Transcatheter delivery devices for delivering a stented prosthesis and methods

Abstract

Transcatheter delivery devices comprise a capsule comprising an inner circumferential surface circumscribing an interior area of the capsule and an elongated axis of the capsule. The stented prosthesis is configured to be mounted within the interior area. The inner circumferential surface is configured to provide resistance to relative circumferential movement between a collapsed portion of the stented prosthesis and the inner circumferential surface defining the interior area. Methods are also provided for positioning a stented prosthesis relative to the interior area of the capsule.

Description

TRANSCATHETER DELIVERY DEVICES FOR DELIVERING A STENTED PROSTHESIS AND METHODSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 625,885, filed January 26, 2024, the entire content of which is incorporated herein by reference.FIELD

[0002] The present disclosure relates generally to transcatheter delivery devices for delivering a stented prosthesis and methods and, more particularly, to transcatheter delivery devices and methods for successful loading and / or recapturing of stented prosthesis within the interior area of a capsule.BACKGROUND

[0003] It is known to provide a stented prosthesis for implanting at a target site of a patient. For example, it is known to provide a transcatheter delivery device for delivering and implanting a prosthetic heart valve at a target site within the vasculature of a patient. Prior to the surgical procedure, the stented prosthesis can be radially collapsed to be received within an interior area of a capsule of the transcatheter delivery device. Furthermore, when deploying the stented prosthesis at the target site, the surgeon may decide to recapture a partially radially expanded portion of the stented prosthesis to again radially contract the portion of the stented prosthesis within the interior area of the capsule of the transcatheter delivery device.

[0004] During loading or recapturing, a portion of the stented prosthesis being radially collapsed into the interior area of the capsule may form one or more undesired radial infolds. The infolds can provide defects in the final expanded shape of the stented prosthesis. Such defects can result in paravalvular leakage due to the mismatch between the native anatomy and the expanded shape of the stented prosthesis. There is a desire to provide improved transcatheter delivery devices and methods to facilitate loading and recapturing of stented prosthesis within the interior area of the capsule without forming infolds.Summary

[0005] The following presents a simplified summary of the disclosure to provide a basic understanding of some aspects described in the detailed description.

[0006] In aspects, transcatheter delivery device is provided for delivering a stented prosthesis comprising a capsule comprising an inner circumferential surface circumscribing an interior area of the capsule and an elongated axis of the capsule. The inner circumferential surface comprises a plurality of discontinuities extending in a direction of the elongated axis. The stented prosthesis is configured to be mounted within the interior area.

[0007] In further aspects, a transcatheter delivery device for delivering a stented prosthesis comprises a capsule comprising an inner circumferential surface circumscribing an interior area of the capsule and an elongated axis of the capsule. The inner circumferential surface comprises a circumferential coefficient of friction in a direction circumscribing the elongated axis that is greater than an axial coefficient of friction along a direction of the elongated axis. The stented prosthesis is configured to be mounted within the interior area.

[0008] In still further aspects, a transcatheter delivery device for delivering a stented prosthesis comprises a capsule comprising an inner circumferential surface circumscribing an elongated axis of the capsule. The inner circumferential surface comprises a polygonal cross-sectional profile along a cross-section taken perpendicular to the elongated axis. The inner circumferential surface defines an interior area of the capsule in a polygonal prism shape extending in a direction of the elongated axis. The stented prosthesis is configured to be mounted within the interior area.

[0009] In additional aspects, a method of positioning a stented prosthesis relative to an interior area of a capsule of a transcatheter delivery device is provided. The method comprises sliding a collapsed portion of the stented prosthesis within the interior area along a direction of an elongated axis of the capsule while providing a resistance to relative circumferential movement between the collapsed portion of the stented prosthesis and an inner circumferential surface defining the interior area without providing a substantial resistance to relative axial sliding movement between the collapsed portion of the stented prosthesis and the inner circumferential surface.

[0010] 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 skilledin 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

[0011] 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:

[0012] FIG. 1 schematically illustrates example aspects of a transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0013] FIG. 2 illustrates a top-down view of the transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0014] FIG. 3 illustrates a side view of a transcatheter delivery device for delivering the transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0015] FIG. 4 illustrates a side view of the transcatheter delivery device for delivering the transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0016] FIG. 5 illustrates a transcatheter delivery device with a collapsed portion of a stented prosthesis being slid into an interior area of a capsule in accordance with aspects of the disclosure;

[0017] FIG. 6 illustrates the transcatheter delivery device FIG 5, with the stented prosthesis being fully collapsed and received within the interior rea of the capsule;

[0018] FIG. 7 is a cross-section of an example a capsule along line 7-7 of FIG. 6, illustrating aspects of the disclosure;

[0019] FIG. 8 is a cross-section of the example of the capsule of FIG. 7 along line 8-8 of FIG. 6;

[0020] FIG. 9 is a cross-section of another example a capsule along line 7-7 of FIG.6, illustrating aspects of the disclosure;

[0021] FIG. 10 is an enlarged view of portions of the capsule of FIG. 9 taken at view 10 of FIG. 9;

[0022] FIG. 11 is a cross-section of the capsule of FIG. 9 taken along line 11-11 of FIG. 9;

[0023] FIG. 12 is a cross-section of another example a capsule along line 7-7 of FIG. 6, illustrating aspects of the disclosure;

[0024] FIG. 13 is an enlarged view of portions of the capsule of FIG. 12 taken at view 13 of FIG. 12;

[0025] FIG. 14 is a cross-section of the capsule of FIG. 12 taken along line 14-14 of FIG. 12;

[0026] FIG. 15 is a cross-section of another example a capsule along line 7-7 of FIG. 6, illustrating aspects of the disclosure;

[0027] FIG. 16 is a cross-section of the capsule of FIG. 15 taken along line 16-16 of FIG. 15; and

[0028] FIG. 17 schematically illustrates a side view of the transcatheter heart valve prosthesis positioned at a treatment site in accordance with aspects of the disclosure;Detailed Description

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] 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 nonexclusive list, such that elements in addition to those specifically recited in the list may also be present.

