Devices, systems and methods for valve replacement

Abstract

Disclosed is a valve replacement that includes a braided helix design that mimics the natural motion of the heart. The braided wire frame of the disclosed valve replacement can be compressed to allow for compact and reliable delivery to the heart, preferably generally via a catheter, and convenient control during implantation, as well as expansion and contraction upon implantation or removal / replacement. The valve replacement can comprise a single component system including an adapter body with an engagement mechanism for securing to the heart and a valve assembly with leaflets disposed within the adapter body. The valve replacement can also comprise a two-piece system with an adapter body and a valve assembly that are compatible with each other and where the valve assembly is removable from the adapter body, such that both can be delivered together or separately and the valve assembly can be removed and replaced.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application is related to U.S. Provisional Application No. 63 / 145,878, filed February 2, 2021, and entitled "Devices, Systems, and Methods for a Self-Adapting Valve Attachment"; International Application No. PCT / US / 21 / 39451, filed June 28, 2021, and entitled "Devices, Systems, and Methods for a Heart-Valve Annulus Reinforcer"; International Application No. PCT / US21 / 51828, filed September 23, 2021, and entitled "Devices, Systems, and Methods for an Implantable Heart-Valve Adapter"; and International Application No. PCT / US21 / 51828, filed May 17, 2021, and entitled "Devices, Systems, and Methods for a Collapsible and Expandable Replacement Heart This application claims priority to and benefit of International Application No. PCT / US21 / 32817, entitled "Devices, Systems, and Methods for a Collapsible Replacement Heart Valve," and International Application No. PCT / US21 / 38886, filed June 24, 2021, entitled "Devices, Systems, and Methods for a Collapsible Replacement Heart Valve," the contents of 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 valve replacement, including single component and two-piece systems. The characteristics of the valve replacement discussed include high flexibility, elasticity, conformability, and functionality as a replaceable heart valve. [Background technology]

[0003] 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 is 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 replace the heart's native (native) 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. Heart valve replacements cause additional problems after implantation. For example, a replacement valve may move or migrate after being placed in a desired location in the heart, or the location may not allow for proper directional flow of blood through other parts of the organ, such as the left ventricular outflow tract. Replacement valves are also not easily retrievable, often due to the possibility that such removal may damage the surrounding heart tissue. This can be particularly problematic if, for example, the replacement valve is not properly and accurately placed in place when implanting the replacement valve in the native heart, as well as if the replacement valve begins to malfunction, which may occur soon after initial implantation or years later. A further problem is that typical replacement valves, particularly laser-cut valve frames, are relatively stiff and inflexible, resulting in the valve not bending with the dynamic movements of the pumping heart. Such inflexible valves are not compatible with such dynamic movements, which can cause trauma to the heart surface, cause breakage in the frame itself, and otherwise create or exacerbate problems during or after implantation. Summary of the Invention [Problem to be solved by the invention]

[0004] Thus, what is needed are devices, systems, and methods for valve replacement that allow for both compact and reliable delivery into the heart and convenient control, preferably entirely via a catheter, of both the expansion and contraction of the valve replacement during implantation or upon removal / replacement. There is also a need for devices, systems, and methods for ensuring properly directional flow of blood through the heart during and after the valve replacement procedure.

[0005] Such devices, systems, and methods should provide the functionality of a single component system having both an adapter body with an engagement mechanism for securing to the heart and a valve assembly with leaflets disposed 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 and in which the valve assembly is removable from the adapter body, allowing both to be delivered together or separately and allowing the adapter body to remain implanted while allowing the valve assembly to be removed and replaced. [Means for solving the problem]

[0006] 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, nor is it intended to define the scope of the appended claims. Its sole purpose is to present concepts of example embodiments in a simplified form as a prelude to the more detailed description presented later 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.

[0007] 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 is highly flexible, elastic, fatigue resistant, and fixable to the native valve tissue. The valve replacement is also self-adaptive, meaning it adapts to and supports the natural movement of the heart. In a preferred embodiment, the valve replacement includes a foldable adapter 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. The valve replacement, whether a single component system or a two-piece system, further includes a valve assembly, the valve assembly including the leaflets and adapted to reside within the adaptive frame.

[0008] The present disclosure provides a valve replacement 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. The two-piece system disclosed herein allows for an even lower profile since the compliant frame and valve assembly can be delivered as two separate devices.

[0009] Further advantages, embodiments, and features of the subject disclosure will become readily apparent to those skilled in the art from the following description, in which preferred embodiments of the disclosure have been shown and described, merely to illustrate one of the best modes suitable for carrying out the subject disclosure. As will be understood, the present disclosure is capable of other different embodiments, and its several details are capable of modification in various obvious embodiments, all without departing from or limiting the scope of the present disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not restrictive.

[0010] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present disclosure and, together with the general description of the disclosure given above and the detailed description of the drawings given below, serve to explain the principles of the present disclosure. In certain embodiments, details that are not necessary for understanding the disclosure or that make other details difficult to perceive may be omitted. [Brief description of the drawings]

[0011] [Figure 1] FIG. 1 illustrates a schematic diagram of one embodiment of a valve replacement as disclosed herein. [Figure 2A] FIG. 1 illustrates a schematic diagram of one embodiment of a valve replacement as disclosed herein. [Figure 2B] FIG. 1 illustrates a schematic diagram of one embodiment of a valve replacement as disclosed herein. [Figure 2C] FIG. 1 illustrates a schematic diagram of one embodiment of a valve replacement as disclosed herein. [Diagram 3] FIG. 1 illustrates a schematic diagram of one embodiment of a valve replacement as disclosed herein. [Figure 4] FIG. 1 illustrates a schematic diagram of one embodiment of a valve replacement as disclosed herein. [Diagram 5] FIG. 1 shows a schematic diagram of one embodiment of a valve replacement as disclosed herein. [Figure 6A] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 6B] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 7A] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 7B] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 7C] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 7D] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 8A] FIG. 1 shows a schematic of the spiral function of the human heart. [Figure 8B] FIG. 1 shows a schematic of the spiral function of the human heart. [Figure 9] FIG. 1 illustrates a schematic diagram of one embodiment of a valve replacement as disclosed herein. [Figure 10A] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 10B] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 11A] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 11B] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 12A] 1 illustrates an embodiment of a valve replacement as disclosed herein. [Figure 12B] 1 illustrates an embodiment of a valve replacement as disclosed herein. [Figure 12C] 1 illustrates an embodiment of a valve replacement as disclosed herein. [Figure 12D] 1 illustrates an embodiment of a valve replacement as disclosed herein. [Figure 12E] 1 illustrates an embodiment of a valve replacement as disclosed herein. [Figure 13A] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 13B] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 13C] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 13D] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 14A] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 14B] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 14C] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 14D] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 14E] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 15A] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 15B] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 16A] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 16B] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 16C] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 16D] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 17A] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 17B] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 17C] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 17D] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 18A] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 18B] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 19A] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 19B] 1A-1D are schematic diagrams illustrating embodiments of a valve replacement as disclosed herein. [Figure 20] FIG. 1 illustrates a schematic diagram of one embodiment of a valve replacement as disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] 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 in order to facilitate describing these embodiments.

