Transcatheter devices and methods

Abstract

Transcatheter devices include a stented prosthesis with an expandable stent frame and a valve structure mounted to the expandable stent frame. The transcatheter devices further include an inner shaft extending through a lumen of the expandable stent frame. The transcatheter devices also include a first inflatable balloon, wherein a distal portion of the inner shaft extends within the first inflatable balloon. The transcatheter devices still further include a second inflatable balloon extending through the lumen of the expandable stent frame. The inner shaft further extends within the second inflatable balloon. The transcatheter devices further include a distal tip attached to a distal end of the distal portion of the inner shaft.

Description

TRANSCATHETER DEVICES AND METHODSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 638,525, filed April 25, 2024, the entire content of which is incorporated herein by reference.FIELD

[0002] The present disclosure relates generally to transcatheter devices and methods and, more particularly, to transcatheter devices and methods of implanting a stented prosthesis.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 connect the atria to the ventricles, while the aortic and pulmonary valves are semilunar valves located between the ventricles and their corresponding artery and regulate the flow of blood leaving the heart. Each of the valves are made from thin, strong flaps of tissue called leaflets. Ideally, native leaflets of a heart valve move apart from each other when the valve is in an open position and meet or “coapf ’ when the valve is in a closed position.

[0004] 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.

[0005] 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.

[0006] 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.

[0007] However, the minimally invasive approaches are sometimes less effective for patients who have uncommonly large leaflets. When the prosthetic heart valve is deployed, these leaflets can cause coronary instruction where the leaflets block the replacement valve when it opens and prevents the flow of blood to the coronary arteries. Further, the prosthetic heart valves over time may become damaged or diseased from stenosis and may need replaced. Catheter-based approaches have also been used to repair or replace the damaged prosthetic heart valves, but similarly the leaflets from the previously implanted prosthetic heart valve can cause coronary obstruction.

[0008] 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

[0009] The following presents a simplified summary of the disclosure to provide a basic understanding of some aspects described in the detailed description.

[0010] In aspects, transcatheter devices comprise a stented prosthesis comprising an expandable stent frame and a valve structure mounted to the expandable stent frame. The transcatheter devices comprise an inner shaft extending through a lumen of the expandable stent frame and a first inflatable balloon. A distal portion of the inner shaft extends within the first inflatable balloon. The transcatheter devices further comprise a second inflatable balloon extending through the lumen of the expandable stent frame. The inner shaft extends within the second inflatable balloon. The transcatheter devices also comprise a distal tip attached to a distal end of the distal portion of the inner shaft.

[0011] 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

[0012] 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:

[0013] FIG. 1 schematically illustrates a side view of a stented prosthesis in an expanded orientation in accordance with aspects of the disclosure;

[0014] FIG. 2 schematically illustrates the stented prosthesis of FIG. 1 in a contracted orientation;

[0015] FIG. 3 schematically illustrates a side view of another embodiment of a stented prosthesis in an expanded orientation in accordance with aspects of the disclosure;

[0016] FIG. 4 illustrates a top view of the stented prosthesis of FIG. 3 taken from the outflow end of the stented prosthesis;

[0017] FIG. 5 illustrates a schematic exploded view of a transcatheter device in accordance with aspects of the disclosure;

[0018] FIG. 6 illustrates a side view of an exemplary embodiment of a transcatheter device including a stented prosthesis in a contracted orientation;

[0019] FIG. 7 schematically illustrates distally advancing the stented prosthesis in the contracted orientation within the patient’s vasculature;

[0020] FIG. 8 schematically illustrates distally advancing the stented prosthesis of the transcatheter device into a preexisting stented prosthesis and further expanding a first inflatable balloon of the transcatheter device;

[0021] FIG. 9 schematically illustrates distally advancing the first inflatable balloon to contact and thereby reposition the preexisting lacerated leaflets of the preexisting stented prosthesis;

[0022] FIG. 10 schematically illustrates inflating the second inflatable balloon to expand the expandable stent frame and thereby implant the stented prosthesis of the transcatheter device within the preexisting stented prosthesis; and

[0023] FIG. 11 schematically illustrates withdrawing the transcatheter device from the patient’s vasculature after implanting the stented prosthesis.Detailed Description

[0024] 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.

[0025] 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.

[0026] 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.

[0027] 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.

[0028] 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.

[0029] 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.

[0030] 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.

[0031] As used herein, the terms “comprising,” “including,” and variations thereof shall be construed as synonymous and open-ended, unless otherwise indicated. A list of elements following the transitional phrases comprising or including is a non-exclusive list, such that elements in addition to those specifically recited in the list may also be present.

