Mandrel for prosthetic heart valve implant device

Abstract

A mandrel shapes a frame of a heart valve prosthesis. The mandrel includes a body portion extending along a mandrel longitudinal axis between a first end and a second end with a central region extending between the first end and the second end. The outer radial surface is spaced apart from the mandrel longitudinal axis at a first circumferential location by a first radial distance and at a second circumferential location by a second radial distance. The first radial distance is different from the second radial distance. The mandrel is received within the interior lumen of the frame. The mandrel includes a cap that circumferentially surrounds the second end of the body portion such that the frame is positioned radially between the body portion and the cap. A method for conferring a shape to an annular frame is provided.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 462,614, filed April 28, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates generally to a transcatheter heart valve implantation device, and more specifically to a spindle for shaping the transcatheter heart valve implantation device. Background Technology

[0004] A heart valve implantation device is known for implanting a heart valve prosthesis into a target site within a patient's vascular system. The heart valve prosthesis is movable from radially collapsed positioning to radially expanded positioning. The shape of the heart valve prosthesis affects valve performance and valve leaflet durability. Giving the heart valve prosthesis a desired shape improves valve performance and increases valve leaflet durability, thereby leading to improved lifespan management. Summary of the Invention

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

[0006] In various aspects, a heart axis is provided for shaping a frame for a heart valve prosthesis. The heart axis includes a body portion extending along a longitudinal axis between a first end and a second end, wherein a central region extends between the first end and the second end. An outer radial surface of the central region is spaced from the longitudinal axis of the heart axis by a first radial distance at a first circumferential location, and spaced from the longitudinal axis of the heart axis by a second radial distance at a second circumferential location spaced from the first circumferential location. The first radial distance differs from the second radial distance. The heart axis is configured to be received within an internal lumen of the frame. A cap-like element is positioned circumferentially around the second end of the body portion such that the frame is configured to be radially positioned between the body portion and the cap-like element.

[0007] In all respects, the central region is spaced apart from the first end by a first distance and from the second end by a second distance.

[0008] In all respects, the first radial distance is greater than the second radial distance.

[0009] In aspects, the body portion comprises, at the first axial location along the mandrel longitudinal axis: a first mandrel extension portion, the first mandrel extension portion being at a first circumferential location, the first mandrel extension portion having the first radial distance. A first mandrel intermediate portion is at a second circumferential location. The first mandrel intermediate portion has the second radial distance. The first circumferential location and the second circumferential location are circumferentially spaced apart around the mandrel longitudinal axis in a range of about 45 degrees to about 75 degrees.

[0010] In aspects, the body portion comprises, at the first axial location along the mandrel longitudinal axis: a second mandrel extension portion, the second mandrel extension portion being at a third circumferential location. The second mandrel extension portion has the first radial distance. The second circumferential location and the third circumferential location are circumferentially spaced apart around the mandrel longitudinal axis in a range of about 45 degrees to about 75 degrees. A second mandrel intermediate portion is at a fourth circumferential location. The second mandrel intermediate portion has the second radial distance. The third circumferential location and the fourth circumferential location are circumferentially spaced apart around the mandrel longitudinal axis in a range of about 45 degrees to about 75 degrees.

[0011] In aspects, the body portion comprises, at the first axial location along the mandrel longitudinal axis: a third mandrel extension portion, the third mandrel extension portion being at a fifth circumferential location. The third mandrel extension portion has the first radial distance. The fourth circumferential location and the fifth circumferential location are circumferentially spaced apart around the mandrel longitudinal axis in a range of about 45 degrees to about 75 degrees. A third mandrel intermediate portion is at a sixth circumferential location. The third mandrel intermediate portion has the second radial distance. The fifth circumferential location and the sixth circumferential location are circumferentially spaced apart around the mandrel longitudinal axis in a range of about 45 degrees to about 75 degrees. The first circumferential location and the sixth circumferential location are circumferentially spaced apart around the mandrel longitudinal axis in a range of about 45 degrees to about 75 degrees.

[0012] In aspects, the cap extends along the mandrel longitudinal axis and comprises one or more protrusions protruding from an end of the cap toward the first end of the body portion.

[0013] In aspects, the one or more protrusions comprise a first protrusion, a second protrusion circumferentially spaced apart from the first protrusion in a range of about 100 degrees to about 140 degrees, and a third protrusion circumferentially spaced apart from the second protrusion in a range of about 100 degrees to about 140 degrees.

[0014] In aspects, a transcatheter heart valve prosthesis includes an annular frame extending along a frame longitudinal axis between an inflow end of the transcatheter heart valve prosthesis and an outflow end of the transcatheter heart valve prosthesis. The annular frame includes a plurality of struts and is configured to adjust between a radially collapsed position and a radially expanded position. The annular frame includes a first radius at a first circumferential location and a second radius at a second circumferential location. The first circumferential location and the second circumferential location are located at a same axial location along the frame longitudinal axis between the inflow end and the outflow end, the first radius being different than the second radius.

[0015] In aspects, the first radius is less than the second radius.

[0016] In aspects, the annular frame includes a first frame extension at a first axial location along the frame longitudinal axis at the first circumferential location. The first frame extension has the first radius. A first frame intermediate portion is at the second circumferential location. The first frame intermediate portion has the second radius. The first circumferential location and the second circumferential location are circumferentially spaced apart around the frame longitudinal axis in a range of about 45 degrees to about 75 degrees.

[0017] In aspects, the annular frame includes a second frame extension at the first axial location along the frame longitudinal axis at a third circumferential location. The second frame extension has the first radius. The second circumferential location and the third circumferential location are circumferentially spaced apart around the frame longitudinal axis in a range of about 45 degrees to about 75 degrees. A second frame intermediate portion is at a fourth circumferential location. The second frame intermediate portion has the second radius. The third circumferential location and the fourth circumferential location are circumferentially spaced apart around the frame longitudinal axis in a range of about 45 degrees to about 75 degrees.

[0018] In aspects, the annular frame includes a third frame extension at the first axial location along the frame longitudinal axis at a fifth circumferential location. The third frame extension has the first radius. The fourth circumferential location and the fifth circumferential location are circumferentially spaced apart around the frame longitudinal axis in a range of about 45 degrees to about 75 degrees. A third frame intermediate portion is at a sixth circumferential location. The third frame intermediate portion has the second radius. The fifth circumferential location and the sixth circumferential location are circumferentially spaced apart around the frame longitudinal axis in a range of about 45 degrees to about 75 degrees. The first circumferential location and the sixth circumferential location are circumferentially spaced apart around the frame longitudinal axis in a range of about 45 degrees to about 75 degrees.

[0019] In various aspects, a method for shaping a ring-shaped frame for a heart valve prosthesis includes: positioning a main body portion of a heart axis within the lumen of the frame. The main body portion extends along a longitudinal axis of the heart axis between a first end and a second end, wherein a central region extends between the first end and the second end. An outer radial surface of the central region is spaced from the longitudinal axis of the heart axis at a first location by a first radial distance, and at a second location circumferentially spaced from the first location by a second radial distance. The first radial distance differs from the second radial distance. The method may include: contacting the frame with the main body portion to shape the frame such that the frame includes a first radius at a first circumferential location and a second radius at a second circumferential location. The first circumferential location and the second circumferential location are located at the same axial position along the frame's longitudinal axis. The first radius differs from the second radius.

[0020] In various respects, the method also includes: positioning the cap-shaped part of the mandrel radially outside the frame such that the cap-shaped part circumferentially surrounds the frame and the body portion, wherein the frame is radially located between the cap-shaped part and the body portion.

[0021] In various respects, the method also includes: contacting the outer radial surface of the frame with one or more protrusions of the cap-like member. The one or more protrusions protrude from an end of the cap-like member toward the first end of the body portion.

[0022] In all respects, the one or more protrusions constrain the outward radial movement of the portion of the frame that contacts the one or more protrusions. The one or more protrusions include a first protrusion, a second protrusion circumferentially spaced from the first protrusion in a range of about 100 degrees to about 140 degrees, and a third protrusion circumferentially spaced from the second protrusion in a range of about 100 degrees to about 140 degrees.

[0023] In all respects, the first radius is smaller than the second radius.

[0024] In various respects, bringing the frame into contact with the main body portion to impart the shape includes: imparting a plurality of frame extensions having the first radius and a plurality of frame intermediate portions having the second radius. The plurality of frame extensions and the plurality of frame intermediate portions are located at the same axial position along the longitudinal axis of the frame.