[0013] FIG. 1 shows a schematic of an embodiment of a valve replacement disclosed herein. FIG. 1 shows a valve replacement ("valve replacement") 100 implanted in a dysfunctional mitral valve. However, the valve replacement is not limited to compatibility with only the mitral valve, but may also be implanted in a tricuspid valve. In a preferred embodiment, the valve replacement includes a braided foldable frame and a braided valve leaflet assembly, which together act to provide a seal.

[0014] As described herein, the adaptability of the foldable frame and leaflet assembly can be implemented in various embodiments. In one embodiment, the valve replacement can include the 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 can include the frame and valve assembly as a single component device (referred to herein for ease of reference as a "single component system"). Regardless of the embodiment, the valve replacement can further include attachments and additional features for catheter delivery, positioning, partial deployment, and retrieval.

[0015] (Overview of Two-Piece Valve Replacement) 2A-2C show schematic diagrams of embodiments of the valve replacement disclosed herein. FIGS. 2A-2C disclose an embodiment of a two-piece system. As shown in FIG. 2A, the two-piece system comprises 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 comprises an opening 205 that fits the valve assembly 250. The adapter 200 further comprises 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 comprises a leaflet structural component 255 that allows blood flow through the valve assembly 250. FIG. 2C discloses the valve replacement as a two-piece system, where the adapter 200 and the valve assembly 250 are cooperatively sized and configured together. The adapter 200 and valve assembly 250 can be fitted as a single unit and compressed in a coupled configuration for insertion into a cardiac catheter for delivery to a target valve, i.e., the two parts are mechanically coupled. This configuration advantageously allows for the delivery and control of both parts of the valve replacement.

[0016] The adapter 200 and valve assembly 250 can also be delivered within a delivery catheter in an uncoupled form, where the two portions are not mechanically coupled. This configuration advantageously allows the delivery catheter to control each portion independently and can also increase the flexibility and torsional characteristics of a delivery catheter including the two portions, which can be advantageous both during delivery of the delivery catheter through the patient's body, vasculature, and desired target, and during delivery of the replacement valve at the target. In such an embodiment, the adapter 200 and valve assembly 250, both as separately delivered portions, can be further compressed, allowing for a low profile that facilitates delivery through vessels that may not be sufficiently healthy or wide in size to allow for delivery of both portions as a single unit.

[0017] (Overview of Single Component Valve Replacement) FIG 3 shows a schematic of one embodiment of a valve replacement as disclosed herein. FIG 3 shows an embodiment of a single component system 300 including an opening 305 for blood flow, a seal skirt 310, and a leaflet structure 315. Although not shown in FIG 3, the single component system 300 may further include a body similar to the body of the adaptor 200 of FIGS. 2A-2C below the seal skirt 310, and an anchor similar to the anchor of the adaptor 200 of FIGS. 2A-2C. In one embodiment, the single component system 300 may function as a permanent implant.

[0018] Whether as a single component system or a two-piece system, the valve replacement allows for a valve-in-valve replacement, and embodiments of the valve-in-valve replacement include replacing an existing leaflet 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.

[0019] (braided structure) The braided structures disclosed herein are applicable to adapter and valve assemblies in single component and two piece systems, 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 single component systems.

[0020] FIG. 4 generally illustrates one embodiment of the valve replacement disclosed herein. FIG. 4 discloses a braided wire frame of the adapter 400 and the valve assembly 450. The braided wire frame allows the adapter 400 and the valve assembly 450 to be compressed and expand in size when released. Similarly, the single component system can be compressed and expanded. The braided wire frame design allows the valve replacement to be compressed to a small diameter, such as 4 mm to 6 mm, so that it can be delivered within a catheter. The braiding of the wires and overlap with other wires reduces stress on the frame, thus reducing or eliminating wire breakage. The braiding also allows the use of wires of various sizes.

[0021] The braided wire frames of the unitary component systems, adapters 400, and valve assemblies 450 can comprise a variety of wire embodiments, such as a single wire, two or more wires (e.g., grafted or welded), and wires spliced ​​together from multiple wires. The wires that make up the unitary component and two-piece systems can be constructed from a variety of materials, such as Nitinol, which has shape memory properties, and can come in a variety of dimensions, such as diameter sizes.

[0022] By integrating a variety of wire thicknesses and braided designs, the replacement heart valve conforms to the various densities and properties (i.e., radial forces and expansion) of the heart's anatomy. This allows the braided frame to have flexible and adaptable performance, allowing the valve replacement to self-adapt to the heart and move with it while being tolerant of anatomical anomalies, as well as the spiral structure of the heart, as disclosed herein. The braided frame also facilitates placement of the valve replacement, maximizing the seal and preventing migration with an integrated and optimized anchoring system. The braided frame geometry of the valve replacement allows for a variety of applications, such as being customizable to the mitral and tricuspid anatomy, requiring fewer sizes to treat most pathologies, facilitating rapid prototyping, allowing various design features to be incorporated, facilitating rapid design advancement through rapid evaluation and optimization of features, and being scalable using conventional processes. The braided structure also allows for more degrees of freedom and the opportunity for the wires to be in various positions.

[0023] One embodiment of manufacturing the braided wire frame includes oversizing the braided wire frame relative to the heart valve, which allows the frame to open more fully and function better due to a greater radial force for the same amount of material and shape. Additionally, manufacturing tolerances for the valve replacement are reduced. Oversizing the braided frame biases the wire frame structure to conform and adapt with greater radial force, resulting in less movement between the wires due to elastic strain energy. As a result, the valve has a higher consistency and manufacturing tolerances associated with, for example, leaflet attachment are greatly improved.

[0024] In one embodiment, the braided frame is wrapped and shaped so that it has sufficient radial strength to self-expand and open to a desired radial volume while still being configured to fit within a catheter.

[0025] Embodiments of the valve replacement may range in diameter from 25 mm to 55 pm or more. In another embodiment, the wire frame is oversized, which involves braiding the wire frame onto 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 first mandrel and stretched over a 29.0 mm mandrel (or 31.0 mm or 33.0 mm, e.g., for larger valves) and shape set again. A temporary string (or other similar method known to those skilled in the art) is then threaded through the loop and tied using the 25.4 mm mandrel as the nominal diameter of the valve frame. This spring loads the loop and compresses the frame (although in other embodiments it may be constructed with other structures other than loops, such as simple points). In this way, the braided valve replacement is shape set at the larger diameter and then restrained at the smaller diameter and held by the string until the fabric is sewn to the frame. In another manufacturing embodiment, the wire frame wraps around the circle five times while repeating the braid pattern three times across its length.