[0037] 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.

[0038] 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.

[0039] 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 U-D lactic copolymer, oligo caprylactone copolymer and poly cyclo-octine can be used separately or in conjunction with other shape memory polymers.

[0040] 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.

[0041] 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.

[0042] FIGS. 1-2 illustrate an example stented prosthesis 101 comprising the illustrated transcatheter heart valve prosthesis although other stented prosthesis may be provided in further embodiments. The transcatheter delivery devices described herein may be used with the stented prosthesis 101 and / or other stented prosthesis (e.g., other transcatheter heart valve prostheses). The stented prosthesis 101 is illustrated to facilitate description of the disclosure. The following description of the stented prosthesis 101 is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention.

[0043] FIGS. 1-2 illustrate a side view and a top / end view, respectively, of the stented prosthesis 101. The stented prosthesis 101 includes a radially-expandable frameor stent 103 and a prosthetic valve 105. The stent 103 of the stented prosthesis 101 supports the prosthetic valve 105 within an interior of the stent 103. In the example stented prosthesis 101 shown in FIGS. 1-2, the stent 103 is self-expandable. However, this is not meant to be limiting, and the stent 103 can be balloon-expandable or mechanically expandable in other embodiments. In some embodiments, the stented prosthesis 101 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.

[0044] The prosthetic valve 105 includes at least one leaflet 201 disposed within and secured to the stent 103. In the embodiment shown in FIGS. 1-2, the prosthetic valve 105 includes exactly three leaflets 201, as shown in FIG. 2. However, this is not meant to be limiting, as the prosthetic valve 105 may include more or fewer leaflets 201. The valve leaflets 201 open and close to regulate flow through the stented prosthesis 101.

[0045] As shown in FIG. 1, the stented prosthesis 101 includes an inflow end 107 and an outflow end 109. The prosthetic leaflets 201 are attached to the stent 103 at commissures 203 such that when pressure at the inflow end 107 exceeds pressure at the outflow end 109, the prosthetic leaflets 201 open to allow blood flow through the stented prosthesis 101 from the inflow end 107 to the outflow end 109. When the pressure at the outflow end 109 exceeds pressure at the inflow end 107, the prosthetic leaflets 201 close to prevent blood flow from the outflow end 109 to the inflow end 107. Accordingly, the at least one leaflet (e.g., the prosthetic leaflets 201) can be attached to the plurality of struts 111, for example, by being directly attached to the plurality of struts 111 at the commissures 203, or by being indirectly attached to the plurality of struts 111, 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 111. In aspects, the stented prosthesis 101 can comprise one or more attachment members 113 (e.g., paddles) positioned at an end, for example, the outflow end 109. The attachment members 113 can be received within pockets of a spindle 401 of the transcatheter delivery device 301 (e.g., illustrated in FIG. 4), such that the spindle 401 and the attachment members 113 can interact to facilitate loading of the stentedprosthesis 101 and, in aspects, allow for possible recapture of the stented prosthesis 101 during the deployment process.

[0046] The stent 103 of the stented prosthesis 101 further includes a plurality of struts 111 that are arranged to form a plurality of openings or cells 115 arranged circumferentially around a longitudinal axis “LA” of the stented prosthesis 101 and longitudinally to form a tubular structure defining a central lumen of the stented prosthesis 101. For example, the stent 103 can extend along the longitudinal axis “LA” between the inflow end 107 and the outflow end 109. The stent 103 is configured to secure the prosthetic valve 105 within the central lumen of the stent 103 and to secure the stented prosthesis 101 in place in the vasculature of the patient. The struts 111 are defined herein as the elongated wire segments of the stent 103. Struts 111 come together to form crowns 117 or nodes 119, as can be seen in FIG. 1. The stent 103 of the stented prosthesis 101 includes a plurality of cells 115 defined as the spaces between the plurality of crowns 117, the plurality of nodes 119, and the plurality of struts 111. The stent 103, and, thus, the plurality of struts 111, can be adjustable between a radially- collapsed position and a radially-expanded position.

[0047] In the example embodiment shown in FIG. 1, the plurality of cells 115 may be diamond-shaped. In the example embodiment shown, the plurality of cells include a plurality of first cells 115 and, in aspects, access cells (e.g., an access cell 121). In particular, the access cells may be larger than the first cells 115 and can provide access to one or more coronary arteries when the stented prosthesis 101 is implanted in the patient. FIG. 1 illustrates an example of an access cell 121, with the struts 111 at the access cell 121 illustrated with dashed lines to show that the struts 111 may not be present at the access cell 121, thus allowing for the access cell 121 to be larger than the first cells 115. The access cells can have an enlarged area relative or compared to the first cells 115. In some embodiments the stented prosthesis 101 may include an outer skirt extending circumferentially around an outer circumference of the stent 103 at or near the inflow end 107 to prevent paravalvular leakage of blood around the outside of the stented prosthesis 101 once implanted in the patient.

[0048] FIGS. 3 and 4 show schematic side views of a transcatheter delivery device 301 for delivering and deploying a transcatheter heart valve prosthesis (e.g., stented prosthesis 101) according to embodiments hereof. One skilled in the art will realize that FIGS. 3 and 4 illustrate one example of a transcatheter delivery device 301 and thatcomponents illustrated in FIGS. 3 and 4 may be removed and / or additional components may be added. The transcatheter delivery device 301 includes a distal end 303, a proximal end 305, and a handle 307. The handle 307 enables a physician to manipulate a distal portion of the transcatheter delivery device 301 and includes actuators for moving parts of the transcatheter delivery device 301 relative to other parts. In the transcatheter delivery device 301, an outer shaft 309 is coupled to an actuator 311 of the handle 307 for moving the outer shaft 309 relative to an inner shaft 403.

