Prosthetic heart valve implant apparatus

Abstract

A transcatheter heart valve implant apparatus is provided for delivering a heart valve prosthesis to a treatment site. The transcatheter heart valve implant apparatus includes a handle defining an elongated opening. A shaft is received within the elongated opening and extends between a proximal shaft end and a distal shaft end. The shaft moves axially relative to the handle. A spindle is attached to the distal shaft end of the shaft and extends between a proximal spindle end and a distal spindle end. The spindle is removably attached to the heart valve prosthesis. A capsule circumferentially surrounds the spindle. The shaft moves axially relative to the handle and the capsule in a distal direction away from the handle from a first shaft position to a second shaft position. Methods of implanting a heart valve prosthesis are provided.

Description

PROSTHETIC HEART VALVE IMPLANT APPARATUSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 432,567, filed April 28, 2023, the entire content of which is incorporated herein by reference.FIELD

[0002] The present disclosure relates generally to a transcatheter heart valve implant apparatus and, more particularly, to a transcatheter heart valve implant apparatus that reduces tension on a valve prosthesis during deployment.BACKGROUND

[0003] It is known to provide a heart valve implant apparatus 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-collapsed position to a radially-expanded position. However, delivery of the heart valve prosthesis can be difficult.SUMMARY

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

[0005] In aspects, a transcatheter heart valve implant apparatus is provided for delivering a heart valve prosthesis to a treatment site. The transcatheter heart valve implant apparatus comprises a handle defining an elongated opening comprising a first cross- sectional size. The transcatheter heart valve implant apparatus comprises a shaft received within the elongated opening and extending between a proximal shaft end and a distal shaft end. The shaft comprises a second cross-sectional size that is less than the first cross- sectional size such that the shaft is configured to move axially relative to the handle. The transcatheter heart valve implant apparatus comprises a spindle attached to the distal shaft end of the shaft and extending between a proximal spindle end and a distal spindle end. Thespindle is configured to be removably attached to the heart valve prosthesis. The transcatheter heart valve implant apparatus comprises a capsule circumferentially surrounding the spindle and a portion of the heart valve prosthesis. The capsule terminates at a distal capsule end that defines a capsule opening through which the heart valve prosthesis extends. The shaft is configured to move axially relative to the handle and the capsule in a distal direction away from the handle from a first shaft position, in which a first distance separates the distal spindle end and the distal capsule end, to a second shaft position, in which a second distance separates the distal spindle end and the distal capsule end. The second distance is less than the first distance.

[0006] In aspects, in the first shaft position, the proximal shaft end is spaced a first separating distance from the handle, and in the second shaft position, the proximal shaft end is spaced a second separating distance from the handle. The second separating distance is less than the first separating distance.

[0007] In aspects, an actuator is attached to the proximal shaft end and spaced apart from the handle.

[0008] In aspects, the handle comprises an actuator with a threaded inner radial surface surrounding the elongated opening and comprising the first cross-sectional size.

[0009] In aspects, the shaft comprises a threaded outer radial surface that engages the threaded inner radial surface.

[0010] In, aspects, the shaft comprises a first shaft portion and a second shaft portion spaced apart and defining a gap between the first shaft portion and the second shaft portion. The first shaft portion and the second shaft portion arere in contact with the actuator such that the gap is circumferentially surrounded by the actuator.

[0011] In aspects, the actuator comprises an actuating member and a torsion coil attached to the actuating member. The torsion coil circumferentially surrounds and extends coaxially with the shaft between a distal torsion end and a proximal torsion end.

[0012] In aspects, the actuator comprises a threaded member attached to the distal torsion end of the torsion coil. The threaded member comprises the threaded inner radial surface.

[0013] In aspects, the shaft comprises a threaded outer radial surface that engages the threaded inner radial surface. The shaft comprises a first shaft portion and a second shaft portion spaced apart and defining a gap between the first shaft portion and the secondshaft portion. The first shaft portion and the second shaft portion are in contact with the threaded member such that the gap is circumferentially surrounded by the threaded member.

[0014] In aspects, a transcatheter heart valve implant apparatus is provided for delivering a heart valve prosthesis to a treatment site. The transcatheter heart valve implant apparatus comprises a handle comprising an actuator with a threaded inner radial surface. The actuator defines an elongated opening comprising a first cross-sectional size. The transcatheter heart valve implant apparatus comprises a shaft received within the elongated opening and extending between a proximal shaft end and a distal shaft end. The shaft comprises a second cross-sectional size that is less than the first cross-sectional size such that the shaft is configured to move axially relative to the handle. The shaft comprises a threaded outer radial surface that engages the threaded inner radial surface of the actuator. The transcatheter heart valve implant apparatus comprises a spindle attached to the distal shaft end of the shaft and extending between a proximal spindle end and a distal spindle end. The spindle is configured to be removably attached to the heart valve prosthesis. The transcatheter heart valve implant apparatus comprises a capsule circumferentially surrounding the spindle and a portion of the heart valve prosthesis. The capsule terminates at a distal capsule end that defines a capsule opening through which the heart valve prosthesis extends. The actuator is configured to rotate and impart axial movement to the shaft to move the shaft axially relative to the handle and the capsule in a distal direction away from the handle from a first shaft position, in which a first distance separates the distal spindle end and the distal capsule end, to a second shaft position, in which a second distance separates the distal spindle end and the distal capsule end. The second distance is less than the first distance.

[0015] In aspects, the shaft comprises a first shaft portion and a second shaft portion spaced apart and defining a gap between the first shaft portion and the second shaft portion. The first shaft portion and the second shaft portion are in contact with the actuator such that the gap is circumferentially surrounded by the actuator.

