Expanding scaffold anchor to facilitate prosthetic heart valve replacement

Abstract

A device and method for anchoring or stabilizing a transcatheter bioprosthetic heart valve and treating or repairing paravalvular leaks following replacement of a patient's native cardiac valve, including the aortic, mitral, tricuspid, and pulmonary valves. The device includes a scaffold anchor that is placed through a native leaflet and into the adjacent annular region to anchor the transcatheter bio prosthetic heart valve due to lack of calcification, tissue asymmetry, or irregular annular morphology. The scaffold anchor may be delivered and positioned with standard transcatheter bioprosthetic heart valve delivery procedures, such as TAVR, TMVR, TTVR, and TPVR.

Description

Attorney Docket No. 026389-0059-W001EXPANDING SCAFFOLD ANCHOR TO FACILITATE PROSTHETIC HEART VALVE REPLACEMENT CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a non-provisional of and claims the benefit of U.S. Provisional Patent Application No. 63 / 721,991, filed on November 18, 2024, the entire contents of which are incorporated herein by reference.FIELD OF THE DISCLOSURE

[0002] The present disclosure relates to prosthetic heart valve replacement procedures, and more specifically to a scaffold anchor that is positioned adjacent to the native valve annulus and / or through the native leaflet to anchor the transcatheter bioprosthetic heart valve and treat paravalvular leakage post valve replacement.BACKGROUND OF THE DISCLOSURE

[0003] Transcatheter valve replacement, especially transcatheter aortic valve replacement (TAVR), is a medical procedure that has revolutionized the treatment of aortic stenosis. The use of the TAVR procedure for the treatment of mitral valve disease remains investigational. The mitral valve is a complex valve structure. Anatomically it is more of an oval shape than a round shape. The standard of care for treating mitral valve disease is surgical repair or replacement of the valve. In patients who are not a surgical candidate, the transcatheter valve replacement procedure has become an attractive alternative. However, treatment for severe mitral stenosis where there is significant calcification or lack thereof is usually surgery where the mitral valve is replaced.

[0004] Accordingly, a need exists for a device and method that treats and / or repairs paravalvular leaks upon replacement of a patient’s native valve (e.g., aortic, tricuspid, mitral, or pulmonary).SUMMARY OF THE DISCLOSURE

[0005] The present disclosure provides a device and method for treating and / or repairing paravalvular leaks after replacement of a patient’s native valve and anchoring or stabilizing theAttorney Docket No. 026389-0059-W001transcatheter bioprosthetic heart valve. The device includes a scaffold anchor that may be preplaced adjacent to the native valve annulus and / or through the native leaflet at a site identified as having a high risk of forming a paravalvular leak due to calcification, tissue asymmetry, or irregular annular morphology. The scaffold anchor may be positioned prior to placement of the transcatheter bioprosthetic heart valve. Additionally, the scaffold anchor may be placed after the placement of the transcatheter bioprosthetic heart valve to treat and / or repair paravalvular leaks. The scaffold anchor can be employed with any of the cardiac valves, such as an aortic valve, a tricuspid valve, a mitral valve, or a pulmonary valve. The scaffold anchor is positioned prior to placement of the transcatheter bioprosthetic valve or after placement of the transcatheter bioprosthetic heart valve with standard valve delivery techniques, e.g., TAVR, TTVR, TMVR, or TPVR procedures. Regardless, the scaffold anchor is configured to treat or repair paravalvular leakage and anchor or stabilize the transcatheter bioprosthetic heart valve.

[0006] In some aspects, the techniques described herein relate to a scaffold anchor for prosthetic heart valve replacement , the scaffold anchor including: a first end; a second end opposite the first end; a longitudinal axis extending between the first end and the second end; a first anchor portion extending from the first end towards the second end, the first anchor portion formed from a self-expanding material; an intermediate portion extending from the first anchor portion towards the second end; and a second anchor portion extending from the intermediate portion to the second end, the second anchor portion formed from the self-expanding material; wherein the first anchor portion and the second anchor portion are configured to move from a retracted position to an expanded position prior to the transcatheter bioprosthetic heart valve being inserted, and wherein in the expanded position the first anchor portion and the second anchor portion are configured to compress after the transcatheter bioprosthetic heart valve is inserted and as the transcatheter bioprosthetic heart valve moves to an expanded position such that the first anchor portion and the second anchor portion are mechanically captured between the transcatheter bioprosthetic heart valve and an annular wall thereby occluding regurgitant pathways and anchoring the transcatheter bioprosthetic heart valve.

