Heart valve repair devices and methods

Abstract

An implantable device is provided that is positioned within a heart valve using a delivery system including a catheter. The device can include leaflet anchors for attachment to the valve leaflets and one or more connectors that form a detachable connection between the anchors and the delivery system. A set of tethers is operable to move the anchors closer together and / or into contact after the connectors are detached, leaving the anchors separate from the delivery system. The device can optionally include a spacer positioned to be compressed by opposing surfaces of the anchors when the anchors are around the spacer.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 420,440, entitled "Heart Valve Repair Devices And Methods," filed October 28, 2022, to Bloodworth et al., which is incorporated herein by reference for all purposes. [Background technology]

[0002] A healthy heart has a generally conical shape that tapers from the apex to the base. The heart consists of four chambers through which blood flows. A natural human heart includes four chambers: two atria (upper chambers), i.e., the left and right atria, and two ventricles (lower chambers), i.e., the left and right ventricles. A wall, the septum, separates the right and left sides of the heart (i.e., each pair of chambers). Each of the four chambers has its own valve (the mitral valve, the tricuspid valve, the aortic valve, and the pulmonary valve, respectively) that prevents upstream (regurgitant) flow into that chamber.

[0003] On the right side of the heart, deoxygenated blood from the body is received in the right atrium and passes downstream (forward) through the tricuspid valve into the right ventricle. From the right ventricle, it is pumped downstream through the pulmonary valve to the lungs by the pulmonary artery, a vessel for blood with low oxygen levels. On the left side of the heart, oxygenated blood from the lungs is received in the left atrium and flows downstream through the mitral valve to the left ventricle. From the left ventricle, it is pumped downstream through the aortic valve to the rest of the body by the aorta, a vessel for oxygen-rich blood. During each heartbeat, there is a diastole (diastole), when the heart chambers relax and passively fill with blood, and a systole, when the heart contracts and pumps blood into the two vessels downstream of the ventricles (i.e., the pulmonary artery and the aorta). Systole includes atrial systole, when the atria contract to eject blood downstream from within the arteries into their respective ventricles, and ventricular systole, when the ventricles contract to eject blood downstream from within the ventricles into their respective downstream blood vessels.

[0004] Structurally, the tricuspid, aortic, and pulmonary valves have three leaflets, while the mitral valve has two leaflets (also known as cusps). In each case, the leaflets act as flaps that open and close to allow downstream (forward) blood flow when pressure urges blood forward through the valve and obstruct blood flow through the valve when pressure urges blood to flow upstream (backward) through the valve (as occurs for the mitral and tricuspid valves during ventricular contraction).

[0005] For example, the mitral valve, which connects the left atrium to the left ventricle, includes an annulus, which is a circular portion of valve tissue surrounding the mitral valve opening, and a pair of leaflets that extend downward from the annulus into the left ventricle. The mitral valve annulus may form a "D" shape, an ellipse, or other non-circular cross-sectional shape having a major axis and a minor axis. The anterior leaflet is larger than the posterior leaflet, so that when they close together, a generally "C"-shaped boundary may be formed between the abutting sides of the leaflets.

[0006] When the mitral valve is functioning properly, the anterior and posterior leaflets of the mitral valve function together as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. During atrial contraction, after the left atrium receives oxygenated blood from the pulmonary veins during diastole, the left atrial muscle contracts and the left ventricle expands (also referred to as "ventricular relaxation" or "diastole"), allowing the oxygenated blood collected in the left atrium to flow into the left ventricle. Then, during ventricular systole, the left atrial muscle relaxes and the left ventricular muscle contracts, resulting in increased blood pressure within the left ventricle, forcing the sides of the two valve leaflets together, thereby closing the one-way mitral valve and preventing blood from flowing back into the left atrium. Instead, this pressurized blood is expelled from the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure or from folding back through the mitral annulus into the left atrium, multiple fibrous cords called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle.

[0007] Native heart valves perform a critical function in ensuring adequate forward flow of blood supply through the cardiovascular system. Under abnormal circumstances, these heart valves may malfunction (e.g., damaged or otherwise malformed) and therefore become less effective due to congenital malformations, inflammatory processes, infectious conditions, disease, etc. Such malfunction can lead to serious cardiovascular damage or death. One form of malfunction is valvular regurgitation.

[0008] Valve regurgitation involves a valve improperly allowing some blood to flow in the wrong direction through the valve. For example, mitral regurgitation occurs when the mitral valve fails to close properly during ventricular contraction, allowing blood to flow upstream from the left ventricle into the left atrium. Similarly, tricuspid regurgitation occurs when the tricuspid valve fails to close properly during ventricular contraction, allowing blood to flow upstream from the right atrium into the right ventricle.

[0009] Mitral valve regurgitation is one of the most common forms of valvular heart disease. It can have many different causes, including leaflet prolapse, papillary muscle insufficiency, stretching of the mitral annulus due to left ventricular dilation, or a combination of these. Mitral regurgitation in the central portion of the valve leaflets can be referred to as central-jet mitral regurgitation, and mitral regurgitation closer to one of the leaflet commissures (i.e., where the leaflets meet) can be referred to as eccentric-jet mitral regurgitation. Central-jet regurgitation occurs when the leaflet edges do not meet in the middle, thus preventing valve closure and resulting in regurgitation. Regurgitation in any of the three-leaflet valves is likewise a serious form of heart disease with many different causes and characterized by various forms of valve dysfunction mechanisms.

[0010] Prior art Figure 1 shows a device for repairing the leaflets, e.g., anterior leaflet 20 and posterior leaflet 22, of a dysfunctional mitral valve MV. A catheter or catheter device 11 is positioned in the left atrium LA above the left ventricle LV. The catheter device is coupled to an implant 13. The implant can be positioned to repair the dysfunctional mitral valve MV.

[0011] While such devices offer significant potential for potentially life-saving repair, challenges remain. For example, one challenge is that when treating a beating heart, the valve leaflets move (both in shape and location) with the heart's ongoing motion. Thus, the repair device must navigate and operate relative to a moving target. Furthermore, one or both leaflets of a dysfunctional valve may be deformed and / or damaged. As a result, the leaflets may not regularly move to a position and configuration that is easily treatable by the repair device. Furthermore, two or three target leaflets may have an abnormally large gap between them, which may be tethered in an unnatural open position due to underlying structural changes (e.g., an enlarged ventricle), etc. Summary of the Invention

[0012] This Summary provides exemplary features and is not intended to limit the scope of the invention in any way. For example, any features included in an example of this Summary are not required by a claim unless the claim explicitly recites those features. Also, features, components, steps, concepts, etc. described in this Summary and in examples elsewhere in this disclosure can be combined in various manners. Various features and steps described elsewhere in this disclosure may be included in the examples summarized herein.

[0013] In some implementations, treatment or repair systems, devices, and related methods include assisting in treating or repairing native valves, including two- and three-cusp native heart valves. The devices herein can be valve repair devices, implantable devices, valve treatment devices, implants, treatment devices, etc. While similar configurations are sometimes described in the examples herein as implantable devices or valve repair devices for illustrative purposes, they can be used with other devices, such as treatment devices, removable devices, devices that are not necessarily implanted but can be removed after treatment, etc.

[0014] In some implementations, a device (e.g., a treatment device, repair device, valve repair device, implantable device, graft, valve treatment device, etc.) configured to be positioned within the native heart valve to enable the native heart valve to form a more effective seal is provided. The device can be part of a system (e.g., a treatment system, repair system, valve repair system, valve treatment system, etc.).

[0015] In some implementations, the device includes an anchor portion, in which one or more anchors of the anchor portion are movable between an open position and a closed position.

[0016] In some implementations, the device can be positioned within the heart valve using a delivery system including a catheter. In some implementations, the device can include a leaflet anchor for attachment to the valve leaflet and one or more connectors that form a separable or removable connection between the anchor and the delivery system. In some implementations, the one or more connectors are severable connectors that form a severable connection between the anchor and the delivery system.

[0017] In some implementations, the set of tethers is operable to move the anchors closer and / or into contact after the connectors are separated or detached, leaving the anchors separated from the delivery system. In some implementations, the device can optionally include a spacer positioned such that the spacer is compressed when around it by opposing surfaces of the anchors.

[0018] In some implementations, the system may include a transvascular delivery system including a steering catheter system and / or a transplantation catheter system. The system may also include a device (e.g., a treatment device, a repair device, a valve repair device, an implantable device, a graft, a valve treatment device, etc.) introduced via the transplantation catheter system. The transplantation catheter system may optionally be guided by the steering catheter system.

[0019] In some implementations, the device includes multiple anchors (e.g., leaflet anchors, tissue anchors, clips, clasps, toggle anchors, staples, rivets, darts, etc.) that attach to the tissue of the valve (e.g., one or more leaflets, annulus, etc.).

[0020] In some implementations, the device includes one or more connectors or severable connectors (e.g., a first anchor severable connector, a second anchor severable connector, and / or a third anchor severable connector) that form respective separable or severable connections (e.g., a first severable connection, a second severable connection, and / or a third severable connection) between the anchor and the delivery system or transplantation catheter system (e.g., a third anchor severable connector can form a third anchor severable connection).

[0021] In some implementations, the device includes a system, apparatus, or mechanism (e.g., a control tether system, tether system, tether mechanism, tether apparatus, joint system, actuation system, connection system, connection mechanism, connection apparatus, control system, etc.) that extendibly connects the first anchor to the delivery system or implantation catheter system. In some implementations, the system connects independently of the corresponding anchor connector for that anchor.

[0022] In some implementations, the system, device, or mechanism is operable to move each anchor closer to and / or into contact with other anchors (and / or other portions of the device, e.g., the central body) after the anchor connectors of each anchor are separated, thereby allowing the implantation catheter system to move away from the anchor attached to the leaflet and then more easily position one or more other anchors at other leaflets or leaflet locations.

[0023] In some implementations, the device can include an optional spacer or central body (e.g., an elastic spacer, filler, wedge, coaptation element, sheet, barrier, etc.). In some implementations, the spacer or central body is positioned so that it can be compressed by opposing surfaces of multiple anchors (e.g., leaflet anchors, tissue anchors, clips, clasps, rivets, etc.). In some implementations, the spacer or central body can form a flexible body with a functionally low flexible compressibility against occluded blood flow, such that its compression causes a dimensional expansion, thereby obstructing or inhibiting the retrograde flow of blood back through the valve.

[0024] In some implementations, various systems, apparatus, devices, etc. herein may be configured to allow the delivery or transfer catheter to be coupled or recoupled to the anchor, central body, or other component after the anchor, central body, or other component has been detached from the delivery or transfer catheter. This may be done using a tether or similar device that allows freedom of movement in the detached state, but can be used (e.g., tensioned, etc.) to bring the delivery / transfer catheter back into contact with the anchor, central body, or other component. In some implementations, after recoupling, the delivery or transfer catheter can be used to (1) remove the anchor, central body, or other component from a first location and / or (2) reposition and / or attach the anchor, central body, or other component to a second location (different from the first location) (e.g., a different tissue location).

[0025] In some implementations, a treatment / repair system for treating / repairing a subject's native valve (e.g., a living subject, a simulation, etc.) includes a transplantation catheter and a device (e.g., a treatment device, a repair device, a valve repair device, an implantable device, a graft, a valve treatment device, etc.). The device can be coupled and / or coupleable to the transplantation catheter. In some implementations, the device includes one, all, or a portion of a first leaflet anchor, a first anchor severable connector, a second leaflet anchor, a control tether system, and an anchor lock.

[0026] In some implementations, the first leaflet anchor has a first leaflet attachment mechanism. In some implementations, the first anchor connector forms a separable / detachable connection between the first leaflet anchor and the transfer catheter, having a coupled state and a separated state (e.g., a coupled state and a detached state, an uncoupled state and a disconnected state, etc.). In some implementations, the first anchor connector is a disconnectable connector that forms a disconnectable connection between the first leaflet anchor and the transfer catheter, having an uncoupled state and a disconnected state.

[0027] In some implementations, the second leaflet anchor has a second leaflet attachment mechanism. In some implementations, the second leaflet anchor is connectable to a transplantation catheter independently of the first anchor connector.

[0028] In some implementations, the control tether system extendibly connects the first leaflet anchor to the implantation catheter, and in some implementations, the control tether system is operable to move the first leaflet anchor relative to the second leaflet anchor when the first anchor connector is in its separated / detached / disconnected state.

[0029] In some implementations, the anchor lock has a locking mechanism that, when the locking mechanism is locked, constrains relative movement of the respective first and second leaflet anchors.

[0030] In some implementations, the first leaflet anchor, the second leaflet anchor, and the first anchor connector are attached to a transfer catheter.

[0031] In some implementations, the control tether system includes a first control tether that extendibly fastens a first leaflet anchor to an optional central body (e.g., a spacer, coaptation element, plug, gap filler, wedge, barrier, sheet, pad, etc.) The central body is detachably attached to the implantation catheter by a central body connector or a severable connector.

[0032] In some implementations, the first control tether extends in series from a first end segment of the first control tether at the proximal end of the transfer catheter, through a central body positioned at the distal end of and slidably received through a first anchor slidable restraint on the first valve leaflet anchor, back through the central body, and to a second end segment of the first control tether at the proximal end of the transfer catheter.

[0033] In some implementations, the second leaflet anchor is inseparably connected to the central body.

[0034] In some implementations, the control tether system includes a first control tether extending in series from a first end segment of the first control tether at the proximal end of the implantation catheter, through a central body slidable restraint on a central body detachably attached to the distal end of the implantation catheter by a central body connector, to a second end segment of the first control tether attached to the first leaflet anchor.

[0035] In some implementations, the control tether system includes a first control tether extending in series from a first end segment of the first control tether at the proximal end of the transfer catheter, through a slidable restraint on a central body that is detachably attached to the distal end of the transfer catheter by a central body connector, through a first anchor slidable restraint on the first leaflet anchor, and back to a second end segment of the first control tether attached to the central body.

[0036] In some implementations, the treatment / repair device further includes a second anchor connector (e.g., a cuttable connector) that forms a separable / detachable connection between the second leaflet anchor and the implantation catheter, the connection having a coupled state (e.g., a connected state, an uncut state, etc.) and a separated state (e.g., a detached state, a cut state, etc.). In some implementations, a control tether system extendably connects the second leaflet anchor to the implantation catheter, and the control tether system is operable to move the second leaflet anchor relative to the first leaflet anchor when the second anchor connector is in its cut state. In some implementations, the second anchor connector is connected to, attached to, or is part of the implantation catheter.

[0037] In some implementations, the control tether system includes a first control tether that extendibly fastens the first leaflet anchor to an optional central body (e.g., a spacer, coaptation element, plug, wedge, barrier, sheet, pad, etc.) detachably attached to the transfer catheter by a detachable connector on the central body. In some implementations, the first control tether extends in series from a first end segment at the proximal end of the transfer catheter, through a central body positioned at the distal end of the transfer catheter, slidably received through a first anchor slidable restraint on the first leaflet anchor, back through the central body, and to a first second end segment at the proximal end of the transfer catheter.

[0038] In some implementations, the control tether system includes a second control tether that extendibly fastens the second leaflet anchor to the central body, the second control tether extending in series from a second first end segment at the proximal end of the transfer catheter, through the central body, slidably received through a second anchor slidable restraint on the second leaflet anchor, back through the central body, and to a second second end segment at the proximal end of the transfer catheter.

[0039] In some implementations, the control tether system includes an anchor tether portion and an extension tether. In some implementations, the anchor tether portion includes a first anchor tether segment and a second anchor tether segment. Each corresponding anchor tether segment extends from an anchor tether segment connection point to a corresponding leaflet anchor. In some implementations, the extension tether portion is connected to the anchor tether portion and extends proximally along the transfer catheter to the proximal end of the transfer catheter.

[0040] In some implementations, the treatment / repair device further includes a third leaflet anchor having a third leaflet attachment mechanism.

[0041] In some implementations, the treatment / repair device further includes a third anchor connector (e.g., a severable connector, etc.) that forms a separable / detachable connection between the third leaflet anchor and the implantation catheter, having a coupled state (e.g., a connected state, a non-disconnected state, etc.) and a separated state (e.g., a detached state, a disconnected state, etc.).

[0042] In some implementations, a control tether system extendibly connects the third leaflet anchor to the delivery catheter or implantation catheter.

[0043] In some implementations, the control tether system is operable to move the third leaflet anchor relative to one or more of the first and second leaflet anchors when the third anchor connector is in its separated / detached state.

[0044] In some implementations, the locking mechanism constrains relative movement of the third leaflet anchor relative to the first and second leaflet anchors when they move together and the locking mechanism is locked.

[0045] In some implementations, the control tether system includes a first control tether that extendibly fastens the first leaflet anchor to a central body that is detachably attached to the transfer catheter by a central body connector (e.g., a severable connector, etc.). In some implementations, the first control tether extends in series from a first end segment of the first control tether at the proximal end of the transfer catheter, through a central body positioned at the distal end of the transfer catheter, slidably received through a first anchor slidable restraint on the first leaflet anchor, back through the central body, and to a second end segment of the first control tether at the proximal end of the transfer catheter.

[0046] In some implementations, the control tether system includes a second control tether that extendibly fastens the second leaflet anchor to the central body, the second control tether extending in series from a second first end segment at the proximal end of the transfer catheter, through a central body positioned at the distal end of the transfer catheter, slidably received through a second anchor slidable restraint on the second leaflet anchor, back through the central body, and to a second second end segment at the proximal end of the transfer catheter.

[0047] In some implementations, the control tether system optionally includes a third control tether that extendibly fastens the third leaflet anchor to the central body. In some implementations, the third control tether extends in series from a first end segment of the third control tether at the proximal end of the transfer catheter, through a central body positioned at the distal end of the transfer catheter, slidably received through a third anchor slidable restraint on the third leaflet anchor, back through the central body, and to a second end segment of the third control tether at the proximal end of the transfer catheter.

[0048] In some implementations, the control tether system includes an anchor tether portion and an extension tether portion. In some implementations, the anchor tether portion includes a first anchor tether segment, a second anchor tether segment, and a third anchor tether segment. Each corresponding anchor tether segment extends from an anchor tether segment connection point to a respective leaflet anchor. In some implementations, the extension tether portion is connected to the anchor tether portion and extends proximally along the transfer catheter to the proximal end of the transfer catheter.

[0049] In some embodiments, the first leaflet anchor is a distal leaflet anchor. In some embodiments, the second leaflet is a proximal leaflet anchor. In some embodiments, the control tether system includes an implant controllable tether that secures the distal leaflet anchor to the proximal end of the implantation catheter. In some embodiments, the proximal leaflet anchor is slidably attached to the implant controllable tether. In some embodiments, the end body slidably receives the implant controllable tether, slides along the implant controllable tether, and moves the distal leaflet anchor closer to (e.g., closer to, contacting, etc.) the proximal leaflet anchor.

[0050] In some implementations, the end body forms a locking mechanism, hi some implementations, the locking mechanism includes a cable lock.

[0051] In some implementations, the proximal leaflet anchor is slidably attached to the implant control tether by a proximal anchor tether portion that forms an eyelet that threads onto the implant control tether.

[0052] In some implementations, the cable lock allows the implant-controlled tether to be pulled out of the end body in only one direction.

[0053] In some embodiments, the implant-controllable tether includes a distal anchor tether portion attached to the distal leaflet anchor. In some embodiments, the distal anchor tether portion forms an eyelet. In some embodiments, the implant-controllable tether includes an extended tether portion having a first end segment, a second end segment, and an intermediate segment intermediate the first and second end segments. In some embodiments, the intermediate segment threads through the eyelet.

[0054] In some implementations, the implant-controlled tether is integrally molded from the proximal end of the implantation catheter to the distal leaflet anchor.

[0055] In some implementations, each leaflet anchor is a clamp-type anchor.

[0056] In some implementations, each leaflet anchor is a T-shaped toggle anchor.

[0057] In some implementations, one or more of the treatment / repair systems described herein include a central body or spacer (e.g., an elastic spacer, etc.). The first and second leaflet anchors form opposing surfaces. The spacer is positioned to be compressed by the opposing surfaces. The spacer forms a flexible body with functionally low flexibility compressibility against obstructed blood flow.

[0058] In some implementations, a system (e.g., a tether system, a coaptation system, a connection system, a controlled tether system, etc.) usable with a device herein has a maximum level of force that can move or connect a first leaflet anchor with a spacer positioned therebetween relative to a second leaflet anchor to receive opposing surfaces. In some implementations, the system (e.g., a tether system, a connection system, etc.) can move opposing surfaces of the anchors together with sufficient force to change the shape of the spacer or central body. In some implementations, when the system (e.g., a controlled tether system, etc.) is actuated with a maximum level of force, the spacer is pushed to extend beyond the opposing surfaces.

[0059] In some implementations, the device (e.g., a treatment device, repair device, valve repair device, implantable device, implant, valve treatment device, etc.) is used in a system (e.g., a treatment system, repair system, valve repair system, valve treatment system, etc.) for treating / repairing a native valve of a subject (e.g., a living subject, a simulation, etc.). The native valve has multiple valve leaflets.

[0060] In some implementations, the system includes a steering catheter system and / or one or more transfer catheters, each of the one or more transfer catheters having a respective catheter distal end for insertion into a proximal end of the steering catheter system and a respective catheter proximal end for user manipulation of the device.

[0061] In some implementations, the device has one, some, or all of a first leaflet anchor, a second leaflet anchor, a first anchor severable connector, a second anchor severable connector, a system (e.g., a tether system, a coaptation system, a connecting system, etc.), a central body, and an anchor lock. In some implementations, the first leaflet anchor and the second leaflet anchor each have a corresponding leaflet attachment mechanism.

[0062] In some implementations, the first anchor connector is connected to the first leaflet anchor. In some implementations, the first anchor connector has a first catheter connector that connects to a first catheter distal end of a first transfer catheter of the one or more transfer catheters. In some implementations, the first anchor connector forms a separable or detachable connection between the first leaflet anchor and the first transfer catheter, having a coupled state (e.g., a coupled state, an uncoupled state, etc.) and a separated state (e.g., a detached state, a coupled state, etc.).

[0063] In some embodiments, the second anchor connector is connected to the second leaflet anchor. In some embodiments, the second anchor connector comprises a second catheter connector connected to a second catheter distal end of a second transfer catheter of the one or more transfer catheters. In some embodiments, the second anchor connector forms a separable or detachable connection between the second leaflet anchor and the second transfer catheter, having a coupled state (e.g., a coupled state, an uncoupled state, etc.) and a separated state (e.g., a detached state, a coupled state, etc.).

[0064] In some implementations, the system (e.g., a tether system, a coaptation system, a connection system, etc.) includes a first control tether connected to a first leaflet anchor and a second control tether connected to a second leaflet anchor. In some implementations, the first control tether extends from a distal end of the first tether at the first leaflet anchor to a proximal end of the first tether at the proximal end of the first catheter. In some implementations, the second control tether extends from a distal end of the second tether at the second leaflet anchor to a proximal end of the second tether at the proximal end of the second catheter. In some implementations, the system is operable to move the respective first and second leaflet anchors relative to one another, e.g., toward one another and / or into contact with one another.

[0065] In some implementations, each of the respective first and second control tethers extends through a central body (e.g., a spacer, a coaptation element, etc.). In some implementations, the central body is slidable along the first and second control tethers such that the first and / or second leaflet anchors can contact the central body.

[0066] In some implementations, the anchor lock constrains the relative movement of the first and second leaflet anchors. In some implementations, the anchor lock forms a cable lock, allowing the tether to be pulled from the central body in only one direction.

