# Patent

## Title
Prosthesis with outer skirt and anchors

## Abstract

A prosthesis can be configured to grasp intralumenal tissue when deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the body cavity, and an outer skirt positioned annularly around an exterior of the expandable frame. In some embodiments, the outer skirt can extend outward from the frame and be secured to an outwardly extending anchor on the frame to create an axial barrier to fluid flow exterior to the frame when deployed within the body cavity.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of priority to U.S. Provisional Appl. Nos. 61/782,707, filed Mar. 14, 2013 and 61/789,783, filed Mar. 15, 2013. The entire contents of the above applications are hereby incorporated by reference and made a part of this specification. Any and all priority claims identified in the Application Data Sheet, or any correction thereto, are hereby incorporated by reference under 37 CFR 1.57.


BACKGROUND OF THE INVENTION
1. Field of the Invention
Certain embodiments disclosed herein relate generally to prostheses for implantation within a lumen or body cavity. In particular, certain embodiments relate to expandable prostheses such as replacement heart valves, such as for the mitral valve, that are configured to atraumatically grasp intralumenal tissue.
2. Description of the Related Art
Human heart valves, which include the aortic, pulmonary, mitral and tricuspid valves, function essentially as one-way valves operating in synchronization with the pumping heart. The valves allow blood to flow downstream, but block blood from flowing upstream. Diseased heart valves exhibit impairments such as narrowing of the valve or regurgitation, which inhibit the valves' ability to control blood flow. Such impairments reduce the heart's blood-pumping efficiency and can be a debilitating and life threatening condition. For example, valve insufficiency can lead to conditions such as heart hypertrophy and dilation of the ventricle. Thus, extensive efforts have been made to develop methods and apparatuses to repair or replace impaired heart valves.
Prostheses exist to correct problems associated with impaired heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace impaired native heart valves. More recently, substantial effort has been dedicated to developing replacement heart valves, particularly tissue-based replacement heart valves that can be delivered with less trauma to the patient than through open heart surgery. Replacement valves are being designed to be delivered through minimally invasive procedures and even percutaneous procedures. Such replacement valves often include a tissue-based valve body that is connected to an expandable frame that is then delivered to the native valve's annulus.
These replacement valves are often intended to at least partially block blood flow. However, a problem occurs when blood flows around the valve on the outside of the prosthesis. For example, in the context of replacement heart valves, paravalvular leakage has proven particularly challenging. An additional challenge relates to the ability of such prostheses to be secured relative to intralumenal tissue, e.g., tissue within any body lumen or cavity, in an atraumatic manner. Further challenges arise when trying to controllably deliver and secure such prostheses in a location such as at a native mitral valve.
SUMMARY OF THE INVENTION
Embodiments of the present disclosure are directed to a prosthesis, such as but not limited to a replacement heart valve. According to some embodiments, a prosthesis can be configured to be deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the body cavity, and an outer skirt positioned annularly around an exterior of the expandable frame. In some embodiments, the outer skirt can extend outward from the frame and be secured to an outwardly extending anchor on the frame to create an axial barrier to fluid flow exterior to the frame when deployed within the body cavity. Further embodiments are directed to methods of delivering a prosthesis, e.g. a replacement heart valve, and methods of using a prosthesis to create a barrier to fluid flow exterior to the prosthesis (e.g., to prevent paravalvular leakage).
In some embodiments a prosthesis can be configured to grasp intralumenal tissue when deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can comprise an expandable frame, a plurality of proximal anchors, a plurality of distal anchors, and a skirt. The expandable frame can comprise a proximal end and a distal end and a longitudinal axis extending therethrough, the frame configured to radially expand and contract for deployment within the body cavity. The plurality of proximal anchors can each connect to the frame so that when the frame is in an expanded configuration an end of each proximal anchor is positioned radially outward from the frame and extends generally distally. The plurality of distal anchors can each connect to the frame so that when the frame is in an expanded configuration an end of each distal anchor is positioned radially outward from the frame and extends generally proximally, wherein the ends of the distal anchors are axially spaced from the ends of the proximal anchors when the frame is in an expanded configuration. The skirt can be annularly positioned around an exterior of the expandable frame and secured to at least some of the plurality of proximal anchors to create an axial barrier to fluid flow exterior to the frame when deployed within the body cavity. In some embodiments, the frame can be configured such that radial expansion of the frame causes the ends of the plurality of proximal anchors and the ends of the plurality of distal anchors to draw closer together.



BRIEF DESCRIPTION OF THE DRAWINGS
These and other features, aspects and advantages are described below with reference to the drawings, which are intended to illustrate but not to limit the invention. In the drawings, like reference characters denote corresponding features consistently throughout similar embodiments.
FIG. 1A is a side view of an embodiment of a prosthesis configured as a replacement heart valve.
FIG. 1B is a side view of the frame from the prosthesis of FIG. 1A.
FIG. 2 is a perspective view of a skirt.
FIG. 3A is a schematic representation of a prosthesis positioned within the heart.
FIG. 3B is a detail schematic representation of the prosthesis positioned within the heart of FIG. 3A.



DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The present specification and drawings provide aspects and features of the disclosure in the context of several embodiments of prostheses, replacement heart valves, delivery devices and methods that are configured for use in the vasculature of a patient, such as for replacement of natural heart valves in a patient. These embodiments may be discussed in connection with replacing specific valves such as the patient's aortic or mitral valve. However, it is to be understood that the features and concepts discussed herein can be applied to products other than heart valve implants. For example, the controlled positioning, deployment, and securing features described herein can be applied to medical implants, for example other types of expandable prostheses, for use elsewhere in the body, such as within a vein, or the like. In addition, particular features of a valve, delivery device, etc. should not be taken as limiting, and features of any one embodiment discussed herein can be combined with features of other embodiments as desired and when appropriate.
With initial reference to FIGS. 1A-B, an embodiment of a prosthesis 10 is shown. The illustrated prosthesis 10 includes a frame 20 that may be self-expanding or balloon expandable. The frame 20 (as best seen in FIG. 1B) can include a proximal end 32, a distal end 34 and proximal 22 and distal 24 anchors. The anchors can allow the frame to engage a native valve annulus or other tissue to be implanted at a target location. The prosthesis 10 can include one or more of a valve 60, an outer skirt 30, a valve skirt 70 and a support band 80. The valve 60 can be designed to replace a damaged or diseased native heart valve such as a mitral valve; though it will be understood that a replacement valve is not required as part of the prosthesis.
The prosthesis can be a replacement heart valve similar to that and including features similar to those disclosed in U.S. Provisional Appl. No. 61/782,707, filed Mar. 14, 2013, U.S. Pat. No. 8,403,983 and U.S. Publication Nos. 2010/0298931, 2011/0313515 and 2012/0078353 the entireties of each of which are hereby incorporated by reference and made a part of this specification. This is inclusive of the entire disclosure and is not in any way limited to the disclosure of the replacement heart valve.
The frame 20 can be made of many different materials, but is preferably made from metal. In some embodiments, the frame 20 can be made from a shape memory material, such as nitinol. A wire frame or a metal tube can be used to make the frame. The wire frame of a metal tube can be cut or etched to remove all but the desired metal skeleton. In some embodiments a metal tube is laser cut in a repeating pattern to form the frame. The flat pattern can be cut from a metal tube and then the tube can be bent and expanded to the shape shown in FIGS. 1A-B. The frame 20 can further be expanded and/or compressed and/or otherwise worked to have the desired shape or shapes, such as for introduction and implantation.
As shown, the frame when in an expanded configuration, such as in a fully expanded configuration, has a bulbous or slightly bulbous shape, with a middle portion being larger than the proximal 32 and distal 34 ends. In some embodiments, the inside diameter of the both ends can be the same, or it can be bigger on one end than the other, while still having a middle portion larger than both the proximal and distal ends. In some embodiments, the effective diameter of the distal frame end is smaller than the effective diameter of the middle portion. The bulbous shape of the frame can advantageously allow the frame to engage a native valve annulus or other body cavity, while spacing the inlet and outlet from the heart or vessel wall. This can help reduce undesired contact between the prosthesis and the heart or vessel, such as the ventricular wall of the heart. In other embodiments, the frame may not have a bulbous portion, and can have substantially the same outer dimension along its entire length, or it may have one end larger than the other end. The prosthesis 10 and frame 20 may be similar to the replacement heart valves and associated frames, and may incorporate and/or interchange features disclosed in U.S. Provisional Appl. No. 61/782,707, U.S. Pat. No. 8,403,983 and U.S. Publication Nos. 2010/0298931 and 2011/0313515, the entireties of each of which are hereby incorporated by reference and made a part of this specification. This is inclusive of the entire disclosure and is not in any way limited to the disclosure of the replacement heart valves and associated frames.
A number of struts collectively make up the frame 20. FIGS. 1A-B illustrate the frame in an expanded configuration with a number of longitudinal struts 12 and undulating struts 14, with cells defined by the open spaces between the struts. The longitudinal struts may be arranged so that they are parallel or generally or substantially parallel to a longitudinal axis of the frame. The longitudinal axis of the frame may be defined as the central axis that extends through the center of the frame between the proximal 32 and distal 34 ends. Any number of configurations of struts can be used, such as the rings of undulating struts shown forming chevrons and diamonds, but also ovals, curves, and various other shapes. The illustrated embodiment includes two rings, or rows of chevrons shown in portion 16 and two rows of diamond-shaped cells shown in portion 18. The two rows of diamonds are partially obscured by the outer skirt 30.
The frame 20 has a non-foreshortening portion 16 and a foreshortening portion 18. These portions can be defined by the frame 20 and the positioning of various types of struts along the frame 20. In the figures it can be seen that the longitudinal struts 12 span the length of the non-foreshortening portion 16, while undulating struts 14 form the foreshortening portion 18. When the frame is radially collapsed or compacted, the struts 14 become more parallel with respect to the longitudinal axis of the frame, causing an outer diameter of the frame to decrease and the longitudinal length of the frame to increase in the foreshortening portion 18. As the frame moves from a compacted position to an expanded position, the longitudinal length of the frame can decrease in the foreshortening portion 18. But, the frame length does not substantially change length in the non-foreshortening portion 16.
Foreshortening of the frame 20 can be used to engage and secure the prosthesis to intralumenal tissue in a body cavity, for example tissue at or adjacent a native valve, such as a native valve annulus and/or leaflets. Opposing anchors 22, 24 can be constructed on the frame 20 so that portions of the anchors, such as tips or ends 26, 28, move closer together as the frame foreshortens. As one example, this can allow the anchors 22, 24 to grasp tissue on opposite sides of the native mitral annulus to thereby secure the prosthesis at the mitral valve.
