Devices, systems and methods for valve replacement

Abstract

Disclosed are devices, systems and methods of valve replacement. The valve replacement device may be a one-piece or two-piece system, and includes an adaptor body and a valve assembly with leaflets positioned within the adaptor body. In a two-piece system, the valve assembly may be detachable from the adaptor body, and both may be delivered together or separately, and the adaptor body may remain implanted while the valve assembly is removed and replaced (i.e., "revalvulation"). Devices (e.g., delivery catheter devices), systems and methods for such delivery and revalvulation of the valve replacement are also disclosed. Such delivery methods may include transseptal insertion of a new minimal leaflet structure and fixation of the valve replacement using several fixation types (e.g., annular superior fixation, annular inferior fixation, radial fixation, leaflet fixation). A braided helix design that mimics the natural motion of the heart and a flange structure that aids in the function of the valve replacement are also disclosed.

Description

[Background technology]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application is U.S. Provisional Application No. 63 / 407,624, filed on Sept. 16, 2022, entitled “Devices, Systems, and Methods for a Valve Replacement”; U.S. Application No. 17 / 240,914, filed April 26, 2021, entitled “Devices, Systems, and Methods for a Collapsible Replacement Heart Valve”; International Application No. PCT / US21 / 51828, filed on September 23, 2021, entitled "Devices, Systems, and Methods for an Implantable Heart-Valve Adapter"; International Application No. PCT / US21 / 32817, filed May 17, 2021, entitled “Devices, Systems, and Methods for a Collapsible and Expandable Replacement Heart Valve”; International Application No. PCT / US21 / 38886, filed June 24, 2021, entitled “Devices, Systems, and Methods for a Collapsible Replacement Heart Valve”; And, International application number PCT / US22 / 15360, filed February 4, 2022, entitled "Devices, Systems, and Methods for a Self-Adapting Valve Attachment" No. 6,399,363, filed on Oct. 13, 2003, and claims priority to and the benefit of the same, all of which are incorporated herein by reference as if set forth in their entireties.

[0002] (Technical field) The present disclosure relates generally to replacement heart valve technology, and more specifically to devices, systems, and methods for the delivery or replacement of "valve replacements," including "one-piece" and "two-piece" systems. Aspects of the present disclosure also relate to unique features of innovative replacement heart valve technology, including a helically braided wire design of the replacement heart valve frame and a multi-point anchoring system that utilizes a combination of upper annular anchoring to anchor to the top of the native heart valve annulus, lower annular anchoring to anchor to the bottom of the native heart valve annulus, and selectable and customizable radial forces within the replacement heart valve that anchor inside the native heart valve annulus.

[0003] (Background technology) Heart valve interventions, such as open-heart surgery, are often required to treat diseases of one or more of the four heart valves, which work together to keep blood flowing properly through the heart. Heart valve replacement and / or repair are often required when a valve is "leaky" (e.g., there is valve regurgitation) or when the valve narrows and does not open properly (e.g., valve stenosis). Replacement heart valve procedures, such as mitral or tricuspid valve replacement, usually involve replacing the heart's native (original, natural) valve with a mechanical and / or tissue valve (biological valve). Common problems with valve replacements and / or frames that carry the valves include deterioration of the leaflets (valve-like structures), breakage or failure of the frame (especially laser-cut Nitinol frames), and undesirable changes in the size of the native valve annulus. Replacement heart valves cause additional problems after implantation. For example, the valve replacement may move or migrate after being placed in the desired position in the heart. Alternatively, the location may not allow proper directional flow of blood through other parts of the organ, such as the left ventricular outflow tract. Summary of the Invention [Problem to be solved by the invention]

[0004] Valve replacements are also not easily retrievable, as such removal can often damage the surrounding heart tissue. This can be particularly problematic if, for example, the valve replacement is not properly and accurately placed in place when implanted in the native heart, and if the valve replacement begins to malfunction. The latter can occur soon after initial implantation, or years later. A further problem is that typical valve replacements, especially laser-cut valve frames, are relatively stiff and inflexible, resulting in the valve not bending (sufficiently) with the dynamic motion of the pumping heart. Such inflexible valves do not conform to these dynamic motions and can cause trauma to the heart surface, break the frame itself, and create or exacerbate other problems during or after implantation. What is needed, therefore, is a treatment solution for structural heart disease (e.g., mitral valve disease) that allows for continuation of treatment options and improvement of the patient's long-term health. Relatedly, there is a need for an effective transcatheter mitral valve replacement (TMVR) that can be delivered simply and reliably while providing a platform for future interventions.

[0005] What is also needed are devices, systems and methods for valve replacement that allow for both compact and reliable delivery into the heart, preferably entirely via a catheter, and convenient control of both the valve replacement during implantation and the expansion and contraction of the valve replacement upon implantation or removal / replacement. What is also needed are devices, systems and methods for ensuring proper directional flow of blood through the heart during and after the valve replacement procedure. What is also needed are devices, systems and methods for ensuring that the valve replacement is properly positioned when implanted into the native heart and prior to removal of the current / previous valve.

[0006] Such devices, systems and methods should provide the functionality of a one-piece system having both an adapter body with an engagement mechanism for securing to the heart and a valve assembly with leaflets positioned within the adapter body. Such devices, systems and methods should also provide the functionality of a two-piece system having an adapter body and a valve assembly that are compatible with each other, where the valve assembly may be detachable from the adapter body, and both may be delivered together or separately, and the adapter body may remain implanted while the valve assembly may be removed and replaced. Some such devices, systems and methods are also relevant to providing transcatheter therapy. [Means for solving the problem]

[0007] The following presents a simplified summary of example embodiments in order to provide a basic understanding of some embodiments of the present disclosure. This summary is not an extensive overview of example embodiments. It is not intended to identify key or critical elements of example embodiments or to define the scope of the appended claims. Its sole purpose is to present some concepts of example embodiments in a simplified form as a prelude to the more detailed description presented below in this specification. It is to be understood that both the following summary and the following detailed description are exemplary and explanatory only and are not limiting.

[0008] The present disclosure is directed to devices, systems and methods for valve replacement that serve the purpose of anchoring, sealing and controlling the position of the leaflets and subvalvular structures. The valve replacement can be highly flexible, elastic, fatigue resistant and fixable to the native valve tissue. The valve replacement is also self-adaptive, i.e., adapts to and supports the natural motion of the heart. In a preferred embodiment, the valve replacement includes a foldable adaptor body that attaches to the native valve tissue and provides a seal. The valve replacement includes a frame optimized for effective sealing and fixation to the valve, the design of the adaptive frame being anatomically inspired and designed to maximize ventricular filling and minimize outflow tract obstruction.

[0009] In some examples, a valve replacement can be a device for assisting the function of a heart valve. One embodiment of the device can include a tubular frame having an inflow end and an outflow end. In some examples, the tubular frame can include at least one braided wire wound in a helical direction. The helical direction can begin at the inflow end and end at the outflow end. The tubular frame can be configured to expand and compress in association with cardiac contraction.

[0010] The valve replacement, whether a one-piece or two-piece system, may further comprise a valve assembly, the valve assembly including leaflets and adapted to reside within an adapter frame. In some embodiments, the valve assembly may include a tubular braided frame, may include an inflow end and an outflow end, and may include at least one commissure post at the outflow end. In some embodiments, the valve assembly may include a leaflet assembly connected to the at least one commissure post. The leaflet assembly may be configured to provide a seal between the inflow end and the outflow end.

[0011] The present disclosure also provides a one- or two-piece valve replacement system that is compressible to a smaller profile when compared to the prior art due to its braided wire frame design, which allows for delivery not only via a transscapular approach, but also via a transfemoral and transnasal approach. In some embodiments, the valve replacement is constructed using braided wires wound in a bipartite manner, allowing the apexes and intersections of the braided wire structure to perform a cylindrical helical motion, and the structure is free to move within the helical spiral configuration. In some embodiments, the shape-set fabric and sewn nodes using sutures that sew the fabric to the frame provide upper and lower constraints within which the braided wire frame structure can move with the helical motion of the heart. In some embodiments, the anchor features of the valve replacement can be braided with cylindrical longitudinal bending symmetry on the helical axis. In other embodiments, the anchor features or commissural posts of the valve replacement can be individually welded onto the braided frame using various types of welding techniques, such as hypotubes or wire-to-wire welding. In other embodiments, anchors may be welded to the valve replacement by replacing sections of the braided wire frame. Some embodiments may also utilize techniques to optimize the valve replacement by optimizing the profile of the valve replacement, for example, by electropolishing the anchor features or the braided wire frame structure.

[0012] The two-piece system disclosed herein allows for an even lower profile since the adapter frame and valve assembly can be delivered as two separate devices. In one embodiment, a device for assisting function of a heart valve may include a tubular braided frame having an inflow end and an outflow end, and a flange structure at the inflow end of the tubular braided frame. The device embodiment may also include at least one feature at the outflow end of the tubular braided frame configured for anchoring to a native leaflet and at least one feature at the outflow end of the tubular braided frame configured for anchoring to a region adjacent to a native mitral annulus. The device embodiment may also include at least one commissural post at the outflow end of the tubular braided frame, which may extend from the tubular braided frame. The device embodiment may also include a leaflet assembly connected to the at least one commissural post. In some examples, a connection between the leaflet assembly and the commissural post may extend from the tubular braided frame. In some embodiments, the leaflet assembly may be configured to provide a seal between the inflow end and the outflow end of the tubular braided frame.

[0013] In another embodiment, a device for assisting function of a heart valve may include an adapter including a tubular braided adapter frame having an inflow end and an outflow end, a flange structure at the inflow end of the tubular braided adapter frame, and at least one anchor at the outflow end of the tubular braided adapter frame. In some embodiments, the device embodiments may further include a valve assembly. In some embodiments, the valve assembly may include a tubular assembly frame having a second inflow end and a second outflow end.

[0014] In some embodiments, the valve assembly may further include a leaflet assembly. In some embodiments, the leaflet assembly may be configured to provide a seal between the second inflow end and the second outflow end. In some embodiments, the tubular assembly frame of the device embodiments may be braided. In some embodiments, the valve assembly may include at least one commissural post at the second outflow end, and the leaflet assembly may be connected to the at least one commissural post. The valve assembly of the device embodiments may be configured to removably engage with the adapter. In some embodiments, the inflow end of the adapter may be proximal to the second inflow end, and the outflow end of the adapter may be proximal to the second outflow end.

[0015] Relatedly, devices, systems and methods for delivering a valve replacement are also described herein. One method embodiment of a method for delivering a heart valve may include advancing a catheter device for carrying the heart valve toward the mitral valve annulus. The method embodiment may also include pushing the catheter device through the mitral valve annulus.

[0016] The method embodiments may also include deploying at least one engagement attachment from the catheter device into the ventricle. The method embodiments may also include securing the at least one engagement attachment to at least one native leaflet in the ventricle. The method embodiments may also include deploying at least one anchor from the catheter device into the ventricle. The method embodiments may also include securing the at least one anchor to native heart tissue in the ventricle. The method embodiments may also include releasing a flange to fit the mitral annulus in the atrium. In some examples, the at least one engagement attachment may include or be at least one clip.

[0017] An embodiment of a delivery catheter apparatus may include a steerable distal end having a nose cone that may be configured to approach the mitral valve upon transseptal entry into the atrium. An embodiment of the device may include a proximal end connected to and spaced a length from the distal end. An embodiment of the device may include a deployable adapter and a sheath that spans at least a portion of the length between the distal end and the proximal end. An embodiment of the device may also include at least one extendable anchor on at least a portion of the adapter. An embodiment of the device may also include an extendable flange disposed from the adapter toward the proximal end.

[0018] The present disclosure also provides "restovalvable" systems, methods and devices in which a leaflet structure of a replacement heart valve can be removed and replaced with another leaflet structure. One method embodiment can include a method of replacing a heart valve, comprising advancing a first catheter device transseptally within the atrium toward the mitral annulus. In some examples, the first catheter device can include a new detachable minimal leaflet structure (MLS).

[0019] The method embodiments may also include positioning the first catheter device such that the new MLS is aligned with and proximate the mitral annulus. In some examples, the method embodiments may also include pushing a second catheter device transapically within the ventricle toward the mitral annulus. In some examples, the second catheter device may be configured to remove the old MLS. In some examples, the method embodiments may also include positioning at least a portion of the second catheter device to grasp the old MLS transapically from the mitral annulus. In some examples, the method embodiments may also include using at least a portion of the second catheter device to secure the old MLS and pull the old MLS from the mitral annulus for transapical removal.

[0020] In some embodiments, the method embodiments may also include inserting the new MLS transseptally into the mitral valve annulus using the first catheter device. In some embodiments, the transseptally inserting step may further include inserting the new MLS into the adaptor. In some embodiments, the old MLS may be in an adaptor in the mitral valve annulus, and the second catheter device may be configured to remove the old MLS from within the adaptor.

[0021] Also described herein is a device for assisting the function of a heart valve. The device may include a flange structure for placement on an inflow end of a heart valve adaptor frame. In some embodiments, the flange structure may include a top plate having a D-shaped peripheral shelf with a first lower surface configured to be placed on at least some of the native tissue. The flange structure may also include a first contour ring structurally below and inboard of the top plate, the first contour ring having a second lower surface configured to be placed on at least some of the native tissue. The flange structure may also include a second contour ring structurally below and inboard of the first contour ring, the third lower surface configured to be placed on at least some of the native tissue.

[0022] Further advantages, embodiments and features of the present subject disclosure will be readily apparent to those skilled in the art from the following description, in which a preferred embodiment of the present disclosure has been shown and described, simply to illustrate one of the best modes for carrying out the present subject disclosure. As will be understood, the present disclosure is capable of other different embodiments, and its several details can be modified in various obvious embodiments without departing from or limiting the scope of the present disclosure. Thus, the drawings and description are to be regarded as illustrative in nature, and not restrictive.

[0023] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present disclosure and, together with the foregoing summary of the disclosure and the detailed description of the drawings provided below, serve to explain the principles of the present disclosure. In certain embodiments, details that are not necessary for an understanding of the present disclosure or that make other details difficult to appreciate may be omitted. [Brief description of the drawings]

[0024] [Figure 1] FIG. 1 illustrates generally one embodiment of the valve replacement disclosed herein.

[0025] [Figure 2A] 2A-2C illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 2B] 2A-2C illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 2C] 2A-2C illustrate generally one embodiment of a valve replacement as disclosed herein.

[0026] [Figure 2D] 2D and 2E illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 2E] 2D and 2E illustrate generally one embodiment of a valve replacement as disclosed herein.

[0027] [Diagram 3] FIG. 3 illustrates generally one embodiment of the valve replacement disclosed herein.

[0028] [Figure 4] FIG. 4 illustrates generally one embodiment of the valve replacement disclosed herein.

[0029] [Diagram 5] FIG. 5 illustrates generally one embodiment of the valve replacement disclosed herein.

[0030] [Figure 6A] 6A and 6B generally illustrate several embodiments of the valve replacement disclosed herein. [Figure 6B] 6A and 6B generally illustrate several embodiments of the valve replacement disclosed herein.

[0031] [Figure 7A] 7A-7D are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 7B] 7A-7D are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 7C] 7A-7D are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 7D] 7A-7D are schematic illustrations of several embodiments of the valve replacement disclosed herein.

[0032] [Figure 8A] FIG. 8A shows a schematic of the spiral function of the human heart.

[0033] [Figure 8B] FIG. 8B illustrates a schematic diagram of one embodiment of a valve replacement as disclosed herein.

[0034] [Figure 8C] 8C-8F are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 8D] 8C-8F are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 8E] 8C-8F are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 8F] 8C-8F are schematic illustrations of several embodiments of the valve replacement disclosed herein.

[0035] [Figure 8G]FIG. 8G illustrates a schematic of the regions of the heart disclosed herein.

[0036] [Figure 9A] 9A and 9B illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 9B] 9A and 9B illustrate generally one embodiment of a valve replacement as disclosed herein.

[0037] [Figure 9C] 9C and 9D illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 9D] 9C and 9D illustrate generally one embodiment of a valve replacement as disclosed herein.

[0038] [Figure 10A] 10A and 10B generally illustrate several embodiments of the valve replacement disclosed herein. [Figure 10B] 10A and 10B generally illustrate several embodiments of the valve replacement disclosed herein.

[0039] [Figure 11A] 11A and 11B generally illustrate several embodiments of the valve replacement disclosed herein. [Figure 11B] 11A and 11B generally illustrate several embodiments of the valve replacement disclosed herein.

[0040] [Figure 12A] 12A-12E are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 12B] 12A-12E are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 12C] 12A-12E are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 12D]12A-12E are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 12E] 12A-12E are schematic illustrations of several embodiments of the valve replacement disclosed herein.

[0041] [Figure 13A] 13A-13D are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 13B] 13A-13D are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 13C] 13A-13D are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 13D] 13A-13D are schematic illustrations of several embodiments of the valve replacement disclosed herein.

[0042] [Figure 13E] 13E-13H are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 13F] 13E-13H are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 13G] 13E-13H are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 13H] 13E-13H are schematic illustrations of several embodiments of the valve replacement disclosed herein.

