1405, and the first diameter 1419 can be less than the slot diameter 1601. With the second diameter 1421 substantially equal to, or slightly greater than, the slot diameter 1601, the outer radial surface of the second segment 1453 can contact and engage the outer wall 1409 that surrounds the slot 1405. For example, the second locking component 1401 can contact an inner radial surface 1603 of the outer wall 1409 when the first locking component 1403 engages the second locking component 1401. In this way, the second locking component 1401 may be in frictional engagement with the first locking component 1403. Accordingly, with the second locking component 1401 engaging the first locking component 1403, the shaft apparatus 803 is prevented from rotating about the central axis 819 relative to the hub 56. In aspects, the second locking component 1401 can comprise a relatively soft material, such as an elastomeric material, a rubber material, etc., such that the frictional force between the second locking component 1401 and the first locking component 1403 may be increased, thus facilitating the prevention of rotation when the second locking component 1401 is in contact with the first locking component 1403. However, since the second diameter 1421 is substantially equal to, or slightly larger than, the slot diameter 1601 of the slot 1405, axial movement of the shaft portion 821 can be permitted. For example, the frictional engagement between second locking component 1401 and the inner radial surface 1603 of the outer wall 1409 can limit rotation and of the second locking component 1401 and indicate to a user/physician that rotation is undesirable and to be avoided. However, the frictional engagement between second locking component 1401 and the inner radial surface 1603 is not so great as to prevent axial movement of the shaft portion 821, such that the shaft portion 821 can continue to move axially (e.g., along 819, 1407) relative to the hub 56.

[00100] With reference to FIG. 16, a locking length of the second locking component 1401 and a hub length of the hub 56 can be selected based on the length of the distal segment 809 (e.g., illustrated in FIGS. 8-9) to limit the second locking component 1401 from passing through and exiting the hub 56 and, upon exiting, rotating while the distal end 823 is in the distal segment 809. For example, the locking length of the second locking component 1401 can be longer than the hub length of the hub 56 to limit the second locking component 1401 from exiting the hub 56 and rotating when rotation is undesirable. Alternatively, the hub length of the hub 56 can be longer than the locking length of the second locking component 1401 to limit the second locking component 1401 from exiting the hub 56 and rotating when rotation is undesirable. In either of these examples, the length along which the second locking component 1401 is within the slot 1405 (e.g., and in contact/frictional engagement with the inner radial surface 1603) is greater than or equal to the length of the distal segment 809, such that rotation while the heart valve prosthesis 10 is within the distal segment 809 can be prevented.

[00101] FIGS. 17-19 illustrate another embodiment of the hub 56 and the shaft apparatus 803. For example, FIG. 17 illustrates a perspective view of the shaft apparatus 803 comprising a second locking component 1701 in engagement with the hub 56 comprising a first locking component 1703. The first locking component 1703 can define an elongated slot 1705 that extends through a length of the first locking component 1703 such that the shaft portion 821 can be received within the elongated slot 1705 and can extend through the hub 56 (e.g., from one side of the hub 56 to an opposing side of the hub 56). The slot 1705 can extend along a slot axis 1707 that, in aspects, may be co-axial with the central axis 819. The first locking component 1703 can comprise an outer wall 1709 that circumferentially surrounds the slot 1705, with the outer wall 1709 extending along the slot axis 1707. The outer wall 1709 is illustrated as comprising a substantially circular cross-sectional shape, though, in aspects, other shapes are possible (e.g., oval, quadrilateral such as square or rectangular, etc.). In aspects, the slot 1705 can comprise a substantially constant slot diameter about the slot axis 1707, such that the slot 1705 comprises a substantially circular cross-sectional shape.

[00102] The shaft portion 821 can be received by the slot 1705 and can pass through the hub 56. FIG. 17 illustrates a portion of the shaft portion 821 (e.g., less than all of the shaft portion 821) for illustrative purposes so as to not obscure portions of the first locking component 1703 from view. However, in operation, a position 1711 of the shaft portion 821 passing through slot 1405 is illustrated with dashed lines.

