Heart valve repair devices and methods

Abstract

An implantable device to be positioned within a heart valve using a delivery system including a catheter. The device may include a leaflet anchor for attachment to a leaflet, and one or more connectors forming a detachable connection between the anchor and the delivery system. After the connector is detached such that the anchors are separated from the delivery system, a set of tethers can be actuated to move the anchors closer to and / or in contact. The device may optionally include a spacer positioned to be compressed by an opposing surface of the anchor when the opposing surface is around the spacer.

Description

[0001] Cross-reference to related applications This application claims priority to provisional U.S. patent application 63 / 420,440 filed by Bloodworth et al. on October 28, 2022, entitled “Heart Valve Repair Devices And Methods,” which is incorporated herein by reference for all purposes. Background Art

[0002] A healthy heart is typically conical in shape, tapering to a lower tip. The heart has four chambers, through which blood flows. A natural human heart contains four chambers: two atria (upper chambers)—the left and right atria—and two ventricles (lower chambers)—the left and right ventricles. A wall, the septum, separates the right and left sides of the heart (i.e., the right and left sides of each pair of chambers). For each of the four chambers, a corresponding natural valve (the mitral, tricuspid, aortic, and pulmonary valves, respectively) prevents upstream (backward) flow into that chamber.

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

[0004] Structurally, the tricuspid, aortic, and pulmonary heart valves have three leaflets, while the mitral valve has two leaflets (also called cusps). In each case, the leaflets act as flaps, opening and closing to allow blood to flow downstream (forward) when pressure urges blood to flow forward through the valve, and blocking blood flow through the valve when pressure urges blood to flow upstream (backward) through the valve (as occurs in the mitral and tricuspid valves during ventricular systole).

[0005] For example, the mitral valve that connects the left atrium to the left ventricle includes an annular portion, which is a ring-shaped portion of valve tissue surrounding the mitral valve orifice, and a pair of leaflets that extend downward from the annular portion into the left ventricle. The mitral valve annular portion can form a "D" shape, an elliptical shape, or other non-circular cross-sectional shape having a major axis and a minor axis. The anterior leaflet can be larger than the posterior leaflet, thereby forming a generally "C"-shaped boundary between the adjacent sides of the leaflets when the leaflets are closed together.

[0006] When the mitral valve functions normally, its anterior and posterior leaflets work 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, dilating the left ventricle (also known as "diastole" or "diastole"), allowing oxygenated blood collected in the left atrium to flow into the left ventricle. Subsequently, during ventricular systole, the left atrial muscle relaxes and the left ventricular muscle contracts. The resulting increase in blood pressure in the left ventricle forces the two leaflets together, closing the one-way mitral valve and preventing blood from flowing back into the left atrium. Instead, pressurized blood is expelled from the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding in half through the mitral annulus toward the left atrium, multiple fibrous cords called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle.

[0007] Natural heart valves play a critical role in ensuring an adequate forward flow of blood through the cardiovascular system. Under abnormal circumstances, such as congenital malformations, inflammatory processes, infectious conditions, and disease, these heart valves can become dysfunctional (e.g., damaged or malformed), reducing their effectiveness. This dysfunction can lead to severe cardiovascular damage or death. One form of dysfunction is valvular regurgitation.

[0008] Valvular regurgitation occurs when a valve inappropriately allows some blood to flow through it in the wrong direction. For example, during ventricular contraction, mitral regurgitation occurs if the mitral valve does not close properly and blood flows upstream from the left ventricle to the left atrium. Similarly, during ventricular contraction, tricuspid regurgitation occurs if the tricuspid valve does not close properly and blood flows upstream from the right ventricle to the right atrium.

[0009] Mitral regurgitation is one of the most common forms of heart valve disease. Mitral regurgitation can have different causes, such as leaflet prolapse, dysfunctional papillary muscles, stretching of the mitral annulus due to left ventricular dilation, more than one of these, and more. Mitral regurgitation in the central portion of the leaflet may be referred to as central-jet mitral regurgitation, while mitral regurgitation near one of the commissures (i.e., the place where the leaflets meet) may be referred to as eccentric-jet mitral regurgitation. Central-jet regurgitation occurs when the edges of the leaflets do not meet in the middle, and therefore the valve does not close and regurgitation exists. Regurgitation in any of the tricuspid valves is also a serious heart condition with diverse causes and manifested by various forms of valve dysfunction mechanisms.

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

[0011] While these devices offer significant potential for potentially life-saving repair procedures, challenges remain. For example, when treating a beating heart, the valve leaflets are in constant motion (changing shape and position) as the heart continues to beat. Therefore, the prosthetic device must be navigated and manipulated relative to a constantly moving target. Furthermore, one or both leaflets of a dysfunctional valve may be malformed and / or damaged. Consequently, the leaflets may not regularly move into a position and configuration conducive to prosthetic treatment. Furthermore, the two or three target leaflets may have unusually large gaps between them and may be tethered in an unnaturally open position, potentially due to changes in the underlying structure (e.g., a dilated ventricle). Summary of the Invention

[0012] The present disclosure provides exemplary features and is not intended to limit the scope of the present invention in any way. For example, any features included in the examples of the present disclosure are not required for the claims unless the claims clearly state these features. In addition, the features, components, steps, concepts, etc. described in the examples of the present disclosure and elsewhere in this disclosure can be combined in various ways. Various features and steps described elsewhere in this disclosure can be included in the examples summarized here.

[0013] In some embodiments, treatment or repair systems, devices, and related methods include aiding in the treatment or repair of native valves, including native bileaflet and trileaflet heart valves. The devices described herein can be valve repair devices, implantable devices, valve treatment devices, implants, treatment devices, and the like. Although sometimes described as implantable devices or valve repair devices for illustrative purposes in the examples herein, similar configurations can be used for other devices, such as treatment devices, removable devices, devices that do not necessarily need to be implanted and can be removed after treatment, and the like.

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

[0015] In some embodiments, the device comprises an anchoring portion. In some embodiments, one or more anchors of the anchoring portion are movable between an open position and a closed position.

[0016] In some embodiments, the device can be positioned within a heart valve using a delivery system comprising a catheter. In some embodiments, the device can include a leaflet anchor for attachment to the leaflet, and one or more connectors forming a decoupleable or detachable connection between the anchor and the delivery system. In some embodiments, the one or more connectors are severable connectors forming a severable connection between the anchor and the delivery system.

[0017] In some embodiments, after the connector is uncoupled or detached to separate the anchor from the delivery system, a set of tethers can be actuated to move the anchors into closer proximity and / or contact. In some embodiments, the device can optionally include a spacer positioned to be compressed by an opposing surface of the anchor when the opposing surface is positioned around the spacer.

[0018] In some embodiments, a system can include a transvascular delivery system comprising a steering catheter system and / or an implantation catheter system. The system can also include a device (e.g., a therapeutic device, a repair device, a valve repair device, an implantable device, an implant, a valve therapy device, etc.) introduced via the implantation catheter system. The implantation catheter system can optionally be guided by the steering catheter system.

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

[0020] In some embodiments, 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) for forming corresponding decoupled 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 implant catheter system (e.g., a third anchor severable connector can form a third anchor severable connection).

[0021] In some embodiments, the apparatus comprises a system, device, or mechanism (e.g., a controlled tether system, tether system, tether mechanism, tether device, apposition system, actuation system, connection system, connection mechanism, connection device, control system, etc.) that extendably connects the first anchor to the delivery system or implant catheter system. In some embodiments, the system does so independently of the corresponding anchor connectors of its anchors.

[0022] In some embodiments, after the anchor connector of each anchor is disconnected, the system, device, or mechanism can be actuated to move each anchor into closer proximity with and / or contact with the other anchors (and / or with another portion of the device, such as the central body). This allows the implant catheter system to be moved independently of the anchors attached to the leaflets, thereby making it easier to position one or more additional anchors at other leaflets or other leaflet locations.

[0023] In some embodiments, the device can include an optional spacer or central body (e.g., an elastic spacer, filler, wedge, apposition element, sheet, barrier, etc.). In some embodiments, the spacer or central body is positioned so that it can be compressed by opposing surfaces of a plurality of anchors (e.g., leaflet anchors, tissue anchors, clips, snaps, rivets, etc.). In some embodiments, the spacer or central body can be formed into a flexible body with low functional flexible compressibility relative to the obstructed blood flow, such that it expands in size when compressed, thereby blocking or inhibiting blood from flowing back through the valve.

[0024] In some embodiments, the various systems, devices, apparatuses, etc. herein can be configured such that after the anchor, hub, or other component is disconnected from the delivery or implantation catheter, the delivery or implantation catheter can be connected or reconnected to the anchor, hub, or other component. This can be achieved by using a tether or similar device that allows free movement in the disconnected state but can also be used (e.g., tensioned, etc.) to bring the delivery / implantation catheter back into contact with the anchor, hub, or other component. In some embodiments, after reconnection, the delivery or implantation catheter can be used to: (1) detach the anchor, hub, or other component from the first location, and / or (2) reposition and / or attach the anchor, hub, or other component to a second location (different from the first location) (e.g., to another tissue location).

[0025] In some embodiments, a treatment / repair system for treating / repairing a native valve of a subject (e.g., a living subject, a simulated subject, etc.) comprises an implantation catheter and a device (e.g., a treatment device, a repair device, a valve repair device, an implantable device, an implant, a valve treatment device, etc.). The device can be coupled and / or coupleable to the implantation catheter. In some embodiments, the device comprises one, all, or some of a first leaflet anchor, a first anchor severable connector, a second leaflet anchor, a controlled tether system, and an anchor lock.

[0026] In some embodiments, the first leaflet anchor has a first leaflet attachment mechanism. In some embodiments, the first anchor connector forms a releasable / detachable connection between the first leaflet anchor and the implantation catheter, having a coupled state and a decoupled state (e.g., a coupled state and a detached state, an uncut state and a cut state, etc.). In some embodiments, the first anchor connector is a severable connector for forming a severable connection between the first leaflet anchor and the implantation catheter, having an uncut state and a cut state.

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

[0028] In some embodiments, the controlled tether system extendably connects the first leaflet anchor to the implantation catheter. In some embodiments, the controlled tether system is actuatable to move the first leaflet anchor relative to the second leaflet anchor with the first anchor connector in its uncoupled / detached / severed state.

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

[0030] In some embodiments, the first leaflet anchor, the second leaflet anchor, and the first anchor connector are mounted on the implantation catheter.

[0031] In some embodiments, the controlled tether system includes a first controlled tether for extendably securing the first leaflet anchor to an optional hub (e.g., a spacer, apposition element, plug, gap filler, wedge, barrier, sheet, pad, etc.) The hub is detachably attached to the implantation catheter via a hub connector or a severable connector.

[0032] In some embodiments, the first controlled tether extends sequentially, starting from a first end segment of the first controlled tether at the proximal end of the implant catheter, through the central body positioned at the distal end of the implant catheter, slidably received by a first anchor slidable limiter on the first leaflet anchor, again through the central body, and reaching a second end segment of the first controlled tether at the proximal end of the implant catheter.

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

[0034] In some embodiments, the controlled tether system includes a first controlled tether that extends sequentially from a first end segment of the first controlled tether at the proximal end of the implant catheter, through a centerbody slidable limiter on a centerbody on the distal end of the implant catheter that is detachably attached by means of a centerbody connector, to a second end segment of the first controlled tether attached to the first leaflet anchor.

[0035] In some embodiments, the controlled tether system includes a first controlled tether that extends sequentially from a first end segment of the first controlled tether at the proximal end of the implant catheter, through a centerbody slidable limiter on the centerbody on the distal end of the implant catheter that is detachably attached by means of a centerbody connector, through a first anchor slidable limiter on the first leaflet anchor, and back to a second end segment of the first controlled tether that is attached to the centerbody.

[0036] In some embodiments, the treatment / repair device further comprises a second anchor connector (e.g., a severable connector) for forming a releasable / detachable connection between the second leaflet anchor and the implant catheter having a coupled state (e.g., a connected state, an unsevered state, etc.) and a decoupled state (e.g., a detached state, a severed state, etc.). In some embodiments, the controlled tether system extensibly connects the second leaflet anchor to the implant catheter, and the controlled tether system is actuatable to move the second leaflet anchor relative to the first leaflet anchor, wherein the second anchor connector is in its severed state. In some embodiments, the second anchor connector is connected to, mounted on, or is part of the implant catheter.

[0037] In some embodiments, the controlled tether system includes a first controlled tether for extendably securing the first leaflet anchor to an optional hub (e.g., a spacer, apposition element, plug, wedge, barrier, sheet, pad, etc.), the hub being detachably attached to the implant catheter via a hub severable connector. In some embodiments, the first controlled tether extends sequentially from a first end segment at the proximal end of the implant catheter, through the hub positioned at the distal end of the implant catheter, slidably received by a first anchor slidable limiter on the first leaflet anchor, again through the hub, to a first second end segment at the proximal end of the implant catheter.

[0038] In some embodiments, the controlled tether system includes a second controlled tether for extendably securing the second leaflet anchor to the central body, the second controlled tether extending sequentially from a second first end segment at the proximal end of the implant catheter, through the central body, slidably received by a second anchor slidable limiter on the second leaflet anchor, again through the central body, to the second second end segment at the proximal end of the implant catheter.

[0039] In some embodiments, the controlled tether system comprises an anchor tether segment and an extension tether. In some embodiments, the anchor tether segment comprises a first anchor tether segment and a second anchor tether segment. Each respective anchor tether segment extends from an anchor tether segment connection point to a respective leaflet anchor. In some embodiments, the extension tether segment is connected to the anchor tether segment and extends proximally along the implant catheter to the proximal end of the implant catheter.

[0040] In some embodiments, the therapeutic prosthetic device further comprises a tertiary leaflet anchor having a tertiary leaflet attachment mechanism.

[0041] In some embodiments, the treatment / repair device further includes a third anchor connector (e.g., a severable connector, etc.) for forming a detachable / detachable connection between the third leaflet anchor and the implantation catheter having a connected state (e.g., a connected state, an uncut state, etc.) and a disconnected state (e.g., a detached state, a cut state, etc.).

[0042] In some embodiments, the controlled tether system extendably connects the third leaflet anchor to the delivery catheter or implantation catheter.

[0043] In some embodiments, the controlled tether system is actuatable to move the third leaflet anchor relative to one or more of the first and second leaflet anchors with the third anchor connector in its uncoupled / detached state.

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

[0045] In some embodiments, the controlled tether system includes a first controlled tether for extendably securing the first leaflet anchor to a hub that is detachably attached to the implant catheter via a hub connector (e.g., a severable connector, etc.). In some embodiments, the first controlled tether extends sequentially, starting from a first controlled tether first end segment at the proximal end of the implant catheter, through the hub positioned at the distal end of the implant catheter, slidably received by a first anchor slidable limiter on the first leaflet anchor, again through the hub, and to a first controlled tether second end segment at the proximal end of the implant catheter.

[0046] In some embodiments, the controlled tether system includes a second controlled tether for extendably securing the second leaflet anchor to the central body, the second controlled tether extending sequentially from a second first end segment at the proximal end of the implant catheter, through the central body positioned at the distal end of the implant catheter, slidably received by a second anchor slidable limiter on the second leaflet anchor, again through the central body, to the second second end segment at the proximal end of the implant catheter.

[0047] In some embodiments, the controlled tether system optionally includes a third controlled tether for extendably securing the third leaflet anchor to the central body. In some embodiments, the third controlled tether extends sequentially, starting from a third controlled tether first end segment at the proximal end of the implant catheter, through the central body positioned at the distal end of the implant catheter, slidably received by a third anchor slidable limiter on the third leaflet anchor, again through the central body, to a third controlled tether second end segment at the proximal end of the implant catheter.

[0048] In some embodiments, the controlled tether system comprises an anchor tether segment and an extension tether segment. In some embodiments, the anchor tether segment comprises a first anchor tether segment, a second anchor tether segment, and a third anchor tether segment. Each respective anchor tether segment extends from an anchor tether segment connection point to a respective leaflet anchor. In some embodiments, the extension tether segment is connected to the anchor tether segment and extends proximally along the implant catheter to the proximal end of the implant catheter.

[0049] In some embodiments, the first leaflet anchor is a distal leaflet anchor. In some embodiments, the second leaflet anchor is a proximal leaflet anchor. In some embodiments, the controlled tether system includes an implant control tether for securing the distal leaflet anchor to the proximal end of the implant catheter. In some embodiments, the proximal leaflet anchor is slidably attached to the implant control tether. In some embodiments, the end body slidably receives the implant control tether to slide along the implant control tether and move the distal leaflet anchor into closer proximity with (e.g., near, in contact with, etc.) the proximal leaflet anchor.

[0050] In some embodiments, the end body forms the locking mechanism.In some embodiments, the locking mechanism comprises a cable lock.

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

[0052] In some embodiments, the cable lock allows the implant control tether to be pulled through the end body in only one direction.

[0053] In some embodiments, the implant control tether comprises a distal anchor tether segment attached to the distal leaflet anchor. In some embodiments, the distal anchor tether segment forms an eyelet. In some embodiments, the implant control tether comprises an extension tether segment having a first end segment, a second end segment, and a middle segment intermediate the first and second end segments. In some embodiments, the middle segment loops through the eyelet.

[0054] In some embodiments, the implant control tether is integral from the proximal end of the implant catheter to the distal leaflet anchor.

[0055] In some embodiments, each leaflet anchor is a clip-type anchor.

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

[0057] In some embodiments, one or more of the therapeutic / repair systems herein comprises 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 having low functional, flexible compressibility relative to obstructed blood flow.

[0058] In some embodiments, a system (e.g., a tether system, an apposition system, a connection system, a controlled tether system, etc.) that can be used with the devices herein has a maximum level of force by which it can move or connect the first leaflet anchor with the second leaflet anchor, with the septum positioned therebetween to receive the opposing surfaces. In some embodiments, the system (e.g., a tether system, a connection system, etc.) can move the opposing surfaces of the anchors together with a force sufficient to change the shape of the septum or the central body. In some embodiments, when the system (e.g., a controlled tether system, etc.) is actuated at the maximum level of force, the septum is extruded, thereby extending beyond the opposing surfaces.

[0059] In some embodiments, a device (e.g., a therapeutic device, a repair device, a valve repair device, an implantable device, an implant, a valve treatment device, etc.) is used in a system (e.g., a therapeutic system, a repair system, a valve repair system, a valve treatment system, etc.) to treat / repair a native valve of a subject (e.g., a living subject, a mimic, etc.), wherein the native valve has a plurality of leaflets.

[0060] In some embodiments, the system comprises a steering catheter system and / or one or more implanted catheters, each of the one or more implanted catheters having a respective distal end for insertion into the proximal end of the steering catheter system and a respective proximal end for manipulating the device by a user.

[0061] In some embodiments, the device comprises 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, an apposition system, a connection system, etc.), a central body, and an anchor lock. In some embodiments, the first leaflet anchor and the second leaflet anchor each have a respective leaflet attachment mechanism.

[0062] In some embodiments, the first anchor connector is connected to the first leaflet anchor. In some embodiments, the first anchor connector comprises a first catheter connector for connecting to a distal end of a first implant catheter of the one or more implant catheters. In some embodiments, the first anchor connector forms a releasable or detachable connection between the first leaflet anchor and the first implant catheter having a coupled state (e.g., a coupled state, an uncut state, etc.) and a decoupled state (e.g., a detached state, a cut state, etc.).

[0063] In some embodiments, the second anchor connector is connected to the second leaflet anchor. In some embodiments, the second anchor connector has a second catheter connector for connecting to a second catheter distal end of a second implant catheter of the one or more implant catheters. In some embodiments, the second anchor connector forms a releasable or detachable connection between the second leaflet anchor and the second implant catheter having a coupled state (e.g., a coupled state, an uncut state, etc.) and a decoupled state (e.g., a detached state, a cut state, etc.).

[0064] In some embodiments, the system (e.g., a tether system, an apposition system, a connection system, etc.) includes a first controlled tether connected to the first leaflet anchor and a second controlled tether connected to the second leaflet anchor. In some embodiments, the first controlled 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 embodiments, the second controlled 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 embodiments, the system is actuatable to move the respective first and second leaflet anchors relative to each other, e.g., into closer proximity and / or contact with each other.

[0065] In some embodiments, each of the respective first and second controlled tethers extends through the central body (e.g., a spacer, an apposition element, etc.) In some embodiments, the central body can slide along the first and second controlled tethers such that the first leaflet anchor and / or the second leaflet anchor can contact the central body.

[0066] In some embodiments, the anchor lock constrains relative movement of the first and second leaflet anchors. In some embodiments, the anchor lock forms a cable lock such that a tether can be pulled through 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 for connecting to a third catheter distal end of a third implant catheter of the one or more implant catheters. In some embodiments, the third anchor connector forms a releasable / detachable connection between the third leaflet anchor and the third implant catheter having a connected state (e.g., a connected state, an uncut state, etc.) and a decoupled state (e.g., a detached state, a cut state, etc.).

[0068] In some embodiments, the system (e.g., a tether system, an apposition system, a connection system, etc.) includes a third controlled tether connected to the third leaflet anchor. In some embodiments, the third controlled tether extends from a third tether distal end at the third leaflet anchor to a third tether proximal end at a proximal end of a third catheter. In some embodiments, the system is actuatable to move the first leaflet anchor, the second leaflet anchor, and / or the third leaflet anchor relative to each other.

[0069] In some embodiments, an optional central body can slide along the first, second and third controlled tethers to the distal ends of their respective first, second and third tethers, bringing the first leaflet anchor, the second leaflet anchor and the third leaflet anchor closer to and / or in contact with each other and / or with the central body.

[0070] In some embodiments, the anchor lock constrains relative movement of the first, second, and third leaflet anchors after they are moved closer together.

[0071] In some embodiments, the first controlled tether comprises a first anchor tether segment attached to the first leaflet anchor at a first distal end. In some embodiments, the first anchor tether segment forms a first eyelet at a first proximal end of the first anchor tether segment.

[0072] In some embodiments, the first controlled tether comprises a first extended tether segment having a first end segment, a first second end segment, and a first intermediate segment. In some embodiments, the first intermediate segment is located between the first first end segment and the first second end segment along the first extended tether segment. In some embodiments, the first intermediate segment is looped through the first eyelet.

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

[0074] In some embodiments, the second intermediate segment is located intermediate the second first end segment and the second second end segment along the second extended tether segment. In some embodiments, the second intermediate segment is looped through the second eyelet.

[0075] In some embodiments, the first catheter connector has a quick release mechanism for first being releasably attached to the first implant catheter during implantation and then being detached during said implantation.

