Devices, systems, and methods to optimize delivery of ring-shaped articles for transcatheter valve replacement

Abstract

In various embodiments, provided herein are methods, devices and systems to optimize delivery of ring-shaped articles for receiving transcatheter valves or stents. These methods, devices and systems are used to treat patients with valvular diseases. In some embodiments, the device includes at least three cables configured to hold a ring-shaped article having a center hole. The at least three cables are further configured to be anchored to supra-annular tissue at a heart valve peri-annular region. The ring-shaped article is positioned and deployed by means of at least three cables used to embed screws or anchors attached to the ring-shaped article into the supra-annular tissue; this deployed ring-shaped article is configured to receive a replacement heart valve in its inner lumen, thereby acting as a landing zone.

Description

DEVICES, SYSTEMS, AND METHODS TO OPTIMIZE DELIVERY OF RING-SHAPED ARTICLES FOR TRANSCATHETER VALVE REPLACEMENTCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 675,773, filed on July 26, 2024, which is incorporated herein by reference in its entirety.FIELD OF INVENTION

[0002] This invention relates to devices, systems, and methods to optimize delivery of ringshaped articles for receiving transcatheter valves, which may be used to treat valvular heart diseases.BACKGROUND OF THE INVENTION

[0003] Valvular heart disease is characterized by damage to or a defect in one of the four heart valves: the mitral, aortic, tricuspid or pulmonary. The mitral and tricuspid valves control the flow of blood between the atria and the ventricles (the upper and lower chambers of the heart). The pulmonary valve controls the blood flow from the heart to the lungs, and the aortic valve governs blood flow between the heart and the aorta, and thereby to the blood vessels in the rest of the body. The mitral and aortic valves are most frequently affected by valvular heart disease.

[0004] Normally functioning valves ensure that blood flows with proper force in the proper direction at the proper time. In a valvular heart disease, a heart valve becomes too narrow and hardened (stenotic) to open fully, or is unable to close completely (incompetent). A stenotic valve forces blood to back up in the adjacent heart chamber, while an incompetent valve allows blood to leak back into the chamber it previously exited. To compensate for poor pumping action, the heart muscle enlarges and thickens, thereby losing elasticity and efficiency. In addition, in some cases, blood pooling in the chambers of the heart has a greater tendency to clot, increasing the risk of stroke or pulmonary embolism. The severity of valvular heart disease varies. In mild cases there may be no symptoms, while in advanced cases, valvular heart disease may lead to congestive heart failure and other complications. Treatment depends upon the extent of the disease.

[0005] Transcatheter valve therapies are one treatment option for patients. For example, transcatheter aortic valve replacement (TAVR - also known as TAVI or transcatheter aortic valve implantation) is a procedure for patients with severe symptomatic aortic stenosis(narrowing of the aortic valve opening) who are not candidates for traditional open chest surgery or are high-risk operable candidates. In these procedures, a replacement valve is inserted percutaneously using a catheter and implanted in the orifice of the native aortic valve. Replacement valves may be artificial (prosthetic valves) or made from animal tissue (bioprosthetic valves). Diseased mitral, tricuspid or pulmonary valves may also be treated with transcatheter valve replacement or implantation. The type of replacement valve selected depends on the patient’s age, condition, and the specific valve affected.

[0006] Since transcatheter valves, unlike surgical valves, are not sewn into the heart, they require a landing zone to which their external profiles must conform and anchor to. Also, some degree of stenosis in the native valve is generally necessary to provide a consistently stable anchor point. However, the native valve’ s shape, size and stenosis vary considerably, and hence are not always favorable, suitable or safe for the deployment of transcatheter valves. If an implanted transcatheter valve does not conform to the native valve’s anatomy or is not stably anchored, paravalvular leakage as well as device embolization or malposition may occur. To fill the gaps between the transcatheter valve and the native valve’s anatomical structures, an external cuff (either fabric or hydrogel) may be added, but this cannot correct large differences in dimension.

[0007] A Device to Optimize aNnUlar orientation of Transcath ether valves (DONUT) is described in U.S. Patent No. 10,869,756 B2 (DEVICES, SYSTEMS, AND METHODS TO OPTIMIZE ANNULAR ORIENTATION OF TRANSCATHETER VALVES). DONUT can correct large differences between a native valve’s anatomical dimensions and the external dimensions of a transcatheter valve stent frame. DONUT may act as a mould for the anatomy of a native valve externally, and its central hole may match a transcatheter replacement valve, for example, a standardized valve or those commercially available ones including but not limited to the MEDTRONIC COREVALVE device and the EDWARDS SAPIEN device. The outside perimeter of the DONUT conforms to the anatomy of a native valve, cardiovascular structure or chamber, and its center hole fits a transcatheter valve. Also DONUT is used for transcatheter heart valve implantation. DONUT is first deployed to a diseased heart valve (e.g., the aortic valve and mitral valve) and serves as a consistent landing zone and stable anchor point. Next, a transcatheter valve is implanted into the center hole of DONUT, even when the native valve’s anatomy and stenosis are not favorable, suitable or safe for the direct deployment of a transcatheter valve.

[0008] Therefore, precise positioning of DONUT at a target heart valve is critical for effective implanting of a transcatheter valve into the center hole of DONUT. Precise positioning andanchoring of the DONUT are important for deploying the transcatheter valve stably at a target location in order to replace the diseased heart valve. U.S. Patent No. 10,869,756 B2 discloses a method of deploying the DONUT to a diseased heart valve, using a delivery catheter with an inflatable balloon at the distal end, which is common in the field of transcatheter valve replacement.

[0009] However, there are anatomical challenges in the deployment of a valve in conforming to the native valve’s anatomy. Currently used delivery systems are problematic because they lack mechanisms for stably and precisely delivering a ring-shaped article or DONUT device to the landing zone. Further, many prior art delivery systems for transcatheter tricuspid and mitral valve deployment are very large in profile, for example 30-42 Fr. Nonetheless, medical device manufacturers are struggling to reduce device profile. The present disclosure provides a solution for these and other problems.SUMMARY OF THE INVENTION

[0010] To solve these problems, described herein is a DONUT Advanced Delivery System (DADS) and a method of deploying DONUT to the aortic valve and / or mitral valve, using DADS. DADS has the potential to dramatically reduce delivery system profile to 6-42 Fr, 18- 28 Fr, or 16-28 Fr. Thus, the reduced profile of DADS would enhance safety of the valve replacement procedures. DADS is designed to have a multiple-cable structure configured to hold DONUT until DONUT is deployed to a target area of the tissue. DADS provides a mechanism to position and deploy DONUT at a precise location of the tissue.

[0011] In various embodiments, DADS has multiple cables, for example at least three cables, to hold DONUT. In some embodiments, each cable has a screw structure at one end thereof, each screw structure configured to embed in the supra-annular tissue, permitting stable deployment.

[0012] The following embodiments and aspects thereof are described and illustrated in conjunction with devices, systems, and methods, which are meant to be exemplary and illustrative, not limiting in scope.

[0013] Provided herein are various embodiments of a device for delivering a ring-shaped article into a heart valve peri-annular region, herein also described as the “landing zone.” In various embodiments, the device includes at least three cables configured to hold the ringshaped article having a center hole. The at least three cables are further configured to be anchored to supra-annular tissue at the heart valve peri-annular region. The ring-shaped article is configured to receive a replacement heart valve.

[0014] In some embodiments, the device further includes three or more flexible cables with central lumens permitting insertion of a rigid or semi-rigid stylet.

[0015] In some embodiments, the flexible cables have a proximal end that may be rotated and a distal end with a screw attached to the cable and the DONUT that may be embedded in supraannular tissue through rotation of the proximal end of the cable.

