TRANSCATHETER DEVICES AND METHODS OF REPLACING A HEART VALVE
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63/625,618, filed January 26, 2024, the entire content of which is incorporated herein by reference.
FIELD
[0002] The present disclosure relates generally to transcatheter devices and methods of replacing a heart valve, and more particularly to a transcatheter devices including a partially expandable stent frame, and methods of replacing a heart valve with a transcatheter device.
BACKGROUND
[0003] A human heart includes four heart valves that determine the pathway of blood flow through the heart: the mitral valve, the tricuspid valve, the aortic valve, and the pulmonary valve . The mitral and tricuspid valves are atrio-ventricular valves, which are between the atria and the ventricles, while the aortic and pulmonary valves are semilunar valves, which are in the arteries leaving the heart. Ideally, native leaflets of a heart valve move apart from each other when the valve is in an open position, and meet or “coapt” when the valve is in a closed position. Problems that may develop with valves include stenosis in which a valve does not open properly, and/or insufficiency or regurgitation in which a valve does not close properly. Stenosis and insufficiency may occur concomitantly in the same valve. The effects of valvular dysfunction vary, with regurgitation or backflow typically having relatively severe physiological consequences to the patient.
[0004] Diseased or otherwise deficient heart valves can be repaired or replaced using a variety of different types of heart valve surgeries. One conventional technique involves an open-heart surgical approach that is conducted under general anesthesia, during which the heart is stopped and blood flow is controlled by a heart-lung bypass machine.
[0005] More recently, minimally invasive approaches have been developed to facilitate catheter-based implantation of a prosthetic heart valve or prosthesis on the beating heart, intending to obviate the need for the use of classical sternotomy and cardiopulmonary bypass. In general terms, an expandable prosthetic valve is compressed about or within a catheter, inserted inside a body lumen of the patient, such as the femoral artery, and delivered to a desired location in the heart.
[0006] However, over time these prosthetic heart valves may also begin to become damaged or diseased, such as for example, stenosis. Accordingly, the diseased or damaged prosthetic heart valve may need replaced. Similar to that described above, catheter-based approaches have also been used to repair or replace the damaged prosthetic heart valves.
[0007] In light of the above, a need exists for a transcatheter device that can manage the leaflets of a heart valve during catheter-based implantations of prosthetic heart valves.
SUMMARY
[0008] The following presents a simplified summary of the disclosure to provide a basic understanding of some aspects described in the detailed description.
[0009] Features of the present disclosure provide a transcatheter device having an expandable stent frame that is configured to achieve a contracted orientation, a partially expanded orientation, and a fully expanded orientation to facilitate the replacement of a damaged and/or diseased heart valve by managing one or more existing leaflets of the defective heart valve. Providing a transcatheter device with the expandable stent frame that can manage the existing leaflets of the defective heart valve can allow a clinician to replace the defective heart valve while preventing obstructions that may be caused by the existing leaflets.
[0010] In aspects, a transcatheter device comprises an expandable stent frame comprising a proximal end and a distal end. The expandable stent frame extends from the proximal end to the distal end and the expandable stent frame is configured to achieve a contracted orientation, a partially expanded orientation, and a fully expanded orientation. The transcatheter device further comprises a sheath configured to receive at least the proximal end of the expandable stent frame. The transcatheter device still further comprises a distal tip coupled to the distal end of the expandable stent frame. Furthermore, an intermediate portion of the expandable stent frame defined between the proximal end and the distal end is configured to bend radially outward in the partially expanded orientation. [0011] In further aspects, a method of replacing a heart valve is provided. The method comprises distally advancing a transcatheter device comprising an expandable stent frame in a contracted orientation to a target treatment site, wherein the expandable stent frame comprises a proximal end and a distal end, and the expandable stent frame extends from the proximal end to the distal end. The method further comprises aligning a portion of the transcatheter device with leaflets of the heart valve. The method still further comprises expanding the expandable stent frame from the contracted orientation to a partially expanded orientation wherein an intermediate portion of the expandable stent frame defined between the proximal end and the distal end bends radially outward. The method then comprises expanding the expandable stent frame from the partially expanded orientation to a fully expanded orientation by releasing the proximal end to radially expand and releasing the distal end to radially expand.
[0012] Additional features and advantages of the aspects disclosed herein will be set forth in the detailed description that follows, and in part will be clear to those skilled in the art from that description or recognized by practicing the aspects described herein, including the detailed description which follows, the claims, as well as the appended drawings. It is to be understood that both the foregoing general description and the following detailed description present aspects intended to provide an overview or framework for understanding the nature and character of the aspects disclosed herein. The accompanying drawings are included to provide further understanding and are incorporated into and constitute a part of this specification. The drawings illustrate various aspects of the disclosure, and together with the description explain the principles and operations thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] 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:
[0014] FIG. 1 is a schematic view of an exemplary transcatheter device in accordance with aspects of the present disclosure;
[0015] FIG. 2A is a side schematic view of an exemplary prosthetic heart valve that can be replaced utilizing the transcatheter device of FIG. 1 in accordance with aspects of the present disclosure; [0016] FIG. 2B is a top schematic view of the exemplary prosthetic heart valve of FIG. 2A illustrating a lacerated leaflet of the prosthetic heart valve;
[0017] FIG. 3 is a side schematic view of an exemplary expandable stent frame of the transcatheter device shown in FIG. 1, shown in a fully expanded orientation in accordance with aspects of the present disclosure;
[0018] FIG. 4 is a side schematic view of another embodiment of the expandable stent frame of the transcatheter device shown in FIG. 1, shown in a fully expanded orientation in accordance with aspects of the present disclosure;
[0019] FIG. 5 is a side schematic view of the expandable stent frame of FIG. 3 indexing with the prosthetic heart valve of FIG. 2A in accordance with aspects of the current disclosure;
[0020] FIG. 6 is a side schematic view of the expandable stent frame of FIG. 4 indexing with the prosthetic heart valve of FIG. 2A in accordance with aspects of the current disclosure;
[0021] FIG. 7 is a schematic cross-sectional view of a distal end portion of the transcatheter device taken at line 7-7 of FIG. 1 showing the expandable stent frame in a contracted orientation;
[0022] FIG. 8 is a schematic cross-sectional view of a distal end portion of the transcatheter device taken at line 7-7 of FIG. 1 showing the expandable stent frame in a partially expanded orientation;
[0023] FIG. 9 is a schematic exploded view of an embodiment of the transcatheter device in accordance with aspects of the disclosure;
[0024] FIG. 10 schematically illustrates distally advancing a transcatheter device to a target treatment site;
[0025] FIG. 11 schematically illustrates aligning a portion of the transcatheter device with leaflets of a heart valve;
[0026] FIG. 12 schematically illustrates expanding an expandable stent frame from a contracted orientation to a partially expanded orientation wherein an intermediate portion of the expandable stent frame defined between the proximal end and the distal end bends radially outward;
[0027] FIG. 13 schematically illustrates distally advancing the partially expanded stent frame to reposition the leaflets of the heart valve; [0028] FIG. 14 schematically illustrates releasing a distal end of the expandable stent frame by distally advancing a distal tip of the transcatheter device relative to the expandable stent frame;
[0029] FIG. 15 schematically illustrates releasing the proximal end of the expandable stent frame by proximally retracting a sheath of the transcatheter device relative to the expandable stent frame; and
[0030] FIG. 16 schematically illustrates proximally retracting the transcatheter device to remove the transcatheter device from the target treatment site.