[0076] In some embodiments, the device has an optional spacer or central body (e.g., an elastic spacer, an apposition element, etc.) that is positioned and configured so that it can be compressed by the opposing surfaces of the first and second leaflet anchors. In some embodiments, the spacer forms a flexible body that has low functional flexible compressibility relative to obstructed blood flow. In some embodiments, the system (e.g., a tether system, an apposition system, a connection system, etc.) can be actuated at a certain level of force to move the first leaflet anchor relative to the second leaflet anchor, wherein the spacer is positioned to receive or contact the opposing surfaces.

[0077] In some embodiments, the system (e.g., tether system, apposition system, connection system, etc.) defines a maximum force level. In some embodiments, when the system is actuated at the maximum force level, the spacer is compressed such that it is squeezed out, thereby extending beyond the opposing surface.

[0078] In some embodiments, a system (e.g., a treatment system, a repair system, a valve repair system, a valve therapy system, etc.) that can be used to treat or repair a natural valve of a subject (e.g., a living subject, a mimetic, etc.) comprises an implantation catheter and a device (e.g., a treatment device, a repair device, a valve repair device, an implantable device, an implant, a valve therapy device, etc.). The implantation catheter has a proximal catheter end and a distal catheter end.

[0079] In some embodiments, the device includes 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 sliding limiter, a proximal anchor connector, a controlled tether having a proximal end and a distal end of the tether, and one, some, or all of the anchor locks on the controlled tether.

[0080] In some embodiments, the distal anchor connector forms a releasable / detachable connection between the distal leaflet anchor and the distal end of the catheter having a coupled state (e.g., a connected state, an uncut state, etc.) and an uncoupled state (e.g., a detached state, a cut state, etc.). In some embodiments, the proximal anchor connector forms a releasable / detachable connection between the proximal leaflet anchor and the distal end of the catheter having a coupled state (e.g., a connected state, an uncut state, etc.) and an uncoupled state (e.g., a detached state, a cut state, etc.).

[0081] In some embodiments, the decoupleable / detachable connection of the proximal anchor connector is independent of the decoupleable / detachable connection of the distal anchor connector.

[0082] In some embodiments, the distal end of the tether is connected to the distal leaflet anchor. In some embodiments, the implant controls the sequential extension of the tethers, starting from the distal end of the tether, through the proximal anchor slidable limiter of the proximal leaflet anchor, and reaching the proximal end of the tether at the proximal end of the catheter.

[0083] In some embodiments, the anchor lock constrains proximal movement of the proximal leaflet anchor relative to the implant control tether.

[0084] In some embodiments, the tether is formed by an extension tether segment and an anchor tether segment. In some embodiments, the anchor tether segment is connected to the distal leaflet anchor and forms an eyelet. In some embodiments, the extension tether segment has a first end segment, a second end segment, and a middle segment located between the first and second end segments. In some embodiments, the middle segment is looped through the eyelet.

[0085] In some embodiments, the device comprises a medial leaflet anchor and a medial anchor connector. In some embodiments, the medial leaflet anchor has a medial leaflet attachment mechanism and a medial anchor slidable limiter.

[0086] In some embodiments, the intermediate anchor connector forms a releasable / detachable connection between the intermediate leaflet anchor and the distal end of the catheter, having a coupled state (e.g., a coupled state, an uncut state, etc.) and a decoupled state (e.g., a detached state, a cut state, etc.). In some embodiments, the releasable / detachable connection of the intermediate anchor connector is independent of the releasable / detachable connection of the distal anchor connector.

[0087] In some embodiments, the tether extends through the intermediate anchor slidable limiter between the distal leaflet anchor and the proximal leaflet anchor.

[0088] In some embodiments, the tether is a single unitary body.

[0089] In some embodiments, the device comprises one or more spring spacers between a pair of consecutive anchors (eg, tissue anchors, clips, snaps, toggle anchors, spiral anchors, staples, rivets, tucks, etc.).

[0090] In some embodiments, the proximal anchor slidable limiter is structurally integral to the proximal leaflet anchor.

[0091] In some embodiments, a device (e.g., a treatment device, a repair device, a valve repair device, an implantable device, an implant, a valve treatment device, etc.) that can be used to treat / repair a natural valve of a subject (e.g., a living subject, a mimic, etc.) includes one or more of a first leaflet anchor, a second leaflet anchor, a spacer / apposition element, and a system (e.g., a tether system, an apposition system, a connection system, etc.).

[0092] In some embodiments, the first leaflet anchor has a first leaflet attachment mechanism. In some embodiments, the second leaflet anchor has a second leaflet attachment mechanism. In some embodiments, the first leaflet attachment mechanism and the second leaflet attachment mechanism are the same type of attachment mechanism; however, in some embodiments, they are different types of attachment mechanisms.

[0093] In some embodiments, the respective first and second leaflet anchors have opposing surfaces. In some embodiments, the spacer or apposition element is positioned to be compressed by the opposing surfaces. In some embodiments, the spacer forms a pliable body having low functional pliable compressibility relative to obstructed blood flow.

[0094] In some embodiments, the system (e.g., a tether system, an apposition system, a connection system, etc.) can be actuated at a certain level of force to move the first leaflet anchor relative to the second leaflet anchor, wherein the spacer is positioned to receive the relative surface.

[0095] In some embodiments, the system defines a maximum force level. In some embodiments, when the system is actuated at the maximum force level, the spacer is compressed such that it is squeezed out, thereby extending beyond the opposing surface.

[0096] In some embodiments, the spacer is integral.

[0097] In some embodiments, the spacer is comprised of medical grade silicone.

[0098] In some embodiments, the device comprises an anchor lock for constraining relative movement of the first leaflet anchor and the second leaflet anchor as the first leaflet anchor and the second leaflet anchor move closer to and / or into contact with the septum.

[0099] In some embodiments, a system (e.g., a therapeutic system, a repair system, etc.) for treating / repairing an organ or other body part of a subject (e.g., a living subject, a simulated subject, etc.) comprises one or more of a delivery / implantation catheter, a first anchor, a first anchor connector, a second anchor, and a controlled tether. In some embodiments, the first anchor has a first attachment body that attaches to the organ and is mounted on the implantation catheter.

[0100] In some embodiments, the first anchor connector connects the first anchor to the implant catheter. In some embodiments, the first anchor connector forms a releasable connection between the first anchor and the implant catheter having a coupled state (e.g., a connected state, an uncut state, etc.) and a decoupled state (e.g., a detached state, a cut state, etc.).

[0101] In some embodiments, the second anchor has a second attachment body that attaches to the organ.In some embodiments, the second anchor is mounted on the implantation catheter independently of the releasable connection of the first anchor connector.

[0102] In some embodiments, the controlled tether extendably connects the first anchor to the implant catheter independently of the first anchor connector. In some embodiments, the controlled tether is actuatable to move the first anchor relative to the second anchor.

[0103] In some embodiments, the system includes an anchor lock having a locking mechanism for constraining relative movement of the first and second anchors when the respective first and second anchors move closer together and / or into contact (e.g., into contact with each other and / or with a spacer).

[0104] In some embodiments, a method for treating or repairing a natural valve of a subject (e.g., a living subject, a simulated subject, etc.) comprises providing a treatment / repair device on a distal end of a delivery catheter or an implantation catheter. The treatment / repair device comprises one or more of: a first leaflet anchor; a first anchor connector for forming a first decoupleable / 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, an apposition system, a connection system, etc.) actuatable to move the first and second leaflet anchors relative to each other, wherein the first decoupleable / detachable connection is decoupled / detached.

[0105] In some embodiments, the first leaflet anchor is positioned at the first leaflet. The first leaflet anchor is attached to the first leaflet. In some embodiments, after the first leaflet anchor is attached to the first leaflet, the first anchor connector is decoupled, detached, severed, etc.

[0106] In some embodiments, the second leaflet anchor is positioned at the second leaflet after the first anchor connector is uncoupled, detached, severed, etc. The second leaflet anchor is attached to the second leaflet. In some embodiments, 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., into closer proximity and / or contact) using the system (e.g., a tether system, an apposition system, a connection system, etc.).

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

[0108] In some embodiments, the treatment / repair device comprises an anchor lock having a locking mechanism for locking the relative positions of the first and second leaflet anchors relative to each other. In some embodiments, 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 each other using the anchor lock.

[0109] In some embodiments, prior to the step of attaching the second leaflet anchor to the second leaflet, slack in the system (eg, tether system, apposition system, connection system, etc.) can be controllably released.

[0110] In some embodiments, the plurality of leaflets includes a third leaflet. In some embodiments, the device includes a second anchor connector for forming a second decoupleable / 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 and second anchor connectors.

[0111] In some embodiments, the system (e.g., a tether system, an apposition system, a connection system, etc.) is actuatable to move the first, second, and third leaflet anchors relative to each other after the first and second decoupleable / detachable connections are decoupled / detached. In some embodiments, after the second leaflet anchor is attached to the second leaflet, the second anchor connector is decoupled or detached. In some embodiments, after the second anchor connector is decoupled 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, second, and third leaflet anchors are brought into closer proximity with each other and / or in contact with each other and / or with an optional central body / spacer therebetween.

[0112] In some embodiments, the system or another system (e.g., a tether system, an engagement system, a connection system, etc.) can be configured such that after the anchor, hub, or other component is disconnected from the delivery or implantation catheter, the delivery or implantation catheter can be connected or reconnected to the anchor, hub, or other component. This can be achieved by using a tether or similar device that allows free movement in the disconnected state but can also be used (e.g., tensioned, etc.) to bring the delivery / implantation catheter back into contact with the anchor, hub, or other component. In some embodiments, after reconnection, the delivery or implantation catheter can be used to: (1) detach the anchor, hub, or other component from a first location (e.g., from tissue at a first tissue location), and / or (2) reposition and / or attach the anchor, hub, or other component to a second location (different from the first location) (e.g., to another tissue location).

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

[0114] Any of the above methods can be performed on a living subject (e.g., a human or other animal) or on a mimic (e.g., a cadaver, a cadaver heart, a virtual human, an anthropomorphic ghost, a simulated body, such as a computer simulated body, e.g., having simulated body parts, tissues, etc.). In the case of a mimic, the body part can alternatively be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.) and can include, for example, a computerized and / or physical representation.

[0115] Any of the above-described systems, components, devices, apparatuses, parts, etc. may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure their safety for use with patients, and the methods herein may include sterilizing (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) one or more of the systems, devices, apparatuses, parts, etc. herein (or the additional method includes or consists of such sterilization).

[0116] A further understanding of the nature and advantages of the embodiments is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings, in which like parts have 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 description of the embodiments set forth below enables one to make and use the embodiments and is not intended to limit the recited claims but rather to serve as an example of the claimed invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0117] To further illustrate various aspects of the embodiments of the present disclosure, certain examples and embodiments will be described in more detail with reference to various aspects of the accompanying drawings. These drawings depict only exemplary embodiments of the present disclosure and, therefore, should not be considered to limit the scope of the present disclosure. In addition, although the drawings may be drawn to scale for some examples, they are not necessarily drawn to scale for all examples. Examples and other features and advantages of the present disclosure will be described and explained in conjunction with additional features through the use of the accompanying drawings, in which: FIG. 1 shows a cross-sectional view of a device positioned to repair a mitral valve.

[0118] Figure 2 showing a cross-sectional view of a human heart in diastole; Figure 3 showing a cross-section of a human heart in systole; Figure 4 showing a cross-sectional view of a human heart in systole, illustrating valvular regurgitation; Figure 5 yes Figure 4 A cross-sectional view of the mitral valve with annotations illustrating the mitral valve leaflets in systole; Figure 6 A healthy mitral valve is shown with the leaflets closed as viewed from the atrial side of the mitral valve; Figure 7 A dysfunctional mitral valve is shown with visible gaps between the leaflets as viewed from the atrial side of the mitral valve; Figure 8 shows the tricuspid valve as viewed from the atrial side of the valve; Figure 9 A cross-sectional view of the heart is shown showing the implant catheter and therapeutic / repair device extending from within the steering catheter system and positioned within the mitral valve.

[0119] Figure 10 Show Figure 9 Details of the therapeutic / prosthetic device shown; Figure 10A Show Figure 10 a therapeutic / prosthetic device wherein a mechanism for opening and closing the paddles of the device is implemented; Figure 10B Shown for opening and closing Figure 10A Embodiment of the paddle mechanism of the device; Figure 10C and 10D Shown can be used similar to Figure 10 Embodiments of the paddle of the device; Figure 10E and 10F Shows something like Figure 10 Implementation scheme of the therapeutic / repair device of the present invention; Figure 11 Show Figure 9 An implantation catheter and a treatment / repair device are provided, wherein a first leaflet anchor of the treatment / repair device is positioned and oriented to clip onto a portion of the first leaflet.

[0120] Figure 12 Show Figure 11 An implantation catheter and treatment / repair device, wherein a first leaflet anchor is clamped to a first leaflet and released from a central body of the treatment / repair device, and wherein a second leaflet anchor of the treatment / repair device is positioned and oriented to clamp to a portion of a second leaflet.

[0121] Figure 13 Show Figure 12 An implantation catheter and treatment / repair device wherein the first and second leaflet anchors are clipped to the respective first and second leaflets and released from the central body, and wherein the central body is positioned at a central apposition location between the leaflets.

[0122] Figure 14 Show Figure 13 A treatment / repair device wherein the anchor is connected to the central body and locked in position relative to the central body, and wherein the implant catheter is disconnected from the treatment / repair device and removed from the body of the subject.

[0123] Figure 15 Shown positioned within the tricuspid valve Figure 9 3. View of an example 3 anchor embodiment of a therapeutic / repair device.

[0124] Figure 16 Show Figure 15 A treatment / repair device wherein the first leaflet anchor of the treatment / repair device is positioned and oriented to clip onto a portion of the first leaflet.

[0125] Figure 17 Show Figure 16 A treatment / repair device wherein a first leaflet anchor is clipped to a first leaflet and released from a central body of the treatment / repair device, and wherein a second leaflet anchor of the treatment / repair device is positioned and oriented to clip to a portion of a second leaflet.

[0126] Figure 18 Show Figure 17 A treatment / repair device wherein the first and second leaflet anchors are clipped to the first and second leaflets, respectively, and released from the central body, and wherein the third leaflet anchor of the treatment / repair device is positioned and oriented to clip to a portion of the third leaflet.

[0127] Figure 19 Show Figure 18 A treatment / repair device wherein the first, second and third leaflet anchors are clipped to the first, second and third leaflets, respectively, and released from the central body, and wherein the central body is positioned at a central apposition location between the leaflets.

[0128] Figure 20 Show Figure 19 A therapeutic / repair device wherein the anchor is moved into contact with the central body.

[0129] Figure 21 Show Figure 20 Examples of therapeutic / repair devices with expanded centrosomes.

[0130] Figures 22A-22D A serial insertion and centrally coupled embodiment of the treatment / repair system is shown.

[0131] Figure 23 is a cross-sectional view of the central body of a sequentially inserted and centrally coupled embodiment of the treatment / repair system of FIG. 22 connected to an implant catheter and a tethered anchor.

[0132] Figure 24 is a cross-sectional view of an example centerbody including spacers.

[0133] Figure 25 is a cross-sectional view of an example centrosome.

[0134] Figure 26 An example end coupling embodiment of a treatment / repair system is shown.

[0135] Figure 27 An example end coupling embodiment of a treatment / repair system is shown.

[0136] Figure 27A and 27B Show Figure 26 or an embodiment of the treatment / repair system of 27 on a native mitral valve.

[0137] Figure 28 An example end coupling embodiment of a treatment / repair system is shown. DETAILED DESCRIPTION

[0138] The following description refers to the accompanying drawings, which illustrate exemplary embodiments of the present disclosure. Other embodiments having different structures and operations do not depart from the scope of the present disclosure.

[0139] Some embodiments of the present disclosure are directed to systems, devices, methods, and the like for treating or repairing defective heart valves. For example, various embodiments of devices, valve repair devices, implantable devices, implants, and systems (including their delivery systems) are disclosed herein, and any combination of these options is possible unless specifically excluded. In other words, the various components of the disclosed devices and systems can be combined unless mutually exclusive or otherwise physically impossible.

[0140] The techniques, methods, operations, steps, etc. described or illustrated herein or in the references incorporated herein, and any methods of using the systems, assemblies, devices, apparatuses, etc. herein, can be performed on a living subject (e.g., a human, other animal, etc.) or on a simulator / simulated subject (e.g., a cadaver, a cadaver heart, a simulator, a virtual human, etc.). When performed on a simulator, the body part (e.g., a heart, tissue, valve, etc.) can be assumed to be simulated or can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, simulated valve, etc.), and can optionally include a computerized and / or physical representation of the body part, tissue, etc. The term "simulator" encompasses use on a cadaver, a computer simulator, a virtual human (e.g., if the demonstration is only performed on a virtual heart), etc.

[0141] The examples summarized above and defined by the enumerated claims may be better understood by reference to the following detailed description, which should be read in conjunction with the illustrative drawings in which like parts have like reference numerals. This detailed description discloses examples that enable one to make and use the embodiments set forth below and is not intended to limit the enumerated claims, but rather to provide examples thereof. Thus, embodiments having different structures and methods do not depart from the scope of the invention as defined in the claims.

[0142] As described herein, when one or more components are described as being connected, joined, attached, coupled, attached, or otherwise interconnected, such interconnection may be a direct interconnection between the components or an indirect interconnection, for example, using one or more intermediate components. Also as described herein, references to "member," "element," "component," or "portion" should not be limited to a single structural member, component, or element, but may include an assembly of components, components, or elements. Also as described herein, the terms "substantially" and "approximately" are defined as at least close to (and including) a given value or condition (preferably within 10%, more preferably within 1%).

[0143] Many variations of the example embodiments described herein are within the scope of the present invention, some of which are described for various embodiments. To the extent feasible, these variations are also contemplated for use with other embodiments. Thus, the therapeutic or prosthetic devices herein may include any combination or subcombination of the features and variations disclosed herein, and may not include some of the described features.

[0144] Figure 2-3 Cross-sectional views of a human heart H are shown during different phases of the cardiac (heartbeat) cycle. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA, respectively, by the tricuspid valve TV and mitral valve MV, i.e., the atrioventricular valves. 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 orifice and has flexible leaflets (e.g., also in FIG. 1 ). Figure 4-7 The anterior and posterior mitral valve leaflets 20 and 22 are depicted in FIG. Figure 8 ), these flexible leaflets extend inwardly across respective orifices that meet or "apposition" in the flow stream to form a one-way flow-blocking 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; therefore, the anatomy of the mitral valve, left atrium LA, and left ventricle LV will be explained in greater detail. However, the devices described herein may also be used to repair other native valves, for example, the devices may be used to repair the tricuspid valve TV, the aortic valve AV, the pulmonary valve PV, and / or the atrioventricular valve.

[0145] The left atrium LA receives oxygenated blood from the lungs via the pulmonary veins PV. Figure 2 During systole (as depicted in Figure 2), blood previously collected in the left atrium LA (at the end of the previous cardiac cycle) moves through the mitral valve MV and into the left ventricle LV due to the expansion of the left ventricle LV. Simultaneously, additional blood flows from the pulmonary veins into the left atrium. During the subsequent systole, atrial contraction occurs first, in which the atria contract, followed by ventricular contraction, in which the ventricles contract.

[0146] During atrial contraction during systole, the left atrium contracts to expel additional blood from within the left ventricle downstream into the left ventricle. During ventricular contraction during systole, as Figure 3 As depicted in Figure 1, the left ventricle LV contracts, forcing blood through the aortic valve AV to the ascending aorta AA, where it circulates back to the rest of the body. During ventricular contraction, the two leaflets of the mitral valve MV close to prevent blood from flowing back from the left ventricle LV into the left atrium LA. Simultaneously, as the left atrium relaxes, blood is collected from the pulmonary veins in the left atrium to begin the next cardiac cycle.

[0147] 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 through the tricuspid valve TV and into the right ventricle RV due to the expansion of the right ventricle RV. Simultaneously, additional blood flows from the vena cava into the right atrium. During systole, the right atrium contracts to expel the additional blood from the right ventricle downstream into the right ventricle. During systole, the right ventricle RV contracts to force blood through the pulmonary valve PV to the pulmonary artery PA, where it flows to the lungs. During ventricular contraction, the three leaflets of the tricuspid valve TV close to prevent blood from flowing back from the right ventricle RV into the right atrium RA. Simultaneously, blood collects in the right atrium from the vena cava to begin the next cardiac cycle.

[0148] Now refer to Figure 2-8 The mitral valve MV comprises two leaflets, namely an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also comprises a valve ring 24 (see Figure 6 ), the annulus is a variably dense, fibrous ring of tissue surrounding the anterior and posterior leaflets 20, 22. Figure 4-5The mitral valve (MV) is anchored to the wall of the left ventricle (LV) by the chordae tendineae CT. The chordae tendineae CT are a series of 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 and posterior leaflets (20, 22) of the mitral valve (MV). The papillary muscles (PM) serve to limit the movement of the anterior and posterior leaflets (20, 22) of the mitral valve (MV) and prevent mitral regurgitation.

[0149] The mitral valve MV opens and closes in response to the pressure difference between the left atrium LA and the left ventricle LV. Rather than opening or closing the mitral valve MV, the papillary muscles PM support and / or brace the anterior and posterior leaflets 20, 22 against the high pressures occurring in the left ventricle LV, which are required for blood to circulate throughout the body. The papillary muscles PM, along with the chordae tendineae CT, are considered part of the subvalvular structure, which is responsible for preventing the mitral valve from prolapsing or flailing into the left atrium LA when the mitral valve MV is closed. Figure 4 As depicted in the left ventricular outflow tract (LVOT) view depicted in FIG, the anatomy of the anterior and posterior leaflets 20, 22 is such that the inner sides of the leaflets coapt at their free end portions, and then the anterior and posterior leaflets 20, 22 separate or diverge from one another from there. The anterior and posterior leaflets 20, 22 diverge in an atrial direction until each leaflet meets the mitral annulus 24.

[0150] Various disease processes may impair the normal function of one or more native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, fibroelastic defects, 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) from a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy, etc.) may distort the geometry of the native valve, which may lead to native valve dysfunction.

[0151] Dysfunctional native valves malfunction in different ways, including: (1) valvular stenosis; and (2) valvular regurgitation. Although stenosis and regurgitation can affect any valve, stenosis is most often found affecting the aortic and pulmonary valves, and regurgitation is most often found affecting the atrioventricular valves (i.e., the mitral and tricuspid valves).

[0152] Both valvular stenosis and valvular regurgitation increase the workload of the heart H and, if left untreated, can lead to very 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 significantly higher. Malfunction of the mitral valve MV or aortic valve AV is particularly problematic and often life-threatening.