[0049] A distal portion of the outer shaft 309, referred to as a capsule 313, is configured to surround the stented prosthesis 101 during delivery to the treatment site (e.g., a native heart valve) and is retracted from the stented prosthesis 101 to expose the stented prosthesis 101 such that it self-expands (in self-expanding embodiments). In this way, the capsule 313 is in frictional engagement with the stented prosthesis 101 while the stented prosthesis 101 is mounted within the interior area 705 of the capsule 313. The inner shaft 403 can be coupled to the handle 307 (e.g., by being directly connected and in contact with the handle 307, or by being indirectly connected to the handle 307 with intermediate structures between the inner shaft 403 and the handle 307) and movement of the handle 307 can translate to movement of the inner shaft 403 and a distal tip or nosecone 315 coupled to a distal end of the inner shaft 403. The inner shaft 403 and distal tip or nosecone 315 may also be translated relative to the outer shaft 309 and the handle 307 via a tip retractor. In the embodiment shown, the inner shaft 403 includes a retainer or spindle 401 for receiving the paddles (e.g., attachment members 113) of the stented prosthesis 101.

[0050] When the actuator 311 is actuated, the actuator 311 moves the outer shaft 309 and the capsule 313 relative to the inner shaft 403, as shown in FIG. 4. As known to those skilled in the art, when the transcatheter delivery device 301 is in position such that the stented prosthesis 101 is at the desired position at the treatment site in the patient’s vasculature, the actuator 311 is actuated (e.g., rotated) to move the capsule 313 relative to the inner shaft 403 and the stented prosthesis 101 disposed between the inner shaft 403 and the capsule 313, thereby enabling the stented prosthesis 101 to deploy via self-expansion at the treatment site and release from the retainer 401, as shown in FIG. 4 (without showing the stented prosthesis 101).

[0051] As schematically shown in FIG. 5, before fully deploying the stented prosthesis 101, the surgeon may decide to recapture the partially deployed stentedprosthesis 101. Once recaptured, the stented prosthesis 101 may be moved to optimize the position of the stented prosthesis 101 before fully deploying and thereby permanently implanting the stented prosthesis 101. During recapture of the partially expanded portion of the stented prosthesis 101 or during initial collapsing and loading of the stented prosthesis 101 into the transcatheter delivery device 301 before beginning the surgical procedure, the transcatheter delivery device 301 and methods of loading the stented prosthesis may be designed to reduce or prevent infolding of the stented prosthesis.

[0052] As shown in FIG. 6, the stented prosthesis 101 is fully radially collapsed and positioned within the interior area of the capsule 313. As shown in the schematic cross-section of FIG. 7, collapsing the stent 103 can encourage portions of the stent to move in circumferential directions 701a, 701b relative to an inner circumferential surface 703 of the capsule 313 that circumscribes an interior area 705 of the capsule 313 and an elongated axis 707 of the capsule 313. In some embodiments, the inner circumferential surface 703 can be designed to resist movement of portions of the stent 103 relative to the inner circumferential surface 703 in the circumferential directions 701a, 701b that may otherwise develop an undesired infold 709. For example, in some embodiments, in the orientation shown in FIG. 7, an increased static contact friction 702a between the inner circumferential surface 703 of the capsule 313 and an outer surface of the stent 103 of the stented prosthesis 101 (e.g., in the illustrated counterclockwise direction about the elongated axis 707) can resist movement of the stent 103 relative to the inner circumferential surface 703 of the capsule 313 in the circumferential direction 701a. Likewise, in the orientation shown in FIG. 7, an increased static contact friction 702b between the inner circumferential surface 703 of the capsule 313 and the outer surface of the stent of the stented prosthesis 101 (e.g., in the illustrated clockwise direction about the elongated axis) can resist relative movement of the stent 103 relative to the inner circumferential surface 703 of the capsule 313 in the circumferential direction 701b. As relative movement between the stent 103 and the inner circumferential surface 703 is prevented, the infold 709 is likewise prevented from developing.

[0053] Resisting relative movement in the circumferential direction is desired while also allowing axial relative movement between the stented prosthesis 101 and the capsule 313 to facilitate loading of the collapsed stented prosthesis into the interior area705 of the capsule 313 and to facilitate deploying of the stented prosthesis from the interior area 705 of the capsule 313 at the treatment site. In some embodiments, the inner circumferential surface 703 comprises a circumferential coefficient of friction in a circumferential direction 801 (i.e., either clockwise or counterclockwise) circumscribing the elongated axis 707 that is greater than an axial coefficient of friction along an axial direction 803 of the elongated axis 707. As shown in FIGS. 8, 10, 12, and 14, the length of the arrow representing the circumferential direction 801 is substantially longer than the arrow representing axial direction 803. The longer length of the arrow of the circumferential direction 801 relative to the length of the arrow of the axial direction 803 schematically represents that the circumferential coefficient of friction is substantially greater than the axial coefficient of friction. In some embodiments, the circumferential coefficient of friction can be greater than the axial coefficient of friction by greater than 20%, such as greater than 50%, such as greater than 80%, such as greater than 100%, such as greater than 150%, such as greater than 200%, such as from about 20% to about 1,000%, such as from about 50% to about 500%, such as from about 50% to about 200%. In some embodiments, circumferential coefficient of friction is within a range from about 0.05 to about 1.0. In some embodiments, the axial coefficient of friction is within a range from less than or about 0.05 to about 0.3. Throughout the application, reference to “coefficient of friction” refers to the static coefficient of friction. As such, reference to the circumferential coefficient of friction refers to the circumferential static coefficient of friction about a direction circling the elongated axis 707. Likewise, reference to the axial coefficient of friction refers to the static coefficient of friction along a direction parallel to the elongated axis 707.

