Heart valve repair devices and methods

Abstract

An implantable device to be positioned within a heart valve, using a delivery system. The device can include leaflet anchors for attaching to valve leaflets. A set of tethers can move the anchors closer, into contact with one another, and / or into contact with a central body. The set of tethers can allow the anchors to move apart, and / or away from a central body.

Description

HEART VALVE REPAIR DEVICES AND METHODSRELATED APPLICATIONS

[0001] The present application claims the benefit of U.S. Provisional Patent Application No. 63 / 638,892, filed on April 25, 2024 and U.S. Provisional Patent Application No. 63 / 569,803, filed on March 26, 2024, which are incorporated herein by reference in their entireties.BACKGROUND

[0002] A healthy heart has a generally conical shape that tapers to a lower apex. The heart is four-chambered through which blood flows, A native human heart includes four chambers: two atria (upper chambers) - the left atrium and the right atrium, and two ventricles (lower chambers) - the left ventricle and the right ventricle. A wall, the septum, separates the right and left sides of the heart (i.e., of each pair of chambers). For each of the four chambers, there is a respective native valve (the mitral, tricuspid, aortic, and pulmonary valves, respectively) preventing the 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 passes downstream (forward) through the tricuspid valve to the right ventricle. From the right ventricle it is pumped downstream through the pulmonary valve to the lungs by way of a blood vessel for blood with low oxygen levels, the pulmonary artery. On the left side of the heart, oxygenated blood from the lungs is received in the left atrium and passes downstream through the mitral valve to the left ventricle. From the left ventricle it is pumped downstream through the aortic valve to the remainder of the body by way of a blood vessel for oxygen rich blood, the aorta. During each heartbeat, there is a diastolic phase (cardiac diastole) when the chambers relax and fill passively with blood, and a systolic phase when the heart contracts and pumps blood into the two blood vessels downstream of the ventricles (i.e., the pulmonary artery and the aorta). The systolic phase includes an atrial systole, when the atria contract to eject blood from within the atria downstream into their respective ventricles; and ventricular systole, when the ventricles contract to eject blood from within the ventricles downstream into their respective downstream blood vessels.

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

[0005] For example, the mitral valve, which connects the left atrium to the left ventricle, includes an annulus portion, which is an annular portion of the valve’s tissue surrounding a mitral valve orifice, and a pair of leaflets extending downward from the annulus portion into the left ventricle. The mitral valve annulus portion can form a "D" -shaped, oval, or otherwise out-of-round cross-sectional shape having major and minor axes. An anterior leaflet can be larger than a posterior leaflet, forming a generally "C "-shaped boundary between the abutting sides of the leaflets when they are closed together.

[0006] With the mitral valve operating properly, the anterior leaflet and the posterior leaflet of the mitral valve function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. During atrial systole, after the left atrium received oxygenated blood from the pulmonary veins during cardiac diastole, the muscles of the left atrium contract and the left ventricle dilates (also referred to as "ventricular diastole" or "diastole"), and the oxygenated blood that is collected in the left atrium flows into the left ventricle. Subsequently, during ventricular systole, the muscles of the left atrium relax and the muscles of the left ventricle contract, and the resulting increased blood pressure in the left ventricle urges the sides of the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back to the left atrium. This pressurized blood is instead expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, a plurality of fibrous cords called chordae tendineae tether the leaflets to papillary muscles in the left ventricle.

[0007] The native heart valves serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system. In abnormal situations, these heart valves may be dysfunctional (e.g., damaged, or otherwise malformed), and thus less effective, such as by congenital malformations, inflammatory processes, infectious conditions, disease, and the like. Such dysfunctionality may result in serious cardiovascular compromise or death. One form of dysfunctionality is valvular regurgitation.

[0008] Valvular regurgitation involves the valve improperly allowing some blood to flow in the wrong direction through the valve. For example, mitral regurgitation occurs when the mitral valve fails to close properly and blood flows upstream into the left atrium from the left ventricle during ventricle systole. Likewise, tricuspid regurgitation occurs when the tricuspid valve fails to close properly and blood flows upstream into the right atrium from the right ventricle during ventricle systole.

[0009] Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, such as leaflet prolapse, dysfunctional papillary muscles, stretching of the mitral valve annulus resulting from dilation of the left ventricle, more than one of these, etc. Mitral regurgitation at a central portion of the leaflets can be referred to as central jet mitral regurgitation and mitral regurgitation nearer to one commissure (i.e., location where the leaflets meet) of the leaflets can 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 thus the valve does not close, and regurgitation is present. Regurgitation in any of the three-leaflet valves is likewise a serious form of heart disease having many different causes and being characterized by various forms of valve failure mechanisms.

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

[0011] While devices like this provide significant potential for potentially lifesaving repairs, there are still challenges. For example, one challenge is that, when treating a beating heart, the leaflets are in motion (both in shape and location) with the continuing operation of the heart. Thus, a repair device must navigate and operate relative to a moving target. Moreover, one or both leaflets of the dysfunctional valve may be deformed and / or damaged. As a result, the leaflets might not regularly move into a position and configuration in which they can be readily treated by the repair device. Moreover, the two or three target leaflets might have unusually large gaps therebetween, and they might be tethered into an unnaturally open position, such as by changes in the underlying structure (e.g., a dilated ventricle).SUMMARY

[0012] This summary provides some examples, and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. Also, the features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure may be included in the examples summarized here.

[0013] In some implementations, treatment or repair systems, devices, and related methods include helping to treat or repair native valves, including native two- and three- leaflet heart valves. The devices herein can be valve repair devices, implantable devices, valve treatment devices, implants, treatment devices, etc. While sometimes described as an implantable device or valve repair device for illustration purposes in examples herein, similar configurations can be used on other devices, e.g., treatment devices, removable devices, devices that are not necessarily implanted and can be removed after treatment, etc.

[0014] Tn some implementations, there is provided a device (e.g., treatment device, repair device, valve repair device, implantable device, implant, valve treatment device, etc.) that is configured to be positioned within a native heart valve to allow the native heart valve to form a more effective seal and / or reduce or inhibit regurgitation. The device can be part of a system (e.g., treatment system, repair system, valve repair system, valve treatment system, etc.).

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

[0016] In some implementations, the device can be positioned within a heart valve, using a delivery system comprising catheters. In some implementations, the device can include leaflet anchors for attaching to valve leaflets, and one or more connectors forming decouplable or detachable connections between the anchors and the delivery system. In some implementations, the one or more connectors are severable connectors forming severable connections between the anchors and the delivery system.

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

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

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

[0020] In some implementations, a valve repair device includes a central body, a plurality of anchors, a plurality of tethers attached to the plurality of anchors, and an actuator. In some implementations, the plurality of anchors can be attached to the central body via the plurality of tethers. In some implementations, the actuator can be coupled to the central body.

[0021] In some implementations, each anchor can be coupled to the central body via a corresponding tether. In some implementations, each anchor can be coupled to the central body via one or more tethers.

[0022] In some implementations, the plurality of tethers are configured to pull the plurality of anchors toward the central body and to allow the plurality of anchors to be spaced apart from the central body. For example, slack in a tether can allow a corresponding anchor to be spaced apart from the central body.

[0023] In some implementations, the plurality of tethers are configured to pull the plurality of anchors against the central body, such that at least a portion of an anchor of the plurality of anchors abutted against the central body.

[0024] In some implementation, the actuator can be operatively coupled to the plurality of anchors when the anchors are pulled against the central body by the tethers. That is, while oneor more anchors of the plurality of anchors are abutted against the central body, the anchor can be coupled to the one or more anchors.

[0025] In some implementations, the actuator is configured to open the one or more anchors that are against the central body. In some implementations, the actuator can simultaneously open the one or more anchors that are against the central body.

[0026] In some implementations, an anchor of the plurality of anchors comprises a paddle. In some implementations, each anchor of the plurality of anchors comprises a paddle.

[0027] In some implementations, the anchor can comprise an actuator engagement extension. In some implementations, the paddle of the anchor comprises an actuator engagement extension.

[0028] In some implementations, the actuator engages the actuator engagement extension to move the paddle from a closed position to an open position. In some implementations, the actuator engagement extension is configured to engage the actuator when the anchor is disposed against the central body.

[0029] In some implementations, the paddle comprises a plurality of actuator engagement extensions. For example, in some implementations, a first actuator engagement extension of the plurality of actuator engagement extensions can be used to open the paddle, while a second actuator engagement extension can be used to close the paddle.

[0030] In some implementations, the actuator is configured to engage the anchor to move the anchor to a closed position. In some implementations, the actuator is configured to engage the anchor to move the anchor to an open position.

[0031] In some implementations, the anchor can comprise a plurality of actuator engagement extensions. In such implementations, the actuator can be configured to engage a first one of the plurality of actuator engagement extensions to move the anchor to a closed position and can be further configured to engage a second one of the plurality of actuator engagement extensions to move the anchor to an open position.

[0032] In some implementations, the tethers are configured to allow the anchors to tilt as the anchors are pulled toward the central body. For instance, by while a tether pulls an anchortoward the central body, the anchor can be permitted to tilt relative to the central body. In some implementations, the anchor can be configured to tilt away from the central body as it is pulled toward the central body.

[0033] In some implementations, each tether is connected to a closed end of each anchor. For instance, a tether can be connected to a closed end of the corresponding anchor.

[0034] In some implementations, a valve repair system includes a valve repair device and a delivery system.

[0035] In some implementations, the delivery system can include one or more catheters and a control handle.

[0036] In some implementations, the valve repair device includes a central body, a plurality of anchors, a plurality of tethers attached to the plurality of anchors, and an actuator. In some implementations, the plurality of anchors can be attached to the central body via the plurality of tethers. In some implementations, the actuator can be coupled to the central body.

[0037] In some implementations, each anchor can be coupled to the central body via a corresponding tether. In some implementations, each anchor can be coupled to the central body via one or more tethers.

[0038] In some implementations, the plurality of tethers are configured to pull the plurality of anchors toward the central body and to allow the plurality of anchors to be spaced apart from the central body. For example, slack in a tether can allow a corresponding anchor to be spaced apart from the central body.

[0039] In some implementations, the plurality of tethers are configured to pull the plurality of anchors against the central body, such that at least a portion of an anchor of the plurality of anchors abutted against the central body.

[0040] In some implementations, the actuator can be operatively coupled to the plurality of anchors when the anchors are pulled against the central body by the tethers. That is, while one or more anchors of the plurality of anchors are abutted against the central body, the anchor can be coupled to the one or more anchors.

[0041] In some implementations, the actuator is configured to open all anchors that are against the central body.

[0042] In some implementations, the actuator can simultaneously open the one or more anchors that are against the central body.

[0043] This disclosure includes methods of repairing a heart valve e.g. native heart valve and / or simulated heart valve). In some implementations, methods of repairing a heart valve include opening a plurality of anchors that are against a central body.

[0044] In some implementations, the plurality of anchors can be simultaneously opened. For example, in some implementations, an implantable device includes an actuator that opens and / or simultaneously opens the plurality of anchors.

[0045] In some implementations, a first anchor of the plurality of anchors is positioned such that a first native heart valve leaflet is in the first anchor. For example, in some implementations, the implantable device can be moved toward the first native heart valve leaflet such that the open first anchor receives the first native heart valve leaflet.

[0046] In some implementations, the first anchor is closed to capture the first leaflet. In some implementations, the plurality of anchors that are against the central body (e.g. , including but not limited to the first anchor) are closed to capture the first leaflet.

[0047] In some implementations, the central body and a remaining one or more anchors are moved away from the first anchor.

[0048] In some implementations, the plurality of anchors are coupled to the central body with a plurality of tethers. In some examples, each tether can couple a corresponding anchor to the central body.

[0049] In some implementations, the remaining one or more anchors that are against the central body are opened. For example, an actuator can be used to open the remaining one or more anchors that are against the central body.

[0050] In some implementations, the remaining one or more anchors that are against the central body are simultaneously opened. For example, an actuator can be used to simultaneously open the remaining one or more anchors that are against the central body.

[0051] In some implementations, a second anchor of the plurality of anchors is positioned such that a second native heart valve leaflet is in the second anchor. For example, in some implementations, the device can be moved toward the second native heart valve leaflet such that the open second anchor receives the second native heart valve leaflet.

[0052] In some implementations, the plurality of anchors that are against the central body are closed to capture the second leaflet. For example, an actuator can be used to close the plurality of anchors that are against the central body, including the second anchor.

[0053] In some implementations, the plurality of anchors that are against the central body are simultaneously closed to capture the second leaflet. For example, an actuator can be used to simultaneously close the plurality of anchors that are against the central body, including the second anchor.

[0054] The present disclosure further includes a vale repair device (e.g. , a heart valve repair device for use in the heart of a real and / or simulated subject). In some implementations a valve repair device includes a central body, a plurality of anchors, and a plurality of tethers attached to the plurality of anchors.

[0055] In some implementations, each anchor can be coupled to the central body via a corresponding tether. In some implementations, each anchor can be coupled to the central body via one or more tethers.

[0056] In some implementations, the plurality of tethers are configured to pull the plurality of anchors toward the central body.

[0057] In some implementations, a connection between each tether and each anchor allows the plurality of anchors to tilt as the anchors are pulled toward the central body. For instance, the connection between a tether and its corresponding anchor can allow the anchor to assume a tilted position relative to the central body while the anchor is pulled toward the central body.

[0058] In some implementations, the plurality of anchors and the central body are configured to move the anchors from the tilted position relative to the central body to a more upright position relative to the central body. For example, when an anchor is sufficiently close to the central body, the anchor can interact with the central body to move from the tilted position tothe more upright position. An anchor can be sufficiently close to the central body if at least a portion of the anchor is able to interact with at least a portion of the central body.

[0059] In some implementations, the central body includes a central post and a retaining wall.

[0060] In some implementations, the retaining wall and the central post are configured to pivot the anchors to a more upright or vertical position. For example, when an anchor is sufficiently close to the central body, the retaining wall can interact with the anchor to cause the anchor to pivot to the more upright position.

[0061] hi some implementations, the anchors and the central body are configured such that pulling the anchors against the central body pivots the anchors to the more upright position. For example, when an anchor is sufficiently close to the central body, the central body can interact with the anchor to cause the anchor to pivot to the more upright position.

[0062] In some implementations, each of the plurality of anchors includes a tilting flange. For example, the tilting flange can interact with a portion of the central body to cause the anchor to tilt.

[0063] In some implementations, the central body includes a bottom wall.

[0064] In some implementations, the tilting flange of an anchor can engage the bottom wall to move the anchor to the more upright position. For example, when an anchor is sufficiently close to the central body, the bottom wall can interact with the anchor to cause the anchor to move to the more upright position.

[0065] In some implementations, rotation of the central body relative to the anchors moves the anchors to the more upright position.

[0066] In some implementations, the central body includes a plurality of petals configured to engage the plurality of anchors upon rotation of the central body relative to the plurality of anchors.

[0067] In some implementations, the plurality of tethers are configured to pull the plurality of anchors toward the central body and to allow the plurality of anchors to be spaced apart fromthe central body. For example, slack in a tether can allow a corresponding anchor to be spaced apart from the central body.

[0068] In some implementations, the plurality of tethers are configured to pull the plurality of anchors against the central body, such that at least a portion of an anchor of the plurality of anchors abutted against the central body.

[0069] This disclosure further provides for a valve repair system. In some implementations, a valve repair system includes a valve repair device and a delivery system.

[0070] In some implementations, the delivery system can include one or more catheters and a control handle.

[0071] In some implementations, the valve repair device includes a central body, a plurality of anchors, and a plurality of tethers attached to the plurality of anchors. In some implementations, the plurality of anchors can be attached to the central body via the plurality of tethers.

[0072] In some implementations, each anchor can be coupled to the central body via a corresponding tether. In some implementations, each anchor can be coupled to the central body via one or more tethers.

[0073] In some implementations, the plurality of tethers are configured to pull the plurality of anchors toward the central body.

[0074] In some implementations, a connection between a tether and a corresponding anchor allows the plurality of anchors to tilt as the anchors are pulled toward the central body. For instance, the connection between a tether and its corresponding anchor can allow the anchor to assume a tilted position relative to the central body while the anchor is pulled toward the central body.

[0075] In some implementations, the plurality of anchors and the central body are configured to move the anchors from the tilted position relative to the central body to a more upright position relative to the central body. For example, when an anchor is sufficiently close to the central body, the anchor can interact with the central body to move from the tilted position tothe more upright position. An anchor can be sufficiently close to the central body if at least a portion of the anchor is able to interact with at least a portion of the central body.

[0076] This disclosure provides methods for repairing a heart valve (e.g., a heart valve in a real or simulated subject). In some implementations the method for repairing a heart valve includes attaching an anchor is to a leaflet of the native heart valve.

[0077] In some implementations, the anchor is pulled toward a central body in a tilted orientation. For example, the anchor can be attached to the central body via a tether. In some implementations, the anchor can be pulled toward the central body via the tether.

[0078] hi some implementations, the anchor is engaged with the central body to move the anchor from the tilted position relative to the central body to a more upright position relative to the central body.

[0079] hi some implementations, the central body is rotated relative to the anchor to move the anchor to the more upright position.

[0080] Implementations of this disclosure provide a valve repair device (e.g. , a heart valve repair device for repairing a valve in a heart of a real or simulated subject). In some implementations, a valve repair device includes a central body, a plurality of spools disposed in the central body, a plurality of anchors, and a plurality of tethers.

[0081] hi some implementations, the plurality of tethers are attached to the plurality of anchors. For example, a tether can be attached to a corresponding anchor.

[0082] In some implementations, the plurality of tethers are wound around the plurality of spools. For example, a tether can attach the corresponding anchor to a corresponding spool.

[0083] In some implementations, rotation of the plurality of spools in a first direction pulls the plurality of tethers to pull the plurality of anchors toward the central body.

[0084] In some implementations, rotation of the plurality of spools in a second direction slackens the tethers to allow the plurality of anchors to be spaced apart from the central body.

[0085] In some implementations, the device includes a plurality of springs bias the plurality of anchors away from the central body.

[0086] In some implementations, the tethers are configured to allow the anchors to tilt as the anchors are pulled toward the central body.

[0087] In some implementations, each tether is connected to a closed end of each anchor.

[0088] Implementations of the present disclosure provide a valve repair system (e.g. , a heart valve repair system for repairing a valve in a heart of a real or simulated subject). In some implementations, the valve repair system includes a valve repair device and a delivery system.

[0089] In some implementations, the delivery system can include one or more catheters and a control handle.

[0090] In some implementations, the valve repair device includes a central body, a plurality of spools disposed in the central body, a plurality of anchors, and a plurality of tethers.

[0091] In some implementations, the plurality of tethers are attached to the plurality of anchors. For example, a tether can be attached to a corresponding anchor.