[0032] The terms “substantial,” “substantially,” and variations thereof as used herein are intended to represent that a described feature is equal or approximately equal to a value or description. For example, a “substantially planar” surface is intended to denote a surface that is planar or approximately planar. Moreover, “substantially” is intended to denote that two values are equal or approximately equal. The term “substantially” may denote values within about 10% of each other, for example, within about 5% of each other, or within about 2% of each other.

[0033] 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.

[0034] 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.

[0035] 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 clotswhich can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and / or life threatening.

[0036] 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.

[0037] FIG. 1 illustrates a side view of a stented prosthesis 101 in an expanded orientation. The stented prosthesis 101 includes expandable stent frame 103 and a valve structure 105 that comprising a plurality of leaflets 107 (e.g., two or three leaflets). The expandable stent frame 103 of the stented prosthesis 101 supports the valve structure 105 within a lumen defined by the expandable stent frame 103. As shown in FIG. 2, a plurality of sutures 201 can mount the valve structure 105 to the expandable stent frame 103 wherein the valve structure 105 can be collapsed within the expandable stent frame 103 in the collapsed orientation shown in FIG. 2. Furthermore, as shown in FIG. 1, the valve structure can be deployed to operate as a valve (e.g., heart valve) when the stented prosthesis 101 radially expanded to the expanded orientation. In the example stented prosthesis 101 is balloon-expandable and may be implanted at a treatment site within a patient to replace a preexisting aortic valve, a pulmonic valve, a mitral valve, or a tricuspid valve. The preexisting valve to be replaced may be a native valve or a previously implanted prosthetic valve, such as a failed surgical replacement valve or a failed preexisting stented prosthesis.

[0038] As shown in FIGS. 1-2, the stented prosthesis 101 includes an inflow end 109 and an outflow end 111. The leaflets 107 are attached to the expandable stent frame 103 such that when pressure at the inflow end 109 exceeds pressure at the outflow end 111, the leaflets 107 open to allow blood flow through the stented prosthesis 101 from the inflow end 109 to the outflow end 111. When the pressure at the outflow end 111 exceedspressure at the inflow end 109, the leaflets 107 close to prevent blood flow from the outflow end 111 to the inflow end 109.

[0039] FIGS. 3-4 illustrate another embodiment of an example stented prosthesis 301 in an expanded orientation. The stented prosthesis 301 includes a stent frame 303 that is generally tubular with a valve structure 305 mounted within a lumen 402 (see FIG. 4) defined by the stent frame 303. Like the stented prosthesis 101 of FIGS. 1-2, the stented prosthesis 301 of FIGS. 3-4 comprises a contracted orientation wherein the stented prosthesis 301 can be delivered within a vasculature to a preexisting heart valve and then expanded with a balloon to be implanted within the preexisting heart valve. In some embodiments, the stented prosthesis 301 can be configured for replacement of a preexisting aortic valve such that an inflow end 309 of the stented prosthesis 301 extends into and anchors within the aortic annulus, while an outflow end 311 of the stented prosthesis 301 is positioned within the aortic sinuses. As shown, the stent frame 303 can comprise struts that define relatively large openings 313 in the outflow portion of the stent frame 303. Once the stented prosthesis 301 is implanted, the relatively large openings 313 can be positioned within the aortic sinuses and help avoid blockage of the coronary ostium.

[0040] In some embodiments, the stent frame 303 may be a unitary frame that supports the valve structure 305 including a plurality of leaflets 407a, 407b, 407c within the lumen 402. FIG. 4 is top view of the stented prosthesis 301 of FIG. 3 taken from the outflow end 311 of the stented prosthesis 301. As shown, in some embodiments, the valve structure 305 can comprise a tricuspid valve comprising three leaflets 407a, 407b, 407c. Although not shown, in further embodiments, the valve structure can comprise a bicuspid valve comprising two leaflets or may comprise a valve structure with more than three leaflets. The stented prosthesis 301 is not required to have the same number of valve structures and / or leaflets as the preexisting valve (e.g., preexisting native valve or preexisting valve structure). The leaflets 407a, 407b, 407c may be attached to a skirt 315 which encloses or lines a portion of the stent frame 303. The leaflets 407a, 407b, 407c may be sutured or otherwise securely attached along their bases to the interior surface of the skirt 315 or otherwise attached to the stent frame 303. Adjoining pairs of leaflets may be attached to one another at their lateral ends to form commissures 417. Free edges409a, 409b, 409c of the leaflets 407a, 407b, 407c comprise portions that coapt with one another. For example, as shown in FIG. 4, a portion of the free edge 409a of the first leaflet 407a is configured to coapt with a portion of the free edge 409b of the second leaflet 407b; a portion of the free edge 409b of the second leaflet 407b is configured to coapt with a portion of the free edge 409c of the third leaflet 407c; and a portion of the free edge 409c of the third leaflet 407c is configured to coapt with a portion of the free edge 409a of the first leaflet 407a. Although not shown, the valve structure 105 of the stented prosthesis 101 can also be schematically represented by the valve structure 305 illustrated in FIG. 4.