[0007] In some aspects, the techniques described herein relate to a scaffold anchor for placement in a leaflet of a native valve intended to be replaced, the scaffold anchor configured to anchor and stabilize a transcatheter bioprosthetic heart valve used to replace the native valve, theAttorney Docket No. 026389-0059-W001scaffold anchor including: a first, closed end; a second, closed end opposite the first end; a longitudinal axis extending between the first end and the second end; a first anchor portion extending from the first end towards the second end, the first anchor portion formed from a selfexpanding material and including tines extending therefrom; an intermediate portion extending from the first anchor portion towards the second end; and a second anchor portion extending from the intermediate portion to the second end, the second anchor portion formed from the selfexpanding material and including tines extending therefrom; wherein when positioned within the leaflet, the first anchor portion and the second anchor portion are on opposite sides of the leaflet and the first anchor portion and the second anchor portion are configured to move from a retracted position to an expanded position prior to the transcatheter bioprosthetic heart valve being inserted.

[0008] In some aspects, the techniques described herein relate to a method for treating paravalvular leak in a patient after heart-valve replacement, the method including: providing a scaffold anchor configured to stabilize a transcatheter bioprosthetic heart valve, the scaffold anchor including a first end; a second end opposite the first end; a longitudinal axis extending between the first end and the second end; a first anchor portion extending from the first end towards the second end, the first anchor portion formed from a self-expanding material; an intermediate portion extending from the first anchor portion towards the second end; a second anchor portion extending from the intermediate portion to the second end, the second anchor portion formed from the self-expanding material; creating a puncture in a leaflet of a native valve; advancing the scaffold anchor through the puncture such that the first anchor portion and the second anchor portion are on opposite sides of the leaflet; expanding the first anchor portion and the second anchor portion from a retracted position to an expanded position prior to insertion of the transcatheter bioprosthetic heart valve; and expanding the transcatheter bioprosthetic heart valve such that the transcatheter bioprosthetic heart valve compresses the first anchor portion and the second anchor portion and such that the first anchor portion and the second anchor portion are mechanically captured between the transcatheter bioprosthetic heart valve and an annular wall of the patient thereby occluding regurgitant pathways and anchoring the transcatheter bioprosthetic heart valve.BRIEF DESCRIPTION OF THE DRAWINGSAttorney Docket No. 026389-0059-W001

[0009] FIG. l is a side view of a scaffold anchor according to an embodiment of the present disclosure in an expanded position.

[0010] FIG. 2 is a front view of the scaffold anchor of FIG. 1.

[0011] FIG. 3 A is a first step of inserting the scaffold anchor of FIG. 1.

[0012] FIG. 3B is a second step of inserting the scaffold anchor of FIG. 1.

[0013] FIG. 4 is a third step of inserting the scaffold anchor of FIG. 1.

[0014] FIG. 5 is a fourth step of inserting the scaffold anchor of FIG. 1.

[0015] FIG. 6 is a front view of multiple scaffold anchors of FIG. 1 positioned relative to a patient’s native valve intended to be replaced.

[0016] FIG. 7 is another front view of multiple scaffold anchors of FIG. 1 positioned relative to a patient’s native valve intended to be replaced.

[0017] FIG. 8 is a side view of the scaffold anchor of FIG. 1 positioned relative to a patient’s native valve intended to be replaced.

[0018] FIG. 9 is a plan view of a heart valve device including the scaffold anchor of FIG. 1.

[0019] FIG. 10 is a cross-sectional view of the heart valve device of FIG. 9.

[0020] FIG. 11 is a perspective view of the heart valve device of FIG. 9.

[0021] FIG. 12 is a side view of an scaffold anchor according to another embodiment of the present disclosure.

[0022] FIG. 13 is a cross-sectional view of the scaffold anchor of FIG. 12 along a longitudinal axis.

[0023] FIG. 14 is a side view of an scaffold anchor according to another embodiment of the present disclosure.Attorney Docket No. 026389-0059-W001

[0024] FIG. 15 is a cross-sectional view of the scaffold anchor of FIG. 14 along a longitudinal axis.

[0025] FIG. 16 is a perspective view of an scaffold anchor according to another embodiment of the present disclosure.

[0026] FIG. 17 is a cross-sectional view of the scaffold anchor of FIG. 16 along a longitudinal axis.

[0027] FIG. 18 is a perspective view of an scaffold anchor according to another embodiment of the present disclosure.

[0028] FIG. 19 is a cross-sectional view of the scaffold anchor of FIG. 18 along a longitudinal axis.

[0029] FIG. 20 is a schematic view illustrating the scaffold anchor of FIG. 16 and the scaffold anchor of FIG. 18 positioned relative to a patient’s native valve.

