TRANSCATHETER VALVE PROSTHESIS WITH A SEALING COMPONENT

A transcatheter valve prosthesis includes a stent, a prosthetic valve component disposed within and secured to the stent, and a sealing component. The sealing component includes a donut-shaped component and at least one pulling suture extending between the donut-shaped component and the stent. The at least one pulling suture is coupled to the stent such that the pulling suture can slide relative to the stent when the stent radially expands from the compressed configuration to the expanded configuration. The sealing component has a delivery configuration in which the donut-shaped component is disposed proximal of a proximal end of the stent and a deployed configuration in which the donut-shaped component is disposed distal of the proximal end of the stent. The pulling suture is configured to longitudinally pull the donut-shaped component as the stent radially expands from the compressed configuration to the expanded configuration.

FIELD OF THE INVENTION

The present invention relates to transcatheter valve prostheses having a sealing component configured to prevent paravalvular leakage.

BACKGROUND OF THE INVENTION

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 atrioventricular 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.

Recently, flexible prosthetic valves supported by stent structures that can be delivered percutaneously using a catheter-based delivery system have been developed for heart and venous valve replacement. These prosthetic valves may include either self-expanding or balloon-expandable stent structures with valve leaflets attached to the interior of the stent structure. The prosthetic valve can be reduced in diameter, by crimping onto a balloon catheter or by being contained within a sheath component of a delivery catheter, and advanced through the venous or arterial vasculature. Once the prosthetic valve is positioned at the treatment site, for instance within an incompetent native valve, the stent structure may be expanded to hold the prosthetic valve firmly in place.

Although transcatheter delivery methods have provided safer and less invasive methods for replacing a defective native heart valve, leakage between the implanted prosthetic valve and the surrounding native tissue is a recurring problem. Leakage sometimes occurs due to the fact that minimally invasive and percutaneous replacement of cardiac valves typically does not involve actual physical removal of the diseased or injured heart valve. Rather, the replacement stented prosthetic valve is delivered in a compressed condition to the valve site, where it is expanded to its operational state within the mitral valve. Calcified or diseased native leaflets are pressed to the side walls of the native valve by the radial force of the stent frame of the stented prosthetic valve. These calcified leaflets do not allow complete conformance of the stent frame with the native valve and can be a source of paravalvular leakage (PVL). Significant pressure gradients across the valve cause blood to leak through the gaps between the implanted stented prosthetic valve and the calcified anatomy.

Embodiments hereof are related to sealing components to seal gaps between the replacement stented prosthetic valve and native valve tissue.

BRIEF SUMMARY OF THE INVENTION

Embodiments hereof relate to a transcatheter valve prosthesis that includes a stent, a prosthetic valve component disposed within and secured to the stent, and a sealing component. The stent has a compressed configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve. The sealing component includes a donut-shaped component and at least one pulling suture extending between the donut-shaped component and the stent. The at least one pulling suture is coupled to the stent such that the pulling suture can slide relative to the stent when the stent radially expands from the compressed configuration to the expanded configuration. The sealing component has a delivery configuration in which the donut-shaped component is disposed proximal of a proximal end of the stent and a deployed configuration in which the donut-shaped component is disposed distal of the proximal end of the stent. The pulling suture is configured to longitudinally pull the donut-shaped component as the stent radially expands from the compressed configuration to the expanded configuration.

Embodiments hereof also relate to a transcatheter valve prosthesis includes a stent, a prosthetic valve component disposed within and secured to the stent, a sealing component, and at least one pulling suture extending between the sealing component and the stent. The stent has a compressed configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve. A first end of the at least one pulling suture is attached to the stent, a second end of the at least one pulling suture is attached to the sealing component, and a body portion of the at least one pulling suture is coupled to the stent such that the pulling suture can slide relative to the stent when the stent radially expands from the compressed configuration to the expanded configuration. The sealing component has a delivery configuration in which the sealing component is disposed proximal of a proximal end of the stent and is longitudinally spaced apart from and not coupled to the stent except via the at least one pulling suture. The sealing component has a deployed configuration in which the sealing component is disposed distal of the proximal end of the stent and encircles an outer surface of the stent. The pulling suture is configured to longitudinally reposition the sealing component as the stent radially expands from the compressed configuration to the expanded configuration.

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the present invention are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. The terms “distal” and “proximal” in the following description refer to a position or direction relative to the direct of blood flow when a prosthesis is deployed at a treatment site. “Distal” and “distally” refer to positions in the direction of blood flow or downstream. “Proximal” and “proximally” refer to positions opposite the direction of blood flow or upstream. The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Although the description of the invention is in the context of treatment of heart valves, the invention may also be used where it is deemed useful in other valved intraluminal sites that are not in the heart. For example, the present invention may be applied to venous valves as well. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following

DETAILED DESCRIPTION

Embodiments hereof relate to a transcatheter valve prosthesis100having a radially-expandable stent102and a sealing component110that encircles or surrounds an outer surface103of the stent102in order to occlude or fill gaps between the perimeter of the transcatheter valve prosthesis100and the native valve annulus, thereby reducing, minimizing, or eliminating leaks there-between.FIG. 1is a side view of the transcatheter valve prosthesis100including the stent102shown in an expanded configuration and the sealing component110shown in a deployed configuration. When the transcatheter valve prosthesis100is deployed within the valve annulus of a native heart valve, the stent102of the transcatheter valve prosthesis100is configured to be radially expanded within native valve leaflets of the patient's defective valve, to thereby retain the native valve leaflets in a permanently open state. The native valve annulus may include surface irregularities on the inner surface thereof, and as a result one or more gaps or cavities/crevices may be present or may form between the perimeter of transcatheter valve prosthesis100and the native valve annulus. For example, calcium deposits may be present on the native valve leaflets (e.g., stenotic valve leaflets) and/or shape differences may be present between the native heart valve annulus and the transcatheter valve prosthesis100. More particularly, in some cases native annuli are not perfectly rounded and have indentations corresponding to the commissural points of the native valve leaflets. As a result, a prosthesis having an approximately circular cross-section does not provide an exact fit in a native valve. These surface irregularities, whatever their underlying cause, can make it difficult for conventional prosthetic valves to form a blood tight seal between the prosthetic valve and the inner surface of the valve annulus, causing undesirable paravalvular leakage and/or regurgitation at the implantation site. As will be described in more detail herein, the sealing component110is coupled to and encircles an outer circumferential surface of the stent102for sealing and preventing paravalvular leakage. The sealing component110functions to block any retrograde flow within the native valve, thereby preventing undesired regurgitation and preventing blood stagnation in and around the native valve sinuses. In addition, when the transcatheter valve prosthesis100is deployed, the sealing component110fills any/all gaps or cavities/crevices between the outer surface103of the stent102and native valve tissue such that blood flow through the target gap or cavity is occluded or blocked, or stated another way blood is not permitted to flow there-through. The sealing component110functions as a continuous circumferential seal around the transcatheter valve prosthesis100to block or prevent blood flow around the outer perimeter of the prosthesis, thereby minimizing and/or eliminating any paravalvular leakage at the implantation site.

