Devices and methods for use with a mitral valve

Abstract

The present application relates to apparatus and methods for use with a mitral valve. A mitral annulus repair device (80) is configured to be implanted within the left atrium of a subject such that no portion of the device (80) extends through the subject's mitral valve. The device (80) is configured to produce tissue ingrowth of the subject into the device (80). The device (80) includes a ring (82) configured to be implanted within 15 mm of the subject's native mitral annulus, and a frame (24) extending upward from the ring (82). The size of the ring (82) is adjustable, and the ring (82) is configured to reduce the diameter of the subject's native mitral annulus by reducing the diameter of the ring (82) after tissue ingrowth into the mitral annulus repair device (80) occurs. Other applications are also described.

Description

[0001] Field of the Invention Embodiments

[0002] Some applications of the present invention generally relate to medical devices and methods. In particular, some applications of the present invention relate to devices and methods for use with prosthetic mitral valves. background

[0003] The atrioventricular valve is a heart valve that prevents backflow from the ventricle to the atrium during systole. They are anchored to the heart wall at the fibrous skeleton by anchoring tendons named chordae tendineae. The chordae tendineae are attached to the papillary muscles. The papillary muscles and chordae tendineae jointly prevent the valve from prolapsing into the atrium when it is closed during systole. The actual opening and closing of the valve is caused by the pressure gradient across the valve. The left atrioventricular valve is a bicuspid valve with two leaflets, and is commonly referred to as a mitral valve. The right atrioventricular valve is a tricuspid valve with three leaflets. These two valves may be damaged and dysfunctional, resulting in leakage during systole, and the valve needs to be repaired or replaced.

[0004] The mitral valve is usually oval or D-shaped, while the tricuspid valve is more rounded. The left ventricle pumps oxygenated blood to the body, and therefore the mitral valve must withstand higher pressures than the tricuspid valve, which only has to pump deoxygenated blood to the nearby lungs.

[0005] The mitral valve is occasionally congenitally abnormal or destroyed by infection or bacterial endocarditis. More commonly, the mitral valve becomes degenerative with age or due to rheumatic fever. There are different heart valve diseases associated with the mitral valve, such as mitral stenosis and mitral regurgitation. In the case of mitral stenosis, due to calcium nodules, leaflet thickening and / or reduced leaflet mobility, the valve orifice, i.e., the cross-section available for blood to pass through, is reduced, and therefore the valve does not allow normal blood flow. In order to overcome the damaged valve and transport an equal amount of blood, the left atrium requires a higher pressure than normal. The continuous pressure overload of the left atrium may cause its size to increase and become more susceptible to atrial fibrillation and loss of atrial kick. The loss of atrial kick caused by atrial fibrillation can lead to a sharp decrease in cardiac output. The reduction in cardiac output, accompanied by an accelerated heart rate and a shortened diastolic time, often leads to congestive heart failure. In most cases, mitral stenosis is due to rheumatic heart disease. Treatment options for mitral stenosis include medical management, surgical repair, surgical replacement of the valve, and percutaneous balloon valvuloplasty.

[0006] Mitral regurgitation causes a heart murmur and can have serious physiological consequences. Mitral regurgitation is caused by ischemic heart disease (such a condition is called "ischemic mitral regurgitation") or mitral valve prolapse. Ischemic mitral regurgitation is the result of ventricular remodeling secondary to ischemic heart disease. The posterior wall of the heart, which is not attached to the fibrous skeleton of the heart, dilates. Due to changes in the geometry of the left ventricle, the posterior leaflet attached to the posterior wall of the heart is displaced and deviates from the anterior leaflet, which causes mitral regurgitation.

[0007] Mitral valve prolapse is a condition caused by degeneration of the connective tissue of the valve. Patients with typical mitral valve prolapse have excess connective tissue. This weakens the leaflets and adjacent tissues, resulting in increased leaflet area and elongation of the chordae tendineae. Elongation of the chordae tendineae often leads to rupture. The twisted leaflets may displace portions of one or both abnormally thickened mitral leaflets into the left atrium during systole. Advanced disease results in leaflet folding, inversion, and displacement into the left atrium. The abnormal leaflet structure leads to incomplete closure of the mitral valve, and consequent mitral regurgitation.

[0008] In mitral regurgitation, the heart has to work harder to pump not only the regular volume of blood but also the extra volume of blood that is flowing back into the left atrium. The increased workload places excessive strain on the left ventricle, which can lead to heart failure.

[0009] Although patients with mild to moderate mitral regurgitation caused by mitral valve prolapse may not experience symptoms, the increasing severity of mitral regurgitation, even in the absence of symptoms, increases the load on the left ventricle. Over time, this can lead to ventricular dilation and congestive heart failure.

[0010] Mitral valve disease is usually treated by open heart surgery, via surgical repair, usually using an annuloplasty ring, or via surgical replacement with a prosthetic valve. In some cases, such as when the valve is too damaged, the mitral valve may need to be replaced. Mitral valve replacement can be performed robotically or manually. Surgical valve replacement or repair is usually a demanding procedure because it requires cardiopulmonary bypass and it can expose the patient, especially the elderly, to many risks.

[0011] A wide variety of percutaneous or transcutaneous medical procedures are currently being developed and / or implemented. For example, known transcatheter procedures are used to replace aortic and pulmonary heart valves. These procedures, which are performed in a cardiac catheterization laboratory under local anesthesia rather than by cardiac surgery, provide benefits to these patients. According to such a method, the valve is inserted into a delivery device similar to a catheter or sheath, and then implanted in a desired position via a passage through a large blood vessel such as, for example, the femoral artery. This includes making a very small perforation on the patient's skin, such as in the groin area, in order to access the femoral artery. This minimally invasive option is generally safer than open heart surgery, and recovery time is generally shorter.

[0012] Overview of the implementation plan

[0013] According to some applications of the present invention, the docking element is placed in the left atrium of the subject so that no portion of the docking element extends through the mitral valve of the subject. Typically, the docking element includes a frame and a ring coupled to the frame. Typically, the frame is made of a shape memory material (e.g., a shape memory alloy such as Nitinol), and the frame is cut and shaped to define more than one unit such as defined by a strut of the shape memory material. Typically, the portion of the frame closest to the ring is covered by a skirt of a material that facilitates tissue ingrowth into the frame. For example, the skirt can be made of a fabric such as PET, PTFE and / or nylon, and can be coupled to the exterior of the frame and / or the ring using sutures. Typically, a portion of the frame configured to be disposed near the mitral annulus (e.g., at the mitral annulus and / or starting slightly above the mitral annulus (e.g., within 15 mm of the mitral annulus)) is covered by the skirt. For some applications, the skirt is configured to be set to a height between 1mm and 2mm above the mitral annulus until between 15mm and 20mm above the mitral annulus. For some applications, a tissue ingrowth element is coupled to the skirt to promote tissue ingrowth. For some applications, the skirt extends from the ring to at least 5mm (e.g., at least 10mm) and / or less than 25mm (e.g., less than 20mm) on the frame, such as a height between 5mm and 25mm, or between 10mm and 20mm. For some applications, starting from where the skirt terminates (i.e., from the upper end of the skirt), the struts of the frame are covered in a sleeve of the same material as the material of the skirt. The sleeve of material is configured to promote tissue ingrowth to the struts of the frame. Typically, the sleeves are sutured together at the junctions between the struts. For some applications, the docking element is deployed in the left atrium so that the frame extends to the top of the left atrium.

[0014] Typically, the docking element becomes anchored to the subject's heart by tissue ingrowth into a portion of the frame that is positioned proximate to the mitral valve annulus (e.g., at the mitral valve annulus and / or slightly above the mitral valve annulus (e.g., within 15 mm of the mitral valve annulus)) and covered by the skirt, and / or by tissue ingrowth from the left atrium wall to the struts of the sleeve-covered frame. Typically, before tissue ingrowth occurs, the docking element is anchored in place within the left atrium by expansion of the frame to contact the walls and top of the left atrium. Additionally, typically, after the prosthetic mitral valve device is placed within the docking element, expansion of the frame to contact the walls and top of the left atrium will not provide sufficient support to anchor the docking element in place within the left atrium, exposing the docking element to left ventricular blood pressure exerted on the prosthetic mitral valve leaflets.