The anchors 22, 24 and anchor tips 26, 28 can be located anywhere along the frame 20 just so long as at least one of the anchors is either connected to the foreshortening portion 18 or the foreshortening portion is positioned between the anchors so that a portion of the anchors will be move closer together with expansion of the frame. As shown, the anchors 24 are connected to the foreshortening portion 18. The foreshortening portion can also be positioned anywhere along the frame, though it is shown towards the distal end 34. In some embodiments, both of the anchor tips 26, 28 are located in the foreshortening portion 18. In some embodiments, the foreshortening portion 18 may extend the entire length of the frame, such that there is no non-foreshortening portion 16.
Preferably, each of the anchors 22, 24 is positioned or extends generally radially outwardly from the frame 20 so that the anchor tips 26, 28 are generally spaced away or radially outward from the rest of the frame 20. For example, the anchor tips may be located radially outward from the middle portion of the frame, with the tips 26 and 28 being axially spaced from one another. In some embodiments, all or part of the structure connected to the anchor tip and extending radially from the frame, including one or more rings and/or struts, can be considered part of the anchor. The anchors can include a base located on the anchor on a side opposite the tip. The base can be for example where the anchor begins to extend from or away from the frame 20.
For example, proximal anchors 22 are shown having first 36 and second 38 struts forming a chevron and connected to longitudinal struts 12 at a base of the anchor. The first and second struts of the anchor 22 are bent at the base so that the anchor 22 extends radially outwardly from the frame as it extends generally distally towards the tip 26. The first and second struts can be connected to each other at a radially outward location to form an outwardly extending loop, and in some embodiments, the first and second struts can be joined at a third strut 40 that continues to extend outwardly and/or generally distally and is then bent such that the tip points distally and extends in a manner generally parallel with the longitudinal axis of the prosthesis. The anchor also includes an eyelet 46. As illustrated, the eyelet is located along the third strut 40, though the eyelet can be positioned in other locations along the anchor 22, such as at the distal end. The tips 26 of the proximal anchors may extend distally and be parallel or substantially parallel with the longitudinal axis of the frame, or the tips 26 may extend generally distally but still radially outwardly inclined or at an acute angle relative to the longitudinal axis of the frame.
As another example, the distal anchors 24 are shown having looped anchors. Each looped anchor has a first base 42 and a second base 44 connected to the frame, wherein the first and second bases are at opposite corners of the same cell. Alternatively, the first and second bases may be located at the distal most corners of adjacent cells. The distal anchors 24 extends generally distally from the frame at the first base 42 but then is bent back around and begins to extend outwardly from the frame in a generally proximal direction. The distal anchor 24 then repeats this configuration in reverse towards the second base 44 such that the two sides of the looped anchor are mirror images of one another. It will be understood that the looped anchor can have other configurations and that it may not be symmetrical.
As illustrated in FIGS. 1A-B, the tips 28 of the distal anchors are circumferentially aligned with the tips 26 of the proximal anchors, though in other embodiments, the tips 28 of the distal anchors may be circumferentially staggered between the tips 26 of the proximal anchors. In the embodiment of FIGS. 1A-B, adjacent distal anchors 26 are spaced apart by one cell, though in other embodiments, adjacent distal anchors may be provided on adjacent cells. Thus, for example, instead of having six distal anchors and twelve proximal anchors as shown in FIGS. 1A-B, there may be a 1:1 correspondence between proximal and distal anchors.
The distal anchors 24 can be positioned to be not as far radially outward as the proximal anchors, and the tips 28 may be positioned radially inward of the tips 26. As described further below, such a configuration may be advantageous in positioning and securing the prosthesis in a mitral valve or other body location. As shown, the distal anchors 24 may comprise loops as described above, having a curved or arcuate atraumatic tip to minimize damage to body tissue.
The illustrated looped distal anchor is made up of the following segments. The first segment 50 extends generally longitudinally with the frame, extending distally or generally distally (e.g., slightly radially inward) with the frame. The strut is then bent back around to point in generally the opposite direction at the second segment 52. The second segment 52 ends in the rounded tip 28 and then the anchor strut repeats to form the mirror image. After the second segment 52 bends back around to point in generally the opposite direction, in the embodiment illustrated the second segment may first extend radially outward at an acute angle relative to the longitudinal axis before bending into a portion that extends parallel or substantially parallel to the longitudinal axis. The paired second segments 52 may extend parallel or generally parallel with one another at least near the tip, though they may also move slightly towards or away from each other in some embodiments. The distal anchors 24 can positioned outward from the frame and yet inward from the position of the proximal anchors 22.
It will be understood that the anchors can have various other configurations. In some embodiments, each of the anchors can extend radially outwardly from the frame at an anchor base and terminate at an anchor tip. The anchors can be connected to the frame at one of many different locations including apices, junctions, other parts of struts, etc. The anchors can comprise first, second, third, or more spaced apart bending stages along the length of each anchor. The anchors can also extend either distally or proximally before and/or after one or more of the bending stages. A portion of the anchor may extend with the frame before or after any bending stages.