The stent102of the transcatheter valve prosthesis100is a frame or scaffold that supports a prosthetic valve104including one or more valve leaflets within the interior of the stent102. The prosthetic valve104is capable of blocking flow in one direction to regulate flow there-through via valve leaflets that may form a bicuspid or tricuspid replacement valve. The valve leaflets may be attached to a graft material106which encloses or lines a portion of the stent102as would be known to one of ordinary skill in the art of prosthetic tissue valve construction. The valve leaflets may be sutured or otherwise securely and sealingly attached along their bases to the interior surface of the graft material106or otherwise secured to the stent102. Adjoining pairs of leaflets are attached to one another at their lateral ends to form commissures. If the transcatheter valve prosthesis100is configured for placement within a native valve having three leaflets such as the aortic, tricuspid, or pulmonary valves, the prosthetic valve component104may include three valve leaflets. If transcatheter valve prosthesis100is configured for placement within a native valve having two leaflets such as the mitral valve, the prosthetic valve component104may include two valve leaflets.

Leaflets may be made of pericardial material; however, the leaflets may instead be made of another material. Natural tissue for replacement valve leaflets may 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 valve leaflets include DACRON® polyester commercially available from Invista North America S.A.R.L. of Wilmington, Del., other cloth materials, nylon blends, polymeric materials, and vacuum deposition nitinol fabricated materials. One polymeric material from which the leaflets can be made is an ultra-high molecular weight polyethylene material commercially available under the trade designation DYNEEMA from Royal DSM of the Netherlands. 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.

The stent102will now be described in more detail. The stent102is illustrated herein in order to facilitate description of the sealing component110attached thereto for preventing and/or repairing paravalvular leakage according to embodiments hereof. It is understood that any number of alternate stents or frames can be used with the sealing components for preventing and/or repairing paravalvular leakage described herein. The configuration of the stent102is merely exemplary.

In the embodiment ofFIG. 1, the stent102is a patterned tubular component that is radially expandable from a compressed or delivery configuration to an expanded or deployed configuration as described in more detail herein. The stent102may be a unitary, generally tubular component defining a central lumen or passageway108and having a first or distal end142and a second or proximal end144. The transcatheter valve prosthesis100is configured for replacement for an aortic valve such that the proximal end144functions as an inflow end of the transcatheter valve prosthesis100and extends into and anchors within the aortic annulus of a patient's left ventricle, while the distal end142functions as an outflow end of the transcatheter valve prosthesis100and is positioned in the patient's ascending aorta or aortic sinuses. The stent102includes a plurality of struts138that form a plurality of side openings140. Stated another way, the plurality of struts138define the plurality of side openings140of the stent102. In an embodiment, the plurality of side openings140may be diamond-shaped. The stent102may be formed by a laser-cut manufacturing method and/or another conventional stent/scaffold forming method, as would be understood by one of ordinary skill in the art. However, it will be understood by one of ordinary skill in the art that the illustrated configuration of the stent102is exemplary and the stent102may have an alternative pattern or configuration. For example, as alternatives to the expanded configuration ofFIG. 1, the stent102may have an expanded or deployed configuration in which the distal end142is enlarged or flared relative to the proximal end144. In another embodiment, the stent102may have an hourglass configuration or profile, or other stent configurations or shapes known in the art for valve replacement. The cross-section of the stent102may be circular, ellipsoidal, rectangular, hexagonal, square, or other polygonal shape, although at present it is believed that circular or ellipsoidal may be preferable when the transcatheter valve prosthesis100is being provided for replacement of the mitral or aortic valves.

Graft material106may enclose or line the stent102as would be known to one of ordinary skill in the art of prosthetic tissue valve construction. Graft material106may be a natural or biological material such as pericardium or another membranous tissue such as intestinal submucosa. Alternatively, graft material106may 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, graft material106may 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 and the ability for the fabric to stretch to conform to a curved surface. Polyester velour fabrics may alternatively be used, such as when it is desired to provide a medium for tissue ingrowth on one side and a smooth surface on the other side. These and other appropriate cardiovascular fabrics are commercially available from Bard Peripheral Vascular, Inc. of Tempe, Ariz., for example.

In embodiments hereof, the stent102is self-expanding to return to an expanded or deployed state or configuration from a compressed or constricted delivery state or configuration and may be made from stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or Nitinol, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal. “Self-expanding” as used herein means that a structure/component has a mechanical memory to return to the expanded or deployed configuration. Mechanical memory may be imparted to the wire or structure that forms the stent102by 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, or a polymer, such as any of the polymers disclosed in U.S. Pat. Appl. Pub. No. 2004/0111111 to Lin, which is incorporated by reference herein in its entirety.

Alternatively, the stent102may be balloon-expandable as would be understood by one of ordinary skill in the art. If balloon-expandable, the stent102is made from a plastically deformable material such that when expanded by a dilatation balloon, the stent102maintains its radially expanded configuration. The stent102may be formed from stainless steel or other suitable metals, such as platinum iridium, cobalt chromium alloys such as MP35N, or various types of polymers or other materials known to those skilled in the art, including said materials coated with various surface deposits to improve clinical functionality.

Delivery of the transcatheter valve prosthesis100may be accomplished via a percutaneous transfemoral approach or a transapical approach directly through the apex of the heart via a thoracotomy, or may be positioned within the desired area of the heart via different delivery methods known in the art for accessing heart valves. During delivery, if self-expanding, the transcatheter valve prosthesis100remains compressed until it reaches a target diseased native heart valve, at which time the transcatheter valve prosthesis100can be released from the delivery catheter and permitted to expand in situ via self-expansion. The delivery catheter is then removed and the transcatheter valve prosthesis100remains deployed within the native target heart valve. Alternatively, as described above, the transcatheter valve prosthesis100may be balloon-expandable and delivery thereof may be accomplished via a balloon catheter as would be understood by one of ordinary skill in the art.

The sealing component110will now be described in more detail with reference toFIGS. 2-5.FIG. 2is a schematic sectional view of the transcatheter valve prosthesis100taken along line A-A ofFIG. 1with the stent102being shown in a compressed configuration and the sealing component110being shown in a delivery configuration, whileFIG. 3is a schematic sectional view of the transcatheter valve prosthesis100taken along line A-A ofFIG. 1with the stent102shown in the expanded configuration and the sealing component110is in the deployed configuration. The sealing component110includes a cylindrical sleeve112formed of a flexible material and a plurality of pulling sutures120(shown inFIGS. 4 and 5) extending between the cylindrical sleeve112and the stent102. The plurality of pulling sutures120are coupled to the stent102such that each pulling suture120can slide relative to the stent102when the stent102radially expands from the compressed configuration to the expanded configuration. Suitable flexible materials for the cylindrical sleeve112include but are not limited to a low-porosity woven fabric, such as polyester, Dacron fabric, or PTFE. Porous materials advantageously provide a medium for tissue ingrowth. Further, the cylindrical sleeve112may be pericardial tissue or may be a knit or woven polyester, such as a polyester or PTFE knit, both of which provide a medium for tissue ingrowth and have the ability to stretch to conform to a curved surface. Polyester velour fabrics may alternatively be used, such as when it is desired to provide a medium for tissue ingrowth on one side and a smooth surface on the other side.

In operation, radial expansion of the stent102from the compressed configuration to the expanded configuration causes the pulling suture120to longitudinally reposition an intermediate portion118of the cylindrical sleeve112. More particularly, when the stent102is in the compressed configuration, the stent102has a first length L1and a first diameter D1. When the stent102radially expands into the expanded configuration, the stent102has a second length L2which is less than the first length L1and a second diameter D2which is greater than the first diameter D1. In embodiments hereof, expansion of the stent102is utilized to reposition the cylindrical sleeve112as the transcatheter valve prosthesis100radially expands. More particularly, when the stent102is in the compressed configuration, the intermediate portion118of the cylindrical sleeve112is disposed at a first longitudinal position proximal of the proximal end144of the stent102. The pulling sutures120longitudinally pull, draw, haul, drag, move or otherwise reposition the intermediate portion118of the cylindrical sleeve112as the transcatheter valve prosthesis100radially expands from the compressed configuration to the expanded configuration. Thus, when the stent102is in the expanded configuration, the intermediate portion118of the cylindrical sleeve112is disposed at a second longitudinal portion that is distal of the proximal end144of the stent102.