[0015] Therefore, before implanting the prosthetic mitral valve device, the docking element is left in place in the left atrium to allow sufficient tissue ingrowth to occur before implanting the prosthetic mitral valve device. Typically, the docking element is configured so that when the prosthetic mitral valve device is implanted, the anchoring of the docking element in the left atrium is mainly carried out via tissue ingrowth to the docking element. Typically, the mitral valve ring can withstand higher loads than other parts of the left atrial wall. Therefore, for some applications, the docking element is configured so that when the prosthetic mitral valve device is implanted, the anchoring of the docking element in the left atrium is mainly carried out via tissue ingrowth from the atrial wall near the mitral valve ring to the docking element. For example, since the docking element includes a skirt (which is configured to be arranged near the mitral valve ring, such as at the mitral valve ring or slightly above the mitral valve ring (e.g., as described above)), the docking element can be configured to promote a greater degree of tissue ingrowth near the mitral valve ring than at other parts of the frame.

[0016] Typically, the docking element is configured to help anchor the prosthetic mitral valve device to the mitral valve of the subject. For some applications, the docking element occupies some areas defined by the natural mitral valve ring. For example, it is usually the case that the skirt occupies some space between (a) the position where the frame becomes anchored to the atrial wall near the natural mitral valve ring (by tissue ingrowth to the skirt and / or the frame itself) and (b) the ring. That is, the docking element typically includes (a) a ring (the prosthetic valve device is anchored in the ring), and (b) a portion of the frame covered by the skirt so as to promote tissue ingrowth from the atrial wall near the mitral valve ring to the portion. Typically, the size of the ring (e.g., the outer circumference of the ring) is smaller than the size of the portion of the frame in which tissue ingrowth exists (e.g., the inner circumference of the portion of the frame). In addition, there is typically a material (e.g., fabric) bridging the ring and the portion of the frame in which tissue ingrowth exists. For some applications, the material of the bridging ring and the portion of the frame in which tissue ingrowth exists is a part of the skirt.

[0017] For some applications, a mitral annulus repair device is implanted in a subject suffering from mitral regurgitation, in which there is backflow of blood from the left ventricle to the left atrium during systole due to incomplete closure of the mitral valve leaflets. Typically, the mitral annulus repair device is substantially similar to the docking element described above. However, for some applications, instead of a ring configured to anchor a prosthetic mitral valve device, the mitral annulus repair device includes an adjustable or self-adjusting ring. Rather than supporting a prosthetic mitral valve device, the adjustable ring is configured to reduce the area of ​​the mitral annulus by adjusting (e.g., via cinching) or self-adjusting to reduce the diameter of the ring after tissue ingrowth occurs.

[0018] Typically, the mitral valve annulus repair device remains in place within the left atrium prior to the ring's diameter being reduced to allow tissue ingrowth to occur. Typically, the mitral valve annulus repair device is configured such that as the ring's diameter is reduced, anchoring of the mitral valve annulus repair device within the left atrium occurs primarily via tissue ingrowth into the mitral valve annulus repair device. For some applications, the mitral valve annulus repair device is configured such that as the ring's diameter is reduced, anchoring of the mitral valve annulus repair device within the left atrium occurs primarily via tissue ingrowth from the atrial wall proximate the mitral valve annulus to the mitral valve annulus repair device. For example, because the mitral valve annulus repair device includes a skirt that is configured to be disposed proximate the mitral valve annulus, such as at the mitral valve annulus and / or slightly above the native mitral valve annulus (e.g., as described above), the mitral valve annulus repair device can be configured to promote a greater degree of tissue ingrowth proximate the mitral valve annulus than at other portions of the frame.

[0019] Typically, after sufficient tissue ingrowth has occurred, the diameter of the ring is reduced by adjustment (e.g., via tightening) or self-adjustment. Typically, because the atrial wall near the mitral annulus has already undergone tissue ingrowth relative to the mitral annulus repair device, reducing the diameter of the ring reshapes the heart by reducing the size of the mitral annulus. Subsequently, the mitral valve leaflets are brought closer to each other, and mitral regurgitation is reduced or eliminated. It should be noted that for some applications, there is no substantial tissue ingrowth relative to the ring of the mitral annulus repair device. Instead, the majority of tissue ingrowth occurs relative to the frame and / or skirt of the mitral annulus repair device. However, because the ring is coupled to the frame and / or skirt and there is tissue ingrowth relative to the frame, the reduction in the diameter of the ring results in a reduction in the size of the mitral annulus.

[0020] For some applications, a mitral ring assembly including an adjustable ring (as described above) is used in conjunction with a prosthetic mitral valve device. For example, the ring can be adjusted to accommodate a prosthetic mitral valve device having a given desired diameter.

[0021] Thus, according to some applications of the present invention, there is provided an apparatus for treating a subject having a diseased mitral valve, the apparatus comprising:

[0022] A docking element configured to be implanted within a left atrium of a subject such that no portion of the docking element extends through a mitral valve of the subject, the docking element comprising:

[0023] a ring configured to be implanted within 15 mm of a native mitral valve annulus of a subject, the ring being smaller than the size of the native mitral valve annulus of the subject;

[0024] The frame extends upward from the ring,

[0025] A portion of the frame is configured to be positioned adjacent to a native mitral valve annulus of a subject,

[0026] and generating tissue ingrowth from an atrial wall of the subject proximate at least the subject's native mitral valve annulus to the docking element, and

[0027] The frame is configured to anchor the docking element within the left atrium by expanding the frame against the inner wall and roof of the left atrium before tissue ingrowth into the docking element occurs,

[0028] and

[0029] a material disposed between portions of the frame and the annulus, the material being configured to form a seal between the atrial wall proximate the native mitral valve annulus and the annulus; and

[0030] A prosthetic mitral valve device, the prosthetic mitral valve device being configured to:

[0031] After left atrium tissue ingrowth into the portion of the frame occurs, the at least partially positioned within the docking element, and

[0032] Becoming anchored to the docking element at least in part by expanding radially against the ring.

[0033] In some applications, the frame does not include additional anchoring portions for anchoring to any additional portion of the subject's body other than the wall and top of the left atrium.

[0034] In some applications, the ring includes an outer portion including a fabric hollow torus and an inner portion including an element selected from the group consisting of an elastic material and a spring.

[0035] In some applications, the ring is configured to be adjustable in size.

[0036] In some applications, the device is for use with a balloon, the prosthetic mitral valve device comprises a balloon-expandable prosthetic mitral valve device configured to be radially expanded by the balloon, and the ring comprises an elastic ring configured to:

[0037] The given diameter is defined when the ring is not subjected to any forces,

[0038] expanding to a second diameter to allow the balloon-expandable prosthetic mitral valve device to be expanded by the balloon, experiencing a diameter reduction that is at least similar to the diameter reduction experienced by the prosthetic mitral valve device due to recoil following balloon deflation, and

[0039] After undergoing expansion and reduction in diameter, sufficient radial force is exerted on the prosthetic mitral valve device to anchor the prosthetic mitral valve device in place, even during left ventricular systole.

[0040] In some applications, the frame includes more than one strut defining more than one cell, and wherein the material includes a fabric skirt configured to cover a portion of the frame extending from the ring up to a height of at least 5 mm from the ring.

[0041] In some applications, when the frame is in a deployed state within the left atrium, the cells are configured to define an open area of ​​at least 3 square centimeters.

[0042] In some applications, the ring is configured to automatically adjust its size.

[0043] In some applications, the ring includes a fabric hollow ring with a spring and a biodegradable material disposed in the hollow ring such that the biodegradable material holds the spring in an expanded configuration, and the ring is configured to automatically adjust in size by the biodegradable material becoming degraded and the radial force of the spring exerting an inward radial force on the ring.

[0044] In some applications:

[0045] The docking element is configured to be placed into the left atrium of the subject via the interatrial septum of the subject by advancing the docking element along the longitudinal axis of the frame in a lateral direction relative to the left atrium; and

[0046] The ring is disposed transversely relative to the frame such that the ring is substantially parallel to a longitudinal axis of the frame.

[0047] In some applications, the docking element is configured to be deployed within the left atrium of the subject such that the longitudinal axis of the frame is substantially parallel to the subject's native mitral valve annulus.