[0016] In some embodiments, the proximal cable may be detached or cut leaving the screws attaching the DONUT device to the supra-annular tissue.

[0017] In some embodiments, there is an additional central hollow lumen catheter with a distal nose cone also with a central hollow lumen, enabling the passing of a wire; this embodiment will permit the advancement of the DONUT within the DADS over the wire.

[0018] According to certain aspects of the present disclosure, a device for delivering a ringshaped article into a heart valve peri-annular region is disclosed. According to various embodiments, the device includes at least three cables configured to hold the ring-shaped article having a center hole. The at least three cables are further configured to deliver screws or other anchoring structures to anchor the ring-shaped article to supra-annular tissue at the heart valve peri-annular region. The at least three cables are further configured to connect and hold the ring-shaped article in an expanded state. The ring-shaped article is configured to receive a replacement heart valve into the center hole.

[0019] In various embodiments, the device further includes at least three stylets, each of the at least three stylets respectively coupled to a corresponding one of the at least three cables.

[0020] In various embodiments, each of the at least three cables is individually directable with the respectively corresponding stylet.

[0021] In various embodiments, each of the at least three cables is threaded or includes a spiral groove at one end thereof to form a screw structure.

[0022] In various embodiments, the screw structure is configured to be embedded in the supra- annular tissue.

[0023] In various embodiments, the device further includes a proximal central catheter, the proximal central catheter passing through the center hole of the ring-shaped article held by the at least three cables.

[0024] In various embodiments, the proximal central catheter has a hollow central lumen permitting a support wire such that the entire device can be passed over the wire.

[0025] In various embodiments, the device further includes a nose cone with a central hollow lumen, attached to the proximal central catheter passing over a wire, the proximal central catheter coupled to the nose cone.

[0026] In various embodiments, the at least three cables and the proximal central catheter are configured to coalesce into a stabilization device.

[0027] In various embodiments, the stabilization device is repositionable with movement of a guide catheter.

[0028] In various embodiments, the stabilization device is configured to act as a modifiable fulcrum.

[0029] In various embodiments, the ring-shaped article comprises an outside surface, and wherein the outside surface comprises an inward surface area that faces toward a center of the ring-shaped article and forms the center hole.

[0030] In various embodiments, the outside surface comprises an outward surface area that faces away from the center of the ring-shaped article and forms a periphery.

[0031] In various embodiments, the periphery of the ring-shaped article is in contact with the at least three cables holding the ring-shaped article.

[0032] In various embodiments, the periphery of the delivered ring-shaped article is configured to anchor to a ventricular, atrial, aortic, or arterial wall.

[0033] In various embodiments, the ring-shaped article has a compressed status and an expanded status, and wherein when the ring-shaped article is expanded, the center hole is configured to receive the replacement heart valve, and the periphery is configured to conform to the anatomy of a native heart valve peri-annular region, cardiovascular structure or chamber.

[0034] In various embodiments, the center hole is configured to facilitate conformity of deployment of a stented transcatheter valve, and wherein the periphery expands to an irregular conformation to conform to the native anatomy of the native heart valve peri-annular region, cardiovascular structure or chamber.

[0035] In various embodiments, the periphery of the delivered ring-shaped article is configured to anchor to the native heart valve peri-annular region.

[0036] In various embodiments, the replacement heart valve is configured to anchor to the center hole of the ring-shaped article.

[0037] In various embodiments, the ring-shaped article is deployed in a cardiovascular structure or chamber distinct from a native heart valve to act as a platform for deployment of a transcatheter valve.

[0038] In various embodiments, the native heart valve is a mitral, aortic, tricuspid or pulmonary valve.

[0039] In various embodiments, the ring-shaped article and the replacement heart valve are not connected to each other.

[0040] In various embodiments, the replacement heart valve is about 10-55 mm in height.

[0041] In various embodiments, the ring-shaped article is about 5-55 mm in height.

[0042] In various embodiments, the replacement heart valve is about 10-55 mm in diameter.

[0043] In various embodiments, the center hole of the ring-shaped article is about 10-55 mm in diameter.

[0044] In various embodiments, the periphery of the ring-shaped article is about 15-80 mm in diameter.

[0045] In various embodiments, the center hole of the ring-shaped article is shaped as a circular, elliptical, oval, or D ring and the periphery of the ring-shaped article is shaped to conform to the region in which the ring-shaped article is deployed.

[0046] In various embodiments, a cross section of the replacement heart valve is a circle, ellipse, oval, or D-shape.

[0047] In various embodiments, the ring-shaped article is self-expandable or balloon expandable.

[0048] In various embodiments, the ring-shaped article comprises a frame made of iron, platinum, titanium, nickel, chromium, cobalt, magnesium, stainless steel, nitinol (nickeltitanium), nickel-chromium, cobalt-chromium, or platinum-iridium, or a combination thereof, or of a solid or hollow plastic material.

[0049] In various embodiments, the replacement heart valve is self-expandable or balloon expandable.

[0050] In various embodiments, the replacement heart valve comprises a stent frame made of iron, platinum, titanium, nickel, chromium, cobalt, magnesium, stainless steel, nitinol (nickeltitanium), nickel-chromium, cobalt-chromium, or platinum-iridium, or a combination thereof, or of a solid or hollow plastic material.

[0051] In various embodiments, the replacement heart valve is a prosthetic valve or a bioprosthetic valve.

[0052] In various embodiments, the replacement heart valve comprises one, two, three, or more leaflets.

[0053] In various embodiments, the device further includes a first delivery catheter configured to deploy the ring-shaped article into a native heart valve peri-annular region or alternative cardiovascular location.

[0054] In various embodiments, the first delivery catheter comprises an inflatable balloon near or at its distal end, wherein the compressed ring-shaped article is configured to be mounted on the inflatable balloon, and wherein the inflatable balloon is configured to be inflated so as toexpand the compressed ring-shaped article.

[0055] In various embodiments, the first delivery catheter comprises an enclosing sheath near or at its distal end, wherein the compressed ring-shaped article is configured to be enclosed in the enclosing sheath, and wherein the enclosing sheath is configured to be retracted so as to expand the compressed ring-shaped article, either through a self-expanding mechanism or through expansion of a balloon, as stated.

[0056] In various embodiments, the device further includes a guide wire, wherein the first delivery catheter is configured to be inserted over the guide wire.

[0057] In various embodiments, the device further includes a second delivery catheter, wherein the second delivery catheter is configured to deploy the replacement heart valve into the center hole of the ring-shaped article.

[0058] In various embodiments, the device further includes a guide wire, wherein the second delivery catheter is configured to be inserted over the guide wire.

[0059] According to other aspects of the present disclosure, a method for delivering a ringshaped article into a heart valve peri-annular region of a patient for transcatheter valve replacement is disclosed. According to various embodiments, the method includes advancing a delivery device including at least three cables into a heart valve peri-annular region, the ringshaped article having a center hole being held between the at least three cables; embedding one end of the at least three cables in a supra-annular tissue at the heart valve peri-annular region; delivering the ring-shaped article into the heart valve peri-annular region; and deploying the ring-shaped article into a native heart valve while the at least three cables are embedded in the supra-annular tissue. The native heart valve is a mitral, aortic, tricuspid or pulmonary valve.

[0060] In various embodiments, the embedding the one end of the at least three cables in the supra-annular tissue comprises embedding at least three screw-like structures at the one end of the at least three cables in the supra-annular tissue for supra-annular sealing.

[0061] In various embodiments, the delivery device further comprises a central hollow lumen catheter also attached to a distal cone, passing through the center hole.