[0054] For purposes of this disclosure, the circumferential coefficient of friction and the axial coefficient of friction of the inner circumferential surface of the capsules of the various embodiments of the disclosure can be measured by mounting the capsule such that the elongated axis of the capsule extends perpendicular to the direction of gravity. An object is provided in the shape of a cube except the bottom surface comprises a circular cylindrical arc with a radius that matches the radius of the inner circumferential surface of the capsule. Furthermore, the cube is designed such that the arc extends 1 / 12 of the circumference of the inner circumferential surface of the capsule. An object with an arcuate surface having surface radius matching the radiusof the inner circumferential surface of the capsule is placed on the lower surface portion of the inner circumferential surface such that the center of gravity of the object is at the lowest possible position within the interior area of the capsule. For measuring the circumferential coefficient of friction, a circumferential force is then applied to the object in a circumferential direction about the elongated axis of the capsule. The circumferential force at which the object begins to move circumferentially is then divided by the weight of the object to obtain the circumferential coefficient of friction. For measuring the axial coefficient of friction, an axial force is applied to the object in a direction of the elongated axis of the capsule. The axial force at which the object begins to move axially is then divided by the weight of the object to obtain the axial coefficient of friction.

[0055] In some embodiments, the increased circumferential coefficient of friction relative to the axial coefficient of friction can be provided by designing the capsule with a higher surface roughness (Ra) in the circumferential direction than in the axial direction. For example, in some embodiments, the inner circumferential surface 703 can comprise a circumferential surface roughness (Ra) in the circumferential direction 801 (i.e., either clockwise or counterclockwise) circumscribing the elongated axis 707 that is greater than an axial surface roughness (Ra) along the axial direction 803 of the elongated axis 707. As shown in FIG. 8, the length of the arrow representing the circumferential direction 801 is substantially longer than the arrow representing axial direction 803. The longer length of the arrow of the circumferential direction 801 relative to the length of the arrow of the axial direction 803 schematically represents that the circumferential surface roughness (Ra) is substantially greater than the axial surface roughness (Ra). In some embodiments, the circumferential surface roughness (Ra) can be greater than the axial surface roughness (Ra) by greater than 20%, such as greater than 50%, such as greater than 80%, such as greater than 100%, such as greater than 150%, such as greater than 200%, such as from about 20% to about 1,000%, such as from about 50% to about 500%, such as from about 50% to about 200%. In some embodiments, circumferential surface roughness is within a range from about 0.1 microns (Ra) to about 40 microns (Ra). In some embodiments, the axial surface roughness can be within a range from less than or about 0.1 microns (Ra) to about 4 microns (Ra). Throughout the application, surface roughness (Ra) can be determined by optical 3D scanning measurement systems that provide contactless surfacetopography measurement of the interior surface of tubes wherein the profile can be analyzed to view the cross-sections perpendicular to the central axis of the elongated axis to determine the circumferential surface roughness (Ra) and, alternatively, wherein the profile can be analyzed to view the cross-sections in the direction of the elongated axis to determine the axial surface roughness (Ra).

[0056] FIGS. 9-13 disclose embodiments of capsules 913, 1213 of the transcatheter delivery device 301 for delivering the stented prosthesis 101. Each capsule 913, 1213 comprises an inner circumferential surface 903, 1203 circumscribing an interior area 905, 1205 of the capsule 913, 1213 and the elongated axis 707 of each capsule 913, 1213. In some embodiments of the disclosure, the inner circumferential surface comprises a cylindrical surface. For example, as shown in FIGS. 7-14, the inner circumferential surface 703, 903, 1203 of the capsules 313, 913, 1213 comprise a circular cylindrical surface where the inner circumferential surface comprises one or more inner concave surface portions approximating a circular profile along a crosssection taken perpendicular to the elongated axis 707 of the capsules 313, 913, 1213. The approximated circular profile comprises a diameter that approximates the overall inner diameter of the capsule. For example, as shown in FIG. 7, the inner circumferential surface 703 comprises an inner surface portion comprising a continuous circular profile along a cross-section taken perpendicular to the elongated axis 707. In further embodiments, the inner circumferential surface comprises a plurality of inner concave surface portions that are each positioned between a pair of discontinuities of a plurality of discontinuities (e.g., elongated grooves 901 or elongated protrusions 1201). For example, as shown in FIG. 9, the inner circumferential surface 903 comprises a plurality of inner concave surface portions 904 that are each positioned between a pair of elongated grooves 901. The plurality of inner concave surface portions 904 approximate a circular profile along a cross-section taken perpendicular to the elongated axis 707 of the capsule 913 wherein the diameter of the circular profile approximates the overall inner diameter of the capsule 913. In another example, as shown in FIG. 12, the inner circumferential surface 1203 comprises a plurality of inner concave surface portions 1204 that are each positioned between a pair of elongated protrusions 1201. The plurality of inner concave surface portions 1204 approximate a circular profile along a cross-section taken perpendicular to the elongated axis 707 ofthe capsule 1213 wherein the diameter of the circular profile approximates the overall inner diameter of the capsule 1213.

[0057] As mentioned previously, the inner circumferential surface 903, 1203 of embodiments of the capsules 913, 1213 can comprise a plurality of discontinuities 901, 1201 that each extend in the direction 708 of the elongated axis 707 wherein the direction 708 can comprise the direction of the axis of symmetry of the interior area of the capsule. As shown in FIGS. 9-10, each discontinuity of the plurality of discontinuities can comprise the elongated groove 901 extending from the inner circumferential surface 903. As shown in FIG. 10, the elongated groove 901 can include a semicircular or arcuate channel although a rectangular, triangular or other shaped channel can be provided in further embodiments. Furthermore, the elongated groove 901 can have a wide range of depths 1001 and widths 1003. In some embodiments, the depth 1001 can be substantially the same as the width 1003 although the depth 1001 and width 1003 may be different in further embodiments. Still further, the depth 1001 and / or width 1003 can be less than about 30%, such as less than about 20%, such as less than about 15%, such as less than about 10% such as less than about 5% of the thickness 1005 ofthe capsule 913. For example, the depth 1001 and / orwidth 1003 can be from about 1% to about 30%, such as from about 1% to about 25%, such as from about 1% to about 20%, such as from about 1% to about 15%, such as from about 1% to about 10%, such as from about 1% to about 5% of the thickness 1005 of the capsule 913.

