Cardiac valve treatment device and delivery device therefor

Abstract

A valve treatment device comprising a connecting element, a first anchor assembly configured to grasp a first leaflet of a natural heart valve, and a second anchor assembly configured to grasp a second leaflet of a natural heart valve. The first anchor assembly is connected to a first side of the connecting element, and the second anchor assembly is connected to a second side of the connecting element and to a bioabsorbable central portion between the first and second anchor assemblies.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 613,675, filed on December 21, 2023, entitled "HEART VALVE TREATMENT DEVICES AND DELIVERY DEVICES THEREFOR", and U.S. Provisional Patent Application No. 63 / 462,183, filed on April 26, 2023, entitled "HEART VALVE TREATMENT DEVICES AND DELIVERY DEVICES THEREFOR", both to Delgado et al. The above applications are hereby incorporated by reference in their entirety for all purposes.

Background Art

[0002] Natural heart valves (i.e., aortic valve, pulmonary valve, tricuspid valve, and mitral valve) play an important role in ensuring forward flow with respect to adequate blood supply through the cardiovascular system. These heart valves can be damaged, for example, by congenital malformations, inflammatory processes, infectious diseases, illnesses, etc., and thus their effectiveness may be reduced. Such damage to the valve can lead to severe cardiovascular disorders or death. Damaged valves can be surgically repaired or replaced during open - heart surgery. However, open - heart surgery is highly invasive and can cause complications. Transvascular techniques can be used to introduce and implant devices to treat the heart in a much less invasive manner than open - heart surgery. As one example, a transvascular technique that can be used to access the native mitral and aortic valves is the transseptal technique. The transseptal technique involves advancing a catheter into the right atrium (e.g., inserting the catheter into the right femoral vein, advancing it up the inferior vena cava, and then into the right atrium). Thereafter, the septum is punctured and the catheter is passed into the left atrium. Similar transvascular techniques can be used, starting in the same way as the transseptal technique but not reaching the puncture of the septum. Instead, a device that pivots a delivery catheter towards the tricuspid valve within the right atrium is implanted inside the tricuspid valve.

[0003] A healthy heart has a roughly conical shape, tapering towards the apex and base. The heart is a four-chambered structure, containing the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall commonly called the septum. The natural mitral valve in the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomical structure from other natural heart valves. The mitral valve includes an annular portion, which is the ring-shaped part of the natural valve tissue surrounding the mitral valve opening, and a pair of leaflets, which extend downward from the annular portion into the left ventricle. The mitral annular portion may form a "D" shape, an elliptical shape, or other non-circular cross-sectional shape with a long axis and a short axis. Because the anterior leaflet is larger than the posterior leaflet, when they are closed together, a roughly "C" shaped boundary may be formed between the abutting sides of the leaflets.

[0004] When functioning correctly, the anterior and posterior leaflets work together as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle relax (also called "ventricular diastole" or "diastole"), the oxygenated blood collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also called "ventricular systole" or "systole"), the blood pressure in the left ventricle rises, causing the two valve leaflets to press together laterally. This closes the one-way mitral valve, preventing blood from flowing back into the left atrium, and instead, it is expelled from the left ventricle through the aortic valve. To prevent the two valve leaflets from dislocating due to pressure or folding back towards the left atrium through the mitral annulus, several fibrous cords called chordae tendineae anchor the leaflets to the papillary muscles in the left ventricle.

[0005] Valve regurgitation involves a valve improperly allowing some blood to flow through the valve in the wrong direction. For example, mitral regurgitation occurs when the natural mitral valve fails to properly close during the systole of cardiac contraction, allowing blood to flow from the left ventricle into the left atrium. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, including leaflet prolapse, papillary muscle dysfunction, stretching of the mitral annulus due to left ventricular dilation, or a combination of these. Mitral regurgitation in the central part of the leaflets can be called central jet mitral regurgitation, while mitral regurgitation closer to one of the leaflets' commissures (i.e., where the leaflets meet) can be called eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle, resulting in valve closure and regurgitation. Tricuspid valve regurgitation, while similar, can occur on the right side of the heart. [Overview of the Initiative] [Means for solving the problem]

[0006] This summary is intended to provide some embodiments and is not intended to limit the scope of the invention in any way. For example, no feature included in the embodiments of this summary is a requirement of the claims unless the claims expressly enumerate such feature. Furthermore, the features, components, steps, concepts, etc., described in this summary and the examples elsewhere in the disclosure can be combined in various ways. Various features and steps described elsewhere in the disclosure can be included in the examples summarized herein.

[0007] A device for treating a target natural valve (e.g., a living subject, a simulation, etc.) is disclosed. The device may be a valve treatment device, a valve repair device, an implantable device, a valve treatment device, a graft, etc. Similar configurations may be described as implantable devices for illustrative purposes in various embodiments herein, but may also be used in other devices that are not necessarily implantable and can be removed after treatment, such as valve treatment devices or valve repair devices.

[0008] In some implementations, a valve therapy device is provided, which may be an implantable device or implant (e.g., an implantable device) configured to be positioned within a natural heart valve so that the natural heart valve can form a more effective seal. In some implementations, the valve therapy device is part of a valve therapy system which includes a delivery system having a catheter and a control handle, in which case the valve therapy device is connected to the delivery system.

[0009] In some implementations, the valve treatment device (e.g., an implantable device or implant) includes an anchor portion. Each anchor includes multiple paddles, each movable between an open position and a closed position.

[0010] In some implementations, a valve treatment device (e.g., an implantable device or implant) includes a coaptation element, a first anchor assembly configured to grasp the first lobe of a natural heart valve, and a second anchor assembly configured to grasp the second lobe of a natural heart valve.

[0011] In some implementations, the first anchor assembly is connected to the first side of the joint element, and the second anchor assembly is connected to the second side of the joint element.

[0012] In some implementations, the valve treatment device is an implantable device or implant that includes a bioabsorbable central portion between a first anchor assembly and a second anchor assembly. In some implementations, the bioabsorbable central portion includes a junction.

[0013] In some implementations, the bioabsorbable central portion includes a first alignment member associated with a first anchor assembly and a second alignment member associated with a second anchor assembly.

[0014] In some implementations, the bioabsorbable central portion includes a connecting element configured to connect a joint element, a first anchor assembly, and a second anchor assembly together.

[0015] In some implementations, the connecting element is screwed into at least one of the first alignment member and the second alignment member.

[0016] In some implementations, the connecting element extends through a first longitudinal passage within the joining element, a second longitudinal passage within the first alignment member, and into a third longitudinal passage within the second alignment member.

[0017] In some implementations, the first anchor assembly includes a first inner paddle, and the second anchor assembly includes a second inner paddle. In some implementations, the first alignment member is attached to the first inner paddle, and the second alignment member is attached to the second inner paddle.

[0018] In some implementations, when the implantable device or implant is assembled, the first alignment member engages with the second internal paddle, and the second alignment member engages with the first internal paddle.

[0019] In some implementations, the first alignment member and the second alignment member are each formed as rectangular blocks.

[0020] In some implementations, the connecting element includes multiple lateral passages used to route actuation lines connected to the first and second anchor assemblies during device placement.

[0021] In some implementations, the lateral passages include a first pair of lateral passages for passing a first actuation line connecting a first anchor assembly to a joint element, and a second pair of lateral passages for passing a second actuation line connecting the first anchor assembly to a joint element.

[0022] In some implementations, the multiple lateral passages include a pair of third lateral passages for passing a third actuation line connecting a second anchor assembly to a joint element, and a pair of fourth lateral passages for passing a fourth actuation line connecting a second anchor assembly to a joint element.

[0023] In some implementations, the first anchor assembly includes an inner paddle and an outer paddle connected to the inner paddle by a bendable portion, the outer paddle being movable between an open and closed position relative to the inner paddle.

[0024] In some implementations, the first anchor assembly includes a gripping member having a fixed arm attached to an outer paddle and a movable arm connected to the fixed arm by a joint portion, the movable arm being movable between an open and a closed position relative to the fixed arm.

[0025] In some implementations, the first anchor assembly is operable between an open and a closed state independently of the second anchor assembly.

[0026] In some implementations, during device deployment, the first anchor assembly is connected to the joint element by multiple actuation lines.

[0027] In some embodiments, during placement of the device, the first anchor assembly can selectively engage and disengage from the engagement element while being connected to the engagement element by a plurality of actuation lines.

[0028] In some implementations, when the first anchor assembly is disengaged from the engagement element, the engagement element and the second anchor assembly are movable relative to the first anchor assembly.

[0029] In some embodiments, a method of treating and / or repairing a native heart valve includes connecting a first anchor assembly to an engagement element by a first actuation line, connecting a second anchor assembly to the engagement element by a second actuation line, and positioning a valve treatment device or a valve repair device at the native heart valve.

[0030] In some implementations, the method includes attaching a first anchor assembly of a valve treatment device / valve repair device to a first valve leaflet of a native heart valve and attaching a second anchor assembly of the valve treatment device / valve repair device to a second valve leaflet of the native heart valve.

[0031] In some embodiments, the method includes attaching a first anchor assembly and a second anchor assembly to an engagement element by a connecting element and removing the first actuation line and the second actuation line.

[0032] In some implementations, positioning a valve treatment device / valve repair device at a native heart valve includes delivering the valve treatment device / valve repair device through a lumen of a catheter in which a first anchor assembly, a second anchor assembly, and the engagement element are axially aligned within the lumen.

[0033] In some embodiments, the engagement element and the connecting element are bioabsorbable.

[0034] In some implementations, connecting a first anchor assembly to a joint element by a first actuation line includes passing the first actuation line through a first pair of lateral passages within the joint element. In some implementations, connecting a second anchor assembly to a joint element by a second actuation line includes passing the second actuation line through a second pair of lateral passages within the joint element.

[0035] In some implementations, connecting the first anchor assembly to the joint element includes connecting the first anchor assembly to the joint element by a third actuation line, and passing the third actuation line through a third pair of lateral passages within the joint element.

[0036] In some implementations, connecting the second anchor assembly to the joint element includes connecting the second anchor assembly to the joint element by a fourth actuation line and passing the fourth actuation line through a fourth pair of lateral passages within the joint element.

[0037] In some embodiments, the method includes applying tension to a first actuation line to engage a first anchor assembly with a connecting element. In some embodiments, the method includes applying tension to a second actuation line to engage a second anchor assembly with a connecting element.

[0038] In some implementations, attaching a first anchor assembly and a second anchor assembly to a joint element by a connecting element includes receiving the connecting element into a first longitudinal passage within the joint element, a second longitudinal passage associated with the first anchor assembly, and a third longitudinal passage associated with the second anchor assembly.

[0039] In some implementations, the method includes screwing a connecting element into at least one of a second longitudinal passage and a third longitudinal passage.

[0040] In some implementations, attaching the first anchor assembly to the first valve leaflet is completed when the first anchor assembly is disengaged from the connecting element.

[0041] In some implementations, attaching the second anchor assembly to the second valve leaflet is completed when the second anchor assembly is disengaged from the connecting element.

[0042] In some implementations, attaching the second anchor assembly of the valve repair device to the second valve leaflet includes engaging the second anchor assembly with a connecting element and moving the connecting element to move the second anchor assembly into a predetermined position for attachment to the second valve leaflet.

[0043] In some implementations, a valve treatment device (such as an implantable device or implant) includes a base, a first anchor assembly connected to a first side of the base, a second anchor assembly connected to a second side of the base, and a connecting member that connects at least the second anchor assembly to the base.

[0044] In some implementations, the first anchor assembly is configured to grasp the first lobe of a natural heart valve, and the second anchor assembly is configured to grasp the second lobe of a natural heart valve.

[0045] In some implementations, the connecting member includes a high-frequency reactive material.

[0046] In some implementations, a method for treating and / or repairing a natural heart valve involves positioning a valve treatment device attached to the natural heart valve. In some implementations, the method involves separating a second anchor assembly from the base by directing radio frequency radiation toward a connecting member.

[0047] In some implementations, this method involves positioning the replacement valve between the lobes of the natural heart valve.

[0048] In some implementations, the valve treatment device includes a connecting member.

[0049] In some implementations, the connecting member is a polymer suture embedded with a high-frequency reactive material.

[0050] In some implementations, the base and connecting members are formed as a single component.

[0051] In some implementations, the base is formed from a polymer material, and a high-frequency reactive material is embedded in the connection portion of the base, which is connected to a second anchor assembly.

[0052] In some implementations, the radio frequency-responsive material is embedded in the central portion of the base.

[0053] In some implementations, the radio frequency-responsive material is the antenna.

[0054] In some implementations, a valve treatment device (such as an implantable device or implant) includes a first anchor assembly configured to grasp a first leaflet of a natural heart valve and a second anchor assembly configured to grasp a second leaflet of a natural heart valve.

[0055] In some implementations, the first anchor assembly includes a first connecting member, and the second anchor assembly includes a second connecting member. In some embodiments, the first connecting member comprises a hook portion of a hook-and-loop fastener, and the second connecting member comprises a loop portion of a hook-and-loop fastener.

[0056] In some embodiments, the first connecting member also includes a loop portion of the hook-and-loop fastener, and the second connecting member also includes a hook portion of the hook-and-loop fastener.

[0057] In some implementations, the first and second connecting members include bioabsorbable materials.

[0058] In some implementations, a method for treating and / or repairing a natural heart valve includes one, some, or all of the following steps: (1) attaching a first anchor assembly to a first leaflet of a natural heart valve; (2) attaching a second anchor assembly to a first leaflet of a natural heart valve; (3) separating the first and second anchor assemblies with a separation tool; and / or (4) positioning a replacement valve between the valve leaflets of a natural heart valve.

[0059] In some implementations, the first anchor assembly includes a first connecting member having a hook portion of a hook-and-loop fastener. In some implementations, the second anchor assembly includes a second connecting member having a loop portion of a hook-and-loop fastener.

[0060] In some implementations, the method further includes the step of compressing the first anchor assembly relative to the second anchor assembly with an installation tool.

[0061] Any of the methods described above, and any method using the Systems, Assemblies, Devices, etc. in this Disclosure, may be performed on living subjects (e.g., humans or other animals) or on simulations (e.g., corpses, corpse hearts, virtual humans, simulators, etc.). In a simulation, body parts may optionally be referred to as "simulated" (e.g., simulated heart, simulated tissue, etc.) and may optionally include computerized and / or physical representations.

[0062] Any of the above systems, assemblies, devices, components, etc. can be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use in patients, and the methods of the present disclosure may include (or additional methods may include or consist of) sterilization (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more of the systems, devices, components, etc. described herein.

[0063] A further understanding of the nature and advantages of the present invention is described below in conjunction with the accompanying drawings, in particular, when similar parts have the same reference number.

[0064] To further clarify the various aspects of the examples within this disclosure, more detailed descriptions of specific examples and implementations will be provided by reference to various aspects of the accompanying drawings. These drawings illustrate only exemplary implementations of the disclosure and are therefore not intended to limit the scope of the disclosure. Furthermore, while some examples may be drawn to scale, not all examples are drawn to scale. Examples of the disclosure and other features and advantages will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawing]