[0043] [Figure 14A] 14A-14E are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 14B] 14A-14E are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 14C] 14A-14E are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 14D]14A-14E are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 14E] 14A-14E are schematic illustrations of several embodiments of the valve replacement disclosed herein.

[0044] [Figure 15A] 15A and 15B generally illustrate several embodiments of the valve replacement disclosed herein. [Figure 15B] 15A and 15B generally illustrate several embodiments of the valve replacement disclosed herein.

[0045] [Figure 16A] 16A-16D are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 16B] 16A-16D are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 16C] 16A-16D are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 16D] 16A-16D are schematic illustrations of several embodiments of the valve replacement disclosed herein.

[0046] [Figure 17A] 17A-17D are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 17B] 17A-17D are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 17C] 17A-17D are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 17D] 17A-17D are schematic illustrations of several embodiments of the valve replacement disclosed herein.

[0047] [Figure 18A]18A and 18B generally illustrate several embodiments of the valve replacement disclosed herein. [Figure 18B] 18A and 18B generally illustrate several embodiments of the valve replacement disclosed herein.

[0048] [Figure 19A] 19A and 19B generally illustrate several embodiments of the valve replacement disclosed herein. [Figure 19B] 19A and 19B generally illustrate several embodiments of the valve replacement disclosed herein.

[0049] [Figure 20] FIG. 20 illustrates a schematic diagram of one embodiment of a valve replacement as disclosed herein.

[0050] [Figure 21A] 21A and 21I illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 21B] 21A and 21I illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 21C] 21A and 21I illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 21D] 21A and 21I illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 21E] 21A and 21I illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 21F] 21A and 21I illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 21G] 21A and 21I illustrate generally one embodiment of a valve replacement as disclosed herein. [Fig. 21H] 21A and 21I illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 21I]21A and 21I illustrate generally one embodiment of a valve replacement as disclosed herein.

[0051] [Figure 21J] 21J and 21M show a schematic diagram of one embodiment of a valve replacement as disclosed herein. [Figure 21K] 21J and 21M show a schematic diagram of one embodiment of a valve replacement as disclosed herein. [Figure 21L] 21J and 21M show a schematic diagram of one embodiment of a valve replacement as disclosed herein. [Figure 21M] 21J and 21M show a schematic diagram of one embodiment of a valve replacement as disclosed herein.

[0052] [Figure 21N] 21N and 21R show a schematic diagram of one embodiment of a valve replacement as disclosed herein. [Figure 21O] 21N and 21R show a schematic diagram of one embodiment of a valve replacement as disclosed herein. [Figure 21P] 21N and 21R show a schematic diagram of one embodiment of a valve replacement as disclosed herein. [Figure 21Q] 21N and 21R show a schematic diagram of one embodiment of a valve replacement as disclosed herein. [Figure 21R] 21N and 21R show a schematic diagram of one embodiment of a valve replacement as disclosed herein.

[0053] [Figure 22A] 22A and 22B illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 22B] 22A and 22B illustrate generally one embodiment of a valve replacement as disclosed herein.

[0054] [Figure 23A] 23A and 23B illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 23B] 23A and 23B illustrate generally one embodiment of a valve replacement as disclosed herein.

[0055] [Figure 24A] FIG. 24A illustrates a schematic diagram of one embodiment of a valve replacement as disclosed herein.

[0056] [Figure 24B] FIG. 24B illustrates a schematic diagram of one embodiment of a valve replacement as disclosed herein.

[0057] [Figure 25A] 25A and 25B illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 25B] 25A and 25B illustrate generally one embodiment of a valve replacement as disclosed herein.

[0058] [Figure 25C] 25C-25E are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 25D] 25C-25E are schematic illustrations of several embodiments of the valve replacement disclosed herein. [Figure 25E] 25C-25E are schematic illustrations of several embodiments of the valve replacement disclosed herein.

[0059] [Figure 25F] 25F-25H illustrate generally one embodiment of a wire frame of the valve replacement disclosed herein. [Figure 25G] 25F-25H illustrate generally one embodiment of a wire frame of the valve replacement disclosed herein. [Fig. 25H] 25F-25H illustrate generally one embodiment of a wire frame of the valve replacement disclosed herein.

[0060] [Figure 26]FIG. 26 illustrates generally one embodiment of a valve replacement as disclosed herein.

[0061] [Figure 27] FIG. 27 illustrates a schematic diagram of one embodiment of a valve replacement as disclosed herein.

[0062] [Figure 28A] 28A-28F illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 28B] 28A-28F illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 28C] 28A-28F illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 28D] 28A-28F illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 28E] 28A-28F illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 28F] 28A-28F illustrate generally one embodiment of a valve replacement as disclosed herein.

[0063] [Figure 29A] 29A and 29B illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 29B] 29A and 29B illustrate generally one embodiment of a valve replacement as disclosed herein.

[0064] [Figure 30A] 30A and 30D show a schematic diagram of one embodiment of a valve replacement as disclosed herein. [Figure 30B] 30A and 30D show a schematic diagram of one embodiment of a valve replacement as disclosed herein. [Figure 30C] 30A and 30D show a schematic diagram of one embodiment of a valve replacement as disclosed herein. [Figure 30D]30A and 30D show a schematic diagram of one embodiment of a valve replacement as disclosed herein.

[0065] [Figure 31A] 31A and 31F show schematic diagrams of one embodiment of a valve replacement as disclosed herein. [Figure 31B] 31A and 31F show schematic diagrams of one embodiment of a valve replacement as disclosed herein. [Figure 31C] 31A and 31F show schematic diagrams of one embodiment of a valve replacement as disclosed herein. [Figure 31D] 31A and 31F show schematic diagrams of one embodiment of a valve replacement as disclosed herein. [Figure 31E] 31A and 31F show schematic diagrams of one embodiment of a valve replacement as disclosed herein. [Fig. 31F] 31A and 31F show schematic diagrams of one embodiment of a valve replacement as disclosed herein.

[0066] [Figure 32A] 32A and 32F illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 32B] 32A and 32F illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 32C] 32A and 32F illustrate generally one embodiment of a valve replacement as disclosed herein. [Fig. 32D] 32A and 32F illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 32E] 32A and 32F illustrate generally one embodiment of a valve replacement as disclosed herein. [Fig. 32F] 32A and 32F illustrate generally one embodiment of a valve replacement as disclosed herein.

[0067] [Figure 33A]33A and 33F illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 33B] 33A and 33F illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 33C] 33A and 33F illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 33D] 33A and 33F illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 33E] 33A and 33F illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 33F] 33A and 33F illustrate generally one embodiment of a valve replacement as disclosed herein.

[0068] [Figure 34A] 34A and 34C illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 34B] 34A and 34C illustrate generally one embodiment of a valve replacement as disclosed herein. [Figure 34C] 34A and 34C illustrate generally one embodiment of a valve replacement as disclosed herein.

[0069] [Diagram 35] FIG. 35 illustrates a schematic diagram of one embodiment of the delivery system disclosed herein.

[0070] [Diagram 36] FIG. 36 illustrates a schematic diagram of one embodiment of the delivery system disclosed herein.

[0071] [Figure 37] FIG. 37 illustrates a schematic diagram of one embodiment of a delivery system disclosed herein.

[0072] [Figure 38]FIG. 38 illustrates a schematic diagram of one embodiment of the delivery system disclosed herein.

[0073] [Figure 39] FIG. 39 illustrates a schematic diagram of one embodiment of a delivery system disclosed herein.

[0074] [Diagram 40] FIG. 40 illustrates a schematic diagram of one embodiment of a delivery system disclosed herein.

[0075] [Figure 41A] FIG. 41A illustrates a schematic diagram of one step of an embodiment of the assembly disclosed herein. [Figure 41B] FIG. 41B illustrates a schematic diagram of one step of an embodiment of the assembly disclosed herein.

[0076] [Diagram 42] FIG. 42 illustrates a schematic diagram of one step of an embodiment of the assembly disclosed herein.

[0077] [Diagram 43] FIG. 43 illustrates a schematic diagram of one step of an embodiment of the assembly disclosed herein.

[0078] [Diagram 44] FIG. 44 illustrates a schematic diagram of one step of an embodiment of the assembly disclosed herein.

[0079] [Diagram 45] FIG. 45 illustrates a schematic diagram of one step of an embodiment of the assembly disclosed herein.

[0080] [Figure 46] FIG. 46 illustrates a schematic diagram of one step of an embodiment of the assembly disclosed herein.

[0081] [Figure 47] FIG. 47 illustrates a schematic diagram of one step of an embodiment of the assembly disclosed herein.

[0082] [Figure 48] FIG. 48 illustrates a schematic diagram of one step of an embodiment of the assembly disclosed herein.

[0083] [Figure 49] FIG. 49 illustrates a schematic diagram of one step of an embodiment of the assembly disclosed herein.

[0084] [Figure 50] FIG. 50 is a flow diagram that generally illustrates the method of delivery of the heart valve disclosed herein.

[0085] [Figure 51] FIG. 51 is a flow diagram that generally illustrates the method of replacing a heart valve disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0086] Before the present system and method are disclosed and described, it should be understood that the present system and method are not limited to a particular method, specific components, or specific implementation. It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. Various embodiments are described with reference to the drawings. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of one or more embodiments. However, it will be apparent that various embodiments may be practiced without these specific details. In other instances, well-known structures and devices are shown in block diagram form to facilitate description of these embodiments.

[0087] FIG. 1 shows a schematic diagram of an embodiment of a valve replacement as disclosed herein. FIG. 1 shows an embodiment of a valve replacement ("valve replacement") 100 implanted in a dysfunctional mitral valve 105. However, the valve replacement 100 is not limited to compatibility with only the mitral valve 105, but may also be implanted in a tricuspid valve (not shown), an aortic valve (not shown), or a pulmonary valve (not shown). In a preferred embodiment, the valve replacement 100 includes a braided collapsible frame and a braided valve and leaflet assembly, which together act to provide a seal. The valve replacement may include an inflow end 110 (shown facing the apex of the mitral valve 105) and an outflow end 115 (shown facing the bottom of the mitral valve 105).

[0088] As described herein, the adaptability of the foldable frame and leaflet assembly may be implemented in a variety of embodiments. In one embodiment, the valve replacement 100 may include a frame and valve assembly as a two-piece device (referred to herein for ease of reference as a "two-piece system"). In another embodiment, the valve replacement 100 may include a frame and valve assembly as a one-piece device (referred to herein for ease of reference as a "one-piece system"). Regardless of the (type of) embodiment, the valve replacement 100 may further include attachments and additional features for catheter delivery, positioning, partial deployment, and retrieval.

[0089] (Overview of two-piece valve replacement)

[0090] 2A-2C are schematic diagrams illustrating an embodiment of a valve replacement 100a disclosed herein. FIG. 2A-2C disclose an embodiment of a two-piece system 100a. As shown in FIG. 2A, the two-piece system 100a includes a heart valve frame 200 (referred to herein as an "adapter" for ease of reference) and a heart valve assembly 250 (referred to herein as a "valve assembly" for ease of reference). In one embodiment, the adapter 200 has an opening 205 that fits the valve assembly 250. The adapter 200 further includes a top sealing skirt 210, a body portion 215, and one or more anchors 220 extending from a bottom of the body portion 215. In one embodiment, the valve assembly 250 includes a leaflet structural component 255 that allows blood flow through the valve assembly 250.

[0091] 2C discloses the valve replacement as a two-piece system 100a, with an adapter 200 and a valve assembly 250 cooperatively sized and configured together such that the adapter 200 and valve assembly 250 can fit and be compressed as a single unit for insertion into a cardiac catheter for delivery to a target valve, i.e., in a configuration in which the two parts are mechanically coupled together. This configuration advantageously allows for delivery and control of both parts of the valve replacement 100a.

[0092] The adapter 200 and valve assembly 250 may also be delivered within a delivery catheter in an unconnected configuration in which the two portions are not mechanically linked together. This configuration advantageously allows the delivery catheter to control each portion independently and may increase the flexibility and torsional characteristics of the delivery catheter including the two portions, which may be advantageous both during delivery of the delivery catheter through the patient's body, vasculature, and desired target, and during delivery of the valve replacement to the target. In such an embodiment, the adapter 200 and valve assembly 250 as separately delivered portions may both be further compressed, allowing for a lower profile conducive to delivery through vessels that may not be healthy enough or wide enough in size to permit delivery of both portions as a single unit.

[0093] 2D-2E are schematic diagrams illustrating one embodiment of a valve replacement disclosed herein. FIG. 2D illustrates another embodiment of a valve replacement as a two-piece system including two separate devices that can be delivered as one system, such as an adapter 200a and an MLS 255. The adapter 200a can be configured to conform and secure to the native valve (as described in detail below). In some embodiments, the adapter 200a can be designed to be conformable to the human anatomy, provide fixation to the native (natural) valve, and interact with native heart tissue. In some embodiments, the MLS can accommodate the leaflets of a replacement heart valve. In some examples, the leaflets 260 of the MLS 255 can be made from a material that includes bovine pericardium. In some embodiments, the MLS 255 can be configured for secure placement within the adapter 200a. In some embodiments, the adapter 200a and the MLS 255 can be coordinately sized and configured together for proper placement and delivered to a patient as a system via the delivery systems and methods described herein.

[0094] 2E illustrates how the adapter 200a and MLS 255 may fit and be compressed as a single unit 265. Such compression may facilitate insertion into a cardiac catheter for delivery to a target valve, i.e., in a configuration in which the two parts are mechanically linked.

[0095] Once installation and delivery is complete (described in more detail below), the two separate devices, adapter 200a and MLS 255, can work together as a single unit 265 or system.

[0096] Similar to the adapter 200a and valve assembly 250 shown in FIG. 2D, the adapter 200a and MLS 255 of FIG. 2E may also be delivered within a delivery catheter in an unconnected configuration, where the two parts are not mechanically linked together, and both parts may be delivered as a single unit 265.

[0097] (Overview of one-piece valve replacement)

[0098] FIG. 3 shows a schematic of one embodiment of a valve replacement as disclosed herein. FIG. 3 shows one embodiment of a one-piece system 300 with an opening 305 for blood flow, a seal skirt 310, and a leaflet structure 315. Although not shown in FIG. 3, the one-piece system 300 may further include a body below the seal skirt 310 similar to the body of the adaptor 200 of FIG. 2A-2C, and may further include an anchor similar to the anchor of the adaptor 200 of FIG. 2A-2C. In one embodiment, the one-piece system 300 may function as a permanent implant.

[0099] Whether a one-piece or two-piece system, the valve replacement allows for a valve-in-valve replacement. Valve-in-valve replacement embodiments include replacing an existing leaflet assembly and valve assembly without reducing the area (e.g., by placing new material over the existing material) and without compromising the functionality of the implanted valve replacement.

[0100] (braided structure)

[0101] The braided structures disclosed herein are applicable to both one-piece and two-piece system adapter and valve assemblies, and thus, while various embodiments of the braided structures may be illustrated in relation to adapter and valve assemblies, it should be understood that such embodiments also relate to one-piece systems.

[0102] FIG. 4 shows a schematic of one embodiment of the valve replacement disclosed herein. FIG. 4 shows a braided wire frame of the adapter 400 and a braided wire frame of the valve assembly 450. The braided wire frame allows the adapter 400 and the valve assembly 450 to be compressed and, upon release, they can expand in size. Similarly, the one-piece system can also be compressed and expanded. Thus, the braided wire frame design allows the valve replacement to be compressed to a small diameter, for example, 4 mm to 6 mm, so that the valve replacement can be delivered within a catheter. The braiding of the wires and their overlap with other wires reduces stress on the frame, so wire breakage is also reduced or eliminated. The braiding also allows wires of various sizes to be used.

[0103] The braided wire frames of the one-piece system, adapter 400, and valve assembly 450 may include a variety of wire embodiments, including a single wire, two or more wires (e.g., grafted or welded), and multiple spliced ​​wires. The wires that make up the one-piece and two-piece systems may be constructed from a variety of materials, such as Nitinol, which has shape memory properties, and may vary in dimensions, such as diameter size.

[0104] By integrating various wire gauges and braid designs, the valve replacement conforms to the various densities and properties (i.e., radial force and expansion) of the heart's anatomy. This allows the braided frame to have flexible and adaptable performance, so that the valve replacement self-adapts to the heart and moves with it while being tolerant of anatomical anomalies, as well as the helical structure of the heart, as disclosed herein. The braided frame also facilitates placement of the valve replacement, maximizing its seal and preventing migration with an integrated and optimized anchoring system. The geometry of the valve replacement braided frame allows for a variety of applications, such as being customizable to the mitral and tricuspid anatomy, allowing smaller sizes (only) to be needed to treat most pathologies, facilitating rapid prototyping, allowing incorporation of various design features, facilitating rapid design advancement through rapid feature evaluation and optimization, and being scalable using conventional processes. The braided construction also allows more flexibility and the opportunity for the wires to be in various positions.