[0041] The leaflets 107, 407a, 407b, 407c may be made of pericardial material; however, the leaflets may be fabricated by other materials in further embodiments. For example, leaflets of the disclosure may be fabricated from natural tissue that can be obtained from, for example, heart valves, aortic roots, aortic walls, aortic leaflets, pericardial tissue, such as pericardial patches, bypass grafts, blood vessels, intestinal submucosal tissue, umbilical tissue and the like from humans or animals. Synthetic materials suitable for use as the leaflets include DACRON polyester commercially available from Invista North America S.A.R.L. of Wilmington, DE, other cloth materials, nylon blends, polymeric materials, and vacuum deposition nitinol fabricated materials. With certain leaflet materials, it may be desirable to coat one or both sides of the leaflet with a material that will prevent or minimize overgrowth. It is further desirable that the leaflet material is durable and not subject to stretching, deforming, or fatigue.

[0042] The skirt 315 may enclose or line the stent frame 303 as would be known to one of ordinary skill in the art of prosthetic tissue valve construction, skirt 315 may be a natural or biological material such as pericardium or another membranous tissues such as intestinal submucosa. Alternatively, skirt 315 may be a low-porosity woven fabric, such as polyester, Dacron fabric, or PTFE, which creates a one-way fluid passage when attached to the stent. In one embodiment, skirt 315 may be a knit or woven polyester, such as a polyester or PTFE knit, which can be utilized when it is desired to provide a medium for tissue ingrowth one side and a smooth surface on the other side.

[0043] FIG. 5 illustrates a schematic exploded view of a transcatheter device 501 in accordance with aspects of the disclosure. The transcatheter device 501 can include adistal portion 503 and a proximal portion 505. As shown, the proximal portion 505 can comprise a handle assembly 507. The handle assembly 507 designed to enable a surgeon to manipulate the distal portion 503 of the transcatheter device 501. The handle assembly can also comprise one or more actuators. For example, as schematically shown, the handle assembly 507 can comprise a first actuator 509 and a second actuator 511 that can facilitate implanting of the stented prosthesis as discussed more fully below. In some embodiments, the transcatheter device 501 may comprise the stented prosthesis 101 of FIGS. 1-2 discussed above, the stented prosthesis 301 of FIGS. 3-4 discussed above, or other stented prosthesis.

[0044] The transcatheter device 501 can comprise an outer shaft 513 although the outer shaft may not be provided in further embodiments. If provided, the outer shaft 513 may include a proximal portion 515 configured to be received within a distal portion 517 of the handle assembly 507 and a distal portion 519 opposite the proximal portion 515 of the outer shaft 513. In some embodiments, the outer shaft 513 may be received within a lumen of an optional sleeve 521 that, if provided, can act as a protective covering for the outer shaft 513 and / or an inner shaft 523. The transcatheter device 501 further comprises an inner shaft 523 that can extend along a substantial length (e.g., the entire length) of the outer shaft 513 and within a lumen of the outer shaft 513. In some embodiments, the proximal end of the inner shaft 523 can be attached to the handle assembly 507 while a distal end 601 of the inner shaft 523 can be attached to a distal tip 603. The distal tip 603 (schematically illustrated in FIG. 6) can be any suitable shape and / or size. For example, the tip may be rounded, rather than pointed, to provide an atraumatic contact surface to avoid damage when advancing the distal portion 503 of the transcatheter device 501 through the vasculature of the patient. While various features are illustrated as example components of the transcatheter device 501, in some embodiments, more or less components may be provided. In further embodiments, only certain portions of schematic features illustrated in FIG. 5 may be considered the transcatheter device 501.

[0045] Further example aspects of distal portions 503 of embodiments of transcatheter devices 501 will now be discussed with further reference to FIG. 6. While FIGS. 6-11 illustrate the stented prosthesis 101 of FIGS. 1-2, other stented prosthesis can be provided in further embodiments. For instance, the stented prosthesis 301 of FIGS. 3-4 can be provided with the distal portion 503 and the method of implanting described herein unless otherwise noted. As shown, the inner shaft 523 extends through the lumen of the expandable stent frame 103. When the stented prosthesis 101, 301 is loaded with the stented prosthesis 101, 301, the expandable stent frame 103, 303 is in the contracted orientation. The contracted orientation of the expandable stent frame 103, 303 reduces the cross-sectional dimension to facilitate navigation of the distal portion 503 of the transcatheter device 501 through the vasculature of the patient when delivering the stented prosthesis 101, 301 to the treatment site.