[0016] In aspects, the actuator comprises an actuating member and a torsion coil attached to the actuating member. The torsion coil circumferentially surrounds and extends coaxially with the shaft between a distal torsion end and a proximal torsion end.

[0017] In aspects, the actuator comprises a threaded member attached to the distal torsion end of the torsion coil. The threaded member comprises the threaded inner radial surface.

[0018] In aspects, the shaft comprises a first shaft portion and a second shaft portion spaced apart and defining a gap between the first shaft portion and the second shaft portion. The first shaft portion and the second shaft portion are in contact with the threaded member such that the gap is circumferentially surrounded by the threaded member.

[0019] In aspects, the threaded member extends substantially coaxially with the torsion coil.

[0020] In aspects, methods of implanting a heart valve prosthesis comprise delivering the heart valve prosthesis to a treatment site. The heart valve prosthesis is surrounded by a capsule and removably attached to a spindle that is attached to a shaft. Methods comprise retracting the capsule in a proximal direction. Methods comprise radially-expanding a first end of the heart valve prosthesis while an opposing second end of the heart valve prosthesis is attached to the spindle. Methods comprise moving the shaft relative to the capsule axially in a distal direction to reduce tension on the heart valve prosthesis such that a distance separating the spindle and a distal capsule end of the capsule decreases. Methods comprise radially-expanding the second end of the heart valve prosthesis by detaching the second end from the spindle.

[0021] In aspects, moving the shaft relative to the capsule comprises rotating an actuator that is threadingly engaged with the shaft.

[0022] In aspects, the threading engagement between the shaft and the actuator is located within a handle.

[0023] In aspects, the actuator comprises an actuating member and a torsion coil attached to the actuating member, such that rotation of the actuating member causes the torsion coil to rotate.

[0024] In aspects, the actuator comprises a threaded member attached to the distal torsion end of the torsion coil. The threaded member comprises the threaded inner radial surface. The threading engagement between the shaft and the threaded member is located adjacent the distal torsion end.

[0025] 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 theart 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

[0026] 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:

[0027] FIG. 1 schematically illustrates a side view of example aspects of a transcatheter heart valve implant apparatus in accordance with aspects of the disclosure;

[0028] FIG. 2 schematically illustrates retraction of a capsule of the transcatheter heart valve implant apparatus in accordance with aspects of the disclosure;

[0029] FIG. 3 schematically illustrates distal movement of a shaft of the transcatheter heart valve implant apparatus in accordance with aspects of the disclosure;

[0030] FIG. 4 illustrates deployment of a heart valve prosthesis in accordance with aspects of the disclosure;

[0031] FIG. 5 schematically illustrates a side view of additional aspects of the delivery of a transcatheter heart valve implant apparatus in accordance with aspects of the disclosure;

[0032] FIG. 6 schematically illustrates retraction of a capsule of the transcatheter heart valve implant apparatus in accordance with aspects of the disclosure;

[0033] FIG. 7 schematically illustrates distal movement of a shaft of the transcatheter heart valve implant apparatus in accordance with aspects of the disclosure;

[0034] FIG. 8 illustrates deployment of a heart valve prosthesis in accordance with aspects of the disclosure;

[0035] FIG. 9 schematically illustrates a side view of additional aspects of the delivery of a transcatheter heart valve implant apparatus in accordance with aspects of the disclosure;

[0036] FIG. 10 schematically illustrates distal movement of a shaft of the transcatheter heart valve implant apparatus in accordance with aspects of the disclosure; and

[0037] FIG. 11 illustrates deployment of a heart valve prosthesis in accordance with aspects of the disclosure.DETAILED DESCRIPTION

[0038] 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.

[0039] 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.

[0040] 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.

[0041] 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.

[0042] 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 apparatusclaim 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.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] Unless otherwise indicated, the terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction toward the clinician. In addition, the term “self-expanding” may be used in the following description with reference to one or more valve or stent structures of the prostheses hereof and is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration or vice versa. Non-exhaustive exemplary self-expanding materials include stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal. Mechanical memory may be imparted to a wire or stent structure by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol. Various polymers that can be made to have shape memory characteristics may also be suitable for use in aspects hereof to include polymers such as polynorborene, transpolyisoprene, styrene -butadiene, and polyurethane. As well poly U-D lactic copolymer, oligo caprylactone copolymer and poly cyclo-octine can be used separately or in conjunction with other shape memory polymers.

[0049] 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 ordamaged 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.

[0050] Heart valve prostheses have been developed for repair and replacement of diseased and / or damaged heart valves. Such heart valve prostheses can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based delivery systems. Such heart valve prostheses generally include a frame or stent and a prosthetic valve mounted within the frame. Such heart valve prostheses are delivered in a radially compressed or crimped configuration so that the heart valve prosthesis can be advanced through the patient’s vasculature. Once positioned at the treatment site, the heart valve prosthesis is expanded to engage tissue at the diseased heart valve region to, for instance, hold the heart valve prosthesis in position.

[0051] FIGS. 1-11 illustrate an example transcatheter heart valve implant apparatus 100 for delivering a heart valve prosthesis 102. The transcatheter heart valve implant apparatus 100 is illustrated to facilitate description of the disclosure. The following description of the transcatheter heart valve implant apparatus 100 and the heart valve prosthesis 102 is merely exemplary in nature and is not intended to limit the scope of the application. In some embodiments, the transcatheter heart valve prosthesis 102 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.

[0052] FIG. 1 illustrates a side view of the transcatheter heart valve implant apparatus 100 that can extend between a distal end 104 and a proximal end 106. The distal end 104 can be used to load and deliver the heart valve prosthesis 102. The proximal end 106 can comprise components, for example, those found in other catheter delivery systems. In aspects, the components at the proximal end 106 may comprise, for example, one or more rotating homeostasis valves, side access ports, guidewires, handles, etc.