[00103] The shaft apparatus 803 can comprise the second locking component 1701 that is attached to the shaft portion 821. The second locking component 1701 can proj ect radially outwardly from the shaft portion 821. As such, the second locking component 1701 can comprise a protrusion, an extension, a bump, an outcropping, or the like. In aspects, the second locking component 1701 can comprise a rounded, spherical cap or spherical dome. As used herein, by being atached, the second locking component 1701 and the shaft portion 821 can be a one-piece formed, single, unitary structure. Alternatively, the shaft portion 821 and the second locking component 1701 can be atached by one or more atachment structure s/methods (adhesives, a forming process that uses heat to melt and atach the two structures together, etc.). The shaft portion 821 can comprise a first diameter 1719, and the shaft apparatus 803 can comprise a second dimension 1721 at the second locking component 1701. The second dimension 1721 comprises the diameter of the shaft portion 821 (e.g., the first diameter 1719) combined with a height or thickness of the second locking component 1701. In this way, the second dimension 1721 is greater than the first diameter 1719.

[00104] FIG. 18 illustrates a side view of the hub 56 and the shaft apparatus 803 along lines 18-18 of FIG. 17 when the second locking component 1701 is not received within the first locking component 1703. FIG. 18 illustrates a position of the shaft apparatus 803 relative to the hub 56 that substantially matches the position illustrated in FIG. 8. In this way, the second locking component 1701 is spaced the separating distance 833 from the hub 56. Accordingly, with the second locking component 1701 not engaging the first locking component 1703, the shaft apparatus 803 can freely rotate 841 about the central axis 819 relative to the hub 56. In aspects, the first locking component 1703 can comprise one or more mechanical structures that can selectively allow or prevent rotation of the shaft apparatus 803. For example, the first locking component 1703 can comprise an actuator 1800 comprising a contact apparatus 1801 positioned within a channel 1803 of the outer wall 1709. The contact apparatus 1801 can comprise a lever 1802, and a contact portion 1804 that is atached to the lever 1802. The lever 1802 is pivotable within the channel 1803. The contact portion 1804 may be atached to an end of the lever 1802, for example, to a surface of the lever 1802 that faces the shaft portion 821. In aspects, the contact portion 1804 can comprise a relative soft material, such as an elastomeric material, a rubber material, etc.. The actuator 1800 can comprise a holding structure 1805 that at least partially contains the contact apparatus 1801 within the channel 1803. For example, the holding structure 1805 can partially, or completely, cover the channel 1803 such that the contact apparatus 1801 is maintained within the channel 1803 and the lever 1802 is prevented from rotating. When the holding structure 1805 covers the channel 1803, the contact portion 1804 is spaced a distance apart from the shaft portion 821, for example, with the holding structure 1805 in contact with one or more of the lever 1802 or the contact portion 1804. [00105] In aspects, the first locking component 1703 is not limited to a single actuator 1800 (e.g., actuator 1800). Rather, in aspects, the first locking component 1703 can comprise a second actuator 1810 that is substantially identical to the actuator 1800, but for being positioned at a different circumferential location about the slot 1705. For example, the second actuator 1810 can comprise a contact apparatus 1811 be positioned within a channel 1813 of the outer wall 1709. Though not required, in aspects, the channel 1813 may be spaced about 180 degrees from the channel 1803 about the axis 1707. The contact apparatus 1811 can comprise a lever 1812, and a contact portion 1814 that is attached to the lever 1812. The lever 1812 is pivotable within the channel 1813. The contact portion 1814 may be attached to an end of the lever 1812, for example, to a surface of the lever 1812 that faces the shaft portion 821. In aspects, the contact portion 1814 can comprise a relative soft material, such as an elastomeric material, a rubber material, etc.. The second actuator 1810 can comprise a holding structure 1815 that at least partially contains the contact apparatus 1811 within the channel 1813. For example, the holding structure 1815 can partially, or completely, cover the channel 1813 such that the contact apparatus 1811 is maintained within the channel 1813 and the lever 1812 is prevented from rotating. When the holding structure 1815 covers the channel 1813, the contact portion 1814 is spaced a distance apart from the shaft portion 821, for example, with the holding structure 1815 in contact with one or more of the lever 1812 or the contact portion 1814.