[0065] [Figure 1] Figure 1 shows a cross-section of a human heart during diastole. [Figure 2] Figure 2 shows a cross-sectional view of the human heart during systole. [Figure 3] Figure 3 shows a cross-section of the human heart during systole, illustrating valve regurgitation. [Figure 4] Figure 4 is a cross-sectional view of Figure 3, with annotations to illustrate the natural shape of the mitral valve leaflets during systole. [Figure 5]Figure 5 illustrates a healthy mitral valve in a state where the valve leaflets are obstructed when viewed from the atrial side. [Figure 6] Figure 6 illustrates a dysfunctional mitral valve, showing a visible gap between the valve leaflets when viewed from the atrial side. [Figure 7] Figure 7 shows the tricuspid valve as viewed from the atrial side. [Figure 8] Figures 8, 9, 10, 11, 12, 13, and 14 show examples of valve treatment devices at various stages of development. [Figure 9] Figures 8, 9, 10, 11, 12, 13, and 14 show examples of valve treatment devices at various stages of development. [Figure 10] Figures 8, 9, 10, 11, 12, 13, and 14 show examples of valve treatment devices at various stages of development. [Figure 11] Figures 8, 9, 10, 11, 12, 13, and 14 show examples of valve treatment devices at various stages of development. [Figure 12] Figures 8, 9, 10, 11, 12, 13, and 14 show examples of valve treatment devices at various stages of development. [Figure 13] Figures 8, 9, 10, 11, 12, 13, and 14 show examples of valve treatment devices at various stages of development. [Figure 14] Figures 8, 9, 10, 11, 12, 13, and 14 show examples of valve treatment devices at various stages of development. [Figure 15] Figure 15 shows an example of a valvular treatment device that is similar to the devices shown in Figures 8, 9, 10, 11, 12, 13, and 14, but in which the paddles are independently controllable. [Figure 16] Figures 16, 17, 18, 19, 20, and 21 illustrate the exemplary devices shown in Figures 8, 9, 10, 11, 12, 13, and 14, illustrating how they are delivered and implanted inside the natural valve. [Figure 17] Figures 16, 17, 18, 19, 20, and 21 illustrate the exemplary devices shown in Figures 8, 9, 10, 11, 12, 13, and 14, illustrating how they are delivered and implanted inside the natural valve. [Figure 18] Figures 16, 17, 18, 19, 20, and 21 illustrate the exemplary devices shown in Figures 8, 9, 10, 11, 12, 13, and 14, illustrating how they are delivered and implanted inside the natural valve. [Figure 19] Figures 16, 17, 18, 19, 20, and 21 illustrate the exemplary devices shown in Figures 8, 9, 10, 11, 12, 13, and 14, illustrating how they are delivered and implanted inside the natural valve. [Figure 20] Figures 16, 17, 18, 19, 20, and 21 illustrate the exemplary devices shown in Figures 8, 9, 10, 11, 12, 13, and 14, illustrating how they are delivered and implanted inside the natural valve. [Figure 21] Figures 16, 17, 18, 19, 20, and 21 illustrate the exemplary devices shown in Figures 8, 9, 10, 11, 12, 13, and 14, illustrating how they are delivered and implanted inside the natural valve. [Figure 22] Figure 22 shows a perspective view of an exemplary device or implant in the closed position. [Figure 23] Figure 23 shows a perspective view of an exemplary device or implant in a closed position. [Figure 24] Figure 24 shows an exemplary valve treatment device with paddles in the open position. [Figure 25A] Figure 25A shows another exemplary valve treatment device with the paddles in the closed position. [Figure 25B] Figure 25B shows a top view of an exemplary valve treatment device. [Figure 26] Figure 26 shows a perspective view of an exemplary device having paddles with adjustable width. [Figure 27]Figure 27 is a cross-sectional view of the exemplary device shown in Figure 26, in which the device is divided into two equal parts. [Figure 28] Figure 28 is another cross-sectional view of the device shown in Figure 26, in which the device is bisected along a plane perpendicular to the plane in which Figure 28 is illustrated. [Figure 29] Figure 29 is a schematic illustration of an exemplary implant catheter assembly connected to an exemplary valve therapeutic device, in which the drive element is connected to a paddle drive control member and to the driver head of the device. [Figure 30] Figure 30 illustrates the assembly of Figure 29, and shows a paddle width adjustment element connected to the inner end of the device's connector and further connected to the paddle width control member, by rotating the device 90 degrees. [Figure 31] Figure 31 is an exploded view of an exemplary valve treatment or repair device. [Figure 32] Figure 32 is a perspective view of the assembled device shown in Figure 31. [Figure 33A] Figure 33A is a front perspective view of the first anchor assembly, an example of the device shown in Figure 31. [Figure 33B] Figure 33B is a rear perspective view of the first anchor assembly, an example of the device shown in Figure 31. [Figure 34A] Figure 34A is a front perspective view of the second anchor assembly, an example of the device shown in Figure 31. [Figure 34B] Figure 34B is a rear perspective view of an exemplary second anchor assembly of the device shown in Figure 31. [Figure 35] Figure 35 is a perspective view of an exemplary inner paddle of the device shown in Figure 31. [Figure 36] Figure 36 is a perspective view of an exemplary gripping member of the implant device shown in Figure 31. [Figure 37] Figure 37 is a perspective view of an exemplary leaflet depth indicator of the device shown in Figure 31. [Figure 38]Figure 38 is a perspective view of an exemplary outer paddle of the device shown in Figure 31. [Figure 39] Figure 39 is a perspective view of an exemplary alignment member of the device shown in Figure 31. [Figure 40] Figure 40 is a perspective view of the first anchor assembly in the open position. [Figure 41] Figure 41 is a cross-sectional perspective view of a connecting element attached to a coupler. [Figure 42] Figures 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, and 53 are perspective views of the device in Figure 31 at various stages of deployment. [Figure 43] Figures 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, and 53 are perspective views of the device in Figure 31 at various stages of deployment. [Figure 44] Figures 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, and 53 are perspective views of the device in Figure 31 at various stages of deployment. [Figure 45] Figures 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, and 53 are perspective views of the device in Figure 31 at various stages of deployment. [Figure 46] Figures 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, and 53 are perspective views of the device in Figure 31 at various stages of deployment. [Figure 47] Figures 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, and 53 are perspective views of the device in Figure 31 at various stages of deployment. [Figure 48] Figures 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, and 53 are perspective views of the device in Figure 31 at various stages of deployment. [Figure 49]Figures 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, and 53 are perspective views of the device in Figure 31 at various stages of deployment. [Figure 50] Figures 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, and 53 are perspective views of the device in Figure 31 at various stages of deployment. [Figure 51] Figures 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, and 53 are perspective views of the device in Figure 31 at various stages of deployment. [Figure 52] Figures 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, and 53 are perspective views of the device in Figure 31 at various stages of deployment. [Figure 53] Figures 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, and 53 are perspective views of the device in Figure 31 at various stages of deployment. [Figure 54] Figure 54 is a perspective view of an exemplary device with the bioabsorbable portion removed. [Figure 55] Figure 55 shows an example of an implanted therapeutic device separated into two parts. [Figure 56] Figure 56 shows an example of an implanted therapeutic device separated into two parts. [Figure 57] Figure 57 shows an example of an implantable therapeutic device having an anchor assembly attached to a base having one or more sutures. [Figure 58] Figure 58 is a magnified, detailed view of the sutures shown in Figure 57. [Figure 59] Figure 59 shows an implantable therapeutic device in which one of the anchor assemblies has been separated from its base. [Figure 60] Figure 60 shows an example of an implantable therapeutic device with an anchor assembly attached to its base. [Figure 61]Figure 61 shows an example of an implantable therapeutic device in which one of the anchor assemblies is separated from the base. [Figure 62] Figure 62 shows a front view of the implantable therapeutic device of Figure 60, which has a radiofrequency-responsive material embedded throughout its base. [Figure 63] Figure 63 shows a front view of the implantable therapeutic device of Figure 60, which has a radiofrequency-responsive material embedded in a portion of its base. [Figure 64] Figure 64 shows a front view of the implantable therapeutic device of Figure 60, with an antenna embedded along the entire length of the base. [Figure 65] Figure 65 shows a front view of the implantable therapeutic device from Figure 60, with an antenna embedded in a portion of its base. [Figure 66] Figure 66 shows an example of an implantable therapeutic device in which the base is separated into two parts. [Figure 67] Figure 67 shows a front view of the implantable therapeutic device of Figure 66, which has a radiofrequency-responsive material embedded in the central portion of its base. [Figure 68] Figure 68 shows a front view of the implantable therapeutic device from Figure 66, with an antenna embedded in the central part of the base. [Figure 69] Figure 69 shows the first anchor assembly of an implantable therapeutic device implanted on the first leaflet of a natural valve. [Figure 70] Figure 70 shows the second anchor assembly of the implantable therapeutic device implanted on the second leaflet of the natural valve. [Figure 71] Figure 71 shows the initial connection of the first and second anchor assemblies. [Figure 72] Figure 72 shows the first and second anchor assemblies fully connected. [Figure 73] Figure 73 shows the use of an installation tool to facilitate the connection between the first anchor assembly and the second anchor assembly. [Figure 74]Figure 74 shows the use of a separation tool to facilitate separation between the first and second anchor assemblies. [Modes for carrying out the invention]

[0066] The following description refers to the accompanying drawings illustrating exemplary implementations of the disclosure. Other implementations having different structures and operations do not deviate from the scope of the disclosure.

[0067] The exemplary implementations of this disclosure relate to systems, devices, methods, etc., for repairing defective heart valves. For example, various implementations of valve therapeutic devices, valve repair devices, implantable devices, grafts, and systems (including systems for delivering them) are disclosed herein, and any combination of these options is possible unless otherwise excluded. In other words, the individual components of the disclosed devices and systems can be combined as long as they are not mutually exclusive or physically impossible to combine.

[0068] Furthermore, any techniques, methods, processes, actions, steps, etc., described or suggested in this disclosure or in references incorporated herein, and any methods using the systems, assemblies, devices, etc. of this disclosure, may be performed on living objects (e.g., humans, other animals, etc.) or on simulations (e.g., corpses, corpse hearts, simulators, virtual people, etc.). When performed on a simulation, for example, body parts such as hearts, tissues, valves, etc., may be assumed to be simulated, or optionally referred to as “simulations” (e.g., simulated hearts, simulated tissues, simulated valves, etc.), and may optionally include computerized and / or physical representations of body parts, tissues, etc. The term “simulation” includes its use for corpses, computer simulators, virtual people (e.g., simply demonstrated in the air on a virtual heart, etc.).

[0069] Where, as described herein, one or more components are described as being interconnected by connection, joining, fastening, linking, mounting or other means, such interconnections may be direct, such as between components, or indirect, such as by using one or more intermediate components. Also, as described herein, references to “member,” “component,” or “part” are not limited to a single structural member, component, or element, but may include assemblies of components, members, or elements. Also, as described herein, the terms “substantially” and “about” are defined as at least close to (and including) a given value or state (preferably within 10%, more preferably within 1%, and most preferably within 0.1%). Although the terms “clasp” and “clasp arm” are frequently used herein in reference to specific examples, the terms “gripping member” and / or “gripping arm” may be used instead, even if they are not configured in exactly the same way as a typical clasp, and may function in the same or similar manner.

[0070] Figures 1 and 2 are cross-sectional views of a human heart H in diastole and systole, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA by the tricuspid valve TV and mitral valve MV, i.e., the atrioventricular valves, respectively. In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., leaflets 20, 22 shown in Figures 3-6, and leaflets 30, 32, 34 shown in Figure 7) that extend inward across their respective openings, forming a unidirectional fluid-occluded surface by joining or "joining" in the flow. The spontaneous valve repair system of this application is described and / or illustrated with respect to the mitral valve MV with respect to high frequency. Therefore, the anatomical structures of the left atrium LA and left ventricle LV are described in more detail. However, the device described herein can also be used in the repair of other natural valves, for example, the device can be used in the repair of the tricuspid valve (TV), aortic valve (AV), and pulmonary valve (PV).

[0071] The left atrium (LA) receives oxygen-rich blood from the lungs. During the diastolic phase, as shown in Figure 1, the blood already collected in the left atrium (LA) (during the systolic phase) moves into the left ventricular LV through the mitral valve (MV) as the left ventricle (LV) expands. During the systolic phase, as shown in Figure 2, the left ventricle (LV) contracts, pumping blood into the body through the aortic valve (AV) and ascending aorta (AA). During systole, the mitral valve leaflets close, preventing blood from flowing back from the left ventricle (LV) into the left atrium (LA), and blood is collected into the left atrium from the pulmonary veins. In some implementations, the device described in this application is used to repair the function of a defective mitral valve (MV). Specifically, the device is configured to assist in the closure of the mitral valve leaflets to prevent, block, or reduce blood from flowing back from the left ventricle (LV) into the left atrium (LA). Many of the devices described in this application are designed to easily grip and secure natural valve leaflets around connecting elements or spacers that act beneficially as fillers within the backflow opening to prevent or block backflow during systole, but this is not essential.

[0072] Referring to Figures 1-7, the mitral valve MV contains two leaflets: anterior leaflet 20 and posterior leaflet 22. The mitral valve MV also contains an annulus 24 (see Figure 5), which is a variablely dense, fibrous annular tissue surrounding the leaflets 20 and 22. Referring to Figures 3 and 4, the mitral valve MV is anchored to the wall of the left ventricle (LV) by chordae tendineae (CT). Chordae tendineae are cord-like tendons that connect papillary muscles (PM) (i.e., muscles located at the base of the chordae tendineae and within the wall of the left ventricle LV) to the leaflets 20 and 22 of the mitral valve MV. The papillary muscles (PM) function to restrict the movement of the leaflets 20 and 22 of the mitral valve MV and to prevent the mitral valve MV from inverting. The mitral valve MV opens and closes in response to pressure changes within the left atrium (LA) and left ventricle (LV). The papillary muscles (PM) do not open or close the mitral valve (MV). Rather, the papillary muscles (PM) support and hold up the valve leaflets (20 and 22) against the high pressure necessary to circulate blood throughout the body. The papillary muscles (PM) and chordae tendineae (CT) together are known as the subvalvular tissue, which functions to maintain the mitral valve (MV) so that it does not prolapse into the left atrium (LA) when the mitral valve (MV) becomes obstructed. As can be seen from the left ventricular outflow tract (LVOT) diagram in Figure 3, the anatomical structure of the valve leaflets (20 and 22) is such that the inner surfaces of the leaflets join at their free ends, and the leaflets (20 and 22) begin to move away from each other, retracting and spreading apart. The leaflets (20 and 22) spread apart towards the atrium until each leaflet contacts the mitral annulus.

[0073] Various disease processes can impair the proper function of one or more natural valves in the heart. These disease processes include degenerative processes (e.g., Barlow's disease, elastic fiber defect, etc.), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricular LV or right ventricular RV due to a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathy, etc.) can distort the shape of the natural valve, which can lead to natural valve dysfunction. However, the majority of patients undergoing valve surgery, such as mitral valve MV surgery, suffer from degenerative diseases that cause dysfunction of the leaflets (e.g., leaflets 20, 22) of the natural valve (e.g., mitral valve MV), resulting in prolapse and regurgitation.

[0074] Generally, natural valves can malfunction in different ways, including (1) stenosis and (2) regurgitation. Stenosis occurs when the natural valve does not open completely, causing impaired blood flow. Typically, stenosis is caused by the accumulation of calcification on the valve leaflets, which thickens the leaflets and impairs the valve's ability to open completely and allow forward blood flow. Regurgitation occurs when the valve leaflets do not completely close, causing blood to leak back into the previous chamber (for example, blood leaking from the left ventricle into the left atrium).

[0075] There are three main mechanisms by which the natural valve becomes regurgitant or inoperable, and these mechanisms include Carpentier type I, type II, and type III dysfunctions. Carpentier type I dysfunction involves annular dilation, which causes normally functioning leaflets to separate from each other and fail to form a tight seal (i.e., the leaflets do not properly join). Examples of dysfunction constituting the type I mechanism include leaflet perforation, such as that found in endocarditis. Carpentier type II dysfunction involves one or more leaflets of the natural valve protruding above the plane of joining. Carpentier type III dysfunction involves restricted movement of one or more leaflets of the natural valve, resulting in abnormal restriction of the leaflets below the plane of the annular dilation. Leaflet restriction can be caused by rheumatic diseases or ventricular dilation.

[0076] Referring to Figure 5, when a healthy mitral valve (MV) is in an occluded position, the anterior leaflet 20 and posterior leaflet 22 join together, thereby preventing blood from leaking from the left ventricle (LV) to the left atrium (LA). Referring to Figures 3 and 6, mitral regurgitation (MR) occurs when the anterior leaflet 20 and / or posterior leaflet 22 of the mitral valve (MV) are displaced into the left atrium (LA) during systole, causing the edges of the leaflets 20 and 22 to no longer contact each other. When joining does not occur in this way, a gap 26 is created between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow back from the left ventricle (LV) to the left atrium (LA) during systole, as illustrated by the mitral regurgitation (MR) pathway shown in Figure 3. Referring to Figure 6, the gap 26 can have a width W of approximately 2.5 mm to 17.5 mm, 5 mm to 15 mm, 7.5 mm to 12.5 mm, or 10 mm. In some situations, the gap 26 can have a width W greater than 15 mm, or even greater than 17.5 mm. As described above, there are several different ways in which valve regurgitation can be caused by dysfunction of the valve leaflets (e.g., the leaflets 20, 22 of the mitral valve MV).

[0077] In any of the situations described above, a valve treatment or repair device (e.g., implantable device, implant, therapeutic device, etc.) is desirable that can engage with the anterior leaflet 20 and posterior leaflet 22, close the gap 26, and prevent or suppress regurgitation of blood through the mitral valve MV. As can be seen from Figure 4, an abstract representation of a valve treatment / repair device, implantable device, or implant 10 is shown implanted between the leaflets 20 and 22 to prevent regurgitation during systole (compare Figure 3 with Figure 4). In some implementations, the connecting elements of the device 10 (e.g., spacers, connecting members, gap fillers, membranes, sheets, plugs, wedges, balloons, etc.) have an overall tapered or triangular shape to naturally adapt to the shape of the natural valve and to the nature of its expanded leaflets (towards the annulus). In this application, the terms spacer, joining element, connecting member, gap filler, plug, etc. are used interchangeably and refer to a member that fills a portion of the space between the leaflets of a natural valve, and / or a member configured such that the leaflets of a natural valve engage or "join" with each other (for example, so that the leaflets join not only with each other but also with a joining element, connecting member, spacer, etc.).

[0078] While stenosis or regurgitation can affect any valve, stenosis has been found to primarily affect either the aortic valve (AV) or the pulmonary valve (PV), and regurgitation has been found to primarily affect either the mitral valve (MV) or the tricuspid valve (TV). Both valve stenosis and regurgitation increase the burden on the heart (H) and, if left untreated, can lead to very serious conditions such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. The left side of the heart (i.e., the left atrium (LA), left ventricle (LV), mitral valve (MV), and aortic valve (AV)) is primarily responsible for circulating blood throughout the body. Therefore, because the pressure is substantially higher on the left side of the heart, mitral valve (MV) or aortic valve (AV) dysfunction is particularly problematic and often life-threatening.

[0079] For malfunctioning natural heart valves, either repair or replacement is possible. Repair typically involves preserving and modifying the patient's natural valve. Replacement typically involves replacing the patient's natural valve with a biological or mechanical substitute. Typically, the aortic valve (AV) and pulmonary valve (PV) are more prone to stenosis. Because stenotic damage sustained by the valve leaflets is irreversible, treatment for stenotic aortic or pulmonary valves can involve removing the valve and replacing it with a surgically implanted valve, or replacing it with a transcatheter valve. The mitral valve (MV) and tricuspid valve (TV) are more prone to deformation of the valve leaflets and / or surrounding tissues, which, as mentioned above, can prevent proper closure of the mitral valve (MV) or tricuspid valve (TV), allowing for regurgitation or backflow of blood from the ventricle to the atrium (for example, deformation of the mitral valve (MV) can allow for regurgitation or backflow from the left ventricle (LV) to the left atrium (LA), as shown in Figure 3). Backflow of blood from the ventricle to the atrium results in valve insufficiency. Deformities in the structure or shape of the mitral valve (MV) or tricuspid valve (TV) are often repairable. In addition, backflow can occur due to dysfunction of the chordae tendineae (CT) (for example, the CT can become stretched or ruptured), which allows the anterior leaflet 20 and posterior leaflet 22 to invert, causing blood to flow back into the left atrium (LA). Problems caused by dysfunction of the chordae tendineae can be repaired by repairing the chordae tendineae or by repairing the structure of the mitral valve (MV) (for example, by fixing the leaflets 20 and 22 at the affected area of ​​the mitral valve).

[0080] The devices and procedures disclosed herein often refer to the repair of mitral valve structures. However, it will be understood that the devices and concepts provided herein may be used in repairing any natural valve, as well as any component of a natural valve. Such devices can be used between the leaflets 20 and 22 of the mitral valve MV to prevent or block the regurgitation of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV (Figure 7), any device and concept herein can be used between any two of the anterior leaflet 30, septal leaflet 32, and posterior leaflet 34 to prevent or block the regurgitation of blood from the right ventricle into the right atrium. In addition, any device and concept provided herein can be used together with all three leaflets 30, 32, and 34 to prevent or block the regurgitation of blood from the right ventricle into the right atrium. That is, the valve treatment devices or implants provided herein may be centrally located between the three leaflets 30, 32, and 34.

[0081] An exemplary device or implant may optionally have connecting elements (e.g., spacers, connecting elements, gap fillers, membranes, sheets, plugs, wedges, balloons, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, a valve treatment device / valve repair device (e.g., an implantable device, an implantable device, a removable treatment device, a temporary treatment device, etc.) may have any combination or any partial combination of the multiple configurations disclosed herein without having connecting elements. When included, the connecting elements (e.g., spacers, connecting members, gap fillers, membranes, sheets, plugs, wedges, balloons, etc.) are configured to be positioned inside the natural heart valve opening, thereby assisting in filling the space between the valve leaflets and forming a more effective seal, thereby reducing or preventing the aforementioned regurgitation. The connecting element may be impermeable to blood (or resistant to blood flow through it) and may have a structure that blocks the regurgitation of blood from the left ventricle or right ventricle to the left atrium or right atrium, respectively, by allowing the natural valve leaflets to close around the connecting element during ventricular systole. The device or implant may be configured to seal two or three natural valve leaflets, i.e., the device can be used with natural mitral valves (bicuspid valves) and natural tricuspid valves. The connecting element is sometimes referred to herein as a spacer because it can fill the space between natural valve leaflets that do not completely close and are not functioning properly (e.g., mitral leaflets 20, 22, or tricuspid leaflets 30, 32, 34).