[0053] In aspects, the transcatheter heart valve implant apparatus 100 can be used in a vessel or artery of a patient, for example, the femoral artery. The proximal end 106 can extend outside of the patient, for example, in the groin area, while the distal end 104 may be delivered intravascularly to an area at or near a heart valve inside the body. However, other uses for the transcatheter heart valve implant apparatus 100 in other areas of the body are also contemplated. The transcatheter heart valve implant apparatus 100 can allow for coaxial use to pass items (e.g., guidewires, valve prosthesis, contrast media, other catheters, etc.) through the transcatheter heart valve implant apparatus 100.

[0054] In aspects, the transcatheter heart valve implant apparatus 100 can comprise a handle 110 positioned adjacent the proximal end 106 of the implant apparatus 100. The handle 110 can comprise an outer surface that allows a physician to grasp and / or manipulate the handle 110 by hand. The handle 110 can define an elongated opening 112 extending through the handle 110, with the elongated opening 112 comprising a first cross-sectional size 114. In aspects, the elongated opening 112 can comprise a substantially circular shape such that the first cross-sectional size 114 comprises a diameter.

[0055] In aspects, the handle 110 can comprise an actuator 118 with a threaded inner radial surface 120 surrounding the elongated opening 112, with the threaded inner radial surface 120 comprising the first cross-sectional size 114. In aspects, the actuator 118 may be positioned within a recess 122 of the handle 110, for example, with the actuator 118 positioned between a first handle portion 124 and a second handle portion 126. The actuator 118 can move relative to the handle 110, for example, by rotating relative to the handle 110. In aspects, the elongated opening 112 can extend along an opening axis 128, with the actuator 118 configured to rotate about the opening axis 128. In aspects, a first portion of the elongated opening 112 may be surrounded by the first handle portion 124, a second portion of the elongated opening 112 may be surrounded by the second handle portion 126, and a third portion of the elongated opening 112 may be surrounded by the threaded inner radial surface 120 of the actuator 118.

[0056] The implant apparatus 100 can comprise a shaft 130 that is received within the elongated opening 112 and can extend between a proximal shaft end 132 and a distal shaft end 134. The proximal shaft end 132 may be adjacent to the proximal end 106 of the implant apparatus 100, and the distal shaft end 134 may be adjacent to the distal end 104 of the implant apparatus 100. The shaft 130 can comprise a second cross-sectional size 136that is less than the first cross-sectional size 114 such that the shaft 130 can move axially relative to the handle 110. In aspects, the shaft 130 can comprise a substantially circular cross-sectional shape such that the second cross-sectional size 136 comprises a diameter. The shaft 130 may comprise one or more hollow cavities or bores extending axially through the shaft 130 between the proximal shaft end 132 and the distal shaft end 134, such that the shaft 130 can receive at least one guidewire that can facilitate guidance of the implant apparatus 100 to a treatment site. In aspects, the shaft 130 can comprise a threaded outer radial surface 138 that can engage the threaded inner radial surface 120. For example, the threaded outer radial surface 138 can comprise the second cross-sectional size 136 such that that threaded outer radial surface 138 can be circumferentially surrounded by, and in contact with, the threaded inner radial surface 120. In aspects, the threaded surfaces 120, 138 can comprise helical structures that can convert a rotational movement to a linear movement or force. In aspects, the elongated opening 112 and the portion of the shaft 130 received within the elongated opening 112 can extend along the opening axis 128, such that the threaded surfaces 120, 138 can wind around the opening axis 128 in the form of a helix.

[0057] In aspects, the shaft 130 can comprise a plurality of shaft portions, for example, a first shaft portion 140 and a second shaft portion 142. The first shaft portion 140 and the second shaft portion 142 may be spaced apart to define a gap 144 between the first shaft portion 140 and the second shaft portion 142. The first shaft portion 140 may be located at a distal end of the handle 110 while the second shaft portion 142 may be located at a proximal end of the handle 110. As used herein, the term ‘distal’ can refer to an end of a structure that is in closer proximity to a treatment site (e.g., treatment site 201 illustrated in FIG. 2) while the term ‘proximal’ can refer to an end of a structure that is farther from the treatment site, for example, by being positioned closer to the proximal end 106 that is at an exterior of the patient’s vasculature.

[0058] The first shaft portion 140 and the second shaft portion 142 may be in contact with the actuator 118 such that the gap 144 may be circumferentially surrounded by the actuator 118. In aspects, the first shaft portion 140 and the second shaft portion 142 may comprise the threaded outer radial surface 138, such that the first shaft portion 140 can threadingly engage the threaded inner radial surface 120 of the actuator 118, and the second shaft portion 142 can threadingly engage the threaded inner radial surface 120 of the actuator118. Accordingly, the threading engagement between the shaft 130 and the actuator 118 may be located within the handle 110.

[0059] The implant apparatus 100 can comprise a spindle 150 attached to the distal shaft end 134 of the shaft 130, with the spindle 150 extending between a proximal spindle end 152 and a distal spindle end 154. In aspects, the distal shaft end 134 of the shaft 130 can be attached to the proximal spindle end 152 of the spindle 150. The spindle 150 can comprise one or more pockets, for example, a first spindle pocket 156, a second spindle pocket 158, etc. The spindle pockets 156, 158 may be located at an outer radial surface of the spindle 150, with the first spindle pocket 156 circumferentially spaced apart from the second spindle pocket 158 about a spindle axis 160 along which the spindle 150 extends between the proximal spindle end 152 and the distal spindle end 154. In aspects, the spindle pockets 156, 158 can define openings, recesses, cavities, or the like within which a portion of the valve prosthesis 102, for example, paddles of the valve prosthesis 102, can be received. In this way, the spindle 150 can receive the paddles of the valve prosthesis 102 to removably attach the spindle 150 to the valve prosthesis 102 and assist in holding the valve prosthesis 102 in a radially-compressed position.