Advantageously, a large majority of the flexible material of the sealing component110is disposed proximal to the proximal end144of the stent102when the transcatheter valve prosthesis100is disposed within a delivery system for delivery thereof. Accordingly, the addition of the sealing component110advantageously does not increase, or minimally increases, the packing profile of transcatheter valve prosthesis100so that transcatheter valve prosthesis100has the ability to pack in lower profile delivery systems. When transcatheter valve prosthesis100is deployed, as shown inFIG. 3, the stent102radially expands and the pulling sutures120pull or move the sealing component110into position such that the intermediate portion118of the sealing component110is now disposed distal to the proximal end144of the stent102. Stated another way, the transcatheter valve prosthesis100is configured such that the sealing component110is primarily disposed beyond the proximal end144of the stent102during delivery and then the sealing component110is pulled and bunched up adjacent to the inflow region of the transcatheter valve prosthesis100during stent deployment so that the sealing component110is now in position to prevent and/or repair paravalvular leakage. The deployment and repositioning of the sealing component110thus does not require user intervention but rather utilizes the expansion of the stent102to deploy and reposition the sealing component110.

The components and deployment of the sealing component110are shown in greater detail inFIGS. 4 and 5.FIG. 4is a perspective view of a portion of the transcatheter valve prosthesis100with the stent102being shown in the compressed configuration and the sealing component110being shown in the delivery configuration, whileFIG. 5is a perspective view of a portion of the transcatheter valve prosthesis100with the stent102being shown in the expanded configuration and the sealing component110being shown in the deployed configuration. The cylindrical sleeve112is a cylindrical or component defining a central lumen or passageway and having a first circumferential edge114and an opposing or second circumferential edge116. As best shown inFIGS. 4 and 5, the first circumferential edge114of the cylindrical sleeve112is attached to the outer surface103of the stent102around the proximal end144of the stent102and the second circumferential edge116of the cylindrical sleeve112is attached to the outer surface103of the stent102distal of the proximal end144of the stent102. The first and second circumferential edges114,116of the cylindrical skirt112may be attached to the stent102by any suitable means known to those skilled in the art, for example and not by way of limitation, suture/stitches, welding, adhesive, or mechanical coupling.

InFIGS. 4 and 5, the pulling suture120is shown in phantom to readily distinguish the pulling suture120from the cylindrical sleeve112. SinceFIGS. 4 and 5illustrate only a portion of the transcatheter valve prosthesis100, only a single pulling suture120is shown. However, in the embodiment ofFIGS. 1-5, the sealing component110includes a total of four pulling sutures. More particularly, as best shown inFIG. 9which is a schematic cross-sectional view of the transcatheter valve prosthesis100taken along line B-B ofFIG. 1, four pulling sutures120A,120B,120C,120D are equally circumferentially spaced around the stent102so that the pulling sutures120A,120B,120C,120D are configured to uniformly pull or draw up the cylindrical sleeve112. The pulling sutures120A,120B,120C,120D are collectively or individually referred to herein as the pulling sutures120or the pulling suture120, respectively.

Each pulling suture120is an elongated component having a first end122and a second or opposing end124with a body portion126extending between the first and second ends122,124. The first end122of the pulling suture120is fixedly attached to the stent102, the second end124of the pulling suture120is fixedly attached to the intermediate portion118of the cylindrical sleeve112, and the body portion126of the pulling suture120is coupled to the stent102such that the pulling suture120can slide relative to the stent102. The slidability of the pulling suture120will be described in more detail with reference toFIG. 8described in more detail herein.

Although described with a total of four pulling sutures, it will be understood by those of ordinary skill in the art that the sealing component110may include more or fewer pulling sutures for repositioning the intermediate portion118of the cylindrical sleeve112. For example,FIG. 10is a schematic cross-sectional view of a transcatheter valve prosthesis1000including a sealing component1010according to another embodiment hereof in which the sealing component1010includes a total of three pulling sutures1020A,1020B,1020C equally circumferentially spaced around the transcatheter valve prosthesis1000. As another example,FIG. 11is a schematic cross-sectional view of a transcatheter valve prosthesis1100including a sealing component1110according to another embodiment hereof in which the sealing component1110includes a total of six pulling sutures1120A,1120B,1120C,1120D,1120E,1120F equally circumferentially spaced around the transcatheter valve prosthesis1100. It will be understood by those of ordinary skill in the art that at least one pulling suture is necessary to reposition the intermediate portion118of the cylindrical sleeve112.

In the embodiment ofFIGS. 1-5, the intermediate portion118of the cylindrical sleeve112includes a double pleat in the delivery configuration of the sealing component110. Stated another way, the intermediate portion118includes a first fold or pleat119A formed thereon and a second fold or pleat119B formed thereon. The first and second folds or pleats119A,119B are formed on the cylindrical sleeve112as a result of the manner in which the cylindrical sleeve112is attached to the stent102and the pulling suture(s)120. The first and second folds or pleats are disposed side by side, or directly adjacent to one another, with a crest117disposed therebetween. As shown inFIGS. 2 and 4, in the delivery configuration of the sealing component110, the intermediate portion118including both first and second folds or pleats119A,119B is disposed proximal of the proximal end144of the stent102. The second end124of the pulling suture120is attached to the crest117disposed between the first and second folds or pleats119A,119B of the intermediate portion118of the cylindrical sleeve112. In an embodiment, the crest117is longitudinally aligned with the proximal end144of the stent102when the sealing component110is in the delivery configuration.

As described above, the pulling suture120is configured to longitudinally pull, draw, haul, drag, move or otherwise reposition the intermediate portion118of the cylindrical sleeve112as the stent102radially expands from the compressed configuration to the expanded configuration. More particularly, the body portion126of the pulling suture120A is slidingly disposed through a hole or opening128formed within a strut138of the stent102. Alternatively, the body portion126of the pulling suture120A may be woven through one or more side openings140of the stent102such that the body portion1226of the pulling suture120can slide relative to the stent102when the stent102radially expands from the compressed configuration to the expanded configuration. When the stent102radially expands, the intermediate portion118of the cylindrical sleeve112folds or bunches into the space or gap146defined between the outer surface103of the stent102and the inner surface of the cylindrical sleeve112. Stated another way, the intermediate portion118of the cylindrical sleeve112is pulled in a distal direction, i.e., towards the distal end142of the stent102, by the radial expansion of the stent102as the struts138separate and the side openings140widen during the stent expansion process. In particular, because the first end122of the pulling suture120A is fixedly attached to one of the struts138of the stent102, the first end122moves with the strut138. When the stent102radially expands, the distance between the first end122of the pulling suture120A and the hole128(formed in an adjacent strut138) increases. Thus, a longer length of the body portion126of the pulling suture120A is taken between the strut138and the hole128. Thus, a smaller length of the body portion126of the pulling suture120A remains between the hole128and the second end124of the pulling suture120A attached to the intermediate portion118of the cylindrical sleeve112, thereby pulling the intermediate portion118closer to the hole128. In the deployed configuration of the sealing component110as best shown inFIG. 5, the intermediate portion118of the cylindrical sleeve110is disposed distal of the proximal end144of the stent102and encircles the outer surface103of the stent102. In this embodiment, the entire cylindrical sleeve112is disposed distal of the proximal end144of the stent102in the deployed configuration of the sealing component110. Further, in this embodiment, the sealing component110in the deployed configuration includes three overlapping layers of the flexible material of the cylindrical sleeve112.