[0082] Optional connecting elements (e.g., spacers, connecting elements, gap fillers, membranes, sheets, plugs, wedges, balloons, etc.) can have a variety of shapes. In some implementations, the connecting element can have an elongated cylindrical shape with a circular cross-section. In some implementations, the connecting element can have an elliptical, oval, crescent, rectangular, or various other non-cylindrical shapes. In some implementations, the connecting element can have an atrial portion positioned within or adjacent to the atrium, a ventricular portion or lower portion positioned within or adjacent to the ventricle, and a side surface extending between the natural valve leaflets. In some implementations configured for use in tricuspid valves, the atrial portion or upper portion is positioned within or adjacent to the right atrium, the ventricular portion or lower portion is positioned within or adjacent to the right ventricle, and the side surface extends between the natural tricuspid valve leaflets.

[0083] In some implementations, the anchor can be configured to fix the device to one or both of the natural valve leaflets so that the connecting element is positioned between the two natural valve leaflets. In some implementations configured for use in tricuspid valves, the anchor can be configured to fix the device to one, two, or three of the tricuspid leaflets so that the connecting element is positioned between the three natural valve leaflets. In some implementations, the anchor can be attached to the connecting element at a position adjacent to the ventricular portion of the connecting element. In some implementations, the anchor can be attached to a drive element (e.g., drive shaft, drive tube, drive wire, etc.), to which the connecting element is also attached. In some implementations, the anchor and the connecting element can be positioned independently of each other by moving each of them separately along the longitudinal axis of the drive element (e.g., drive shaft, drive rod, drive tube, drive wire, etc.). In some implementations, the anchor and the connecting element can be positioned simultaneously by moving the anchor and the connecting element together along the longitudinal axis of the actuating element (e.g., shaft, actuating wire, etc.). The anchor may be configured to be positioned behind the natural valve leaflets when implanted, so that the valve leaflets are gripped by the anchor.

[0084] The device or implant can be configured to be implanted via a delivery system or other delivery means. The delivery system may comprise one or more of the following: a guide / delivery sheath, a delivery catheter, a maneuverable catheter, an implant catheter, a tube, or a combination thereof. The joint element and anchor may be compressible into a radially compressed state and self-expandable into a radially expanded state when the compressive pressure is released. The device may be configured such that the anchor expands radially away from the joint element, which is initially still compressed, to form a gap between the joint element and the anchor. The natural valve leaflet can then be positioned within this gap. The joint element can close the gap between the joint element and the anchor by expanding radially, thereby trapping the valve leaflet between the joint element and the anchor. In some implementations, the anchor and joint element are optionally configured to self-expand. The implantation methods for various implementations may differ and are described in more detail below for each implementation. Further information regarding these delivery methods and other delivery methods can be found in U.S. Patent No. 8,449,599, U.S. Patent Publication No. 2014 / 0222136, U.S. Patent Publication No. 2014 / 0067052, U.S. Patent Publication No. 2016 / 0331523, and PCT Patent Publication No. 2020 / 076898, each of which is incorporated herein by reference in its entirety for all purposes. These methods may be carried out on living animals or on simulations such as corpses, corpse hearts, or simulators (e.g., simulating body parts, hearts, tissues, etc.).

[0085] The disclosed device or implant can be configured such that the anchor is connected to the valve leaflet and can resist large systolic pressures that bias the device toward the left atrium by utilizing tension from the natural chordae tendineae. During diastole, the device can rely on compressive and retaining forces applied to the valve leaflet grasped by the anchor.

[0086] Referring here to Figures 8 to 15, the schematically illustrated device or implant 100 (e.g., artificial device, valve treatment device, valve restoration device, valve treatment device, implantable device, etc.) is shown at various stages of development. The device or implant 100, as well as other similar devices / implants, are described in more detail in PCT Patent Application Publication No. 2018 / 195215, PCT Patent Application Publication No. 2020 / 076898, and PCT Patent Application Publication No. 2019 / 139904, which are incorporated herein by reference in their entirety. The device 100 may include any other features relating to other devices or implants described in this application or the applications cited above, and the device 100 may be positioned to engage with valve tissue (e.g., valve leaflets 20, 22, 30, 32, 34) as part of any suitable valve restoration system (e.g., any valve restoration system disclosed in this application or the applications cited above).

[0087] The device or implant 100 is deployed from a delivery system 102. The delivery system 102 may include one or more of the following: a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a maneuverable catheter, an implant catheter, a tube, a channel, a pathway, or a combination thereof. The device or implant 100 includes a joint portion 104 and an anchor portion 106.

[0088] In some implementations, the joint portion 104 of the device or implant 100 includes a joint element 110 that is fitted to be embedded between the leaflets of a natural valve (e.g., a natural mitral valve, a natural tricuspid valve, etc.) and is slidably attached to an actuation element 112 (e.g., an actuation wire, shaft, tube, hypotube, line, suture, braid, etc.). The anchor portion 106 includes one or more anchors 108 that are actuated between an open and closed state and can take on a wide variety of forms, such as a paddle, gripping element, or the like. When the actuation element 112 is actuated, the anchor portion 106 of the device 100 opens and closes, gripping the natural valve leaflets during embedding. The actuation element 112 (and other actuation elements disclosed herein) can take on a wide variety of different forms (e.g., wire, rod, shaft, tube, screw, suture, line, strip, combination thereof, etc.), can be made from a wide variety of different materials, and can have a wide variety of forms. For example, the drive element may have threads so that the anchor portion 106 is moved relative to the joint portion 104 by rotating the drive element. Alternatively, the drive element may not have threads so that the anchor portion 106 is moved relative to the joint portion 104 by pushing or pulling the drive element 112.

[0089] The anchor portion 106 and / or anchor of device 100 includes an outer paddle 120 and an inner paddle 122, connected between the cap 114 and the joint element 110 by portions 124, 126, and 128 in some implementations. Portions 124, 126, and 128 can be articulated and / or flexible to move between all the positions described below. The interconnection of the outer paddle 120, the inner paddle 122, the joint element 110, and the cap 114 by portions 124, 126, and 128 can constrain the device to the positions and movements illustrated herein.

[0090] In some implementations, the delivery system 102 includes a maneuverable catheter, an implantable catheter, and a drive element 112 (e.g., a drive wire, shaft, tube, hypotube, line, suture, braid, etc.). These can be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the drive element 112 extends through the delivery catheter and further through a connecting element 110 to the distal end (e.g., a cap 114 or other attachment part at the distal connection of the anchor portion 106). The extension and retraction of the drive element 112 increase and decrease the distance between the connecting element 110 and the distal end of the device (e.g., a cap 114 or other attachment part), respectively. In some implementations, a collar or other mounting member (e.g., clamp, clip, locking member, suture, friction link, buckle, snap engagement, lasso, etc.) directly or indirectly attaches the joining element 110 to the delivery system 102, thereby allowing the drive element 112 to open and close the paddles 120, 122 of the anchor portion 106 and / or anchor 108 by sliding through the collar or other mounting member, and in some implementations, through the joining element 110 when driven.

[0091] In some implementations, the anchor portion 106 and / or anchor 108 may include a mounting portion or gripping member (e.g., a gripping arm, a clasp arm, etc.). The illustrated gripping member may include a clasp 130 including a base or fixed arm 132, a movable arm 134, an optional friction-enhancing element, or other fixing structure 136 (e.g., a protrusion, projection, ridge, groove, textured surface, adhesive, etc.), and a joint portion 138. The fixed arm 132 is attached to the inner paddle 122. In some implementations, the fixed arm 132 is attached to the inner paddle 122 with the joint portion 138 positioned in close proximity to the joining element 110. The joint portion 138 provides spring force between the fixed arm 132 and the movable arm 134 of the clasp 130. The joint portion 138 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or a hemispherical joint. In some implementations, the joint portion 138 is a flexible member made of a material integrally formed with the fixed arm 132 and the movable arm 134. The fixed arm 132 is attached to the inner paddle 122 and remains stationary or substantially stationary with respect to the inner paddle 122 when the movable arm 134 opens, releasing the clasp 130 and exposing an optional thrust or other friction-enhancing element 136.

[0092] In some implementations, the latch 130 is opened by applying tension to an actuation line 116 attached to the movable arm 134, thereby causing the movable arm 134 to articulate, flex, or rotate on the joint 138. The actuation line 116 extends through the delivery system 102 (e.g., through a maneuverable catheter and / or implant catheter). Other actuation mechanisms are also possible.

[0093] The drive line 116 can take a wide variety of forms, such as a line, suture, wire, rod, catheter, or similar. The clasp 130 may be equipped with a spring force so that it continues to provide a clamping force to the grasped natural valve leaflet in the occluded position. Optional punctures of the clasp 130, or other friction-enhancing elements 136, may grasp, clamp, and / or puncture the natural valve leaflet to further secure it.

[0094] During implantation, the paddles 120, 122 can be opened and closed, for example, to grip the natural valve leaflets (e.g., the leaflets of a natural mitral valve) between the paddles 120, 122 and / or between the paddles 120, 122 and the connecting element 110 (e.g., a spacer, plug, membrane, etc.). A latch 130 may be used to grip and / or further secure the natural valve leaflets by engaging them with an optional puncture or other friction-enhancing element 136 and clamping the leaflets between the movable arm 134 and the fixed arm 132. The optional puncture or other friction-enhancing element 136 of the latch 130 (e.g., projections, bumps, grooves, textured surfaces, adhesives, etc.) can increase friction with the leaflets or partially or completely puncture the leaflets. The actuation line 116 can be actuated separately so that each latch 130 can be opened and closed independently. By operating independently, one valve leaflet can be gripped at a time, or the retainer 130 can be repositioned on a valve leaflet that was not adequately gripped without altering the good grip on other valve leaflets. The retainer 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in the open position or at least partially open position), thereby allowing the valve leaflets to be gripped in various positions required by particular circumstances.

[0095] Referring here to Figure 8, device 100 is shown in an extended or fully open state for deployment from the implant delivery catheter of the delivery system 102. Device 100 is positioned at the end of the catheter of the delivery system 102 in the fully open position. In the extended state, the cap 114 is separated from the joint element 110 so that the paddles 120, 122 are fully extended. In some implementations, the angle formed between the interiors of the outer paddle 120 and the inner paddle 122 is approximately 180 degrees. The clasp 130 can be kept closed when deployed through the delivery system. The drive line 116 can be extended and can be attached to the movable arm 134.

[0096] Referring to Figure 9, although the device 100 is shown in the same extended state as in Figure 8, the clasp 130 is in a fully open position between the fixed portion 132 and the movable portion 134 of the clasp 130, in the range of approximately 140 to 200 degrees, approximately 170 to 190 degrees, or approximately 180 degrees.

[0097] Referring here to Figure 10, the device 100 is shown in either a retracted or fully closed state. To move the device 100 from the extended state to the retracted state, the drive element 112 is retracted, pulling the cap 114 toward the joining element 110. The connection portion 126 (e.g., joint, flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is constrained to move such that a compressive force acting from the cap 114 onto the outer paddle 120 pulls the paddle or gripping member toward the joining element 110 and moves radially outward. When moving from the open position to the closed position, the outer paddle 120 maintains an acute angle with respect to the drive element 112. The outer paddle 120 can optionally be biased toward the closed position. The inner paddle 122 moves over a considerably large angle during the same operation to orient itself away from the joining element 110 in the open state, and further to fold along the side of the joining element 110 in the closed state.

[0098] Referring to Figures 11-13, the device 100 is shown in a partially open and gripping-ready state. To transition from a fully closed state to a partially open state, the drive element (e.g., drive wire, shaft, tube, hypo tube, line, suture, braid, etc.) is extended to push the cap 114 away from the joint element 110, thereby pulling the outer paddle 120 and the inner paddle 122, and partially widening the anchor or anchor portion 106. The drive line 116 is also retracted, thereby opening the clasp 130 so that it can grip the valve leaflet. In some implementations, the pair of inner and outer paddles 122, 120 are driven collectively, rather than individually, by a single drive element 112. The position of the clasp 130 also depends on the positions of the paddles 122, 120. For example, referring to Figure 10, closing the paddles 122 and 120 also means closing the clasp. In some implementations, the paddles 120 and 122 can be controlled independently. In the example shown in Figure 15, the device 100 may have two drive elements 111 and 113 and two independent caps 115 and 117 (or other mounting parts), so that one paddle can be controlled using one independent drive element (e.g., drive wire, shaft, tube, hypotube, line, suture, braid, etc.) and cap (or other mounting part), and the other paddle can be controlled using the other independent drive element and cap (or other mounting part).

[0099] Referring to Figure 12, one clasp 130 can be closed by extending one drive line 116. Referring to Figure 13, another clasp 130 can be closed by extending another drive line 116. The clasps 130 can be opened and closed in a reciprocating manner by driving one or both of the drive lines 116 in a reciprocating manner.

[0100] Referring here to Figure 14, device 100 is shown in both a fully closed and deployed state. The delivery system 102 and the drive element 112 are retracted, and the paddles 120, 122 and the clasp 130 remain in the fully closed position. After deployment, device 100 can be maintained in the fully closed position by a mechanical latch, or it can be biased to remain closed by using a spring material such as steel, other metals, plastics, composite materials, etc., or by using a shape memory alloy such as Nitinol. For example, the connecting portions 124, 126, 128, the joint portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) can be formed from a metal such as steel, or from a shape memory alloy such as Nitinol, which can be manufactured from wire, sheet, tube, or laser-sintered powder, and are further biased to hold the outer paddle 120 closed around the connecting element 110, and to clamp the clasp 130 around the natural valve leaflet. Similarly, the fixed arm 132 and movable arm 134 of the clasp 130 are biased to clamp the valve leaflet. In some implementations, the mounting or connecting portions 124, 126, 128, the joint portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) can be formed from any other suitable elastic material such as metal or polymer material to maintain the device 100 in a closed state after implantation.

[0101] Figure 15 illustrates an embodiment in which the paddles 120 and 122 can be controlled independently. The device 101 shown in Figure 15 is similar to the device shown in Figure 11, except that the device 100 in Figure 15 includes drive elements configured as two independent drive elements 111 and 113 connected to two independent caps 115 and 117. In order to move the first inner paddle 122 and the first outer paddle 120 from a fully closed state to a partially open state, the drive element 111 is extended, pushing the cap 115 away from the connecting element 110, thereby pulling the outer paddle 120 and the inner paddle 122, and partially widening the first anchor 108. The drive element 113 is extended to move the second inner paddle 122 and the second outer paddle 120 from a fully closed state to a partially open state, thereby pushing the cap 115 away from the spacer or connecting element 110, and thereby pulling the outer paddle 120 and the inner paddle 122, partially widening the second anchor 108. The independent paddle control shown in Figure 15 can be implemented in any device disclosed in this application. For comparison, in the example shown in Figure 11, the pair of inner paddles 122 and outer paddles 120 are driven collectively, rather than individually, by a single drive element 112.

[0102] Referring to Figures 16 to 21, the implantable device 100 shown in Figures 8 to 14 is delivered and deployed inside the natural mitral valve MV of the heart H. Referring to Figure 16, the delivery sheath / catheter is inserted through the septum into the left atrium LA, and the implant / device 100 is deployed from the delivery catheter / sheath in a fully open state as shown in Figure 16. Subsequently, the implant / device is moved to a fully occluded state as shown in Figure 17 by retracting the drive element 112.

[0103] As can be seen from Figure 18, the implant / device is moved to a position within the mitral valve MV and further into the ventricular LV, and partially opened to grasp the valve leaflets 20 and 22. For example, as illustrated in Figure 18, the steerable catheter can be advanced and manipulated, or bent to position the steerable catheter. The implant catheter connected to the implant / device can be advanced from inside the steerable catheter to position the implant, as illustrated in Figure 18.

[0104] Referring here to Figure 19, the implant catheter can be retracted into the steerable catheter to position the mitral valve leaflets 20, 22 within the clasp 130. The actuation line 116 extends to close one of the clasps 130 and capture the leaflet 20. Figure 20 shows another actuation line 116 that then extends to close the other clasp 130 and capture the remaining leaflet 22. Finally, as can be seen from Figure 21, the delivery system 102 (e.g., maneuverable catheter, implant catheter, etc.), actuation element 112, and actuation lines 116 are then retracted, and the device or implant 100 is fully closed and deployed into the natural mitral valve MV.

[0105] Any of the disclosures disclosed in this application may be used in a wide variety of different valve therapy devices. Figures 22-24 show embodiments of valve therapy devices that may be modified to include any of the disclosures disclosed in this application. Any combination or partial combination of the components disclosed in this application may be combined with, substituted for, and / or added to any combination or partial combination of the components of the valve therapy devices illustrated in Figures 8-24.

[0106] Referring here to Figure 22, an example of a valve treatment device described as an implantable device or implant 200 for illustrative purposes is shown. Device 200 is one of many different configurations that device 100 schematically illustrated in Figures 8 to 14 can take. Device 200 may include any other features relating to the device or implant described herein, and device 200 may be positioned to engage with valve tissue 20, 22 as part of any suitable valve treatment system and / or valve repair system (e.g., any valve treatment system or repair system and / or treatment system disclosed herein). Device / implant 200 may be an artificial spacer device, a valve treatment device, or another type of implant attached to the leaflets of a natural valve.

[0107] In some implementations, the device or implant 200 includes a joint portion 204, a proximal or mounting portion 209, an anchor portion 206, and a distal portion 207. In some implementations, the joint portion 204 of the device optionally includes a joint element 210 (e.g., a spacer, connecting member, plug, membrane, sheet, gap filler, plug, wedge, balloon, etc.) for implantation between the leaflets of a natural valve. In some implementations, the anchor portion 206 includes a plurality of anchors 208. The anchors can be configured in various ways. In some implementations, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a clasp 230. In some implementations, the mounting portion 209 includes a first collar or proximal collar 211 (or other mounting member) for engaging with the capture mechanism of the delivery system. The delivery system for device 200 may be identical or similar to the delivery system 102 described above, and may include one or more of the following: catheters, sheaths, guide catheters / sheaths, delivery catheters / sheaths, maneuverable catheters, implant catheters, tubes, channels, pathways, combinations thereof, etc. The capture mechanism can be configured in various ways, and in some implementations may include one or more of the following: clamps, clips, pins, sutures, lines, lassos, ropes, snares, buckles, locking members, latches, etc.

[0108] In some implementations, the joining elements 210 and paddles 220, 222 are formed from a flexible material which may be a metal fabric formed in a mesh, woven, braided or any other preferred manner, or from a flexible material which is laser-cut or otherwise cut. The material may be a cloth, a shape memory alloy wire such as Nitinol to provide shape-setting ability, or any other flexible material suitable for implantation in the human body.

