Axisymmetric adjustable device for treating mitral regurgitation

Abstract

To provide a prosthetic device for improving the function of a mitral valve.SOLUTION: A device includes an axisymmetrical or elongated, adjustable sealing member configured to be positioned between mitral valve leaflets. The device also includes an expandable anchor frame configured to be positioned within one or more heart chambers, for maintaining the sealing member at a desired position and size / shape between valve leaflets. The sealing member reduces mitral regurgitation by filling the gap that can occur between opposing leaflets of a damaged mitral valve, thus restoring proper mitral valve closure.SELECTED DRAWING: Figure 2A

Description

[Technical field]

[0001] The present invention relates to heart valve repair, and more particularly to methods and apparatus for repairing heart valves by placing devices between the leaflets to improve valve closure. [Background technology]

[0002] In vertebrates, the heart is a hollow muscular organ with four pumping chambers, namely the left atrium, right atrium, left ventricle, and right ventricle, each with its own one-way pumping valve. The native heart valves are identified as the aortic, mitral (or bicuspid), tricuspid, and pulmonary valves. These valves separate the heart chambers and are each attached to an annulus between them. The annulus comprises a dense fibrous ring attached directly or indirectly to the muscle fibers of the atria and ventricles. The leaflets are flexible collagen structures that attach to and extend inward from the annulus to meet at coaptation edges. The aortic, tricuspid, and pulmonary valves usually have three leaflets, while the mitral valve usually has two.

[0003] If any of the heart valves do not function properly, it can seriously impair the work of the heart and therefore the health of the patient. Various problems with the heart valves can occur for several clinical reasons. Stenosis of the heart valves is when these valves do not open properly. Insufficiency is when the valves do not close properly. Repair or replacement of the aortic or mitral valves is the most common, as they are located on the left side of the heart where the pressures and loads are greatest. In valve replacement surgery, the replacement prosthetic valve is implanted in the native valve annulus, which may involve the removal of the native valve leaflets.

[0004] In many patients with valvular insufficiency, surgical or percutaneous repair (i.e., "valvuloplasty") is a desirable alternative to valve replacement. Reconstruction of the valve annulus (i.e., "annuloplasty") is central to many reconstructive valvuloplasty procedures. Reconstruction of the valve annulus is typically accomplished by implanting an artificial ring (i.e., "annuloplasty ring") to stabilize the valve annulus and correct or prevent valve failure that may result from annular insufficiency. Annuloplasty rings typically consist of an elastic core covered by a fibrous sewing ring. Annuloplasty may be performed solely to repair a damaged or diseased valve annulus, or in combination with other procedures such as leaflet repair.

[0005] Heart valves can lose their ability to close properly due to an enlargement of the annulus around the valve, or loose, prolapsed leaflets. The leaflets can also become constricted due to diseases, such as rheumatic diseases, which can leave gaps in the valve between the leaflets. When a heart valve fails to close, blood leaks in the reverse direction (opposite the normal flow of blood), commonly referred to as regurgitation. Common examples of such regurgitation include mitral regurgitation (i.e., leakage of blood back through the mitral valve into the left atrium) and aortic regurgitation (i.e., leakage of blood back through the aortic valve into the left ventricle). Regurgitation severely impairs the function of the heart, as more blood must be pumped through the regurgitating valve to maintain proper circulation.

[0006] Regurgitation of a heart valve makes the heart less efficient, reduces blood circulation and puts stress on the heart. In the early stages, regurgitation of a heart valve can make a person feel fatigued and short of breath. If left untreated, the problem can lead to congestive heart failure, arrhythmia, or death.

[0007] Mitral regurgitation may be caused by insufficiency of the mitral valve structure, such as resulting from direct injury to the mitral valve leaflets. Such regurgitation may be caused by a change in the shape of the mitral valve annulus, damaging the posterior and / or anterior leaflets, and / or damaging the chordae tendineae. In such regurgitation, the anterior and posterior leaflets no longer coapt properly to seal the valve, so that the anterior and posterior leaflets do not coapt to completely close the mitral annulus during systole, leaving an opening between the anterior and posterior leaflet edges.

[0008] Various methods of repairing the mitral valve are known in the art. The implantation of an annuloplasty ring, typically about the posterior aspect of the mitral valve, has proven successful in some cases. Such an annuloplasty ring can remodel the surrounding annulus, thereby resulting in proper coaptation of the native leaflets. Another technique for repairing the mitral valve is known as the "bow-tie" repair, which involves suturing the anterior and posterior leaflets together edge-to-edge toward the center of the leaflets, thereby allowing blood to flow through the two lateral openings thus formed. This process was originally developed by Dr. Ottavio Alfieri and involves placing the patient on extracorporeal bypass in order to access and suture the mitral leaflets. Later, the bow-tie technique was adapted to include beating heart repair using percutaneous methods such as using a catheter to attach sutures or clips to secure the opposing leaflets together.

[0009] Another approach to repairing native valves with non-coapted leaflets, including the mitral and aortic valves, involves inserting a device between the leaflets sized and positioned to close the gap between the leaflets that would otherwise be non-coapted. Examples of such repair devices and techniques are disclosed in U.S. Patent No. 5,399,433 to Hauser et al. and U.S. Patent No. 5,499,433 to Maurer et al., which disclose devices that include tethers that are deployed in the lower ventricle and secure the occlusion device within the mitral valve annulus.

[0010] There is currently a need for improved means for performing heart valve repair. The present invention fulfills this need. [Prior art documents] [Patent documents]

[0011] [Patent Document 1] U.S. Patent No. 8,968,395 [Patent Document 2] US Patent Application Publication No. 2009 / 0043382 [Patent Document 3] U.S. Patent Application Serial No. 16 / 112388 Summary of the Invention [Means for solving the problem]

[0012] The present invention provides several devices and methods for improving valve function. The devices and methods herein reduce or eliminate valve regurgitation without interfering with normal valve function, i.e., without interfering with the natural movement of the valve leaflets, chordae tendineae, or papillary muscles.

[0013] It should be understood that each of the sealing elements disclosed herein can be used with any and all of the anchoring elements disclosed herein, even if the particular combination of sealing elements and anchoring elements may not be clearly shown in the figures herein. In other words, based on the description of a particular device, it should not be difficult for a person skilled in the art to combine features of a particular one of two such devices. Thus, it should be understood that many of the sealing elements and anchoring elements are interchangeable, and the present invention encompasses all of these permutations. Furthermore, each of the sealing elements disclosed herein can be used alone or in combination with other anchoring devices, and each of the anchoring elements disclosed herein can be used alone or in combination with other implanted devices, such as the anchoring elements and sealing elements disclosed in U.S. Patent Application Publication No. 2013 / 0133634, filed on August 24, 2018, entitled "Transcatheter Device for Treating Mitral Regurgitation."

[0014] The device of the present invention can be utilized in standard open surgery, minimally invasive surgery, or percutaneous surgery. In one embodiment, the device can be delivered through an open chest, for example, transapically or transatrially. In another embodiment, the device can be introduced through an incision made over the roof of the left atrium. In yet another embodiment, the device can be delivered through the right chest into the left ventricle by thoracoscope, which may be performed transapically. The device can also be delivered percutaneously, such as by passing a catheter into the patient's arterial system (e.g., through the femoral or brachial artery).

[0015] Advantages of the device include a low delivery profile, which is helpful for minimally invasive, percutaneous delivery methods. The device is configured to properly interact with the native leaflets, ventricle, atrium, and subvalvular tissue. The device maintains, rather than impedes, the mobility and dynamic movement of the native leaflets (except for proper coaptation, if necessary). The native leaflets and chordae tendineae are maintained and continue to function (including against systolic closing pressure). Thus, subvalvular processes and left ventricular coordination are preserved. The device can be configured to not outwardly expand the native mitral leaflets or annulus, so that left ventricular outflow tract (LVOT) impingement / obstruction should not be a concern. With this shape and low profile of the sealing element, flow resistance during diastole is minimal, and no areas of hemostasis are created by the device. A single device can be applicable for a wide range of valve sizes.

[0016] The device may be applicable to many mitral regurgitation conditions, including those caused by leaflet prolapse with varying amounts of annular dilation (Type I), localized leaflet prolapse (Type II), and leaflet tethering (Type IIIb).