[0105] One embodiment of manufacturing the braided wire frame includes oversizing the braided wire frame relative to the heart valve. This allows the frame to open more fully and function better because it tolerates a larger radial force for the same amount of material and geometry. Additionally, manufacturing tolerances for manufacturing the valve replacement are reduced. Oversizing the braided frame creates a bias in the wire frame structure, resulting in less movement between the wires, as the elastic strain energy tends to conform and accommodate the larger radial force. As a result, the valve has a higher degree of consistency and manufacturing tolerances associated with, for example, leaflet attachment are greatly improved.

[0106] In one embodiment, the braided frame is wrapped and shaped so that it is configured to fit within a catheter while having sufficient radial strength to self-expand and open to a desired radial volume.

[0107] Embodiments of the valve replacement may range in diameter from 25 mm to 55 mm or more. In another embodiment, the wire frame is oversized, which involves braiding the wire frame over a 25.4 mm diameter (or 28.0 mm or 32.0 mm, depending on the desired valve size) mandrel and shape setting by treatment in a salt / sand bath at 505°C. The frame is then removed from the original mandrel and stretched and re-shape set over a 29.0 mm mandrel (or 31.0 mm or 33.0 mm, for example, for larger valves). A temporary string (or other similar method known to those skilled in the art) is then threaded through the loop and tied with the 25.4 mm mandrel as the nominal diameter of the valve frame. This spring loads the loop and compresses the frame (although other embodiments may have other configurations other than loops, such as simple points). In this manner, the braided valve replacement may be shape set at a larger diameter and then restrained at a smaller diameter and held with strings until the fabric is sewn onto the frame. In another manufacturing embodiment, the wire frame repeats the braid pattern three times over its length during five wraps around the circle.

[0108] The braided wire structure of the valve replacement embodiments provides significant advantages over valve structures that rely on laser cut frames or valve structures that have cellular structures with fixed nodes along the valve replacement frame instead of a helical over-under braid pattern that allows the valve replacement frame to move with the natural helical motion of the native heart. The braided structure, such as that described in certain embodiments herein, provides a collapsible scaffold with greater range and ability to conform to the native heart structure because the "nodes" where the wires are wrapped in a braided over-under style are not fixed in some embodiments and can slide over each other to conform to anatomical contours. Such unfixed, slidable nodes with an over-under braid style may allow for more flexibility and mobility than a pattern of fixed, immovable nodes at the wire crossing points. Relatedly, during manufacturing, the flange embodiments intentionally position the outermost ring of braided nodes outward to minimize leakage between the braided wires and increase the stiffness around the "D" shape.

[0109] Embodiments of the valve replacement may be compatible with various sizes of catheters, such as 26F, 28F, 30F, 32F, and 34F.

[0110] FIG. 5 shows a schematic of one embodiment of a valve replacement disclosed herein. As shown in FIG. 5, the adaptor 510 can be compatible with a human heart 505. Here, embodiments that achieve coaptation can include sealing and anchoring by adjusting the up-down pattern of the braid to achieve separable sections of the braid that can behave independently. The adaptor 510 can be constructed of a variety of materials and can also vary in dimensions. In one embodiment, the adaptor 510 can be constructed of a Nitinol wire braid made of one or more wires of different diameters. When released, the adaptor can expand in size (e.g., the body expands to a diameter of 25 mm or more and the sealing skirt expands to anywhere from 40 mm to 70 mm in diameter).

[0111] The valve replacement may include other types of wires, such as stainless steel, cobalt chrome, and other types of implant metals. In other embodiments, the valve replacement may include polymeric materials, such as biocompatible plastics and fiber-reinforced polymers. Some embodiments may include a drawn-filled tubular body (outer material is NiTi and inner material is a more radiopaque material) for the valve replacement or portions of the valve replacement (e.g., anchors or features desired to be visible under fluoroscopy). The valve replacement or portions thereof may be made of a hollow tubular body. Additionally, flat wires or other cross-section wires may be selected for portions of the valve replacement, such as to provide tailored / increased stiffness for the anchors.

[0112] (Braided wire frame flanges and anchors)

[0113] The adapters are designed to maintain native ventricular filling by directing flow into the ventricle in a way that limits turbulence and maximizes efficient flow, for example, toward the ventricular wall, between the papillary muscles, or otherwise toward the apex of the ventricle (the "virtual ventricular apex").

[0114] The adapters are also designed to be anatomically customized with patient and condition specific sizing. Sizing can be based on anatomical data, for example, using a sizing tool to determine the adapter diameter and flange length while simultaneously optimizing the valve orientation for both ventricular outflow considerations and ventricular efficiency. In this example, the parameters of the sizing tool are fed into a parametric device model, which automatically creates the pattern for the shape set tooling.

[0115] FIG. 6A shows a schematic of one embodiment of a valve replacement disclosed herein. As shown in FIG. 6A, the adapter can include an adapter body 605 and one or more atrial flanges 610. In one embodiment where the adapter is applied to a valve such as the mitral valve, the circumference of the atrial flange 610 is separated into a 1 / 3 portion 613 and a 2 / 3 portion 616. The 1 / 3 portion 613 of the atrial flange 620 engages the fibrous aortic-mitral curtain and is angled to prevent the valve from being pulled into the LVOT. This feature also maximizes sealing during systole. The 2 / 3 portion 616 of the atrial flange 620 engages the muscle wall and is angled to pull the valve away from the LVOT and direct flow toward the apex of the ventricle, between the papillary muscles, or toward the ventricular wall. In other embodiments, the adapter body and atrial flange function similarly or identically when applied to a tricuspid valve.

[0116] FIG. 6B illustrates a schematic of one embodiment of a valve replacement body disclosed herein. As shown in FIG. 6B, the adaptor may include a valve and retainer 615 within an inner frame of the adaptor body. The adaptor may also include subvalvular anchors 620 for leaflet management. In one embodiment, the subvalvular anchors 620 are comprised of one or more of an anterior leaflet anchor 625, an anchor strut 630, and a posterior leaflet anchor 645. For example, the adaptor may include a single anterior leaflet anchor clip 625, two anchor struts 630, and three posterior leaflet anchor clips 645. The anchors may be configured to radially overlap or bias upwardly relative to the adaptor body. In some embodiments, the anchor struts may be configured to land or be anchored adjacent to a fibrous landing zone near the native heart valve to be replaced in the native heart tissue. For example, in some embodiments, the anchor struts are configured to be positioned posterior to the trigon in the fibrous landing zone of the native heart, hi some embodiments, the anchor struts are also configured to be positioned posterior to the fibrous or muscular landing zones near the anterior or posterior leaflets of the native heart.

[0117] FIG. 7A shows a schematic of one embodiment of a valve replacement as disclosed herein. FIG. 7A shows one embodiment of a wire braided frame on which the adapter is constructed. The wire braided frame may include a 24-point braid pattern with dual posterior leaflet anchors 705 that are used to maintain symmetry and provide an additional 2x structural anchoring. The wire braided frame may also include dual stabilizing anchors 710. The wire braided frame may also have anchor positions available in 15 degree increments.

[0118] The anchors, in some embodiments, may be extensions of the tubular braided frame, extending from the outflow end and functioning as mating attachments. In other embodiments, the wire braided frame of the adapter may have anchors that are grafted, welded, or fused. For example, FIG. 7A shows the combination of a larger gauge wire (0.0175 inches to 0.02 inches) (represented by stabilizing anchor 710) with a smaller gauge wire (0.012 to 0.0175 inches) (represented by posterior leaflet anchor 705 and further represented by additional wire 715) by a joining operation at the interface between the different sized wires. The connection interface may be a weld or a weld to the supporting tubular body.

[0119] The embodiment of the weld used may relate to the material from which the valve replacement is constructed. In one embodiment of the anchor comprising a hollow tubular (hypotube) material, a simple weld or other helical weld pattern may be used to join the anchor to the frame since the inner diameter of the hypotube matches perfectly with the diameter of the wire. Both ends of the hypotube may then be beveled to provide a smooth transition for the wire to be attached. A radiopaque wire may be inserted into the hypotube and positioned at the peak of the anchor (such an embodiment provides optimal fluoroscopic visibility) or at any (suitable) location along the hypotube for clinical visualization. In some embodiments, hypotube anchors are also preferred because the hypotube material may be selected to have a higher stiffness or strength than other wires used in the helical braided structure of the replacement valve. Additionally, the hypotube material may be shaped to provide a longer surface area along the distal tip of the hypotube anchor that presses against the native heart anatomy to prevent migration of the replacement heart valve. The combination of higher stiffness and a longer surface area along the distal tip of the hypotube anchor distributes the anchoring force of the replacement heart valve along a wider or larger area of ​​the native heart structure, thereby reducing the potential for damage to the native heart structure. Additionally, hypotube anchors offer the opportunity for greater customization of the anchor system, as the hypotube anchor material can be selected and sized based on the desired stiffness and contact area at the distal tip of the anchor that is secured to the native heart structure.

[0120] 7B and 7C are schematic illustrations of several embodiments of the valve replacement disclosed herein. The valve replacement embodiments of FIG. 7B and 7C may include one or more anchor features. In one embodiment, as shown in FIG. 7B, the valve replacement may include an atrial seal skirt 705, a frame body 710, and a stabilization anchor 715, which are covered with fabric for purposes of sealing flow and / or promoting (e.g., affecting either promotion or inhibition) tissue growth after implantation. The anchor features 715 may be struts or stabilization anchors 715. They may help prevent the valve replacement from migrating into the atrium. In some examples, the stabilization anchors 715, or portions thereof, may be configured or designed to rest on a particular region of the annulus (e.g., the trigone region). The embodiment may further include an anchor feature 720, which may not be covered with fabric in some embodiments. In some embodiments, the anchor feature 720 may be or may include a clip 720 or hanger designed or configured to retain the native leaflet. Figure 7C shows a valve replacement including anchor features that may be a posterior leaflet anchor (or strut) 725 and a clip 720. In other embodiments, the clip and anchor are covered with fabric.

[0121] FIG. 7D shows a schematic of an embodiment of the valve replacement disclosed herein. FIG. 7D shows an embodiment of the valve replacement including a clip component 735 for improved delivery control through secure attachment of the valve replacement to the delivery catheter and for improved efficiency and effectiveness of leaflet attachment. FIG. 7D is a flat pattern schematic of a wire frame with clip 735, which may be a looped portion of the wire frame extending from the body of the wire frame. In some embodiments, clip 735 may be positioned at two or more separate locations around the circumference of the valve replacement. In other embodiments, clip 735 may be shaped 180 degrees to provide a hook shape for clipping onto the native valve leaflets. For example, clip 735 may be attached onto the native valve leaflets to provide fixation of the valve replacement when the valve replacement is released from the delivery system. In some embodiments, the clip encompasses the native anterior leaflets and / or posterior leaflets of, for example, the native heart valve, mitral valve, or tricuspid valve. In some embodiments, the clip is wrapped around the native leaflets and prevents the replacement heart valve from migrating into the atrium of the native heart. In embodiments, the clip is made of a hypotube material that includes a hollow tube (hypotube) material having an inner diameter that mates with a helically wound wire of the frame of the valve replacement device (including the one-piece frame body or the frame body of the adapter of a two-piece system).

[0122] Various embodiments of the valve replacement may include various quantities of anchors at various angles and orientations. For example, one embodiment may include six anchors, and another embodiment may include three anchors. In one embodiment including three anchors applicable to the mitral valve, the valve replacement has an angle of about 150° between the medial and lateral anchor struts, and the A2 anchor (or A2 clip) is secured to the anterior leaflet at or near the A2 region of the anterior leaflet (further described in connection with FIG. 8G), and the A2 anchor (or A2 clip) is symmetric between the two anchor struts. In another embodiment including three anchors applicable to the tricuspid valve, the valve replacement includes uniform 120° / 120° / 120° spacing of the anchors. In another embodiment including three anchors, the valve replacement has an angle of about 150° between the medial and lateral anchors, the P2 anchor (or P2 clip) is secured to the posterior leaflet at or near the P2 region of the posterior leaflet and secured to the posterior valve at or near the P2 region of the posterior valve, and the P2 anchor (or P2 clip) is symmetric between the two anchor struts. Other angles and geometries are possible and within the scope of this disclosure.

[0123] In another embodiment, for smaller hearts, the valve replacement has an angle of about 150° between the upper medial and lateral anchor struts, the A2 anchor (or A2 clip) is generally symmetric between the two upper anchor struts, an angle of about 180° between the lower medial and lateral anchor struts, and the P2 anchor (or P2 clip) is generally symmetric between the two lower anchor struts. In another embodiment, for larger hearts, the valve replacement has an angle of about 150° between the upper medial and lateral anchor struts, the A2 anchor (or A2 clip) is generally symmetric between the two upper anchor struts, and an angle of about 210° between the lower medial and lateral anchor struts, and the P2 anchor (or P2 clip) is generally symmetric between the two lower anchor struts.

[0124] The anchors (including clips) can be made of the same wire as the braided frame, or they can be made of a different wire (both in material and size). This provides a novel aspect. The ability to make the wire for the anchors thicker and / or more durable allows the anchors needed to attach the valve replacement to the valve tissue and hold it in place to be stronger and / or more rigid without compromising the flexibility of the body frame. This allows the valve replacement to remain firmly and securely positioned within the heart valve while allowing it to move and function with the natural movement of the heart.

[0125] Another novel aspect is the synchronization between the flanges and the anchors. When implanted, the flanges provide a downward force on the heart tissue and the anchors provide an upward force. These two forces exerted by the valve replacement further secure the valve replacement in place without compromising the fluidity of the braided body frame or the functionality of the leaflets.

[0126] (Spiral braid design)

[0127] The novel helical braid design of the valve replacement embodiments purposefully exploits the natural spiral motion of the beating human heart to balance both flexibility and strength. Studies of the human heart have revealed that the ejection and suction mechanisms are due to a helical design of muscles in a "coil within a coil" formation, responsible for clockwise and counterclockwise rotation and functional activity. More specifically, the underlying anatomy of the human heart includes a helical braid with transverse base loops of contractile muscles overlapping the diagonal helix responsible for ejection and suction within the heart.

[0128] The disclosed braided helix design is configured to reduce stress on the individual components of the valve replacement as it moves with the heart, i.e., the leaflets and anchors and other components have less stress (only) and the valve replacement moves less as it is held in place by its natural helical motion with the heart.

[0129] Figure 8A shows a schematic of the spiral function of the human heart. As shown in Figure 8A, twisting and untwisting motions in the heart are caused by an internal helical spiral in the descending and ascending apical loop muscle segments, and the heart has a natural clockwise twist / contraction for ejection and a natural counterclockwise relaxation / stretching for intake. In heart disease, the natural spiral shape of the heart is architecturally altered.

[0130] FIG. 8B illustrates a schematic of one embodiment of a valve replacement disclosed herein. As shown in FIG. 8B, one embodiment of the valve replacement includes a helical braid design that mimics and reinforces the normal helical and elliptical formations of the heart and its twisting / rotational motion. In some embodiments, the helical braid design may form a wire frame. In some examples, the helical braid design may be braided to allow the frame to move in multiple directions (e.g., three directions). Relatedly, in some examples, the braid design may allow the frame to accommodate movement along the longitudinal axis and the rotational axis (e.g., movement from simultaneous compression and twisting). In one embodiment, the helical braid design includes a design that resembles a frame that can move and / or flex (e.g., symmetrically about the helical axis) as the braided wires are compressed and / or stretched around the aperture center. In some embodiments, the helical braid design may implement tensegrity and / or floating compression principles, for example, by shaping the wires and frame into a predetermined configuration (e.g., to allow the wires to slide past one another in a non-rigid manner). For example, some principles may help decouple axial and rotational motion, so that the device may move in three dimensions to accommodate longitudinal motion and rotation while the heart is beating. As a further example, such motion may be free within constrained ranges, which may be defined by the shaping of the Nitinol and the shaping of the fabric sewn onto the frame, allowing the braided frame wires to move past one another in the top and bottom braids within a predetermined range of motion in one or more (or any) directions.

[0131] Both the adapter and valve assembly of the one-piece system as well as the two-piece system may include a helical braided design. A normal heart develops ejection and suction as a functional result of the integrity of the apical ellipse contraction. The helical braided design of the valve replacement maximizes myocardial shortening and stretching, thereby reinforcing the desired apical ellipse of healthy heart motion.

[0132] For example, as the human heart muscle compresses and descends, the braided helical wire of the valve replacement is not rigid, but rather compresses and descends with the heart muscle, thereby reinforcing the natural helical compression and descending of the heart muscle surrounding the braided wire. The braided helical design allows the valve replacement to conform to and reinforce the natural movement of the heart. The braided helical design of the valve replacement creates a twisted helical coil that creates a twist in a clockwise direction. Also, as the human heart muscle lengthens and fills, the braided helical design reinforces the natural helical length and filling of the braided wire with the surrounding heart muscle, resulting in a twist-free helical coil in the adapter or valve that generates an ejection force.

[0133] The novel braided helical design is important for heart valve repair. With the braided helical design, valve replacement embodiments reinforce the natural helical motion of the heart and more naturally accommodate and seat within the desired valve region. For example, valve replacement embodiments will tend to stay within the desired mitral or tricuspid valve region because the braided helical design moves with the natural motion of the heart (contracts, twists to shorten, untwists to lengthen). This allows the valve replacement to self-correct and naturally seat within the valve area, conform to the natural motion of the heart, and promote central vortex flow.