[0092] In some implementations, the plurality of tethers are wound around the plurality of spools. For example, a tether can attach the corresponding anchor to a corresponding spool.

[0093] In some implementations, a valve repair device includes a center clip and a plurality of anchors. The center clip is configured to capture the plurality of anchors after the plurality of anchors have been attached to leaflets of a native heart valve. For example, the center clip can be configured to maintain the plurality of anchors in a closed position after the plurality of anchors have been attached to leaflets of a native heart valve.

[0094] hi some implementations, a plurality of tethers are attached to the plurality of anchors. For example, a tether can be attached to a corresponding anchor. In some implementations, the corresponding anchor can be attached to the center clip via the tether.

[0095] In some implementations, the plurality of tethers are configured to pull the plurality of anchors toward the center clip.

[0096] In some implementations, tethers are configured to allow the anchors to tilt as the anchors are pulled toward the center clip.

[0097] In some implementations each tether is connected to a closed end of each anchor.

[0098] In some implementations, a valve repair system (e.g., a valve repair system for repairing a heart of a real or simulated subject) includes a valve repair device and a delivery system.

[0099] In some implementations, the delivery system can include one or more catheters and a control handle.

[0100] In some implementations, the valve repair device includes a center clip and a plurality of anchors.

[0101] In some implementations, the center clip is configured to capture the plurality of anchors after the plurality of anchors have been attached to leaflets of a native heart valve. For example, the center clip can be configured to maintain the plurality of anchors in a closed position after the plurality of anchors have been attached to leaflets of a native heart valve.

[0102] In some implementations, this disclosure provides a method of repairing a valve (e.g., a native heart valve of a real or simulated subject. In some implementations, the method includes attaching a plurality of anchors to a plurality of leaflets of the native heart valve.

[0103] In some implementations, the plurality of anchors are captured with a center clip after the plurality of anchors have been attached to leaflets of the native heart valve. For example, the center clip can be configured to maintain the plurality of anchors in a closed position after the plurality of anchors have been attached to leaflets of a native heart valve.

[0104] In some implementations, a valve repair device (e.g., a valve repair device for repairing a heart of a real or simulated subject) includes a central body and a plurality of anchors.

[0105] In some implementations, the central body has a plurality of expandable strips.

[0106] In some implementations, the valve repair device includes a plurality of anchors attached to the plurality of expandable strips. For example, an anchor can be attached to a corresponding expandable strip. In some implementations, the plurality of anchors are attached directly to the plurality of expandable strips.

[0107] In some implementations, the expandable strips are configured to move the plurality of anchors inward and outward.

[0108] In some implementations, each anchor comprises a paddle and a gripping member attached to the paddle.

[0109] In some implementations, the paddle comprises a fixed arm and a movable arm.

[0110] In some implementations, the fixed arm of each paddle is fixed to one of the expandable strips.

[0111] In some implementations, the gripping member is attached to the movable arm of the paddle.

[0112] In some implementations, a valve repair system (e.g., a valve repair system for repairing a heart of a real or simulated subject) includes a valve repair device and a delivery system.

[0113] In some implementations, the delivery system can include one or more catheters and a control handle.

[0114] In some implementations, the valve repair device includes a central body and a plurality of anchors.

[0115] In some implementations, the central body has a plurality of expandable strips.

[0116] In some implementations, the plurality of anchors are attached to the plurality of expandable strips. For example, an anchor can be attached to a corresponding expandable strip. In some implementations, the plurality of anchors are attached directly to the plurality of expandable strips.

[0117] In some implementations, the expandable strips are configured to move the plurality of anchors inward and outward.

[0118] In some implementations, a valve repair device e.g., a valve repair device for repairing a heart of a real or simulated subject) includes a central body and a plurality of anchors.

[0119] In some implementations, each anchor comprises a paddle and a gripping member.

[0120] In some implementations, the paddles are connected to the central body.

[0121] In some implementations, the gripping members are configured to move toward and away from the central body while the paddles are connected to the central body and the gripping members are coupled to the paddles.

[0122] In some implementations, the gripping members are movable toward and away from the central body by tilting the paddles toward and away from the central body.

[0123] In some implementations, the paddles are tilted by pulling a portion of the paddles into (e.g., toward) the central body.

[0124] In some implementations, the gripping members are movable toward and away from the central body by sliding the gripping members along the paddles.

[0125] In some implementations, the plurality of anchors comprises three paddles and three gripping members.

[0126] In some implementations, a valve repair system (e.g., a valve repair system for repairing a heart of a real or simulated subject) includes a valve repair device and a delivery system.

[0127] In some implementations, the delivery system can include one or more catheters and a control handle.

[0128] In some implementations, the valve repair device includes a central body and a plurality of anchors.

[0129] In some implementations, each anchor comprises a paddle and a gripping member.

[0130] In some implementations, the paddles are connected to the central body.

[0131] In some implementations, the gripping members are configured to move toward and away from the central body while the paddles are connected to the central body and the gripping members are coupled to the paddles.

[0132] In some implementations, a valve repair device e.g., a valve repair device for repairing a heart of a real or simulated subject) includes a first anchor, a second anchor, and a coupling member attached to the first anchor and the second anchor.

[0133] In some implementations, the coupling member is configured to allow the first anchor to move relatively away from the second anchor during diastole.

[0134] In some implementations, the coupling member is configured to pull the first anchor relatively toward the second anchor during systole.

[0135] In some implementations, the coupling member comprises one or more of an elastic material and a spring.

[0136] In some implementations, a valve repair system includes e.g. , a valve repair system for repairing a heart of a real or simulated subject) a valve repair device and a delivery system.

[0137] In some implementations, the delivery system can include one or more catheters and a control handle.

[0138] In some implementations, the valve repair device includes a first anchor, a second anchor, and a coupling member attached to the first anchor and the second anchor.

[0139] In some implementations, the coupling member is configured to allow the first anchor to move relatively away from the second anchor during diastole.

[0140] In some implementations, the coupling member is configured to pull the first anchor relatively toward the second anchor during systole.

[0141] In some implementations, a valve repair device (e.g., a valve repair device to be used for repairing a heart of a real or simulated subject) is disclosed. In some implementations, the valve repair device includes a central body. The central body can include a bore.

[0142] In some implementations, the valve repair device includes an actuation element (e.g., a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.). In some implementations, the actuation element includes a worm gear attached to the actuation element, e.g., attached to a distal end of the actuation element.

[0143] In some implementations, the valve repair device includes a plurality of anchors. In some implementations, each anchor includes a paddle.

[0144] In some implementations, the paddle can include a first arm that is hingeably attached to a second arm by a hinge portion. In some implementations the hinge portion comprises an actuation gear. In some implementations, the first arm, second arm, and hinge portion can comprise a gripping member of the paddle.

[0145] In some implementations, the worm gear is attached to a distal end of the actuation element such that it extends from a bore of the central body. The worm gear can engage one or more actuation gears of one or more anchors that are engaged with the central body.

[0146] In some implementations, rotating the actuation element and the worm gear in a first direction causes the second arm of the paddle to move and / or pivot in an opening direction via the actuation gear. Moving and / or pivoting the second arm of the paddle in the opening direction can move the anchor, paddle, and / or second arm toward an open condition. In some implementations, the opening direction can be a counterclockwise direction.

[0147] In some implementations, rotating the actuation element and the worm gear in a second direction causes the second arm of the paddle to move in a closing direction via the actuation gear. Moving and / or pivoting the second arm of the paddle in the closing direction can move the anchor, paddle, and / or second arm toward a closed condition. In some implementations, the closing direction can be a clockwise direction.

[0148] In some implementations, the valve repair device includes a plurality of tethers attached to the plurality of anchors. In some implementations, one or more tethers can be associated with a corresponding anchor.

[0149] In some implementations, the plurality of tethers are configured to pull the plurality of anchors against the central body. In some implementations, the plurality of tethers are further configured to allow the plurality of anchors to be spaced apart from the central body, e.g., when there is slack in the tethers.

[0150] In some implementations, the paddles or the gripping members of the valve repair device include a locking mechanism that prohibits rotation of the second arm of the paddles when the locking mechanism is in a locked condition.

[0151] In some implementations, the paddles or the gripping members of the valve repair device include a biasing member arranged between the first arm and the second arm. The biasing member can be configured to bias the second arm in the closing direction, e.g., toward a closed condition.

[0152] In some implementations, a valve repair device (e.g., a valve repair device to be used for repairing a heart of a real or simulated subject) is disclosed. In some implementations, the valve repair device includes a central body and a plurality of anchors.

[0153] In some implementations, each of the anchors includes a gripping member having a first arm, a second arm, and a hinge portion that hingeably connects the first arm to the second arm.

[0154] In some implementations, the valve repair device includes a pivot arm. In some implementations, the anchor includes the pivot arm. The pivot arm can extend away from the central body and pass through a portion of the second arm and back to the central body.

[0155] In some implementations, the second arm can include a hinge barrel that the pivot arm passes through. In some implementations, the second arm can include an opening on an outer surface of the gripping member that the pivot arm passes through.

[0156] In some implementations, the valve repair device includes an actuation element that can extend through a bore of the central body. In some implementations, the actuation element can include one or more of a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.

[0157] In some implementations, the actuation element can include an actuation arm connected to the gripping member. In some implementations, the actuation arm can be connected to the first arm. In some implementations, the actuation arm can be connected to the hinge portion.

[0158] In some implementations, movement of the actuation element in a proximal direction causes the second arm to pivot in an opening direction. Moving and / or pivoting the second arm of the gripping member in the opening direction can move the anchor, gripping member, and / or second arm toward an open condition. In some implementations, the opening direction can be a counterclockwise direction.

[0159] In some implementations, movement of the actuation element in a distal direction causes the second arm to pivot in a closing direction. Moving and / or pivoting the second arm of the gripping member in the closing direction can move the anchor, gripping member, and / or second arm toward a closed condition. In some implementations, the closing direction can be a clockwise direction.

[0160] In some implementations, the valve repair device includes a plurality of paddles. In such implementations, the pivot arm can extend from a paddle of the plurality of paddles, through the second arm, and back to the one of the plurality of paddles. In some implementations, the second arm can include a hinge barrel that the pivot arm passes through. In some implementations, the second arm can include an opening on an outer surface of the gripping member that the pivot arm passes through.

[0161] In some implementations, when the gripping member is in a closed condition, further movement of the actuation element in the distal direction applies additional force in the closing direction via the second arm of the gripping member.

[0162] In some implementations, the second arm of the gripping member can be biased in the closing direction, e.g., toward a closed condition. In some implementations, the second arm of the gripping member can be biased in the closing direction, e.g., toward a closed condition by the hinge portion of the gripping member.

[0163] In some implementations, at least a portion of the gripping member can be formed from a shape-set alloy. For instance, one or more of the first arm, the second arm, or the hinged portion can be formed from the shape-set alloy. In some implementations, the shape-set alloy is shape-set in the closed condition.

[0164] In some implementations, the gripping member comprises one or more friction enhancing elements, including, but not limited to barbs, roughened and / or textured surface, an adhesive surface, disposed on the first arm.

[0165] In some implementations, the valve repair device includes a plurality of tethers attached to the plurality of anchors. In some implementations, one or more tethers can be associated with a corresponding anchor.

[0166] In some implementations, the plurality of tethers are configured to pull the plurality of anchors against the central body. In some implementations, the plurality of tethers are further configured to allow the plurality of anchors to be spaced apart from the central body, e.g., when there is slack in the tethers.

[0167] In some implementations, a valve repair device (e.g., a valve repair device to be used for repairing a heart of a real or simulated subject) is disclosed. In some implementations, the valve repair device includes a central body and a plurality of anchors.

[0168] In some implementations, an anchor of the plurality of anchors includes a gripping member. The gripping member can have a first arm, a second arm, and a hinge portion that hingeably connects the first arm to the second arm. In some implementations, each anchor includes a gripping member.

[0169] In some implementations, the valve repair device includes an actuation element. In some implementations, the actuation element extends through a bore of the central body. In some implementations, the actuation element can include one or more of a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.

[0170] In some implementations, the actuation element includes an actuation arm. In some implementations, the actuation arm can be connected to the second arm via a tether connected to an end portion of the actuation arm. In some implementations, the tether can comprise one or more of a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.

[0171] In some implementations, movement of the actuation element in a distal direction causes tension in the tether to cause the second arm to pivot in an opening direction. Movingand / or pivoting the second arm of the gripping member in the opening direction can move the anchor, gripping member, and / or second arm toward an open condition. In some implementations, the opening direction can be a counterclockwise direction.

[0172] In some implementations, movement of the actuation element in a proximal direction causes the end of the actuation arm to engage the second arm to pivot the second arm in a closing direction. Moving and / or pivoting the second arm of the gripping member in the closing direction can move the anchor, gripping member, and / or second arm toward a closed condition. In some implementations, the closing direction can be a clockwise direction.

[0173] In some implementations, while the anchor and / or gripping member is in a closed condition, further movement of the actuation element in the proximal direction applies additional force in the closing direction via engagement of the end of the actuation arm and the second arm of the gripping member.

[0174] In some implementations, the actuation arm biases the gripping member in the closing direction, e.g., toward the closed condition.

[0175] In some implementations, the actuation arm can include a spring portion that biases the end of the actuation arm in the closing direction, e.g., biases the gripping member toward a closed condition.

[0176] In some implementations, the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition.

[0177] In some implementations, the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition, by the hinge portion.

[0178] In some implementations, at least a portion of the gripping member can be formed from a shape-set alloy. For instance, one or more of the first arm, the second arm, or the hinged portion can be formed from the shape-set alloy. In some implementations, the shape-set alloy is shape-set in the closed condition.

[0179] In some implementations, the gripping member comprises one or more friction enhancing elements, including, but not limited to barbs, roughened and / or textured surface, an adhesive surface, disposed on the first arm.

[0180] In some implementations, the valve repair device includes a plurality of tethers attached to the plurality of anchors. In some implementations, one or more tethers can be associated with a corresponding anchor.

[0181] In some implementations, the plurality of tethers are configured to pull the plurality of anchors against the central body. In some implementations, the plurality of tethers are further configured to allow the plurality of anchors to be spaced apart from the central body, e.g., when there is slack in the tethers.

[0182] In some implementations, a valve repair device (e.g., a valve repair device to be used for repairing a heart of a real or simulated subject) is disclosed. In some implementations, the valve repair device includes a central body and a plurality of anchors.

[0183] In some implementations, an anchor of the plurality of anchors includes a gripping member having a first arm, a second arm, and a hinge portion that hingeably connects the first arm to the second arm. In some implementations, each anchor includes a gripping member.

[0184] In some implementations, the valve repair device includes an actuation element. In some implementations, the actuation element can include one or more of a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.

[0185] In some implementations, the actuation element extends through a bore of the central body and out of an opening disposed distally of the hinge portion and to the gripping member, e.g., the second arm.

[0186] In some implementations, retracting the actuation element applies tension to the actuation element to cause the second arm to pivot in an opening direction. In some implementations, the actuation element can be retracted in a retraction direction. Moving and / or pivoting the second arm in the opening direction can move the anchor, gripping member,and / or second arm toward an open condition. In some implementations, the opening direction can be a counterclockwise direction.

[0187] In some implementations, extending the actuation element releases tension on the actuation element to allow the second arm to pivot in the closing direction. In some implementations, the actuation element can be extended in an extending direction. Moving and / or pivoting the second arm of the gripping member in the closing direction can move the anchor, gripping member, and / or second arm toward a closed condition. In some implementations, the closing direction can be a clockwise direction.

[0188] In some implementations, the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition.

[0189] In some implementations, the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition, by the hinge portion.

[0190] In some implementations, at least a portion of the gripping member can be formed from a shape-set alloy. For instance, one or more of the first arm, the second arm, or the hinged portion can be formed from the shape-set alloy. In some implementations, the shape-set alloy is shape-set in the closed condition.

[0191] In some implementations, the gripping member comprises one or more friction enhancing elements, including, but not limited to barbs, roughened and / or textured surface, an adhesive surface, disposed on the first arm.

[0192] In some implementations, the valve repair device includes a plurality of tethers attached to the plurality of anchors. In some implementations, one or more tethers can be associated with a corresponding anchor.

[0193] In some implementations, the plurality of tethers are configured to pull the plurality of anchors against the central body. In some implementations, the plurality of tethers are further configured to allow the plurality of anchors to be spaced apart from the central body, e.g., when there is slack in the tethers.

[0194] In some implementations, the actuation element comprises one or more tethers of the plurality of tethers.

[0195] In some implementations, tension is not applied to the second arm of the gripping member unless the anchor is pulled against the central body by the tethers. In some implementations, tension via the one or more tethers can be applied to the gripping member while the anchor is pulled against the central body.

[0196] In some implementations, the actuation element and the one or more tethers are formed from a single suture.

[0197] In some implementations, the actuation element comprises one or more tethers of the plurality of tethers, and when the anchor is spaced apart from the central body by the one or more tethers, the second arm remains in a closed condition while the actuation element is retracted.

[0198] In some implementations, a valve repair device (e.g., a valve repair device to be used for repairing a heart of a real or simulated subject) is disclosed. In some implementations, the valve repair device includes a central body and a plurality of anchors.

[0199] In some implementations, an anchor of the plurality of anchors includes a gripping member. In some implementations, each of the anchors of the plurality of anchors includes a corresponding gripping member. In some implementations, the gripping member includes a first arm, a second arm, and a hinge portion that hingeably connects the first arm to the second arm.

[0200] In some implementations, the valve repair device includes a routing member. In some implementations, the routing member can comprise one or more of a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.

[0201] In some implementations, the routing member extends distally beyond the hinge portion. In some implementations, the routing member can be retracted to a retracted position that is proximal of the hinge portion.

[0202] In some implementations, the valve repair device include an actuation element that extends through a bore of the central body, around the routing member, and to the second arm of the gripping member.

[0203] In some implementations, retracting the actuation element applies tension to the actuation element to cause the second arm to pivot in an opening direction. In some implementations, the actuation element can be retracted in a retraction direction. Moving and / or pivoting the second arm in the opening direction can move the anchor, gripping member, and / or second arm toward an open condition. In some implementations, the opening direction can be a counterclockwise direction.

[0204] In some implementations, when the routing member is retracted to the retracted position, further retraction of the actuation element in the retraction direction applies tension to the actuation element to cause the second arm to pivot in the closing direction. Moving and / or pivoting the second arm in the closing direction can move the anchor, gripping member, and / or second arm toward a closed condition. In some implementations, the closing direction can be a clockwise direction.

[0205] In some implementations, extending the actuation element releases tension on the actuation element to allow the second arm to pivot in the closing direction. In some implementations, the actuation element can be extended in an extended direction.

[0206] In some implementations, the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition.

[0207] In some implementations, the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition, by the hinge portion.