[0048] In some applications, the frame includes more than one strut defining more than one cell, and wherein within at least a portion of the frame, the struts of the frame are covered by a fabric sleeve.

[0049] In some applications, adjacent fabric sleeves are sewn to each other at the joints between the struts covered by the fabric sleeves.

[0050] According to some applications of the present invention, there is also provided a method for treating a subject having a diseased mitral valve, the method comprising:

[0051] inserting a docking element into a left atrium of a subject, the docking element comprising a ring and a frame extending from the ring;

[0052] The docking element is deployed within the left atrium of the subject such that:

[0053] No portion of the docking element extends through the subject's mitral valve,

[0054] The ring was placed within 15 mm of the subject's mitral annulus.

[0055] The size of the ring is smaller than that of the native mitral valve ring.

[0056] a portion of the frame is disposed adjacent a native mitral valve annulus of the subject, and the portion of the frame is configured to generate tissue ingrowth from an atrial wall of the subject adjacent at least the native mitral valve annulus of the subject to the docking element,

[0057] The frame anchors the docking element within the left atrium by expanding the frame against the inner wall and roof of the left atrium before tissue ingrowth into the docking element occurs, and

[0058] A material is disposed between portions of the frame and the annulus, the material being configured to form a seal between an atrial wall proximate a native mitral valve annulus and the annulus;

[0059] inserting a prosthetic mitral valve device into the interior of the annulus; and

[0060] The prosthetic mitral valve device is radially expanded against the annulus such that the prosthetic mitral valve device is anchored within the annulus.

[0061] According to some applications of the present invention, there is also provided an apparatus for treating a subject having a diseased mitral valve, the apparatus comprising:

[0062] A mitral valve annulus repair device configured to be implanted in the left atrium of a subject such that no portion of the mitral valve annulus repair device extends through the subject's mitral valve, the mitral valve annulus repair device configured to produce tissue ingrowth of the subject into the mitral valve annulus repair device, the mitral valve annulus repair device comprising:

[0063] a ring configured to be implanted within 15 mm of a native mitral valve annulus of a subject; and

[0064] A frame extends upwardly from the ring, the frame being configured to anchor the mitral annulus repair device in the left atrium by expanding the frame against the inner wall and top of the left atrium before tissue ingrowth into the mitral annulus repair device occurs,

[0065] The ring is adjustable in size and is configured to reduce the diameter of the subject's native mitral annulus by reducing the diameter of the ring after tissue ingrowth into the mitral annulus repair device occurs.

[0066] In some applications, the mitral annulus repair device is configured such that:

[0067] There is no tissue ingrowth relative to the parenchyma of the annulus,

[0068] There is substantial ingrowth relative to the first portion of the frame, and

[0069] The ring is configured to reduce the diameter of the mitral valve annulus by reducing the diameter of a second portion of the frame coupled to the ring and the second portion of the frame causing the first portion of the frame to reduce the diameter of the mitral valve annulus.

[0070] In some applications, the frame includes more than one strut defining more than one cell, wherein a first portion of the frame extends from the ring to a height of at least 5 mm from the ring, and the first portion of the frame is covered by a fabric skirt configured to promote tissue ingrowth into the fabric skirt. In some applications, the cell defined by the struts defines an open area of ​​at least 3 square centimeters.

[0071] In some applications, the ring is configured to be manually adjustable in size.

[0072] In some applications, the ring includes a hollow ring of fabric, the rope is disposed in the hollow ring, and the ring is configured to be manually adjustable in size by an operator pulling a portion of the rope.

[0073] In some applications, the ring is configured to automatically adjust its size.

[0074] In some applications, the ring includes a fabric hollow ring with a spring and a biodegradable material disposed in the hollow ring such that the biodegradable material holds the spring in an expanded configuration, and the ring is configured to automatically adjust in size by the biodegradable material becoming degraded and the radial force of the spring exerting an inward radial force on the ring.

[0075] In some applications:

[0076] The mitral annulus repair device is configured to be placed into the left atrium of the subject via the atrial septum of the subject by advancing the mitral annulus repair device along the longitudinal axis of the frame in a lateral direction relative to the left atrium; and

[0077] The ring is disposed transversely relative to the frame such that the ring is substantially parallel to a longitudinal axis of the frame.

[0078] In some applications, the mitral annulus repair device is configured to be deployed within the left atrium of a subject such that a longitudinal axis of the frame is substantially parallel to the mitral annulus of the subject.

[0079] In some applications, the frame includes more than one strut defining more than one cell, and in at least a portion of the frame, the struts of the frame are covered by a fabric sleeve.

[0080] In some applications, adjacent fabric sleeves are sewn to each other at the joints between the struts covered by the fabric sleeves.

[0081] In some applications, the frame does not include additional anchoring portions for anchoring to any additional portion of the subject's body other than the wall and top of the left atrium.

[0082] According to some applications of the present invention, there is also provided a method for treating a subject having a diseased mitral valve, the method comprising:

[0083] inserting a mitral valve annulus repair device into the left atrium of a subject, the mitral valve annulus repair device comprising a ring and a frame extending from the ring;

[0084] deploying the docking element into the left atrium of the subject such that (a) no portion of the mitral annulus repair device extends through the subject's mitral valve, (b) the annulus is disposed within 15 mm of the subject's native mitral annulus, and (c) the frame is expanded against the inner wall and top of the left atrium, the frame anchoring the mitral annulus repair device within the left atrium;

[0085] causing tissue ingrowth relative to the material by leaving the mitral annulus repair device in the left atrium of the subject; and

[0086] After tissue ingrowth relative to the material occurs, the diameter of the subject's native mitral valve annulus is reduced by reducing the diameter of the annulus.

[0087] The present invention will be more fully understood from the following detailed description of embodiments of the present invention taken in conjunction with the accompanying drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS

[0088] Figure 1A , Figure 1B and Figure 1Cis a schematic diagram of a docking element configured to facilitate anchoring a prosthetic mitral valve device to a mitral valve of a subject according to some applications of the present invention;

[0089] Figure 2 is a schematic diagram of a cross-sectional view of a frame of a docking element according to some applications of the present invention;

[0090] Figure 3A , Figure 3B and Figure 3C is a schematic diagram of a docking element configured to facilitate anchoring a prosthetic mitral valve device to a mitral valve of a subject according to some applications of the present invention;

[0091] Figure 3D and Figure 3E is a schematic diagram of a docking element according to some applications of the present invention, wherein the skirt of the docking element is connected to Figure 3A-3C The different ways shown in the figure are sewn to the frame;

[0092] Figure 4A , Figure 4B and Figure 4C is a schematic diagram of a docking element configured to facilitate anchoring a prosthetic mitral valve device to a mitral valve of a subject according to some applications of the present invention;

[0093] Figure 4D and Figure 4E is a schematic diagram of a docking element according to some applications of the present invention, wherein the skirt of the docking element is connected to Figure 4A-4C The different ways shown in the figure are sewn to the frame;

[0094] Figure 5A , Figure 5B and Figure 5C shows various steps of balloon expansion of a frame of a prosthetic mitral valve device within the annulus of a docking element according to some applications of the present invention;

[0095] Fig. 6A is a schematic diagram of a docking element according to some applications of the present invention;

[0096] Figure 6B is a schematic diagram of a ring of docking elements according to some applications of the present invention;

[0097] Figure 7 is a schematic diagram of a mitral valve annulus repair device according to some applications of the present invention;

[0098] Fig. 8A , Figure 8B and Figure 8C is a schematic diagram of a ring of a mitral valve ring repair device according to some applications of the present invention;

[0099] Fig.9A and Fig. 9B is a schematic diagram of a ring of a mitral valve ring repair device according to some applications of the present invention;

[0100] Fig. 10A and Fig. 10B is a schematic diagram of the internal components of a ring of a mitral valve ring repair device according to some applications of the present invention;

[0101] Fig.11A , Fig. 11B and Fig. 11C Schematic diagram of a mitral valve annulus repair device and its components according to some optional applications of the present invention.