[0058] As further shown in FIGS. 12-13, each discontinuity of the plurality of discontinuities can comprise the elongated protrusion 1201 extending from the inner circumferential surface 1203. As shown in FIG. 12, the elongated protrusion 1201 can include a semicircular or arcuate protrusion although a rectangular, triangular or other shaped protrusion can be provided in further embodiments. Furthermore, the elongated protrusion 1201 can have a wide range of heights 1301 and widths 1303. In some embodiments, the height 1301 can be substantially the same as the width 1303 although the height 1301 and width 1303 may be different in further embodiments. Still further, the height 1301 and / or width 1303 can be less than about 30%, such as less than about 20%, such as less than about 15%, such as less than about 10% such as less than about 5% of the thickness 1005 of the capsule 1213. For example, the height 1301 and / or width 1303 can be from about 1% to about 30%, such as from about 1% to about 25%,such as from about 1% to about 20%, such as from about 1% to about 15%, such as from about 1% to about 10%, such as from about 1% to about 5% of the thickness 1005 of the capsule 1213.

[0059] As shown in FIGS. 9 and 12, each discontinuity of the plurality of discontinuities 901, 1201 is spaced a distance 907, 1207 from each adjacent discontinuity of a pair of adjacent discontinuities. For example, as shown each discontinuity is spaced a circumferential distance 907, 1207 from each adjacent discontinuity that is substantially equal such that the plurality of discontinuities 901, 1201 comprise a circular array of discontinuities equally spaced about to the elongated axis 707 of the capsule 913, 1213. Although nonequal spacing may be provided in some embodiments, equal spacing can provide for consistent torque resistance to relative rotational movement between the stented prosthesis 101 and the interior surface of the capsule to avoid formation of the infolds.

[0060] As shown in FIGS. 11 and 14, each discontinuity 901, 1201 can be substantially parallel to one another and can be substantially parallel to the elongated axis 707. As shown, in some embodiments, the elongated axis can comprise the symmetrical axis of the interior area 905, 1205 of the capsule 913, 1213. Although nonparallel orientations of the discontinuities can be provided in some embodiments, parallel orientations can be beneficial in some embodiments to help avoid rotation of the stented prosthesis 101 as the prosthesis is moved in the direction 708 of the elongated axis 707 from the proximal portion 1101a, 1201a of the capsule 913, 1213 to the distal portion 1101b, 1201b of the capsule 913, 1213. To facilitate movement of the stented prosthesis 101 within the capsule and the discourage formation of infolds, the inner circumferential surface 903, 1203 and each discontinuity of the plurality of discontinuities 901, 1201 can extend from the proximal portion 1101a, 1201a to the distal portion 1101b, 1201b of the capsule 913, 1213. Furthermore, as shown, each discontinuity of the plurality of discontinuities 901, 1201 extends to a distal end 1103b, 1203b ofthe distal portion 1101b, 1201b ofthe capsule 913,1213. As further illustrated in FIGS. 11 and 14, each discontinuity of the plurality of discontinuities 901, 1201 extends along a continuous path in the direction 708 of the elongated axis 707 from the proximal portion 1101a, 1201a of the capsule 913, 1213 to the distal portion 1101b, 1201b of the capsule 913, 1213. Although a discontinuous path (e.g., by a series of bumps, aligned channels) may be provided, a continuous path can provide reducedresistance to removal and / or insertion of the stented prosthesis 101 from / into the capsule.

[0061] FIGS. 15-16 discloses embodiments of another capsule 1513 of the transcatheter delivery device 301 for delivering the stented prosthesis 101. The capsule 1513 comprises an inner circumferential surface 1503 circumscribing the elongated axis 707 of the capsule 1513. As shown, the inner circumferential surface 1503 can comprise a polygonal cross-sectional profde along a cross-section taken perpendicular to the elongated axis 707. As shown, the elongated axis 707 can comprise an axis if symmetry of the capsule 1513. The inner circumferential surface 1503 defines an interior area 1505 of the capsule 1513 in a polygonal prism shape extending in the direction 708 of the elongated axis 707. The polygonal cross-sectional profile can extend from a proximal portion 1601a of the capsule 1513 to a distal end 1603b of a distal portion 1601b of the capsule 1513. The constant cross-sectional polygonal profile in the direction 708 of the elongated axis 707 can allow relatively low resistance to loading and unloading the stented prosthesis 101 into the interior area 1505 while resisting rotational movement between the stented prosthesis 101 and the interior circumferential surface 1503 of the capsule 1513. As discussed previously, the resistance in relative rotational movement between the interior circumferential surface 1503 and the capsule 1513 can inhibit, such as prevent, formation of infolds within the stented prosthesis 101 during initial loading or recapture of the stented prosthesis 101.

[0062] As shown in FIG. 15, the polygonal cross-sectional profile can comprise 10 sides of equal length although more or less sides can be provided in further embodiments, In some embodiments, the polygonal cross-sectional provide may be provided with 5 to 30 sides, such as from 10 to 30 sides although more than 30 sides may be provided in further embodiments. Providing an increased number of sides can more closely approximate a circular profile to maximize the area available to receive the stented prosthesis 101. While the number of sides can be limited to the extent that sufficient rotational resistance is provided to prevent infolding.

[0063] Although not shown, in some embodiments, the capsules of the disclosure may comprise a distal end portion wherein the interior area flares outwardly in the distal direction to provide a enlarged opening into the interior area at a distal end of the capsule that has a larger diameter than a diameter of portions of the interior area positioned proximal to the distal end portion. The outwardly flared interior area of thedistal end portion of the capsule can help with loading and recapture of the stented prosthesis. As shown and described above, features of the various capsules (e.g., plurality of discontinuities 901, 1201, the polygonal cross-sectional profile, surface roughness profile, coefficient of friction profile) can extend the entire length of the interior area of the capsule. Although not shown, in some embodiments, the features may only extend over a distal segment of a portion proximal to the outwardly flared portion, or a substantial length (e.g., the entire length) of the portion of the capsule proximal to the outwardly flared portion.