In the illustrated embodiment there are twelve proximal anchors 22 and six distal anchors 24. It will be understood that other numbers and groupings of anchors can be used. For example, in some embodiments with twelve distal anchors, two anchors can share the first segment 50 where the anchor base 42, 44 is connected to the frame. In some embodiments there may be twelve anchors on one side and twelve on the other. In addition, the distal and proximal anchors may be aligned so the tips point generally towards each other, or they may be spaced so that the tips point between two tips on the opposite side.
The anchor tips 26 and 28 as described above advantageously provide atraumatic surfaces that may be used to grasp intralumenal tissue without causing unnecessary or undesired trauma to tissue. For example, the proximal anchors tips 26 and distal anchor tips 28 may form flat, substantially flat, curved or other non-sharp surfaces to allow the tips to engage and/or grasp tissue, without necessarily piercing or puncturing through tissue. A looped end or looped anchor may assist the frame in not getting caught up on structures at or near the treatment location. For example, each loop can be configured so that when the frame is deployed in-situ and expands, the movement of each loop from a delivered position to a deployed position can avoids getting caught on the papillary muscles.
The prosthesis 10 may include a valve 60. The valve 60 can be a replacement heart valve which includes a plurality of valve leaflets. The plurality of valve leaflets can function in a manner similar to the natural mitral valve, or to other valves in the vascular system. The plurality of valve leaflets can open in a first position and then engage one another to close the valve in a second position. The plurality of valve leaflets can be made to function as a one way valve such that flow in one direction opens the valve and flow in a second direction opposite the first direction closes the valve. The replacement heart valve 60 can be constructed so as to open naturally with the beating of the heart. For example, the plurality of valve leaflets can open during diastole and close during systole.
In some embodiments, the leaflets can be coupled to a valve skirt 70. For example, FIG. 1A shows a seam 62 where the proximal ends of the leaflets can be connected to the valve skirt 70.
The valve skirt 70 can be used to at least partially control how fluid flows through and/or around the valve 60. The valve skirt 70 can surround at least a portion of the valve and be connected to the valve leaflets 62. In some embodiments, the valve skirt 70 can form an inner wall connected to and positioned within the frame 20. The valve skirt 70 can also be made to move with the foreshortening portion 18 of the frame 20.
The valve skirt 70 can extend the length of the frame 20 or it can extend along only part of the length of the frame 20. In some embodiments, the ends of the heart valve 60 can coincide with ends of the valve skirt 70. In addition, one or more of the ends of the frame 20 can coincide with the ends of the valve skirt 70. In the illustrated embodiment, the proximal end of the valve skirt 70 is positioned proximally from the proximal end of the heart valve 60. The valve skirt 70 can not only extend to the distal end of the frame 20 but can also extend to the outside of the frame and is shown attached to and extending the tip 28 of each distal anchor 24. As shown, the skirt 70 is sewn to each distal anchor.
Other shapes and configurations can also be used for the valve 60 and valve skirt 70. In some embodiments, the valve skirt 70 may extend along the length of the leaflets 62, but is not connected to them. In the illustrated embodiments, the valve skirt 70 is attached to the frame 20 and the leaflets 62 are attached to the valve skirt 70.
The valve skirt 70 can be constructed in multiple different ways. The valve skirt 70 can be made of knit polyester or another stretchable or flexible fabric. In some embodiments, the valve skirt 70 is made from a material that is more flexible than the valve leaflet material. The distal and/or proximal end of the skirt 70 can be straight, curved, or have any other desired configuration. For example, the valve skirt 70 is shown with straight ends. In other embodiments the skirt distal end can be patterned to generally correspond to the undulations at the distal end 34 of the frame 20. Similarly, the proximal ends may also correspond in shape. The valve skirt 70 can be formed of one piece or multiple pieces. For example, the valve skirt 70 attached to the valve 60 can be one piece and then each distal anchor can be covered by a separate piece of material of the valve skirt 70. It is to be understood that other configurations of the valve skirt 70 can also be employed. For example, the anchors may remain uncovered, or only a portion may be covered.
In another embodiment of the valve skirt 70 the end can extend past the frame and can be wrapped around it. Thus, the valve skirt 70 can extend from the inside of the frame 20 to the outside of the frame. The skirt can extend completely around the frame for 1⁄4, 1⁄3, 1⁄2, or more of the length of the distal anchors. The skirt can also cover the distal anchors 24. The skirt can be a one piece skirt, but it will be understood that the skirt can be made of multiple pieces.
The valve skirt 70, and particularly portions that cover the distal anchors 24, can beneficially be used to help prevent leakage of blood flow around the heart valve. In addition, the skirt can encourage tissue in-growth between the skirt and the natural tissue. This may further help to prevent leakage of blood flow around the heart valve.
Looking to FIG. 2, an outer skirt or apron 30 is shown that may also form part of the prosthesis 10. FIG. 1A shows the outer skirt 30 attached to the frame 20. The outer skirt 30 can have a portion shaped to correspond generally with the shape of an outer portion of the frame 20. For example, a first portion 64 of the outer skirt 30 can have a cylindrical or generally cylindrical shape with an inner diameter that substantially corresponds in size to, or may be larger or slightly larger than, an outer diameter of the frame 20. In some embodiments, the first portion 64 surrounds the bulbous region of the frame and may be located surrounding the largest outer diameter of the frame 20. The outer skirt 30 can have a second portion 66 with an annular shape that extends away from the first portion 64 to an outer border with a diameter larger than the diameter of the first portion. As illustrated in FIG. 2, the second portion 66 is shown flaring outward from the first portion 64 and extending generally perpendicularly from the first portion 64. Thus, the illustrated second portion forms an annular ring comprising a proximal edge and a distal edge, wherein a diameter of the proximal edge is larger than a diameter of the distal edge.