[0026] Valve replacement embodiments can be compatible with a variety of catheter sizes, such as 26F, 28F, 30F, 32F, and 34F.

[0027] FIG. 5 shows a schematic of one embodiment of a valve replacement disclosed herein. As shown in FIG. 5, an adaptor 510 can fit into a human heart 505, where an embodiment that achieves coaptation can include sealing and locking by adjusting the over-and-under 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 come in a variety of sizes. In one embodiment, the adaptor 510 can be constructed of a Nitinol wire braid 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 seal skirt expands to anywhere from 40 mm to 70 mm in diameter).

[0028] The valve replacement can include other types of wires, such as stainless steel, cobalt chrome, and other types of implant metals. In other embodiments, the valve replacement can include polymeric materials, such as biocompatible plastics and fiber-reinforced polymers. Some embodiments can include a drawn-fill tube (outer material NiTi, inner material some more highly radiopaque material) for the valve replacement or a portion of the valve replacement (e.g., anchors, or features desired to be seen under fluoroscopy). The valve replacement or a portion thereof can be made of a hollow tube. Additionally, flat wires or wires of other cross sections can be selected for portions of the valve replacement, such as to provide tailored / increased stiffness for the anchors.

[0029] (Braided wire frame flanges and anchors) The adapters are designed to maintain native ventricular filling by directing flow into the ventricle toward the ventricular wall, between the papillary muscles, or toward the apex of the ventricle (the "virtual apex") to limit turbulence and maximize efficient flow.

[0030] The adapter is also designed to be anatomically customizable with patient and condition specific sizing. Sizing can be done, for example, based on anatomical data and a sizing tool is used 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 sizing tool parameters are fed into a parametric device model, which automatically creates a pattern for the shape set tooling.

[0031] FIG. 6A shows a schematic of an 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 one-third portion 613 and a two-third portion 616. The one-third portion 613 of the atrial flange 620 is angled to engage the fibrous aortic-mitral curtain and prevent the valve from being pulled into the LVOT. This feature also maximizes the seal during systole. The two-thirds portion 616 of the atrial flange 620 is angled to engage the muscle wall and pull the valve away from the LVOT and direct flow towards the ventricular apex, between the papillary muscles, or towards the ventricular wall. In other embodiments, the adapter body and atrial flange function similarly or identically when applied to a tricuspid valve.

[0032] FIG. 6B illustrates a schematic of an embodiment of a valve replacement disclosed herein. As shown in FIG. 6B, the adaptor can include a valve and retainer 615 within an inner frame of the adaptor body. The adaptor can also include subvalvular anchors 620 for leaflet management. In one embodiment, the subvalvular anchors 620 are comprised of one or more of anterior leaflet anchors 625, trigonal anchors 630, and posterior leaflet anchors 645. For example, the adaptor can include a single anterior leaflet anchor 625, two trigonal anchors 630, and three posterior leaflet anchors 645. The anchors can be configured to radially overlap and bias upwards relative to the adaptor body.

[0033] FIG. 7A illustrates a schematic of one embodiment of a valve replacement disclosed herein. FIG. 7A illustrates an embodiment of a wire braid frame on which the adapter is constructed. The wire braid frame can include a 24-point braid pattern with dual posterior leaflet anchors 705 that are used to maintain symmetry and provide additional double structural fixation. The wire braid frame can also include dual stabilizing anchors 710. It is also shown that the wire braid frame can have anchor positions available in 15 degree increments.

[0034] The anchors, in some embodiments, may be extensions of the tubular braided frame, extending from the outflow end to serve as mating attachments. In other embodiments, the wire braided frame of the adapter may have anchors grafted, welded, or fused. For example, FIG. 7A shows the combination of a larger gauge wire (0.0175 inch-0.02 inch) (represented by stabilizing anchor 710) with a smaller gauge wire (0.012-0.0175 inch) (represented by posterior leaflet anchor 705 and further represented by additional wire 715) with a joining operation at the interface between the different sized wires. The joining interface may be a weld or a weld to the supporting tube.

[0035] The embodiment of the weld used may relate to the material the valve replacement is constructed from. In anchor embodiments that include a hollow tube (hypotube) material, a helical weld pattern can be used to join the anchor to the frame since the inner diameter of the hypotube fits perfectly with the diameter of the wire. Both ends of the hypotube can then be beveled to provide a smooth transition with the attached wire. A radiopaque wire can be inserted inside the hypotube and placed at the peak of the anchor (such an embodiment provides optimal fluoroscopic visualization).

[0036] 7B and 7C are schematic illustrations of embodiments of the valve replacement disclosed herein. In one embodiment, as shown in FIG. 7B, the valve replacement can include an atrial seal skirt 705, a frame body 710, and a stabilization anchor 715 that are covered with fabric for purposes of flow sealing and / or promoting (e.g., affecting either promotion or inhibition) tissue growth after implantation. This embodiment can further include a clip 720 that is not covered with fabric. FIG. 7C shows a valve replacement that includes a posterior leaflet anchor 725 and a clip 720.

[0037] 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 for improved delivery control through secure attachment of the valve replacement to the delivery catheter and for improved efficiency and effectiveness of attachment of the leaflets. 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 can be positioned at two or more separate locations around the circumference of the valve replacement. In other embodiments, clip 735 is shaped 180 degrees to provide a hook shape that clips onto the native leaflets. For example, clip 735 can be attached onto the native leaflets to provide fixation of the valve replacement once the valve replacement is released from the delivery system.

[0038] Various embodiments of the valve replacement can include various amounts of anchors. For example, one embodiment can include six anchors, while another embodiment can include three anchors. In a preferred embodiment including three anchors applicable to the mitral valve, the valve replacement has a 150° angle between the P1 and P3 anchors, and the P2 anchor is symmetrical between the P1 and P3 anchors. In a preferred embodiment including three anchors applicable to the tricuspid valve, the valve replacement includes uniform 120° / 120° / 120° spacing of the anchors.

[0039] The anchors can be made of the same wire as the braided frame, or they can be made of different wires. This provides a novel aspect, as the wire for the anchors can be thicker and / or more durable, making the anchors needed to attach to the valve tissue and hold the valve replacement in place stronger and / or more rigid without configuring the flexibility of the body frame. This allows the valve replacement to move and function with the natural movement of the heart while remaining firmly and securely positioned within the heart valve. Another novel aspect is the synchronization of the flanges and 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 configuring the fluidity of the braided body frame or the functionality of the leaflets.