[0067] In some embodiments, the device includes a third anchor and a third anchor connector. In some embodiments, the third leaflet anchor has a third leaflet attachment mechanism. In some embodiments, the third anchor connector is connected to the third leaflet anchor. In some embodiments, the third anchor connector has a third catheter connector that connects to a third catheter distal end of a third transfer catheter of the one or more transfer catheters. In some embodiments, the third anchor connector forms a separable / detachable connection between the third leaflet anchor and the third transfer catheter, having a coupled state (e.g., a coupled state, an uncoupled state, etc.) and a separated state (e.g., a detached state, a coupled state, etc.).

[0068] In some implementations, the system (e.g., tether system, coaptation system, connection system, etc.) includes a third control tether connected to a third leaflet anchor. In some implementations, the third control tether extends from a third tether distal end at the third leaflet anchor to a third tether proximal end at the third catheter proximal end. In some implementations, the system is operable to move the first leaflet anchor, the second leaflet anchor, and / or the third leaflet anchor relative to one another.

[0069] In some implementations, the optional central body is slidable along the first, second, and third control tethers at their respective distal ends, thereby bringing the first, second, and third leaflet anchors closer together and / or into contact with each other and / or the central body.

[0070] In some implementations, the anchor lock constrains the relative movement of the first leaflet anchor, the second leaflet anchor, and the third leaflet anchor after they are approximated.

[0071] In some implementations, the first control tether includes a first anchor tether portion attached to the first leaflet anchor at a first distal end of the first anchor tether portion, hi some implementations, the first anchor tether portion forms a first eyelet at a first proximal end of the first anchor tether portion.

[0072] In some implementations, the first control tether includes a first extended tether section having a first end segment, a first second end segment, and a first intermediate segment. In some implementations, the first intermediate segment is intermediate the first end segment and the first second end segment along the first extended tether section. In some implementations, the first intermediate segment threads through the first eyelet.

[0073] In some embodiments, the second control tether includes a second anchor tether portion attached to the second leaflet anchor at a second distal end of the second anchor tether portion. In some embodiments, the second anchor tether portion forms a second eyelet at a second proximal end of the second anchor tether portion. In some embodiments, the second control tether includes a second extension tether portion having a second first end segment, a second second end segment, and a second intermediate segment.

[0074] In some implementations, the second intermediate segment is intermediate the second first end segment and the second second end segment along the second extended tether portion, hi some implementations, the second intermediate segment passes through the second eyelet.

[0075] In some implementations, the first catheter connector has a quick release mechanism that is initially separably / removably attached to the first implantation catheter during implantation and then disengaged during implantation.

[0076] In some implementations, the device has an optional spacer or central body (e.g., an elastic spacer, a coaptation element, etc.) positioned and configured to be compressed by opposing surfaces of the first and second leaflet anchors. In some implementations, the spacer forms a flexible body with functionally low flexible compressibility against obstructed blood flow. In some implementations, the system (e.g., a tether system, a coaptation system, a connecting system, etc.) is actuable with a force level to move the first leaflet anchor relative to the second leaflet anchor having a spacer positioned to receive or contact opposing surfaces.

[0077] In some implementations, a system (e.g., a tether system, a joint system, a connection system, etc.) defines a maximum level of force. In some implementations, when the system is actuated at the maximum level of force, the spacer is compressed such that it is pushed out to extend beyond the opposing surface.

[0078] In some implementations, a system (e.g., a treatment system, repair system, valve repair system, valve therapy system, etc.) usable to treat or repair a native valve in a subject (e.g., a living subject, a simulation, etc.) includes a transplantation catheter and a device (e.g., a treatment device, repair device, valve repair device, implantable device, graft, valve therapy device, etc.). The transplantation catheter has a proximal catheter end and a distal catheter end.

[0079] In some implementations, the device includes one, some, or all of a distal leaflet anchor having a distal leaflet attachment mechanism, a distal anchor connector, a proximal leaflet anchor having a proximal leaflet attachment mechanism and a proximal anchor slidable restraint, a proximal anchor connector, a control tether having a tether proximal end and a tether distal end, and an anchor lock on the control tether.

[0080] In some implementations, the distal anchor connector forms a separable / detachable connection between the distal leaflet anchor and the distal end of the catheter, having a coupled state (e.g., connected state, non-disconnected state, etc.) and a separated state (e.g., detached state, disconnected state, etc.). In some implementations, the proximal anchor connector forms a separable or detachable connection between the proximal leaflet anchor and the distal end of the catheter, having a coupled state (e.g., connected state, non-disconnected state, etc.) and a separated state (e.g., detached state, disconnected state, etc.).

[0081] In some implementations, the separable / detachable connection of the proximal anchor connector is independent from the separable / detachable connection of the distal anchor connector.

[0082] In some implementations, the tether distal end is connected to the distal leaflet anchor, hi some implementations, the implant-controlled tether extends in series from the tether distal end, through a proximal anchor slidable restraint of the proximal leaflet anchor, to the tether proximal end at the catheter proximal end.

[0083] In some implementations, the anchor lock constrains proximal movement of the proximal leaflet anchor relative to the implant-controlled tether.

[0084] In some embodiments, the tether is formed from an extension tether portion and an anchor tether portion. In some embodiments, the anchor tether portion is connected to the distal leaflet anchor and forms an eyelet. In some embodiments, the extension tether portion has a first end segment, a second end segment, and an intermediate segment intermediate the first and second end segments. In some embodiments, the intermediate segment threads through the eyelet.

[0085] In some implementations, the device includes a mid-leaflet anchor and a mid-anchor connector, hi some implementations, the mid-leaflet anchor has a mid-leaflet attachment mechanism and a mid-anchor slidable restraint.

[0086] In some implementations, the intermediate anchor connector forms a separable / detachable connection between the intermediate leaflet anchor and the catheter distal end, having a coupled state (e.g., a connected state, an undisconnected state, etc.) and a disconnected state (e.g., a detached state, a disconnected state, etc.). In some implementations, the separable / detachable connection of the intermediate anchor connector is independent from the separable / detachable connection of the distal anchor connector.

[0087] In some implementations, the tether extends through an intermediate anchor slidable restraint between the distal and proximal leaflet anchors.

[0088] In some implementations, the tether is integrally molded.

[0089] In some implementations, the device includes one or more spring spacers between consecutive pairs of anchors (eg, tissue anchors, clips, clasps, toggle anchors, helical anchors, staples, rivets, darts, etc.).

[0090] In some implementations, the proximal anchor slidable restraint is a structurally integral part of the proximal leaflet anchor.

[0091] In some implementations, a device (e.g., a treatment device, repair device, valve repair device, implantable device, graft, valve treatment device, etc.) that can be used to treat / repair a native valve of a subject (e.g., a living subject, a simulation, etc.) includes one or more of a first leaflet anchor, a second leaflet anchor, a spacer / coaptation element, and a system (e.g., a tether system, a coaptation system, a connection system, etc.).

[0092] In some implementations, the first leaflet anchor has a first leaflet attachment mechanism. In some implementations, the second leaflet anchor has a second leaflet attachment mechanism. In some implementations, the first leaflet attachment mechanism is the same type of attachment mechanism as the second leaflet attachment mechanism, while in some implementations, they are different types of attachment mechanisms.

[0093] In some implementations, each of the first and second leaflet anchors has opposing surfaces. In some implementations, the spacer or coaptation element is positioned to be compressed by the opposing surfaces. In some implementations, the spacer forms a flexible body with functionally low flexible compressibility against occluded blood flow.

[0094] In some implementations, the system (e.g., a tether system, a coaptation system, a connection system, etc.) is actuatable with a force level to move the first leaflet anchor relative to the second leaflet anchor, and the spacer is positioned to receive the opposing surface.

[0095] In some implementations, the system defines a maximum level of force, and in some implementations, when the system is actuated at the maximum level of force, the spacer is compressed such that it is pushed out to extend beyond the opposing surface.

[0096] In some implementations, the spacer is integrated.

[0097] In some implementations, the spacer is constructed from medical grade silicone.

[0098] In some implementations, the device includes an anchor lock that constrains relative movement of the first and second leaflet anchors as they move closer to and / or into contact with the spacer.

[0099] In some implementations, a system (e.g., a treatment system, a repair system, etc.) usable to treat / repair an organ or other body part of a subject (e.g., a living subject, a simulation, etc.) includes one or more of a delivery / implantation catheter, a first anchor, a first anchor connector, a second anchor, and a control tether. In some implementations, the first anchor has a first attachment body for attachment to the organ and is attached to the implantation catheter.

[0100] In some implementations, the first anchor connector connects the first anchor to the transfer catheter, hi some implementations, the first anchor connector forms a separable connection between the first anchor and the transfer catheter having a coupled state (e.g., a coupled state, an uncoupled state, etc.) and a separated state (e.g., a detached state, a coupled state, etc.).

[0101] In some implementations, the second anchor has a second attachment body for attachment to the organ, hi some implementations, the second anchor is attached to the transfer catheter independently from the separable connection of the first anchor connector.

[0102] In some implementations, the control tether extendibly connects the first anchor to the transfer catheter independently of the first anchor connector, hi some implementations, the control tether is actuatable to move the first anchor relative to the second anchor.

[0103] In some implementations, the system includes an anchor lock having a locking mechanism for constraining relative movement of the respective first and second anchors as they approach and / or contact (e.g., with each other and / or the spacer).

[0104] In some implementations, a method for treating or repairing a native valve of a subject (e.g., a live subject, a simulation, etc.) includes providing a treatment / repair device at a distal end of a delivery or implantation catheter. The treatment / repair device includes one or more of: a first leaflet anchor; a first anchor connector that forms a first separable / detachable connection between the first leaflet anchor and the delivery / implantation catheter; a second leaflet anchor connected to the delivery / implantation catheter independently of the first anchor connector; and a system (e.g., a tether system, a coupling system, a connecting system, etc.) that is operable to move the first leaflet anchor and the second leaflet anchor relative to each other when the first separable / detachable connection is separated / detached.

[0105] In some implementations, the first leaflet anchor is positioned on the first leaflet. The first leaflet anchor is attached to the first leaflet. In some implementations, after the first leaflet anchor is attached to the first leaflet, the first anchor connector is separated, detached, cut, etc.

[0106] In some implementations, after the first anchor connector is separated, detached, cut, etc., the second leaflet anchor is positioned on the second leaflet. The second leaflet anchor is attached to the second leaflet. In some implementations, after the first and second leaflet anchors are attached to the respective first and second leaflets, the first and second leaflet anchors are brought together (e.g., closer together and / or brought into contact) using a system (e.g., a tether system, a coaptation system, a connecting system, etc.).

[0107] In some implementations, the treatment / repair device can be released from the implantation catheter.

[0108] In some implementations, the treatment / repair device includes an anchor lock having a locking mechanism that locks the relative positions of the first and second leaflet anchors relative to one another. In some implementations, after the step of moving the first and second leaflet anchors, the relative positions of the first and second leaflet anchors are locked relative to one another using the anchor lock.

[0109] In some implementations, slack on the system (e.g., tether system, coaptation system, connecting system, etc.) is controllably released prior to attaching the second leaflet anchor to the second leaflet.

[0110] In some implementations, the plurality of leaflets includes a third leaflet. In some implementations, the device includes a second anchor connector that forms a second separable / detachable connection between the second leaflet anchor and the implantation catheter, and a third leaflet anchor connected to the implantation catheter independently of the first anchor connector and the second anchor connector.

[0111] In some embodiments, the system (e.g., a tether system, a coaptation system, a connection system, etc.) is operable to move the first leaflet anchor, the second leaflet anchor, and the third leaflet anchor relative to one another after the first separable / detachable connection and the second separable / detachable connection are separated / detached. In some embodiments, after the second leaflet anchor is attached to the second leaflet, the second anchor connector is separated or detached. In some embodiments, after the second anchor connector is separated or detached, the third leaflet anchor is positioned at the third leaflet. The third leaflet anchor is attached to the third leaflet. In some embodiments, the first leaflet anchor, the second leaflet anchor, and the third leaflet anchor are brought closer together and / or into contact with one another and / or with the optional central body / spacer therebetween.

[0112] In some implementations, the system or another system (e.g., a tether system, a joint system, a connection system, etc.) may be configured such that after detaching the anchors, central body, or other component from the delivery or implantation catheter, the delivery or implantation catheter can be coupled or recoupled to the anchors, central body, or other component. This can be done using a tether or similar device that allows freedom of movement in the detached state, but can be used to bring the delivery / implantation catheter back into contact with the anchors, central body, or other component (e.g., tensioned, etc.). In some implementations, after recoupling, the delivery or implantation catheter can be used to (1) detach the anchors, central body, or other component from a first location (e.g., detach from tissue at a first tissue location) and / or (2) reposition and / or attach the anchors, central body, or other component to a second location (different from the first location) (e.g., a different tissue location).

[0113] In some implementations, after separating the first anchor connector, the method includes moving the first leaflet anchor and the delivery / implantation catheter together using a system (e.g., a tether system, a coaptation system, a connection system, etc.). In some implementations, the method includes coupling (e.g., recoupling) the delivery / implantation catheter to the first anchor. In some implementations, the method includes detaching the first leaflet anchor from the first location (e.g., from the tissue at the first location) and attaching the first leaflet anchor to another location (e.g., a different tissue location).

[0114] Any of the above methods can be performed on a living subject (e.g., a human, other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, an anthropomorphic ghost, a simulator such as a computer simulator in which body parts, tissues, etc. are simulated). In a simulation, the body parts may optionally be referred to as "simulations" (e.g., simulated hearts, simulated tissues, etc.) and may include, for example, computerized and / or physical representations.

[0115] Any of the above systems, assemblies, devices, apparatus, components, etc. can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure safety for patient use, and the methods herein can include (or additional methods can include or consist of) sterilization (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more systems, devices, apparatus, components, etc. described herein.

[0116] The nature and advantages of the implementations described in the following description and claims will be better understood, particularly when considered in conjunction with the accompanying drawings, in which like parts are designated with like reference numerals. Other features and advantages will become apparent from the following detailed description and claims, particularly when considered in conjunction with the accompanying drawings. The detailed descriptions of implementations set forth below to enable construction and use of the implementations are not intended to limit the scope of the recited claims, but rather to serve as examples of the invention as claimed. [Brief explanation of the drawings]

[0117] To further clarify various aspects of implementations of the present disclosure, specific examples and implementations will be described in more detail by reference to various aspects of the accompanying drawings. These drawings depict only exemplary implementations of the present disclosure and therefore should not be considered to limit the scope of the present disclosure. Moreover, while the figures may be drawn to scale in some examples, the figures are not necessarily drawn to scale in all examples. Examples and other features and advantages of the present disclosure will be described and explained with additional specificity through the use of the accompanying drawings.

[0118] [Figure 1] FIG. 1 is a cross-sectional view of a device positioned to repair a mitral valve. [Figure 2] FIG. 1 is a cross-sectional view of a human heart in diastole. [Figure 3] FIG. 1 is a cross-sectional view of a human heart during systole. [Figure 4] FIG. 1 is a cross-sectional view of a human heart in systole, illustrating valvular regurgitation. [Figure 5] FIG. 5 is a cross-sectional view of FIG. 4 annotated to show the mitral valve leaflets in systole. [Figure 6] FIG. 1 illustrates a healthy mitral valve with the leaflets closed as viewed from the atrial side of the mitral valve. [Figure 7]FIG. 1 illustrates a dysfunctional mitral valve with visible gaps between the leaflets when viewed from the atrial side of the mitral valve. [Figure 8] FIG. 1 is a diagram showing the tricuspid valve as seen from the atrial side of the tricuspid valve. [Figure 9] FIG. 1 is a cross-sectional view of a heart showing a transfer catheter and treatment / repair device extending from within a steering catheter system and positioned within the mitral valve. [Figure 10] FIG. 10 shows details of the treatment / repair device shown in FIG. 9. [Figure 10A] 11 shows the treatment / repair device of FIG. 10 along with an implementation of a mechanism for opening and closing the paddles of the device. [Figure 10B] 10B shows an implementation of a mechanism for opening and closing the paddles of the device of FIG. 10A. [Figure 10C] 11A-11C show an implementation of a paddle that can be used in a device similar to that of FIG. 10. [Figure 10D] 11A-11C show an implementation of a paddle that can be used in a device similar to that of FIG. 10. [Figure 10E] 11 shows an implementation of a treatment / repair device similar to that of FIG. 10. [Figure 10F] 11 shows an implementation of a treatment / repair device similar to that of FIG. 10. [Figure 11] FIG. 10 illustrates the transfer catheter and treatment / repair device of FIG. 9 with the first leaflet anchor of the treatment / repair device positioned and oriented to anchor to a portion of the first leaflet. [Figure 12] 12 illustrates the implantation catheter and treatment / repair device of FIG. 11 , showing a first leaflet anchor secured to the first leaflet and released from the central body of the treatment / repair device, and a second leaflet anchor of the treatment / repair device positioned and oriented to be secured to a portion of the second leaflet. [Figure 13]FIG. 13 illustrates the implantation catheter and treatment / repair device of FIG. 12, with the first and second leaflet anchors fastened to the respective first and second leaflets and released from the central body, and the central body positioned at the central coaptation position between the leaflets. [Figure 14] FIG. 14 illustrates the treatment / repair device of FIG. 13 with the anchors connected to and locked in place relative to the central body and the transfer catheter disconnected from the treatment / repair device and removed from the subject's body. [Figure 15] 10 is a diagram of an exemplary three-anchor implementation of the treatment / repair device of FIG. 9 positioned within a tricuspid valve. [Figure 16] 16 illustrates the treatment / repair device of FIG. 15 with the first leaflet anchor of the treatment / repair device positioned and oriented to anchor to a portion of the first leaflet. [Figure 17] 17 shows the treatment / repair device of FIG. 16 with a first leaflet anchor secured to the first leaflet and released from the central body of the treatment / repair device, and a second leaflet anchor of the treatment / repair device positioned and oriented to be secured to a portion of the second leaflet. [Figure 18] 18 illustrates the treatment / repair device of FIG. 17, with the first and second leaflet anchors fastened to the first and second leaflets, respectively, and released from the central body, and with the third leaflet anchor of the treatment / repair device positioned and oriented to be fastened to a portion of the third leaflet. [Figure 19] 19 illustrates the treatment / repair device of FIG. 18 with the first, second, and third leaflet anchors fastened to the first, second, and third leaflets, respectively, and released from the central body, with the central body positioned at a central coaptation position between the leaflets. [Figure 20] FIG. 20 illustrates the treatment / repair device of FIG. 19 showing the anchors moving into contact with the central body. [Figure 21] 21A-21C illustrate an exemplary central body expansion of the treatment / repair device of FIG. 20. [Figure 22A] FIG. 1 illustrates a serially inserted centrally coupled implementation of the treatment / repair system. [Figure 22B] FIG. 1 illustrates a serially inserted centrally coupled implementation of the treatment / repair system. [Figure 22C] FIG. 1 illustrates a serially inserted centrally coupled implementation of the treatment / repair system. [Figure 22D] FIG. 1 illustrates a serially inserted centrally coupled implementation of the treatment / repair system. [Figure 23] 23 is a cross-sectional view of a central body of a serially inserted centrally coupled implementation of the treatment / repair system of FIG. 22 connected to a transfer catheter and a tether anchor. [Figure 24] FIG. 10 is a cross-sectional view of an exemplary center body including a spacer. [Figure 25] FIG. 1 is a cross-sectional view of an exemplary center body. [Figure 26] FIG. 1 illustrates an exemplary end-coupled implementation of the treatment / repair system. [Figure 27] FIG. 1 illustrates an exemplary end-coupled implementation of the treatment / repair system. [Figure 27A] 28 illustrates an implementation of the treatment / repair system of FIG. 26 or FIG. 27 on a native mitral valve. [Figure 27B] 28 illustrates an implementation of the treatment / repair system of FIG. 26 or FIG. 27 on a native mitral valve. [Figure 28] FIG. 1 illustrates an exemplary end-coupled implementation of the treatment / repair system. DETAILED DESCRIPTION OF THE INVENTION

[0119] In the following description, reference is made to the accompanying drawings that illustrate exemplary implementations of the present disclosure. Other implementations having different structure and operation do not depart from the scope of the present disclosure.

[0120] Some implementations of the present disclosure are directed to systems, devices, methods, etc. for treating or repairing defective heart valves. For example, various implementations of devices, valve repair devices, implantable devices, implants, and systems (including systems for delivering them) are disclosed herein, and unless otherwise excluded, any combination of these options can be made. In other words, individual components of the disclosed devices and systems can be combined unless they are mutually exclusive or physically impossible.

[0121] The techniques, methods, acts, steps, etc. described or suggested in this specification or the references incorporated herein, and any methods using the systems, assemblies, apparatus, devices, etc. herein, can be performed on living subjects (e.g., humans, other animals, etc.) or on simulated / simulated subjects (e.g., cadavers, cadaver hearts, simulators, virtual persons, etc.). When performed on a simulation, body parts, such as hearts, tissues, valves, etc., can be assumed to be simulated or, optionally, can be referred to as "simulated" (e.g., simulated hearts, simulated tissues, simulated valves, etc.), and can optionally include computerized and / or physical representations of body parts, tissues, etc. The term "simulation" encompasses use with cadavers, computer simulators, virtual persons (e.g., when simply demonstrating a virtual heart in mid-air), etc.

[0122] The examples summarized above and defined by the recited claims can be better understood by reference to the following detailed description, which should be read in conjunction with the accompanying illustrative drawings, in which like parts are designated with like reference numerals. The detailed description discloses examples set forth below to enable implementations to be made and used, and is not intended to limit the scope of the recited claims, but rather to provide examples thereof. Accordingly, implementations having different structures and methods do not depart from the scope of the invention as defined by the claims.

[0123] As described herein, when one or more components are described as being connected, joined, attached, coupled, attached, or otherwise interconnected, such interconnection can be direct, such as between the components, or can be indirect, such as through the use of one or more intermediate components. Also, as described herein, references to a "member," "element," "component," or "portion" are not limited to a single structural member, component, or element, but can include an assembly 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 condition (preferably within 10 of, more preferably within 1 of).

[0124] Many variations of the exemplary implementations described herein are within the scope of the present invention, some of which are described in various implementations. To the extent that they are feasible, these variations are also contemplated for use in other implementations. Thus, the treatment or repair devices herein may include any combination or subcombination of the features and variations disclosed herein, or may exclude some described features.

[0125] 2-3 show cross-sectional views of a human heart H during distinct phases of the cardiac cycle. 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, or 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 defines a respective opening and has flexible leaflets (e.g., the anterior and posterior leaflets 20 and 22 of the mitral valve, also shown in FIGS. 4-7, and the tricuspid valve leaflets 30, 32, and 34 shown in FIG. 8) that extend inward across their respective openings and meet, or "coapt," in flow to form a unidirectional fluid-occluding surface. The organ repair systems, and more particularly the native heart valve repair systems of the present application, are often described and / or illustrated with respect to the mitral valve MV, and therefore the anatomical structures of the mitral valve, left atrium LA, and left ventricle LV will be described in more detail. However, the devices described herein can also be used to repair other native valves, for example, the devices can be used to repair the tricuspid valve TV, aortic valve AV, pulmonary valve PV, and / or atrioventricular valves.

[0126] The left atrium LA receives oxygenated blood from the lungs via the pulmonary veins PVS. At the beginning of the cardiac cycle, during diastole, or relaxation (as shown in Figure 2), blood already collected in the left atrium LA (at the end of the previous cardiac cycle) moves through the mitral valve MV into the left ventricle LV due to expansion of the left ventricle LV. Simultaneously, additional blood flows from the pulmonary veins into the left atrium. During the subsequent systole, first there is atrial contraction, in which the atria contract, followed by ventricular contraction, in which the ventricles contract.