[0030] FIG. 21 is a side view of an scaffold anchor according to another embodiment of the present disclosure.

[0031] FIG. 22 is a cross-sectional view of the scaffold anchor of FIG. 21 along a longitudinal axis.DETAILED DESCRIPTION

[0032] Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways.

[0033] The use of a TAVR valve to replace the mitral valve with sufficient calcification to anchor the TAVR valve to address mitral stenosis has been previously reported in literature. The use of a TAVR valve to replace the mitral valve remains an off-label use. The procedure isAttorney Docket No. 026389-0059-W001complex with the need to assess left ventricular outflow tract obstruction (LVOT) from the procedure. Treatment of mitral regurgitation using a TAVR valve is even more complex as the current TAVR valve has a significant risk of valve embolization due to a lack of calcium.Currently available technology associated with the complex, large profile, left ventricular obstruction requires a dedicated valve with a dedicated system. Similar issues are present in other prosthetic heart valve procedures, as well.

[0034] A scaffold anchor 10 for use during prosthetic heart valve replacement procedures is thus disclosed. The scaffold anchor 10 is configured for pre-placement within or adjacent to the native valve annulus or leaflet region at a site identified as having a high risk of forming a paravalvular leak due to calcification, tissue asymmetry, or irregular annular morphology. The scaffold anchor 10 may include a self-expanding braided structure that, upon release from a retracted state, expands to engage tissue and to occupy cavities or gaps associated with annular calcifications. Following placement of the scaffold anchor 10, deployment of a transcatheter bioprosthetic heart valve — whether aortic, mitral, tricuspid, pulmonary, transcatheter, or surgically delivered — compresses and mechanically captures the scaffold anchor 10 between the transcatheter bioprosthetic heart valve frame and the native annulus. This compression creates a sealing interface that reduces or eliminates regurgitant pathways and simultaneously provides supplemental anchoring support to stabilize the transcatheter bioprosthetic heart valve against axial or radial displacement. The scaffold anchor 10 is compatible with standard valve-delivery techniques.

[0035] As shown in FIGS. 1-8, a scaffold anchor 10 is used with a transcatheter bioprosthetic heart valve 14 (or other prosthetic heart valve) to overcome the issues commonly associated with using the transcatheter bioprosthetic heart valve 14 to replace the mitral valve (or any valve). The scaffold anchor 10 is configured to secure or anchor the transcatheter bioprosthetic heart valve 14 in position where there is minimal calcification while reducing the risk of embolization and minimizing left ventricular obstruction. The scaffold anchor 10 can be placed in any location where anatomy can provide a suitable anchoring force. The scaffold anchor 10 is delivered into the heart via a transcatheter approach, which is minimally invasive.Attorney Docket No. 026389-0059-W001

[0036] As shown in FIGS. 1 and 2, the scaffold anchor 10 is formed from a self-expanding material (e.g., Nitinol, braided Nitinol, cobalt-chromium, and MP35N alloys, etc.). The selfexpanding material may also include hybrid or radiopaque-filled fdaments, such as Ta-NiTi or Pt-NiTi composite wires). The scaffold anchor 10 is configured to move from a retracted position (not shown) during delivery into the heart by a catheter 18 to an expanded position (FIGS. 1 and 2) upon removal of the catheter 18. The scaffold anchor 10 is also configured to compress (contract, crumple, etc.), as necessary, against the surrounding native tissue, as discussed below.

[0037] In some embodiments, the scaffold anchor 10 includes a first end 30, a second end 34 opposite the first end 30, and a longitudinal axis 38 extending through the first end 30 and the second end 34. The scaffold anchor 10 also includes a first anchor portion 42 extending from the first end 30 toward the second end 34, an intermediate portion 46 extending from the first anchor portion 42 toward the second end 34, and a second anchor portion 50 extending between the intermediate portion 46 and the second end 34. The first end 30 and the second end 34 are both closed such that fluid cannot pass through the scaffold anchor 10. In other embodiments, one or both of the first and second ends 30, 34 may be open instead.

[0038] When in the retracted position, the first anchor portion 42, the intermediate portion 46, and the second anchor portion 50 are configured to be received in the catheter 18 and advanced to a desired location in the heart via the catheter 18. The catheter 18 is also configured to re-sheath the scaffold anchor 10, when necessary, to position the scaffold anchor 10.