[0040] (Spiral braid design) The novel helical braid design of the replacement heart valve embodiments purposefully utilizes 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 mechanism is 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 lateral base loops of muscles for contraction overlying the diagonal helix responsible for ejection and suction within the heart.

[0041] The disclosed braided helix design is configured to place less stress on the individual components of the valve replacement as it moves with the heart, i.e., less stress on the leaflets and anchors and other components, and less movement as the valve replacement is kept in place by its natural helical motion with the heart.

[0042] Figure 8A generally illustrates the spiral function of the human heart. As shown in Figure 8A, twisting and untwisting motion within the heart occurs through an internal spiral within 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.

[0043] FIG. 8B shows a schematic of one embodiment of the valve replacement disclosed herein. As shown in FIG. 8B, one embodiment of the replacement heart valve includes a helical braid design that mimics and reinforces the normal helical and elliptical formation of the heart and its twisting / rotating motion. In one embodiment, the helical braid design includes a design that mimics a frame where the braided wires always rotate in one direction as they are compressed and / or stretched around the center of the opening. Both the adapter and the valve assembly of the single component system and the two-piece system can include a helical braid design. The normal heart develops ejection and aspiration as a functional result of the integrity of the contraction of the apical ellipse. The helical braid design of the replacement heart valve maximizes the shortening and stretching of the myocardium, thereby reinforcing the desired apical ellipse of healthy heart movement.

[0044] For example, as the human heart muscle compresses and descends, the braided helical wire of the valve replacement compresses and descends with the heart muscle rather than being rigid, reinforcing the natural helical compression and descending of the heart muscle surrounding the braided wire. The braided helical design allows the replacement heart valve to conform to and reinforce the natural movement of the heart. The braided helical design of the valve replacement creates a spiral 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 with the heart muscle around the braided wire, resulting in a twist-free helical coil within the adapter or valve that generates an ejection force.

[0045] The novel braided helix design is important for the treatment of heart valves. By configuring the braided helix design, the replacement heart valve embodiments enhance the natural helical motion of the heart and more naturally accommodate and fit within the desired valve region. For example, the valve replacement embodiments tend to stay in the desired mitral or tricuspid valve region because the braided helix design moves with the natural movement of the heart (contracts, twists to shorten, and untwists to lengthen). This allows the replacement heart valve to self-correct and naturally fit within the valve area, thus matching the natural movement of the heart and encouraging central vortex flow.

[0046] In this way, the novel braided helix design promotes the natural movement of the heart. In one embodiment, the valve replacement is held in place by the combined forces 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 motions. As the heart pumps, this twisting motion encourages the flow of fluid through the valve replacement, allowing for better flow dynamics.

[0047] (Material cover) In some embodiments, the various materials are prepared prior to assembly into a continuous cover, while in other embodiments, the materials can be added and undergo post-assembly modification treatments that are applied only to specific locations of the valve replacement.

[0048] FIG. 9 shows a schematic of one embodiment of the valve replacement disclosed herein. As shown in FIG. 9, tissue attachment and engraftment can be promoted in areas where fixation to tissue is desired, while cellular interaction can be limited to simple endothelialization or no reaction at all, to allow for later disturbance of parts of the device without risk of tissue or thrombus embolization. In short, the various materials used either contribute to chemical bonding or not. For example, in a preferred embodiment, the material in contact between the inner part of the adaptor and the outer part of the valve assembly is not bonded, allowing movement of both parts, while the material on the outside of the adaptor bonds with the human tissue. Thus, in some locations, materials can be used that inhibit or promote cell growth.

[0049] FIG. 9 further illustrates that the valve replacement 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 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, while the material on the other side of the flange may be knit to facilitate tissue infiltration for anchoring. Alternatively, alternating rings of non-porous and engraftment materials may be placed on both sides of the flange. These techniques may be applied to any surface of the device.

[0050] Material differences range from entirely different materials - natural tissue or synthetic fibers - to physical and chemical surface modifications to obtain the desired mechanical and biocompatible properties. These modifications include, but are not limited to, coatings, etching, mechanical biasing, ion implantation, various deposition techniques, oxidation / nitridation / carbonization, etc. Modifications can be used in any combination to obtain the desired results.

[0051] 10A and 10B generally depict an embodiment of a valve replacement disclosed herein. As shown in FIGS. 10A and 10B, the embodiment of the valve replacement can include a continuous element of material around the outside of the frame. The continuous seal can consist of a material (such as fabric) that extends from the inflow end of the valve replacement to the outside of the body of the valve replacement. A strip of fabric that extends inward can be sewn around the inflow edge of the valve replacement body, with a non-porous coating forming a continuous seal that extends into the ventricle.

[0052] The continuous surface of the fabric can also be locally influenced, with tailored or opposing properties, such as coated with medical grade polymers where tissue attachment is not desired, coated with hydrogels where space-filling or latent action is desired, or coated with hydrophilic tissue adhesives. The continuous material structure of the fabric can be voluminous in nature, filling space and allowing the circular heart valve to conform to the asymmetric shape of the annulus. In combination with other attachment methods, embodiments of the mitral valve adapter made in this manner aid in the engagement and attachment of leaflet tissue and other subvalvular structures. The partially porous fabric provides an improved seal for the valve replacement, allowing the fabric's compliance to conform to irregularly shaped anatomical structures.

[0053] In other embodiments, the valve replacement can be fabricated using restraints that hold the valve replacement at specific dimensions while attaching materials that affect the performance of the device. To eliminate the inherent freedom of movement and unpredictability that exists between opposing members of the frame structure in an unloaded state, manufacturing techniques are disclosed that act to affect the placement of the braided wire frame. These techniques include restraining the radial expansion of the frame, for example by threading a number of sutures through or around the structure to hold it at a specific dimension other than its unconstrained "free" dimension. In a subsequent manufacturing step, the structure is assembled into an assembly that adopts this new configuration, which is considered the final dimension. When the restraint is removed from the braided frame, it will attempt to return to its original "free" dimension - exerting additional radial force on the surrounding structure while being restrained at the desired dimension.

[0054] The degree of radial force transferred from the frame to the fabric can be tailored as needed 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) is 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.

[0055] To further expand on this concept, structures having the features described herein can be co-located in a single or linked design to engage both the mitral and aortic valve apparatus and / or annulus, with the intent to affect the leaflets of both valves and the angle of the valves relative to one another to most effectively manage flow through the ventricles and maximize the efficiency of the outflow tract.

[0056] In some embodiments, the valve replacement is covered with a material that continuously encases the frame. Examples of materials are fabric and animal tissue. The use of locally modifiable materials to vary properties such as porosity and surface roughness allows for a level of control over cellular interaction in various parts of the device. In other embodiments, the adapter body and atrial flange can be covered with fabric to seal flow and / or affect (e.g., either promote or inhibit) tissue growth after implantation.