[0046] As further illustrated in FIG. 6, the distal portion 503 of the transcatheter device 501 can further comprise a first inflatable balloon 605. A distal portion 607 of the inner shaft 523 extends within the first inflatable balloon 605 and a distal end 601 of the distal portion 607 of the inner shaft is attached to the distal tip 603. In some embodiments, the distal portion 607 of the inner shaft 523 can comprise a fluid port 611 that can introduce fluid into the first inflatable balloon 605 to inflate the first inflatable balloon 605. The first inflatable balloon 605 can be positioned toward the distal end of the distal portion 503 of the transcatheter device 501. In some embodiments, as shown, the first inflatable balloon 605 can abut the distal tip 603. In further embodiments, the first inflatable balloon 605 can be attached to the distal tip 603. For example, the first inflatable balloon 605 can be attached to the distal tip 603 by contacting the distal tip 603 although the first inflatable balloon 605 can be indirectly attached to the distal tip 603 in further embodiments. As discussed more fully below, the first inflatable balloon 605 is adapted to be inflated to act as a rammer to move portions of a plurality of leaflets of a heart valve away from the aortic sinuses and help avoid blockage of the coronary ostium.

[0047] The first inflatable balloon 605 can comprise a wide range of materials configured to flex to facilitate inflating of the balloon. In some embodiments, the first inflatable balloon 605 can comprise a non-compliant material. For example, the noncomplaint material can comprise nylon although the first inflatable balloon 605 can comprise other non-compliant materials in further embodiments. A noncompliant material is designed to provide the balloon with a maximum inflation size / shape upon full inflation. Further inflation will result in minimal if any additional change in size / shape.Rather, overinflation may result in the noncompliant material failing (i.e., the balloon bursting) rather than the balloon significantly further changing size / shape.

[0048] The transcatheter device 501 further comprises a second inflatable balloon 609 extending through the lumen of the expandable stent frame 103, 303. Indeed, as shown, the second inflatable balloon 609 extends through the lumen of the expandable stent frame 103, 303, extends proximally through the outflow end 111, 311 of the stented prosthesis 101, 103 and extends distally through the inflow end 109, 309 of the stented prosthesis 101, 301. The second inflatable balloon 609 can extend from a proximal portion 609a of the second inflatable balloon 609 to a distal portion 609b of the second inflatable balloon wherein an intermediate portion 609c of the second inflatable balloon 609 extends through the lumen defined by the expandable stent frame 103, 303 of the stented prosthesis 101, 301. The inner shaft 523 can extend within the second inflatable balloon 609. For example, as shown, the inner shaft 523 can extend through the proximal portion 609a, intermediate portion 609c, and distal portion 609b of the second inflatable balloon 609. Furthermore, the first inflatable balloon 605 can be positioned within a distal portion of the second inflatable balloon 609. In some embodiments, the distal portion 609b of the second inflatable balloon 609 is attached to the distal tip 603 to circumscribe the first inflatable balloon 605. For instance, in some embodiments, both the distal portion 609b of the second inflatable balloon 609 and the first inflatable balloon 605 can be directly attached to the distal tip 603. In further embodiments, the distal portion 609b of the second inflatable balloon 609 may be attached to the first inflatable balloon while the first inflatable balloon 605 is positioned within (partially or entirely) the second inflatable balloon 609. In further embodiments, a part of the distal portion 609b of the second inflatable balloon 609 can be positioned between the first inflatable balloon 605 and the distal tip 603.

[0049] The second inflatable balloon 609 can comprise a semi-compliant material. For example, the second inflatable balloon 609 comprises a high durometer polyurethane although other polymers may be provided in further embodiments. In some embodiments, the second inflatable balloon 609 can comprise a poly ether block amide. Due to the semi-compliant material, the second inflatable balloon 609 does not have a predetermined shape or limit in size. As such, the second inflatable balloon 609 can actas an expansion member for a wide range of stented prostheses having various shapes and / or sizes.