[0109] Actuating elements (e.g., actuating wires, shafts, tubes, hypotubes, lines, sutures, braids, etc.) may extend from a delivery system (not shown) and engage with the device or implant 200 to enable its operation. In some implementations, the driving element engages with the cap 214 of the distal portion 207 by extending through a proximal collar 211 and a spacer or bonding element 210. The driving element may be configured to engage with the cap 214 detachably by a screw connection or similar connection, so that the driving element can be disengaged and removed from the device 200 after implantation.

[0110] The joint element 210 extends from the proximal collar 211 (or other mounting member) to the inner paddle 222. In some implementations, the joint element 210 has an overall elongated and circular shape, but other shapes and configurations are possible. In some implementations, the joint element 210 has an elliptical shape or cross-section when viewed from above, a tapered shape or cross-section when viewed from the front, and a circular shape or cross-section when viewed from the side. A mixture of these three geometric shapes can result in a three-dimensional shape relating to the illustrated joint element 210 that achieves the advantages described herein. It can also be understood that the circular shape of the joint element 210 substantially follows or approximates the shape of the paddle frame 224 when viewed from above.

[0111] The size and / or shape of the bonding element 210 can be selected to minimize the number of implants (preferably one) required for a single patient, while simultaneously maintaining a low transflap gradient. In some implementations, the anterior-posterior distance at the apex of the bonding element is approximately 5 mm, and the medial-lateral distance at the widest point of the bonding element is approximately 10 mm. In some implementations, the overall geometry of the device 200 can be based on these two dimensions and the overall shape strategy described above. It will be readily apparent that using other anterior-posterior and medial-lateral distances as a starting point for the device will result in devices with different dimensions. Furthermore, using other dimensions and shape strategies described above will also result in devices with different dimensions.

[0112] In some implementations, the outer paddle 220 is articulately attached to the cap 214 of the distal portion 207 by a connecting portion 221 and to the inner paddle 222 by a connecting portion 223. The inner paddle 222 is articulately attached to the joint element by a connecting portion 225. Thus, the anchor 208 is configured similarly to a leg, with the inner paddle 222 resembling the upper portion of the leg, the outer paddle 220 resembling the lower portion of the leg, and the connecting portion 223 resembling the knee portion of the leg.

[0113] In some implementations, the inner paddle 222 is rigid, relatively rigid, and has a stiff portion, and / or is hardened by a reinforcing member or fixing portion of the clasp 230. The inner paddle 222, the outer paddle 220, and the joint element can all be interconnected as described herein.

[0114] In some implementations, the paddle frame 224 is attached to the cap 214 at its distal portion 207 and extends to a connecting portion 223 between the inner paddle 222 and the outer paddle 220. In some implementations, the paddle frame 224 is formed from a more rigid and harder material compared to the material forming the paddles 222, 220, so that the paddle frame 224 provides support for the paddles 222, 220.

[0115] The paddle frame 224 can provide additional clamping force between the inner paddle 222 and the connecting element 210, and can assist in winding the valve leaflet around the side surface of the connecting element 210. That is, the paddle frame 224 can be configured to have a rounded three-dimensional shape extending from the cap 214 to the connecting portion 223 of the anchor 208. The connections between the paddle frame 224, the outer paddle 220 and the inner paddle 222, the cap 214, and the connecting element 210 can restrict each of these members to the movement and position described herein. In particular, the connecting portion 223 is restricted by its connection between the outer paddle 220 and the inner paddle 222, and by its connection to the paddle frame 224. Similarly, the paddle frame 224 is restricted by its attachment to the connecting portion 223 (and thus to the inner paddle 222 and the outer paddle 220), and by its attachment to the cap 214.

[0116] The wider configuration of the paddle frame 224 provides an increased surface area compared to the case with only the inner paddle 222. This increased surface area allows the clamping force of the paddle 220 and paddle frame 224 on the natural valve leaflet to be distributed over a relatively large surface area of ​​the natural valve leaflet, further protecting the natural valve leaflet tissue.

[0117] Additional features of device 200, modified versions of the device, a delivery system for the device, and methods for using the device and the delivery system are disclosed in Patent Cooperation Treaty International Application PCT / US2018 / 028189 (International Publication 2018 / 195215). Any combination or subcombination of the features disclosed in this application may be combined with any combination or subcombination of the features disclosed in Patent Cooperation Treaty International Application PCT / US2018 / 028189 (International Publication 2018 / 195215). Patent Cooperation Treaty International Application PCT / US2018 / 028189 (International Publication 2018 / 195215) is incorporated herein by reference in its entirety.

[0118] Referring here to Figure 23, an embodiment of the device or implant 300 is shown. Device 300 is one of many different configurations that device 100 schematically shown in Figures 8 to 14 can take. Device 300 may include any other features of the device or implant considered in this application, and device 300 may be positioned to engage with valve tissue 20, 22 as part of any suitable valve restoration system (e.g., any valve restoration system disclosed in this application).

[0119] The device or implant 300 includes a proximal or mounting portion 305, an anchor portion 306, and a distal portion 307. In some implementations, the device / implant 300 includes a joint portion 304, which optionally includes a joint element 310 (e.g., a spacer, plug, membrane, sheet, etc.) for embedding between the leaflets 20, 22 of the natural valve. In some implementations, the anchor portion 306 includes a plurality of anchors 308. In some implementations, each anchor 308 may include one or more paddles, for example, an outer paddle 320, an inner paddle 322, a paddle extension member, or a paddle frame 324. The anchor may also include a clasp 330 and / or be connected to a clasp 330. In some implementations, the mounting portion 305 includes a first collar or proximal collar 311 (or other mounting member) for engaging with the capture mechanism of the delivery system.

[0120] The anchor 308 can be attached to other parts of the device and / or to each other in various different ways (e.g., directly, indirectly, by welding, suture, adhesive, link, latch, integral molding, or a combination of some or all of these). In some implementations, the anchor 308 is attached to the joint element 310 by a connecting portion 325 and to the cap 314 by a connecting portion 321.

[0121] The anchor 308 may include a first part or outer paddle 320 and a second part or inner paddle 322, separated by a connecting part 323. The connecting part 323 can be attached to a paddle frame 324 which is hinged to a cap 314 or other mounting part. Thus, the anchor 308 is configured similarly to a leg, with the inner paddle 322 resembling the upper part of a leg, the outer paddle 320 resembling the lower part of a leg, and the connecting part 323 resembling the knee portion of a leg.

[0122] In an implementation having a connecting element 310, the connecting element 310 and the anchor 308 can be connected to each other in various ways. As shown in the illustrated example, the connecting element 310 and the anchor 308 can be connected to each other by integrally forming the connecting element 310 and the anchor 308 as a single integrated component. This can be achieved, for example, by forming the connecting element 310 and the anchor 308 from a continuous strip 301 made of a braided or woven material such as braided or woven Nitinol wire. In the illustrated example, the connecting element 310, the outer paddle portion 320, the inner paddle portion 322, and the connecting portions 321, 323, and 325 are formed from the continuous strip 301.

[0123] Similar to the anchor 208 of the device or implant 200 described above, the anchor 308 may be configured to transition between different configurations by axially moving the distal end of the device (e.g., cap 314, etc.) relative to the proximal end of the device (e.g., proximal collar 311, or other mounting element, etc.). This movement may occur along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar 311, or other mounting element, etc.) of the device.

[0124] In some implementations, in the linear configuration, the paddle portions 320, 322 are aligned or linear with respect to the orientation of the longitudinal axis of the device. In some implementations, the connecting portion 323 of the anchor 308 is adjacent to the longitudinal axis of the spacer or joining element 310. From the linear configuration, the anchor 308 can be moved to a fully folded configuration (e.g., Figure 23) by, for example, moving its proximal and distal ends toward each other and / or moving it toward the midpoint or center of the device.

[0125] In some implementations, the clasp includes a movable arm connected to the anchor. In some implementations, the clasp 330 includes a base or fixed arm 332, a movable arm 334, an optional thrust / friction-enhancing element 336, and a joint portion 338. The fixed arm 332 is attached to the inner paddle 322 with the joint portion 338 positioned in close proximity to the connecting element 310. The joint portion 338 is equipped with a spring force such that the fixed arm 332 and the movable arm 334 are biased toward each other when the clasp 330 is closed.

[0126] The fixed arm 332 is attached to the inner paddle 322 by means of sutures through a hole or slot. The fixed arm 332 can be attached to the inner paddle 322 by any suitable means, such as screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesive, or similar. The fixed arm 332 remains substantially stationary relative to the inner paddle 322 when the movable arm 334 is released, thereby releasing the clasp 330 and exposing the optional piercing 336. The clasp 330 is released by applying tension to the drive line attached to the movable arm 334, thereby causing the movable arm 334 to articulate, pivot, and / or flex on the joint portion 338.

[0127] In summary, the device or implant 300 is similar in structure and operation to the device or implant 200 described above, except that the bonding element 310, outer paddle 320, inner paddle 322, and connecting portions 321, 323, 325 are formed from a single piece of material 301. In some implementations, the piece of material 301 is attached to the proximal collar 311, cap 314, and paddle frame 324 by being woven or inserted through openings in the proximal collar 311, the cap 314, and the paddle frame 324 configured to receive the continuous piece of material 301. The continuous strip 301 may be a single layer of material or may include two or more layers. In some implementations, part of the device 300 has a single layer of material strip 301, while other parts are formed from multiple overlapping or overlapping layers of material strip 301.

[0128] For example, Figure 23 shows a joint element 310 and an inner paddle 322, such that they are formed from multiple overlapping layers consisting of strips of material 301. A single continuous strip of material 301 can start and end at various locations on the device 300. The ends of the material strip 301 can be located at the same or different locations on the device 300. For example, in the illustrated embodiment of Figure 23, the material piece 301 starts and ends at the location of the inner paddle 322.

[0129] Similar to the devices or implants 200 described above, the size of the connecting element 310 may be selected to minimize the number of implants required for a single patient (preferably one) while simultaneously maintaining a low transflap gradient. In particular, by forming many of the components of the device 300 from material pieces 301, the device 300 can be fabricated to be smaller than the device 200. For example, in some implementations, the anterior-posterior distance at the top of the connecting element 310 is less than 2 mm, and the inward-outward distance at the widest point of the device 300 (i.e., the width of the paddle frame 324 wider than the connecting element 310) is approximately 5 mm.

[0130] Additional features of device 300, modified versions of the device, a delivery system for the device, and methods for using the device and the delivery system are disclosed in Patent Cooperation Treaty International Application PCT / US2019 / 055320 (International Publication 2020 / 076898). Any combination or subcombination of the configurations disclosed in this application may be combined with any combination or subcombination of the features disclosed in Patent Cooperation Treaty International Application PCT / US2019 / 055320 (International Publication 2020 / 076898). Patent Cooperation Treaty International Application PCT / US2019 / 055320 (International Publication 2020 / 076898) is incorporated herein by reference in its entirety.

[0131] Figure 24 illustrates another example of a number of valve treatment or repair systems 400 for treating or repairing a patient's natural valve, to which the concepts of this application may be applied. The valve treatment or repair system 400 includes a delivery device 401 and a valve treatment device and / or valve repair device 402.

[0132] The valve treatment device 402 includes a base assembly 404, a pair of paddles 406, and a pair of gripping members 408 (e.g., clasps, clasp arms, grippers, gripping arms, latches, etc.). In one example, the paddles 406 can be formed integrally with the base assembly. For example, the paddles 406 can be formed as extensions of links in the base assembly. In the illustrated embodiment, the base assembly 404 of the valve treatment device 402 includes a shaft 403, a coupler 405 configured to move along the shaft, and a lock 407 configured to lock the coupler in a stationary position on the shaft. The coupler 405 is mechanically connected to the paddles 406 such that the movement of the coupler 405 along the shaft 403 causes the paddles to move between an open position and a closed position. Thus, the coupler 405 functions as a means for mechanically connecting the paddle 406 to the shaft 403, and as it moves along the shaft 403, it moves the paddle 406 between their open and closed positions.

[0133] In some implementations, the gripping member 408 is pivotally connected to the base assembly 404 so that the width of the opening 414 between the paddle 406 and the gripping member 408 can be adjusted by moving the gripping member (for example, the gripping member 408 can be pivotally connected to the shaft 403 or to any other suitable member of the base assembly). The gripping member 408 may include a puncture portion 409 for attaching the gripping member to the valve tissue when the valve treatment device 402 is attached to the valve tissue. When the paddle 406 is in the closed position, the paddle engages with the gripping member 408, and as a result, the valve tissue is attached to the puncture portion 409 of the gripping member, thereby securing the valve treatment device 402 to the valve tissue. In some implementations, the gripping member 408 is configured to engage with the paddle 406, and as a result, the punctured portion 409 engages with the valve tissue member and the paddle 406 to secure the valve treatment device 402 to the valve tissue member. For example, in certain situations, it may be advantageous for the paddle 406 to maintain an open position and for the gripping member 408 to move outward toward the paddle 406 to engage the valve tissue with the paddle 406.

[0134] Although the embodiment shown in Figure 24 illustrates a pair of paddles 406 and a pair of gripping members 408, it will be understood that the valve treatment device 402 may include any suitable number of paddles and gripping members.

[0135] In some implementations, the valve therapy system 400 includes an installation shaft 413 that is detachably attached to the shaft 403 of the base assembly 404 of the valve therapy device 402. The installation shaft 413 is removed from the shaft 403 after the valve therapy device 402 has been fixed to the valve tissue, thereby removing the valve therapy device 402 from the remainder of the valve repair system 400, so that the valve therapy device 402 may remain attached to the valve tissue and the delivery device 401 may be removed from the patient's body.

[0136] The valve treatment system 400 may also include a paddle control mechanism 410, a gripper control mechanism 411, and a lock control mechanism 412. The paddle control mechanism 410 is mechanically attached to the coupler 405, thereby moving the coupler along the shaft and causing the paddle 406 to move between an open position and an closed position. The paddle control mechanism 410 can take any suitable form and may include, for example, a shaft, wire, tube, hypotube, rod, suture, line, etc. For example, the paddle control mechanism may include a hollow shaft, a catheter tube, or a sleeve fitted onto the positioning shaft 413 and shaft 403 and connected to the coupler 405.

[0137] The gripping member control mechanism 411 is configured to move the gripping member 408 so that the width of the opening 414 between the gripping member and the paddle 406 can be changed. The gripping member control mechanism 411 can take any suitable form, such as a line, suture or wire, rod, catheter, tube, hypotube, etc.

[0138] The lock control mechanism 412 is configured to lock and unlock the locking member. The locking member 407 locks the coupler 405 to a stationary position relative to the shaft 403 and can take many different forms, and the type of lock control mechanism 412 can be indicated by the type of locking member used. In examples where the locking member 407 includes a pivotable plate, the lock control mechanism 412 is configured to engage with the pivotable plate and move the plate between an inclined position and a substantially non-inclined position. The lock control mechanism 412 can be, for example, a rod, a suture, a wire, or any other member that can move the pivotable plate of the locking member 407 between an inclined position and a substantially non-inclined position.

[0139] The valve treatment device 402 is movable from an open position to a closed position. The base assembly 404 includes a link driven by a coupler 405. The coupler 405 is movably mounted on the shaft 403. To move the valve treatment device from the open position to the closed position, the coupler 405 moves along the shaft 403, thereby moving the link.

[0140] The gripping member control mechanism 411 moves the gripping member 408 to provide a wider or narrower gap in the opening 414 between the gripping member and the paddle 406. In the illustrated example, the gripping member control mechanism 411 includes a line, such as a suture or wire, connected to the opening in the end of the gripping member 408. When the line is pulled, the gripping member 408 is driven inward, widening the opening 414 between the gripping member and the paddle 406.

[0141] To move the valve treatment device 402 from the open position to the closed position, the lock control mechanism 412 moves the lock member 407 to the unlocked state. After the lock member 407 is unlocked, the paddle control mechanism 410 can move the coupler 405 along the shaft 403.

[0142] After the paddle 406 is moved to the closed position, the locking member 407 is moved to the locked position by the lock control mechanism 412, thereby maintaining the valve treatment device 402 in the closed position. After the valve treatment device 402 is maintained in the locked position by the lock 407, the valve treatment device 402 is removed from the delivery device 401 by detaching the shaft 403 from the installation shaft 413. In addition, the valve treatment device 402 is removed from the paddle control mechanism 410, the gripper control mechanism 411, and the lock control mechanism 412.

[0143] Additional configurations of device 402, modified versions of the device, delivery systems for the device, and methods for using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application PCT / US2019 / 012707 (International Publication WO2019139904 brochure). Any combination or subcombination of the configurations disclosed in this application may be combined with any combination or subcombination of the features disclosed in Patent Cooperation Treaty International Application PCT / US2019 / 012707 (International Publication 2019139904). Patent Cooperation Treaty International Application PCT / US2019 / 012707 (International Publication WO2019139904) is incorporated herein by reference in its entirety.

[0144] The clasps or valve leaflet gripping devices disclosed herein can take on a wide variety of different forms. Examples of clasps are disclosed in Patent Cooperation Treaty International Application PCT / US2018 / 028171 (International Publication Brochure WO2018195201). Any combination or partial combination of each component disclosed herein can be combined with any combination or partial combination of each component disclosed in Patent Cooperation Treaty International Application PCT / US2018 / 028171 (International Publication Brochure WO2018195201). Patent Cooperation Treaty International Application PCT / US2018 / 028171 (International Publication Brochure WO2018195201) is incorporated herein by reference in its entirety.

[0145] Referring to Figures 25A and 25B, an exemplary implementation of the valve therapy device 402 has a connecting element 3800. The valve therapy device 402 may have the same configuration as the valve therapy device shown in Figure 24 by adding the connecting element. The connecting element 3800 can take on a wide variety of different configurations. The connecting element 3800 can be compressible and / or expandable. For example, the connecting element can be compressed to fit inside one or more catheters of a delivery system, and / or expand when moved from one or more catheters, and / or can be compressed by paddles 406 to adjust the size of the connecting element. In the example illustrated in Figures 25A and 25B, the size of the connecting element 3800 can be reduced by compressing the connecting element with paddles 406 and increased by pulling the paddles 406 apart from each other. The joining element 3800 may extend beyond the outer edge 4001 of the gripping member or clasp 408, as shown in the figure, to provide an additional surface area for closing the gap of the mitral valve.

[0146] The connecting element 3800 can be connected to the valve treatment device 402 in a variety of different ways. For example, the connecting element 3800 can be fixed to the shaft 403, slidably positioned around the shaft, connected to the coupler 405, connected to the locking member 407, and / or connected to the central portion of the clasp or gripping member 408. In some implementations, the coupler 405 can take the form of the connecting element 3800. That is, a single member can be used as a coupler 405 that moves the paddle 406 between an open position and a closed position, and also as a connecting element 3800 that closes the gap between the valve leaflets 20, 22 when the device 402 is attached to the valve leaflets.