[0208] In some implementations, at least a portion of the gripping member can be formed from a shape-set alloy. For instance, one or more of the first arm, the second arm, or the hinged portion can be formed from the shape-set alloy. In some implementations, the shape-set alloy is shape-set in the closed condition.

[0209] In some implementations, the gripping member comprises one or more friction enhancing elements, including, but not limited to barbs, roughened and / or textured surface, an adhesive surface, disposed on the first arm.

[0210] In some implementations, the valve repair device includes a plurality of tethers attached to the plurality of anchors. In some implementations, one or more tethers can be associated with a corresponding anchor.

[0211] In some implementations, the plurality of tethers are configured to pull the plurality of anchors against the central body. In some implementations, the plurality of tethers are further configured to allow the plurality of anchors to be spaced apart from the central body, e.g., when there is slack in the tethers.

[0212] In some implementations, a valve repair device (e.g., a valve repair device to be used for repairing a heart of a real or simulated subject) is disclosed. In some implementations, the valve repair device includes a central body and a plurality of anchors.

[0213] In some implementations, an anchor of the anchors plurality of anchors includes a gripping member. In some implementations, each anchor of the plurality of anchors includes a corresponding gripping member.

[0214] In some implementations, the griping member includes a first arm, a second arm, and a hinge portion that hingeably connects the first arm to the second arm.

[0215] In some implementations, the first arm includes a catch member arranged on the first arm.

[0216] In some implementations, the second arm includes a flexible portion. The flexible portion can include a head having a barbed end. In some implementations, the catch member of the first arm can be engaged by the barbed end of the head attached to the flexible portion of the second arm.

[0217] In some implementations, the valve repair device includes an actuation element. In some implementations, the actuation element can include one or more of a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.

[0218] In some implementations, the actuation element extends through a bore of the central body, around the hinge portion, and to the head of the second arm of the gripping member.

[0219] In some implementations, retracting the actuation element applies tension to the actuation element which causes the head of the second arm to pivot to disengage the barbed end from the catch member. In some implementations, the actuation element is retracted in a retraction direction.

[0220] In some implementations, further retraction of the actuation element (e.g., further retraction of the actuation once the barbed end is disengaged from the catch member) causes the second arm to pivot in an opening direction. Moving and / or pivoting the second arm in the opening direction can move the anchor, gripping member, and / or second arm toward an open condition. In some implementations, the opening direction can be a counterclockwise direction.

[0221] In some implementations, the second arm comprises a U-shaped end. In some implementations, the flexible portion of the second arm is arranged in a gap of the U-shaped end of the second arm.

[0222] In some implementations, the flexible portion of the second arm contacts the U- shaped end of the actuation arm before the second arm moves in the opening direction because of the retraction of the actuation element. That is, responsive to retraction of the actuation element, the flexible portion of the second arm can contact the U-shaped end of the second arm before the second arm moves toward the opening condition.

[0223] In some implementations, the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition.

[0224] In some implementations, the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition, by the hinge portion.

[0225] In some implementations, at least a portion of the gripping member can be formed from a shape-set alloy. For instance, one or more of the first arm, the second arm, or the hinged portion can be formed from the shape-set alloy. In some implementations, the shape-set alloy is shape-set in the closed condition.

[0226] In some implementations, the gripping member comprises one or more friction enhancing elements, including, but not limited to barbs, roughened and / or textured surface, an adhesive surface, disposed on the first arm.

[0227] In some implementations, the valve repair device includes a plurality of tethers attached to the plurality of anchors. In some implementations, one or more tethers can be associated with a corresponding anchor.

[0228] In some implementations, the plurality of tethers are configured to pull the plurality of anchors against the central body. In some implementations, the plurality of tethers are further configured to allow the plurality of anchors to be spaced apart from the central body, e.g., when there is slack in the tethers.

[0229] In some implementations a valve repair device (e.g., a valve repair device to be used for repairing a heart of a real or simulated subject) is disclosed. In some implementations, the valve repair device includes a central body and a plurality of anchors.

[0230] In some implementations, an anchor of the plurality of anchors includes a gripping member. In some implementations, each of the anchors includes a gripping member.

[0231] In some implementations, the gripping member includes a first arm, a second arm, and a hinge portion that hingeably connects the first arm to the second arm.

[0232] In some implementations, the second arm includes an extension portion extending from the second arm. The extension portion can include a rod, shaft, barb, dart, protrusion, etc.In some implementations, the extension portion can be biased in an extending direction, e.g., extending away from the second arm.

[0233] In some implementations, the extension portion can include a folding barbed portion extending from the second arm. The folding barbed portion can be biased in an extending direction, e.g., extending away from the second arm.

[0234] In some implementations, the valve repair device includes an actuation element. In some implementations, the actuation element can include one or more of a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.

[0235] In some implementation, the actuation element extends through a bore of the central body, around the hinge portion, through an opening in the second arm, and to the extension portion and / or the folding barbed portion.

[0236] In some implementations, retracting the actuation element applies tension to the actuation element to cause the extending portion and / or folding barbed portion to move toward the second arm.

[0237] In some implementations, further retraction of the actuation element after the folding barbed portion is folded against the second arm causes the second arm to pivot in an opening direction. Moving and / or pivoting the second arm in the opening direction can move the anchor, gripping member, and / or second arm toward an open condition. In some implementations, the opening direction can be a counterclockwise direction.

[0238] In some implementations the extension portion and / or folding barbed portion is integrally formed with the second arm.

[0239] In some implementations the extension portion and / or folding barbed portion can comprise and / or be formed from a shape-setting alloy and is shape-set in an extended condition.

[0240] In some implementations, the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition.

[0241] In some implementations, the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition, by the hinge portion.

[0242] In some implementations, at least a portion of the gripping member can be formed from a shape-set alloy. For instance, one or more of the first arm, the second arm, or the hinged portion can be formed from the shape-set alloy. In some implementations, the shape-set alloy is shape-set in the closed condition.

[0243] In some implementations, the gripping member comprises one or more friction enhancing elements, including, but not limited to barbs, roughened and / or textured surface, an adhesive surface, disposed on the first arm.

[0244] In some implementations, the valve repair device includes a plurality of tethers attached to the plurality of anchors. In some implementations, one or more tethers can be associated with a corresponding anchor.

[0245] In some implementations, the plurality of tethers are configured to pull the plurality of anchors against the central body. In some implementations, the plurality of tethers are further configured to allow the plurality of anchors to be spaced apart from the central body, e.g., when there is slack in the tethers.

[0246] In some implementations, a valve repair device has a central body. In some implementations a valve repair device has a central body and a plurality of anchors.

[0247] In some implementations, an anchor of the plurality of anchors has a mounting plate. In some implementations, each anchor of the plurality of anchors has a mounting plate and a paddle. The mounting plate can include a first alignment feature for engaging a corresponding second alignment feature of the central body. The paddle can be attached to the mounting plate.

[0248] In some implementations, each of the anchors can be individually released from the central body and re-engaged with the central body.

[0249] In some implementations, the first alignment feature engages the second alignment feature of the central body to align the anchor in a desired position relative to the central body.

[0250] In some implementations, the first alignment feature is a protrusion and the second alignment feature is an opening.

[0251] In some implementations, the first alignment feature is an opening and the second alignment feature is a protrusion.

[0252] In some implementations, the first alignment feature is a rectangular protrusion and the second alignment feature is a rectangular opening.

[0253] In some implementations, the first alignment feature is a rectangular opening and the second alignment feature is a rectangular protrusion.

[0254] In some implementations, the first alignment feature is a cross-shaped protrusion and the second alignment feature is a cross-shaped receptacle.

[0255] In some implementations, the first alignment feature is a cross-shaped receptacle and the second alignment feature is a cross-shaped protrusion.

[0256] In some implementations, the first alignment feature is at least a portion of a cylinder and the second alignment feature is a rounded groove in the central body.

[0257] In some implementations, the first alignment feature is a locking eyelet extending from the mounting plate and the second alignment feature is an opening in the central body for receiving the locking eyelet.

[0258] In some implementations, the valve repair device includes one or more tethers extending from the central body to the mounting plate of an anchor of the plurality of anchors. In some implementations, each of the anchors of the plurality of anchors are coupled to the central body via one or more tethers.

[0259] In some implementations, releasing tension on a tether of the one or more tethers allows the anchor of the plurality of anchors to move away from the central body. In some implementations, applying tension to the tether of the one or more tethers pulls the anchor into engagement with the central body.

[0260] In some implementations, the central body includes a central bore. In such implementations, one or more tethers can extend through the central bore and out of an opening in the central body. In some implementations, the opening in the central body is arranged proximal of the second alignment feature.

[0261] In some implementations, the central body includes a central bore. In such implementations, one or more tethers extend through the central bore and out of an opening in the central body that is arranged distal of the second alignment feature.

[0262] In some implementations, the central body includes a central bore. In such implementations, one or more tethers extend through the central bore and out of an opening in the central body. In some implementations, the opening is arranged to one side of the second alignment feature.

[0263] In some implementations, the central body includes a central bore. In such implementations, one or more tethers extend through the central bore and out of openings in the central body. In some implementations, the openings are arranged on two sides of the second alignment feature.

[0264] In some implementations, the valve repair device also includes a locking member that can be compressed against a locking surface of the central body to lock the position of one or more tethers extending between the locking member and the locking surface.

[0265] In some implementations, the locking member and the locking surface have a tapered shape.

[0266] In some implementations, the locking member and the locking surface have a frustoconical shape.

[0267] In some implementations, a single tether extends from the central body, through the mounting plate of the anchor of the plurality of anchors, and back into the central body. In some implementations, each anchor of the plurality of anchors has a single tether extending from the central body, through the mounting plate of the respective anchor, and back into the central body.

[0268] In some implementations, the paddles of the anchors can be independently opened by actuation elements engaging each of the paddles.

[0269] In some implementations, the anchor of the plurality of anchors further includes a gripping member. In some implementations, each of the plurality of anchors includes a respective gripping member. In some implementations, the gripping member has a first arm hingeably connected to a second arm by a hinge portion, wherein the first arm of the gripping member is attached to the mounting plate.

[0270] In some implementations, the anchor include a second mounting plate attached to the second arm of the gripping member. In some implementations, each of the plurality of anchors includes a respective second mounting plate attached to the second arm of the gripping member.

[0271] In some implementations, the second mounting plate includes a routing flange with an opening for the actuation element, e.g., to receive the actuation element. The actuation element extends through the opening in the routing flange so that retracting the actuation element in a proximal direction through the central body causes the gripping member to open.

[0272] In some implementations, the mounting plate includes a bore and an actuation element extends through the bore of the mounting plate to engage the paddle.

[0273] In some implementations, extending the actuation element in a distal direction causes the paddle to open and retracting the actuation element in a proximal direction causes the paddle to close.

[0274] In some implementations, extending the actuation element in a distal direction causes the paddle to close and retracting the actuation element in a proximal direction causes the paddle to open.

[0275] In some implementations, rotating the actuation element in a first direction causes the paddle to open and rotating the actuation element in a second direction causes the paddle to close.

[0276] In some implementations, the actuation element is a tube that extends through the bore of the mounting plate to engage a distal end of the paddle.

[0277] In some implementations, the distal end of the paddle has a proximally extending pin that is received by the actuation element. In some implementations, the actuation element is tube-shaped.

[0278] In some implementations, the actuation element threadably engages the distal end of the paddle.

[0279] In some implementations, the valve repair device also includes a locking pin extending through a central bore of the central body. In some implementations, a locking eyelet is attached to a mounting plate of the anchor. In some implementations, each mounting plate is attached to a corresponding locking eyelet. In such implementations, openings are provided in the central body for receiving the locking eyelets of the anchor and / or anchors.

[0280] In some implementations, the locking pin threadably engages with a threaded proximal opening of the central bore.

[0281] In some implementations, the locking eyelet of one anchor is offset from the locking eyelets of the other anchors so that the locking eyelets of all of the plurality of anchors can be moved into alignment with the locking pin.

[0282] In some implementations, the locking eyelets can be axially offset or staggered axially relative to each other. In some implementations, the locking eyelets are configured to align with a central longitudinal axis of the valve repair device when moved into alignment with the locking pin.

[0283] In some implementations, the valve repair device also includes a sheath extending along the actuation element to the paddle so that when the sheath is in an extended condition the sheath engages the bore of the mounting plate so that the anchor is engaged with the central body. When the sheath is retracted to a retracted condition, the anchor is able to move away from the central body. In some implementations, each paddle is associated with a corresponding sheath.

[0284] In some implementations, the actuation element is biased to move the anchor laterally away from the central body when the sheath is retracted to the retracted condition.

[0285] In some implementations, the anchors are moved to a distally staggered bailout position by extending the actuation element and sheath for each anchor to a different distance.

[0286] In some implementations, the valve repair device includes a gripping member attached to the paddle of each anchor.

[0287] In some implementations, the gripping member has a first arm, a second arm, a hinge portion hingeably attaching the first arm to the second arm, and a secondary actuation element connected to the second arm.

[0288] In some implementations, tension applied to the secondary actuation element opens the gripping member by moving the second arm away from the first arm.

[0289] In some implementations, a valve repair system includes a delivery system with one or more catheters and a control handle and any of the valve repair devices described herein.

[0290] In some implementations, the delivery system includes a positioning arm extending from a catheter of the delivery system to engage an anchor of the valve repair device.

[0291] In some implementations, the positioning arm comprises the actuation element of the valve repair device, e.g., the actuation element associated with the anchor of the valve repair device.

[0292] In some implementations, extending the positioning arm from the catheter allows the positioning arm to flex laterally to allow the anchor to move away from the central body.

[0293] In some implementations, the positioning arm is biased to flex laterally outward and away from the central body.

[0294] In some implementations, retracting the positioning arm into the catheter causes the positioning arm to straighten so that the anchor is moved into engagement with the central body.

[0295] In some implementations, a sheath is extended along the positioning arm to cause the positioning arm to straighten so that the anchor is moved into engagement with the central body.

[0296] In some implementations, the delivery system further includes a guide extending through the positioning arm to a distal cap.

[0297] In some implementations, the distal cap is connected to the central body of the valve repair device.

[0298] In some implementations, the distal cap includes a stop for engaging the anchors when the anchors are moved into engagement with the distal cap.

[0299] In some implementations, extending the positioning arm moves the anchor along the guide and into engagement with the distal cap.

[0300] In some implementations, applying a force to the positioning arm in the extending direction after the anchor has engaged the distal cap compresses the positioning arm.

[0301] In some implementations, compressing the positioning arm causes the positioning arm to straighten.

[0302] In some implementations, the positioning arm can comprise and / or be formed from a hypotube with a central lumen and a plurality of segments.

[0303] In some implementations, the plurality of segments of the hypotube are cut from a single tube.

[0304] In some implementations, each segment extends from a first end to a second end.

[0305] In some implementations, the first end and / or the second end include a plurality of retaining slots and a plurality of corresponding keyed retaining tabs.

[0306] In some implementations, the retaining slots are rotationally symmetric.

[0307] In some implementations, the retaining slots of the first end of a segment are rotationally offset from the retaining slots of the second end of the segment.

[0308] In some implementations, the plurality of retaining slots and plurality of corresponding keyed retaining tabs have a T-shape.

[0309] In some implementations, the plurality of retaining slots and plurality of corresponding keyed retaining tabs have an arrow shape.

[0310] In some implementations, compressing the hypotube causes slanted sides of the arrow-shaped keyed retaining tabs to engage slanted sides of the arrow-shaped retaining slots.

[0311] Any of the above method(s) can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, imaginary person, anthropomorphic ghost, simulator, such as a computer simulator, e.g., with the body parts, tissue, etc. being simulated). With a simulation, the body parts can optionally be referred to as “simulated’- (e.g., simulated heart, simulated tissue, etc.) and can comprise, for example, computerized and / or physical representations.

[0312] Any of the above systems, assemblies, devices, apparatuses, components, etc. can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of one or more systems, devices, apparatuses, components, etc. herein (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0313] A further understanding of the nature and advantages of the implementations are set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals. Other features and advantages will become apparent from the following detailed description and claims, particularly when considered with the accompanying drawings. The detailed description ofimplementations, as set out below to enable one to build and use the implementations, are not intended to limit the enumerated claims, but rather, they are intended to serve as examples of the claimed invention.BRIEF DESCRIPTION OF THE DRAWINGS

[0314] To further clarify various aspects of implementations of the present disclosure, a more particular description of the certain examples and implementations will be made by reference to various aspects of the appended drawings. These drawings depict only example implementations of the present disclosure and are therefore not to be considered limiting of the scope of the disclosure. Moreover, while the figures might be drawn to scale for some examples, the figures are not necessarily drawn to scale for all examples. Examples and other features and advantages of the present disclosure will be described and explained with additional specificity and through the use of the accompanying drawings in which:

[0315] FIG. 1 A shows a cutaway view of a heart with a device positioned to repair a mitral valve.

[0316] FIG. IB shows a cutaway view of a heart with the device shown in FIG. 1 A attached to leaflets of the mitral valve.

[0317] FIG. 2 illustrates a cutaway view of the human heart in a diastolic phase;

[0318] FIG. 3 illustrates a cutaway view of the human heart in a systolic phase;

[0319] FIG. 4 illustrates a cutaway view of the human heart in a systolic phase showing valvular regurgitation;

[0320] FIG. 5 is the cutaway view of FIG. 4 annotated to illustrate mitral valve leaflets in the systolic phase;

[0321] FIG. 6 illustrates a healthy mitral valve with the leaflets closed as viewed from an atrial side of the mitral valve;

[0322] FIG. 7 illustrates a dysfunctional mitral valve with a visible gap between the leaflets as viewed from an atrial side of the mitral valve;

[0323] FIG. 8 illustrates a tricuspid valve viewed from an atrial side of the tricuspid valve;

[0324] FIGS. 9 illustrates a cutaway view of a heart showing an implant catheter and treatment / repair device extended from within a steering catheter system and positioned within a mitral valve.

[0325] FIG. 10 illustrates details of the treatment / repair device illustrated in FIG. 9;

[0326] FIG. 10A illustrates the treatment / repair device of FIG. 10 with an implementation of a mechanism for opening and closing paddles of the device;

[0327] FIG. 10B illustrates an implementation of a mechanism for opening and closing paddles of the device of FIG. 10A;

[0328] FIGS. 10C and 10D illustrate an implementation of paddles that can be used in a device similar to the device of FIG. 10;

[0329] FIGS. 10E and 10F illustrate an implementation of a treatment / repair device that is similar to the treatment / repair device of FIG. 10;

[0330] FIG. 11 illustrates the implant catheter and treatment / repair device of FIG. 9, with a first leaflet anchor of the treatment / repair device located and oriented to clip on to a portion of a first leaflet.