[0050] The transcatheter device 501 can further comprise a bumper 613 mounted on the inner shaft 523. For example, the bumper 613 can be mounted on the inner shaft 523 indirectly by being directly mounted to the outer shaft 513 (if provided). Alternatively, although not shown, the bumper 613 can be mounted directly on the inner shaft 523. As shown, the bumper 613 can be proximally spaced a distance from a proximal end of the expandable stent frame 103, 303. For example, as shown, the bumper 613 is illustrated as proximally spaced a distance from the outflow end 111, 311 of the stented prosthesis 101, 301 that corresponds to the proximal end of the expandable stent frame 103, 303. As further illustrated, in some embodiments, the bumper 613 can be positioned within the second inflatable balloon 609. As such, the bumper 613 can remain mounted on the inner shaft 523 (i.e., directly or indirectly) regardless of whether or not the second inflatable balloon 609 is inflated.

[0051] In some embodiments, the stented prosthesis 101, 301 can be mounted on the inner shaft 523 by inserting the distal tip 603 of the distal portion 503 into the outflow end 111 , 311 of the stented prosthesis 101, 301 and into the lumen defined by the expandable stent frame 103, 303 when the stented prosthesis 101, 301 is in the expanded orientation. The distal tip 603 then be pushed out of the inflow end 109, 309 of the stented prosthesis 101, 301 wherein the intermediate portion 609c of the second inflatable balloon 609 and the inner shaft 523 extends through the lumen defined by the expandable stent frame 103, 303. The expandable stent frame can then be crimped from the expanded orientation to the contracted orientation illustrated in FIG. 6 wherein the contracted stented prosthesis 101, 301 is trapped in position between the bumper 613 and the first inflatable balloon 605. Indeed, once crimped, the expandable stent frame 103, 303 is plastically deformed to the contracted orientation and remains in the contracted orientation until radially expanded by the second inflatable balloon 609. In the contracted orientation, the lumen of the expandable stent frame has a smaller cross- sectional dimension than the cross-sectional dimension of the bumper 613 and the first inflatable balloon 605 in the deflated orientation (taken along a cross-section perpendicular to an elongated axis of the inner shaft 523). Thus, an excessive proximalshift of the contracted stented prosthesis 101, 301 relative to the inner shaft 523 is therefore prevented by interaction between the stented prosthesis 101, 301 and the bumper 613. Furthermore, an excessive distal shift of the contracted stented prosthesis 101, 301 relative to the inner shaft 523 is further prevented by interaction between the stented prosthesis 101, 301 and the first inflatable balloon 605. Consequently, the contracted stented prosthesis 101, 301 is mounted on the inner shaft 523 with the intermediate portion 609c of the second inflatable balloon 609 extending through the lumen defined by the expandable stent frame 103, 303 while the contracted stented prosthesis is trapped on the elongated axis of the inner shaft 523 between the first inflatable balloon 605 and the bumper 613.

[0052] As schematically shown in FIG. 5, in some embodiments, the handle assembly 507 can comprise a first fluid port 525 in fluid communication with an interior of the first inflatable balloon 605. For example, the first fluid port 525 can be placed in fluid communication with a lumen of the inner shaft 523 that is in fluid communication with the fluid port 611 inside the first inflatable balloon 605. In some embodiments, the first actuator 509 can open a valve to introduce pressurized fluid (e.g., air) from a source 527 of pressurized fluid to inflate the first inflatable balloon 605. As shown in FIG. 6, in some embodiments, the first inflatable balloon 605 can comprise an optional valve 615 designed to permit fluid flow from the first inflatable balloon 605 to the second inflatable balloon 609 once the first inflatable balloon 605 is fully inflated. As such, the first actuator 509 can be designed to be activated to first inflate the first inflatable balloon 605. The first actuator 509 can then be actuated again wherein further fluid passes through the valve 615 to inflate the second inflatable balloon 609 without substantial further inflation of the first inflatable balloon 605.

[0053] As further schematically shown in FIG. 5, in some embodiments, the handle assembly 507 can comprise a second fluid port 529 in fluid communication with an interior of the second inflatable balloon 609. For example, the second fluid port 529 can be placed in fluid communication with a lumen of the outer shaft 513 that is in fluid communication with a fluid port 617 inside the second inflatable balloon 609. In some embodiments, the second actuator 511 can open a valve to introduce pressurized fluid(e.g., air) from the source 527 of pressurized fluid to inflate the second inflatable balloon 609.

[0054] Methods of implanting the stented prostheses of the transcatheter devices of the disclosure will now be described with reference to FIGS. 7-11. Methods will be discussed for implanting the stented prosthesis 101 of FIGS. 1-2 with the understanding that, unless otherwise indicated, similar or identical methods can be employed for implanting the stented prosthesis 301 of FIGS. 3-4.