[0147] The connecting element 3800 may be configured to be positioned around one or more of the shafts or other control elements of the valve repair system 400. For example, the connecting element 3800 may be positioned around shaft 403, shaft 413, paddle control mechanism 410, and / or lock control mechanism 412.

[0148] The valve treatment device 402 may include any other mechanisms described in relation to other devices considered in this application, and the valve repair device 402 may be positioned to engage with valve tissue as part of any suitable valve repair or treatment system (e.g., any valve repair or treatment system disclosed in this application). Additional configurations of device 402, modified versions of the device, delivery systems for the device, and methods for using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application PCT / US2019 / 012707 (International Publication WO2019139904 brochure). Any combination or subcombination of the configurations disclosed in this application may be combined with any combination or subcombination of the configurations disclosed in Patent Cooperation Treaty International Application PCT / US2019 / 012707 (International Publication 2019139904).

[0149] Figures 26 to 30 show an embodiment of one of many valve treatment systems or valve repair systems for restoring a patient's natural valve to which the concepts of this application may be applied. Referring to Figures 29 and 30, the valve treatment system includes an implantable catheter assembly 1611 and an implantable valve treatment device 8200. Referring to Figures 26 to 28, the device 8200 includes a proximal or attachment portion 8205, a paddle frame 8224, and a distal portion 8207. The attachment portion 8205, the distal portion 8207, and the paddle frame 8224 can be configured in various ways.

[0150] In the example illustrated in Figure 26, the paddle frame 8224 can be symmetrical along the longitudinal axis YY. However, in some implementations, the paddle frame 8224 is not symmetrical about axis YY. Furthermore, referring to Figure 26, the paddle frame 8224 includes an outer frame portion 8256 and an inner frame portion 8260.

[0151] In some implementations, the connector 8266 (e.g., a molded metal member, a molded plastic member, a tether, a wire, a strut, a line, a cord, a suture, etc.) is attached to the outer frame portion 8256 at the outer end of the connector 8266 and to the coupler 8972 at the inner end 8968 of the connector 8266 (see Figure 28). Between the connector 8266 and the mounting portion 8205, the outer frame portion 8256 forms a curved shape. For example, in the illustrated example, the shape of the outer frame portion 8256 resembles that of an apple, in that it widens towards the mounting portion 8205 and narrows towards the distal portion 8207. However, in some implementations, the outer frame portion 8256 can have other shapes.

[0152] The inner frame portion 8260 extends from the mounting portion 8205 toward the distal portion 8207. Subsequently, the inner frame portion 8260 extends inward to form a retaining portion 8272 that is attached to the drive cap 8214. The retaining portion 8272 and the drive cap 8214 can be configured to be attached in any suitable manner.

[0153] In some implementations, the inner frame portion 8260 is a rigid frame portion, and the outer frame portion 8256 is a flexible frame portion. The proximal end of the outer frame portion 8256 is connected to the proximal end of the inner frame portion 8260, as shown in Figure 26.

[0154] The width adjustment element 8211 (e.g., width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment suture, width adjustment screw or bolt, etc.) is configured to move the outer frame portion 8256 from an expanded position to a constricted position by pulling the inner end 8968 (Figure 28) and a portion of the connector 8266 into the drive cap 8214. The drive element 8102 is configured to open and close the paddle by moving the inner frame portion 8260, according to some implementations disclosed herein.

[0155] As shown in Figures 27 and 28, the connector 8266 has an inner end 8968 that engages with a width adjustment element 8211, allowing the user to move the inner end 8968 inside the receiver 8912 (e.g., an internally threaded member, column, conduit, hollow member, notched receiving portion, tube, shaft, sleeve, post, housing, cylinder, track, etc.) to move the outer frame portion 8256 between a constricted position and an expanded position. In the illustrated example, the inner end 8968 includes a post 8970 attached to the outer frame portion 8256 and a coupler 8972 extending from the post 8970. The coupler 8972 is configured to be detachable from both the width adjustment element 8211 and the receiver 8912. The coupler 8972 can take on a wide variety of different forms. For example, the coupler 8972 may include one or more screw connections, features that engage with threads, and locking connections such as outwardly biased arms, walls, or other parts. When the coupler 8972 is attached to the width adjustment element 8211, the coupler is released from the receiver 8912. When the coupler 8972 is removed from the width adjustment element 8211, the coupler is fixed to the receiver. However, the inner end 8968 of the connector can be configured in various ways. Any configuration can be used that allows the outer frame portion 8256 to be properly attached to the coupler in order to enable the width adjustment element 8211 to move the outer frame portion 8256 between a constricted position and an expanded position. The coupler can also be configured in various ways, and the coupler can be a separate component of, for example, the connector or the inner end of the connector, or it can be integrated with another part of the device.

[0156] The width adjustment element 8211 allows the user to expand or contract the outer frame portion 8256 of the device 8200. In the example shown in Figures 27 and 28, the width adjustment element 8211 includes an externally threaded end that screws into the coupler 8972. The width adjustment element 8211 adjusts the width of the outer frame portion 8256 by moving the coupler within the receiver 8912. When the width adjustment element 8211 is unscrewed from the coupler 8972, the coupler engages with the inner surface of the receiver 8912, thereby setting the width of the outer frame portion 8256.

[0157] In some implementations, the receiver 8912 can be integrally formed with the distal cap 8214. The paddle opens and closes by moving the cap 8214 relative to the body of the mounting portion 8205. In the illustrated example, the receiver 8912 slides inside the body of the mounting portion. When the coupler 8972 is removed from the width adjustment element 8211, the width of the outer frame portion 8256 is fixed, while the actuation element 8102 moves the receiver 8912 and cap 8214 relative to the body of the mounting portion 8205. As the cap moves, the device can open and close in the same manner as in other implementations disclosed above.

[0158] In the illustrated embodiment, the driver head 8916 is positioned at the proximal end of the actuation element 8102. The driver head 8916 detachably connects the drive element 8102 to the receiver 8912. In the illustrated example, the width adjustment element 8211 extends through the drive element 8102. The drive element moves the distal cap 8214 by advancing axially in the opposite direction to direction Y. The movement of the distal cap 8214 relative to the mounting portion 8205 is effective in opening and closing the paddle, as indicated by the arrows in Figure 27. That is, the device is closed by moving the distal cap 8214 toward direction Y, and the device is opened by moving the distal cap toward the opposite direction Y.

[0159] As also shown in Figures 27 and 28, the width adjustment element 8211 extends through the actuating element 8102, the driver head 8916, and the receiver 8912, and engages with a coupler 8972 attached to the inner end 8968. When the outer frame portion 8256 is moved to the stenotic position, the device or implant 8200 may be more easily operated to a position for implantation in the heart by reducing contact and / or friction between the device 8200 and the natural structures of the heart (e.g., chordae tendineae). When the outer frame portion 8256 is moved to the expanded position, the anchor portion of the device or implant 8200 is provided with a larger surface area to engage with and capture the leaflets of the natural heart valves.

[0160] Referring to Figures 29 and 30, an implementation of the implant catheter assembly 1611 is shown, in which a latch actuation line 624 extends through the handle 1616, an actuation element 8102 is connected to a paddle actuation control device 1626, and a width adjustment element 8211 is connected to a paddle width control device 1628. The proximal end portion 1622a of the shaft or catheter of the implant catheter assembly 1611 may be connected to the handle 1616, and the distal end portion 1622b of the shaft or catheter may be connected to the device 8200. The actuation element 8102 may extend distally from the paddle actuation control 1626, through the handle 1616, through the delivery shaft or catheter of the implant catheter assembly 1611, and through the proximal end of the device 8200, and the actuation element is connected to the driver head 8916. The actuation element 8102 may be axially movable relative to the outer shaft of the implant catheter assembly 1611 and the handle 1616 in order to open and close the device.

[0161] The width adjustment element 8211 may extend distally from the paddle width control 1628, through the paddle actuation control 1626, through the actuation element 8102 (and consequently through the handle 1616, the outer shaft of the implant catheter assembly 1611, and the device 8200), and the width adjustment element is connected to a movable coupler 8972. The width adjustment element 8211 can be made axially movable relative to the drive element 8102, relative to the outer shaft of the implant catheter assembly 1611, and relative to the handle 1616. The clasp drive line 624 may extend through the handle 1616 and through the outer shaft of the implant catheter assembly 1611, and can be made axially movable relative to the handle 1616 and the outer shaft of the implant catheter assembly 1611. The clasp drive line 624 can also be made axially movable relative to the drive element 8102.

[0162] Referring to Figures 29 and 30, the width adjustment element 8211 can be detachably connected to the coupler 8972 of the device 8200. By advancing or retracting the width adjustment element 8211 using the paddle width control member 1628, the paddle is expanded or narrowed. When the actuation element 8102 is advanced and retracted by the paddle actuation control 1626, the paddle of the device opens and closes.

[0163] In the embodiments shown in Figures 29 and 30, the catheter or shaft of the implant catheter assembly 1611 is an elongated shaft that extends axially between a proximal end portion 1622a connected to the handle 1616 and a distal end portion 1622b connected to the device 8200. The outer shaft of the implant catheter assembly 1611 may also include an intermediate portion 1622c positioned between the proximal end portion 1622a and the distal end portion 1622b.

[0164] Referring here to Figures 31 to 41, examples of device 500 (e.g., artificial devices, valve treatment devices, implantable devices, implants, etc.) are shown. Device 500 may include any other configurations relating to other devices or implants described in this application or the applications cited above, and device 500 may be positioned to engage with valve tissue (e.g., valve leaflets 20, 22, 30, 32, 34) as part of any suitable valve treatment system or valve repair system (e.g., any valve treatment system or valve repair system disclosed in this application or the applications cited above).

[0165] The device or implant 500 is deployed from a delivery system. The delivery system can be any suitable delivery system (e.g., any delivery system disclosed in this application, or any of the applications referenced above, such as the delivery system 102 in Figures 8-20). The delivery system may include one or more of the following: catheters, sheaths, guide catheters / sheaths, delivery catheters / sheaths, maneuverable catheters, implant catheters, tubes, channels, pathways, combinations thereof, etc. The device or implant 500 has a proximal end 502 and a distal end 503. The device or implant 500 may also be configured to include an optional connecting portion 504 and an anchor portion 506. The connecting portion 504 and the anchor portion 506 may be configured in a variety of ways.

[0166] In some implementations, the joint portion 504 of the device or implant 500 includes a joint member 510 (e.g., a spacer, joint element, gap filler, membrane, sheet, plug, wedge, block, etc.) which is fitted to be embedded between the leaflets of a natural valve (e.g., a natural mitral valve, a natural tricuspid valve, etc.). The anchor portion 506 is configured to connect to the joint element 510. In some implementations, the anchor portion 506 includes one or more anchor assemblies 512, 514 which are operable between open and closed states and can take a wide variety of forms, such as paddles, gripping elements and / or similar. In the illustrated implementation, the anchor portion 506 includes a first anchor assembly 512 and a second anchor assembly 514.

[0167] In some implementations, when assembled, the joint element 510 is sandwiched between the first anchor assembly 512 and the second anchor assembly 514, and as a result, the joint element 510 defines the central portion 516 of the device or implant 500. In some implementations, all or part of the joint portion 504 is bioabsorbable. Therefore, in some implementations, the central portion 516 of the device or implant 500 may be bioabsorbable. Any device or implant considered in this application or in the applications cited above may be configured to include a bioabsorbable central portion 516. In some implementations, a portion of the anchor portion 506 may also be optionally bioabsorbable.

[0168] In some implementations, the first anchor assembly 512 and the second anchor assembly 514, when assembled, contact or engage with any connecting element 510. In some implementations, the first anchor assembly 512 and / or the second anchor assembly 514 can be selectively moved between a first position in which the first anchor assembly 512 and / or the second anchor assembly 514 contact or engage with the connecting element 510, and a second position in which the first anchor assembly 512 and / or the second anchor assembly 514 do not contact or are disengaged from the connecting element 510.

[0169] In some implementations, at the second position, each of the first anchor assembly 512 and the second anchor assembly 514 is positioned in line with the connecting element 510 to provide a slender delivery form as it advances through the delivery system (i.e., aligns along the longitudinal axis of the catheter lumen). In some implementations, at the second position, two or more of the first anchor assembly 512, the second anchor assembly 514, the optional connecting element 504, and one or more alignment members 556 are positioned in alignment with the connecting element 510 to provide a slender delivery form as it advances through the delivery system (i.e., aligns along the longitudinal axis of the catheter lumen).

[0170] In some implementations, the first anchor assembly 512 and the second anchor assembly 514 may be configured to operate independently. For example, the first anchor assembly 512 may operate to grip the leaflet of a natural valve, while the second anchor assembly 514 remains in a ready-to-grip or open position. Furthermore, in some implementations, the first anchor assembly 512 may be in a second position (i.e., not in contact with or disengaged from the joint element 510), while the second anchor assembly 514 may be in a first position (i.e., in contact with or engaged with the joint element 510). As a result, the first anchor assembly 512 can grip the leaflet of a natural valve in the closed position and remain in a predetermined position while the second anchor assembly 514 moves relative to the first anchor assembly 512 to a position with the joint element 510 in which the second anchor assembly 514 can grip the leaflet of another natural valve.

[0171] Referring to Figure 31, the joining element 510 can be constructed in various ways. In the illustrated example, the joining element 510 has a substantially rectangular body having a proximal end 520, a distal end 522 opposite to the proximal end 520, a first surface 524 extending between the proximal end 520 and the distal end 522, a second surface 526 opposite to the first surface 524 and extending between the proximal end 520 and the distal end 522, a first side surface 527 extending between the first surface 524 and the second surface 526, and a second side surface 529 opposite to the first side surface 527 and extending between the first surface 524 and the second surface 526. In some embodiments, the first surface 524 is parallel to the second surface 526.

[0172] Referring to Figure 41, in the illustrated example, the coupling element 510 includes a longitudinal passage 528 extending through the coupling element 510 from the proximal end 520 to the distal end 522. A coupler 530 (e.g., a shaft, wire, pipe, hypotube, rod, pusher, etc.) is received within the longitudinal passage 528 to connect to the coupling element 510. In some implementations, the coupler 530 screws into the coupling element 510. For example, in some implementations, the coupler 530 includes a male thread 532 on the distal end portion 534 of the coupler 530. The male thread 532 is configured to engage with a female thread 536 in the longitudinal passage 528. In some implementations, the coupler 530 may include a stop 538 that abuts against the proximal end 520 and is configured to limit the extent to which the coupler 530 can be received within the longitudinal passage 528. The stopper 538 may be configured in various ways (e.g., radial shoulders, annular protrusions, cross pins, or rods).

[0173] Referring to Figures 31 and 41, in some embodiments, the joint element 510 may be configured to include a plurality of transverse passages extending through the joint element 510 from a first face 524 to a second face 526. The transverse passages can be configured in various ways, including in terms of size, number, orientation, and arrangement. In the illustrated implementation, the joint element 510 includes a first pair of transverse passages 542, a second pair of transverse passages 544 located proximal to the first pair of transverse passages 542, a third pair of transverse passages 546 located proximal to the second pair of transverse passages 544, and a fourth pair of transverse passages 548 located proximal to the third pair of transverse passages 546. In some implementations, each pair of transverse passages 542, 544, 546, and 548 is symmetrical with respect to a longitudinal passage 528.

[0174] The bonding element 510 may be made from a bioabsorbable material. The bioabsorbable material can take on a wide variety of different forms. The bioabsorbable material may be a bioabsorbable polymer such as polyurethane, poly(D,L) lactide, poly(lactic acid-co-glycol) acid, poly(α-hydroxy acid), cross-linked polyester hydrogel, poly(orthoester), polyanhydride, and polyethylene glycol. The bioabsorbable material may also be any synthetic material that can be used in a valve treatment device / valve repair device 500, which degrades over time within the heart and is optionally replaced by tissue over a period of time due to the presence of the device in the blood.

[0175] The first anchor assembly 512 and the second anchor assembly 514 are each attached to the joint element 510 and configured to grip the leaflets of the natural valve. Each of the first anchor assembly 512 and the second anchor assembly 514 may be configured in various ways. The first anchor assembly 512 and the second anchor assembly 514 are operable between open and closed states and can take a wide range of forms, such as paddles and gripping elements. Referring to Figures 31-39, in some implementations, each of the first anchor assembly 512 and the second anchor assembly 514 includes an outer paddle 550, an inner paddle 552, a gripping member 554 (e.g., a clasp, clasp arm, gripper, gripping arm, latch, etc.), and optionally, a leaflet depth indicator 558. In some implementations, the alignment member 556 (e.g., block, body, plug, spacer, etc.) may be configured to interact with the first anchor assembly 512 and the second anchor assembly 514, respectively.

[0176] Referring to Figure 35, the inner paddle 552 can be configured in various forms. In the illustrated example, the inner paddle 552 is configured as a thin, elongated strip having a proximal end or first end 560, a distal end or second end 562 opposite the proximal end 560, and an intermediate portion 564 between the proximal end 560 and the distal end 562. The inner paddle 552 includes an inner surface 566 and an outer surface 568 opposite and parallel to the inner surface 566. In some embodiments, the inner paddle 552 may be configured to include a plurality of lateral passages extending from the inner surface 566 and the outer surface 568 through the inner paddle 552.

[0177] Lateral passages can be configured in various forms, including in terms of size, number, orientation, and arrangement. In the illustrated implementation, the inner paddle 552 includes a first pair of lateral passages 572, a second pair of lateral passages 574 located proximal to the first pair of lateral passages 572, a third pair of lateral passages 576 located proximal to the second pair of lateral passages 574, and a fourth pair of lateral passages 578 located proximal to the third pair of lateral passages 576.

[0178] In some implementations, the intermediate portion 564 forms a flexible or bendable region. For example, Figure 35 shows the intermediate portion 564 bent to form a U-shape such that the proximal end 560 is parallel to or approximately parallel (e.g., ±10 degrees) to the distal end 562 (i.e., in the closed state). The intermediate portion 564 may be bent or curved such that the angle between the proximal end 560 and the distal end 562 increases. For example, as shown in Figure 40, the angle between the proximal end 560 and the distal end 562 is right-angled or approximately right-angled (e.g., ±10 degrees) (i.e., in the open state).

[0179] In some implementations, the inner paddle 552 is biased to a closed position. In some implementations, the inner paddle 552 or a portion thereof (e.g., the intermediate portion 564) may be made of steel or a metal such as a shape memory alloy such as nitinol that is biased to the closed position (e.g., the shape memory alloy may be shaped to be set in the closed position).