[0064] A methods of positioning the stented prosthesis 101 relative to an interior area of the capsule 313, 913, 1213, 1513 of a transcatheter delivery device 301 will now be discussed with initial reference to FIG. 5. As shown in FIG. 5, during initial loading of the stented prosthesis 101 into the capsule or during recapture of the stented prosthesis 101 during a surgical procedure, a collapsed proximal portion of the stented prosthesis 101 is being slid within the interior area of the capsule 313, 913, 1213, 1513 along a direction 501 of the elongated axis 707. While sliding the collapsed portion of the stented prosthesis 101, a resistance to relative circumferential movement between the collapsed portion of the stented prosthesis 101 and the inner circumferential surface 703, 903, 1203, 1503 is provided without providing a substantial resistance to relative axial sliding movement between the collapsed portion of the stented prosthesis 101 and the inner circumferential surface 703, 903, 1203, 1503. In some embodiments, greater resistance to relative circumferential movement compared to a resistance to axial sliding movement is provided by the circumferential surface roughness of the inner circumferential surface in the direction 801 circumscribing the elongated axis 707 being greater than the axial surface roughness of the inner circumferential surface along the axial direction 803 of the elongated axis 707. In some embodiments, greater resistance to relative circumferential movement compared to a resistance to axial sliding movement is provided by a plurality of discontinuities 901, 1201 extending in the direction 708 of the elongated axis 707. For example, each discontinuity of the plurality of discontinuities can comprise elongated groove 901 extending within the inner circumferential surface 903. In another example, each discontinuity of the plurality of discontinuities can comprise an elongated protrusion 1201 extending from the inner circumferential surface 1203. In some embodiments, greater resistance to relative circumferential movement compared to a resistance to axial sliding movement isprovided by inner circumferential surface 1503 comprising the polygonal cross- sectional profde along a cross-section taken perpendicular to the elongated axis. In such embodiments, sliding the collapsed portion of the stented prosthesis 101 within the interior area 1505 comprises sliding the collapsed portion of the stented prosthesis 101 within a polygonal prism shaped interior area 1505 of the capsule 1513.

[0065] FIG. 17 illustrates the stented prosthesis 101 at a treatment site 1701 within a patient’s vasculature. In aspects, the treatment site 1701 can comprise a location of a native aortic annulus (hereinafter “annulus”) 1703 of a native heart valve, for example, the annulus of a patient’s left ventricle. The treatment site 1701 can comprise one or more native valve leaflets 1705 and corresponding native sinuses 1707. In some instances, paravalvular leakage can occur when blood travels through a gap 1709 around the outside of the stented prosthesis 101, with the gap 1709 formed between the stented prosthesis 101 and the annulus 1703. To avoid paravalvular leakage, the stented prosthesis 101 can be radially expanded such that an outer radial surface of the stented prosthesis 101 can contact the annulus 1703 and / or the native valve leaflets 1705, thus reducing or eliminating the gap 1709 and causing the blood to flow through the central lumen 205 of the stented prosthesis 101. The stent 103 of the stented prosthesis 101 can comprise an asymmetric hourglass shape with a first section 1713 at the inflow end 107, a second section 1715 at the outflow end 109, and a waist section 1717 positioned between the first section 1713 and the second section 1715. In aspects, the first section 1713 can comprise a first diameter 1721 and the second section 1715 can comprise a second diameter 1723, with the second diameter 1723 greater than the first diameter 1721. Additionally, in some embodiments the stented prosthesis 101 may include an outer skirt extending circumferentially around an outer circumference of the stent 103 at or near the inflow end 107 to prevent paravalvular leakage of blood around the outside of the stented prosthesis 101 once implanted in the patient. Thus, features of the disclosure may be employed alone or in combination with a stented prosthesis 101 having an outer skirt or other external sealing member (not shown) or a stented prosthesis 101 having no outer skirt.

[0066] As will be appreciated by the discussion above, the shape of the stented prosthesis 101 closely fits the anatomy of the treatment site 1701 wherein any deformity in shape that may be caused by infolding can be avoided by features of the disclosure,thereby enhancing the sealing between the stented prosthesis 101 and the native anatomy to prevent paravalvular leakage of blood that may otherwise occur.

[0067] In accordance with the disclosure, non-limiting aspects of the disclosure will now be described. Various combinations of the aspects can be provided in accordance with the disclosure.

[0068] Aspect 1. A transcatheter delivery device for delivering a stented prosthesis.The transcatheter delivery device comprises a capsule comprising an inner circumferential surface circumscribing an interior area of the capsule and an elongated axis of the capsule. The inner circumferential surface comprises a plurality of discontinuities extending in a direction of the elongated axis. The stented prosthesis is configured to be mounted within the interior area.

[0069] Aspect 2. The transcatheter delivery device of Aspect 1, wherein the inner circumferential surface comprises a cylindrical surface.

[0070] Aspect 3. The transcatheter delivery device of Aspect 2, wherein the cylindrical surface comprises a circular cylindrical surface.

[0071] Aspect 4. The transcatheter delivery device of any one of Aspects 1-3, wherein each discontinuity of the plurality of discontinuities comprises an elongated protrusion extending from the inner circumferential surface.

[0072] Aspect 5. The transcatheter delivery device of any one of Aspects 1-3, wherein each discontinuity of the plurality of discontinuities comprises an elongated groove extending within the inner circumferential surface.

[0073] Aspect 6. The transcatheter delivery device of any one of Aspects 1-5, wherein each discontinuity of the plurality of discontinuities is spaced a distance from each adjacent discontinuity of a pair of adjacent discontinuities.

[0074] Aspect 7. The transcatheter delivery device of Aspect 6, wherein the distance between each discontinuity and each corresponding adjacent discontinuity is substantially equal.

[0075] Aspect 8. The transcatheter delivery device of any one of Aspects 1-7, wherein each discontinuity of the plurality of discontinuities are substantially parallel to the elongated axis.

[0076] Aspect 9. The transcatheter delivery device of any one of Aspects 1-8, wherein the inner circumferential surface extends from a proximal portion of the capsule to a distal portion of the capsule. Each discontinuity of the plurality ofdiscontinuities extends from the proximal portion of the capsule to the distal portion of the capsule.