[00106] FIG. 19 illustrates a side view of the hub 56 and the shaft apparatus 803 when the second locking component 1701 is received within the first locking component 1703. FIG. 19 illustrates a position of the shaft apparatus 803 relative to the hub 56 that substantially matches the position illustrated in FIG. 9. In this way, the second locking component 1701 engages the first locking component 1703, for example, by being received within the slot 1705. As used herein, by engaging the first locking component 1703, the second locking component 1701 can be received within the slot 1705 and may travel past the actuator 1800 and the second actuator 1810.

[00107] In aspects, as the second locking component 1701 passes by the actuator 1800, the second locking component 1701 can contact or engage the holding structure 1805, for example, the engagement portion 1807 that projects outwardly from the holding structure 1805 and toward the second locking component 1701. The contact between the second locking component 1701 and the engagement portion 1807 can cause the holding structure 1805 to move or translate, such that the holding structure 1805 may no longer cover the channel 1803. The holding structure 1815 of the second actuator 1810 can be moved in a similar manner. For example, in aspects, the second locking component 1701 contacting the engagement portion 1807 can cause the shaft portion 821 to move toward the second actuator 1810, whereupon the shaft portion 821 may contact the engagement portion 1817. In response, the holding structure 1815 can move or translate, such that the holding structure 1815 may no longer cover the channel 1813. Accordingly, the second locking portion 1701 can cause movement/translation ofthe holding structures 1805, 1815, such that the channels 1803, 1813 may be uncovered by the holding structures 1805, 1815.

[00108] With the channel 1803 uncovered, the contact apparatus 1801 can move from the retracted position illustrated in FIG. 18, to an extended position illustrated in FIG. 19. For example, the contact apparatus 1801 can rotate (e.g., clockwise from the perspective of FIG. 19), which can cause the contact portion 1804 to move into contact with the shaft portion 821. In this way, the contact portion 1804 is in frictional engagement with the shaft portion 821 . Accordingly, in the retracted position, the contact portion 1804 is not in contact with the shaft portion 821, while in the extended position, the contact portion 1804 is in contact with the shaft portion 821. Likewise, with the second channel 1813 uncovered, the second contact apparatus 1811 can move from the retracted position illustrated in FIG. 18, to an extended position illustrated in FIG. 19. For example, the second contact apparatus 1811 can rotate (e.g., counter-clockwise from the perspective of FIG. 19), which can cause the second contact portion 1814 to move into contact with the shaft portion 821. In this way, the second contact portion 1814 is in frictional engagement with the shaft portion 821. Accordingly, in the retracted position, the contact portion 1814 is not in contact with the shaft portion 821, while in the extended position, the contact portion 1814 is in contact with the shaft portion 821. The levers 1802, 1812, can be biased to move to the extended position illustrated in FIG. 19, for example, spring-biased or the like.

[00109] This frictional engagement between the contact portions 1804, 1814 and the shaft portion 821 can prevent the shaft apparatus 803 from rotating about the central axis 819 relative to the hub 56. However, the shaft apparatus 803 can still move axially relative to the hub 56, such that while rotational movement is restricted/prevented, axial movement is allowed. As with the previous embodiments illustrated in FIGS. 10-16, the hub length of the hub 56 and/orthe locking length ofthe second locking component 1701 and/orthe shaft portion 821 can be selected such that rotation while the distal end 823 is in the distal segment 809 is prevented.