[0134] In this way, the novel braided helical design promotes the natural movement of the heart. In one embodiment, the valve replacement is held in place by the combined force of the flange and anchor sections, with the helical braid between the flange and anchor sections. The helical braid twists back and forth with the natural movement of the heart, allowing for pumping and squeezing. As the heart pumps, the twisting motion encourages the flow of fluid (blood) through the valve replacement, allowing for better flow dynamics.

[0135] 8C-8F are schematic diagrams of one embodiment 805 of a valve replacement disclosed herein. The frame 810 of the valve replacement embodiment 805 may incorporate a helical structure using braided wire technology and manufacturing. The frame 810 may utilize overlapping helical strands that conform to the natural motion of the heart and promote central vortex flow, as described above with respect to FIG. 8B. For example, the valve replacement 805 may promote not only contraction-like motion, but also twisting, radial expansion, and other motions that mimic the motion of the heart.

[0136] The frame 810 may be made from braided wire. The characteristics of the frame, including density and characteristics of the cardiac anatomy, braid design, wire thickness, etc., may facilitate the aforementioned movements as well as enhance placement accuracy, maximize seal, and prevent migration, especially in conjunction with an integrated and optimized anchor system (described in more detail below). In some embodiments, the frame 810 may be made from a material that includes wire with a predetermined thickness and geometry designed to enhance strength.

[0137] FIG. 8G illustrates various regions of cardiac tissue. For example, FIG. 8G illustrates a schematic of the aortic-mitral valve curtain 815, anterior leaflet 820, and posterior leaflet 825. As is typical in most human hearts, the anterior leaflet 820 may be slightly larger than the posterior leaflet 825. The anterior leaflet 820 and the posterior leaflet 825 may be divided into separate regions, labeled, for example, "A2" and "P2."

[0138] 9A and 9B show a schematic of one embodiment of a valve replacement disclosed herein, and FIG. 9B shows a vertical view of the embodiment shown in FIG. 9A. The valve replacement embodiment of FIG. 9A and 9B may include a flange having a flatter surface. The flatter surface may be configured to rest on the annulus of the atrial region. In some examples, the exterior surface area of ​​the valve replacement embodiment where the flange may meet the tubular adapter frame may be referred to as a transition point for present purposes, which resembles a right angle. In some cases, such a right angle may not conform to the surrounding native tissue, leaving an empty space between the tissue and the surface of the valve replacement embodiment.

[0139] 9C and 9D show a schematic of one embodiment of a valve replacement disclosed herein, and FIG. 9D shows a vertical view of the embodiment shown in FIG. 9C. The valve replacement embodiment of FIG. 9C and 9D may include flanges with more curved surfaces. For example, more specifically, the transition point of the valve replacement embodiment of FIG. 9C and 9D may be more curved (as opposed to a right angle). Such a design may help the surface of the valve replacement embodiment to expand into the space between the surface and the surrounding native tissue.

[0140] (Material cover)

[0141] In some embodiments, the various materials are prepared prior to assembly into a continuous cover, while in other embodiments the materials may be subject to additional and post-assembly modification treatments that are applied only to specific locations of the valve replacement.

[0142] In some embodiments of the valve replacement disclosed herein, tissue attachment and ingrowth (engraftment) may be promoted in areas where anchoring to tissue is desired, while cellular interaction may be limited to simple endothelialization or complete lack of reaction, allowing later disturbance of parts of the device without risk of tissue or thrombotic embolism. In short, various materials may be used that may or may not contribute to chemical bonding. For example, in a preferred embodiment, the material in contact between the inner portion of the adaptor and the outer portion of the valve assembly does not bond, allowing movement of both portions, while the material on the outside of the adaptor bonds with the tissue of the body. Thus, depending on the location, materials may be used that inhibit or promote cell growth.

[0143] Some valve replacement embodiments may be fully or partially encased in a continuous material covering to elicit the desired type of physiological response as well as mechanical behavior. Although the covering is continuous and there are no gaps in material at the transition of physical features, the material may be locally altered in multiple areas of the device to behave differently. For example, the material covering one side of the flange may be intentionally non-porous to facilitate sealing, and the material on the other side of the flange may be knit to facilitate tissue ingrowth for anchoring. Alternatively, the flange may be alternating rings of non-porous and engraftment material on both sides of the flange. These techniques may be applied to any surface of the device.

[0144] Material differences can range from entirely different materials - natural tissue or synthetic fibers - to physical and chemical surface modifications to obtain desired mechanical and biocompatible properties. These modifications can include, but are not limited to, coatings, etching, mechanical biasing, ion implantation, various deposition techniques, oxidation / nitridation / carbonization. Modifications can be used in any combination to obtain the desired results.

[0145] 10A and 10B show schematics of several embodiments of the valve replacement disclosed herein. As shown in FIG. 10A and 10B, one embodiment of the valve replacement may include a continuous element of material around the outside of the frame. A continuous seal may be constructed of material (e.g., fabric) that extends from the inflow edge 1005 of the valve replacement to the outer ring 1010 of the body of the valve replacement. A strip of ingrowth fabric may be sewn around the inflow edge of the valve replacement, forming a continuous seal with a non-porous coating that extends into the ventricle. The material may be configured to fill the space between the inner fabric and the outer fabric. For example, in one embodiment, a filling fabric is selectively placed within the valve replacement to fill the spaces and gaps between the material or areas where the frame and fabric have gaps.

[0146] The continuous surface of the fabric can be locally influenced, locally adjusted in properties, or locally tailored to opposing properties, such as by coating with medical polymers where tissue attachment is not desired, coating with hydrogels where space-filling or latent action is desired, or coating with hydrophilic tissue adhesives. The continuous material structure of the fabric can be voluminous in nature, filling spaces and allowing the circular heart valve to conform to the asymmetric shape of the annulus. In combination with other attachment methods, an embodiment of a mitral valve adapter made in this manner aids in the engagement and attachment of leaflet tissue and other subvalvular structures. The partially porous fabric provides improved sealing of the valve replacement, allowing the fabric's compliance to conform to irregularly shaped anatomical structures. In some embodiments, the fabric is selectively treated by partially immersing it in a coating that imparts additional properties to the fabric, such as improved sealing.

[0147] In other embodiments, the valve replacement may be manufactured using restraints that hold it at a particular dimension while materials that affect device performance are attached. To eliminate the inherent freedom of movement and unpredictability that exists between opposing members of the frame structure when unloaded, a manufacturing technique is disclosed that acts to affect the placement of the braided wire frame. This technique involves restraining the radial expansion of the frame with restraints, for example, threading a number of sutures through or around the structure to hold the structure at a particular dimension other than the unconstrained "free" dimension. In subsequent manufacturing steps, the structure is assembled into an assembly that adopts this new configuration, which is considered to be the final dimension. When the restraints are removed from the braided frame, the braided frame attempts to return to its original "free" dimension - applying additional radial force to the surrounding structure while being restrained at the desired dimension.

[0148] The degree of radial force transferred from the frame to the fabric material can be tailored as required to achieve an optimum combination or performance characteristics. In particular, the strain energy density of the structure can be made more uniform. Greater stiffness (resulting in a better seal) can be achieved with less material, resulting in a lower profile structure. The sutures ultimately bias the structure toward the diameter and height desired for the valve structure.

[0149] To further extend the concept, structures having the features described herein may be co-deployed, either alone or in a linked design, to engage both the mitral and aortic valve apparatus and / or annulus, with the intent of influencing the leaflets of both valves and the angle of the valves relative to each other to ensure the most effective management of flow through the ventricle and maximize the efficiency of the outflow tract.

[0150] In some embodiments, the valve replacement is covered with a material that continuously encapsulates the frame. Examples of such materials are fabric and animal tissue. By using locally modifiable materials to vary properties such as porosity and surface roughness, a level of control over cellular interactions in various parts of the device can be achieved. In other embodiments, the adapter body and atrial flange can be covered with fabric for flow sealing purposes and / or to affect (e.g., either promote or inhibit) tissue growth after implantation.

[0151] The materials used also aid in the loading and deployment of the valve replacement. For example, the materials may facilitate the valve replacement functioning as a revalvulation system, where a tubular braided fabric tube (coated with a polymer to reduce porosity to blood) surrounds the frame and constrains the diameter. The tubular body is sewn onto the frame, possibly together with the leaflet panels, the strings can be removed, and what remains is a pretensioned frame constrained by the fabric. In some embodiments, an elastomer-coated tubular knit shaped fabric is attached to the braided frame. In some embodiments, a dip-coated braided frame, such as a urethane-dipped frame, is utilized as the entire device or as part of it. In other embodiments, treated panels are sewn to the braided frame. In other embodiments, sections of treated fabric are cut into panels configured to be sewnable to at least partially circular surfaces, such as flanges.

[0152] (Sewing method and belt loops)

[0153] 11A and 11B show schematic diagrams of several embodiments of the valve replacement disclosed herein. More specifically, FIGS. 11A and 11B show various embodiments of the manufacturing materials for the valve replacement focusing on a two-piece system, but are consistent with one-piece systems. In some embodiments, the materials of the various components may be made of the same or different materials. Such materials may include, for example, textured or hard-knit style fabrics or textiles, bioabsorbable meshes (e.g., polymeric), elastomeric scaffolds, or other materials. Other materials with similar or different properties may also be used. For example, materials may be used that are permeable or impermeable, have various degrees of elasticity, stretchability in a given or arbitrary direction, biocompatibility, etc.

[0154] 11A shows the flange outer material 1105, flange rim material 1110, outer adapter cuff material 1115, and inner adapter cuff material 1120 of the valve replacement. The flange outer material 1105 may form a circular top element and may further include a coating to reduce fluid permeability. The flange rim material 1110 may form a circular bottom element that stretches to allow expansion of the valve replacement upon deployment. The outer adapter cuff material 1115 may comprise a cross stitch that connects the ends to form a tubular shape. The inner adapter cuff material 1120 may include a running stitch or cross stitch that connects the ends to form a tubular shape, and the fabric of the inner adapter cuff material 1120 may have limited elasticity, and any stitching maintains the integrity of the inner adapter cuff material 1120.

[0155] In one embodiment, the flange rim material 1110 and the outer adapter cuff material 1115 may be combined by cross stitching or any other method known to one of skill in the art to form the secant bottom element. The flange may be stitched at the location furthest from the anchor slot. The formed secant bottom element may be positioned on the bottom of the adapter or one-piece system, the shape-setting threads around the body of the frame are cut, and a lap stitch is used to close or secure the anchor slot.

[0156] In another embodiment, the inner adapter cuff material 1120 can be attached to the inner opening of the flange outer material 1105 to form a top piece of material. The top piece of material can be slid over the top of the adapter or one-piece system and then the fabric is lap stitched where it is closest to the frame.

[0157] In another embodiment, the bottom and top elements of material may be connected, such as by applying a lap stitch at the bottom of the frame to connect the top element of material to the bottom element of material. To this end, the fabric of the flange outer material 1105 and the flange rim material 1110 may be smoothed, held in place (such as with sewing clips), and connected around the wire flanges (such as with a running stitch). In this case, the flange border may be circular and not rigid. Excess fabric may be trimmed off and additional stitching may be added around the flange and each wire flange tip. Additional stitching may be applied along the wires to secure the fabric together and to maintain flushness with the wire flanges. The stitching may be applied to the second intersection of the wires, continued to the next wire, and sewn up to the tip of the wire flange. This process may be continued around the flanges and repeated with the next set of wires.

[0158] An embodiment of the outer adapter cuff material cuff 1115 may be folded in half and secured together (such as with sewing clips) and then blanket stitched around the edges. The blanket stitch allows the outer adapter cuff material 1115 to hold its shape without wrinkling the fabric. The outer adapter cuff material 1115 may be turned inside out and placed over the anchor wire, after which the outer adapter cuff material 1115 may be secured (such as with a running stitch) to the front and back (front and back) of the anchor wire, with the stitch seam (used to close the anchor slot) being caught (hooked) between the front and back fabric of the outer adapter cuff material 1115 and secured to the adapter or one-piece system. The running stitch may encircle the front of the outer adapter cuff material 1115, the seam, and the back of the outer adapter cuff material 1115, along the base of the anchor wire. Once the outer adapter cuff material 1115 is secured to the base, stitching can continue along the anchor wire to prevent the outer adapter cuff material 1115 from slipping or sliding on the anchor. The fabric is not so loose that it can be slightly caught and leaves excess fabric, but not so tight that it affects the shape of the wire.

[0159] In some embodiments, the stitching of fabric to the helical braided wire structure of the replacement valve body performs several functions, including: it helps to restrain the braided wire of the replacement valve body from migrating into the ventricle or atrium, helps to prevent perivalvular leakage, while at the same time allowing slight movement along the loose nodes of the upper and lower braids to allow the replacement valve body to move with the natural spiral motion of the heart.

[0160] 11B shows the inner valve cuff material 1125 and the outer adapter cuff material 1130. In one embodiment, the leaflets may be connected to the inner valve cuff material 1125, for example, along a strip of fabric with a double running stitch along the belly of the leaflets, the stitch being uniform across the entire leaflet to allow proper valve opening and closing. The leaflets or commissure tabs may be exposed, for example, by laser cutting with a slot on top of the inner valve cuff material 1125 (in this case, the strip of inner valve cuff material 1125 may be folded in half, making sure the leaflets are aligned on top of each other, and the ends of the inner valve cuff material 1125 may be attached to the junction of the belly and the tabs with a double running stitch). Following exposure of the leaflet tabs, the inner valve cuff material 1125 may be placed into the valve assembly frame, and the tabs may be pulled through the commissure wires to lay flat between the leaflets and the inner valve cuff material cuff 1125.

[0161] In one embodiment, the ends of the outer valve cuff material 1130 may be connected and the outer valve cuff material 1130 slid over the outside of the valve assembly frame.

[0162] In another embodiment, the inner valve cuff material 1125 and the outer valve cuff material 1130 can be connected together. After placing the inner valve cuff material 1125 inside the valve assembly frame and the outer valve cuff material 1130 outside the valve assembly frame, the two pieces can be connected (e.g., by tying the pieces together with a square knot) to the bottom of the frame just below the commissure wires, and the pieces can be sewn along the bottom of the frame. Following the commissure attachment described in the following paragraph, the pieces can be joined by sewing through the frame, and the top of the valve assembly frame can be stitched. An additional step can include stitching around the wires that transition from the annulus commissures downward and away from the peaks along the top circumference of the valve to form a Z-shaped pattern. In this case, the stitches can connect the inner fabric behind the leaflets to the outer valve cuff material 1130.

[0163] In one embodiment of commissure attachment, leaflet tabs are fed through the commissures, with each tab folded over onto its own leaflet and wrapped around the commissure wire. The ends of the tabs may be held together upon entry of the tabs and secured together, for example with a running stitch vertically inside the valve assembly. The stitch may continue in front of and around the commissures, for example 3-4 times, entering and exiting at the location of the running stitch. The stitch may be vertical, including embodiments such as a running stitch along the y-axis and a lap stitch along the x-axis.

[0164] In other embodiments of the manufacture of materials for a valve replacement focused on a one-piece system, the fabric for the various pieces may include stretchy and translucent fabric, and the outer adapter cuff material 1115 and the flange rim material 1110 may be sewn together to create the outer piece. Cross stitching may be used to connect the edges of the outer adapter cuff material 1115 and to connect the outer adapter cuff material 1115 to the flange rim material 1110.

[0165] In another embodiment, where the fabric for the portion includes a non-flexible and opaque fabric with a visible coating, the inner adapter cuff material 1120 and the flange outer material 1105 can be sewn together to create the inner element (inner piece). A running stitch can be used to connect the edges of the tubular inner adapter cuff material 1120 and a cross stitch can be used to connect the inner adapter cuff material 1120 to the flange outer material 1105.

[0166] For those embodiments focused on one-piece systems, an inner valve cuff material may be created, the leaflets attached to the inner adapter cuff material 1120, the leaflet tabs placed through slots in the inner adapter cuff material 1120 where the junctions of the inner adapter cuff material 1120 and the tabs meet, and the leaflets held in place, such as with a sewing clip. Using a double running stitch, the ventral edge of each leaflet is sewn to the inner adapter cuff material 1120. The tabs and top edges of the leaflets are flush and level with one another, and the running stitch on each ventral side of the leaflet is level and uniform. (Inconsistent stitching can lead to a defective valve.) After the leaflets are attached to the inner adapter cuff material 1120, the inner adapter cuff material 1120 is folded in half to keep the leaflets level and held in place. A double running stitch may then be sewn directly down from the leaflet tab junction and back toward the leaflet tab junction while continuing the running stitch away from the leaflets. (The running stitch should be away from the abdominal side of the leaflet.) After these steps, the inner valve cuff material forms a tubular body.

[0167] A first set of material may be created by connecting, such as by cross stitching, the inner valve cuff material from above to the flange outer material 1105. The leaflets are spaced apart from the stitching.