[0331] FIG. 12 illustrates the implant catheter and treatment / repair device of FIG. 11 , with the first leaflet anchor clipped on to the first leaflet and released from a central body of the treatment / repair device, and with a second leaflet anchor of the treatment / repair device located and oriented to clip on to a portion of a second leaflet.

[0332] FIG. 13 illustrates the implant catheter and treatment / repair device of FIG. 12, with the first and second leaflet anchors clipped on to the respective first and second leaflets and released from the central body, and with the central body positioned at a central, coaptation location between the leaflets.

[0333] FIG. 14 illustrates the treatment / repair device of FIG. 13, with the anchors connected to, and locked into position with respect to, a central body, and with the implant catheter disconnected from the treatment / repair device and removed from the subject’s body.

[0334] FIG. 15 illustrates a view of an example 3 -anchor implementation of the treatment / repair device of FIG. 9, positioned within a tricuspid valve.

[0335] FIG. 16 illustrates the treatment / repair device of FIG. 1 , with a first leaflet anchor of the treatment / repair device located and oriented to clip on to a portion of a first leaflet.

[0336] FIG. 17 illustrates the treatment / repair device of FIG. 16, with the first leaflet anchor clipped on to the first leaflet and released from a central body of the treatment / repair device, and with a second leaflet anchor of the treatment / repair device located and oriented to clip on to a portion of a second leaflet.

[0337] FIG. 18 illustrates the treatment / repair device of FIG. 17, with the first and second leaflet anchors respectively clipped on to the first and second leaflets and released from the central body, and with a third leaflet anchor of the treatment / repair device located and oriented to clip on to a portion of a third leaflet.

[0338] FIG. 19 illustrates the treatment / repair device of FIG. 18, with the first, second and third leaflet anchors respectively clipped on to the first, second and third leaflets, and released from the central body, and with the central body positioned at a central, coaptation location between the leaflets.

[0339] FIG. 20 illustrates the treatment / repair device of FIG. 19, with the anchors moved into contact with the central body.

[0340] FIG. 21 illustrates an example expansion central body of the treatment / repair device of FIG. 20.

[0341] FIG. 22 is a schematic illustration of an example of a valve repair system.

[0342] FIG. 23 illustrates the valve repair system of FIG. 22 with paddles and clasps in an open condition.

[0343] FIG. 24 illustrates the valve repair system of FIG. 23 with a leaflet and an anchor tethered to a remainder of a valve repair device.

[0344] FIG. 25 illustrates the valve repair system of FIG. 24 with two leaflets and two anchors tethered to a remainder of the valve repair device.

[0345] FIG. 26 illustrates the valve repair system of FIG. 25 with the two anchors and attached leaflets pulled back to the remainder of the valve repair device by the tethers.

[0346] FIG. 27 illustrates the valve repair system of FIG. 26 where the delivery system has been separated from the device.

[0347] FIG. 28 illustrates a valve repair system with anchors connected to native valve leaflets and tethered to a central body.

[0348] FIG. 29 illustrates the valve repair system of FIG. 28 with the anchors pulled to the central body by tethers.

[0349] FIG. 30 illustrates the valve repair system of FIG. 29 with the anchors pulled downward into the central body to move the anchors to a more upright position.

[0350] FIG. 31 illustrates the valve repair system of FIG. 30 where the delivery system has been separated from the device.

[0351] FIG. 32 illustrates a valve repair system with anchors connected to native valve leaflets and tethered to a central body.

[0352] FIG. 33 illustrates the valve repair system of FIG. 32 with the anchors pulled toward the central body by tethers.

[0353] FIG. 34 illustrates the valve repair system of FIG. 33 with the anchors pulled against the central body to move the anchors to a more upright position.

[0354] FIG. 35 is a perspective view of a valve repair system.

[0355] FIGS. 36 and 37 are top views of a valve repair system.

[0356] FIGS. 38-42 are schematic illustrations of a valve repair system.

[0357] FIG. 43 is a perspective view of a delivery system for delivering anchors to native heart valve leaflets.

[0358] FIG. 44 is a side view of a portion of a valve repair system.

[0359] FIG. 45 is a perspective view of a portion of the valve repair system illustrated by FIG. 44.

[0360] FIG. 46 is the top view of the valve repair system illustrated by FIG. 44.

[0361] FIG. 47 is a side view of a valve repair system that is similar to the valve repair system illustrated by FIG. 44.

[0362] FIG. 48 is a side view of a valve repair system that is similar to the valve repair system illustrated by FIG. 44.

[0363] FIGS. 49-56 are cross-sectional views of a valve repair system.

[0364] FIG. 57 A is a perspective view of a valve repair device with an expandable central body.

[0365] FIG. 57 illustrates a perspective view of an expandable / expansion member in an expanded configuration;

[0366] FIG. 58 illustrates a perspective view of the expandable / expansion member of FIG. 57 in a collapsed configuration;

[0367] FIG. 59 illustrates an exploded perspective view of the expandable / expansion member and an example actuation mechanism for the expandable coaptation element;

[0368] FIG. 60 illustrates a sectional view of the expandable / expansion member and the actuation mechanism of FIG. 59;

[0369] FIG. 61 illustrates a sectional view of the expandable / expansion member and the actuation mechanism of FIG. 59;

[0370] FIG. 62 illustrates a perspective view of the expandable / expansion member and the actuation mechanism of FIG. 59;

[0371] FIG. 63 illustrates a front view of the expandable / expansion member and the actuation mechanism of FIG. 59;

[0372] FIG. 64 illustrates a front view of an example expandable / expansion member and an example actuation mechanism for an expandable coaptation element;

[0373] FIG. 65 illustrates an exploded view of the actuation mechanism of FIG. 64;

[0374] FIG. 66 illustrates a sectional view of the expandable / expansion member and the actuation mechanism of FIG. 64;

[0375] FIG. 67 illustrates a sectional view of the expandable / expansion member and the actuation mechanism of FIG. 64;

[0376] FIG. 68 illustrates a perspective view of the sectioned expandable / expansion member and the actuation mechanism of FIG. 67 ;

[0377] FIG. 69 illustrates an example expandable / expansion member and an example actuation mechanism for an expandable coaptation element;

[0378] FIGS. 70-72 are schematic illustrations of a valve repair system.

[0379] FIGS. 73 and 74A-74E are schematic illustrations of a valve repair system.

[0380] FIGS. 75A-75D illustrate a consecutively inserted, center-coupled implementation of a treatment / repair system.

[0381] FIG. 76 is a cutaway view of a central body of the consecutively inserted, center- coupled implementation of a treatment / repair system of FIGS. 25A-75D, being connected to an implant catheter and tethered anchors.

[0382] FIG. 77 is a cutaway view of an example central body, including a spacer.

[0383] FIG. 78 is a cutaway view of an example central body.

[0384] FIG. 79 illustrates an example end-coupled implementation of a treatment / repair system.

[0385] FIG. 80 illustrates an example end-coupled implementation of a treatment / repair system.

[0386] FIGS. 80A and 80B illustrate an implementation of the treatment / repair system of FIGS. 79 or 80 on a native mitral valve.

[0387] FIG. 81 illustrates an example end-coupled implementation of a treatment / repair system.

[0388] FIGS. 82-85 are schematic illustrations of a valve repair device.

[0389] FIGS. 86 and 87 illustrate implantation of the valve repair device illustrated by FIGS. 82-85 on leaflets of a native heart valve.

[0390] FIG. 88 is a perspective view of a valve repair device with gear-actuated paddles and its aesthetic features;

[0391] FIG. 89 is side view of the valve repair device of FIG. 88 with a paddle in an option condition;

[0392] FIG. 90 is a side view of the valve repair device of FIG. 88 with the paddle in a closed condition;

[0393] FIG. 91 is a side view of the valve repair device of FIG. 88 with one of the paddles separated from a central body and valve leaflets captured by the paddle engaged by the central body and the paddle separated from the central body;

[0394] FIG. 92 is a side view of the valve repair device of FIG. 91 with the paddles including optional locking mechanisms;

[0395] FIG. 93 is a side view of the valve repair device of FIG. 91 with the paddles including optional biasing members;

[0396] FIG. 94 is a side view of a gripping member of a valve repair device and its aesthetic features showing the gripping member in a closed condition, wherein a second arm of the gripping member including a hinge for pivoting around a pivot arm extending from the central body;

[0397] FIG. 95 shows the gripping member of FIG. 94 in an open condition and positioned to capture a valve leaflet;

[0398] FIG. 96 shows the gripping member of FIG. 95 in a closed condition with a valve leaflet captured by the gripping member;

[0399] FIG. 97 is a side view of a gripping member of a valve repair device showing the gripping member in a closed condition, wherein an actuation arm of an actuation element includes a tether for connecting to a second arm of the gripping member;

[0400] FIG. 98 shows the gripping member of FIG. 97 in an open condition and positioned to capture a valve leaflet;

[0401] FIG. 99 shows the gripping member of FIG. 97 in a closed condition with a valve leaflet captured by the gripping member;

[0402] FIG. 100 is a side view of a gripping member of a valve repair device showing the gripping member in a closed condition, wherein an actuation element extends from an opening in a central body that is disposed distally to a hinge portion of the gripping member;

[0403] FIG. 101 shows the gripping member of FIG. 100 in an open condition and positioned to capture a valve leaflet;

[0404] FIG. 102 shows the gripping member of FIG. 100 in a closed condition with a valve leaflet captured by the gripping member;

[0405] FIG. 103 shows the gripping member of FIG. 100 in a closed condition with a valve leaflet captured by the gripping member and the gripping member separated from the central body and tethered to the central body by attachment sutures or tethers;

[0406] FIG. 104 is a side view of a gripping member of a valve repair device showing the gripping member in a closed condition, wherein an actuation element extends from an opening in a central body and around a routing member before engaging the gripping member;

[0407] FIG. 105 shows the gripping member of FIG. 104 in an open condition and positioned to capture a valve leaflet;

[0408] FIG. 106 shows the gripping member of FIG. 104 in an open condition and with the routing member retracted so that the actuation element extends proximal to a hinge portion of the gripping member;

[0409] FIG. 107 shows the gripping member of FIG. 104 in a closed condition with a valve leaflet captured by the gripping member and the routing member in the retracted position;

[0410] FIG. 108 shows the gripping member of FIG. 104 in a closed condition with a valve leaflet captured by the gripping member and the routing member in the extended position;

[0411] FIG. 109 shows the gripping member of FIG. 104 in a closed condition with a valve leaflet captured by the gripping member and the routing member in the retracted position;

[0412] FIG. 110 is a side view of a gripping member of a valve repair device showing the gripping member in a closed condition, wherein a second arm of the gripping member includes a flexible portion and a head having a barbed end and a hook for engaging a catch member of a first arm of the gripping member;

[0413] FIG. 110A is a partial front view of the gripping member of FIG. 110;

[0414] FIG. 11 1 shows the gripping member of FIG. 110 in the closed condition with the head and barbed end of the second arm disengaged from the catch member of the first arm;

[0415] FIG. 112 shows the gripping member of FIG. 110 in an open condition and positioned to capture a valve leaflet;

[0416] FIG. 113 shows the gripping member of FIG. 110 in a closed condition with a valve leaflet captured by the gripping member;

[0417] FIG. 114 shows the gripping member of FIG. 110 in a closed condition with a valve leaflet captured by the gripping member, wherein the barbed end is engaged with the catch member of the first arm;

[0418] FIG. 115 is a side view of a gripping member of a valve repair device showing the gripping member in a closed condition, wherein a second arm of the gripping member includes a folding barbed portion in an extended condition;

[0419] FIG. 116 shows the gripping member of FIG. 115 in the closed condition with the folding barbed portion in a retracted condition;

[0420] FIG. 117 shows the gripping member of FIG. 115 in an open condition and positioned to capture a valve leaflet;

[0421] FIG. 118 shows the gripping member of FIG. 110 in a closed condition with a valve leaflet captured by the gripping member and the folding barbed portion in the retracted condition;

[0422] FIG. 119 shows the gripping member of FIG. 110 in a closed condition with a valve leaflet captured by the gripping member and the folding barbed portion in the extended condition;

[0423] FIG. 120 shows a top perspective view of an example of a valve repair device and its aesthetic features;

[0424] FIG. 121 shows a top perspective view of the valve repair device of FIG. 120 with an anchor in an open condition;

[0425] FIG. 122 shows a cross-sectional view of the valve repair device of FIG. 120;

[0426] FIG. 123 shows a top perspective view of the valve repair device of FIG. 120 with an anchor in a released condition;

[0427] FIG. 124 shows a bottom perspective view of the released anchor of the valve repair device of FIG. 123;

[0428] FIG. 125 shows a cross-sectional view of the valve repair device of FIG. 123;

[0429] FIG. 126 shows a cross-sectional view of the valve repair device of FIG. 120 with the anchor in a retracted condition;

[0430] FIG. 127 shows a cross-sectional view of the valve repair device of FIG. 120 with actuation elements locked;

[0431] FIG. 128 shows a cross-sectional view of the valve repair device of FIG. 120 with a locking element retracted;

[0432] FIG. 129 shows a cross-sectional view of the valve repair device of FIG. 120 with a handshake coupling decoupled;

[0433] FIG. 130 shows a cross-sectional view of a catheter of the delivery mechanism of the valve repair device of FIG. 120;

[0434] FIG. 131 shows a top perspective view of an example of a valve repair device and its aesthetic features;

[0435] FIG. 132 shows a top perspective view of the valve repair device of FIG. 131 with an anchor having a paddle in an open condition and a gripping member in a closed condition;

[0436] FIG. 133 shows a top perspective view of the valve repair device of FIG. 132 with the gripping member in an open condition;

[0437] FIG. 134 shows a side view of the valve repair device of FIG. 133;

[0438] FIG. 135 shows a top perspective view of the valve repair device of FIG. 131 with an anchor in a released condition;

[0439] FIG. 136 shows a bottom perspective view of the released anchor of the valve repair device of FIG. 135;

[0440] FIG. 137 shows a cross-sectional view of the valve repair device of FIG. 135;

[0441] FIG. 138 shows a cross-sectional view of the valve repair device of FIG. 131 with the anchor in a retracted condition;

[0442] FIG. 139 shows a cross-sectional view of the valve repair device of FIG. 131 with actuation elements locked;

[0443] FIG. 140 shows a cross-sectional view of the valve repair device of FIG. 131 with a locking element retracted;

[0444] FIG. 141 shows a cross-sectional view of the valve repair device of FIG. 131 with a handshake coupling decoupled;

[0445] FIG. 142 shows a cross-sectional view of the valve repair device of FIG. 131 with a delivery mechanism retracted;

[0446] FIG. 143 shows a cross-sectional view of a catheter of the delivery mechanism of the valve repair device of FIG. 131;

[0447] FIG. 144 shows a top perspective view of an example of a valve repair device and its aesthetic features;

[0448] FIG. 145 shows a top perspective view of the valve repair device of FIG. 144 with an anchor having a paddle in an open condition and a gripping member in a closed condition;

[0449] FIG. 146 shows a top perspective view of the valve repair device of FIG. 145 with the gripping member in an open condition;

[0450] FIG. 147 shows a side view of the valve repair device of FIG. 146;

[0451] FIG. 148 shows a top perspective view of the valve repair device of FIG. 144 with an anchor in a released condition;

[0452] FIG. 149 shows a bottom perspective view of the released anchor of the valve repair device of FIG. 148;

[0453] FIG. 150 shows a cross-sectional view of the valve repair device of FIG. 148;

[0454] FIG. 151 shows a cross-sectional view of the valve repair device of FIG. 144 with the anchor in a retracted condition;

[0455] FIG. 152 shows a cross-sectional view of the valve repair device of FIG. 144 with actuation elements locked;

[0456] FIG. 153 shows a cross-sectional view of the valve repair device of FIG. 144 with a locking element retracted;

[0457] FIG. 154 shows a cross-sectional view of the valve repair device of FIG. 144 with a handshake coupling decoupled;

[0458] FIG. 155 shows a cross-sectional view of a catheter of the delivery mechanism of the valve repair device of FIG. 144;

[0459] FIG. 156 shows the valve repair device of FIG. 144 with anchors moved to an elongated position;

[0460] FIG. 157 shows a top perspective view of an example of a valve repair device and its aesthetic features;

[0461] FIG. 158 shows the valve repair device of FIG. 157 with an anchor in an open condition;

[0462] FIG. 159 shows a bottom perspective view of an anchor of the valve repair device of FIG. 157 in a closed condition;

[0463] FIG. 160 shows a bottom perspective view of an anchor of the valve repair device of FIG. 158;

[0464] FIG. 161 shows a side view of the valve repair device of FIG. 158 positioned for leaflet capture;

[0465] FIG. 162 shows a partial cross-sectional view of the valve repair device of FIG. 157 with an anchor in the retracted condition;

[0466] FIG. 163 shows a partial cross-sectional view of the valve repair device of FIG. 162 with the anchor in a released condition;

[0467] FIG. 164 shows a top perspective view of the valve repair device of FIG. 163 ;

[0468] FIG. 165 shows a cross-sectional view of an anchor locking mechanism of the valve repair device of FIG. 157;

[0469] FIG. 166 shows a perspective view of the anchor locking mechanism of the valve repair device of FIG. 157 ;

[0470] FIG. 167 shows a cross-sectional view of the valve repair device of FIG. 157 with an actuation element retracted;

[0471] FIG. 168 shows a cross-sectional view of the valve repair device of FIG. 157 with a delivery mechanism retracted;

[0472] FIG. 169 shows a cross-sectional view of a catheter of the delivery mechanism of the valve repair device of FIG. 157;

[0473] FIG. 170 shows the valve repair device of FIG. 157 with anchors moved to a delivery configuration;

[0474] FIG. 171 shows a side view of an example of a valve repair device with anchors in a released condition;

[0475] FIG. 172 shows a side view of the valve repair device of FIG. 171 with the anchors in a retracted condition;

[0476] FIG. 173 shows a side view of an example of a valve repair device with anchors in a released condition;

[0477] FIG. 174 shows a side view of the valve repair device of FIG. 173 with the anchors in a retracted condition;

[0478] FIG. 175 shows a side view of an example of a valve repair device with anchors in a released condition;

[0479] FIG. 176 shows a side view of the valve repair device of FIG. 175 with the anchors in a retracted condition;

[0480] FIG. 177 shows a side view of a hypotube and its aesthetic features usable and / or for use in a valve repair device;

[0481] FIG. 178 shows a top perspective view of a segment of the hypotube of FIG. 177;

[0482] FIG. 179 shows a top view of the hypotube of FIG. 177;

[0483] FIG. 180 shows a side view of a hypotube and its aesthetic features usable and / or for use as an actuation element in a valve repair device;

[0484] FIG. 181 shows a top perspective view of a segment of the hypotube of FIG. 180;

[0485] FIG. 182 shows a top view of the hypotube of FIG. 180;

[0486] FIG. 183 shows an enlarged view of the hypotube of FIG. 180 with the hypotube in a bent condition; and

[0487] FIG. 184 shows an enlarged view of the hypotube of FIG. 180 with the hypotube in a straight condition.DETAILED DESCRIPTION

[0488] The following description refers to the accompanying drawings, which illustrate example implementations of the present disclosure. Other implementations having different structures and operation do not depart from the scope of the present disclosure.