[0180] The outer paddle 550 can be configured in various forms. In the illustrated embodiment, the outer paddle 550 is configured as a thin, elongated strip having a first end 580 and a second end 582 opposite the first end 580. The outer paddle 550 includes an inner surface 586 and an outer surface 588 opposite and parallel to the inner surface 586. In some embodiments, the outer paddle 550 may be configured to include a plurality of lateral passages extending from the inner surface 566 and the outer surface 568 through the outer paddle 550. In the illustrated embodiment, the outer paddle 550 includes a first pair of lateral passages 590 located adjacent to the second end 582.

[0181] In some implementations, the inner paddle 552 and the outer paddle 550 may be formed as a single, unified structure. In other implementations, the outer paddle 550 and the inner paddle 552 may be configured to be fixed to each other. For example, as shown in Figure 40, in the illustrated implementation, the distal end 562 of the inner paddle 552 may be joined to the first end 580 of the outer paddle 550 in a variety of different ways (e.g., directly, indirectly, by welding, suture, adhesive, link, latch, integrally formed, or a combination of some or all of these). In the illustrated implementation, the distal end 562 of the inner paddle 552 includes a narrowed portion 591 configured to be welded to the inner surface 586 of the outer paddle.

[0182] Referring to Figure 36, the gripping member 554 may be configured in various forms, including any configuration of the gripping member disclosed herein. In some implementations, the gripping member 554 may be configured to include a base or movable arm 592, a fixed arm 594, and an optional friction-enhancing element or other fixing structure 596 (e.g., spikes, projections, bumps, grooves, textured surfaces, adhesives, etc.).

[0183] The movable arm 592 includes a first end 600 and a second end 602 opposite the first end 600. In some embodiments, the movable arm 592 includes friction-enhancing elements or other fixed structures 596. For example, in the illustrated embodiment, the movable arm 592 includes spikes or other friction-enhancing elements 596 at the first end 600, which face or project radially outward (e.g., toward the fixed arm 594). In some embodiments, the movable arm 592 may be configured to include a plurality of lateral passages 608 extending through the movable arm 592. In the illustrated embodiment, the movable arm 592 includes three lateral passages 608 located at the first end 600.

[0184] In some implementations, the movable arm 592 and the fixed arm 594 are joined by a joint portion 610. The joint portion 610 provides a spring force between the movable arm 592 and the fixed arm 594. The joint portion 610 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or a similar joint. In some implementations, the joint portion 610 is a flexible member made of a material integrally formed with the movable arm 592 and the fixed arm 594.

[0185] The gripping member 554 is operable between an open and a closed state. For example, Figure 36 shows a joint portion 610 bent to form a U-shape such that the movable arm 592 is parallel or nearly parallel (e.g., ±10 degrees) to the fixed arm 594 (i.e., in the closed state). The joint portion 610 can be flexed or bent so that the angle between the movable arm 592 and the fixed arm 594 increases. For example, as shown in Figure 40, the angle between the movable arm 592 and the fixed arm 594 is right or approximately right (e.g., ±10 degrees) (i.e., in the open state).

[0186] In some implementations, the gripping member 554 is biased toward the closed position. In some implementations, the gripping member 554 or a portion thereof (e.g., the joint portion 610) may be formed of a metal such as steel or a shape memory alloy such as Nitinol, which is biased toward the closed position (for example, the shape memory alloy may be shaped to be set in the closed position).

[0187] Referring to Figure 40, the fixed arm 594 is attached to the outer paddle 550 and remains stationary or substantially stationary relative to the outer paddle 550 when the movable arm 592 is opened to expose an optional, piercing or other friction-enhancing element 596. The fixed arm 594 can be attached to the outer paddle 550 in various different ways (e.g., directly or indirectly by welding, sutures, adhesive, links, latches, integral molding, or a combination of some or all of these). In some implementations, the fixed arm 594 may be attached to the distal end 562 of the inner paddle 552 which is attached to the outer paddle 550.

[0188] Referring to Figures 31-34 and 37, the illustrated implementation includes an arbitrary leaflet depth indicator 558. The arbitrary leaflet depth indicator 558 can be configured in a variety of ways. For example, the leaflet depth indicator 558 may be any of the arbitrary leaflet depth indicators and may function in the same or similar way as any of the leaflet depth indicators disclosed in PCT application PCT / US2022 / 037983, filed July 22, 2022, which is incorporated herein by reference in its entirety. The illustrated arbitrary leaflet depth indicator 558 is a mechanical leaflet depth indicator that is visually observed (e.g., by fluorescence fluoroscopy or other known imaging techniques). That is, the arm of the arbitrary mechanical leaflet depth indicator 558 moves based on the presence of leaflets in the clasp and is observed using imaging techniques to determine the presence or absence of leaflets in the clasp. In some implementations, the arbitrary leaflet depth indicator 558 may be an electronic leaflet depth indicator that provides a signal indicating the presence, type, and / or state of tissue in the clasp. For example, an optional electronic leaflet depth indicator may be any of the electronic leaflet depth indicators disclosed in PCT application PCT / US2022 / 037983. In some implementations, the optional leaflet depth indicator may be a combination of electrically and mechanically / optically observed leaflet depth indicators.

[0189] Referring to Figures 32, 39-40, the alignment member 556 (e.g., block, body, plug, spacer, etc.) is configured to be positioned between the first anchor assembly 512 and the second anchor assembly 514 when the anchor assemblies 512, 514 are attached to the joint element 510. Thus, together with the joint element 510, the alignment member 556 at least partially defines the central portion 516 of the device 500. The alignment member 556 can be configured in various ways. Referring to Figure 39, in the illustrated embodiment, the alignment member 556 is formed as a rectangular block having an upper end 640, a lower end 642 opposite the upper end 640, a first surface 644 extending between the upper end 640 and the lower end 642, and a second surface 646 opposite the first surface 644 and extending between the upper end 640 and the lower end 642. In some implementations, the longitudinal axis passage 648 extends from the upper end 640 to the lower end 642 through the alignment member 556.

[0190] In Figures 33A-33B, the first anchor assembly 512 is shown in a closed state. In the illustrated embodiment, the second surface 646 of the alignment member 556 is attached to the inner surface 5666 of the inner paddle 552 adjacent to or near the intermediate portion 564. The alignment member 556 can be attached to the inner paddle 552 by any suitable means (e.g., adhesive, fasteners, welding, etc.). The alignment member 556 may be made from a bioabsorbable material. Bioabsorbable materials can take a wide variety of different forms. Bioabsorbable materials can be bioabsorbable polymers such as polyurethane, poly(D,L) lactide, poly(lactic acid-co-glycol), poly(α-hydroxy acid), crosslinked polyester hydrogel, poly(orthoester), polyanhydride, and polyethylene glycol. The bioabsorbable material may be any synthetic material that can be used in the valve treatment device 500, which degrades over time within the heart and is optionally replaced by tissue over a period of time due to the presence of the device in the blood.

[0191] In Figures 34A-34B, the second anchor assembly 514 is illustrated in a closed state. Since the second anchor assembly 514 is substantially identical to the first anchor assembly 512, the description of the first anchor assembly 514 applies equally to the second anchor assembly 514. Furthermore, similar components of the second anchor assembly 514 use the same reference numerals as those equivalent components of the first anchor assembly 512.

[0192] The difference between the second anchor assembly 514 and the first anchor assembly 512 lies in the position of the alignment member 556 on the inner surface 566 of the inner paddle 552. In particular, the alignment member 556 of the second anchor assembly 514 is more proximal (further from the middle portion and closer to the alignment member 512 of the first anchor assembly 512), as shown in Figures 33A-34B. Thus, when assembled, the alignment members 556 on the first and second anchor assemblies 512 and 514 are stacked along the longitudinal axis LA, as shown in Figure 32.

[0193] Referring to Figures 42-44, the device 500 is illustrated at various stages of deployment and assembly. Referring to Figure 42, in some implementations, the first anchor assembly 512 is attached to the joint element 510 by a number of actuation elements (e.g., actuation lines, actuation wires, actuation shafts, actuation rods, actuation tubes, etc.). In the illustrated implementation, the actuation elements are formed as actuation lines. As shown in Figure 42, the first actuation line 650 forms a loop through a third pair of lateral passages 576 on the inner paddle 552 and through a third pair of lateral passages 546 on the joint element 510. Similarly, the second actuation line 652 forms a loop through a first pair of lateral passages 572 on the inner paddle 552 and through a first pair of lateral passages 542 on the joint element 510. When tension is applied to both ends of the first actuation line 650 and the second actuation line 652, the inner surface 566 of the inner paddle 552 is pulled and engages with the first surface 524 of the joint element 510, as shown in Figure 43. Since the first actuation line 650 and the second actuation line 652 each form a loop through a pair of aligned lateral passages, the first anchor assembly 512 is well aligned with the joint element 510.

[0194] By releasing the tension in the first actuation line 650 and the second actuation line 652 (i.e., allowing slack), the first anchor assembly 512 can be disengaged from the coupling element 510 while still being connected via the first actuation line 650 and the second actuation line 652, as shown in Figure 42. Being able to disengage the first anchor assembly 512 from the coupling element 510 can be advantageous. For example, during the delivery of the device 500 through a delivery system (e.g., within the lumen of a catheter), the first anchor assembly 512 can be positioned in line with the coupling element 510 (e.g., below the coupling element 510 in Figure 42, along the longitudinal axis LA). As a result, the device 500 within the lumen of the catheter when delivered can be smaller than when the first anchor assembly 512 is engaged with the coupling element 510, as shown in Figure 43.

[0195] Referring to Figure 44, in some implementations, the second anchor assembly 514 is attached to the opposite side of the joint element 510 from the first anchor assembly 512. The second anchor assembly 514 can be attached to the joint element 510 in a similar manner to the first anchor assembly 512 (i.e., by multiple actuation elements). In the illustrated implementation, the second anchor assembly 514 is attached to the joint element 510 by multiple actuation lines (e.g., suture lines). In the illustrated implementation, the third actuation line 654 forms a loop through a fourth pair of lateral passages 578 on the inner paddle 552 of the second anchor assembly 514 and through a fourth pair of lateral passages 548 on the joint element 510. Similarly, the fourth actuation line 656 forms a loop through a second pair of lateral passages 574 on the inner paddle 552 and through a second pair of lateral passages 544 on the joint element 510.

[0196] When tension is applied to both ends of the third and fourth actuation lines 654 and 656, the inner surface 566 of the inner paddle 552 is retracted and engages with the second surface 526 of the joint element 510. Furthermore, the alignment member 556 on the second anchor assembly 514 is positioned between the joint element 510 and the alignment member 556 on the first anchor assembly 512, with the second surface 646 of the alignment member 556 on the first anchor assembly 512 engaging with the inner surface 566 of the inner paddle 552 of the second anchor assembly, and the second surface 646 of the alignment member 556 on the second anchor assembly 514 engaging with the inner surface 566 of the inner paddle 552 of the first anchor assembly 512. As a result, the alignment member 556 helps ensure that the joint element 510 and the first and second anchor assemblies are properly aligned with each other when assembled. For ease of illustration, the alignment member 556 on the second anchor assembly 514 is shown removed from the second anchor assembly 514 in Figure 44.

[0197] By releasing (i.e., loosening) the tension in the third actuation line 654 and the fourth actuation line 656, the second anchor assembly 514 can be disengaged from the connecting element 510 while still being connected via the third actuation line 654 and the fourth actuation line 656, as shown in Figure 44. Thus, like the first anchor assembly 512, the second anchor assembly 514 can be positioned inline with the connecting element 510 along the longitudinal axis LA for delivery through the lumen of the catheter.

[0198] Figures 45–49 illustrate an exemplary device 500 that operates between an open and a closed state. The device 500 may be actuated by a number of actuation elements (e.g., actuation lines, actuation wires, actuation shafts, actuation rods, actuation tubes, etc.). The actuation elements are omitted in Figures 42–44 for the sake of simplification of these drawings. Referring to Figure 45, it is shown that the first anchor assembly 512 and the second anchor assembly 514 are attached to the joint element 510 as described above in Figures 42–44. The first and second anchor assemblies 512 and 514, respectively, are in the closed state. The first anchor assembly 512 and the second anchor assembly 514 may be actuated to move between an open and a closed state in a variety of ways, including any method disclosed herein.

[0199] In the illustrated embodiment, a fifth actuation line 658 loops through a first pair of lateral passages 590 on the outer paddle 550 and extends distally to the distal end 503 of the device 500. A first pair of tubes 660 (e.g., hypotubes) extends distally along the device 500 such that each end 662 of the first pair of tubes 660 is at or adjacent to the distal end 503. The fifth actuation line 658 extends into the first pair of tubes 660 at the distal end 503. Similarly, a sixth actuation line 664 forms a loop through a first pair of lateral passages 590 on the outer paddle 550 of the second anchor assembly 514. The sixth actuation line 664 extends distally to the distal end 503 of the device 500. A second pair of tubes 666 (e.g., the lower tube) extends distally along the device 500 such that each end 668 of the second pair of tubes 666 is at or adjacent to the distal end 503. A sixth actuation line 664 extends within the second pair of tubes 666 at the distal end 503.

[0200] The seventh actuation line 670 extends proximal to the first end 600 of the movable arm 592 of the first anchor assembly 512, forming a loop through two of the lateral passages 608. Similarly, the eighth actuation line 672 (Figure 46) extends proximal to the first end 600 of the movable arm 592 of the second anchor assembly 514, forming a loop through two of the lateral passages 608.

[0201] Referring to Figure 46, tension is applied to the fifth actuation line 658 and the sixth actuation line 664 by pulling them proximal through tubes 660 and 666, respectively, in order to move the outer paddle 550 to the open position. The ends 662 and 668 of tubes 660 and 666 are at or adjacent to the distal end 503 of the device 500, respectively, and the fifth actuation line 658 and the sixth actuation line 664 form a loop through the first pair of lateral passages 590 on the outer paddle 550, so that applying tension to the fifth actuation line 658 and the sixth actuation line 664 provides a distally directed force to the second end 582. As a result, the force causes the middle section 564 to bend, allowing the outer paddle 550 to pivot away from the inner paddle 552.

[0202] When the outer paddle 550 moves to the open position, the gripping member 554 moves together with the outer paddle 550. In order to keep the gripping member 554 in the closed position, the seventh actuation line 670 and the eighth actuation line 672 remain loose so as not to apply force to the movable arm 592.

[0203] Referring to Figures 47-48, with the outer paddle 550 in the open position (i.e., tension applied to the fifth actuation line 658 and the sixth actuation line 664), tension can be applied to the seventh actuation line 670 and the eighth actuation line 672 to move the gripping member 554 between the closed and open positions. Since the seventh actuation line 670 and the eighth actuation line 672 loop through the lateral passage 608 at the first end 600 of the movable arm 592, applying tension to the seventh actuation line 670 and the eighth actuation line 672 provides a force directed proximal to the first end 600 of the movable arm 592. As a result, the force causes the joint portion 610 to bend or flex, as shown in Figure 47, allowing the movable arm 592 to pivot proximal to the inner paddle 552.

[0204] In the open state, each gripping member 554 is ready to capture and can be positioned to capture the valve leaflets. Once positioned to capture the valve leaflets, tension can be released from the seventh actuation line 670 and the eighth actuation line 672 to allow the movable arm 592 to return to the closed state, as shown in Figure 48.

[0205] Referring to Figure 49, with the gripping member 554 in the closed position, the outer paddle 550 can be moved to the closed position. In particular, tension can be removed from the fifth actuation line 658 and the sixth actuation line 664, allowing the intermediate portion 564 to return the outer paddle 550 to the closed position.

[0206] Naturally, the first anchor assembly 512 and the second anchor assembly 514 are operable independently. Therefore, the outer paddle 550 and inner paddle 552 of the first anchor assembly 512, as well as the gripping member 554, can move between open and closed positions, and vice versa, independently of the second anchor assembly 514. Furthermore, each of the first anchor assembly 512 and the second anchor assembly 514 may be configured to disengage from the connecting element 510. Therefore, for example, the second anchor assembly 514 can capture the first valve leaflet at a position away from the connecting element 510, as shown in Figure 44. Both the connecting element 510 and the first anchor assembly 512, which can engage with the connecting element 510, can move independently of the second anchor assembly 514 via the coupler 530 to a position where the first anchor assembly 512 can capture the second valve leaflet.

[0207] Referring to Figure 50, after the first and second anchor assemblies 512, 514 are closed, the fifth actuation line 658 and the sixth actuation line 664 can be removed by frosting the fifth actuation line 658 and the sixth actuation line 664 out of the lateral passage 590 of the outer paddle 550, or by removing the actuation lines and pulling out the tube 660. The first anchor assemblies 512 and the second anchor assemblies 514 remain attached to the joint element 510 via the first actuation line 650, the second actuation line 652, the third actuation line 654, and the fourth actuation line 656.

[0208] Referring to Figures 51-52, before the removal of the first, second, third, and fourth actuation lines 650, 652, 654, and 656, the coupler 530 may be pulled out from the longitudinal passage 528 (e.g., not screwed in from the female thread 536 of the longitudinal passage 528) and replaced with the connecting element 674 (e.g., a pin, wire, shaft, tube, rod, pusher, etc.). As shown in Figure 51, once the first anchor assembly 512 and the second anchor assembly 514 are attached to the joint element 510, the longitudinal passage 528 of the joint element 510 aligns with the respective longitudinal passages 648 of the alignment member 556.

[0209] The connecting element 674 can be configured in various ways. Any configuration can be used that can fasten the joining element 510, the first anchor assembly 512, and the second anchor assembly 514 together. Referring to Figure 31, in the illustrated embodiment, the connecting element 674 is a cylindrical rod having a distal end 676 and a proximal end 678 opposite the distal end 676. The distal end 676 includes a male thread 680, and the proximal end 678 includes an enlarged head 682. The connecting element 674 has a length LC configured to extend from the proximal end 520 of the joining element 510, through the joining element 510, through the alignment member 556 on the second anchor assembly 514, and into the alignment member 556 on the first anchor assembly 512.

[0210] In some implementations, the longitudinal passage 648 in the alignment member 556 on the first anchor assembly 512 includes a female thread 684 (Figure 51) configured to engage with a male thread 680 on the connecting element 674. As shown in Figure 52, the connecting element 674 is received through the longitudinal passage 528 (Figure 51) and the longitudinal passage 648 of the alignment member 556 on the second anchor assembly 514, and is screwed into the longitudinal passage 648 of the alignment member 556 of the first anchor assembly 512 until the head 682 of the connecting element 674 abuts against the joining element 510.

[0211] In some implementations, the connecting elements can be omitted, and the components of the ported device 500 can be fixed together with one or more of the lines 650, 652, 654, and 656. For example, the components of the ported device 500 can be fixed together by applying tension to the lines 650, 652, 654, and / or 656 to fix them together in a taught state (e.g., by locking, anchoring, or tying), and then by cutting the lines 650, 652, 654, and 656.