[0127] During atrial contraction during systole, the left atrium contracts, ejecting additional blood from downstream into the left ventricle. During ventricular contraction during systole, as shown in Figure 3, the left ventricle (LV) contracts, forcing blood through the aortic valve (AV) into the ascending aorta (AA), where it circulates back through the rest of the body. During ventricular contraction, the two leaflets of the mitral valve (MV) close, preventing blood from backflowing from the left ventricle (LV) back into the left atrium (LA). Simultaneously, left atrial relaxation allows blood to again collect from the pulmonary veins into the left atrium, ready for the start of the next cardiac cycle.

[0128] The right atrium (RA) receives deoxygenated blood from the body via two veins, the posterior (inferior) vena cava (IVC) and the anterior (superior) vena cava (SVC), and from the coronary venous network via the coronary sinus (CS). At the beginning of the cardiac cycle, during diastole, blood previously collected in the right atrium (RA) at the end of the previous cardiac cycle moves into the right ventricle (RV) through the tricuspid valve (TV) due to the expansion of the right ventricle (RV). Simultaneously, additional blood flows from the vena cava into the right atrium. During atrial contraction (systole), the right atrium contracts, expelling additional blood from the right atrium downstream into the right ventricle. During ventricular contraction (systole), the right ventricle (RV) contracts, forcing blood through the pulmonary valve (PV) into the pulmonary artery (PA), where it flows to the lungs. During ventricular contraction, the three leaflets of the tricuspid valve (TV) close, preventing blood from flowing backward from the right ventricle (RV) back into the right atrium (RA). At the same time, blood is collected from the vena cava into the right atrium for the start of the next cardiac cycle.

[0129] Referring now to FIGS. 2-8, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24 (see FIG. 6), which is a variably dense, fibrous ring of tissue surrounding the anterior leaflet 20 and the posterior leaflet 22. Referring now to FIGS. 4-5, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae CT. The chordae tendineae CT are multiple cord-like tendons that connect the papillary muscles PM (i.e., muscles located at the base of the chordae tendineae CT and within the wall of the left ventricle LV) to the anterior leaflet 20 and posterior leaflet 22 of the mitral valve MV. The papillary muscles PM function to limit the movement of the anterior leaflet 20 and posterior leaflet 22 of the mitral valve MV and to prevent the mitral valve MV from everting.

[0130] The mitral valve MV opens and closes in response to the pressure difference between the left atrium LA and the left ventricle LV. The papillary muscles PM do not open or close the mitral valve MV; rather, they support and / or reinforce the anterior and posterior leaflets 20 and 22 against the high pressure generated within the left ventricle LV, which is necessary to circulate blood throughout the body. The papillary muscles PM and chordae tendineae CT are collectively known as part of the subvalvular tissue, which functions to prevent the mitral valve MV from prolapsing or flapping into the left atrium LA as it closes. As shown in the left ventricular outflow tract (LVOT) diagram in FIG. 4 , the anatomy of the anterior and posterior leaflets 20 and 22 is such that the medial surfaces of the leaflets meet at their free ends, from which the anterior and posterior leaflets 20 and 22 retract and diverge from each other. The anterior and posterior leaflets 20 and 22 diverge toward the atrium until each leaflet contacts the mitral valve annulus 24.

[0131] Various disease processes can impair the proper function of one or more native valves in the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, elastic fiber deficiency, etc.), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricle LV or right ventricle RV due to a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other cardiac diseases (e.g., cardiomyopathies, etc.) can distort the shape of the native valves, which can cause them to malfunction.

[0132] Dysfunctional native valves malfunction in a variety of ways, including (1) valvular stenosis and (2) valvular regurgitation. While both stenosis and regurgitation can affect any valve, stenosis is more commonly found affecting the vena cava and pulmonary valves, and regurgitation is more commonly found affecting the atrioventricular valves (i.e., the mitral and tricuspid valves).

[0133] Both valve stenosis and valve regurgitation increase the strain on the heart H and, if left untreated, can lead to serious conditions such as endocarditis, congestive heart failure, permanent heart damage, and cardiac arrest, which can ultimately lead to death. Because 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, the pressures on the left side of the heart are substantially higher, and malfunction of the mitral valve MV or aortic valve AV is particularly problematic and often life-threatening.

[0134] Valve stenosis occurs when the native valve does not open properly and / or completely, which can result in inappropriate blood flow (e.g., obstructed blood flow, jets, etc.). Often, valve stenosis results from the buildup of calcified material on the valve leaflets, which thickens the leaflets and impairs the valve's ability to function properly.

[0135] Valve regurgitation typically occurs when the leaflets of a valve do not close completely, allowing blood to leak back into the previous (upstream) heart chamber (e.g., the mitral valve does not close completely, allowing blood to leak from the left ventricle into the left atrium). There are three main mechanisms by which native valves become regurgitant (e.g., incompetent), including Carpentier Type I, Type II, and Type III insufficiency.

[0136] Carpentier Type I insufficiency involves dilation of the valve annulus, which causes normally functioning valve leaflets to separate and fail to form a tight seal (e.g., the leaflets do not coapt properly). Mechanistic Type I insufficiency includes leaflet perforation, such as occurs in endocarditis. Carpentier Type II insufficiency involves prolapse of one or more native valve leaflets above the plane of coaptation. Carpentier Type III insufficiency involves restricted movement of one or more native valve leaflets, resulting in abnormal constraining of the leaflets below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease or ventricular dilation.

[0137] Dysfunction of a native heart valve may require replacement or repair. Replacement may involve replacing the target native valve with a biological or mechanical substitute. Repair may involve preserving or modifying the target native valve. In some implementations, the devices described herein are used to restore the function of a defective native valve. That is, the devices are configured to assist in the closure of the leaflets of the native valve to prevent blood from flowing backward. Some of the devices described herein are designed to easily grasp and secure the native valve leaflets. In some implementations, the native valve leaflets are grasped and / or secured around a coaptation element (e.g., a spacer, gap filler, wedge, plug, foam, sponge, etc.) that beneficially acts as a filler within the regurgitation opening to help prevent backflow or regurgitation, although this is not required in all implementations.

[0138] Many patients undergoing valve surgery, such as mitral valve MV surgery, suffer from degenerative diseases that can cause the leaflets of a native valve (e.g., the mitral valve MV) to malfunction, resulting in prolapse, flail, and / or regurgitation. Referring to FIG. 6 , when a healthy mitral valve MV is in the occluded position, the anterior leaflet 20 and the posterior leaflet 22 coapt, preventing blood from leaking from the left ventricle LV into the left atrium LA. Referring to FIGS. 4 and 7 , mitral regurgitation (MR) can occur when displacement of the anterior leaflet 20 and / or the posterior leaflet 22 of the mitral valve MV prevents the anterior leaflet 20 and the posterior leaflet 22 from properly coapting or closing. This lack of coaptation can result in a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which can allow blood to regurgitate (e.g., from the left ventricle LV into the left atrium LA, as illustrated by the mitral regurgitation MR flow path shown in FIG. 4 ).

[0139] 7, gap 26 can have a width W of about 2.5 mm to about 17.5 mm, about 5 mm to about 15 mm, about 7.5 mm to about 12.5 mm, or about 10 mm. In some circumstances, gap 26 can have a width W greater than 15 mm, or even greater than 17.5 mm. As discussed above, there are several different ways in which the valve leaflets (e.g., the anterior leaflet 20 and posterior leaflet 22 of the mitral valve MV) can become incompetent, causing valvular regurgitation.

[0140] In any of the above situations, improved valve function may be achieved using a treatment / repair device or implant that is capable of engaging the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent backflow of blood through the mitral valve MV. As illustrated in FIG. 5 (compare FIGS. 4 and 5), an abstract representation of a device 10 or implant is shown implanted between the anterior leaflet 20 and the posterior leaflet 22 to prevent backflow during systole.

[0141] In some implementations, the coaptation elements (e.g., spacers, coaptation elements, gap fillers, plugs, wedges, sheets, barriers, etc.) of device 10 are generally tapered or sloped to naturally conform to the shape of the native valve and the nature of its expanded (towards the annulus 24) leaflets. In this application, the terms spacer, coaptation element, and gap filler are used interchangeably to refer to elements that fill a portion of the space between the leaflets of the native valve and / or that are configured to engage or "coapt" the leaflets of the native valve (e.g., so that the leaflets not only coapt against each other but also against the coaptation elements, spacers, etc.).

[0142] The mitral valve MV and tricuspid valve TV are more susceptible to deformation of the valve leaflets and / or surrounding tissue, which, as described above, can prevent the mitral valve MV or tricuspid valve TV from functioning properly, allowing blood to regurgitate or backflow from the ventricle into the atrium (e.g., a deformed mitral valve MV can allow regurgitation or backflow from the left ventricle LV into the left atrium LA, as shown in FIG. 4). Regurgitation or backflow of blood from the ventricle into the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or tricuspid valve TV are often repairable. Additionally, regurgitation can occur due to dysfunction of the chordae tendineae CT (e.g., the chordae tendineae CT can stretch or rupture), allowing the anterior and posterior leaflets 20 and 22 to evertate, resulting in blood regurgitation into the left atrium LA. Problems caused by dysfunctional chordae CT can be repaired by repairing the chordae CT or the structure of the mitral valve MV (e.g., by fixating the anterior leaflet 20 and posterior leaflet 22 at the affected portion of the mitral valve).

[0143] 7-8, the systems, devices, procedures, and concepts disclosed herein for treating / repairing native valve structures will be described in detail, often using the mitral valve as an illustrative example. The systems, devices, and procedures can be used on the left side of the heart to connect the anterior and posterior leaflets 20 and 22 of the mitral valve MV to help prevent or inhibit backflow of blood from the left ventricle into the left atrium. The devices, procedures, and concepts disclosed herein can also be used to treat / repair a single leaflet of a native valve.

[0144] Similar to the mitral valve, other valves (e.g., the vena cava, pulmonary, and tricuspid valves) can be treated / repaired using the devices, procedures, and concepts disclosed herein. For example, on the right side of the heart, as on the left side of the heart, such devices, procedures, and concepts can be used to connect any two of the three tricuspid valve leaflets (e.g., the anterior leaflet 30, the septal leaflet 32, and the posterior leaflet 34) to prevent or inhibit the backflow of blood from the right ventricle into the right atrium. Furthermore, the devices, procedures, and concepts disclosed herein can be used to connect all three of the tricuspid valve leaflets 30, 32, and 34 to prevent or inhibit the backflow of blood from the right ventricle into the right atrium.

[0145] The devices, procedures, systems, and concepts disclosed herein can also be used to treat / repair a single leaflet of a valve. In summary, depending on the circumstances, the described devices, procedures, systems, and concepts can be used to treat or repair any native valve and any component of a native valve.

[0146] In some implementations, the systems herein can be configured as organ repair systems for repairing an organ, such as a heart, or a valve of the heart. In some implementations, the systems can be configured to treat / repair another part of the body. In some implementations, the systems herein are valve treatment / repair systems for repairing or treating a valve. In some implementations, the systems herein include a treatment and / or repair device (e.g., a valve repair device, a valve repair implant, a valve treatment device, a treatment device, an implant, a device, etc.).

[0147] In some implementations, the treatment / repair systems herein comprise a delivery system having a distal end that is inserted into a subject (e.g., a live patient, a simulation, etc.) and a proximal end that is retransmitted outside of the subject. The delivery system can include a transplantation catheter system having catheter components (e.g., a delivery catheter and / or a transplantation catheter) configured and sized to receive, deliver, and implant or otherwise deploy a treatment / repair device within the subject.

[0148] The treatment / repair devices herein can be used by medical professionals to repair or treat a subject's native valve, in some implementations, by repairing and / or supporting one or more leaflets of the subject's valve.

[0149] In some implementations, the device can be delivered to the valve by a delivery system through the subject's vasculature. The delivery catheter and / or implantation catheter(s) can have a distal end for insertion into the proximal end of the steering catheter system and a proximal end for manipulation by a user of the delivery system.

[0150] In some implementations, the system is provided with a series of controllable components for actuation of various functions, some of which are described herein and others known in the art. In some implementations, the system is configured so that a user (e.g., a medical professional) can operate various controls (e.g., one or more of knobs, motors, buttons, switches, sliders, gears, motors, screws, cams, gimbals, etc.) to control the system. In some implementations, the system can include features known to be available in other transvascular devices, although the actuation of the functions and the associated controllable components themselves may be unique.

[0151] In some implementations, the system is provided with a wide range of associated components and methods, such as those that may be described herein, either directly or indirectly.

[0152] Further details and background information regarding systems, devices, and methods for transvascular heart valve treatment / repair (including associated features, components, operations, steps, etc.) that may be used with the systems, devices, methods, etc. herein may be found in U.S. Patent Application No. 8,449,599, U.S. Patent Application Publication Nos. 2014 / 0222136, 2014 / 0067052, and 2016 / 0331523, and PCT Patent Application Publication No. WO 2020 / 076898, each of which is incorporated herein by reference in its entirety for all purposes. In some implementations, the leaflet anchors described in any of these incorporated references can optionally be used as leaflet anchors in the implementations described herein. Also, the coaptation elements, spacers, etc. described in any of these incorporated references can optionally be used as central bodies in any of the implementations described herein.

[0153] An exemplary transvascular technique usable with the systems, devices, methods, etc. herein for treating / repairing a native valve may include advancing a catheter or catheter device into the atrium (e.g., inserting a catheter device into the right femoral vein, above the inferior vena cava, and into the right atrium). In some implementations, the tricuspid valve is treated from the right atrium. In a transseptal transvascular technique, the septum may be punctured from the right atrium, and the catheter device passed into the left atrium. In some cases, the catheter device may be coupled to a device (e.g., a treatment device, a repair device, a graft, etc.). The device may be positioned to repair the incompetent native valve.

[0154] The delivery systems herein may comprise one or more components that form a steering catheter system and / or a transfer catheter system. In some implementations, the delivery system may have one or more components that form a steering catheter system and a transfer catheter system.

[0155] In some implementations, the transfer catheter system includes one or more transfer catheters that can position and implant or otherwise deploy a therapeutic or repair device. Optionally, the one or more transfer catheters can be steerable catheters capable of navigating the vasculature of a subject, thereby forming all or part of a steerable catheter system rather than being a separate system. The delivery system can further include additional devices for transvascular procedures, such as a sheath, a control guidewire, an external catheter control system, and controls (e.g., one or more of a knob, motor, button, switch, slider, gear, motor, screw, cam, gimbal, etc.).

[0156] In some implementations, the steering catheter system includes one or more steering catheters capable of navigating the vasculature of a subject.

[0157] In some implementations, such as those with separate steering catheter systems, the one or more steering catheters can be individually or collectively configured to guide one or more implantation catheters through the vasculature of a subject. In some implementations, this can involve positioning the distal end of the steering catheter system upstream (relative to the direction of blood flow) of the defective valve and pointing the distal end of the implantation catheter system downstream (in the direction of blood flow) through the valve.

[0158] In some implementations, the transfer catheter system is inserted into the steering catheter system starting before insertion into the subject's body, or inserted into the proximal end of the steering catheter system after the distal end of the steering catheter system is positioned upstream of the valve. With the steering catheter system in place and the transfer catheter inserted, the transfer catheter system extends downstream from within the steering catheter system toward the valve.

[0159] The components of the treatment / repair device can be configured to traverse a subject's vasculature through a delivery system in an operational configuration. In some implementations, the treatment / repair device is structurally configurable with a first, small form factor (e.g., small diameter) delivery configuration structurally laid out to traverse the delivery system through a subject's vasculature, and a second operational configuration structurally suitable for valve treatment or repair operations. In some such implementations, the implantation catheter includes one or more actuators that function to actuate the treatment / repair device from the delivery configuration to the operational configuration while the device is located at its deployed position within the subject's heart.

[0160] In some implementations, the components of the device can be configured to simultaneously traverse a subject's vasculature through a delivery system as a single implantable unit.

[0161] In some implementations, the device components can be configured to traverse a delivery system transvascularly through a subject's vasculature one at a time, hi some implementations, the components are incorporated into an implantable device within the body (e.g., within the heart during an implantation procedure).

[0162] In some implementations herein, the treatment / repair system includes and uses multiple anchors (e.g., leaflet anchors, tissue anchors, clips, clasps, toggle anchors, staples, rivets, darts, etc.) that are attached to tissue (e.g., tissue of an organ). In some implementations, the treatment or repair device can be in the form of and / or include at least one or more of the independently actuable leaflet anchors (e.g., clips, clasps, clamps, toggle anchors, staples, rivets, darts, knots, etc.).

[0163] In some implementations, the leaflet anchor is a structured attachment device (when in an operative configuration) having a leaflet attachment mechanism for affixing itself to the leaflet in any one or more of a variety of ways. The attachment mechanism can be in the form of, for example, an attachment body (e.g., a bar). In some implementations, there are multiple attachment bodies (first attachment body, second attachment body, third attachment body, etc.), each of which can have any of a variety of cross-sections (e.g., a relatively flat, paddle-type cross) and can extend longitudinally in any of a wide variety of shapes (e.g., linear or circular) to form a compression structure (e.g., a paddle or ring).

[0164] In some implementations, the attachment bodies can be configured to attach to the leaflets, such as by compressing the leaflets, thereby constraining their movement relative to the anchor. For example, in some implementations of clamp-type anchors, two attachment bodies in the form of paddles can be configured to be hinged at one end to form jaws that can engage, clamp, or clasp to the leaflets, thereby attaching them to the leaflets. In some implementations, the anchor attachment device (or attachment mechanism) of the clasp mold can be provided with two controls (or control mechanisms), one to actuate the attachment device between an open configuration and an attached configuration (optionally using a spring to move the jaws toward the open or closed position) and one to lock the attachment device onto the leaflets. In some implementations, the controls can be controlled using control wires, such as sutures, wires, lines, tethers, etc.

[0165] Similarly, any leaflet anchor herein may be provided with various other forms of tissue attachment mechanisms, such as frictional devices, adhesive devices, tissue-piercing mechanisms, and / or various forms of grapnels. The anchor(s) may take on and / or include various forms, such as, for example, clasps, clamps, clips, darts, staples, hooks, bars, rods, screws, knots, toggle anchors, etc.

[0166] In some implementations, each leaflet anchor can include or be in the form of a toggle anchor having a bar with a respective centrally attached anchor tether (e.g., a tether or tether portion associated with the particular anchor). The bar can be fabricated to pierce, penetrate, and pass longitudinally through the wall of the leaflet, pulling the anchor tether like a needle pulling a thread. To accomplish this, the bar can be oriented parallel to the anchor tether, and then the end of the bar is pierced through the wall of the leaflet using a sharp point or edge (either at the end of the bar or on a separate piercer that includes or is attached to the toggle anchor). In some implementations, a structural support member can be used to support the leaflet structure during penetration.

[0167] In some implementations, after passing through the wall, the anchor tether is pulled, causing the bar to toggle (rotate) and press laterally against the tissue wall, with the distal (anchor) end of the anchor tether retracting against and extending back through the tissue wall, forming a T-shaped configuration (where the bar forms the top of a capital T). This T-shaped toggle anchor (also known as a T-element anchor) prevents the bar from backing through the hole in the tissue (leaflet) when pulled by the anchor tether. The anchor can use various variations in the structure of the toggle anchor bar, such as a bar made of fabric folded like an elongated accordion, where the anchor tether extends through multiple bellows of the accordion and is then compressed into the accordion-folded configuration to form the bar.

[0168] In some implementations, the device also includes one or more connectors, such as separable, removable, or severable connectors, where at least one of the one or more connectors is an anchor connector or anchor severable connector in the form of a fastener or connection that secures, attaches, or couples, directly or indirectly, the structure of an associated anchor of one or more anchors to the structure of a catheter of the delivery / implantation catheter system (e.g., first anchor connector, first anchor severable connector, second anchor connector, second anchor severable connector, etc.).

[0169] In some implementations, each anchor connector securely structurally fastens, couples, attaches, etc., the anchor and catheter together. Each such anchor connector allows a user (via a delivery or implantation catheter system) to first position an associated anchor for attaching the connector to a valve portion, such as a valve leaflet, and then, after the anchor is attached to that leaflet, user actuation can separate, detach, or cut the connection provided by the anchor connector, thereby disconnecting and releasing the anchor from the implantation catheter. Separating / detaching / cutting the anchor connector effectively removes the constraint of that connector that prevents the anchor from being separated from the implantation catheter. The implantation catheter can then move independently away from the anchor, e.g., to position one or more other anchors at other leaflets or leaflet locations.

[0170] In some implementations, a connector (e.g., a severable connector, anchor connector, catheter connector, etc.) can be a structure that, in a first, non-disconnected state, forms a connection that joins and fastens the structures of two separate components (e.g., an anchor and a delivery catheter) to the extent that they are constrained (typically having substantial rigidity) to move synchronously with one another in one or more degrees of freedom (and typically six degrees of freedom). In some implementations, a severable connector can be controllably separable / detachable to a second, separated state (e.g., a detached state, a disconnected state, etc.), in which the constraint on synchronous movement in at least one of the constrained degrees of freedom relative to one another (typically six relative degrees of freedom) is released (terminated). In other words, the connector or severable connector forms a separable / detachable / disconnectable connection between a first component and a second component. In some implementations, a separable / detachable / disconnectable connection includes a coupled, connected, or undisconnected state in which the connector constrains the first and second components to move synchronously relative to one another in a set of one or more constrained degrees of freedom. In some implementations, a separable / detachable / disconnectable connection can also include a separated, detached, or disconnected state in which the first and second components are not constrained by the connector to move synchronously relative to one another, e.g., in at least one constrained degree of freedom of the set of one or more constrained degrees of freedom.

[0171] In some implementations, two objects moving synchronously in one or more degrees of freedom encompasses a situation in which two objects move together in one or more degrees of freedom (e.g., translation and / or rotation) and maintain their position relative to each other, as would occur with a rigid connection between the two objects.

[0172] The transition from a coupled state to a separated state (e.g., from a connected state to a detached state, from an undisconnected state to a disconnected state, etc.) may occur controllably through various physical connection structures, such as retained by a retractable mechanical stop, retained by a clamp or clasp, retained by an integral connector that can be disconnected, etc. In some implementations, the connector structure may be formed by (e.g., includes) an integral portion of one or both of two separate components and / or by an entirely separate structural element attached to one or both of two separate components.

[0173] In some implementations, the connector's six degrees of freedom may be three translational degrees of freedom (e.g., translation along a given set of mutually perpendicular x-, y-, and z-axes, each of which may be parallel to the direction in which the end of the transfer catheter faces) and three rotational degrees of freedom (e.g., rotation about a given set of x-, y-, and z-axes, respectively). A rigid connection between two separate components may not be flexible enough to allow a medical professional to functionally control the position and orientation of one component (e.g., an anchor) without using anything other than the movement of the other component (e.g., the distal tip of the transfer catheter). While some flexibility is inherent in any material, particularly transvascular devices, there are also levels of stiffness that can provide functionality to the device when used in this type of procedure.

[0174] In some implementations, at least some of the anchors (e.g., one or more clips, clasps, clamps, toggle anchors, staples, rivets, darts, knots, etc.) connected to the implantation catheter system (and / or to other anchors) by connectors are each further connected to a control tether system having one or more control tethers (e.g., sutures or other types of cords). In some implementations, each control tether connects its respective anchor to the implantation catheter system such that control is maintained over the anchor via the controllable connection between the anchor and the implantation catheter system after the connector is separated, detached, released, cut, etc., thereby releasing the connector's constraint on the relative movement of the implantation catheter and anchor.