[0062] In various embodiments, the method further includes individually directing each of the at least three cables to embed a respectively corresponding one end of the cable in a specific point of the supra-annular tissue by controlling a stylet associated with a respectively corresponding one of the at least three cables.

[0063] In various embodiments, the method further includes embedding respectively the distal screw-like corresponding one end of each of the cables in a specific point of the supra-annular tissue through a rotational mechanism.

[0064] In various embodiments, the delivery device holding the ring-shaped article is advanced via an external delivery catheter.

[0065] According to other aspects of the present disclosure, a method for transcatheter valve replacement is disclosed. According to various embodiments, the method includes advancing the device of claim 1 into the heart valve peri-annular region; embedding one end of each of the at least three cables in the supra-annular tissue; delivering the ring-shaped article into the heart valve peri-annular region; deploying the ring-shaped article into a native heart valve while a distal screw-like structure of each of the at least three cables is embedded in the supra-annular tissue; advancing the replacement heart valve; and deploying the advanced replacement heart valve into the center hole of the ring-shaped article.

[0066] In various embodiments, the ring-shaped article is deployed transfemorally, transaortically, transseptally, transapically, or by alternative venous or arterial approach.

[0067] In various embodiments, the replacement heart valve is deployed transfemorally, transaortically, transseptally, transapically, or by alternative venous or arterial approach.

[0068] In various embodiments, deploying the ring-shaped article comprises delivering the ring-shaped article that is compressed to the native heart valve peri-annular region, expanding the compressed ring-shaped article in the native heart valve peri-annular region and anchoring the expanded ring-shaped article to the native heart valve peri-annular region.

[0069] In various embodiments, anchoring the expanded ring-shaped article comprises anchoring the expanded ring-shaped article onto a valve annulus peri-annular region.

[0070] In various embodiments, anchoring the expanded ring-shaped article comprises anchoring the expanded ring-shaped article onto a ventricular wall near a valve annulus.

[0071] In various embodiments, anchoring the expanded ring-shaped article comprises anchoring the expanded ring-shaped article onto an atrial wall near a valve annulus.

[0072] In various embodiments, anchoring the expanded ring-shaped article comprises anchoring the expanded ring-shaped article onto an aorta wall near a valve annulus.

[0073] In various embodiments, anchoring the expanded ring-shaped article comprises anchoring the expanded ring-shaped article onto an arterial wall near a valve annulus or vascular landing zone.

[0074] In various embodiments, anchoring the expanded ring-shaped article comprises anchoring the expanded ring-shaped article not onto a valve annulus peri-annular region but onto a ventricular wall, an atrial wall, an aortic wall, or an arterial wall near a valve annulus.

[0075] In various embodiments, anchoring the expanded ring-shaped article comprises anchoring the expanded ring-shaped article not onto a valve annulus peri-annular region butonto a ventricular wall, an atrial wall, an aortic wall, or an arterial wall far from a valve annulus.

[0076] In various embodiments, the anchored ring-shaped article pushes native leaflets of the native heart valve aside.

[0077] In various embodiments, the anchored ring-shaped article does not push native leaflets of the native heart valve aside.

[0078] According to other aspects of the present disclosure, a delivery system for a heart valve is disclosed. According to various embodiments, the delivery system includes a ring-shaped article with an interior hole, the interior hole being configured to receive a replacement heart valve; and a control device for temporarily securing the ring-shaped article prior to deployment into a heart valve. The control device includes a plurality of cables that includes at least three cables, each of the plurality of cables having a mounting end with a fastener or screw-like device, the fastener or screw like device being configured for attachment to supra-annular tissue, and a central space formed between the plurality of cables, the ring-shaped article being temporarily held within the central space.

[0079] In various embodiments, the fastener is a screw.

[0080] In various embodiments, the central space is generally centered along a center axis of the control device.

[0081] In various embodiments, each of the plurality of cables has a non-mounting end, the non-mounting end being closer to the center axis than the mounting end.

[0082] In various embodiments, the control device further includes a ring-shaped spacer between the plurality of cables, the ring-shaped spacer being located near the mounting end of each cable of the plurality of cables, the ring-shaped spacer having an internal space configured for movement of the ring-shaped article from or into the internal space.BRIEF DESCRIPTION OF DRAWINGS

[0083] Exemplary embodiments are illustrated in the referenced figures. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than restrictive.

[0084] FIG. 1A depicts, in accordance with various embodiments of the present invention, a DONUT Advanced Delivery System (DADS) in which a ring-shaped article is in a collapsed configuration.

[0085] FIG. IB depicts, in accordance with various embodiments of the present invention, a perspective view of the DADS in which the ring-shaped article is in an expanded configuration.

[0086] FIG. 2 depicts, in accordance with various embodiments of the present invention, a bottom view of a DADS enclosed within a central hollow lumen catheter.

[0087] FIG. 3 depicts, in accordance with various embodiments of the present invention, individually directable cables and stylet mediated screw deployment mechanism of a DADS.

[0088] FIG. 4 depicts, in accordance with various embodiments of the present invention, a procedure of deploying a DONUT to a mitral valve, using a DADS.DETAILED DESCRIPTION OF THE INVENTION

[0089] All references cited herein are incorporated by reference in their entirety as though fully set forth. Unless defined otherwise, technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0090] One skilled in the art will recognize many methods and materials similar or equivalent to those described herein, which could be used in the practice of the present invention. Indeed, the present invention is in no way limited to the methods and materials described. For purposes of the present invention, the following terms are defined below.Devices and Systems

[0091] Provided herein are various embodiments of a device for delivering a collapsible ringshaped article into a heart valve peri-annular region. The device and the ring-shaped article are for a transcatheter valve replacement or implantation. Referring to FIGS. 1 A and IB, in some embodiments, the DADS, delivery system, delivery catheter, or device 100 includes at least three cables 101, 102, 103 configured to hold the ring-shaped article 200 having a center hole or interior hole. As shown in FIG. 1A, the at least three cables 101, 102, 103 attached to the ring-shaped article 200 are disposed in a delivery catheter 300 in a collapsed configuration. Once the at least three cables 101, 102, 103 attached to the ring-shaped article 200 are released from delivery catheter 300, they are in an expanded configuration. The at least three cables 101, 102, 103 are further configured to be anchored to supra-annular tissue at the heart valve peri-annular region. The at least three cables 101, 102, 103 function as a control device for temporarily securing the ring-shaped article 200 prior to deployment into a native heart valve. The control device has a central space formed by the at least three cables 101, 102, 103 such that the ring-shaped article 200 is held within the central space until the ring-shaped article 200 is deployed. The central space is generally centered along a center axis of the control device.Each of the plurality of cables 101, 102, 103 has a non-mounting end, the non-mounting end being closer to the center axis than the mounting end. The control device further includes a ring-shaped spacer between the plurality of cables 101, 102, 103, the ring-shaped spacer being located near the mounting end of each cable of the plurality of cables, the ring-shaped spacer having an internal space configured for movement of the ring-shaped article 200 from or into the internal space.

[0092] Once the ring-shaped article 200 is delivered to the target heart valve peri-annular region, the delivered ring-shaped article 200 is configured to receive a replacement heart valve through the center hole of the ring-shaped article 200.

[0093] In various embodiments, the device 100 further includes at least three stylets 501, 502, 503, as exemplified in FIG. 3. Each of the at least three stylets 501, 502, 503 is respectively coupled to a corresponding one of the at least three cables 101, 102, 103. In various embodiments, each of the at least three cables 101, 102, 103 is individually directable with the respectively corresponding stylet 501, 502, 503.