[00110] It will be appreciated that the first locking component 1703 is not limited to the actuators 1800, 1810 illustrated in FIGS. 17-19. Rather, in aspects, variations of the actuators 1800, 1810 can be provided within the hub 56, wherein the actuator can selectively prevent rotation of the shaft apparatus 803. In aspects, the actuator can comprise one or more of levers, springs, or other mechanical structures that can move between a disengaged (or retracted) position, in which the actuator does not contact the shaft apparatus 803 and does not restrict rotation of the shaft apparatus 803, and an engaged (or extended) position, in which the actuator contacts the shaft apparatus 803 and prevents rotation of the shaft apparatus 803. The movement of the actuator from the disengaged position to the engaged position can be triggered, for example, by the second locking component 1701 traveling through the slot 1705 and contacting a portion of the actuator. Accordingly, the actuator 1800, 1810 illustrated and described relative to FIGS. 17-19 comprises one possible example of an actuator. In further aspects, the second locking component 1701 can function to prevent rotation by engaging with an inner radial surface of the outer wall 1709 without the presence of the actuator 1800, 1810. In this way, the second locking component 1701 can be in frictional engagement with the outer wall 1709, which can prevent rotation of the shaft apparatus 803 while allowing for axial movement of the shaft apparatus 803 relative to the hub 56.

[00111] Aspect 1. A delivery assembly is provided for delivering a heart valve prosthesis to a treatment site. The delivery assembly comprises a hub comprising a first locking component and a shaft apparatus extending along a central axis. The shaft apparatus comprises a shaft portion that terminates at a distal end and a second locking component attached to the shaft portion. The shaft apparatus is configured to move axially relative to the hub in a distal direction along the central axis. When the distal end is located a first distance from the hub, the shaft apparatus is configured to rotate relative to the hub about the central axis, and the first locking component is spaced apart from the second locking component. When the distal end is located a second distance from the hub, the first locking component is configured to engage the second locking component such that the shaft apparatus is prevented from rotating relative to the hub about the central axis, and the second distance is greater than the first distance. [00112] Aspect 2. The delivery assembly of aspect 1, wherein the first locking component comprises an outer wall surrounding an elongated slot and a first radial wall spaced apart from a second radial wall such that a first slot portion of the slot is defined between the first radial wall and the second radial wall.

[00113] Aspect 3. The delivery assembly of any one of aspects 1-2, wherein the second locking component extends radially outwardly from the central axis, and the second locking component is positioned within the first slot portion when the first locking component engages the second locking component such that the second locking component is between the first radial wall and the second radial wall.

[00114] Aspect 4. The delivery assembly of any one of aspects 1-3, wherein the first locking component comprises a radially-extending second slot portion spaced circumferentially apart from the radially-extending first slot portion, and the first locking component comprises a third radial wall spaced apart from the second radial wall such that the second slot portion is defined between the second radial wall and the third radial wall.

[00115] Aspect 5. The delivery assembly of any one of aspects 1-4, wherein the first locking component comprises an outer wall surrounding an elongated slot, the slot comprising a substantially constant slot diameter.

[00116] Aspect 6. The delivery assembly of any one of aspects 1-5, wherein the shaft apparatus comprises a shaft portion attached to the second locking component such that the shaft portion and the second locking component extend along the central axis, the shaft portion comprising a first diameter, and the second locking component comprising a second diameter that is larger than the first diameter.

[00117] Aspect 7. The delivery assembly of any one of aspects 1-6, wherein the shaft apparatus is received with the slot. The first diameter is less than the slot diameter, and the second diameter is greater than or equal to the slot diameter.

[00118] Aspect 8. The delivery assembly of any one of aspects 1-7, wherein the second locking component extends radially outwardly from the central axis.

[00119] Aspect 9. The delivery assembly of any one of aspects 1-8, wherein the second locking component contacts an actuator of the first locking component such that the first locking component contacts the second locking component.