[0025] In all respects, the frame extensions of the plurality of frame extensions and the middle portions of the plurality of frame middle portions are circumferentially spaced from the longitudinal axis of the frame in a range of about 45 degrees to about 75 degrees.

[0026] Additional features and advantages of the aspects disclosed herein will be set forth in the detailed description below, and will be apparent to those skilled in the art, in part, from that description or by practice of the aspects described herein (including the detailed description below, the claims, and the drawings). It should be understood that what will become apparent to those skilled in the art are presented as an overview or framework intended to provide for understanding the nature and features of the aspects disclosed herein. Drawings are included to provide further understanding, and these drawings are incorporated in and form part of this specification. The drawings illustrate various aspects of this disclosure and, together with the description, explain their principles and operation. Attached Figure Description

[0027] These and other features, aspects, and advantages will be better understood when the following detailed description is read with reference to the accompanying drawings, in which:

[0028] Figure 1 A side view of an example aspect of a transcatheter heart valve implantation device according to various aspects of the present disclosure is schematically illustrated.

[0029] Figure 2 This is a top view image of a valve component attached to a frame of a transcatheter heart valve implantation device according to various aspects of this disclosure;

[0030] Figure 3 The retraction of the sac-like component of a transcatheter heart valve implantation device according to various aspects of this disclosure is schematically illustrated.

[0031] Figure 4 Examples of the development of heart valve prostheses according to various aspects of this disclosure are illustrated;

[0032] Figure 5 An additional side view schematically illustrates the delivery of a transcatheter heart valve implantation device according to various aspects of this disclosure;

[0033] Figure 6 The retraction of the sac-like component of a transcatheter heart valve implantation device according to various aspects of this disclosure is schematically illustrated.

[0034] Figure 7 Examples of transcatheter heart valve implantation devices according to various aspects of this disclosure are illustrated along... Figure 1 Sectional view of line 7-7;

[0035] Figure 8 Examples of mandrels in a disassembled state according to various aspects of this disclosure are shown;

[0036] Figure 9 Examples of mandrels in an assembled state according to various aspects of this disclosure are shown;

[0037] Figure 10An example is illustrated of a framework for contact with the main body portion of the mandrel according to various aspects of this disclosure;

[0038] Figure 11 Examples of transcatheter heart valve implantation devices according to various aspects of this disclosure are illustrated along... Figure 10 A sectional view along line 11-11;

[0039] Figure 12 An assembled mandrel according to various aspects of this disclosure is illustrated, the mandrel having a cap-like member including one or more protrusions;

[0040] Figure 13 Examples of protrusions extending from the cap-shaped member according to various aspects of this disclosure are shown;

[0041] Figure 14 Examples of transcatheter heart valve implantation devices according to various aspects of this disclosure are illustrated along... Figure 13 Sectional view of line 14-14.

[0042] Figure 15 A perspective view of a balloon for use with a balloon-expandable cardiac valve frame, according to various aspects of this disclosure, is illustrated; and

[0043] Figure 16 Examples are illustrated along various aspects of this disclosure. Figure 15 End view of the balloon (line 16-16). Detailed Implementation

[0044] The aspects will now be described more fully below with reference to the accompanying drawings, in which exemplary aspects are shown. Where appropriate, the same reference numerals are used throughout the drawings and disclosure to refer to the same or similar parts. However, this disclosure may be embodied in many different forms and should not be construed as limited to the aspects set forth herein.

[0045] As used herein, the term “about” means that quantities, dimensions, formulations, parameters and other quantities and characteristics are not and need not be precise, but may be approximate and / or larger or smaller as required, reflecting tolerances, conversion factors, rounding and measurement errors, and other factors known to those skilled in the art.

[0046] Ranges in this document may be expressed as from “about” one value and / or to “about” another value. When expressing such ranges, each aspect includes from one value and / or to another value. Similarly, when a value is expressed as an approximation using the antecedent “about,” it should be understood that the value forms the other aspect. It should also be understood that the endpoints of each of these ranges are significant both with respect to and independently of the other endpoint.

[0047] The directional terms used in this article (e.g., up, down, right, left, front, back, top, bottom, upper, lower, etc.) refer only to the accompanying drawings and are not intended to imply absolute orientation.

[0048] Unless otherwise expressly stated, it is not intended that any method set forth herein require its steps to be performed in a particular order, nor does it imply that any device requires a particular orientation. Therefore, in cases where a method claim does not actually describe the order in which its steps are followed, or where any device claim does not actually describe the order or orientation of the components, or where the claims or specification do not otherwise specifically state that the steps will be limited to a particular order, or where a particular order or orientation of the device's components is not described, it is never intended to infer any order or orientation. This applies to any possible non-explicit basis of interpretation, including logical questions relating to the arrangement of steps, the flow of operations, the order of components, or the orientation of components; general meanings derived from grammatical organization or punctuation; and the number or type of aspects described in the specification.

[0049] As used herein, unless the context clearly indicates otherwise, the singular forms “a” and “the” include plural references. Thus, for example, unless the context clearly indicates otherwise, a reference to “a” component includes aspects having two or more such components.

[0050] As used herein, the terms “exemplary,” “example,” or their various forms are intended to serve as an example, instance, or illustration. No aspect or design described herein as “exemplary” or “example” should be construed as preferred or advantageous over other aspects or designs. Furthermore, examples are provided for clarity and understanding purposes only and are not intended to limit or constrain the disclosed subject matter or relevant parts of this disclosure in any way. It will be understood that numerous additional or alternative examples of varying scope may be presented, but these have been omitted for the sake of brevity.

[0051] As used herein, unless otherwise indicated, the terms “contains,” “includes,” and their variations shall be interpreted as synonymous and open-ended. The list of elements following the transitional phrase “contains” or “includes” is a non-exclusive list, allowing for the presence of elements other than those specifically described in the list.

[0052] As used herein, the terms “substantial,” “substantially,” and their variations are intended to indicate that the described feature is equal to or approximately equal to a value or description. For example, a “substantially flat” surface is intended to indicate a flat or approximately flat surface. Furthermore, “substantially” is intended to indicate that two values ​​are equal or approximately equal. The term “substantially” can mean values ​​that are within about 10% of each other, for example, values ​​that are within about 5% of each other, or values ​​that are within about 2% of each other.

[0053] Modifications may be made to this disclosure without departing from the scope or spirit of the claimed subject matter. Unless otherwise stated, terms such as "first," "second," etc., are not intended to imply temporal, spatial, or sequential aspects. Rather, such terms are used merely as identifiers or names of features, elements, items, etc. For example, the first end and the second end typically correspond to end A and end B, or two distinct ends.

[0054] Unless otherwise indicated, the terms “distal” and “proximal” are used in the following description with respect to positioning or orientation relative to the treating clinician. “Distal” and “towards distal” refer to positioning away from or in a direction away from the clinician, while “proximal” and “towards proximal” refer to positioning close to or in a direction toward the clinician. Additionally, the term “self-expanding” may be used in the following description with reference to one or more valve or stent structures of the prosthesis of the present invention, and is intended to convey that these structures are shaped or formed from a material that provides mechanical memory, allowing the structure to return from a compressed or contracted delivery configuration to an expanded, unfolded configuration, and vice versa. Non-exhaustive exemplary self-expanding materials include stainless steel, pseudoelastic metals such as nitinol or nickelitan, various polymers, or so-called superalloys that may have a base metal of nickel, cobalt, chromium, or other metals. Mechanical memory can be imparted to the wire or stent structure by heat treatment, for example, to achieve spring tempering in stainless steel, or to set shape memory in a sensitive metal alloy such as nickelitan. Various polymers capable of being formulated to possess shape memory properties are also applicable to aspects of this invention, including polymers such as polynorbornene, trans-polyisoprene, styrene-butadiene, and polyurethane. PolyLD lactic acid copolymers, oligomeric caprolactone copolymers, and polycyclooctane can also be used alone or in combination with other shape memory polymers.

[0055] Diseases associated with heart valves (such as those caused by damage or defects) can include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis causes the valve to narrow and harden, which can prevent blood flow to the downstream chambers of the heart from occurring at the proper rate and can make it harder for the heart to work to pump blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backward, resulting in reduced cardiac efficiency. Diseased or damaged valves, which can be congenital, age-related, drug-induced, or in some cases caused by infection, can lead to an enlarged, thickened heart that has lost its elasticity and efficiency. Some symptoms of heart valve disease can include weakness, shortness of breath, dizziness, fatigue, palpitations, anemia, and edema, as well as blood clots that can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to debilitate and / or endanger a person's life.