[0057] The materials used further aid in the loading and deployment of the valve replacement. For example, the materials can facilitate the valve replacement functioning as a revalve system, where a tubular braided fabric tube (coated with a polymer to reduce porosity to blood) surrounds the frame and constrains its diameter. The tube is sewn to the frame, possibly together with the leaflet panels, and when the lacing is removed, what remains is a pretensioned frame constrained by the tube.

[0058] (Sewing method and belt loops) 11A and 11B show schematic diagrams of embodiments of the valve replacement disclosed herein. More specifically, FIGs. 11A and 11B show various embodiments of fabrication materials for the valve replacement, focusing on a two-piece system.

[0059] 11A shows the Allan flange 1105, secant flange 1110, secant outer cuff 1115, and Allan inner cuff 1120 of the valve replacement. The Allan flange 1105 includes a circular top element and may further include a coating to reduce fluid permeability. The secant flange 1110 includes a circular bottom element that stretches to allow expansion of the valve replacement upon deployment. The secant outer cuff 1115 includes a cross stitch that attaches the ends to form a tubular body. The Allan inner cuff 1120 includes a running stitch or cross stitch that attaches the ends to form a tubular body, and the fabric of the Allan inner cuff 1120 has limited stretch, and any stitching maintains the integrity of the Allan inner cuff 1120.

[0060] In one embodiment, the secant flange 1110 and the secant outer cuff 1115 can be combined by cross stitching or any other method known to one of skill in the art to form a secant bottom element. The flanges are sewn together at the location furthest from the anchor slots. The formed secant bottom element can be placed onto the bottom of an adapter or single component system where the shape set threads around the frame torso are cut and a lap stitch is used to close or secure the anchor slots.

[0061] In another embodiment, an Allan inner cuff 1120 can be attached to the inner opening of the Allan flange 1105 to form an Allan top element. The Allan top element can be slid onto the top of the adapter or single component system after the fabric is lap stitched closest to the frame.

[0062] In another embodiment, the secant bottom and allan top elements can be connected, such as by a lap stitch at the bottom of the frame to connect the allan top element to the secant bottom element. To this end, the fabric of the allan flange 1105 and secant flange 1110 can be smoothed, held in place (such as with sewing clips) and connected around the wire flanges (such as with a running stitch), where the flange borders can be circular and not rigid. Excess fabric can be trimmed and additional stitching can be added around the flanges and each wire flange tip. Additional stitching can be done along the wires to secure the fabric together and to keep it flush with the wire flanges. The stitching is done to the second crossing wire, continues to the next wire and stitches up to the tip of the wire flange. This process continues around the flanges and is repeated with the next set of wires.

[0063] In one embodiment of the secant outer cuff 1115, the secant outer cuff 1115 may be folded in half and secured together (such as with sewing clips) and then blanket stitched around the outer edge. The blanket stitch allows the secant outer cuff 1115 to hold its shape without wrinkling the fabric. The secant outer cuff 1115 is placed inside out over the anchor wire and then secured (such as with a running stitch) to the front and back of the anchor wire, with the stitch seam (used to close the anchor slot) catching between the front and back fabric of the secant outer cuff 1115 and securing it to the adapter or unitary system. The running stitch may encompass the front of the secant outer cuff 1115, the seam, and the back of the secant outer cuff 1115 along the base of the anchor wire. Once the secant outer cuff 1115 is secured at the base, stitching can continue along the anchor wire to keep the secant outer cuff 1115 from slipping or sliding on the anchor. The fabric should not be so loose that excess fabric is left, but not so tight that it affects the shape of the wire, just enough to catch slightly.

[0064] FIG. 11B shows the Allan inner valve cuff 1125 and the Allan outer valve cuff 1130. In one embodiment, the leaflets may be connected to the Allan inner valve cuff 1125, such as along a strip of fabric with a double running stitch along the belly of the leaflets, where the stitch is uniform across the leaflets to allow for proper opening and closing of the valve. The leaflet tabs may be exposed, for example, by laser cutting a slot into the top of the Allan inner valve cuff 1125 (where the strip of Allan inner valve cuff 1125 may be folded in half, making sure the leaflets are aligned over one another, where the ends of the Allan inner valve cuff 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 Allan inner valve cuff 1125 may be placed into the valve assembly frame, and the tabs may be pulled through the commissure wires and laid flat between the leaflets and the Allan inner valve cuff 1125.

[0065] In one embodiment, the ends of the Allan outer valve cuff 1130 are connected and the Allan outer valve cuff 1130 can slide over the outside of the valve assembly frame.

[0066] In another embodiment, the Allan inner valve cuff 1125 and the Allan outer valve cuff 1130 can be connected together. After placing the Allan inner valve cuff 1125 inside the valve assembly frame and the Allan outer valve cuff 1130 outside the valve assembly frame, the two pieces can be connected to the bottom of the frame (e.g., by riveting both pieces with a square knot) directly below the commissure wires and the pieces can be sewn along the bottom of the frame. Following the commissure connection described in the next paragraph, both parts can be joined by sewing through the frame and the top of the valve assembly frame can be sewn. An additional step can include sewing around the wires that move from the commissures down and away from the peaks along the upper perimeter of the valve to form a Z-shaped pattern. In this case, the stitches can connect the inner fabric behind the leaflets to the Allan outer valve cuff 1130.

[0067] In one embodiment of commissure attachment, commissure tabs are fed through the commissures, with each tab folded over towards its own commissure and wrapped around the commissure wire. The ends of the tabs may be held together against the entry of the tabs and secured with a running stitch or the like vertically inside the valve assembly. The stitch may continue in front of and around the commissures, for example 3-4 times, and may be present interleaved 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.

[0068] In another embodiment of the manufacture of materials for valve replacement that focuses on a single component system, the fabric for the secant portion includes a stretchy and translucent fabric, and the secant outer cuff 1115 and the secant flange 1110 are sewn together to create the outer piece. Cross stitching can be used to connect the edges of the secant outer cuff 1115 and to connect the secant outer cuff 1115 to the secant flange 1110.

[0069] In another embodiment, the fabric for the Alan portion includes a non-flexible and opaque fabric that allows the coating to be seen, and the Alan inner cuff 1120 and the Alan flange 1105 are sewn together to create the inner portion. A running stitch can be used to connect the edges of the Alan inner cuff 1120, and a cross stitch is used to connect the Alan inner cuff 1120 to the Alan flange 1105.

