Apparatus, system, and method for implantable heart valve adapters

Abstract

The present invention provides an apparatus, system, and method for an implantable cardiac valve adapter that enables compact and safe delivery to the heart, convenient control of the adapter during implantation, and convenient control of valve expansion and contraction during implantation, removal, and replacement. [Solution] An implantable heart valve adapter device comprising a tubular braided frame, wherein the tubular braided frame comprises an inlet end and an outlet end, the tubular braided frame extends outward from the inlet end to form at least one flange, and the tubular braided frame extends outward from the outlet end to form at least one engagement fitting.

Description

Technical Field

[0001] (Related Application) This application claims the priority and benefit of U.S. Provisional Application No. 63 / 082,035, filed on September 23, 2020, entitled "Devices, Systems, and Methods for a Mitral-Valve Adapter Attachment", the entire disclosure of which is incorporated herein by reference.

[0002] (Technical Field) The present disclosure generally relates to cardiac valve replacement techniques, and to devices, systems, and methods for an implantable cardiac valve adapter, such as a mitral valve, and more specifically to implantation at a desired treatment site. Features of the disclosed cardiac valve adapter include high flexibility, elasticity, conformity, and serving as a receptacle for a replaceable cardiac valve.

Background Art

[0003] Heart valve interventions, such as open-heart surgery, are often necessary to treat disease of one or more of the four heart valves that work together to keep blood flowing properly through the heart. Heart valve replacement and / or repair are often necessary when a valve is "leaking" (e.g., there is valvular regurgitation) or when a valve is narrowed and does not open properly (e.g., valvular stenosis). Typically, heart valve replacement surgeries, such as mitral valve replacement, involve replacing the heart's original valve (natural valve) with a mechanical valve and / or tissue valve (bioplasty valve). Common problems with valve and / or valve frame replacement include a) deterioration of the valve leaflets (valve-like structures), b) damage or failure of the frame (especially with laser-cut nitinol frames), and c) undesirable changes in the size of the natural valve annulus. Heart valve replacement can lead to further problems after implantation. For example, a replacement valve may move or shift after being placed in the desired location within the heart, or its location may not allow for proper directional blood flow through other parts of the organ, such as the left ventricular outflow tract. Furthermore, replacement valves cannot be easily removed, as such removal would almost always damage the surrounding cardiac tissue. This can be particularly problematic if, for example, the replacement valve was not properly and accurately positioned when implanted in the natural heart, and in the event of valve failure, which may occur several years after initial implantation. A further problem is that typical replacement valves, especially laser-cut valve frames, are relatively rigid and inflexible, potentially resulting in a valve that is inflexible against the dynamic movements of the heart's pumping function. Such inflexible valves are unsuitable for these dynamic movements, which can lead to trauma to the cardiac surface, fracture of the frame itself, or otherwise cause or worsen problems during or after implantation. [Overview of the project] [Problems that the invention aims to solve]

[0004] Therefore, there is a need for devices, systems, and methods to improve and facilitate valve implantation using a heart valve adapter, which enables compact and reliable delivery to the heart, convenient control of the adapter during implantation, and preferably convenient control of valve expansion and contraction during catheter-based implantation or removal / replacement. Furthermore, there is a need for devices, systems, and methods to ensure proper directional blood flow through the heart during and after valve replacement procedures. [Means for solving the problem]

[0005] The following provides a brief overview of exemplary embodiments to offer a basic understanding of some embodiments of the disclosure of the present invention. This overview is not a comprehensive overview of the exemplary embodiments. It is not intended to identify any important or definitive elements of the exemplary embodiments or to describe the scope of the appended claims. Its sole purpose is to present, in a brief form, some concepts of the exemplary embodiments as an introduction to the more detailed description presented below herein. It will be understood that both the following overall description and the subsequent detailed description are merely illustrative and descriptive, and not restrictive.

[0006] This disclosure relates to apparatus, systems, and methods for heart valve adapters that serve the purpose of locking, sealing, and managing / controlling the position of valve leaflets and subvalvular structures. The adapter is highly flexible, resilient, and fatigue-resistant and secures the valve receiver to the natural valve tissue. As disclosed herein, the adapter receiver receives a replacement heart valve that can be replaced several years after implantation in the event of problems such as recurrent mitral regurgitation.