[0175] In some implementations, the control tether controllably connects the anchor to the implantation catheter system separately from the connections to the other anchors to the implantation catheter system, or the control tether connects the anchor to the implantation catheter system via one or more other anchors of the plurality of anchors. When the control tether detachably connects the anchor to the implantation catheter system, the control tether may be attached to the implantation catheter system only at the distal catheter portion within the subject's body, or may extend through the implantation catheter system to the proximal end of the implantation catheter system so that it may be directly accessed by medical personnel.

[0176] In some implementations, the tether can be a structure that physically joins two or more separate components (e.g., joining an anchor and a transfer catheter system, or an anchor and another anchor, or other components). In some implementations, the tether can join the components so that they are not flexibly constrained to move separately from one another in one or more (and typically six) degrees of freedom, but are constrained from separating from one another (in one or more degrees of freedom) further than a defined tether limit (e.g., the amount of slack in the tether, e.g., the length of the tether available for expansion). This unconstrained movement within the defined tether limit can be large enough to allow the components to move independently a sufficient distance to facilitate separate placement of the components in functionally independent locations (e.g., such that a first leaflet anchor is attached to a first portion of a first leaflet, while a transfer catheter is positioned with a second leaflet anchor at a first portion of a second leaflet in a different location). In some implementations of tethers that combine and join two or more separate components, the components may be constrained (in one or more degrees of freedom) to not separate from each other further than defined tether limits.

[0177] As used herein, this tether flexibility should be understood to be as flexible as necessary to allow a medical professional to functionally control the position and orientation of one component (e.g., the distal tip of a transfer catheter) without experiencing functionally significant interfering forces delivered through the tether from the opposing movement or position of another tethered component (e.g., a tethered anchor), as long as that tethered component is within the freedom of movement provided by the tether constraints. Simply stated, the tether is flexible enough to allow anchors to be attached to the valve leaflets at greater distances from each other than anchors directly connected to each other. Therefore, mechanical extension devices other than simple cords (e.g., a series of flexible rods and / or joints) may be within the scope of this specification, so long as they provide usable tether flexibility.

[0178] As used herein, a tether may be understood to include multiple individual (separate) portions of a tether that are connected, such as by one tether portion threading through an eyelet formed by another tether portion to form an entire tether. Also, as used herein, limited portions of the tethers and their tether portions are referred to as segments of the respective tethers and / or tether portions. For example, a tether or tether portion may be said to have a first end segment, a second end segment, and an intermediate or central segment (see, e.g., FIG. 25 and related disclosure).

[0179] The control tether is configured such that the tether can be controllably actuated to move one or more connected components relative to the other components (e.g., to cause the leaflet anchors, and thus the leaflets, to coapt after the leaflet anchors are attached to their respective leaflets). The control tether can be formed by (e.g., include) an integral part of one or both of the coapted components and / or by an entirely separate structural element (such as a suture) that attaches or passes through one or both of the two coapted components.

[0180] In some implementations, the control tether (or portion thereof) may be a looped tether. In some implementations, the looped tether (or looped tether portion) can be connected from a proximal end that is actuatable and detachable from or by the implantation catheter system (e.g., the end can remain outside the subject during initial insertion) to a distal end that forms a loop (e.g., slack) that connects to a main connection point associated with a portion of a therapeutic or repair device. As a result, the looped tether can be used to controllably actuate or connect (e.g., hold together) that portion of the device for as long as necessary for implantation, and then the (looped) tether can be removed without physically cutting or severing the device from the looped tether.

[0181] In some implementations, the looped tether extends from a first end segment of the tether (e.g., a first end segment of the control tether or a first end segment of the extension tether) at the proximal end of the transfer catheter system (protruding from the proximal user side of the transfer catheter), down along (through or across) the transfer catheter system to its distal (implantation) end, optionally through a central body positioned at the distal end of the transfer catheter system, and to and slidably received by the tether's main connection point (e.g., a respective anchor of the device). The tether is configured for this removable operation by extending in series (end-to-end) from and through (looped around) the central body, (optionally) back and through the central body, along (through or across) the transfer catheter system back to its proximal end, and to a second end segment of the tether (e.g., a second end segment of the control tether or a second end segment of the extension tether) at the proximal end of the transfer catheter system (which projects from the proximal, user-side of the transfer catheter along with the first end segment of the looped tether). This type of looped tether can be removed from the body by pulling on the first end segment of the tether, leaving the graft implanted, while releasing the second end segment, with the first end segment reeling around the path of the tether loop. Other forms of looped tethers or other releasable tethers that can be used to controllably actuate or connect (e.g., hold together) devices or components thereof and then removed without physically cutting or severing the device are also within the scope of this disclosure.

[0182] In some implementations, the treatment or repair device includes a system (e.g., a control tether system, a tether system, an adjustment system, a coaptation system, an actuation system, a connection system, a control system, etc.). In some implementations, the system can include a central body configured as a coaptation element and / or a spacer. The central body can be configured to be operable to guide (e.g., move, adjust, etc.) and maintain the position of the anchors and, therefore, the valve leaflets. More specifically, with the anchor connectors separated or detached and the central body positioned between the anchors facing opposing surfaces of the anchors, the central body operates to use a level of force (e.g., a connection force, an adjustment force, etc.) up to a maximum level of force (e.g., a maximum allowable level such as a safety limit) to pull and guide the valve leaflets into a position where they are positioned, held, and maintained in proximity to improve their operation as operable valve closure elements.

[0183] In some implementations, as a spacer, the central body is configured with a gap-filling shape, structure, and composition that seals the gap between the valve leaflets to reduce regurgitation. In some implementations, the central body structure is shaped and positioned relative to the valve leaflets so that, upon coaptation, the opposing surfaces of the anchors and their respective leaflets close around the central body at the appropriate time in the cardiac cycle. In some implementations, the central body / spacer can be configured to seal against the opposing surfaces of two or three anchors, and thus against the leaflets of two or three native valves, depending in part on the type of valve to which it is adapted. The central body / spacer can be shaped in any of a variety of shapes, as may be appropriate for the intended use. For example, various shapes may include a cylindrical capsule shape, such as an elongated cylindrical shape characterized by a circular, elliptical, oval, crescent, or even rectangular longitudinal cross-section. In some implementations, the central body can have an upstream (e.g., atrial or upper) portion positioned in or adjacent to the atrium, a downstream (e.g., ventricular or lower) portion positioned in or adjacent to the ventricle, and lateral sides extending between the native valve leaflets. In some implementations, the spacer can be structured as a tubular braided wire, for example, composed of a nitinol mesh.

[0184] In some implementations, the spacer may be a conformable spacer having low compressibility such that when mechanically compressed, it compressively expands in one dimension to become wider and / or longer (or expands in one or more other dimensions) so that the spacer conforms to adjacent opposing surfaces, fills the adjacent space, and may be extruded beyond it.

[0185] In some implementations, the anchors are inserted into the subject simultaneously. In some implementations, at least some of the anchors are individually pulled to a central position by a system having separate, separately extending control tethers (e.g., a control tether system, tether system, coaptation system, actuation system, connection system, control system, etc.). This can be done with two- and three-cusp valves and can incorporate procedures for treating / repairing three-cusp valves using only two-cusp anchors.

[0186] 2-14 , in some implementations of the treatment or repair system (e.g., co-inserted, centrally coupled implementations), a treatment or repair device 101 for use by a medical professional in treating or repairing a subject's native valve is delivered to the valve through the vascular system by a delivery system for valve treatment / repair. In some implementations, the delivery system comprises a steering catheter system including a steering catheter 103 that can operate similarly to other steering catheter systems.

[0187] In some implementations, delivery involves positioning the distal end of the steering catheter 103 upstream (relative to the direction of blood flow 105) of a defective native valve (e.g., the mitral valve MV) and directing the distal end of the steering catheter downstream (in the direction of blood flow) through the native valve.

[0188] In some implementations, the delivery system is provided with a delivery or transfer catheter system including a delivery or transfer catheter 111. In some implementations, the transfer catheter begins to move within the steering catheter system prior to insertion into the subject's body. In some implementations, the transfer catheter is inserted into the proximal end of the steering catheter system (extending outside the subject's body for access by the user) after the steering catheter system is positioned upstream of the native valve. In some implementations, with the steering catheter system in place and the transfer catheter inserted, the distal implant end of the transfer catheter extends downstream from within the steering catheter system toward the native valve (e.g., as shown in FIG. 9 ). In some implementations, the transfer catheter may be steerable. In some implementations, the transfer catheter may be used without a separate steerable catheter.

[0189] At its distal end, a delivery or implantation catheter 111 mounts and carries some or all portions of device 101 (e.g., a treatment device, a repair device, a valve treatment device, a valve repair device, an implantable device, an implant, etc.). In some implementations, device 101 includes two leaflet anchors, e.g., a first leaflet anchor 113 and a second leaflet anchor 115. In some implementations, each anchor has a respective leaflet attachment mechanism (e.g., a first leaflet attachment mechanism and a second leaflet attachment mechanism) in the form of an actuatable clip with an independent actuator and actuation control so that each anchor can be separately and independently attached to a respective leaflet position.

[0190] In some implementations, the clip anchors can each be configured to include two paddles, an outer paddle 117 and an inner paddle 119. In some implementations, the two paddles are connected at one end by a hinge 120. In some implementations, the clip anchors are configured to be affixed to the valve leaflets by, for example, actuating the hinge to clip onto the leaflets by engaging and thus gripping the edges of the leaflets that require constraint for improved valve movement.

[0191] In some implementations, device 101 also includes an anchor connector (e.g., a separable connector, a detachable connector, a cuttable connector, etc.) for each corresponding anchor, e.g., first anchor connector 121 for first leaflet anchor 113 and second anchor connector 123 for second leaflet anchor 115. In some implementations, the first anchor connector forms a separable connection (e.g., a detachable connection, a cuttable connection, a releasable connection, etc.) of the first anchor, and the second anchor connector forms a separable connection (e.g., a detachable connection, a cuttable connection, a releasable connection, etc.) of the second anchor. In some implementations, the device is further provided with an optional central body 131 (e.g., a spacer, a coaptation element, a plug, a gap filler, etc.) and a central body connector 133. In some implementations, the central body connector 133 is a structural fastener that forms a separable connection (e.g., a removable connection, a severable connection, a releasable connection, etc.) of the central body that fastens the central body 131 to the delivery / implantation catheter 111 when in a connected or non-disconnected state (e.g., limiting and / or constraining their relative movement to be synchronized).

[0192] In some implementations, the first connector 121 and the second connector 123, respectively, when in a connected or undisconnected state, fasten their respective first and second leaflet anchors 113 and 115 to the central body 131, thereby forming a first anchor separable connection and a second anchor separable connection that indirectly fastens the first anchor connector and the second anchor connector to the delivery / implantation catheter 111 via the central body. In some implementations, these first anchor separable connection and second anchor separable connection are distinct and independent from one another in that separation or removal of one of the first anchor connector and the second anchor connector does not separate or remove the connection made by the other connector (e.g., does not release the constraint to move in synchronization). Various connector techniques and / or mechanisms, such as those for separating or removing a graft from a transplantation catheter (e.g., clasps, clamps, releases, ties, fasteners, loops, etc.), may be suitable for use as or as parts of connectors.

[0193] In their connected state, the connectors limit and / or constrain the relative motion between their respective devices, typically in six degrees of freedom. For example, in their connected state, the first anchor connector limits and / or constrains the relative motion between the first leaflet anchor and the central body, typically requiring them to move synchronously in six degrees of freedom. Separating or releasing the connector connection places the connector connection in a separated, detached, or released state, which removes the limit and / or constraint on the synchronous (relative) motion between the respective devices (compared to their undetached state). The removed limit and / or constraint is typically six degrees of freedom, but may be fewer degrees of freedom.

[0194] Although various forms of the term "sever" are used herein, it should be understood that in the context of this application and claims, the terms "sever," "severable," "severing," and the like, and similar terms, encompass separating, disconnecting, removing, detaching, and the like (even if no severing occurs).

[0195] In some implementations, the treatment / repair device 101 also includes a system or mechanism, such as a control tether system or mechanism, or other adjustment system / mechanism. In some implementations, the system includes a corresponding control tether for each anchor, e.g., first control tether 141 for first leaflet anchor 113 and second control tether 143 for second leaflet anchor 115.

[0196] In some implementations, each control tether is in the form of a flexible cord (e.g., a suture). In some implementations, each control tether is a looped tether that extendibly fastens its primary connection (which is one or more points on its corresponding anchor) to the central body 131 (and thus to the delivery / implantation catheter 111). In some implementations, this is done by extending in series (end-to-end) from a first end segment at the proximal end of the transfer catheter of the transfer catheter system to its distal (implantation) end, through the central body 131 (positioned at the distal end of the transfer catheter system) to a corresponding anchor of the control tether, slidably received along the length of the corresponding anchor by and through one or more anchor slidable constraints (e.g., a first anchor slidable constraint, a second anchor slidable constraint, a third anchor slidable constraint, an intermediate anchor slidable constraint, and a final anchor slidable constraint), and back through and / or away from the central body and transfer catheter to the second end segment at the proximal end of the transfer catheter system (together with the first end segment of the control tether).

[0197] In some implementations, both the first and second end segments of each control tether are accessible by the user, either directly or using a control mechanism for the implantable device (e.g., one or more of a button, switch, lever, slider, knob, gear, motor, threaded part, screw, cam, gimbal, etc.). In use, the user individually and controllably increases the slack (tether limit) of the control tether by feeding (inserting) one or both control tether ends into the delivery / implantation catheter 111, increasing the available tether length between the central body 131 and the anchors and allowing the corresponding anchor to be more relatively separated from the central body in any direction. The user individually and controllably reduces the slack of each control tether by withdrawing (pulling) one or both control tether ends from the implantation catheter, reducing the available tether slack between the central body and the anchors and restricting the corresponding anchor to be less relatively separated from the central body in any direction. This controllable slack allows the anchors to move controllably in six degrees of freedom, independent of the central body and transfer catheter, and to be pulled back into the central body for placement on the central body.

[0198] In some implementations, the independent movement of the anchors is limited by a corresponding tether limit beyond which each anchor cannot move (e.g., the tether length available for movement). The tether limit is the amount of slack provided to the corresponding control tether. In some implementations, the control tether loops back on itself, so the tether limit changes by half the amount of the control tether length adjusted by the user.

[0199] Using slidable eyelet-type restraints that may be formed as part of the anchor structure, each control tether slidably and / or fixedly connects to its anchor at two locations along the anchor and is slidably fed back to the central body 131 at two locations along the central body. This two-point control tether connection between the anchor and the central body provides greater control over the relative positions of the anchor and central body when slack in the controlled tether is later taken up (e.g., the control tether is tightened).

[0200] Prior to insertion into a subject's body, some or all portions of device 101, such as first and second leaflet anchors 113 and 115, and / or first anchor connector 121 (connected), are mounted together on the distal end of delivery / implantation catheter 111. When mounted on the implantation catheter prior to insertion, the structures of these portions of the device have structural form factors that are sized and shaped within the constraints imposed by the delivery system such that the mounted portions simultaneously traverse the delivery system (as a single implantable unit) through the subject's vasculature.

[0201] In some implementations, these portions of the device 101 may be structurally adapted to switch between a first, small form factor (e.g., small diameter) delivery configuration (as shown in FIG. 9 ) and a second operational configuration configured for therapeutic or repair operations, the delivery configuration being suitable for the attached portion of the device to traverse a delivery system through the vasculature of a subject as a single implantable unit (optionally having a delivery configuration similar to that of other systems).

[0202] In some implementations, the implantation catheter includes one or more actuators that function to actuate the device 101 from a delivery configuration to an operating configuration, while the device is located within the subject's heart. These actuators and their controls may be handle-type controls similar to other actuators and controls for deployment of the implant from within the delivery system (e.g., one or more of buttons, switches, levers, sliders, knobs, gears, motors, threaded components, screws, cams, gimbals, etc.).

[0203] With the delivery or implantation catheter 111 extending from within the steering catheter 103 and pointing downstream toward the mitral valve MV, the implantation catheter moves downstream into, and partially or completely through, the mitral valve to the extent necessary based on the device and valve geometry. When initially delivered to the heart in a delivery configuration, the delivery / implantation catheter 111 actuates the device 101 from the delivery configuration to the working configuration, either before or after passing through the mitral valve MV (as shown in FIG. 9 ).

[0204] As shown in Figures 10-11, with the delivery / implantation catheter 111 moved downstream into and through the mitral valve MV and the device 101 actuated into the operative configuration, the user actuates the implantation catheter to move the device.

[0205] In some implementations, the transfer catheter moves to position the first leaflet anchor 113 at a first location within the heart, positioned and oriented to attach (by clipping) the anchor to a first portion of the edge of the first leaflet 151 that requires constraint for improved movement (e.g., a first portion of the edge of the anterior leaflet 20). The first leaflet anchor 113 is then actuated to attach it to the first portion of the edge of the first leaflet (e.g., actuating the hinge 120 of the first leaflet anchor to seat, e.g., clamp, onto the leaflet edge and attach it to the leaflet).

[0206] Anchor systems, devices, mechanisms, etc. herein for attaching anchors to tissue can take a variety of different forms, e.g., clamping mechanisms, fastening mechanisms, suction mechanisms, adhesive mechanisms, etc. In some implementations, the anchoring systems, devices, mechanisms, etc. are separate and / or independent from systems, devices, mechanisms, etc. for controlling tethers. In some implementations, anchoring systems, devices, mechanisms, etc. for attaching anchors to tissue can be comparable to other anchor actuation systems, such as those using sutures, threaded members, cams, shafts, and / or springs, etc. for controlled opening and closing of clamps, clasps, etc. In some implementations, the clamping systems, devices, or mechanisms are used to clamp and anchor to tissue, e.g., to a valve leaflet.

[0207] 10A shows a treatment or repair device 101 including an exemplary clamping mechanism 200. In some implementations, the clamping mechanism comprises a line 202, such as a suture or wire, and a biasing element 204, such as a spring, elastic member, or the like. In some implementations, the biasing element 204 biases the outer paddle 117 and the inner paddle 119 toward each other. In some implementations, the biasing element 204 biases the outer paddle 117 and the inner paddle 119 away from each other.

[0208] In some implementations, such as when a biasing element biases the outer paddle 117 and the inner paddle 119 toward each other, the line 202 can be routed to pull the line, causing the outer paddle 117 and the inner paddle 119 to move away from each other and open the paddles. In some implementations, such as when a biasing element biases the outer paddle 117 and the inner paddle 119 away from each other, the line 202 can be routed to pull the line, causing the outer paddle 117 and the inner paddle 119 to move toward each other and close the paddles.

[0209] When in the closed position, the relative positions of the outer paddle 117 and inner paddle 119 may optionally be locked.

[0210] 10B illustrates an example of a clamping mechanism 300. In some implementations, the clamping mechanism 300 comprises an actuating element 302 (e.g., a wire, rod, tube, shaft, etc.), an optional follower 304, and a drive link 306 (e.g., a post, shaft, plate, etc.). In the example shown, the optional follower 304 is attached to the distal end of the actuating element 302. In some implementations, the optional follower 304 may be attached to the actuating element 302 by a fastener 307, such as a clip, nut, cap, washer, etc.

[0211] In some implementations, the drive link 306 is pivotally coupled to an optional follower 304 at a pivot 308. In some implementations, the follower 304 is omitted, and the line of the drive link 306 is pivotally connected directly to the actuation element 302. In some implementations, the drive link 306 is pivotally connected to the outer paddle 117 at a pivot 310. In some implementations, movement of the actuation element 302 in a direction 320 can move the drive link 306, which in turn moves the outer paddle 117 toward an open state. In some implementations, movement of the actuation element 302 in a direction 322 can move the drive link 306, which in turn moves the outer paddle toward a closed state. An optional biasing element can bias the outer paddle 117 toward or away from the inner paddle 119. When in the closed position, the relative positions of the outer paddle 117 and inner paddle 119 may optionally be locked.

[0212] The first and second leaflet anchors 113, 115 can take a variety of different forms. In some implementations, the anchors 113, 115 can be configured to snap into an open position and snap into a closed position. For example, the first and second leaflet anchors 113, 115 can be configured like a snap-on hair clip.

[0213] 10C and 10D , in some implementations, the leaflet anchor 413 includes a first arm 417 and a second arm 419. In some implementations, the first arm 417 and the second arm 419 are formed from a single piece of curved and / or bent material, such as a piece of metal or plastic having spring-like properties. In some implementations, the first arm 417 and the second arm 419 are connected together at a closed end 430.

[0214] In some implementations, the first arm 417 and / or the second arm 419 are shaped to snap into a closed configuration ( FIG. 10C ) and to snap into an open configuration ( FIG. 10D ). In some implementations, by moving the first arm 417 in the direction indicated by arrow 422 past the centerline or snap-over line 420, the leaflet anchor snaps into the closed state shown by FIG. 10C . In some implementations, by moving the first arm 417 in the direction indicated by arrow 424 past the centerline or snap-over line 420, the leaflet anchor snaps into the open state shown in FIG. 10D .

[0215] 10E and 10F show an example of a clamping mechanism 500 that uses the leaflet anchor 413 shown by FIGS. 10C and 10D. In some implementations, as illustrated, the clamping mechanism 500 includes a base 502 (e.g., a frame, a coaptation element, and / or a tube, etc.), an actuating element 504 (e.g., a wire, a hypotube, a flexible shaft, etc.), and the leaflet anchor 413. A closed end 430 of the leaflet anchor 413 may be fixed to or coupled to a distal end 432 of the base 502. In some implementations, the actuating element 504 may extend through the base 502 and be releasably coupled to a first arm 417.

[0216] 10E, in some implementations, pushing the first arm 417 with the actuation element 504 in the direction indicated by arrow 524 past the centerline or snap-over line 420 causes the leaflet anchor 413 to snap into the open state. Referring to FIG. 10F, in some implementations, pulling the first arm 417 with the actuation element 504 in the direction indicated by arrow 522 past the centerline or snap-over line 420 causes the leaflet anchor to snap into the closed state.

[0217] In some implementations, the first leaflet anchor 113 can be a detachable anchor. In some implementations, with the first leaflet anchor 113 attached in a first location on the first leaflet, the user actuates a control that detaches or detaches the first anchor connector 121, thereby releasing the first leaflet anchor from its primary connection to the implantation catheter (e.g., its connection via the first anchor connector). Thus, the central body and implantation catheter are free to translate and rotate together in six degrees of freedom relative to the first leaflet anchor. In some implementations, detachment or detachment of a detachably attached first leaflet anchor 113 leaves only the first control tether 141 loosely connecting the first leaflet anchor 113 to the delivery / implantation catheter 111. Thus, they are constrained to each other only in that they cannot be separated from each other any further than allowed by the slack length limit of the first anchor tether.

[0218] In some implementations, the first anchor connector 121 allows the delivery or implantation catheter 111 and central body 131 to position the first leaflet anchor 113 in the correct position for attachment to the first leaflet 151, and then separate / detach / disconnect / release / unsecure the first leaflet anchor from the implantation catheter, central body, and second leaflet anchor 115 after the first leaflet anchor is attached to the first leaflet. In some implementations, the delivery / implantation catheter 111, central body 131, and second leaflet anchor 115 can then move separately from the first leaflet anchor 113 to position the second leaflet anchor 115 at a second location in the heart, positioned and oriented to grip a first portion of the edge of the second leaflet 153 (e.g., a first portion of the edge of the posterior leaflet 22) that requires constraint for improved movement. The second leaflet anchor 115 can be a detachable anchor.