[0070] For those embodiments focused on a single component system, an Allan inner valve cuff can be created where the leaflets are attached to the Allan inner cuff 1120, the leaflet tabs are placed through slots in the Allan inner cuff 1120 where the Allan inner cuff 1120 and tab junction meet, and the leaflets are held in place such as with a sewing clip. Using a double running stitch, the ventral edge of each leaflet is sewn to the Allan inner cuff 1120. The top edges of the tabs and leaflets are flat and level with each other, and the running stitch on each ventral side of the leaflet is level and even. (After the leaflets are attached to the Allan inner cuff 1120, the Allan inner cuff 1120 is folded in half to hold the leaflets horizontally and in place. A double running stitch is then sewn directly down from the leaflet tab junction and then back up towards the leaflet tab junction while continuing the running stitch away from the leaflets. (The running stitch should be away from the belly of the leaflets.) With these steps, the Allan inner valve cuff forms a tubular body.

[0071] The Allan set can be made by connecting the Allan inner valve cuff from above to the Allan flange 1105, such as by cross stitching.

[0072] Once the Arran set is made, it can be connected to the secant set (the secant flange 1110 and the secant outer cuff 1115 sewn together earlier) by using a running stitch through the frame (between the double running stitches at the bulge of the leaflet) and then stitching the belly of the leaflet to secure both sets together. Tabs are then passed through the commissures and secured, and a lap stitch is used to connect the secant set and the Arran set at the base of the frame. Before finishing the lap stitch, the fabric is cut to create the deployment opening. After connection, a beta stitch is applied to the flange and the cuff is fixed in position.

[0073] 12A-12E show schematic diagrams of embodiments of valve replacements disclosed herein. More specifically, FIGs. 12A-12E show deployment belt loops commonly used in two-piece systems. The deployment belt loops can include one or more loop sets.

[0074] In a preferred embodiment, the adapter includes seven belt loops at the base of the adapter body, with belt loops on either side of the three anchors and one belt loop at the vertical seam. The adapter further includes 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 seen behind the long anchor (P1 / P3 anchor). The adapter also includes four belt loops along the flange, located on cross wires to the left and right of the long anchor. The adapter further includes two belt loops at the tip of the long anchor. In a preferred embodiment, the belt loop at the tip of the anchor includes three loops and all other belt loops include two loops, but it should be noted that the belt loops are not limited to a particular number of loops.

[0075] 12A shows the belt loops associated with the P1 and P3 anchors. The adapter is comprised of one or more belt loops 1205 behind the P1 and / or P3 anchors 1220 (i.e., on the body and not visible unless the anchor is lifted) and along the horizontal seam 1210. The adapter also includes one or more belt loops 1215 to the left and right of the P1 and / or P3 anchors 1220.

[0076] 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 flush with the ground. The adapter further includes a belt loop 1230 to the side of the P1 anchor 1235 and the P2 anchor 1240, which is also approximately flush with the ground.

[0077] 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 1210 and vertical seams 1250 and one belt loop 1255 is at the bottom of the vertical seam 1250.

[0078] 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 towards the flange. In other embodiments, the anchor may be perpendicular to the body.

[0079] 12E shows an anchor loop associated with the P1 and / or P3 anchors. In one embodiment, the anchor loop includes a double loop 1275 disposed on cross wires on the left and right flanges of the P1 anchor 1220 and / or P3 anchor 1220, and the anchor loop further includes a triple loop 1280 at the tip of the P1 anchor 1220 and / or P3 anchor 1220.

[0080] 13A-13D show schematic diagrams of embodiments of valve replacements disclosed herein. Figures 13A-13D show deployment belt loops typically used in single component systems. The deployment belt loops can include one or more loop sets. In a preferred embodiment, the single component system includes seven belt loops, the belt loops on the adapter body of the single component system are double loops, and the belt loops located on the horizontal seam are on cross wires along the same plane.

[0081] 13A shows the belt loops between P1 1305 and P3 anchor 1310. One belt loop 1315 is located along the horizontal seam 1320, one belt loop is located at the junction of the horizontal seam 1320 and the vertical seam 1325 and is aligned with the cross wires. The other two belt loops are located just outside of P1 1305 and P3 anchor 1310.

[0082] 13B shows a belt loop between the P2 anchor 1330 and the P1 anchor 1305 or P3 anchor 1310. One loop 1335 is placed along the horizontal seam and secured flush with the P2 anchor 1330 and the outer crossed wires of the long anchor (P1 / P3 anchor).

[0083] 13C shows belt loops 1340 of the long anchor, which are located on either side of the long anchor, and FIG. 13D shows belt loops 1345 of the P2 anchor 1330, which are located on either side of the P2 anchor 1330.

[0084] 13E and 13F show an embodiment of the location of deployment apertures 1350 located directly underneath each long anchor and on either side 1355 of the P2 anchor 1330.

[0085] 13G and 13H show another embodiment of the location of the deployment opening 1375. In this embodiment, fabric is removed (e.g., in a triangular shape) away from the commissures 1365 to expose the wire peaks, two peaks 1360. Lap stitches 1370 are placed around the perimeter of the frame to capture the wire around the exposed peaks.

[0086] (Engagement structure) FIG. 14A illustrates a schematic of one embodiment of a valve replacement disclosed herein. In an embodiment, as shown in FIG. 14A, the adapter or single component system includes a body 1405 and an atrial seal skirt 1410. The adapter body 1405 and the seal skirt 1410 can be constructed of various materials and have different dimensions. For example, the adapter body 1405 and the seal skirt 1410 can be constructed of wire braids of one or more wires of different diameters. The wires can be made of a material such as Nitinol and designed to be compressed to a small diameter such as 4 mm to 6 mm to be delivered within a catheter. When released, the adapter body 1405 and the seal skirt 1410 can expand in size (i.e., the body expands to a diameter of 25 mm or more and the seal skirt expands to anywhere from 40 mm to 70 mm in diameter).

[0087] The exterior surface of the adapter body 1405 may also be covered with a number of small, short barbs 1415. The barbs 1415 may be used to engage the leaflets or annulus of a dysfunctional heart valve, such as the mitral valve. The barbs 1415 may consist of a basic short wire and / or may have extra barb components, such as fish hook barbs, to hold the annular tissue stationary.

[0088] The adapter body 1405 may also have one or more hooks 1420 or 1425 of different sizes (more or less than the barbs 1415) that can hook under the native valve tissue. These larger hooks may or may not have fish-hook-like barbs. The larger hooks may act like a spring to engage the native valve tissue and prevent it from moving.

[0089] In a preferred embodiment, the seal skirt 1410 may be connected to a catheter and, as the adaptor body 1405 is released and engaged with biological tissue, the adaptor attachment is sequentially released from the catheter. The seal skirt 1410 may be designed to flex to radially overlap the adaptor body 1405 below, toward, or beyond a plane that defines the junction between the adaptor body 1405 and the seal skirt 1410. Multiple barbs 1415 on the adaptor body 1405 cooperate to forcefully engage the native annulus and resist downward pressure on the seal skirt 1410, such that the seal skirt 1410 forms a strong seal against the atrial tissue surrounding the native valve annulus.