[0094] In various embodiments, each of the at least three cables 101, 102, 103 is threaded or includes a spiral groove at one end thereof to form a screw structure 101a, 102a, 103 a. In some embodiments, the screw structure 101a, 102a, 103a is positioned in the DONUT ring 200. In some embodiments, the screw structure 101a, 102a, 103a is configured to be embedded in the supra-annular tissue. For example, each screw structure 101a, 102a, 103a is configured to rotate in response to rotation of a corresponding stylet 501, 502, 503 such that the screw structures 101a, 102a, 103a can be embedded in the supra-annular tissue by screw actions.

[0095] In various embodiments, device 100 further includes a proximal catheter 104. The proximal catheter 104 passes through the center hole of the ring-shaped article 200 held by the at least three cables 101, 102, 103. In some embodiments, the hollow proximal catheter 104 is attached to a hollow distal nose cone 105, permitting a generally central wire 106 in a common central lumen.

[0096] In various embodiments, the delivery system 100 includes a nose cone 105 attached to a central hollow lumen catheter 104 passing over a wire 106. In some embodiments, catheter 104 is coupled to the nose cone 105.

[0097] In various embodiments, the nose cone 105 and the proximal hollow catheter 104 enable advancement of the delivery catheter 100 housing the collapsible ring-shaped article 200 over a guide wire 106. Following advancement of the ring-shaped article 200 housed in the delivery catheter 100 over the wire 106, the delivery catheter 100 is pulled back, exposing the collapsible ring-shaped article 200 which is then advanced with the help of the at least threecables 101, 102, 103 and their central stylets 501, 502, 503 to precisely advance, position and deploy the at least three screws 101, 102, 103 to the supra-annular space.

[0098] FIG. 2 depicts, in accordance with various embodiments of the present invention, a bottom view of a DADS 100 at the level of a circular stabilization device 400 enclosed within and towards the distal end of a central hollow lumen catheter / guide catheter 300. Referring to FIG. 2, in some embodiments, the (at least three) cables 101, 102, 103 and the central hollow lumen catheter 104 are configured to coalesce into the stabilization device 400. In some embodiments, the stabilization device 400 is repositionable with movement of the guide catheter 300. The guide catheter 300 is outside the stabilization device 400. In some embodiments, the stabilization device 400 is configured to act as a modifiable fulcrum.

[0099] Referring to FIGS. 1A and 2, in some embodiments, the cables 101, 102, 103 are attached to the ring-shaped article 200 or DONUT and compressed or collapsed within the delivery catheter 300 with the nose cone 105, advanced over the wire 106. Referring to FIG. IB, the ring-shaped article 200 may be in an expanded status / configuration, advanced with independent movement of the stylets 501, 502, 503 within their respective delivery cables 101, 102, 103, and also in an expanded state when the three cables 101, 102, 103 are deployed releasing the three cables from the DONUT 200 and its three distal screws 101a, 102a, 103a, with a rotational maneuver individually.

[0100] In various embodiments, the ring-shaped article 200 includes an outside surface. The outside surface includes an inward surface area that faces toward a center of the ringshaped article 200 and forms the center hole. The outside surface includes an outward surface area that faces away from the center of the ring-shaped article 200 and forms a periphery.

[0101] In various embodiments, the periphery of the ring-shaped article 200 is in contact with the at least three cables 101, 102, 103 holding the ring-shaped article. In various embodiments, the periphery of the delivered ring-shaped article 200 is configured to anchor to a ventricular, atrial, aortic, or arterial wall.

[0102] In various embodiments, the ring-shaped article 200 has a compressed status and an expanded status. In some embodiments, when the ring-shaped article 200 is expanded, the center hole of the ring-shaped article is configured to receive the replacement heart valve, and the periphery is configured to conform to the anatomy of a native heart valve peri-annular region, cardiovascular structure or chamber. In some embodiments, the center hole is configured to facilitate conformity of deployment of a stented transcatheter valve. In some embodiments, the periphery expands to an irregular conformation to conform to the native anatomy of the native heart valve peri-annular region, cardiovascular structure or chamber.

[0103] In various embodiments, the periphery of the delivered ring-shaped article 200 is configured to anchor to the native heart valve peri-annular region. In various embodiments, the subsequently inserted replacement heart valve is configured to anchor to the center hole of the ring-shaped article 200.

[0104] In various embodiments, the ring-shaped article 200 is deployed in a cardiovascular structure or chamber distinct from a native heart valve to act as a platform for deployment of a transcatheter valve. In various embodiments, the native heart valve is a mitral, aortic, tricuspid or pulmonary valve. In some embodiments, the ring-shaped article 200 and the replacement heart valve are not connected to each other. In some embodiments, deployment of the transcatheter valve is subsequent to deployment of the ring-shaped article 200.

[0105] In various embodiments, the replacement heart valve is about 10-55 millimeters (“mm”) in height. In various embodiments, the ring-shaped article 200 is about 5-55 mm in height. In various embodiments, the replacement heart valve is about 10-55 mm in diameter. In various embodiments, the center hole of the ring-shaped article 200 is about 10-55 mm in diameter. In various embodiments, the periphery of the ring-shaped article 200 is about 15-80 mm in diameter.

[0106] In some embodiments, the “diameter” used herein refers to the periphery’s diameter (i.e., peripheral diameter) when the ring-shaped article 200 is expanded. In various embodiments, the periphery of the ring-shaped article 200 has an adjustable diameter. A user may measure the native valve’s dimensions, adjust the periphery’s diameter to fit the size and shape of the native valve, compress and load the ring-shaped article 200 to a delivery catheter, deliver and deploy the ring-shaped article to the native valve, to which the periphery of the expanded ring-shaped article conforms and anchors. In one embodiment, the ring-shaped article 200’ s height is less than the replacement valve’s height. In another embodiment, the ring-shaped article 200’s height is about 5-10%, 10-20%, 20-30%, 30-40%, 40-50%, 50-60%, 60-70%, 70-80%, 80-90%, or 90-95% of the replacement valve’s height. In various embodiments, the ring-shaped article 200 does not have a diaphragm.

[0107] In various embodiments, the center hole of the ring-shaped article 200 is shaped as a circular, elliptical, oval, or D ring and the periphery of the ring-shaped article is shaped to conform to the region in which the ring-shaped article is deployed. In various embodiments, a cross section of the replacement heart valve is a circle, ellipse, oval, or D-shape. In some embodiments, the ring-shaped article 200 is self-expandable or balloon expandable.

[0108] In various embodiments, the ring-shaped article 200 includes a frame made of iron, platinum, titanium, nickel, chromium, cobalt, magnesium, stainless steel, nitinol (nickel-titanium), nickel-chromium, cobalt-chromium, or platinum-iridium, or a combination thereof, or of a solid or hollow plastic material. In some embodiments, the replacement heart valve is self-expandable or balloon expandable.

[0109] In various embodiments, the replacement heart valve includes a stent frame made of iron, platinum, titanium, nickel, chromium, cobalt, magnesium, stainless steel, nitinol (nickel-titanium), nickel-chromium, cobalt-chromium, or platinum-iridium, or a combination thereof, or of a solid or hollow plastic material. In some embodiments, the replacement heart valve is a prosthetic valve or a bioprosthetic valve. In some embodiments, the replacement heart valve includes one, two, three, or more leaflets.

[0110] In various embodiments, device 100 further includes a first delivery catheter 300 configured to deploy the ring-shaped article 200 into a native heart valve peri-annular region or alternative cardiovascular location. In some embodiments, the first delivery catheter 300 includes an inflatable balloon near or at its distal end. In some embodiments, the compressed ring-shaped article 200 is configured to be mounted on the inflatable balloon. In some embodiments, the inflatable balloon is configured to be inflated so as to expand the compressed ring-shaped article 200.