[0219] In some implementations, the user then provides appropriate slack in the first control tether 141 to allow the implantation catheter to move freely (with the second leaflet anchor 115 still attached) to a second location (e.g., a location on the second leaflet 153 requiring constraint) without pulling the first leaflet anchor 113 and the first leaflet 151 together and without being detrimentally pulled and tugged by movement of the first leaflet due to the action of the heart.

[0220] In some embodiments, with the delivery or transfer catheter 111 extending through the mitral valve MV, the device 101 is actuated into an operating configuration, as shown in FIG. 12 . In some embodiments, the first leaflet anchor 113 is attached to the first leaflet 151, and the first anchor connector 121 is separated / detached / cut / unsecured to release the first leaflet anchor from direct attachment to the transfer catheter (although it may still be indirectly attached via a tether connection to another component that may be directly attached to the transfer catheter). In some embodiments, the user actuates the transfer catheter to move the transfer catheter and its attachment portion of the device to position the second leaflet anchor at a second location within the heart, positioned and oriented to grasp a first portion of the edge of the second leaflet 153 requiring constraint for improved operation (e.g., a first portion of the edge of the posterior leaflet 22). This positioning is performed without pulling the first leaflet anchor and the first leaflet toward the second leaflet.

[0221] If the slack in the first control tether is not already adequate, the user can controllably release (extend) the slack on the first control tether 141 to provide this movement without adverse resistance from the first valve leaflet. This can be done by the user releasing the slack on the end of the control tether suture at the proximal end of the implantation catheter, as in the case of other transvascular mechanisms having wires, cords, lines, etc. for control. The implantation catheter can then be actuated to position the second leaflet anchor 115 in a second position. The second leaflet anchor 115 can then be actuated to attach it to a first portion of the edge of the second leaflet (e.g., actuating the second leaflet anchor to clamp against the leaflet edge to attach it to the leaflet).

[0222] In some implementations, with the second leaflet anchor 115 attached to a first location on the second leaflet 153, a user actuates a control that causes the second anchor connector 123 to detach / remove / disconnect / unsecure, and thus release, the second leaflet anchor from the implantation catheter. Thus, the delivery / implantation catheter 111 and central body 131 are free to translate and rotate in six degrees of freedom relative to the second leaflet anchor 115.

[0223] Separation or removal of the separably attached second leaflet anchor 115 leaves only the second control tether 143 loosely connecting the second leaflet anchor to the transfer catheter, and they are therefore constrained to one another only in that they cannot separate from one another any farther than allowed by the slack length limit of the first anchor tether.

[0224] In some implementations, the second anchor connector 123 provides the delivery or transfer catheter 111 to position the second leaflet anchor 115 at a first position for attachment to the second leaflet 153, and then (within the limits allowed by the slack in the second control tether 143) separates / detaches / unsecures / cuts, and thus releases, the second leaflet anchor 115 from its direct attachment to the transfer catheter after the second leaflet anchor is attached to the second leaflet. The delivery / transfer catheter 111 can then be moved separately from the second leaflet anchor 115, such as to position the transfer catheter and central body 131 at a location central to the leaflets.

[0225] In some implementations, the system (e.g., control tether system, tether system, coaptation system, actuation system, connection system, control system, etc.) is configured to allow a user to provide adequate slack in the second control tether 143 to allow the implantation catheter to move freely into position between the leaflets without pulling on either the first leaflet anchor 113 and the first leaflet 151, or the second leaflet anchor 115 and the second leaflet 153, together (and without being detrimentally pulled and tugged by heartbeat-driven movement of the first and second leaflets due to cardiac activity).

[0226] In some implementations, as shown in FIG. 13 , the delivery or transfer catheter 111 and central body 131 are configured so that they can be manipulated by a user to position the intercuspate position. This positioning occurs without pulling the second leaflet anchor and the second leaflet into the coaptation position. Once the delivery / transfer catheter 111 is in the coaptation position, one or more controls (e.g., handle controls, buttons, knobs, switches, sliders, gears, other controls, etc.) can be actuated at the proximal end of the delivery system, e.g., on the handle. In some implementations, the control unit tightens the first control tether 141 and the second control tether 143, respectively, shortening and removing their corresponding slack. The control unit can be configured to controllably tighten one control tether at a time or all control tethers at once.

[0227] While the location of the distal end of the delivery / implantation catheter 111 establishes where the first and second leaflets 151, 153 are pulled, leaflet structural forces and dynamic blood flow forces from each leaflet determine the actual location where the resulting device 101 (e.g., pair of anchors and centerbody) ultimately resides. Based on the attachment of the respective control tethers, each anchor defines opposing surfaces that can be pulled closer together and / or into contact with the centerbody.

[0228] With the first and second leaflet anchors 113, 115 connected to (e.g., in contact with, near, etc.) the delivery / implantation catheter 111 and the central body 131 and thereby connected to one another, the anchor lock locking mechanism locks the anchors into a position (or area) relative to the central body and to one another, thereby constraining the relative movement of the first and second leaflet anchors, and the central body. In some examples, this involves holding the anchors and central body in contact and stationary (e.g., completely stationary, mostly stationary, portions (e.g., connected surfaces) completely stationary while other portions / extensions may move relative to one another, etc.). A variety of structural / mechanical locking mechanisms can be used as anchor locks to effect this locking of the anchors. For example, the central body can be provided with one or more locks that structurally mate with and interlock with each tether anchor to lock them in place.

[0229] In some implementations, the first anchor connector 121 and the second anchor connector 123 can be configured to act as all or part of an anchor lock locking mechanism. In some implementations, the anchors can be configured with locking mechanisms that directly lock to each other to form an anchor lock. In some implementations, segments of the first control tether 141 and the second control tether 143 can be detached and used as part of the anchor lock to lock the first leaflet anchor 113 and the second leaflet anchor 115 in place relative to the central body and / or each other. In some implementations, distal segments of the tightened control tethers are actuated (e.g., pulled), thereby tensioning or drawing the anchors and tightening them toward the central body (thereby moving the anchors toward each other and / or into contact with each other and / or another portion of the device, e.g., the central body, spacer, etc.). In some implementations, actuated control tethers can be locked together to lock the anchors in their relative positions, and then the distal segments of the control tethers can be separated / detached / cut / excised from their respective remaining (proximal) control tether segments (and from the implantation catheter), permanently leaving the distal segments holding the anchors in their fully connected (e.g., touching) relative positions. The term "clinch" includes pulling and / or tightening.

[0230] In some implementations, once the first and second leaflet anchors 113, 115 are locked in place relative to the central body 131 and each other, the first and second control tethers 141, 143 and the delivery / implantation catheter 111 are disconnected from the device 101 and removed from the subject's body (see FIG. 14 ). In some implementations, the second end segment of each control tether is released to advance into the delivery / implantation catheter (passing through the anchor slidable restraint and then back into the implantation catheter), while the first end segment is continuously pulled from the implantation catheter until the entire length of the control tether exits the delivery / implantation catheter. In some implementations where the distal segment of the control tether is severed from the proximal segment, each proximal segment may need to be pulled individually from the implantation catheter.

[0231] With all of the control tethers (or segments thereof) removed, the control can be actuated to cause the central body connector 133 to detach / disconnect / disconnect / unsecure and release the central body from the delivery or transfer catheter (if the central body is the last component released from the transfer catheter, the entire device can then be detached or released from the delivery or transfer catheter). Upon full release, the central body 131 and connected, locked anchors are fully released to translate and rotate in six degrees of freedom along with the valve leaflets. Finally, the delivery system can be removed from the subject.

[0232] By allowing one or more inserted anchors to be separated from each other (and from the rest of the implant) prior to leaflet attachment, the anchors can be attached to the leaflets without resistance from other previously attached anchors. The device can be deployed without experiencing difficulties that can be caused by excessive leaflet spacing and movement relative to each other.

[0233] The devices and / or systems herein can include a wide variety of simultaneous centrally coupled implementations, some of which are explicitly described herein. To the extent appropriate (e.g., capable of implementation), these are also contemplated for use in other embodiments. For example, other implementations can include combinations or subcombinations of features and components disclosed for the following implementations.

[0234] In some simultaneously inserted centrally coupled implementations, the device can include three or more anchors. In some implementations, the treatment / repair device is provided with three anchors, at least two of which are separably attached to the central body. This is particularly advantageous when implanted to improve the operation of valves with three leaflets, such as the tricuspid, aortic, and pulmonary valves.

[0235] 15-20 show an exemplary centrally coupled implementation having three simultaneously inserted anchors during implantation into the tricuspid valve TV. Unless otherwise indicated, elements of the device are substantially the same as similarly named items in the previously described implementations. Where possible, reference numbers are incremented by 100 from the associated centrally coupled implementation.

[0236] In some implementations, a device 201 (e.g., a treatment device, repair device, valve treatment device, valve repair device, implantable device, implant, etc.) is delivered by a delivery system through the vasculature to the tricuspid valve TV for valve treatment or repair similar to the centrally coupled implementations. A transplantation catheter is inserted into the subject's body and extends downstream toward the tricuspid valve. At its distal end, the transplantation catheter carries the device 201, which includes three anchors: a first leaflet anchor 213, a second leaflet anchor 215, and a third leaflet anchor 217, each having a leaflet attachment mechanism in the form of an actuatable clip configured to clip onto the edge of a leaflet requiring constraint for improved valve operation (e.g., the third leaflet attachment mechanism).

[0237] In some implementations, the device 201 also includes a connector for each anchor, e.g., a first anchor connector, a second anchor connector, and / or a third anchor connector. In some implementations, the device is further provided with an optional central body 231 and a central body connector that rigidly fastens the central body to the transfer catheter. In some implementations, the first anchor connector, the second anchor connector, and the third anchor connector are configured to secure and / or rigidly fasten their respective anchors to the central body 231 in six degrees of freedom, which in turn rigidly fastens them indirectly to the transfer catheter via the central body.

[0238] Device 201 also includes first control tether 241, second control tether 243, and / or third control tether 245, each in the form of a flexible suture. Each control tether tightens its respective anchor to central body 231 and, therefore, to the implantation catheter. Each control tether controllably provides slack for the anchor to move independently of the central body and implantation catheter, limited by a corresponding tether limit (slack) and effective tether length for movement. Each control tether slidably and / or fixedly connects to its anchor at two locations along the anchor and to central body 231 at two locations along the central body.

[0239] In some implementations, each control tether is a looped tether that extendibly anchors its primary connection (at one or more points on its corresponding anchor) to the central body 131 (and thus the delivery / implantation catheter 111) by extending in series (end-to-end) from a first end at the proximal end of the transfer catheter of the transfer catheter system to its distal (implantation) end, through the central body 131 (positioned at the distal end of the transfer catheter system) to the control tether's corresponding anchor, being slidably received by and passing through (looped around) one or more slidable restraints along the length of the corresponding anchor, back to and through the central body and transfer catheter at its proximal end, and / or away from there to a second end (e.g., the second end segment of the third control tether) at the proximal end of the transfer catheter system (with the first end segment of the control tether).

[0240] The device 201 may optionally be structurally configured with a first, small form factor delivery configuration and a second operating configuration configured for valve treatment or repair operations. In some implementations, a small form factor, side-by-side, serial delivery configuration (e.g., spaced 120 degrees apart) may be thin enough to pass through a transvascular catheter system. In others, more complex delivery configurations may be required.

[0241] With the implantation catheter extending from within the steering catheter system pointing downstream toward the tricuspid valve TV, the implantation catheter moves downstream into and partially or completely through the tricuspid valve to the extent necessary based on the geometry of the device and valve. When initially delivered to the heart in a delivery configuration, either before or after passing through the tricuspid valve TV, the implantation catheter can actuate the device 201 from the delivery configuration to the operating configuration.

[0242] 16 , with the transfer catheter moved downstream into and through the tricuspid valve TV and device 201 actuated into an operative configuration, the transfer catheter can be actuated to move the transfer catheter and device to position and orient first leaflet anchor 213 at a first location within the heart to grasp a first portion of the edge of first leaflet 251 requiring constraint for improved operation. First leaflet anchor 213 can then be actuated to attach it to the first portion of the edge of the first leaflet.

[0243] With the first leaflet anchor 213 attached to the first leaflet 251, the first anchor connector can be separated / detached / cut / unsecured to release the first leaflet anchor from the transfer catheter. The central body 231 and transfer catheter can be released to translate and rotate together relative to the first leaflet anchor 213. Separation or detachment of the detachably attached first leaflet anchor 213 leaves only the first control tether 241 loosely connecting the first leaflet anchor 213 to the transfer catheter.

[0244] The first anchor connector allows the transfer catheter and central body 231 to position the first leaflet anchor 213 in the correct position to attach it to the first leaflet 251, and then after the first leaflet anchor is attached to the first leaflet, it can be unlocked and released from the transfer catheter, central body, second leaflet anchor 215, and third leaflet anchor 217. The transfer catheter, central body 231, second leaflet anchor 215, and third leaflet anchor 217 can then move separately from the first leaflet anchor 213 to position the second leaflet anchor 215 at a second location in the heart to grasp a first portion of the edge of the second leaflet 253 requiring constraint for improved operation.

[0245] 17 , the first control tether 241 can provide enough slack to allow the transfer catheter to move freely to a second location on the second leaflet 253 without pulling on the first leaflet anchor 213 and first leaflet 251 along with the first control tether 241. The transfer catheter and attachment portion of the device can be moved to a second location within the heart and position (install and orient) the second leaflet anchor to grasp a first portion of the edge of the second leaflet 253 that requires constraint for improved movement.

[0246] If the slack in the first control tether is not already adequate, slack can be controllably released on first control tether 241 to provide for this movement without adverse resistance from the first leaflet. The transfer catheter can be actuated to position second leaflet anchor 215 in a second position. Second leaflet anchor 215 can be actuated to attach to a first portion of the edge of the second leaflet.

[0247] With the second leaflet anchor 215 attached to the second leaflet 253, the second anchor connector can be separated / detached / cut / unsecured to release the second leaflet anchor from the implantation catheter. In some implementations, separation or removal of the detachably attached second leaflet anchor 115 leaves only the second control tether 143 loosely connecting the second leaflet anchor to the implantation catheter.

[0248] In some implementations, the second anchor connector allows the transfer catheter and central body 231 to position the second leaflet anchor 215 in the correct position to attach it to the second leaflet 253, and then, after the second leaflet anchor is attached to the second leaflet, the second leaflet anchor can be unlocked and released from the transfer catheter, central body 231, and third leaflet anchor 217. The transfer catheter, central body, and third leaflet anchor can then move separately from the second leaflet anchor 215 and the first leaflet anchor 213 to position it in a third location within the heart to grasp a first portion of the edge of the third leaflet 255 requiring constraint for improved movement.

[0249] 18 , the second control tether 243 can provide enough slack to allow the transfer catheter to move freely to a third location at the third leaflet 255 without pulling together the first leaflet anchor 213 and first leaflet 251, or the second leaflet anchor 215 and second leaflet 253. The transfer catheter, and portions of the device, can move to a third location within the heart and position (install and orient) the third leaflet anchor to grasp a first portion of the edge of the third leaflet 255 that requires constraint for improved movement.

[0250] If there is not already sufficient slack in the first control tether and the second control tether, the slack on the first control tether 241 and the second control tether 243 can be controllably released to provide for this movement without substantial detrimental resistance from the second leaflet 253. The transfer catheter can be actuated to position the third leaflet anchor 217 in a third position. The third leaflet anchor 217 can be actuated to attach to a first portion of the edge of the third leaflet.

[0251] With the third leaflet anchor 217 attached to the third leaflet 255, the third anchor connector can be detached / disconnected / cut / unsecured to release the third leaflet anchor from the implantation catheter. In some implementations, detachment or detachment of the detachable third leaflet anchor leaves only the third control tether 245 loosely connecting the third leaflet anchor to the implantation catheter.

[0252] In some implementations, the third anchor connector allows the transfer catheter to first position the third leaflet anchor 217 for attachment to the third leaflet 255, and then, after the third leaflet anchor is attached to the third leaflet, to separate / detach / cut / unsecure the third leaflet anchor 217, thereby releasing the third leaflet anchor 217 from the transfer catheter (within the limits allowed by the slack in the third control tether 245). The transfer catheter can then be moved separately from the third leaflet anchor 217, for example, to position the transfer catheter and central body 231 at a location central to the leaflets.

[0253] As shown in FIG. 19, the third control tether 245 may be provided with adequate slack to allow the implantation catheter to move freely to a location between the leaflets (e.g., a central location, a commissure location, etc.) without pulling together either the first leaflet anchor 213 and the first leaflet 251, the second leaflet anchor 215 and the second leaflet 253, or the third leaflet anchor 217 and the third leaflet 255.

[0254] In some implementations, the transfer catheter and central body 231 are then positioned at a coaptation position (e.g., a central location, a commissure location, etc.) between the leaflets. Once the transfer catheter is in the coaptation position, the user actuates a control (e.g., one or more handle controls, buttons, knobs, switches, a touchscreen, etc.) to tighten the first control tether 241, the second control tether 243, and the third control tether 245, respectively, shortening and removing (or reducing) their corresponding slack. Leaflet structural forces and dynamic blood flow forces from each leaflet determine where the resulting device 201 (e.g., connected anchors and central body) will ultimately be located.

[0255] As shown in FIG. 20 , first leaflet anchor 213, second leaflet anchor 215, and third leaflet anchor 217 are connected to (e.g., in contact with) central body 231. The anchors may be locked in place (or relative areas) relative to the central body and each other. Various mechanisms can be used to implement this locking of the anchors. For example, as part of the anchor lock, the central body may be provided with one or more mechanical locks (e.g., clips, clamps, structurally mating portions, interlocking portions, etc.) to lock each tether anchor in place and / or relative to each other. In some implementations, they are locked to contact and / or remain stationary relative to each other (e.g., completely stationary, mostly stationary, with portions (e.g., contact surfaces) that are stationary and other portions (e.g., extensions) that can move somewhat, etc.).

[0256] Optionally, the anchor connector may be configured to act as all or part of the anchor lock. Optionally, the anchors may be configured with mechanical locks that directly lock together as part of the anchor lock. Optionally, distal segments of the first, second, and third control tethers may be detached and used as part of the anchor lock to lock the first, second, and third leaflet anchors 213, 215, and 217 in place relative to the central body and / or each other. In some implementations, the distal segments of the tightened control tethers are clenched together toward the central body and then separated / detached / cut / released from their respective remaining proximal segments (and the implantation catheter) to permanently hold the anchors in their final connected position.

[0257] In some implementations, with first, second, and third leaflet anchors 213, 215, and 217 locked in place relative to central body 231 and each other, first, second, and third control tethers 241, 243, and 245, and the transfer catheter are disconnected from device 201 and removed from the subject's body (see FIG. 14 ). More specifically, the second end segment of each control tether is released to advance into the transfer catheter (upward through the anchor slidable restraint and then downward back through the transfer catheter), while the first end segment is continuously pulled from the transfer catheter until the entire length of the control tether exits the transfer catheter.

[0258] In some implementations, once the first leaflet anchor 213, the second leaflet anchor 215, and the third leaflet anchor 217 are locked in place relative to the central body 231 and each other, the transfer catheter is disconnected from the device 201 and removed from the subject's body. Thus, the central body 231 and the three attached anchors are released to translate and rotate in six degrees of freedom along with the valve.

[0259] By allowing one or more inserted anchors to be separated from each other (and from the rest of the implant) prior to leaflet attachment, the anchors can be attached to the leaflets without resistance from other previously attached anchors, allowing the device to be deployed without suffering from difficulties caused by leaflets with excessive spacing and movement.

[0260] While the described three-anchor implementation connects three leaflets on a tricuspid valve, other scenarios are within the scope of the present disclosure. For example, on a mitral valve (or any three-leaflet valve), two of the three anchors can be attached to the first leaflet, while the third leaflet anchor is attached to the second leaflet. During the implantation process, anchors can be attached alternately to the two leaflets (e.g., to the first leaflet, then the second leaflet, then back to the first leaflet), or a single-anchor leaflet can be attached to its anchor either before or after a leaflet with two anchors. Advantageously, this can provide additional structural support for damaged leaflets at risk of further structural failure and / or better attachment to leaflets with characteristics indicating poor anchor attachment properties. In some implementations, the two anchors on one leaflet can be positioned adjacent to each other on the leaflet (e.g., touching) or spaced apart along the leaflet.

[0261] Using two anchors on one leaflet (as can be done with any device herein having only two anchors, devices with three anchors, and / or devices with more anchors) and bringing them closer together can cause a portion of the leaflet to crease, which can be useful in treating various leaflet problems, such as prolapse.

[0262] 9-14 , in some simultaneously inserted centrally coupled implementations, the second leaflet anchor 115 may be non-separably connected to the central body 131 (e.g., connected to the central body without the use of a controllable anchor connector such that the second leaflet anchor cannot be controllably separated from the central body while in the subject's body). In some implementations, this non-separably connected anchor is still detachably connected to the delivery / implantation catheter 111 in that the central body 131 is detachably connected to the implantation catheter. In some implementations, the first leaflet anchor 113 is detachably connected to the central body 131 by a first anchor connector 121.

[0263] In some implementations, the first anchor connector 121 still allows the delivery or implantation catheter 111 to position the first leaflet anchor 113 in the correct position for attachment to the first leaflet 151, and then the first leaflet anchor can be detached / detached / disconnected / unsecured, and thereby released, from the implantation catheter, central body 131, and second leaflet anchor after it has been attached to the first leaflet 151. The delivery / implantation catheter 111 and central body 131 can then detach and move away from the first leaflet anchor 113 to position the second leaflet anchor 115 at a second location within the heart, where it may be attached to a first portion of the edge of the second leaflet 153.

[0264] In some implementations, for example, when second leaflet anchor 115 is attached by a non-cuttable connector (e.g., a connector that is not a cuttable connector), the location of second leaflet 153 is used as the coaptation location (to the extent that the catheter remains firmly in place). In some implementations (e.g., as described above), leaflet structural forces and dynamic blood flow forces from each leaflet lock the anchors in place relative to the central body (and each other) and determine where the resulting device 101 will end up once delivery / implantation catheter 111 is disconnected from device 101.

[0265] Centrally coupled implementations in which multiple or all anchors are detachable may offer the user greater flexibility in selecting which anchors are attached to which leaflets. Nevertheless, implementations with one or more anchors that are non-detachable can offer benefits in the form of procedural simplification: fewer connectors to separate / detach / disconnect and fewer anchors to lock in place (relative to the central body). They may also benefit from the cost and size advantages of a less complex structure.

[0266] When three or more anchors are combined, one anchor may be non-separable, while the others are separable. In some implementations, two or more anchors may be non-separable, while at least one anchor is separable. In some implementations, greater flexibility in use is emphasized, for example, with two separable anchors. In some implementations, cost and size of a less complex structure may be emphasized, for example, with only one or no separable anchors.

[0267] In some simultaneously inserted centrally coupled implementations, the system (e.g., a controlled tether system, a tether system, etc.) includes one or more multi-anchor control tethers, each having multiple anchor tether segments (e.g., a first anchor tether segment, a second anchor tether segment, and a third anchor tether segment), each extending from an anchor tether segment connection point (or multiple anchor tether segment connection points) on the anchor tether section to a corresponding one of the anchors having an anchor connector (thereby joining the anchor tether segments). In forming the anchor tether section, the anchor tether segments can be connected at the connection points with a connection mechanism, or the segments can be integrally formed (e.g., forming an integral tether that is integrally formed at their connection points in their original formation). The connection points can typically be located on or within the central body before and / or after the anchor connectors are separated / detached / cut.