[0056] Heart valve prostheses have been developed for the repair and replacement of diseased and / or damaged heart valves. These prostheses are delivered via the skin and unfolded at the site of the diseased heart valve using a catheter-based delivery system. They typically consist of a frame or stent and a prosthetic valve housed within the frame. These prostheses are delivered in a radially compressed or coiled configuration, allowing them to be advanced through the patient's vascular system. Once positioned at the treatment site, the prosthesis expands to engage with tissue located in the region of the diseased heart valve, for example, to hold the prosthesis in place.

[0057] Figure 1 and Figure 2 An example transcatheter heart valve prosthesis 10 is illustrated. The axillary axis described herein can be used with the transcatheter heart valve prosthesis 10 and / or other transcatheter heart valve prostheses. The transcatheter heart valve prosthesis 10 is illustrated to facilitate the description of this disclosure. The following description of the transcatheter heart valve prosthesis 10 is merely exemplary in nature and is not intended to limit the application and potential use of the heart valve prosthesis 10.

[0058] Figure 1 and Figure 2 Side and top (outflow end) views of a transcatheter heart valve prosthesis 10 are illustrated, respectively. The transcatheter heart valve prosthesis 10 includes a radially expandable annular frame or stent 15 and a prosthetic valve 20. The annular frame 15 (e.g., "frame") of the transcatheter heart valve prosthesis 10 supports the prosthetic valve 20 within the frame 15, for example, wherein the prosthetic valve 20 (e.g., ... Figure 2 (As illustrated in the example) Attached to frame 15. Figure 1 and Figure 2 In the example transcatheter heart valve prosthesis 10 shown, the frame 15 is self-expanding. However, this is not intended to be limiting, and in other embodiments, the frame 15 may be balloon-expandable or mechanically expandable. The frame 15 includes a plurality of struts 16, allowing the frame 15 to be adjusted between radially collapsed positioning and radially expanded positioning.

[0059] The prosthetic valve 20 includes at least one leaflet 21, which is disposed within and fixed to the frame 15. Figure 1 and Figure 2 In the illustrated embodiment, the prosthetic valve 20 includes exactly three leaflets 21, such as Figure 2 As shown. However, this does not imply limitation, as the prosthetic valve 20 may include more or fewer leaflets 21. The valve leaflets 21 open and close to regulate flow through the transcatheter prosthetic heart valve 10.

[0060] like Figure 1As shown, the transcatheter heart valve prosthesis 10 includes an inflow end 11 and an outflow end 12. A prosthesis leaflet 21 is attached to a frame 15 at a junction 25 such that when the pressure at the inflow end 11 exceeds the pressure at the outflow end 12, the prosthesis leaflet 21 opens to allow blood to flow from the inflow end 11 through the heart valve prosthesis 10 to the outflow end 12. When the pressure at the outflow end 12 exceeds the pressure at the inflow end 11, the prosthesis leaflet 21 closes to prevent blood from flowing from the outflow end 12 to the inflow end 11. Therefore, at least one leaflet (e.g., the prosthesis leaflet 21) can be attached to a plurality of struts 16, for example, by directly attaching the struts 16 to the junction 25, or by indirectly attaching the struts 16, for example, by attaching to a skirt, a junction bracket, or other structure (e.g., a mechanical actuator) to the struts 16.

[0061] The frame 15 of the transcatheter heart valve prosthesis 10 also includes a plurality of struts 16 arranged to form a plurality of openings or units 18 circumferentially and longitudinally arranged around the longitudinal axis LA of the frame of the transcatheter heart valve prosthesis 10 to form a tubular structure defining a central lumen 13 of the transcatheter heart valve prosthesis 10. For example, the frame 15 may extend along the longitudinal axis LA between the inlet end 11 and the outlet end 12. The longitudinal axis LA may extend through the centroid of the frame 15. For example, if the inlet end 11 and the outlet end 12 have circular cross-sectional shapes, the longitudinal axis LA may pass through the midpoint or center of the circular shape of the inlet end 11 and the outlet end 12. If the inlet end 11 and the outlet end 12 have elliptical cross-sectional shapes, the longitudinal axis LA may pass through the midpoint or center of the elliptical shape of the inlet end 11 and the outlet end 12 (e.g., the midpoint or center of both the major and minor axes perpendicular at the center).

[0062] Frame 15 is configured to secure the prosthetic valve 20 within the central lumen 13 of frame 15 and to secure the transcatheter heart valve prosthesis 10 in the appropriate location within the patient's vascular system. Support strips 16 are defined herein as elongated wire segments of frame 15. Support strips 16 are aggregated to form a coronal portion 17 or node 19, as... Figure 1As can be seen, the frame 15 of the heart valve prosthesis 10 includes a plurality of units 18 defined as spaces between a plurality of coronals 17, a plurality of nodes 19, and a plurality of struts 16. The frame 15 and thus the plurality of struts 16 are adjustable between radially collapsed positioning and radially expanded positioning. The frame 15 may include a central frame region 24 that surrounds the center of the frame 15 along the longitudinal axis LA of the frame. For example, a first end 26 of the central frame region 24 may be spaced apart from the inflow end 11 by a first separation distance 27, and a second end 28 of the central frame region 24 may be spaced apart from the outflow end 12 by a second separation distance 29.

[0063] exist Figure 1 In the illustrated example embodiment, the plurality of units 18 may be rhomboid in shape. In the illustrated example embodiment, the plurality of units includes a plurality of first units 18 and one or more access units 14. Specifically, the access units are larger than the first units 18 and provide access to one or more coronary arteries when the transcatheter heart valve prosthesis 10 is implanted in a patient. In the illustrated embodiment, there are exactly six access units 14. However, this is not intended to be limiting, as the frame 15 of the transcatheter heart valve prosthesis 10 may include more, fewer, or no access units 14. Each access unit 14 has an area enlarged relative to or compared to the first units 18, such as... Figure 1 As can be seen in the image. Furthermore, entry into unit 14 can be located in addition to... Figure 1 In locations other than those shown. Although not shown, in some embodiments, the transcatheter heart valve prosthesis 10 may include an outer skirt that extends circumferentially around the outer circumference of the stent 15 at or near the inlet end 11 to prevent paravalvular leakage of blood around the outside of the transcatheter heart valve prosthesis 10 once implanted in a patient.

[0064] Figure 3 and Figure 4 A side view schematically illustrates a delivery assembly 30 for delivering and deploying a transcatheter heart valve prosthesis (e.g., transcatheter heart valve prosthesis 10) according to an embodiment of the invention. Those skilled in the art will recognize that... Figure 3 and Figure 4 An example of delivery component 30 is shown, and it is removable. Figure 3 and Figure 4 The illustrated components and / or additional components may be added. The delivery assembly 30 includes a distal end 31, a proximal end 32, and a handle 33. The handle 33 allows a physician to manipulate the distal portion of the delivery assembly 30 and includes actuators for moving parts of the delivery assembly 30 relative to other parts. In the delivery assembly 30, an outer shaft 34 is coupled to an actuator 39 of the handle 33 for moving the outer shaft 34 relative to an inner shaft 36.

[0065] The distal portion of the outer shaft 34 (referred to as the sac-like element 35) is configured to surround the transcatheter heart valve prosthesis (e.g., transcatheter heart valve prosthesis 10) during delivery to the treatment site (e.g., a natural heart valve) and retract from the transcatheter heart valve prosthesis to expose it, allowing it to self-expand. The inner shaft 36 is coupled to the stem 33, and movement of the stem 33 translates into movement of the inner shaft 36 and a distal end or anterior cone 37 coupled to the distal end of the inner shaft 36. The inner shaft 36 and the distal end or anterior cone 37 may also be translated relative to the outer shaft 34 and the stem 33 via a distal retractor. In the illustrated embodiment, the inner shaft 36 includes a retainer or main shaft 38 for receiving a paddle-like structure of the transcatheter heart valve prosthesis 10.

[0066] When actuator 39 is actuated, actuator 39 moves the outer shaft 34 and the capsule-shaped member 35 relative to the inner shaft 36, such as Figure 4 As shown. As those skilled in the art know, when the delivery assembly 30 is in place such that the transcatheter heart valve prosthesis 10 is positioned at the desired location at the treatment site in the patient's vascular system, the actuator 39 is actuated to move the sac-like element 35 relative to the inner axis 36 and the transcatheter heart valve prosthesis 10 disposed between the inner axis 36 and the sac-like element 35, thereby enabling the transcatheter heart valve prosthesis 10 to unfold at the treatment site via self-expansion and release from the main axis 38, as Figure 4 As shown (transcatheter heart valve prosthesis 10 is not shown).