DETAILED DESCRIPTION
[0031] 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.
[0032] 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.
[0033] 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.
[0034] 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.
[0035] 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.
[0036] 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.
[0037] 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.
[0038] 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.
[0039] 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. 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.
[0040] 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.
[0041] Unless otherwise indicated, the terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction toward the clinician. In addition, the term “self-expanding” may be used in the following description with reference to one or more valve or stent structures of the prostheses hereof and is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration or vice versa. Non-exhaustive exemplary self-expanding materials include stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal. Mechanical memory may be imparted to a wire or stent structure by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol. Various polymers that can be made to have shape memory characteristics may also be suitable for use in aspects hereof to include polymers such as polynorborene, transpolyisoprene, styrene-butadiene, and polyurethane. As well poly L-D lactic copolymer, oligo caprylactone copolymer and poly cyclo-octine can be used separately or in conjunction with other shape memory polymers.
[0042] 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.
[0043] Heart valve prostheses have been developed for repair and replacement of diseased and/or damaged heart valves. Such heart valve prostheses can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based delivery systems. Such heart valve prostheses generally include a frame or stent and a prosthetic valve mounted within the frame. Such heart valve prostheses are delivered in a radially compressed or crimped configuration so that the heart valve prosthesis can be advanced through the patient’s vasculature. Once positioned at the treatment site, the heart valve prosthesis is expanded to engage tissue at the diseased heart valve region to, for instance, hold the heart valve prosthesis in position.
[0044] However, over time these heart valve prostheses may fail and require another procedure to replace the damaged heart valve. In order to facilitate the replacement of the failed prosthetic heart valve, a transcatheter device including a replacement prostheses can be employed.
[0045] FIG. 1 shows an exemplary transcatheter device 700 in accordance with the present disclosure. In some aspects, the transcatheter device 700 can comprise a handle device 902, a sheath 702, and a distal tip 704. In aspects, the handle device 902 can comprise one or more actuators (i.e., one actor, two actuators, etc.) configured to actuate various components of the transcatheter device 700. For example, the handle device 902 can be configured to proximally retract and/or distally advance the sheath 702. In some examples, the handle device 902 can be configured to proximally retract and/or distally advance the distal tip 704. The handle device 902 should not be construed to be limited to the above examples, and thus can interact with other components of the transcatheter device 700, which will become more apparent hereinafter.
[0046] In some aspects, the handle device 902 can be configured to actuate components of the transcatheter device 700 by any suitable actuating means. For example, the handle device 902 can actuate components of the transcatheter device 700 by sliding movements (e .g . , proximally and/or distally sliding the actuator in a proximal or distal direction), rotational movements (e.g., clockwise and/or counter clockwise rotation), and/or pressure actuated movements (e.g., button presses). In some aspects, the handle device 902 can be configured to be mechanically actuated, electrically actuated, electromechanically actuated, and/or any other suitable actuating means. It should be understood that the above examples are not meant to be limiting, and any other suitable handle device may be utilized with the transcatheter device 700 described hereinafter.
[0047] FIGS. 2A and 2B illustrate an exemplary implanted prosthetic heart valve 200 that has been previously implanted within a patient and has failed, such as for example, by calcification of the implanted prosthetic heart valve 200 resulting in a narrowing of the opening of the implanted prosthetic heart valve 200. Accordingly, the exemplary implanted prosthetic heart valve 200 will be utilized hereinafter with reference to a transcatheter device 700 in accordance with the present disclosure in order to described various operations and components of the transcatheter device 700. [0048] As shown, the implanted prosthetic heart valve 200 can comprise a stent frame 202, and prosthetic heart valve leaflets 204. In some aspects, the stent frame 202 may be a self-expandable stent frame, such as for example, a nitinol self-expanding stent frame, or may be a balloon expandable stent frame. In further aspects, the stent frame 202 can comprise a proximal portion 201 (outflow end) and a distal portion 203 (inflow end). In some aspects, the proximal portion 201 and the distal portion 203 can comprise a larger diameter than an intermediate portion 205 of the stent frame 202. In some aspects, the proximal portion 201 may have a greater diameter, a smaller diameter, or an equal diameter to that of the distal portion 203. In some aspects, the stent frame 202 can comprise a lumen 207 extending through a central axis 209 of the stent frame 202.
[0049] In aspects, the prosthetic heart valve leaflets 204 can comprise one or more leaflets, such as for example, three leaflets (shown in FIG. 2B) to emulate a tricuspid valve. In some aspects, the prosthetic heart valve leaflets 204 can comprise two leaflets, such as for example, to emulate a bicuspid valve. As illustrated in FIG. 2B, the prosthetic heart valve leaflets 204 of the implanted prosthetic heart valve 200 may be lacerated (e.g., by a laceration device). In some non-limiting examples, the prosthetic heart valve leaflets 204 can be lacerated to bisect (e.g., lacerated to divide the prosthetic heart valve leaflets 204 into two substantially equal parts) one or more of the prosthetic heart valve leaflets 204. For example, FIG. 2B shows a lacerated portion 206 of one of the prosthetic heart valve leaflets 204 that has been lacerated to bisect the prosthetic heart valve leaflets 204.
[0050] The lacerated portion 206 can comprise a first lacerated portion 208 and a second laceration portion 210 that are substantially equal in size. In other aspects, various other locations along one or more of the prosthetic heart valve leaflets 204 can be lacerated such that the first lacerated portion 208 and the second lacerated portion 210 are not substantially equal. In other aspects, the prosthetic heart valve leaflets 204 can be lacerated to form more than two lacerated pieces. It should be understood that while FIG. 2B only shows one of the three prosthetic heart valve leaflets 204 lacerated, the other two leaflets can be lacerated as described above. The leaflets can be lacerated by scalpel, electrode, or other cutting technique. It should be further understood that FIG. 2B is merely exemplary and should not limit the transcatheter device 700 to use with only the lacerated leaflets as described above. Thus, the transcatheter device 700 can be employed with other types of lacerated leaflets. In some aspects, the prosthetic heart valve leaflets 204 may be lacerated prior to inserting the transcatheter device 700. In aspects, the prosthetic heart valve leaflets 204 may be lacerated while concurrently inserting the transcatheter device 700 into the patient and/or may be lacerated with a lacerating feature of the transcatheter device 700. Alternatively, in some aspects, the prosthetic heart valve leaflets 204 may not be lacerated wherein the heart valve may be replaced without lacerating the existing leaflets.
[0051] It should be understood that while the transcatheter device 700 will be referred to hereinafter as being utilized with the exemplary implanted prosthetic heart valve 200, other suitable implanted prosthetic heart valves known in the art may be utilized with the transcatheter device 700 and methods described in further detail later. Furthermore, the transcatheter device 700 may also be utilized in a native heart valve (i.e., an aortic valve, a mitral valve, a tricuspid valve, and/or a pulmonic valve).
[0052] As shown in FIG. 3, the transcatheter device 700 can comprise an expandable stent frame 300 in accordance with the current disclosure. In some aspects, the expandable stent frame 300 can comprise a proximal end 302 (outflow end) and a distal end 304 (inflow end). The expandable stent frame 300 can extend from the proximal end 302 to the distal end 304. In aspects, the expandable stent frame 300 can be configured to achieve a contracted orientation 706 (shown in FIG. 7), a partially expanded orientation 802 (shown in FIG. 8), and a fully expanded orientation 301, 401 (shown in FIGS. 3-4). In some aspects, the expandable stent frame 300 can further comprise a lumen 316 extending from the proximal end 302 to the distal end 304 along a central axis 305 of the expandable stent frame 300.