The outer skirt 30 can attach to the frame, and more preferably attach to the anchors, in one of many different ways. The outer skirt 30 can be sewn to the frame and/or valve skirt. The outer skirt 30 can also be wrapped around a portion of the frame and then sewn to itself. In the embodiments illustrated in FIGS. 1A and 2, the second portion 66 can be attached to the proximal anchors. For example, a plurality of circumferentially spaced tabs 68 extending radially outward from the proximal edge of the second portion 66 can be used to attach the outer skirt 30 to the proximal anchors. Wings 72 on either side of the tab 68 can be wrapped around a proximal anchor and connected to each other and/or to the proximal anchor 22 to form a sleeve. The tabs 68 themselves may also form sleeves that are configured to surround at least a portion of the proximal anchors. In some embodiments, the proximal anchors 22 can include eyelets 46 that may be used to secure the skirt to the anchor. The one or both wings 72, or other parts of the tab 68, can be attached to the eyelet 46, for example by stitching the tab to the eyelet.
As shown, the eyelet 46 is spaced proximally from the end of the anchor. In other embodiments, the eyelet can be at the distal end of the anchor 22. In some embodiments, the proximal anchors can be looped anchors or have a looped end. A small tab can be passed through the looped anchor or looped end and connected to the skirt to form a loop on the skirt. Further, the outer skirt 30 may attach directly to the eyelets 46 without the need for tabs 68.
In the embodiment illustrated in FIG. 1A, the outer skirt 30 is only attached to the frame via the proximal anchors, and the first portion 64 remains unattached to any portion of the frame or any anchors. Thus, as illustrated in FIG. 1A, the first portion 64 when attached to the frame extends distally from the proximal anchors 22 and terminates in a free distal edge. In other embodiments, the first portion 64 may also be attached to portions of the frame and/or the distal anchors. Because of the bulbous shape of the frame, the free distal edge may be spaced radially outward from the frame when the frame is in an expanded configuration.
In some embodiments, the outer skirt can attach to the frame at a distal end of the skirt, or at some other location and then curve up and out towards the proximal anchors. Thus, the outer skirt may not have a distinct first portion and second portion. In still other embodiments, the outer skirt may extend along a substantial portion of the frame. The outer skirt may be attached to the distal ends of the proximal anchors and extend to the base of the anchor and then extend along the frame to a location parallel with the ends of the proximal anchors, or even more distal still, such as to the base of the distal anchors 24.
In some embodiments, the outer skirt 30 can be part of, or connected to, the valve skirt 70, such as being connected to the valve skirt 70 at or near the distal end 34 of the frame.
The outer skirt 30 can be constructed in multiple different ways and may be made of similar material to the valve skirt 70. The outer skirt 30 can be made of a layer of resilient material, such as knit polyester or another stretchable or flexible fabric. In some embodiments, the outer skirt 30 is made from a material that is more flexible than the valve leaflet material. The distal and/or proximal end of the outer skirt 30 can be straight, curved, or have any other desired configuration. The outer skirt 30 can be formed of one piece or multiple pieces. For example, the outer skirt 30 attached to the frame 20 can be one piece and then each proximal anchor 22 can be covered by a separate piece of material of the outer skirt 30. It is to be understood that other configurations of the outer skirt 30 can also be employed. For example, the anchors may remain uncovered, or only a portion may be covered.
The prosthesis 10 can also include a support band 80 as is shown in FIG. 1A. The support band 80 may be placed or positioned around or within the frame 20 at the proximal end 32. The support band 80 can be used to reinforce and/or constrain the frame 20. The support band 80 can help to control the expansion of the frame 20 from the compacted to the expanded state. The support band 80 can also be used to reduce the amount of motion that occurs at the proximal end 32 after the prosthesis 10 has been implanted at the mitral heart valve or other location.
In some embodiments, the support band 80 may comprise a polyester fabric band. The support band 80 may comprise a no-stretch or limited stretch material. Preferably the support band 80 is not made of an elastic material or a material known to have high elasticity. In some embodiments, the support band 80 is made from a material that is less flexible than the valve skirt material and/or the valve leaflet material. The distal and proximal ends of the support band 80 can be straight, curved, undulating with the undulations of frame, or any other desired configuration.
The support band 80 can be connected to the valve frame with a plurality of stitches, loops, knots, staples, or other types of connections. In some embodiments, the frame 20 can be sandwiched between two sides or layers of the support band 80. Preferably, the support band 80 is a single layer positioned within and attached to the frame 20 with a plurality of stitches around one or more of the longitudinal and/or undulating struts. In some embodiments, the support band 80 can be attached to the proximal end of the valve skirt 40.
The outer skirt 30 can beneficially prevent axial flow of fluid around an exterior of the prosthesis. For example, with the outer skirt 30 be positioned annularly around an exterior of the expandable frame and secured to at least some of the plurality of proximal anchors, the outer skirt creates an axial barrier to fluid flow exterior to the frame when deployed within a body cavity. In addition, the skirt can encourage tissue in-growth between the skirt and the natural tissue. This may further help to prevent leakage of blood flow around the heart valve.
In one embodiment, the outer skirt 30 can be used to help prevent leakage of blood flow around a heart valve, such as a mitral valve, when the prosthesis is placed in a native heart valve. For example, the outer skirt 30 can engage an atrial side of the mitral valve. The proximal anchors can also engage the mitral valve forcing the outer skirt 30 into close contact with the valve to block flow from passing through the mitral valve from outside of the frame.