[0090] 14B-14E show, in schematic form, an embodiment of a valve replacement disclosed herein. In these figures, the seal 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 initially round cross section. The adapter body 1405 has barbs 1415 designed to engage with the native leaflets 1450. When the barbs 1410 are engaged, the fixing / attaching feature of the adapter accessory causes the adapter body to 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 accommodation and conformity is achieved via different vias, wire diameters, or mechanisms that allow such. As shown in FIG. 14C, the change in shape creates a sharper curve radius to create a D-shape. The change from a circular cross section to a D-shaped cross section may pull on the leaflets, useful, for example, in the mitral valve where an implant such as an adapter 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 incorporate the sealing skirt and other features described in the previous figures.

[0091] 15A and 15B show schematic diagrams of embodiments of the valve replacement disclosed herein. FIG 15A shows an embodiment of the valve replacement implanted in a dysfunctional mitral valve with a body 1505 deployed in the mitral valve and a 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.

[0092] Deployment as disclosed in FIG. 15A ensures good engagement of the barbs with the posterior leaflet, but not necessarily with the anterior leaflet. The system is normally in this geometric state, but can be designed to be mechanically expandable by design such that it can be expanded to engage the anterior leaflet and then released to its normal position after the barbs and / or hooks have engaged the anterior leaflet. This biases the anterior leaflet towards the posterior leaflet, away from the LVOT and prevents occlusion after the procedure. Also shown is a delivery catheter 1520 and a guidewire 1525.

[0093] In another embodiment, the body of the valve replacement can be used to engage the leaflets with the barbs, where the body expands 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 a final configuration - symmetric or asymmetric - thereby drawing the leaflets towards the device and away from the LVOT.

[0094] 15B shows a schematic of an embodiment of an adapter attachment as disclosed herein, and discloses the final configuration of the adapter in its original position after release, where the anterior leaflet is drawn towards and held against the posterior leaflet, ensuring no obstruction of the LVOT.

[0095] 16A and 16D are schematic illustrations of an embodiment 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 FIG. 16B, the inflow end of the valve replacement can include anchor retraction sutures that pass through the flow section and are secured to the underside of the flange. These sutures allow control of the anchors by pulling and releasing the cords. Alternatively, the sutures can be releasably attached to the delivery system to provide similar manipulation of the anchors. FIG. 16B further discloses the cords attached to the anchors. FIG. 16C-16D show a collapsible flange attachment configuration.

[0096] 17A-17D show schematic diagrams of embodiments of the valve replacement disclosed herein. Figures 17A-17D 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 member, such as one 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.

[0097] Valve Assembly 18A and 18B show schematics of valve replacement embodiments disclosed herein. As shown in FIG. 18A and 18B, valve replacement embodiments can be fabricated with restraints to hold the adapter frame at a particular dimension while attaching materials that affect device performance. A manufacturing technique is disclosed that acts to affect the placement of the braided wire frame, eliminating the inherent freedom of movement and unpredictability that exists between opposing members of the frame structure in an unloaded state. This technique involves restraining the radial expansion of the frame, for example by threading a number of sutures through or around the structure to hold it at a particular dimension other than its unconstrained "free" dimension. In a subsequent manufacturing step, the structure is assembled into an assembly that adopts this new configuration, which is considered the final dimension. When the restraint is removed from the braided frame, it will attempt to return to its original "free" dimension - exerting additional radial force on the surrounding structure while being restrained at the desired dimension.

[0098] The degree of radial force transferred from the frame to the fabric material can be tailored as needed to achieve an optimal 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) is 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.

[0099] 19A and 19B generally illustrate an embodiment of a valve replacement disclosed herein. FIG. 19A generally illustrates an embodiment of a valve assembly in which leaflets 1905 are assembled to one another and / or to a frame by sewing. The leaflets are joined at commissure joints 1910 and then sewn, welded or otherwise attached to commissure struts and other points on the frame such as wires or wire crossings or material attached to the frame, for example, the leaflets are attached to a cuff which is then attached to the frame. Once assembled, the leaflets cooperate to close on the outflow side (distal if embedded in a mitral valve leaflet) when fluid pressure is increased distally, causing the leaflets to close or coapt in a Y pattern 1920.

[0100] As shown in FIG. 19B, the valve assembly 1930 includes a braided frame and an outer cuff cover 1935. This cuff, covering the complete outer frame, can function as an extended seal zone. The abdominal stitches 1940 are sewn to the frame, while the bellows stitches 1945 are not. In this embodiment, the distal leaflet ends 1950 are shown coapted to close the valve in a gentle Y-shape. In some embodiments, the coapting regions of the valve can include some "relaxation" to ensure sufficient and effective contact between the three leaflets and 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, valves or portions of valves extracted from animals can be sewn to the disclosed frame structure.

[0101] One embodiment of the valve replacement disclosed herein is shown generally in Figure 20. Figure 20 is a bottom perspective view of a single component system including a flange 2005, an adapter body 2010, tabs 2015 that fit the leaflets, and a braided wire frame that makes up the leaflets 2020.

[0102] Other embodiments may include combinations and subcombinations of features described or shown in the various figures, including embodiments 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 an embodiment, or removing one or more features from an embodiment and adding one or more features extracted from one or more other embodiments, providing the advantages of the features incorporated in such combinations and subcombinations. As used in this paragraph, "feature" or "feature" may refer to the structure and / or function of an apparatus, article of manufacture or system, and / or to a method step, act or aspect.

[0103] References throughout this specification to "one embodiment," "an embodiment," "exemplary embodiment," and the like 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, if a particular feature, structure, or characteristic is described in connection with one embodiment, it will be within the knowledge of one of ordinary skill in the art to affect such feature, structure, or characteristic in connection with other embodiments, whether or not expressly described.

[0104] Unless the context clearly indicates otherwise, (1) the word "and" indicates the conjunctive mood, (2) the word "or" indicates the disjunctive mood, (3) when an article is expressed in the disjunctive mood and is followed by the words "or both," both the conjunctive and disjunctive moods are intended, and (4) the words "and" or "or" between the last two items in a series apply to the entire series.

[0105] When a group is expressed with the term "one or more" followed by a plural noun, when that noun is further used to refer to one or more members of the group, both the singular and the plural of the noun must be indicated. For example, if a group is expressed as having "one or more members," followed by a reference to a "member" of the group, this means that "member" if there is one member of the group.