[0168] Once the first set of material is made, it can be connected to the second set (e.g., flange rim material 1110 and outer adapter cuff material 1115, previously sewn together) using a running stitch through the frame (between the double running stitches on the belly of the leaflet), followed by securing both sets together using stitches on the belly of the leaflet. Tabs are then secured through the commissures, and a lap stitch is used to connect the second set to the first set at the base of the frame. A deployment opening is created by cutting the fabric before finishing the lap stitch. After connection, a beta stitch is installed on the flange to anchor the position of the cuff.

[0169] 12A-12E are schematic diagrams illustrating multiple embodiments of the valve replacement disclosed herein. More specifically, FIGs. 12A-12E illustrate multiple deployment belt loops that are typically used in two-piece systems. The multiple deployment belt loops may include one or multiple loop sets.

[0170] In a preferred embodiment, the adapter has seven belt loops at the base of the adapter's body, with three belt loops on either side of the anchors and one belt loop at the vertical seam. The adapter also has five belt loops at the horizontal seam between the body and the flange, with the five belt loops located on cross wires flush with each other. A hidden belt loop can be found behind the long anchor (P1 / P3 anchor). The adapter also includes four belt loops located on cross wires to the left and right of the long anchor along the flange. Additionally, the adapter has two belt loops at the tip of the long anchor. In a preferred embodiment, the belt loop at the tip of the anchor has three loops and all other belt loops have two loops, but it should be appreciated that the belt loops are not limited to a particular number of loops.

[0171] 12A shows the belt loops associated with the P1 and P3 anchors. The adapter has one or more belt loops 1205 rearward of the P1 and / or P3 anchors 1220 (i.e., on the body and hidden from view unless the anchors are lifted) and along the horizontal seam 1210. The adapter also has one or more belt loops 1215 to the left and right of the P1 and / or P3 anchors 1220.

[0172] 12B shows the belt loop between the P1 anchor 1235 and the P2 anchor 1240. The belt loop 1225 along the horizontal seam 1210 is in the same plane. The adapter also has a belt loop 1230 to the side of the P1 anchor 1235 and the P2 anchor 1240, which is also generally in the same plane.

[0173] 12C shows the belt loops between the P1 anchor 1235 and the P3 anchor 1260. One belt loop 1245 is at the junction of the horizontal seam 1210 and the vertical seam 1250, and one belt loop 1255 is at the bottom of the vertical seam 1250.

[0174] 12D shows the belt loop between the P2 anchor 1240 and the P3 anchor 1260. The belt loop 1265 along the horizontal seam 1210 is flush. The P3 anchor 1260 is slightly higher, so the belt loop 1270 near the P3 anchor 1260 is adjusted to be approximately the same height as the P3 anchor 1260. The belt loop 1230 is in a position relative to the position of the P2 anchor 1240. In a preferred embodiment, the anchor is biased toward the flange. In other embodiments, the anchor may be perpendicular to the body.

[0175] 12E shows an anchor loop associated with the P1 anchor and / or the P3 anchor. In one embodiment, the anchor loop has a double loop 1275 positioned at the cross wires on the left and right flanges of the P1 anchor 1220 and / or the P3 anchor 1220, and the anchor loop further has a triple loop 1280 at the tip of the P1 anchor 1220 and / or the P3 anchor 1220.

[0176] 13A-13D are schematic diagrams illustrating multiple embodiments of the valve replacement disclosed herein. Figures 13A-13D show multiple deployment belt loops typically used in one-piece systems. The multiple deployment belt loops may include one or multiple loop sets.

[0177] In a preferred embodiment, the one-piece system has seven belt loops, the belt loops on the adapter body of the one-piece system are double loops, and the belt loops located on the horizontal seam are on cross wires along the same plane.

[0178] 13A shows the belt loops between the P1 anchor 1305 and the P3 anchor 1310. Three belt loops 1315 are located along the horizontal seam 1320, one belt loop is located at the junction where the horizontal seam 1320 meets the vertical seam 1325 and is aligned with the commissure wires. The other two belt loops are located just outside the P1 anchor 1305 and the P3 anchor 1310.

[0179] 13B shows a belt loop between the P2 anchor 1330 and the P1 anchor 1305 or P3 anchor 1310. Two loops 1335 are located along the horizontal seam and are secured flush with the P2 anchor 1330 and the outer crossed wires of the long anchors (P1 / P3 anchors).

[0180] FIG. 13C shows belt loops 1340 of the long anchor, the belt loops 1340 being located on either side of the long anchor.

[0181] FIG. 13D shows belt loops 1345 of the P2 anchor 1330, which are located on either side of the P2 anchor 1330.

[0182] 13E and 13F show one embodiment of the location of deployment apertures, with deployment apertures 1350 located directly underneath each long anchor and on either side 1355 of the P2 anchor 1330.

[0183] 13G and 13H show another embodiment of the location of the deployment opening 1375. In this embodiment, the fabric is removed (e.g., in a triangular shape) two peaks 1360 away from the commissure (i.e., commissure pillar) 1365 to expose the wire peaks. Lap stitches 1370 are placed around the frame to capture the wire around the exposed peaks.

[0184] (Engagement structure)

[0185] FIG. 14A illustrates a schematic of one embodiment of a valve replacement as disclosed herein. In one embodiment, as shown in FIG. 14A, an adapter or one-piece system includes a body 1405 and an atrial sealing skirt 1410 (which may be a flange in some aspects). The adapter body 1405 and sealing skirt 1410 may be constructed of a variety of materials and may also vary in size. For example, the adapter body 1405 and sealing skirt 1410 may be constructed of a wire braid of one or more wires of different diameters. The wires may be made of a material such as Nitinol and may be designed to be compressed to a small diameter, such as 4 mm to 6 mm, so that they can be delivered within a catheter. When released, the adapter body 1405 and sealing skirt 1410 may expand in size (i.e., the body expands to a diameter of 25 mm or more and the sealing skirt expands to anywhere from 40 mm to 70 mm in diameter).

[0186] The outer surface of the adapter body 1405 may be covered with a number of small short barbs 1415 that may be used to engage the leaflets or annulus of a dysfunctional heart valve, such as the mitral valve. The barbs 1415 may be constructed from basic short wires and / or may have additional (special) barb components, such as fish hook barbs, to hold the annulus fixedly.

[0187] The adapter body 1405 may also have one or more hooks 1420, 1425 of different sizes (more or less than the barbs 1415) that can hook under the native valve tissue (capable of hook engagement). These larger hooks may or may not have fish-hook barbs. The larger hooks may act like a spring to engage the native valve tissue and prevent it from moving.

[0188] In a preferred embodiment, the sealing skirt 1410 may be connected to a catheter and the adapter attachment may be sequentially released from the catheter when the adapter body 1405 is released to engage the annular tissue. The sealing skirt 1410 may be designed to deflect downwardly to radially overlap the adapter body 1405 toward or beyond a plane that defines the junction between the adapter body 1405 and the sealing skirt 1410. The multiple barbs 1415 on the adapter body 1405 cooperate to ensure that the adapter body 1405 is tightly engaged with the native annulus and resists downward pressure of the sealing skirt 1410, allowing the sealing skirt 1410 to form a strong seal against the atrial tissue surrounding the native valve annulus.

[0189] 14B-14E show schematic diagrams of several embodiments of the valve replacement disclosed herein. In these figures, the sealing skirt is not shown for ease of illustration. As shown in FIG. 14B, the adapter body 1405 is designed with a braid of varying weave density and / or wire diameter and / or combined with a releasable mechanism such that the adapter body has an initial circular cross section. The adapter body 1405 has barbs 1415 designed to engage with the native leaflets 1450. When the barbs 1410 are engaged, the anchoring / attaching feature of the adapter attachment makes it conform to a "D-shape" or other asymmetric shape, while the adapter body 1405 remains cylindrical or other special shape to receive the valve structure. This adaptability and conformity is achieved via different weaves, wire diameters, or mechanisms that allow such. As shown in FIG. 14C, the change in shape creates a sharper curve radius and forms a D-shape. The change from a circular cross section to a D-shaped cross section may cause the leaflets to be pulled. This may be useful, for example, in mitral valves where an implant such as an adaptor body may cause outflow tract obstruction. Figures 14D and 14E disclose perspective views of structures and features corresponding to Figures 14B and 14C. The embodiments disclosed in Figures 14B-14E may also have the sealing skirt and other features described in the previous figures. Figures 15A and 15B show schematic diagrams of several embodiments of the valve replacement disclosed herein. Figure 15A discloses one embodiment of a valve replacement implanted in a dysfunctional mitral valve with the body 1505 deployed in the mitral valve and the sealing skirt 1510 deployed against the floor of the left atrium. In this embodiment, the adaptor body 1505 is oriented at a slight angle (i.e., 10-30 degrees relative to the plane of the skirt) such that when deployed, the adaptor body 1505 is biased toward the posterior leaflet 1515.

[0190] Deployment as disclosed in Fig. 15A ensures good engagement of the barbs with the posterior leaflets, but not necessarily with the anterior leaflets. The system may be designed to be normally in this geometric state, but may be designed to be mechanically expandable by design so that it can expand to engage the anterior leaflets and then be released to return to its normal position after the barbs and / or hooks have engaged the anterior leaflets. This urges the anterior leaflets towards the posterior leaflets, away from the left ventricular outflow tract (LVOT), ensuring that they are not occluded after the procedure. Also shown is a delivery catheter 1520 and a guidewire 1525.

[0191] In another embodiment, the body of the valve replacement may be used to engage the leaflets with the barbs, which expand to a larger diameter than the deployed diameter to ensure engagement with the leaflets. As the device is further deployed, the diameter of the engagement portion decreases to its final configuration - symmetric or asymmetric - thereby drawing the leaflets towards the device and away from the LVOT.

[0192] FIG 15B is a schematic diagram of one embodiment of the adapter attachment disclosed herein, showing the final configuration of the adapter in its original position after release, where the anterior leaflet is pulled and held towards the posterior leaflet to ensure no obstruction of the LVOT.

[0193] 16A and 16B are schematic illustrations of several embodiments of the valve replacement disclosed herein. FIG. 16A shows a top view of the valve replacement, and FIG. 16B shows a bottom view of the valve replacement. As shown in FIG. 16A and 16B, the inflow end of the valve replacement can include an anchor retraction cord that passes through the flow section and is anchored to the underside of the flange (the outflow end is the opposite end from the inflow end as shown in FIG. 16A). These sutures allow control of the anchor by pulling and releasing the cord. Alternatively, the sutures can be releasably attached to the delivery system to provide similar manipulation of the anchor. FIG. 16B further discloses a cord attached to the anchor. FIG. 16C and FIG. 16D show a collapsible flange attachment configuration.

[0194] 17A-17D are schematic diagrams illustrating several embodiments of the valve replacement disclosed herein. They show attachment configurations for the collapsible anchors and clips, and also disclose close-up views of the suture patterns used to collapse and control the anchors from all angles of the valve replacement. In these embodiments, a delivery component, including one or more sutures, is connected at a first end to an engagement attachment, and the one or more sutures are connected at a second end to a control mechanism.

[0195] (Valve Assembly)

[0196] 18A and 18B show schematics of several embodiments of the valve replacement disclosed herein. As shown in FIG. 18A and 18B, one embodiment of the valve replacement can be manufactured using restraints that hold the adapter frame at a particular dimension while attaching materials that affect device performance. To eliminate the inherent freedom of movement and unpredictability that exists between opposing members of the frame structure when unloaded, a manufacturing technique is disclosed that acts to affect the placement of the braided wire frame. This technique involves restraining the radial expansion of the frame with restraints, for example, threading a number of sutures through or around the structure to hold the structure at a particular dimension other than the unconstrained "free" dimension. In subsequent manufacturing steps, the structure is assembled into an assembly that adopts this new configuration, which is considered to be the final dimension. When the restraints are removed from the braided frame, the braided frame attempts to return to its original "free" dimension - applying additional radial force to the surrounding structure while being restrained at the desired dimension.

[0197] The degree of radial force transferred from the frame to the fabric material can be tailored as required to achieve an optimum combination or performance characteristics. In particular, the strain energy density of the structure can be made more uniform. Greater stiffness (resulting in a better seal) can be achieved with less material, resulting in a lower profile structure. The sutures ultimately bias the structure toward the diameter and height desired for the valve structure.

[0198] 19A and 19B show schematic diagrams of several embodiments of a valve replacement as disclosed herein. FIG. 19A shows schematic diagrams of one embodiment of a valve assembly in which leaflets 1905 are assembled to each other and / or to a frame by suturing. The leaflets are joined at commissure seams 1910 and then sewn, welded, or otherwise attached to commissure posts 1915 (located at the outflow end) and to other points on the frame such as wires or wire crossings or to material attached to the frame (inflow end is opposite outflow end). For example, the leaflets are attached to a cuff and the cuff is attached to the frame. Once assembled, when fluid pressure is increased distally, the leaflets cooperate to close on the outflow side (distal if implanted in a mitral valve) and the leaflets close or coapt in a Y-pattern 1920.

[0199] As shown in FIG. 19B, the valve assembly 1930 includes a braided frame with an outer cuff cover 1935. The cuff on the complete outer frame can function as an extended sealing zone. The abdominal stitch 1940 can be sewn to the frame, but the bellows stitch 1945 is not sewn to the frame. In this embodiment, the distal leaflet ends 1950 are shown coapted to close the valve in a loose Y-shape. In some embodiments, the coaptation (coapte) area of ​​the valve can include some "slack" to ensure sufficient and effective contact between the three leaflets to ensure complete closure of the valve. The leaflets can be composed of tissues such as porcine pericardium or other materials known in the art. In some cases, a valve or part of a valve excised (removed) from an animal can be sewn into the disclosed frame structure.

[0200] FIG. 20 shows a schematic of one embodiment of a valve replacement as disclosed herein. FIG. 20 is a bottom perspective view of a one-piece system including a flange 2005, an adapter body 2010, and a braided wire frame that comprises commissure posts 2015 that are compatible with the leaflets. In some embodiments, the commissure posts 2015 may extend from the valve replacement and its braided wire frame, and in some examples, the commissure posts 2015 may be configured to connect to a non-native leaflet (not shown in FIG. 20, but shown without a reference number in FIGS. 21A-21R). For example, the non-native leaflet may be cut and folded and sewn to the commissure posts 2015, and in some embodiments, may extend or protrude somewhat beyond the plane of the valve replacement and / or its braided wire frame.

[0201] 21A-21I are schematic diagrams illustrating one embodiment of a valve replacement as disclosed herein. The valve replacement embodiment of FIGs. 21A-21I may represent an embodiment of a TMVR system and may be used to perform an embodiment of a method related to TMVR.

[0202] Some TMVR solutions disclosed herein may utilize valve replacement embodiments 2100 and may include several types of fixation. For example, valve replacement embodiments 2100 may feature one or more types of fixation, and in some embodiments, may feature three or more fixation mechanisms. For example, some valve replacement embodiments 2100 may utilize four-point fixation. In some embodiments, such multi-point fixation may be configured to distribute the workload of the implantation across the device by utilizing a combination of fixation mechanisms. In contrast, some conventional devices may use only radial forces (described in more detail below) - essentially relying on "brute force radial forces" - for their positioning, fixation, and sealing.

[0203] For example, one type is a top-annulus fixation. In some embodiments, this can be accomplished by a flange being placed, clamped, or clinched onto the annulus or onto a shelf above the annulus (e.g., the mitral shelf). In some embodiments, the flange can be configured and / or designed to prevent migration into the ventricle and eliminate paravalvular leakage. Another type is a bottom-annulus fixation. By utilizing anchor features, which in some embodiments can be struts 2255, 2260 (described in more detail below), such fixation can provide stability at the medial and lateral positions beneath the native heart valve anatomy in the bottom-annulus region. For example, in some embodiments, the lower annulus anchors function as struts or braces to allow slight movement of the valve replacement with the natural spiral motion of the native heart, but restrain movement of the valve replacement, e.g., to inward and outward positions or directions, or anterior and posterior directions, so that the valve replacement does not migrate into the atrium of the native heart and paravalvular leak does not occur.

[0204] Such sub-annular fixation may also include or be associated with other anchoring features, including leaflet fixation. Other anchoring features may be clips for fixation to native tissue, and thus some embodiments may utilize leaflet clips 2105, 2110. In some embodiments, the struts 2255, 2260 may be longer and project further out from the device than the clips 2105, 2110, with the tips of the struts designed and / or configured to press against and project into the native anatomy (e.g., the trigone area). Meanwhile, in some embodiments, the clips may have a more curved shape, such as a shape that curves upward and inward toward the native leaflets, or a shape otherwise similarly configured to hold the leaflets in place.

[0205] In some embodiments, the anchoring features for securing the native leaflets may be hangers that may hook or capture onto the leaflets, rather than clips 2105, 2110 that clip onto the native leaflets. Such securing may prevent migration into the atrium and control (restrain) the movement of the native leaflets. In some embodiments, the aforementioned leaflet clips 2105, 2110 may be deployed prior to the deployment of the struts 2255, 2260, as described elsewhere herein. Such sub-annular securing may be restrictive enough to prevent, for example, the device embodiment 2100 from migrating into the mitral valve region and leaking, yet loose enough to move with the natural movement of the heart. Such movement may be facilitated by an overlapping wire structure without many rigid securing points, in accordance with other aspects of the present disclosure. In some embodiments, the native leaflets may be captured by leaflet anchors or engagement attachments (e.g., clips) that may hook onto the native leaflets (rather than pinching them) to prevent migration towards the native atrium. In such embodiments, the native leaflets may also be captured by anchoring posts that may transfer compressive loads to the native annulus or native anatomical structures adjacent to the native annulus at the commissure zone below the annulus in the native ventricular region to prevent migration into the native atrium.