In preferred embodiments, the prostheses 10 in the form of a replacement heart such as described above may be deployed into a heart valve annulus. The prosthesis 10 may be delivered into the mitral valve in a radially compacted or collapsed configuration and positioned when compacted so that the anchor tips 26, 28 of the opposing anchors 22, 24 are disposed on opposite sides of the native annulus 98 as shown in FIGS. 3A and 3B. As the replacement heart valve 10 is expanded, the opposing anchors are drawn closer together and may grasp tissue on opposite sides of the native annulus 98 and securely hold the replacement heart valve 10 in position. As such, the replacement heart valve 10 can be held securely in position without requiring a substantial radial force against the native annulus. Because the anchor tips are preferably atraumatic, the grasping or engaging of tissue by the prosthesis minimizes damage to the native tissue. The foreshortening portion 18 can be used to move the anchor tips 26, 28 closer together as the replacement heart valve 10 moves to the expanded position to thereby engage the native valve annulus. The prosthesis can be deployed into a heart valve or otherwise deployed in manners similar to those described with respect to a replacement heart valve in U.S. Publication Nos. 2010/0298931 and 2012/0078353 the entireties of each of which are hereby incorporated by reference and made a part of this specification.
FIGS. 3A and 3B show a schematic representation of the replacement heart valve 10 installed in a human heart 84. The heart is shown in cross-section, and represents typical anatomy, including a left atrium 78 and left ventricle 86. The left atrium 78 and left ventricle 86 communicate with one another through a mitral annulus 98. Also shown schematically is a native anterior mitral leaflet 90 having chordae tendineae 92 that connect a downstream end of the anterior mitral leaflet 90 and to the left ventricle 86.
In one preferred embodiment, a method is provided of delivering a replacement valve to a native mitral valve and atraumatically securing the replacement valve relative to the native mitral valve annulus 98. The replacement valve can be mounted on a delivery device and delivered to the native mitral valve annulus while the replacement valve is in a radially compacted state. The replacement valve may be positioned so that the ends or tips of the distal anchors are on a ventricular side of the native leaflets 90 beyond a location where chordae tendineae 92 connect to free ends of the native leaflets. At least a portion of the replacement valve can be released from the delivery device to thereby expand the distal anchors radially outwardly. At this time the distal anchors may extend between at least some of the chordae. The distal anchors (along with the frame) can be moved toward the ventricular side of the native valve annulus with the distal anchors extending between at least some of the chordae tendineae to provide tension on the chordae tendineae. With tension provided on the chordae tendineae, the replacement valve can be further released from the delivery device to thereby expand the proximal anchors radially outwardly. The proximal anchors upon further release of the replacement valve from the delivery device can move into engagement with tissue on an atrial side of the native valve annulus, such as with the atrial side of the native valve annulus.
The method just described may utilize any of the prostheses herein described, including any of the prostheses described in the patents and applications incorporated by reference herein. In one embodiment, a prosthesis where the ends of the distal anchors are not positioned as far out radially as the ends of the proximal anchors when the frame is expanded can beneficially be used in this method. Thus, the distal anchors may have a suitable length for extending between and providing tension on the chordae tendineae, but need not and may in some embodiments not engage tissue with the tips 28. Thus, in some embodiments the some or all of the distal anchors remain spaced from tissue on the ventricular side of the native valve annulus after delivery and expansion. The interaction between the distal anchors and the chordae tendineae may therefore be sufficient to secure the distal end of the prosthesis, while the engagement of the proximal anchors with tissue on the atrial side of the native valve annulus will help further secure and orient the prosthesis
As illustrated in FIGS. 3A and 3B, the distal anchors may comprise loops, such as any of the looped structures previously described or described in the patents and applications incorporated by reference herein. The proximal and/or distal anchors may also be covered with a resilient material such as described above for the outer skirt 30 and valve skirt 70 that promotes tissue growth with adjacent body tissue. Such material may also be useful to prevent paravalvular leakage. The atraumatic distal anchors may advantageously prevent snagging of the prosthesis on internal structures, such as the papillary muscles.
When the prosthesis is in an expanded configuration within the native mitral heart valve, the engagement of the proximal anchors 22 with tissue on the atrial side of the native mitral valve causes at least the second portion 66 of the outer skirt 30 to also engage the tissue on the atrial side of the native mitral valve. The first portion 64 of the outer skirt extends distally from the proximal anchors toward the ventricle. Because the diameter of the first portion 64 is close or the same in dimension as the frame, at least at the proximal edge of the first portion 64, the outer skirt form a barrier to blood flow around the outside or external to the frame. The outer skirt 30 can be forced against the outside of the frame 20 by the native leaflets. Where the native leaflets do not force the outer skirt 30 against the frame, or where the contact is not as strong, the outer skirt 30 is still present to block, or impede blood flow. It will be understood that having multiple contact points between the native valve and the outer skirt can allow the outer skirt to securely cover areas where there are fewer contacts between the two. As described above, the outer skirt may also promote tissue growth with tissue that it contacts.
Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. In addition, while a number of variations of the invention have been shown and described in detail, other modifications, which are within the scope of this invention, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the invention. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed invention. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.
Similarly, this method of disclosure, is not to be interpreted as reflecting an intention that any claim require more features than are expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment. Thus, the claims following the Detailed Description are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment.