[0489] Some implementations of the present disclosure are directed to systems, devices, methods, etc. for treating or repairing a defective heart valve. For example, various implementations of devices, valve repair devices, implantable devices, implants, and systems (including systems for delivery thereof) are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless mutually exclusive or otherwise physically impossible.

[0490] The techniques, methods, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on a living subject (e.g., human, other animal, etc.) or on a simulation / simulated subject (e.g., a cadaver, cadaver heart, simulator, imaginary person, etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.

[0491] The examples summarized above and defined by the enumerated claims may be better understood by referring to the following detailed description, which should be read with the accompanying illustrative drawings, in which like parts bear like reference numerals. This detailed description disclosing examples, set out below to enable one to build and use the implementations, is not intended to limit the enumerated claims, but rather, it is intended toprovide examples of them. Therefore, implementations having differing structures and methods, will not depart from the scope of the invention defined in the claims.

[0492] As described herein, when one or more components are described as being connected, joined, affixed, coupled, attached, or otherwise interconnected, such interconnection can be direct as between the components or can be indirect such as using one or more intermediary components. Also as described herein, reference to a "member," "element," "component," or "portion" shall not be limited to a single structural member, component, or element but can include an assembly of components, members, or elements. Also as described herein, the terms "substantially" and "about" are defined as at least close to (and includes) a given value or state (preferably within 10 of and more preferably within 1 of).

[0493] Numerous variations of the example implementations described herein are within the scope of the invention, some of which are described for various implementations. To the extent they are viable, these variations are also envisioned for use with other implementations. Thus, a treatment or repair device herein may include any combination or sub-combination of the features and variations disclosed herein, and it may exclude some described features.

[0494] FIGS. 2-3 show cutaway views of a human heart H during distinct phases of a cardiac (heartbeat) cycle. A right ventricle RV and a left ventricle LV are separated from a right atrium RA and a left atrium LA, respectively, by a tricuspid valve TV and a mitral valve MV; i.e., the atrioventricular valves. Additionally, an aortic valve AV separates the left ventricle LV from an ascending aorta AA, and a pulmonary valve PV separates the right ventricle from a pulmonary artery PA. Each of these valves defines respective orifices, and has flexible leaflets (e.g., mitral valve anterior and posterior leaflets 20, 22 as also depicted in FIGS. 4-7, and tricuspid valve leaflets 30, 32, 34 as depicted in FIG. 8) extending inward across the respective orifices that come together or "coapt" in the flow stream to form the one-way, fluid-occluding surfaces. Organ repair systems, and more particularly native heart valve repair systems of the present application are frequently described and / or illustrated with respect to the mitral valve MV ; and therefore, the anatomical structures of the mitral valve, the left atrium LA and left ventricle LV will be explained in greater detail. However, the devices described herein can also be used to repair other native valves, e.g., the devices can be used to repair a tricuspid valve TV, an aortic valve AV, a pulmonary valve PV, and / or an atrioventricular valve.

[0495] The left atrium LA receives oxygenated blood from the lungs via pulmonary veins PVS. At the beginning of the cardiac cycle, during a diastolic phase, or diastole (as depicted in FIG. 2), blood that was previously collected in the left atrium LA (during the end of a prior cardiac cycle) moves through the mitral valve MV and into the left ventricle LV by expansion of the left ventricle LV. At the same time, additional blood flows into the left atrium from the pulmonary veins. During a subsequent systolic phase, first there is an atrial systole in which the atria contract, and then there is a ventricular systole in which the ventricles contract.

[0496] In the atrial systole of the systolic phase, the left atrium contracts to eject additional blood from within the left atrium downstream into the left ventricle. In the ventricular systole of the systolic phase, as depicted in FIG. 3, the left ventricle LV contracts to force the blood through the aortic valve AV to the ascending aorta AA, where it circulates back through the rest of the body. During ventricular systole, the two leaflets of the mitral valve MV close to prevent the blood from regurgitating from the left ventricle LV back into the left atrium LA. At the same time, with the left atrium relaxing, blood is again collected in the left atrium from the pulmonary vein for the start of the next cardiac cycle.

[0497] The right atrium RA receives deoxygenated blood from the body via two veins, a posterior (inferior) vena cava IVC and an anterior (superior) vena cava SVC; and it receives deoxygenated blood from the coronary venous network via the coronary sinus CS. At the beginning of the cardiac cycle, during the diastolic phase, blood that was previously collected in the right atrium RA during the end of the prior cardiac cycle moves through the tricuspid valve TV and into the right ventricle RV by expansion of the right ventricle RV. At the same time, additional blood flows into the right atrium from the vena cava. In the atrial systole of the systolic phase, the right atrium contracts to eject additional blood from within the right atrium downstream into the right ventricle. In the ventricular systole of the systolic phase, the right ventricle RV contracts to force the blood through the pulmonary valve PV to the pulmonary artery PA, where it flows to the lungs. During ventricular systole, the three leaflets of the tricuspid valve TV close to prevent the blood from regurgitating from the right ventricle RV back into the right atrium RA. At the same time, blood is collected in the right atrium from the vena cava for the start of the next cardiac cycle.

[0498] Referring now to FIGS. 2-8, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24 (seeFIG. 6), which is a variably dense fibrous ring of tissues that encircles the anterior and posterior leaflets 20, 22. Referring to FIGS. 4-5, the mitral valve MV is anchored to a wall of the left ventricle LV by chordae tendineae CT. The chordae tendineae CT are a plurality of cord-like tendons that connect papillary muscles PM (i.e., the muscles located at the base of the chordae tendineae CT and within the walls 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 movements of the anterior and posterior leaflets 20, 22 of the mitral valve MV and prevent the mitral valve MV from being reverted.

[0499] The mitral valve MV opens and closes in response to pressure differences 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 pressure occurring in the left ventricle LV, that pressure being needed to circulate blood throughout the body. Together the papillary muscles PM and the chordae tendineae CT are known as parts of the subvalvular apparatus, which functions to keep the mitral valve MV from prolapsing or flailing into the left atrium LA when the mitral valve closes. As depicted in a Left Ventricular Outflow Tract (LVOT) view depicted in FIG. 4, 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 from there the anterior and posterior leaflets 20, 22 recede or spread apart from each other. The anterior and posterior leaflets 20, 22 spread apart in the atrial direction, until each leaflet meets with the mitral annulus 24.

[0500] Various disease processes can impair proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's Disease, fibroelastic deficiency, etc.), inflammatory processes (e.g., Rheumatic Heart Disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricle LV or the right ventricle RV from prior heart attacks (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy, etc.) can distort a native valve's geometry, which can cause the native valve to dysfunction.

[0501] Dysfunctional native valves malfunction in diverse ways, including: (1) valve stenosis; and (2) valve regurgitation. Although both stenosis and regurgitation can affect any valve, stenosis is often found to affect the aortic and pulmonary valves, and regurgitation is often found to affect the atrioventricular valves (i.e., the mitral and tricuspid valves).

[0502] Both valve stenosis and valve regurgitation increase the workload of the heart H and may lead to serious conditions if left untreated, such as endocarditis, congestive heart failure, permanent heart damage, and cardiac arrest, possibly leading to an ultimately death. Because the left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) are primarily responsible for circulating the flow of blood throughout the body, there are substantially higher pressures on the left side heart, and a dysfunction of the mitral valve MV or the aortic valve AV is particularly problematic and often life threatening.

[0503] Valve stenosis can cause a native valve not to open properly and / or completely and thereby cause improper blood flow (e.g., obstructed blood flow, jetting, etc.). Often, valve stenosis results from buildup of calcified material on the leaflets of a valve, which causes the leaflets to thicken and impairs the ability of the valve to function properly.

[0504] Valve regurgitation generally occurs when the leaflets of the valve do not close completely, thereby causing blood to leak back into the prior (upstream) chamber (e.g., a mitral valve failure to close completely, causing blood to leak from the left ventricle to the left atrium). There are three main mechanisms by which a native valve becomes regurgitant (e.g., incompetent), which include Carpentier's type I, type II, and type III malfunctions.

[0505] A Carpentier type I malfunction involves the dilation of an annulus such that normally functioning leaflets are distracted from each other and fail to form a tight seal (e.g., the leaflets do not coapt properly). Included in a type I mechanism malfunction are perforations of the leaflets, as are present in endocarditis. A Carpentier type II malfunction involves prolapse of one or more leaflets of a native valve above a plane of coaptation. A Carpentier type III malfunction involves restriction of the motion of one or more leaflets of a native valve such that the leaflets are abnormally constrained below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease or dilation of a ventricle.

[0506] Malfunctioning native heart valves may need to be replaced or repaired. Replacement can involve replacing the subject's native valve with a biological or mechanical substitute. Repair can involve the preservation and correction of the subject's native valve. In some implementations, the devices described by the present application are used to repair the function of a defective native valve. That is, the devices are configured to help close the leafletsof the native valve to inhibit blood from regurgitating. Some of the devices described in the present application are designed to easily grasp and secure the native leaflets. In some implementations, the native leaflets are grasped and / or secured around a coaptation element (e.g., a spacer, gap filler, wedge, plug, foam, sponge, etc.) that beneficially acts as a filler in the regurgitant orifice to help inhibit back flow or regurgitation, though this is not necessary for all implementations.

[0507] Many patients undergoing valve surgery, such as surgery to the mitral valve MV, suffer from a degenerative disease that causes a malfunction in a leaflet of a native valve (e.g., the mitral valve MV), which can result in prolapse, flail, and / or regurgitation. Referring to FIG. 6, when a healthy mitral valve MV is in a 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. Referring to FIGS. 4 and 7, mitral regurgitation MR can occur when the anterior leaflet 20 and / or the posterior leaflet 22 of the mitral valve MV is displaced such that the anterior and posterior leaflets 20, 22 do not properly coapt or close. This failure to coapt causes a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which can allow blood to flow backwards (e.g., into the left atrium LA from the left ventricle LV, as illustrated by the mitral regurgitation MR flow path depicted in FIG. 4).

[0508] Referring to FIG. 7, the gap 26 may have a width W 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 situations, the gap 26 may have a width W greater than 15 mm or even 17.5 mm. As set forth above, there are several different ways that a leaflet (e.g., anterior and posterior leaflets 20, 22 of mitral valve MV) may malfunction, which can thereby lead to valvular regurgitation.

[0509] In any of the above-mentioned situations, improvement of the valve function might be achievable using a treatment / repair device or implant capable of engaging the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent the regurgitation of blood through the mitral valve MV. As depicted in FIG. 5, an abstract representation of a device 10, or implant, is shown implanted between the anterior and posterior leaflets 20, 22 such that regurgitation does not occur during systole (compare FIG. 4 with FIG. 5).

[0510] In some implementations, the coaptation element (e.g., spacer, coaptation element, gap filler, plug, wedge, sheet, barrier, etc.) of the device 10 has a generally tapered or sloped shape (e.g., triangular shape, etc.) that naturally adapts to the native valve geometry and to its expanding leaflet nature (toward the annulus 24). In this application, the terms spacer, coaptation element, and gap filler are used interchangeably and refer to an element that fills a portion of the space between native valve leaflets and / or that is configured such that the native valve leaflets engage or "coapt" against (e.g., such that the native leaflets coapt against the coaptation element, spacer, etc. instead of only against one another).

[0511] The mitral valve MV and the tricuspid valve TV are more prone to deformation of leaflets and / or surrounding tissue, which, as described above, can prevent the mitral valve MV or tricuspid valve TV from functioning properly, allowing for the regurgitation or back flow of blood from the ventricle into the atrium (e.g., a deformed mitral valve MV may allow for regurgitation or back flow from the left ventricle LV to the left atrium LA, as depicted in FIG. 4). The regurgitation or back flow of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or the tricuspid valve TV are often repairable. In addition, regurgitation can occur due to the chordae tendineae CT becoming dysfunctional (e.g., the chordae tendineae CT may stretch or rupture), which allows the anterior leaflet 20 and the posterior leaflet 22 to be reverted such that blood is regurgitated into the left atrium LA. The problems occurring due to dysfunctional chordae tendineae CT can be repaired by repairing the chordae tendineae CT or the structure of the mitral valve MV (e.g., by securing the anterior and posterior leaflets 20, 22 at the affected portion of the mitral valve).

[0512] With reference to FIGS. 7-8, the systems, devices, procedures, and concepts disclosed herein are described in detail for treating / repairing the structure of a native valve, often using a mitral valve as an illustrative example. On the left side of a heart the systems, devices, and procedures can be used between the anterior and posterior leaflets 20, 22 of the mitral valve MV to connect them and help prevent or inhibit regurgitation of blood from the left ventricle into the left atrium. The devices, procedures and concepts disclosed herein can also be used to treat / repair a single leaflet of a native valve.

[0513] Like the mitral valve, the other valves (e.g., aortic, pulmonic, and tricuspid valves) can be treated / repaired using the devices, procedures and concepts disclosed herein. Forexample, like the left side of the heart, on the right side of a heart such devices, procedures and concepts can be used between any two of the three leaflets on 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 regurgitation of blood from the right ventricle into the right atrium. Moreover, the devices, procedures and concepts disclosed herein can be used between all three tricuspid valve leaflets 30, 32, 34 to connect all three of them and prevent or inhibit regurgitation of blood from the right ventricle to the right atrium.

[0514] The devices, procedures, systems, and concepts disclosed herein can also be used to treat / repair a single leaflet of a valve. In sum, depending on the situation, the described devices, procedures, systems, and concepts might be used to treat or repair any native valve, as well as any component of a native valve.

[0515] In some implementations, the systems herein can be configured as organ repair systems for repairing an organ, e.g., the heart, or a valve of a heart. In some implementations, the systems can be configured to treat / repair another part of the body. In some implementations, the systems herein are valve treatment / repair systems for repairing or treating a valve. In some implementations, the systems herein include a treatment and / or repair device (e.g., a valve repair device, a valve repair implant, a valve treatment device, a treatment device, an implant, a device, etc.).

[0516] In some implementations, the treatment / repair systems herein comprise a delivery system having a distal end that is inserted into a subject (e.g., a living patient, a simulation, etc.), and a proximal end that remails outside of the subject. The delivery system can include an implant catheter system having catheter components (e.g., delivery and / or implant catheters) configured and sized to receive, deliver, and implant, or otherwise deploy, the treatment / repair device within a subject.

[0517] The treatment / repair devices herein can be used by medical personnel in repairing or treating the subject’s native valve. In some implementations, this is done by repairing and / or supporting one or more leaflets of the subject’s valve.

[0518] In some implementations, the device can be delivered to the valve by the delivery system through the subject’s vascular system. The delivery and / or implant catheter(s) can havea distal end for insertion into a proximal end of a steering catheter system, and a proximal end for manipulation by a user of the delivery system.

[0519] In some implementations, the system is provided with an array of controllable parts that are for various actuation activities, some of which are described herein and others which are known in the art. In some implementations, the system is configured such that a user (e.g., medical personnel) can operate various controls (e.g., one or more of knobs, motors, buttons, switches, sliders, gears, motors, screws, cams, gimbles, etc.) to control the system. In some implementations, the system can comprise mechanisms known to be useable in other transvascular devices, though the actuation activities and related controllable parts themselves may be unique.

[0520] In some implementations, the system is provided with a wide array of related parts and methods, such as may be described herein, either directly or indirectly.

[0521] Additional details and background information on systems, devices, and methods for transvascular heart valve treatment / repair (with associated mechanisms, components, operations, steps, etc.) that can be used with the systems, devices, methods, etc. herein can be found in U.S. Pat. No. 8,449,599 and U.S. Patent Application Publication Nos. 2014 / 0222136, 2014 / 0067052, 2016 / 0331523, and PCT patent application publication Nos. W02020 / 076898, each of which is incorporated herein by reference in its entirety for all purposes. In some implementations, leaflet anchors described in any of these incorporated references can optionally be used as leaflet anchors in the implementations described herein. Also, coaptation elements, spacers, etc. described in any of these incorporated references can optionally be used as a central body in any of the implementations described herein.

[0522] An example transvascular technique that can be used with the systems, devices, methods, etc. herein for treating / repairing a native valve can comprise advancing a catheter or catheter device into an atrium (e.g., inserting the catheter device into the right femoral vein, up the inferior vena cava and into the right atrium). In some implementations, the tricuspid valve is treated from the right atrium. In transeptal transvascular techniques, the septum can be punctured from the right atrium, and the catheter device passed into the left atrium. In some instances, the catheter device can be coupled to a device (e.g., treatment device, repair device, implant, etc.). The device can be positioned to repair a dysfunctional native valve.

[0523] The delivery systems herein can comprise one or more components forming a steering catheter system and / or an implant catheter system. In some implementations, the delivery systems can have one or more components forming a steering catheter system and an implant catheter system.

[0524] In some implementations, the implant catheter system includes one or more implant catheters capable of placing and implanting, or otherwise deploying, a treatment or repair device. Optionally, the one or more implant catheters can be steerable catheters capable of navigating a subject’s vascular system, thereby also forming all or part of the steering catheter system rather than being a separate system. The delivery system can further include additional devices for transvascular procedures, such as sheaths, control guidewire, external catheter control systems and controls (e.g., one or more of knobs, motors, buttons, switches, sliders, gears, motors, screws, cams, gimbles, etc.), and the like.

[0525] In some implementations, a steering catheter system includes one or more steering catheters capable of navigating a subject’s vascular system.

[0526] In some implementations, e.g., ones having a separate steering catheter system, the one or more steering catheters can be either individually or collectively configured to guide the one or more implant catheters through the subject’ s vascular system. In some implementations, this can involve positioning a distal end of the steering catheter system upstream of a defective valve (relative to a blood flow direction) and pointing the distal end of the implant catheter system downstream (in the blood flow direction) through the valve.

[0527] In some implementations, the implant catheter system starts off inserted within the steering catheter system prior to its insertion into the subject’s body or is inserted into a proximal end of the steering catheter system after the steering catheter system’s distal end is positioned upstream of the valve. With the steering catheter system in place and the implant catheter inserted, the implant catheter system is extended downstream from within steering catheter system, toward the valve.

[0528] The component parts of the treatment / repair device can be configured to traverse the subject’s vascular system through the delivery system in an operational configuration. In some implementations, the treatment / repair device can be structurally configured with a first, small-form-factor (e.g., small diameter) delivery configuration structurally laid out fortraversing the delivery system through the subject’s vascular system, and a second, operational configuration structurally appropriate for valve treatment or repair operations. In some such implementations, the implant catheter includes one or more actuators functional to actuate the treatment / repair device from the delivery configuration to the operational configuration while the device is located at its installation location within the subject’ s heart.