[0039] When in the expanded position, the first anchor portion 42 and the second anchor portion 50 each have a dimension that is greater than a dimension of the intermediate portion 46. In the illustrated embodiment, each of the first and second anchor portions 42, 50 have the same maximum dimensions, although other configurations are possible. For example, as shown, the first and second anchor portions 42, 50 have a first maximum dimension when viewed from the side and a second maximum dimension when viewed from the front. The second maximum dimension is greater than the first maximum dimension, giving each of the first and second anchor portions 42, 50 a generally rectangular cross-section.Attorney Docket No. 026389-0059-W001

[0040] The intermediate portion 46 may have any suitable cross-sectional shape. As shown, the intermediate portion 46 includes an hour-glass configuration such that the dimensions thereof adjacent to the first and second anchor portions 42, 50 are generally greater than a dimension at or adjacent to the center of the scaffold anchor 10.

[0041] Additionally, a first distance extending between the first end 30 and a location on the intermediate portion incorporating the first anchor portion 42 takes up a greater portion of the overall length than a second distance extending between the second end 34 and the location on the intermediate portion incorporating the second anchor portion 50. The first distance takes up about two thirds of the overall length and the second distance takes up about one third of the overall length. These proportions can be modified in other embodiments.

[0042] Each of the first anchor portion 42 and the second anchor portion 50 includes a plurality of tines 60 to enhance securing or anchoring of the scaffold anchor 10 with surrounding tissue.

[0043] When positioned in a desired location via the catheter 18, the intermediate portion 46 is configured to be positioned within a hole 70 (e.g., puncture) formed in a portion of the native valve 74, while the first anchor portion 42 and the second anchor portion 50 are configured to be positioned on opposite sides of the native valve 74. In an exemplary embodiment, the intermediate portion 46 is configured to be positioned within a hole 70 in a leaflet 78 of the native mitral valve 74, while the first anchor portion 42 and the second anchor portion 50 are configured to be positioned on opposite sides of the mitral valve 74.

[0044] Once the scaffold anchor 10 is properly positioned and in the expanded position, the surgeon can insert the transcatheter bioprosthetic heart valve 14 into the opening 82 of native valve 74 and expand the transcatheter bioprosthetic heart valve 14. When the transcatheter bioprosthetic heart valve 14 expands to the expanded position, the first and second anchor portions 42, 50 are configured to take up extra space between the transcatheter bioprosthetic heart valve 14 and the surrounding native tissue (e g., an annular wall, leaflet calcification). Also, the first and second anchor portions 42, 46 are configured to compress or contract into the native tissue as necessary as the transcatheter bioprosthetic heart valve 14 expands. In other words, the first and second anchor portions 42, 50 are configured to crumple or compressAttorney Docket No. 026389-0059-W001laterally inwards, e.g., towards the longitudinal axis 38 thereof. Thus, the scaffold anchor 10 may be mechanically captured between the transcatheter bioprosthetic heart valve 14 and the surrounding native tissue due to being compressed therebetween. Because the scaffold anchor 10 is mechanically captured it occupies potential leak cavities and disrupts regurgitant flow paths. When used with a transcatheter bioprosthetic heart valve 14, the scaffold anchor 10 may have the benefits described above.

[0045] As noted above, the scaffold anchor 10 can include an hourglass shape, however, the scaffold anchor 10 may have other suitable shapes and sizes. As shown in FIGS. 12-17, the hourglass shape of the scaffold anchor 10 is formed by a bulbous first anchor portion 42 and a bulbous second anchor portion 50 on opposite sides of the intermediate portion 46. In the embodiment illustrated in FIGS. 12-13, the first and second anchor portions 42, 50 are generally ovular and symmetrical about a horizontal plane extending therebetween and vertical plane extending the longitudinal axis 38 thereof. The maximum diameter of each of the first and second anchor portions 42, 50 may be between 5 mm and 15 mm. In the embodiment illustrated in FIGS. 14-15, the first and second anchor portions 42, 50 are not the same. That is, the first anchor portion 42 is generally spherical or cylindrical, while the second anchor portion 50 is generally ovular. Thus, the first and second anchor portions 42, 50 are symmetrical about a vertical plane extending along the longitudinal axis 38 thereof but are asymmetrical relative to a horizontal plane extending therebetween. In some examples, the maximum diameter of the second anchor portion 50 may be between 10 mm to 17 mm and the first anchor portion 42 may be between 10 mm and 22 mm. The first anchor portion 42 may be a ventricle-side anchor portion and the second anchor portion 50 may be an atrium-side anchor portion, and the differing diameters may accommodate the natural dimensional mismatch between the atrial and ventricular aspects of the annulus. The lengths of the scaffold anchors 10 along the longitudinal axes may be 20 mm to 50 mm. Although not pictured, the scaffold anchors 10 of both the embodiments illustrated in FIGS. 12-13 and 14-15 may include jagged, irregular, wavy, undulating, or generally non-smooth edges and tines to enhance anchoring of the scaffold anchor 10 with surrounding tissue. Regardless of the embodiment, the adjacent surfaces of the first and second anchor portions 42, 50 of the scaffold anchors of FIGS. 12-15 are generally convex surfaces. The geometry of the scaffold anchors 10 of both the embodiments of FIGS. 12-13 andAttorney Docket No. 026389-0059-W00114-15 enables stable anchoring within irregular annular contours and ensures circumferential contact with the native tissue while allowing controlled compression by the transcatheter bioprosthetic heart valve 14 as it expands and compresses the anchor 10 (and the anchor portions 42, 50) into surrounding annular tissue (e.g., an annular wall, leaflet calcification).