[00120] Aspect 10. A delivery assembly is provided for delivering a heart valve prosthesis to a treatment site. The delivery assembly comprises a hub comprising a first locking component that defines an elongated slot and a shaft extending along a central axis. The shaft apparatus comprises a shaft portion extending through the elongated slot and terminating at a distal end and, the shaft apparatus comprises a second locking component attached to the shaft portion. The shaft apparatus is configured to move axially relative to the hub in a distal direction along the central axis. The first locking component is configured to contact the second locking component such that the shaft apparatus is selectively prevented from rotating relative to the hub about the central axis.

[00121] Aspect 11. The delivery assembly of aspect 10, wherein the elongated slot extends along a slot axis and comprises a non-constant diameter about the slot axis.

[00122] Aspect 12. The delivery assembly of any one of aspects 10-11, wherein the second locking component extends radially outwardly from the shaft portion. The second locking component comprises a radial size that is larger than a minimum slot radius of the slot and smaller than a maximum slot radius of the slot.

[00123] Aspect 13. The delivery assembly of any one of aspects 10-12, wherein the shaft portion is attached to the second locking component such that the shaft portion and the second locking component extend along the central axis. The shaft portion comprises a first diameter, and the second locking component comprises a second diameter that is larger than the first diameter. The shaft apparatus is configured to move axially relative to the hub along the central axis while the shaft apparatus is prevented from rotating relative to the hub about the central axis.

[00124] Aspect 14. The delivery assembly of any one of aspects 10-13, wherein the second locking component contracts an inner radial surface of the outer wall when the first locking component engages the second locking component.

[00125] Aspect 15. Methods of delivering a heart valve prosthesis to a treatment site comprise distally advancing the heart valve prosthesis attached to a shaft in a distal direction of a delivery path extending from a point of entry into a vasculature to the treatment site. Methods comprise rotating the heart valve prosthesis about a central axis of the shaft apparatus while the heart valve prosthesis is positioned within a proximal segment of the delivery path. Methods comprise continuing to distally advance the heart valve prosthesis through a distal segment of the delivery path toward the treatment site. Methods comprise preventing the heart valve prosthesis from rotating about the central axis while the heart valve prosthesis is positioned within the distal segment of the delivery path. [00126] Aspect 16. The method of aspect 15, wherein preventing the heart valve prosthesis from rotating comprises positioning a second locking component of the shaft apparatus within a first locking component such that the second locking component contacts the first locking component.

[00127] Aspect 17. The method of any one of aspects 15-16, wherein the first locking component comprises an outer wall surrounding an elongated slot defined between a first radial wall and a second radial wall. The second locking component is received within the slot between the first radial wall and the second radial wall.

[00128] Aspect 18. The method of any one of aspects 15-17, wherein the shaft apparatus comprises a non-constant diameter with the second locking component comprising a segment with a larger diameter than a diameter of the first locking component.

[00129] Aspect 19. The method of any one of aspects 15-18, wherein the second locking component projects radially outwardly from the shaft apparatus.

[00130] 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 delivery assembly (30) for delivering a heart valve prosthesis (10) to a treatment site (701), the delivery assembly (30) comprising: a hub (56) comprising a first locking component (815, 1403, 1703); and a shaft apparatus (803) extending along a central axis (819), the shaft apparatus (803) comprising: a shaft portion (821) that terminates at a distal end (823); and a second locking component (827, 1401, 1701) attached to the shaft portion (821), wherein the shaft apparatus (803) is configured to move axially relative to the hub (56) in a distal direction along the central axis (819); wherein, when the distal end (823) is located a first distance (835) from the hub (56): the shaft apparatus (803) is configured to rotate relative to the hub (56) about the central axis (819) and the first locking component (815, 1403, 1703) is spaced apart from the second locking component (827, 1401, 1701); and when the distal end (823) is located a second distance (901) from the hub (56): the first locking component (815, 1403, 1703) is configured to engage the second locking component (827, 1401, 1701) such that the shaft apparatus (803) is prevented from rotating relative to the hub (56) about the central axis (819), the second distance (901) greater than the first distance (835).