[0153] Valvular stenosis may prevent the native valve from opening properly and / or completely, resulting in improper blood flow (e.g., obstructed blood flow, jetting, etc.). Typically, valvular stenosis is caused by a buildup of calcified material in the valve leaflets, which thickens the leaflets and impairs the valve's ability to function properly.

[0154] Valve regurgitation typically occurs when the leaflets of a valve do not close completely, thereby causing blood to leak back into the preceding (upstream) chamber (for example, the mitral valve fails to close completely, causing blood to leak from the left ventricle into the left atrium). There are three main mechanisms by which a native valve becomes regurgitant (or incompetent), including Carpentier Type I, Type II, and Type III dysfunction.

[0155] Carpentier type I dysfunction involves dilation of the annulus, causing the normally functioning leaflets to diverge from each other and fail to form a tight seal (e.g., the leaflets do not coapt properly). Type I mechanistic dysfunction involves leaflet perforation, as occurs with endocarditis. Carpentier type II dysfunction involves prolapse of one or more leaflets of the native valve above the plane of coaptation. Carpentier type III dysfunction involves restriction of movement of one or more leaflets of the native valve, causing them to be abnormally constrained below the plane of the annulus. Leaflet restriction may occur due to rheumatic disease or ventricular dilatation.

[0156] A dysfunctional native heart valve may require replacement or repair. Replacement may involve replacing the subject's native valve with a biological or mechanical substitute. Repair may involve preserving and correcting the subject's native valve. In some embodiments, the devices described herein are used to repair the function of a defective native valve. That is, these devices are configured to help close the leaflets of the native valve to inhibit blood from flowing back. Some of the devices described in this application are designed to easily grasp and secure the native leaflets. In some embodiments, the native leaflets are grasped and / or secured around an apposition element (e.g., a spacer, gap filler, wedge, plug, foam, sponge, etc.) that advantageously acts as a filler in the regurgitant orifice to help inhibit backflow or reflux, but this is not required in all embodiments.

[0157] Many patients who undergo valve surgery, such as mitral MV surgery, have degenerative disease that causes the leaflets of the native valve (e.g., mitral MV) to malfunction, leading to prolapse, flocculation, and / or regurgitation. Figure 6 When the healthy mitral valve MV is in the closed position, the anterior leaflet 20 and the posterior leaflet 22 coapt, which prevents blood from leaking from the left ventricle LV to the left atrium LA. Figure 4 and 7 Mitral regurgitation MR can occur when the anterior leaflet 20 and / or posterior leaflet 22 of the mitral valve MV are displaced such that the anterior leaflet 20 and posterior leaflet 22 cannot properly coapt or close. This coaptation failure causes a gap 26 to form between the anterior leaflet 20 and the posterior leaflet 22, allowing blood to flow backward (e.g., from the left ventricle LV into the left atrium LA, as in Figure 4 The MR flow path of mitral regurgitation is depicted).

[0158] refer to Figure 7 , the width W of gap 26 can be between about 2.5 mm and about 17.5 mm, between about 5 mm and about 15 mm, between about 7.5 mm and about 12.5 mm, or about 10 mm. In some cases, gap 26 can have a width W greater than 15 mm or even 17.5 mm. As stated above, leaflets (e.g., anterior leaflet 20 and posterior leaflet 22 of the mitral valve MV) can malfunction in several different ways, potentially causing valvular regurgitation.

[0159] In any of the above situations, valve function may be improved by using a treatment / repair device or implant that can engage the anterior and posterior leaflets 20, 22 to close the gap 26 and prevent regurgitation of blood through the mitral valve MV. Figure 5 , an abstract representation of a device 10 or implant is shown implanted between the anterior and posterior leaflets 20, 22 so that regurgitation does not occur during systole (the Figure 4 and Figure 5 for comparison).

[0160] In some embodiments, the apposition element (e.g., a spacer, apposition element, gap filler, plug, wedge, sheet, barrier, etc.) of device 10 has a generally tapered or angled shape (e.g., a triangular shape, etc.) that naturally conforms to the native valve geometry and its expanded leaflet properties (toward the annulus 24). In this application, the terms spacer, apposition element, and gap filler are used interchangeably and refer to an element that fills a portion of the space between the native valve leaflets and / or is configured to cause the native valve leaflets to coapt or "appose" (e.g., cause the native leaflets to appose the apposition element, spacer, etc., rather than just to appose each other).

[0161] 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, thereby allowing blood to flow back from the ventricles into the atria (e.g., a deformed mitral valve MV may allow blood to flow back from the left ventricle LV into the left atrium LA, as described above). Figure 4 ). Regurgitation, or backflow of blood from the ventricles into the atria, can cause valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or tricuspid valve TV are generally repairable. Additionally, regurgitation can occur because the chordae tendineae CT become dysfunctional (e.g., the chordae tendineae CT may stretch or rupture), which causes the anterior and posterior leaflets 20, 22 to reverse, allowing blood to flow back into the left atrium LA. Problems that occur due to dysfunctional chordae tendineae CT can be repaired by repairing the structure of the chordae tendineae CT or the mitral valve MV (e.g., by securing the anterior and posterior leaflets 20, 22 at the affected portion of the mitral valve).

[0162] refer to Figure 7-8 The systems, devices, procedures, and concepts disclosed herein for treating / repairing the structure of a native valve are generally described in detail using the mitral valve as an illustrative example. On the left side of the heart, the systems, devices, and procedures can be used between the anterior leaflet 20 and the posterior leaflet 22 of the mitral valve MV to connect them and help prevent or inhibit backflow of blood from the left ventricle to the left atrium. The devices, procedures, and concepts disclosed herein can also be used to treat / repair a single leaflet of a native valve.

[0163] As with the mitral valve, other valves (e.g., the aortic valve, the pulmonary valve, and the tricuspid valve) can be treated / repaired using the devices, procedures, and concepts disclosed herein. For example, as with the left side of the heart, on the right side of the heart, such devices, procedures, and concepts can be used between any two of the three leaflets of the tricuspid valve (e.g., the anterior leaflet 30, the septal leaflet 32, and the posterior leaflet 34) to connect them and prevent or inhibit the backflow of blood from the right ventricle to the right atrium. Furthermore, the devices, procedures, and concepts disclosed herein can be used between all three leaflets of the tricuspid valve 30, 32, 34 to connect all three and prevent or inhibit the backflow of blood from the right ventricle to the right atrium.

[0164] The devices, procedures, systems and concepts disclosed herein can also be used to treat / repair individual leaflets of a valve. In summary, the devices, procedures, systems and concepts described can be used to treat or repair any native valve and any component of a native valve, as appropriate.

[0165] In some embodiments, the systems herein can be configured as an organ repair system for repairing an organ, e.g., a heart or heart valve. In some embodiments, the systems herein can be configured to treat / repair another part of the body. In some embodiments, the systems herein are valve treatment / repair systems for repairing or treating a valve. In some embodiments, the systems herein comprise 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.).

[0166] In some embodiments, the therapeutic / repair system herein includes a delivery system having a distal end that is inserted into a subject (e.g., a living patient, a simulant, etc.) and a proximal end that remains outside the subject. The delivery system can include an implantation catheter system having a catheter component (e.g., a delivery and / or implantation catheter) that is configured and sized to receive, deliver, and implant or otherwise deploy the therapeutic / repair device within the subject.

[0167] The therapeutic / repair devices herein can be used by medical personnel to repair or treat a subject's natural valve. In some embodiments, this is accomplished by repairing and / or supporting one or more leaflets of the subject's valve.

[0168] In some embodiments, the device can be delivered to the valve by a delivery system through the subject's vascular system.The delivery and / or implantation catheter 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.

[0169] In some embodiments, the system is provided with an array of controllable components for various actuation activities, some of which are described herein and others known in the art. In some embodiments, the system is configured so that a user (e.g., a medical professional) can manipulate various controls (e.g., one or more of knobs, motors, buttons, switches, sliders, gears, motors, screws, cams, universal joints, etc.) to control the system. In some embodiments, the system may include mechanisms known to be used with other transvascular devices, but the actuation activities and associated controllable components themselves may be unique.

[0170] In some embodiments, the system is provided with a number of interrelated parts and methods, such as may be directly or indirectly described herein.

[0171] Additional details and background information regarding systems, devices, and methods (and associated mechanisms, components, operations, steps, etc.) for transvascular heart valve treatment / repair that can be used with the systems, devices, methods, etc. herein can be found in U.S. Patent No. 8,449,599, U.S. Patent Application Publication Nos. 2014 / 0222136, 2014 / 0067052, and 2016 / 0331523, and PCT Patent Application Publication No. WO2020 / 076898, each of which is incorporated herein by reference in its entirety for all purposes. In some embodiments, the leaflet anchors described in any of these incorporated references can optionally be used as leaflet anchors in the embodiments described herein. In addition, the apposition elements, spacers, etc. described in any of these incorporated references can optionally be used as the central body in any of the embodiments described herein.

[0172] An example transvascular technique that can be used with the systems, devices, methods, etc. for treating / repairing a native valve herein can include advancing a catheter or catheter device into the atrium (e.g., inserting a catheter device into the right femoral vein, up into the inferior vena cava, and into the right atrium). In some embodiments, the tricuspid valve is treated from the right atrium. In a transseptal transvascular technique, the septum can be punctured from the right atrium, and the catheter device advanced into the left atrium. In some cases, the catheter device can be coupled to a device (e.g., a therapeutic device, a repair device, an implant, etc.). The device can be positioned to repair a dysfunctional native valve.

[0173] The delivery systems herein can include one or more components that form a steering catheter system and / or an implantation catheter system. In some embodiments, a delivery system can have one or more components that form a steering catheter system and an implantation catheter system.

[0174] In some embodiments, the implantable catheter system comprises one or more implantable catheters capable of placing and implanting or otherwise deploying a therapeutic or prosthetic device. Optionally, the one or more implantable catheters can be steerable catheters capable of traversing the vascular system of the subject, thereby also forming all or part of a steerable catheter system, rather than as a separate system. The delivery system may further comprise additional devices for transvascular procedures, such as sheaths, control guidewires, external catheter control systems and controls (e.g., one or more of knobs, motors, buttons, switches, sliders, gears, motors, screws, cams, universal joints, etc.), etc.

[0175] In some embodiments, the steering catheter system comprises one or more steering catheters capable of traversing the vasculature of a subject.

[0176] In some embodiments, for example, embodiments having a separate steering catheter system, the one or more steering catheters can be individually or collectively configured to guide the one or more implant catheters through the vasculature of the subject. In some embodiments, this can involve positioning the distal end of the steering catheter system upstream (with respect to the direction of blood flow) of the defective valve and pointing the distal end of the implant catheter system downstream (in the direction of blood flow) through the valve.

[0177] In some embodiments, the implant catheter system is initially inserted into the steering catheter system before the implant catheter system is inserted into the subject, or is 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 implant catheter inserted, the implant catheter system extends downstream from within the steering catheter system toward the valve.

[0178] Components of the therapeutic / repair device can be configured to be passed through the vasculature of a subject via a delivery system in an operational configuration. In some embodiments, the therapeutic / repair device can be structurally configured with a first, small form factor (e.g., small diameter) delivery configuration that is structurally arranged for passing the delivery system through the vasculature of a subject, and a second, operational configuration that is structurally suitable for a valve treatment or repair procedure. In some such embodiments, the implantation catheter includes one or more actuators for actuating the therapeutic / repair device from the delivery configuration to the operational configuration when the device is in its installed position within the heart of the subject.

[0179] In some embodiments, the components of the device can be configured to be simultaneously traversed through the vasculature of a subject as a single implantable unit via a delivery system.

[0180] In some embodiments, the components of the device can be configured to be passed transvascularly through the delivery system piece by piece through the subject's vascular system. In some embodiments, the pieces are assembled into an implantable device within the body (e.g., within the heart during an implantation procedure).

[0181] In some embodiments herein, a treatment / repair system comprises and uses a plurality of anchors (e.g., leaflet anchors, tissue anchors, clips, snaps, toggle anchors, staples, rivets, tucks, etc.) attached to tissue (e.g., tissue of an organ). In some embodiments, it is also possible that the system is in the form of a treatment or repair device and / or includes a treatment or repair device that includes at least one or more independently actuatable leaflet anchors (e.g., clips, snaps, clamps, toggle anchors, staples, rivets, tucks, knots, etc.).

[0182] In some embodiments, the leaflet anchor is an attachment device that is configured (once in an operative configuration) with a leaflet attachment mechanism for attaching itself to the leaflet in any one or more of a variety of ways. For example, this attachment mechanism can be in the form of an attachment body (e.g., a rod). In some embodiments, there will be a plurality of attachment bodies (a first attachment body, a second attachment body, a third attachment body, etc.), each of which can have any of a variety of cross-sections (e.g., a relatively flat paddle-shaped cross-section) and extend longitudinally in any of a variety of shapes (e.g., a straight line or a circle) to form a compression structure (e.g., a paddle or a ring).

[0183] In some embodiments, the attachment bodies can be configured to attach to the leaflets, such as by pressing against the leaflets, and thereby constraining movement of the leaflets relative to the anchor. For example, in some embodiments of a clip-on anchor, two attachment bodies in the form of paddles can be configured so that one end of them is attached with a hinge to form jaws that can bite down and clamp or snap onto the leaflets, thereby attaching to the leaflets. In some embodiments, such a snap-on anchor attachment device (or attachment mechanism) can be provided with two control devices (or control mechanisms), one control device that actuates the attachment device between an open configuration and an attached configuration (optionally using a spring to load the jaws toward an open or closed position), and one control device that locks the attachment device to the leaflets. In some embodiments, the control device can be controlled using a control line, such as a suture, wire, thread, tether, or the like.

[0184] Likewise, any leaflet anchor herein can be provided with various other forms of tissue attachment mechanisms, such as friction means, adhesive means, tissue piercing means, and / or various forms of grabbers. Anchors can take and / or include various forms, such as snaps, clamps, clips, tucks, staples, hooks, rods, bars, screws, knots, toggle anchors, and the like.

[0185] In some embodiments, each leaflet anchor can include a toggle anchor or be in the form of a toggle anchor having a rod with a centrally attached corresponding anchor tether (e.g., a tether or tether segment associated with a particular anchor). The rod can be caused to longitudinally pierce, penetrate, and pass through the wall of the leaflet, pulling the anchor tether with it, much like a needle pulling a thread. To achieve this manipulation, the rod can be oriented parallel to the anchor tether, and then a sharp point or edge (either located at the end of the rod or on a separate penetrator that includes or is attached to the toggle anchor) is used to push the end of the rod through the wall of the leaflet. In some embodiments, a structural support member can be used to support the leaflet structure during penetration.

[0186] In some embodiments, after passing through the wall, the anchor tether is pulled, and the rod is thereby toggled (rotated) to press laterally against the wall of the tissue, wherein the distal end of the anchor tether (the anchor end) is pulled back and extends back through the penetrating wall of the tissue, forming a T-shaped configuration (with the rod forming the top of a capital T). This T-shaped toggle anchor (also known as a T-type anchor) prevents the rod from returning through the hole in the tissue (leaflet) when pulled by the anchor tether. The anchor may use variations of the structure for toggling the anchor rod, such as a rod made of an elongated accordion-pleated fabric, wherein the anchor tether extends through multiple leaves of the accordion pleats, which are then squeezed into the accordion-pleat structure to form the rod.

[0187] In some embodiments, the device further comprises one or more connectors, such as decoupleable, detachable, or severable connectors. At least one of the one or more connectors is an anchor connector or an anchor severable connector (e.g., a first anchor connector, a first anchor severable connector, a second anchor connector, a second anchor severable connector, etc.), in the form of a fastener or connection for directly or indirectly fastening, attaching, or coupling the structure of an associated anchor of the one or more anchors to the structure of a catheter of a delivery catheter system / implantation catheter system.

[0188] In some embodiments, each anchor connector structurally rigidly fastens, couples, attaches, etc. the anchor and the catheter together. Each such anchor connector enables a user (via a delivery or implantation catheter system) to first position the associated anchor for attachment to a valve portion, such as a leaflet, and then, after the anchor is attached to the leaflet, upon user actuation, to uncouple, detach, or sever the connection provided by the anchor connector and thereby loosen and release the anchor from the implantation catheter. Uncoupling / detaching / severing the anchor connector thereby eliminates the constraint of the connector separating the anchor from the implantation catheter. The implantation catheter can then be moved separately away from the anchor, for example, to position one or more other anchors at other leaflets or leaflet locations.

[0189] In some embodiments, a connector (e.g., a severable connector, an anchor connector, a catheter connector, etc.) can be a structure that forms a connection that, in a first, unsevered state, joins and secures two distinct components (e.g., an anchor and a delivery catheter) such that they are constrained (typically with considerable stiffness) to move synchronously with one another in one or more degrees of freedom (and typically six degrees of freedom). In some embodiments, the severable connector can be controllably decoupled / detached to a second, decoupled state (e.g., a detached state, a severed state, etc.), breaking (ending) the constraint that the components move synchronously with one another in at least one of the constrained degrees of freedom (typically six relative degrees of freedom). In other words, the connector or severable connector forms a decoupleable / detachable / severable connection between a first component and a second component. In some embodiments, the decoupleable / detachable / severable connection includes a coupled, connected, or unsevered state, wherein the connector constrains the first component and the second component to move synchronously with one another in a set of one or more constrained degrees of freedom. In some embodiments, the decoupling / detachable / severable connection may also include a decoupled, detached, or severed state in which the first component and the second component are not constrained by the connector to move synchronously relative to each other, for example, in at least one constrained degree of freedom of the set of one or more constrained degrees of freedom.

[0190] In some embodiments, synchronized movement of two objects relative to one or more degrees of freedom encompasses a state in which the two objects simultaneously move together (e.g., translate and / or rotate) in the one or more degrees of freedom to maintain their positions relative to each other, such as would occur if there were a rigid connection between the two objects.

[0191] The transition from the coupled state to the uncoupled state (e.g., from a connected state to a detached state, from an unsevered state to a severed state, etc.) can controllably occur via various physical connection structures, such as those maintained by retractable mechanical stops, by clamps or snaps, by a cuttable integral connector, etc. In some embodiments, the connector structure can be formed from (e.g., include) an integral part of one or both of the two different components, and / or formed from a completely separate structural element attached to one or both of the two different components.

[0192] In some embodiments, the six degrees of freedom of the connector can be three translational degrees of freedom (e.g., translation along a given set of x, y, and z axes, respectively, that are perpendicular to one another, one of which can be parallel to the direction in which the end of the implanted catheter is facing) 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 different components can provide the necessary stiffness to allow medical personnel to functionally control the position and orientation of one component (e.g., the anchor) simply by moving one component (e.g., the distal tip of the implanted catheter). Any material, especially a transvascular device, inherently has a certain degree of flexibility, but when used in this type of procedure, the material also needs to have a certain degree of rigidity to enable the device to perform its function.

[0193] In some embodiments, at least some of the anchors (e.g., one or more clips, snaps, clamps, toggle anchors, staples, rivets, tucks, knots, etc.) connected to the implant catheter system (and / or to other anchors) via a connector are each further connected to a controlled tether system having one or more controlled tethers (e.g., sutures or other types of tethers). In some embodiments, each controlled tether connects its corresponding anchor to the implant catheter system such that control of the anchor is maintained via the controllable connection between the anchor and the implant catheter system after the connector is uncoupled, detached, released, severed, etc. to break the connector's constraint on relative movement between the implant catheter and the anchor.

[0194] In some embodiments, the controlled tether either controllably connects the anchor to the implanted catheter system independently of connections between the implanted catheter system and other anchors, or the controlled tether connects the anchor to the implanted catheter system via one or more other anchors in the plurality of anchors. In the case where the controlled tether detachably connects the anchor to the implanted catheter system, the controlled tether may be attached only to a distal catheter section of the implanted catheter system located within the subject's body, or may extend backward through the implanted catheter system to a proximal end of the implanted catheter system so that medical personnel can directly operate it.

[0195] In some embodiments, a tether can be a structure that physically joins two or more distinct components (e.g., joining an anchor and an implant catheter system, or an anchor and another anchor, or other components, etc.). In some embodiments, the tether can join the components so that they are free and unconstrained in moving apart from each other in one or more (and typically six) degrees of freedom, but are constrained (in one or more degrees of freedom) to not separate from each other beyond a defined tether limit (e.g., the amount of slack in the tether, i.e., the available length to which the tether can extend). This unconstrained movement within the defined tether limit can be sufficient to allow the components to move independently over distances sufficient to facilitate separate placement of the components in functionally independent positions (e.g., placement where a first leaflet anchor is attached to a first portion of a first leaflet and an implant catheter is positioned such that a second leaflet anchor is located at a first portion of a second leaflet at a different location). In some embodiments where the tether joins more than two distinct components, the components, in combination, can be constrained (in one or more degrees of freedom) to not separate from each other beyond the defined tether limit.

[0196] As used herein, such tether flexibility is understood to mean that, as long as the tethered component (e.g., tethered anchor) is within the degrees of freedom of movement permitted by the confines of the tether, the tether is sufficiently flexible to enable medical personnel to functionally control the position and orientation of a component (e.g., the distal tip of an implant catheter) without having forces that significantly impede function due to opposing movement or position of the tethered component being conveyed through the tether. In short, the tether is flexible enough to allow the anchors to be attached to the leaflets while being at a greater distance from each other than if the anchors were directly connected to each other. Thus, mechanical extension devices other than simple tethers (e.g., a series of flexible rods and / or connectors) are within the scope of this disclosure so long as they provide usable tether flexibility.

[0197] As used herein, a tether may be understood to comprise a plurality of individual (separate) tether segments that are connected, for example, by looping one tether segment through an eyelet formed by another tether segment to form a tether as a whole. Furthermore, as used herein, a finite portion of a tether and its tether segments will be referred to as a segment of the respective tether and / or tether segment. For example, a tether or tether segment may be referred to as having a first end segment, a second end segment, and an intermediate or center segment (see, e.g., Figure 25 and related public content).

[0198] A controlled tether is a tether that is controllably 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 leaflet anchors to appose and thereby engage their respective leaflets after the leaflet anchors have been attached to their respective leaflets). A controlled tether can be formed from (e.g., include) an integral part of one or both of the engagement components and / or from an entirely separate structural element (such as a suture) attached to or passed through one or both of the two engagement components.

[0199] In some embodiments, the controlled tether (or a segment thereof) can be a looped tether. In some embodiments, the looped tether (or a segment of the looped tether) can be connected from a proximal end, which can be actuated and removed from or using an implantable catheter system (e.g., the end of the implantable catheter system can remain outside the subject's body during initial insertion), to a distal end, which forms a loop (e.g., a tether loop) that connects to a primary connection point associated with a portion of a therapeutic or prosthetic device. Thus, the looped tether can be used to controllably actuate or connect (e.g., hold together) the portions of the device as needed for implantation, and the (looped) tether can then be removed without physically cutting or severing the device from the looped tether.