[0046] The hourglass shape of the scaffold anchor 10 may also include generally cylindrical or disc-shaped first and second anchor portions 42, 50, as shown in FIGS. 16-17. In the illustrated embodiment, the first and second anchor portions 42, 50 have the same dimensions. That is, each has a maximum diameter ranging from 10 mm to 15 mm and a maximum length of 5 mm to 15 mm. The intermediate portion 46 has a length that is much smaller than the length of each of the first and second portions 42, 50. That is the length of the intermediate portion 46 is only up to about 1 mm. In the embodiment of FIGS. 16-17, includes gaps or zones of reduced stiffness, which force the first and second anchor portions 42, 50 to compress or crumple inwardly towards the longitudinal axis 38. Thus, the zones may create a hinged framework, which permits controlled folding and adaptation to uneven calcifications, providing effective cavity filling and a self-limiting deformation pattern that prevents tissue trauma. Also, in the illustrated embodiment, the peripheral edges of both the first and second anchor portions 42, 50 are jagged, irregular, wavy, undulating, or generally non-smooth. Additionally, the tines, such as those shown and described relative to FIG. 1, may be included as well.

[0047] In still other configurations, shown in FIGS. 18-20, the first anchor portion 42 and the second anchor portion 50 are each shaped like a bowl. That is, each of the first and second anchor portions 42, 50 include a first end that is coupled to the intermediate portion 46 and a second end that is a free end. The outer surfaces of the first and second anchor portions 42, 50 are generally convex. Also, the outer diameter of the first and second anchor portions 42, 50 generally increases from the first end towards the second end when in the expanded position. The first and second portions 42, 50 are nested in that the second end of the first anchor portion 42 is positioned adjacent to the first end of the second anchor portion 50. In some embodiments, shown in FIGS. 21-22, there may more anchor portions. That is, there may be a third anchor portion 54 having the same configuration as the first and second anchor portions 42, 50. The anchor portions 42, 50, 54 expand laterally, effectively filling crescent-shaped or eccentric leakage regions without obstructing central flow. When compressed by the expansion of theAttorney Docket No. 026389-0059-W001transcatheter bioprosthetic heart valve 14, the structure resists downstream migration and cannot be displaced in the direction of blood flow, ensuring long-term positional stability.

[0048] In the embodiments of FIGS. 12-22, the scaffold anchors 10 include a delivery wire 100 that is coupled thereto via an electrolytic detachment coupler 104. The delivery wire 100 is coupled to and extends from the first anchor portion 42. Once the scaffold anchor 10 is appropriately positioned the delivery wire 100 may be disconnected

[0049] It should be understood that multiple scaffold anchors 10 may be used to secure a single transcatheter bioprosthetic heart valve 14 and treating and / or repairing leakage through areas where leakage is predicted to occur, as shown in FIGS. 6-7.

[0050] In some embodiments, as shown in FIGS. 9-11, one or more self-expanding scaffold anchors 10 (the same or similar to those described above with respect to FIGS. 1-8) may be formed with or otherwise coupled to a self-expanding frame 14a of the valve 14. In the illustrated embodiment, there are three scaffold anchors 10 that are positioned equidistantly around the perimeter of the frame 14a. In other embodiments, there may be more or fewer scaffold anchors 10 and they may have any suitable relative spacing. In some embodiments, the self-expanding scaffold anchors 10 may be formed integrally with and of the same material as the frame 14a. In other embodiments, the scaffold anchors 10 may be formed separately from the frame 14a and then coupled thereto. In such case, the scaffold anchors 10 may be made of the same or different self-expanding material of the frame 14a. In still other embodiments the scaffold anchors 10 may include tines (not shown).

[0051] The scaffold anchor 10 may be utilized with many prosthetic heart valves for replacement of any native heart valve, such as, mitral, aortic (aortic regurgitation with no calcium), and tricuspid valves. It allows for the continued use of the currently available transcatheter bioprosthetic heart valves 14.