[0111] In various embodiments, the first delivery catheter 300 includes an enclosing sheath near or at its distal end. In some embodiments, the compressed ring-shaped article 200 is configured to be enclosed in the enclosing sheath. In some embodiments, the enclosing sheath is configured to be retracted so as to expand the compressed ring-shaped article 200.

[0112] In various embodiments, the device 100 further includes a guide wire 106. In some embodiments, device 100, enclosed within the delivery catheter 300 is configured to be inserted over the guide wire 106.

[0113] In various embodiments, the device 100 further includes a second delivery catheter. In some embodiments, the second delivery catheter is configured to deploy the replacement heart valve into the center hole of the ring-shaped article 200.

[0114] In various embodiments, the device 100 further includes a guide wire. In some embodiments, the second delivery catheter is configured to be inserted over the guide wire.

[0115] In some embodiments, the first delivery catheter 300 and the second delivery catheter are the same delivery catheter. In other embodiments, the first delivery catheter 300 and the second delivery catheter are two different delivery catheters.

[0116] In some embodiments, the first delivery catheter 300 includes an inflatable balloon near or at its distal end, and the compressed ring-shaped article 200 is configured to be mounted on the inflatable balloon. In some embodiments, the inflatable balloon is configuredto be inflated so as to expand the compressed ring-shaped article 200. In other embodiments, the first delivery catheter 300 acts as an enclosing sheath, and the compressed ring-shaped article 200 is configured to be enclosed within it. In some embodiments, and the delivery catheter 300 is configured to be retracted so as to expand the compressed ring-shaped article 200. In various embodiments, the enclosing sheath is just the distal portion of the first delivery catheter 300. In other embodiments, the enclosing sheath is a separate component located near or at the distal end of the first delivery catheter 300.

[0117] In one embodiment, the periphery of the ring-shaped article 200 is configured to anchor to the ventricular side of the native heart valve. In another embodiment, the periphery is configured to anchor to the atrial side of the native heart valve. Still in another embodiment, the periphery is configured to anchor to the aorta or arterial side of the native heart valve. Still in another embodiment, the periphery is configured to anchor to another cardiovascular structure or chamber, including but not restricted to the left ventricular outflow tract, the left atrial surface, the right atrial surface, the superior vena cava, the inferior vena cava or the pulmonary artery.

[0118] In various embodiments, the periphery of the ring-shaped article 200 is configured to anchor onto the annulus of the native valve or valve annulus. In various embodiments, the periphery is configured to anchor onto the ventricular wall near the valve annulus. In various embodiments, the periphery is configured to anchor onto the atrial wall near the valve annulus. In various embodiments, the periphery is configured to anchor onto the aortic wall near the valve annulus. In various embodiments, the periphery is configured to anchor the arterial wall near the valve annulus. In some embodiments, the periphery is configured to anchor not onto the valve annulus but onto the ventricular wall, the atrial wall, the aortic wall, or the arterial wall near the valve annulus. In other embodiments, the periphery is configured to anchor onto the valve annulus and onto the ventricular wall, the atrial wall, the aortic wall, or the arterial wall near the valve annulus. In some embodiments, the anchored periphery pushes the native leaflets aside. In other embodiments, the anchored periphery does not push the native leaflets aside.

[0119] In various embodiments, the ring-shaped article 200 is self-expandable or balloon expandable. In various embodiments, the ring-shaped article 200 includes a stent frame. In some embodiments, the stent frame of the ring-shaped article 200 is made of iron, platinum, titanium, nickel, chromium, cobalt, magnesium, stainless steel, nitinol (nickeltitanium), nickel-chromium, cobalt-chromium, or platinum-iridium, or a combination thereof.

[0120] In various embodiments, the ring-shaped article 200 includes an external layerover the stent frame. In some embodiments, the external layer is made of an animal tissue or a synthetic material, or a combination thereof. Examples of suitable animal tissues include but are not limited to bovine-derived, porcine-derived, equine-derived, human-derived cardiovascular or stem-cell derived tissues. Examples of suitable synthetic materials include but are not limited to polyester fabric, hydrogel, plastic resin, expansile polymer or inflatable hollow plastic material.

[0121] In various embodiments, the ring-shaped article 200 includes entirely a hollow plastic material that may be inflated with air, fluid or a plastic resin.

[0122] In various embodiments, the replacement heart valve is configured to anchor to the center hole of the ring-shaped article 200. In various embodiments, the ring-shaped article 200 and the replacement heart valve are separate items and are individually delivered and / or deployed. In certain embodiments, the ring-shaped article 200 is deployed before the replacement heart valve is deployed.

[0123] In some embodiments, the ring-shaped article 200 and the replacement heart valve are not connected to each other before, during or after their deployment. In other embodiments, the ring-shaped article 200 and the replacement heart valve are not connected before deployment and are connected after deployment. In various embodiments, the ringshaped article 200 and the replacement heart valve are connected via a connector including but not limited to a hinge, click-and-lock system, tongue-and-groove system, interlocking structure, clasp, hook, ring, bolts, nut, screw, nail, fastener, magnet, mortise and / or tenon. In some embodiments, the connector includes two or more components, for example, a click-and- lock system or a tongue-and-groove system. In other embodiments, the connector includes only one component, for example, a bridge, string, wire, beam or joist.

[0124] In various embodiments, the replacement heart valve is a self-expandable valve, a balloon expandable valve, or any other suitable replacement valve. In a non-limiting example, a self-expandable replacement valve is constructed with a nitinol self-expanding valve stent frame and porcine pericardial leaflets. In another non-limiting example, a balloon-expandable replacement valve is constructed with a cobalt-chromium balloon-expandable valve stent frame and bovine pericardial leaflets.

[0125] In some embodiments, the replacement heart valve is a prosthetic valve, a bioprosthetic valve, or any other suitable replacement valve. In accordance with the present invention, a prosthetic valve is made of purely artificial or non-biological materials, and a bioprosthetic valve is made of animal tissues alone or in combination with artificial or non- biological materials. In various embodiments, the replacement valve includes one, two, three,or more leaflets. In various embodiments, the leaflets are biological or artificial.

[0126] Suitable examples of guide wires, sheaths, and catheters that may be utilized with the presently disclosed devices, systems and methods described herein will be apparent to a person of skill in the art.Methods

[0127] Provided are various embodiments of a method for delivering a ring-shaped article into a heart valve peri-annular region of a subject or patient for transcatheter valve replacement. In accordance with the present invention, the method may be used to treat a subject with valvular diseases. In various embodiments, the method includes: advancing a delivery device 100 including at least three cables 101, 102, 103 into a heart valve peri-annular region, the ring-shaped article 200 having a center hole being held between the at least three cables; embedding one ends of the at least three cables in a supra-annular tissue at the heart valve peri-annular region; delivering the ring-shaped article into the heart valve peri-annular region; and deploying the ring-shaped article into a native heart valve while the at least three cables are embedded in the supra-annular tissue. For example, the native heart valve is a mitral, aortic, tricuspid or pulmonary valve.

[0128] In various embodiments, the delivery device 100 and the ring-shaped article 200 are advanced together.

[0129] In various embodiments, embedding one end of the at least three cables 101, 102, 103 in the supra-annular tissue includes embedding at least three screw structures 101a, 102a, 103a at the one end of the at least three cables in the supra-annular tissue for supra- annular sealing.

[0130] In various embodiments, the delivery device 100 and the ring-shaped article 200 are detachably connected until the ring-shaped article is deployed into the native heart valve. In various embodiments, the delivery device 100 and the ring-shaped article 200 are not connected after the ring-shaped article is deployed into the native heart valve.