[0077] Aspect 10. The transcatheter delivery device of Aspect 9, wherein each discontinuity of the plurality of discontinuities extends along a continuous path in the direction of the elongated axis from the proximal portion of the capsule to the distal portion of the capsule.

[0078] Aspect 11. The transcatheter delivery device of any one of Aspects 9-10, wherein each discontinuity of the plurality of discontinuities extends to a distal end of the distal portion of the capsule.

[0079] Aspect 12. A transcatheter delivery device for delivering a stented prosthesis. The transcatheter delivery device comprises a capsule comprising an inner circumferential surface circumscribing an interior area of the capsule and an elongated axis of the capsule. The inner circumferential surface comprises a circumferential coefficient of friction in a direction circumscribing the elongated axis that is greater than an axial coefficient of friction along a direction of the elongated axis. The stented prosthesis is configured to be mounted within the interior area.

[0080] Aspect 13. The transcatheter delivery device of Aspect 12, wherein the inner circumferential surface comprises a cylindrical surface.

[0081] Aspect 14. The transcatheter delivery device of Aspect 13, wherein the cylindrical surface comprises a circular cylindrical surface.

[0082] Aspect 15. The transcatheter delivery device of any one of Aspects 12-14, wherein the circumferential coefficient of friction is within a range from about 0.05 to about 1.0.

[0083] Aspect 16. The transcatheter delivery device of any one of Aspects 12-15, wherein the axial coefficient of friction is within a range from less than or about 0.05 to about 0.3.

[0084] Aspect 17. The transcatheter delivery device of any one of Aspects 12-14, wherein the circumferential surface roughness is within a range from about 0.1 microns to about 40 microns.

[0085] Aspect 18. The transcatheter delivery device of any one of Aspects 12-14 and 17, wherein the axial surface roughness is within a range from less than or about 0. 1 microns to about 4 microns.

[0086] Aspect 19. The transcatheter delivery device of any one of Aspects 12-18, wherein the inner circumferential surface comprises a plurality of discontinuities extending in a direction of the elongated axis.

[0087] Aspect 20. The transcatheter delivery device of Aspect 19, wherein each discontinuity of the plurality of discontinuities comprises an elongated protrusion extending from the inner circumferential surface.

[0088] Aspect 21. The transcatheter delivery device of Aspect 19, wherein each discontinuity of the plurality of discontinuities comprises an elongated groove extending within the inner circumferential surface.

[0089] Aspect 22. The transcatheter delivery device of any one of Aspects 19-21, wherein each discontinuity of the plurality of discontinuities is spaced a distance from each adjacent discontinuity of a pair of adjacent discontinuities.

[0090] Aspect 23. The transcatheter delivery device of Aspect 22, wherein the distance between each discontinuity and each corresponding adjacent discontinuity is substantially equal.

[0091] Aspect 24. The transcatheter delivery device of any one of Aspects 19-23, wherein each discontinuity of the plurality of discontinuities are substantially parallel to the elongated axis.

[0092] Aspect 25. The transcatheter delivery device of any one of Aspects 19-24, wherein the inner circumferential surface extends from a proximal portion of the capsule to a distal portion of the capsule. Each discontinuity of the plurality of discontinuities extends from the proximal portion of the capsule to the distal portion of the capsule.

[0093] Aspect 26. The transcatheter delivery device of Aspect 25, wherein each discontinuity of the plurality of discontinuities extends along a continuous path in the direction of the elongated axis from the proximal portion of the capsule to the distal portion of the capsule.

[0094] Aspect 27. The transcatheter delivery device of any one of Aspects 25-26, wherein each discontinuity of the plurality of discontinuities extends to a distal end of the distal portion of the capsule.

[0095] Aspect 28. A transcatheter delivery device for delivering a stented prosthesis. The transcatheter delivery device comprises a capsule comprising an inner circumferential surface circumscribing an elongated axis of the capsule. The innercircumferential surface comprises a polygonal cross-sectional profile along a crosssection taken perpendicular to the elongated axis. The inner circumferential surface defines an interior area of the capsule in a polygonal prism shape extending in a direction of the elongated axis. The stented prosthesis is configured to be mounted within the interior area.

[0096] Aspect 29. The transcatheter delivery device of Aspect 28, wherein the polygonal cross-sectional profile comprises from 5 to 30 sides.

[0097] Aspect 30. The transcatheter delivery device of Aspect 29, wherein the polygonal cross-sectional profile comprises from 10 to 30 sides.

[0098] Aspect 31. A method of positioning a stented prosthesis relative to an interior area of a capsule of a transcatheter delivery device. The method comprises sliding a collapsed portion of the stented prosthesis within the interior area along a direction of an elongated axis of the capsule while providing a resistance to relative circumferential movement between the collapsed portion of the stented prosthesis and an inner circumferential surface defining the interior area without providing a substantial resistance to relative axial sliding movement between the collapsed portion of the stented prosthesis and the inner circumferential surface.

[0099] Aspect 32. The method of Aspect 31, wherein the inner circumferential surface comprises a cylindrical surface.

[0100] Aspect 33. The method of Aspect 32, wherein the cylindrical surface comprises a circular cylindrical surface.

[0101] Aspect 34. The method of any one of Aspects 31-33, wherein a circumferential surface roughness of the inner circumferential surface in a direction circumscribing the elongated axis that is greater than an axial surface roughness of the inner circumferential surface along the direction of the elongated axis.

[0102] Aspect 35. The method of any one of Aspects 31-34, wherein the inner circumferential surface comprises a plurality of discontinuities extending in the direction of the elongated axis.

[0103] Aspect 36. The method of Aspect 35, wherein each discontinuity of the plurality of discontinuities comprises an elongated protrusion extending from the inner circumferential surface.

[0104] Aspect 37. The method of Aspect 35, wherein each discontinuity of the plurality of discontinuities comprises an elongated groove extending within the inner circumferential surface.