[0052] It should be understood that in some embodiments, all or constituent portions of the scaffold anchors 10 may include a flexible, biocompatible membrane, which is configured to enhance sealing and treat and / or repair residual paravalvular leakage. The membrane may be, for example but without limitation, expanded polytetrafluoroethylene (ePTFE), polyethyleneAttorney Docket No. 026389-0059-W001terephthalate (PET), or polyurethane-based composites. The membrane may be attached to the scaffold anchor 10 by suturing, bonding, or over-molding. The membrane is configured to conform dynamically during expansion of the transcatheter bioprosthetic heart valve 14, thereby forming a continuous seal between the native annulus, the scaffold anchor 10, and the outer skirt of the transcatheter bioprosthetic heart valve 14.

[0053] Additionally, it should also be understood that in some embodiments, the scaffold anchors 10 may include high-visibility markers for precise positioning of the scaffold anchor. For example, the high-visibility markers may be radiopaque markers or wires positioned to enable fluoroscopic visualization during orientation and deployment. Moreover, each of the scaffold anchors discussed herein are re-sheathable, such that they can be repositioned and redeployed, as necessary, during a procedure.

[0054] This disclosure provides a leakage repair system for use during a prosthetic, replacement valve (e.g., heart valve) implantation. The system includes an scaffold anchor 10 of any of the embodiments disclosed herein and a delivery catheter 18 configured to advance and deploy the scaffold anchor 10 prior to the placement of the transcatheter bioprosthetic heart valve 14. As discussed herein, the scaffold anchor 10 is constructed to deform and become permanently retained between the native annulus and the transcatheter bioprosthetic heart valve 14 frame upon valve expansion, thereby occluding potential regurgitant pathways and anchoring the transcatheter bioprosthetic heart valve 14. The scaffold anchor 10 may be defined by a braided scaffold of self-expanding material having a bias to collapse or crumple laterally inward during valve expansion. The scaffold anchor 10 may include tines (e.g., protruding wire hook and loop elements) configured to engage tissue and prevent migration. The scaffold anchor 10 may include radiopaque markers and / or wires positioned to enable fluoroscopic visualization during orientation and deployment. The scaffold anchor 10 may include one or more zones or gaps of reduced stiffness configured to permit controlled crumpling or folding during valve deployment. The scaffold anchor 10 many include geometry that can be asymmetric to accommodate different chamber dimensions. The scaffold anchor 10 includes forms, upon deformation, a cavity-filling structure that reduces or eliminates paravalvular regurgitant flow paths. That is, deployment of the transcatheter bioprosthetic heart valve 14 mechanically captures the scaffold anchor 10 between the valve frame and native tissue, providing primaryAttorney Docket No. 026389-0059-W001anchoring without separate fixation elements. The scaffold anchor 10 may further include a flexible, biocompatible membrane, as described above. The catheter 18 may include a dilator and pusher assembly sized to accommodate various anchor diameters between 0.018 inches and 0.021 inches, and a total working length of approximately 300 cm. The catheter 18 is configured for use with preformed distal tip geometry to enable positioning in the heart.

[0055] Additionally, the disclosure provides a method for treating and / or repairing paravalvular leak after heart-valve replacement. The method includes the steps of acquiring preimplant imaging data and identifying anatomic regions of elevated paravalvular leak risk. The method also includes delivering a localized, conformable scaffold anchor 10 to at least one of the regions prior to valve implantation. Specifically, the method includes puncturing a leaflet of a native valve and advancing the scaffold anchor through the puncture such that the first anchor portion and the second anchor portion are on opposite sides of the leaflet. Then, the method includes expanding the first anchor portion 42 and the second anchor portion 50 from a retracted position to an expanded position prior to insertion of the transcatheter bioprosthetic heart valve. Then, the method also includes deploying the transcatheter bioprosthetic heart valve 14 such that its expansion compresses and fixes the scaffold anchor 10 within the annular tissue. Thus, the method includes expanding the transcatheter bioprosthetic heart valve such that the transcatheter bioprosthetic heart valve compresses the first anchor portion 42 and the second anchor portion 52 and such that the first anchor portion 42 and the second anchor portion 50 are mechanically captured between the transcatheter bioprosthetic heart valve and an annular wall of the patient thereby occluding regurgitant pathways. The method finally includes verifying the absence or reduction of regurgitant flow (PVL) after implantation.