[0067] Minimally invasive percutaneous interventional procedures (including endovascular procedures) require access to the venous or arterial system. Generally, the goal is to create the smallest possible incision point with the shortest possible tissue contact time upon entry into the body. Small incisions and short tissue contact times typically result in improved patient outcomes, fewer complications, less trauma to the blood vessel or organ being accessed, and less trauma to the skin and tissue through which the entry point is formed. Various medical procedures involving the percutaneous delivery or implantation of structural elements (such as heart valves, heart valve repair devices, occluders, grafts, electrical stimulators, leads, etc.) require entry. Some procedures use relatively large devices that require relatively large sheaths to deliver the device to the intended site within the body. With such procedures, entry site trauma can occur, often resulting in vascular injury, excessive bleeding, increased case time, increased risk of infection, and increased hospital stay. To minimize entry trauma, physicians attempt to use the smallest possible device and place the smallest possible sheath size. However, if a physician discovers during the procedure that a larger device is needed, this can be problematic. This necessitates increasing the sheath size, which is a lengthy procedure and increases the patient's risk.

[0068] Figure 5 and Figure 6An embodiment of a guide sheath 50 is depicted, which is positioned and accessed through an incision 60 in the patient's skin 65 and into the patient's blood vessel 40. The sheath 50 has a tubular shaft 55 and a proximal hub 56, which has a hemostatic seal and a Luer lock 57. Figure 5 The sheath 50 is shown positioned in its normal, undilated state within the blood vessel 40, while Figure 6 A sheath 50 positioned within a blood vessel 40 is shown, wherein a delivery device 75 delivers another device 70 being advanced through the sheath 50, causing a tubular shaft 55 to expand or deform at the location where the device 70 passes. As the device 70 passes, the shaft 55 expands at an expansion region 58, and subsequently retracts or returns to its original diameter after the device 70 moves past or is removed from the shaft. Thus, the tubular shaft 55 is configured to be both expandable and retractable.

[0069] In some embodiments, the expandability of shaft 55 (and any shaft described according to any embodiment set forth herein) is achieved via the elasticity of shaft 55, which can result in shaft 55 being self-expanding or mechanically expandable or mechanically expandable. For the purposes of this application, self-expanding means that shaft 55 is configured to automatically expand to a predetermined or nominal diameter (without any type of actuation, mechanical actuation, or other actuation). Furthermore, for the purposes of this application, mechanically expandable means that shaft 55 is configured to expand when a positionable medical device is positioned through shaft 55. That is, the device itself is being passed through shaft 55, causing the shaft 55 to expand, as... Figure 6 As depicted. Alternatively, the expandable characteristics of shaft 55 may be caused by factors other than elasticity.

[0070] After the device passes through, shaft 55 is configured to be retractable, retractable, or return to its original unexpanded state, such as... Figure 5 As depicted. In some embodiments, retractability can be achieved through the elasticity of shaft 55, which can result in shaft 55 being self-retractable, self-recovering, self-contracting, mechanically retractable, mechanically recoverable, or mechanically contractible. For the purposes of this application, self-retractability means that shaft 55 is configured to automatically retract to a predetermined or nominal diameter (without any type of actuation, mechanical actuation, or other actuation). Furthermore, for the purposes of this application, mechanical retractability means that shaft 55 is configured to retract or recover when a device or component is used to retract or recover shaft 55. Alternatively, the retractability characteristic of shaft 55 may be caused by factors other than elasticity.

[0071] For the purposes of this application, any device that can be positioned via a guide sheath according to any embodiment disclosed or contemplated herein may be referred to as a positionable medical device or an insertable medical device. Such devices include guidewires, dilators, delivery devices (for delivering and / or placing structural elements such as heart valves, heart valve repair devices, occluders, grafts, electrical stimulators, leads, etc.), guiding catheters, guiding sheaths, diagnostic catheters, stent delivery systems, balloon catheters, and other known vascular devices. Other devices may include non-vascular devices such as endoscopes and other common surgical instruments. Furthermore, the guide sheath is configured to receive tissue or organ. Thus, by way of a non-limiting example, guide sheath 50 is described as an expandable guide sheath 50 for introducing a delivery assembly 30 including a transcatheter heart valve prosthesis 10.

[0072] Figure 7 Examples are given from Figure 1 The view shown by line 7-7 is a top view of the heart valve prosthesis 10 entering and exiting the end 12. In various respects, the central frame region 24 may include one or more extensions and one or more intermediate portions located at a first axial position 701 in the central frame region 24. The first axial position 701 is... Figure 1 The image illustrates, and includes, a position along the longitudinal axis LA of the frame and within the central frame region 24. In various aspects, the central frame region 24 may surround the midpoint of the frame 15, which is approximately midway between the inflow end 11 and the outflow end 12. In various aspects, the central frame region 24 may surround a length along the longitudinal axis LA of the frame, a length occupied by the leaflet 21 in its fully open position and in its closed position. In various aspects, when the leaflet 21 is in its fully open position, a first axial position 701 may be located in the position occupied by the leaflet 21.

[0073] One or more extensions of frame 15 may include a first frame extension 703, a second frame extension 705, and a third frame extension 707 at a first axial position 701. One or more intermediate portions of frame 15 may include a first intermediate frame portion 711, a second intermediate frame portion 713, and a third intermediate frame portion 715 at the first axial position 701. Frame extensions 703, 705, 707 and intermediate frame portions 711, 713, 715 may be circumferentially spaced about the longitudinal axis LA of the frame, wherein frame extensions 703, 705, 707 and intermediate frame portions 711, 713, 715 are alternately positioned. For example, the first frame extension 703 is circumferentially positioned between the first intermediate frame portion 711 and the third intermediate frame portion 715. The first intermediate frame portion 711 is circumferentially positioned between the first frame extension 703 and the second frame extension 705. The second frame extension 705 is circumferentially positioned between the middle portion 711 of the first frame and the middle portion 713 of the second frame. The middle portion 713 of the second frame is circumferentially positioned between the second frame extension 705 and the third frame extension 707. The third frame extension 707 is circumferentially positioned between the middle portion 713 of the second frame and the middle portion 715 of the third frame. The middle portion 715 of the third frame is circumferentially positioned between the third frame extension 707 and the first frame extension 703.

[0074] In various aspects, frame extensions 703, 705, and 707 may include radii to the frame 15 (e.g., distance from the frame's longitudinal axis LA to the frame) that differ from the radii of the frame intermediate portions 711, 713, and 715. For example, a first frame extension 703 is positioned at a first circumferential location 721 and has a first radius 723. In various aspects, the first frame extension 703 may include a circular shape, wherein the first radius 723 forms the maximum radius of the first frame extension 703, and wherein the radius on the opposite circumferential side of the first circumferential location 721 is smaller than the first radius 723. The first frame intermediate portion 711 may be positioned at a second circumferential location 725 and may have a second radius 727. In various aspects, the first circumferential location 721 and the second circumferential location 725 are located at the same axial position (e.g., the first axial location 701) along the frame's longitudinal axis LA between the inflow end 11 and the outflow end 12. In various aspects, the intermediate portion 711 of the first frame may be flatter and less rounded than the extension portion 703 of the first frame, wherein the second radius 727 forms the minimum radius of the intermediate portion 711 of the first frame, and wherein the radius on the opposite circumferential side of the second circumferential position 725 is greater than the second radius 727. In this way, in various aspects, the extension portions 703, 705, 707 of the frame may include shapes different from the intermediate portions 711, 713, 715 of the frame. In various aspects, the first radius 723 may differ from the second radius 727, for example, wherein the first radius 723 is larger than the second radius 727. In various aspects, the difference between the first radius 723 and the second radius 727 may be in the range of about 1 millimeter (“mm”) to about 4 mm or about 1.5 mm to about 2.5 mm. In other aspects, the difference between the first radius 723 and the second radius 727 may be about 1.6 mm or about 2.2 mm. The first circumferential position 721 and the second circumferential position 725 may be circumferentially spaced apart around the longitudinal axis LA of the frame (e.g., within a range of about 45 degrees to about 75 degrees around the longitudinal axis LA of the frame).