[0060] The implant apparatus 100 can comprise a capsule 164 circumferentially surrounding the spindle 150, at least a portion of the heart valve prosthesis 102, and the distal shaft end 134 of the shaft 130. The capsule 164 comprises a substantially hollow cavity 166 within which the spindle 150, at least a portion of the heart valve prosthesis 102, and the distal shaft end 134 of the shaft 130 can be received. The capsule 164 can extend between a proximal capsule end 168 and a distal capsule end 170, with the capsule 164 terminating at the distal capsule end 170. The distal capsule end 170 can define a capsule opening 172 through which the heart valve prosthesis 102 can extend. As will be described herein, in aspects, the capsule 164 can move relative to the heart valve prosthesis 102, the spindle 150, and the shaft 130. In addition, the shaft 130 can move relative to the capsule 164. While not illustrated in FIG. 1, the implant apparatus 100 can comprise other structures and components that can facilitate delivery and deployment of the heart valve prosthesis 102. For example, the implant apparatus 100 can comprise one or more guidewires that can facilitate tracking of the implant apparatus 100 to a treatment site. The implant apparatus 100 can comprise a tapered tip attached to, or positioned distally from, the distal capsule end 170, with the tapered tip comprising a tapered shape to ease thepassage of the implant apparatus 100 through the vasculature. Further, the implant apparatus 100 can comprise holding catheters, additional handles, etc. not illustrated in FIG. 1.

[0061] FIG. 1 illustrates the valve prosthesis 102 in a radially-compressed position during intraluminal delivery to a treatment site. In the radially-compressed position, the valve prosthesis 102 can be removably attached to the spindle 150 and circumferentially surrounded by the capsule 164. The valve prosthesis 102 can extend coaxially with the shaft 130, with the valve prosthesis 102 comprising a smaller cross-sectional size (e.g., diameter) than the capsule 164. As such, the capsule 164, along with the spindle 150, can maintain the valve prosthesis 102 in the radially-compressed position during delivery. Accordingly, in aspects, methods of implanting the valve prosthesis 102 can comprise delivering the heart valve prosthesis 102 to a treatment site 201 (e.g., illustrated in FIG. 2), with the heart valve prosthesis 102 surrounded by the capsule 164 and removably attached to the spindle 150 that is attached to the shaft 130. During this delivery, the valve prosthesis 102 can be moved in a distal direction 178 through the patient’s vasculature and toward the treatment site 201.

[0062] FIG. 2 illustrates the valve prosthesis 102 upon reaching the treatment site 201 and after the delivery. In aspects, the treatment site 201 can comprise the location within the patient at which the valve prosthesis 102 is intended to be deployed. The treatment site 201 can comprise, for example, a native heart valve annulus, areas at or near a pulmonary valve, etc. In aspects, upon reaching the treatment site 201, methods can comprise retracting the capsule 164 in a proximal direction 203 that is opposite the distal direction 178. In aspects, retracting the capsule 164 can comprise moving the capsule 164 in the proximal direction 203 relative to the valve prosthesis 102, the spindle 150, and the shaft 130. The capsule 164 can be attached, for example, at the proximal capsule end 168, to a handle or other structure at an exterior of the patient’s vasculature, such that the movement and retraction of the capsule 164 in the proximal direction 203 can be controlled by a physician. After retracting the capsule 164, methods can comprise radially-expanding a first end 205 of the heart valve prosthesis 102 while an opposing second end 207 of the heart valve prosthesis 102 remains attached to the spindle 150. For example, the first end 205 may be located at a distal end of the valve prosthesis 102 while the second end 207 may be located at a proximal end of the valve prosthesis 102. Accordingly, and as illustrated in FIG. 2, after retracting the capsule 164, the first end 205 of the valve prosthesis 102 maybe in the radially-expanded position while the second end 207 may be in the radially- compressed position due to being attached to the spindle 150.

[0063] In aspects, the valve prosthesis 102 may contact the distal capsule end 170 due to the valve prosthesis 102 radially-expanding and extending through the capsule opening 172. In aspects, this contact between the valve prosthesis 102 and the distal capsule end 170 can create tension between the valve prosthesis 102 and the spindle 150, for example, by creating tension in the distal direction 178. This tension can limit the ability of the second end 207 of the valve prosthesis 102 from detaching from the spindle 150. For example, to detach from the spindle 150, the second end 207 of the valve prosthesis 102 can move in an outward radial direction (e.g., radial direction 401 illustrated in FIG. 4). However, due to the tension, friction between the paddles of the valve prosthesis 102 and the spindle 150 may increase, which can limit the ability of the paddles from moving in the outward radial direction.

[0064] FIG. 3 illustrates movement of the shaft 130 relative to the capsule 164 to reduce tension on the valve prosthesis 102 and improve the ability of the valve prosthesis 102 to detach from the spindle 150. For example, methods can comprise moving the shaft 130 relative to the capsule 164 axially in the distal direction 178 to reduce tension on the heart valve prosthesis 102 such that a distance separating the spindle 150 and the distal capsule end 170 of the capsule 164 decreases. In aspects, the term ‘moving relative to’ can comprise movement of one body or structure with respect to a second body or structure, with the second body or structure remaining in a substantially fixed location. For example, in aspects, moving the shaft 130 relative to the capsule 164 can comprise maintaining the capsule 164 in a substantially fixed or static position while moving the shaft 130 in the distal direction 178.