[0007] Further advantages, embodiments, and features of the disclosure of the present invention will be immediately apparent to those skilled in the art from the following description, which merely illustrates preferred embodiments of the disclosure of the present invention to describe one of the best modes of carrying out the disclosure of the present invention. As will be acknowledged below, the disclosure of the present invention can be made into other different embodiments without departing from or limiting the scope of this specification, and some of its details can be modified in various obvious embodiments. Accordingly, the drawings and description will be considered illustrative rather than restrictive.

[0008] The accompanying drawings incorporated herein and constituting part of herein illustrate embodiments of the disclosure and, together with the general description of the disclosure above and the detailed description of the drawings below, help to illustrate the principles of the disclosure. In certain examples, details that are not necessary for understanding the disclosure, or that would make it difficult to understand other details, may be omitted. [Brief explanation of the drawing]

[0009] [Figure 1] Embodiments of the heart valve adapter disclosed herein are schematically shown. [Figure 2] Embodiments of the heart valve adapter disclosed herein are schematically shown. [Figure 3A] Embodiments of the heart valve adapter disclosed herein are schematically shown. [Figure 3B] Embodiments of the heart valve adapter disclosed herein are schematically shown. [Figure 3C] Embodiments of the heart valve adapter disclosed herein are schematically shown. [Figure 3D] Embodiments of the heart valve adapter disclosed herein are schematically shown. [Figure 4] Embodiments of the heart valve adapter disclosed herein are schematically shown. [Figure 5] Embodiments of the heart valve adapter disclosed herein are schematically shown. [Figure 6]Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 7] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 8] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 9A] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 9B] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 9C] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 10A] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 10B] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 10C] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 10D] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 10E] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 11A] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 11B] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 11C] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 12A] Schematically shows an embodiment of the heart valve adapter disclosed in this specification [Figure 12B] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 13A] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 13B] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 13C] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 14A] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 14B] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 14C] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 14D] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 15] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 16A] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 16B] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 17A] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 17B] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 18] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 19] Schematically shows an embodiment of the heart valve adapter disclosed in this specification. [Figure 20] Schematically shows an embodiment of the heart valve adapter disclosed in this specification.

Embodiments for Carrying Out the Invention

[0010] Before disclosing and describing the System and Method, it should be understood that the System and Method are not limited to any particular method, component, or implementation. It should also be understood that the terms used herein are for the purpose of describing a particular embodiment only and are not intended to limit it. Various embodiments will be described with reference to the drawings. The following description includes numerous specific details to enable a full understanding of one or more embodiments. However, it will be apparent that various embodiments can be carried out without these specific details. In some cases, well-known structures and apparatus are shown in block diagram form to facilitate the description of these embodiments.

[0011] This specification discloses devices, systems, and methods for providing a thinner heart valve adapter while simultaneously increasing the rigidity and strength of the locking / stabilizing element. Furthermore, a heart valve adapter (referred to herein simply as “adapter” for ease of use) comprising at least a foldable adapter body and a sealing skirt assembly that together serve to provide a sealing portion is disclosed. The disclosures and corresponding concepts described herein that apply to the treatment of mitral valve pathology can similarly be applied to the treatment of aortic valve, as well as tricuspid valve and pulmonary valve.

[0012] The adapter can be delivered using a catheter and can be easily controlled and reliably deployed using common catheter guidance techniques. The adapter may be equipped with valve engagement devices, such as locking attachments, for the purpose of fixation to the natural valve. For example, the adapter can be positioned close to the posterior leaflet and has a fixed and locking function that extends and is positioned at any location between 120 and 180 degrees, preferably in a 150-degree span. The adapter may further be equipped with attachments and additional features for catheter delivery, positioning, partial deployment, and removal.

[0013] Figure 1 schematically shows an embodiment of a heart valve adapter disclosed herein. In an embodiment, as shown in Figure 1, the adapter is a tubular braided frame comprising at least a body portion 105 having an inlet end and an outlet end. In some embodiments, the adapter may further comprise an atrial sealing skirt portion 110 extending outward from the inlet end of the tubular braided frame. The adapter body 105 and sealing skirt 110 can be made of a variety of materials and can be of a variety of dimensions. For example, the adapter body 105 and sealing skirt 110 may be made of a wire braid of one or more wires having different diameters, the wires extending outward as flanges away from the body portion 105, and the extended flanges constitute the sealing skirt 110. 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 into a catheter. The adapter body 105 and the sealing skirt 110 can expand in size when released (i.e., the body can expand to a diameter of 25 mm or more, and the sealing skirt can expand to a diameter in the range of 40 mm to 70 mm). Other materials that can be used to make the wire include, but are not limited to, stainless steel, cobalt-chromium, and nylon.