[0529] In some implementations, the component parts of the device can be configured for simultaneously traversing the subject’s vascular system through the delivery system as a single implantable unit.

[0530] In some implementations, the component parts of the device can be configured to transvascularly traverse the delivery system through the subject’s vascular system on a piece- by-piece basis. In some implementations, the pieces are assembled into an implantable device within the body (e.g., within the heart during an implantation procedure).

[0531] In some implementations herein, a treatment / repair system includes and uses a plurality of anchors (e.g., leaflet anchors, tissue anchors, clips, clasps, toggle anchors, staples, rivets, darts, etc.) that attach to tissue (e.g., tissue of an organ). In some implementations, the system is in the form of and / or comprises a treatment or repair device that includes at least one of or a plurality of independently actuatable leaflet anchors (e.g., clips, clasps, clamps, toggle anchors, staples, rivets, darts, knots, etc.) are also possible.

[0532] In some implementations, a leaflet anchor is an attachment device structured (once it is in an operational configuration) with a leaflet-attachment mechanism to affix itself to a leaflet, in any one or more of a variety of ways. This attachment mechanism can be, for example, in the form of an attachment-body (e.g., a bar). In some implementations, 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-type cross), and longitudinally extending in any of a wide variety of shapes (e.g., a straight line or a circle) to form compressive structures (e.g., paddles or rings).

[0533] In some implementations, the attachment-bodies can be configured affix to the leaflet, such as by pressing against the leaflet and thereby constraining the movement of the leaflet with respect to the anchor. For example, in some implementations of a clamp-type anchor, two attachment-bodies in the form of paddles can be configured such that they areattached at one end with a hinge to form a jaw that can bite down and clamp or clasp on to a leaflet and thereby affix to the leaflet. In some implementations, this clasp-type anchor attachment apparatus (or attachment mechanism) can be provided with two control apparatuses (or control mechanisms), one that actuates the attachment apparatus between an open configuration and an attached configuration (optionally using a spring to load the jaw towards an open or closed position), and one that locks the attachment apparatus onto a leaflet. In some implementations, the control apparatuses can be controlled using control wires, such as sutures, wires, lines, tethers, etc.

[0534] Likewise, any leaflet anchor herein can be provided with various other forms of tissue-attachment mechanisms such as friction devices, adhesion devices, tissue piercing mechanisms and / or various forms of grapnel. The anchor(s) can take and / or comprise a variety of forms, e.g., clasps, clamps, clips, darts, staples, hooks, bars, rods, screws, knots, toggle anchors, etc.

[0535] In some implementations, each leaflet anchor can comprise or be in the form of a toggle anchor, having a bar with a centrally attached respective anchor tether (e.g., a tether or tether section associated with a specific anchor). The bar can be made to longitudinally pierce, penetrate, and pass through a wall of a leaflet, pulling the anchor tether with it like a needle pulling a thread. To do this maneuver, the bar can be oriented parallel to the anchor tether, and then an end of the bar is pushed through a wall of a leaflet using a sharp point or edge (the point either being on an end of the bar or on a separate penetrator that contains or is attached to the toggle anchor). In some implementations, a structural support member can be used to support leaflet structures during penetration.

[0536] In some implementations, after passing through the wall, the anchor tether is pulled and the bar thereby toggles, (rotates) to laterally press against the wall of tissue with a distal (anchor) end of the anchor tether pulled back against, and extending back through, the penetrated wall of tissue in a T-shaped configuration (where the bar forms the top of an uppercase T). This T-shaped toggle anchor (also known as a T-element anchor) prevents or inhibits the bar from passing back through the hole in the tissue (leaflet) when pulled by the anchor tether. The anchor can use variations for the structure of a toggle anchor bar, such as a bar made of an elongated accordion-folded fabric with the anchor tether extending throughmultiple leaves of the accordion that are then squeezed into an accordion-folded structure to forming the bar.

[0537] In some implementations, the device also includes one or more connectors, such as decouplable, detachable, or severable connectors. At least one of these one or more connectors is an anchor connector or 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 that fastens, attaches, or couples the structure of an associated anchor of the one or more anchors, either directly or indirectly, to the structure of a catheter of the delivery catheter system / implant catheter system.

[0538] In some implementations, each anchor connector structurally fastens, couples, attaches, etc. the anchor and catheter together rigidly. Each such anchor connector provides for the user (via the delivery or implant catheter system) to first position the associated anchor for affixing it to a valve portion like a leaflet, and then, after the anchor is affixed to that leaflet, with user actuation, to decouple, detach, or sever the connection provided by the anchor connector, and thereby unfasten and release the anchor from the implant catheter. The decoupling / detaching / severing of the anchor connector thereby removes that connector’s constraint on the anchor from becoming separated from the implant catheter. The implant catheter can then move separately away from the anchor, to, for example, position one or more other anchors at other leaflets or leaflet locations.

[0539] In some implementations, a connector (e.g., a severable connector, an anchor connector, a catheter connector, etc.) can be a structure forming a connection that, in a first, unsevered state, joins and fastens the structures of two distinct components (e.g., an anchor and a delivery catheter) to the extent that they are constrained (typically with substantial rigidity) so as to move in sync with one another, in one or more degrees of freedom (and typically in six degrees of freedom). In some implementations, a severable connector can be controllably decouplable / detachable to a second, decoupled state (e.g., detached state, severed state, etc.) that breaks (ends) the constraint on the in-sync movement in at least one of the constrained degrees of freedom (and typically in six relative degrees of freedom) from one another. Put another way, the connector or severable connector forms a decouplable / detachable / severable connection between a first component and a second component. In some implementations, the decouplable / detachable / severable connection includes a coupled, connected, or unsevered statein which the connector constrains the first component and the second component to move in sync with one another in a set of one or more constrained degrees of freedom. In some implementations, the decouplable / detachable / severable connection can also include a decoupled, detached, or severed state in which the first component and the second component are not constrained by the connector to relatively move in sync with one another, e.g., in at least one constrained degree of freedom of the set of one or more constrained degrees of freedom.

[0540] In some implementations, two objects moving in sync with regard to one or more degrees of freedom encompasses a state in which the two objects move (e.g., translate and / or rotate) together in the one or more degrees of freedom, at the same time, to retain their positions relative to one another, such as would occur with a rigid connection between the two objects.

[0541] The transition from the coupled to decoupled states (e.g., from connected to detached states, from unsevered to severed states, etc.) can controllably occur via a variety of physical connection structures, such as being held by a retractable mechanical stop, being held by a clamp or clasp, being held by an integral connector that can be cut, etc. In some implementations, the connector structure can be formed by (e.g., include) integral portions of one or both of the two distinct components, and / or by wholly separate structural elements that attach to one or both of the two distinct components.

[0542] In some implementations, six degrees of freedom of the connector might be three translational degrees of freedom (e.g., respectively translating along a given set of x, y and z axes that are normal to one another, one of which might be parallel to the direction in which the end of the implant catheter is facing), and three rotational degrees of freedom (e.g., respectively rotating around the given set of x, y, and z axes). A rigid connection between two distinct components can be inflexible to the degree necessary for medical personnel to functionally control the position and orientation of one component (e.g., an anchor) using nothing but movement of the other component (e.g., a distal tip of an implant catheter). A certain degree of flexibility is inherent in any material (particularly in transvascular devices), but there is also a level of rigidity that can provide functionality for the device when used in this type of procedure.

[0543] In some implementations, at least some of the anchors (e.g., one or more clips, clasps, clamps, toggle anchors, staples, rivets, darts, knots, etc.) that are connected to the implant catheter system (and / or to other anchors) by connectors, are each further connected to a controlled tether system having one or more controlled tethers (e.g., sutures or other types of cords). In some implementations, each controlled tether connects its respective anchor to the implant catheter system such that control is maintained on the anchor via a controllable connection between the anchor and the implant catheter system after the connector decouples, detaches, releases, severs, etc. to break the connector’s constraint between the relative movement of the implant catheter and the anchor.

[0544] In some implementations, either the controlled tether controllably connects the anchor to the implant catheter system separately from the implant catheter system’ s connection to other anchors, or the controlled tether connects the anchor to the implant catheter system via one or more other anchors of the plurality of anchors. In the case wherein the controlled tether separably connects the anchor to the implant catheter system, the controlled tether either can be affixed to the implant catheter system only at a distal catheter section that is within the subject’s body or can extend back through the implant catheter system to a proximal end of the implant catheter system, so that it might be directly accessed by medical personnel.

[0545] In some implementations, a tether can be a structure physically joining 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 implementations, a tether can join components such that they are flexibly unconstrained with regard to moving separately from one another in one or more (and typically six) degrees of freedom, but are constrained not to separate from one another (in one or more degrees of freedom) by farther than a defined tether limitation (e.g., an amount of tether slack, e.g., an available length of tether to extend). This unconstrained movement within a defined tether limitation can be large enough to allow for the independent movement of the components at a distance adequate to facilitate separate placement of the components in functionally independent locations (e.g., placement wherein a first leaflet anchor is attached to a first portion of a first leaflet while an implant catheter is positioned with a second leaflet anchor at a first portion of a second leaflet at a different location). In some implementations of a tether joining more than two distinct components, in combination the components can be constrained not to separate from one another (in one or more degrees of freedom) by farther than a defined tether limitation.

[0546] As used herein, this tether flexibility should be understood as being flexible to the degree necessary for medical personnel to functionally control the position and orientation of one component (e.g., a distal tip of an implant catheter) free of functionally significant impeding forces delivered through the tether from a contrary movement or position of another tethered component (e.g., a tethered anchor), so long as that tethered component is within the freedom of movement provided by the extent of the tether limitation. In simplified terms, the tether is flexible enough to allow anchors to be attached to leaflets at a greater distance from one another than anchors directly connected to one another. As such, mechanical extension devices other than a simple cord (e.g., a series of flexible rods and / or joints) are within the scope herein, so long as they provide usable tether flexibility.

[0547] As used herein, a tether may be understood to include multiple individual (separate) sections of tether that are connected, such as by having one tether section loop through an eyelet formed by another tether section to form the tether as a whole. Also, as used herein, limited portions of tethers, and of their tether sections, will be referred to as segments of the respective tethers and / or tether sections. For example, a tether or tether section can be said to have a first- end segment, a second-end segment, and an intermediate or center segment (see, e.g., FIG. 78 and the related disclosure).

[0548] A controlled tether is a tether controllably configured such that the tether can be controllably actuated to move one or more connected components relative to other components (e.g., to coapt leaflet anchors, and thereby their respective leaflets, after the leaflet anchors are attached to their respective leaflets). A controlled tether can be formed by (e.g., include) integral portions of one or both joined components, and / or by wholly separate structural elements (such as sutures) that attach or pass through one or both of the two joined components.

[0549] In some implementations a controlled tether (or section thereof) can be a looped tether. In some implementations, a looped tether (or looped tether section) can connect from a proximal end, which is actuatable and removable from or with the implant catheter system (e.g., an end of which could remain outside the subject during initial insertion), to a distal end forming a loop (e.g., a bight) that connects to a primary connection point associated with some portion of a treatment or repair device. As a result, the looped tether can be used to controllably actuate or connect (e.g., hold together) that portion of the device while needed for implantation,and then the (looped) tether can be removed without physically cutting or severing device from the looped tether.

[0550] In some implementations, a looped tether is configured for this removable operation by serially extending (end-to-end) from a segment at a first end of the tether (e.g., a controlled- tether first-end segment or an extension-tether first-end segment), which is at a proximal end of the implant catheter system (protruding from a proximal, user end of the implant catheter), down along (through or aside) the implant catheter system to its distal (implantation) end, optionally through and out of a central body positioned at a distal end of the implant catheter system, to the tether’s primary connection point (e.g., a respective anchor) of the device, slidably received by and passing through (looped around) that primary connection point, back into and through the central body (optionally), back along (through or aside) the implant catheter system to its proximal end, to a segment at a second end of the tether (e.g., a controlled- tether second-end segment or an extension-tether second-end segment) at the proximal end of the implant catheter system (protruding from the proximal, user end of the implant catheter along with the first-end segment of the looped tether). A looped tether of this type can be removed from a body while leaving an implanted implant by pulling on the first-end segment of the tether while releasing the second-end segment to be pulled around the path of the tether loop by the first-end segment. Other forms of looped tethers or other releasable tethers, which can be used to controllably actuate or connect (e.g., hold together) the device or components thereof, and then removed without physically cutting or severing the device, are within the scope of this disclosure as well.

[0551] In some implementations, the treatment or repair device includes a system (e.g., controlled tether system, tether system, adjustment system, coaptation system, actuation system, connection system, control system, etc.). In some implementations, the system can include a central body configured as a coaptation element and / or a spacer. The central body can be configured to be actuatable to guide (e.g., move, adjust, etc.) and maintain the position of the anchors, and thereby the leaflets. More particularly, with anchor connectors being in a decoupled or detached state and the central body positioned and located between the anchors and facing opposing surfaces of anchors, the central body operates to pull and guide leaflets, using a level of force (e.g., connection force, adjustment force, etc.) up to a maximum level of force (e.g., a maximum allowable level such as a safety limit), to a single location where theyare closely positioned, held, and maintained to improve their operation as an operable valve closure element.

[0552] In some implementations, as a spacer, the central body is configured with a gapfilling shape, structure and composition that obstructs gaps between leaflets to reduce regurgitation. In some implementations, the central body structure is shaped and positioned with respect to the leaflets such that, upon coaptation, opposing surfaces of the anchors, and their respective leaflets, close around the central body during appropriate portions of the cardiac cycle. In some implementations, the central body / spacer can be configured to seal against opposing surfaces of two or three anchors, and thereby against two or three nativevalve leaflets, depending in part upon the type of valve for which it is adapted. The central body / spacer can be shaped in any of a variety of shapes, as might be appropriate for the intended use. For example, the variety of shapes can include cylindrical capsule shapes, such as an elongated cylindrical shape characterized by a longitudinal cross-section that is: round, oval, ovoid, crescent shaped, or even rectangular. In some implementations, the central body can have an upstream (e.g., atrial, or upper) portion positioned in or adjacent to an atrium, a downstream (e.g., ventricular, or lower) portion positioned in or adjacent to the ventricle, and a side surface that extends between native leaflets. In some implementations, the spacer can, for example, be structured as a tubular- shaped braided wire composed of a nitinol mesh.

[0553] In some implementations, the spacer can be a compliant spacer with a low compressibility that, when mechanically compressed, compressively expands in some dimensions to be wider and / or longer (or expanding in one or more other dimensions) such that it both conforms to adjacent opposing surfaces and fills up adjacent spaces, and possibly extrudes therebeyond.

[0554] In some implementations, anchors are simultaneously inserted into the subject. In some implementations, at least some of the anchors are individually pulled to a central location by a system (e.g., controlled tether system, tether system, coaptation system, actuation system, connection system, control system, etc.) having distinct and separately extending controlled tethers. This can be done with two- and three-leaflet valves and can incorporate procedures for treating / repairing three-leaflet valves using only two leaflet anchors.

[0555] With reference to FIGS. 2-14, in some implementations (e.g., a simultaneously inserted, center-coupled implementation), of a treatment or repair system, a treatment or repair device 101 usable and / or for use by medical personnel in treating or repairing a subject’s native valve, is delivered through the vascular system to the valve by a delivery system for valve treatment / repair. In some implementations, the delivery system is provided with a steering catheter system including a steering catheter 103, which can operate similar to other steering catheter systems.

[0556] In some implementations, the delivery involves positioning a distal end of the steering catheter 103 upstream of the defective native valve (e.g., mitral valve MV, etc.) (relative to a blood flow direction 105) and pointing the distal end of the steering catheter downstream (in the blood flow direction) through the native valve.

[0557] In some implementations, the delivery system is provided with a delivery catheter system or implant catheter system including a delivery catheter or implant catheter 111. In some implementations, the implant catheter starts off within a steering catheter system prior to its insertion into the subject’s body. In some implementations, the implant catheter is inserted into a steering catheter system proximal end (which extends outside the subject’s body for access by a user) after the steering catheter system is positioned upstream of the native valve. In some implementations, with the steering catheter system in place and the implant catheter inserted, a distal, implantation end of the implant catheter is extended from within steering catheter system downstream toward the native valve (e.g., as depicted in FIG. 9). In some implementations, the implant catheter can be steerable. In some implementations, the implant catheter can be used without a separate steerable catheter.

[0558] At its distal end, the delivery or implant catheter 111 mounts and carries some or all portions of a device 101 (e.g., treatment device, repair device, valve treatment device, valve repair device, implantable device, implant, etc.). In some implementations, device 101 comprise two leaflet anchors, e.g., a first leaflet anchor 113 and a second leaflet anchor 115. In some implementations, each anchor has a respective leaflet- attachment mechanism (e.g., a first leaflet- attachment mechanism, and a second leaflet- attachment mechanism) in the form of an actuatable clip with independent actuators and actuation controls such that each anchor can be separately and independently affixed to respective leaflet locations.

[0559] In some implementations, clip anchors can be configured such that each includes two paddles, an outer paddle 117 and an inner paddle 119. In some implementations, the two paddles are connected at one end with a hinge 120. In some implementations, these clip anchors are configured to affix to a leaflet by clipping onto a leaflet, e.g., by actuating the hinge to bite down onto, and thereby grasp, an edge of the leaflet requiring constraint for improved valve operation.

[0560] In some implementations, the device 101 also includes an anchor connector (e.g., a decouplable connector, a detachable connector, a severable connector, etc. ) for each respective anchor, e.g., 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 implementations, the first anchor connector forms a first anchor decouplable connections (e.g., detachable connection, severable connection, releasable connection, etc.), and a second anchor connector forms a second anchor decouplable connection (e.g., detachable connections, severable connection, releasable connection, etc.). In some implementations, the device is further provided with an optional central body 131 (e.g., a spacer, a coaptation element, a plug, a gap filler, etc.) and a centerbody connector 133. In some implementations, the center-body connector 133 is a structural fastener that forms a center-body decouplable connection (e.g., detachable connections, severable connection, releasable connection, etc.) that fastens the central body 131 to the delivery / implant catheter 111 when in a connected state or unsevered state (e.g., it restricts and / or constrains their relative movement to be in-sync).

[0561] In some implementations, the first and second connectors 121, 123 respectively form a first anchor decouplable connection and a second anchor decouplable connection that fasten their respective first and second leaflet anchors 113, 115 to the central body 131 when in a connected state or unsevered state, and thereby indirectly fasten the first and second anchor connectors to the delivery / implant catheter 111 via the central body. In some implementations, these first and second anchor decouplable connections are distinct and independent of one another in that the decoupling or detaching of one of the first anchor and second anchor connectors does not decouple or detach the connection made by the other connector (e.g., it does not release the constraint to move in-sync). Various connector technologies and / or mechanisms, such as those for decoupling or detaching implants from implant catheters (e.g., clasps, clamps, releases, ties, fasteners, loops, etc.), may be appropriate for use as the connectors or as part of the connectors.