[0055] As shown in FIG. 7, the stented prosthesis 101, 301 can be delivered as part of the transcatheter device 501. The stented prosthesis 101, 301 is delivered through the vasculature of the patient to a preexisting heart valve 701 of the patent while the stented prosthesis 101, 301 is in the collapsed orientation on the inner shaft 523 of the transcatheter device 501. During delivery, the stented prosthesis 101, 301 can be axially restrained in the collapsed orientation on the inner shaft 523. For instance, The stented prosthesis 101, 301 can be axially restrained by the first inflatable balloon 605 being positioned distally from a distal end of the expandable stent frame 103, 303. In addition, or alternatively, the stented prosthesis 101, 301 can be axially restrained by the bumper 613 mounted to the inner shaft 523 and positioned proximally from a proximal end of the expandable stent frame 103, 303.

[0056] As shown, the preexisting heart valve 701 comprises a preexisting defective prosthetic heart valve that was previously mounted to replace a defective native heart valve 703. In further embodiments, the preexisting heart valve can comprise a defective native heart valve wherein the stented prosthesis 101, 301 is replacing a native heart valve rather than a preexisting defective stented prosthesis.

[0057] As further shown in FIG. 7, in some embodiments, a laceration device 705 can be introduced to lacerate at least one leaflet of the plurality of leaflets of the preexisting heart valve 701. FIG. 8 illustrates the preexisting heart valve 701 shown in simplified form to more clearly show the preexisting leaflets 801 that are lacerated along laceration 803 into a first portion 801a and a second portion 801b. In some embodiments, all of the preexisting leaflets may be lacerated prior to implanting the stented prosthesis 101, 301.

[0058] As shown in FIGS. 7 and 8, the first inflatable balloon 605 can be aligned with the plurality of preexisting leaflets 801. The first inflatable balloon 605 can then be inflated by introducing fluid through a first conduit 524 at a location exterior of a vasculature of the patient. For example, the handle assembly 507 can comprise a first fluid port 525 in fluid communication with an interior of the first inflatable balloon 605. For example, the first fluid port 525 can be placed in fluid communication with a lumen of the inner shaft 523 that is in fluid communication with the fluid port 611 inside the first inflatable balloon. In some embodiments, the first actuator 509 can open a valve to introduce pressurized fluid (e.g., air) from the first conduit 524 in fluid communication with a source 527 of pressurized fluid to inflate the first inflatable balloon 605. For example, the first actuator 509 can be engaged by a surgeon to open a valve to flow pressurized fluid from the source 527 of pressurized fluid to travel through the lumen of the inner shaft 523 and out the fluid port 611 to inflate the first inflatable balloon 605 to a predetermined size and shape shown schematically in FIG. 8.

[0059] As shown in FIG. 9, the method can further comprise distally advancing the transcatheter delivery device in distal direction 901 to distally move portions of the plurality of preexisting leaflets 801 of the preexisting heart valve 701 with the inflated first inflatable balloon 605 (e.g., with the second balloon still deflated). The preexisting leaflets 801 are thereby moved out of the vicinity of the aortic sinuses 903 and help avoid blockage of the coronary ostium 905. In embodiments where one or more of the leaflets are lacerated, distally advancing the transcatheter device 501 can splay the first portion 801a and the second portion 801b of the lacerated leaflet 801 with the inflated first inflatable balloon 605.

[0060] The method can then comprise inflating the second inflatable balloon 609 to expand the expandable stent frame 103, 303 of the stented prosthesis to deploy the valve structure of the stented prosthesis 101, 301 while distally moved portions of the plurality of leaflets 801 are pinned relative to the preexisting heart valve 701 by the expandable stent frame 103, 303. In some embodiments, the first actuator 509 can be activated again to add additional pressurized fluid to the interior of the first inflatable balloon 605 that immediately passes through the optional valve 615 to inflate the second inflatable balloon 609. Alternatively, the second actuator 511 can be activated toindependently inflate the second inflatable balloon 609 by introducing fluid through a second conduit 528 at a location exterior of the vasculature of the patient. For instance, the second actuator 511 can open a valve to allow pressurized fluid to pass through the second conduit 528 from the source 527 of pressurized fluid, through the second fluid port 529, through the lumen of the outer shaft 513 and out the fluid port 617 to inflate the second inflatable balloon 609. Providing the ability to inflate both balloons with a single actuator can simplify the control mechanism in some embodiments. In further embodiments, providing independent actuators for each inflatable balloon can be beneficial to help regulate the maximum pressure applied to each balloon.

[0061] As shown in FIG. 9, inflating the first inflatable balloon 605 can begin expanding the distal end of the expandable stent frame 103, 303. Providing initial expansion at the distal end can help properly pin the preexisting leaflets in place when fully implanting the stented prosthesis 101, 301 in the fully expanded orientation shown in FIG. 10.