[0017] The embodiments of the present disclosure provide devices and methods for improving the function of a heart valve, such as a defective mitral valve. The devices and methods disclosed herein are desirably delivered into a subject's heart using percutaneous or minimally invasive surgical methods. Thus, the desired delivery methods described herein may not require extracorporeal circulation (e.g., sending blood from the subject's circulation outside the body to perform the applied process and then returning it to the subject's circulation). For example, in one embodiment, a delivery catheter (or similar delivery device) is inserted through an incision in the chest wall and then through the heart tissue (e.g., through the apex) into a chamber of the patient's beating heart. The delivery catheter can deliver a prosthetic device into the heart in a collapsed form, which is then expanded within the heart to treat the defective heart valve. Because the delivery method may not require extracorporeal circulation, the complexity can be greatly reduced compared to traditional open-heart surgery.

[0018] One embodiment of the present invention for treating the mitral valve is a device including an expandable prosthetic sealing member having an axially symmetric top surface profile (alternatively, an elongated or elliptical top surface profile) when expanded, the sealing member shaped to contact the leaflets of the mitral valve when expanded. The device also includes an anchoring member coupled to the sealing member and configured to secure the sealing member at a desired position between the mitral valve leaflets. The anchoring member may have an axially symmetric top surface profile. The sealing member and the anchoring member are radially collapsible and radially expandable, allowing the device to be delivered and deployed by a catheter.

[0019] A variety of anchoring elements are within the scope of the present invention. Many of the anchoring elements can be axially symmetric, i.e., symmetric about an axis running from a lower (e.g., ventricular) end to an upper (e.g., atrial) end. In one embodiment, the anchoring element can have an upper portion configured to extend around the mitral valve annulus to contact atrial tissue adjacent the mitral valve annulus, a lower portion configured to extend around the native leaflets to engage ventricular tissue adjacent the mitral valve annulus without impeding the movement of the mitral valve leaflets, and a central portion configured to support a sealing member. The anchoring element upper portion can have multiple radially extending arms to engage cardiac tissue, such as atrial tissue adjacent the mitral valve. The lower portion can have multiple radially extending arms to engage cardiac tissue, such as ventricular tissue adjacent the mitral valve, and can be dimensioned such that when the lower portion is deployed, the native leaflets can open and close as the heart beats, with or without restriction from the lower portion. In one embodiment of the device, the native leaflets are not restricted in their opening and closing by any and all parts of the device except for the sealing element, which engages with the native leaflets during systole to form a seal between the native leaflets, thereby preventing mitral regurgitation.

[0020] The anchoring member according to the present invention can be configured such that it does not expand the native mitral valve annulus, as such annular expansion may otherwise reduce valve efficiency. For example, the anchoring member can be configured such that it does not subject the native mitral valve annulus to radial expansion forces. The anchoring member can be configured such that the lower anchoring portion pushes the native annulus upward when the upper anchoring portion pushes the native annulus downward, such that the tissue of the native annulus is held between the lower and upper anchoring portions, but the annulus does not experience radial expansion forces from the anchoring member. Such an embodiment can even prevent further annular expansion by fixing the annulus between the opposing anchoring portions.

[0021] Anchoring members according to the present invention can be made self-expandable, such as by being constructed from a memory material, such as Nitinol. The anchoring members may alternatively be formed from other materials, such as stainless steel or cobalt chrome.

[0022] Another tethering element according to the invention is configured to be deployed in a single heart chamber, such as the atrium, with only the sealing elements extending from the chamber into the heart valve and annulus. For example, the tethering element can have multiple upper arms configured to engage with an upper portion of the heart chamber, and multiple lower arms configured to engage with a lower portion of the same heart chamber. The upper or lower arms, or other structure of the tethering element, can have curved portions configured to act as cushions so that the tethering element can flex in response to the movement of the heart chamber as the heart beats.

[0023] The sealing element according to the present invention is configured to be introduced in a radially collapsed but elongated configuration and then shortened and radially expanded to a desired shape to improve valve function. The sealing element can be axisymmetric or elongated (e.g., elliptical) in top surface profile and can be dimensioned to be deployed in the annulus of a native valve of the heart (e.g., the mitral valve) at a position between the native leaflets so that it contacts the native leaflets during ventricular systole to prevent backflow of blood from the ventricle to the atrium, but can open and close as the heart beats. The sealing element can have an upper end, a lower end, an anterior surface, and a posterior surface. The anterior surface can be configured to coapt with the anterior mitral leaflet and the posterior surface can be configured to coapt with the posterior mitral leaflet. The sealing element can have a mesh support frame having a delivery configuration in which the mesh support frame is substantially tubular with a delivery diameter and an expanded configuration in which the mesh support frame is radially expanded at a central portion thereof to have an expanded central diameter, but the ends of the mesh support frame remain at the delivery diameter. The expanded median diameter can be at least two times the delivery diameter, at least three times the delivery diameter, at least four times the delivery diameter, at least five times the delivery diameter, etc. The jacket can cover the mesh support frame to prevent blood from passing therethrough. The sealing element in the expanded configuration can comprise an axisymmetric, elongated, or elliptical top profile.

[0024] The outer covering of the sealing element may preferably wrap around the outside and / or inside of the central anchoring portion, or any other support structure for the sealing element, such that the wireform elements of the central anchoring portion or other support frame are covered and / or encapsulated by the sealing element to prevent the native valve leaflets from contacting any frame elements of the central anchoring portion.

[0025] A system for treating a mitral valve according to an embodiment of the present invention can include a delivery catheter, an anchoring member, and a prosthetic sealing member. The anchoring member can be self-expanding and / or axisymmetric and can have multiple radially expandable arms for engaging cardiac tissue. The sealing member can be adapted to occlude a gap between the leaflets of the mitral valve to reduce regurgitation. The prosthetic sealing member can have a collapsed state and an expanded state, where in the collapsed state the sealing member is longer and thinner than in the expanded state. The sealing member can have an outer surface formed with biological tissue. The elongated cross-sectional profile of the sealing member can be secured to allow blood to flow around the sealing member.

[0026] A method according to the present invention for improving heart valve function includes advancing a distal end of a delivery catheter to a location of a patient's mitral or other heart valve, within which is a prosthetic device having an anchoring member and a sealing member. The sealing member can be configured to expand to a configuration to reduce regurgitation through the mitral valve. The anchoring member can have an upper portion configured to expand to engage atrial tissue, a central portion configured to expand to support the sealing member, and a lower portion configured to expand to engage ventricular tissue. The anchoring member can have an upper portion to engage an upper portion of a heart chamber and a lower portion configured to engage a lower portion of the same heart chamber. The anchoring member can be self-expandable and / or formed from a memory material and can be mounted in a compressed state within the distal end of the delivery catheter. The method can further include releasing the anchoring member upper portion from the catheter in a position such that the anchoring member upper portion engages the desired heart tissue, releasing the sealing member from the catheter, and releasing the anchoring member lower portion from the catheter in a position such that the anchoring member lower portion engages the desired heart tissue. This deployment sequence can be performed in different orders, such as releasing the anchoring member lower portion first, then the sealing member, then the upper portion, or releasing the sealing member before or after releasing the lower and upper anchoring portions. After deployment of the anchoring member portions and the sealing member, the sealing member should be positioned between the leaflets of the mitral valve such that the leaflets coapt against the sealing member during systole. The length and width of the sealing member can be adjusted to improve the function of the heart valve after initial deployment by the user. The device can be delivered and deployed to the mitral valve or other heart valves using a variety of delivery techniques, such as percutaneous or transapical.

[0027] The method of the present invention may include the steps of advancing a distal end of a delivery catheter to a location of a heart valve (e.g., mitral valve) of a patient's heart, wherein within the distal end is a prosthetic device having an anchoring member and a sealing member, wherein the sealing member can be configured to expand into an axially symmetric or elongated and symmetric (e.g., elliptical) configuration to engage the native mitral valve leaflets during systole, but still open and close as the heart beats; releasing an anchoring member portion from the catheter to a location in the heart at or adjacent to the native valve annulus to engage cardiac tissue and anchor the anchoring member within the heart; releasing the sealing member from the catheter; and radially expanding the sealing member, wherein as the sealing member expands, it shortens in length and increases in diameter, and wherein the sealing member comprises an axially symmetric or elongated / elliptical top surface profile after expansion. After release of the anchoring member and sealing member, the sealing member is positioned between the leaflets of the mitral valve so that the leaflets coapt against the sealing member during systole, allowing the leaflets to open and close as the heart beats.

[0028] The sealing member after expansion can have a circular top profile, or an elongated top profile (e.g., an elliptical top profile). The sealing member can be rotated about its central axis relative to the native annulus to a desired rotational position, where the sealing member is aligned with the native valve features within the annulus to improve coaptation of the leaflets to the sealing member. This rotation can be selectively performed by a user, who can also lock the sealing member in the desired rotational position. For an elongated sealing element, rotating the sealing member about its central axis can include aligning the long axis of the sealing member to be substantially parallel (within 10 degrees) to a line between the commissures of the mitral valve.