[0014] The adapter body 105 and the sealing skirt 110 can be strategically covered with fabric 115 for the purpose of sealing the flow and / or promoting (e.g., influencing either promotion or inhibition) tissue growth after implantation. In other embodiments, the fabric 115 can cover only the sealing skirt 110 or a portion of the engaging attachment described later. The fabric 115 can extend to the inner and outer portions of the tubular braided frame, which may include the body 105, the sealing skirt 110, and / or some engaging attachment.

[0015] In some embodiments, the outer surface of the adapter body 105 is an extension of the tubular braided frame and can be covered with a number of small, short barbs 120 extending outward from the outflow end to function as an engaging fixture. The barbs 120 can be used to engage with the leaflets or annulus of a dysfunctional heart valve, such as the mitral valve. The barbs 120 can consist of basic short wires and / or may have special barb components, such as fishhook barbs, to securely hold annular tissue.

[0016] The adapter body 105 may also have one or more hooks 125 or 135 of different sizes (more or fewer than the spines 120) that can hook under the natural valve tissue. These larger hooks may or may not have fishhook-type spines. The larger hooks may have a spring-like function that engages with the natural valve tissue to prevent it from moving. In some embodiments, the hooks 125 or 135 are extensions of a tubular braided frame that extend outward from the outlet end to function as engaging fixtures.

[0017] In a preferred embodiment, the sealing skirt 110 can be coupled to the catheter, and the adapter is sequentially released from the catheter as the adapter body 105 is released and engages with the annular tissue. The sealing skirt 110 may be designed to curve downward toward or through a plane defining the junction between the adapter body 105 and the sealing skirt 110. Multiple spines 120 on the adapter body 105 cooperate to ensure that the adapter body 105 engages firmly with the natural annulus and resists the downward pressure of the sealing skirt 110, so that the sealing skirt 110 generates a firm seal against the atrial tissue surrounding the natural annulus.

[0018] Figure 2 schematically shows one embodiment of a heart valve adapter disclosed herein. As shown in Figure 2, the adapter comprises an adapter body 205 and a sealing skirt 210, the sealing skirt 210 expanding substantially near the plane of the junction between the adapter body 205 and the sealing skirt 210. The adapter may further include a spine 215 having the ability to be retracted via a cord 220 passing through a catheter 225. The spine 215 can securely grasp the natural valve and press it against the adapter body 205. When the spine 215 is retracted, the cord 220 can be withdrawn via the catheter 225.

[0019] The adapter may further include locking functionality similar to the engaging attachments disclosed herein. For example, the adapter may lock onto the notochord. In one embodiment, this can be done with a suture intentionally looped behind a valve leaflet / notochord structure that can be tightened. In another embodiment, locking can be achieved with a vine-like structure that holds and wraps around the notochord in one direction, such as a spine that allows for unidirectional movement.

[0020] Figures 3A to 3D schematically illustrate one embodiment of a heart valve adapter disclosed herein. In these figures, a sealing skirt is not shown for the sake of illustration. As shown in Figure 3A, the adapter body 305 is designed with braids of different weave densities and / or wire diameters such that the adapter body initially has a round cross-section, and / or is combined with a release mechanism. The adapter body 305 has a spine 310 designed to engage with the natural valve membrane 350. When the spine 310 engages, the adapter locking / fitting function causes the adapter to adapt to a "D-shape" or other asymmetrical shape, maintaining the receiving body 305 in a cylindrical or special shape to receive other valve structures. This adaptation and fit is achieved through different weaves, wire diameters, or mechanisms that enable such adaptations. As shown in Figure 3B, a sharper curvature radius is generated to create a D-shape by the change in shape. The change from a circular cross-section to a D-shaped cross-section can pull the valve leaflets, which may be useful in mitral valves where grafts such as adapter bodies could cause outflow tract obstruction. Figures 3C and 3D disclose perspective views of the structure and mechanism corresponding to Figures 3A and 3B. The embodiments disclosed in Figures 3A to 3D may also include the sealing skirt and other features shown in the earlier drawings.