[0102] Detailed description of implementation plan

[0103] Reference now Figure 1A , Figure 1B and Figure 1C , which are schematic diagrams of a docking element 20 according to some applications of the present invention. Figure 1A shows a side view of the docking element, and Figure 1B Shows relative to Figure 1A The view shown is a view of the docking element rotated through 90 degrees about the longitudinal axis 22 of the frame 24 of the docking element. The docking element is generally configured to facilitate the attachment of a prosthetic mitral valve device 28 ( Figure 1A ) anchored to the subject's mitral valve. Figure 1C The docking element is shown deployed inside the left atrium 26 of a subject before the prosthetic mitral valve device is placed inside the docking element. As shown, in this state, the native mitral valve leaflet 30 is still in place. The docking element is disposed in its entirety inside the left atrium 26 and does not extend into the left ventricle 31.

[0104] Typically, the prosthetic mitral valve device is a stented valve that includes a stent frame 32 configured to support a prosthetic valve leaflet 34. The prosthetic mitral valve device is typically implanted within the native mitral valve of a subject with a diseased native valve, and the prosthetic valve leaflets function to replace the function of the native valve leaflets. Typically, the prosthetic valve leaflets are configured to act as a one-way valve, whereby in their open position relative to each other, the leaflets allow flow from the inlet (on the atrial side) through the prosthetic valve device to the outlet (on the ventricular side), while reverse flow is prevented due to the collapsible, slack portion of the valve leaflets collapsing inward to block reverse flow.

[0105] Typically, the docking element 20 is implanted in the left atrium more than one week or more than one month prior to implantation of the prosthetic mitral valve device. After implantation of the docking element and before implantation of the prosthetic mitral valve device, the anchoring of the docking element is typically enhanced by tissue ingrowth occurring around the docking element, such as described below. Typically, no portion of the docking element extends through the subject's native mitral valve. In addition, typically, due to the fact that no portion of the docking element extends through the subject's native mitral valve, the native mitral valve leaflets are able to continue to function in their normal manner after implantation of the docking element and before implantation of the prosthetic mitral valve device.

[0106] For some applications, the docking element includes a frame 24 and a ring 40 coupled to the frame. Ring 40 is described in further detail below. Typically, in the case of the deployed state of the ring inside the left atrium, the ring is transversely disposed relative to the frame so that the plane defined by the ring is substantially parallel to the longitudinal axis of the frame.

[0107] For some applications, the docking element is placed into left atrium 26 via atrial septum 42 by advancing the docking element along its longitudinal axis in a lateral direction relative to the left atrium of the subject (eg, Figure 1C ). Subsequently, the docking element is deployed within the left atrium of the subject, substantially without rotating the longitudinal axis of the docking element, such that the ring 40 is disposed proximate to the mitral valve annulus 44 (e.g., at and / or slightly above the mitral valve annulus (e.g., as described above)) and laterally relative to the frame. (It should be noted that in some cases, the frame can be rotated about the longitudinal axis, and / or there can be a small amount of rotation of the longitudinal axis itself in order to align the ring with the native mitral valve annulus.) Thus, even in the deployed state of the docking element, the longitudinal axis of the frame is substantially parallel to the plane defined by the mitral valve annulus of the subject. By deploying the docking element in this manner, the longitudinal axis of the docking element does not need to be significantly rotated relative to the left atrium between transseptal insertion into the left atrium and deployment within the left atrium. In contrast, if the ring is disposed at the longitudinal end of the frame so that the plane defined by the ring is substantially perpendicular to the longitudinal axis of the frame, this would make transseptal insertion of the docking element challenging. This is because the longitudinal axis of the docking element would need to be rotated within the relatively small volume defined by the left atrium (approximately 90 degrees relative to the atrial septum) and released from the delivery device.

[0108] Typically, the frame 24 is made of a self-expandable shape memory material (e.g., a shape memory alloy such as Nitinol), and the frame 24 is cut and shaped to define more than one cell 45 defined by struts 46 of the shape memory material. Alternatively or additionally, the frame is assembled from a wire made of a self-expandable shape memory material (e.g., a shape memory alloy such as Nitinol). Typically, the portion of the frame closest to the ring is covered by a skirt 48 of a material that facilitates tissue ingrowth into the frame. For example, the skirt can be made of a fabric such as PET, PTFE, and / or nylon, and can be coupled to the exterior of the frame and / or the ring using sutures. Typically, a portion of the frame configured to be disposed near the mitral annulus (e.g., at the mitral annulus and / or slightly above the mitral annulus (e.g., within 15 mm of the mitral annulus)) is covered by a skirt. For some applications, the skirt is configured to be disposed from between 1 mm and 2 mm above the mitral annulus to a height between 15 mm and 20 mm above the mitral annulus. For some applications (not shown), tissue ingrowth elements are coupled to the skirt to promote tissue ingrowth. For example, such tissue ingrowth elements may include hooks or loops (loops) (e.g., similar to those used in hook-and-loop fasteners), barbs, clips, pins, etc. For some applications, the skirt extends from the loop to the frame by at least 5 mm (e.g., at least 10 mm) and / or less than 25 mm (e.g., less than 20 mm), such as a height H1 between 5 mm and 25 mm, or between 10 mm and 20 mm. For some applications, starting from where the skirt terminates (i.e., from the upper end of the skirt), the struts of the frame are covered in a sleeve 50 of the same material as the material of the skirt 48. The sleeve of material is configured to promote tissue ingrowth to the struts of the frame. Typically, the sleeves are sutured together at the junctions between the struts. For some applications, the docking element is deployed in the left atrium so that the frame 24 extends to the top of the left atrium.

[0109] Typically, the docking element 20 becomes anchored to the subject's heart by tissue ingrowth into a portion of the frame that is disposed proximate to the mitral annulus (e.g., at the mitral annulus and / or slightly above the mitral annulus (e.g., as described above)) and covered by the skirt 48, and / or by tissue ingrowth from the left atrium wall to the struts 46 of the frame (which are covered by the sleeve 50 in some applications). Typically, before tissue ingrowth occurs, the docking element is anchored in place within the left atrium by expansion of the frame so as to contact the wall and top of the left atrium. For some applications, the frame is configured to apply only a relatively low pressure to the inner wall of the left atrium so that the frame conforms to the shape of the left atrium rather than forcing the atrium to deform. Typically, the shape of the frame changes as the shape of the subject's left atrium changes during the subject's cardiac cycle. For some applications, in this manner, the frame allows the natural compliance of the inner wall of the left atrium to be substantially maintained.

[0110] Typically, after the prosthetic mitral valve device is placed inside the docking element, expansion of the frame to contact the walls and top of the left atrium will not provide sufficient support to anchor the docking element in place within the left atrium, leaving the docking element exposed to the left ventricular blood pressure exerted on the prosthetic mitral valve leaflets. Therefore, prior to implanting the prosthetic mitral valve device, the docking element is left in place within the left atrium to allow adequate tissue ingrowth to occur prior to implanting the prosthetic mitral valve device.

[0111] Typically, the docking element is configured so that when the prosthetic mitral valve device is implanted, the anchoring of the docking element in the left atrium is mainly carried out via tissue ingrowth to the docking element. Typically, the mitral valve annulus is able to withstand higher loads than other parts of the left atrial wall. Therefore, for some applications, the docking element is configured so that when the prosthetic mitral valve device is implanted, the anchoring of the docking element in the left atrium is mainly carried out via tissue ingrowth from the atrial wall near the mitral valve annulus to the docking element. For example, since the docking element includes a skirt 48 (which is configured to be arranged near the mitral valve annulus, for example, at the mitral valve annulus and / or slightly above the mitral valve annulus (for example, as described above)), the docking element can be configured to promote a greater degree of tissue ingrowth near the mitral valve annulus than at other parts of the frame.

[0112] The two-stage implantation procedure described above is somewhat similar to a valve-in-valve procedure, in which a new prosthetic valve is implanted inside a previously implanted prosthetic valve. The previously implanted prosthetic valve is typically initially anchored to the native mitral valve via suture, but then becomes anchored due to tissue ingrowth into the prosthetic valve. In such a case, the new valve typically becomes anchored within the previously implanted valve, and the previously implanted valve is firmly anchored to the native mitral valve due to tissue ingrowth relative to the previously implanted valve and mechanical forces applied to the heart by the previously implanted prosthetic valve. Similarly, according to some applications of the present invention, initially, docking element 20 is implanted and docking element 20 is allowed to become anchored to the subject's heart due to tissue ingrowth relative to the docking element and mechanical forces applied to the heart by the docking element. Subsequently, after the docking element is anchored in the subject's heart, the prosthetic mitral valve device is anchored to the docking element. For some applications, stent frame 32 of prosthetic mitral valve device 28 has an hourglass-shaped outer profile that is configured to facilitate anchoring of the frame to annulus 40 of docking element 20 .