[0562] In their connected states, the connectors restrict and / or constrain relative movement from between their respective devices, typically in six degrees of freedom. For example, in its connected state, the first anchor connector restricts and / or constrains relative movement between the first leaflet anchor and the central body, typically requiring them to move in sync in six degrees of freedom. Decoupling or releasing the connector connections places them in decoupled, detached, or released states, which remove the restrictions and / or constraints on insync (relative) movement between the respective devices (as compared with their unsevered states). The removed restrictions and / or constraints are typically in six degrees of freedom, but can be in fewer degrees of freedom.

[0563] While the term “sever” in various forms is used herein, it should be understood that in the context of this application and the claims, the term “sever,” “severable,” “severing,” etc. and similar terms encompass decoupling, disconnection, detachment, removal, etc. (even if no cutting is done).

[0564] In some implementations, the treatment / repair device 101 also includes a system or mechanism, such as a controlled tether system or mechanism or other adjustment system / mechanism. In some implementations, the system includes a respective controlled tether for each anchor, e.g., a first controlled tether 141 for the first leaflet anchor 113 and a second controlled tether 143 for the second leaflet anchor 115.

[0565] In some implementations, each controlled tether is in the form of a flexible cord (e.g., a suture). In some implementations, each controlled tether is a looped tether that extendibly fastens a primary connection (being one or more points on its respective anchor) to the central body 131 (and thereby to the delivery / implant catheter 111). In some implementations, it does so by serially extending (end-to-end) from a first-end segment at a proximal end of an implant catheter of the implant catheter system to its distal (implantation) end, through and out of the central body 131 (positioned at a distal end of the implant catheter system) to the controlled tether’s respective anchor, slidably being received by and passing through (looped around) one or more anchor slidable restraints (e.g., a first anchor slidable restraint, a second anchor slidable restraint, a third anchor slidable restraint, an intermediate anchor slidable restraint and a last anchor slidable restraint) along a length of the respective anchor, back into and through and / or aside the central body and implant catheter to its proximalend, to a second-end segment at the proximal end of the implant catheter system (along with the first-end segment of the controlled tether).

[0566] In some implementations, both the first-end and second-end segments of each controlled tether are accessible by the user, either directly or using a control mechanism (e.g., one or more of a button, switch, lever, slider, knob, gear, motor, threaded component, screw, cam, gimble, etc.) for implantable devices. In use, individually and controllably the user increases the controlled tether’s slack (the tether limitation) by feeding (inserting) one or both controlled tether’s ends into the delivery / implant catheter 111 to increase the available tether length between the central body 131 and the anchor, allowing the respective anchor more relative separation in any direction from the central body. Individually and controllably, the user reduces each controlled tether’s slack by drawing (pulling) one or both controlled tethers’ ends out from the implant catheter to decrease the available tether slack between the central body and the anchor, restricting the respective anchor to less relative separation in any direction from the central body. This controllable slack provides for the anchor to move independently of the central body and implant catheter with six degrees of freedom to a controllable extent, and to be drawn back to the central body for affixing in place on the central body.

[0567] In some implementations, independent movement of the anchor is limited by a respective tether limitation that the respective anchor cannot move beyond (e.g., the tether length available for movement). That tether limitation is the degree of slack given to the respective controlled tether. In some implementations, the tether limitation changes by half the amount of controlled tether length adjusted by the user because the controlled tether loops back on itself.

[0568] Using slidable eyelet-type restraints that can be formed as part of the anchor structure, each controlled tether slidingly and / or fixedly connects to its anchor at two locations along the anchor, and slidably feeds back into the central body 131 at two locations along the central body. This two-point controlled tether connection between the anchor and central body provides better control over the relative positions of the anchor and the central body when the controlled tether slack is later removed (e.g., the controlled tether is tightened).

[0569] Prior to insertion into the subject’s body, some, or all portions of the device 101, e.g., the first and second leaflet anchors 113, 115 and / or the first anchor connector 121 (in aconnected state). In some implementations, the first and second leaflet anchors 113, 115 and / or the first anchor connector 121 (in a connected state) are mounted together on the distal end of the delivery / implant catheter 111. As mounted on the implant catheter prior to insertion, the structure of these portions of the device has a structural form factor sized and shaped within the limitations imposed by the delivery system for the mounted portions to simultaneously traverse the delivery system through the subject’s vascular system (as a single implantable unit).

[0570] In some implementations, these portions of the device 101 can be structurally adapted to switch between a first, small-form-factor (e.g., small diameter) delivery configuration, and a second, operational configuration configured for treatment or repair operations (as depicted in FIG. 9). The delivery configuration is appropriate for the mounted portions of the device to traverse the delivery system through the subject’s vascular system as a single implantable unit (optionally with a delivery configuration similar to those of other systems).

[0571] In some implementations, the implant catheter includes one or more actuators that function to actuate the device 101 from the delivery configuration to the operational configuration with the device located within the subject’s heart. These actuators and their controls can be handle-type controls similar other actuators and controls (e.g., one or more of buttons, switches, levers, sliders, knobs, gears, motors, threaded components, screws, cams, gimbles, etc.) for the deployment of implants from within delivery systems.

[0572] With the delivery or implant catheter 111 extended from within steering catheter 103, pointing downstream toward the mitral valve MV, the implant catheter moves downstream into and partially or entirely through the mitral valve to the extent needed based upon the geometry of the device and the valve. If it is first delivered to the heart in a delivery configuration, either before or after passing through the mitral valve MV, the delivery / implant catheter 111 actuates the device 101 from delivery configuration to operational configuration (as depicted in FIG. 9).

[0573] As depicted in FIGS. 10-11, with the delivery / implant catheter 111 moved downstream into and through the mitral valve MV, and the device 101 actuated into the operational configuration, the user actuates the implant catheter to move the device.

[0574] In some implementations, the implant catheter is moved, positioning the first leaflet anchor 113 at a first position within the heart, being located and oriented to affix the anchor (by clipping on) to a first portion of the edge of a first leaflet 151 requiring constraint for improved operation (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 anchor, e.g., clamp down, etc., on the leaflet edge, affixing it to the leaflet).

[0575] The anchoring systems, apparatuses, mechanisms, etc. for attaching the anchors to tissue herein can take a variety of different forms, e.g., clamping mechanisms, clasping mechanisms, suction mechanisms, adhering mechanisms, etc. In some implementations, the anchoring systems, apparatuses, mechanism, etc. are separate and / or independent from systems, apparatuses, mechanisms, etc. for the controlled tether. In some implementations, anchoring systems, apparatuses, mechanisms, etc. for attaching the anchors to tissue can be comparable to other anchor actuation systems, such as those that use sutures, threaded members, cams, shafts, and / or springs, etc. for controlled opening and closing of a clamp, clasp, etc. In some implementations, a clamping system, apparatus, or mechanism is used to clamp onto tissue, e.g., onto a leaflet, for anchoring.

[0576] FIG. 10A illustrates a treatment or repair device 101 that includes an example clamping mechanism 200. In some implementations, the clamping mechanism comprises a line 202, such as a suture or wire, and a biasing element 204, such as a spring, resilient member, etc. In some implementations, the biasing element 204 biases the outer paddle 117 and the inner paddle 119 toward one another. In some implementations, the biasing element 204 biases the outer paddle 117 and the inner paddle 119 away from one another.

[0577] In some implementations, such as when the biasing element biases the outer paddle 117 and the inner paddle 119 toward one another, the line 202 can be routed such that pulling on the line moves the outer paddle 117 and the inner paddle 119 away from one another to open the paddles. In some implementations, such as when the biasing element biases the outer paddle 117 and the inner paddle 1 19 away from one another, the line 202 can be routed such that pulling on the line moves the outer paddle 117 and the inner paddle 119 toward one another to close the paddles.

[0578] Once in the closed position, the relative positions of the outer paddle 117 and the inner paddle 119 can optionally be locked.

[0579] FIG. 10B illustrates an example of a clamping mechanism 300. In some implementations, the clamping mechanism 300 comprises an actuation element 302 (e.g., wire, rod, tube, shaft, suture, etc.), an optional follower 304, and a drive link 306 (e.g., strut, shaft, plate, etc.). In the illustrated example, the optional follower 304 is attached to a distal end of the actuation element 302. In some implementations, the optional follower 304 can be attached to the actuation element 302 by a fastener 307, such as a clip, nut, cap, washer, etc.

[0580] In some implementations, the drive link 306 is pivotably coupled to the optional follower 304 at a pivot axis 308. In some implementations, the follower 304 is omitted and line the drive link 306 is pivotally connected directly to the actuation element 302. In some implementations, the drive link 306 is pivotally connected to the outer paddle 117 at a pivot axis 310. In some implementations, movement of the actuation element 302 in the direction 320 moves the drive link 306, which in turn moves the outer paddle toward 117 an open condition. In some implementations, movement of the actuation element 302 in the direction 322 moves the drive link 306, which in turn moves the outer paddle toward a closed condition. An optional biasing element can bias the outer paddle 117 toward or away from the inner paddle 119. Once in the closed position, the relative positions of the outer paddle 117 and the inner paddle 119 can optionally be locked.

[0581] The first leaflet anchor 113 and the second leaflet anchor 115 can take a variety of different forms. In some implementations, the anchors 113, 115 can be configured to snap to an open position and to snap to a closed position. For example, the first leaflet anchor 113 and the second leaflet anchor 1 15 can be configured like a snap hair clip.

[0582] Referring to FIGS. 10C and 10D, in some implementations, a leaflet anchor 413 includes a first arm 417 and a second arm 419. In some implementations, the first arm 417 and the second arm 419 are formed from a single piece curved and / or bent material, such as a piece of metal or plastic that has spring-like properties. In some implementations, the first arm 417 and the second arm 419 are connected together at a closed end 430.

[0583] In some implementations, the first arm 417 and / or the second arm 419 are shape set to snap to a closed configuration (FIG. 10C) and to snap to an open configuration (FIG. 10D).In some implementations, moving the first arm 417 past a center or snap-over line 420 in the direction indicated by arrow 422 causes the leaflet anchor to snap to the closed condition illustrated by FIG. 10C. In some implementations, moving the first arm 417 past the center or snap-over line 420 in the direction indicated by arrow 424 causes the leaflet anchor to snap to the open condition illustrated by FIG. 10D.

[0584] FIGS. 10E and 10F illustrate an example of a clamping mechanism 500 that uses the leaflet anchor 413 illustrated by FIGS. 10C and 10D. In some implementations, as illustrated, the clamping mechanism 500 includes a base 502 (e.g., a frame, a coaptation element, and / or a tube, etc.) an 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 a distal end 432 of the base 502. In some implementations, the actuation element 504 can extend through the base 502 and can be releasably coupled to the first arm 417.

[0585] Referring to FIG. 10E, in some implementations, pushing the first arm 417 with the actuation element 504 past a center or snap-over line 420 in the direction indicated by arrow 524 causes the leaflet anchor 413 to snap to the open condition. Referring to FIG. 10F, in some implementations, pulling the first arm 417 with the actuation element 504 past the center or snap-over line 420 in the direction indicated by arrow 522 causes the leaflet anchor to snap to the closed condition.

[0586] In some implementations, the first leaflet anchor 1 13 can be a separable anchor. In some implementations, with the first leaflet anchor 113 attached to the first location on the first leaflet, the user actuates a control decoupling or detaching the first anchor connector 121 and thereby releasing the first leaflet anchor from its primary connection to the implant catheter (e.g., its connection by the first anchor connector). Therefore, the central body and the implant catheter are freed to translate and rotate together in six degrees of freedom relative to the first leaflet anchor. In some implementations, the decoupling or detachment of the separably attached first leaflet anchor 113 leaves only the first controlled tether 141 loosely connecting the first leaflet anchor 113 to the delivery / implant catheter 111. Thus, they are constrained by one another only in that they cannot separate from one another by a distance farther than is allowed by the length of the slack, which is a limitation of the first anchor tether.

[0587] In some implementations, the first anchor connector 121 provides for the delivery or implant catheter 111 and central body 131 to position the first leaflet anchor 113 in a correct position for affixing to the first leaflet 151, and then after the first leaflet anchor is affixed to the first leaflet, to decouple / detach / sever / release / unfasten the first leaflet anchor from the implant catheter, central body and second leaflet anchor 115. In some implementations, the delivery / implant catheter 111, central body 131 and second leaflet anchor 115 can then move separately from the first leaflet anchor 113, such as to position the second leaflet anchor 115 at a second position within the heart, being located and oriented to grasp a first portion of the edge of a second leaflet 153 requiring constraint for improved operation (e.g., a first portion of the edge of the posterior leaflet 22). The second leaflet anchor 1 15 can be a separable anchor.

[0588] In some implementations, the user then gives the first controlled tether 141 adequate slack to allow the implant catheter to freely move (with the second leaflet anchor 115 still attached) to a second location (such as at a location on a second leaflet 153 requiring constraint) without pulling the first leaflet anchor 113 and the first leaflet 151 along with it, and without being detrimentally pulled and tugged upon by the motion of the first leaflet due to the operation of the heart.

[0589] In some implementations, as depicted in FIG. 12, with the delivery or implant catheter 111 extending through the mitral valve MV, the device 101 is actuated into an operational configuration. In some implementations, the first leaflet anchor 113 is affixed to the first leaflet 151, and the first anchor connector 121 is decoupled / detached / severed / unfastened / released to free the first leaflet anchor from direct attachment to the implant catheter (though it can still be indirectly attached via tethered connections to other components that can still be directly attached to the implant catheter). In some implementations, the user actuates the implant catheter to move the implant catheter and its attached portions of the device, positioning the second leaflet anchor at a second position within the heart, being located and oriented to grasp a first portion of the edge of a second leaflet 153 requiring constraint for improved operation (e.g., a first portion of the edge of the posterior leaflet 22). This positioning occurs without pulling the first leaflet anchor and the first leaflet to the second leaflet.

[0590] If the first controlled tether slack is not already adequate, the user can controllably release (lengthen) slack on the first controlled tether 141 to provide for this movement withoutdetrimental resistance from the first leaflet. This can be done by the user releasing slack on an end of the controlled tether suture at the proximal end of the implant catheter, as for other transvascular mechanisms having wires, chords, lines, etc. for control. The implant catheter can then be actuated to position the second leaflet anchor 115 at the second position. The second leaflet anchor 115 can then be actuated to attach it to the first portion of the edge of the second leaflet (e.g., the second leaflet anchor is actuated to clamp down on the leaflet edge to affix it to the leaflet).

[0591] In some implementations, with the second leaflet anchor 115 attached to the first location on the second leaflet 153, the user actuates a control causing the second anchor connector 123 to decouple / detach / sever / unfasten and thereby release the second leaflet anchor from the implant catheter. Therefore, the delivery / implant catheter 111 and central body 131 are freed to translate and rotate in six degrees of freedom relative to the second leaflet anchor 1 15.

[0592] The decoupling or detachment of the separably attached second leaflet anchor 115 leaves only the second controlled tether 143 loosely connecting the second leaflet anchor to the implant catheter. Thus, they are constrained by one another only in that they cannot separate from one another by a distance farther than is allowed by the length of the slack, which is a limitation of the first anchor tether.

[0593] In some implementations , the second anchor connector 123 provides for the delivery or implant catheter 111 to first position the second leaflet anchor 115 for affixing to a second leaflet 153, and then, after the second leaflet anchor is affixed to the second leaflet, to decouple / detach / unfasten / sever and thereby release the second leaflet anchor 115 from attachment directly to the implant catheter (within the limits allowed by the slack in the second controlled tether 143). The delivery / implant catheter 111 can then move separately from the second leaflet anchor 115, such as to position the implant catheter and central body 131 at location central to the leaflets.

[0594] In some implementations, the system (e.g., controlled tether system, tether system, coaptation system, actuation system, connection system, control system, etc.) is configured such that a user can give the second controlled tether 143 adequate slack to allow the implant catheter to freely move to a location between the leaflets without pulling either the first leafletanchor 113 and the first leaflet 151, or the second leaflet anchor 1 15 and second leaflet 153, along with it (and without being detrimentally pulled and tugged upon by the heartbeat-driven motion of the first and second leaflets due to the heart activity).

[0595] In some implementations, as depicted in FIG. 13, the delivery or implant catheter 111 and central body 131 are configured such that they can be manipulated by a user to be positioned at a coaptation location between the leaflets. This positioning occurs without pulling the second leaflet anchor and the second leaflet to the coaptation location. Once the delivery / implant catheter 111 is at the coaptation location, one or more controls (e.g., handle controls, buttons, knobs, switches, sliders, gears, other controls, etc.) can be actuated at the proximal end of the delivery system, e.g., on a handle. In some implementations, the controls respectively tighten the first and second controlled tethers 141, 143, to shorten and remove their respective slack. The controls can be configured to controllably tighten one controlled tether at a time, or all controlled tethers at once.

[0596] While the location of the distal end of the delivery / implant catheter 111 will establish a location towards which the first and second leaflets 151, 153 are drawn, the leaflet structural forces and the dynamic blood flow forces from each leaflet will determine the actual location where the resulting device 101 (e.g., the pair of anchors and the central body) will end up. Based on the attachment of the respective controlled tethers, each anchor will define an opposing surface that can be drawn closer and / or into contact with the central body.

[0597] With the first and second leaflet anchors 113, 115 connected to the delivery / implant catheter 111 and central body 131 (e.g., in contact with, closer to, etc.), and thereby connected to one another, an anchor-lock locking mechanism locks the anchors into position (or region) relative to the central body and one another, thereby constraining relative movements of the first leaflet anchor, the second leaflet anchor, and the central body. In some examples, this entails holding the anchors and central body in contact and stationary (e.g., completely stationary, mostly stationary, portions (e.g., connected surfaces) are completely stationary while other portions / extensions can move, etc.) relative to each other. A variety of structural / mechanical locking mechanisms can be used as the anchor-lock to effectuate this locking of the anchors. For example, the central body can be provided with one or more locks that structurally mate and interlock with each tethered anchor to lock them in position.

[0598] In some implementations, the first and second anchor connectors 121, 123 can be configured to act as all or part of the anchor-lock locking mechanism. In some implementations, the anchors can be configured with locking mechanisms that lock directly to one another to form the anchor-lock. In some implementations, segments of the first and second controlled tethers 141, 143 can be cut off and used as part of the anchor-lock to lock the first and second leaflet anchors 113, 115 into position with respect to the central body and / or one another. In some implementations, distal segments of the tightened controlled tethers are actuated (e.g., pulled), thereby tensioning or pulling on the anchors to cinch them toward the central body (and thereby moving the anchors together toward one another and / or into contact with each other and / or with another portion of the device, e.g., a central body, spacer, etc.). In some implementations, the actuated controlled tethers can be locked together to lock the anchors into their relative positions, and then the distal segments of the controlled tethers can be decoupled / detached / severed / cut / etc. from their respective remaining (proximal) controlled tether segments (and from the implant catheter) to permanently leave the distal segments holding the anchors in their fully connected (e.g., in contact) relative positions. The term “cinch” includes pulling and / or tightening.