[0021] Figure 4 schematically illustrates one embodiment of a heart valve adapter disclosed herein. Figure 4 discloses a cross-section of the mitral valve having space to the left of the anterior leaflet, specifically the anterior leaflet 405, the posterior leaflet 410, and the left ventricular outflow tract (LVOT) 415 leading to the aortic valve 420. Figure 4 serves to illustrate in detail the embodiments disclosed in the following figures.

[0022] Figure 5 schematically shows an embodiment of a heart valve adapter disclosed herein. Figure 5 discloses an embodiment of an adapter implanted in a dysfunctional mitral valve, where the adapter body 505 unfolds in the mitral valve and the sealing skirt 510 unfolds relative to the floor of the left atrium. In this embodiment, the adapter body 505 is oriented at a slight angle (i.e., 10 to 30 degrees relative to the plane of the skirt) such that when the adapter body 505 is unfolded it is biased toward the posterior leaflet 515.

[0023] The deployment as disclosed in Figure 5 ensures good engagement of the spinous portion (not necessarily the anterior portion) with the posterior leaflet. The system is typically designed to be in this geometric state, but can be mechanically expandable by design so that it can expand to engage with the anterior leaflet, and then be released after the spinous portion and / or hook have engaged with the anterior leaflet and return to their normal position. This pushes the anterior leaflet toward the posterior leaflet and away from the LVOT, ensuring that it is not occluded after the procedure. The delivery catheter 520 and guidewire 525 are also shown.

[0024] Figure 6 schematically shows an embodiment of the heart valve adapter disclosed herein. Figure 6 discloses an embodiment in which the adapter body 605 is configured in a D-shaped cross-section as disclosed in Figures 3A to 3D.

[0025] Figure 7 schematically illustrates an embodiment of a heart valve adapter disclosed herein. As shown in Figure 7, the adapter embodiment can be mechanically expanded after implantation and, using a balloon catheter, bring about engagement of the anterior leaflet or other locking mechanism. Such balloon catheter approaches are common in valve and vascular stenting and are known in the art. Methods for the temporary mechanical expansion of the adapter body include, but are not limited to, a tightening mechanism that can be pulled or actuated and then released, and a pre-sprung wire, etc.

[0026] In another embodiment, the adapter body can be used to engage the valve leaflet with a spine, and the body expands to a diameter larger than its diameter when deployed to ensure engagement with the valve leaflet. As the device is further deployed, the diameter of the engaging portion shrinks to the final configuration (symmetrical or asymmetrical), and as a result the valve leaflet is pulled away from the LVOT towards the device.

[0027] Figure 8 schematically shows one embodiment of the heart valve adapter disclosed herein. Figure 8 discloses the final configuration of the adapter in its original position after release, in which the anterior leaflet is pulled and held toward the posterior leaflet, ensuring that there is no obstruction of the LVOT.

[0028] Figure 9A schematically shows an embodiment of a heart valve adapter disclosed herein. Figure 9 discloses a wire braided frame constituting the adapter. As further shown in Figure 9, the wire braided frame may have a 24-point braid pattern with double posterior leaflet locking portions 905, which are used to maintain symmetry and provide an additional double structural locking. The wire braided frame may also have double stabilizing locking portions 910. It is also shown that the wire braided frame may have locking positions available in 15-degree increments. In some embodiments, the locking portions may be extensions of the tubular braided frame and may extend outward from the outflow end to function as engaging fixtures.

[0029] In other embodiments, the wire braid frame of the adapter may have a locking portion (or, as disclosed herein, a thorn, hook, or clip) to be joined. For example, Figure 9A shows a combination of larger gauge wire (0.0175'' to 0.02'') (represented by a stabilizing locking portion 910) and smaller gauge wire (0.012'' to 0.0175'') (represented by a rear-pointed locking portion 905 and further represented by an additional wire 915) by a joining operation at the interface between wires of different sizes. The joining interface may be a welded portion or a welded portion with a support tube.

[0030] Figure 9B schematically shows one embodiment of a heart valve adapter disclosed herein. As shown in Figure 9B, the stabilizing lock 910 can be shaped to include a second bend on the U-shaped end. In other embodiments, the stabilizing lock is positioned symmetrically with the P2 lock over a 150-degree span. At this angle, the stabilizing lock is optimally inserted posterior to the posterior leaflet and extends to the mitral annulus near the fibrous triangle.