[0105] Aspect 38. The method of any one of Aspects 35-37, wherein each discontinuity of the plurality of discontinuities is spaced a distance from each adjacent discontinuity of a pair of adjacent discontinuities.

[0106] Aspect 39. The method of Aspect 38, wherein the distance between each discontinuity and each corresponding adjacent discontinuity is substantially equal.

[0107] Aspect 40. The method of any one of Aspects 35-39, wherein each discontinuity of the plurality of discontinuities are substantially parallel to the elongated axis.

[0108] Aspect 41. The method of any one of Aspects 35-40, wherein the inner circumferential surface extends from a proximal portion of the capsule to a distal portion of the capsule. Each discontinuity of the plurality of discontinuities extends from the proximal portion of the capsule to the distal portion of the capsule.

[0109] Aspect 42. The method of Aspect 41, wherein each discontinuity of the plurality of discontinuities extends along a continuous path in the direction of the elongated axis from the proximal portion of the capsule to the distal portion of the capsule.

[0110] Aspect 43. The method of any one of Aspects 41-42, wherein each discontinuity of the plurality of discontinuities extends to a distal end of the distal portion of the capsule.

[0111] Aspect 44. The method of Aspect 31, wherein the inner circumferential surface comprises a polygonal cross-sectional profde along a cross-section taken perpendicular to the elongated axis.

[0112] Aspect 45. The method of Aspect 44, wherein the sliding the collapsed portion of the stented prosthesis within the interior area comprises sliding the collapsed portion of the stented prosthesis within a polygonal prism shaped interior area of the capsule.

[0113] Aspect 46. The transcatheter delivery device of any one of Aspects 44-45, wherein the polygonal cross-sectional profde comprises from 5 to 30 sides.

[0114] Aspect 47. The transcatheter delivery device of Aspect 46, wherein the polygonal cross-sectional profde comprises from 10 to 30 sides.

Claims

What is claimed is:

1. A transcatheter delivery device (301) for delivering a stented prosthesis (101) comprising: a capsule (913), (1213) comprising an inner circumferential surface (903), (1203) circumscribing an interior area (905), (1205) of the capsule (913), (1213) and an elongated axis (707) of the capsule (913), (1213), the inner circumferential surface (903), (1203) comprising a plurality of discontinuities (901), (1201) extending in a direction (708) of the elongated axis (707), wherein the stented prosthesis (101) is configured to be mounted within the interior area (905), (1205).

2. The transcatheter delivery device (301) of claim 1, wherein each discontinuity (901), (1201) of the plurality of discontinuities (901), (1201) comprises an elongated protrusion (1201) extending from the inner circumferential surface (1203).

3. The transcatheter delivery device (301) of any one of claims 1-2, wherein each discontinuity (901), (1201) of the plurality of discontinuities (901), (1201) comprises an elongated groove (901) extending within the inner circumferential surface (903).

4. The transcatheter delivery device (301) of any one of claims 1-3, wherein each discontinuity (901), (1201) of the plurality of discontinuities (901), (1201) is spaced a distance from each adjacent discontinuity (901), (1201) of a pair of adjacent discontinuities (901), (1201).

5. The transcatheter delivery device (301) of claim 4, wherein the distance (907), (1207) between each discontinuity (901), (1201) and each corresponding adjacent discontinuity (901), (1201) is substantially equal.

6. The transcatheter delivery device (301) of any one of claims 1-5, wherein each discontinuity (901), (1201) of the plurality of discontinuities (901), (1201) are substantially parallel to the elongated axis (707).

7. A transcatheter delivery device (301) for delivering a stented prosthesis (101) comprising: a capsule (1513) comprising an inner circumferential surface (1503) circumscribing an elongated axis (707) of the capsule (1513), the inner circumferential surface (1503) comprising a polygonal cross-sectional profde along a cross-section taken perpendicular to the elongated axis (707), wherein the inner circumferential surface (1503) defines an interior area (1505) of the capsule (1513) in a polygonal prism shape extending in a direction (708) of the elongated axis (707), wherein the stented prosthesis (101) is configured to be mounted within the interior area (1505).

8. The transcatheter delivery device (301) of claim 7, wherein the polygonal cross-sectional profile comprises from 5 to 30 sides.

9. A method of positioning a stented prosthesis (101) relative to an interior area (705), (905), (1205), (1505) of a capsule (313), (913), (1213), (1513) of a transcatheter delivery device (301) comprising: sliding a collapsed portion of the stented prosthesis (101) within the interior area (705), (905), (1205), (1505) along a direction of an elongated axis (707) of the capsule (313), (913), (1213), (1513) while providing a resistance to relative circumferential movement between the collapsed portion of the stented prosthesis (101) and an inner circumferential surface (703), (903), (1203), (1503) defining the interior area (705), (905), (1205), (1505) without providing a substantial resistance to relative axial sliding movement between the collapsed portion of the stented prosthesis (101) and the inner circumferential surface (703), (903), (1203), (1503).

10. The method of claim 9, wherein a circumferential surface roughness of the inner circumferential surface (703), (903), (1203), (1503) in a direction (801) circumscribing the elongated axis (707) that is greater than an axial surface roughness of the inner circumferential surface (703), (903), (1203), (1503) along the direction (803) of the elongated axis (707).

11. The method of any one of claims 9-10, wherein the inner circumferential surface (703), (903), (1203), (1503) comprises a plurality of discontinuities (901), (1201) extending in the direction of the elongated axis (707).

12. The method of claim 11, wherein each discontinuity (901), (1201) of the plurality of discontinuities (901), (1201) comprises an elongated protrusion (1201) extending from the inner circumferential surface (1203).

13. The method of claim 12, wherein each discontinuity (901), (1201) of the plurality of discontinuities (901), (1201) comprises an elongated groove (901) extending within the inner circumferential surface (903).

14. The method of claim 9, wherein the inner circumferential surface (1503) comprises a polygonal cross-sectional profde along a cross-section taken perpendicular to the elongated axis (707).

15. The method of claim 14, wherein the polygonal cross-sectional profde comprises from 5 to 30 sides.

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