[0029] Deployment of the device can be performed in response to feedback from valve performance monitoring and / or visualization techniques. For example, a user can monitor valve performance while expanding or rotating the sealing element and set the final expansion configuration and / or rotational position of the sealing element to the configuration that maximizes valve performance based on valve performance and / or visualization feedback.

[0030] The anchoring member can include an upper portion and a lower portion. A central portion can be included and configured to support the sealing member. In one embodiment, the upper portion is configured to expand to engage atrial tissue and the lower portion is configured to expand to engage ventricular tissue. A method of deploying the anchoring member can include releasing the upper portion to engage atrial tissue and releasing the lower portion to engage ventricular tissue. In one embodiment, the upper portion is configured to expand to engage upper atrial tissue and the lower portion is configured to expand to engage lower atrial tissue adjacent the native annulus. A method of deploying the anchoring member can include releasing the upper portion to engage upper atrial tissue and releasing the lower portion to engage lower atrial tissue. The step of releasing the anchoring member upper portion from the catheter can occur before, simultaneously with, or after the step of releasing the anchoring member lower portion from the catheter.

[0031] The device can be delivered using a variety of approaches, including percutaneous or transapical approaches through the subject's vasculature.

[0032] Other objects, features and advantages of the present invention will become apparent from a consideration of the following detailed description. [Brief description of the drawings]

[0033] [Figure 1] FIG. 1 is a cross-sectional view of the heart. [Figure 2A] 1 is a side cross-sectional view of a heart with a repair device according to one embodiment of the present invention deployed therein. [Figure 2B] 1 is a side cross-sectional view of a heart with a repair device according to one embodiment of the present invention deployed therein. [Figure 2C] 1 is a side cross-sectional view of a heart with a repair device according to one embodiment of the present invention deployed therein. [Figure 2D] 1 is a side cross-sectional view of a heart with a repair device according to one embodiment of the present invention deployed therein. [Figure 3A] 1A-1D are side views of a sealing element at different stages of expansion, according to one embodiment of the present invention. [Figure 3B] 1A-1D are side views of a sealing element at different stages of expansion, according to one embodiment of the present invention. [Figure 3C] 1A-1D are side views of a sealing element at different stages of expansion, according to one embodiment of the present invention. [Figure 3D] 1A-1D are side views of a sealing element at different stages of expansion, according to one embodiment of the present invention. [Figure 3E] FIG. 3B is a top view of the sealing element shown in FIG. 3A in an expanded stage. [Figure 3F] FIG. 3C is a top view of the sealing element in the expanded stage shown in FIG. 3B. [Figure 3G] FIG. 3D is a top view of the sealing element in the expanded stage shown in FIG. 3C. [Figure 3H] FIG. 3E is a top view of the sealing element in the expanded stage shown in FIG. 3D. [Figure 4A] FIG. 13 is a side view of a grooved tube sealing element frame in a compressed configuration according to one embodiment of the present invention. [Figure 4B] FIG. 13 is a perspective view of a grooved tube sealing element frame in an expanded configuration according to one embodiment of the present invention. [Figure 5A] 1A-1D are side views of a braided mesh closure element at different expansion stages, according to one embodiment of the present invention. [Figure 5B] 1A-1D are side views of a braided mesh closure element at different expansion stages, according to one embodiment of the present invention. [Figure 5C] 1A-1D are side views of a braided mesh closure element at different expansion stages, according to one embodiment of the present invention. [Figure 6A] 1A-1C are top views of a sealing element at one expansion stage, according to one embodiment of the present invention. [Figure 6B] 1A-1C are top views of a sealing element at one expansion stage, according to one embodiment of the present invention. [Figure 6C] 1A-1C are top views of a sealing element at one expansion stage, according to one embodiment of the present invention. [Figure 6D]Top view of a sealing element at a certain expansion stage according to an embodiment of the present invention. [Figure 7A] Perspective view of a mechanism for controlling the expansion of a sealing element according to an embodiment of the present invention. [Figure 7B] Perspective view of a mechanism for controlling the expansion of a sealing element according to an embodiment of the present invention. [Figure 7C] Perspective view of a mechanism for controlling the expansion of a sealing element according to an embodiment of the present invention. [Figure 8A] Perspective view of a device according to an embodiment of the present invention. [Figure 8B] Top view of a mooring part according to an embodiment of the present invention. [Figure 8C] Bottom view of a mooring part according to an embodiment of the present invention. [Figure 8D] Side view of a heart chamber containing the device of FIG. 8A at a certain deployment stage according to an embodiment of the present invention. [Figure 8E] Side view of a heart chamber containing the device of FIG. 8A at a certain deployment stage according to an embodiment of the present invention. [Figure 8F] Side view of a heart chamber containing the device of FIG. 8A at a certain deployment stage according to an embodiment of the present invention. [Figure 8G] Side view of a heart chamber containing the device of FIG. 8A at a certain deployment stage according to an embodiment of the present invention. [Figure 9A] Side view of a device according to an embodiment of the present invention. [Figure 9B] Top view of a frame according to an embodiment of the present invention. [Figure 9C] Bottom view of a frame according to an embodiment of the present invention. [Figure 9D] Side view of a heart chamber containing the device of FIG. 9A at a certain deployment stage according to an embodiment of the present invention. [Figure 9E] Side view of a heart chamber containing the device of FIG. 9A at a certain deployment stage according to an embodiment of the present invention. [Figure 9F]9B is a side view of a heart chamber with the device of FIG. 9A in one stage of deployment, according to one embodiment of the present invention. [Figure 9G] 9B is a side view of a heart chamber with the device of FIG. 9A in one stage of deployment, according to one embodiment of the present invention. [Figure 10A] FIG. 2 is a side view of a device according to one embodiment of the present invention. [Figure 10B] 10B is a side view of a heart chamber with the device of FIG. 10A therein at one stage of deployment, according to one embodiment of the present invention. [Figure 10C] 10B is a side view of a heart chamber with the device of FIG. 10A therein at one stage of deployment, according to one embodiment of the present invention. [Figure 10D] 10B is a side view of a heart chamber with the device of FIG. 10A therein at one stage of deployment, according to one embodiment of the present invention. [Figure 10E] 10B is a side view of a heart chamber with the device of FIG. 10A therein at one stage of deployment, according to one embodiment of the present invention. [Figure 11A] 1 is a perspective view of a mooring frame according to one embodiment of the present invention with various portions expanded; FIG. [Figure 11B] 1 is a perspective view of a mooring frame according to one embodiment of the present invention with various portions expanded; FIG. [Figure 11C] 1 is a perspective view of a mooring frame according to one embodiment of the present invention with various portions expanded; FIG. [Figure 11D] FIG. 11C is a diagram of a device having the anchoring elements of FIGS. 11A-11C in an expanded configuration, according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] A cross-section of a human heart 10 is shown in FIG. 1. The heart 10 has a muscular heart wall 11, an apex 19, and four chambers: right atrium 12, right ventricle 14, left atrium 16, and left ventricle 18. Blood flow is controlled by four major valves: the tricuspid valve 20, the pulmonary valve 22, the mitral valve 24, and the aortic valve 26. Blood enters the right atrium 12 of the heart 10 through the superior vena cava 28 and the inferior vena cava 30. The right atrium 12 pumps blood through the tricuspid valve 20 (which is in an open configuration) into the right ventricle 14. The right ventricle 14 then pumps blood through the pulmonary valve 22 into the pulmonary artery 32 (which branches into an artery that leads to the lungs). The tricuspid valve 20 is then closed to prevent blood from flowing back from the right ventricle 14 into the right atrium. The free edges of the leaflets of the tricuspid valve 20 are connected within the right ventricle 14 via right ventricular chordae tendineae 34 to right ventricular papillary muscles 36 to control movement of the tricuspid valve 20 .

[0035] After leaving the lungs, the oxygenated blood flows through the pulmonary veins 38 into the left atrium 16 of the heart 10. The mitral valve 24 controls blood flow between the left atrium 16 and the left ventricle 18. The mitral valve 24 is closed during ventricular systole, when blood is ejected from the left ventricle 18 into the aorta 40. The mitral valve 24 then opens to allow blood from the left atrium 16 to refill the left ventricle 18. The free edges of the leaflets 42a, 42p of the mitral valve 24 are connected within the left ventricle 18 via the left ventricular chordae tendineae 44 to the left ventricular papillary muscles 46 to control the mitral valve 24. Blood from the left ventricle 18 is pumped through the aortic valve 26 into the aorta 40, which branches into arteries that lead to all parts of the body except the lungs. The aortic valve 26 includes three cusps 48 that open and close as the heart beats to control the flow of blood from the left ventricle 18 to the aorta 40 of the heart.