[0113] For some applications, the docking element and the prosthetic mitral valve device are implanted above the natural mitral valve in the same procedure as each other, and the docking element is usually implanted before the prosthetic mitral valve device. For some such applications, when the prosthetic mitral valve device is initially implanted, the prosthetic mitral valve leaflets are kept open, for example, using sutures. Typically, the prosthetic mitral valve leaflets maintain an open state (e.g., using sutures) for a period of more than one week or more than one month, during which time period the docking element becomes anchored to the subject's heart by tissue ingrowth according to the techniques described above. In this way, during the time period in which the docking element becomes anchored to the subject's heart by tissue ingrowth, the docking element does not need to withstand the blood load that impacts the prosthetic valve leaflets. Subsequently, the element (e.g., suture) that keeps the prosthetic valve leaflets open is removed, allowing the prosthetic valve leaflets to begin to function.

[0114] Typically, the cells 45 defined by the struts 46 of the frame 24 are relatively large. For example, the cells can define an open area greater than 3.0 square centimeters (e.g., greater than 4.0 square centimeters) and / or less than 6.0 square centimeters (e.g., less than 5.5 square centimeters), such as 3.0-6.0 square centimeters (or 4.0-5.5 square centimeters). For some applications, the cells are configured so that the open portion of the cell is disposed at the junction of the pulmonary veins and the left atrium. Typically, the skirt 48 does not extend to the height of the frame at which the pulmonary veins are disposed at the junction of the left atrium. In this way, the frame does not interfere with blood flow from the pulmonary veins to the left atrium.

[0115] According to the corresponding applications of the present invention, the docking element 20 and / or the prosthetic mitral valve device 28 are delivered to the heart of the subject via the femoral vein transapically, transseptally and / or transaortically. For some applications, by delivering the docking element 20 and the prosthetic mitral valve device 28 in separate delivery steps, the size of the delivery device used to deliver the docking element 20 and the prosthetic mitral valve device 28 can be smaller than the case where the prosthetic mitral valve device is delivered together with the docking element (other conditions remain unchanged). For some applications, reducing the size of the required delivery device in the manner described above facilitates transseptal insertion of the docking element and / or the prosthetic mitral valve device.

[0116] As described above, typically, the docking element 20 is configured to facilitate anchoring the prosthetic mitral valve device 28 to the mitral valve of the subject. For some applications, the docking element occupies some area defined by the natural mitral valve annulus. For example, it is typically the case that the skirt 48 occupies some space between (a) the position where the frame becomes anchored to the atrial wall near the natural mitral valve annulus (by tissue ingrowth to the skirt and / or the frame itself) and (b) the ring 40. That is, the docking element typically includes (a) the ring 40 (within which the prosthetic valve device is anchored), and (b) a portion of the frame covered by the skirt 48 so as to promote tissue ingrowth from the atrial wall near the mitral valve annulus to the portion. Typically, the size of the ring (e.g., the outer circumference of the ring) is smaller than the size of the portion of the frame in which tissue ingrowth exists (e.g., the inner circumference of the portion of the frame). In addition, there is typically a material (e.g., fabric) bridging the ring and the portion of the frame in which tissue ingrowth exists. For some applications, the material bridging the ring and the portion of the framework where tissue ingrowth occurs is part of skirt 48 .

[0117] In light of the above, for some applications, the size of the prosthetic mitral valve is smaller than the size of the native mitral valve. For example, the prosthetic valve leaflets 34 of the prosthetic mitral valve device can span a diameter that is smaller than the measured diameter of the native mitral valve annulus (the diameter of the native mitral valve annulus is typically measured using a mitral valve measurement ring and / or using an imaging method, such as ultrasound). Alternatively, since the native mitral valve annulus is typically elliptical, the maximum diameter spanned by the leaflets can be smaller than the major axis of the ellipse defined by the native mitral valve annulus. For some applications, one or more advantages of a prosthetic valve sized in this manner, relative to the case of a larger prosthetic valve, may include: the prosthetic valve device has a lower curling profile (and therefore uses a delivery device with a smaller diameter), less foreign matter inside the subject's heart, less force applied to the prosthetic valve leaflets (and therefore improved durability), better anchoring of the prosthetic valve device, less interference with native anatomical structures, and / or better maintenance of a patent left ventricular outflow tract. Typically, smaller sized leaflets allow for a shorter frame of the prosthetic mitral valve device, thereby reducing obstruction of the left ventricular outflow tract (other things being equal).Alternatively or additionally, a prosthetic mitral valve device having prosthetic valve leaflets spanning a diameter that is less than the diameter of the native mitral valve annulus may be used for various reasons.

[0118] Typically, the prosthetic mitral valve device becomes anchored within the ring 40 of the docking element 20. Typically, the inner diameter of the ring 40 is greater than 20 mm. For some applications, the inner diameter of the ring 40 is smaller than the inner diameter of the natural mitral valve ring 44. For example, the inner diameter of the ring 40 can be less than 30 mm, for example less than 28 mm. As described above, for some applications, the docking element occupies some area defined by the natural mitral valve ring. For example, it is typically the case that the skirt 48 occupies some space between the position where the frame (by tissue ingrowth into the skirt and / or the frame itself) becomes anchored to the natural mitral valve ring and the ring 40. In this way, the ring acts as an artificial mitral valve ring that is smaller than the natural mitral valve ring. Typically, for such applications, the prosthetic mitral valve is configured to have a diameter that is smaller than the natural mitral valve. For example, the ratio of the diameter of the prosthetic mitral valve to the diameter (or major axis) of the natural mitral valve can be less than 7:8, or less than 3:4. For some applications, the prosthetic mitral valve has a diameter that is smaller than the diameter of the native mitral valve and has an effective orifice area of ​​1.8 cm2 or greater, which is generally large enough for healthy heart function in most patients.

[0119] Reference now Figure 2 , Figure 2 is a schematic diagram of a cross-sectional view of a frame 24 of a docking element 20 according to some applications of the present invention. Figure 2The dashed circles in the ' indicate where the frame was cut to produce the cross-sectional view shown. As shown, the frame generally defines cells 51 that are configured to be disposed on the sides of the frame that is placed adjacent to the mitral valve annulus. For some applications, cells 51 define an open area that is greater than 3.0 square centimeters (e.g., greater than 4.0 square centimeters) and / or less than 6.0 square centimeters (e.g., less than 5.5 square centimeters), such as 3.0-6.0 square centimeters (or 4.0-5.5 square centimeters). Typically, the ring 40 ( Figure 2 4 (not shown) is disposed inside the unit 51. In addition, typically, the skirt 48 covers any space between the pillars defining the unit 51 and the ring 40 so as to seal the space. For some applications, the skirt additionally covers the space (or portion thereof) defined by another unit. For some applications, the ring 40 is directly coupled to the pillars defining the unit 51 (e.g., as shown in FIG. Figure 4A-4B Optionally, the ring is coupled to the struts defining the unit 51 via the skirt 48. For example, the skirt 48 may be sewn to both the struts defining the unit 51 and the ring 40 (e.g., as shown in FIG. Figure 3A-3B shown).

[0120] Typically, before tissue ingrowth occurs, the docking element is anchored in place in the left atrium by expanding the framework so as to contact the wall and top of the left atrium. For some applications, the framework is configured to apply relatively low pressure only to the inner wall of the left atrium so that the framework conforms to the shape of the left atrium, rather than forcing the atrium to deform. For some applications, in this way, the framework allows the natural compliance of the inner wall of the left atrium to be maintained substantially. For example, the framework can be configured so that a force of 1N is required to reduce the diameter of the framework by 10mm. For some applications, each unit of the framework defines an open area greater than 3.0 square centimeters (e.g., greater than 4.0 square centimeters) and / or less than 6.0 square centimeters (e.g., less than 5.5 square centimeters), such as 3.0-6.0 square centimeters (or 4.0-5.5 square centimeters). It should be noted that the framework 24 is typically configured so that the contact between the framework and the left atrium is substantially evenly distributed on the wall of the left atrium and the top of the left atrium. It should also be noted that typically the frame does not include any additional anchoring portions for anchoring to body parts other than the wall and top of the left atrium, such as the left atrial appendage and / or the pulmonary veins.