## Claims

1. A prosthesis configured to grasp intralumenal tissue when deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis, the prosthesis comprising:
an expandable frame comprising a proximal end and a distal end and a longitudinal axis extending therethrough, the frame configured to radially expand and contract for deployment within the body cavity;
a plurality of anchors each connected to the frame so that when the frame is in an expanded configuration an end of each anchor is positioned radially outward from the frame, the plurality of anchors comprising a plurality of distal anchors having ends which extend proximally when the frame is in an expanded configuration, the ends of the distal anchors being circumferentially spaced apart such that at least one of the plurality of distal anchors is configured to extend between chordae tendineae when the frame is in an expanded configuration; and
a skirt annularly positioned around an exterior of the expandable frame to create an axial barrier to fluid flow exterior to the frame when deployed within the body cavity, the skirt comprising:
a first portion having a proximal end and a distal end, the proximal end being positioned at a location spaced between the proximal and distal ends of the frame and being unattached to the frame or plurality of anchors, the distal end of the first portion being positioned closer to the distal end of the frame than the proximal end of the first portion; and
a second portion shaped to extend radially outward from the frame at a location spaced between the proximal end and the distal end to prevent axial flow of fluid around an exterior of the prosthesis, the second portion shaped to extend radially from a proximal end of the first portion;

wherein when the frame is in an expanded configuration, the frame has a larger cross-sectional dimension in a middle portion of the frame and a smaller cross-sectional dimension in a proximal portion and a distal portion of the frame, and wherein the ends of the anchors are positioned radially outward from the middle portion of the frame.

2. The prosthesis of claim 1, wherein the skirt comprises a plurality of wings or sleeves that surround at least some of the anchors.

3. The prosthesis of claim 1, wherein at least some of the plurality of anchors comprise looped ends, and the skirt is attached to the looped ends.

4. The prosthesis of claim 1, wherein the plurality of anchors comprise a plurality of proximal anchors having ends which extend distally when the frame is in an expanded configuration, wherein the ends of the proximal anchors are axially spaced from the ends of the distal anchors when the frame is in an expanded configuration.

5. The prosthesis of claim 4, wherein the skirt is secured to at least some of the proximal anchors.

6. The prosthesis of claim 5, wherein the skirt extends distally from the ends of the proximal anchors to a free distal edge.

7. The prosthesis of claim 4, wherein the second portion of the skirt is configured to extend radially outward from the frame between ends of the proximal and distal anchors.

8. The prosthesis of claim 4, wherein the plurality of proximal anchors are integrally formed with the frame.

9. The prosthesis of claim 1, further comprising a second skirt covering distal anchors to facilitate in-growth of adjacent tissue when the prosthesis is deployed within a body cavity.

10. The prosthesis of claim 1, further comprising a valve body attached to the frame.

11. The prosthesis of claim 1, wherein the proximal end and the distal end have substantially the same cross-sectional dimension.