[0053] In some aspects, the transcatheter device 700 can comprise a prosthetic heart valve 303 (also shown in FIG. 16) comprising the expandable stent frame 300. For example, the prosthetic heart valve 303 can comprise one or more leaflets 338 (e.g., two or more leaflets). In some examples, the one or more leaflets 338 can comprise three leaflets to emulate a tricuspid valve. In some aspects, the one or mor leaflets 338 can comprise two leaflets, such as for example, to emulate a bicuspid valve. Any other suitable number of leaflets may be utilized.
[0054] The term “fully expanded orientation” should be construed to mean that the expandable stent frame 300 cannot expand any further with respect to the location at which the expandable stent frame 300 has been deployed (i.e., fully released from the transcatheter device 700). For example, when the expandable stent frame 300 is discussed with reference to the implanted prosthetic heart valve 200, the term “fully expanded orientation” will refer to the expandable stent frame 300 being fully released from the transcatheter device 700 whereby the expandable stent frame 300 has engaged the implanted prosthetic heart valve 200 such that the expandable stent frame 300 can no longer expand. Accordingly, the term “fully expanded orientation” can mean that the expandable stent frame 300 cannot radially expand any further with respect to the location at which it has been deployed, but may still be capable of further radial expansion when the expandable stent frame 300 is free from surrounding structure. In some cases, the term “fully expanded orientation” may refer to the expandable stent frame 300 not being capable of any further radial expansion regardless of the location at which the expandable stent frame 300 is deployed (i.e., the expandable stent frame 300 cannot radially expand any further, even when free from surrounding structure).
[0055] In aspects, a proximal portion 306 of the expandable stent frame 300 adjacent the proximal end 302 can comprise a first plurality of cell structures 310. In further aspects, a distal portion 308 of the expandable stent frame 300 adjacent the distal end 304 can comprise a second plurality of cell structures 312. As show, the first plurality of cell structures 310 and the second plurality of cell structures 312 can comprise diamond-shaped cell structures.
[0056] It should be understood that the expandable stent frame 300 is merely exemplary and any other suitable expandable stent frames may be utilized with the exemplary transcatheter device 700 described herein. Furthermore, the first plurality of cell structures 310 and the second plurality of cell structures 312 should not be limited to diamond-shaped cell structures and should not be limited to the number of cell structures and/or size of the cell structures shown in FIG. 3. Accordingly, more or less suitable cell structures with a variety of different shapes and sizes can be employed with the transcatheter device 700.
[0057] In aspects, the proximal portion 306 can comprise a first outwardly bulging circumferential portion 314. The first outwardly bulging circumferential portion 314 can encircle the lumen 316 of the expandable stent frame 300 and may bulge radially outward with respect to at least one commissure post 318. In some aspects, the first outwardly bulging circumferential portion 314 can taper towards the distal portion 308 and adjoin a first end of the at least one commissure post 318. In aspects, a second end of the at least one commissure post 318 can adjoin the distal portion 308. The distal portion 308 can comprise a second outwardly bulging circumferential portion 320 that can encircle the lumen 316 and may bulge radially outward with respect to the at least one commissure post 318. In some aspects, the second outwardly bulging circumferential portion 320 can taper towards the proximal portion 306. In aspects, as shown, the second outwardly bulging circumferential portion 320 can have a smaller diameter than the first outwardly bulging circumferential portion 314. In other aspects, the second outwardly bulging circumferential portion 320 can have a greater diameter than the first outwardly bulging circumferential portion 314. In yet another aspect, the second outwardly bulging circumferential portion 320 can have a substantially equal diameter to that of the first outwardly bulging circumferential portion 314.
[0058] In some aspects, the transcatheter device 700 can comprise a skirt 321 comprising a base portion 322 coupled to an intermediate portion 324 of the expandable stent frame 300. The skirt 321 can further comprise an axial edge portion 326 that is configured to flip over an outer surface of the base portion 322 of the skirt 321. The base portion 322 is shown generally above dotted line 328, while the axial edge portion 326 is shown generally below the dotted line 328. The dotted line 328 is utilized herein to show a general location of where the base portion 322 is coupled to the intermediate portion 324 of the expandable stent frame 300.
[0059] In some aspects, the axial edge portion 326 is not coupled to the intermediate portion 324. In this way, the axial edge portion 326 can be configured to flip over the outer surface of the base portion 322 of the skirt 321 about the dotted line 328. In some examples, the axial edge portion 326 can flip over the outer surface of the base portion 322 of the skirt 321 as a result of distally advancing and/or proximally retracting the transcatheter device 700. It should be noted that the dotted line 328 is merely exemplary and used only visually to described the base portion 322 and the axial edge portion 326 of the skirt 321, and thus is not limiting. For example, the base portion 322 of the skirt
321 should not be construed to be coupled to the intermediate portion 324 of the expandable stent frame 300 only along the dotted line 328. The base portion 322 and/or the axial edge portion 326 can be at any portion along a length of the skirt 321 (e.g., any portion above or below the dotted line 328). For example, the axial edge portion 326 can be a length from about 1 mm to about 3 mm. In some aspects, if the transcatheter device 700 is utilized to replace an implanted prosthetic heart valve 200 (e.g., such as that shown in FIG. 1), the skirt 321 may flip as a result of contacting a portion of the implanted prosthetic heart valve 200, such as for example, contacting one or more of the prosthetic heart valve leaflets 204 of the implanted prosthetic heart valve 200.
[0060] In some aspects, the axial edge portion 326 can be configured such that it does not flip over the outer surface of the base portion 322 of the skirt 321. For example, by limiting a length of the axial edge portion 326 from about 1mm to about 2mm, the skirt 321 will be prevented from flipping over the outer surface of the base portion 322. Rather, the skirt 321 will bend (i.e., as opposed to flipping) such that the inner surface of the axial edge portion 326 will face a direction towards the distal end 304 of the expandable stent frame 300. This is a result of the force that is required to flip the axial edge portion 326 over the outer surface of the base portion 322 being greater than any force actually applied to the axial edge portion 326 (e.g., a frictional force between the prosthetic heart valve leaflets 204 of the implanted prosthetic heart valve 200 and the axial edge portion 326).
[0061] In some aspects, the base portion 322 can be coupled to the expandable stent frame 300 along one or more of the at least one commissure posts 318. The base portion
322 can be coupled to the intermediate portion 324 of the expandable stent frame 300 by any suitable coupling means. For example, the base portion 322 can be coupled to the expandable stent frame 300 by stitching, such as for example, coupling the base portion 322 to the expandable stent frame 300 by a stitching pattern that extends from the first end of one or more of the commissure posts 318 to the second end of one or more of the commissure posts 318 and along a portion of the distal portion 308 (i.e., along one or more of the second plurality of cell structures 312). While the axial edge portion 326 has been described above as being configured to flip over an outer surface of the base portion 322 of the skirt 321, in some aspects, the axial edge portion 326 can also be coupled to the expandable stent frame 300 (i.e., by a stitching pattern such as the one described above). In this example, the axial edge portion 326 would not be configured to flip over the base portion 322 (e.g., would remain fixed to the expandable stent frame 300).