[0056] The terms “substantially,” “essentially,” “approximately,” “about,” or any other version thereof, are defined as being close to as understood by one of ordinary skill in the art, and in one non-limiting embodiment the term is defined to be within 10%, in another embodiment within 5%, in another embodiment within 1% and in another embodiment within 0.5%. The term “one of,” without a more limiting modifier such as “only one of,” and when applied herein to two or more subsequently defined options such as “one of A and B” should be construed to mean an existence of any one of the options in the list alone (e.g., A alone or B alone) or any combination of two or more of the options in the list (e.g., A and B together).Attorney Docket No. 026389-0059-W001

[0057] Any numerical range recited herein includes all values from the lower value to the upper value. For example, if a range is stated as 1% to 50%, it is intended that the narrower ranges thereof, such as 2% to 40%, 10% to 30%, 1% to 3%, etc., are expressly enumerated by said statement. These specific examples represent only a limited subset of what is intended to be covered, and all possible combinations of numerical values between and including the lowest value and the highest value of the enumerated range are to be considered to be expressly stated in this application.

[0058] A device or structure that is “configured” in a certain way is configured in at least that way but may also be configured in ways that are not listed.

[0059] The terms “coupled,” “coupling,” or “connected” as used herein can have several different meanings depending on the context in which these terms are used. For example, the terms coupled, coupling, or connected can have a mechanical or electrical connotation. For example, as used herein, the terms coupled, coupling, or connected can indicate that two elements or devices are directly connected to one another or connected to one another through intermediate elements or devices via an electrical element, electrical signal or a mechanical element depending on the particular context.

[0060] In the foregoing specification, specific embodiments are described. However, one of ordinary skill in the art appreciates that various modifications and changes may be made without departing from the scope of the invention as set forth in the claims below. Accordingly, the specification and figures are to be regarded in an illustrative rather than a restrictive sense, and all such modifications are intended to be included within the scope of present teachings.

[0061] One of ordinary skill in the art appreciates that various modifications and changes can be made without departing from the scope of the invention as set forth in the claims below. The benefits, advantages, solutions to problems, and any element(s) that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as a critical, required, or essential features or elements of any or all the claims. The invention is defined solely by the appended claims including any amendments made during the pendency of this application and all equivalents of those claims as issued.Attorney Docket No. 026389-0059-W001

[0062] Moreover, in this document, relational terms such as first and second, top and bottom, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. The terms “comprises,” “comprising,” “has,” “having,” “includes,” “including,” “contains,” “containing,” or any other variation thereof, are intended to cover a nonexclusive inclusion, such that a process, method, article, or apparatus that comprises, has, includes, contains a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by “comprises ...a,” “has ...a,” “includes ...a,” or “contains ...a” does not, without more constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises, has, includes, contains the element. Unless the context of their usage unambiguously indicates otherwise, the articles “a,” “an,” and “the” should not be interpreted as meaning “one” or “only one.” Rather these articles should be interpreted as meaning “at least one” or “one or more.” Likewise, when the terms “the” or “said” are used to refer to a noun previously introduced by the indefinite article “a” or “an,” “the” and “said” mean “at least one” or “one or more” unless the usage unambiguously indicates otherwise.

[0063] Various features of the invention are set forth in the following claims.

Claims

Attorney Docket No. 026389-0059-W001CLAIMSWhat is claimed is:

1. A scaffold anchor for transcatheter bioprosthetic heart valve replacement , the scaffold anchor comprising:a first end;a second end opposite the first end;a longitudinal axis extending between the first end and the second end;a first anchor portion extending from the first end towards the second end, the first anchor portion formed from a self-expanding material;an intermediate portion extending from the first anchor portion towards the second end; anda second anchor portion extending from the intermediate portion to the second end, the second anchor portion formed from the self-expanding material;wherein the first anchor portion and the second anchor portion are configured to move from a retracted position to an expanded position prior to the transcatheter bioprosthetic heart valve being inserted, andwherein in the expanded position the first anchor portion and the second anchor portion are configured to compress after the transcatheter bioprosthetic heart valve is inserted and as the transcatheter bioprosthetic heart valve moves to an expanded position such that the first anchor portion and the second anchor portion are mechanically captured between the transcatheter bioprosthetic heart valve and an annular wall thereby occluding regurgitant pathways and anchoring the transcatheter bioprosthetic heart valve.

2. The scaffold anchor of claim 1, wherein at least one of the first anchor portion and the second anchor portion includes tines for enhancing anchoring of the scaffold anchor relative to native tissue adjacent to the native valve.

3. The scaffold anchor of claim 1, wherein the first anchor portion, the intermediate portion, and the second anchor portion collectively define an hourglass shape.Attorney Docket No. 026389-0059-W0014. The scaffold anchor of claim 3, wherein the first anchor portion and the second anchor portion are rectangular.