When deployed in situ, the sealing component110may be positioned in situ at the native valve annulus, slightly above the valve annulus, slightly below the valve annulus, or some combination thereof. Longitudinal placement and/or the size and shape of the sealing component110may be adjusted or adapted according to each application and to a patient's unique needs. For example, depending on the anatomy of the particular patient, the positioning of the second circumferential edge116of the cylindrical sleeve112relative to the stent102may be selected or adjusted so that in situ the sealing component110is positioned between the transcatheter valve prosthesis100and the interior surfaces of the native valve leaflets, between the transcatheter valve prosthesis100and the interior surfaces of the native valve annulus, and/or between the transcatheter valve prosthesis100and the interior surfaces of the left ventricular outflow track (LVOT).

FIGS. 6, 7, and 8illustrate method steps of assembling the sealing component110onto the transcatheter valve prosthesis100. InFIG. 6, the first circumferential edge114of the cylindrical sleeve112is disposed around and attached to the proximal end144of the stent102. The first circumferential edge114of the cylindrical sleeve112may be attached to the proximal end144of the stent102along the entire perimeter thereof with a running stitch. The second circumferential edge116of the cylindrical sleeve112may also be seamed with a running stitch but is not yet attached to the stent102. Next, as shown inFIG. 7, the cylindrical sleeve112is folded or inverted like a sock so that the second circumferential edge116of the cylindrical sleeve112is disposed adjacent to the stent102, distal to the proximal end144thereof. In an embodiment, approximately one-third (⅓) of the total length of the cylindrical sleeve112extends beyond the proximal end144of the stent102. The second circumferential edge116of the cylindrical sleeve112is disposed adjacent to the stent102such that the cylindrical sleeve112covers the first set of diamond-shaped side openings140adjacent to the proximal end144of the stent102.

Once the cylindrical sleeve112is inverted as desired, the pulling sutures120are put into place.FIG. 8is a schematic cross-sectional view of the transcatheter valve prosthesis100showing placement of only a single pulling suture120for clarity. AlthoughFIG. 8illustrates positioning of only a single pulling suture, the other three pulling sutures are similarly attached to the stent102. The first end122of the pulling suture120A is fixedly attached to the stent102at a first node148A of the stent102. The body portion126of the pulling suture120A is threaded through the hole128positioned through a strut138at a second node148B of the stent102. The spacing between the first node148A and the second node148B of the stent102may vary according to application and the desired amount of repositioning of the intermediate portion118of the cylindrical sleeve112. In an embodiment, the first node148A and the second node148B of the stent102are spaced apart by two other nodes of the stent102as shown inFIG. 8. The intermediate portion118of the cylindrical sleeve112may then be folded into the double pleat configuration, and the second end124of the pulling suture120(not shown inFIG. 8) is attached to the crest117disposed between the first and second folds or pleats119A,119B of the intermediate portion118of the cylindrical sleeve112as described above with reference toFIG. 4. After all of the pulling sutures120are in place, at least some portion of the second circumferential edge116of the cylindrical sleeve112is be attached to the stent102along the entire perimeter thereof with a running stitch. In an embodiment, the second circumferential edge116of the cylindrical sleeve112is attached to the stent102around the proximal end144thereof. However, in another embodiment, the second circumferential edge116of the cylindrical sleeve112is attached to the stent102anywhere along the axial length of the frame depending on the desired placement of the sealing component110.

In another embodiment hereof, the transcatheter valve prosthesis may further include a plurality of restraining sutures. More particularly,FIG. 12is a perspective view of a portion of a transcatheter valve prosthesis1200including the stent102shown in the compressed configuration and a sealing component1210shown in a delivery configuration whileFIG. 13is a perspective view of the portion of the transcatheter valve prosthesis1200with the stent102shown in the expanded configuration and the sealing component1210shown in a deployed configuration. The sealing component1210is similar to the sealing component110. The sealing component1210includes a cylindrical sleeve1212formed of a flexible material and a plurality of pulling sutures1220extending between the cylindrical sleeve1212and the stent102. The plurality of pulling sutures1220are coupled to the stent102such that a body portion1226of each pulling suture1220can slide relative to the stent102when the stent102radially expands from the compressed configuration to the expanded configuration. The cylindrical sleeve1212is a cylindrical or tubular component defining a central lumen or passageway and having a first circumferential edge1214and an opposing or second circumferential edge1216. The first circumferential edge1214of the cylindrical sleeve1212is attached to the outer surface of the transcatheter valve prosthesis1200around a proximal end144of the stent102and the second circumferential edge1216of the cylindrical sleeve1212is attached to the outer surface of the transcatheter valve prosthesis1200distal of the proximal end144of the stent102.

InFIGS. 12 and 13, the pulling suture1220is shown in phantom to readily distinguish the pulling suture1220from the cylindrical sleeve1212. The pulling suture1220is an elongated component having a first end1222and a second or opposing end1224with a body portion1226extending between the first and second ends1222,1224. The first end1222of the pulling suture1220is fixedly attached to the stent102, the second end1224of the pulling suture1220is fixedly attached to an intermediate portion1218of the cylindrical sleeve1212, and the body portion1226of the pulling suture1220is coupled to the stent102such that the pulling suture1220can slide relative to the stent102. Similar to the pulling suture120, the pulling suture1220is configured to longitudinally pull, draw, haul, drag, move or otherwise reposition the intermediate portion1218of the cylindrical sleeve1212as the stent102radially expands from the compressed configuration to the expanded configuration. More particularly, the body portion1226of the pulling suture1220A is slidingly disposed through the hole or opening128formed within a strut138of the stent102. When the stent102radially expands, the intermediate portion1218of the cylindrical sleeve1122folds or bunches into the space or gap1246defined between the outer surface103of the stent102and the inner surface of the cylindrical sleeve1212. In particular, because the first end1222of the pulling suture1220A is fixedly attached to one of the struts138of the stent102, the first end1222moves with the strut138. When the stent102radially expands, the distance between the first end1222of the pulling suture1220A and the hole128(formed in an adjacent strut138) increases. Thus, a longer length of the body portion1226of the pulling suture1220A is taken between the strut138and the hole128. Thus, a smaller length of the body portion1226of the pulling suture1220A remains between the hole128and the second end1224of the pulling suture1220A attached to the intermediate portion1218of the cylindrical sleeve1212, thereby pulling the intermediate portion1218closer to the hole128.

In the deployed configuration of the sealing component1210, the intermediate portion1218of the cylindrical sleeve1210is disposed distal of the proximal end144of the stent102and encircles the outer surface103of the stent102. In this embodiment, the entire cylindrical sleeve1212is disposed distal of the proximal end144of the stent102in the deployed configuration of the sealing component1210. Further in this embodiment, the sealing component1210in the deployed configuration includes three overlapping layers of the flexible material of the cylindrical sleeve1212.