[0121] Typically, after the prosthetic mitral valve is placed inside the docking element, the expansion of the frame to contact the wall and top of the left atrium will not provide sufficient support to anchor the docking element in the proper position in the left atrium, so that the docking element is exposed to the left ventricular blood pressure applied to the prosthetic mitral valve leaflet. Therefore, before the implantation of the prosthetic mitral valve device, the docking element is left in the proper position in the left atrium to allow sufficient tissue ingrowth to occur before the implantation of the prosthetic mitral valve device. Typically, the docking element is configured so that when the prosthetic mitral valve device is implanted, the anchoring of the docking element in the left atrium is mainly carried out via tissue ingrowth to the docking element. Typically, the mitral valve annulus can withstand higher loads than other parts of the left atrium wall. Therefore, for some applications, the docking element is configured so that when the prosthetic mitral valve device is implanted, the anchoring of the docking element in the left atrium is mainly carried out via tissue ingrowth from the atrial wall near the mitral valve annulus to the docking element. For some applications, skirt 48 is configured to be at least partially disposed proximate to the mitral annulus (e.g., at the mitral annulus and / or slightly above the mitral annulus (e.g., as described above)) so as to promote tissue ingrowth from the atrial wall proximate the mitral annulus into the frame.

[0122] Reference now Figure 3A , Figure 3B and Figure 3C , which are schematic illustrations of a docking element 20 configured to facilitate attachment of a prosthetic mitral valve device 28 ( Figure 1A ) is anchored to the subject's mitral valve. Figure 3A shows a cross-sectional view of a docking element, Figure 3A The dashed circles in indicate where the frame was cut to produce the cross-sectional views shown. Figure 3B A three-dimensional view of the docking element is shown. Figure 3C 4 shows a docking element disposed within the left atrium of a subject before the prosthetic mitral valve device is deployed. As mentioned above, for some applications, the ring 40 is coupled to the struts ( Figure 2 For example, the skirt 48 may be sewn to both the struts and the ring 40 defining the cell 51. An example of a frame according to such an application is shown in Figure 3A-3B As shown, the skirt 48 fills any space between the struts and the ring 40 defining the unit 51 so as to seal that space.

[0123] refer to Figure 3C For some applications, the inner diameter of the ring 40 is less than the inner diameter of the native mitral valve annulus 44. For example, the inner diameter of the ring 40 can be less than 30 mm, such as less than 28 mm. As described above, for some applications, the docking element occupies some area defined by the native mitral valve annulus. (It should be noted that for Figure 3A and Figure 3BThe configuration of the skirt shown in Figure 3C ) For example, it is typically the case that the skirt 48 occupies the space between the location where the frame becomes anchored to the atrial wall near the native mitral valve annulus (via tissue ingrowth into the skirt and / or the frame itself) and the ring 40. Furthermore, it is typically the case that the skirt seals the space between the location where the frame becomes anchored to the native mitral valve annulus and the ring 40. In this way, the ring acts as an artificial mitral valve annulus that is smaller than the native mitral valve annulus.

[0124] Reference now Figure 3D and Figure 3E , which are schematic diagrams of docking elements 20 according to some applications of the present invention, wherein the skirt 48 is Figure 3A-3C In all other respects, as shown in Figure 3D and Figure 3E The framework shown is generally similar to the reference Figure 3A-3C The framework described is similar.

[0125] Reference now Figure 4A , Figure 4B and Figure 4C , which are schematic illustrations of a docking element 20 configured to facilitate attachment of a prosthetic mitral valve device 28 ( Figure 1A ) is anchored to the subject's mitral valve. Figure 4A A view of the docking element from below the ring 40 is shown. Figure 4B A three-dimensional view of the docking element is shown. Figure 4C 1 shows the docking elements disposed within the left atrium of a subject before the prosthetic mitral valve device is deployed. As mentioned above, for some applications, the ring 40 is directly coupled to the struts ( Figure 2 For example, the skirt 48 may be welded to the support pillars defining the unit 51 at the welding points 60 ( Figure 4A An example of a framework according to such an application is shown in Figure 4A-4C Typically, the skirt 48 fills any space between the struts defining the unit 51 and the ring 40 so as to seal that space.

[0126] refer to Figure 4C, for some applications, the inner diameter of the ring 40 is less than the inner diameter of the native mitral valve annulus 44. For example, the inner diameter of the ring 40 can be less than 30 mm, such as less than 28 mm. As described above, for some applications, the docking element occupies some area defined by the native mitral valve annulus. For example, it is typically the case that the skirt 48 occupies the space between the position where the frame becomes anchored to the atrial wall near the native mitral valve annulus (by tissue ingrowth into the skirt and / or the frame itself) and the ring 40. In addition, typically, the skirt seals the space between the frame and the atrial wall near the native mitral valve annulus. In this way, the ring acts as an artificial mitral valve annulus that is smaller than the native mitral valve annulus.

[0127] Reference now Figure 4D and Figure 4E , which are schematic diagrams of docking elements 20 according to some applications of the present invention, wherein the skirt 48 is Figure 4A-4C In all other respects, as shown in Figure 4D and Figure 4E The framework shown is generally similar to the reference Figure 4A-4C The framework described is similar.

[0128] It should be noted that although Figure 1A-Figure 1C The sleeve 50 is shown disposed around the struts 46 of the frame 24, but for some applications, the struts of the frame are not covered by the sleeve. Examples of such applications are shown in FIG. Figure 3A-Figure 4E Shown in.

[0129] Reference now Figure 5A-5C , which show various steps of the frame 32 of the prosthetic mitral valve device 28 being expanded by a balloon 74 within the ring 40 of the docking element 20 according to some applications of the present invention. (As described in further detail below, for some applications, the ring 40 includes a hollow ring 72 and an inner ring 70, which is in Figure 5A-5C ) After tissue ingrowth occurs and the prosthetic mitral valve device is deployed, the ring 40 is configured to exert radial forces on the frame of the prosthetic mitral valve device so as to anchor the prosthetic mitral valve device, even when strong forces are applied to the prosthetic mitral valve device (e.g., during ventricular contraction). Typically, the prosthetic mitral valve device is delivered to the native mitral valve via a delivery device while in a radially constrained configuration. For some applications, the prosthetic mitral valve device is configured to radially self-expand after release from the delivery device. Optionally, the prosthetic mitral valve device is configured to be expanded by a balloon 74, for example using balloon expansion techniques known in the art. For example, the frame 32 of the prosthetic mitral valve device can be made of a metal such as stainless steel or cobalt chromium.

[0130] Typically, where the prosthetic mitral valve device is balloon expandable, the frame 32 of the prosthetic mitral valve device is expanded to a given diameter due to balloon inflation, but then experiences a slight recoil after balloon deflation due to the elastic properties of the frame 32 and / or due to the ring 40 radially compressing the frame. FIG. 5A to FIG. 5B and then to Figure 5C As the prosthetic mitral valve expands within the ring 40, the ring is typically configured as follows:

[0131] (a) defines a given diameter when the ring is not subjected to any forces,

[0132] (b) expanding to a second diameter to allow the balloon-expandable prosthetic mitral valve device to open to its maximum diameter, such as Figure 5B As shown,

[0133] (c) undergoes a diameter reduction that is at least similar to the diameter reduction experienced by a prosthetic mitral valve device during its recoil (which is typically in the range of 1% to 10%, e.g., 2% to 6%), such as Figure 5C shown, and

[0134] (d) After undergoing a change in diameter, sufficient radial force is exerted on the prosthetic mitral valve device to anchor the prosthetic mitral valve device in place, even during left ventricular systole.

[0135] Reference now Fig. 6A , Fig. 6A 4 is a schematic diagram of a docking element 20 according to some applications of the present invention. It should be noted that for illustrative purposes, the docking element is shown without the skirt 48. Fig. 6A See also Figure 6B , Figure 6B is a schematic diagram of a ring 40 according to some applications of the present invention.