[0031] Figure 9C schematically illustrates one embodiment of a heart valve adapter disclosed herein. As shown in Figure 9C, the wire braided frame may include a posterior leaflet locking portion 905 instead of a stabilizing locking portion. In this embodiment, the posterior leaflet locking portion 905 and flange 920 provide the necessary fixation of the graft and locking to the natural valve annulus. In other embodiments, a single quadruple locking portion designated as a P4 locking portion may provide even more structural locking by extending four loops instead of just two. P4 refers to a locking portion with four bumps in the location of the P2 locking portion. The number and location of these locking portions can fall anywhere within the 180-degree span of the locking features described above. Additionally, additional locking portions and / or leaflet clips can enhance the posterior leaflet locking portion.

[0032] Figures 10A to 10E schematically illustrate one embodiment of a heart valve adapter disclosed herein. In one embodiment, as shown in Figure 10A, the adapter may comprise an atrial sealing skirt 1005, an adapter body 1010, and a stabilizing locking portion 1015, all covered with fabric, for the purpose of sealing flow and / or promoting post-implantation tissue growth (e.g., influencing either promotion or inhibition). The embodiment may further comprise a clip 1020 that is not covered with fabric.

[0033] Figures 10B and 10C show embodiments of the adapter. Figure 10B shows an adapter that has only a stabilizing locking portion 1025 which is not covered with fabric. Figure 10C shows an adapter that has a fabric layer and a rear-pointed locking portion 1030 having a clip 1035.

[0034] Figure 10D shows an embodiment of the adapter through which the delivery rod 1040 is inserted. As shown in Figure 10D, a suture or rigid rod can be passed through the tab at the inlet end of the adapter and used to restrict the graft to an intermediate compressed state. Figure 10E shows an embodiment of the bottom of the adapter shown in Figure 10E.

[0035] Figures 11A to 11C schematically illustrate one embodiment of a cardiac valve adapter disclosed herein. These figures show one embodiment of an adapter comprising a clip component for the purpose of improving delivery control through secure attachment of the adapter to the delivery catheter and for the purpose of improving the efficiency and effectiveness of leaflet implantation.

[0036] Figure 11A is a schematic diagram of the flat pattern of the wireframe of an adapter having a clip 1105, where the clip 1105 can be a loop-shaped portion of the wireframe extending outward from the body of the wireframe. In some embodiments, the clip 1105 can be positioned at two or more separate locations around the circumference of the adapter. In other embodiments, the clip 1105 is shaped 180 degrees so that it can provide a hook shape that clips onto a natural valve ring. For example, when the adapter is released from the delivery system, the clip 1105 can be attached to the natural valve ring, providing fixation of the adapter.

[0037] Figure 11B shows an embodiment of the wireframe of an adapter having a clip 1105, a rear-pointed locking portion 1110, and a flange 1115. Figure 11C shows an embodiment of the wireframe of an adapter having a clip 1105, a rear-pointed locking portion 1110, and a flange 1115. In various embodiments, some or all of the engaging fixtures (locking portions, spikes, hooks, and clips) may have a material layer covering some or all of the engaging fixtures.

[0038] Furthermore, the locking and clips disclosed herein serve the purpose of improving the control and removal of the adapter. For example, the locking and clips can be controlled (e.g., partially or completely contracted) by attaching sutures and / or other cord-type control features to the locking and clips and then passing this line through the frame of the adapter.

[0039] In one embodiment of the foldable locking mechanism, the cord is sewn through the tip of the locking mechanism five to seven times, and the excess is secured with a figure-eight knot. The ends of the cord are then passed through the inside of the adapter and wrapped around it, and pulled out to the bottom through an existing hole in the flange. Leaving 4 mm of excess cord, the ends are tied with two square knots, and the ends are cut off. These fixed sutures become pull tabs that can be grasped and pulled apart with forceps to fold the locking mechanism or clip using vertical force.

[0040] In an embodiment of the foldable flange, the cord is looped through an existing hole in the flange, leaving a diamond pattern facing the top of the adapter. Both ends of the cord are tied together with two square knots to form a closed loop. This allows forceps to grasp the cord and fold the flange. In other embodiments, both the locking / clip and the flange fold simultaneously, resulting in an even greater ability to remove the adapter.