[0206] With regard to leaflet anchoring, in some embodiments, different points in the native tissue may be associated with anchoring features. For example, in some embodiments, the valve replacement embodiment 2100 may incorporate four points for anchoring, sealing, and fixation. In the illustrated embodiment, two general points or regions of the native leaflet tissue may be associated with two leaflet anchors or engagement attachments (e.g., clips) 2105, 2110, and two general points or regions of the native tissue may be associated with two anchors or struts 2115, 2120. These multiple anchoring points may provide stability while maintaining the LVOT, prevent perivalvular leakage, and prevent trauma to tissue associated with the native heart wall.

[0207] Such multi-point fixation using valve replacement embodiment 2100 can result in a flexible, compliant valve system that can promote structural stability by maintaining central flow through the valve.

[0208] Another type of fixation is selective radial force fixation. In some embodiments, directional radial force fixation can be controlled via a receiver or adapter to help prevent migration while maintaining the LVOT. In some examples, such radial force can be generated by oversizing the valve frame 2125 (e.g., a nitinol wire frame wrapped or woven around a mandrel) for the annulus hole and forcing it against the wall of the annulus. In some embodiments, the valve frame 2125 can be shaped to be about 10% oversized for the annulus hole while allowing some limited movement. Such radial force fixation can also prevent migration into the atrium and ventricle while maintaining the LVOT.

[0209] Also, as described elsewhere, the natural helical features associated with valve frame embodiment 2125 may be based on a more holistic understanding of the nature of the heart and its motion. For example, such features may be configured to mimic the motion of a healthy heart by using the natural helical structure (as described above) to contract and twist with each beat of the heart.

[0210] Such features may include a braided wire design (as described and illustrated in more detail elsewhere) which, in some embodiments, may provide enhanced flexibility and conformance. Such braided wire design embodiments may be configured to not only accommodate and move with the heart, but also be tolerant of anatomical anomalies (e.g., by incorporating a variety of different wire thicknesses and braid designs) and conform (mimic) the various densities and properties (i.e., radial forces and expansion) of the cardiac anatomy.

[0211] Additionally, braided wire design embodiments may leverage the strength of Nitinol through geometry and unique braided wire structure. In some embodiments, such structures may purposely omit fixation nodes at the wire intersections, allowing the braided wires to move relative to one another in a controlled manner. Such features may help the replacement valve move with the natural spiral motion of the heart. Some braided wire design embodiments may also facilitate placement in the native heart, maximize a seal in the human anatomy, and prevent undesired movement with an integrated and optimized new fixation system. Thus, such features may be designed with the recognition that the mitral valve is not simply a structure to be "stented."

[0212] In contrast, earlier valve frame designs by others (e.g., centered laser-cut nitinol on a lattice) did not feature such a helical structure or were not configured to allow similar dynamic movement. Rather, such conventional designs were often limited to fixed nodes throughout the lattice design and did not allow for the use of a variety of wire gauges, thereby preventing the flexibility and adaptability required for the human heart.

[0213] These different fixation aspects (as discussed above) may help distribute the workload of valve replacement embodiment 2100 (e.g., during implantation) throughout the device 2100, providing maximum stability while preserving the LVOT and preventing peripheral leakage and trauma to the native heart wall. Additionally, such multiple fixation aspects and multi-point anchoring systems may enable methods that allow for a simpler and safer approach to transcatheter mitral valve replacement (as described herein), resulting in a safer overall procedure for the patient.

[0214] Figures 21J-21M show a schematic of one embodiment 2100a of a valve replacement as disclosed herein. Similar to the valve replacement embodiment 2100 shown in Figures 21A-21I, the valve replacement 2100a may have two leaflet clips (e.g., leaflet clips 2105, 2110) and two anchors (e.g., anchors 2115, 2120) for fastening to native heart tissue. Unlike the flange embodiment shown in Figures 21A-21I, which may be characterized by a flatter surface and a more right-angled transition point or region, the flange embodiment shown in Figures 21J-21S may have a more curved or more funnel-like shape, where the transition point or region corresponding to the annulus may continue further down into the mitral valve, where it may bend and be pushed outward to fill the gap between the valve surface and the native anatomy. In some valve replacement embodiments, the transition region may be between a flat flange portion (which may be configured to sit on top of the annulus in the atrium) that includes and includes a ring of funnel-shaped contour of the flange, and an adapter portion that is extruded radially into the annulus. Such contoured transition portion may help promote central vortex flow, providing improved sealing performance and anchoring. The funnel-shaped portion may have a shape-setting braided wire and material covering that is contoured and configured to fill the gap between the native anatomy and the transition region (between the annulus toward the atrial and ventricular regions).

[0215] Figures 21N-21R show schematic diagrams of one embodiment 2100a of a valve replacement as disclosed herein. Similar to valve replacement embodiment 2100 shown in Figures 21A-21I and valve replacement embodiment 2100a shown in Figures 21J-21M, valve replacement 2100b may have two leaflet clips (e.g., leaflet clips 2105, 2110) and two anchors (e.g., anchors 2115, 2120) for fastening to native heart tissue, although valve replacement 2100b may have different material layers, may be of a different design, and may cover less than the entire surface area of ​​valve replacement 2100a.

[0216] Delivery Method Embodiments

[0217] 22A-26B may illustrate a method and / or system for delivering a valve replacement incorporating an embodiment of the valve replacement, such as valve replacement embodiment 2100. In some examples, the method and / or system may include placing a two-piece adapter and MLS together as one piece and loading them together into a delivery system, according to some aspects of the disclosure and as described below. Some method embodiments may also be applied to a one-piece device that comprises both the adapter and the MLS as a single device.

[0218] As an initial step in the method embodiments described herein, a sheathed valve / implant 2215 may be positioned above the mitral valve via a transseptal procedure. For example, FIG. 22A shows a transseptal puncture 2200 (e.g., in the transfemoral region) through which a guidewire 2205 may enter the left atrium 2210. The guidewire 2205 may be used by the method and / or system to aid in the delivery of valve replacement embodiments, such as valve replacement embodiment 2100.

[0219] The methods and / or systems described herein may allow for a large surface area of ​​motion and may allow for bending / deflection of the guidewire (and / or other delivery system components) in several directions, such as medial and lateral and anterior and posterior. Using such orientations, the guidewire 2205 may advance into the mitral valve 2220.

[0220] FIG. 22B shows the sheathed valve / implant 2215 entering the atrium 2210 along the guidewire 2205.

[0221] Following the guidewire 2205, the sheathed valve / implant 2215 can be centered above the mitral valve 2220 and advanced over the wire 2205 into the ventricle 2225. Some embodiments of the delivery methods described herein can also include verifying that there is clearance above the mitral valve 2220 and that there is a proper bend for movement before advancing further down. In some examples, the method can include tracking the sheathed valve / implant 2215 as it moves down through the native heart structure.

[0222] 23A, the sheathed valve / implant 2215 may then be moved down through the septal puncture into the ventricle 2230. Some method embodiments may include inspecting the path or trajectory before moving further into the ventricle 2230, retracting, and then returning to move further down into the ventricle 2230 to ensure that the path is not obstructed and that the correct path has been selected.

[0223] 23B is a view from the ventricular perspective showing the sheathed valve / implant 2215 moving further down into the ventricle 2225 / 2230 for deployment of the annulus sub-anchor. In some embodiments, the anterior clip 2235 may be released or extended prior to moving down to determine its position relative to the 360° of the device 2215. Then, based on the determined position of the anterior clip 2235, it may be oriented or aligned with the position of the anterior leaflet 2240 as the device 2215 (including the implant) is advanced into the ventricle.

[0224] In some embodiments, after entering the ventricle 2225, the anterior clip 2235 (which may also be referred to as the A2 clip 2235) may be removed from the sheath and aligned with the anterior leaflet 2240. Then, after entry into the ventricle is complete, the anterior clip 2235 may be gently slid over the surface of the anterior leaflet 2240 to a predetermined position (e.g., the A2 region) to secure the anterior leaflet 2240. In some embodiments, the position may include a position where the anterior leaflet 2240 is behind the anterior clip 2235. The anterior clip 2235 can be used to wrap the anterior leaflet 2240, and in some embodiments, the anterior leaflet 2240 can also be secured, which can include the anterior clip 2235 gripping the anterior leaflet 2240 and / or a particular region thereof (e.g., the A2 region) to provide sub-annular securement and prevent migration of the valve replacement into the atrium.

[0225] Then, once the anterior leaflet 2240 is secured within the anterior clip 2235, the posterior clip 2245 (which may also be referred to as the P2 clip 2245) may be removed or released from the sheath and proximate to the posterior leaflet 2250. In some embodiments, the posterior clip 2245 may be used to encapsulate the posterior leaflet 2250, which in some embodiments may also be secured, which may include the aspect that the posterior clip 2245 grips the posterior leaflet 2250 and / or certain regions thereof (e.g., the P2 region) to provide sub-annular securement and prevent migration of the valve replacement into the atrium.

[0226] Fixation of both the anterior 2240 and posterior 2250 leaflets may prevent the native leaflets 2240, 2250 from interfering with the function of the new valve 2265. The new valve 2265 may be a prosthetic or bovine valve. Once both clips 2235, 2245 are secured in the proper position (within the intercommissural space, i.e., in the commissure-commissural space), the device 2215 may be pulled back slightly toward the atrium 2230. In some embodiments, the clips 2235, 2245 provide fixation by having their distal ends (the free ends opposite to where they are attached to the valve replacement) press against the underside of the annulus, preventing dislodging or migration of the valve replacement.

[0227] In some embodiments, the clips 2235, 2245 may include two vertical small loop structures configured to open and close and connect with the leaflets 2240, 2250, thereby enveloping (not necessarily "sandwiching") the leaflets 2240, 2250. In this manner, for example, the clips 2235, 2245 may envelop the anterior leaflet 2240 (which may be closer to the aortic valve 2405) and the posterior leaflet 2250, and / or portions thereof. In some embodiments, the anterior clip 2235 may be an A2 clip for securing the A2 anterior region of the anterior leaflet 2240, and the posterior clip 2245 may be a P2 clip for securing the posterior region or a particular portion thereof. In some embodiments, enveloping the native leaflets 2240, 2250 in these regions may provide a particularly desirable form of fixation (although other forms are contemplated).

[0228] FIG. 24A illustrates a schematic representation of one embodiment of a valve replacement as disclosed herein. FIG. 24B also illustrates a schematic representation of one embodiment of a valve replacement as disclosed herein. Relatedly, method embodiments as disclosed herein may further comprise releasing the inner and outer strut anchors 2255, 2260 as shown in FIG. 24A and FIG. 24B. Some method embodiments may include first pulling the device 2215 up toward the atrium and determining or verifying that the strut anchors 2255, 2260 are below the annulus 2265 and not within the atrium 2230. Some aspects of such determination may include, for example, using echo techniques, locating the tip of the anchor using 3D and / or 2D images, and / or otherwise locating the anchor (relative to the "shelf" as further described below).

[0229] In some embodiments, the clips 2235, 2245 may be released or extended based on some trigger mechanism controlled by the operator, which may include, for example, pulling on some type of (e.g., first) string.

[0230] 24A shows the inner anchor 2260 and the outer anchor 2255 with the sheaths removed. In some embodiments, the extended or released inner anchor 2260 and the outer anchor 2255 may be anchored to the trigone region of the native tissue (which may be proximate to the anterior region of the lower annulus of the native heart) or may remain within and may reside between the chordae tendineae. In some embodiments, there may be a desired target region of the native tissue for the anchor. For example, the inner anchor 2260 may be positioned on or within the inner region 2275 of the native heart tissue, while the outer anchor 2255 may be positioned on or within the outer region 2280 of the native heart tissue.

[0231] In some embodiments, the distance or diameter from the inner anchor 2255 and outer anchor 2260 to the anterior clip 2235 and posterior clip 2245 can range from 65° to 115° from each other, not necessarily 90°, and in some embodiments, about 75°. In some examples, the design of the device 2215 can be such that the inner and outer anchors 2255, 2260 and the anterior and posterior clips 2235, 2245 are spaced apart, and the inner and outer anchors 2260, 225 can be aligned to the appropriate pre-designated position for the anchors by appropriately gripping the anterior and posterior leaflets 2240, 2250 using the clips 2235, 2245. Thus, removing the anchors 2255, 2260 from the sheath can help achieve complete fixation on the ventricular side.

[0232] In some embodiments, the operator may control many aspects of delivery, as well as the movement and orientation of the guidewire 2205 and device 2215, as well as the release and sheath removal (and sequence) of the clips 2235, 2245 and anchors 2255, 2260. The relative simplicity associated with and deployment of such processes is expected to allow for a broad group of qualified operators. In some embodiments, the anchors 2255, 2260 may also be released or extended based on some type of trigger mechanism controlled by the operator, which may include, for example, pulling some type of (e.g., second) string.

[0233] Embodiments of the delivery methods described herein may also include removing the sheath from the flange 2500 within the annular body 2505 on the atrial side 2510, as shown in FIG. 25A (rear perspective view). In some embodiments, deployment of the flange 2500 may be triggered by or occur in conjunction with retracting or removing the sheath 2515.

[0234] As shown in Fig. 25B, releasing and deploying the flange 2500 may clamp the flange 2500 onto the annulus 2505 and / or onto the ledge or just above the annulus 2505. In a sense, this may help to pinch or trap the annulus 2505 between the flange 2500 and the anchors 2255, 2260 and clips 2235, 2245 (see other figures, especially shown in Fig. 24), thereby creating a higher level of fixation while allowing an acceptable range of movement. (For example, as previously mentioned, the device may move with the contraction of the heart, not only with the contraction of the heart, but also with the twisting of the heart.) Such fixation may help prevent the device 2215 and its components from being inadvertently injected or dislodged into the atrium 2230 / ventricle 2225 (see Fig. 24).

[0235] Then, once the device 2215 is in place as previously described, the tube can be withdrawn and the guidewire removed, as shown in FIG.

[0236] Figures 25C-25E illustrate schematic diagrams of several embodiments of the valve replacement disclosed herein, and Figures 25F-25H illustrate schematic diagrams of one embodiment of a wire frame for the valve replacement disclosed herein.

[0237] In particular, Figures 25C-25E show one embodiment of the valve replacement flange 2515. The flange 2515 may have a contoured "funnel" shape that fits over the toroid (as opposed to a "top hat" shaped flange with a right angle transition).

[0238] The frame of the flange 2515 may include one or more wires. For example, one embodiment may feature a flange 2515 having multiple (e.g., three) wires, as shown in Figures 25F-25H, and may have a braided construction, aspects of which may be similar to the braided constructions described elsewhere in this disclosure. In some examples, the wires of the flange may form looped petals and terminate in an outer ring 2525. In some embodiments, the petals may be uniform and shaped to a predetermined arrangement corresponding to the anatomy.

[0239] The angle between the intersections 2520 of the outer ring 2525 may vary. In embodiments where the angle is larger (potentially fewer wires), the braid may require increased wire contact against the toroid, which may have a longer overall compressed length. In some such embodiments, the contact with the toroid may be straighter, stiffer, and / or stronger, resulting in a shorter overall compressed length.

[0240] Some flange 2515 embodiments and other related features can be created to have a specific desired shape using a tool or shape-setting process. The shape-setting tool can be derived from carefully constructed geometric surfaces to optimally interact with the diseased mitral annulus. In one such technique, the flange tip can be forced inward (towards the center of the implant). This can buckle the wire in a controlled manner, minimizing the triangular gap between the wire annulus.

[0241] In some examples, the flange 2515 may be manufactured using a layer of material 2530 (e.g., a "one-piece sock"), a contoured ring 2535 (with or without grooves), a contoured nesting ring 2540 (with or without grooves), and a top plate 2545 with a D-shaped perimeter shelf 2550. Such components may be assembled onto a cylindrical mandrel 2555 using locator pins to together control wire buckling. The D-shaped perimeter 2550 may be configured to (optimally) seal the annulus and provide more coverage, especially at and medial to the natural commissures. In some embodiments, the braid itself and the D-shaped perimeter 2550 may provide transition areas for anatomical features, for example, with localized flexibility to accommodate the aortic mitral curtain or LVOT. Additionally, in some embodiments, the straight sides of the "D" of the D-shaped perimeter 2550 may be configured so as not to block or compress native anatomy and not to interrupt blood flow circulation in the aortic pathway. In some embodiments, the tool for constructing the flange 2515 may include a top plate and nested contoured rings to create a transition zone. In some embodiments, prior to shaping the flange, the petals of the flange (or end loops of the flange) may be braided to be shorter than the other petals or ends of the flange at the D-shaped perimeter, for example, to accommodate the LVOT or aortic-mitral curtain.