[0136] For some applications, ring 40 includes a hollow annular ring 72 (which is typically made of a fabric such as PET, PTFE, and / or nylon) and an inner ring 70. The inner ring is typically made of an elastic material having the characteristics described above (i.e., characteristics (a)-(d) listed above). For example, Fig. 6A As shown, the inner ring can be made of a polymer material, a suture material, a rubber and / or a superelastic metal material, which is designed or cut in a manner to provide the features described above. Alternatively or additionally, the inner ring can include a spring made of one or more wires 76, the spring acting as an elastic ring having the features described above, such as Figure 6B For some applications, the inner ring has Figure 9A-9B The spring 102 shown and / or Figure 11A-11C The spring 120 shown is of similar configuration.

[0137] Reference now Figure 7 , Figure 7 is a schematic diagram of a mitral annulus repair device 80 according to some applications of the present invention. Typically, mitral annulus repair device 80 is implanted in a subject suffering from mitral regurgitation, in which there is backflow of blood from the left ventricle to the left atrium during systole due to incomplete closure of the mitral valve leaflets.

[0138] In general, the mitral annulus repair device 80 is substantially similar to the docking element 20, except for the differences described below. Similar reference numerals are used for components of the mitral annulus repair device that are similar to components of the docking element 20. As shown, many of the components of the mitral annulus repair device are similar to components of the docking element 20. However, for some applications, in place of the ring 40 (which is configured to anchor a prosthetic mitral valve device), the mitral annulus repair device includes an adjustable or self-adjusting ring 82. Rather than being used to support a prosthetic mitral valve device, the adjustable ring 82 is configured to reduce the area of ​​the mitral annulus after tissue ingrowth has occurred by being adjusted (e.g., via tightening) or self-adjusting to reduce the diameter of the ring, as described below with reference to FIG. Figures 8A-11C It should be noted that although the configuration of the frame and skirt of the mitral valve annulus repair device 80 is similar to that of Figure 4A-4C The configuration of the docking element 20 shown is similar, but the scope of the present invention includes any configuration of the frame 24 and / or skirt 48 described above with reference to the docking element 20 used in the mitral annulus repair device 80. For example, Figure 1A-Figure 1C , Figure 3A-3E and / or Figure 4A-4E Any configuration of frame and skirt shown in .

[0139] Typically, the mitral valve annulus repair device 80 remains in place within the left atrium prior to the reduction in diameter of the ring 82 to allow tissue ingrowth to occur. Typically, the mitral valve annulus repair device is configured such that as the diameter of the ring is reduced, anchoring of the mitral valve annulus repair device within the left atrium occurs primarily via tissue ingrowth into the mitral valve annulus repair device. For some applications, the mitral valve annulus repair device is configured such that as the diameter of the ring is reduced, anchoring of the mitral valve annulus repair device within the left atrium occurs primarily via tissue ingrowth from the atrial wall near the mitral valve annulus to the mitral valve annulus repair device. For example, because the mitral valve annulus repair device includes a skirt 48 (which is configured to be disposed near the mitral valve annulus, such as at or slightly above the mitral valve annulus (e.g., as described above)), the mitral valve annulus repair device can be configured to promote a greater degree of tissue ingrowth of the atrial wall near the mitral valve annulus than at other portions of the frame.

[0140] Typically, after sufficient tissue ingrowth has occurred, the diameter of the ring is reduced by adjustment (e.g., via tightening) or self-adjustment. Typically, because the atrial wall near the mitral annulus has undergone tissue ingrowth relative to the mitral annulus repair device, reducing the diameter of the ring reshapes the heart by reducing the size of the mitral annulus. Subsequently, the mitral valve leaflets are brought closer to each other, and mitral regurgitation is reduced or eliminated. It should be noted that for some applications, there is no substantial tissue ingrowth relative to the ring 82. Instead, the majority of tissue ingrowth occurs relative to the frame 24. Nevertheless, because the ring is coupled to the frame and there is tissue ingrowth from the atrial wall near the mitral annulus relative to the frame, the reduction in the diameter of the ring results in a reduction in the size of the mitral annulus.

[0141] Reference now Figure 8A-8C , which are schematic diagrams of a ring 82 of a mitral valve ring repair device 80 according to some applications of the present invention. Figure 8A-8C The ring is shown without the frame 24, but the ring is typically coupled to the frame, such as Figure 7 ) For some applications, the ring 82 includes a hollow ring 90 (which is typically made of a fabric such as PET, PTFE, and / or nylon) and a string 92 that passes through the ring. The string is typically attached to the ring at a first end 94 (e.g., via sutures), and a second end 96 of the string is free. Typically, the ring is coupled to the frame 24 of the mitral annulus repair device (e.g., via sutures). The second end of the string is typically pulled by the operator, which causes the diameter of the ring to decrease, such as from FIG. 8B to FIG. 8C This, in turn, reduces the size of the mitral valve annulus, as described above. For some applications (not shown), both ends of the rope extend from the annular ring, and both ends of the rope are pulled by the operator (like a drawstring) to reduce the diameter of the ring. Typically, after the diameter of the ring is reduced to the desired diameter, the ends of the rope are tied in a knot to secure the ring at that diameter. Alternatively or additionally, the ring may include a ratchet mechanism (or similar mechanism, not shown) to secure the diameter of the ring.

[0142] Reference now Figure 9A-9B , which are schematic diagrams of a ring 82 of a mitral valve ring repair device 80 according to some applications of the present invention. Figure 9A-9B The ring is shown without the frame 24, but the ring is typically coupled to the frame, such as Figure 7 shown.) Fig. 9B For some applications, the ring 82 includes a hollow annular ring 90, which is generally as shown in FIG. Figure 8A-8CDescribed. For some applications, a biodegradable ring 100 made of a biodegradable material (such as polylactide and / or polyglycolide) and having a first diameter or rope length is disposed within a hollow annulus. For some applications, a spring 102 is disposed within the annulus and surrounds the biodegradable ring so as to apply an inward radial force to the biodegradable ring. Typically, after a certain period of time (by which time tissue ingrowth as described above has occurred), the biodegradable ring becomes degraded, and the radial force of the spring applies an inward force on the annulus, causing the diameter of the ring 82 to decrease. This, in turn, reduces the size of the mitral annulus, as described above. The transition of the ring 82 (from the configuration before the ring 100 becomes degraded to the configuration after the ring 100 becomes degraded) occurs during Fig.9A The cross-sectional view of the ring shown in FIG.

[0143] Reference now Figure 10A-10B , which are schematic diagrams of the internal components of the ring 82 of the mitral valve ring repair device 80 according to some applications of the present invention. For some applications, the ring 82 includes a hollow ring 90 ( Figure 10A-10B ), which is usually as shown in reference Figure 8A-8C Descriptive, and Figure 10A-10B 1 and 1 . For some applications, a spring 110 is disposed within the ring. The spring is initially held open by a biodegradable material 112 (such as polylactide and / or polyglycolide) disposed between the coils of the spring, thereby forcing the spring to remain open. Typically, after a certain period of time (by which time tissue ingrowth as described above has occurred), the biodegradable material decomposes and the spring closes (e.g., from FIG. 10A to FIG. 10B The radial force of the spring exerts an inward force on the annulus, causing the diameter of the annulus 192 to decrease. This in turn reduces the size of the mitral annulus, as described above.

[0144] Reference now Figure 11A-11C , which are schematic diagrams of a ring 82 and its components of a mitral valve ring repair device 80 according to some applications of the present invention. Fig.11A The ring is shown without the frame 24, but the ring is typically coupled to the frame, such as Figure 7 For illustration purposes, Fig. 11B and Fig. 11C The inner parts of the ring are shown without the outer ring 90. Figure 11A-11C The ring 82 shown is generally similar to the reference Figure 10A-10B The rings shown and described are similar. However, Figure 11A-11CThe ring shown in FIG. 1 includes a spring 120 made of a self-expandable shape memory material (e.g., a shape memory alloy such as Nitinol) that is shaped into a small diameter configuration but is prevented from assuming the small diameter configuration by a biodegradable material 112. Typically, after a certain period of time (by which time tissue ingrowth as described above has occurred), the biodegradable material decomposes and the shape memory material assumes a smaller diameter configuration (e.g., from FIG. 11B to FIG. 11C The radial force of the spring exerts an inward force on the annulus, causing the diameter of the annulus 82 to decrease. This in turn reduces the size of the mitral annulus, as described above.