[0041] Furthermore, foldable locking sections and flanges can be improved by enabling the ability to control the locking sections / clips and flanges during adapter deployment. For example, by passing a cord through a loop left by a pull tab, the locking sections can be controlled by folding one or both of them away from the base of a delivery device such as a catheter. This is useful when delivering the adapter and gives the physician the ability to have more precise control over the placement and positioning of the locking sections / stabilizing elements.

[0042] Figures 12A and 12B schematically illustrate one embodiment of a heart valve adapter disclosed herein. Figure 12A shows a top view of the adapter, and Figure 12B shows a bottom view of the adapter. As shown in Figures 12A and 12B, the inlet end of the adapter may be provided with a locking retraction cord that passes through the flow portion and reaches the underside of the flange. This suture allows for control of the locking portion by pulling and releasing the cord. Alternatively, the suture may be releasably attached to the delivery system to provide similar operation of the locking portion. Figure 12B further discloses a cord attached to a locking portion.

[0043] Figures 13A to 13C schematically illustrate one embodiment of a heart valve adapter disclosed herein. Figures 13A to 13C show mounting configurations for a foldable flange. Figure 13C shows, in one embodiment, a method by which sutures extending from a delivery system are connected to points on the adapter, allowing for control of flange repositioning and / or orientation during deployment.

[0044] Figures 14A to 14D schematically illustrate one embodiment of a heart valve adapter disclosed herein. Figures 14A to 14D show the mounting configuration of a foldable locking portion and a clip, and further disclose enlarged views of the suture pattern used to fold and control the locking portion from all angles of the adapter. In these embodiments, for example, a delivery component having one or more suture lines is connected at a first end to an engagement attachment, and one or more suture lines are connected at a second end to a control mechanism.

[0045] Figure 15 schematically shows an embodiment of a cardiac valve adapter disclosed herein. As shown in Figure 9, an embodiment of the adapter may have a shape and structure that supports the Valsalva sinus structure. Such a structure can enhance coronary perfusion by ensuring coronary patency and mimicking the function of a natural valve, or by adding further hemodynamically responsive members, such as valve leaflet-shaped cardiac valve leaflets, to the proximal portion of the device.

[0046] As disclosed herein and corresponding to Figure 9, the frame's fit and inherent adaptability to asymmetrical anatomical structures are suited to an unmet need for a device that can be used at the aortic valve site when balloon expansion of calcified tissue results in an asymmetrically shaped orifice.

[0047] Figures 16A and 16B schematically illustrate one embodiment of a heart valve adapter disclosed herein. As shown in Figures 16A and 16B, the embodiment of the adapter may comprise a continuous piece of material around the outside of the adapter frame. The continuous seal extending from the skirt of the adapter may consist of a material (such as fabric) extending from the inlet edge of the receiving portion of the adapter to the outside of the receiving body. An inwardly extending fabric strip may be sewn around the inlet edge of the skirt, and the non-porous covering forms a continuous seal extending into the ventricle.

[0048] The continuous surface of the fabric can locally influence and characterize modifiable or contradictory properties, such as coating with medical polymers in areas where tissue adhesion is undesirable, space filling, or hydrogels with desired latent effects, or hydrophilic tissue adhesives. The continuous material structure of the fabric can be voluminous, fill spaces, and conform round heart valves to the asymmetrical shape of the annulus. Combined with other attachment methods, embodiments of mitral valve adapters fabricated in this way assist in the engagement and attachment of leaflet tissue and other subvalvular structures. Partially porous fabrics result in improved sealing of replacement valves and allow adaptation to irregularly shaped anatomical structures due to the fabric's conformability.

[0049] Figures 17A and 17B schematically illustrate one embodiment of a heart valve adapter disclosed herein. As shown in Figures 17A and 17B, the adapter embodiment can be fabricated using constraints that hold the mitral valve adapter frame to specific dimensions while attaching materials that affect device performance. A fabrication technique is disclosed that acts to affect the arrangement of the braided wire frame by removing the inherent freedom of movement and unpredictability that exists between opposing members of the frame structure in an unloaded state. This technique includes restricting the radial expansion of the frame with constraints, such as supplying some number of sutures through or around the structure to hold it to specific dimensions other than its unrestricted "free" dimensions. In a subsequent fabrication process, the structure is incorporated into an assembly that adopts this new configuration, which is considered to be the final dimensions. Once the constraints are removed from the braided frame, the braided frame attempts to return to its original "free" dimensions by applying additional radial forces to the surrounding structure while being constrained to the desired dimensions.