[0268] In some implementations, the system is a controlled tether system that includes an extension tether portion configured to extendibly fasten the primary connection points of the anchor tether segments to the delivery / implantation catheter 111 (optionally through the central body 131) (and thereby connect to their respective anchors). In some implementations, to make this connection releasably, the extension tether portion extends in series (end to end) from a first end segment of the extension tether at the proximal end of the transfer catheter system (projecting from the proximal user side of the transfer catheter), down along (through or across) the transfer catheter to its distal (implantation) end, into a central body 131 positioned at the distal end of the transfer catheter, where it is slidably received by and connected to (loops around / passes through) the main connection point of the anchor tether segment, back from the central body, back along (through or across) the transfer catheter to its proximal end, and to a second end segment of the extension tether at the proximal end of the transfer catheter system (projecting from the proximal user side of the transfer catheter system along with the first end segment of the extension tether of the extension tether portion).

[0269] In some implementations, the connection is formed between the extension tether portion and the primary connection point of the anchor tether segment by an intermediate segment of the extension tether portion wrapping around the primary connection point of the interconnected anchor tether segment. With this configuration, the extension tether portion can be slidably disconnected (by pulling on one end of the extension tether portion) from the interconnected anchor tether segment when the anchor lock constrains the relative movement of the connected leaflet anchors.

[0270] In some simultaneously inserted centrally coupled implementations, the control tethers do not extend end-to-end from the catheter proximal end to their anchors and back. Instead, each control tether (e.g., a first control tether) extends end-to-end from a first tether end (e.g., a first end segment of the first control tether) at the proximal end of the transfer catheter system (protruding from the proximal user side of the transfer catheter), down along (through or across) the transfer catheter to its distal (implant) end, through and exiting a central body 131 positioned at (and detachably connected to) the distal end of the transfer catheter system, and to the control tether's corresponding anchor.

[0271] In some embodiments, the control tether is attached to the corresponding anchor of the control tether, such that the first control tether extends in series from a first end segment of the first control tether at the proximal end of the transfer catheter system, through a central body slidable restraint on a central body detachably attached to the distal end of the transfer catheter system (by a central body connector), to a second end segment of the first control tether attached to the corresponding anchor of the control tether.

[0272] In some embodiments, the control tether's corresponding anchor is slidably received by and passes through one or more slidable restraints along the length of the corresponding anchor, then returns to the central body to which the anchor is fixedly connected. In some implementations, the first control tether extends in series from a first end segment of the first control tether at the proximal end of the transfer catheter system, through a central body slidable restraint on a central body detachably attached to the distal end of the transfer catheter system (by a central body connector), through a slidable restraint on the control tether's corresponding anchor (e.g., a first slidable restraint on the first leaflet anchor), and back to a second end segment of the first control tether attached to the central body.

[0273] In some implementations, each control tether can slidably connect to its corresponding anchor at one or more locations along the anchor. In some implementations, each tether slidably connects to the central body 131 at one location along the central body and to the corresponding anchor at two locations (as shown in FIGS. 12-13). This provides a two-point tether connection between each corresponding anchor and the central body, restricting the orientation of the anchors when connected (e.g., when contacting each other and / or the central body).

[0274] In some implementations, the anchored and centerbody-anchored versions reduce both the overall required length of tether needed and the total number of tether ends extending from the proximal end of the implantation catheter, but some form of tether cutting mechanism (e.g., a tether cutter) may be required to separate one or more tether segments at the distal end of the control tether. Cutting the control tether leaves one or more proximal tether segments for removal from the subject after implantation is complete. The tether cutter can be configured to cut each control tether individually, or it may be configured to cut all control tethers (that need to be cut) at once.

[0275] In some simultaneously inserted centrally coupled implementations, rather than being in the form of a fully flexible cord, such as a suture, one or more of the control tethers may be in a less flexible form, such as a mechanism or shaft with selectively established bending and torsional flexibility to allow greater flexibility in some degrees of freedom than others. While limiting free independent movement of the anchors during the associated implantation period, this form of control tether may provide some normalizing force to limit the movement and orientation of the anchors relative to each other and the central body to limit complications from fluctuations in blood flow during implantation. In some implementations, the control tether describes a degree of slack that may flexibly allow movement within its movable degrees of freedom.

[0276] In some simultaneously inserted centrally coupled implementations, the anchor is a T-shaped toggle anchor.

[0277] 20-21 , the central body in various implementations can be provided with various forms of joint elements or spacers, such as, for example, a tubular braided wire formed from a nitinol mesh, a molded part, etc. In some centrally coupled implementations, the central body 261 can be a spacer. In some implementations, the spacer can be an elastic spacer, e.g., a spacer formed from a flexible body (material and structure) with low flexibility compressibility for functionally occluding blood flow. The flexible body can be made of various materials, e.g., rubber-like materials and / or material structures (e.g., material combinations), and has elastomeric properties that provide a low-stiffness / high-flow, viscous behavior that deforms rather than compresses under compressive loads, with the body substantially regaining its original shape when the deforming force is removed. In this manner, the elastic spacer can be formed as a relatively incompressible, flexible, monolithic structure that can be molded under compression without significant loss of volume. Exemplary materials can include elastomers such as medical grade silicone, for example, non-reactive, flexible, heat-resistant, water-resistant, and biocompatible polymers that may be suitable for aesthetic medical applications.

[0278] A functionally low flexibility compressibility with respect to occluded blood flow of the flexible body can include a combination of an adequate level of flexibility and a sufficiently low level of compressibility to provide a medically relevant dimensional expansion of the flexible body to blood flow in response to a functionally available level of force from a mechanism that moves the anchors into contact with a spacer (or another type of central body). In some implementations, this can be a force that leads to a dimensional expansion that has a medically significant effect on retrograde blood flow when the flexible body is compressed with available force from a system and / or mechanism to move and compress the anchors into contact with the spacer.

[0279] In some implementations, when compressed with force between opposing surfaces of the anchors, the elastic spacer is flexible enough to conform to the shape of the anchors, rigid enough to expand dimensionally to fill the gap between the anchors, and (generally) protrudes from between the anchors to an extent that the coaptation force is sufficiently high. This expansion maintains the relative position of the anchors in conformity and typically also provides a flow-blocking obstacle to prevent backflow through the valve.

[0280] In some implementations, the flexibility of the elastic spacer also allows the anchors to have a less rigid connection relative to one another, with the elastic spacer holding the anchors in place so that they conform relative to one another. Thus, the anchors can move relative to one another in response to forces exerted on them by the valve leaflets and blood flow. Thus, the elastic spacer central body may allow connected anchors (e.g., anchors in contact with the spacer, central body, etc.) to move relative to one another, thereby adapting to blood flow and the natural movement of the valve leaflets during the cardiac cycle.

[0281] In some implementations, the elastic spacer material and structure are not simply adapted to be clamped into a collapsed shape with reduced volume and dimensions (as existing spacers are). Instead, they are sized, structurally formed, and shaped so that when mechanically compressed between the anchors, they compressively expand and bulge outward, becoming wider and / or longer than their uncompressed shape. In response to forces (e.g., compressive, actuating, moving, connecting, etc.) available from a system and / or mechanism (e.g., a connection system that adjusts the connection and position between the anchors and the spacer), the elastic spacer can be extruded to extend beyond the anchor-facing surface (typically balloon-like) to fill the space adjacent to and beyond the boundaries of the anchors. This effect can occur due to the typical monolithic form of the material and structure (e.g., not simply a flexible mesh on a frame) and its functionally low compressibility.

[0282] In some implementations, as the first leaflet anchor 213, the second leaflet anchor 215, and the third leaflet anchor 217 are drawn into the conforming central body 261 by their respective control tethers, the control tethers are pulled with a centering force sufficient to deform the conforming central body, filling any voids between the anchors and typically forcing the anchors to act as compression bodies that protrude beyond the anchor boundaries into the inter-leaflet spaces. This also draws the leaflets together, further improving the seal. In some implementations, the anchors are attached directly to a structural component of the conforming central body via the control tethers. The structural component can be a central, shaft-shaped catheter with a spacer forming a flexible periphery.

[0283] Advantageously, this conforming central body allows the leaflets to function and move more normally relative to one another during valve operation, especially compared to devices that do not use a central body or that use a central body that holds the leaflets rigidly.

[0284] The above-described devices and systems provide and / or can be used in one or more methods for treating / repairing a subject's native valve, the valve having multiple leaflets (e.g., a first leaflet and a second leaflet, and possibly a third leaflet). In some implementations, the method involves providing a treatment or repair device 101 mounted on the distal end of a delivery or implantation catheter 111. The method can be performed in a living animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., a simulated body part, heart, tissue), etc.

[0285] In some implementations, the device 101 includes a first leaflet anchor 113, a second leaflet anchor 115, a first anchor connector 121, and / or a system (e.g., a control tether system, a tether system, a coaptation system, an actuation system, a connection system, etc.). In some implementations, the first anchor connector forms a separable / detachable / disconnectable connection between the first leaflet anchor 113 and the delivery or implantation catheter 111. In some implementations, the second leaflet anchor is connected to the implantation catheter independently of the first anchor connector. In some implementations, the system is operable to bring the first and second leaflet anchors closer together and / or into contact (e.g., with each other and / or with the optional central body, coaptation element, or spacer) even when the first connection is separated or detached (e.g., in its separated, detached, or disconnected state).

[0286] In some implementations, the method includes the steps of delivering a treatment / repair device attached to a transfer catheter to the valve, positioning a first leaflet anchor 113 at the first leaflet, attaching the first leaflet anchor to the first leaflet, separating / removing / cutting the first anchor connector 121, positioning a second leaflet anchor 115 at the second leaflet, attaching the second leaflet anchor to the second leaflet, connecting the first and second leaflet anchors, and releasing the device 101 from the transfer catheter.

[0287] In some implementations, the first anchor connector 121 is separated / detached / cut after the first leaflet anchor 113 is attached to the first leaflet. In some implementations, the second leaflet anchor 115 is also positioned at the second leaflet after the first anchor connector is separated / detached / cut. Once the second leaflet anchor is positioned at the second leaflet, the second leaflet anchor can be attached to the second leaflet.

[0288] In some implementations, after the first and second leaflet anchors are attached to the respective first and second leaflets (and the first anchor connector 121 is separated / detached / disconnected), the first and second leaflet anchors are approximated and / or contacted (with each other and / or another portion of the device) using a system (e.g., a control tether system, a tether system, a coaptation system, a connection system, an actuation system, a control system, etc.). In some implementations, once they are connected and / or moved into a desired relative position, the device 101 is released from the implantation catheter.

[0289] In some implementations, the method can include use of an anchor lock. In some implementations, the device 101 includes an anchor lock with a locking mechanism that locks the relative positions of the first and second leaflet anchors (relative to each other). In some implementations, after the first and second leaflet anchors are connected (e.g., contacted, connected to each other via contact with another part or the central body, etc.), the first and second leaflet anchors are locked in their relative positions relative to each other using the anchor lock.

[0290] In some implementations, the system may originally be provided without enough slack to allow the second leaflet anchor 115 to be positioned on the second leaflet without interference from its connection to the first leaflet. The method may further include controllably releasing the slack on the system. In some implementations, this will generally occur after the step of separating / detaching / disconnecting the first anchor connector 121 and before the step of attaching the second leaflet anchor to the second leaflet.

[0291] In the case of a valve having three leaflets, device 101 can include a second anchor connector that forms a separable / detachable / disconnectable connection between second leaflet anchor 115 and the implantation catheter. In some implementations, the third leaflet anchor is connected to the implantation catheter independently of the first and second anchor connectors, and the system is operable to bring the first, second, and third leaflet anchors into approximation and / or contact (with each other and / or with another portion of the device, e.g., central body, spacer, edge, surface, etc.) after the first and second separable / detachable connections are separated / detached / disconnected.

[0292] In some implementations, after the second leaflet anchor 115 is attached to the second leaflet (of the three leaflets), the second anchor connector is separated / detached / cut. In some implementations, the third leaflet anchor is positioned on the third leaflet and the third leaflet anchor is attached to the third leaflet. In some implementations, in the moving step, the first leaflet anchor, the second leaflet anchor, and the third leaflet anchor move toward each other and / or into contact with each other (or with another part of the device).

[0293] In some implementations of the methods in which the various systems, devices, apparatuses, etc. herein may be used, including but not limited to the methods described above for treating / repairing a subject's native valve, the various systems, devices, apparatuses, etc. herein may include one or more anchors that can be detached from and / or reattached to the valve leaflets, and the method may include detaching the one or more anchors from the one or more valve leaflets and / or reattaching the one or more anchors to the one or more valve leaflets.

[0294] In some implementations, after the anchor connectors are separated / detached / disconnected, a system (e.g., a controlled tether system, a tether system, a coaptation system, an actuation system, a connection system, a control system, etc.) can be used to connect the corresponding leaflet anchor to the implantation catheter. In some implementations, the implantation catheter can be used to reposition the corresponding anchor relative to that leaflet (or another leaflet). In some implementations, the leaflet anchor can then be attached to its new position, and the method can proceed as described above.

[0295] In some implementations, the method may further include moving the first leaflet anchor and the transfer catheter using the system, detaching the first anchor connector from the first location (e.g., detaching it from the tissue at the first location), and attaching the first leaflet anchor to another location (e.g., a different tissue location).

[0296] The method can be performed on a living subject or in a simulation, such as a cadaver, a cadaver heart, a simulator (eg, a simulated body part, heart, tissue, etc.), etc.

[0297] In some implementations, each of the multiple leaflet anchors is inserted into the subject in series, with some (or more) being separately pulled (independently of each other) toward and against the central body by separate control tethers. Further details of these implementations can be obtained from similar aspects of the first (simultaneously inserted, centrally coupled) implementation. These sequentially inserted implementations are applicable to two- and three-leaflet valves (as further described) and can incorporate currently used procedures for repairing three-leaflet valves using only two leaflet anchors.

[0298] 2-8, 22A, 22B, 22C, 22D, 23, and 24, in some implementations (e.g., in a serially inserted, centrally coupled implementation of the treatment or repair system), a treatment or repair device 301 for use by a medical professional in treating or repairing a native mitral valve MV of a subject's heart can be constructed or assembled within the heart (at the valve location) using a delivery system. With reference to FIG. 22A, in some implementations, the delivery system includes a steering catheter system and / or steering catheter 303 that can operate similarly to other steering catheter systems or steering catheters. Accelerating delivery through the vasculature can involve positioning the distal end of the steering catheter 303 in position upstream of the valve (relative to the direction of blood flow) and directing the distal end of the steering catheter downstream (in the direction of blood flow) through the valve.

[0299] 22B-22D , in some implementations, the delivery system further comprises a transfer catheter system including one or more transfer catheters (which may be the same as or similar to other catheters herein and may be in addition to or instead of a steering catheter). In some implementations, the transfer catheter system comprises multiple transfer catheters. In some implementations, each transfer catheter has a catheter distal end that traverses the steering catheter system for implantation of the treatment / repair device and a catheter proximal end (e.g., a first catheter proximal end, a second catheter proximal end, and a third catheter proximal end) accessible to the user for remotely manipulating and operating the device during implantation.

[0300] In some implementations, the first transfer catheter 311 of the multiple transfer catheters begins moving within the steering catheter system prior to insertion into the subject's body, or is inserted into the proximal (user-side) end of the steering catheter system (with its proximal end extending outside the subject's body) after the distal end of the steering catheter system is positioned upstream of the mitral valve MV. In some implementations, once the steering catheter system is in place and the first transfer catheter 311 is inserted into the steering catheter system, the first catheter distal end of the first transfer catheter 311 extends downstream from within the steering catheter system toward the mitral valve (similar to the transfer catheter shown in FIG. 9 ).

[0301] In some implementations, at its first catheter distal end, the first transfer catheter 311 carries a first leaflet anchor 313 of the device's multiple leaflet anchors. Each leaflet anchor of the multiple leaflet anchors is in the form of an actuatable clip having an independent actuator and actuation control so that each anchor can be separately and independently attached to a respective leaflet location. In some implementations, the leaflet anchors are structurally adapted to be attached to the leaflets by clipping onto the leaflets.

[0302] In some implementations, each of the multiple leaflet anchors comprises and is attached to the distal end of the transfer catheter (of one or more transfer catheters) by a corresponding anchor connector (of the multiple anchor connectors); e.g., first leaflet anchor 313 is attached to first transfer catheter 311 by first anchor connector 321, second leaflet anchor 315 is attached to second transfer catheter 316 by second anchor connector 323, third leaflet anchor is attached to third transfer catheter by third anchor connector, etc. Additional leaflet anchors may optionally be attached to the transfer catheter by respective additional anchor connectors. In some implementations, each anchor connector has a corresponding catheter connector (e.g., a first catheter connector adapted to connect to the first catheter distal end of the transfer catheter of the first anchor connector, a second catheter connector adapted to connect to the second catheter distal end of the transfer catheter of the second anchor connector, and a third catheter connector adapted to connect to the third catheter distal end of the transfer catheter of the third anchor connector).

[0303] In some implementations, the anchor connector is constructed to operate between a connected state (e.g., a non-disconnected state) and a detached / detached state (e.g., a disconnected state). In the connected state, the leaflet anchors of the anchor connector are constrained to move in one or more (and typically six) degrees of freedom relative to their delivery / implantation catheter (e.g., they are constrained to move synchronously with one another). In the detached / detached state of the anchor connector, the relative motion of the leaflet anchors and their connected implantation catheter is no longer constrained by the anchor connector.

[0304] In some implementations, each leaflet anchor also comprises and is attached to a corresponding anchor tether in the form of a control tether (of the plurality of control tethers), e.g., first control tether 341 is attached to first leaflet anchor 313, second control tether 343 is attached to second leaflet anchor 315. In some implementations, each of the first and second control tethers is in the form of a flexible cord (e.g., suture, wire, line, braid, thread, yarn, etc.).

[0305] In some implementations, with each anchor connector connected to the distal end of its delivery or transfer catheter, the control tether extends from the distal end of the control tether at its corresponding leaflet anchor to the proximal end of the control tether at the catheter proximal end of the connected transfer catheter. In some implementations, the transfer catheter can be removed after the anchors are connected to the leaflets, but each control tether secures its corresponding anchor to the steering catheter by extending serially through the steering catheter 303 from the corresponding tether distal end (e.g., first tether distal end, second tether distal end, third tether distal end) at its corresponding anchor to the tether proximal end (e.g., first tether proximal end, second tether proximal end, third tether proximal end) protruding from the proximal (user side) end of the steering catheter. In some implementations, each control tether is accessible, controllable, and actuable by the user at the proximal end of the steering catheter, either directly or using a control mechanism for the implantable device (e.g., a knob, motor, button, switch, slider, gear, motor, screw, cam, gimbal, etc.).

[0306] In some implementations, the treatment / repair device may further comprise a locking central body 331, e.g., a locking central body, and a central body connector 333 that connects the central body to a central body implantation catheter 335. In some implementations, the central body is sized and shaped (adapted) to receive the proximal ends of the control tethers of the implanted individual leaflet anchors and forms one or more central body openings through which the first control tether 341 and the second control tether 343 extend. In some implementations, the central body is slidable along the control tethers to their distal ends, with the control tethers threaded through the central body openings.

[0307] In some implementations, once the central body is inserted into the heart, the control tethers can be pulled through the central body and out its proximal end to approximate and / or contact the leaflet anchors (with each other and / or with another portion of the device). The control tethers can be configured to pull against the edges of the central body, which can also help direct the force that approximates and / or contacts the leaflet anchors.

[0308] In some embodiments, during use, the first connected assembly including the first transfer catheter 311, the first anchor connector 321, the first leaflet anchor 313, and the first control tether 341 is controllably inserted into the steering catheter 303 by a user. Using the first transfer catheter, the first leaflet anchor is guided into the leaflet of the valve. In some embodiments, the first leaflet anchor 313 is attached to the leaflet, and the first anchor connector 321 is then separated / detached / cut. In some embodiments, the first transfer catheter 311, and any remaining portion of the first anchor connector 321 still attached thereto, are then withdrawn from the steering catheter 303.

[0309] In some implementations, from the time of insertion, the first control tether 341 extends from the first leaflet anchor 313 (attached to the leaflet) to the proximal end of the steering catheter outside the subject's body. After implantation of the first leaflet anchor is complete, each of the other assemblies of transfer catheter, anchor connector, anchor, and control tether are 1) inserted into the steering catheter, 2) attach their anchors to the leaflets, 3) remove / disconnect / cut their anchor connectors, and 4) implanted so that the transfer catheter remains attached to the leaflets when withdrawn from the steering catheter (in the manner in which the first assembly was made).

[0310] Once all of the anchors have been inserted and attached in series to the valve leaflets, a user (outside the subject's body) can feed each of the control tethers into the central body openings that form a passageway through the locking central body 331, thereby stringing the central body over the entire set of control tethers. In some implementations, this central body passageway forms an anchor lock in the form of a tightening cable lock 351 that allows the control tethers to be withdrawn from the central body in only one direction, such that the central body can be advanced along the control tethers toward the anchors but cannot be pulled along the control tethers away from the anchors. The central body implantation catheter 335 can be used to controllably insert the central body 331 into the steering catheter 303 and hold the control tethers to prevent them from being fully withdrawn into the subject's body (thereby advancing the central body along the control tethers toward the anchors).

[0311] As used herein, a cable lock can comprise a device in which a cable (e.g., a tether) is locked in place by a cord locking element (e.g., a cog, tongue, lock, clamp, set screw, cam, lever, etc.) that compresses and locks the cord to, for example, prevent or inhibit movement of the cord relative to the cable lock in one or both directions that the cord extends through the cable lock. This compression can occur through various ratcheting or sliding mechanisms, similar to cable locks.

[0312] In some implementations, the central body implantation catheter 335 can be used to position or position the locking central body 331 within the center of the valve, and the control tethers can be pulled proximally to move the anchors toward (and to) the location of the central body, locking the anchors to the central body, thereby assembling the device in a form operable to support improved valve operation.

[0313] In some implementations, with the anchors fully opposed and locked to the central body, a tether cutting device (e.g., a tether cutter 345 on the locking central body 331 or central body implantation catheter 335) cuts the control tethers, so that the distal segments of the control tethers and their respective anchors remain clamped and locked in place relative to the locking central body 331 to maintain the anchor connections.

[0314] In some implementations, the central body and locking mechanism, after moving into contact with the central body, form an anchor lock that constrains the relative movement of the first, second, and third leaflet anchors. The remaining (detached) proximal segment of the control tether is then withdrawn proximally from the steering catheter, removing them from the subject's body.

[0315] In some embodiments, with all of the proximal segments of the control tether removed, a control can be actuated to separate / detach / cut the central body connector 333, releasing the central body and thereby releasing the assembled device from the central body implantation catheter. In some embodiments, the central body 331 and first and second leaflet anchors 313, 315 are fully released to translate and rotate with the leaflets (relative to the central body implantation catheter 335 and the remainder of the delivery system) in six degrees of freedom. In some embodiments, the central body implantation catheter 335 and steering catheter are removed from the subject, concluding the procedure using a typical procedure.

[0316] In some implementations, by allowing one or more inserted anchors to be separated from one another (and from the rest of the implant) prior to leaflet attachment, the anchors can be attached to the leaflets without interference or resistance from other previously attached anchors. Thus, the device can be deployed without experiencing difficulties caused by leaflets having excessive spacing and movement relative to one another.

[0317] In some implementations, the procedure / method may differ from some other implementations in that it provides a greater number of anchors and / or anchors with a larger form factor for use through a steering catheter of limited size, further isolating the anchoring procedure from interference by other anchors. Of course, combinations of these implementations, such as those in which multiple anchors are inserted on each of multiple sequentially inserted transfer catheters, are within the scope of this specification.