The sealing component1210further includes a plurality of restraining sutures1230extending between the cylindrical sleeve1212and the stent102. SinceFIGS. 12 and 13illustrate only a portion of the transcatheter valve prosthesis1200, only a single restraining suture1230is shown. However, in the embodiment ofFIGS. 12 and 13, the sealing component1210includes a total of four restraining sutures1230that are equally circumferentially spaced around the stent102. The plurality of restraining sutures1230are configured to restrain the sealing component1210from extending radially outwards as the sealing component1210transforms from the delivery configuration to the deployed configuration. InFIGS. 12 and 13, the restraining suture1230is shown in phantom to readily distinguish the restraining suture1230from the cylindrical sleeve1212. Each restraining suture1230is longitudinally or axially spaced apart from each pulling suture1220but the sutures1230,1220are circumferentially aligned.

The restraining suture1230is an elongated component having a first end1232and a second or opposing end1234with a body portion1236extending between the first and second ends1232,1234. The first end1232of the restraining suture1230is fixedly attached to the stent102, the second end1234of the restraining suture1230is fixedly attached to a second intermediate portion1237of the cylindrical sleeve1212, and the body portion1236of the restraining suture1230is coupled to the stent102such that the restraining suture1230can slide relative to the stent102when the stent102radially expands from the compressed configuration to the expanded configuration. More particularly, the body portion1236of the restraining suture1230is slidingly disposed through a hole or opening1229formed within a strut138of the stent102. The restraining suture1230is configured to restrain, hold, or otherwise prevent the cylindrical sleeve1212from extending radially outwards as the sealing component1210transforms from the delivery configuration to the deployed configuration. In an embodiment, the second intermediate portion1237of the cylindrical sleeve1212is distal to the intermediate portion1218of the cylindrical sleeve1212. The plurality of restraining sutures1230actuate simultaneously with the plurality of pulling sutures1220to ensure that the cylindrical sleeve1212does not flip radially outwards towards the distal end of the transcatheter valve prosthesis1200. In particular, because the first end1232of the restraining suture1230is fixedly attached to one of the struts138of the stent102, the first end122moves with the strut138. When the stent102radially expands, the distance between the first end1232of the restraining suture1230and the hole1229(formed in an adjacent strut138) increases. Thus, a longer length of the body portion1236of the restraining suture1230is taken between the strut138and the hole1229. Thus, the length of the body portion1236of the restraining suture1230extending between the hole1229and the second end1234of the restraining suture1230attached to the second intermediate portion1237of the cylindrical sleeve1212decreases, thereby restraining or preventing the cylindrical sleeve1212from flipping radially outwards as the second intermediate portion1237is pulled closer towards the hole1229.

FIGS. 14 and 15illustrate another embodiment of a sealing component1410in which the sealing component1410has a single pleat configuration in the delivery configuration rather than the double pleat configuration of the sealing component110. More particularly,FIG. 14is a perspective view of a portion of a transcatheter valve prosthesis1400including the stent102shown in the compressed configuration and the sealing component1410shown in a delivery configuration whileFIG. 15is a perspective view of the portion of the transcatheter valve prosthesis1400with the stent102shown in the expanded configuration and the sealing component1410shown in a deployed configuration. The sealing component1410is similar to the sealing component110except that the sealing component1410has a single pleat configuration in the delivery configuration rather than the double pleat configuration of the sealing component110. The sealing component1410includes a cylindrical sleeve1412formed of a flexible material and a plurality of pulling sutures1420extending between the cylindrical sleeve1412and the stent102. The plurality of pulling sutures1420are coupled to the stent102such that a body portion1426of each pulling suture1420can slide relative to the stent102when the stent102radially expands from the compressed configuration to the expanded configuration. The cylindrical sleeve1412is a cylindrical or component defining a central lumen or passageway and having a first circumferential edge1414and an opposing or second circumferential edge1416. The first circumferential edge1414of the cylindrical sleeve1412is attached to the outer surface of the transcatheter valve prosthesis1400around the proximal end144of the stent102and the second circumferential edge1416of the cylindrical sleeve1412is attached to the outer surface of the transcatheter valve prosthesis1400distal of the proximal end144of the stent102.

InFIGS. 14 and 15, the pulling suture1420is shown in phantom to readily distinguish the pulling suture1420from the cylindrical sleeve1412. The pulling suture1420is an elongated component having a first end1422and a second or opposing end1424with a body portion1426extending between the first and second ends1422,1424. The first end1422of the pulling suture1420is attached to the stent102, the second end1424of the pulling suture1420is attached to the intermediate portion1418of the cylindrical sleeve1412, and the body portion1426of the pulling suture1420is coupled to the stent102such that the pulling suture1420can slide relative to the stent102. In this embodiment, the intermediate portion1418of the cylindrical sleeve1412includes a single pleat in the delivery configuration. Stated another way, the intermediate portion1418includes a single fold or pleat1419formed thereon. In the delivery configuration of the sealing component1410, the intermediate portion1418including the single fold or pleat1419is disposed proximal of the proximal end144of the stent102. The second end1424of the pulling suture1420is attached to the single fold or pleat1419of the intermediate portion1418of the cylindrical sleeve1412.

Similar to the pulling suture120, the pulling suture1420is configured to longitudinally pull, draw, haul, drag, move or otherwise reposition the intermediate portion1418of the cylindrical sleeve1412as the stent102radially expands from the compressed configuration to the expanded configuration. More particularly, the body portion1426of the pulling suture1420A is slidingly disposed through a hole or opening128formed within a strut138of the stent102. When the stent102radially expands, the intermediate portion1418of the cylindrical sleeve1412folds or bunches into the space or gap1446defined between the outer surface103of the stent102and the inner surface of the cylindrical sleeve1412. In the deployed configuration of the sealing component1410, the intermediate portion1418of the cylindrical sleeve1410is disposed distal of the proximal end144of the stent102and the cylindrical sleeve1412encircles the outer surface103of the stent102. In particular, because the first end1422of the pulling suture1420A is fixedly attached to one of the struts138of the stent102, the first end1422moves with the strut138. When the stent102radially expands, the distance between the first end1422of the pulling suture1420A and the hole128(formed in an adjacent strut138) increases. Thus, a longer length of the body portion1426of the pulling suture1420A is taken between the strut138and the hole128. Thus, a smaller length of the body portion1426of the pulling suture1420A remains between the hole128and the second end1424of the pulling suture1420A attached to the intermediate portion1418of the cylindrical sleeve1412, thereby pulling the intermediate portion1418closer to the hole128.

In this embodiment, the sealing component1410in the deployed configuration includes three overlapping layers of the flexible material of the cylindrical sleeve1412. Further, in this embodiment, the sealing component1410is disposed both proximal to and distal to the proximal end144of the stent102when the sealing component1410is in the deployed configuration. In another embodiment (now shown), the sealing component1410is disposed only distal to the proximal end144of the stent102when the sealing component1410is in the deployed configuration.

FIGS. 16 and 17illustrate another embodiment of a sealing component1610in which the sealing component1610does not include any pleats in the delivery configuration. More particularly,FIG. 16is a perspective view of a portion of a transcatheter valve prosthesis1600including the stent102in the compressed configuration and the sealing component1610shown in a delivery configuration whileFIG. 17is a perspective view of the portion of the transcatheter valve prosthesis1600with the stent102in the expanded configuration and the sealing component1610shown in a deployed configuration. The sealing component1610includes a cylindrical sleeve1612formed of a flexible material and a plurality of pulling sutures1620extending between the cylindrical sleeve1612and a stent102. The plurality of pulling sutures1620are coupled to the stent102such that a body portion1626of each pulling suture1620can slide relative to the stent102when the stent102radially expands from the compressed configuration to the expanded configuration. The cylindrical sleeve1612is a cylindrical or component defining a central lumen or passageway and having a first circumferential edge1614and an opposing or second circumferential edge1616. The first circumferential edge1614of the cylindrical sleeve1612is attached to the outer surface of the transcatheter valve prosthesis1600around the proximal end144of the stent102. In this embodiment, the second circumferential edge1616of the cylindrical sleeve1612is not attached to the outer surface of the transcatheter valve prosthesis1600but rather is disposed proximal to the proximal end144of the stent102in the delivery configuration of the sealing component1610.