[0050] In some embodiments, the tubular braided frame of the adapter can be a braid of one or more wires, and the braid of one or more wires can be a zigzag braid or an upper and lower double braid.

[0051] Figure 18 schematically illustrates one embodiment of a heart valve adapter disclosed herein. As shown in Figure 18, the pull cord 1805 may include a drawstring 1810 that is tightened to facilitate the removal of the valve portion. Figure 18 shows a pull cord 1805 tightening the outflow end of a foldable valve adapter constructed from a tightening drawstring and tethering segment 1815, similar to a hangman's knot, with a drawstring that surrounds the outflow end of the valve via a loop. The long end extending from the knot can be tethered to a commissar column that forms a hookable portion of the exposed suture material. Radiopaque markers may be provided at both ends of the tether to facilitate the guidance of the hook to the tether.

[0052] Figure 19 schematically shows an embodiment of the heart valve adapter disclosed herein. As shown in Figure 19, an additional cylindrical tube 1905 can be used to introduce countertraction, which allows for tightening of the tightening knot. The increase in tension / countertraction results in the valve end being irreversibly folded due to friction at the knot. Thus, the valve can be retracted and removed from the body more easily and safely.

[0053] Figure 20 schematically shows one embodiment of a heart valve adapter disclosed herein. More specifically, Figure 20 shows a partially compressed valve after a drawstring has been tightened.

[0054] The degree of radial force transmitted from the frame to the fabric can be adjusted as needed to achieve the optimal combination or performance characteristics. In detail, the strain energy density of the structure can be made more uniform. Greater stiffness can be achieved with less material (resulting in a better seal), and consequently, a thinner structure can be obtained. The sutures ultimately allow the structure to be biased for the desired diameter and height for the valve structure.

[0055] To further expand the concept, structures having the features described herein can be developed individually or jointly in combined designs to engage with both the mitral valve apparatus and the aortic valve apparatus and / or annulus. The intention is to influence the leaflets of both valves, as well as the valve angles relative to each other, to ensure the most effective management of flow through the ventricle and the maximization of outflow tract efficiency.

[0056] Other embodiments may include, for example, combinations and partial combinations of features described or illustrated in some figures, while bringing to fruition the benefits of the features incorporated into such combinations and partial combinations, including embodiments that provide or apply features in a different order than in the described embodiments, take individual features from one embodiment and incorporate such features into another embodiment, remove one or more features from an embodiment, or remove one or more features from an embodiment and add one or more features taken from one or more other embodiments. The one or more “features” used in this paragraph may refer to the structure and / or function of an apparatus, a product of manufacture or system, and / or a stage, implementation, or method of a method.

[0057] Throughout this specification, references to “one embodiment,” “one example,” and “exemplary embodiment” indicate that the embodiments described may have certain features, structures, or characteristics, but not all embodiments may necessarily lack these specific features, structures, or characteristics. Furthermore, such phrases do not necessarily refer to the same embodiments. Moreover, when describing certain features, structures, or characteristics in relation to one embodiment, whether explicitly stated or not, it will be within the knowledge of those skilled in the art that this description may affect such features, structures, or characteristics in relation to other embodiments.

[0058] Unless the context clearly indicates otherwise, (1) the word “and” indicates conjunction, (2) the word “or” indicates disjunction, (3) when an item is described disjunctionally and followed by the words “or both of these,” it is intended to be both conjunction and disjunction, and (4) the words “and” or “or” between the last two items in a list apply to all items in the list.

[0059] When a group is described using the phrase "one or more" followed by multiple nouns, any additional use of any of those nouns to indicate one or more components of the group shall indicate both the singular and plural forms of those nouns. For example, a group described as having "one or more components" followed by the description of its "components" shall mean "that component" if the group contains only one component.

[0060] The terms "a" and "an" refer to one or more such entities. Therefore, in this specification, the terms "a" (or "an"), "one or more," and "at least one" are interchangeable. It should also be noted that the terms "equip," "include," and "have" are interchangeable. [Explanation of symbols]

[0061] 205 Adapter body 210 Sealing Skirt 215 Thorns 225 Catheter 220 string

Claims

1. An implantable heart valve adapter device comprising a tubular braided frame, The tubular braided frame comprises an inlet end and an outlet end, The tubular braided frame extends outward from the inlet end and forms at least one flange, The tubular braided frame extends outward from the outflow end and forms at least one engaging attachment. Implantable heart valve adapter device.