[0131] In various embodiments, the method further includes detaching or cutting a proximal catheter 104 passing through the center hole, leaving the at least three screw structures 101a, 102a, 103a in the supra-annular tissue.

[0132] In various embodiments, the method further includes individually directing each of the at least three cables 101, 102, 103 to embed a respectively corresponding one end of the cable in a specific point of the supra-annular tissue by controlling a stylet 501, 502, 503 associated with a respectively corresponding one of the at least three cables 101, 102, 103.

[0133] In various embodiments, the delivery device 100 holding the ring-shaped article 200 is advanced via a delivery catheter 300.

[0134] Also provided are various embodiments of a method for transcatheter valve replacement. In various embodiments, the method includes: advancing a device 100 for delivering a ring-shaped article 200 into a heart valve peri-annular region, the device including at least three cables 101, 102, 103; embedding one ends of the at least three cables in supraannular tissue; delivering the ring-shaped article 200 into the heart valve peri-annular region; deploying the ring-shaped article 200 into a native heart valve while the at least three cables 101, 102, 103 are embedded in the supra-annular tissue; advancing a replacement heart valve; and deploying the advanced replacement heart valve into a center hole of the ring-shaped article 200.

[0135] In various embodiments, the ring-shaped article 200 is deployed transfemorally, transaortically, transseptally, transapically, or by alternative venous or arterial approach.

[0136] In various embodiments, the replacement heart valve is deployed transfemorally, transaortically, transseptally, transapically, or by alternative venous or arterial approach.

[0137] In various embodiments, deploying the ring-shaped article 200 includes delivering the ring-shaped article that is compressed to the native heart valve peri-annular region, expanding the compressed ring-shaped article in the native heart valve peri-annular region and anchoring the expanded ring-shaped article to the native heart valve peri-annular region.

[0138] In various embodiments, anchoring the expanded ring-shaped article 200 includes anchoring the expanded ring-shaped article onto a valve annulus peri-annular region.

[0139] In various embodiments, anchoring the expanded ring-shaped article 200 includes anchoring the expanded ring-shaped article onto a ventricular wall near a valve annulus.

[0140] In various embodiments, anchoring the expanded ring-shaped article 200 includes anchoring the expanded ring-shaped article onto an atrial wall near a valve annulus.

[0141] In various embodiments, anchoring the expanded ring-shaped article 200 includes anchoring the expanded ring-shaped article onto an aorta wall near a valve annulus.

[0142] In various embodiments, anchoring the expanded ring-shaped article 200 includes anchoring the expanded ring-shaped article onto an arterial wall near a valve annulus.

[0143] In various embodiments, anchoring the expanded ring-shaped article 200 includes anchoring the expanded ring-shaped article not onto a valve annulus peri-annularregion but onto a ventricular wall, an atrial wall, an aortic wall, or an arterial wall near a valve annulus.

[0144] In various embodiments, anchoring the expanded ring-shaped article 200 includes anchoring the expanded ring-shaped article not onto a valve annulus peri-annular region but onto a ventricular wall, an atrial wall, an aortic wall, or an arterial wall far from a valve annulus.

[0145] In various embodiments, the anchored ring-shaped article 200 pushes native leaflets of the native heart valve aside.

[0146] In various embodiments, the anchored ring-shaped article 200 does not push native leaflets of the native heart valve aside.

[0147] One feature is directed to the deploying the ring-shaped article 200 such that it does not disrupt the native valve itself. As an advantageous and beneficial result, hemodynamic compromise is prevented. In some examples, the ring-shaped article 200 is deployed in a cardiovascular structure or chamber distinct from the native valves to act as a platform for deployment of a transcatheter valve. In other examples, the distinct cardiovascular structure or chamber may include, but is not restricted to, the superior or inferior vena cava, the pulmonary artery, or the ascending or descending aorta.

[0148] In various embodiments, the subject is human. In various embodiments, the subject is a mammal. In various embodiments, the devices, systems and methods described herein are configured for humans. The devices, systems, and methods described herein are customizable for use in mammals in which a heart valve may be replaced. “Mammal” as used herein refers to any member of the class Mammalia, including but not limited to, humans, domestic animals, farm animals, zoo animals, sport animals, pet animals such as dogs, cats, guinea pigs, rabbits, rats, mice, horses, cattle, cows; primates such as apes, monkeys, orangutans, and chimpanzees; canids such as dogs and wolves; felids such as cats, lions, and tigers; equids such as horses, donkeys, and zebras; food animals such as cows, pigs, and sheep; ungulates such as deer and giraffes; rodents such as mice, rats, hamsters and guinea pigs; and so on. In certain embodiments, the mammal is a human subject. The term does not denote a particular age or sex. Thus, adult, newborn, fetuses, male or female mammalian heart surgery is within the scope of this disclosure.

[0149] Also in accordance with the present invention, additional steps include, but are not limited to, anesthesia, sterilization, heparinization, accessing the patient’s heart via various routes such as transfemoral, transaortic, transapical, transseptal, transcaval, transaxillary, and transsubclavian approaches, ventricular pacing, stitching of the access site or percutaneousfemoral closure.EXAMPLES

[0150] The following examples are provided to better illustrate the claimed invention and are not to be interpreted as limiting the scope of the invention. To the extent that specific materials are mentioned, it is merely for purposes of illustration and is not intended to limit the invention.Example 1 Delivery of DONUT to a Mitral Valve via DADS

[0151] FIG. 4 illustrates an example of an implantation procedure for a DONUT device as disclosed herein. After induction of anesthesia, and sterile preparation, an incision is performed at the femoral or jugular or similar large bore vein. Alternatively, percutaneous femoral access may be performed with or without pre-closure. A guide wire 106 is inserted via the femoral or jugular vein and the right atrium, through a transseptal puncture on the interatrium septum, into the left atrium, thorough the mitral valve and into the left ventricle. A DONUT device 200 held by at least three cables 101, 102, 103 of a delivery device 100 is mounted at the distal end of a delivery catheter 300. The loaded delivery catheter 300 is advanced over the guide wire 106 and inserted through the mitral valve into the left ventricle, and places the DONUT device 200 on the atrial side of the mitral valve and near the valve annulus. One end of the at least three cables 101, 102, 103 is embedded in the supra-annular tissue, and then the DONUT device 200 is delivered into the heart valve peri-annular region. Although screw structures 101a, 102a, 103a are not shown in FIG. 4, in some embodiments, the at least three cables 101, 102, 103 include the at least three screw structures 101a, 102a, 103a, respectively, at one end thereof. While the at least three cables 101, 102, 103 are embedded the supra-annular tissue, the DONUT device 200 is deployed into a native heart valve. The deployed DONUT device 200’ s periphery conforms to the mitral valve’s periannular anatomy and anchors to the atrial wall near the valve annulus. After deploying the DONUT device 200 into the native heart valve, the delivery catheter 300 and the delivery device 100 are retracted from the left ventricle.Example 2 Delivery of DONUT to a Tricuspid Valve via DADS