[0036] 2A-2D show a device 50 deployed within the native mitral valve 24 and mitral annulus 25, according to one embodiment of the present invention. The device 50 has a support tether 52 and a sealing element 54. The support tether 52 can be configured to allow the native leaflets 42a, 42p to move freely. In FIG. 2A, the native mitral valve 24 is in early diastole, and the native leaflets 42a, 42p begin to open, allowing blood to flow from the left atrium 16 to fill the left ventricle 18. In full diastole, as shown in FIG. 2B, the mitral leaflets 42a, 42p are fully open. In early systole, as shown in FIG. 2C, early regurgitation into the left atrium 16 pushes the mitral leaflets 42a, 42p back (upward) into engagement with each other and with the sealing element 54. During full systole, as shown in FIG. 2D, the native mitral valve leaflets 42a, 42p tightly wrap around the sealing element 54 under maximum contractile pressure, effectively eliminating any backflow.

[0037] A sealing element 60 according to an embodiment of the present invention is shown in Figures 3A-3D and 3E-3H. The sealing element 60 shown in Figures 3A and 3E has a fully compressed state that may be useful for delivery through a catheter, where the sealing element 60 is substantially tubular and may have an initial / delivery length 62a and an initial / delivery maximum diameter 64a. The sealing element 60 may be expanded by shortening the lengths 62b, 62c, as shown in Figures 3B-3C and 3F-3G, thus increasing the maximum diameters 64a, 64b of the sealing element. As shown in Figures 3D and 3H, the sealing element 60 may reach its deployed length 62d and deployed maximum diameter 64d. The sealing element 60 according to the present invention may have an initial / delivery length 62a between 15-60 mm, between 40-50 mm, between 30-55 mm, etc. The sealing element 60 may have an initial / delivery maximum diameter 64a between 0-10 mm, between 5-8 mm, 6 mm, etc. A sealing element 60 according to the present invention can have a deployed length 62d between 20-45 mm, between 25-35 mm, about 30 mm, etc., and can have a deployed maximum diameter 64d between 5-40 mm, between 10-30 mm, between 15-25 mm, etc. The height / length to diameter ratio can vary depending on the particular application. Exemplary ranges of height / length to diameter ratios are 10:1 or 5:1 or 3:1, and ranges therebetween, when delivered, and 1:4 or 1:2 or 1:1 or 2:1, and ranges therebetween, when deployed. It is noted that each of these ratios and ranges for a particular sealing element dimension (e.g., delivery diameter, deployed diameter, delivery height / length, deployed height / length, etc.) may be combined with any and all of the other sealing elements according to the present invention.

[0038] The sealing elements and / or anchoring elements according to the present invention may include radiopaque or other visualization markers to enhance user visualization of the device. For example, in the embodiment of Figures 3A-3H, radiopaque or other visualization markers 63, 65 are included. Marker 63 is located towards the end of the sealing element and can be used to visualize the height / length of the sealing element. Circumference marker 65 is located towards the widest point around the sealing element and can be used to visualize the diameter of the sealing element. All markers can also be used to monitor the position of the sealing element.

[0039] The sealing element 60 can have an expansion control element 66, the length of which can be adjusted to thereby control the overall length of the sealing element, and thereby the expansion of the sealing element. The sealing element 60 can preferably have a sealing surface (not shown), which can be in the form of a jacket that prevents blood from passing therethrough. The sealing surface can be supported by an expandable support frame (not shown). It is noted that in the configuration shown in Figures 3A-3D, the expansion control element 66 coincides with a central axis of the sealing element 60, and the sealing element 60 can be axisymmetric about it during deployment and after expansion.

[0040] An expandable support frame 70 in a so-called "fluted tube" configuration according to one embodiment of the present invention is shown in Figures 4A and 4B. As shown in Figure 4A, in its compressed / delivery configuration, the support frame 70 comprises a substantially cylindrical body 72, as well as a delivery length 74a and a delivery maximum diameter 76a. The structure of the support frame 70 with the breaks 78 between the rib-like elements 80 allows the rib-like elements 80 to bend outward and the support frame 70 to expand radially, as shown in Figure 4B, so that the support frame 70 reaches a deployed length 74b and a deployed maximum diameter 76b. Note that the deployed length 74b is shorter than the delivery length 74a, but the deployed maximum diameter 76b is larger than the delivery maximum diameter 76a. This delivery configuration is useful for delivery to a human heart by a catheter. Adding a sealing surface (not shown), such as in the form of a jacket, to the support frame 70 creates a sealing element according to an embodiment of the present invention. Expansion of the support frame 70 may be achieved by mechanisms such as tethers, ratchets, and / or may include constructing the support frame 70 from a shape memory material such as Nitinol.

[0041] A support frame 90 according to one embodiment of the invention may include a braided mesh sleeve, as shown in Figures 5A-5C, in which strands 92 (such as wires or other strand-like elements) are braided or otherwise formed into a mesh structure that defines a generally tubular structure 94. The mesh structure may allow the frame 90 to expand radially when its length is compressed and to contract radially when its length is extended (in a manner similar to the contractible finger traps used in children's toys). The support frame 90 has a distal end 96 and a proximal end 98, and has lengths 100a, 100b, 100c and maximum diameters 102a, 102b, 102c. Diameters 104, 106 at the distal end 96 and proximal end 98 may be generally fixed, such that this portion of the support frame 90 does not appreciably expand radially, even when its maximum diameter is expanded. As the length of the support frame 90 is shortened from its delivery length 100a to its deployed length 100c, the maximum diameter of the support frame 90 increases from its delivery maximum diameter 102a to its deployed maximum diameter 102c. It should be noted that depending on how the support frame is formed (e.g., how the strands 92 are braided, the materials used, etc.), the central portion 108 of the support frame 90 can remain substantially tubular even when the central portion 108 and the support frame 90 are radially expanded. In other embodiments, the support frame 90 may form a more spherical shape, with the shape varying in the radial dimension around the frame 90. Adding a sealing surface (not shown), such as in the form of a jacket, to the support frame 90 creates a sealing element according to an embodiment of the present invention. Expansion of the support frame 90 can be accomplished by mechanisms such as tethers, ratchets, and / or can include constructing the support frame 90 from a shape memory material such as Nitinol.

[0042] The support frame and sealing element according to the invention may be configured to form a non-circular profile when viewed from above. For example, in the embodiment of Figures 6A-6D, the sealing element 110, which may have a side profile similar to that shown in Figures 3A-3D during delivery and expansion, instead of having a circular top profile as shown in Figures 3E-3H, forms an elongated / elliptical top profile when deployed, where the major axis 112d is much larger than the minor axis 114d when the sealing element 110 is fully expanded as shown in Figure 6d. Such non-circular / elliptical sealing elements may include radiopaque or other visualization markers 115, 117, for example, positioned along / adjacent to the major axis 112a-112d and / or minor axis 114a-114d toward the periphery of the sealing element, which allows the user to see not only the dimensions (major and / or minor axis) but also the rotational orientation of the sealing element about its central axis relative to the anchoring element and / or the native valve. Upon delivery, the maximum diameter can be between 0-10 mm, between 5-8 mm, between 6-7 mm, etc. The expanded minor diameter 114d can be between 5-20 mm, between 10-15 mm, etc., and the expanded major diameter 112d can be between 10-40 mm, between 15-40 mm, between 20-30 mm, etc.

[0043] The expansion of the sealing element can be controlled by the use of various mechanisms. For example, as shown in FIG. 7A, an internal tethering mechanism 120 can comprise a tether line 122 having a first end 124 that can be secured to an end of a support frame (not shown) and a second end 126 that can be threaded through the opposite end of the support frame. Pulling the second end 126 thereby shortens the length of the internal tether within the support frame, which shortens its length and expands radially. The internal tethering mechanism can include a lock, such as a knot, a one-way lock, or other locking mechanism (not shown), at the opposite end of the support frame to secure the internal tether at a desired length corresponding to the desired shape (i.e., maximum diameter / length) of the deployed sealing element. Such tethers can be used with any and all of the sealing elements and support frames of the present invention and can be particularly useful for sealing elements having a self-expanding support frame where the tether acts to constrain and control the expansion of the support frame.