[0075] The second frame extension 705 is positioned at a third circumferential position 731 and has a first radius 723. In various aspects, the second frame extension 705 may include a shape substantially the same as that of the first frame extension 703. The second frame intermediate portion 713 may be positioned at a fourth circumferential position 733 and may have a second radius 727. In various aspects, the second frame intermediate portion 713 may include a shape substantially the same as that of the first frame intermediate portion 711. The third circumferential position 731 and the fourth circumferential position 733 are located at the same axial position (e.g., the first axial position 701) along the frame longitudinal axis LA between the inflow end 11 and the outflow end 12. The third circumferential position 731 and the fourth circumferential position 733 may be circumferentially spaced apart about the frame longitudinal axis LA (e.g., within a range of about 45 degrees to about 75 degrees around the frame longitudinal axis LA).

[0076] The third frame extension 707 is positioned at a fifth circumferential position 737 and has a first radius 723. In various aspects, the third frame extension 707 may include a shape substantially the same as that of the first frame extension 703. The third frame intermediate portion 715 may be positioned at a sixth circumferential position 739 and may have a second radius 727. In various aspects, the third frame intermediate portion 715 may include a shape substantially the same as that of the first frame intermediate portion 711. The fifth circumferential position 737 and the sixth circumferential position 739 are located at the same axial position (e.g., the first axial position 701) along the frame longitudinal axis LA between the inflow end 11 and the outflow end 12. The fifth circumferential position 737 and the sixth circumferential position 739 may be circumferentially spaced apart about the frame longitudinal axis LA (e.g., within a range of about 45 degrees to about 75 degrees around the frame longitudinal axis LA). In all respects, the first circumferential position 721 and the sixth circumferential position 739 may be circumferentially spaced around the longitudinal axis LA of the frame (e.g., within a range of about 45 degrees to about 75 degrees around the longitudinal axis LA of the frame).

[0077] In all respects, the positions of the middle portions 711, 713, and 715 of the frame can substantially match the positions of the connecting parts of the frame 15 (e.g., in terms of size, shape, positioning, and function). Figure 2(The illustrated joint 25 is substantially the same). For example, frame 15 may include a first joint 751 located substantially at a second circumferential position 725, for example aligned with the middle portion 711 of the first frame. Frame 15 may include a second joint 753 located substantially at a fourth circumferential position 733, for example aligned with the middle portion 713 of the second frame. Frame 15 may include a third joint 755 located substantially at a sixth circumferential position 739, for example aligned with the middle portion 715 of the third frame. In various respects, a first axis 771 may be perpendicular to the longitudinal axis LA of the frame, wherein the first axis 771 intersects the longitudinal axis LA of the frame, the second frame extension 705 at the third circumferential position 731, and the middle portion 715 of the third frame at the sixth circumferential position 739. In all respects, the second axis 773 may be perpendicular to the longitudinal axis LA of the frame, wherein the second axis 773 intersects the longitudinal axis LA of the frame, the first frame extension 703 at the first circumferential position 721, and the second frame intermediate portion 713 at the fourth circumferential position 733. In all respects, the third axis 775 may be perpendicular to the longitudinal axis LA of the frame, wherein the third axis 775 intersects the longitudinal axis LA of the frame, the third frame extension 707 at the fifth circumferential position 737, and the first frame intermediate portion 711 at the second circumferential position 725.

[0078] In some aspects, the central frame region 24 may include a substantially constant shape and size along the length of the central frame region 24 between the first end 26 and the second end 28. That is, by including a substantially constant shape and size, the frame extensions 703, 705, 707 may be spaced by substantially the same radial distance along the length of the central frame region 24 (e.g., and at the same circumferential location) from the frame longitudinal axis LA, and the frame intermediate portions 711, 713, 715 may be spaced by substantially the same radial distance along the length of the central frame region 24 (e.g., and at the same circumferential location) from the frame longitudinal axis LA. In this way, other axial locations along the frame longitudinal axis LA of the central frame region 24 (e.g., axial locations different from the first axial location 701) may include frame extensions that are substantially the same in shape, size, and positioning as the frame extensions 703, 705, 707 at the first axial location 701, and may include frame intermediate portions that are substantially the same in shape, size, and positioning as the frame intermediate portions 711, 713, 715 at the first axial location 701. However, in other respects, the central frame region 24 may not include a substantially constant shape and / or size along the length of the central frame region 24 between the first end 26 and the second end 28.

[0079] Figure 8An example is shown of a frame 15 used to give shape (e.g., relative to) a heart valve prosthesis 10. Figure 7 The mandrel 801 (of the illustrated and described shape) may include a body portion 803 and one or more cap-like elements, such as a first cap-like element 805 and a second cap-like element 807. A frame 15 is schematically illustrated to show that the frame 15 may initially include a cylindrical shape or a shape different from the mandrel 801 before contacting it. Figure 7 Other shapes illustrated. For example, as noted, by employing a mandrel 801, mechanical memory can be imparted to the frame 15 through heat treatment to achieve spring tempering or set shape memory. Thus, the apparatus and method of this disclosure provide, alone or in combination, a mandrel 801 for imparting shape to the frame 15 and a frame 15 having the shape imparted thereon by the mandrel 801.

[0080] The main body portion 803 may extend along the longitudinal axis 811 of the mandrel between a first end 813 and a second end 815. The main body portion 803 may include a central region 817 spaced from the first end 813 by a first distance 818 and from the second end 815 by a second distance 821. In all respects, when the frame 15 contacts the main body portion 803, the central region 817 of the main body portion 803 may substantially match the size and position of the central frame region 24. The main body portion 803 may include an outer radial surface 823 circumferentially surrounding and extending along the longitudinal axis 811 of the mandrel. The outer radial surface 823 may be formed into several shapes based on the desired shape of the frame 15, and... Figure 8 In this configuration, the outer radial surface 823 may be formed into an hourglass shape with non-constant cross-sectional dimensions along the longitudinal axis 811 of the mandrel. The main body portion 803 may include one or more protrusions 825 that project radially outward from the outer radial surface 823, wherein the one or more protrusions 825 define an exposed head, protrusion, extension, etc., that can be received within the unit 18 of the frame 15. In this way, the protrusions 825 may limit the possibility of accidental displacement or movement of the frame 15 relative to the main body portion 803.

[0081] The spindle 801 includes: a first cap-shaped member 805 positioned circumferentially around a first end 813 of a body portion 803; and a second cap-shaped member 807 positioned circumferentially around a second end 815 of the body portion 803. In various aspects, the first cap-shaped member 805 may include a recess ( Figure 8(Not shown in the image), the recess is sized to receive the first end portion 813. The first cap 805 may include a surrounding wall 831 that circumferentially surrounds the first end portion 813. In this way, the outflow end portion 12 of the frame 15 may be radially received between the surrounding wall 831 of the first cap 805 and the first end portion 813 of the body portion 803. The frame 15 may contact the body portion 803 such that the first end portion 813 of the body portion 803 can shape the outflow end portion 12 of the frame 15. The second cap 807 may include a recess 833 that is sized to receive the second end portion 815. The second cap 807 may include a surrounding wall 835 that circumferentially surrounds the second end portion 815. In this way, the inflow end portion 11 of the frame 15 may be radially received between the surrounding wall 835 of the second cap 807 and the second end portion 815 of the body portion 803. The frame 15 is accessible to the main body portion 803 such that a second end portion 815 of the main body portion 803 can shape the inflow end portion 11 of the frame 15. In this way, a method for shaping the frame 15 of the heart valve prosthesis 10 may include positioning the main body portion 803 of the spindle 801 within the lumen 13 of the frame 15. Figure 9 A mandrel 801 is illustrated, wherein a main body portion 803 is received within a first cap 805 and a second cap 807. Therefore, the method may include positioning the second cap 807 of the mandrel 801 radially outside a frame 15 such that the second cap 807 circumferentially surrounds the frame 15 and the main body portion 803, wherein the frame 15 is radially positioned between the second cap 807 and the main body portion 803.