[0065] Moving the shaft 130 relative to the capsule 164 can comprise rotating (e.g., rotation 311 illustrated with arrowhead) the actuator 118 that is threadingly engaged with the shaft 130. The actuator 118 can rotate relative to the handle 110, for example. In aspects, the actuator 118 can rotate (e.g., about the opening axis 128), which can impart axial movement (e.g., along the opening axis 128) to the shaft 130 to move the shaft axially relative to the handle 110 and the capsule 164 in the distal direction 178 away from the handle 110 from a first shaft position to a second shaft position. In this way, the actuator 118 and the shaft 130 can function as a mechanical linear actuator that translates rotationalmotion to linear motion with relatively little friction. The first shaft position is illustrated in FIG. 2, wherein in the first shaft position, a first distance 301 separates the distal spindle end 154 from the distal capsule end 170. The second shaft position is illustrated in FIG. 3, wherein in the second shaft position, a second distance 303 separates the distal spindle end 154 from the distal capsule end 170. Due to the movement of the shaft 130 in the distal direction 178, the second distance 303 is less than the first distance 301. The shaft 130 can be moved due to rotation of the actuator 118. For example, the actuator 118 can rotate about the opening axis 128, with the actuator 118 remaining at a fixed axial position relative to the opening axis 128 (e.g., with the actuator 118 not moving in the distal direction 178 or the proximal direction 203). The threaded inner radial surface 120 is threadingly engaged with the threaded outer radial surface 138 of the first shaft portion 140. Due to rotation of the actuator 118 and, thus rotation of the threaded inner radial surface 120 about the opening axis 128, the actuator 118 can cause the shaft 130 to move linearly / axially along the opening axis 128. Movement of the shaft 130 can likewise cause the spindle 150 to move linearly / axially along the opening axis 128 in the distal direction 178, and likewise cause the valve prosthesis 102 to move linearly / axially along the opening axis 128 in the distal direction 178.

[0066] This movement of the spindle 150 and the valve prosthesis 102 from the first shaft position to the second shaft position can cause the distance separating the distal spindle end 154 from the distal capsule end 170 to decrease from the first distance 301 to the second distance 303. As such, the aforementioned tension between the valve prosthesis 102 and the spindle 150 can be reduced. In aspects, after movement of the shaft 130 to the second shaft position, the valve prosthesis 102 may not be in contact with the distal capsule end 170. Though, in some aspects, after movement of the shaft 130 to the second shaft position, the valve prosthesis 102 may remain in contact with the distal capsule end 170, but with tension on the valve prosthesis 102 reduced as compared to the first shaft position of FIG. 2. In aspects, in the first shaft position (e.g., illustrated in FIG. 2), the distal shaft end 134 is spaced a first separating distance 307 from the handle 110, and in the second shaft position (e.g., illustrated in FIG. 3), the distal shaft end 134 is spaced a second separating distance 309 from the handle 110. The second separating distance 309 may be greater than the first separating distance 307, indicating the movement of the shaft 130, for example, the first shaft portion 140, in the distal direction 178 relative to the handle 110. Likewise, as the firstshaft portion 140 moves in the distal direction 178, the width of the gap 144 separating the first shaft portion 140 from the second shaft portion 142 may increase.

[0067] As illustrated in FIG. 4, methods can comprise radially-expanding the second end 207 of the heart valve prosthesis 102 by detaching the second end 207 from the spindle 150. For example, with tension on the valve prosthesis 102 reduced, the second end 207 of the valve prosthesis 102 can move from the radially-contracted position (e.g., illustrated in FIGS. 2-3) to the radially-expanded position of FIG. 4. That is, the second end 207 can move in an outward radial direction 401 such that paddles 403 at the second end 207 of the valve prosthesis 102 can be released from the spindle pockets 156, 158. In aspects, the valve prosthesis 102 can comprise a framework comprising a wire or plurality of wires 409 made of a shape-memory material (e.g., NITINOL™) and one or more pieces of fabric 411 (i.e., cloth, material, etc.) to which the wire or wires 409 can be attached. The wires 409 can be shaped and aligned such that when the wires 409 are aligned generally coaxially, a central lumen can run along the length of the valve prosthesis 102. In aspects, the wires 409 can comprise a series of sinusoidal bends around their circumference, which allow for the compression and expansion of the valve prosthesis 102 with minimal force. The wires 409 may be attached separately to the fabric 411. In addition, or alternatively, the wires 409 may be attached to each other at some or all of their adjacent apices. The valve prosthesis 102 comprises one or more valve leaflets disposed within and secured to the wires 409, with the valve leaflets configured to open and close to regulate blood flow through the valve prosthesis 102.

[0068] FIGS. 5-8 illustrate additional embodiments of the implant apparatus 100, wherein the implant apparatus 100 of FIGS. 5-8 can comprise some features that are substantially identical to features of the implant apparatus 100 illustrated in FIGS. 1-4. For example, the implant apparatus 100 illustrated in FIGS. 5-8 can comprise the valve prosthesis 102, the shaft 130, the handle 110, the spindle 150, and the capsule 164. The shaft 130 can comprise the first shaft portion 140 and the second shaft portion 142 with the gap 144 therebetween. However, the position of the first shaft portion 140 and the second shaft portion 142 relative to the handle 110 may differ in FIGS. 5-8 from FIGS. 1-4.

[0069] Referring to FIG. 5, in aspects, the handle 110 can comprise an actuator 501. In contrast with the actuator 118 of FIGS. 1-4, the actuator 501 of FIG. 5 can comprise a plurality of components that, together, can function to impart axial movement to the shaft130. For example, the actuator 501 can comprise an actuating member 503, a torsion coil 505, and a threaded member 507. The actuating member 503 can be positioned within the recess 122 between the first handle portion 124 and the second handle portion 126. The actuating member 503 can move, for example, rotate about the opening axis 128, relative to the first handle portion 124 and the second handle portion 126. In this way, the actuating member 503 can rotate in a similar manner to the actuator 118.