5. The scaffold anchor of claim 3, wherein the first anchor portion and the second anchor portion are ovular.

6. The scaffold anchor of claim 3, wherein at least one of the first anchor portion and the second anchor portion is cylindrical.

7. The scaffold anchor of claim 1, wherein each of the first anchor portion and the second anchor portion has a first end and a second end opposite the first end, the first end being coupled to the intermediate portion, the second end being a free end, and an outer surface defining a convex shape in the expanded position, and wherein the second end of the first anchor portion is positioned adjacent to the first end of the second anchor portion.

8. The scaffold anchor of claim 7, wherein the first anchor portion and the second anchor portion are nested relative to one another.

9. The scaffold anchor of claim 1 , wherein at least one of the first anchor portion and the second anchor portion includes a zone having a reduced stiffness compared to the remainder thereof, and wherein the zone is configured to force the at least one of the first anchor portion and the second anchor portion to compress in a direction away from the intermediate portion.

10. The scaffold anchor of claim 1, wherein the first anchor portion and the second anchor portion are configured to compress laterally inwardly towards the longitudinal axis as the transcatheter bioprosthetic heart valve moves to the expanded position.

11. The scaffold anchor of claim 1, further comprising a delivery wire coupled to the first anchor portion into position within the leaflet.

12. A scaffold anchor for placement in a leaflet of a native valve intended to be replaced, the scaffold anchor configured to scaffold anchor and stabilize a transcatheter bioprosthetic heart valve used to replace the native valve, the scaffold anchor comprising:a first, closed end;Attorney Docket No. 026389-0059-W001a second, closed end opposite the first end;a longitudinal axis extending between the first end and the second end;a first anchor portion extending from the first end towards the second end, the first anchor portion formed from a self-expanding material and including tines extending therefrom;an intermediate portion extending from the first anchor portion towards the second end; anda second anchor portion extending from the intermediate portion to the second end, the second anchor portion formed from the self-expanding material and including tines extending therefrom;wherein when positioned within the leaflet, the first anchor portion and the second anchor portion are on opposite sides of the leaflet and the first anchor portion and the second anchor portion are configured to move from a retracted position to an expanded position prior to the transcatheter bioprosthetic heart valve being inserted.

13. The scaffold anchor of claim 12, wherein the first anchor portion, the intermediate portion, and the second anchor portion collectively define an hourglass shape and wherein the first anchor portion and the second anchor portion are one of rectangular, ovular, spherical, and cylindrical.

14. The scaffold anchor of claim 12, wherein at least one of the first anchor portion and the second anchor portion includes a zone having a reduced stiffness compared to the remainder thereof, and wherein the zone is configured to force the at least one of the first anchor portion and the second anchor portion to compress in a direction away from the intermediate portion.

15. The scaffold anchor of claim 12, wherein the first anchor portion and the second anchor portion are configured to compress laterally inwardly towards the longitudinal axis in the expanded position.

16. The scaffold anchor of claim 12, further comprising a delivery wire coupled to the first anchor portion and configured to guide the scaffold anchor into position within the leaflet.

17. A method for treating paravalvular leak in a patient after heart-valve replacement, the method comprising:Attorney Docket No. 026389-0059-W001providing an scaffold anchor configured to stabilize a transcatheter bioprosthetic heart valve, the scaffold anchor includinga first end;a second end opposite the first end;a longitudinal axis extending between the first end and the second end;a first anchor portion extending from the first end towards the second end, the first anchor portion formed from a self-expanding material;an intermediate portion extending from the first anchor portion towards the second end;a second anchor portion extending from the intermediate portion to the second end, the second anchor portion formed from the self-expanding material;creating a puncture in a leaflet of a native valve;advancing the scaffold anchor through the puncture such that the first anchor portion and the second anchor portion are on opposite sides of the leaflet;expanding the first anchor portion and the second anchor portion from a retracted position to an expanded position prior to insertion of the transcatheter bioprosthetic heart valve; andexpanding the transcatheter bioprosthetic heart valve such that the transcatheter bioprosthetic heart valve compresses the first anchor portion and the second anchor portion and such that the first anchor portion and the second anchor portion are mechanically captured between the transcatheter bioprosthetic heart valve and an annular wall of the patient thereby occluding regurgitant pathways and anchoring the transcatheter bioprosthetic heart valve.

18. The method of claim 17, further comprising enhancing stabilization of at least one of the first anchor portion and the second anchor portion with tines extending therefrom into native tissue.

19. The method of claim 17, wherein creating a puncture in the leaflet of the native valve includes puncturing the leaflet with a wire.

20. The method of claim 17, wherein advancing the scaffold anchor including advancing the scaffold anchor using a delivery wire extending from the first anchor portion.

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