[0062] Once the stented prosthesis has been implanted, the first inflatable balloon 605 and the second inflatable balloon 609 can then be deflated and contracted. As shown in FIG. 11, the implanted expanded stented prosthesis 101, 301 maintains the expanded orientation as the second expandable balloon 609 plastically deformed the stented prosthesis 101, 301 into the illustrated shape that is retained after deflating the balloons. Then, as shown in FIG. 11, the remaining portions of the transcatheter device 501 can be withdrawn as represented by arrow 1101.

[0063] Aspect 1. A transcatheter device comprises a stented prosthesis comprising an expandable stent frame and a valve structure mounted to the expandable stent frame. The transcatheter device comprises an inner shaft extending through a lumen of the expandable stent frame. The transcatheter device comprises a first inflatable balloon, wherein a distal portion of the inner shaft extends within the first inflatable balloon. The transcatheter device comprises a second inflatable balloon extending through the lumen of the expandable stent frame, wherein the inner shaft extends within the second inflatable balloon. The transcatheter device comprises a distal tip attached to a distal end of the distal portion of the inner shaft.

[0064] Aspect 2. The transcatheter device of aspect 1, further including a bumper mounted on the inner shaft.

[0065] Aspect 3. The transcatheter device of any one of aspects 1-2, wherein the bumper is further positioned within the second inflatable balloon.

[0066] Aspect 4. The transcatheter device of any one of aspects 1-3, wherein the bumper is proximally spaced a distance from a proximal end of the expandable stent frame.

[0067] Aspect 5. The transcatheter device of any one of aspects 1-4, wherein the first inflatable balloon is positioned within a distal portion of the second inflatable balloon.

[0068] Aspect 6. The transcatheter device of any one of aspects 1-5, further including a handle assembly comprising a first fluid port in fluid communication with an interior of the first inflatable balloon.

[0069] Aspect 7. The transcatheter device of any one of aspects 1-6, further including a second fluid port in fluid communication with an interior of the second inflatable balloon.

[0070] Aspect 8. The transcatheter device of any one of aspects 1-7, wherein the first inflatable balloon comprises a non-compliant material.

[0071] Aspect 9. The transcatheter device of any one of aspects 1-8, wherein the first inflatable balloon comprises nylon.

[0072] Aspect 10. The transcatheter device of any one of aspects 1-9, wherein the second inflatable balloon comprises a semi-compliant material.

[0073] Aspect 11. The transcatheter device of any one of aspects 1-10, wherein the second inflatable balloon comprises a high durometer polyurethane.

[0074] Aspect 12. The transcatheter device of any one of aspects 1-11, wherein the second inflatable balloon comprises a polyether block amide.

[0075] Aspect 13. A method of implanting a stented prosthesis with the transcatheter device of aspect 1 comprises delivering the stented prosthesis to a heart valve of a patient while the stented prosthesis is in a collapsed orientation on the inner shaft of the transcatheter device. The method further comprises aligning the first inflatable balloon with a plurality of leaflets of a heart valve of a patient. The method alsocomprises inflating the first inflatable balloon and distally advancing the transcatheter delivery device to distally move portions of the plurality of leaflets of the heart valve with the inflated first inflatable balloon. The method then comprises inflating the second inflatable balloon to expand the expandable stent frame of the stented prosthesis to deploy the valve structure of the stented prosthesis while distally moved portions of the plurality of leaflets are pinned relative to the heart valve by the expandable stent frame.

[0076] Aspect 14. The method of aspect 13, further comprising lacerating at least one leaflet of the plurality of leaflets into a first portion and a second portion, wherein distally advancing the transcatheter device splays the first portion and the second portion of the at least one lacerated leaflet with the inflated first inflatable balloon.

[0077] Aspect 15. The method of any one of aspects 13-14, wherein lacerating the at least one leaflet of the plurality of leaflets comprises lacerating each leaflet of the plurality of leaflets into the corresponding first portion and the corresponding second portion.

[0078] Aspect 16. The method of any one of aspects 13-15, wherein the heart valve comprises a prosthetic heart valve.

[0079] Aspect 17. The method of any one of aspects 13-16, wherein the inflating the first inflatable balloon comprises introducing fluid through a first conduit at a location exterior of a vasculature of the patient.

[0080] Aspect 18. The method of any one of aspects 13-17, wherein the inflating the second inflatable balloon comprises introducing fluid through a second conduit at a location exterior of a vasculature of the patient.

[0081] Aspect 19. The method of any one of aspects 13-18, further comprising axially restraining the stented prosthesis in the collapsed orientation on the inner shaft when delivering the stented prosthesis.