12. A replacement heart valve suitable for use for securement to a native mitral valve annulus, comprising the prosthesis of claim 1.

13. The prosthesis of claim 12, wherein the middle portion of the frame is configured to engage tissue of a native mitral valve.

14. The prosthesis of claim 1, wherein the second portion of the skirt is configured to extend radially outward from the middle portion of the frame.

15. The prosthesis of claim 1, wherein the first portion of the skirt is configured to surround a middle portion of the frame, the middle portion of the frame being configured to engage intalumenal tissue.

16. A prosthesis configured to grasp intralumenal tissue when deployed within a body cavity and prevent axial flow of fluid around in exterior of the prosthesis, the prosthesis comprising:
an expandable frame comprising a proximal end and a distal end and a longitudinal axis extending therethrough, the frame configured to radially expand and contract for deployment within the body cavity;
a distal anchoring portion connected to the frame so that when the frame is in an expanded configuration an end of the distal anchoring portion is positioned radially outward from the frame, the distal anchoring portion comprising a plurality of distal anchors comprising circumferentially spaced apart ends; and
a skirt annularly positioned around an exterior of the expandable frame to create an axial barrier to fluid flow exterior to the frame when deployed within the body cavity, the axial barrier being positioned at least proximally of the end of the distal anchoring portion, the skirt comprising:
a first portion having a proximal end and a distal end, the distal end of the first portion being positioned more distal than the end of the distal anchoring portion; and
a second portion shaped to extend radially outward from the frame at a location spaced between the proximal end and the distal end to prevent axial flow of fluid around an exterior of the prosthesis;

wherein when the frame is in an expanded configuration:
a cross-sectional dimension of the proximal end of the frame;
the distal end of the frame and the proximal end have different cross-sectional dimensions, and
the ends of the anchors are positioned radially outward from the middle portion of the frame.

17. The prosthesis of claim 16, the prosthesis comprising a proximal anchoring portion connected to the frame so that when the frame is in an expanded configuration an end of the proximal anchoring portion is positioned radially outward from the frame.

18. The prosthesis of claim 17, wherein the proximal anchoring portion comprises a plurality of proximal anchors and wherein the plurality of proximal anchors and the plurality of distal anchors are circumferentially staggered.

19. The prosthesis of claim 16, wherein at least some of the plurality of distal anchors are sized to extend between at least some of the chordae tendineae.

20. The prosthesis of claim 16, wherein the distal end of the first portion is positioned at a base of the distal anchoring portion.

21. The prosthesis of claim 16, wherein the distal anchoring portion comprises at least six distal anchors.

22. A prosthesis configured to grasp intralumenal tissue when deployed within a native mitral valve and prevent axial flow of fluid around in exterior of the prosthesis, the prosthesis comprising:
an expandable frame comprising a proximal end and a distal end and a longitudinal axis extending therethrough, the frame configured to radially expand and contract for deployment within the native mitral valve;
a proximal anchoring portion sized to contact an atrial side of a native mitral valve annulus when the prosthesis is deployed within the native mitral valve, the proximal anchoring portion being connected to the frame at a location distal of the proximal end of the frame, wherein the proximal anchoring portion extends radially outward from the frame when the frame is in an expanded configuration;
a distal anchoring portion sized to be positioned on a ventricular side of the native mitral valve annulus when the prosthesis is deployed within the native mitral valve, the distal anchoring portion comprising a plurality of spaced apart distal anchors extending towards a proximal end of the expandable frame, wherein the distal anchors are positioned radially outward from the frame when the frame is in an expanded configuration; and
a skirt disposed along an exterior of the prosthesis to create an axial barrier to fluid flow exterior to the prosthesis when deployed within the native mitral valve, the skirt comprising:
a generally cylindrical portion extending along an exterior of the frame, wherein a proximal end of the generally cylindrical portion is positioned distally of the proximal end of the frame and a distal end of the generally cylindrical portion is positioned proximally of the distal anchors; and
a ring portion sized to contact an atrial side of a native mitral valve annulus when the prosthesis is expanded and deployed within the native mitral valve, the ring portion extending radially outward from the frame at the proximal end of the generally cylindrical portion, wherein at least a portion of the ring portion extends along the proximal anchoring portion;

wherein when the frame is in an expanded configuration a cross-sectional dimension in a middle portion of the frame is larger than a cross-sectional dimension of the proximal end of the frame.

23. The prosthesis of claim 22, wherein the expandable frame comprises a foreshortening portion having a plurality of cells and wherein the skirt has an axial dimension less than two cell lengths.

24. The prosthesis of claim 22, wherein the generally cylindrical portion of the skirt is configured to contact the expandable frame along a first surface and tissue of the native mitral valve along a second surface to create an axial barrier to fluid flow exterior to the prosthesis when deployed within the native mitral valve.

25. The prosthesis of claim 22, wherein an inner diameter of the generally cylindrical portion of the skirt substantially corresponds in size to an outer diameter of the frame along which the generally cylindrical portion extends.