[0200] In some embodiments, the looped tether is configured to perform this removable operation by extending sequentially (end to end) starting from a segment at the first end of the tether located at the proximal end of the implant catheter system (e.g., a controlled tether first end segment or an extended tether first end segment) (protruding from the proximal user end of the implant catheter), down the implant catheter system (through or alongside the implant catheter system) to its distal end (implantation end), optionally through and out of a central body positioned at the distal end of the implant catheter system, to a tether main connection point of the device (e.g., a corresponding anchor), being slidably received by and passing through (around) the main connection point, returning and passing through the central body (optionally), again along the implant catheter system (through or alongside the implant catheter system) back to its proximal end, to a segment at the second end of the tether located at the proximal end of the implant catheter system (e.g., a controlled tether second end segment or an extended tether second end segment) (protruding from the proximal user end of the implant catheter and the first end segment of the looped tether). This type of looped tether can be removed from the body while leaving the implant implanted by pulling on a first end segment of the tether while releasing the second end segment to be pulled by the first end segment 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 a device or components thereof (e.g., hold them together) and then remove them without physically cutting or severing the device are also within the scope of the present disclosure.

[0201] In some embodiments, the treatment or repair device comprises a system (e.g., a controlled tether system, a tether system, an adjustment system, an apposition system, an actuation system, a connection system, a control system, etc.). In some embodiments, the system can include a central body configured as an apposition element and / or a spacer. The central body can be configured to be actuatable to guide (e.g., move, adjust, etc.) and maintain the position of the anchors, thereby maintaining the leaflets. More specifically, when the anchor connector is in a disengaged or detached state and the central body is positioned and located between the anchors and facing the opposing surfaces of the anchors, the central body uses a certain 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 leaflets to a position where the leaflets are tightly positioned, held, and maintained to improve their operation as an operable valve closure element.

[0202] In some embodiments, as a spacer, the central body is configured with a gap-filling shape, structure, and composition for blocking the gap between the leaflets to reduce regurgitation. In some embodiments, the central body structure is shaped and positioned relative to the leaflets so that after apposition, the opposing surfaces of the anchors and their corresponding leaflets close around the central body during the appropriate portion of the cardiac cycle. In some embodiments, the central body / spacer can be configured to seal against the opposing surfaces of two or three anchors, and thereby against two or three native leaflets, depending in part on the type of valve to which they are adapted. The central body / spacer can be formed in any of a variety of shapes, such as may be suitable for the intended use. For example, the various shapes can include a cylindrical capsule shape, such as an elongated cylindrical shape, characterized by a longitudinal cross-section that is: circular, elliptical, oval, crescent-shaped, or even rectangular. In some embodiments, the central body can have an upstream (e.g., atrial or superior) portion positioned in or adjacent to the atria, a downstream (e.g., ventricular or inferior) portion positioned in or adjacent to the ventricles, and a lateral surface extending between the native valve leaflets. In some embodiments, the septum can be configured, for example, as a tubular braided wire comprised of a nitinol mesh.

[0203] In some embodiments, the spacer can be a flexible spacer with low compressibility that, when mechanically compressed, compressibly expands in some dimensions to become wider and / or longer (or expands in one or more other dimensions) so that it conforms to adjacent opposing surfaces and fills adjacent spaces, and may extrude beyond them.

[0204] In some embodiments, the anchors are inserted into the subject simultaneously. In some embodiments, at least some of the anchors are individually pulled to a central position by a system of controlled tethers (e.g., a controlled tether system, a tether system, an apposition system, an actuation system, a connection system, a control system, etc.) having distinct and independently extending tethers. This can be accomplished with both bileaflet and trileaflet valves and can be incorporated into a procedure for treating / repairing a trileaflet valve using only two leaflet anchors.

[0205] refer to Figure 2-14 In some embodiments of the treatment or repair system (e.g., a simultaneously inserted and centrally connected embodiment), a treatment or repair device 101 for use by medical personnel to treat or repair a subject's native valve is delivered by a delivery system through the vascular system to the valve for valve treatment / repair. In some embodiments, the delivery system includes a steering catheter system including a steering catheter 103, which can operate similarly to other steering catheter systems.

[0206] In some embodiments, delivery involves positioning the distal end of the steering catheter 103 upstream (relative to the blood flow direction 105 ) of a defective native valve (e.g., mitral valve MV, etc.) and directing the distal end of the steering catheter downstream (in the direction of blood flow) through the native valve.

[0207] In some embodiments, the delivery system is provided with a delivery catheter system or implantation catheter system comprising a delivery catheter or implantation catheter 111. In some embodiments, the implantation catheter begins within the steering catheter system prior to its insertion into the subject. In some embodiments, after the steering catheter system is positioned upstream of the native valve, the implantation catheter is inserted into the proximal end of the steering catheter system (which extends outside the subject for manipulation by the user). In some embodiments, with the steering catheter system in place and the implantation catheter inserted, the distal implantation end of the implantation catheter extends downstream from within the steering catheter system toward the native valve (e.g., as Figure 9 ). In some embodiments, the implant catheter can be steerable. In some embodiments, the implant catheter can be used without a separate steerable catheter.

[0208] The distal end of the delivery or implantation catheter 111 mounts and carries some or all portions of a 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 embodiments, the device 101 includes two leaflet anchors, e.g., a first leaflet anchor 113 and a second leaflet anchor 115. In some embodiments, 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 independent actuators and actuation controls such that each anchor can be individually and independently attached to a respective leaflet location.

[0209] In some embodiments, the clip anchors can be configured to each include two paddles, an outer paddle 117 and an inner paddle 119. In some embodiments, the two paddles are connected at one end using a hinge 120. In some embodiments, these clip anchors are configured to attach to the leaflets by clipping onto them, e.g., by actuating the hinges to bite down and thereby grasp the edges of the leaflets that need to be constrained to improve valve function.

[0210] In some embodiments, the device 101 further comprises an anchor connector (e.g., a decoupleable connector, a detachable connector, a severable connector, etc.) for each respective anchor, for example, a first anchor connector 121 for the first leaflet anchor 113 and a second anchor connector 123 for the second leaflet anchor 115. In some embodiments, the first anchor connector forms a decoupleable connection (e.g., a detachable connection, a severable connection, a releasable connection, etc.) for the first anchor, and the second anchor connector forms a decoupleable connection (e.g., a detachable connection, a severable connection, a releasable connection, etc.) for the second anchor. In some embodiments, the device further comprises an optional central body 131 (e.g., a spacer, an apposition element, a plug, a gap filler, etc.) and a central body connector 133. In some embodiments, the central body connector 133 is a structural fastener that is used to form a central body-disconnectable connection (e.g., a detachable connection, a severable connection, a releasable connection, etc.) that secures the central body 131 to the delivery / implantation catheter 111 when in a connected state or an uncut state (e.g., it limits and / or constrains their relative movement to synchronized movement).

[0211] In some embodiments, the first connector 121 and the second connector 123 form a first anchor releasable connection and a second anchor releasable connection, respectively, for securing their respective first leaflet anchors 113 and second leaflet anchors 115 to the central body 131 when in a connected or uncut state, thereby indirectly securing the first and second anchor connectors to the delivery / implantation catheter 111 via the central body. In some embodiments, these first and second anchor releasable connections are distinct and independent of each other, in that uncoupling or detaching one of the first and second anchor connectors does not uncouple or detach the connection formed by the other connector (e.g., it does not release the constraint on synchronized movement). Various connector technologies and / or mechanisms, such as those for uncoupling or detaching an implant from an implantation catheter (e.g., snaps, clamps, releases, ties, fasteners, rings, etc.), may be suitable for use as a connector or a portion of a connector.

[0212] In the connected state, the connectors limit and / or constrain relative movement between their respective devices, typically in six degrees of freedom. For example, in the connected state, the first anchor connector limits and / or constrains relative movement between the first leaflet anchor and the central body, typically requiring them to move synchronously in six degrees of freedom. Decoupling or releasing the connector connection places them in a decoupled, detached, or released state, which eliminates the limits and / or constraints on the synchronous (relative) movement between the respective devices (compared to their uncut state). The limits and / or constraints eliminated are typically in six degrees of freedom, but can be in fewer degrees of freedom.

[0213] While various forms of the term "sever" are used herein, it should be understood that in the context of the present application and claims, the terms "sever," "severable," "severing," and the like encompass decoupling, disconnecting, detaching, removing, and the like (even if no cutting is performed).

[0214] In some embodiments, the treatment / repair device 101 further comprises a system or mechanism, such as a controlled tether system or mechanism or other adjustment system / mechanism. In some embodiments, the system comprises a respective controlled tether for each anchor, for example, a first controlled tether 141 for the first leaflet anchor 113 and a second controlled tether 143 for the second leaflet anchor 115.

[0215] In some embodiments, each controlled tether is in the form of a flexible cord (e.g., a suture). In some embodiments, each controlled tether is a looped tether that is used to extendably secure a primary connection (which is one or more points on a corresponding anchor) to the central body 131 (and thus to the delivery / implantation catheter 111). In some embodiments, this is achieved by extending sequentially (end-to-end) from a first end segment located at the proximal end of an implant catheter of an implant catheter system to its distal end (implantation end), passing through the central body 131 (located at the distal end of the implant catheter system) and exiting therefrom to the corresponding anchor of the controlled tether, being slidably received by and passed through (encircled by) one or more anchor slidable limiters (e.g., a first anchor slidable limiter, a second anchor slidable limiter, a third anchor slidable limiter, an intermediate anchor slidable limiter, and a final anchor slidable limiter) along the length of the corresponding anchor, returning and passing through and / or alongside the central body and implant catheter to its proximal end, and reaching the second end segment located at the proximal end of the implant catheter system (and the first end segment of the controlled tether).

[0216] In some embodiments, the first and second end segments of each controlled tether are user-operable, either directly or using a control mechanism of the implantable device (e.g., one or more of a button, switch, lever, slider, knob, gear, motor, threaded component, screw, cam, universal wheel, etc.). In use, the user individually and controllably increases the slack (tether restriction) of the controlled tether by feeding (inserting) one or both ends of the controlled tether into the delivery / implantation catheter 111 to increase the available tether length between the central body 131 and the anchor, thereby allowing the corresponding anchor to be more spaced apart from the central body in any direction. The user individually and controllably decreases the slack of each controlled tether by withdrawing (pulling) one or both ends of the controlled tether from the implantation catheter to reduce the available tether slack between the central body and the anchor, thereby restricting the corresponding anchor to be less spaced apart from the central body in any direction. This controlled relaxation allows the anchor to move independently of the central body and the implant catheter within a controlled range with six degrees of freedom, and also to be pulled back toward the central body for attachment to the central body in place.

[0217] In some embodiments, the independent movement of the anchors is limited by a corresponding tether limit (e.g., the tether length available for movement), beyond which the corresponding anchor cannot move. The tether limit is the amount of slack imparted to the corresponding controlled tether. In some embodiments, because the controlled tether loops back on itself, the tether limit can be changed by half the amount of the controlled tether length adjusted by the user.

[0218] Each controlled tether is slidably and / or fixedly connected to its anchor at two locations along the anchor using a slidable eyelet-type restraint that may be formed as part of the anchor structure, and is slidably fed back into the central body 131 at two locations along the central body. This two-point controlled tether connection between the anchor and the central body allows for greater control over the relative positions of the anchor and central body when the controlled tether slack is subsequently removed (e.g., the controlled tether is tightened).

[0219] Prior to insertion into a subject, some or all portions of the device 101, e.g., the first leaflet anchor 113 and the second leaflet anchor 115 and / or the first anchor connector 121 (in a connected state), are mounted together on the distal end of the delivery / implantation catheter 111. When mounted on the implantation catheter prior to insertion, the structure of these portions of the device has a structural form factor of size and shape that is within the constraints imposed by the delivery system, such that the mounted portions can be simultaneously passed through the delivery system through the vasculature of the subject (as a single implantable unit).

[0220] In some embodiments, the configuration of these portions of device 101 can be adapted to operate in a first, small form factor (e.g., small diameter) delivery configuration and a second, operational configuration (e.g., configured for a therapeutic or repair procedure) in which the device 101 is positioned. Figure 9 The delivery configuration is adapted to switch between the mounted portion of the device as a single implantable unit through the delivery system through the vascular system of the subject (optionally having a delivery configuration similar to that of the other systems).

[0221] In some embodiments, the implantation catheter includes one or more actuators for actuating the device 101 from a delivery configuration to an operational configuration in which the device is located within the heart of a subject. These actuators and their controls can be handle-type controls similar to other actuators and controls (e.g., one or more of buttons, switches, levers, sliders, knobs, gears, motors, threaded components, screws, cams, universal joints, etc.) used to deploy the implant from within the delivery system.

[0222] With the delivery or implantation catheter 111 extending from within the steering catheter 103 and directed downstream toward the mitral valve MV, the implantation catheter is moved downstream into the mitral valve and partially or completely through the mitral valve to the desired extent, depending on the geometry of the device and valve. If first delivered to the heart in the delivery configuration, either before or after crossing the mitral valve MV, the delivery / implantation catheter 111 actuates the device 101 from the delivery configuration to the operational configuration (e.g., Figure 9 (depicted in ).

[0223] like Figure 10-11 , with the delivery / implantation catheter 111 moved downstream into and through the mitral valve MV and the device 101 actuated into the operational configuration, the user actuates the implantation catheter to move the device.

[0224] In some embodiments, the implantation catheter is moved to position the first leaflet anchor 113 at a first location within the heart, positioned and oriented to attach the anchor to (by clipping onto) a first portion of the edge of the first leaflet 151 that requires constraint to improve function (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., the hinge 120 of the first leaflet anchor is actuated to the anchor at the leaflet edge, e.g., clipping down, thereby attaching it to the leaflet).

[0225] The anchoring systems, devices, mechanisms, etc. used herein for attaching anchors to tissue can take a variety of different forms, such as, for example, clamping mechanisms, snap mechanisms, suction mechanisms, adhesive mechanisms, etc. In some embodiments, the anchoring systems, devices, mechanisms, etc. are separate and / or distinct from the systems, devices, mechanisms, etc. used for controlled tethering. In some embodiments, the anchoring systems, devices, mechanisms, etc. used for attaching anchors to tissue can be comparable to other anchor actuation systems, such as those that use sutures, threaded members, cams, shafts, and / or springs to controllably open and close clamps, snaps, etc. In some embodiments, the clamping system, device, or mechanism is used to clamp to tissue, such as to a valve leaflet, for anchoring.

[0226] Figure 10A A therapeutic or prosthetic device 101 is shown including an example clamping mechanism 200. In some embodiments, the clamping mechanism includes a line 202, such as a suture or wire, and a biasing element 204, such as a spring, elastic member, etc. In some embodiments, the biasing element 204 biases the outer paddle 117 and the inner paddle 119 toward each other. In some embodiments, the biasing element 204 biases the outer paddle 117 and the inner paddle 119 away from each other.

[0227] In some embodiments, for example, when a biasing element biases outer paddle 117 and inner paddle 119 toward each other, wire 202 can be arranged such that pulling on the wire moves outer paddle 117 and inner paddle 119 away from each other to open the paddle. In some embodiments, for example, when a biasing element biases outer paddle 117 and inner paddle 119 away from each other, wire 202 can be arranged such that pulling on the wire moves outer paddle 117 and inner paddle 119 toward each other to close the paddle.

[0228] Once in the closed position, the relative positions of outer paddle 117 and inner paddle 119 may optionally be locked.

[0229] Figure 10B An example of a clamping mechanism 300 is shown. In some embodiments, the clamping mechanism 300 includes 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 embodiments, the optional follower 304 can be attached to the actuating element 302 via a fastener 307, such as a clamp, nut, cap, washer, etc.

[0230] In some embodiments, drive link 306 is pivotally coupled to optional follower 304 at pivot axis 308. In some embodiments, follower 304 is omitted, and drive link 306 is pivotally coupled directly to actuating element 302. In some embodiments, drive link 306 is pivotally coupled to outer paddle 117 at pivot axis 310. In some embodiments, movement of actuating element 302 in direction 320 moves drive link 306, which in turn moves outer paddle 117 toward the open condition. In some embodiments, movement of actuating element 302 in direction 322 moves drive link 306, which in turn moves outer paddle 117 toward the closed condition. An optional biasing element can bias outer paddle 117 toward or away from inner paddle 119. Once in the closed position, the relative positions of outer paddle 117 and inner paddle 119 can optionally be locked.

[0231] The first leaflet anchor 113 and the second leaflet anchor 115 can take a variety of different forms. In some embodiments, the anchors 113, 115 can be configured to snap into an open position and snap into a closed position. For example, the first leaflet anchor 113 and the second leaflet anchor 115 can be configured like a snap hairpin.

[0232] refer to Figure 10C and 10D In some embodiments, leaflet anchor 413 comprises a first arm 417 and a second arm 419. In some embodiments, first arm 417 and 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 embodiments, first arm 417 and second arm 419 are connected together at closed end 430.

[0233] In some embodiments, the first arm 417 and / or the second arm 419 are shaped to snap into a closed configuration ( Figure 10C ) and snap to the open configuration ( Figure 10D In some embodiments, moving the first arm 417 past the center or snap line 420 in the direction indicated by arrow 422 may cause the leaflet anchor to snap onto the leaflet anchor. Figure 10CIn some embodiments, moving the first arm 417 past the center or snap line 420 in the direction indicated by arrow 424 can cause the leaflet anchor to snap onto the leaflet anchor. Figure 10D Opening conditions are shown.

[0234] Figure 10E and 10F Shown using Figure 10C and 10D An example of a clamping mechanism 500 for a leaflet anchor 413 is shown. In some embodiments, as shown, the clamping mechanism 500 includes a base 502 (e.g., a frame, an apposition element, and / or a tube, etc.), an actuation element 504 (e.g., a wire, a hypotube, a flexible shaft, etc.), and the leaflet anchor 413. The closed end 430 of the leaflet anchor 413 can be fixed to or coupled to the distal end 432 of the base 502. In some embodiments, the actuation element 504 can extend through the base 502 and can be releasably coupled to the first arm 417.

[0235] refer to Figure 10E In some embodiments, pushing the first arm 417 past the center or snap line 420 using the actuation element 504 in the direction indicated by the arrow 524 can snap the leaflet anchor 413 into the open condition. Figure 10F In some embodiments, pulling the first arm 417 past the center or snap line 420 using the actuation element 504 in the direction indicated by arrow 522 can snap the leaflet anchor into a closed condition.

[0236] In some embodiments, the first leaflet anchor 113 can be a detachable anchor. In some embodiments, with the first leaflet anchor 113 attached to the first position on the first leaflet, the user actuates a control to uncouple or detach the first anchor connector 121 and thereby release the first leaflet anchor from its primary connection to the implantation catheter (e.g., the connection made through the first anchor connector). As a result, the central body and implantation catheter are freed to translate and rotate together with six degrees of freedom relative to the first leaflet anchor. In some embodiments, uncoupling or detaching the detachably attached first leaflet anchor 113 simply causes the first controlled tether 141 to loosely connect the first leaflet anchor 113 to the delivery / implantation catheter 111. Thus, they are only constrained by each other in that they cannot be separated from each other by a greater distance than the length of slack allows, which is a limitation of the first anchor tether.

[0237] In some embodiments, the first anchor connector 121 enables the delivery or implantation catheter 111 and central body 131 to position the first leaflet anchor 113 in the correct location for attachment to the first leaflet 151, and then, after the first leaflet anchor is attached to the first leaflet, to disconnect / detach / sever / release / loosen the first leaflet anchor from the implantation catheter, central body, and second leaflet anchor 115. In some embodiments, the delivery / implantation catheter 111, central body 131, and second leaflet anchor 115 can then be moved separately from the first leaflet anchor 113 to position the second leaflet anchor 115 at a second location within the heart, positioned and oriented to grasp a first portion of an edge of the second leaflet 153 that needs to be constrained to improve function (e.g., a first portion of an edge of the posterior leaflet 22). The second leaflet anchor 115 can be a detachable anchor.

[0238] In some embodiments, the user then provides sufficient slack to the first controlled tether 141 to allow the implant catheter to move freely (with the second leaflet anchor 115 still attached) to a second position (e.g., at a location on the second leaflet 153 where restraint is desired) without pulling the first leaflet anchor 113 and the first leaflet 151 along with it, and without being adversely pulled and tugged by movement of the first leaflet due to heart function.

[0239] In some embodiments, as Figure 12 , with a delivery or implantation catheter 111 extended through the mitral valve MV, the device 101 is actuated into an operational configuration. In some embodiments, the first leaflet anchor 113 is attached to the first leaflet 151, and the first anchor connector 121 is uncoupled / detached / cut / loosened / released to free the first leaflet anchor from being directly attached to the implantation catheter (although it may still be indirectly attached to other components via tethered connections, which may still be directly attached to the implantation catheter). In some embodiments, the user actuates the implantation catheter to move the implantation catheter and its attached device portions to position the second leaflet anchor at a second location within the heart, positioned and oriented to grasp a first portion of an edge of the second leaflet 153 that needs to be constrained to improve function (e.g., a first portion of an edge of the posterior leaflet 22). This positioning occurs without requiring the first leaflet anchor and the first leaflet to be pulled toward the second leaflet.

[0240] If the first controlled tether slack is not sufficient, the user can controllably release (extend) slack on the first controlled tether 141 to provide such movement without creating adverse resistance from the first leaflet. This can be accomplished by the user releasing slack on the end of the controlled tether suture at the proximal end of the implant catheter, as with other transvascular mechanisms having a wire, chord, line, etc. for control. The implant catheter can then be actuated to position the second leaflet anchor 115 at a second location. 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 so that it clamps onto the leaflet edge to attach it to the leaflet).

[0241] In some embodiments, with the second leaflet anchor 115 attached to the first position on the second leaflet 153, the user actuates a control to uncouple / detach / sever / release the second anchor connector 123 and thereby release the second leaflet anchor from the implantation catheter. Consequently, the delivery / implantation catheter 111 and the central body 131 are released to translate and rotate with six degrees of freedom relative to the second leaflet anchor 115.

[0242] Uncoupling or detaching the detachably attached second leaflet anchor 115 only loosens the second controlled tether 143 connecting the second leaflet anchor to the implantation catheter. Thus, they are only constrained by each other in that they cannot be separated from each other by a greater distance than their relaxed length allows, which is a limitation of the first anchor tether.

[0243] In some embodiments, the second anchor connector 123 allows the delivery or implantation catheter 111 to first position the second leaflet anchor 115 for attachment to the second leaflet 153, and then to uncouple / detach / release / cut the second leaflet anchor after it has attached to the second leaflet, thereby freeing the second leaflet anchor 115 from being directly attached to the implantation catheter (within the limits allowed by the slack in the second controlled tether 143). The delivery / implantation catheter 111 can then be moved separately from the second leaflet anchor 115 to position the implantation catheter and central body 131 at the center of the leaflet.