[0212] In some implementations, the connecting element 674 is made from a bioabsorbable material. The bioabsorbable material can take on a wide variety of different forms. The bioabsorbable material can be a bioabsorbable polymer such as polyurethane, poly(D,L) lactide, poly(lactic acid-co-glycol) acid, poly(α-hydroxy acid), cross-linked polyester hydrogel, poly(orthoester), polyanhydride, and polyethylene glycol. The bioabsorbable material may also be any synthetic material that can be used in the valve therapeutic device 500, which degrades over time within the heart and is optionally replaced by tissue over a period of time due to the presence of the device in the blood.

[0213] Referring to Figure 53, when the connecting element 674 installs and secures the joint element 510, the first anchor assembly 512, and the second anchor assembly 514 together, the first actuation line 650, the second actuation line 652, the third actuation line 654, and the fourth actuation line 656 may be fluted from the lateral passages 576, 542, 578, and 574 in the inner paddle 552 and from the lateral passages 546, 542, 548, and 544 in the joint element 510, respectively. Figures 49-53 show the pipe 660 and the fifth and sixth actuation lines 658, 664 which are removed before the coupler 530 is replaced by the connecting element 674, but it should be understood that the coupler 530 can be replaced by the connecting element 674 before the pipe 660 and the fifth and sixth actuation lines 658, 664 are removed. The device 500 is assembled with the connecting element 674 securing the joint element 510, the first anchor assembly 512, and the second anchor assembly 514 together, and with the first, second, third, and fourth actuation lines 650, 652, 654, and 656 removed.

[0214] Referring to Figure 54, the device 500 is illustrated with a bioabsorbable portion (i.e., a bonding element 510, an alignment member 556, and a connecting element 674) that defines the central portion 516 of the removed device 500. Over time, the bioabsorbable portion of the implanted device 500 decomposes and is replaced by tissue growth. The remaining portion of the device after the bioabsorbable portion has decomposed is the first and second anchor assemblies 512, 514. An advantage of the device 500 having a central portion 516 defined by a bioabsorbable portion is that if the device 500 needs to be removed in the future, the first and second anchor assemblies 512, 514 can be separated by cutting the endografted tissue that defines the central portion 516 of the device, since the tissue has replaced the bioabsorbable portion of the implanted device 500.

[0215] Implanted valve therapeutic / repair devices, such as the exemplary devices described herein, which are fixed to the leaflets of a natural heart valve via anchor assemblies, may require removal and / or disassembly to facilitate follow-up therapies, such as transcatheter valve replacement. That is, a transcatheter replacement valve may not be able to be placed in the natural valve when the leaflets are connected by an existing device. To allow the leaflets to expand during replacement valve placement, devices such as the implantable therapeutic and / or repair devices of this disclosure may be configured to be separable or separable so that the anchor assemblies attached to each of the valve leaflets are no longer joined together, and / or so that the leaflets and anchor assemblies can expand during replacement valve placement.

[0216] Referring here to Figures 55–74, various valve treatment and / or repair devices are shown that can be isolated as desired, for example, after implantation. Any of the implantable devices described herein may incorporate the features of the devices shown in Figures 55–74, i.e., these may be added to the aforementioned prior devices.

[0217] Referring here to Figure 55, the transplanted device 700 is shown in a separated state to allow for the transplantation of another device or replacement valve. Device 700 may have the same or similar configuration as device 100 described above. In some implementations, device 700 includes a base 702, a connecting portion 704, a first anchor assembly 706, and a second anchor assembly 708.

[0218] In some implementations, each anchor assembly 706, 708 includes a gripping member 710 for securing the anchor assembly 706, 708 to one of the valve leaflets 20, 22. As can be seen in Figure 55, the second anchor assembly 708 is separated from the base 702, which can be achieved by any of the techniques described herein. Separating the second anchor assembly 708 from the base 702 allows the second anchor assembly 708 to move freely relative to the leaflet 22 to which it is attached. In some implementations, the remaining components of the device 700, namely the base 702, the joint portion 704, and the first anchor portion 706, move freely relative to the other leaflets 20. In other words, separating the second anchor assembly 708 from the base 702 allows the leaflets 20, 22 to move in their unprocessed state. As a result, leaflets 20 and 22 may be captured by different implantable valve treatment devices or spread by the implantation of replacement valves.

[0219] Referring here to Figure 56, the previously transplanted exemplary device 800 is shown separated to allow for the transplantation of another device or replacement valve. Device 800 may have the same or similar configuration as devices 100, 700 described above. In some implementations, device 800 includes a base 802, a first anchor assembly 804, and a second anchor assembly 806. In some implementations, as shown here, device 800 does not include a connecting element such as the connecting element 704 of device 700 shown in Figure 55.

[0220] In some implementations, each anchor assembly 804, 806 includes a gripping member 808 for securing the anchor assembly 804, 806 to one of the valve leaflets 20, 22. As can be seen in Figure 56, the second anchor assembly 806 is separated from the base 802, which can be achieved by any of the techniques described herein. Separating the second anchor assembly 806 from the base 802 allows the second anchor assembly 806 to move freely with respect to the leaflet 22 to which the second anchor assembly 806 is attached. The remaining components of the device 800, namely the base 802 and the first anchor portion 804, move freely with respect to the other leaflets 20. In other words, separating the second anchor assembly 806 from the base 802 allows the leaflets 20, 22 to move in their unprocessed state. As a result, the leaflets 20, 22 can be captured by different implantable valve treatment devices or spread by implantation of replacement valves.

[0221] Referring here to Figures 57-59, an implantable valve therapy device 900 is shown. The device 900 may be configured to include any configuration of any other valve therapy device described herein. In some implementations, the device 900 includes a base 902 which optionally includes a spacer or bonding element not shown. The optional spacer may be any suitable spacer, such as the spacers and bonding elements described herein.

[0222] In some implementations, device 900 includes a first anchor assembly 904 and a second anchor assembly 906. In some implementations, the first anchor assembly 904 is attached to the base 902 by a first connecting member 908, and the second anchor assembly 906 is attached to the base 902 by a second connecting member 910. In some implementations, each of the first and second anchor assemblies 904 and 906 includes a gripping member 912 for securing the anchor assemblies 904 and 906 to one of the valve leaflets 20 and 22.

[0223] In some implementations, the first connecting member 908 and the second connecting member 910 may be formed from any suitable material or component for attaching the anchor assemblies 904, 906 to the base. For example, as shown in Figures 57-59, the first and second connecting members 908, 910 may take the form of sutures routed through one or more mounting openings 914 of the base 902 and around the mounting portions 916 of the anchor assemblies 904, 906.

[0224] In some implementations, to facilitate the separation of one of the anchor assemblies 904, 906 from the base 902, one of the connecting members 908, 910 may be formed from a polymer material embedded with a high-frequency reactive material, such as iron oxide. In some implementations, upon exposure to a radio frequency field, the radio frequency reactive material heats up, melting the polymer material of the connecting members 908, 910, thereby separating the attached anchor assemblies 904, 906 from the base 902.

[0225] In the illustrated examples shown in Figures 57-59, the first connecting member 908 does not contain high-frequency reactive material and / or is formed integrally with the base 902 and the first anchor assembly 904. In some implementations, the second connecting member 910 is formed from polymer sutures embedded with high-frequency reactive material. As shown in Figure 59, when the second connecting member 910 is exposed to a radio frequency field so that the polymer sutures melt, the second anchor assembly 906 is detached from or removed from the base 902, while the first anchor assembly 904 remains connected to and attached to the base 902. In this way, elements of the device 900 are prevented from being detached from the valve leaflets 20, 22 gripped by the gripping member 912, even though the device 900 itself is separated into two parts.

[0226] Following the removal of the second anchor assembly 906 from the base 902, a new portable valve repair device or portable valve replacement can be installed between the valve leaflets.

[0227] Referring here to Figures 60-68, an implantable valve treatment device 1000 is shown. The device 1000 may be configured to include any configuration of any other valve treatment device described herein. In some embodiments, the device 1000 includes a base 1002 which optionally includes a spacer or bonding element not shown. The optional spacer may be any suitable spacer, such as the spacers and bonding elements described herein.

[0228] In some implementations, device 1000 includes a first anchor assembly 1004 and a second anchor assembly 1006. In some implementations, the first anchor assembly 1004 is attached to the base 1002 at a first mounting position 1008, and the second anchor assembly 1006 is attached to the base 1002 at a second mounting position 1010.

[0229] In some implementations, the first and second anchor assemblies 1006, 1008 may be configured to be attached to the first and second mounting positions 1008, 1010 of the base 1002 by any suitable method. For example, the first and second anchor assemblies 1006, 1008 may be formed integrally with the base 1002, or may be fixed to the base 1002 via adhesive, or may be embedded in the base 1002. Each of the first and second anchor assemblies 1004, 1006 includes a gripping member 1012 for fixing the anchor assembly 1004, 1006 to one of the valve leaflets 20, 22.

[0230] Referring here to Figure 61, the second anchor assembly 1006 is shown separated from the base 1002, similar to the devices 800 and 900 shown in Figures 55-59. The base 1002 may be formed from any suitable material, such as a polymer material partially embedded with a radio frequency reactive material 1020 similar to the second connecting member 910 described herein.

[0231] Referring now to Figures 62-63, different arrangements of the radio frequency reactive material 1020 within the base 1002 are shown. Each of the arrangements of the base 1002 shown in Figures 62-63 is configured to separate one or both of the first anchor assembly 1004 and the second anchor assembly 1006 from the base 1002.

[0232] In some implementations, the base 1002 in Figure 62 includes a radio frequency reactive material 1020 embedded throughout the polymer base 1002 such that exposure to a radio frequency field raises the temperature of the entire base 1002, resulting in the melting of the material of the base 1002 as well as the first and second mounting positions 1008 and 1010, thereby separating both the first anchor assembly 1004 and the second anchor assembly 1006. In the embodiment of Figure 63, the radio frequency reactive material 1020 is embedded in the second mounting position 1010 such that exposure to a radio frequency field raises the temperature of the second mounting position 1010, resulting in the melting of the material at the second mounting position 1010, separating the second anchor assembly 1006 from the base 1002.

[0233] Referring here to Figures 64-65, the radio frequency-responsive material 1020 embedded in the base 1002 is shown as an antenna 1022 whose temperature rises when exposed to a radio frequency field. The antenna 1022 may be tuned to respond to a specific radio frequency or a range of radio frequencies. Each of the base 1002 arrangements shown in Figures 64-65 is configured to separate one or both of the first anchor assembly 1004 and the second anchor assembly 1006 from the base 1002.

[0234] In some implementations, the base 1002 in Figure 64 includes an antenna 1022 embedded throughout the polymer base 1002 such that exposure to a radio frequency field increases the temperature of the entire base 1002, causing both the material of the base 1002 and the first and second mounting positions 1008 and 1010 to melt, thereby separating both the first anchor assembly 1004 and the second anchor assembly 1006. In Figure 65, the antenna 1022 is embedded in the second mounting position 1010 such that exposure to a radio frequency field increases the temperature of the second mounting position 1010 so that the material of the second mounting position 1010 melts, separating the second anchor assembly 1006 from the base 1002.

[0235] Referring here to Figures 66-68, the base 1002 is shown as being divided into two parts: a first mounting position 1008 located within the first part 1014 of the base 1002, and a second mounting position 1010 located within the second part 1016 of the base 1002. After division, the first anchor assembly 1004 and first piece 1014 of the base 1002, and the second anchor assembly 1006 and second piece 1016 of the base 1002, move together with the attached leaflets 20 and 22, but independently of each other.

[0236] In some implementations, in order to achieve the division of the base 1002 into first and second pieces 1014, 1016, the base 1002 is formed from a preferred material such as a polymer material, at least partially embedded with a radio frequency reactive material 1020 along the central portion 1018. Referring here to Figures 67-68, different forms of the radio frequency reactive material 1020 within the base 1002 are shown.

[0237] Each of the base 1002 arrangements shown in Figures 67-68 is configured to separate the base 1002 into a first piece 1014 and a second piece 1016. In some implementations, the base 1002 in Figure 67 includes a radio frequency-responsive material 1020 embedded throughout the base 1002 in a central portion 1018, so that exposure to a radio frequency field increases the temperature of the central portion 1018, causing the material in the central portion 1018 to melt, thereby separating the base 1002 into first and second pieces 1014, 1016, each containing its respective anchor assemblies 1004, 1006. In the embodiment of Figure 68, the radio frequency-responsive material 1020 embedded in the central portion 1018 is shown as an antenna 1022 whose temperature rises when exposed to a radio frequency field. The antenna 1022 may be tuned to respond to a specific radio frequency or range of radio frequencies. The temperature rise of the antenna 1022 after exposure to the radio frequency field melts the material of the central portion 1018 of the base 1002, separating the base 1002 into first and second pieces 1014, 1016, which include their respective anchor assemblies 1004, 1006.

[0238] Referring here to Figures 69-74, an implantable valve treatment device 1100 is shown. The device 1100 may be configured to include any of the configurations of other valve treatment devices described herein. In some implementations, the device 1100 includes a first anchor assembly 1102 and a second anchor assembly 1104. In some implementations, each of the first and second anchor assemblies 1102, 1104 includes a gripping member 1106 for securing the respective anchor assembly 1102, 1104 to one of the natural leaflets 20, 22.

[0239] In some implementations, the first anchor assembly 1102 includes a first connecting member 1108, and the second anchor assembly 1104 includes a second connecting member 1110. In some implementations, the first and second connecting members 1108 and 1110 facilitate the creation of connections between the first and second anchor assemblies 1102 and 1104 after they have been attached to the natural leaflets 20 and 22, respectively.

[0240] The first and second connecting members 1108 and 1110 may be formed from any suitable material or mechanism that enables the formation of a connection between the first and second anchor assemblies 1102 and 1104 after each of the first and second anchor assemblies 1102 and 1104 has been attached to one of the natural leaflets 20 and 22, respectively. For example, in the illustrated example, the first connecting member 1108 is formed from the hook side of the hook-and-loop fastener, and the second connecting member 1110 is formed from the loop side of the hook-and-loop fastener. In another embodiment, each of the connecting members 1108 and 1110 includes both the hook-and-loop and loop sides of the hook-and-loop fastener.

[0241] Referring here to Figures 69-73, the process of attaching the device 1100 to the natural leaflets 20, 22 is shown. Referring here to Figures 69-70, the first and second anchor assemblies 1102, 1104 are each attached separately to the natural leaflets 20, 22. In particular, Figure 69 shows the first anchor assembly 1102, which is delivered into the natural valve by the delivery system 1112 and attached to one of the natural leaflets 20. In the embodiment of Figure 70, the second anchor assembly 1104 is delivered into the natural valve by the delivery system 1112 and attached to the other natural leaflet 22.

[0242] The delivery system 1112 may be any suitable delivery system such as the delivery systems described in this disclosure. In some implementations, the first anchor assembly 1104 may be delivered via a catheter 1114 and secured in place via a tool 1116 that compresses the gripping member 1106 onto the leaflets 20, 22. In some embodiments, the gripping member 1106 may be biased in a closing direction and may be opened and held, for example, by an actuating member of the delivery system 1112.

[0243] In some embodiments, the actuating member may be used to open the gripping member 1106 and position the gripping member 1106, such that the gripping member 1106 can be closed by releasing the actuating member, thereby capturing the leaflets 20, 22 by the gripping member 1106 and securing the anchor assemblies 1102, 1104 to the leaflets 20, 22.

[0244] In some embodiments, after implantation of the first and second anchor assemblies 1102, 1104, the closing of the shrinking leaflets 20, 22 causes the first connecting member 1108 to contact the second connecting member 1110, such that the surface fastener can form an initial connection between the first anchor assembly 1102 and the second anchor assembly 1104, as shown in FIG. 71. In some embodiments, during subsequent pulsations of the heart, the closing of the native valve cusp further engages the first connecting member 1108 and the second connecting member 1110 until the first anchor assembly 1102 is almost or fully connected to the second anchor assembly 1104, as shown in FIG. 72.

[0245] Referring now to FIG. 73, any attachment tool 1116 can be delivered to the ventricular side of the native valve to further compress the first and second anchor assemblies 1102, 1104 together to ensure that the first and second connecting members 1108, 1110 are fully engaged. (In some implementations, the attachment tool 1116 can be inserted through the opening of the native valve and reach the device 1100 from the ventricular side of the valve.) In some embodiments, the connecting members 1108, 1110 may be configured to include a bioabsorbable portion that ultimately degrades and is replaced by in - tissue growth.

[0246] In some embodiments, the device 1110 can be separated after implantation to enable the delivery and implantation of a new valve therapy device or replacement valve. In some implementations, to facilitate separation of the first and second anchor assemblies 1102, 1104, a separation tool 1118 can be positioned by a delivery system 1112 to separate the first connecting member 1108 from the second connecting member 1110. The separation tool 1118 can have any suitable shape, such as the wedge shape shown in FIG. 74, for example.

[0247] [Examples] Example 1 A valve therapy device comprising: a joining member; a first anchor assembly connected to a first side of the joining element and configured to grip a first leaflet of a native heart valve; a second anchor assembly connected to a second side of the joining element and configured to grip a second leaflet of the native heart valve; and a bioabsorbable central portion between the first anchor assembly and the second anchor assembly, the bioabsorbable central portion including the joining element.

[0248] Example 2. The valve therapy device according to Example 1, wherein the bioabsorbable central portion further comprises a first alignment member associated with the first anchor assembly and a second alignment member associated with the second anchor assembly.

[0249] Example 3. The valve treatment device according to Example 2, wherein the bioabsorbable central portion further comprises a connecting element configured to connect the joining element, the first anchor assembly, and the second anchor assembly together.

[0250] Example 4. The valve treatment device according to Example 3, wherein the connecting element is screwed into at least one of the first alignment member and the second alignment member.

[0251] Example 5. The valve treatment device according to Example 3 or 4, wherein the connecting element extends through a first longitudinal passage in the joining element, a second longitudinal passage in the first alignment member, and into a third longitudinal passage in the second alignment member.

[0252] Example 6. A valve treatment device according to any one of Examples 2 to 5, wherein the first anchor assembly includes a first internal paddle, the second anchor assembly includes a second internal paddle, the first alignment member is attached to the first internal paddle, and the second alignment member is attached to the second internal paddle.

[0253] Example 7. The valve treatment device according to Example 6, wherein, in the assembled state, the first alignment member engages with the second inner paddle, and the second alignment member engages with the first inner paddle.

[0254] Example 8. A valve treatment device according to any one of Examples 2 to 7, wherein the first alignment member and the second alignment member are each formed as rectangular blocks.

[0255] Example 9. The valve treatment device according to any one of Examples 1 to 7, wherein the joining element includes a plurality of lateral passages used to pass actuation lines connected to the first anchor assembly and the second anchor assembly during deployment of the valve treatment device.