[0044] The expansion of the sealing element according to the present invention can be controlled by a generally highly rigid rod 130 that resists both tension and compression, as shown in FIG. 7B. A first end 132 of the rod 130 can be fixed to a first end of a support frame (not shown), with the rod 130 passing through a locking mechanism 134 at a second end of the support frame, the second end 134 of the rod 130 being beyond the locking mechanism from the first end 132. The rod 130 can include a tooth-like element 136 that is selectively engaged by the locking mechanism 134. For example, the locking mechanism 134 can allow the tooth-like element to pass outwardly through the locking mechanism (when it is desired to shorten the rod 130, thereby shortening the support frame, to expand radially), but prevent the tooth-like element from passing inwardly through the locking mechanism.

[0045] Another option for controlling the expansion of the sealing element is a linear screw mechanism 140, in which an elongated screw 142 has a first end 144 fixed to a first end of a support frame (not shown). A screw receiving nut 146 is fixed to a second end of the support frame via an extender 148. Either the screw receiving nut 146 or the first end 144 of the screw are rotatably fixed to the support frame, allowing the screw to be rotated relative to the screw receiving nut, thereby advancing / retracting the screw 142 through the screw receiving nut 146, thereby adjusting the length of the linear screw mechanism and the length / expansion of the support frame.

[0046] 8A is a perspective view of a device 150 configured for deployment having portions that are anchored to the atrium, ventricle, and annulus of a patient. Anchoring element 152 anchors and supports sealing element 154. Anchoring element 152 has an atrial portion 156 with an atrial arm 158 that terminates at an atrial arm distal end 160 that is sized and shaped to extend across the lower part of the atrium and engage the annulus from the atrial side. Ventricular portion 162 has a ventricular arm 164 that terminates at a ventricular arm distal end 166. Ventricular arm 164 can be sized and shaped to extend around a "rocking" region where the native leaflets rock as the heart beats, so that it does not engage against the native leaflets as they open and close. Ventricular arm 164 bends around the leaflet rocking region and then bends back up to engage the annulus from the ventricular side. It should be noted that the illustrated anchoring elements 152, when expanded in air or otherwise in the absence of compressive forces (such as those that may be present when deployed in the heart), are axisymmetric when viewed directly from above or below, as can be seen in Figures 8B-8C, so that upon deployment, the surgeon or other user need not worry about whether the anchoring elements 152 of the device 150 will rotate about their central axis to be in the correct deployed position relative to the native valve and annulus. In the particular embodiment shown, the expanded diameter 161 of the upper anchoring element 156 is slightly larger than the expanded diameter 167 of the lower anchoring element 162, although the invention is not limited to this configuration. The expanded diameter 167 of the lower anchoring portion can be between 25 and 60 mm, and the expanded diameter 161 of the upper anchoring portion can be between 30 and 70 mm. It should be noted that when expanded within a real heart, the individual arms 158, 164 of the upper and lower anchoring elements 156, 162 may be compressed or otherwise distorted by interaction with the heart tissue, such that each arm may be distorted by the heart tissue into a shape slightly different than the shape of the other arms.

[0047] The anchoring element 152 of FIG. 8A includes a central portion 168 that passes through the sealing element 154. The central portion 168 can be configured to act as a support frame for the sealing element and / or can be configured to shorten (e.g., by incorporating a shortening mechanism, such as in FIGS. 7A-7C ) to effect shortening and thereby expansion of the sealing element 154. In the particular embodiment shown, the central portion 168 of the sealing element circumscribes the axis of the sealing element 154 and the axis of the anchoring element 152. It should be noted that the sealing element 154 can be axisymmetric (e.g., circular) in its top profile (i.e., about its central axis) as in FIGS. 3E-3H or non-circular (e.g., elliptical) as in FIGS. 6A-6D . The sealing element 154, particularly if it has a non-circular / elliptical top surface profile, can be configured to pivot relative to the anchoring element 152 (selectively or responsively to bodily movements such as blood flow / valve movement) and can be provided with a lock that can be actuated to prevent further rotation of the sealing element 154 relative to the anchoring element 152. With such rotation, a surgeon or other user can deploy the axisymmetric anchoring element, confirm correct deployment of the anchoring element (e.g., viewed directly or indirectly via fluoroscopy), then rotate the sealing element to a desired rotated position, and then lock the sealing element in that desired position.

[0048] 8D-8G are side views showing the left atrium 16, left ventricle 18, mitral valve 24, and mitral valve annulus 25 with device 150 at various stages of deployment, according to one embodiment of the present invention. Device 150 is secured within distal end 170 of delivery catheter 172, as in FIG. 8D, which is advanced percutaneously or minimally invasively through left atrium 16 of heart 10 into the patient's mitral valve 24. In FIG. 8E, ventricular anchoring portion 166 is released from catheter 172 and expanded beneath mitral valve 24 to contact cardiac tissue. In FIG. 8F, sealing element 154 and central anchoring portion 168 are positioned between leaflets 42a and 42p of mitral valve 24. At this point, sealing element 154 may be expanded, or expansion may not occur until after deployment of atrial anchoring portion 156. Note that in Fig. 8F, the sealing element is shown expanded, but that expansion may occur after deployment of the atrial anchoring portion. In Fig. 8G, when the device 150 is fully released from the catheter 172, the atrial anchoring portion 156 is expanded above the mitral valve 24 and into contact with cardiac tissue.

[0049] Once the location and functionality of device 150 has been confirmed (by fluoroscopy and / or other remote viewing methods), catheter 172 is withdrawn from the patient. It should be noted that although percutaneous delivery via the atrial side has been shown, other deployment approaches, including a transapical approach, are also within the scope of the present invention.

[0050] 9A shows a device 180 configured for deployment with an anchoring portion that is entirely anchored within the atrium of a patient. Anchoring element 182 anchors and supports sealing element 184. Anchoring element 182 has an upper atrial portion 186 with an upper atrial arm 188 that terminates at an upper atrial arm distal end 190. The upper atrial arm 188 is sized and configured to bend upward through the center of the atrium and then bend outward to engage the top surface of the atrium. The upper atrial arm 188 can include a middle curved portion 189 that can act as a buffer that flexes and bends to allow the anchoring element 182 to be compressed as the heart beats and the shape of the atrium changes. The lower atrial portion 192 has a lower atrial arm 194 that terminates at a lower atrial arm distal end 196. The lower atrial arm 194 is sized and shaped to extend outward across the lower part of the atrium and engage the valve annulus from the atrial side. It should be noted that the illustrated anchoring elements 182 can be axisymmetric when expanded in the absence of compressive or other distorting forces, so that upon deployment, the surgeon or other user does not need to worry about whether the anchoring elements 182 of the device 180 have rotated about their central axis to be in the correct deployed position relative to the native valve and annulus. For example, when expanded without compressive / distorting forces (e.g., expanded in air), the anchoring elements 182 are symmetric when viewed from above or below, as shown in Figures 9B-9C. In the particular embodiment shown, the expanded diameter 191 of the upper anchoring element 186 is generally equal to the expanded diameter 197 of the lower anchoring element 192, although other dimensions are also within the scope of the invention. The expanded diameter 191 of the upper anchoring portion and the expanded diameter of the lower anchoring portion can range from 30 to 70 mm. It should be noted that when expanded within a real heart, the individual arms 188, 194 of the upper and lower anchoring elements 186, 192 may be compressed or otherwise distorted by interaction with the heart tissue, such that each arm may be distorted by the heart tissue into a shape slightly different than the shape of the other arms.

[0051] The anchoring element 182 of FIG. 9A includes a sealing element support portion 200 that passes under the atrial portions 186, 192 and through the sealing element 184 and is configured to hold the sealing element 184 in a desired position within the native annulus after the other anchoring portions 186, 192 are deployed in a desired heart chamber, such as the left atrium 16 shown. In the particular embodiment shown, the sealing element support portion 200 is coincident with the axis of the sealing element 184 and the axis of the anchoring element 182. The sealing element support portion 200 may be configured to act as a support frame for the sealing element 184 and / or may be configured to shorten (e.g., by incorporating a shortening mechanism, such as in FIGS. 7A-7C ) to effect shortening and thereby expansion of the sealing element 184. It should be noted that the sealing element 184 can be axisymmetric (e.g., circular) in its top profile (i.e., about its central axis) as in Figures 3E-3H, or noncircular (e.g., elliptical) as in Figures 6A-6D. The sealing element 184, particularly in the case of a noncircular / elliptical top profile, can be configured to pivot relative to the anchoring element 182 (selectively or responsively to bodily movements such as blood flow / valve movements) and can be provided with a lock that can be actuated to prevent the sealing element 184 from further rotating relative to the anchoring element 182. With such rotation, a surgeon or other user can deploy the axisymmetric anchoring element, confirm correct deployment of the anchoring element (e.g., viewed directly or indirectly by fluoroscopy), then rotate the sealing element to a desired rotated position, and then lock the sealing element in that desired position.