[0082] Aspect 20. The method of any one of aspects 13-19, wherein the stented prosthesis is axially restrained by the first inflatable balloon being positioned distally from a distal end of the expandable stent frame.

[0083] Aspect 21. The method of any one of aspects 19-20, wherein the stented prosthesis is axially restrained by a bumper mounted to the inner shaft and positioned proximally from a proximal end of the expandable stent frame.

[0084] Aspect 22. The method of any one of aspects 13-21, wherein inflating the first inflatable balloon expands a distal portion of the second inflatable balloon.

[0085] It should be understood that while various aspects have been described in detail relative to certain illustrative and specific examples thereof, the present disclosure should not be considered limited to such, as numerous modifications and combinations of the disclosed features are possible without departing from the scope of the following claims.

Claims

What is claimed is:

1. A transcatheter device (501) comprising: a stented prosthesis (101, 301) comprising an expandable stent frame (103, 303) and a valve structure (105, 305) mounted to the expandable stent frame (103, 303); an inner shaft (523) extending through a lumen of the expandable stent frame (103, 303); a first inflatable balloon (605), wherein a distal portion (503) of the inner shaft (523) extends within the first inflatable balloon (605); a second inflatable balloon (609) extending through the lumen of the expandable stent frame (103, 303), wherein the inner shaft (523) extends within the second inflatable balloon (609); and a distal tip (603) attached to a distal end (601) of the distal portion (503) of the inner shaft (523).

2. The transcatheter device (501) of claim 1, further including a bumper (613) mounted on the inner shaft (523).

3. The transcatheter device (501) of claim 2, wherein the bumper (613) is further positioned within the second inflatable balloon (609).

4. The transcatheter device (501) of any one of claims 2-3, wherein the bumper (613) is proximally spaced a distance from a proximal end of the expandable stent frame (103, 303).

5. The transcatheter device (501) of any one of claims 1-4, wherein the first inflatable balloon (605) is positioned within a distal portion (609b) of the second inflatable balloon (609).

6. A method of implanting the stented prosthesis (101, 301) of the transcatheter device (501) of claim 1 comprising: delivering the stented prosthesis (101, 301) to a heart valve of a patient while the stented prosthesis (101, 301) is in a collapsed orientation on the inner shaft (523) of the transcatheter device (501); aligning the first inflatable balloon (605) with a plurality of leaflets (801) of a heart valve of a patient; inflating the first inflatable balloon (605); distally advancing the transcatheter delivery device to distally move portions of the plurality of leaflets (801) of the heart valve with the inflated first inflatable balloon (605); and then inflating the second inflatable balloon (609) to expand the expandable stent frame (103, 303) of the stented prosthesis (101, 301) to deploy the valve structure (105, 305) of the stented prosthesis (101, 301) while distally moved portions of the plurality of leaflets (801) are pinned relative to the heart valve by the expandable stent frame (103, 303).

7. The method of claim 6, further comprising lacerating at least one leaflet of the plurality of leaflets (801) into a first portion (801a) and a second portion (801b), wherein distally advancing the transcatheter device (501) splays the first portion (801a) and the second portion (801b) of the at least one lacerated leaflet (801) with the inflated first inflatable balloon (605).

8. The method of claim 7, wherein lacerating the at least one leaflet of the plurality of leaflets (801) comprises lacerating each leaflet of the plurality of leaflets (801) into the corresponding first portion (801a) and the corresponding second portion (801b).

9. The method of any one of claims 6-8, wherein the heart valve comprises a prosthetic heart valve (701).

10. The method of any one of claims 6-9, wherein the inflating the first inflatable balloon (605) comprises introducing fluid through a first conduit (524) at a location exterior of a vasculature of the patient.

11. The method of any one of claims 6-10, wherein the inflating the second inflatable balloon (609) comprises introducing fluid through a second conduit (528) at a location exterior of a vasculature of the patient.

12. The method of any one of claims 6-11, further comprising axially restraining the stented prosthesis (101, 301) in the collapsed orientation on the inner shaft (523) when delivering the stented prosthesis (101, 301).13 The method of claim 12, wherein the stented prosthesis (101, 301) is axially restrained by the first inflatable balloon (605) being positioned distally from a distal end (109, 309) of the expandable stent frame (103, 303).

14. The method of any one of claims 12-13, wherein the stented prosthesis (101, 301) is axially restrained by a bumper (613) mounted to the inner shaft (523) and positioned proximally from a proximal end (111, 311) of the expandable stent frame (103, 303).

15. The method of any one of claims 6-14, wherein inflating the first inflatable balloon (605) expands a distal portion (609b) of the second inflatable balloon (609).

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