[0062] In some aspects, the skirt 321 can extend (as shown in FIG. 3) to only a portion of the distal portion 308, such as for example, leaving a portion of the second plurality of cell structures 312 uncovered. Allowing a portion of the second plurality of cell structures 312 to remain uncovered by the skirt 321 may be beneficial in reducing systolic blood pumping forces while the transcatheter device 700 is in the partially expanded orientation 802. In some examples where the expandable stent frame 300 comprises the prosthetic heart valve described previously (e.g., having one or more leaflets), leaving a portion of the second plurality of cell structures 312 uncovered by the skirt 321 will allow the prosthetic heart valve to function while the transcatheter device 700 is in the partially expanded orientation 802. In some aspects, the second plurality of cell structures 312 can be fully covered, such as for example, the skirt 321 may extend to the distal end 304 of the expandable stent frame 300. In other aspects, the skirt 321 can be omitted and the transcatheter device 700 will still function accordingly.
[0063] In aspects, an inner surface of the axial edge portion 326 comprises a higher coefficient of friction than an outer surface of the axial edge portion 326. The term “inner surface” and “outer surface” are used to denote the surfaces of the axial edge portion 326 when the axial edge portion 326 has not been flipped, as shown. Thus, when the axial edge portion 326 is flipped, the inner surface will appear to be the outer surface and the outer surface will appear to be the inner surface. However, the inner surface should be construed to be the surface that faces a direction of the lumen 316 while the axial edge portion 326 has not been flipped, and thus when the axial edge portion 326 is flipped the “inner surface,” despite facing a direction away from the lumen 316, will still be referenced as “inner surface.”
[0064] In the example generally described above for replacing an implanted prosthetic heart valve 200 (e.g., such as the implanted prosthetic heart valve 200, shown in FIG. 2), the inner surface comprising a higher coefficient of friction than the outer surface of the axial edge portion 326 may be beneficial in providing higher friction (compared to that of the outer surface of the axial edge portion 326) between a portion of the implanted prosthetic heart valve 200 and the axial edge portion 326, such as for example, providing greater friction between the axial edge portion 326 and one or more of the prosthetic heart valve leaflets 204 of the implanted prosthetic heart valve 200. The higher friction may be especially useful in repositioning the prosthetic heart valve leaflets 204 of the implanted prosthetic heart valve 200, such as for example, helping to distally advance the prosthetic heart valve leaflets 204 in a distal direction (i.e., to avoid obstructing the coronary arteries while replacing the implanted prosthetic heart valve 200). Furthermore, providing a lower coefficient of friction on the outer surface as compared to the inner surface will help to prevent the expandable stent frame from getting stuck within the transcatheter device 700 (e.g., the skirt 321 getting stuck within the sheath 702).
[0065] In some aspects, the skirt 321 can comprise a radiopaque polymer. For example, a radiopaque polymer may be beneficial in facilitating a clinician in determining when the expandable stent frame 300 has been properly positioned within a patient. Any suitable polymer known in the art may be utilized. In other aspects, the skirt 321 can comprise a fabric. For example, the fabric may comprise any suitable material such as, but not limited to, woven polyester such as polyethylene terephthalate, polytetrafluoroethylene (PTFE), or other biocompatible materials.
[0066] Still viewing FIG. 3, in aspects the distal end 304 of the expandable stent frame 300 can comprise a plurality of crowns 330. In further aspects, at least one crown of the plurality of crowns 330 can comprise a tongue 332 configured to be received by the distal tip 704 (explained in further detail with reference to FIG. 8). In one example, “received by” can mean “received within.” For example, the tongue 332 can be received within the distal tip 704. In some aspects, each crown of the plurality of crowns 330 can comprise a tongue 332 that is configured to be received by the distal tip 704. In some examples, each crown of the plurality of crowns 330 can comprise a tongue 332. For example, if the plurality of crowns 330 comprises a first crown and a second crown then the first crown and the second crown can comprise a tongue 332. In some examples, if the plurality of crowns 330 comprises a first crown, a second crown, and a third crown then the first crown, the second crown, and the third crown can each comprise a tongue 332. Any other suitable combination for the number of crowns and tongues may be acceptable (e.g., one crown with one tongue, two crowns with one tongue, three crowns with two tongues, and so on). In some aspects, the tongue 332 can comprise a solid tongue (e.g., no holes), such as that shown in FIG. 3. In alternative aspects, the tongue 332 can comprise a hollow tongue. For example the tongue 332 can comprise a wire structure (such as that shown in FIG. 5) that comprises a cut out portion within the center of the tongue 332.
[0067] In some aspects, the plurality of crowns 330 can comprise three or less crowns. In an example with three crowns, as shown in FIG. 3, each crown (e.g., a first crown, a second crown, and a third crown) may be equidistantly spaced around the distal end 304 of the expandable stent frame 300. In some examples, the three crowns can be skewed around the distal end 304 of the expandable stent frame 300 (e.g., not equidistantly spaced). It should be noted that while FIG. 3 illustrates an embodiment with three crowns, FIG. 3 is not meant to be limiting. For example, the plurality of crowns can comprise two crowns. In some such examples, the plurality of crowns 330 can comprise a first crown and a second crown. In such an example, the first crown and the second crown can be diametrically opposed (e.g., a circumferential distance from one crown to another is equal when measured clockwise and/or counterclockwise) around the distal end 304 of the expandable stent frame 300. In other examples with two crowns, the two crowns do not have to be diametrically opposed, and may have any other suitable position around the distal end 304 of the expandable stent frame 300. [0068] In some aspects (not shown), the distal end 304 can comprise more than three crowns 330 (e.g., four crowns, five crowns, and so on) or less than two crowns (e.g., one crown). However, reducing the number of crowns 330 may be especially beneficial in facilitating the loading of the expandable stent frame 300 within the transcatheter device 700 by reducing the amount of crowns 330 that will need to be received by (e.g., within) the distal tip 704, which will become more apparent hereinafter.
[0069] In aspects, the proximal end 302 of the expandable stent frame 300 can comprise a plurality of crowns 334. For example, the proximal end 302 of the expandable stent frame 300 can comprise one crown, two crowns, three crowns, and so on. In some aspects, at least one crown of the plurality of crowns 334 of the proximal end 302 can comprise a tongue 336 configured to be received by the sheath 702. In one example, “received by” can mean “received within.” For example, the tongue 336 can be received within the sheath 702. In some aspects, any other number of tongues can be provided. For example, each crown of the plurality of crowns 334 can comprise a tongue 336. The plurality of crowns 334 can be positioned around the proximal end 302 of the expandable stent frame 300 similarly as described above with reference to the plurality of crowns 330 of the distal end 304 of the expandable stent frame 300. [0070] FIG. 4 illustrates an additional embodiment of an expandable stent frame 400. As shown, the expandable stent frame 400 can comprise a proximal portion 402 (inflow end) and a proximal end 403 (outflow end) that are similar to the proximal portion 306 and the proximal end 302 respectively, as described with reference to FIG. 3. Thus, FIG. 3 can be referenced to further understand the proximal portion 402 of FIG. 4. In aspects, a distal portion 404 of the expandable stent frame 400 can comprise a plurality of cell structures 406 that converge towards a plurality of crowns 408 positioned at a distal end 410 ofthe expandable stent frame 400. In aspects, the plurality of crowns 408 can comprise an elongated crown portion 412 configured to facilitate compressing the expandable stent frame 400.