InFIGS. 16 and 17, the pulling suture1620is shown in phantom to readily distinguish the pulling suture1620from the cylindrical sleeve1612. The pulling suture1620is an elongated component having a first end1622and a second or opposing end1624with a body portion1626extending between the first and second ends1622,1624. The first end1622of the pulling suture1620is fixedly attached to the stent102, the second end1624of the pulling suture1620is fixedly attached to the second circumferential edge1616of the cylindrical sleeve1612, and the body portion1626of the pulling suture1620is coupled to the stent102such that the pulling suture1620can slide relative to the stent102. As described above, the second end1624of the pulling suture1620is attached to the second circumferential edge1616of the cylindrical sleeve1612.

Similar to the pulling suture120, the pulling suture1620is configured to longitudinally pull, draw, haul, drag, move or otherwise reposition the intermediate portion1618of the cylindrical sleeve1612as the stent102radially expands from the compressed configuration to the expanded configuration. More particularly, the body portion1626of the pulling suture1620A is slidingly disposed through a hole or opening128formed within a strut138of the stent102. When the stent102radially expands, the second circumferential edge1616of the cylindrical sleeve1612inverts or rotates radially outward until the cylindrical sleeve1612lies flush or generally parallel to the outer surface103of the stent102. In the deployed configuration of the sealing component1610, the entire cylindrical sleeve1610is disposed distal of the proximal end144of the stent102and the cylindrical sleeve1612encircles the outer surface103of the stent102. In this embodiment, the sealing component1610in the deployed configuration includes a single layer of the flexible material of the cylindrical sleeve1612.

FIGS. 18 and 19illustrate another embodiment of a sealing component1810in which the sealing component1810includes a donut-shaped component that is pulled into place via a plurality of pulling sutures1820. More particularly,FIG. 18is a perspective view of a transcatheter valve prosthesis1800including the stent102in the compressed configuration and the sealing component1810shown in a delivery configuration whileFIG. 19is a perspective view of the transcatheter valve prosthesis1800with the stent102in the expanded configuration and the sealing component1810shown in a deployed configuration. The sealing component1810includes a donut-shaped component1850formed of a flexible material and the plurality of pulling sutures1820extending between the donut-shaped component1850and the stent102. The donut-shaped component1850is an annular component having an outer circumferential surface1852and an inner circumferential surface1854which defines a central lumen or passageway1856therethrough. The inner circumferential surface1854is dimensioned or configured to abut against the outer surface103of the stent102in the expanded configuration. Although it is shown inFIGS. 18-19to have a length or height configurated to extend over the proximal or inflow portion of the stent102, the length or height of the donut-shaped component1850may vary according to application and may extend over a greater or lesser amount of the stent102. Suitable flexible materials for the donut-shaped component1850include but are not limited to a natural or biological material such as pericardium or another membranous tissue such as intestinal submucos or a low-porosity woven fabric, such as polyester, Dacron fabric, or PTFE. Porous materials advantageously provide a medium for tissue ingrowth. Further, the donut-shaped component1850may be pericardial tissue or may be a knit or woven polyester, such as a polyester or PTFE knit, both of which provide a medium for tissue ingrowth and have the ability to stretch to conform to a curved surface. Polyester velour fabrics may alternatively be used, such as when it is desired to provide a medium for tissue ingrowth on one side and a smooth surface on the other side. In the delivery configuration, as shown onFIG. 18, the donut-shaped component1850is spaced apart from and not coupled to the stent102except via the plurality of pulling sutures1820. Further, the donut-shaped component1850is disposed proximal to the proximal end144of the stent102in the delivery configuration of the sealing component1810.

The plurality of pulling sutures1820are coupled to the stent102such that a body portion1826of each pulling suture1820can slide relative to the stent102when the stent102radially expands from the compressed configuration to the expanded configuration. InFIGS. 18 and 19, the pulling suture1820is shown in phantom to readily distinguish the pulling suture1820from the donut-shaped component1850. The pulling suture1820is an elongated component having a first end1822and a second or opposing end1824with the body portion1826extending between the first and second ends1822,1824. The first end1822of the pulling suture1820is fixedly attached to the stent102, the second end1824of the pulling suture1820is fixedly attached to the donut-shaped component1850, and the body portion1826of the pulling suture1820is coupled to the stent102such that the pulling suture1820can slide relative to the stent102.

Similar to the pulling suture120, the pulling suture1820is configured to longitudinally pull, draw, haul, drag, move or otherwise reposition the donut-shaped component1850as the stent102radially expands from the compressed configuration to the expanded configuration. More particularly, the body portion1826of the pulling suture1820is slidingly disposed through a hole or opening128formed within a strut138of the stent102. When the stent102radially expands, the donut-shaped component1850is pulled distally towards the stent102until the donut-shaped component1850is disposed around the outer surface103of the stent102. In the deployed configuration of the sealing component1810, the donut-shaped component1850is disposed distal of the proximal end144of the stent102and the donut-shaped component1850encircles the outer surface103of the stent102.

In the embodiment ofFIGS. 18 and 19, each pulling suture1820has the same length and the donut-shaped component1850is pulled up or repositioned in a uniform manner such that the donut-shaped component1850in the deployed configuration forms a circular ring around the outer surface103of the stent102. Stated another way, in the deployed configuration of the sealing component1810, the donut-shaped component1850is a circular ring.FIGS. 20, 21, and22illustrate another embodiment of a sealing component2010in which the sealing component2010includes a donut-shaped component that is an undulating ring when the sealing component2010is in the deployed configuration. When the sealing component2010is in the deployed configuration, the material of the donut-shaped component bunches or gathers up into the undulating or wavy ring so that the bunched or gathered up material of the sealing component2010as deployed may further prevent and/or repair paravalvular leakage.

More particularly,FIG. 20is a perspective view of a transcatheter valve prosthesis2000including the stent102in the compressed configuration and the sealing component2010shown in a delivery configuration whileFIG. 21is a perspective view of the transcatheter valve prosthesis2000with the stent102in the expanded configuration and the sealing component2010shown in a deployed configuration. The sealing component2010includes a donut-shaped component2050formed of a flexible material and a plurality of pulling sutures2020A,2020B extending between the donut-shaped component2050and the stent102.FIG. 22is a perspective view of the donut-shaped component2050in the deployed configuration, the donut-shaped component2050being removed from the transcatheter vale prosthesis2000for illustrative purposes only. The donut-shaped component2050is an annular component having an outer circumferential surface2052and an inner circumferential surface2054which defines a central lumen or passageway2056therethrough. The inner circumferential surface2054is dimensioned or configured to abut against the outer surface103of the stent102in the expanded configuration. Although it is shown inFIGS. 20-22to have a length or height configurated to extend over the proximal or inflow portion of the stent102, the length or height of the donut-shaped component2050may vary according to application and may extend over a greater or lesser amount of the stent102. Suitable flexible materials for the donut-shaped component2050include but are not limited to a natural or biological material such as pericardium or another membranous tissue such as intestinal submucos or a low-porosity woven fabric, such as polyester, Dacron fabric, or PTFE. Porous materials advantageously provide a medium for tissue ingrowth. Further, the donut-shaped component2050may be pericardial tissue or may be a knit or woven polyester, such as a polyester or PTFE knit, both of which provide a medium for tissue ingrowth and have the ability to stretch to conform to a curved surface. Polyester velour fabrics may alternatively be used, such as when it is desired to provide a medium for tissue ingrowth on one side and a smooth surface on the other side. In the delivery configuration, as shown onFIG. 20, the donut-shaped component2050is spaced apart from and not coupled to the stent102except via the plurality of pulling sutures2020A,2020B. Further, the donut-shaped component2050is disposed proximal to the proximal end144of the stent102in the delivery configuration of the sealing component2010.