[0318] While some implementations have been described as connecting three leaflets on a tricuspid valve, other scenarios are within the scope of the concepts herein. For example, multiple anchors could be attached to one or more leaflets on either a two-leaflet valve or another three-leaflet valve. During the implantation process, anchors could be attached between leaflets (e.g., back and forth between two or three leaflets), or between two points on one leaflet and then another leaflet, alternating. Advantageously, this can provide additional structural support for damaged leaflets at risk of further structural failure and / or better attachment to leaflets with characteristics indicative of poor anchor attachment properties.

[0319] A wide variety of sequentially inserted and centrally coupled implementations are within the scope of this specification, some of which are explicitly described herein. To the extent they are usable, these variations are also contemplated for use with other implementations herein. Thus, the treatment / repair systems and / or devices can include any combination or subcombination of the features and variations disclosed herein, and can exclude some described features.

[0320] Referring to FIG. 25, in some serially inserted centrally coupled implementations, rather than each control tether being integrally formed (e.g., an integrally formed anchor tether long enough to extend through the length of the steering catheter), each control tether may be formed in two portions: a relatively short anchor tether portion 363 (e.g., three control tethers would have a first anchor tether portion, a second anchor tether portion, and a third anchor tether portion) and a looped extension tether portion 365 (e.g., a first extension tether portion, a second extension tether portion, and a third extension tether portion).

[0321] In some implementations, each anchor tether portion 363 may be permanently attached to its corresponding anchor 367 at a distal end (e.g., a first distal end, a second distal end, and a third distal end) of the anchor tether portion. In some implementations, at a proximal end (e.g., a first proximal end, a second proximal end, and a third proximal end) of the anchor tether portion 363, the anchor tether portion forms eyelets 369 (e.g., a first eyelet, a second eyelet, and a third eyelet) in the form of a slidable eyelet-type restraint that serves as the primary connection for the extension tether portion 365. This connection typically occurs prior to insertion of the anchor into a subject.

[0322] In some implementations, each looped extension tether portion 365 has a proximal first end segment 371, a proximal second end segment 373, and a distal intermediate segment 375. For example, a first control tether will have a first first end segment, a first second end segment, and a first intermediate segment. Similarly, a second control tether will have a second first end segment, a second second end segment, and a second intermediate segment, and a third control tether will have a third first end segment, a third second end segment, and a third intermediate segment.

[0323] In some implementations, the intermediate segment is intermediate the first and second end segments relative to (along) the extended tether portion. In some implementations, when each anchor and its respective two tether portions (anchor tether portion and extended tether portion) are initially implanted, the first and second end segments 371, 373 of the extended tether portion 365 are constrained as they extend from the proximal end of the steering catheter, and the intermediate segment 375 forms slack that extends through the eyelets of the anchor tether portion 363, such that the corresponding anchors can be brought closer together and / or into contact by pulling the first and second end segments of the extended tether portion 365 together.

[0324] Similar to some of the serially inserted centrally coupled implementations described above, when all of the anchors are attached to their respective leaflets, the locking central body 331 can be implanted within the center of the valve. In some implementations, the looped extension tether portions 365 of the control tether can be pulled proximally to move the anchors toward and into place at the central body, tightening the control tether and locking each anchor 367 to the central body, thereby assembling the device in a configuration operable to support improved valve operation. In some implementations, the anchor tether portions 363 are sufficiently long so that after assembly of the device (by tightening and locking), they extend through the central body and are constrained (locked) by the locking central body to maintain the structure of the implant.

[0325] In some implementations, rather than having a tether-cutting device operating inside the heart, each of the looped extension tether portions can be removed from the subject's body by pulling on the first end segment of each looped extension tether portion while releasing the second end segment, causing the second end segment of the extension tether portion to slide up to the eyelet, slip out through the eyelet, and then be pulled out of the body.

[0326] In some serially inserted centrally coupled implementations, rather than each anchor having its own associated transfer catheter, a single transfer catheter (or transfer catheter system) is repeatedly used to implant each anchor one at a time in a serial manner. To this end, in some implementations, the catheter connector of the first anchor connector 321 has a quick-release mechanism that is initially separably or removably attached to the first transfer catheter 311 during the implantation procedure and then detached during the implantation procedure so that the second anchor connector 323 can be attached to the first transfer catheter during implantation. For example, the single transfer catheter 311 can be repeatedly threaded through the steerable catheter 303 to attach a leaflet anchor to the native valve leaflet, detach from the leaflet anchor, withdrawn from the steerable catheter, attached to the next leaflet anchor, and then threaded back through the steerable catheter to deploy the next anchor. This allows a series of anchors to be implanted using a single transfer catheter.

[0327] In some implementations, each leaflet anchor has its own tether. In some implementations, the first leaflet anchor in a series of leaflet anchors has a tether, and subsequent leaflet anchors have loops through which the first anchor's tether threads (see examples in FIGS. 26 and 27 ). Implementations using a first anchor with a tether threaded through the loops of subsequent tethers can be implemented using a single implantation catheter or multiple implantation catheters (e.g., each anchor connected to its own implantation catheter, as described above).

[0328] Quick release mechanisms and / or devices can generally be attached and detached without adverse effects to the subject and in a time frame short enough to be used in setting up implantation of an implant or device.

[0329] In some serially inserted centrally coupled implementations, each anchor connector may be more rigidly constrained by a reduced number of degrees of freedom rather than rigidly clamping (constraining) its corresponding anchor in six degrees of freedom. For example, pivoting and / or translating some of the anchors may allow the anchors the ability to elastically adapt to changing leaflet positions during fluctuations in blood flow. This reduced constraint may come at the expense of significant user controllability. User preference and / or case-specific circumstances may best determine the preferred form of connector.

[0330] In some sequentially inserted centrally coupled implementations, some or all of the sequentially inserted transfer catheters can carry two or more anchors in a manner similar to the first implementation. Advantageously, this limits the number of transfer catheter insertions while allowing a greater number of anchors to be inserted.

[0331] In some partial simultaneous or hybrid anchor delivery implementations, for each sequential set of simultaneous delivery anchors, the anchors are tethered to the catheter by a single control tether. In some implementations, each anchor has one or more respective anchor slidable restraints (e.g., eyelets) along which the single multi-anchor control tether extends in series, or each anchor is attached to a short-length first end segment of an anchor tether portion having an eyelet at its proximal end (along which the single multi-anchor tether extends in series).

[0332] In some serially inserted centrally coupled implementations, rather than being in the form of a fully flexible cord such as a suture, one or more of the tethers (or tether portions) may be in a less flexible form, such as a mechanism or shaft, with its bending and torsional flexibility selectively established to allow it to be more flexible in some degrees of freedom than others. While partially restricting the free and independent movement of the anchors during the associated implantation period, this form of tether may provide some normalizing force to limit movement and orientation of the anchors relative to each other and the central body due to fluctuations in blood flow during implantation. In some implementations, slack represents the degree to which the tether can flexibly allow movement within its movable degrees of freedom.

[0333] In some serially inserted centrally bonded implementations, the anchors are T-shaped toggle anchors. In some implementations, other types of anchors are used (e.g., any of the other anchors described herein, clips, clasps, darts, hooks, staples, screws, coils, etc.).

[0334] In some implementations, the system / device can include a central body. In some implementations, the central body can include a compliant spacer 381. In some implementations, the compliant spacer can be formed with a unitary, relatively incompressible, flexible periphery that has sufficiently low stiffness (low compressibility) so that it can be molded under compression without significant loss of volume. The central body and other central body structural details described elsewhere herein can be incorporated herein.

[0335] In some implementations, the conforming central body (e.g., its spacer) allows the leaflets to function and move more normally relative to one another during valve operation, especially compared to devices that do not use a central body or that use a central body that holds the leaflets rigidly.

[0336] In some end-coupled implementations, the multiple leaflet anchors (e.g., anchor group) that are ultimately implanted are strung along a single implant-controllable tether (first control tether) formed by one or more lengths of tether running along a single path with a distal leaflet anchor at the distal end of the implant-controllable tether (which may be the first leaflet anchor to be implanted). In some implementations, the anchor group includes one or more (e.g., multiple) additional leaflet anchors slidably connected to the implant-controllable tether proximal to the distal leaflet anchor. This can be achieved in a variety of different ways. In some implementations, the distal leaflet anchor has a tether, and subsequent leaflet anchors have a loop through which the tether of the distal anchor passes. This example, with a distal anchor having a tether that passes through a loop of the subsequent tether, can be implemented using a single transfer catheter or multiple transfer catheters, as described above. In some implementations, the additional leaflet anchors include a proximal leaflet anchor (also referred to as a second leaflet anchor) and a mid-leaflet anchor (which may be one of one or more mid-leaflet anchors) intermediate the distal and proximal leaflet anchors.

[0337] In other words, in the anchor group formed by the distal leaflet anchor and the additional leaflet anchor, the proximal leaflet anchor can be at the proximal end of the anchor group, the distal leaflet anchor can be at the distal end of the anchor group, and one or more mid-leaflet anchors are intermediate the distal and proximal leaflet anchors, including a third mid-leaflet anchor and a fourth mid-leaflet anchor, etc. In some implementations, each leaflet anchor comprises a corresponding leaflet attachment mechanism (e.g., a first distal leaflet attachment mechanism, a third mid-leaflet attachment mechanism, and a second proximal leaflet attachment mechanism).

[0338] In some implementations, an anchor lock is included that locks onto the implant-controllable tether adjacent to the proximal leaflet anchor and restricts any proximal movement of the (proximal) proximal leaflet anchor along the implant-controllable tether. To this end, the anchor lock may comprise an end body integral with the proximal leaflet anchor or may form a separate end body connected to the implantation catheter using an end body connector. In some implementations, the anchor lock is configured to apply a distal force to the proximal leaflet anchor, such as by being positioned proximally relative to the proximal leaflet anchor or by otherwise preventing the proximal leaflet anchor from moving distally. In some implementations, a middle leaflet anchor intermediate the distal and proximal leaflet anchors is slidably threaded on the implant-controllable tether and is held on the implant-controllable tether by the distal leaflet anchor and the end body.

[0339] In some implementations, the leaflet anchors are implanted using a delivery system including a transfer catheter having a proximal catheter end and a distal catheter end. In some implementations, the leaflet anchors are detachably connectable to the transfer catheter using one or more anchor connectors (e.g., a distal anchor connector forms a detachable / separable / disconnectable connection for the distal anchor, a middle anchor connector forms a detachable / separable / disconnectable connection for the middle anchor, and a proximal anchor connector forms a detachable / separable / disconnectable connection for the proximal anchor), each of which is severed after its respective leaflet anchor is attached to the leaflet.

[0340] In some implementations, the one or more anchor connectors may be in the form of a connector cartridge that sequentially detaches / disconnects / severs that connection from the first implanted leaflet anchor to the last implanted leaflet anchor, which may or may not be a distal and proximal leaflet anchor, respectively.

[0341] Once all of the leaflet anchors (of the anchor group) are attached to the leaflets, in some implementations, the implant-controllable tether can be pulled proximally through the end body opening formed by the anchor lock end body, drawing the distal leaflet anchors toward the proximal leaflet anchors and connecting (e.g., contacting another portion therebetween, connecting another portion therebetween, contacting another portion therebetween, etc.) the distal and proximal leaflet anchors, and any intermediate leaflet anchors that are drawn together in the process. Once the distal and proximal leaflet anchors have been moved into position, in some implementations, the anchor lock locks to the implant-controllable tether, constraining the distal and proximal leaflet anchors (e.g., the first and second leaflet anchors) from moving away from each other relative to the implant-controllable tether. Optionally, the anchor lock can be a one-way tightening mechanism that automatically locks when moved distally along the implant-controllable tether. Once the distal and proximal leaflet anchors are fully connected and the anchor lock is locked to the implant-controlled tether, in some implementations, the entire group of anchors is thereby connected and end-tied in place along the implant-controlled tether. The segment of the implant-controlled tether extending proximally from the anchor lock can then be separated (e.g., cut or otherwise disconnected) from the remaining anchor-connected portion (e.g., the distal portion) of the implant-controlled tether and removed from the subject.

[0342] In some implementations, the end-bonded anchors can be constrained together sequentially along a single implant tether path between two longitudinal ends of a segment of the implant-controlled tether. In some implementations, the implant tether segments forming the path can be made of multiple lengths of tether material connected and / or looped in series and / or parallel along the implant tether path between the longitudinal ends defined by the proximal and distal leaflet anchors. The terms "distal" and "proximal" anchors can be used with reference to the position of the anchors along the implant-controlled tether, rather than the location of the implanted anchors within the heart. The terms "first implanted" and "last implanted" refer to the chronological order in which the anchors are attached to the valve leaflets, which may or may not be the sequential order in which they are positioned along the tether or attached to the implantation catheter.

[0343] In some implementations, the implant-controlled tether includes two connected implant tether portions, a looped extension tether portion that forms a proximal portion of the implant-controlled tether, and a distal anchor tether portion that forms a distal portion of the implant-controlled tether (and is attached to the distal leaflet anchor). In some implementations, the extension tether portion extends between an extension tether proximal end segment at the catheter proximal end of the implantation catheter of the delivery system and an extension tether distal end segment connected to the proximal end of the distal anchor tether portion.

[0344] In some implementations, during assembly and connection of the implant, the pair of mid-leaflet anchors along the implant-controlled tether are not directly and separately moved toward the mid-position by the anchor lock alone. Instead, an overall force is applied to the proximal and distal leaflet anchor locations, with the distal leaflet anchor being pulled proximally by the distal end of the distal anchor tether section, and the proximal leaflet anchor being restrained and / or pushed distally by the end body supported on the implantation catheter. Note that the mid-leaflet anchors may nevertheless be moved toward each other by the natural rhythm and force of the leaflets, as each leaflet exerts force on its corresponding leaflet anchor(s).

[0345] In some implementations, various systems, apparatus, devices, etc. herein may be configured to allow the delivery or transfer catheter to be coupled or recoupled to the anchor, central body, or other component after the anchor, central body, or other component has been separated from the delivery or transfer catheter. This may be done using a tether or similar device that allows freedom of movement in the separated state, but can be used to bring the delivery / transfer catheter back into contact with the anchor, central body, or other component (e.g., tensioned, etc.). The configuration may be similar to the tether and control systems and mechanisms described herein with respect to bringing the anchors and / or central bodies together. In some implementations, after recoupling, the delivery or transfer catheter can be used to (1) remove the anchor, central body, or other component from a first location and / or (2) reposition and / or attach the anchor, central body, or other component to a second location (different from the first location) (e.g., a different tissue location).

[0346] Additional details and features of other implementations of this specification may be included herein, unless specifically stated and functionally unencumbered.

[0347] 26 , prior to implantation, end-coupled implementations can include multiple leaflet anchors, including a distal leaflet anchor 401 integrally attached to a distal end 403 of an implant-controllable tether. In some implementations, the implant-controllable tether includes two portions, the first portion being a distal anchor tether portion 405. The distal leaflet anchor 401 can be the first implanted leaflet anchor. In some implementations, at its proximal end, the distal anchor tether portion 405 forms a distal anchor tether eyelet 407, and at its distal end, the distal anchor tether portion 405 can be attached to the distal leaflet anchor. In some implementations, the distal anchor tether portion is long enough to extend the entire length of the locked leaflet anchor when the locking operation is complete.

[0348] In some embodiments, the second portion of the implantation-controllable tether is a looped extension tether portion 411 having a first end segment and a second end segment, both extending from the proximal end of the delivery system. In some embodiments, the implantation-controllable tether also includes a longitudinal intermediate segment 415. In some embodiments, the intermediate segment 415 of the extension tether portion extends through and around the distal anchor tether eyelet 407 of the distal anchor tether portion 405. With this loop configuration, the extension tether portion can be removed by pulling on one of its end segments after the locking operation is complete.

[0349] In addition to the distal leaflet anchor 401, the plurality of anchors can include one or more additional anchors. In some implementations, as shown, the plurality of anchors can include four additional anchors, including a (second) proximal leaflet anchor 427, which can be the last leaflet anchor implanted. Intermediate the distal and proximal leaflet anchors are a third, fourth, and fifth leaflet anchors, each of which is a middle leaflet anchor 421, each of which can be implanted in that order from the distal leaflet anchor 401 to the proximal leaflet anchor 427. In some implementations, each additional anchor has a corresponding anchor tether portion, including three middle anchor tether portions 423 and a proximal anchor tether portion 429 (e.g., a second anchor tether portion). The additional anchor tether portion forms an eyelet through which the implant-controlled tether (e.g., the combined extension tether portion 411 and distal anchor tether portion 405) passes, allowing the entire anchor group to be tethered via the implant-controlled tether. In the two-anchor minimum case, there is no mid-cusp anchor 421 or mid-anchor tether portion 423.

[0350] In some implementations, after the distal leaflet anchor 401 is attached to its corresponding leaflet and detached / separated / cut from the distal catheter end of the transfer catheter of the transfer catheter system, additional anchor tether portions (first the middle anchor tether portion 423, then the proximal anchor tether portion 429) of additional anchors (e.g., the mid-leaflet anchor 421 and / or the proximal leaflet anchor 427) are guided by the transfer catheter to the corresponding heart valve leaflet, where the additional anchors are also attached to the leaflet. Each additional anchor can be attached sequentially, one at a time, with each corresponding additional anchor tether portion arranged in a string along the extension tether portion 411. When all of the anchors in the group are attached to the leaflets, the result is a series of consecutively arranged leaflet anchors positioned in series in order along the single transfer-controlled tether in a suture configuration.

[0351] In some embodiments, when all of the anchor groups are attached to their respective leaflets, the end body 431 (having a configuration and fastening features similar to the locking-type central body of the previous embodiment and its variations) is detachably connected to the transfer catheter using an end body connector and advanced along the implant-controlling tether by pulling the extension tether proximally, which causes the implant-controlling tether to be pulled back through the end body while holding the end body using the transfer catheter. In some embodiments, the distal anchor tether 405 is pulled from the end body, fastening the end body against the distal anchor tether, mutually pulling the distal leaflet anchor 401 and the proximal leaflet anchor 427 toward each other via the distal anchor tether. Pulling the extension tether 411 against the end body's transfer catheter completes the implant assembly. As this occurs, the mid-leaflet anchors 421 naturally adjust their position based on their relative positions on the various leaflets and the tension and path along which the distal anchor tether 405 extends.

[0352] In some implementations, the extended tether portion 411 is then removed from the subject's body, leaving the implanted device in place, by pulling the first end segment of the extended tether portion while releasing the second end segment of the extended tether portion so that it is retracted through and around the looped path of the extended tether portion.

[0353] In some implementations, the systems, devices, methods, etc. herein include suturing the leaflets, with each suture placed a planned distance from the previous one. Some sutures may extend back and forth between multiple leaflets, while others may extend across a single leaflet. The sutures may be placed along the leaflets at predetermined intervals by selecting attachment locations and / or by using spacers between successive anchors.

[0354] 27A and 27B illustrate one of many potential uses for the example of FIGS. 26 and 27. Referring to FIG. 27A, distal leaflet anchor 401 is attached to leaflet 20. Next, leaflet anchor 421 is routed along tether 405 and attached to leaflet 22. Next, leaflet anchor 425 is routed along tether 405 and attached to leaflet 22. Next, leaflet anchor 427 is routed along tether 405 and attached to leaflet 20. This sequence creates a reciprocating suture pattern. Any number of anchors can be used. While the mitral valve is shown, the sequence illustrated by FIGS. 27A and 27B is applicable to any valve, such as the tricuspid valve. Furthermore, the example illustrated by FIGS. 27A and 27B can be used in the tricuspid valve in the same or similar manner as the examples shown in FIGS. 16-20.

[0355] 27B , in some implementations, once all the anchors are attached, an end body 431 or lock (having a configuration and fastening function similar to the locking central body of the previous examples and variations) advances along the tether 405 by drawing the tether proximally. The tether is pulled back through the end body, drawing the leaflet anchors 401, 421, 425, 427 together. As a result, the anchors 401, 421, 425, 427 draw the leaflets 20 and 22 together, reducing regurgitation through the native valve within the region of the anchors. The mid-leaflet anchors 421, 425 naturally adjust their position on the tether 405. The end body 431 or lock is secured onto the tether 405 to fix the relative positions of the leaflet anchors 401, 421, 425, 427, completing the native valve repair. The tether 405 can be detached at the end body 431 and removed.

[0356] Note that this example can provide suturing of the valve leaflets, with each suture placed a planned distance from the previous one. Some sutures can extend back and forth between multiple leaflets, while other sutures can extend across a single leaflet. The sutures can be placed along the leaflets at predetermined intervals by selecting the attachment locations and / or by using spacers between successive anchors.

[0357] 27 , in some end-coupled implementations, the distal leaflet anchor 451 is permanently attached (e.g., integrally molded in that it is not made from separate pieces) to a single, integral control tether 453 that is long enough to extend through the length of the steering catheter from its distal end to its proximal end. In some implementations (similar to others described above), the mid leaflet anchor 455 and the proximal leaflet anchor 457 can have anchor tether portions 459 that are laced on the integral control tether 453. In some implementations, a tether cutting device in the implantation catheter is used to sever and remove most of the long integral control tether 453 from the implant after the implant is fully assembled and the anchors are fastened together by the end bodies 431.

[0358] 28 , in some end-coupled implementations, one or more (spring-type) spring spacers 471 are disposed on a segment of the implant-controllable tether 473 extending between some or all consecutive pairs of leaflet anchors 475 attached to the valve leaflets 477 (e.g., pairs of leaflet anchors occurring consecutively along the implant-controllable tether). The one or more spring spacers 471 are disposed by providing them on an extension tether portion, each provided between each consecutive pair of anchors that the spring spacer separates. These spring spacers can help maintain the anchors at a preferred distance from one another. Structurally, these spring spacers 471 can be formed as one of the spacer configurations described above or can be of other configurations, such as accordion-fold pledgets, with the implant-controllable tether 473 extending through and penetrating each accordion-fold portion (as shown).

[0359] Referring to FIG. 28, in some implementations, rather than an additional leaflet anchor having an anchor tether portion forming an eyelet through which an extension tether portion slidably extends, the leaflet anchor 475 can include structurally integrated openings that form slidable restraints 481 (e.g., proximal anchor slidable restraint and intermediate anchor slidable restraint) through which segments of the implant-controlled tether 473 slidably extend.

[0360] In some end-coupled implementations, the anchors are configured as T-shaped toggle anchors. This type of anchor may provide enhanced support for lateral loads that occur between successive anchors, particularly for successive anchors attached to different leaflets. Other types of anchors are possible, such as those described elsewhere herein.

[0361] Additional features, modifications, delivery systems, and methods for using the devices and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904). Any combination or subcombination of each feature disclosed in this application can be combined with any combination or subcombination of each feature disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904). Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904) is incorporated herein by reference in its entirety for all purposes.

[0362] The clasps or leaflet grasping devices disclosed herein can take a wide variety of different forms, such as those disclosed in Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201). Combinations and subcombinations of features in this application may be combined with features disclosed in Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201), which is incorporated herein by reference in its entirety for all purposes.

[0363] Any of the various systems, devices, apparatus, etc. of the present disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with subjects, and the methods herein can include or consist of sterilization (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more systems, devices, apparatus, etc. of the present disclosure.

[0364] Although various inventive aspects, concepts, and features of the present disclosure may be described and illustrated herein as embodied in combination in the examples herein, these various aspects, concepts, and features may be used in many alternative embodiments individually or in various combinations and subcombinations thereof. Unless expressly excluded herein, all such combinations and subcombinations are intended to be within the scope of this application. Furthermore, while various alternative embodiments of the various aspects, concepts, and features of the present disclosure may be described herein, including alternative materials, structures, configurations, methods, devices, and components, as well as alternatives in form, fit, function, and the like, such descriptions are not intended to be a complete or exhaustive list of available alternatives, whether currently known or later developed. Those skilled in the art may readily incorporate one or more of the aspects, concepts, or features of the present invention into additional embodiments and uses, even if such embodiments are not explicitly disclosed herein.