[0106] The term "a" or "an" entity refers to one or more of that 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 be used interchangeably. [Explanation of symbols]

[0107] 100 Valve replacement part 200 Heart valve frame 250 Heart valve assembly

Claims

1. A device for assisting the function of a heart valve, comprising: a tubular braided frame having an inflow end and an outflow end; a flange structure at an inflow end of the tubular braid frame; at least one anchor at an outflow end of the tubular braided frame, the at least one anchor configured to be secured to native valve tissue; at least one commissure tab at an outflow end of the tubular braid frame; a leaflet assembly connected to the at least one commissure tab, the leaflet assembly configured to provide a seal between an inflow end and an outflow end of the tubular braided frame; A device comprising:

2. 10. The device of claim 1, wherein the tubular braided frame further comprises at least one braided wire wound in a helical direction, the helical direction beginning at the inflow end and ending at the outflow end, the tubular braided frame configured to expand and compress in conjunction with cardiac contraction.

3. 3. The device of claim 2, wherein the at least one braided wire comprises a wire of a first material type, the wire of the first material type comprising a first wire type, a first wire bundle, a first strip, a first rod, a first tube, or combinations thereof.

4. 4. The device of claim 3, wherein one or both of the flange structure and the at least one anchor comprises one or both of the first wire type and a wire of a second material type, the wire of the second material type comprising a second wire type, a second wire bundle, a second strip, a second rod, a second tube, or a combination thereof.

5. The device of claim 2 , wherein one or both of the flange structure and the at least one anchor are configured to radially overlap the tubular braided frame.

6. 3. The device of claim 2, wherein a layer of material extends over one or more of an outer portion of the tubular braided frame, an inner portion of the tubular braided frame, a top of the flange structure, a bottom of the flange structure, a top of the at least one anchor, and a bottom of the at least one anchor.

7. The device of claim 2 , wherein the tubular braided frame further comprises an engagement attachment, the engagement attachment comprising a barb, a hook, a clip, or a combination thereof.

8. 7. The device of claim 6, wherein the layer of material extending over an outer portion of the tubular braided frame comprises one or more belt loops at one or both of an inflow end and an outflow end of the tubular braided frame.

9. 3. The device of claim 2, wherein the tubular braided frame comprises a radial force when in compression, the tubular braided frame being configured to expand against the radial force when the device is delivered to a heart valve.

10. A device for assisting the function of a heart valve, comprising: an adapter including a tubular braided adapter frame having an inlet end and an outlet end; a flange structure at the inlet end of the tubular braid adapter frame; at least one anchor at the outflow end of the tubular braided adapter frame, the at least one anchor configured to be secured to native valve tissue; A device comprising:

11. Further comprising a valve assembly; 11. The device of claim 10, wherein the valve assembly comprises a tubular braided valve assembly frame having a second inflow end and a second outflow end, the valve assembly comprising at least one commissure tab at the second inflow end, the valve assembly comprising a leaflet assembly connected to the at least one commissure tab, the leaflet assembly configured to provide a seal between the second inflow end and the second outflow end.

12. 12. The device of claim 11, wherein the valve assembly is configured to removably engage the adapter, an inflow end of the adapter proximal to the second inflow end, and an outflow end of the adapter proximal to the second outflow end.

13. 11. The device of claim 10, wherein the tubular braided adapter frame further comprises at least one braided wire wound in a helical direction, the helical direction beginning at the inflow end and ending at the outflow end, the at least one braided wire wound in a helical direction configured to expand and compress in conjunction with cardiac contraction.

14. 12. The device of claim 11, wherein the tubular braided valve assembly frame further comprises at least one braided wire wound in a helical direction beginning at the second inflow end and ending at the second outflow end, the at least one braided wire wound in a helical direction configured to expand and compress in conjunction with cardiac contraction.

15. 14. The device of claim 13, wherein the at least one braided wire comprises a wire of a first material type, the wire of the first material type comprising a first wire type, a first wire bundle, a first strip, a first rod, a first tube, or combinations thereof.

16. 16. The device of claim 15, wherein one or both of the flange structure and the at least one anchor comprise one or both of the first wire type and a wire of a second material type, the wire of the second material type comprising a second wire type, a second wire bundle, a second strip, a second rod, a second tube, or a combination thereof.

17. The device of claim 10 , wherein one or both of the flange structure and the at least one anchor are configured to radially overlap the tubular braid adapter frame.

18. The device of claim 10 , wherein a layer of material extends over one or more of an outer portion of the tubular braided adapter frame, an inner portion of the tubular braided adapter frame, a top of the flange structure, a bottom of the flange structure, a top of the at least one anchor, and a bottom of the at least one anchor.

19. The device of claim 10 , wherein the tubular braided frame further comprises an engagement attachment, the engagement attachment comprising a barb, a hook, a clip, or a combination thereof.

20. 11. The device of claim 10, wherein the layer of material extending over an outer portion of the tubular braided adapter frame comprises one or more belt loops at one or both of an inflow end and an outflow end of the tubular braided adapter frame.

21. 15. The device of claim 14, wherein one or both of the tubular braided adapter frame and the tubular braided valve assembly frame are configured to contain a radial force when in a compressed state and to expand against the radial force when delivered to the heart valve.

22. A device for assisting the function of a heart valve, comprising: a valve assembly including a tubular braided frame; the tubular braid frame includes at least one braided wire having an over-and-under braid pattern; the valve assembly includes an inlet end and an outlet end; the valve assembly includes at least one commissure tab at the inflow end, the valve assembly includes a leaflet assembly connected to the at least one commissure tab, the leaflet assembly configured to provide a seal between the inflow end and the outflow end.

23. 23. The device of claim 22, wherein the at least one braided wire is wound in a helical direction beginning at the inflow end and ending at the outflow end, and wherein the valve assembly is configured to expand and compress in response to cardiac contraction.

24. 24. The device of claim 23, wherein the valve assembly comprises a wire of a first material type, the wire of the first material type comprising a first wire type, a first wire bundle, a first strip, a first rod, a first tube, or combinations thereof.

25. 23. The device of claim 22, wherein a layer of material extends across one or both of an outer portion of the valve assembly and an inner portion of the valve assembly.

26. 24. The device of claim 23, wherein the tubular braided frame comprises a radial force when in a compressed state, the tubular braided frame being configured to self-expand due to the radial force when the device is delivered to a heart valve.

27. A device for assisting the function of a heart valve, comprising: a tubular frame having an inlet end and an outlet end; A device, wherein the tubular frame includes at least one braided wire wound in a helical direction and having an over-and-under braid pattern, the helical direction beginning at the inflow end and ending at the outflow end, the tubular frame being configured to expand and compress in connection with cardiac contraction.

28. 28. The device of claim 27, wherein the tubular frame comprises wires of a first material type, the wires of the first material type comprising a first wire type, a first wire bundle, a first strip, a first rod, a first tube, or a combination thereof.

29. 30. The device of claim 27, wherein a layer of material extends across one or both of an outer portion of the tubular frame and an inner portion of the tubular frame.

30. 28. The device of claim 27, wherein the tubular frame comprises a radial force when in a compressed state, the tubular frame being configured to expand against the radial force when the device is delivered to a heart valve.

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