[0082] Figure 10 An example is shown of the main body portion 803 in contact with the frame 15, such that the frame 15 has a shape that substantially matches the shape of the main body portion 803. For illustrative purposes and to avoid obscuring the main body portion 803 and the various parts of the frame 15, a mandrel 801 without the first cap 805 and the second cap 807 is shown. However, in operation, the first cap 805 and the second cap 807 can interact with... Figure 9 The illustrated positioning is essentially the same relative to the main body 803 and the frame 15. In this way, the first cap-shaped member 805 can be positioned circumferentially around a first end 813 of the main body 803, such that the frame 15 can be radially positioned between the main body 803 and the first cap-shaped member 805. Similarly, the second cap-shaped member 807 can be positioned circumferentially around a second end 815 of the main body 803, such that the frame 15 can be radially positioned between the main body 803 and the second cap-shaped member 807. Figure 10As illustrated, frame 15 can be positioned to contact body portion 803 such that protrusion 825 can extend through unit 18. Central frame region 24 contacts central region 817 of body portion 803. For example, body portion 803 of mandrel 801 can be received within lumen 13 of frame 15. Thus, the method may include: contacting frame 15 with body portion 803 to give frame 15 shape, such that frame 15 includes a first radius 723 at a first circumferential position 721 and a second radius 727 at a second circumferential position 725. In various aspects, contacting frame 15 with body portion 803 to give shape may include: giving a plurality of frame extensions 703, 705, 707 (e.g., having a first radius 723) and a plurality of frame intermediate portions 711, 713, 715 (e.g., having a second radius 727).

[0083] Figure 11 Examples are shown along Figure 10 A cross-sectional view of the main body portion 803 of line 11-11. In various respects, the central region 817 may include a first axial position 1101 located in the central region 817 (e.g., Figure 10 (as illustrated) one or more extensions and one or more intermediate portions. The first axial position 1101 includes a position along the longitudinal axis 811 of the spindle and within the central region 817.

[0084] One or more extensions of the main body portion 803 may include a first mandrel extension 1103, a second mandrel extension 1105, and a third mandrel extension 1107 at a first axial position 1101. One or more intermediate mandrel portions of the main body portion 803 may include a first intermediate mandrel portion 1111, a second intermediate mandrel portion 1113, and a third intermediate mandrel portion 1115 at the first axial position 1101. The mandrel extensions 1103, 1105, 1107 and the intermediate mandrel portions 1111, 1113, 1115 may be circumferentially spaced around the longitudinal axis 811 of the mandrel, with the central mandrel extensions 1103, 1105, 1107 and the intermediate mandrel portions 1111, 1113, 1115 being alternately positioned. For example, the first mandrel extension 1103 may be circumferentially positioned between the first intermediate mandrel portion 1111 and the third intermediate mandrel portion 1115. The first mandrel intermediate portion 1111 is circumferentially positioned between the first mandrel extension portion 1103 and the second mandrel extension portion 1105. The second mandrel extension portion 1105 is circumferentially positioned between the first mandrel intermediate portion 1111 and the second mandrel intermediate portion 1113. The second mandrel intermediate portion 1113 is circumferentially positioned between the second mandrel extension portion 1105 and the third mandrel extension portion 1107. The third mandrel extension portion 1107 is circumferentially positioned between the second mandrel intermediate portion 1113 and the third mandrel intermediate portion 1115. The third mandrel intermediate portion 1115 is circumferentially positioned between the third mandrel extension portion 1107 and the first mandrel extension portion 1103.

[0085] In various aspects, the mandrel extensions 1103, 1105, and 1107 may include radii different from those of the intermediate mandrel portions 1111, 1113, and 1115 (e.g., radial distances from the longitudinal axis 811 of the mandrel). For example, the first mandrel extension 1103 is positioned at a first circumferential location 1121, wherein the outer radial surface 823 is spaced from the longitudinal axis 811 of the mandrel at the first circumferential location 1121 by a first radial distance 1123. In various aspects, the first mandrel extension 1103 may include a circular shape, wherein the first radial distance 1123 forms the maximum radius of the first mandrel extension 1103, and wherein the radius on the opposite circumferential side of the first circumferential location 1121 is smaller than the first radial distance 1123. The first intermediate mandrel portion 1111 may be positioned at a second circumferential location 1125, wherein the outer radial surface 823 is spaced from the longitudinal axis 811 of the mandrel at the second circumferential location 1125 by a second radial distance 1127. In various aspects, the first circumferential position 1121 and the second circumferential position 1125 are located at the same axial position (e.g., the first axial position 1101) along the longitudinal axis 811 of the mandrel. In various aspects, the intermediate portion 1111 of the first mandrel may be flatter and less round than the extension portion 1103 of the first mandrel, wherein the second radial distance 1127 forms the minimum radius of the intermediate portion 1111 of the first mandrel, and wherein the radius on the opposite circumferential side of the second circumferential position 1125 is greater than the second radial distance 1127. In various aspects, the first radial distance 1123 may differ from the second radial distance 1127, for example, wherein the first radial distance 1123 is greater than the second radial distance 1127. In various aspects, the difference between the first radial distance 1123 and the second radial distance 1127 may be in the range of about 1 mm to about 4 mm or about 1.5 mm to about 2.5 mm. In other aspects, the difference between the first radial distance 1123 and the second radial distance 1127 may be about 1.6 mm or about 2.2 mm. The first circumferential position 1121 and the second circumferential position 1125 may be circumferentially spaced apart about the longitudinal axis 811 of the mandrel (e.g., within a range of about 45 degrees to about 75 degrees around the longitudinal axis 811 of the mandrel).

[0086] The second mandrel extension 1105 is positioned at a third circumferential position 1131 and includes a first radial distance 1123. In various aspects, the second mandrel extension 1105 may include a shape substantially the same as the first mandrel extension 1103. The second mandrel intermediate portion 1113 may be positioned at a fourth circumferential position 1133 and may include a second radial distance 1127. In various aspects, the second mandrel intermediate portion 1113 may include a shape substantially the same as the first mandrel intermediate portion 1111. The third circumferential position 1131 and the fourth circumferential position 1133 are located at the same axial position (e.g., the first axial position 1101) along the longitudinal axis 811 of the mandrel. The third circumferential position 1131 and the fourth circumferential position 1133 may be circumferentially spaced apart about the longitudinal axis 811 of the mandrel (e.g., within a range of about 45 degrees to about 75 degrees around the longitudinal axis 811 of the mandrel).

[0087] The third mandrel extension 1107 is positioned at a fifth circumferential position 1137 and includes a first radial distance 1123. In various aspects, the third mandrel extension 1107 may include a shape substantially the same as the first mandrel extension 1103. The third mandrel intermediate portion 1115 may be positioned at a sixth circumferential position 1139 and may include a second radial distance 1127. In various aspects, the third mandrel intermediate portion 1115 may include a shape substantially the same as the first mandrel intermediate portion 1111. The fifth circumferential position 1137 and the sixth circumferential position 1139 are located at the same axial position (e.g., the first axial position 1101) along the longitudinal axis 811 of the mandrel. The fifth circumferential position 1137 and the sixth circumferential position 1139 may be circumferentially spaced apart about the longitudinal axis 811 of the mandrel (e.g., within a range of about 45 degrees to about 75 degrees about the longitudinal axis 811 of the mandrel). In all respects, the first circumferential position 1121 and the sixth circumferential position 1139 may be circumferentially spaced around the longitudinal axis 811 of the mandrel (e.g., within a range of about 45 degrees to about 75 degrees around the longitudinal axis 811 of the mandrel).

[0088] In various respects, the positions of the mandrel intermediate portions 1111, 1113, and 1115 can be given matching shapes within the frame 15 to form frame intermediate portions 711, 713, and 715 at corresponding positions. Similarly, the positions of the mandrel extension portions 1103, 1105, and 1107 can be given matching shapes within the frame 15 to form frame extension portions 703, 705, and 707. For example, the frame 15 can be radially compressed to contact the outer radial surface 823 of the body portion 803, thereby causing the frame 15 to adopt the shape of the outer radial surface 823 of the body portion 803. In various respects, the first axis 1171 can be perpendicular to the longitudinal axis 811 of the mandrel, wherein the first axis 1171 intersects the longitudinal axis 811 of the mandrel, the second mandrel extension portion 1105 at the third circumferential position 1131, and the third mandrel intermediate portion 1115 at the sixth circumferential position 1139. In all respects, the second axis 1173 may be perpendicular to the longitudinal axis 811 of the mandrel, wherein the second axis 1173 intersects the longitudinal axis 811 of the mandrel, the first mandrel extension 1103 at the first circumferential position 1121, and the second mandrel intermediate portion 1113 at the fourth circumferential position 1133. In all respects, the third axis 1175 may be perpendicular to the longitudinal axis 811 of the mandrel, wherein the third axis 1175 intersects the longitudinal axis 811 of the mandrel, the third mandrel extension 1107 at the fifth circumferential position 1137, and the first mandrel intermediate portion 1111 at the second circumferential position 1125.