[0244] In some embodiments, the system (e.g., a controlled tether system, a tether system, an apposition system, an actuation system, a connection system, a control system, etc.) is configured such that a user can impart sufficient slack to the second controlled tether 143 to allow the implant catheter to move freely to a position between the leaflets without pulling the first leaflet anchor 113 and the first leaflet 151 or the second leaflet anchor 115 and the second leaflet 153 along with it (and without being adversely pulled and tugged by the heartbeat-driven movement of the first and second leaflets due to cardiac pulsation).

[0245] In some embodiments, as Figure 13 As depicted in , the delivery or implantation catheter 111 and the central body 131 are configured so that they can be manipulated by a user to be positioned in a coapted position between the leaflets. This positioning occurs without requiring the second leaflet anchor and the second leaflet to be pulled into the coapted position. Once the delivery / implantation catheter 111 is in the coapted 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, such as on a handle. In some embodiments, the controls tighten the first controlled tether 141 and the second controlled tether 143, respectively, to shorten and remove their respective slack. The controls can be configured to controllably tighten one controlled tether at a time, or to controllably tighten all controlled tethers at once.

[0246] While the position of the distal end of the delivery / implantation catheter 111 will determine the position at which the first and second leaflets 151, 153 are pulled, the leaflet structural forces and the dynamic blood flow forces from each leaflet will determine the actual ultimate position of the resulting device 101 (e.g., a pair of anchors and the central body). Based on the attachment of the corresponding controlled tether, each anchor will define an opposing surface that can be pulled closer to and / or into contact with the central body.

[0247] With the first leaflet anchor 113 and the second leaflet anchor 115 connected to the delivery / implantation catheter 111 and the central body 131 (e.g., in contact, closer together, etc.), and thereby connected to each other, an anchor lock locking mechanism locks the anchors into an appropriate position (or region) relative to the central body and each other, thereby restricting relative movement of the first leaflet anchor, the second leaflet anchor, and the central body. In some examples, this requires that the anchors and the central body remain in contact and stationary relative to each other (e.g., completely stationary, mostly stationary, portions (e.g., connecting surfaces) completely stationary while other portions / extensions can move, etc.). Various structural / mechanical locking mechanisms can be used as anchor locks to achieve such locking of the anchors. For example, the central body can be provided with one or more locks that structurally cooperate and interlock with each tethered anchor to lock them in place.

[0248] In some embodiments, 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 embodiments, the anchors can be configured with a locking mechanism that locks directly to each other to form an anchor lock. In some embodiments, segments of the first controlled tether 141 and the second controlled tether 143 can be severed and used as part of an anchor lock to lock the first leaflet anchor 113 and the second leaflet anchor 115 relative to the central body and / or to each other. In some embodiments, the distal segments of the tightened controlled tethers are actuated (e.g., pulled), thereby tensioning or pulling the anchors to tighten them toward the central body (and thereby moving the anchors toward each other and / or into contact with each other and / or another part of the device, such as the central body, spacer, etc.). In some embodiments, the actuated controlled tethers can be locked together to lock the anchors in their relative positions, and the distal segments of the controlled tethers can then be uncoupled / detached / severed / cut, etc., from their respective remaining (proximal) controlled tether segments (and implant catheters) such that the distal segments permanently hold the anchors in their fully connected (e.g., touching) relative positions. The term "tie" encompasses pulling and / or tightening.

[0249] In some embodiments, once the first and second leaflet anchors 113, 115 are locked into position relative to the central body 131 and each other, the first and second controlled tethers 141, 143 and the delivery / implantation catheter 111 are disconnected from the device 101 and removed from the subject's body (see FIG. Figure 14 In some embodiments, the second end segment of each controlled tether is released to advance into the delivery / implantation catheter (to pass upward through the anchor slidable limiter and then back down the implantation catheter), while the first end segment is continuously pulled from the implantation catheter until the full length of the controlled tether is out of the delivery / implantation catheter. In some embodiments, it may be necessary to pull each proximal segment individually from the implantation catheter, where the distal segment of the controlled tether is cut from the proximal segment.

[0250] With all controlled tethers (or segments thereof) removed, a control can be actuated to cause the central body connector 133 to uncouple / detach / cut / release, releasing the central body from the delivery or implantation catheter (if the central body is the last component released from the implantation catheter, the entire device can be separated or released from the delivery or implantation catheter). When fully released, the central body 131 and the attached locking anchors are fully freed to translate and rotate with the leaflets in six degrees of freedom. Ultimately, the delivery system can be removed from the subject. By separating one or more inserted anchors from each other (and from the rest of the implant) before the leaflets are attached, the anchors can be attached to the leaflets without resistance from other previously attached anchors. The device can be placed without encountering difficulties that may arise from excessive spacing and movement of the leaflets relative to each other.

[0251] The devices and / or systems herein may include various simultaneous centrally coupled embodiments, some of which are explicitly described herein. It is also contemplated that these embodiments may be used in conjunction with other embodiments, to the extent appropriate (e.g., practicable). For example, other embodiments may include combinations or subcombinations of features and components disclosed with respect to the following embodiments.

[0252] In some embodiments of simultaneously inserted central links, the device may include three or more anchors. In some embodiments, the therapeutic / repair device is provided with three anchors, at least two of which are detachably attached to the central body. This is particularly advantageous for improving the function of valves with three leaflets, such as the tricuspid valve, aortic valve, and pulmonary valve, during implantation.

[0253] exist Figure 15-20 , an example of a central coupling embodiment with simultaneous insertion of three anchors during implantation of a tricuspid valve TV is depicted. Unless otherwise indicated, the elements of the device are substantially identical to similarly named items in the previously referenced embodiments. Where possible, reference numerals are incremented by 100 from the relevant central coupling embodiment.

[0254] In some embodiments, a device 201 (e.g., a treatment device, a repair device, a valve treatment device, a valve repair device, an implantable device, an implant, etc.) is delivered by a delivery system through the vascular system to the tricuspid valve TV for valve treatment or repair, similar to the central connection embodiment. An implantation catheter is inserted into the subject and extends downstream toward the tricuspid valve. The implantation catheter carries the device 201 at its distal end, and the device includes three anchors, namely 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 that is configured to clip to an edge of a leaflet that needs to be constrained to improve valve function (e.g., the third leaflet attachment mechanism).

[0255] In some embodiments, the device 201 further comprises a connector for each anchor, e.g., a first anchor connector, a second anchor connector, and / or a third anchor connector. In some embodiments, the device further comprises an optional central body 231, and a central body connector that rigidly secures the central body to the implant catheter. In some embodiments, the first, second, and third anchor connectors are configured to fixedly and / or rigidly secure their respective anchors to the central body 231 with six degrees of freedom, thereby indirectly rigidly securing them to the implant catheter via the central body.

[0256] Device 201 also includes a first controlled tether 241, a second controlled tether 243, and / or a third controlled tether 245, each in the form of a flexible suture. Each controlled tether secures its corresponding anchor to central body 231, and thereby to the implant catheter. Each controlled tether can be controllably relaxed, thereby allowing the anchor to move independently of the central body and implant catheter, such movement being limited by the corresponding tether limit (slack), that is, by the length of the tether available for movement. Each controlled tether is slidably and / or fixedly connected to its anchor at two locations along the anchor, and is slidably and / or fixedly connected to central body 231 at two locations along the central body.

[0257] In some embodiments, each controlled tether is a looped tether that is used to extendably secure a primary connection (which is one or more points on a corresponding anchor) to the central body 131 (and thus to the delivery / implantation catheter 111). This can be accomplished by extending sequentially (end to end) from a first end (e.g., the third controlled tether first end segment) located at the proximal end of the implantation catheter system to its distal end (implantation end), through the central body 131 (located at the distal end of the implantation catheter system) and out from there to the corresponding anchor of the controlled tether, being slidably received by and passed through (around) one or more slidable limiters along the length of the corresponding anchor, returning and passing through and / or alongside the central body and implantation catheter to its proximal end, and to a second end (e.g., the third controlled tether second end segment) located at the proximal end of the implantation catheter system (and the first end segment of the controlled tether).

[0258] Device 201 can optionally be structurally configured with a first, small form factor delivery configuration and a second, operational configuration configured for valve treatment or repair procedures. In some embodiments, a small form factor, side-by-side serial delivery configuration (e.g., spaced 120° apart) can be sufficiently slender to pass through a transvascular catheter system. In other cases, a more complex delivery configuration may be required.

[0259] With the implant catheter extending from the steering catheter system and pointing downstream toward the tricuspid valve TV, the implant catheter is moved downstream into the tricuspid valve and partially or completely through the tricuspid valve to the desired extent, depending on the geometry of the device and valve. If it is first delivered to the heart in the delivery configuration, the implant catheter can actuate the device 201 from the delivery configuration to the operational configuration before or after crossing the tricuspid valve TV.

[0260] like Figure 16 , with the implantation catheter moved downstream into and through the tricuspid valve TV and the device 201 actuated to an operational configuration, the implantation catheter can be actuated to move the implantation catheter and the device, positioning the first leaflet anchor 213 at a first location within the heart, positioned and oriented to grasp a first portion of the edge of the first leaflet 251 that requires restraint to improve function. The first leaflet anchor 213 can then be actuated to attach it to the first portion of the edge of the first leaflet.

[0261] With the first leaflet anchor 213 attached to the first leaflet 251, the first anchor connector can be uncoupled / detached / cut / loosen to release the first leaflet anchor from the implantation catheter. The central body 231 and the implantation catheter can be released to translate and rotate together relative to the first leaflet anchor 213. Uncoupling or detaching the detachably attached first leaflet anchor 213 leaves only the first controlled tether 241 loosely connecting the first leaflet anchor 213 to the implantation catheter.

[0262] The first anchor connector allows the implantation catheter and central body 231 to position the first leaflet anchor 213 in the correct location for attachment to the first leaflet 251, and then, after the first leaflet anchor is attached to the first leaflet, to unclip and release the first leaflet anchor from the implantation catheter, central body, second leaflet anchor 215, and third leaflet anchor 217. The implantation catheter, central body 231, second leaflet anchor 215, and third leaflet anchor 217 can then be moved separately from the first leaflet anchor 213 to position the second leaflet anchor 215 at a second location within the heart to grasp a first portion of the edge of the second leaflet 253 that needs to be constrained to improve function.

[0263] like Figure 17 , first controlled tether 241 can be given enough slack to allow the implantation catheter to move freely to a second position at second leaflet 253 without pulling first leaflet anchor 213 and first leaflet 251 with it. The implantation catheter and attached device portion can be moved to a second position within the heart, positioning (locating and orienting) the second leaflet anchor to grasp a first portion of the edge of second leaflet 253 that needs to be constrained to improve function.

[0264] If the first controlled tether slack is insufficient, the slack can be controllably released on the first controlled tether 241 to provide such movement without creating adverse resistance from the first leaflet. The implantation catheter can be actuated to position the second leaflet anchor 215 at a second location. The second leaflet anchor 215 can be actuated to attach it to a first portion of the edge of the second leaflet.

[0265] With the second leaflet anchor 215 attached to the second leaflet 253, the second anchor connector can be uncoupled / detached / cut / loosen to release the second leaflet anchor from the implantation catheter. In some embodiments, uncoupling or detaching the detachably attached second leaflet anchor 115 leaves only the second controlled tether 143 loosely connecting the second leaflet anchor to the implantation catheter.

[0266] In some embodiments, the second anchor connector enables the implantation catheter and central body 231 to position the second leaflet anchor 215 in the correct location for attachment to the second leaflet 253, and then, after the second leaflet anchor is attached to the second leaflet, to unclip and release the second leaflet anchor from the implantation catheter, central body 231, and third leaflet anchor 217. The implantation catheter, central body, and third leaflet anchor can then be moved separately from the second leaflet anchor 215 and first leaflet anchor 213 to be positioned at a third location within the heart to grasp a first portion of the edge of the third leaflet 255 that needs to be constrained to improve function.

[0267] like Figure 18 , second controlled tether 243 can be given enough slack to allow the implantation catheter to move freely to a third position at third leaflet 255 without pulling with it either first leaflet anchor 213 and first leaflet 251 or second leaflet anchor 215 and second leaflet 253. The implantation catheter and device portion can be moved to the third position within the heart, positioning (locating and orienting) the third leaflet anchor to grasp a first portion of the edge of third leaflet 255 that needs to be restrained to improve manipulation.

[0268] If the first and second controlled tether slack are insufficient, the slack on first and second controlled tethers 241, 243 can be controllably released to provide such movement without creating substantial adverse resistance from second leaflet 253. The implantation catheter can be actuated to position third leaflet anchor 217 at a third location. Third leaflet anchor 217 can be actuated to attach it to a first portion of the edge of the third leaflet.

[0269] With the third leaflet anchor 217 attached to the third leaflet 255, the third anchor connector can be uncoupled / detached / cut / loosen to release the third leaflet anchor from the implantation catheter. In some embodiments, uncoupling or detaching the detachable third leaflet anchor leaves only the third controlled tether 245 loosely connecting the third leaflet anchor to the implantation catheter.

[0270] In some embodiments, the third anchor connector allows the implantation catheter to first position the third leaflet anchor 217 for attachment to the third leaflet 255, and then to uncouple / detach / cut / release the third leaflet anchor after it has attached to the third leaflet, thereby releasing the third leaflet anchor 217 from the implantation catheter (within the limits allowed by the slack in the third controlled tether 245). The implantation catheter can then be moved separately from the third leaflet anchor 217 to position the implantation catheter and central body 231 at the center of the leaflet.

[0271] like Figure 19 As depicted, the third controlled tether 245 can be given sufficient slack to allow the implant catheter to move freely to a position between the leaflets (e.g., a center position, a commissure position, etc.) without pulling 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 along with it.

[0272] In some embodiments, the implant catheter and central body 231 are then positioned at a coapted position (e.g., a central position, a commissure position, etc.) between the leaflets. Once the implant catheter is in the coapted position, the user actuates a control (e.g., one or more handle controls, buttons, knobs, switches, a touch screen, etc.) to tighten the first controlled tether 241, the second controlled tether 243, and the third controlled tether 245, respectively, to shorten and remove (or reduce) their respective slack. The leaflet structural forces and the dynamic blood flow forces from each leaflet will determine the final position of the resulting device 201 (e.g., the attached anchors and central body).

[0273] like Figure 20, where a first leaflet anchor 213, a second leaflet anchor 215, and a third leaflet anchor 217 are connected to (e.g., in contact with) a central body 231. The anchors can be locked into position (or relative regions) relative to the central body and each other. Various mechanisms can be used to achieve this locking of the anchors. For example, as part of the anchor lock, the central body can be provided with one or more mechanical locks (e.g., clips, clamps, structurally mating portions, interlocking portions, etc.) for locking each tethered anchor in position and / or relative to each other. In some embodiments, these locks are in contact with each other and / or stationary relative to each other (e.g., completely stationary, mostly stationary, portions (e.g., contact surfaces) stationary while other portions (e.g., extensions) can move slightly, etc.).

[0274] Optionally, the anchor connector can be configured to act as all or part of an anchor lock. Optionally, the anchors can be configured with mechanical locks that lock directly to each other as part of the anchor lock. Optionally, the distal segments of the first, second, and third controlled tethers can be severed and used as part of the anchor lock to lock the first leaflet anchor 213, the second leaflet anchor 215, and the third leaflet anchor 217 into place relative to the central body and / or to each other. In some embodiments, the distal segments of the tightened controlled tethers are laced toward the central body and each other and then uncoupled / detached / severed / released from their respective remaining proximal segments (and implantation catheter) to permanently maintain the anchors in their final connected position.

[0275] In some embodiments, with first leaflet anchor 213, second leaflet anchor 215, and third leaflet anchor 217 locked in place relative to central body 231 and to each other, first controlled tether 241, second controlled tether 243, and third controlled tether 245 and the implantation catheter are disconnected from device 201 and removed from the subject's body (see FIG. Figure 14 More specifically, the second end segment of each controlled tether is released to advance into the implant catheter (to pass upward through the anchor slidable limiter and then back along the implant catheter) while the first end segment is continuously pulled from the implant catheter until the full length of the controlled tether is out of the implant catheter.

[0276] In some embodiments, 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 implantation 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 freed to translate and rotate with the valve in six degrees of freedom.

[0277] By separating one or more inserted anchors from each other (and from the rest of the implant) before the leaflets are attached, the anchors can be attached to the leaflets without resistance from other previously attached anchors. The device was placed without encountering difficulties caused by excessive spacing and movement of the leaflets.

[0278] While the described 3-anchor embodiment connects the three leaflets on the tricuspid valve, other scenarios are also within the scope of the present disclosure. For example, on a mitral valve (or any tri-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, the anchors can be attached to the two leaflets alternately (e.g., attached to the first leaflet, then to the second leaflet, then to the first leaflet again), or a single-anchor leaflet can have its anchor attached before or after the leaflet with two anchors. Advantageously, this can provide additional structural support to damaged leaflets that are at risk for further structural damage, and / or better attach to leaflets that have features that indicate poor anchor attachment features. In some embodiments, the two anchors on one leaflet can be placed adjacent to each other on the leaflet (e.g., touching, etc.), or can be placed in a spaced-apart manner along the leaflet.

[0279] Using two anchors on one leaflet (this applies to any device described 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 collapse, which can help treat various leaflet problems, such as prolapse.

[0280] Reference again Figure 9-14 In some simultaneously inserted hub-coupled embodiments, the second leaflet anchor 115 can be inseparably connected to the hub 131 (e.g., connected to the hub without the use of a controllable anchor connector such that the second leaflet anchor cannot be controllably separated from the hub while in the subject). In some embodiments, such an inseparably connected anchor remains detachably connected to the delivery / implantation catheter 111 because the hub 131 is detachably connected to the implantation catheter. In some embodiments, the first leaflet anchor 113 is detachably connected to the hub 131 via the first anchor connector 121.

[0281] In some embodiments, first anchor connector 121 still allows delivery or implantation catheter 111 to position first leaflet anchor 113 in the correct location for attachment to first leaflet 151, and then to uncouple / detach / cut / release the first leaflet anchor after it is attached to first leaflet 151, thereby releasing the first leaflet anchor from implantation catheter, central body 131, and second leaflet anchor. Delivery / implantation catheter 111 and central body 131 can then be separated and moved away from first leaflet anchor 113 to position second leaflet anchor 115 at a second location within the heart, where it can be attached to a first portion of the edge of second leaflet 153.

[0282] In some embodiments, such as where the second leaflet anchor 115 is attached via a non-severable connector (e.g., a connector that is not a severable connector), the position of the second leaflet 153 serves as the position of coaptation (to the extent that the catheter is rigidly held in place). In some embodiments (e.g., as previously described), once the anchors are locked into position relative to the central body (and each other) and the delivery / implantation catheter 111 is disconnected from the device 101, the leaflet structural forces and the dynamic blood flow forces from each leaflet will determine the actual final position of the resulting device 101.

[0283] Centrally coupled embodiments in which multiple or all anchors are detachable may provide the user with greater flexibility in selecting which anchor to attach to which leaflet. However, embodiments in which one or more anchors are non-detachable have the benefit of making the procedure simpler, i.e., fewer connectors to uncouple / detach / cut, and fewer anchors to lock in place (relative to the central body). These may also offer cost and size advantages due to a less complex structure.

[0284] When three or more anchors are combined, one anchor may be inseparable while the other anchors are detachable. In some embodiments, two or more anchors may be inseparable while at least one anchor is detachable. In some embodiments, greater flexibility during use may be emphasized, such as when two detachable anchors are used. In some embodiments, cost and size may be emphasized for a less complex structure, such as when no detachable anchors or only one detachable anchor is used.

[0285] In some embodiments of simultaneous insertion of a central connection, a system (e.g., a controlled tether system, a tether system, etc.) includes one or more multi-anchor controlled tethers, each controlled tether having an anchor tether segment with multiple anchor tether segments (e.g., a first anchor tether segment, a second anchor tether segment, and a third anchor tether segment), each anchor tether segment extending from an anchor tether segment connection point (or multiple anchor tether segment connection points) on the anchor tether segment to a corresponding one of the anchors having an anchor connector (thereby joining the anchor tether segments). When forming the anchor tether segment, the anchor tether segments can be connected at the connection point using a connection mechanism, or they can be integral (e.g., forming an integral tether that is integral at the connection point in its original configuration). The connection point can generally be located at or within the central body before and / or after the anchor connector is disconnected / detached / severed.

[0286] In some embodiments, the system is a controlled tether system comprising extension tether segments configured to extendably secure the primary connection points of the anchor tether segments (and thereby connect them to their respective anchors) to the delivery / implantation catheter 111 (optionally through the central body 131). In some embodiments, to removably make this connection, the extension tether segments extend sequentially (end to end), starting with an extension tether first end segment located at the proximal end of the implant catheter system (protruding from the proximal user end of the implant catheter), down the implant catheter (passing therethrough or alongside it) to its distal end (implantation end), into the central body 131 positioned at the distal end of the implant catheter, slidably received by and connected to (looped around / through) the primary connection points of the anchor tether segments, exiting the central body back along the implant catheter (passing therethrough or alongside it) back to its proximal end, to an extension tether second end segment located at the proximal end of the implant catheter system (protruding from the proximal user end of the implant catheter system and the extension tether first end segment of the extension tether segment).

[0287] In some embodiments, the connection between the extension tether segment and the main connection point of the anchor tether segment is formed by an intermediate segment of the extension tether segment looped around the main connection point of the interconnecting anchor tether segment. This configuration allows the extension tether segment to be slidably disconnected from the interconnecting anchor tether segment (by pulling on one end of the extension tether segment) while the anchor lock constrains relative movement of the connected leaflet anchors.

[0288] In some simultaneously inserted, centrally coupled embodiments, the controlled tethers do not extend end-to-end from the proximal end of the catheter to their anchors and back. Instead, each controlled tether (e.g., a first controlled tether) extends end-to-end, starting from a first tether end (e.g., a first controlled tether first end segment) located at the proximal end of the implant catheter system (protruding from the proximal user end of the implant catheter), down the implant catheter (through or alongside it) to its distal end (implantation end), through and out of the central body 131 located at (removably connected to) the distal end of the implant catheter system, to its respective anchor.

[0289] In some embodiments, the controlled tethers are attached to the respective anchors of the controlled tethers at their respective anchors. Thus, the first controlled tether extends sequentially, starting from a first end segment of the first controlled tether located at the proximal end of the implanted catheter system, through a hub slidable limiter detachably attached to the hub at the distal end of the implanted catheter system (via a hub connector), to a second end segment of the first controlled tether attached to the respective anchor of the controlled tether.