[0256] Example 10. The valve treatment device according to Example 9, wherein the plurality of lateral passages include a pair of first lateral passages for passing a first actuation line connecting the first anchor assembly to the joint element, and a pair of second lateral passages for passing a second actuation line connecting the first anchor assembly to the joint element.

[0257] Example 11. The valve treatment device according to Example 10, wherein the plurality of lateral passages include a pair of third lateral passages for passing a third operating line connecting the second anchor assembly to the joint element, and a pair of fourth lateral passages for passing a fourth operating line connecting the second anchor assembly to the joint element.

[0258] Example 12. The valve treatment device according to any one of Examples 1 to 11, wherein the first anchor assembly comprises an inner paddle and an outer paddle connected to the inner paddle by a bendable portion, the outer paddle being movable between an open and a closed position relative to the inner paddle.

[0259] Example 13. The valve treatment device according to Example 12, wherein the first anchor assembly further comprises a gripping member having a fixed arm attached to the outer paddle and a movable arm connected to the fixed arm by a joint portion, the movable arm being movable between an open state and a closed state relative to the fixed arm.

[0260] Example 14. The valve treatment device according to any one of Examples 1 to 13, wherein the first anchor assembly is operable between an open state and a closed state independently of the second anchor assembly.

[0261] Example 15. The valve therapy device according to any one of Examples 1 to 14, wherein the first anchor assembly is connected to the joint element by a plurality of actuation lines during deployment of the valve therapy device.

[0262] Example 16. The valve treatment device according to Example 15, wherein during deployment of the valve treatment device, a first anchor assembly is selectively engageable and disengagable with the joining element while remaining connected to the joining element by a plurality of operating lines.

[0263] Example 17. The valve treatment device according to Example 16, wherein when the first anchor assembly is disengaged from the joining element, the joining element and the second anchor assembly are movable relative to the first anchor assembly.

[0264] Example 18. A method of repairing a natural heart valve, comprising: connecting a first anchor assembly to a joining element by a first operating line; connecting a second anchor assembly to the joining element by a second operating line; placing a valve treatment device on the natural heart valve; attaching the first anchor assembly of the valve treatment device to a first valve leaflet of the natural heart valve; attaching the second anchor assembly of the valve treatment device to a second valve leaflet of the natural heart valve; attaching the first anchor assembly and the second anchor assembly to the joining element by a connecting element; removing the first operating line and the second operating line.

[0265] [[ID=二十六]]Example 19. The method according to Example 18, further comprising delivering the valve treatment device through a lumen of a catheter in which the first anchor assembly, the second anchor assembly, and the joining element are axially aligned within the lumen to position the valve treatment device on the natural heart valve.

[0266] Example 20. The method according to Example 18 or 19, wherein connecting the first anchor assembly to the joint element by the first actuation line further comprises passing the first actuation line through a first pair of lateral passages within the joint element.

[0267] Example 21. The method of Example 20, wherein connecting the second anchor assembly to the joint element by the second actuation line further comprises passing the second actuation line through a second pair of lateral passages within the joint element.

[0268] Example 22. The method according to Example 20 or 21, further comprising connecting the first anchor assembly to the joint element by a third actuation line, and passing the third actuation line through a third pair of lateral passages within the joint element.

[0269] Example 23. The method according to Example 21, further comprising connecting a second anchor assembly to a joint element by a fourth actuation line, and passing the fourth actuation line through a fourth pair of lateral passages within the joint element.

[0270] Example 24. The method according to any one of Examples 18 to 23, further comprising applying tension to the first working line to engage the first anchor assembly with the connecting element.

[0271] Example 25. The method of Example 24, further comprising applying tension to the second working line to engage the second anchor assembly with the connecting element.

[0272] Example 26. The method of Example 25, further comprising attaching the first anchor assembly and the second anchor assembly to the joint element by the connecting element, wherein the connecting element is received in a first longitudinal passage of the joint element, a second longitudinal passage related to the first anchor assembly, and a third longitudinal passage related to the second anchor assembly.

[0273] Example 27. The method of Example 26, further comprising screwing the connecting element into at least one of the second longitudinal axial passage and the third longitudinal axial passage.

[0274] Example 28. The method according to any one of Examples 18 to 27, wherein the attachment of the first anchor assembly to the first valve leaflet is completed with the first anchor assembly disengaged from the joint element.

[0275] Example 29. The method according to Example 28, further comprising: attaching the second anchor assembly of the valve treatment device to the second valve leaflet by engaging the second anchor assembly with a connecting element and moving the connecting element to move the second anchor assembly to a predetermined position for attachment to the second valve leaflet.

[0276] Example 30. The method according to any one of Examples 18 to 29, wherein the connecting element and the connecting element are bioabsorbable.

[0277] Example 31. Valve treatment system, A delivery system including a catheter and a control handle, A valve treatment device connected to the delivery system, Joining member and A first anchor assembly connected to a first side surface of the joint element, configured to grip a first leaflet of a natural heart valve, A second anchor assembly connected to a second side surface of the joint element, wherein the second anchor assembly is configured to grip a second leaflet of the natural heart valve, A valve treatment system comprising: a bioabsorbable central portion between the first anchor assembly and the second anchor assembly, wherein the bioabsorbable central portion includes the connecting element.

[0278] Example 32. The valve treatment system according to Example 31, wherein the bioabsorbable central portion further comprises a first alignment member associated with the first anchor assembly and a second alignment member associated with the second anchor assembly.

[0279] Example 33. The valve treatment system according to Example 32, wherein the bioabsorbable central portion further comprises a connecting element configured to connect the joining element, the first anchor assembly, and the second anchor assembly together.

[0280] Example 34. The valve treatment system according to Example 33, wherein the connecting element is screwed into at least one of the first alignment member and the second alignment member.

[0281] Example 35. The valve treatment system according to Example 33 or 34, wherein the connecting element extends through a first longitudinal passage in the joining element, a second longitudinal passage in the first alignment member, and into a third longitudinal passage in the second alignment member.

[0282] Example 36. A valve treatment system according to any one of Examples 32 to 35, wherein the first anchor assembly includes a first internal paddle, the second anchor assembly includes a second internal paddle, the first alignment member is attached to the first internal paddle, and the second alignment member is attached to the second internal paddle.

[0283] Example 37. The valve treatment system according to Example 36, wherein, in the assembled state, the first alignment member engages with the second inner paddle, and the second alignment member engages with the first inner paddle.

[0284] Example 38. A valve treatment system according to any one of Examples 32 to 37, wherein the first alignment member and the second alignment member are each formed as rectangular blocks.

[0285] Example 39. A valve treatment system according to any one of Examples 31 to 37, wherein the joining element includes a plurality of lateral passages used to pass actuation lines connected to the first anchor assembly and the second anchor assembly during deployment of the valve treatment device.

[0286] Example 40. The valve treatment system according to Example 39, wherein the plurality of lateral passages include a first pair of lateral passages for passing a first actuation line connecting the first anchor assembly to the joint element, and a second pair of lateral passages for passing a second actuation line connecting the first anchor assembly to the joint element.

[0287] Example 41. The valve treatment system according to Example 40, wherein the plurality of lateral passages include a pair of third lateral passages for passing a third operating line connecting the second anchor assembly to the joint element, and a pair of fourth lateral passages for passing a fourth operating line connecting the second anchor assembly to the joint element.

[0288] Example 42. A valve treatment system according to any one of Examples 31 to 41, wherein the first anchor assembly comprises an inner paddle and an outer paddle connected to the inner paddle by a bendable portion, the outer paddle being movable between an open and a closed position relative to the inner paddle.

[0289] Example 43. The valve treatment system according to Example 42, wherein the first anchor assembly further comprises a gripping member having a fixed arm attached to the outer paddle and a movable arm connected to the fixed arm by a joint portion, the movable arm being movable between an open state and a closed state relative to the fixed arm.

[0290] Example 44. A valve treatment device according to any one of Examples 31 to 43, wherein the first anchor assembly is operable between an open state and a closed state independently of the second anchor assembly.

[0291] Example 45. A valve therapy device according to any one of Examples 31 to 44, wherein the first anchor assembly is connected to the joint element by a plurality of actuation lines during deployment of the valve therapy device.

[0292] Example 46. The valve treatment device according to Example 45, wherein, during the deployment of the valve treatment device, the first anchor assembly remains connected to the joint element by a plurality of working lines and can selectively engage with and disengage from the joint element.

[0293] Example 47. The valve treatment device according to Example 46, wherein the joint element and the second anchor assembly are movable relative to the first anchor assembly when the first anchor assembly is disengaged from the joint element.

[0294] Example 48. Valve treatment device, The base and, A first anchor assembly connected to the first side surface of the base, configured to grip the first leaflet of a natural heart valve, A second anchor assembly connected to a second side surface of the base, wherein the second anchor assembly is configured to grip a second leaflet of the natural heart valve, A valve treatment device comprising a connecting member containing a radio frequency reactive material, wherein the connecting member connects at least the second anchor assembly to the base.

[0295] Example 49. The valve treatment device according to Example 48, wherein the base further comprises a connecting member.

[0296] Example 50. The valve treatment device according to Example 48 or Example 49, wherein the connecting member is a polymer suture embedded with a high-frequency reactive material.

[0297] Example 51. A valve treatment device according to any one of Examples 48 to 50, wherein the base and the connecting member are formed as a single component.

[0298] Example 52. The valve treatment device according to Example 51, wherein the base is formed from a polymer material, and a high-frequency reactive material is embedded in the connection portion of the base which is connected to the second anchor assembly.

[0299] Example 53. A valve treatment device according to any one of Examples 48 to 52, wherein the high-frequency reactive material is embedded in the central portion of the base.

[0300] Example 54. A valve treatment device according to any one of Examples 48 to 52, wherein the radio frequency reactive material is an antenna.

[0301] Example 55. A method for repairing a natural heart valve, The arrangement involves arranging a valve therapy device attached to the natural heart valve, wherein the valve therapy device comprises a first anchor assembly connected to a first side of the base and a first valve leaflet of the natural heart valve, a second anchor assembly connected to a second side of the base and a second valve leaflet of the natural heart valve, and a connecting member connecting at least the second anchor assembly to the base, wherein the connecting member includes a radio frequency reactive material. By directing the radio frequency radiation toward the connecting member, the second anchor assembly is separated from the base, A method comprising positioning a replacement valve between the first valve leaflet and the second valve leaflet of the natural heart valve.

[0302] Example 56. The method according to Example 55, wherein the base further comprises a connecting member.

[0303] Example 57. The method according to Example 55 or Example 56, wherein the connecting member is a polymer suture embedded with a high-frequency reactive material.

[0304] Example 58. The method according to any one of Examples 55 to 57, wherein the base and the connecting member are formed as a single component.

[0305] Example 59. The method according to any one of Examples 55 to 58, wherein the base is formed from a polymer material and the high-frequency reactive material is embedded in the connection portion of the base which is connected to the second anchor assembly.

[0306] Example 60. The method according to any one of Examples 55 to 59, wherein the radio frequency reactive material is embedded in the central portion of the base.

[0307] Example 61. The method according to any one of Examples 55 to 60, wherein the radio frequency reactive material is an antenna.

[0308] Example 62. Valve treatment device, A first anchor assembly configured to grasp a first leaflet of a natural heart valve, wherein the first anchor assembly comprises a first connecting member, A second anchor assembly configured to grasp a second leaflet of the natural heart valve, wherein the second anchor assembly comprises a second connecting member, A valve treatment device in which the first connecting member comprises a hook portion of a hook-and-loop fastener, and the second connecting member comprises a loop portion of the hook-and-loop fastener.

[0309] Example 63. The valve treatment device according to Example 62, wherein the first connecting member comprises a loop portion of a hook-and-loop fastener, and the second connecting member comprises a hook portion of a hook-and-loop fastener.

[0310] Example 64. The valve treatment device according to either Example 62 or Example 63, wherein the first and second connecting members include a bioabsorbable material.

[0311] Example 65. A method for repairing a natural heart valve, Attaching a first anchor assembly to the first leaflet of the natural heart valve, wherein the first anchor assembly comprises a first connecting member, and the first connecting member comprises a hook portion of a hook-and-loop fastener. Attaching a second anchor assembly to a second leaflet of the natural heart valve, wherein the second anchor assembly comprises a second connecting member, and the second connecting member comprises a loop portion of the hook-and-loop fastener. The first anchor assembly is separated from the second anchor assembly using a separation tool, A method comprising positioning a replacement valve between the first valve leaflet and the second valve leaflet of the natural heart valve.

[0312] Example 66. The method of Example 65, further comprising the step of compressing the first anchor assembly relative to the second anchor assembly with an installation tool.

[0313] Example 67. The method according to Example 65 or Example 66, wherein the first connecting member comprises the loop portion of the hook-and-loop fastener, and the second connecting member comprises the hook portion of the hook-and-loop fastener.

[0314] Example 68. The method according to any one of Examples 65 to 67, wherein the first and second connecting members include a bioabsorbable material.

[0315] Any of the various systems, assemblies, devices, components, and equipment in this disclosure may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use in patients, and methods of this disclosure may include (or additional methods may include or consist of) sterilization of the relevant systems, devices, components, and equipment (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0316] While various inventive aspects, concepts, and configurations of this disclosure may be described and illustrated in combination in the examples of this disclosure, these various aspects, concepts, and configurations can be used individually or in various combinations and further in their subcombinations in many alternative examples. Unless expressly excluded in this disclosure, all such combinations and subcombinations are intended to be within the scope of this application. Furthermore, while alternative materials, structures, configurations, methods, devices, and components, as well as alternatives in terms of form, fit, function, or similarity, may be described in this disclosure with respect to various alternative examples relating to various aspects, concepts, and disclosures of this disclosure, such descriptions are not intended to be a complete or exhaustive list of available alternatives, whether currently known or to be developed later. A person skilled in the art will readily be able to adopt one or more aspects, concepts, or configurations of the present invention in additional examples and uses within the scope of this application, even if such examples are not expressly disclosed in this disclosure.

[0317] In addition, even if some configurations, concepts, or aspects of the present disclosure are described in the present disclosure as preferred configurations or methods, such descriptions are not intended to imply that such configurations are essential or necessary unless expressly stated so. Furthermore, although exemplary or representative values ​​and ranges may be included to aid in understanding the present application, such values ​​and ranges are not intended to be constrained and are intended to be only significant when expressly stated.

[0318] Furthermore, while various aspects, configurations, and concepts may be expressly identified in this disclosure as inventive or as forming part of the disclosure, such identification is not intended to be exclusive. Rather, there may be inventive aspects, concepts, and configurations that are not expressly identified or expressed as part of a particular disclosure but are fully described herein and are instead described in the appended claims. Descriptions of exemplary methods or processes are not limited to including all steps as essential in all cases, and the order in which multiple steps are presented is not to be construed as essential or indispensable unless expressly stated. The terms used in the claims are to have their entirely ordinary meanings and are not in any way limited by the descriptions of embodiments herein.

Claims

1. A valve treatment device, Joining elements, A first anchor assembly connected to the first side surface of the joint element, configured to grip the first leaflet of a natural heart valve, A second anchor assembly connected to a second side surface of the joint element, wherein the second anchor assembly is configured to grip a second leaflet of the natural heart valve, A valve treatment device comprising a bioabsorbable central portion between the first anchor assembly and the second anchor assembly, wherein the bioabsorbable central portion includes the connecting element.

2. The valve treatment device according to claim 1, wherein the bioabsorbable central portion further comprises a first alignment member associated with the first anchor assembly and a second alignment member associated with the second anchor assembly.

3. The valve treatment device according to claim 2, wherein the bioabsorbable central portion further comprises a connecting element configured to connect the joining element, the first anchor assembly, and the second anchor assembly together.

4. The valve treatment device according to claim 3, wherein the connecting element is screwed into at least one of the first alignment member and the second alignment member.

5. The valve treatment device according to claim 3, wherein the connecting element extends through a first longitudinal passage in the joining element, a second longitudinal passage in the first alignment member, and into a third longitudinal passage in the second alignment member.

6. The valve treatment device according to claim 1, wherein the connecting element comprises a plurality of lateral passages used to route the actuation lines connected to the first anchor assembly and the second anchor assembly during deployment of the valve treatment device.

7. The valve treatment device according to claim 6, wherein the plurality of lateral passages include a first pair of lateral passages for passing a first working line connecting the first anchor assembly to the joint element, and a second pair of lateral passages for passing a second working line connecting the first anchor assembly to the joint element.

8. The valve treatment device according to claim 7, wherein the plurality of lateral passages include a pair of third lateral passages for passing a third operating line connecting the second anchor assembly to the joint element, and a pair of fourth lateral passages for passing a fourth operating line connecting the second anchor assembly to the joint element.

9. The valve treatment device according to claim 1, wherein the first anchor assembly comprises an inner paddle and an outer paddle connected to the inner paddle by a bendable portion, the outer paddle being movable between an open state and a closed state relative to the inner paddle.

10. The valve treatment device according to claim 9, wherein the first anchor assembly further comprises a gripping member having a fixed arm attached to the outer paddle and a movable arm connected to the fixed arm by a joint portion, the movable arm being movable between an open state and a closed state relative to the fixed arm.

11. A valve treatment device, The base and, A first anchor assembly connected to the first side surface of the base, configured to grip the first leaflet of a natural heart valve, A second anchor assembly connected to the second side surface of the base, wherein the second anchor assembly is configured to grip the second leaflet of the natural heart valve, A valve treatment device comprising a connecting member containing a high-frequency reactive material, wherein the connecting member connects at least the second anchor assembly to the base.

12. The valve treatment device according to claim 11, wherein the base further comprises a connecting member.

13. The valve treatment device according to claim 11, wherein the connecting member is a polymer suture embedded with the high-frequency reactive material.

14. The valve treatment device according to claim 11, wherein the base and the connecting member are formed as a single component.

15. The valve treatment device according to claim 14, wherein the base is formed from a polymer material, and the high-frequency reactive material is embedded in the connection portion of the base that is connected to the second anchor assembly.

16. The valve treatment device according to claim 11, wherein the high-frequency reactive material is embedded in the central portion of the base.

17. The valve treatment device according to claim 11, wherein the high-frequency reactive material is an antenna.

18. A valve treatment device, A first anchor assembly configured to grasp a first leaflet of a natural heart valve, wherein the first anchor assembly comprises a first connecting member, A second anchor assembly configured to grip a second leaflet of the natural heart valve, the second anchor assembly comprising a second connecting member, A valve treatment device in which the first connecting member comprises a hook portion of a hook-and-loop fastener, and the second connecting member comprises a loop portion of the hook-and-loop fastener.

19. The valve treatment device according to claim 18, wherein the first connecting member comprises a second loop portion of the hook-and-loop fastener, and the second connecting member comprises a second hook portion of the hook-and-loop fastener.

20. The valve treatment device according to claim 18, wherein the first and second connecting members include a bioabsorbable material.

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