[0071] The expandable stent frame 400 can operate similar to that shown in FIG. 3. However, in some aspects, the expandable stent frame 400 can comprise uniform connecting structures 407. The uniform connecting structures 407 may be especially useful for providing uniform expansion and compression of the expandable stent frame 400. Furthermore, the uniform connecting structures 407 will help to provide support (e.g., rigidity) to the expandable stent frame 400.
[0072] In further aspects, at least one crown of the plurality of crowns 408 is configured to be received by the distal tip 704 (explained in further detail with reference to FIG. 8). In one example, “received by” can mean “received within.” For example, the at least one crown can be received within the distal tip 704. The elongated crown portion 412 will be beneficial to provide a receiving structure to be received by the distal tip 704, while also promoting uniform expansion and compression of the expandable stent frame 400.
[0073] Although not show, at least one crown of the plurality of crowns 408 may further comprise a tongue similar to that described in FIG. 3. In this case, the tongue can be configured to be received by the distal tip 704, such as for example, the tongue(s) can be received within the distal tip 704. In some aspects, each crown of the plurality of crowns 408 can comprise a tongue that is configured to be received by the distal tip 704.
[0074] In aspects, the expandable stent frame 400 can comprise one or more commissure posts 414. The one or more commissure posts 414 can be substantially similar to that described above with reference to FIG. 3.
[0075] In further aspects, a skirt (not shown) can be coupled to the expandable stent frame 400 as described in FIG. 3. For example, the skirt can be coupled to an intermediate portion 416 of the expandable stent frame 400, such as for example, being coupled to the one or more commissure posts 414 by a stitching pattern. In some aspects, the expandable stent frame 400 can comprise a first outwardly bulging circumferential portion 418 and a second outwardly bulging circumferential portion 420 substantially similar to FIG. 3 otherwise than where denoted above.
[0076] In some aspects, similar to that of FIG. 3 (not shown here for clarity), the transcatheter device 700 can comprise a prosthetic heart valve comprising the expandable stent frame 400. For example, the prosthetic heart valve can comprise one or more leaflets, such as the leaflets described with reference to FIG. 3.
[0077] It should be understood that the expandable stent frame 300, 400 is merely exemplary and thus not meant to be limiting. Accordingly, various elements of the expandable stent frame 300, 400 may be used interchangeably with one another. It should further be understood that other expandable stent frames known in the art may further be utilized in combination with the transcatheter device 700 disclosed herein.
[0078] FIGS. 5 and 6 illustrate the expandable stent frame 300, 400 respectively, after being inserted into the lumen 207 of the implanted prosthetic heart valve 200. In aspects, as shown in both FIGS. 5 and 6, the proximal portion 306, 402 is configured to index with the stent frame 202 of the implanted prosthetic heart valve 200. In some examples, “index” can mean contacting, engaging, holding, interlocking, interconnecting, joining, mating, coupling, and/or the like. For example, the first outwardly bulging circumferential portion 314, 418 can index with an inner region 502 of the proximal portion 201 of the stent frame 202.
[0079] In some examples, the first outwardly bulging circumferential portion 314, 418 will index by way of a radial expansion force while in the fully expanded orientation 301, 401. For instance, as shown in FIGS. 5 and 6, the first outwardly bulging circumferential portion 314, 418 is fully expanded such that the first outwardly bulging circumferential portion 314, 418 is biased against the inner region 502 of the proximal portion 201 of the stent frame 202. In this way, the expandable stent frame 300, 400 will resist lateral and axial movement, when in the fully expanded orientation 301, 401.
[0080] In some examples, the distal portion 308, 404 is configured to index with the stent frame 202 of the implanted prosthetic heart valve 200. For example, the second outwardly bulging circumferential portion 320, 420 can index with an inner region 504 of the distal portion 203 of the stent frame 202. [0081] In some examples, the second outwardly bulging circumferential portions 320, 420 will index by way of a radial expansion force while in the fully expanded orientation 301, 401. For example, the second outwardly bulging circumferential portion 320, 420 is fully expanded such that the second outwardly bulging circumferential portion 320, 420 is biased against the inner region 504 of the distal portion 203 of the stent frame 202. In this way, the expandable stent frame 300, 400 will further resist lateral and axial movement, when in the fully expanded orientation 301, 401.
[0082] In some aspects, because the first outwardly bulging circumferential portion 314, 418 and the second outwardly bulging circumferential portion 320, 420 are greater than the intermediate portion 205 of the stent frame 202 when in the fully expanded orientation 301, 401, the expandable stent frame 300, 400 will further resist movement. For example, the expandable stent frame 300, 400 will not be able to move axially when in the fully expanded orientation 301, 401.
[0083] FIG. 7 shows the exemplary transcatheter device 700 comprising the sheath 702 and the distal tip 704. In aspects, the sheath 702 can be configured to receive at least the proximal end 302, 403 of the expandable stent frame 300, 400. For example, the sheath 702 can be slidably positioned over the expandable stent frame 300, 400. Furthermore, as shown, the distal tip 704 can be coupled to the distal end 304, 410 of the expandable stent frame 300, 400. For example (as explained previously), the distal end 304, 410 of the expandable stent frame 300, 400 can be received by (e.g., within) the distal tip 704.
[0084] In aspects, the exemplary transcatheter device 700 can further comprise a distal tip hub 708, wherein an outer shaft 710 can be coupled to the distal tip hub 708. The transcatheter device 700 can comprise an inner shaft 712. Furthermore in some aspects, the inner shaft 712 can be configured to slidably move with respect to the distal tip hub 708 and the outer shaft 710. In some examples, the inner shaft 712 can be configured to distally advance the distal tip 704 relative to the expandable stent frame 300, 400. In aspects, the inner shaft 712 can comprise an inner lumen 713 configured to receive an object. For example, the inner lumen 713 can be configured to receive a guide wire.
[0085] As shown in FIG. 7, the expandable stent frame 300, 400 is in the contracted orientation 706. In aspects, the contracted orientation 706 can comprise the proximal end 302, 403 being in a collapsed state within the sheath 702. For example, the sheath 702 can radially compress (e.g., apply a radial compression force to the proximal end 302, 403) the proximal end 302, 403 of the expandable stent frame 300, 400 to compress the proximal end 302, 403 into the collapsed state. In aspects, the contracted orientation 706 can comprise the distal end 304, 410 being in the collapsed state within the distal tip 704. For example, the distal tip 704 can comprise a lumen 714 that retains the distal end 304, 410 of the expandable stent frame 300, 400 therein. In some examples, the lumen 714 can comprises one or more slots for receiving the tongue 332 within the distal tip 704. In some aspects, when the expandable stent frame 300, 400 is in the contracted orientation 706, the expandable stent frame 300, 400 can be contracted (e.g., compressed) around the outer shaft 710.
[0086] FIG. 8 illustrates the transcatheter device 700 with the expandable stent frame 300, 400 in the partially expanded orientation 802. In aspects, the sheath 702 is configured to be proximally and/or distally retracted relative to the expandable stent frame 300, 400. For example, as shown, the sheath 702 has been proximally retracted. In some aspects, proximally retracting the sheath 702 expands the expandable stent frame 300, 400 from the contracted orientation 706 to the partially expanded orientation 802. In further aspects, the intermediate portion 324, 416 ofthe expandable stent frame 300, 400 defined between the proximal end 302, 403 and the distal end 304, 410 is configured to bend radially outward in the partially expanded orientation 802. For example, the partially expanded orientation 802 can comprise the intermediate portion 324, 416 being bent radially outward relative to the sheath 702. In some examples, “bend” means that the intermediate portion 324, 416 bows radially outwardly to form a substantially convex outer profile, as shown. In some examples, the convex outer profile can resemble a balloon-shaped structure.