[0070] The actuating member 503 can circumferentially surround, and be attached to, the torsion coil 505. The torsion coil 505 can be attached to the actuating member 503 with the torsion coil 505 extending coaxially with the shaft 130 between a distal torsion end 511 and a proximal torsion end 513. In aspects, the actuating member 503 and the torsion coil 505 can be attached such that rotation of the actuating member 503 about the opening axis 128 can likewise cause the torsion coil 505 to rotate about the opening axis 128. The torsion coil 505 is received within the elongated opening 112 of the handle 110, such that the torsion coil 505 can move (e.g., rotate) relative to the handle 110. In aspects, the distal torsion end 511 of the torsion coil 505 can be adjacent to the distal shaft end 134 of the shaft 130, and the proximal torsion end 513 of the torsion coil 505 can be adjacent to the handle 110. The torsion coil 505 is substantially hollow and defines a cavity 517 extending between the distal torsion end 511 and the proximal torsion end 513. The cavity 517 is sized to receive the shaft 130 therein, such that the shaft 130 can move relative to the torsion coil 505

[0071] In aspects, the actuator 501 can comprise a threaded member 507 attached to the distal torsion end 511 of the torsion coil 505, with the threaded member 507 comprising the threaded inner radial surface 120. The threaded member 507 can be attached to the torsion coil 505 in an end-to-end manner such that rotation of the torsion coil 505 can likewise cause the threaded member 507 to rotate. In aspects, the threaded member 507 and the torsion coil 505 can comprise substantially the same circular cross-sectional shape and size. In this way, the threaded member 507 can receive the shaft 130 within a cavity of the threaded member 507. Accordingly, the shaft 130 can extend through the torsion coil 505 and the threaded member 507 between the proximal shaft end 132 and the distal shaft end 134. The threaded member 507 can extend substantially coaxially with the torsion coil 505.

[0072] The shaft 130 can comprise the plurality of shaft portions, for example, the first shaft portion 140 and the second shaft portion 142. The first shaft portion 140 and thesecond shaft portion 142 may be spaced apart to define the gap 144 between the first shaft portion 140 and the second shaft portion 142. The first shaft portion 140 and the second shaft portion 142 may be in contact with the threaded member 507, such that the gap 144 is surrounded by the threaded member 507. In this way, the threading engagement between the shaft 130, for example, the first shaft portion 140, and the threaded member 507 is located adjacent the distal torsion end 511. The torsion coil 505 and the threaded member 507 can comprise the first cross-sectional size 114, and the first shaft portion 140 can comprise the second cross-sectional size 136, wherein the second cross-sectional size 136 is less than the first cross-sectional size 114. As such, the shaft 130 comprises the threaded outer radial surface 138 that engages the threaded inner radial surface 120 of the threaded member 507. Accordingly, as illustrated in FIG. 5, methods of implanting the valve prosthesis 102 can comprise delivering the heart valve prosthesis 102 to the treatment site 201 (e.g., illustrated in FIG. 6), with the heart valve prosthesis 102 surrounded by the capsule 164 and removably attached to the spindle 150 that is attached to the shaft 130. During this delivery, the valve prosthesis 102 can be moved in the distal direction 178 through the patient’s vasculature and toward the treatment site 201.

[0073] FIG. 6 illustrates the valve prosthesis 102 upon reaching the treatment site 201 and after the delivery. In aspects, upon reaching the treatment site 201, methods can comprise retracting the capsule 164 in the proximal direction 203 that is opposite the distal direction 178, wherein the retraction can comprise moving the capsule 164 in the proximal direction 203 relative to the valve prosthesis 102, the spindle 150, and the shaft 130. After retracting the capsule 164, methods can comprise radially-expanding the first end 205 of the heart valve prosthesis 102 while an opposing second end 207 of the heart valve prosthesis 102 remains attached to the spindle 150.

[0074] FIG. 7 illustrates movement of the shaft 130 relative to the capsule 164 to reduce tension on the valve prosthesis 102 and improve the ability of the valve prosthesis 102 to detach from the spindle 150. For example, methods can comprise moving the shaft 130 relative to the capsule 164 axially in the distal direction 178 to reduce tension on the heart valve prosthesis 102 such that a distance separating the spindle 150 and the distal capsule end 170 of the capsule 164 decreases. For example, moving the shaft 130 relative to the capsule 164 can comprise rotating 311 the actuator 501, for example, the actuating member 503 that can cause the torsion coil 505 to rotate. Rotation of the actuating member503 likewise can induce rotation of the torsion coil 505, due to the attachment of the torsion coil 505 and the actuating member 503. Similarly, due to the attachment of the torsion coil 505 and the threaded member 507, rotation of the torsion coil 505 can cause the threaded member 507 to likewise rotate.

[0075] In aspects, due to the attachment of the actuating member 503, the torsion coil 505, and the threaded member 507, the actuating member 503, the torsion coil 505, and the threaded member 507 can rotate as a single, unitary structure. For example, the actuating member 503 can rotate about the opening axis 128. A central angle can represent the distance, measured in degrees, to which the actuating member 503 rotates about the opening axis 128, with the central angle having an apex at the opening axis 128. In this way, when the actuating member 503 rotates half a revolution about the opening axis 128, the central angle may be about 180 degrees. In aspects, the central angle of the actuating member 503, the torsion coil 505, and the threaded member 507 can be substantially the same. That is, when the actuating member 503 rotates about the opening axis 128, for example, 90 degrees, then the torsion coil 505 and the threaded member 507 may likewise rotate the same amount (e.g., 90 degrees).