In this embodiment, the sealing component2010includes a total of four pulling sutures including a first pair or set of pulling sutures2020A coupled to opposing locations on the stent102and a second pair or set of pulling sutures2020B coupled to opposing locations on the stent102. One of the pulling sutures2020B is not visible onFIGS. 20-21. The four pulling sutures2020A,2020B are equally circumferentially spaced around the stent102with each pulling suture2020A being disposed between a pair of pulling sutures2020B. Stated another way, the pair of pulling sutures2020A are circumferentially offset by approximately ninety degrees from the pair of pulling sutures2020B. As will be explained in more detail herein, the first set of pulling sutures2020A is configured to longitudinally pull the donut-shaped component2050a greater amount than the second set of pulling sutures2020B such that in the deployed configuration of the sealing component2010, the donut-shaped component2050is an undulating ring.

The pulling sutures2020A are coupled to the stent102such that a body portion2026A of each pulling suture2020A can slide relative to the stent102when the stent102radially expands from the compressed configuration to the expanded configuration. InFIGS. 20 and 21, the pulling suture2020A is shown in phantom to readily distinguish the pulling suture2020A from the donut-shaped component2050. The pulling suture2020A is an elongated component having a first end2022A and a second or opposing end2024A with the body portion2026A extending between the first and second ends2022A,2024A. The first end2022A of the pulling suture2020A is fixedly attached to the stent102, the second end2024A of the pulling suture2020A is fixedly attached to the donut-shaped component2050, and the body portion2026A of the pulling suture2020A is coupled to the stent102such that the pulling suture2020A can slide relative to the stent102.

Similarly, the pulling sutures2020B are coupled to the stent102such that a body portion2026B of each pulling suture2020B can slide relative to the stent102when the stent102radially expands from the compressed configuration to the expanded configuration. InFIGS. 20 and 21, the pulling suture2020B is shown in phantom to readily distinguish the pulling suture2020B from the donut-shaped component2050. The pulling suture2020B is an elongated component having a first end2022B and a second or opposing end2024B with the body portion2026B extending between the first and second ends2022B,2024B. The first end2022B of the pulling suture2020B is fixedly attached to the stent102, the second end2024B of the pulling suture2020B is fixedly attached to the donut-shaped component2050, and the body portion2026B of the pulling suture2020B is coupled to the stent102such that the pulling suture2020B can slide relative to the stent102.

Each pulling suture2020A,2020B is configured to longitudinally pull, draw, haul, drag, move or otherwise reposition the donut-shaped component2050as the stent102radially expands from the compressed configuration to the expanded configuration. More particularly, the body portion2026A of each pulling suture2020A is slidingly disposed through a hole or opening128A formed within a strut138of the stent102and the body portion2026B of each pulling suture2020B is slidingly disposed through a hole or opening128B formed within a strut138of the stent102. When the stent102radially expands, the donut-shaped component2050is pulled distally towards the stent102until the donut-shaped component2050is disposed around the outer surface103of the stent102. In the deployed configuration of the sealing component2010, the donut-shaped component2050is disposed distal of the proximal end144of the stent102and the donut-shaped component2050encircles the outer surface103of the stent102.

In this embodiment, the pulling sutures2020A,2020B are configured to longitudinally pull, draw, haul, drag, move or otherwise reposition the donut-shaped component2050in a non-uniform manner such that the donut-shaped component2050in the deployed configuration forms a undulating or wavy ring around the outer surface103of the stent102. More particularly, each suture of the first set of pulling sutures2020A is longer than the each suture of the second set of pulling sutures2020B. The relatively increased length of each pulling suture2020A allows the pulling suture2020A to span across a greater number of side openings140of the stent102such that the distance of travel of the donut-shaped component2050is relatively increased when the stent102radially expands. In addition, each suture of the first set of pulling sutures2020A is coupled to the stent102closer to the proximal end144of the stent102than the each suture of the second set of pulling sutures2020B. If the pulling sutures2020A,2020B were the same size and configured to travel the same distance when the stent102radially expands, different attachment locations of the pulling sutures2020A,2020B may vary the final longitudinal position of the donut-shaped component2050when the stent102radially expands. More particularly, if the pulling sutures2020A,2020B were the same size and configured to travel the same distance when the stent102radially expands, positioning each pulling suture2020A closer to the proximal end144of the stent102allows the pulling suture2020A to span across a greater number of side openings140of the stent102such that the distance of travel of the donut-shaped component2050is relatively increased when the stent102radially expands. Thus, the variable length of the pulling sutures2020A,2020B, as well as the variable attachment location relative to the proximal end144of the stent102, may cause the pulling sutures2020B to be configured to longitudinally pull or move the donut-shaped component2050a greater amount than the pulling sutures2020A. As best shown onFIG. 22, opposing portions2060A,2060B of the donut-shaped component2050that are attached to the pulling sutures2020B are pulled a greater amount than the opposing portions2062A,2062B of the donut-shaped component2050that are attached to the pulling sutures2020A. As a result, the deployed configuration of the donut-shaped component2050includes bumps or bulges along the opposing portions2060A,2060B that are disposed closer to the distal end142of the stent102than the opposing portions2062A,2062B. Due to the bumps or bulges along the opposing portions2060A,2060B, the donut-shaped component2050in the deployed configuration form an undulating or wavy ring around the outer surface103of the stent102.

As described above, in order to longitudinally pull or move the donut-shaped component2050a greater amount than the pulling sutures2020A, the pulling sutures2020B are longer than the pulling sutures2020A and are also coupled to the stent102closer to the proximal end144of the stent102than the pulling sutures2020A. However, in order to longitudinally pull or move the donut-shaped component2050a greater amount than the pulling sutures2020A, the pulling sutures2020B may be longer than the pulling sutures2020A or may be coupled to the stent102closer to the proximal end144of the stent102than the pulling sutures2020A. Stated another way, it is not required that the pulling sutures2020A,2020B have variable lengths in addition to variable attachment locations relative to the proximal end144of the stent102. For example, in another embodiment, the pulling sutures2020B are longer than the pulling sutures2020A in order to longitudinally pull or move the donut-shaped component2050a greater amount than the pulling sutures2020A but the pulling sutures2020A,2020B do not have a variable attachment location relative to the proximal end144of the stent102. In another embodiment, the pulling sutures2020B are coupled to the stent102closer to the proximal end144of the stent102than the pulling sutures2020A in order to longitudinally pull or move the donut-shaped component2050a greater amount than the pulling sutures2020A but the pulling sutures2020A,2020B do not have variable lengths.