[0087] In some aspects, the partially expanded orientation 802 can further comprise the proximal end 302, 403 being in the collapsed state within the sheath 702. For example, the sheath 702 can apply the previously described radial compression force to maintain the proximal end 302 in the collapsed state. In aspects, the partially expanded orientation 802 can further comprise the distal end 304, 410 being in the collapsed state within the distal tip 704. For example, the distal tip 704 can comprise the lumen 714 that retains the distal end 304, 410 of the expandable stent frame 300, 400 (such as that described above for the contracted orientation 706).
[0088] In some examples not shown, the transcatheter device 700 may further comprise one or more releasable cords around the expandable stent frame 300, 400 when in the contracted orientation 706 and the partially expanded orientation 802. For example, employing a releasable cord around the intermediate portion 324, 416 can maintain the expandable stent frame 300, 400 in the contracted orientation 706 after the sheath 702 has been proximally retracted. In this way, releasing the releasable cord can bend the expandable stent frame 300, 400 radially outward as shown in FIG. 8. Similarly, releasable cords can be utilized with the proximal end 302, 403 and the distal end 304, 410 as described with reference to the intermediate portion 324, 416.
[0089] FIG. 9 illustrates the exemplary handle device 902 that can be utilized with the transcatheter device 700. In aspects, the handle device 902 can comprise one or more actuators 904. In aspects, the one or more actuators 904 can be configured to actuate the sheath 702 and/or the distal tip 704. For example, the one or more actuators 904 can proximally and/or distally retract the sheath 702 and/or the distal tip 704. In some examples, a first actuator can actuate the sheath 702 (e.g., by a sliding movement of the first actuator) while a second actuator can actuate the distal tip 704 (e.g., by a slide movement of the second actuator). In some examples, a first actuator can proximally and/or distally retract the sheath 702 by way of a shaft 906 interconnected to the sheath 702. In further examples, a second actuator can proximally and/or distally retract the distal tip 704 by the inner shaft 712. The above described configurations of the handle device 902 are merely exemplary, and thus any other suitable configurations for actuating the transcatheter device 700 can be utilized. Furthermore, the handle device 902 should not be construed as being configured to only actuate the above- mentioned components. Rather, the handle device 902 can actuate any other suitable components of the transcatheter device 700, such as for example, the distal tip hub 708, the outer shaft 710, etc. Furthermore, because the handle device 902 is merely exemplary, any other suitable handle device may be utilized in actuating the transcatheter device 700.
[0090] FIGS. 10-16 will now describe a method of replacing a heart valve 1002 with initial reference to FIGS. 1-9 with the understanding that similar or identical methods may be provided in the other embodiments of the disclosure. In some aspects, the heart valve 1002 can comprise an implanted prosthetic heart valve 200. In some aspects, the heart valve 1002 can comprise a native heart valve, such as for example, a tricuspid valve, a pulmonary valve, a mitral valve, and/or an aortic valve.
[0091] Referring to FIG. 10, the method can comprise distally advancing a transcatheter device 700 comprising an expandable stent frame 300, 400 in a contracted orientation 706 to a target treatment site 1004. In aspects, the expandable stent frame 300, 400 can comprise a proximal end 302, 403 and a distal end 304, 410, wherein the expandable stent frame 300, 400 can extend from the proximal end 302, 403 to the distal end 304, 410. In some examples, the target treatment site 1004 comprises the implanted prosthetic heart valve 200, as shown. In other examples, the target treatment site 1004 can comprise a native heart valve, such as for example, a tricuspid valve, a pulmonary valve, a mitral valve, and/or an aortic valve. In some aspects, the transcatheter device 700 can comprise a prosthetic heart valve 303 (see FIG. 16) comprising the expandable sent frame 300, 400.
[0092] Furthermore, in some aspects, distally advancing the transcatheter device 700 can further comprise distally advancing the transcatheter device 700 along a guide wire 1006 and through a patient’s vasculature. In some examples, the transcatheter device 700 can be distally advanced along the guide wire 1006 through an incision that is made at an anatomical location of the patient’s vessel. For example, a transfemoral approach that involves making an incision in the groin and operates as a passageway for guiding the transcatheter device 700 to the target treatment site 1004. In some aspects, the transcatheter device 700 can be distally advanced along the guide wire by way of an inner lumen 713 extending through the transcatheter device 700.
[0093] As shown in FIG. 11, in some aspects, the method can comprise aligning a portion of the transcatheter device 700 with leaflets 1102 of the heart valve 1002. In some examples, the leaflets 1102 can comprise prosthetic heart valve leaflets 204. For example, if the target treatment site 1004 is an implanted prosthetic heart valve 200, the leaflets 1102 can be the prosthetic heart valve leaflets 204. In some examples, the leaflets 1102 can comprise native heart valve leaflets (not shown). For example, if the target treatment site 1004 is a native heart valve (such as those described above), the leaflets 1102 can be native leaflets. As one example to illustrate this principle, if the transcatheter device 700 is distally advanced into the implanted prosthetic heart valve 200 (e.g., the target treatment site 1004), then the leaflets 1102 of the heart valve 1002 can be the prosthetic heart valve leaflets 204 of the implanted prosthetic heart valve 200. As another example demonstrating the above mentioned principle, if the transcatheter device 700 is distally advanced into the native heart valve (e.g., the target treatment site 1004), then the leaflets 1102 of the heart valve 1002 can be the leaflets of the native heart valve (e.g., tricuspid valve, aortic valve, etc.). In other examples, if the transcatheter device 700 is distally advanced into the implanted prosthetic heart valve 200 (e.g., the target treatment site 1004), the leaflets 1102 of the heart valve 1002 can be the leaflets of the native heart valve (e.g., tricuspid valve, aortic valve, etc.).
[0094] In some aspects, the portion of the transcatheter device 700 that is aligned with the leaflets 1102 of the heart valve can comprise a distal portion 1104 of the transcatheter device 700. In some examples, the distal portion 1104 can be a distal end of the sheath 702. In other examples, the distal portion 1104 can be a portion of a distal tip 704 of the transcatheter device 700, such as for example, a proximal portion or a distal portion of the distal tip 704. In other examples, the distal portion 1104 can comprise any other suitable portion of the transcatheter device 700.
[0095] In aspects, as shown in FIG. 12, the method can comprise expanding the expandable stent frame 300, 400 from the contracted orientation 706 to a partially expanded orientation 802, wherein an intermediate portion 324, 416 of the expandable stent frame 300, 400 defined between the proximal end 302, 403 and the distal end 304, 410 bends radially outward. For example, as shown, the intermediate portion 324, 416 can radially expand outward within the heart valve 1002, such that a distance between the intermediate portion 324, 416 and the heart valve 1002 is decreased. In some examples, when the distance is decreased, one or more sections of the intermediate portion 324, 416 can contact one or more sections of the heart valve 1002. For example, a section of the intermediate portion 324, 416 can contact the leaflets 1102 of the heart valve 1002. In some examples, the leaflets 1102 that may be contacted by the intermediate portion 324, 416 can be the prosthetic heart valve leaflets 204 of the implanted prosthetic heart valve 200. In other examples, the leaflets 1102 that may be contacted by the intermediate portion 324, 416 can be the leaflets of the native heart valve (not illustrated). In alternative examples, the intermediate portion 324, 416 can bend radially outward, but not contact the heart valve 1002. For example, an apex (e.g., the portion that is radially bent outward the furthest) of the intermediate portion 324, 416 can be positioned to expand above an intermediate portion 1202 of the heart valve 1002, such that a point of contact (e.g., the apex and the intermediate portion 1202 of the heart valve 1002 with the smallest diameter) between the intermediate portion 324, 416 of the expandable stent frame 300, 400 and the intermediate portion 1202 of the heart valve is removed. In this way, the intermediate portion 324, 416 will not contact the heart valve 1002. In some examples where the heart valve 1002 is the implanted prosthetic heart valve 200, the intermediate portion 1202 can be the intermediate portion 205 of the implanted prosthetic heart valve 200. In some examples where the heart valve 1002 is the native heart valve, the intermediate portion 1202 can be an intermediate portion of the native heart valve.