[0052] As shown in Figures 9D-9G, the device 180 can be deployed by a transapical approach to the heart 10. The device 180 is secured within a distal end 204 of a delivery catheter 202, and the distal end 204 of the catheter is advanced through an opening 206 in the heart wall 11 (e.g., through an opening in the wall of the left ventricle 18, such as a transapical opening at the apex) into the patient's mitral valve 24. In Figure 9E, as the device 180 begins to be ejected from the catheter 202, the upper atrial anchoring portion 186 is expanded toward an upper region of the left atrium 16 to contact heart tissue. In Figure 9F, the lower atrial anchoring portion 192 is ejected from the delivery catheter 202 and expanded to contact a lower portion of the atrium 16. Figure 9G shows the sealing element 184 and sealing element support portion 200 positioned between the leaflets of the mitral valve 24, with the sealing element 184 being extended between the leaflets. The device 180 is fully ejected from the catheter 202. Once the position and functionality of device 180 has been confirmed (by fluoroscopy and / or other remote viewing methods), catheter 202 may then be withdrawn from the patient and opening 206 may be closed by sutures 208 and / or other methods / devices for closing the opening.

[0053] FIG. 10A shows a device 210 having a sealing element 212 tethered by a tether 214 and a tether 216. The device 210 can be positioned on a distal end 218 of a delivery catheter 220 and advanced into the heart. In one embodiment, the device 210 is advanced transapically through an opening 222 in the heart wall into the left ventricle 18 and up to the mitral valve 24, where the opening 222 can be at the apex 19, as shown in FIG. 10B. The sealing element 212 can be released from the catheter 216 to a position between the native leaflets 42a and 42p, as shown in FIG. 10C. FIG. 10D shows the catheter 220 retracted such that the tether 214 is released from the catheter distal end 218, where the tether 214 can be rigid or flexible depending on the desired application. Once the catheter is removed from the heart 10, the tether 216 is deployed to the heart wall 11, as shown in FIG. 10E. The user can then adjust the length of tether 214 before locking tether 214 to tether 216 at the desired length. Note that locking tether 214 to the tether at the desired tether length can be accomplished by known methods such as a sliding locking mechanism that initially allows the tether to slide through the lock, but prevents further movement due to knots in the tether line, etc.

[0054] It should be noted that the sealing element 212 may be selectively fully or partially expanded at various times during deployment, such as when initially released from the delivery catheter, after the tether has been stretched, after the tether has been secured, or after the tether length has been established. The length of the tether may also be adjusted at various times. For example, the sealing element 212 may be partially expanded when released from the catheter and fully expanded just before or when the tether length is established to verify, such as by fluoroscopy, that the leaflets are properly sealed against the sealing element. It should be noted that while transapical delivery through the ventricle and apex is illustrated, other deployment approaches are also within the scope of the present invention, including percutaneous approaches through the vascular and / or atrial sides.

[0055] The anchor frame 230 according to the present invention can be formed from a memory material such as Nitinol and / or can have a central portion 232 configured to act as a support frame for the sealing elements. For example, as shown in FIG. 11A, the frame 230 can be formed as a generally tubular form of shape memory material having a central portion 232, an upper portion 234, and a lower portion 236, each portion configured with rib-like elements 240a-c with gaps 238a-c between them. The central portion 232 can be radially expanded to a desired shape by bending the rib-like elements 240b outward, as shown in FIG. 11B, and the desired shape can be set in the memory material by known methods. The upper portion 234 and lower portion 236 can similarly be formed to a desired shape, as shown in FIG. 11C, and the desired shape can be set in the memory material. Note that the rib-like elements 240a-c are configured to flare outward to form arms and other frame / anchoring structures. Adding a fluid-occlusive envelope 242 to the frame central portion 232 creates a sealing element 244. Note that the device may have a top opening 246 and / or a bottom opening 248 in the sealing element portion, which allows some blood flow into and out of the sealing element, but avoids blood pooling therein. Alternatively, one or both of the top and bottom of the sealing element portion may be completely closed.

[0056] The anchor frame according to the present invention can be made from a variety of biocompatible materials, including metals and polymers. For example, a memory material such as Nitinol can be used, thereby forming an anchor frame that can be compressed against / into a catheter for minimally invasive / percutaneous delivery and then expands to a "remembered" shape when released from the catheter. Non-memory materials such as stainless steel or cobalt chrome are also within the scope of the present invention. The anchor frame can include a biocompatible outer covering such as Dacron or other fabrics. The biocompatible outer covering can encourage tissue ingrowth to promote tissue anchoring. The biocompatible outer covering can instead resist tissue ingrowth.

[0057] The sealing element according to the present invention can be formed from a variety of biocompatible materials, including metal, fabric, plastic, and tissue. Some materials that can be used for such sealing elements include materials currently used to form the apex of prosthetic heart valves. For example, synthetic materials (e.g., polymers such as thermoplastic elastomers or resins, including polyurethane and silicone, etc.), natural / processed tissues (e.g., valve leaflet tissue, bovine or equine pericardium, etc.), fabrics (e.g., Dacron), etc. can be used.

[0058] The sealing element may preferably wrap around the outside and / or inside of any anchoring portions that serve to directly support or shape the sealing element, such that any wireform / rib-like elements of the support frame portions are covered and / or encapsulated by the sealing element material to prevent the native valve leaflets from contacting any frame elements, such as the sealing element support frame.

[0059] Upon deployment of a device according to the invention, such as the deployment procedures shown in Figures 8D-8G or 9D-9G or 10B-10E, a surgeon or other user can controllably expand the sealing element to a desired diameter / length, or the sealing element can be configured to self-expand to a preset configuration, such as upon release from a delivery catheter. For example, if the sealing element includes a memory material (e.g., Nitinol) support frame, the support frame automatically expands to the preset memory material configuration (length / diameter) upon release from a radial constraint, such as the delivery lumen of the delivery catheter. Alternatively, a surgeon or other user can actively control the expansion of the sealing element to a particular selected diameter / length, such as by actuating a length / diameter adjustment element, such as those shown in Figures 7A-7C. Before, during, and / or after the expansion of the sealing element, the surgeon / user can actively monitor the function of the heart valve and / or the coaptation of the leaflets (with the sealing element) and / or the position / size of the sealing element by various techniques, such as fluoroscopy or other visualization techniques (including the use of radiopaque markers on the sealing element). The surgeon / user can select the final diameter / length of the sealing element based on information about the function of the heart valve and / or the coaptation of the leaflets. The surgeon / user can also selectively rotate the sealing element about its central axis relative to the support tether (before, during, or after deployment of the support tether) to better position the sealing element between the native leaflets, such as when the sealing element has an elliptical top surface profile as shown in Figures 6A-6D. For example, with such an elliptical contoured sealing element, a user can deploy the anchoring element and then rotate the sealing element (expanded or unexpanded) relative to the anchoring element and native valve to position the minor axis extending generally perpendicular to the anterior and posterior mitral valve leaflets and the major axis extending between the valve commissure points. Once the desired rotational position is reached, the sealing element can be locked in that position.

[0060] If a user (e.g., a surgeon or other medical staff) is not satisfied with the initial placement of all or a portion of the device, the device or portion thereof can be retracted (fully or partially) into the catheter and then redeployed to a desired position. For example, if after initial deployment, the position of the sealing element is too high or too low relative to the mitral valve leaflets, the device or portion thereof can be at least partially retracted into the catheter and then redeployed to a higher or lower position than the previous position. Similarly, if a user is not satisfied with the deployed size of the sealing element, the user can adjust the length / radius of the sealing element until the desired sealing / coaptation with the native leaflets is achieved. Also, for sealing elements with non-circular / elliptical top surface contours, the user can modify the rotational position of the sealing element to a desired rotational position that can optimize valve function.

[0061] Radiopaque markers or other enhanced visualization markers can be included with the device to make the device and its key elements more clearly visible when the device is deployed or examined using fluoroscopy or other visualization techniques. For example, enhanced visualization markers, such as radiopaque markers, can be affixed to portions such as the sealing and / or anchoring elements.