[0089] Figure 12 A mandrel 801 is illustrated, having a first cap-shaped member 805 and a second cap-shaped member 807 receiving a main body portion 803. In various aspects, the second cap-shaped member 807 extends along the longitudinal axis 811 of the mandrel and includes one or more protrusions projecting from an end 1201 of the second cap-shaped member 807 toward a first end 813 of the main body portion 803. For example, the one or more protrusions may include a first protrusion 1203, a second protrusion 1205, and a third protrusion 1207. Figure 13 A close-up enlarged view of a first protrusion 1203 positioned relative to the outer radial surface 823 of the main body portion 803 is shown. For example, the first protrusion 1203 may be spaced apart from the outer radial surface 823 of the central region 817 to define a gap 1301 between the first protrusion 1203 and the outer radial surface 823. In various respects, gaps substantially the same as gap 1301 may be defined between a second protrusion 1205 and the outer radial surface 823, and between a third protrusion 1207 and the outer radial surface 823.

[0090] Figure 14 Examples include the main body 803, frame 15, and protrusions 1203, 1205, and 1207 along... Figure 12A cross-sectional view along line 14-14. For example, a second gap 1401 may be defined between the second protrusion 1205 and the outer radial surface 823, and a third gap 1403 may be defined between the third protrusion 1207 and the outer radial surface 823. It should be understood that... Figure 14 The dimensions of the gaps 1301, 1401, 1403, etc., are merely illustrative and not necessarily drawn to scale, so that they may be larger or smaller than those shown. For example, in each respect, the gaps 1301, 1401, 1403 may be in the range of 0.6 mm to about 0.7 mm, but other gap dimensions may be envisioned based on the thickness of the tubing used to form the frame.

[0091] In all respects, protrusions 1203, 1205, and 1207 can be positioned at substantially the same circumferential location as the frame intermediate portions 711, 713, and 715 and the spindle intermediate portions 1111, 1113, and 1115. For example, a first radial axis 1405 may intersect the first spindle intermediate portion 1111, the first frame intermediate portion 711, and the first protrusion 1203. A second radial axis 1407 may intersect the second spindle intermediate portion 1113, the second frame intermediate portion 713, and the second protrusion 1205. A third radial axis 1409 may intersect the third spindle intermediate portion 1115, the third frame intermediate portion 715, and the third protrusion 1207. In this way, the first frame intermediate portion 711 can be radially positioned between the first spindle intermediate portion 1111 and the first protrusion 1203. The second frame intermediate portion 713 can be radially positioned between the second spindle intermediate portion 1113 and the second protrusion 1205. The third frame intermediate portion 715 can be radially positioned between the third mandrel intermediate portion 1115 and the third protrusion 1207. In various respects, the second protrusion 1205 and the first protrusion 1203 are circumferentially spaced apart within a range of approximately 100 degrees to approximately 140 degrees. The third protrusion 1207 can be circumferentially spaced apart from the second protrusion 1205 within a range of approximately 100 degrees to approximately 140 degrees. The third protrusion 1207 can be circumferentially spaced apart from the first protrusion 1203 within a range of approximately 100 degrees to approximately 140 degrees. In various respects, although the aforementioned protrusions can be spaced apart within a range of approximately 100 degrees to approximately 140 degrees, the maximum radial increase in spacer angle can be approximately 120 degrees.

[0092] Protrusions 1203, 1205, and 1207 can restrict the outward radial expansion of the frame intermediate portions 711, 713, and 715, and keep the frame intermediate portions 711, 713, and 715 close to, for example, contact with the mandrel intermediate portions 1111, 1113, and 1115. In this way, protrusions 1203, 1205, and 1207 can constrain the outward radial movement of the portions of frame 15 that contact protrusions 1203, 1205, and 1207 (e.g., frame intermediate portions 711, 713, and 715). Reference Figures 1 to 14 The shape of the frame 15 described herein offers several advantages. For example, because the frame 15 includes a non-circular shape with a non-constant radius at the central frame region 24, the likelihood of the leaflet 21 accidentally contacting the frame 15 when it is in a fully open position is reduced. For example, as... Figure 7 As illustrated, the locations of the joints 751, 753, and 755 may include a reduced radius compared to the circumferentially located area of ​​the frame 15 between the joints 751, 753, and 755. Therefore, when the leaflet 21 is in the fully open position, the leaflet 21 is less likely to contact the frame 15 at areas with an expanded radius (e.g., at frame extensions 703, 705, and 707). Without being bound by theory, it is believed that the frame 15 of this disclosure, with its expanded radius areas (e.g., at frame extensions 703, 705, and 707), reduces the likelihood of leaflet 21 abrading the frame 15 compared to frames with other shapes (e.g., circular cross-sections) where the leaflet 21 might be more likely to contact, thereby extending the usable functional lifespan and improving the lifespan management of the valve prosthesis 10.

[0093] Figure 15 An example is illustrated of a balloon 1501 for radially expanding the frame 15 when the frame 15 is not a self-expanding frame 15. For example, the frame 15 may include a balloon-expandable material, and the balloon 1501 may be used to engage the frame 15 and give it shape. In this way, the frame 15 may have a shape given by the balloon 1501, in contrast to the mandrel 801. The balloon 1501 may include an inflatable material, such as, for example, nylon. The balloon 1501 may be in fluid communication with a conduit (e.g., a pipe, fitting, etc.) in fluid communication with a fluid source. In this way, the fluid source can deliver fluid (e.g., gas, etc.) through the conduit and deliver it to the balloon 1501, such that the balloon 1501 can be inflated and radially expanded. The balloon 1501 may apply a radial force to the frame 15 and cause the frame 15 to expand radially, wherein the shape of the balloon 1501 is given to the frame 15.

[0094] like Figure 15As illustrated, balloon 1501 may include multiple regions, such as, for example, a first region 1503, a second region 1507, and a central region 817 between the first region 1503 and the second region 1507. The first region 1503, the second region 1507, and the central region 817 may be arranged to extend along a longitudinal axis 811. In various aspects, the second region 1507 may have a rounded or circular shape with a substantially constant radius around the longitudinal axis 811. Similarly, in various aspects, the central region 817 may have a rounded or circular shape with a substantially constant radius around the longitudinal axis 811. The first region 1503 may have a shape including one or more lobes or extensions (e.g., similar to...). Figure 11 (The illustrated shape). In this way, the first region 1503 can contact / engage the frame 15 and give the frame 15 a corresponding shape.

[0095] Figure 16 Examples are shown along Figure 15 The figure shows an end view of the balloon 1501 along lines 16-16. As illustrated, the second region 1507 is in the foreground and has a rounded or circular shape. The first region 1503 is in the background (e.g., behind the second region 1507) and has a shape with one or more lobes or extensions. Because it is obscured by the second region 1507, the portions of the first region 1503 (e.g., the middle portions 1111, 1113, 1115) are illustrated with dashed lines.

[0096] In all respects, the first region 1503 may have some similarities to Figure 11The illustrated mandrel 801 has a specific shape. For example, the first region 1503 may include a first extension 1103 at a first circumferential position 1121, a first intermediate portion 1111 at a second circumferential position 1125, a second extension 1105 at a third circumferential position 1131, a second intermediate portion 1113 at a fourth circumferential position 1133, a third extension 1107 at a fifth circumferential position 1137, and a third intermediate portion 1115 at a sixth circumferential position 1139. In various aspects, the extensions 1103, 1105, and 1107 may include a first radial distance 1123, while the intermediate portions 1111, 1113, and 1115 may include a second radial distance 1127. In various aspects, the first region 1503 may include a third radial distance 1509 at a position 1511 that is angularly offset from the first circumferential position 1121. In all respects, the angle between the first circumferential position 1121 and position 1511 is in the range of about 20 degrees to about 40 degrees, or about 30 degrees. In all respects, the first radial distance 1123 can be at most about 20 mm, or at most about 18 mm, or at most about 15 mm. In all respects, the second radial distance 1127 can be at most about 15 mm, or at most about 13 mm, or at most about 12.5 mm, or at most about 10 mm. In all respects, the third radial distance 1509 can be at most about 18 mm, or at most about 15 mm, or at most about 12 mm. It should be understood that the sizes listed herein are merely exemplary, and other sizes are possible depending on, for example, the dimensions of frame 15, leaflet dimensions, etc.

[0097] Therefore, as the balloon 1501 expands radially due to its inflation, it can contact the frame 15 (e.g., since the balloon 1501 is received within the lumen of the frame 15) and shape the frame 15, wherein this shape can be substantially similar to or identical to the shapes of the first region 1503, the second region 1507, and the central region 817. Thus, the second region 1507 can shape the inflow end 11 of the frame 15 (e.g., the shape of the second region 1507), while the first region 1503 can shape the outflow end 12 of the frame 15 (e.g., the shape of the first region 1503).