[0096] In some aspects, partially expanding the expandable stent frame 300, 400 further comprises maintaining both the proximal end 302, 403 and the distal end 304, 410 in a collapsed state (as shown in FIG. 12). In some examples, partially expanding the expandable stent frame 300, 400 comprises proximally retracting a sheath 702 of the transcatheter device 700. In this example, the sheath 702 can be proximally retracted far enough to expand the expandable stent frame 300, 400 from the contracted orientation 706 to the partially expanded orientation 802, but not so far as to release the proximal end 302, 403 from the sheath 702.
[0097] In some aspects, after expanding the expandable stent frame 300, 400 from the contracted orientation 706 to the partially expanded orientation 802, the method can further comprise recapturing the expandable stent frame 300, 400 to collapse the expandable stent frame 300, 400 from the partially expanded orientation 802 to the contracted orientation 706 prior to expanding the expandable stent frame 300, 400 from the partially expanded orientation 802 to a fully expanded orientation 301, 401. In some examples, recapturing the expandable stent frame 300, 400 can comprise distally advancing the sheath 702 to apply a radially compressive force to the expandable stent frame 300, 400 to collapse the expandable stent frame 300, 400 from the partially expanded orientation 802 to the contracted orientation 706.
[0098] Viewing FIG. 13, in some aspects, the method can further comprise distally advancing the partially expanded stent frame 300, 400 to reposition the leaflets 1102 of the heart valve 1002. Prior to advancing, the partially expanded stent frame may already be in contact with the leaflets or it may not be in contact with the leaflets and is brought into contact with the leaflets when advanced. In some aspects, repositioning can comprise folding, collapsing, flattening, pushing, and/or bunching the leaflets 1102 in any one of a distal, radial and/or proximal direction within the target treatment site 1004. In some aspects, a base portion 322 of a skirt 321 is coupled to the expandable stent frame 300, 400, and distally advancing the partially expanded expandable stent frame 300, 400 flips over an axial edge portion 326 of the skirt 321 relative to an outer surface of the base portion 322 of the skirt 321, wherein an inner surface 1301 of the axial edge portion 326 faces a direction away from an outer surface 1303 of the base portion 322. As such, the higher friction inner surface 1301 of the axial edge portion 326 faces outward and in contact with the leaflets 1102 (see FIG. 13) where friction between the skirt and the leaflets 1102 is increased. As such, the relatively high friction contact between the leaflets 1102 and the flipped outwardly facing inner surface 1301 of the axial edge portion 326 can more effectively reposition the leaflets 1102 by dragging the leaflets 1102 in the distal direction together with the partially expanded stent frame 300, 400 (as shown in FIG. 13). Thus, flipping over the axial edge portion 326 of the skirt 321 results in the flipped inner surface 1301 of the axial edge portion 326 contacting the leaflets 1102 to facilitate the repositioning of the leaflets 1102 of the heart valve 1002 (e.g., by increasing friction between the leaflets 1102 and the skirt 321). In some examples, “flips over” can mean folding along an axis of the base portion 322. In some examples, the skirt 321 can only partially flip such that the surface of the axial edge portion 326 faces a direction towards the proximal end 302, 403 of the expandable stent frame 300, 400. In further aspects (not shown), after flipping over the axial edge portion 326 of the skirt 321, the method can comprise proximally retracting the partially expanded expandable stent frame 300, 400 (e.g., to adjust a position of the expandable stent frame 300, 400), wherein the axial edge portion 326 flips back to the original position. In this way, frictional force can be reduced during proximal retracting by presenting the relatively lower friction outer surface facing outwardly to interface with an inner surface of the sheath. In some aspects, the expandable stent frame 300, 400 can be expanded from the partially expanded orientation 802 to a fully expanded orientation 301, 401 (described hereinafter with reference to FIGS. 14 and 15) after repositioning the leaflets 1102 with the partially expanded stent frame 300, 400.
[0099] As illustrated in FIGS. 14 and 15, the method can further comprise expanding the expandable stent frame 300, 400 from the partially expanded orientation 802 to a fully expanded orientation 301, 401 by releasing the proximal end 302, 403 to radially expand and releasing the distal end 304, 410 to radially expand. As shown in FIG. 14, releasing the distal end 304, 410 can comprise distally advancing the distal tip 704 of the transcatheter device 700 relative to the expandable stent frame 300, 400. As shown in FIG. 15, in aspects, releasing the proximal end 302, 403 can comprise proximally retracting the sheath 702 of the transcatheter device 700 relative to the expandable stent frame 300, 400.
[00100] In some examples, expanding the expandable stent frame 300, 400 from the partially expanded orientation 802 to the fully expanded orientation 301, 401 can comprise initially releasing the distal end 304, 410 (e.g., distally advancing the distal tip 704, as shown in FIG. 14) to radially expand prior to releasing the proximal end 302, 403 (e.g., maintaining the proximal end 302, 403 in the collapsed state, as shown in FIG. 14), wherein the distal end 304, 410 achieves a radially expanded state while the proximal end 302, 403 is maintained in the collapsed state. In this example, expanding the expandable stent frame 300, 400 from the partially expanded orientation 802 to the fully expanded orientation 301, 401 can further comprise releasing the proximal end 302, 403 (e.g., proximally retracting the sheath 702, shown in FIG. 15) to radially expand after initially releasing the distal end 304, 410.
[00101] In some examples not shown, expanding the expandable stent frame 300,
400 from the partially expanded orientation 802 to the fully expanded orientation 301,
401 can comprise initially releasing the proximal end 302, 403 (e.g., proximally retracting the sheath 702) to radially expand prior to releasing the distal end 304, 410 (e.g., maintaining the distal end 304, 410 in the collapsed state), wherein the proximal end 302, 403 achieves a radially expanded state while the distal end 304, 410 is maintained in the collapsed state. In this example, expanding the expandable stent frame 300, 400 from the partially expanded orientation 802 to the fully expanded orientation 301, 401 further comprises releasing the distal end 304, 410 (e.g., distally advancing the distal tip 704) to radially expand after initially releasing the proximal end 302, 403.
[00102] In some examples, expanding the expandable stent frame 300, 400, from the partially expanded orientation 802 to the fully expanded orientation 301, 401 can further comprise deploying the prosthetic heart valve 303 comprising the expandable stent frame 300, 400. For example, deploying the prosthetic heart valve 303 can comprise releasing one or more leaflets 338 coupled to the expandable tent frame 300, 400. In some such examples, the one or more leaflets 338 can be coupled to the expandable stent frame 300, 400, and releasing the one or more leaflets 338 can comprise flowing blood through an opening between the one or more leaflets 338.