[0076] Rotation 311 of the threaded member 507 can impart axial movement to the shaft 130 to move the shaft axially relative to the handle 110 and the capsule 164 in the distal direction 178 away from the handle 110 from the first shaft position to the second shaft position. For example, the first shaft position is illustrated in FIG. 6, wherein in the first shaft position, the first distance 301 separates the distal spindle end 154 from the distal capsule end 170. The second shaft position is illustrated in FIG. 7, wherein in the second shaft position, the second distance 303 separates the distal spindle end 154 from the distal capsule end 170. Due to the movement of the shaft 130 in the distal direction 178, the second distance 303 is less than the first distance 301. In this way, due to the rotation 311 of the threaded member 507, for example, rotation of the threaded inner radial surface 120, the actuator 501 (e.g., the actuating member 503, the torsion coil 505, and the threaded member 507) can cause the first shaft portion 140 to move linearly / axially away from the handle 110. Movement of the first shaft portion 140 can likewise cause the spindle 150 to move linearly / axially in the distal direction 178, and likewise cause the valve prosthesis 102 to move linearly / axially in the distal direction 178. Accordingly, as described above relative to FIG. 3, the movement of the spindle 150 and the valve prosthesis 102 from the first shaftposition to the second shaft position can reduce the tension between the valve prosthesis 102 and the spindle 150. As illustrated in FIG. 8, and substantially identical to the method illustrated in FIG. 4, methods can comprise radially-expanding the second end 207 of the heart valve prosthesis 102 by detaching the second end 207 from the spindle 150.

[0077] FIG. 9-11 illustrate additional embodiments of the implant apparatus 100, wherein the implant apparatus 100 of FIGS. 9-11 can comprise some features that are substantially identical to features of the implant apparatus 100 illustrated in FIGS. 1-8. For example, the implant apparatus 100 illustrated in FIGS. 9-11 can comprise the valve prosthesis 102, the shaft 130, the handle 110, the spindle 150, and the capsule 164. In aspects, the shaft 130 illustrated in FIGS. 9-11 may not comprise two separate portions (e.g., the first shaft portion 140 and the second shaft portion 142), but, rather, may comprise a single, unitary, one-piece shaft 130.

[0078] Referring to FIG. 9, in aspects, the shaft 130 can extend between the distal shaft end 134 and the proximal shaft end 132 through the elongated opening 112 of the handle 110 and may be attached at the proximal shaft end 132 to an actuator 901. The handle 110 may define the elongated opening 112 comprising the first cross-sectional size 114. In aspects, the elongated opening 112 may be surrounded by a substantially circular wall that is substantially smooth and void of a threaded surface. The shaft 130 may comprise the second cross-sectional size 136 that is less than the first cross-sectional size 114, such that the shaft 130 can move relative to the handle 110 and the capsule 164. In aspects, the actuator 901 can comprise a larger cross-sectional size than the shaft 130, such that a physician can hold or grip the actuator 901 and apply axial force to the shaft 130. The actuator 901 is spaced apart from the handle 110, with the actuator 901 and the shaft 130 configured to move relative to the handle 110. While FIG. 9 illustrates the first end 205 of the valve prosthesis 102 in the radially-expanded position, the valve prosthesis 102 may initially be in the radially-compressed position similar to the embodiments illustrates in FIG. 1 and 5. In this way, the valve prosthesis 102 can be moved in the distal direction 178 and delivered to the treatment site 201 while surrounded by the capsule 164. As illustrated in FIG. 9, upon reaching the treatment site 201 and after delivery, the capsule 164 can be retracted in the proximal direction 203, which can allow the first end 205 of the heart valve prosthesis 102 to radially-expand.

[0079] FIG. 10 illustrates movement of the shaft 130 relative to the capsule 164 to reduce tension on the valve prosthesis 102 and improve the ability of the valve prosthesis 102 to detach from the spindle 150. For example, methods can comprise moving the shaft 130 relative to the capsule 164 and the handle 110 in the distal direction 178 to reduce tension on the heart valve prosthesis 102 such that a distance separating the spindle 150 and the distal capsule end 170 of the capsule 164 decreases. For example, the shaft 130 may initially be in a first shaft position (e.g., illustrated in FIG. 9), in which the proximal shaft end 132 is spaced a first separating distance 1001 from the handle 110. The physician can grip the actuator 901 and apply a linear force to the actuator 901 and the shaft 130 in the distal direction 178 to move the actuator 901 and the proximal shaft end 132 closer to the handle 110. FIG. 10 illustrates the shaft 130 in a second shaft position, in which the proximal shaft end 132 is spaced a second separating distance 1003 from the handle 110. In aspects, the second separating distance 1003 is less than the first separating distance 1001. Accordingly, and as described above relative to FIGS. 3 and 7, the movement of the shaft 130, the spindle 150, and the valve prosthesis 102 from the first shaft position to the second shaft position can reduce the tension between the valve prosthesis 102 and the spindle 150. As illustrated in FIG. 11, and substantially identical to the method illustrated in FIGS. 4 and 8, methods can comprise radially-expanding the second end 207 of the heart valve prosthesis 102 by detaching the second end 207 from the spindle 150.

[0080] It should be understood that while various aspects have been described in detail relative to certain illustrative and specific examples thereof, the present disclosure should not be considered limited to such, as numerous modifications and combinations of the disclosed features are possible without departing from the scope of the following claims.

Claims

What is claimed is:

1. A transcatheter heart valve implant apparatus for delivering a heart valve prosthesis to a treatment site, the transcatheter heart valve implant apparatus comprising: a handle defining an elongated opening comprising a first cross-sectional size; a shaft received within the elongated opening and extending between a proximal shaft end and a distal shaft end, the shaft comprising a second cross-sectional size that is less than the first cross-sectional size such that the shaft is configured to move axially relative to the handle; a spindle attached to the distal shaft end of the shaft and extending between a proximal spindle end and a distal spindle end, the spindle configured to be removably attached to the heart valve prosthesis; and a capsule circumferentially surrounding the spindle and a portion of the heart valve prosthesis, the capsule terminating at a distal capsule end that defines a capsule opening through which the heart valve prosthesis extends, the shaft configured to move axially relative to the handle and the capsule in a distal direction away from the handle from a first shaft position, in which a first distance separates the distal spindle end and the distal capsule end, to a second shaft position, in which a second distance separates the distal spindle end and the distal capsule end, the second distance less than the first distance.