[0062] 3B-3D, 8E, 9A, and 11A-11D are computer-generated, to-scale drawings, and the dimensions are to-scale within each of the drawings. All dimensions listed are examples, and devices according to the invention can have dimensions outside of these particular values ​​or ranges. Although in some of the figures the sealing element material is depicted as extending between, but not covering, the frame portions, in various embodiments of the invention (including each of the embodiments of the invention depicted in the figures), the sealing element material can preferably wrap around the outside and / or inside of the supporting frame portions, such that the wireform / ribbed frame elements are covered and / or encapsulated by the sealing element material to prevent the native leaflets from contacting any of the frame elements.

[0063] Although the particular embodiments described above are directed to mitral valve repair, the present invention may also be applicable for use in repairing other heart valves, including the aortic, tricuspid, and pulmonary valves.

[0064] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. To facilitate review of the various embodiments of the present disclosure, the following terminology is provided.

[0065] The singular terms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. The term "or" refers to a single element of stated alternative elements or a combination of two or more elements, unless the context clearly dictates otherwise.

[0066] The term "include" means "comprise." For example, a device that includes or comprises A and B includes A and B, but can optionally include C, or other components other than A and B. Furthermore, a device that includes or comprises A or B can include A or B, or A and B, and optionally one or more other components, such as C.

[0067] The term "subject" refers to both human and other animal subjects. In certain embodiments, the subject is a human or other mammal, such as a primate, cat, dog, cow, horse, rodent, sheep, goat, or pig. In certain examples, the subject is a human patient.

[0068] Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present disclosure, suitable methods and materials are described below. In case of conflict, the present specification, including the terminology, will control. Furthermore, the materials, methods, and examples are merely illustrative and are not intended to be limiting.

[0069] In view of the many possible embodiments to which the inventive principles of this disclosure may be applied, it should be recognized that the illustrated embodiments are merely examples of the invention and should not be construed as limiting the scope of the invention. Rather, the scope of the invention is defined by the following claims. We therefore claim as our invention all that comes within the scope and spirit of these claims.

[0070] [Section 1] a prosthetic sealing element having an axisymmetric or elliptical top cross-sectional profile, the prosthetic sealing element having dimensions such that it is deployed within the annulus of a native mitral valve of the heart at a position between the mitral valve leaflets to contact and create a seal with the native mitral valve leaflets during ventricular systole to prevent backflow of blood from the left ventricle into the left atrium, the prosthetic sealing element having a generally elongated and radially collapsed delivery configuration and further having a deployed configuration in which it is shortened and radially expanded to an axisymmetric or elliptical top cross-sectional profile, the prosthetic sealing element further having dimensions such that the native mitral valve leaflets can open and close as the heart beats; an anchoring element adapted for deployment within the heart, the anchoring element coupled to the artificial sealing element and configured to support the artificial sealing element in a desired position between the native leaflets and dimensioned to position the artificial sealing element between the mitral valve leaflets when deployed within the heart; 16. A device for treating a mitral valve comprising: [Section 2] 2. The device of paragraph 1, wherein the anchoring element has an upper portion configured to extend to contact cardiac tissue and a lower portion configured to extend to contact cardiac tissue. [Section 3] 3. The device of paragraph 2, wherein an upper portion of the anchoring element is configured to be anchored within the heart by extending to contact atrial tissue adjacent the mitral valve annulus, and a lower portion of the anchoring element is configured to be anchored within the heart by extending to contact ventricular tissue adjacent the mitral valve annulus. [Section 4] 3. The device of paragraph 2, wherein an upper portion of the anchoring element is configured to be anchored within the heart by extending toward the apex of the atrium and contacting atrial tissue, and a lower portion of the anchoring element is configured to be anchored within the heart by extending and contacting atrial tissue adjacent the mitral valve annulus. [Section 5] 2. The device of claim 1, wherein the anchoring element has an expanded diameter of between 25 mm and 70 mm. [Section 6] 2. The device of claim 1, wherein the artificial sealing element has a delivery diameter of 10 mm or less and an expanded diameter of 10 mm to 35 mm. [Section 7] 2. The device of claim 1, wherein the prosthetic sealing element when expanded is elongated, the prosthetic sealing element having a delivery diameter of 10 mm or less, an expanded major axis of 10 mm to 35 mm, and an expanded minor axis of 5 mm to 15 mm. [Section 8] 2. The device of paragraph 1, wherein the anchoring elements are axially symmetric when expanded in the absence of radial compressive forces. [Section 9] 2. The device of claim 1, wherein the anchoring element comprises a memory material. [Section 10] A delivery catheter; an anchoring member configured to engage cardiac tissue adjacent the native heart valve, the anchoring member being collapsible and expandable and configured to have an axially symmetric top surface profile when expanded in the absence of radial compressive forces; A collapsible and expandable prosthetic sealing member with an axisymmetric or elliptical top surface profile in an expanded configuration, wherein the anchoring member is configured to expand from an elongated, radially compressed configuration to a shortened, radially expanded configuration, wherein in the expanded state the prosthetic sealing member is adapted to close gaps between the leaflets of the heart valve to reduce regurgitation, and wherein in the expanded state the prosthetic sealing member is adapted to engage the native leaflets during systole but allow the native leaflets to open and close as the heart beats. an artificial device comprising: Equipped with A system for repairing a heart valve, wherein the anchoring member and the prosthetic sealing member are configured to be disposed in a collapsed state within the delivery catheter. [Section 11] 11. The system of clause 10, wherein the artificial sealing member is configured to rotate about an axis relative to the anchoring member. [Section 12] 12. The system of claim 11, wherein the artificial sealing member is configured to be selectively rotated relative to the anchoring member, and the artificial device comprises a locking portion configured to selectively lock the artificial sealing member at a selected rotational location relative to the anchoring member. [Section 13] 11. The system of claim 10, wherein the anchoring member comprises an upper portion and a lower portion, the upper portion adapted to engage with atrial tissue adjacent the native valve and the lower portion adapted to engage with ventricular tissue adjacent the native valve. [Section 14] 11. The system of claim 10, wherein the delivery catheter has a distal opening, and the anchoring member and the artificial sealing member are configured to be advanced in a collapsed state into and out of the distal opening of the delivery catheter. [Section 15] advancing a distal end of a delivery catheter to a location of a heart valve in a patient's heart, within the distal end being a prosthetic device having an anchoring member and a sealing member, the sealing member configured to expand into a symmetric configuration to engage the native valve leaflets during systole but still allow the native valve leaflets to open and close as the heart beats; releasing a portion of the anchoring member from the delivery catheter to a location in the heart at or adjacent to a native valve annulus to engage cardiac tissue and anchor the anchoring member within the heart; expelling the sealing member from the delivery catheter; expanding the sealing member, the sealing member decreasing in length but increasing in diameter as it expands, the sealing member having an axisymmetric or elliptical top surface profile after expansion; Including, Thus, after releasing the anchoring member and the sealing member, the sealing member is positioned between the leaflets of the heart valve such that the native leaflets coapt against the sealing member during systole and can open and close as the heart beats. [Section 16] 16. The method of claim 15, wherein the sealing member after expansion has an axially symmetric top surface profile. [Section 17] 16. The method of claim 15, wherein the heart valve is a mitral valve and the sealing member after expansion has an elliptical top surface profile. [Section 18] rotating the sealing member about its central axis to a desired rotational position relative to the native annulus, wherein the sealing member is aligned with the native leaflets within the native annulus to improve coaptation of the leaflets to the sealing member; locking the sealing member in the desired rotational position; 20. The method of claim 17, further comprising: [Section 19] 20. The method of claim 18, wherein rotating the sealing member about its central axis comprises aligning a long axis of the sealing member to be substantially parallel (within 10 degrees) to a line between the commissures of the mitral valve. [Section 20] monitoring valve performance while expanding the sealing element; setting the final expanded configuration of the sealing element to a configuration that maximizes valve performance; 20. The method of claim 15, further comprising: [Section 21] 16. The method of claim 15, wherein the anchoring member comprises an upper portion and a lower portion, the upper portion and the lower portion being separately deployed. [Section 22] 22. The method of claim 21, wherein the step of releasing the lower portion of the anchoring member from the delivery catheter occurs before the step of releasing the upper portion of the anchoring member from the delivery catheter. [Section 23] 22. The method of claim 21, wherein the step of releasing the upper portion of the anchoring member from the delivery catheter occurs before the step of releasing the lower portion of the anchoring member from the delivery catheter. [Section 24] 22. The method of clause 21, wherein an upper portion of the anchoring member comprises an atrial portion configured to engage atrial tissue adjacent an annulus of a mitral valve and a lower portion of the anchoring member comprises a ventricular portion configured to engage ventricular tissue adjacent the annulus of the mitral valve. [Section 25] 22. The method of claim 21, wherein the anchoring member is configured to be deployed within the atrium with an upper portion of the anchoring member facing toward the apex of the atrium and engaging tissue and a lower portion of the anchoring member facing toward the bottom of the atrium and engaging tissue adjacent to the native annulus. [Section 26] the anchoring member comprises an upper portion configured to expand to engage atrial tissue, a central portion configured to expand to support the sealing member, and a lower portion configured to expand to engage ventricular tissue, and the step of deploying the anchoring member comprises: Releasing the top portion to engage atrial tissue; Releasing the lower portion into engagement with ventricular tissue; 20. The method of claim 15, comprising: [Section 27] 16. The method of clause 15, wherein the anchoring member comprises a self-expandable frame mounted in a compressed state within the distal end of the delivery catheter. [Section 28] 16. The method of clause 15, wherein the anchoring member and the sealing member are delivered percutaneously through the patient's vasculature. [Section 29] 16. The method of clause 15, wherein the anchoring member and the sealing member are delivered transapically to the native valve. [Section 30] 16. The method of claim 15, wherein the anchoring member has an expanded configuration in which the anchoring member has an axisymmetric top surface profile in the absence of radial compression. [Section 31] 31. The method of claim 30, wherein the anchoring member has an expanded configuration in which the anchoring member has an elongated top surface profile in the absence of radial compression. [Section 32] 16. The method of claim 15, wherein the prosthetic device after deployment does not outwardly expand the native leaflets or the native annulus except for engagement of the native leaflets against the sealing member during systole. [Section 33] A sealing element configured to be anchored between the native valve leaflets to improve valve function, a mesh support frame having a delivery configuration and an expanded configuration, wherein in the delivery configuration the mesh support frame is substantially tubular having a delivery diameter, and in the expanded configuration the mesh support frame is radially expanded to an expanded central diameter at its center while ends of the mesh support frame remain at the delivery diameter, the expanded diameter being at least twice the delivery diameter; a cover covering the mesh support frame, the cover preventing blood from passing therethrough; A sealing element comprising: [Section 34] 34. The sealing element of clause 33, wherein the expanded median diameter is at least three times the delivery diameter. [Section 35] 34. The sealing element of clause 33, wherein the expanded median diameter is at least 5 times the delivery diameter. [Section 36] 34. The sealing element of claim 33, wherein the sealing element in the expanded configuration has an axially symmetric top surface profile. [Section 37] 34. The sealing element of claim 33, wherein the sealing element in the expanded configuration comprises an elongated top surface profile. [Section 38] 40. The sealing element of claim 37, wherein the sealing element in the expanded configuration has an elliptical top profile. [Explanation of symbols]