[00103] Turning to FIG. 16, in some aspects, the method can comprise removing the transcatheter device 700 from the target treatment site 1004. For example, the method can comprise proximally retracting the transcatheter device 700 to remove the transcatheter device 700 from the target treatment site 1004 and out of the patient’s vasculature. In some examples, removing the transcatheter device 700 from the target treatment site 1004 can first comprise proximally retracting the distal tip 704, such as for example, proximally retracting the distal tip 704 to abut a distal end of the sheath 702, and then further comprising removing the transcatheter device 700 from the target treatment site 1004. In other examples, removing the transcatheter device 700 from the target treatment site 1004 can comprise proximally retracting the distal tip 704, thereby removing the transcatheter device 700 from the target treatment site 1004. In this example, the transcatheter device 700 can then be proximally retracted from the patient’s vasculature.
[00104] 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.
[00105] Aspect 1. A transcatheter device comprising an expandable stent frame comprising a proximal end and a distal end. The expandable stent frame extends from the proximal end to the distal end. The expandable stent frame is configured to achieve a contracted orientation, a partially expanded orientation, and a fully expanded orientation. The transcatheter device further comprises a sheath configured to receive at least the proximal end of the expandable stent frame and a distal tip coupled to the distal end of the expandable stent frame. An intermediate portion of the expandable stent frame defined between the proximal end and the distal end is configured to bend radially outward in the partially expanded orientation.
[00106] Aspect 2. The transcatheter device of Aspect 1, wherein the partially expanded orientation comprises the intermediate portion being bent radially outward relative to the sheath.
[00107] Aspect 3. The transcatheter device of any one of Aspects 1-2, wherein the contracted orientation comprises the proximal end being in a collapsed state within the sheath.
[00108] Aspect 4. The transcatheter device of Aspect 3, wherein the partially expanded orientation further comprises the proximal end being in the collapsed state within the sheath.
[00109] Aspect 5. The transcatheter device of any one of Aspects 1-4, wherein the contracted orientation comprises the distal end being in a collapsed state within the distal tip.
[00110] Aspect 6. The transcatheter device of Aspect 5, wherein the partially expanded orientation further comprises the distal end being in the collapsed state within the distal tip. [00111] Aspect 7. The transcatheter device of any one of Aspects 1-6, further comprising a skirt comprising a base portion coupled to the intermediate portion of the expandable stent frame.
[00112] Aspect 8. The transcatheter device of Aspect 7, wherein the skirt further comprises an axial edge portion that is configured to flip over an outer surface of the base portion of the skirt.
[00113] Aspect 9. The transcatheter device of Aspect 8, wherein an inner surface of the axial edge portion comprises a higher coefficient of friction than an outer surface of the axial edge portion.
[00114] Aspect 10. The transcatheter device of any one of Aspects 7-9, wherein the skirt comprises a radiopaque polymer.
[00115] Aspect 11. The transcatheter device of any one of Aspects 7-9 , wherein the skirt comprises a fabric.
[00116] Aspect 12. The transcatheter device of any one of Aspects 1-11, wherein the distal end comprises a plurality of crowns.
[00117] Aspect 13. The transcatheter device of Aspect 12, wherein at least one crown of the plurality of crowns of the distal end comprises a tongue configured to be received by the distal tip.
[00118] Aspect 14. The transcatheter device of any one of Aspects 12-13, wherein the plurality of crowns comprise three or less crowns.
[00119] Aspect 15. The transcatheter device of any one of Aspects 1-14, wherein the proximal end comprises a plurality of crowns.
[00120] Aspect 16. The transcatheter device of Aspect 15, wherein at least one crown of the plurality of crowns of the proximal end comprises a tongue configured to be received by the sheath.
[00121] Aspect 17. The transcatheter device of any one of Aspects 1-16, further comprising a prosthetic heart valve comprising the expandable stent frame.
[00122] Aspect 18. A method of replacing a heart valve comprising distally advancing a transcatheter device comprising an expandable stent frame in a contracted orientation to a target treatment site, wherein the expandable stent frame comprises a proximal end and a distal end, and the expandable stent frame extends from the proximal end to the distal end. The method further comprises aligning a portion of the transcatheter device with leaflets of the heart valve and expanding the expandable stent frame from the contracted orientation to a partially expanded orientation wherein an intermediate portion of the expandable stent frame defined between the proximal end and the distal end bends radially outward. The method then comprises expanding the expandable stent frame from the partially expanded orientation to a fully expanded orientation by releasing the proximal end to radially expand and releasing the distal end to radially expand.
[00123] Aspect 19. The method of Aspect 18, wherein the portion of the transcatheter device that is aligned with the leaflets of the heart valve comprises a distal portion of the transcatheter device.
[00124] Aspect 20. The method of any one of Aspects 18-19, wherein partially expanding the expandable stent frame further comprises maintaining both the proximal end and the distal end in a collapsed state.
[00125] Aspect 21. The method of any one of Aspects 18-20, further comprising distally advancing the partially expanded stent frame to reposition the leaflets of the heart valve.
[00126] Aspect 22. The method of Aspect 21, wherein the expandable stent frame is expanded from the partially expanded orientation to the fully expanded orientation after repositioning the leaflets with the partially expanded stent frame.
[00127] Aspect 23. The method of any one of Aspects 18 - 22, wherein releasing the distal end comprises distally advancing a distal tip of the transcatheter device relative to the expandable stent frame.
[00128] Aspect 24. The method of any one of Aspects 18 - 23, wherein releasing the proximal end comprises proximally retracting a sheath of the transcatheter device relative to the expandable stent frame.
[00129] Aspect 25. The method of any one of Aspects 21 -22, wherein a base portion of a skirt is coupled to the expandable stent frame, and distally advancing the partially expanded expandable stent frame flips over an axial edge portion of the skirt relative to an outer surface of the base portion of the skirt, wherein a surface of the axial edge portion faces a direction away from an outer surface of the base portion.
[00130] Aspect 26. The method of Aspect 25, wherein flipping over the axial edge portion of the skirt results in the surface of the axial edge portion contacting the leaflets to facilitate the repositioning of the leaflets of the heart valve.
[00131] Aspect 27. The method of any one of Aspects 20 - 26, wherein expanding the expandable stent frame from the partially expanded orientation to the fully expanded orientation comprises initially releasing the distal end to radially expand prior to releasing the proximal end, wherein the distal end achieves a radially expanded state while the proximal end is maintained in the collapsed state.
[00132] Aspect 28. The method of Aspect 27, wherein expanding the expandable stent frame from the partially expanded orientation to the fully expanded orientation further comprises releasing the proximal end to radially expand after initially releasing the distal end.
[00133] Aspect 29. The method of any one of Aspects 18-28, wherein, after expanding the expandable stent frame from the contracted orientation to the partially expanded orientation, further comprising recapturing the expandable stent frame to collapse the expandable stent frame from the partially expanded orientation to the contracted orientation prior to expanding the expandable stent frame from the partially expanded orientation to the fully expanded orientation.
[00134] Aspect 30. The method of any one of Aspects 18-29, wherein the target treatment site comprises an implanted prosthetic heart valve.
[00135] Aspect 31. The method of any one of Aspects 18-30, wherein the transcatheter device further comprises a prosthetic heart valve comprising the expandable stent frame.