[0152] Similar to an example of an implantation procedure for a DONUT device 200 as disclosed in Example 1, the DONUT device 200 may be delivered to a tricuspid valve viaDADS 100. After induction of anesthesia, and sterile preparation, an incision is performed at the femoral or jugular or other large bore vein. Alternatively, percutaneous femoral access may be performed with or without pre-closure. A guide wire 106 is inserted via the femoral vein and the inferior or superior vena cava, across the tricuspid valve to the right ventricle. In some embodiment, the delivery system 100 comes up the inferior vena cava to reach tricuspid. In some embodiments, direct access may be obtained via the right atrium. A DONUT device 200 held by at least three cables 101, 102, 103 of a delivery device 100 is enclosed in the enclosing sheath at the distal end of a delivery catheter 300. The ring-shaped article or DONUT device 200 held by the three cables 101, 102, 103 may be already in an expanded status prior to deployment at the landing zone. The loaded delivery catheter 300 is advanced over the guide wire 106 and inserted through the tricuspid valve into the right ventricle, and places the delivery device 100 holding DONUT device 200 on the atrial side of the tricuspid valve and near the valve annulus. In tandem, each of the at least three cables 101, 102, 103 is embedded in a supraannular tissue at the heart valve peri -annular region. The DONUT device 200 is delivered into the heart valve peri-annular region. Then, the DONUT device 200 is deployed into a native heart valve while the at least three cables 101, 102, 103 are embedded in the supra-annular tissue. In some embodiments, at least three screw structures 101a, 102a, 103a at one end of the at least three cables 101, 102, 103 are embedded in the supra-annular tissue for supra-annular sealing. Screw actions of the at least three screw structures 101a, 102a, 103 a are controlled by corresponding stylets 501, 502, 503 associated with respectively corresponding at least three cables 101, 102, 103. The deployed DONUT device 200’ s periphery conforms to the tricuspid valve’s peri-annular anatomy and anchors to the atrial wall, peri-annular tissues near the valve annulus. After deploying the DONUT device 200 into the native heart valve, the delivery catheter 300 and the delivery device 100 are retracted from the right ventricle.

[0153] In various embodiments, the same or similar steps may be used for other heart valves, such as the aortic valve and pulmonary valve, in which cases the DONUT or ringshaped article is first deployed to the respective heart valve peri-annular region. In various embodiments, the DONUT may be deployed in a cardiovascular structure or chamber distinct from the native valves to act as a platform for deployment of a transcatheter valve or stent or stent-like structure. This may include but is not restricted to the superior or inferior vena cava, the pulmonary artery or the ascending or descending aorta.

[0154] Additional standard steps that may be performed during the procedure include heparinization, and closure of the femoral artery or vein. The closure may be achieved eitherby manual compression, suture-mediated pre-closure, or surgical closure. The procedure may be performed by local anesthesia with conscious sedation or general anesthesia, in which case the patient is generally woken up immediately after the procedure. Heparinization may be reversed at the end of the procedure by administration of protamine. Heparin intolerant individuals may be anti coagulated during the procedure using direct thrombin inhibitors.

[0155] In various embodiments, the same or similar steps may be used any heart valve, such as the aortic, mitral valve, pulmonary valve and tricuspid valve, in which cases the DONUT is first deployed to the respective heart valve.

[0156] Although the application has been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that the embodiments of the application extend beyond the specifically disclosed embodiments to other alternative embodiments and / or uses and modifications and equivalents thereof.

[0157] In some embodiments, the terms “a” and “an” and “the” and similar references used in the context of describing a particular embodiment of the application (especially in the context of certain of the following claims) can be construed to cover both the singular and the plural. The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (for example, “such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the application and does not pose a limitation on the scope of the application otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the application.

[0158] Preferred embodiments of this application are described herein, including the best mode known to the inventors for carrying out the application. Variations on those preferred embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. It is contemplated that skilled artisans can employ such variations as appropriate, and the application can be practiced otherwise than specifically described herein. Accordingly, many embodiments of this application include all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the application unless otherwise indicated herein orotherwise clearly contradicted by context.

[0159] It is to be understood that the embodiments of the application disclosed herein are illustrative of the principles of the embodiments of the application. Other modifications that can be employed can be within the scope of the application. Thus, by way of example, but not of limitation, alternative configurations of the embodiments of the application can be utilized in accordance with the teachings herein. Accordingly, embodiments of the present application are not limited to that precisely as shown and described.

Claims

CLAIMS1. A device for delivering a ring-shaped article into a heart valve peri-annular region, the device comprising: at least three cables configured to hold the ring-shaped article having a center hole, wherein: the at least three cables are further configured to deliver screws or other anchoring structures to anchor the ring-shaped article to supra-annular tissue at the heart valve periannular region; the at least three cables are further configured to connect and hold the ring-shaped article in an expanded state; and the ring-shaped article is configured to receive a replacement heart valve into the center hole.

2. The device of claim 1, further comprising at least three stylets, each of the at least three stylets respectively coupled to a corresponding one of the at least three cables.

3. The device of claim 2, wherein each of the at least three cables is individually directable with the respectively corresponding stylet.

4. The device of claim 1, wherein each of the at least three cables is threaded or includes a spiral groove at one end thereof to form a screw structure.

5. The device of claim 4, wherein the screw structure is configured to be embedded in the supra-annular tissue.

6. The device of claim 1, further comprising a proximal central catheter, the proximal central catheter passing through the center hole of the ring-shaped article held by the at least three cables.

7. The device of claim 6, wherein the proximal central catheter has a hollow central lumen permitting a support wire such that the entire device can be passed over the wire.

8. The device of claim 1, further comprising a nose cone with a central hollow lumen, attached to the proximal central catheter passing over a wire, the proximal central catheter coupled to the nose cone.

9. The device of claim 8, wherein the at least three cables and the proximal central catheter are configured to coalesce into a stabilization device.

10. The device of claim 9, wherein the stabilization device is repositionable with movement of a guide catheter.

11. The device of claim 10, wherein the stabilization device is configured to act as amodifiable fulcrum.

12. The device of claim 1, wherein the ring-shaped article comprises an outside surface, and wherein the outside surface comprises an inward surface area that faces toward a center of the ring-shaped article and forms the center hole.

13. The device of claim 12, wherein the outside surface comprises an outward surface area that faces away from the center of the ring-shaped article and forms a periphery.

14. The device of claim 13, wherein the periphery of the ring-shaped article is in contact with the at least three cables holding the ring-shaped article.

15. The device of claim 13, wherein the periphery of the delivered ring-shaped article is configured to anchor to a ventricular, atrial, aortic, or arterial wall.

16. The device of claim 13, wherein the ring-shaped article has a compressed status and an expanded status, and wherein when the ring-shaped article is expanded, the center hole is configured to receive the replacement heart valve, and the periphery is configured to conform to the anatomy of a native heart valve peri-annular region, cardiovascular structure or chamber.

17. The device of claim 16, wherein the center hole is configured to facilitate conformity of deployment of a stented transcatheter valve, and wherein the periphery expands to an irregular conformation to conform to the native anatomy of the native heart valve peri-annular region, cardiovascular structure or chamber.

18. The device of claim 16, wherein the periphery of the delivered ring-shaped article is configured to anchor to the native heart valve peri -annular region.

19. The device of claim 16, wherein the replacement heart valve is configured to anchor to the center hole of the ring-shaped article.

20. The device of claim 1, wherein the ring-shaped article is deployed in a cardiovascular structure or chamber distinct from a native heart valve to act as a platform for deployment of a transcatheter valve.

21. The device of claim 20, wherein the native heart valve is a mitral, aortic, tricuspid or pulmonary valve.

22. The device of claim 1, wherein the ring-shaped article and the replacement heart valve are not connected to each other.

23. The device of claim 1, wherein the replacement heart valve is about 10-55 mm in height.

24. The device of claim 1, wherein the ring-shaped article is about 5-55 mm in height.

25. The device of claim 1, wherein the replacement heart valve is about 10-55 mm in diameter.

26. The device of claim 13, wherein the center hole of the ring-shaped article is about 10- 55 mm in diameter.

27. The device of claim 26, wherein the periphery of the ring-shaped article is about 15-80 mm in diameter.

28. The device of claim 13, wherein the center hole of the ring-shaped article is shaped as a circular, elliptical, oval, or D ring and the periphery of the ring-shaped article is shaped to conform to the region in which the ring-shaped article is deployed.