[0145] For some applications, a mitral valve ring device including an adjustable ring (as described above with reference to Figure 7-11C ) is used in combination with a prosthetic mitral valve device 28. For example, a generally Figure 1A-Figure 6B The techniques described above, however, allow the diameter of the annulus to be adjusted to accommodate a prosthetic mitral valve device having a given desired diameter.

[0146] For some applications, the devices and methods described herein are performed mutatis mutandis for the tricuspid valve and / or a different valve in a subject.

[0147] For some applications, the devices and methods described herein are performed in combination with devices and methods described in International Patent Application No. PCT / IL2018 / 050229 of Benichou et al., entitled “Dockingelement,” filed on March 1, 2018 (published as WO 18 / 178966), which claims priority to U.S. Provisional Application No. 62 / 476,989 of Benichou, entitled “Dockingelement,” filed on March 27, 2017, which is incorporated herein by reference.

[0148] Those skilled in the art will appreciate that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes combinations and sub-combinations of the various features described hereinabove, as well as variations and modifications of the present invention that would occur to those skilled in the art after reading the foregoing description and that are not in the prior art.

Claims

1. An apparatus for treating a subject having a diseased mitral valve, the apparatus comprising: A mitral valve annulus repair device configured to be implanted in the left atrium of the subject such that no portion of the mitral valve annulus repair device extends through the subject's mitral valve, the mitral valve annulus repair device comprising: a ring configured to be implanted within 15 mm of a native mitral valve annulus of the subject; and a frame extending upwardly from the annulus, the frame being configured to anchor the mitral annulus repair device in the left atrium by expanding the frame against the inner wall and top of the left atrium before tissue ingrowth into the mitral annulus repair device occurs, --------The frame includes a plurality of pillars defining a plurality of cells, a first portion of the frame, the first portion of the frame extending from the ring to a height of at least 5 mm from the ring, the first portion of the frame being covered by a fabric skirt, the fabric skirt being configured to promote tissue ingrowth into the fabric skirt, the mitral annulus repair device being configured to produce tissue ingrowth of the subject into the mitral annulus repair device such that there is substantial tissue ingrowth relative to the frame and / or the fabric skirt, but there is no substantial tissue ingrowth relative to the annulus, and The ring is adjustable in size and is configured to reduce a diameter of the subject's native mitral valve annulus by a reduction in diameter of the ring after tissue ingrowth into the frame and / or the fabric skirt occurs.

2. The apparatus of claim 1, wherein the cells defined by the struts define an open area of ​​at least 3 square centimeters.

3. A device according to claim 1 or 2, wherein the ring is configured to be manually adjustable in size.

4. The apparatus of claim 3, wherein the ring comprises a fabric hollow ring, wherein a cord is disposed within the hollow ring, and the ring is configured to be manually adjustable in size by an operator pulling a portion of the cord.

5. The device according to claim 1 or 2, wherein the ring is configured to automatically adjust its size.

6. The apparatus of claim 5 , wherein the ring comprises a fabric hollow ring, wherein a spring and a biodegradable material are disposed within the hollow ring such that the biodegradable material holds the spring in an expanded configuration, and wherein the ring is configured to automatically adjust in size by the biodegradable material becoming degraded and the radial force of the spring exerting an inward radial force on the ring.

7. The apparatus according to claim 1 or 2, wherein: The mitral annulus repair device is configured to be placed into the left atrium of the subject via the interatrial septum of the subject by advancing the mitral annulus repair device along the longitudinal axis of the frame in a lateral direction relative to the left atrium; and The ring is disposed transversely relative to the frame such that the ring is substantially parallel to a longitudinal axis of the frame.

8. The apparatus of claim 7, wherein the mitral annulus repair device is configured to be deployed within the left atrium of the subject such that a longitudinal axis of the frame is substantially parallel to the mitral annulus of the subject.

9. The apparatus of claim 1 or 2, wherein in at least a portion of the frame, the struts of the frame are covered by a fabric sleeve.

10. The apparatus of claim 9, wherein adjacent fabric sleeves are sewn to each other at junctions between the struts covered by the fabric sleeves.

11. The apparatus according to claim 1 or 2, wherein the frame does not include an additional anchoring portion for anchoring to any additional portion of the subject's body other than the wall and top of the left atrium.

12. An apparatus for treating a subject having a diseased mitral valve, the apparatus comprising: A docking element configured to be implanted within a left atrium of the subject such that no portion of the docking element extends through a mitral valve of the subject, the docking element comprising: a ring configured to be implanted within 15 mm of a native mitral valve annulus of the subject, the ring having a size smaller than a size of a native mitral valve annulus of the subject; --------A frame extending upward from the ring, -----------------A portion of the frame is configured to be disposed adjacent a native mitral valve annulus of the subject and to generate tissue ingrowth from an atrial wall of the subject adjacent at least the native mitral valve annulus of the subject to the docking element, and ----------------- the frame is configured to anchor the docking element within the left atrium by expansion of the frame against the inner wall and roof of the left atrium before tissue ingrowth into the docking element occurs, and a material disposed between the portion of the frame and the annulus, the material being configured to form a seal between an atrial wall proximate the native mitral valve annulus and the annulus; and A prosthetic mitral valve device, the prosthetic mitral valve device being configured to: being at least partially positioned within the docking element after ingrowth of tissue of the left atrium into the portion of the frame has occurred, and becomes anchored to the docking element at least in part by expanding radially against the ring.

13. The apparatus of claim 12, wherein the frame comprises no further anchoring portions for anchoring to any further portion of the subject's body other than the wall and top of the left atrium.

14. The apparatus of claim 12, wherein the ring comprises an outer portion and an inner portion, the outer portion comprising a fabric hollow ring, the inner portion comprising an element selected from the group consisting of an elastic material and a spring.

15. The apparatus of claim 12, wherein the ring is configured to be adjustable in size.

16. The device of claim 12, wherein the prosthetic mitral valve device is for use with a balloon, wherein the prosthetic mitral valve device comprises a balloon-expandable prosthetic mitral valve device configured to be radially expanded by the balloon, and wherein the ring comprises an elastic ring configured to: defines a given diameter when the ring is not subjected to any force, expanding to a second diameter to allow the balloon-expandable prosthetic mitral valve device to be expanded by the balloon, experiences a diameter reduction that is at least similar to a diameter reduction experienced by the prosthetic mitral valve device due to recoil following deflation of the balloon, and After undergoing such expansion and reduction in diameter, sufficient radial force is exerted on the prosthetic mitral valve device to anchor the prosthetic mitral valve device in place even during left ventricular systole.

17. An apparatus according to any one of claims 12-16, wherein the frame comprises more than one strut defining more than one cell, and wherein the material comprises a fabric skirt configured to cover a portion of the frame extending from the ring to a height of at least 5 mm from the ring.

18. The device of claim 17, wherein the cells are configured to define an open area of ​​at least 3 square centimeters when the frame is in a deployed state within the left atrium.

19. The device according to any one of claims 12-16, wherein the ring is configured to automatically adjust its size.

20. The apparatus of claim 19, wherein the ring comprises a fabric hollow ring, wherein a spring and a biodegradable material are disposed within the hollow ring such that the biodegradable material holds the spring in an expanded configuration, and wherein the ring is configured to automatically adjust in size by the biodegradable material becoming degraded and the radial force of the spring exerting an inward radial force on the ring.

21. The apparatus according to any one of claims 12 to 16, wherein: The docking element is configured to be placed into the left atrium of the subject via the interatrial septum of the subject by advancing the docking element along the longitudinal axis of the frame in a lateral direction relative to the left atrium; and The ring is disposed transversely relative to the frame such that the ring is substantially parallel to a longitudinal axis of the frame.

22. The apparatus of claim 21, wherein the docking element is configured to be deployed within the left atrium of the subject such that a longitudinal axis of the frame is substantially parallel to a native mitral valve annulus of the subject.

23. The apparatus of any one of claims 12-16, wherein the frame comprises more than one strut defining more than one cell, and wherein within at least a portion of the frame, the struts of the frame are covered by a fabric sleeve.

24. The apparatus of claim 23, wherein adjacent fabric sleeves are sewn to each other at junctions between the struts covered by the fabric sleeves.

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