[0290] In some embodiments, at the respective anchors of the controlled tethers, it is slidably received by and passed through one or more slidable restraints along the length of the respective anchors and then returned to the hub to which it is fixedly connected. In some embodiments, the first controlled tether extends sequentially, starting from a first end segment of the first controlled tether located at the proximal end of the implant catheter system, through a hub slidable restraint on the hub that is detachably attached to the distal end of the implant catheter system (via a hub connector), through a slidable restraint on the respective anchors of the controlled tethers (e.g., a first slidable restraint on the first leaflet anchor), and back to a second end segment of the first controlled tether attached to the hub.

[0291] In some embodiments, each controlled tether can be slidingly connected to its respective anchor at one or more locations along the anchor. In some embodiments, each tether is slidingly connected to the central body 131 at one location along the central body and to its respective anchor at two locations (e.g., Figure 12-13 ). This provides a two-point tether connection between each respective anchor and the central body to constrain the orientation of the anchors when connected (e.g., when in contact with each other and / or the central body).

[0292] In some embodiments, while both the anchor-attached and hub-attached versions can reduce the total length of the tether required and the total number of tether ends extending from the proximal end of the implant catheter, some form of tether severing mechanism (e.g., a tether cutter) may still be required to separate one or more tether segments at the distal end of the controlled tether. Severing the controlled 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 controlled tether individually, or it can be configured to cut all (required) controlled tethers at once.

[0293] In some simultaneously inserted centrally linked embodiments, one or more controlled tethers are not in the form of a fully flexible cord, such as a suture, but may be in a less flexible form, such as a mechanism or axis whose bending and torsional flexibility is selectively established to allow for greater flexibility in one degree of freedom than in another. While limiting the free independent movement of the anchors during the implant-related period, this form of controlled tether can provide a normalizing force to limit the movement and orientation of the anchors relative to each other and the central body, thereby reducing complications caused by blood fluctuations during implantation. In some embodiments, slack describes the degree to which a controlled tether can be flexibly allowed to move within its movable degrees of freedom.

[0294] In some simultaneously inserted, center-coupled embodiments, the anchors are T-shaped toggle anchors.

[0295] refer to Figure 20-21 Although various embodiments may include a central body with various forms of apposition elements or spacers, such as a tubular braided wire formed from a molded component of a nitinol mesh, etc., in some central coupling embodiments, the central body 261 may be a spacer. In some embodiments, the spacer may be an elastic spacer, such as one formed from a flexible, compressible body (material and structure) with low functional compressibility relative to obstructed blood flow. This flexible body may be made of various materials, such as rubber-like materials and / or material structures (e.g., combinations of materials) that exhibit elastomeric properties, providing a low-stiffness / high-fluidity viscous behavior that deforms rather than compresses under compressive loads, wherein the flexible body substantially returns to its original shape when the deforming force is removed. Thus, this elastic spacer may be formed as a relatively incompressible, flexible, monolithic body that can be molded under compression without significant loss of volume. Exemplary materials may include elastomers, such as medical-grade silicones, elastomers suitable for cosmetic medical applications, such as non-reactive, flexible, high-temperature-resistant, water-resistant, and biocompatible polymers.

[0296] The low functional pliable compressibility of the flexible body relative to obstructed blood flow can include a combination of a sufficient level of flexibility and a sufficiently low level of compressibility to provide a medically relevant dimensional expansion of the flexible body into the blood flow in response to a functionally available level of force from a mechanism to move the anchor into contact with the septum (or another type of central body). In some embodiments, when the flexible body is compressed using forces available in a system and / or mechanism to move the anchor into contact with the septum and compress it, such forces can cause dimensional expansion that can have a medically significant effect on blood regurgitation.

[0297] In some embodiments, when compressed by the force between the opposing surfaces of the anchors, the resilient spacer is sufficiently flexible to conform to the shape of the anchors, and its incompressibility enables it to expand in size to fill the gap and (typically) protrude outward from between the anchors when the apposition force reaches a sufficiently high level. This expansion can both conformably maintain the relative position of the anchors and generally form an obstruction to blood flow to prevent regurgitation through the valve.

[0298] In some embodiments, the flexibility of the elastic spacer also allows the elastic spacer to conformably hold the anchors in position relative to each other, such that they have a less rigid connection to each other. Thus, the anchors can move relative to each other in response to forces applied to them by the leaflets and blood flow. Thus, the elastic spacer central body can allow connected anchors (e.g., anchors in contact with the spacer, central body, etc.) to move relative to each other, thereby accommodating blood flow and the natural movement of the leaflets during the cardiac cycle.

[0299] In some embodiments, the resilient spacer material and structure is not simply adapted to be clamped into an extruded shape that is reduced in volume and size (unlike existing spacers). Instead, it is sized, structurally configured, and shaped such that when mechanically compressed between anchors, its dimensions expand under compression, bulging outward and becoming wider and / or longer than its uncompressed shape. Thus, the resilient spacer can extrude to extend beyond the opposing surfaces of the anchors (typically in a balloon-like manner) to fill the space adjacent to and beyond the boundaries of the anchors in response to forces (e.g., compression forces, actuation forces, movement forces, connection forces, 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). This effect may arise from the typically monolithic form of the material and structure (e.g., it is not simply a flexible mesh on a frame) and low functional compressibility.

[0300] In some embodiments, when the first leaflet anchor 213, the second leaflet anchor 215, and the third leaflet anchor 217 are pulled to the flexible central body 261 by their corresponding controlled tethers, the controlled tethers are pulled with sufficient centering force to force the anchors to act as compression bodies, causing the flexible central body to deform to fill all gaps between the anchors and generally protrude beyond the boundaries of the anchors into the space between the leaflets. In doing so, the leaflets are also further pulled together, thereby further improving the seal. In some embodiments, the anchors are directly attached to a structural portion of the flexible central body via the controlled tethers. The structural portion can be a central axis-like catheter, and the spacer forms a flexible periphery around the central axis-like catheter.

[0301] Advantageously, such a flexible central body allows the leaflets to function and move more normally relative to each other during valve operation, particularly compared to devices that do not utilize a central body or devices that utilize a central body that rigidly retains the leaflets.

[0302] The above-described devices and systems provide and / or can be used to perform one or more methods for treating / repairing a subject's native valve, wherein the valve has multiple leaflets (e.g., a first leaflet and a second leaflet, and in some cases, a third leaflet). In some embodiments, the methods require providing a treatment or repair device 101 mounted at the distal end of a delivery catheter or implantation catheter 111. The methods can be performed on a living animal or a simulated object, such as a cadaver, a cadaver heart, a simulated object (e.g., a simulated body part, heart, tissue, etc.), etc.

[0303] In some embodiments, 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 controlled tether system, a tether system, an apposition system, an actuation system, a connection system, etc.). In some embodiments, the first anchor connector forms a decoupled / detachable / severable connection between the first leaflet anchor 113 and the delivery or implantation catheter 111. In some embodiments, the second leaflet anchor is connected to the implantation catheter independently of the first anchor connector. In some embodiments, the system can be actuated to move the first and second leaflet anchors into closer proximity and / or contact (e.g., contact with each other and / or contact with an optional central body, apposition element, or spacer) even if the first connection has been decoupled or detached (e.g., in its decoupled state, detached state, or severed state).

[0304] In some embodiments, the method includes the following steps: delivering a therapeutic / repair device mounted on an implant catheter to the valve, positioning a first leaflet anchor 113 at the first leaflet, attaching the first leaflet anchor to the first leaflet, disconnecting / detaching / 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 implant catheter.

[0305] In some embodiments, the first anchor connector 121 is uncoupled / detached / severed after the first leaflet anchor 113 is attached to the first leaflet. In some embodiments, the second leaflet anchor 115 is then positioned at the second leaflet after the first anchor connector is uncoupled / detached / severed. Once the second leaflet anchor is positioned at the second leaflet, the second leaflet anchor can be attached to the second leaflet.

[0306] In some embodiments, after the first and second leaflet anchors are attached to the respective first and second leaflets (and the first anchor connector 121 is uncoupled / detached / severed), the first and second leaflet anchors are moved into closer proximity and / or contact (with each other and / or with another portion of the device) using a system (e.g., a controlled tether system, a tether system, an apposition system, a connection system, an actuation system, a control system, etc.). In some embodiments, once they are connected and / or moved to the desired relative position, the device 101 is released from the implantation catheter.

[0307] In some embodiments, the method can include the use of an anchor lock. In some embodiments, device 101 includes an anchor lock having a locking mechanism that locks the relative positions of the first and second leaflet anchors relative to each other. In some embodiments, after the first and second leaflet anchors are connected (e.g., in contact, connected to each other via contact with another portion or central body, etc.), the first and second leaflet anchors lock their relative positions relative to each other using the anchor lock.

[0308] In some embodiments, the system can initially be set without sufficient slack to position the second leaflet anchor 115 at the second leaflet without interfering with the connection to the first leaflet. The method can further comprise controllably releasing the slack in the system. In some embodiments, this will typically occur after the step of uncoupling / detaching / severing the first anchor connector 121 and before the step of attaching the second leaflet anchor to the second leaflet.

[0309] In the case of a valve having three leaflets, the device 101 can include a second anchor connector that forms a decoupling / detachable / severable connection between the second leaflet anchor 115 and the implantation catheter. In some embodiments, the third leaflet anchor is connected to the implantation catheter independently of the first and second anchor connectors, and after the first and second decoupling / detachable connections are decoupled / detached / severed, the system can be actuated to move the first, second, and third leaflet anchors into closer proximity and / or contact (with each other and / or with another portion of the device, e.g., a central body, a septum, an edge, a surface, etc.).

[0310] In some embodiments, after the second leaflet anchor 115 is attached to the second leaflet (of the three leaflets), the second anchor connector is disconnected / detached / severed. In some embodiments, the third leaflet anchor is positioned at the third leaflet and attached to the third leaflet. In some embodiments, during the moving step, the first, second, and third leaflet anchors are moved closer to and / or into contact with each other (or with another portion of the device).

[0311] In some embodiments of methods in which the various systems, devices, apparatus, etc. herein may be used, including but not limited to the above-mentioned methods for treating / repairing a subject's native valve, the various systems, devices, apparatus, etc. herein may include one or more anchors that are detached from the leaflets and / or that can be reattached to the leaflets, and the methods may include detaching one or more anchors from one or more leaflets and / or reattaching one or more anchors to one or more leaflets.

[0312] In some embodiments, after the anchor connector is disconnected / detached / severed, a system (e.g., a controlled tether system, a tether system, an apposition 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 embodiments, the implantation catheter can be used to reposition the corresponding anchor relative to its leaflet (or another leaflet). In some embodiments, the leaflet anchor can then be attached at the new location, and the method can continue as previously described.

[0313] In some embodiments, the method can further include using the system to move the first leaflet anchor and the implantation catheter, detaching the first anchor connector from the first location (e.g., detaching from tissue at the first location), and attaching the first leaflet anchor at another location (e.g., a different tissue location).

[0314] The methods described above can be performed on a living subject or a simulated subject, such as a cadaver, a cadaver heart, a simulated subject (eg, a simulated body part, heart, tissue, etc.), or the like.

[0315] In some embodiments, each of the plurality of leaflet anchors is sequentially inserted into the subject, with some (or more) being individually (independently) pulled toward the central body by different controlled tethers. Additional details of these embodiments may be referenced to similar aspects of the first (simultaneous insertion, centrally coupled) embodiment. These sequential insertion embodiments are applicable to both bileaflet and trileaflet valves (as further described) and can be incorporated into currently used procedures for repairing trileaflet valves using only two leaflet anchors.

[0316] refer to Figure 2-8 , 22A, 22B, 22C, 22D, 23 and 24, in some embodiments (e.g., in embodiments of sequential insertion, central coupling of the treatment or repair system), a delivery system can be used to construct or assemble a treatment or repair device 301 within the heart (at the location of the valve) for use by medical personnel in treating or repairing a subject's native mitral heart valve MV. Figure 22A In some embodiments, the delivery system is provided with a steering catheter system and / or steering catheter 303, which can operate similarly to other steering catheter systems or steering catheters. Advancing delivery within the vascular system can involve positioning the distal end of the steering catheter 303 at an appropriate position upstream (relative to the direction of blood flow) of the valve and directing the distal end of the steering catheter downstream (in the direction of blood flow) through the valve.

[0317] refer to Figures 22B-22D In some embodiments, the delivery system further includes an implantation catheter system comprising one or more implantation catheters (which may be the same or similar to other catheters described herein; and may also serve as a supplement to or replacement for the steering catheter). In some embodiments, the implantation catheter system includes a plurality of implantation catheters. In some embodiments, each implantation catheter has a distal catheter end that passes through the steering catheter system to implant the treatment / repair device, and a proximal catheter end (e.g., a first proximal catheter end, a second proximal catheter end, and a third proximal catheter end) that can be operated by a user to remotely control and operate the device during implantation.

[0318] In some embodiments, the first implant catheter 311 of the plurality of implant catheters is initially located within the steering catheter system prior to insertion into the subject, or is inserted into the proximal end (user end) of the steering catheter system (whose proximal end extends outside the subject) after the distal end of the steering catheter system is positioned upstream of the mitral valve MV. In some embodiments, with the steering catheter system in place and the first implant catheter 311 inserted into the steering catheter system, the distal end of the first implant catheter 311 extends downstream from within the steering catheter system toward the mitral valve (similar to Figure 9 implanted catheter depicted in ).

[0319] In some embodiments, the first implant catheter 311 carries a first leaflet anchor 313 of the plurality of leaflet anchors of the device at its first catheter distal end. Each leaflet anchor of the plurality of leaflet anchors is in the form of an actuatable clip having an independent actuator and actuation control, so that each anchor can be individually and independently attached to a corresponding leaflet location. In some embodiments, the leaflet anchor is structured to be attached to the leaflet by clipping onto the leaflet.

[0320] In some embodiments, each of the plurality of leaflet anchors is provided with a corresponding anchor connector (among the plurality of anchor connectors) and is attached to the distal end of an implant catheter (among the one or more implant catheters) via the corresponding anchor connector, e.g., the first leaflet anchor 313 is attached to the first implant catheter 311 via the first anchor connector 321, the second leaflet anchor 315 is attached to the second implant catheter 316 via the second anchor connector 323, the third leaflet anchor is attached to the third implant catheter via the third anchor connector, and so on. Additional leaflet anchors can optionally be attached to the implant catheter via corresponding additional anchor connectors. In some embodiments, each anchor connector has a corresponding catheter connector (e.g., a first catheter connector for connecting to the distal end of the first catheter of the implant catheter of the first anchor connector, a second catheter connector for connecting to the distal end of the second catheter of the implant catheter of the second anchor connector, and a third catheter connector for connecting to the distal end of the third catheter of the implant catheter of the third anchor connector).

[0321] In some embodiments, the anchor connector is configured to actuate between a connected state (e.g., an uncut state, etc.) and a detached / uncoupled state (e.g., a cut state, etc.). In its connected state, the leaflet anchors of the anchor connector are constrained from moving in one or more (typically six) degrees of freedom relative to their delivery / implantation catheters (e.g., they are constrained to move synchronously with each other). In the detached / uncoupled state of the anchor connector, the relative movement of the leaflet anchors and the implantation catheter connected thereto is no longer constrained by the anchor connector.

[0322] In some embodiments, each leaflet anchor is also provided with and attached to a respective anchor tether in the form of a controlled tether (of a plurality of controlled tethers), e.g., first controlled tether 341 is attached to first leaflet anchor 313, and second controlled tether 343 is attached to second leaflet anchor 315. In some embodiments, each of the first and second controlled tethers is in the form of a flexible cord (e.g., a suture, wire, thread, braid, silk, yarn, etc.).

[0323] In some embodiments, with each anchor connector connected to the distal end of its delivery or implantation catheter, the controlled tether extends from the distal end of the controlled tether at its corresponding leaflet anchor to the proximal end of the controlled tether at the proximal end of the connected implantation catheter. In some embodiments, although the implantation catheter can be removed after the anchor is attached to the leaflet, each controlled tether is secured to its corresponding anchor to the steering catheter 303 by sequentially extending through the steering catheter from the corresponding tether distal end (e.g., the first tether distal end, the second tether distal end, and the third tether distal end) at its corresponding anchor to the tether proximal end (e.g., the first tether proximal end, the second tether proximal end, and the third tether proximal end) protruding from the proximal end (user end) of the steering catheter. In some embodiments, each controlled tether can be operated, controlled, and actuated by the user at the proximal end of the steering catheter, either directly or using a control mechanism (e.g., a knob, motor, button, switch, slider, gear, motor, screw, cam, universal joint, etc.) of the implantable device.

[0324] In some embodiments, the treatment / repair device can further include a central body 331 for locking, for example, the central body, and a central body connector 333 for connecting the central body to a central body implantation catheter 335. In some embodiments, the central body defines one or more central body orifices that are sized and shaped to receive the proximal ends of the control tethers of the respective leaflet anchors to be implanted, and through which extend a first control tether 341 and a second control tether 343. In some embodiments, with the control tethers threaded through the central body orifices, the central body can slide along the control tethers to their distal ends.

[0325] In some embodiments, once the central body is inserted into the heart, a controlled tether can be pulled through the central body from the proximal end to move the leaflet anchors closer together and / or into contact (with each other and / or with another portion of the device). The controlled tether can be configured to pull against an edge of the central body, which in turn can help direct the force to move the leaflet anchors closer together and / or into contact.

[0326] In some embodiments, during use, the user controllably inserts the first connection assembly comprising the first implant catheter 311, the first anchor connector 321, the first leaflet anchor 313, and the first controlled tether 341 into the steering catheter 303. Using the first implant catheter, the first leaflet anchor is guided to the leaflets of the valve. In some embodiments, the first leaflet anchor 313 is attached to the leaflets, and then the first anchor connector 321 is disconnected / detached / cut. In some embodiments, the first implant catheter 311 and any remaining portions of the first anchor connector 321 still attached thereto are then withdrawn from the steering catheter 303.

[0327] In some embodiments, from the time of insertion, a first controlled tether 341 extends from the first leaflet anchor 313 (which is attached to the leaflets) 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 implant catheters, anchor connectors, anchors, and controlled tethers is implanted, where they: 1) are inserted into the steering catheter; 2) have their anchors attached to the leaflets; 3) have their anchor connectors detached / disconnected / cut, and 4) remain attached to the leaflets (in a manner similar to the first assembly) when the implant catheter is withdrawn from the steering catheter.

[0328] Once all anchors are sequentially inserted and attached to the leaflets, a user (outside the subject's body) can feed each controlled tether through the central body orifice that forms a passage through the locking central body 331, thereby stringing the central body to the entire set of controlled tethers. In some embodiments, this central body passage forms an anchor lock in the form of a clip-on cable lock 351, allowing the controlled tethers to be pulled through the central body in only one direction, so that the central body can be advanced along the controlled tether toward the anchor, but not along the controlled tether away from the anchor. Using its central body implantation catheter 335, the central body 331 can be controllably inserted into the steering catheter 303, and the controlled tether can be grasped so that it cannot be fully pulled into the subject (thereby causing the central body to be advanced along the controlled tether toward the anchor).

[0329] As used herein, a cable lock may include a device in which a cable (e.g., a tether) is locked in place by a cable lock element (e.g., a gear, tongue, lock, clamp, set screw, cam, lever, etc.) that squeezes the cable to lock the cable, e.g., to prevent or inhibit movement of the cable relative to the cable lock in one or both directions in which the cable extends through the cable lock. This squeezing may occur by various ratchet or sliding mechanisms, as with cable locks.

[0330] In some embodiments, using a central body implantation catheter 335, a locking central body 331 can be placed or positioned within the center of the valve, and a controlled tether can be pulled proximally to move the anchor toward (and to) the position of the central body and lock the anchor to the central body, thereby assembling the device in a form that can be used to help improve valve function.

[0331] In some embodiments, with the anchors fully abutted and locked to the hub, a tether severing device (e.g., a tether cutter 345 on the locking hub 331 or hub implant catheter 335) severs the controlled tethers such that the distal segments of the controlled tethers and their corresponding anchors remain taut and locked in place relative to the locking hub 331 to maintain the connection of the anchors.

[0332] In some embodiments, the central body and the locking mechanism form an anchor lock for constraining relative movement of the first, second, and third leaflet anchors after being moved into contact with the central body. The remaining (cut) proximal segment of the controlled tether is then pulled proximally through the steering catheter to remove it from the subject's body.

[0333] In some embodiments, with all proximal segments of the controlled tether removed, a control can be actuated to uncouple / detach / sever 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 the 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 rest 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, and the procedure is completed using typical procedures.

[0334] In some embodiments, by enabling the attachment of one or more inserted anchors to be detachable 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 placed without encountering difficulties that can arise from excessive spacing and movement of the leaflets relative to one another.

[0335] In some embodiments, the procedure / method may differ from some other embodiments in that it provides for a greater number of anchors and / or anchors having a larger form factor for use with limited-size steering catheters, and it further isolates the anchoring procedure from interference with other anchors. It should be understood that combinations of these embodiments, such as embodiments in which multiple anchors are inserted on each of multiple, successively inserted implant catheters, are within the scope of this disclosure.

[0336] While some embodiments are described as attaching three leaflets on a tricuspid valve, other scenarios are within the scope of the concepts herein. For example, multiple anchors can be attached to one or more leaflets of a bicuspid valve or another tricuspid valve. During the implantation process, the anchors can be attached alternately between the leaflets (e.g., back and forth between two or three leaflets), or alternately between two points on one leaflet and then to another leaflet. Advantageously, this can provide additional structural support to damaged leaflets that are at risk for further structural damage, and / or better attach to leaflets that have features that indicate poor anchor attachment characteristics.

[0337] Various embodiments of continuously inserted central couplings are within the scope of this disclosure, some of which are explicitly described herein. It is also contemplated that these variations may be used with other embodiments herein, to the extent applicable. Thus, the therapeutic / repair system and / or device may include any combination or subcombination of the features and variations disclosed herein, and may not include some of the described features.

[0338] refer to Figure 25 In some continuously inserted centrally linked embodiments, rather than being a single unitary body (e.g., a unitary anchor tether of sufficient length to extend through the steering catheter), each controlled tether can be formed into two segments: a relatively short anchor tether segment 363 (e.g., three controlled tethers would have a first anchor tether segment, a second anchor tether segment, and a third anchor tether segment); and a looped extension tether segment 365 (e.g., a first extension tether segment, a second extension tether segment, and a third extension tether segment).