[0365] Furthermore, although some features, concepts, or aspects of the present disclosure may be described herein as being preferred arrangements or methods, such description is not intended to imply that such features are essential or required unless expressly so stated. Still further, while example or representative values ​​and ranges may be included to aid in understanding the present application, such values ​​and ranges should not be construed in a limiting sense, and are intended to be significant values ​​or ranges only where explicitly stated.

[0366] Moreover, while various aspects, features, and concepts may be expressly identified herein as being inventive or forming part of the disclosure, such identification is not intended to be exhaustive; rather, there may be inventive aspects, concepts, and features fully described herein without being so explicitly identified or as part of a particular disclosure, which disclosure would instead be set forth in the appended claims. The description of an exemplary method or process is not limited to the inclusion of every step as necessary in all cases, nor should the order in which steps are presented be construed as essential or required unless expressly so stated. Treatment techniques, methods, steps, etc., as described or suggested herein or within the documents incorporated herein, may be performed on live animals or on non-living simulations, such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., where body parts, tissues, etc. are simulated), etc. The terms used in the claims are to be given their entirely ordinary meaning and are not limited in any way by the descriptions of examples within the specification.

[0367] While forms of the invention have been illustrated and described, it will be apparent that various modifications can be made without departing from the spirit and scope of the invention. Thus, while the invention has been described in detail with reference to only preferred embodiments, those skilled in the art will understand that various modifications can be made without departing from the scope of the invention. Accordingly, the present invention is not intended to be limited by the foregoing discussion, but is defined with reference to the following claims.

Claims

1. A subject system usable to treat or repair a native multi-cusp valve, comprising: A transfer catheter; a device releasably coupled to the transfer catheter, the device including a first leaflet anchor, a first anchor connector, a second leaflet anchor, a control tether system, and an anchor lock.

2. The system of claim 1 , wherein the first leaflet anchor comprises a first leaflet attachment mechanism.

3. The system of claim 1 or 2, wherein the first anchor connector forms a separable connection between the first leaflet anchor and the transfer catheter, the connection having a coupled state and a separated state.

4. 4. The system of claim 1, wherein the second leaflet anchor has a second leaflet attachment mechanism, and the second leaflet anchor is connectable to the transfer catheter independently of the first anchor connector.

5. 5. The system of claim 1, wherein the control tether system extendsably connects the first leaflet anchor to the transfer catheter, and the control tether system is operable to move the first leaflet anchor closer to and / or into contact with the second leaflet anchor when the first anchor connector is in its separated state.

6. 6. The system of claim 1, wherein the anchor lock includes a locking mechanism that, when the locking mechanism is locked, restricts relative movement of the corresponding first and second leaflet anchors.

7. The system of claim 1 , wherein the first leaflet anchor, the second leaflet anchor, and the first anchor connector are attached to the transfer catheter.

8. 8. The system of claim 1, wherein the control tether system includes a first control tether that extendably fastens the first leaflet anchor to a central body that is detachably attached to the transfer catheter by a central body connector, the first control tether extending in series from a first end segment of the first control tether at the proximal end of the transfer catheter, through the central body positioned at the distal end of the transfer catheter, slidably received through a first anchor slidable restraint on the first leaflet anchor, back through the central body, and to a second end segment of the first control tether at the proximal end of the transfer catheter.

9. The system of claim 8 , wherein the second leaflet anchor is inseparably connected to the central body.

10. 10. The system of claim 1, wherein the control tether system includes a first control tether extending in series from a first end segment of the first control tether at the proximal end of the transfer catheter, through a central body slidable restraint on a central body detachably attached to the distal end of the transfer catheter by a central body connector, to a second end segment of the first control tether attached to the first leaflet anchor.

11. 11. The system of claim 1, wherein the control tether system includes a first control tether extending in series from a first end segment of a first control tether at a proximal end of the transfer catheter, through a central body slidable restraint on a central body detachably attached to a distal end of the transfer catheter by a central body connector, through a first anchor slidable restraint on the first leaflet anchor, and back to a second end segment of the first control tether attached to the central body.

12. the device further includes a second anchor connector that forms a separable connection between the second leaflet anchor and the transfer catheter, the second anchor having a coupled state and a separated state; the control tether system extendibly connects the second leaflet anchor to the transfer catheter, the control tether system being operable to move the second leaflet anchor closer to and / or into contact with the first leaflet anchor (or another portion of the device) when the second anchor connector is in its separated state; The system of claim 1 , wherein the second anchor connector is attached to the transfer catheter.

13. the control tether system includes a first control tether extendibly fastening the first leaflet anchor to a central body detachably attached to the transfer catheter by a central body connector, the first control tether extending in series from a first end segment at the proximal end of the transfer catheter, through the central body positioned at the distal end of the transfer catheter, slidably received through a first anchor slidable restraint on the first leaflet anchor, back through the central body, and to a first second end segment at the proximal end of the transfer catheter; 13. The system of claim 12, wherein the control tether system includes a second control tether that extendably fastens the second leaflet anchor to the central body, the second control tether extending in series from a second first end segment at the proximal end of the transfer catheter, through the central body, slidably received through a second anchor slidable restraint on the second leaflet anchor, back through the central body, and to a second second end segment at the proximal end of the transfer catheter.

14. the control tether system is an anchor tether section including a first anchor tether segment and a second anchor tether segment, each corresponding anchor tether segment extending from an anchor tether segment connection point to a corresponding one of the leaflet anchors; an extension tether portion connected to the anchor tether portion and extending proximally along the transfer catheter to a proximal end of the transfer catheter.

15. The system of claim 12 , wherein the device further comprises a third leaflet anchor having a third leaflet attachment mechanism.

16. the device further includes a third anchor connector that forms a separable connection between the third leaflet anchor and the transfer catheter, the connection having a coupled state and a separated state; the control tether system extendibly connects the third leaflet anchor to the transfer catheter, the control tether system being operable to move the third leaflet anchor closer to and / or into contact with the first and second leaflet anchors (or another portion of the device) when the third anchor connector is in its separated state; The system of claim 15 , wherein the locking mechanism constrains relative movement of the third leaflet anchor with respect to the first and second leaflet anchors when the locking mechanism is locked.

17. 17. The system of claim 16, wherein the control tether system includes a first control tether that extendably fastens the first leaflet anchor to a central body that is detachably attached to the transfer catheter by a central body connector, the first control tether extending in series from a first end segment of the first control tether at the proximal end of the transfer catheter, through the central body positioned at the distal end of the transfer catheter, slidably received through a first anchor slidable restraint on the first leaflet anchor, back through the central body, and to a second end segment of the first control tether at the proximal end of the transfer catheter.

18. 18. The system of claim 17, wherein the control tether system includes a second control tether that extendably fastens the second leaflet anchor to the central body, the second control tether extending in series from a second first end segment at the proximal end of the transfer catheter, through the central body positioned at the distal end of the transfer catheter, slidably received through a second anchor slidable restraint on the second leaflet anchor, back through the central body, and to a second second end segment at the proximal end of the transfer catheter.

19. 19. The system of claim 18, wherein the control tether system includes a third control tether that extendably fastens the third leaflet anchor to the central body, the third control tether extending in series from a first end segment of the third control tether at the proximal end of the transfer catheter, through the central body positioned at the distal end of the transfer catheter, slidably received through a third anchor slidable restraint on the third leaflet anchor, back through the central body, and to a second end segment of the third control tether at the proximal end of the transfer catheter.

20. the control tether system an anchor tether section including a first anchor tether segment, a second anchor tether segment, and a third anchor tether segment, each corresponding anchor tether segment extending from an anchor tether segment connection point to a corresponding one of the leaflet anchors; an extension tether portion connected to the anchor tether portion and extending proximally along the transfer catheter to a proximal end of the transfer catheter.

21. the first leaflet anchor is a distal leaflet anchor; the second leaflet anchor is a proximal leaflet anchor; the control tether system includes an implant control tether that secures the distal leaflet anchor to the proximal end of the implantation catheter; the proximal leaflet anchor is slidably attached to the implant control tether; an end body slidably receiving the implant-controllable tether and sliding along the implant-controllable tether and moving the distal leaflet anchor toward and / or into contact with the proximal leaflet anchor (or another portion of the system), the end body forming the locking mechanism; The system of claim 12 , wherein the locking mechanism comprises a cable lock.

22. 22. The system of claim 21, wherein the proximal leaflet anchor is slidably attached to the implant control tether by a proximal anchor tether portion that forms an eyelet that threads onto the implant control tether.

23. 22. The system of claim 21, wherein the cable lock allows the implant-controlled tether to be pulled from the end body in only one direction.

24. the implant-controllable tether includes a distal anchor tether portion attached to the distal leaflet anchor, the distal anchor tether portion forming an eyelet; 22. The system of claim 21, wherein the implant-controlled tether includes an extended tether portion having a first end segment, a second end segment, and an intermediate segment intermediate the first end segment and the second end segment, the intermediate segment passing through the eyelet.

25. 22. The system of claim 21, wherein the implant-controlled tether is integrally molded from the proximal end of the transfer catheter to the distal leaflet anchor.

26. 26. The system of any one of claims 1 to 25, wherein each leaflet anchor is a clamp-type anchor.

27. 27. The system of any one of claims 1 to 26, wherein each leaflet anchor is a T-shaped toggle anchor.

28. Further comprising an elastic spacer; the first leaflet anchor and the second leaflet anchor form opposing surfaces; the spacer is positioned to be compressed by the opposing surfaces; 28. The system of any one of claims 1 to 27, wherein the spacer forms a flexible body having a functionally low flexible compressibility against occluded blood flow.

29. the control tether system has a maximum level of force capable of connecting the first and second leaflet anchors together with the spacer positioned therebetween to receive the opposing surfaces; 30. The device of claim 28, wherein actuation of the control tether system at the maximum level of force causes the spacer to be pushed to extend beyond the opposing surface.

30. 1. A subject device for use in a system for treating or repairing a native valve having multiple leaflets, said system including one or more transfer catheters, each transfer catheter of said one or more transfer catheters having a corresponding catheter distal end for insertion into the vasculature and a corresponding catheter proximal end configured to allow manipulation of said device, said device comprising: a first leaflet anchor and a second leaflet anchor, each leaflet anchor having a corresponding leaflet attachment mechanism; a first anchor connector connected to the first leaflet anchor, the first anchor connector having a first catheter connector that connects to a first catheter distal end of a first transfer catheter of the one or more transfer catheters, the first anchor connector forming a separable connection between the first leaflet anchor and the first transfer catheter, the connection having a coupled state and a separated state; a second anchor connector connected to the second valve leaflet anchor, the second anchor connector having a second catheter connector that connects to a second catheter distal end of a second transfer catheter of the one or more transfer catheters, the second anchor connector forming a separable connection between the second valve leaflet anchor and the second transfer catheter, the second anchor connector having a coupled state and a separated state.

31. 31. The device of claim 30, further comprising a system including a first control tether connected to the first leaflet anchor and a second control tether connected to the second leaflet anchor, the first control tether extending from a first tether distal end at the first leaflet anchor to a first tether proximal end at a first catheter proximal end, and the second control tether extending from a second tether distal end at the second leaflet anchor to a second tether proximal end at a second catheter proximal end, the system operable to approximate and / or contact the first and second leaflet anchors with each other and / or with another portion of the device.

32. 32. The device of claim 30 or 31, further comprising a central body, each of the respective first and second control tethers extending through the central body, the central body being slidable along the first and second control tethers to bring the first leaflet anchor into proximity with and / or contact with the second leaflet anchor (or another portion of the device).

33. 33. The device of any one of claims 30 to 32, further comprising an anchor lock that constrains the relative movement of the first and second leaflet anchors.

34. 34. The device of claim 33, wherein the anchor lock forms a cable lock, allowing the tether to be pulled from the central body in only one direction.

35. a third leaflet anchor having a third leaflet attachment mechanism; 35. The device of any one of claims 30 to 34, further comprising: a third anchor connector connected to the third leaflet anchor, the third anchor connector having a third catheter connector that connects to a third catheter distal end of a third transfer catheter of the one or more transfer catheters, the third anchor connector forming a separable connection between the third leaflet anchor and the third transfer catheter, the connection having a coupled state and a separated state.

36. 36. The device of claim 35, wherein the system includes a third control tether connected to the third leaflet anchor, the third control tether extending from a third tether distal end at the third leaflet anchor to a third tether proximal end at a third catheter proximal end, and the system is operable to bring the first leaflet anchor, the second leaflet anchor, and the third leaflet anchor closer together and / or into contact with each other and / or another portion of the device.

37. 37. The device of claim 35 or 36, wherein the central body is slidable along the first, second, and third control tether distal ends thereof to bring the first, second, and third leaflet anchors into closer proximity and / or into contact with each other (or with another portion of the system).

38. 38. The device of any one of claims 35 to 37, wherein an anchor lock is configured to constrain the relative movement of the first, second, and third leaflet anchors after they are brought closer together and / or into contact (with each other and / or with another part of the system).

39. the first control tether includes a first anchor tether portion attached to the first leaflet anchor at a first distal end of the first anchor tether portion, the first anchor tether portion forming a first eyelet at a first proximal end of the first anchor tether portion; 39. The device of any one of claims 30 to 38, wherein the first control tether includes a first extended tether portion having a first end segment, a first second end segment, and a first intermediate segment, the first intermediate segment being intermediate to the first end segment and the first second end segment along the first extended tether portion, and the first intermediate segment passing through the first eyelet.

40. the second control tether includes a second anchor tether portion attached to the second leaflet anchor at a second distal end of the second anchor tether portion, the second anchor tether portion forming a second eyelet at a second proximal end of the second anchor tether portion; 40. The device of any one of claims 30 to 39, wherein the second control tether includes a second extended tether portion having a second first end segment, a second second end segment, and a second intermediate segment, the second intermediate segment being intermediate to the second first end segment and the second second end segment along the second extended tether portion, and the second intermediate segment passing through the second eyelet.

41. 41. The device of any one of claims 30 to 40, wherein the first catheter connector has a quick release mechanism that is initially releasably attached to the first transfer catheter during implantation and then subsequently detached during said implantation.

42. 42. The device of any one of claims 30 to 41, further comprising a resilient spacer positioned to be compressed by opposing surfaces of the first and second leaflet anchors, the resilient spacer forming a flexible body having a functionally low flexibility compressibility with respect to obstructed blood flow, the system being operable with a force level to approximate the first leaflet anchor to the second leaflet anchor with the resilient spacer positioned to receive and / or contact the opposing surfaces of the first and second leaflet anchors.

43. 43. The device of claim 42, wherein the system defines a maximum level of force, and wherein actuation of the system at the maximum level of force causes the elastic spacer to extend beyond the opposing surface.

44. A subject system usable for repairing a native multi-cusp valve, comprising: a transfer catheter having a proximal catheter end and a distal catheter end; a system including a distal leaflet anchor having a distal leaflet attachment mechanism, a distal anchor connector, a proximal leaflet anchor having a proximal leaflet attachment mechanism and a proximal anchor slidable restraint, a proximal anchor connector, an implant-controlled tether having a tether proximal end and a tether distal end, and an anchor lock on the implant-controlled tether; the distal anchor connector forms a separable connection between the distal leaflet anchor and the catheter distal end, the connection having a coupled state and a separated state; the proximal anchor connector forms a separable connection between the proximal leaflet anchor and the catheter distal end, the separable connection having a coupled state and a separated state, the separable connection of the proximal anchor connector being independent from the separable connection of the distal anchor connector.

45. 45. The system of claim 44, wherein the distal end of the tether is connected to the distal leaflet anchor and / or the implant-controlled tether extends in series from the distal end of the tether through the proximal anchor slidable restraint of the proximal leaflet anchor to the proximal end of the tether at the proximal end of the catheter.

46. 46. ​​The system of claim 44 or 45, wherein the anchor lock restricts proximal movement of the proximal leaflet anchor relative to the implant-controlled tether.

47. the implantation-controlled tether is formed from an extension tether portion and an anchor tether portion; the anchor tether portion is connected to the distal leaflet anchor to form an eyelet; 47. The system of any one of claims 44 to 46, wherein the extended tether portion has a first end segment, a second end segment, and an intermediate segment intermediate the first end segment and the second end segment, the intermediate segment passing through the eyelet.

48. further comprising a mid-cusp anchor and a mid-anchor connector; the mid-leaflet anchor having a mid-leaflet attachment mechanism and a mid-anchor slidable restraint; the intermediate anchor connector forms a separable connection between the intermediate leaflet anchor and the catheter distal end, the separable connection having a coupled state and a separated state, the separable connection of the intermediate anchor connector being independent from the separable connection of the distal connector; 47. The system of any one of claims 44 to 46, wherein the implant-controlled tether extends through the intermediate anchor slidable restraint between the distal and proximal leaflet anchors.

49. 49. The system of any one of claims 44 to 48, wherein the implant-controlled tether is integrally molded.

50. 50. The system of any one of claims 44 to 49, further comprising one or more spring spacers between successive pairs of anchors.

51. 51. The system of any one of claims 44 to 50, wherein the proximal anchor slidable restraint is a structurally integral part of the proximal leaflet anchor.

52. The subject device for repairing a native multi-cusp valve comprises: a first leaflet anchor having a first leaflet attachment mechanism; a second leaflet anchor having a second leaflet attachment mechanism, each of the first and second leaflet anchors having opposing surfaces; an elastic spacer positioned to be compressed by the opposing surfaces, the elastic spacer forming a flexible body having functionally low flexible compressibility with respect to occluded blood flow; a system actuatable at a force level to move the first leaflet anchor into proximity and / or contact with the second leaflet anchor (or another portion of the device) with the elastic spacer positioned to receive the opposing surface.

53. 53. The device of claim 52, wherein the system defines a maximum level of force, and wherein actuation of the system at the maximum level of force causes the elastic spacer to be extruded so as to extend beyond the opposing surface.

54. 54. The device of claim 52 or 53, further comprising an anchor lock that constrains relative movement of the first and second leaflet anchors when moved toward and / or into contact with the elastic spacer.

55. 1. An organ repair system for repairing an organ in a subject, comprising: A transfer catheter; a first anchor having a first attachment body for attachment to the organ and attached to the transfer catheter; a first anchor connector connecting the first anchor to the transfer catheter, the first anchor connector forming a separable connection between the first anchor and the transfer catheter, the first anchor connector having a coupled state and a separated state; a second anchor having a second attachment for attachment to the organ, the second anchor being attached to the transfer catheter independently of the separable connection of the first anchor connector; a control tether that extendibly connects the first anchor to the transfer catheter independently of the first anchor connector, the control tether being operable to approximate the first anchor to the second anchor.

56. 55. The organ repair system of claim 54, further comprising an anchor lock having a locking mechanism that restricts relative movement of each of the first and second anchors after they are closer together.

57. 1. A method for treating or repairing a simulated native valve on a simulation, the native valve having a plurality of leaflets including a first leaflet and a second leaflet, the method comprising: providing a treatment or repair device releasably coupled to a distal end of a transfer catheter, the treatment or repair device including: a first leaflet anchor; a first anchor connector forming a first separable connection between the first leaflet anchor and the transfer catheter; a second leaflet anchor connected to the transfer catheter independently of the first anchor connector; and a system operable to move the first leaflet anchor into proximity with and / or contact with the second leaflet anchor (or another portion of the treatment or repair device) when the first separable connection is separated; positioning the first leaflet anchor on the first leaflet; Attaching the first leaflet anchor to the first leaflet; separating the first anchor connector after the first leaflet anchor is attached to the first leaflet; positioning the second leaflet anchor on the second leaflet after the first anchor connector is separated; Attaching the second leaflet anchor to the second leaflet; using the system to move the first leaflet anchor into proximity with and / or contact with the second leaflet anchor (or another portion of the treatment or repair device) after the first and second leaflet anchors are attached to the respective first and second leaflets; and releasing the treatment or repair device from the transfer catheter.

58. 58. The method of claim 57, wherein the treatment or repair device includes an anchor lock having a locking mechanism that locks the relative positions of the first and second leaflet anchors relative to one another, and further comprising, after the step of moving the first leaflet anchor to approach and / or contact the second leaflet anchor (or another portion of the treatment or repair device), using the anchor lock to lock the relative positions of the first and second leaflet anchors relative to one another.

59. 59. The method of claim 57 or 58, further comprising controllably releasing slack on the system before attaching the second leaflet anchor to the second leaflet.

60. 60. The method of any one of claims 57 to 59, wherein the plurality of leaflets includes a third leaflet, and the treatment or repair device includes a second anchor connector that forms a second separable connection between the second leaflet anchor and the transfer catheter, and a third leaflet anchor that is connected to the transfer catheter independently of the first anchor connector and the second anchor connector, and the system is operable to move the first leaflet anchor, the second leaflet anchor, and the third leaflet anchor toward each other and / or into contact (with each other and / or with another portion of the device) after the first separable connection and the second separable connection are separated.

61. separating the second anchor connector after the second leaflet anchor is attached to the second leaflet; positioning the third leaflet anchor at the third leaflet after the second anchor connector is separated; attaching the third leaflet anchor to the third leaflet; 61. The method of claim 60, wherein in the moving step, the first leaflet anchor, the second leaflet anchor, and the third leaflet anchor move closer to each other and / or into contact with each other and / or another portion of the treatment or repair device.

62. After the step of disconnecting the first anchor connector, the method further comprises: moving the first leaflet anchor and the transfer catheter into contact using the system; coupling the transfer catheter to the first leaflet anchor; Removing the first leaflet anchor from a first location; 62. The method of any one of claims 57 to 61, comprising attaching the first leaflet anchor to a different location than the first location.

63. 1. A method for treating or repairing a simulated valve, the valve having a plurality of leaflets including a first leaflet and a second leaflet, the method comprising: providing a device on a distal end of a transfer catheter, the device including: a first leaflet anchor; a first anchor connector forming a first separable connection between the first leaflet anchor and the transfer catheter; a second leaflet anchor connected to the transfer catheter independently of the first anchor connector; and a system operable to approximate the first and second leaflet anchors while the first separable connection is separated; positioning the first leaflet anchor on the first leaflet; Attaching the first leaflet anchor to the first leaflet; separating the first anchor connector after the first leaflet anchor is attached to the first leaflet; positioning the second leaflet anchor on the second leaflet after the first anchor connector is separated; Attaching the second leaflet anchor to the second leaflet; approximating the first and second leaflet anchors using the system after the first and second leaflet anchors have been attached to the respective first and second leaflets; and releasing the device from the transfer catheter.

64. 64. The method of claim 63, wherein the device includes an anchor lock having a locking mechanism that locks the relative positions of the first and second leaflet anchors relative to one another, and further comprising, after the step of approximating the first and second leaflet anchors, using the anchor lock to lock the relative positions of the first and second leaflet anchors relative to one another.

65. the plurality of leaflets includes a third leaflet, wherein the device includes a second anchor connector that forms a second separable connection between the second leaflet anchor and the transfer catheter, and a third leaflet anchor that is connected to the transfer catheter independently of the first anchor connector and the second anchor connector, and the system is operable to approximate the first leaflet anchor, the second leaflet anchor, and the third leaflet anchor after the first separable connection and the second separable connection are separated; separating the second anchor connector after the second leaflet anchor is attached to the second leaflet; positioning the third leaflet anchor at the third leaflet after the second anchor connector is separated; attaching the third leaflet anchor to the third leaflet; 65. The method of claim 64, wherein the step of approximating the first and second leaflet anchors approximates all of the first, second, and third leaflet anchors.

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