2. The apparatus according to claim 1, wherein the tubular braided frame is constructed of one or more materials that are expandable or compressible, or expandable and compressible.

3. The apparatus according to claim 2, further comprising the outer and inner portions of the tubular braided frame, the at least one flange, and the material layer extending over the at least one engaging fixture.

4. The apparatus according to claim 2, wherein the apparatus comprises an outer portion and an inner portion of the tubular braided frame, and a material layer extending over at least one flange.

5. The apparatus according to claim 2, wherein the engaging attachment includes at least one of a locking portion, a spine portion, a hook, a clip, or a combination thereof.

6. The apparatus according to claim 2, wherein the tubular braided frame is one or more wire braids, the one or more wire braids are either zigzag braids or upper and lower double braids, and the one or more wires include one of nitinol wire, stainless steel, cobalt chromium, and nylon.

7. An implantable heart valve adapter delivery system, An implantable heart valve adapter including a tubular braided frame, The tubular braided frame has an inlet end and an outlet end, The tubular braided frame extends outward from the inlet end and forms at least one flange, The tubular braided frame extends outward from the outlet end and forms at least one engagement attachment, an implantable heart valve adapter, A delivery component including one or more suture lines connected at the first end to at least one engagement device, Equipped with, An implantable heart valve adapter delivery system in which the one or more suture lines are connected to a control mechanism at a second end.

8. The system according to claim 7, wherein the tubular braided frame is constructed of one or more materials that are expandable or compressible, or both expandable and compressible.

9. The implantable heart valve adapter comprises an outer and inner portion of the tubular braided frame, the at least one flange, and a material layer extending over the at least one engagement fitting, according to claim 8.

10. The implantable heart valve adapter comprises an outer portion and an inner portion of the tubular braided frame and a material layer extending over at least one flange, according to claim 8.

11. The system according to claim 8, wherein the engaging attachment includes at least one of a locking portion, a spine portion, a hook, a clip, or a combination thereof.

12. A method for percutaneous deployment and positioning of an implantable heart valve adapter, Implantable heart valve adapter and delivery components, Equipped with, The implantable heart valve adapter includes a tubular braided frame and an inlet end and an outlet end, The tubular braided frame extends outward from the inlet end and forms at least one flange, The tubular braided frame extends outward from the outlet end and forms at least one engaging attachment, The delivery component includes one or more suture lines, The one or more suture lines pass through the at least one engaging device and are connected to the control mechanism, and the control mechanism controls the pulling of the one or more suture lines. The aforementioned method, The steps include percutaneously placing the implantable heart valve adapter into either a vein or an artery, The steps include delivering the implantable heart valve adapter to the natural heart valve, The steps include: positioning the implantable heart valve adapter at the location of the natural heart valve; The steps include: pulling the one or more suture lines to enlarge the at least one engaging device; Methods that include...

13. The method according to claim 12, wherein the tubular braided frame is constructed of one or more materials that are expandable or compressible, or expandable and compressible, and the device includes outer and inner portions of the tubular braided frame, the at least one flange, and the at least one engaging fitting, with a layer of material extending over them.

14. The method according to claim 13, wherein the vein is the femoral vein, and the step of delivering the implantable heart valve adapter to the natural heart valve includes the step of delivering the implantable heart valve adapter through the superior vena cava.

15. The method according to claim 13, wherein the vein is the femoral vein, and the step of delivering the implantable heart valve adapter to the natural heart valve includes the step of delivering the implantable heart valve adapter through the puncture site of the vena cava and the atrial septum.

16. The method according to claim 13, wherein the step of percutaneously positioning the replacement heart valve delivery system in one of a vein or an artery includes the step of inserting the replacement heart valve delivery system into one of the vein or an artery using a guide wire.

17. The method according to claim 13, wherein the engaging attachment includes at least one of a locking portion, a spine portion, a hook, a clip, or a combination thereof.

18. The method according to claim 13, wherein the tubular braided frame is one or more wire braids, the one or more wire braids are either zigzag braids or double braids, and the one or more wires include one of nitinol wire, stainless steel, cobalt chromium, and nylon.

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