[0242] In some embodiments, the layer of material 2530 may cover at least a portion or all of the flange 2515. In some embodiments, the top plate 2545, the first contour ring 2535, and the second contour ring 2540 may each have a lower surface, which in some examples may be covered by the layer of material 2530. In some embodiments, at least one of the lower surface of the top plate 2545, the lower surface of the first contour ring 2535, and the lower surface of the second contour ring 2540 may be configured to contact at least a portion of the native tissue, due in part to the braid structures and orientations described herein, to reduce gaps between the native tissue and a valve replacement incorporating the flange 2515.

[0243] In some embodiments, the first contour ring 2535 can have a particular pattern or contour and the second contour ring 2540 can have a pattern or contour that can be different from one another. Additionally, in some embodiments, the second contour ring 2540 can have an outer edge and an inner edge. In some examples, the outer edge of the second contour ring 2540 can be adjacent to the first contour ring 2535 (and, for example, its inner edge). In some examples, the inner edge of the second contour ring 2540 can be adjacent to the cylindrical mandrel 2555 or the heart valve adaptor frame.

[0244] As shown in Figures 25D and 25G, the flange 2515 may also include one or more tabs 260 (eg, three as shown) to help hold the MLS in place.

[0245] (Embodiment of the valve restoration method)

[0246] Also disclosed herein is a method of replacing a valve, which may be referred to as "restivalvulcation." Embodiments of the restivalvulcation method may offer advantages over existing valve replacement methods. For example, a typical "valve-on-valve" procedure essentially crushes and destroys the old valve in order to install a new valve. While such methods are better than no option for patients in need of valve replacement, they do come with certain drawbacks. In particular, space is extremely limited across the cardiac leaflets and annulus area. Thus, stacking multiple devices or structures across the leaflets or within the annulus of the native cardiac valve results in a loss of available cardiac area for therapy and natural cardiac function.

[0247] Limited areas of native tissue in and around the mitral valve region can be maintained according to the methods described herein. Furthermore, according to aspects of the present disclosure described below, revalvulation is more likely to be performed safely in younger population groups, thereby expanding the currently projected number of patients who may currently be treated with TMVR.

[0248] One revalvulation method embodiment for replacing a valve (e.g., 2215) may require both transapical and transseptal access. A replacement valve body or replacement MLS may be delivered transseptally to the heart valve to be replaced. For example, as shown in Figures 22A and 22B and 26, a guidewire 2605 may be inserted and advanced through a transseptal puncture 2610 and used to advance a catheter 2615 and a new MLS (not shown).

[0249] Unlike the delivery method embodiments described above, which involve delivering the entire device embodiment 2215, only the new MLS / replacement valve itself may need to be delivered through the transseptal puncture 2610 within a sheath or catheter 2615.

[0250] Some restavulsion method embodiments may include maintaining vigilance during advancement to ensure that the existing leaflet structure 262 is cleared and / or that the guidewire 2605 is not inadvertently (mistakenly) placed in the wrong path within the native heart. In some method embodiments, the sheath or catheter 2615 may then be positioned over the existing implant within the native heart valve.

[0251] As shown in FIG. 27, the guidewire 2605 may then be externally (transapically) removed from the transapical sheath 2730 to form a line or "rail" from transseptal to transapical. This guidewire / rail 2605 may allow removal of the old MLS 2215 and delivery of a new MLS (not shown) from the same wire. Using the same rail for both removal and delivery ensures that both actions are performed in the same plane, providing advantages that are readily apparent to the ordinarily skilled technician. For example, a replacement procedure using the rail 2605 would allow manipulation from both ends of the rail 2605. This procedure also results in a less invasive procedure, with less abrasion and dissection of native tissue, and no risk of crossed wires.

[0252] Thus, in addition to transseptal access to the implant, some revalvulation embodiments may also include transapical access to the implant. Some embodiments may include determining that a revalvulation device (such as the MLS removal device 2805 shown in FIG. 28A) is not entangled within the chordae tendineae 2735, for example, by advancing a transapical sheath 2730 toward the valve opening near the annulus.

[0253] Some revalvulation embodiments may also include orienting markers on the catheter 2715 to align with tabs 2740 on the old valve / MLS 2215. Such orientation or alignment may be performed using, for example, endoscopy / fluoroscopy or "snaring" techniques, which may include "loop and lasso" and other methods known to those of skill in the relevant art.

[0254] FIG. 28A illustrates the process of gripping the tabs 2740 of the old MLS 2215. In some exemplary aspects (not exhaustive or limiting) of removing the old MLS 2215, multiple markers may be placed on the tabs 2740, on some features of the valve 2215, and on the hooks or graspers 2805 of the grabber 2810 (as shown in FIG. 28G). One non-limiting embodiment (shown) may feature three tabs 2740 for removing the old MLS 2215. Another non-limiting embodiment (not shown) may feature one tab configured to be gripped. In the revalvulcanization method embodiments described herein for transapical removal of the old MLS 2215, other embodiments may be implemented. This disclosure is not intended to limit method embodiments to a single aspect of transapical removal.

[0255] Once in the proper position, the grasper 2805 may be released and inserted into the spot of the tab 2740 to snare or grasp the tab. Some method embodiments may also include turning on suction to capture unwanted and potentially harmful debris to prevent the occurrence of a cerebral embolism and / or stroke. The grasper 2805 may then be ready to pull on the tab 2740 to remove the old MLS 2215. In some embodiments, such steps may be performed by the first operator.

[0256] At the same time that the old MLS / valve 2215 is ready to be removed, new leaflets can be put into position for delivery / placement as part of a new MLS 2720 on the transseptal or atrial side, as shown in Figures 28B and 28C. In some embodiments, such a step on the transseptal side can be performed by a second operator.

[0257] The grasper 2805 may then pull the tab 2740 to remove the old MLS 2215, as shown in FIG. 28D. This may be done essentially simultaneously as the new MLS 2720 is advanced into place, as shown in FIG. 28B, after which the sheath 2615 may be released, as shown in FIG. 28C and FIG. 28E, to allow the new MLS 2720 and flange 2815 to radially expand, as shown in FIG. 28F. In some embodiments, the replacement of the old MLS 2215 with the new MLS 2720 may be done quickly to reduce complications such as regurgitation. Thus, as the new valve MLS 2720 is advanced into place from the transseptal side, the old valve MLS 2215 may be pulled / pulled down from the transapical side, thereby "restivalvulating."

[0258] Some such revalvulization embodiments may include pacing (e.g., rapid pacing and resting the heart) or non-pacing and deceleration of the heart (such as may be used for valve-on-valve procedures). Some method embodiments may include the use of backstop tabs (to backstop the new MLS2720 from going too deep into the atrium) and the use of positive pressure.

[0259] Specifically, after the old MLS 2215 and potentially associated structures are removed transapically as shown in FIG. 29B, the catheter 2615 and guidewire 2605 are also removed transseptally as shown in FIG. 30A-30D. One advantage of revalvulation using a two-piece system is that replacement of the old MLS / internal valve 2215 does not require tearing away native tissue as collateral damage. While it may involve tearing away fibers of the adapter, the lost fibers can be immediately or quickly sealed back with the new MLS 2720. Thus, the adapter can remain in place while the old / new MLS 2215, 2720 (for example) are replaced, as in some aspects of the anchor system (which may function as a new annulus functionally).

[0260] In some embodiments, the new MLS2720 may have a different design in one or more aspects than the old MLS2215. For example, the predetermined oversize of the new MLS2720 may differ based on different needs, purposes, or adapter dimensions that have changed over time. Thus, embodiments of the methods described herein may feature customizable radial forces.

[0261] In further embodiments, revalvulation may be performed solely via a transseptal approach on the atrial side of the heart, without the need for a transapical catheter approach from the ventricular side, by removing the old MLS and inserting the new MLS through it with the same transseptal catheter system in the atrium of the native heart. In other embodiments, instead of removing the old MLS, a new MLS is inserted into the old MLS via a "valve-in-valve" procedure, which may be performed transapically or transseptally. In these embodiments, the new MLS is designed with an oversized, shaped helical braid pattern with sufficient outward radial force when deployed within the existing MLS, such that the new MLS frame displaces the old MLS and creates space within the annulus for the new MLS to function properly within the annulus.

[0262] (Embodiment of anchor fixing)

[0263] The following describes several embodiments that may feature one or more of: (1) upper toroid fixation, (2) lower toroid fixation, (3) leaflet fixation, and / or (4) radial force fixation. Each of these embodiments may be embodied as a one-piece or two-piece system.

[0264] 31A-31F are schematic diagrams illustrating one embodiment of a valve replacement as disclosed herein. FIGs. 31A-31F illustrate a device embodiment 3100 that uses two anchoring features or clips 3105, 3110. In some examples, the device embodiment 3100 may function similarly to the device 2215 previously described and illustrated in terms of delivery and operation, but without the anchors and the previously described steps associated with such anchors. For example, two leaflet clips 3105, 3110 may be configured to attach and / or secure to different regions of native tissue, such as a leaflet.

[0265] 32A-32F show a schematic of one embodiment of a valve replacement as disclosed herein. FIG. 32A-32F show a device embodiment 3200 using two clips 3205, 3210 as previously described without anchoring posts, but the two leaflet clips 3205, 3210 are each substantially wider (and in some embodiments substantially twice as wide) than the two leaflet clips 3105, 3110 illustrated for device 3100. For example, the two leaflet clips 3205, 3210 may be configured to attach and / or secure to different regions of native tissue, such as a leaflet. For example, in some embodiments, the two wider leaflet clips 3205, 3210 may grip and secure a much larger area (or a larger area) of the native leaflet, such as the A2 anterior region or the P2 posterior region.

[0266] 33A-33F are schematic diagrams illustrating one embodiment of a valve replacement as disclosed herein. FIGs. 33A-33F illustrate an embodiment 3300 of a device including four clips 3305, 3310, 3315, 3320, but no anchors. In some embodiments, the four clips 3305, 3310, 3315, 3320 may each be configured to attach and / or secure to a different predetermined region of native tissue, such as a leaflet and its region. In some embodiments, at least two of the four leaflet clips 3305, 3310, 3315, 3320 may be configured to secure an anterior leaflet region (e.g., 3320 and 3315 may be attached to either side of the A2 anterior leaflet region) and a posterior leaflet region (e.g., 3305 and 3310 may be attached to either side of the P2 posterior leaflet region).

[0267] Figures 34A-34C are schematic diagrams illustrating one embodiment of a valve replacement as disclosed herein, showing an embodiment 3400 of the device (i.e., the "Dragonfly") with two leaflet clips 3410, 3425 and four anchor posts (two inner posts 3405, 3430 and two outer posts 3415, 3420).

[0268] In some embodiments, the clips and anchors may each be configured to anchor to a different predetermined region of the native tissue, such as the leaflets, the intercommissural region, and under the chordae tendineae, respectively. In some examples, the clips 3410, 3425 may be configured to clip to a specific region of the native leaflets, for example, the clips 3410, 3425 may be attached around and around the native anterior and posterior leaflets in the A2 and P2 regions, respectively, and the anchor posts may be positioned adjacent and under the anterior leaflets (anchors 3405, 3415) and posterior leaflets (anchors 3430, 3420). In some embodiments, the clips and anchors may each be configured to anchor to a different predetermined region of the native tissue, such as the leaflets, the intercommissural region, and under the chordae tendineae, respectively. For example, the clips may be configured to clip to a specific region of the native leaflets, for example, the anterior 2 region or the posterior 2 region, respectively. As a further example, the anchors may be configured to be positioned and anchored to the native heart trigone region, intercommissural region, under the leaflets, and / or under the chordae tendineae near the annulus of a native heart valve (e.g., mitral, tricuspid, or aortic valve) to be treated.

[0269] (Implant Delivery Device)

[0270] 35 illustrates an embodiment 3500 of an implant delivery catheter according to aspects of the present disclosure. The catheter 3500 can have a proximal end 3505 and a distal end 3510. In some embodiments, the distal end 3510 can include a nosecone 3515. In some embodiments, below the nosecone 3515 can be a steerable end of the catheter system.

[0271] Between the distal end 3510 and the proximal end 3505 there can be a liner 3525 connected to the steerable end 3520. In some embodiments, the liner 3525 can be connected to an implant steering knob 3530 at the proximal end 3505. In some embodiments, the proximal end 3505 can also include a pullwire slider 3535. Also, in some embodiments, there can be an implant shaft depth indicator 3540 between the pullwire slider 3535 and the implant steering knob 3530.

[0272] FIG. 36 illustrates a tethered implant catheter embodiment 3600 according to aspects of the disclosure. The tethered implant catheter embodiment 3600 may be similar in some respects to the implant catheter embodiment 3500 of FIG. 35. For example, the catheter 3600 may also have a proximal end 3505a and a distal end 3510a. The distal end 3510a may include a nose cone 3515a, which may be connected (towards the proximal end 3505a) to a steering catheter 3520a. The steering catheter 3520a may be connected (towards the proximal end 3505a) to a liner 3525a. In some embodiments, the liner 3525a may be connected (towards the proximal end 3505a) to a guide insertion lock 3605. In some embodiments, there may be a pull wire lock 3610 from the guide insertion lock 3605 to the proximal end 3505a. Also, from the pull wire lock 3610 towards the proximal end 3505a, there may be a suture locking solution 3615.

[0273] 37 illustrates a sheathed implant catheter embodiment 3700 according to aspects of the disclosure. In some embodiments, the sheathed implant catheter embodiment 3700 can have a proximal end 3735 and a distal end 3740. Near the proximal end 3735 there can be a sheath steering knob 3705. In some embodiments, the sheath steering knob 3705 can facilitate steering in two directions relative to a single plane. From the sheath steering knob 3705 towards the distal end 3740 there can be a sheath retrieval handle 3710, which can include a knob.

[0274] The sheathed implant catheter embodiment 3700 may also have a nosecone retrieval handle 3730 near the distal end 3740, which may include a color-coded knob. From the nosecone retrieval handle 3730 to the proximal end 3735 may be a steering knob 3725, which in some embodiments may be configured for steering in two directions on a single plane. From the steering knob 3725 to the proximal end 3735 may be a retrieval handle 3720, which may include a knob.

[0275] Between the distal end 3740 (with the nose cone retrieval feature 3730 and / or chock steering feature 3725) and the proximal end 3735 (with the sheath steering feature 3705) there may be a cradle clamp 3715. In some embodiments, the cradle clamp 3715 may comprise essentially a single horizontal point or a single point cylindrical loop along the outside of the sheathed implant catheter embodiment 3700.

[0276] FIG 38 illustrates a sheathed implant embodiment 3800 in accordance with aspects of the present disclosure. More specifically, FIG 38 illustrates, in some respects, how the sheathed implant embodiment 3800 performs the movements associated with positioning and delivery of a valve replacement. The sheathed implant embodiment 3800 can have a nose cone retriever 3805 on one end.

[0277] In some embodiments, the sheathed implant embodiment 3800 may have features for steering in two planes. Additional features may allow for removal and re-sheathing of the sheath.

[0278] 39 illustrates a schematic of one embodiment 3900 of a two-piece assembly according to aspects of the present disclosure. The two-piece preparation assembly embodiment 3900 can have a proximal end 3910 and a distal end 3905. At the distal end 3905 can be a nose cone 3915, which in some embodiments can be connected to a distal suture 3920.

[0279] In some examples, the two-piece prep assembly embodiment 3900 may have a generally cylindrical shape and may require multiple layers and / or internal components. In some embodiments, the layers may vary from one side (e.g., proximal end 3910) to the other side (e.g., distal end 3905) of the two-piece prep assembly embodiment 3900 and may vary depending on the manipulation and deployment sequence. That is, the cross-sections of the layers and components at specific lateral points of the assembly embodiment 3900 may be different at different times. In some embodiments, the assembly embodiment 3900 may include a hypotube through which the distal suture 3920 may pass at or near the distal end 3905. Also, near the distal end 3905, the outer layer may include an adaptor 3925, inside which may be a valve 3930, and above which may be disposed a valve sheath 3935.

[0280] The assembly embodiment 3900 may include one or more lumens between layers, such as an inner multi-lumen 3940 inside the valve 3930, and an outer multi-lumen 3945. Outside the outer multi-lumen 3945, possibly on the proximal end 3910, there may be a retractable guide sheath 3950. Inside the outer multi-lumen 3945, flange sutures 3955 may be housed. The flange sutures 3955 may assist in releasing the flanges. Inside the inner multi-lumen 3940, there may be an intermediate suture 3960. Above the inner multi-lumen, there may be a steering catheter 3965. Inside the adapter 3925, there may be a pull wire 3970, which in some embodiments may assist in performing or triggering operations according to various aspects of the present disclosure.

[0281]

[00111] Figure 40 illustrates in greater detail certain aspects of an embodiment 3900a of the two-piece assembly of Figure 39 according to aspects of the present disclosure. Figure 40 illustrates a tethered layout of the two-piece valve.

[0282] In some embodiments, the outer multi-lumen 3945a may use three sutures 4000 (which may also be referred to as flange sutures 4000) to control the flange (and its release or extension). In some embodiments, the inner multi-lumen 3940a may use three sutures 4005 (which may also be referred to as middle sutures 4005) to control the middle suture. At the distal end 3905a there may be a pull wire 4010. Also at the distal end 3905a there may be a distal suture set 3920a (which may also be referred to as distal sutures 3920a), which may pass through a hypotube.