2. The implant apparatus of claim 1, wherein in the first shaft position, the proximal shaft end is spaced a first separating distance from the handle, and in the second shaft position, the proximal shaft end is spaced a second separating distance from the handle, the second separating distance less than the first separating distance.

3. The implant apparatus of claim 2, further comprising an actuator attached to the proximal shaft end and spaced apart from the handle.

4. The implant apparatus of claim 1, wherein the handle comprises an actuator with a threaded inner radial surface surrounding the elongated opening and comprising the first cross-sectional size.

5. The implant apparatus of claim 4, wherein the shaft comprises a threaded outer radial surface that engages the threaded inner radial surface.

6. The implant apparatus of claim 5, wherein the shaft comprises a first shaft portion and a second shaft portion spaced apart and defining a gap between the first shaft portion and the second shaft portion, the first shaft portion and the second shaft portion in contact with the actuator such that the gap is circumferentially surrounded by the actuator.

7. The implant apparatus of claim 4, wherein the actuator comprises an actuating member and a torsion coil attached to the actuating member, the torsion coil circumferentially surrounding and extending coaxially with the shaft between a distal torsion end and a proximal torsion end.

8. The implant apparatus of claim 7, wherein the actuator comprises a threaded member attached to the distal torsion end of the torsion coil, the threaded member comprising the threaded inner radial surface.

9. The implant apparatus of claim 8, wherein the shaft comprises a threaded outer radial surface that engages the threaded inner radial surface, the shaft comprising a first shaft portion and a second shaft portion spaced apart and defining a gap between the first shaft portion and the second shaft portion, the first shaft portion and the second shaft portion in contact with the threaded member such that the gap is circumferentially surrounded by the threaded member.

10. A transcatheter heart valve implant apparatus for delivering a heart valve prosthesis to a treatment site, the transcatheter heart valve implant apparatus comprising: a handle comprising an actuator with a threaded inner radial surface, the actuator defining an elongated opening comprising a first cross-sectional size; a shaft received within the elongated opening and extending between a proximal shaft end and a distal shaft end, the shaft comprising a second cross-sectional size that is less than the first cross-sectional size such that the shaft is configured to move axiallyrelative to the handle, the shaft comprising a threaded outer radial surface that engages the threaded inner radial surface of the actuator; a spindle attached to the distal shaft end of the shaft and extending between a proximal spindle end and a distal spindle end, the spindle configured to be removably attached to the heart valve prosthesis; and a capsule circumferentially surrounding the spindle and a portion of the heart valve prosthesis, the capsule terminating at a distal capsule end that defines a capsule opening through which the heart valve prosthesis extends, the actuator configured to rotate and impart axial movement to the shaft to move the shaft axially relative to the handle and the capsule in a distal direction away from the handle from a first shaft position, in which a first distance separates the distal spindle end and the distal capsule end, to a second shaft position, in which a second distance separates the distal spindle end and the distal capsule end, the second distance less than the first distance.

11. The implant apparatus of claim 10, wherein the shaft comprises a first shaft portion and a second shaft portion spaced apart and defining a gap between the first shaft portion and the second shaft portion, the first shaft portion and the second shaft portion in contact with the actuator such that the gap is circumferentially surrounded by the actuator.

12. The implant apparatus of claim 10, wherein the actuator comprises an actuating member and a torsion coil attached to the actuating member, the torsion coil circumferentially surrounding and extending coaxially with the shaft between a distal torsion end and a proximal torsion end.

13. The implant apparatus of claim 12, wherein the actuator comprises a threaded member attached to the distal torsion end of the torsion coil, the threaded member comprising the threaded inner radial surface.

14. The implant apparatus of claim 13, wherein the shaft comprises a first shaft portion and a second shaft portion spaced apart and defining a gap between the first shaft portion and the second shaft portion, the first shaft portion and the second shaft portion in contactwith the threaded member such that the gap is circumferentially surrounded by the threaded member.

15. The implant apparatus of claim 14, wherein the threaded member extends substantially coaxially with the torsion coil.

16. A method of implanting a heart valve prosthesis comprising: delivering the heart valve prosthesis to a treatment site, the heart valve prosthesis surrounded by a capsule and removably attached to a spindle that is attached to a shaft; retracting the capsule in a proximal direction; radially-expanding a first end of the heart valve prosthesis while an opposing second end of the heart valve prosthesis is attached to the spindle; moving the shaft relative to the capsule axially in a distal direction to reduce tension on the heart valve prosthesis such that a distance separating the spindle and a distal capsule end of the capsule decreases; and radially-expanding the second end of the heart valve prosthesis by detaching the second end from the spindle.

17. The method of claim 16, wherein moving the shaft relative to the capsule comprises rotating an actuator that is threadingly engaged with the shaft.

18. The method of claim 17, wherein the threading engagement between the shaft and the actuator is located within a handle.

19. The method of claim 17, wherein the actuator comprises an actuating member and a torsion coil attached to the actuating member, such that rotation of the actuating member causes the torsion coil to rotate.

20. The method of claim 19, wherein the actuator comprises a threaded member attached to the distal torsion end of the torsion coil, the threaded member comprising the threaded inner radial surface, further wherein the threading engagement between the shaft and the threaded member is located adjacent the distal torsion end.

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