[0339] In some embodiments, each anchor tether segment 363 can be permanently attached to its corresponding anchor 367 at the distal end (e.g., the first distal end, the second distal end, and the third distal end) of the anchor tether segment. In some embodiments, at the proximal end (e.g., the first proximal end, the second proximal end, and the third proximal end) of the anchor tether segment 363, the anchor tether segment forms an eyelet 369 (e.g., the first eyelet, the second eyelet, and the third eyelet) in the form of a slidable eyelet-type limiter that serves as the primary connection for the extension tether segment 365. This connection is typically made prior to inserting the anchor into the subject.

[0340] In some embodiments, each looped extended tether segment 365 has a proximal first end segment 371, a proximal second end segment 373, and a distal intermediate segment 375. For example, a first controlled tether will have a first first end segment, a first second end segment, and a first intermediate segment. Similarly, a second controlled tether will have a second first end segment, a second second end segment, and a second intermediate segment, and a third controlled tether will have a third first end segment, a third second end segment, and a third intermediate segment.

[0341] In some embodiments, the intermediate segment is intermediate between the first and second end segments relative to (along) the extension tether segment. In some embodiments, when each anchor and its corresponding two tether segments (anchor tether segment and extension tether segment) are first implanted, the first and second end segments 371, 373 of the extension tether segment 365 are constrained such that they extend beyond the proximal end of the steering catheter, while the intermediate segment 375 forms a loop that extends through the eyelet of the anchor tether segment 363, so that the corresponding anchors can be brought into closer proximity and / or contact by pulling the first and second end segments of the extension tether segment 365.

[0342] As with some previously described sequentially inserted centrally coupled embodiments, when all anchors have been attached to their respective leaflets, the locking hub 331 can be implanted within the center of the valve. In some embodiments, the looped, extending tether segments 365 of the controlled tethers can be pulled proximally to move the anchors toward and into position within the hub, and the controlled tethers can be tightened to lock the corresponding anchors 367 to the hub, thereby assembling the device in a form that can be used to help improve valve function. In some embodiments, the anchor tether segments 363 are sufficiently long that, after the device is assembled (by tightening and locking), they extend through the hub and are constrained (locked) by the locking hub to maintain the structure of the implant.

[0343] In some embodiments, rather than utilizing a tether cutting device that operates inside the heart, each looped extension tether segment can be removed from the subject's body by pulling on the first end segment of each looped extension tether segment and simultaneously releasing the second end segment. Thus, the second end segment of the extension tether segment slides into and out of the eyelet and is then pulled out of the body.

[0344] In some serially inserted, centrally coupled embodiments, rather than each anchor having its own associated implantation catheter, a single implantation catheter (or implantation catheter system) is reused to sequentially implant each anchor one at a time. To this end, in some embodiments, the catheter connector of the first anchor connector 321 has a quick-release mechanism for first being releasably or detachably attached to the first implantation catheter 311 during the implantation procedure, and then being detached during the implantation procedure so that the second anchor connector 323 can be attached to the first implantation catheter during implantation. For example, a single implantation catheter 311 can be repeatedly routed through the steerable catheter 303, leaflet anchors attached to native valve leaflets, detached from the leaflet anchors, pulled from the steerable catheter, attached to the next leaflet anchor, and then reintroduced through the steerable catheter to deploy the next anchor. This allows a series of anchors to be implanted using a single implantation catheter.

[0345] In some embodiments, each leaflet anchor has its own tether. In some embodiments, the first of a series of leaflet anchors has a tether and subsequent leaflet anchors have a loop through which the tether of the first anchor is routed (see Figure 26 and 27 In embodiments where a first anchor has a tether, threading of the tether through the loops of subsequent tethers can be performed using a single implantation catheter or multiple implantation catheters (e.g., each anchor connected to its own implantation catheter, as described above).

[0346] The quick release mechanism and / or device is generally capable of being attached and detached within a sufficiently short timeframe for placement of the implant or device without negatively impacting the subject.

[0347] In some embodiments of serially inserted, centrally coupled connections, rather than each anchor connector rigidly securing (constraining) its corresponding anchor with six degrees of freedom, it may be rigidly constrained to fewer degrees of freedom. For example, some pivoting and / or translation of the anchor may allow the anchor to elastically adapt to changing leaflet positions during blood flow fluctuations. This reduced constraint may come at the expense of user controllability. User preferences and / or case-specific facts may most appropriately determine the preferred form of connector.

[0348] In some embodiments of sequentially inserted centrally coupled catheters, some or all of the sequentially inserted implant catheters may carry more than one anchor, in a manner similar to the first embodiment. Advantageously, this limits the number of implant catheter insertions while allowing a greater number of anchors to be inserted.

[0349] In some partially simultaneous or hybrid anchor delivery embodiments, for each set of consecutive simultaneously delivered anchors, more than one anchor is secured to the catheter by a single controlled tether. In some embodiments, each anchor has one or more corresponding anchor slidable restraints (e.g., eyelets) through which a single multi-anchor controlled tether sequentially extends, or each anchor is attached to a first end segment of a shorter length anchor tether segment having an eyelet at its proximal end through which the single multi-anchor tether sequentially extends.

[0350] In some embodiments of continuously inserted central linkages, one or more tethers (or tether segments) are not in the form of a completely flexible cord, such as a suture, but may be in a less flexible form, such as a mechanism or shaft whose bending and torsional flexibility is selectively established to allow greater flexibility in one degree of freedom than in another. While partially restricting the free independent movement of the anchors during the implant-related period, this form of tether can provide a normalizing force to restrict the movement and orientation of the anchors relative to each other and the central body in blood fluctuations during implantation. In some embodiments, slack describes the degree to which the tether can flexibly allow movement within its movable degrees of freedom.

[0351] In some embodiments of continuously inserted center links, the anchor is a T-shaped toggle anchor. In some embodiments, other types of anchors are used (e.g., any of the other anchors described herein, clips, snaps, tucks, hooks, staples, screws, coils, etc.).

[0352] In some embodiments, the system / device can include a central body. In some embodiments, the central body can include a flexible spacer 381. In some embodiments, the flexible spacer can be formed with an integral, relatively incompressible, flexible periphery (with low compressibility) that has a sufficiently low stiffness so that it can be molded under compression without significant loss of volume. The structural details of the central body and other central bodies described elsewhere herein may be incorporated herein.

[0353] In some embodiments, a flexible central body (e.g., its spacers) allows the leaflets to function and move more normally relative to each other during valve operation, particularly compared to devices that do not use a central body or devices that use a central body that rigidly holds the leaflets.

[0354] In some end-coupled embodiments, the multiple leaflet anchors (e.g., a group of anchors) that are ultimately implanted are strung along a single implant control tether (a first controlled tether) formed by one or more lengths of tether extending along a single path with a distal leaflet anchor (which may be the first leaflet anchor to be implanted) at the distal end of the implant control tether. In some embodiments, the anchor group includes one or more (e.g., a plurality) of additional leaflet anchors slidably connected to the implant control tether near the distal leaflet anchor. This can be achieved in a variety of different ways. In some embodiments, the distal leaflet anchor has a tether, and subsequent leaflet anchors have the distal anchor's tether routed as a loop through it. This example of a distal anchor having a tether threaded through the loop of the subsequent tether can be implemented using a single implantation catheter or multiple implantation catheters, as described above. In some embodiments, the additional leaflet anchor includes a proximal leaflet anchor (the proximal leaflet anchor is also referred to as a second leaflet anchor), and an intermediate leaflet anchor (which may be one of one or more intermediate leaflet anchors) between the distal and proximal leaflet anchors.

[0355] In other words, in an anchor set formed by a distal leaflet anchor and an additional leaflet anchor, the proximal leaflet anchor can be at the proximal end of the anchor set, the distal leaflet anchor can be at the distal end of the anchor set, and one or more intermediate leaflet anchors, including a third intermediate leaflet anchor, a fourth intermediate leaflet anchor, and so on, are intermediate the distal and proximal leaflet anchors. In some embodiments, each leaflet anchor is provided with a respective leaflet attachment mechanism (e.g., a first distal leaflet attachment mechanism, a third intermediate leaflet attachment mechanism, and a second proximal leaflet attachment mechanism).

[0356] In some embodiments, an anchor lock is included that locks to the implant control tether near the proximal leaflet anchor, thereby restricting any proximal movement of the proximal leaflet anchor (proximally) along the implant control tether. To this end, the anchor lock can include an end body that is integral with the proximal leaflet anchor, or it can form a separate end body that is connected to the implant catheter using an end body connector. In some embodiments, it is configured to apply a distal force to the proximal leaflet anchor, for example by being positioned proximal to the proximal leaflet anchor or by otherwise preventing the proximal leaflet anchor from moving distally. In some embodiments, an intermediate leaflet anchor is slidably connected in series on the implant control tether between the distal and proximal leaflet anchors and is retained on the implant control tether by the distal leaflet anchor and the end body.

[0357] In some embodiments, the leaflet anchor set is implanted using a delivery system comprising an implantation catheter having a proximal catheter end and a distal catheter end. In some embodiments, the leaflet anchor set can be detachably connected to the implantation catheter using one or more anchor connectors (e.g., a distal anchor connector forming a distal anchor detachable / disconnectable / severable connection, an intermediate anchor connector forming an intermediate anchor detachable / disconnectable / severable connection, and a proximal anchor connector forming a proximal anchor detachable / disconnectable / severable connection), wherein the respective connections are severed after their respective leaflet anchors are attached to the leaflets.

[0358] In some embodiments, the one or more anchor connectors can be in the form of a connector tube for continuously detaching / disconnecting / severing its connection from the first to the last implanted leaflet anchors, where the first and last implanted leaflet anchors may or may not be the distal and proximal leaflet anchors, respectively.

[0359] With all leaflet anchors (in the anchor set) attached to the leaflets, in some embodiments, the implant control tether can be pulled proximally through the end-body aperture formed by (or on) the anchor lock end-body to pull the distal leaflet anchor toward the proximal leaflet anchor, thereby connecting the distal and proximal leaflet anchors (e.g., bringing them into contact, connecting with another portion between them, bringing them into contact with another portion, etc.) and any intermediate leaflet anchors pulled together by them in the process. With the distal and proximal leaflet anchors moved into position, in some embodiments, the anchor lock locks onto the implant control tether, thereby restricting the distal and proximal leaflet anchors (e.g., the first and second leaflet anchors) from moving apart relative to the implant control tether. Optionally, the anchor lock can be a one-way tightening mechanism that automatically locks when moved distally along the implant control tether. With the distal and proximal leaflet anchors fully connected and the anchor lock locked to the implant control tether, in some embodiments, the entire anchor set is thereby connected and coupled into position along the end of the implant control tether. The segment of the implant control tether extending proximally from the anchor lock can then be separated (eg, cut or otherwise disconnected) from the remaining anchor-connected portion (eg, distal portion) of the implant control tether and removed from the subject.

[0360] In some embodiments, the end coupling anchors can be continuously constrained together along a single implant tether path between the two longitudinal ends of a segment of an implant control tether. In some embodiments, the implant tether segment forming the path can be formed from multiple lengths of tether material connected and / or looped in series and / or in 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 location of the anchors along the implant control tether rather than the location of the implanted anchors within the heart. The terms "first implanted" and "last implanted" refer to the temporal order in which the anchors are attached to the leaflets, which may or may not be the sequential order in which they are positioned along the tether or mounted on the implant catheter.

[0361] In some embodiments, the implant control tether comprises two connected implant tether segments, a looped extension tether segment forming a proximal portion of the implant control tether, and a distal anchor tether segment forming a distal portion of the implant control tether (and attached to the distal leaflet anchor). In some embodiments, the extension tether segment extends between an extension tether proximal end segment located at the proximal end of an implantation catheter of a delivery system and an extension tether distal end segment connected to the proximal end of the distal anchor tether segment.

[0362] In some embodiments, when the implant is assembled and connected, no pair of intermediate leaflet anchors along the implant control tethers are directly and individually moved toward a neutral position solely by the anchor lock. Instead, the entire force is applied at the locations of the proximal and distal leaflet anchors, wherein the distal end of the distal anchor tether segment pulls the distal leaflet anchor proximally, and wherein the end body supported on the implant catheter constrains and / or pushes the proximal leaflet anchor distally. It should be noted that the intermediate leaflet anchors can still be moved toward each other by the natural rhythms and forces of the leaflets, as each leaflet exerts a force on its respective leaflet anchor.

[0363] In some embodiments, the various systems, devices, apparatuses, etc. herein can be configured such that after an anchor, hub, or other component is disconnected from a delivery or implantation catheter, the delivery or implantation catheter can be connected or reconnected to the anchor, hub, or other component. This can be accomplished by using a tether or similar device that allows free movement in the disconnected state but can also be used (e.g., tensioned, etc.) to bring the delivery / implantation catheter back into contact with the anchor, hub, or other component. This configuration can be similar to the tether and control systems and mechanisms described herein for bringing the anchor and / or hub together. In some embodiments, after reconnection, the delivery or implantation catheter can be used to: (1) detach the anchor, hub, or other component from a first location, and / or (2) reposition and / or attach the anchor, hub, or other component to a second location (different from the first location) (e.g., to another tissue location).

[0364] Additional details and features of other embodiments herein may be included herein where not specifically described and not functionally excluded.

[0365] refer to Figure 26 , prior to implantation, an end-coupled embodiment can include a plurality of leaflet anchors, including a distal leaflet anchor 401 integrally attached to a distal end 403 of an implant control tether. In some embodiments, the implant control tether comprises two segments, the first segment being a distal anchor tether segment 405. The distal leaflet anchor 401 can be the first leaflet anchor implanted. In some embodiments, the distal anchor tether segment 405 defines a distal anchor tether eyelet 407 at its proximal end, and the distal anchor tether segment 405 can be attached to a distal leaflet anchor at its distal end. In some embodiments, when the locking operation is complete, the distal anchor tether segment is long enough to extend across the full length of the locked leaflet anchor.

[0366] In some embodiments, the second segment of the implant control tether is a looped extension tether segment 411 having a first end segment and a second end segment, both of which extend beyond the proximal end of the delivery system. In some embodiments, the implant control tether further comprises a longitudinal intermediate segment 415. In some embodiments, the intermediate segment 415 of the extension tether segment loops through and extends around the distal anchor tether eyelet 407 of the distal anchor tether segment 405. This looped configuration enables the extension tether segment to be removed by pulling on one of its end segments after the locking operation is completed.

[0367] In addition to the distal leaflet anchor 401, the plurality of anchors can include one or more additional anchors. In some embodiments, as depicted, 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 third, fourth, and fifth leaflet anchors, each of which is an intermediate leaflet anchor 421, and each of which can be implanted in the order in which they are positioned between the distal leaflet anchor 401 and the proximal leaflet anchor 427. In some embodiments, each additional anchor has a corresponding anchor tether segment, including three intermediate anchor tether segments 423 and a proximal anchor tether segment 429 (e.g., a second anchor tether segment). The additional anchor tether segments form an eyelet through which the implant control tether (e.g., the combination of the extension tether segment 411 and the distal anchor tether segment 405) is threaded, such that the entire anchor set is tethered and secured via the implant control tether. In the case of a minimum 2 anchor, there is no middle leaflet anchor 421 or middle anchor tether segment 423.

[0368] In some embodiments, after the distal leaflet anchor 401 is attached to its corresponding leaflet and detached / disconnected / severed from the distal end of the implantation catheter of the implantation catheter system, in a chronological order, for additional anchors (e.g., the intermediate leaflet anchor 421 and / or the proximal leaflet anchor 427), the additional anchor tether segments of the additional anchors (first the intermediate anchor tether segment 423, followed by the proximal anchor tether segment 429) are guided by the implantation catheter to the corresponding heart valve leaflet, where the additional anchors are attached to the leaflets. Each additional anchor can be attached sequentially, one after the other, with each corresponding additional anchor tether segment being serially connected along the extended tether segment 411. When all anchors in the anchor group have been attached to the leaflets, the result is a series of continuously placed leaflet anchors that are sequentially positioned in a suture configuration along a single implant control tether in a sequential order.

[0369] In some embodiments, once all anchor groups are attached to their respective leaflets, an end-body 431 (similar in form and tethering function to the locking hub of previous embodiments and variations), which is detachably connected to an implantation catheter using an end-body connector, is advanced along the implant control tether by pulling the extension tether segment proximally, thereby pulling the implant control tether back through the end-body while the implantation catheter is used to hold the end-body. In some embodiments, the distal anchor tether segment 405 is pulled through the end-body, tethering the end-body to the distal anchor tether segment, thereby pulling the distal leaflet anchor 401 and the proximal leaflet anchor 427 toward each other via the distal anchor tether segment. This pulling of the extension tether segment 411 relative to the implantation catheter completes the implant assembly. As this occurs, the intermediate leaflet anchors 421 naturally adjust their positions based on their relative positions on the various leaflets and the tension and path of the distal anchor tether segment 405 extension.

[0370] In some embodiments, the extension tether segment 411 is then removed from the subject's body while leaving the implanted device in place by pulling the first end segment of the extension tether segment while releasing the second end segment to be pulled through and around the path of the loop of the extension tether segment.

[0371] In some embodiments, the systems, devices, methods, etc. herein comprise suturing the leaflets, wherein each slit is a planned distance from the previous slit. A portion of the suturing can extend back and forth between multiple leaflets, while other portions can be performed on a single leaflet. Slits can be placed at predetermined intervals along the leaflets by selecting attachment locations and / or by using spacers between consecutive anchors.

[0372] Figure 27A and 27B Show Figure 26 and 27 One of many potential uses for this example. Figure 27A , distal leaflet anchor 401 is attached to leaflet 20. Leaflet anchor 421 is then deployed along tether 405 and attached to leaflet 22. Leaflet anchor 425 is then deployed along tether 405 and attached to leaflet 22. Leaflet anchor 427 is then deployed along tether 405 and attached to leaflet 20. This sequence forms a back and forth suturing pattern. Any number of anchors may be used. Although the mitral valve is shown, Figure 27A and 27B The sequence shown can be applied to any valve, such as the tricuspid valve. Figure 27A and 27B The example shown can be used with Figure 16-20 The same or similar approach as shown is used in the tricuspid valve.

[0373] refer to Figure 27B In some embodiments, when all anchor sets are attached, an end body 431 or lock (similar in form and tethering function to the locking center body of previous examples and variations) is advanced along tether 405 by pulling the tether proximally. The tether is pulled back through the end body to draw the leaflet anchors 401, 421, 425, 427 together. Thus, anchors 401, 421, 425, 427 draw leaflets 20, 22 together to reduce regurgitation through the native valve in the area of ​​the anchors. The intermediate leaflet anchors 421, 425 naturally adjust their position on tether 405. The end body 431 or lock is secured to tether 405, securing the relative positions of leaflet anchors 401, 421, 425, 427 and completing the native valve repair. Tether 405 can be severed at end body 431 and removed.

[0374] It should be noted that this example can provide for suturing of the leaflets, wherein each slit is a planned distance from the previous slit. A portion of the suturing can extend back and forth between multiple leaflets, while other portions can be performed on a single leaflet. By selecting the attachment locations and / or by using spacers between consecutive anchors, slits can be placed at predetermined intervals along the leaflets.

[0375] refer to Figure 27 In some end-coupled embodiments, the distal leaflet anchor 451 is permanently attached to a single integral controlled tether 453 (e.g., it is integral because it is not made of separate segments) that is long enough to extend through the length of the steering catheter from its distal end to its proximal end. In some embodiments (similar to other embodiments previously described), the medial leaflet anchor 455 and the proximal leaflet anchor 457 can have anchor tether segments 459 serially attached to the integral controlled tether 453. In some embodiments, after the implant is fully assembled and the anchors are tied together by the end bodies 431, a tether cutting device in the implant catheter is used to sever and remove the majority of this long integral controlled tether 453 from the implant.

[0376] refer to Figure 28In some end-coupled embodiments, one or more (spring-type) spring spacers 471 are placed on segments of the implant control tether 473 that extend between some or all pairs of consecutive leaflet anchors 475 attached to the leaflets 477 (e.g., pairs of leaflet anchors that appear consecutively along the implant control tether). The one or more spring spacers 471 are placed by feeding along the extended tether segment, with each spring spacer fed between a corresponding pair of consecutive anchors that will be separated by the spring spacer. These spring spacers can help maintain the anchors at a preferred distance from each other. Structurally, these spring spacers 471 can be formed in one of the forms of spacers described above, or they can have other configurations, such as accordion pleat wadding, with the implant control tether 473 penetrating and extending through each accordion pleat (as depicted).

[0377] refer to Figure 28 In some embodiments, rather than having additional leaflet anchors with anchor tether segments forming eyelets through which extension tether segments slidably extend, the leaflet anchors 475 can include structurally integral apertures forming slidable limiters 481 (e.g., a proximal anchor slidable limiter and an intermediate anchor slidable limiter) through which segments of the implant control tether 473 slidably extend.

[0378] In some end-coupled embodiments, the anchor is configured as a T-shaped toggle anchor. This type of anchor can provide enhanced support for lateral loads occurring between consecutive anchors, particularly when attached to different leaflets. Other types of anchors are also possible (e.g., those described elsewhere herein).

[0379] 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. WO 2019139904). Any combination or subcombination of features disclosed in this application may be combined with any combination or subcombination of features disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO 2019139904). Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO 2019139904) is incorporated herein by reference in its entirety for all purposes.

[0380] The buckles or leaflet grasping devices disclosed herein can take a variety of different forms, such as those disclosed in Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO 2018195201). Combinations and subcombinations of features in this application can be combined with features disclosed in Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO 2018195201), which is incorporated herein by reference in its entirety for all purposes.

[0381] Any of the various systems, devices, apparatus, etc. disclosed herein can be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on a subject, and the methods herein may comprise or consist of sterilizing (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) one or more of the systems, devices, apparatus, etc. disclosed herein.

[0382] Although the various inventive aspects, concepts and features of the present disclosure can be described and illustrated herein as being embodied in combination in the examples herein, these various aspects, concepts and features can be used in many alternative examples individually or in their various combinations and sub-combinations. Unless expressly excluded herein, all such combinations and sub-combinations are intended to be within the scope of the present application. In addition, although various alternative examples regarding the various aspects, concepts and features of the present disclosure may be described herein, such as alternative materials, structures, configurations, methods, devices and components, alternatives regarding form, coordination and function, etc., these descriptions are not intended to be a complete or exhaustive list of available alternative examples currently known or developed later. Those skilled in the art can easily use one or more of these inventive aspects, concepts or features for additional examples and uses within the scope of the present application, even if such examples are not clearly disclosed herein.

[0383] In addition, although some features, concepts or aspects of the present disclosure may be described herein as preferred arrangements or methods, such description is not intended to imply that such features are required or essential unless expressly stated. In addition, examples or representative values ​​and ranges may be included to aid in understanding the present application, however, such values ​​and ranges should not be construed as limiting and are considered critical values ​​or ranges only when so expressly stated.