Although the embodiment ofFIGS. 20-22is described with a total of four pulling sutures2020A,2020B and two resulting bumps or bulges along the opposing portions2060A,2060B, it will be understood by those of ordinary skill in the art that the sealing component2010may include more or fewer pulling sutures for repositioning the donut-shaped component2050and the number of resulting bumps or bulges of the donut-shaped component may vary from the embodiment ofFIGS. 20-22. For example,FIG. 23is a perspective view of a donut-shaped component2350in a deployed configuration according to another embodiment, with the donut-shaped component being removed from a transcatheter vale prosthesis for illustrative purposes only. Similar to the donut-shaped component2050, the donut-shaped component2350is an annular component having an outer circumferential surface2352and an inner circumferential surface2354which defines a central lumen or passageway2356therethrough. The inner circumferential surface2354is dimensioned or configured to abut against the outer surface103of the stent102in the expanded configuration. The donut-shaped component2350in the deployed configuration includes a total of five portions2360A that include bulges or bumps and a total of five portions2362A that do not include bulges or bumps. Each portion2360A of the donut-shaped component2350that includes a bulge or bump is coupled to a pulling suture that is configured to longitudinally pull or move the donut-shaped component2350a greater amount than the pulling sutures that are coupled to portions2362A that do not include bulges or bumps. In an embodiment, the donut-shaped component is configured to include at two portions that include bulges or bumps and may include between two and six portions that include bulges or bumps.

According to a first embodiment hereof, a transcatheter valve prosthesis includes a stent, a prosthetic valve component disposed within and secured to the stent, and a sealing component. The stent has a compressed configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve. The sealing component includes a donut-shaped component and at least one pulling suture extending between the donut-shaped component and the stent. The at least one pulling suture is coupled to the stent such that the pulling suture can slide relative to the stent when the stent radially expands from the compressed configuration to the expanded configuration. The sealing component has a delivery configuration in which the donut-shaped component is disposed proximal of a proximal end of the stent and a deployed configuration in which the donut-shaped component is disposed distal of the proximal end of the stent. The pulling suture is configured to longitudinally pull the donut-shaped component as the stent radially expands from the compressed configuration to the expanded configuration.

In an aspect of the first embodiment, and in combination with any other aspects herein, in the deployed configuration of the sealing component the donut-shaped component encircles an outer surface of the stent.

In an aspect of the first embodiment, and in combination with any other aspects herein, in the deployed configuration of the sealing component the donut-shaped component is a circular ring.

In an aspect of the first embodiment, and in combination with any other aspects herein, in the deployed configuration of the sealing component the donut-shaped component is an undulating ring.

In an aspect of the first embodiment, and in combination with any other aspects herein, the sealing component includes a plurality of pulling sutures extending between the donut-shaped component and the stent. The pulling sutures are circumferentially spaced around the stent.

In an aspect of the first embodiment, and in combination with any other aspects herein, the plurality of pulling sutures includes a first set of pulling sutures and a second set of pulling sutures. The first set of pulling sutures is configured to longitudinally pull the donut-shaped component a greater amount than the second set of pulling sutures such that in the deployed configuration of the sealing component the donut-shaped component is an undulating ring.

In an aspect of the first embodiment, and in combination with any other aspects herein, each suture of the first set of pulling sutures is longer than the each suture of the second set of pulling sutures.

In an aspect of the first embodiment, and in combination with any other aspects herein, each suture of the first set of pulling sutures is coupled to the stent closer to the proximal end of the stent than the each suture of the second set of pulling sutures.

In an aspect of the first embodiment, and in combination with any other aspects herein, the donut-shaped component is an annular component having an outer circumferential surface and an inner circumferential surface which defines a central lumen therethrough. The inner circumferential surface is configured to abut against the outer surface of the stent in the deployed configuration.

In an aspect of the first embodiment, and in combination with any other aspects herein, in the deployed configuration the donut-shaped component is spaced apart from and not coupled to the stent except via the at least one pulling suture.

In an aspect of the first embodiment, and in combination with any other aspects herein, radial expansion of the stent from the compressed configuration to the expanded configuration causes the pulling suture to longitudinally reposition the donut-shaped component such that the sealing component has a delivery configuration in which the donut-shaped component is disposed at a first longitudinal position and the sealing component has a deployed configuration in which the donut-shaped component is disposed at a second longitudinal position. The first longitudinal portion is proximal of a proximal end of the stent and the second longitudinal portion is distal of the proximal end of the stent.

In an aspect of the first embodiment, and in combination with any other aspects herein, a first end of the at least one pulling suture is attached to the stent, a second end of the at least one pulling suture is attached to the donut-shaped component, and a body portion of the at least one pulling suture is coupled to the stent such that the pulling suture can slide relative to the stent when the stent radially expands from the compressed configuration to the expanded configuration.

According to a second embodiment hereof, a transcatheter valve prosthesis includes a stent, a prosthetic valve component disposed within and secured to the stent, a sealing component, and at least one pulling suture extending between the sealing component and the stent. The stent has a compressed configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve. A first end of the at least one pulling suture is attached to the stent, a second end of the at least one pulling suture is attached to the sealing component, and a body portion of the at least one pulling suture is coupled to the stent such that the pulling suture can slide relative to the stent when the stent radially expands from the compressed configuration to the expanded configuration. The sealing component has a delivery configuration in which the sealing component is disposed proximal of a proximal end of the stent and is longitudinally spaced apart from and not coupled to the stent except via the at least one pulling suture. The sealing component has a deployed configuration in which the sealing component is disposed distal of the proximal end of the stent and encircles an outer surface of the stent. The pulling suture is configured to longitudinally reposition the sealing component as the stent radially expands from the compressed configuration to the expanded configuration.

In an aspect of the second embodiment, and in combination with any other aspects herein, in the deployed configuration of the sealing component the donut-shaped component is a circular ring.

In an aspect of the second embodiment, and in combination with any other aspects herein, in the deployed configuration of the sealing component the donut-shaped component is an undulating ring.

In an aspect of the second embodiment, and in combination with any other aspects herein, a plurality of pulling sutures extend between the sealing component and the stent. The pulling sutures are circumferentially spaced around the stent.

In an aspect of the second embodiment, and in combination with any other aspects herein, the plurality of pulling sutures includes a first set of pulling sutures and a second set of pulling sutures. The first set of pulling sutures is configured to longitudinally pull the donut-shaped component a greater amount than the second set of pulling sutures such that in the deployed configuration of the sealing component the donut-shaped component is an undulating ring.

In an aspect of the second embodiment, and in combination with any other aspects herein, each suture of the first set of pulling sutures is longer than the each suture of the second set of pulling sutures.

In an aspect of the second embodiment, and in combination with any other aspects herein, each suture of the first set of pulling sutures is coupled to the stent closer to the proximal end of the stent than the each suture of the second set of pulling sutures.

In an aspect of the second embodiment, and in combination with any other aspects herein, the sealing component is an annular component having an outer circumferential surface and an inner circumferential surface which defines a central lumen therethrough. The inner circumferential surface is configured to abut against the outer surface of the stent in the deployed configuration.

While various embodiments according to the present invention have been described above, it should be understood that they have been presented by way of illustration and example only, and not limitation. For example, although the sealing component110is shown in the above embodiments as encircling the proximal end144of the transcatheter valve prosthesis100, it will be understood by one of ordinary skill in the art that the sealing component110may alternatively be disposed at other longitudinal positions along the transcatheter valve prosthesis. For example, the sealing component may be disposed around the distal end142of the transcatheter valve prosthesis100, or only around a middle or intermediate waist portion of the transcatheter valve prosthesis. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the invention. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the appended claims and their equivalents. It will also be understood that each feature of each embodiment discussed herein, and of each reference cited herein, can be used in combination with the features of any other embodiment. All patents and publications discussed herein are incorporated by reference herein in their entirety.