[0098] It should be understood that although various aspects have been described in detail with respect to certain illustrative and specific examples, this disclosure should not be considered limited thereto, as many modifications and combinations of the disclosed features are possible without departing from the scope of the appended claims.

Claims

1. A heart axis for shaping a frame of a heart valve prosthesis, the heart axis comprising: The main body extends along the longitudinal axis of the mandrel between a first end and a second end, wherein a central region extends between the first end and the second end, and the outer radial surface of the central region is spaced apart from the longitudinal axis of the mandrel by a first radial distance at a first circumferential position, and spaced apart from the longitudinal axis of the mandrel by a second radial distance at a second circumferential position spaced apart from the first circumferential position, the first radial distance being different from the second radial distance, the mandrel being configured to be received within the internal lumen of the frame; and A cap-shaped member is positioned circumferentially around the second end of the body portion, such that the frame is configured to be radially positioned between the body portion and the cap-shaped member.

2. The mandrel according to claim 1, wherein the central region is spaced apart from the first end by a first distance and from the second end by a second distance.

3. The mandrel according to claim 1, wherein the first radial distance is greater than the second radial distance.

4. The mandrel according to claim 3, wherein the main body portion comprises at a first axial position along the longitudinal axis of the mandrel: A first mandrel extension portion, the first mandrel extension portion being at the first circumferential position, the first mandrel extension portion having the first radial distance; and The first mandrel middle portion is located at the second circumferential position, the first mandrel middle portion has the second radial distance, and wherein the first circumferential position and the second circumferential position are circumferentially spaced apart from the longitudinal axis of the mandrel in a range of about 45 degrees to about 75 degrees.

5. The mandrel according to claim 4, wherein the main body portion comprises at the first axial position along the longitudinal axis of the mandrel: A second mandrel extension portion, the second mandrel extension portion being at a third circumferential position, the second mandrel extension portion having the first radial distance, and wherein the second circumferential position and the third circumferential position are circumferentially spaced apart from the longitudinal axis of the mandrel in a range of about 45 degrees to about 75 degrees. and The second mandrel middle portion, the second mandrel middle portion at the fourth circumferential position, the second mandrel middle portion having the second radial distance, and wherein the third circumferential position and the fourth circumferential position are circumferentially spaced apart around the longitudinal axis of the mandrel in a range of about 45 degrees to about 75 degrees.

6. The mandrel of claim 5, wherein the main body portion comprises at the first axial position along the longitudinal axis of the mandrel: A third mandrel extension portion, the third mandrel extension portion being at a fifth circumferential position, the third mandrel extension portion having the first radial distance, and wherein the fourth circumferential position and the fifth circumferential position are circumferentially spaced apart around the longitudinal axis of the mandrel in a range of about 45 degrees to about 75 degrees. and The third mandrel middle portion, the third mandrel middle portion at the sixth circumferential position, the third mandrel middle portion having the second radial distance, and wherein the fifth circumferential position and the sixth circumferential position are circumferentially spaced apart from the longitudinal axis of the mandrel in a range of about 45 degrees to about 75 degrees, and wherein the first circumferential position and the sixth circumferential position are circumferentially spaced apart from the longitudinal axis of the mandrel in a range of about 45 degrees to about 75 degrees.

7. The mandrel of claim 1, wherein the cap extends along the longitudinal axis of the mandrel and includes one or more protrusions projecting from one end of the cap toward the first end of the body portion.

8. The mandrel according to claim 7, wherein the one or more protrusions comprise: First protrusion; The second protrusion is circumferentially spaced from the first protrusion within a range of about 100 degrees to about 140 degrees. and The third protrusion is circumferentially spaced from the second protrusion within a range of about 100 degrees to about 140 degrees.

9. A transcatheter heart valve prosthesis, said transcatheter heart valve prosthesis comprising: An annular frame extending along a longitudinal axis between the inlet and outlet ends of the transcatheter heart valve prosthesis, the annular frame including a plurality of struts and configured to be adjustable between radially collapsed and radially expanded positioning, the annular frame including a first radius at a first circumferential position and a second radius at a second circumferential position, the first and second circumferential positions being located at the same axial position along the longitudinal axis between the inlet and outlet ends, the first radius being different from the second radius.

10. The mandrel according to claim 9, wherein the first radius is greater than the second radius.

11. The heart valve prosthesis of claim 10, wherein the annular frame comprises, at a first axial position along the longitudinal axis of the frame: A first frame extension portion, the first frame extension portion being at the first circumferential position, the first frame extension portion having the first radius; and The first frame middle portion, located at the second circumferential position, having the second radius, and wherein the first circumferential position and the second circumferential position are circumferentially spaced apart from the frame longitudinal axis within a range of approximately 45 degrees to approximately 75 degrees.

12. The heart valve prosthesis of claim 11, wherein the annular frame comprises, at the first axial position along the longitudinal axis of the frame: The second frame extension, located at a third circumferential position, has the first radius, and wherein the second circumferential position and the third circumferential position are circumferentially spaced apart from the longitudinal axis of the frame in a range of about 45 degrees to about 75 degrees. and The second frame middle portion, the second frame middle portion at the fourth circumferential position, the second frame middle portion having the second radius, and wherein the third circumferential position and the fourth circumferential position are circumferentially spaced apart around the longitudinal axis of the frame in a range of about 45 degrees to about 75 degrees.

13. The heart valve prosthesis of claim 12, wherein the annular frame comprises, at the first axial position along the longitudinal axis of the frame: The third frame extension, located at a fifth circumferential position, has the first radius, and wherein the fourth and fifth circumferential positions are circumferentially spaced apart from the longitudinal axis of the frame in a range of approximately 45 degrees to approximately 75 degrees. and The third frame middle portion, the third frame middle portion at the sixth circumferential position, the third frame middle portion having the second radius, and wherein the fifth circumferential position and the sixth circumferential position are circumferentially spaced apart from the longitudinal axis of the frame in a range of about 45 degrees to about 75 degrees, and wherein the first circumferential position and the sixth circumferential position are circumferentially spaced apart from the longitudinal axis of the frame in a range of about 45 degrees to about 75 degrees.

14. A method for giving shape to an annular frame of a heart valve prosthesis, the method comprising: The main body of the mandrel is positioned within the cavity of the frame, the main body extending between a first end and a second end along the longitudinal axis of the mandrel, wherein a central region extends between the first end and the second end, the outer radial surface of the central region being spaced apart from the longitudinal axis of the mandrel at a first position by a first radial distance, and spaced apart from the longitudinal axis of the mandrel at a second position circumferentially spaced from the first position by a second radial distance, the first radial distance being different from the second radial distance; The frame is brought into contact with the main body to give the frame a shape, such that the frame includes a first radius at a first circumferential position and a second radius at a second circumferential position, the first circumferential position and the second circumferential position being located at the same axial position along the longitudinal axis of the frame, and the first radius being different from the second radius.

15. The method according to claim 14, further comprising: The cap-shaped part of the mandrel is positioned radially outside the frame such that the cap-shaped part circumferentially surrounds the frame and the main body portion, wherein the frame is radially located between the cap-shaped part and the main body portion.

16. The method according to claim 15, further comprising: The outer radial surface of the frame is brought into contact with one or more protrusions of the cap-shaped member, the one or more protrusions protruding from the end of the cap-shaped member toward the first end of the body portion.

17. The method of claim 16, wherein the one or more protrusions constrain outward radial movement of a portion of the frame that contacts the one or more protrusions, the one or more protrusions comprising: First protrusion; The second protrusion is circumferentially spaced from the first protrusion within a range of about 100 degrees to about 140 degrees. and The third protrusion is circumferentially spaced from the second protrusion within a range of about 100 degrees to about 140 degrees.

18. The method of claim 14, wherein the first radius is greater than the second radius.

19. The method of claim 18, wherein contacting the frame with the body portion to impart the shape comprises: A plurality of frame extensions having the first radius and a plurality of frame intermediate portions having the second radius are provided, the plurality of frame extensions and the plurality of frame intermediate portions being located at the same axial position along the longitudinal axis of the frame.

20. The method of claim 19, wherein the frame extensions of the plurality of frame extensions are circumferentially spaced from the intermediate portions of the plurality of frame intermediate portions about a longitudinal axis of the frame in a range of about 45 degrees to about 75 degrees.

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