[0283] The two-piece assembly embodiment 3900a may connect various sutures 4000, 4005 with an anchor suture loop 4015. The anchor suture loop 4015 may be disposed towards the distal end 3905a.

[0284] Also described herein is a sequence of use, for example, for deploying the two-piece assembly embodiment 3900, 3900a, including (1) a starting configuration, (2) a pre-valvulation procedure step to advance an adaptor (e.g., adaptor 3925), (3) another pre-valvulation procedure step to advance a valve (e.g., valve 3930), (4) a further pre-valvulation procedure step to release the valve (e.g., valve 3930), (5) a further pre-valvulation procedure step to size the valve, (6) a deployment procedure step including positioning, (7) a deployment procedure step to extend and deploy anchors, (8) a deployment procedure step of final positioning, and (9) a step of de-deploying the delivery system and removing the delivery system itself. Some aspects of the sequence may be similar to the valve delivery methods described in the previous disclosure. As with other methods described in this disclosure, some sequences of steps and / or details thereof described below may be altered in operative order, may be unnecessary (omitted) in some embodiments, and / or may be further combined in some aspects.

[0285] FIG 41A illustrates a starting configuration according to various aspects of the present disclosure. As shown in FIG 41A, the distal end 4105 of the guide catheter / sheath 4110 must cross the septum 4120 to break through the space of the atrium 4125. In some embodiments, the distal end 4105 of the guide catheter / sheath 4110 can be deflected between 0° and 30° upon entry.

[0286] 41B and 42 each illustrate a pre-valving procedure step of advancing an adaptor 4225 (e.g., adaptor 3925). As shown in FIG. 41B, the shaft 4115 of the delivery system 4120 (which may be associated with an adaptor in some embodiments) may also be advanced to the distal end 4105 of the guide catheter / sheath 4110.

[0287] Also, as shown in FIG. 42, the adaptor 4225 may be advanced until it is completely within the atrium 4120 (as shown in FIG. 41B). In some embodiments, the adaptor 4225 may be advanced in a range of about 3-7 cm, and in some examples, about 5 cm. In some embodiments, this distance may correspond to approximately the length L of the adaptor 4225. In some examples, the length L of the adaptor 4225 may be associated with a portion that extends from anterior to the distal suture 4205 region to posterior to the portion associated with the middle suture 4210 (e.g., away from the distal suture 4205). During the pre-valvulation / delivery procedure, an MLS or replacement MLS may be loaded onto or into the catheter / sheath 4110 on either side (anterior or posterior) of the adaptor 4225.

[0288] Similar in some respects to the distal suture 3920, 3920a of the two-piece assembly embodiment 3900, 3900a, the adapter 4225 may have a distal suture 4205 with three suture sets. Similar in some respects to the middle suture 4005, 4005a, the adapter 4225 may also have a middle suture 4210 with three suture sets. Similar in some respects to the flange suture 3955, the adapter 4200 or guide catheter 4230 may also have a flange (or flange restraining) suture 4215 with three suture sets.

[0289] In some embodiments, appropriate tension in the flange restraining suture 4215 can help allow the proximal edge of the flange to expand to a larger diameter than the guide catheter 4230 (which can be similar in some respects to the guide catheter 3925).

[0290] The flange sutures 4215 can be tightened to secure the adapter 4225 to the distal end 4220 of the guide catheter 4230. The tension of the flange retention sutures 4215 can also be used to activate and / or hold other features in place (e.g., tabs and anchor features) and can also be used to prevent some features from blocking the valve passageway.

[0291] FIG. 43 shows a pre-valvulation procedure step for advancing the valve replacement 4300. The valve 4300 can be covered by a valve sheath 4305. In some embodiments, the valve sheath 4305 and the sheathed valve replacement can be advanced over the inner multi-lumen 4315 after being pushed by a steerable catheter sheath 4310. In a pre-valvulation embodiment, the steerable catheter sheath 4310 is advanced under the folded flange portion of the valve replacement, thereby shortening the effective length of the delivery system and maximizing the space required within the atrium to effectively deliver the replacement valve. Additionally, as the valve 4300 is advanced, the midline suture 4210a can be pushed distally (out of the inner multi-lumen). Tension can also be maintained in the flange retaining suture 4215a to keep the adapter 4225a firmly positioned on the end of the guide catheter 4230a. The midline suture 4210a may have a moderate amount of slack, but the distal retention suture 4205a may need to be loosened to allow the distal end of the valve 4300 to protrude beyond the distal end of the receiver 4320. Once the distal end of the valve 4300 reaches or passes a tab (not shown), the valve 4300 may be fully inserted into the receiver 4320 portion of the adapter 4225a.

[0292] 44 illustrates a pre-valvulation procedure that may include the step of releasing the valve 4300a. For example, the sheath 4305a over the valve 4300a may be retracted. In some embodiments, the sheath 4305a may be retracted in the range of 3-5 cm, and in some embodiments, about 4 cm. This may allow the valve 4300a to expand within the receiver 4320a portion of the adapter 4225b. The profile 4400 of the valve 4300a may expand outward upon release.

[0293] FIG. 45 illustrates a pre-valvulation procedure step to size the valve 4300b. As shown in FIG. 44, after or as the valve profile 4400 expands, the midline suture 4210b and the distal suture 4205b may be tightened to reduce the valve profile 4400a. Based in part on such tightening, the section of the hypotube between the inner multi-lumen 4315a and the nosecone 4505 may be shortened to a shorter and / or minimum exposed length. In some embodiments, this may include a retraction in the range of 1-4 cm, and most commonly in the range of 2-3 cm. The steerable catheter shaft 4310a and the inner multi-lumen 4315a may reside at the proximal end of the receiver 4320a.

[0294] The anchor 4500 may be tethered, and preferably remains tethered. In some embodiments, the anchor retaining suture 4015a may need to be tightened. The outer multi-lumen 3945b may be advanced and positioned flush with the distal end of the guide catheter 4230b. In some embodiments, such advancement may be in the range of 4-6 cm, and in some embodiments, approximately 5 cm. The flange retaining suture 3955a may remain under tension.

[0295] 46 illustrates a positioning step of the deployment procedure. For example, the guide catheter 4230c can be deflected to direct the implant 4610 toward the mitral valve annulus 4605. The steerable catheter 4310b can be advanced relative to the guide catheter 4230c and used to provide additional (dual-plane) deflection. Additionally, the rotational and axial positions of the guide catheter 4230c and the steerable catheter 4310b can be adjusted (e.g., by an operator, such as a physician) to direct the implant 4610 toward the mitral valve annulus 4605.

[0296] FIG. 47 illustrates a portion of the deployment procedure including extension and deployment of anchor 4500a. Once the desired trajectory is achieved, the hypotube and inner and outer multi-lumen 4315b, 3945c can be extended and advanced while keeping the steerable catheter shaft 4310c and guide sheath catheter 4230d stationary to place or position the implant 4610a at the correct depth within the mitral valve annulus 4605a. Once the desired trajectory and depth of the implant 4610a has been confirmed, the anchor 4500a can be released and alignment to the mitral valve 4605a can be reconfirmed.

[0297] 48 illustrates the final positioning step of the deployment procedure. Details of the final positioning, such as rotation, deflection, and axial translation of the guide catheter 4230e, steerable catheter 4310d, inner and outer multi-lumen 4315b, 3945d, and hypotube, can be determined (e.g., by an operator such as a physician). Such final positioning can also include releasing tension on the sutures.

[0298] 49 illustrates the sequence steps of deployment. The implant 4610b is ready for release from the delivery system and deployment into the native mitral valve annulus 4605b. In some embodiments, such release can be triggered by retraction of the pull wires and sutures. After release and deployment of the implant 4610b, the remainder of the assembly embodiment can be retracted according to other aspects of the disclosure.

[0299] 50 is a flow diagram that generally illustrates a method 5000 of delivering a heart valve according to aspects of the present disclosure. In some embodiments, the method 5000 may include a step 5005 of advancing an embodiment of a catheter device for carrying the heart valve toward the mitral valve annulus. The method 5000 may include a step 5010 of pushing an embodiment of the catheter device through the mitral valve annulus.

[0300] Method 5000 may further include a step 5015 of deploying at least one clip from an embodiment of a catheter device within the ventricle. Method 5000 may further include a step 5020 of securing said at least one clip to at least one native leaflet within the ventricle. Method 5000 may further include a step 5025 of deploying at least one anchor from an embodiment of a catheter device within the ventricle.

[0301] The method 5000 may further include a step 5030 of securing the at least one anchor to native heart tissue within the ventricle. The method 5000 may further include a step 5035 of releasing the flange within the atrium to fit the mitral valve annulus.

[0302] 51 is a flow diagram that generally illustrates a method 5100 of replacing a heart valve that is part of a two-piece assembly according to aspects of the present disclosure. In some embodiments, the method 5100 may include a step 5105 of transseptally advancing an embodiment of a first catheter device carrying a new MLS into the atrium toward the mitral valve annulus. The method 5100 may further include a step 5110 of positioning the embodiment of the first catheter device carrying the new MLS above the mitral valve annulus.

[0303] Method 5100 may further include step 5115 of pushing a second catheter device embodiment transapically toward the mitral annulus to remove old MLS within the ventricle. Method 5100 may further include step 5120 of positioning the second catheter device embodiment (or a component thereof) to grasp the old MLS transapically from the mitral annulus.

[0304] Method 5100 may further include step 5125 of anchoring the old MLS using a second catheter device embodiment (or components thereof) to pull it away from the mitral annulus and remove it transapically. Method 5100 may further include step 5130 of rapidly inserting a new MLS transseptally into the mitral annulus using the first catheter device embodiment.

[0305] One or more of the foregoing steps (including steps involving both transapical and transseptal procedures) may be performed with the aid of a guidewire (in some embodiments, the same guidewire).

[0306] Other embodiments may include combinations and subcombinations of the features described or illustrated in the figures, including embodiments that are equivalent to, for example, providing or applying features in a different order than in the described embodiments, extracting individual features from one embodiment and inserting such features into another embodiment, removing one or more features from one embodiment, or removing one or more features from one embodiment and adding one or more features extracted from one or more other embodiments, and may provide advantages of the features incorporated in such combinations and subcombinations. As used in this paragraph, the singular "feature" and the plural "features" may refer to the structure and / or function of an apparatus, article of manufacture, or system, and / or to a method step, operation, or modality.

[0307] Throughout this specification, references to "one embodiment," "one embodiment," "one exemplary embodiment," etc. indicate that the described embodiment may include a particular feature, structure, or characteristic, but not all embodiments necessarily include that particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Moreover, when a particular feature, structure, or characteristic is described in the context of one embodiment, it is within the knowledge of one of ordinary skill in the art to affect such feature, structure, or characteristic in the context of other embodiments, whether or not explicitly stated.

[0308] Unless the context clearly indicates otherwise, (1) the term "and" indicates a conjunctive sense, (2) the term "or" indicates a disjunctive sense, (3) when an item is expressed disjunctively and followed by the term "or both," both the conjunctive and disjunctive sense are intended, and (4) the term "and" or "or" between the last two items in a series applies to the entire series.

[0309] When a group is expressed with the term "one or more" followed by a plural noun, any further use of the noun to refer to one or more members of the group must indicate both the singular and the plural of the noun. For example, a group expressed as having "one or more members," followed by a reference to the plural "members" of the group, means the singular "member" if there is only one member of the group.

[0310] The article "a" or "an" refers to one or more of a given entity. Thus, the terms "a" (or "an"), "one or more," and "at least one" can be used interchangeably herein. It should also be noted that the terms "comprising," "including," and "having" can also be used interchangeably.

Claims

1. 1. An implant configured for transcatheter deployment within a native mitral valve having a native mitral annulus, a native posterior mitral leaflet, and a native anterior mitral leaflet, the implant comprising: the native mitral valve is within a native heart having a native left atrium and a native left ventricle; The implant is a tubular frame having an inlet end and an outlet end; a flange having, as manufactured, a funnel-shaped profile, a D-shaped periphery, and a circular cross section; at least one leaflet clip extending radially outward from the outflow end of the tubular frame; Equipped with the tubular frame is formed from at least one helically oriented braided wire; a valve assembly mounted within the tubular frame of the implant and spaced radially inward; the flange is configured to extend against the native mitral valve annulus in the intra-annular space of the native heart toward the native left ventricle when deployed within the native mitral valve; the circular cross section is smaller than the D-shaped perimeter; the flange is configured to resist migration of the implant toward the native ventricle and to resist paravalvular leakage when deployed within the native mitral valve; the at least one leaflet clip, when deployed within the native mitral valve, permits relative movement between the implant and the native mitral valve annulus and resists movement of the implant toward the native atrium; The at least one helical braided wire of the annular frame mimics the movement of the natural heart. An implant characterized by:

2. The at least one leaflet clip includes a rear leaflet clip extending radially outward from the outflow end of the tubular frame.

2. The implant of claim 1.

3. The at least one leaflet clip further includes a front leaflet clip extending radially outward from the outflow end of the tubular frame.

3. The implant of claim 2.

4. the posterior leaflet clip, when deployed within the native mitral valve, is hooked posteriorly to the P2 region of the native posterior mitral valve leaflet; The anterior leaflet clip, when deployed within the native mitral valve, hooks posteriorly to the A2 region of the native anterior mitral valve leaflet.

4. The implant of claim 3.

5. a middle anchor strut and a lateral anchor strut carried by the tubular frame and configured for subannular valve placement; Further provided with The intermediate and lateral anchor struts, when deployed within the native mitral valve, allow medial and lateral movement of the native mitral valve annulus and resist movement of the implant toward the native atrium.

5. The implant of claim 4.

6. The posterior leaflet clip, the anterior leaflet clip, the middle anchor struts, and the lateral anchor struts are angled toward the atrium.

6. The implant of claim 5.

7. the intermediate anchor strut, when deployed within the native mitral valve, extends into the intermediate commissure region below the mitral valve annulus of the native heart; The lateral anchor struts, when deployed within the native mitral valve, extend into the lateral commissure region below the mitral valve annulus of the native heart.

7. The implant of claim 6.

8. The D-shape of the flange has straight sides 8. The implant of claim 7.

9. The funnel-shaped profile of the flange promotes sealing, anchoring, and vortex flow through the implant.

9. The implant of claim 8.

10. The flange is configured to fill a gap between the flange and the native mitral valve.

10. The implant of claim 9.

11. The tubular frame of the implant is self-expanding when deployed within the native mitral valve.

11. The implant of claim 10.

12. The at least one helically braided wire of the tubular frame is self-expanding when deployed within the native mitral valve.

12. The implant of claim 11.

13. The tubular frame is larger than the native mitral annulus of the native mitral valve by an amount less than 10%.

13. The implant of claim 12.

14. the implant does not constrict the left ventricular outflow tract (LVOT) when deployed partially within the native mitral valve by one or more of the tubular frames being no larger than the native mitral annulus of the native mitral valve by an amount no greater than 10%; the implant is deformable; The anterior leaflet clip hooks posterior to the A2 region of the native anterior mitral valve leaflet but does not pinch it.

14. The implant of claim 13.

15. Fabric attached to the tubular frame 15. The implant of claim 14, further comprising:

16. The valve assembly mounted within the tubular frame of the implant includes a minimum leaflet structure (MLS).

16. The implant of claim 15.

17. a valve replacement configured to be received within the tubular frame of the implant; 16. The implant of claim 15, further comprising:

18. The valve replacement is configured to be sized to cooperate with and seat within the tubular frame of the implant when deployed within the native mitral valve.

18. The implant of claim 17.

19. The valve replacement is removable from the tubular frame of the implant after deployment within the native mitral valve.

19. The implant of claim 18.

20. The valve replacement further comprises a fabric.

20. The implant of claim 19.

21. the tubular frame of the implant further comprises a plurality of tabs at an inflow end of the tubular frame; The tabs resist atrial migration of the valve replacement when deployed within the tubular frame of the implant within the native mitral valve.

21. The implant of claim 20.

22. The intermediate and lateral anchor struts and the posterior and anterior leaflet clips are part of the tubular frame of the implant and not part of the valve replacement.

22. The implant of claim 21 .

23. The implant does not constrict the left ventricular outflow tract (LVOT) when deployed partially within the native mitral valve by multipoint fixation with one or more of the intermediate anchor struts, the lateral anchor struts, the posterior leaflet clip, and the anterior leaflet clip.

23. The implant of claim 22.

24. The implant is configured to self-expand when delivered to the native mitral valve.

24. The implant of claim 23.

25. The at least one helical braided wire of the annular frame comprises a nitinol wire wound in a helical spiral.

25. The implant of claim 24.

26. The at least one helical braided wire of the annular frame includes a first wire.

18. The implant of claim 17.

27. An inner fabric extends over the inner portion of the tubular frame of the implant.

27. The implant of claim 26.

28. An outer fabric extends over an outer portion of the tubular frame of the implant.

28. The implant of claim 27.

29. One or more of the flange, the anchor post, and the leaflet clip include a second wire.

29. The implant of claim 28.

30. The tubular frame of the implant is rolled up and down.

30. The implant of claim 29.

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