29. The device of claim 1, wherein a cross section of the replacement heart valve is a circle, ellipse, oval, or D-shape.

30. The device of claim 1, wherein the ring-shaped article is self-expandable or balloon expandable.

31. The device of claim 1, wherein the ring-shaped article comprises a frame made of iron, platinum, titanium, nickel, chromium, cobalt, magnesium, stainless steel, nitinol (nickel-titanium), nickel-chromium, cobalt-chromium, or platinum-iridium, or a combination thereof, or of a solid or hollow plastic material.

32. The device of claim 1, wherein the replacement heart valve is self-expandable or balloon expandable.

33. The device of claim 1, wherein the replacement heart valve comprises a stent frame made of iron, platinum, titanium, nickel, chromium, cobalt, magnesium, stainless steel, nitinol (nickel-titanium), nickel-chromium, cobalt-chromium, or platinum-iridium, or a combination thereof, or of a solid or hollow plastic material.

34. The device of claim 1, wherein the replacement heart valve is a prosthetic valve or a bioprosthetic valve.

35. The device of claim 1, wherein the replacement heart valve comprises one, two, three, or more leaflets.

36. The device of claim 1, further comprising a first delivery catheter configured to deploy the ring-shaped article into a native heart valve peri-annular region or alternative cardiovascular location.

37. The device of claim 36, wherein the first delivery catheter comprises an inflatable balloon near or at its distal end, wherein the compressed ring-shaped article is configured to be mounted on the inflatable balloon, and wherein the inflatable balloon is configured to be inflated so as to expand the compressed ring-shaped article.

38. The device of claim 36, wherein the first delivery catheter comprises an enclosing sheath near or at its distal end, wherein the compressed ring-shaped article is configuredto be enclosed in the enclosing sheath, and wherein the enclosing sheath is configured to be retracted so as to expand the compressed ring-shaped article, either through a selfexpanding mechanism or through expansion of a balloon, as stated.

39. The device of claim 36, further comprising a guide wire, wherein the first delivery catheter is configured to be inserted over the guide wire.

40. The device of claim 1, further comprising a second delivery catheter, wherein the second delivery catheter is configured to deploy the replacement heart valve into the center hole of the ring-shaped article.

41. The device of claim 40, further comprising a guide wire, wherein the second delivery catheter is configured to be inserted over the guide wire.

42. A method for delivering a ring-shaped article into a heart valve peri-annular region of a patient for transcatheter valve replacement, the method comprising: advancing a delivery device including at least three cables into a heart valve peri-annular region, the ring-shaped article having a center hole being held between the at least three cables; embedding one end of the at least three cables in a supra-annular tissue at the heart valve peri-annular region; delivering the ring-shaped article into the heart valve peri-annular region; and deploying the ring-shaped article into a native heart valve while the at least three cables are embedded in the supra-annular tissue, wherein the native heart valve is a mitral, aortic, tricuspid or pulmonary valve.

43. The method of claim 42, wherein the embedding the one end of the at least three cables in the supra-annular tissue comprises embedding at least three screw-like structures at the one end of the at least three cables in the supra-annular tissue for supra-annular sealing.

44. The method of claim 43, wherein the delivery device further comprises a central hollow lumen catheter also attached to a distal cone, passing through the center hole.

45. The method of claim 42, further comprising individually directing each of the at least three cables to embed a respectively corresponding one end of the cable in a specific point of the supra-annular tissue by controlling a stylet associated with a respectively corresponding one of the at least three cables.

46. The method of any one of claims 42-45, further comprising embedding respectively the distal screw-like corresponding one end of each of the cables in a specific point of the supra-annular tissue through a rotational mechanism.

47. The method of claim 42, wherein the delivery device holding the ring-shaped article is advanced via an external delivery catheter.

48. A method for transcatheter valve replacement, the method comprising: advancing the device of claim 1 into the heart valve peri-annular region; embedding one end of each of the at least three cables in the supra-annular tissue; delivering the ring-shaped article into the heart valve peri-annular region; deploying the ring-shaped article into a native heart valve while a distal screw-like structure of each of the at least three cables is embedded in the supra-annular tissue; advancing the replacement heart valve; and deploying the advanced replacement heart valve into the center hole of the ring-shaped article.

49. The method of claim 48, wherein the ring-shaped article is deployed transfemorally, transaortically, transseptally, transapically, or by alternative venous or arterial approach.

50. The method of claim 48, wherein the replacement heart valve is deployed transfemorally, transaortically, transseptally, transapically, or by alternative venous or arterial approach.

51. The method of claim 48, wherein deploying the ring-shaped article comprises delivering the ring-shaped article that is compressed to the native heart valve periannular region, expanding the compressed ring-shaped article in the native heart valve peri-annular region and anchoring the expanded ring-shaped article to the native heart valve peri-annular region.

52. The method of claim 51, wherein anchoring the expanded ring-shaped article comprises anchoring the expanded ring-shaped article onto a valve annulus peri-annular region.

53. The method of claim 51, wherein anchoring the expanded ring-shaped article comprises anchoring the expanded ring-shaped article onto a ventricular wall near a valve annulus.

54. The method of claim 51, wherein anchoring the expanded ring-shaped article comprises anchoring the expanded ring-shaped article onto an atrial wall near a valve annulus.

55. The method of claim 51, wherein anchoring the expanded ring-shaped article comprises anchoring the expanded ring-shaped article onto an aorta wall near a valve annulus.

56. The method of claim 51, wherein anchoring the expanded ring-shaped article comprises anchoring the expanded ring-shaped article onto an arterial wall near a valve annulus or vascular landing zone.

57. The method of claim 51, wherein anchoring the expanded ring-shaped article comprisesanchoring the expanded ring-shaped article not onto a valve annulus peri-annular region but onto a ventricular wall, an atrial wall, an aortic wall, or an arterial wall near a valve annulus.

58. The method of claim 51, wherein anchoring the expanded ring-shaped article comprises anchoring the expanded ring-shaped article not onto a valve annulus peri-annular region but onto a ventricular wall, an atrial wall, an aortic wall, or an arterial wall far from a valve annulus.

59. The method of claim 51, wherein the anchored ring-shaped article pushes native leaflets of the native heart valve aside.

60. The method of claim 51, wherein the anchored ring-shaped article does not push native leaflets of the native heart valve aside.

61. A delivery system for a heart valve, the delivery system comprising: a ring-shaped article with an interior hole, the interior hole being configured to receive a replacement heart valve; and a control device for temporarily securing the ring-shaped article prior to deployment into a heart valve, the control device having: a plurality of cables that includes at least three cables, each of the plurality of cables having a mounting end with a fastener or screw-like device, the fastener or screw like device being configured for attachment to supra-annular tissue, and a central space formed between the plurality of cables, the ring-shaped article being temporarily held within the central space.

62. The delivery system of claim 60, wherein the fastener is a screw.

63. The delivery system of claim 60, wherein the central space is generally centered along a center axis of the control device.

64. The delivery system of claim 63, wherein each of the plurality of cables has a nonmounting end, the non-mounting end being closer to the center axis than the mounting end.

65. The delivery system of claim 60, wherein the control device further includes a ringshaped spacer between the plurality of cables, the ring-shaped spacer being located near the mounting end of each cable of the plurality of cables, the ring-shaped spacer having an internal space configured for movement of the ring-shaped article from or into the internal space.

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