2. The delivery assembly (30) of claim 1, wherein the first locking component (815) comprises an outer wall (1005) surrounding an elongated slot (1001), the first locking component (815) comprising a first radial wall (1007) spaced apart from a second radial wall (1009) such that a first slot portion (1013) of the slot (1001) is defined between the first radial wall (1007) and the second radial wall (1009).

3. The delivery assembly (30) of claim 2, wherein the second locking component (827) extends radially outwardly from the central axis (819), the second locking component (827) positioned within the first slot portion (1013) when the first locking component (815) engages the second locking component (827) such that the second locking component (827) is between the first radial wall (1007) and the second radial wall (1009).

4. The delivery assembly (30) of claim 3, wherein the first locking component (815) comprises a radially-extending second slot portion (1017) spaced circumferentially apart from the radially-extending first slot portion (1013), the first locking component (815) comprising a third radial wall (1019) spaced apart from the second radial wall (1009) such that the second slot portion (1017) is defined between the second radial wall (1009) and the third radial wall (1019).

5. The delivery assembly (30) of claim 1, wherein the first locking component (1403) comprises an outer wall (1409) surrounding an elongated slot (1405), the slot (1405) comprising a substantially constant slot diameter.

6. The delivery assembly (30) of claim 5, wherein the shaft apparatus (803) comprises a shaft portion (821) attached to the second locking component (1401) such that the shaft portion (821) and the second locking component (1401) extend along the central axis (819), the shaft portion (821) comprising a first diameter, and the second locking component (1401) comprising a second diameter that is larger than the first diameter.

7. The delivery assembly (30) of claim 6, wherein the shaft apparatus (803) is received within the slot (1405) and the first diameter is less than the slot diameter, the second diameter greater than or equal to the slot diameter.

8. The delivery assembly (30) of claim 5, wherein the second locking component (1701) extends radially outwardly from the central axis (819).

9. The delivery assembly (30) of claim 8, wherein the second locking component (1701) contacts an actuator (1800) of the first locking component (1703) such that the first locking component (1703) contacts the second locking component (1701).

10. A method of delivering a heart valve prosthesis (10) to a treatment site (701) comprising: distally advancing the heart valve prosthesis (10) attached to a shaft in a distal direction of a delivery path (805) extending from a point of entry into a vasculature to the treatment site (701); rotating the heart valve prosthesis (10) about a central axis (819) of the shaft apparatus (803) while the heart valve prosthesis (10) is positioned within a proximal segment (807) of the delivery path (805); then continuing to distally advance the heart valve prosthesis (10) through a distal segment (809) of the delivery path (805) toward the treatment site (701); and preventing the heart valve prosthesis (10) from rotating about the central axis (819) while the heart valve prosthesis (10) is positioned within the distal segment (809) of the delivery path (805).

11. The method of claim 10, wherein preventing the heart valve prosthesis (10) from rotating comprises positioning a second locking component (827, 1401, 1701) of the shaft apparatus (803) within a first locking component (815, 1403, 1703) such that the second locking component (827, 1401, 1701) contacts the first locking component.

12. The method of claim 11, wherein the first locking component comprises an outer wall (1005) surrounding an elongated slot (1001) defined between a first radial wall (1007) and a second radial wall (1009), the second locking component (827) received within the slot (1001) between the first radial wall (1007) and the second radial wall (1009).

13. The delivery assembly (30) of claim 11, wherein the shaft apparatus (803) comprises a non-constant diameter with the second locking component (1401) comprising a segment with a larger diameter than a diameter of the first locking component (1403).

14. The delivery assembly (30) of claim 11, wherein the second locking component (1701) projects radially outwardly from the shaft apparatus (803).