[0384] Furthermore, while various aspects, features, and concepts may be expressly identified herein as inventive or forming part of the present disclosure, such identification is not intended to be exclusive, and there may be inventive aspects, concepts, and features that are fully described herein but not expressly identified as part of this particular disclosure, rather, such disclosure is set forth in the appended claims. The description of an exemplary method or process is not limited to including all steps required in all cases, nor is the order of the steps presented to be construed as required or necessary unless expressly so stated. The therapeutic techniques, methods, steps, and the like described or suggested herein or incorporated by reference herein can be performed on living animals or non-living mimics, such as cadavers, cadaver hearts, anthropomorphic ghosts, phantoms (e.g., utilizing simulated body parts, tissues, etc.), and the like. The terms used in the claims have their full ordinary meaning and are not limited in any way by the description of the examples in the specification.

[0385] While forms of the present invention have been shown and described, it will be apparent that various modifications may be made without departing from the spirit and scope of the invention. Thus, while the invention has been described in detail with reference only to preferred embodiments, it will be understood by those skilled in the art that various modifications may be made without departing from the scope of the invention. The present invention is therefore not intended to be limited by the foregoing discussion, and is defined by reference to the appended claims.

Claims

1. A system for treating or repairing a natural valve of a subject, the natural valve having a plurality of leaflets, the system comprising: Implantation of catheters; as well as A device is releasably coupled to the implantation catheter, the device comprising a first leaflet anchor, a first anchor connector, a second leaflet anchor, a controlled tether system, and an anchor lock.

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

3. The system of any one of claims 1 to 2, wherein the first anchor connector forms a decoupleable connection between the first leaflet anchor and the implantation catheter having a coupled state and a decoupled state.

4. The system of any one of claims 1 to 3, wherein the second leaflet anchor has a second leaflet attachment mechanism, the second leaflet anchor being connectable to the implantation catheter independently of the first anchor connector.

5. A system according to any one of claims 1 to 4, wherein the controlled tether system extendably connects the first leaflet anchor to the implantation catheter, and the controlled tether system is capable of being actuated to move the first leaflet anchor closer to and / or in contact with the second leaflet anchor, wherein the first anchor connector is in its disengaged state.

6. The system of any one of claims 1 to 5, wherein the anchor lock has a locking mechanism that, when locked, restricts relative movement of the respective first and second leaflet anchors.

7. The system of any one of claims 1 to 6, wherein the first leaflet anchor, the second leaflet anchor, and the first anchor connector are mounted on the implantation catheter.

8. A system according to any one of claims 1 to 7, wherein the controlled tether system includes a first controlled tether, which extends to secure the first leaflet anchor to a central body in an extendable manner, and the central body is detachably attached to the implant catheter via a central body connector, and the first controlled tether extends sequentially, starting from a first end segment of the first controlled tether at the proximal end of the implant catheter, through the central body positioned at the distal end of the implant catheter, slidably received by a first anchor slidable limiter on the first leaflet anchor, and again through the central body to reach the second end segment of the first controlled tether at the proximal end of the implant catheter.

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

10. A system according to any one of claims 1 to 9, wherein the controlled tether system includes a first controlled tether that extends sequentially, starting from a first end segment of the first controlled tether at the proximal end of the implant catheter, through a centerbody slidable limiter on a centerbody on the distal end of the implant catheter that is detachably attached by means of a centerbody connector, to a second end segment of the first controlled tether attached to the first leaflet anchor.

11. A system according to any one of claims 1 to 10, wherein the controlled tether system includes a first controlled tether that extends sequentially, starting from a first end segment of the first controlled tether at the proximal end of the implant catheter, through a centerbody sliding limiter on the centerbody on the distal end of the implant catheter that is detachably attached by means of a centerbody connector, through a first anchor sliding limiter on the first leaflet anchor, and back to a second end segment of the first controlled tether attached to the centerbody.

12. The system according to any one of claims 1 to 11, wherein: The apparatus further comprises a second anchor connector for forming a decoupleable connection between the second leaflet anchor and the implantation catheter having a coupled state and a decoupled state; the controlled tether system extendably connects the second leaflet anchor to the implantation catheter, and the controlled tether system is actuatable to move the second leaflet anchor into closer proximity with and / or contact with the first leaflet anchor (or another portion of the device), wherein the second anchor connector is in its decoupled state; and The second anchor connector is mounted on the implant catheter.

13. The system of claim 12, wherein: The controlled tether system includes a first controlled tether for extendably securing the first leaflet anchor to a hub that is detachably attached to the implant catheter via a hub connector, the first controlled tether extending sequentially from a first end segment at the proximal end of the implant catheter, through the hub positioned at the distal end of the implant catheter, slidably received by a first anchor slidable limiter on the first leaflet anchor, again through the hub, to a first second end segment at the proximal end of the implant catheter; and The controlled tether system includes a second controlled tether for extensibly securing the second leaflet anchor to the central body, the second controlled tether extending sequentially from a second first end segment at the proximal end of the implant catheter, through the central body, slidably received by a second anchor slidable limiter on the second leaflet anchor, again through the central body, to the second second end segment at the proximal end of the implant catheter.

14. The system of claim 12, wherein the controlled tether system comprises: an anchor tether segment comprising a first anchor tether segment and a second anchor tether segment, each respective anchor tether segment extending from an anchor tether segment connection point to a respective leaflet anchor; and An extension tether segment is connected to the anchor tether segment and extends proximally along the implant catheter to a proximal end of the implant catheter.

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

16. The system of claim 15, wherein: The apparatus further comprises a third anchor connector for forming a decoupleable connection between the third leaflet anchor and the implantation catheter having a coupled state and a decoupled state; the controlled tether system extendably connects the third leaflet anchor to the implantation catheter, and the controlled tether system is actuatable to move the third leaflet anchor into closer proximity with and / or contact with the first and second leaflet anchors (or with another portion of the device), wherein the third anchor connector is in its decoupled state; and Wherein when the locking mechanism is locked, the locking mechanism restricts the relative movement of the third leaflet anchor relative to the first and second leaflet anchors.

17. A system according to claim 16, wherein the controlled tether system includes a first controlled tether for extendably securing the first leaflet anchor to a central body detachably attached to the implant catheter via a central body connector, the first controlled tether extending sequentially from a first end segment of the first controlled tether at the proximal end of the implant catheter, through the central body positioned at the distal end of the implant catheter, slidably received by a first anchor slidable limiter on the first leaflet anchor, again through the central body, to a second end segment of the first controlled tether at the proximal end of the implant catheter.

18. A system according to claim 17, wherein the controlled tether system includes a second controlled tether for extensibly securing the second leaflet anchor to the central body, the second controlled tether extending sequentially from a second first end segment at the proximal end of the implant catheter, through the central body positioned at the distal end of the implant catheter, slidably received by a second anchor slidable limiter on the second leaflet anchor, again through the central body, to the second second end segment at the proximal end of the implant catheter.

19. A system according to claim 18, wherein the controlled tether system includes a third controlled tether for extensibly securing the third leaflet anchor to the central body, and the third controlled tether extends sequentially, starting from the first end segment of the third controlled tether at the proximal end of the implant catheter, through the central body positioned at the distal end of the implant catheter, slidably received by the third anchor sliding limiter on the third leaflet anchor, again through the central body, and reaching the second end segment of the third controlled tether at the proximal end of the implant catheter.

20. The system of any one of claims 16 to 19, wherein the controlled tether system comprises: an anchor tether segment comprising a first anchor tether segment, a second anchor tether segment, and a third anchor tether segment, each respective anchor tether segment extending from an anchor tether segment connection point to a respective leaflet anchor; and An extension tether segment is connected to the anchor tether segment and extends proximally along the implant catheter to a proximal end of the implant catheter.

21. The system of claim 12, wherein The first leaflet anchor is a distal leaflet anchor; The second leaflet anchor is a proximal leaflet anchor; The controlled tether system includes an implant control tether for securing the distal leaflet anchor to the proximal end of the implant catheter, The proximal leaflet anchor is slidably attached to the implant control tether; an end body slidably receiving the implant control tether to slide along the implant control tether and move the distal leaflet anchor into closer proximity with and / or contact with the proximal leaflet anchor (or another portion of the system), the end body forming the locking mechanism; and The locking mechanism includes a cable lock.

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

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

24. The system of claim 21, wherein: The implant control tether comprises a distal anchor tether segment attached to the distal leaflet anchor, the distal anchor tether segment forming an eyelet; and The implant control tether includes an extended tether section having a first end section, a second end section, and a middle section intermediate the first end section and the second end section, the middle section being looped through the eyelet.

25. The system of claim 21, wherein the implant control tether is integral from the proximal end of the implant catheter to the distal leaflet anchor.

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

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

28. The system of any one of claims 1 to 27, further comprising a resilient spacer, wherein said first and second leaflet anchors forming opposing surfaces; The spacer is positioned to be compressed by the opposing surfaces; and The spacer forms a flexible body having low functional flexible compressibility relative to obstructed blood flow.

29. The apparatus of claim 28, wherein: the controlled tether system having a maximum level of force by which the controlled tether system is capable of coupling the first leaflet anchor and the second leaflet anchor with the spacer positioned therebetween to receive the opposing surfaces; and When the controlled tether system is actuated at the maximum level of force, the spacer is extruded to extend beyond the opposing surface.

30. A device in a system for treating or repairing a native valve of a subject, the native valve having a plurality of leaflets, the system having one or more implantation catheters, each of the one or more implantation catheters having a respective distal catheter end for insertion into vasculature and a respective proximal catheter end configured to allow manipulation of the device, the device comprising: a first leaflet anchor and a second leaflet anchor, each leaflet anchor having a respective leaflet attachment mechanism; a first anchor connector connected to the first leaflet anchor, the first anchor connector having a first catheter connector for connecting to a first catheter distal end of a first implant catheter of the one or more implant catheters, wherein the first anchor connector forms a decoupleable connection between the first leaflet anchor and the first implant catheter having a coupled state and a decoupled state; as well as A second anchor connector connected to the second leaflet anchor, the second anchor connector having a second catheter connector for connecting to the second catheter distal end of a second implant catheter among the one or more implant catheters, wherein the second anchor connector forms a detachable connection between the second leaflet anchor and the second implant catheter having a connected state and a decoupled state.

31. The device according to claim 30 further comprises a system comprising a first controlled tether connected to the first leaflet anchor and a second controlled tether connected to the second leaflet anchor, wherein the first controlled tether extends from the distal end of the first tether at the first leaflet anchor to the proximal end of the first tether at the proximal end of the first catheter, wherein the second controlled tether extends from the distal end of the second tether at the second leaflet anchor to the proximal end of the second tether at the proximal end of the second catheter, and wherein the system is capable of being actuated to bring the corresponding first and second leaflet anchors closer together and / or in contact with each other and / or with another part of the device.

32. The device according to any one of claims 30 to 31 further comprises a central body, wherein each of the corresponding first and second controlled tethers extends through the central body, and wherein the central body is capable of sliding along the first and second controlled tethers to bring the first leaflet anchor closer to the second leaflet anchor and / or into contact with the second leaflet anchor (or with another part of the device).

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

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

35. The apparatus according to any one of claims 30 to 34, further comprising: a tertiary leaflet anchor having a tertiary leaflet attachment mechanism; as well as A third anchor connector connected to the third leaflet anchor, the third anchor connector having a third catheter connector for connecting to the third catheter distal end of a third implant catheter among the one or more implant catheters, wherein the third anchor connector forms a detachable connection between the third leaflet anchor and the third implant catheter having a connected state and a decoupled state.

36. A device according to claim 35, wherein the system includes a third controlled tether connected to the third leaflet anchor, wherein the third controlled tether extends from a distal end of the third tether at the third leaflet anchor to a proximal end of the third tether at the proximal end of the third catheter; and wherein the system is capable of being actuated to bring the first leaflet anchor, the second leaflet anchor and the third leaflet anchor closer together and / or in contact with each other and / or in contact with another part of the device.

37. A device according to any one of claims 35 to 36, wherein the central body is capable of sliding along the first, second and third controlled tethers to the distal ends of the respective first, second and third tethers to bring the first leaflet anchor, the second leaflet anchor and the third leaflet anchor closer to and / or in contact with each other (or in contact with another part of the system).

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

39. The apparatus according to any one of claims 30 to 38, wherein: the first controlled tether comprising a first anchor tether segment attached to the first leaflet anchor at a first distal end of the first anchor tether segment, the first anchor tether segment forming a first eyelet at a first proximal end of the first anchor tether segment; and The first controlled tether includes a first extended tether section having a first end segment, a first second end segment, and a first intermediate segment, wherein the first intermediate segment is located between the first first end segment and the first second end segment along the first extended tether section, and the first intermediate segment is looped through the first eyelet.

40. The apparatus according to any one of claims 30 to 39, wherein: the second controlled tether comprising a second anchor tether segment attached to the second leaflet anchor at a second distal end of the second anchor tether segment, the second anchor tether segment forming a second eyelet at a second proximal end of the second anchor tether segment; and The second controlled tether includes a second extended tether segment having a second first end segment, a second second end segment, and a second intermediate segment, wherein the second intermediate segment is located intermediate the second first end segment and the second second end segment along the second extended tether segment, and the second intermediate segment is looped through the second eyelet.

41. The device of any one of claims 30 to 40, wherein the first catheter connector has a quick release mechanism for first being detachably attached to the first implant catheter during implantation and then being detached during implantation.

42. A device according to any one of claims 30 to 41, further comprising a resilient spacer positioned to be compressed by the opposing surfaces of the first and second leaflet anchors, the resilient spacer forming a flexible body having low functional flexible compressibility relative to obstructed blood flow, wherein the system is capable of being actuated with a certain level of force to bring the first leaflet anchor closer to the second leaflet anchor, wherein the resilient spacer is positioned to receive and / or contact the opposing surfaces of the first and second leaflet anchors.

43. The device of claim 42, wherein the system defines a maximum force level, and wherein the resilient spacer extends beyond the opposing surface when the system is actuated at the maximum level of force.

44. A system capable of repairing a native valve of a subject, the native valve having a plurality of leaflets, the system comprising: an implanting catheter having a proximal catheter end and a distal catheter end; as well as An apparatus comprising 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 limiter, a proximal anchor connector, a system comprising an implant control tether having a tether proximal end and a tether distal end, and an anchor lock on the implant control tether; wherein the distal anchor connector forms a decoupleable connection between the distal leaflet anchor and the distal end of the catheter having a coupled state and a decoupled state; The proximal anchor connector forms a detachable connection between the proximal leaflet anchor and the distal end of the catheter having a coupled state and a decoupled state, the decoupleable connection of the proximal anchor connector being independent of the decoupleable connection of the distal anchor connector.

45. A system according to claim 44, wherein the distal end of the tether is connected to the distal leaflet anchor, and / or wherein the implant controls the tether to extend sequentially, starting from the distal end of the tether, through the proximal anchor slidable limiter of the proximal leaflet anchor, to the proximal end of the tether at the proximal end of the catheter.

46. ​​The system of any one of claims 44 to 45, wherein the anchor lock constrains proximal movement of the proximal leaflet anchor relative to the implant control tether.

47. A system according to any one of claims 44 to 46, wherein: The implant control tether is formed from an extension tether segment and an anchor tether segment; The anchor tether segment is connected to the distal leaflet anchor and forms an eyelet; and The extension tether segment has a first end segment, a second end segment, and a middle segment located between the first end segment and the second end segment, and the middle segment is looped through the eyelet.

48. The system of any one of claims 44 to 46, further comprising a medial leaflet anchor and a medial anchor connector, wherein: The intermediate leaflet anchor has an intermediate leaflet attachment mechanism and an intermediate anchor slidable limiter; the intermediate anchor connector forming a releasable connection between the intermediate leaflet anchor and the distal end of the catheter having a coupled state and a decoupled state, the releasable connection of the intermediate anchor connector being independent of the releasable connection of the distal connector; and The implant control tether extends between the distal leaflet anchor and the proximal leaflet anchor through the intermediate anchor slidable limiter.

49. The system of any one of claims 44 to 48, wherein the implant control tether is a unitary body.

50. The system of any one of claims 44 to 49, further comprising one or more spring spacers positioned between a pair of consecutive anchors.

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

52. A device for repairing a native valve of a subject, the native valve having a plurality of leaflets, the device comprising: a first leaflet anchor having a first leaflet attachment mechanism; a second leaflet anchor having a second leaflet attachment mechanism, the respective first and second leaflet anchors having opposing surfaces; a resilient spacer positioned to be compressed by the opposing surfaces, the resilient spacer forming a pliable body having a low functional pliable compressibility relative to obstructed blood flow; as well as A system that is actuable with a level of force to move the first leaflet anchor closer to and / or into contact with the second leaflet anchor (or another portion of the device), wherein the resilient spacer is positioned to receive the opposing surfaces.

53. The apparatus of claim 52, wherein the system defines a maximum force level, and wherein when the system is actuated at the maximum level of force, the resilient spacer is extruded so as to extend beyond the opposing surface.

54. The device according to any one of claims 52 to 53 further comprises an anchor lock for restraining the relative movement of the first leaflet anchor and the second leaflet anchor when the first leaflet anchor and the second leaflet anchor move closer to and / or contact the elastic spacer.

55. An organ repair system for repairing an organ of a subject, comprising: Implantation of catheters; a first anchor having a first attachment body for attachment to the organ and mounted on the implantation catheter; a first anchor connector for connecting the first anchor to the implant catheter, the first anchor connector forming a decoupleable connection between the first anchor and the implant catheter having a coupled state and a decoupled state; a second anchor having a second attachment body for attachment to the organ, the second anchor being mounted on the implant catheter independently of the releasable connection of the first anchor connector; as well as A controlled tether is provided for extendably connecting the first anchor to the implant catheter independently of the first anchor connector, the controlled tether being actuatable to bring the first anchor into closer proximity with the second anchor.

56. The organ repair system of claim 54, further comprising an anchor lock having a locking mechanism for restricting relative movement of the first and second anchors after the respective first and second anchors are brought into closer proximity.

57. A method for treating or repairing a simulated native valve on a mimic, the native valve having a plurality of leaflets including a first leaflet and a second leaflet, the method comprising: A therapeutic or repair device is provided that is releasably coupled to a distal end of an implantation catheter, wherein the therapeutic or repair device comprises: a first leaflet anchor; a first anchor connector for forming a first releasable connection between the first leaflet anchor and the implantation catheter; a second leaflet anchor connected to the implantation catheter independently of the first anchor connector; and a system actuatable to move the first leaflet anchor into closer proximity with and / or contact with the second leaflet anchor (or another portion of the therapeutic or prosthetic device), wherein the first decoupleable connection has been decoupled; positioning the first leaflet anchor at the first leaflet; attaching the first leaflet anchor to the first leaflet; After the first leaflet anchor is attached to the first leaflet, decoupling the first anchor connector; positioning the second leaflet anchor at the second leaflet after the first anchor connector is decoupled; attaching the second leaflet anchor to the second leaflet; After the first and second leaflet anchors are attached to the respective first and second leaflets, using the system to move the first leaflet anchor into closer proximity with and / or contact with the second leaflet anchor (or another portion of the therapeutic or prosthetic device); and The therapeutic or prosthetic device is released from the implantation catheter.

58. A method according to claim 57, wherein the treatment or repair device includes an anchor lock having a locking mechanism for locking the relative positions of the first and second leaflet anchors relative to each other, and the method further includes, after the step of moving the first leaflet anchor closer to and / or into contact with the second leaflet anchor (or another part of the treatment or repair device), using the anchor lock to lock the relative positions of the first and second leaflet anchors relative to each other.

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

60. A method according to any one of claims 57 to 59, wherein the plurality of leaflets includes a third leaflet, wherein the treatment or repair device includes a second anchor connector forming a second releasable connection between the second leaflet anchor and the implant catheter and a third leaflet anchor connected to the implant catheter independently of the first and second anchor connectors, and wherein after the first and second releasable connections are decoupled, the system is capable of actuating to move the first, second and third leaflet anchors into closer proximity and / or contact (to each other and / or to another part of the device).

61. The method of claim 60, further comprising: After the second leaflet anchor is attached to the second leaflet, decoupling the second anchor connector; positioning the third leaflet anchor at the third leaflet after decoupling the second anchor connector; and attaching the third leaflet anchor to the third leaflet; Wherein in the moving step, the first, second and third leaflet anchors are moved closer to each other and / or into contact with each other and / or into contact with another portion of the treatment or repair device.

62. The method of any one of claims 57 to 61, wherein after the step of decoupling the first anchor connector, the method comprises the steps of: using the system to move the first leaflet anchor and the implantation catheter into contact; coupling the implantation catheter to the first leaflet anchor; detaching the first leaflet anchor from the first position; as well as The first leaflet anchor is attached at another location different from the first location.

63. A method for treating or repairing a valve on a mimetic, the valve having a plurality of leaflets including a first leaflet and a second leaflet, the method comprising: A device is provided on a distal end of the implantation catheter, wherein the device comprises: a first leaflet anchor; a first anchor connector for forming a first releasable connection between the first leaflet anchor and the implantation catheter; a second leaflet anchor connected to the implantation catheter independently of the first anchor connector; and a system actuatable to move the first and second leaflet anchors into closer proximity, wherein the first decoupleable connection is decoupled; positioning the first leaflet anchor at the first leaflet; attaching the first leaflet anchor to the first leaflet; After the first leaflet anchor is attached to the first leaflet, decoupling the first anchor connector; positioning the second leaflet anchor at the second leaflet after the first anchor connector is decoupled; attaching the second leaflet anchor to the second leaflet; After the first and second leaflet anchors are attached to the respective first and second leaflets, using the system to move the first and second leaflet anchors into closer proximity; as well as The device is released from the implantation catheter.

64. A method according to claim 63, wherein the device includes an anchor lock having a locking mechanism for locking the relative positions of the first and second leaflet anchors relative to each other, and the method further includes, after the step of moving the first and second leaflet anchors closer together, using the anchor lock to lock the relative positions of the first and second leaflet anchors relative to each other.

65. The method of claim 64, wherein the plurality of leaflets includes a third leaflet, wherein the device includes a second anchor connector forming a second releasable connection between the second leaflet anchor and the implantation catheter, and a third leaflet anchor connected to the implantation catheter independently of the first and second anchor connectors, and wherein after decoupling of the first and second releasable connections, the system is actuatable to move the first, second, and third leaflet anchors into closer proximity, and the method further comprising: After the second leaflet anchor is attached to the second leaflet, decoupling the second anchor connector; positioning the third leaflet anchor at the third leaflet after the second anchor connector is decoupled; attaching the third leaflet anchor to the third leaflet; and Wherein in the step of moving the first and second leaflet anchors closer together, all of the first, second and third leaflet anchors are moved closer together.

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