[0071] 10. Heart 11 Heart Wall 12 Right atrium 14 Right ventricle 16 Left atrium 18 Left ventricle 19 Apex 20 Tricuspid Valve 22 Pulmonary valve 24 Mitral Valve 25 Mitral Valve Annulus 26 Aortic Valve 28 Superior vena cava 30 Inferior vena cava 32 Pulmonary artery 34 Right ventricular chordae tendineae 36 Right ventricular papillary muscle 38 Pulmonary vein 40 Aorta 42a Leaflet 42p leaflet 44 Left ventricular chordae tendineae 46 Left ventricular papillary muscle 48 Valve leaflets 50 Devices 52 Support mooring section 54 Sealing elements 60 Sealing elements 62a Length 62b Length 62c Length 62d Length 63 Marker 64a maximum diameter 64b maximum diameter 64c maximum diameter 64d maximum diameter 65 Marker 66 Extended Control Elements 70 Support Frame 72 Cylinder body 74a Delivery Length 74b Deployment length 76a Maximum delivery diameter 76b Maximum unfolded diameter 78 Break 80 Rib-like elements 90 Support Frame 92 Strand 94 Tubular structure 96 Distal end 98 Proximal end 100a Length 100b Length 100c Length 102a maximum diameter 102b maximum diameter 102c maximum diameter 104 diameter 106 diameter 108 Central part 110 Support frame 112a Long axis 112b Long axis 112c Long diameter 112d Long diameter 114a Minor diameter 114b Minor diameter 114c Short diameter 114d Minor diameter 115 Marker 117 Marker 120 Internal tethering mechanism 122 Tether Line 124 First end 126 Second End 130 Rod 132 First end 134 Locking mechanism 136 Tooth element 140 Linear screw mechanism 142 Screw 144 First end 146 Screw receiving nut 148 Extender 150 devices 152 Mooring elements 154 Sealing elements 156 Upper anchoring element, atrial anchoring part 158 Atrial Arm 160 Atrial arm distal end 161 Expanded Diameter 162 Ventricular section, lower anchoring element 164 Ventricular Arm 166 Distal end of ventricular arm, ventricular anchoring part 167 Expanded Diameter 168 Central part 170 Distal end 172 Catheter 180 devices 182 Mooring elements 184 Sealing elements 186 Upper atrial portion, upper anchoring element 188 Upper Atrial Arm 189 Middle curve 190 Upper atrial arm distal end 191 Expanded diameter 192 Lower atrial portion, lower anchoring element 194 Lower Atrial Arm 196 Distal end of lower atrial arm 197 Expanded Diameter 200 Sealing element support part 202 Catheter 204 Distal end 206 Aperture 208 Suture 210 Devices 212 Sealing elements 214 Tether 216 Tethering part, catheter 218 Distal end 220 Catheter 222 Aperture 230 Mooring Frame 232 Central part 234 Top 236 Lower 238a Break 238b Gap 238c Break 240a Rib-like element 240b Rib-like element 240c ribbed element 242 Fluid Obstruction Envelope 244 Sealing elements 246 Top opening 248 Lower opening

Claims

1. 1. A device for improving defective mitral or tricuspid valve function, the device being configured to be delivered to a subject's heart using a percutaneous or minimally invasive surgical method, comprising: The device is an expandable prosthetic sealing member having an elongated or elliptical top profile when expanded, the sealing member being shaped to contact the leaflets of the heart valve when expanded; an anchoring member coupled to the sealing member and configured to secure the sealing member at a desired position between the leaflets; Equipped with The anchoring member is a top portion configured to expand to engage tissue adjacent the atrial annulus; a lower portion configured to expand to engage tissue adjacent the ventricular annulus; Equipped with The device further comprises a radiopaque or other visible marker.

2. The device of claim 1 , wherein the anchoring member has an axisymmetric top surface profile, meaning symmetric about an axis extending from the ventricular end to the atrial end.

3. The device of claim 1 or 2, wherein the anchoring member comprises a central portion configured to support the sealing member.

4. The device of any one of claims 1 to 3, wherein the anchoring member comprises a biocompatible covering such as Dacron or other fabric.

5. The device of claim 4 , wherein the biocompatible covering is configured to encourage tissue ingrowth to promote tissue anchoring.

6. The device of any one of claims 1 to 5, wherein the sealing member is configured to self-expand into a preset configuration.

7. The device of claim 6 , wherein the sealing member comprises a memory material support frame configured to automatically expand to a preset memory material configuration upon release from a radial constraint.

8. The device of claim 7 , wherein the memory material is Nitinol.

9. 9. The device of any one of claims 1 to 8, wherein the sealing member has a mesh support frame with a delivery configuration and an expanded configuration, wherein in the delivery configuration the mesh support frame is substantially tubular and, in the expanded configuration, the ends of the mesh support frame remain at a delivery diameter and the mesh support frame is radially expanded to a central portion thereof to an expanded central diameter.

10. 10. The device of claim 9, wherein the expanded diameter is at least twice the delivery diameter.

11. A device according to any one of claims 1 to 7, wherein the major expanded diameter of the elongated or elliptical top profile of the sealing member is between 10 and 40 mm.

12. The device of claim 11, wherein the minor expanded diameter of the elongated or elliptical top profile of the sealing member is between 5 and 20 mm.

13. The device of claim 11 or 12, wherein during delivery, the maximum diameter of the elongated or elliptical top profile of the sealing member is 0-10 mm.

14. The device of any one of claims 1 to 13, wherein a marker is fixed to a portion of the sealing member and / or the anchoring member.

15. The device of any one of claims 1 to 14, wherein the anchoring member is formed from nitinol, stainless steel, or cobalt chrome.

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