[0599] In some implementations, once the first and second leaflet anchors 113, 115 are locked into position with respect to the central body 131 and one another, the first and second controlled tethers 141, 143 and the delivery / implant catheter 111 are disconnected from the device 101 and removed from the subject’s body (see, FIG. 14). In some implementations, the second-end segment of each controlled tether is freed to advance into the delivery / implant catheter (to pass up through the anchor slidable restraints and then back down the implant catheter) while the first-end segment is continuously pulled from the implant catheter until the full length of the controlled tether comes out of the delivery / implant catheter. In some implementations, where distal segments of the controlled tethers were cut from proximal segments, each proximal segment may need to be individually pulled from the implant catheter.

[0600] With all of the controlled tethers (or segments thereof) removed, a control can be actuated causing the center-body connector 133 to decouple / detach / sever / unfasten, releasing the central body from the delivery or implant catheter (if the central body is the last component released from the implant catheter, the entire device can then be decoupled or released from the delivery or implant catheter). When fully released, the central body 131 and connectedlocked anchors are completely freed to translate and rotate in six degrees of freedom with the leaflets. Finally, the delivery system can be removed from the subject.

[0601] By making one or more inserted anchors separable from one another (and the rest of the implant) prior to leaflet attachment, anchors can be attached to leaflets without resistance from other previously attached anchors. The device can be placed without suffering the difficulties that may be caused by leaflets having excessive spacing and movement relative to one another.

[0602] The devices and / or systems herein can comprise a wide variety of simultaneous, center-coupled implementations, some of which are expressly described herein. To the extent appropriate (e.g., can be implemented), these are also envisioned for use with other implementations. For example, other implementations can include combinations or subcombinations of the features and components disclosed for the implementations below.

[0603] In some simultaneously inserted center-coupled implementations, the device can include three or more anchors. In some implementations, a treatment / repair device is provided with three anchors, at least two of which are separably attached to a central body. This is particularly advantageous when implanted to improve the operation of a valve with three leaflets, such as the tricuspid, aortic and pulmonary valves.

[0604] In FIGS. 15-20, an example simultaneously inserted center-coupled implementation with three anchors is depicted during implantation in a tricuspid valve TV. Unless indicated otherwise, elements of the device are substantively the same as similarly named items in the earlier referenced implementations. Where possible, reference numbers are incremented by 100 from the related center-coupled implementation.

[0605] In some implementations, device 201 (e.g., treatment device, repair device, valve treatment device, valve repair device, implantable device, implant, etc.) is delivered through the vascular system to the tricuspid valve TV by a delivery system for valve treatment or repair having similarities to the center-coupled implementation. An implant catheter is inserted into the subject’s body and extended downstream toward the tricuspid valve. At its distal end, the implant catheter carries the device 201, which includes three anchors, a first leaflet anchor 213, a second leaflet anchor 215, and a third leaflet anchor 217, each with a leaflet-attachmentmechanism in the form of an actuatable clip configured to clip on to the edge of a leaflet that requires constraint for improved valve operation (e.g., a third leaflet-attachment mechanism).

[0606] In some implementations, the device 201 also includes a connector for each anchor, e.g., a first anchor connector, a second anchor connector, and / or a third anchor connector. In some implementations, the device is further provided with an optional central body 231, and a center-body connector rigidly fastening the central body to the implant catheter. In some implementations, the first, second and third anchor connectors are configured to fixedly and / or rigidly fasten their respective anchors to the central body 231 in six degrees of freedom, and thereby indirectly rigidly fasten them to the implant catheter via the central body.

[0607] The 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 fastens its respective anchor to the central body 231 , and thereby the implant catheter. Each controlled tether can controllably be given slack for the anchor to move independently of the central body and implant catheter, being limited by a respective tether limitation (slack), being the tether length available for movement. Each controlled tether slidingly and / or fixedly connects to its anchor at two locations along the anchor, and to the central body 231 at two locations along the central body.

[0608] In some implementations, each controlled tether is a looped tether that extendibly fastens a primary connection (being one or more points on its respective anchor) to the central body 131 (and thereby to the delivery / implant catheter 111). It can be done by serially extending (end-to-end) from a first end (e.g., a third controlled-tether first-end segment) at a proximal end of the implant catheter system to its distal (implantation) end, through and out of the central body 131 (positioned at a distal end of the implant catheter system) to the controlled tether’ s respective anchor, slidably being received by and passing through (looped around) one or more slidable restraints along a length of the respective anchor, back into and through and / or aside the central body and implant catheter to its proximal end, to a second end (e.g., a third controlled-tether second-end segment) at the proximal end of the implant catheter system (along with the first-end segment of the controlled tether).

[0609] The device 201 can optionally be structurally configured with a first, small-form- factor delivery configuration and a second, operational configuration configured for valvetreatment or repair operations. In some implementations, a small-form-factor, side-by-side serial delivery configuration (e.g., spaced at 120° angles) might be slim enough to pass through a transvascular catheter system. In others, a more complex delivery configuration might be necessary.

[0610] With the implant catheter extended from within steering catheter system, pointing downstream toward the tricuspid valve TV, the implant catheter moves downstream into and partially or entirely through the tricuspid valve to the extent needed based upon the geometry of the device and the valve. If it is first delivered to the heart in a delivery configuration, either before or after passing through the tricuspid valve TV, the implant catheter can actuate the device 201 from a delivery configuration to an operational configuration.

[0611] As depicted in FIG. 16, with the implant catheter moved downstream into and through the tricuspid valve TV, and the device 201 actuated into the operational configuration, the implant catheter can be actuated to move the implant catheter and the device, positioning the first leaflet anchor 213 at a first position within the heart, being located and oriented to grasp a first portion of the edge of a first leaflet 251 requiring constraint for improved operation. The first leaflet anchor 213 can then be actuated to attach it to the first portion of the edge of a first leaflet.

[0612] With the first leaflet anchor 213 attached to the first leaflet 251, the first anchor connector can be decoupled / detached / severed / unfastened to release the first leaflet anchor from the implant catheter. The central body 231 and implant catheter can be freed to translate and rotate together relative to the first leaflet anchor 213. The decoupling or detachment of the separably attached first leaflet anchor 213 leaves only the first controlled tether 241 loosely connecting the first leaflet anchor 213 to the implant catheter.

[0613] The first anchor connector provides for the implant catheter and central body 231 to position the first leaflet anchor 213 in a correct position for affixing to the first leaflet 251, and then after the first leaflet anchor is affixed to the first leaflet, to unfasten and release the first leaflet anchor from the implant catheter, central body, second leaflet anchor 215 and third leaflet anchor 217. The implant catheter, central body 231, second leaflet anchor 215 and third leaflet anchor 217 can then move separately from the first leaflet anchor 213 to position thesecond leaflet anchor 215 at a second position within the heart to grasp a first portion of the edge of a second leaflet 253 requiring constraint for improved operation.

[0614] As depicted in FIG. 17, the first controlled tether 241 can be given adequate slack to allow the implant catheter to freely move to a second location at a second leaflet 253 without pulling the first leaflet anchor 213 and the first leaflet 251 along with it. The implant catheter and the attached portions of the device 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 a second leaflet 253 requiring constraint for improved operation.

[0615] If the first controlled-tether slack is not already adequate, the slack can be controllably released on the first controlled tether 241 to provide for this movement without detrimental resistance from the first leaflet. The implant catheter can be actuated to position the second leaflet anchor 215 at the second position. The second leaflet anchor 215 can be actuated to attach it to the first portion of the edge of the second leaflet.

[0616] With the second leaflet anchor 215 attached to the second leaflet 253, the second anchor connector can be decoupled / detached / severed / unfastened to release the second leaflet anchor from the implant catheter. In some implementations, the decoupling or detachment of the separably attached second leaflet anchor 115 leaves only the second controlled tether 143 loosely connecting the second leaflet anchor to the implant catheter.

[0617] In some implementations, the second anchor connector provides for the implant catheter and central body 231 to position the second leaflet anchor 215 in a correct position for affixing to a second leaflet 253, and then after the second leaflet anchor is affixed to the second leaflet, to unfasten and release the second leaflet anchor from the implant catheter, central body 231 and third leaflet anchor 217. The implant catheter, central body and third leaflet anchor can then move separately from the second leaflet anchor 215 and the first leaflet anchor 213 to position the at a third position within the heart to grasp a first portion of the edge of a third leaflet 255 requiring constraint for improved operation.

[0618] As depicted in FIG. 18, the second controlled tether 243 can be given adequate slack to allow the implant catheter to freely move to a third location at a third leaflet 255 without pulling the first leaflet anchor 213 and the first leaflet 251 , or the second leaflet anchor 215 and the second leaflet 253, along with it. The implant catheter and portions of the device can bemoved to a third position within the heart, positioning (locating and orienting) the third leaflet anchor to grasp a first portion of the edge of a third leaflet 255 requiring constraint for improved operation.

[0619] If the first controlled-tether slack and second controlled-tether slack are not already adequate, slack on the first controlled tether 241 and second controlled tether 243 can be controllably released to provide for this movement without substantial detrimental resistance from the second leaflet 253. The implant catheter can be actuated to position the third leaflet anchor 217 at the third position. The third leaflet anchor 217 can be actuated to attach it to the first portion of the edge of the third leaflet.

[0620] With the third leaflet anchor 217 attached to the third leaflet 255, the third anchor connector can be decoupled / detached / severed / unfastened to release the third leaflet anchor from the implant catheter. In some implementations, the decoupling or detachment of the separable third leaflet anchor leaves only the third controlled tether 245 loosely connecting the third leaflet anchor to the implant catheter.

[0621] In some implementations, the third anchor connector provides for the implant catheter to first position the third leaflet anchor 217 for affixing to a third leaflet 255, and then, after the third leaflet anchor is affixed to the third leaflet, to decouple / detach / sever / unfasten and thereby release the third leaflet anchor 217 from the implant catheter (within the limits allowed by the slack in the third controlled tether 245). The implant catheter can then move separately from the third leaflet anchor 217, such as to position the implant catheter and central body 231 at location central to the leaflets.

[0622] As depicted in FIG. 19, the third controlled tether 245 can be given adequate slack to allow the implant catheter to freely move to a location (e.g., a central location, a commissural location, etc.) between the leaflets without pulling either the first leaflet anchor 213 and the first leaflet 251, the second leaflet anchor 215 and second leaflet 253, or the third leaflet anchor 217 and third leaflet 255 along with it.

[0623] In some implementations, the implant catheter and central body 231 are then positioned at a coaptation location between the leaflets (e.g., a central location, a commissural location, etc.). Once the implant catheter is at the coaptation location, the user actuates controls (e.g., one or more handle controls, buttons, knobs, switches, touchscreens, etc.) to respectivelytighten the first, second and third controlled tethers 241, 243, 245, 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 location where the resulting device 201 (e.g., the connected anchors and the central body) will end up.

[0624] As depicted in FIG. 20, with the first, second and third leaflet anchors 213, 215, 217 connected to (e.g., in contact with) the central body 231. The anchors can be locked into position (or relative regions) with respect to the central body and one another. A variety of mechanisms can be used to effectuate 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, portions that structurally mate, interlocking portions, etc.) to lock each tethered anchor in position and / or relative to each other. In some implementations, these are locked into contact and / or stationary relative to each other (e.g., completely stationary, mostly stationary, with portions that are stationary (e.g., contact surfaces) and other portions (e.g., extensions) that can move somewhat, etc.)

[0625] Optionally, the anchor connectors can be configured to act as all or a part of the anchor-lock. Optionally, the anchors can be configured with mechanical locks that lock directly to one another as part of the anchor-lock. Optionally, distal segments of the first, second and third controlled tethers can be cut off and used as part of the anchor-lock to lock the first, second and third leaflet anchors 213, 215, 217 into position with respect to the central body and / or one another. In some implementations, distal segments of the tightened controlled tethers are cinched together toward the central body and one another, and then decoupled / detached / severed / released from their respective remaining proximal segments (and the implant catheter) to permanently hold the anchors in their final connected positions.

[0626] In some implementations, with the first, second and third leaflet anchors 213, 215, 217 locked into position with respect to the central body 231 and one another, the first, second and third controlled tethers 241, 243, 245 and the implant catheter are disconnected from the device 201 and removed from the subject’ s body (see, FIG. 14). More particularly, the second- end segment of each controlled tether is freed to advance into the implant catheter (to pass up through the anchor slidable restraints and then back down the implant catheter) while the first- end segment is continuously pulled from the implant catheter until the full length of the controlled tether comes out of the implant catheter.

[0627] In some implementations, once the first, second and third leaflet anchors 213, 215, 217 are locked into position with respect to the central body 231 and one another, the implant catheter is disconnected from the device 201 and removed from the subject’s body. Therefore, the central body 231 and the three attached anchors are freed to translate and rotate with the valves in six degrees of freedom.

[0628] By making one or more inserted anchors separable from one another (and the rest of the implant) prior to leaflet attachment, anchors can be attached to leaflets without resistance from other previously attached anchors. The device was placed without suffering the difficulties caused by leaflets having excessive spacing and movement.

[0629] While the described 3 -anchor implementation connects three leaflets on a tricuspid valve, other scenarios are also within the scope of this disclosure. For example, on a mitral valve (or any three-leaflet valve), two of the three anchors can be attached to a first leaflet while the third leaflet anchor is attached to a second leaflet. During the process of implanting, the anchors can be attached alternately to the two leaflets (e.g., to the first leaflet, then to the second, then again to the first), or the single-anchor leaflet can be attached to its anchor either before or after the leaflet with two anchors. Advantageously, this can offer additional structural support to a damaged leaflet at risk of further structural failure, and / or better attachment to a leaflet having characteristics indicating poor anchor-attachment characteristics. In some implementations, two anchors on one leaflet can be placed adjacent to each other on the leaflet (e.g., in contact, etc.) or can be placed spaced apart along the leaflet.

[0630] Using two anchors on one leaflet (which can be done with any devices herein having only two anchors, devices having three anchors, and / or devices having more anchors) and bringing them closer together can plicate a portion of the leaflet, which could help treat various leaflet issues, e.g., prolapse, etc.

[0631] With reference again to FIGS. 9-14, in some simultaneously inserted center-coupled implementations, the second leaflet anchor 115 can be inseparably connected to the central body 131 (e.g., connected to the central body without the use of a controllable anchor connector such that the second leaflet anchor cannot be controllably separated from the central body while within the body of a subject). In some implementations, this inseparably connected anchor is still separably connected to the delivery / implant catheter 111, in that the central body 131 isseparably connected to the implant catheter. In some implementations, the first leaflet anchor 113 is separably connected to the central body 131 by a first anchor connector 121.

[0632] In some implementations, the first anchor connector 121 still provides for the delivery or implant catheter 111 to position the first leaflet anchor 1 13 in a correct position for affixing to the first leaflet 151, and then after the first leaflet anchor is affixed to the first leaflet 151, to decouple / detach / sever / unfasten and thereby release the first leaflet anchor from the implant catheter, central body 131 and second leaflet anchor. The delivery / implant catheter 111 and central body 131 can then separate and move away from the first leaflet anchor 1 13, such as to position the second leaflet anchor 115 at a second position within the heart, where it can be attached to the first portion of the edge of the second leaflet 153.

[0633] In some implementations, such as with the second leaflet anchor 115 attached by a non-severable-connector (e.g., a connector that is not a severable connector), the location of the second leaflet 153 is used as a coaptation location (to the extent that the catheter remains rigidly in place). In some implementations (e.g., as described previously), the leaflet structural forces and the dynamic blood flow forces from each leaflet will determine the actual location where the resulting device 101 will end up once the anchors are locked into position with respect to the central body (and one another), and the delivery / implant catheter 111 is disconnected from the de vice 101.

[0634] Center-coupled implementations with multiple or all anchors separable can provide the user with a greater flexibility in the choice of which anchor attaches to which leaflet. Nevertheless, implementations with one or more anchors that are inseparable can provide benefits in the form of procedural simplicity of fewer connectors to decouple / detach / sever and fewer anchors to lock into position (with respect to the central body). These can also benefit from the cost and size advantages of a less complicated structure.

[0635] When combined three or more anchors, one anchor might be inseparable while the others are separable. In some implementations, two or more anchors might be inseparable while at least one is separable. In some implementations, greater flexibility during use is emphasized, e.g., with two separable anchors. In some implementations, the cost and size of a less complicated structure can be emphasized, e.g., with non or only one anchor separable.

[0636] In some simultaneously inserted center-coupled implementations, the system (e.g., controlled tether system, tether system, etc.) includes one or more multi-anchor controlled tethers that each have an anchor-tether section with a plurality of 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 a plurality of anchor-tether segment connection points) on the anchor-tether section to a respective one of the anchors having anchor connectors (thereby joining the anchor-tether segments). In forming the anchor-tether section, the anchor-tether segments can be connected at the connection points with connection mechanisms, or they can be unitary (e.g., form a unitary tether that is unitary at their connection points in their original formation). The connection points can be located at or within the central body prior to and / or after the anchor connectors are decoupled / detached / severed.

[0637] In some implementations, the system is a controlled tether system that includes an extension-tether section that is configured to extendibly fasten a primary connection point of the anchor-tether segments (and thereby to connect to their respective anchors) to the delivery / implant catheter 111 (optionally through central body 131). In some implementations, to removably make this connection, the extension-tether section serially extends (end-to-end) from an extension-tether first-end segment at a proximal end of the implant catheter system (protruding from a proximal, user end of the implant catheter), down along (through or aside) the implant catheter to its distal (implantation) end, into the central body 131 positioned at a distal end of the implant catheter, slidably received by and connecting to (loopingly passing around / through) the primary connection point of the anchor-tether segments, back out of the central body, back along (through or aside) the implant catheter to its proximal end, to an extension-tether second-end segment at the proximal end of the implant catheter system (protruding from the proximal, user end of the implant catheter system along with the extension-tether first-end segment of the extension-tether section).

[0638] In some implementations, the connection is formed between the extension- tether section and the primary connection point of the anchor- tether segments by an intermediate segment of the extension-tether section looping around the primary connection point of the interconnected anchor-tether segments. This configuration provides for the extension-tether section to be slidingly disconnected from the interconnected anchor-tether segments (by pullingon one end of the extension-tether section) once the anchor-lock constrains relative movement of the connected leaflet anchors.

[0639] In some simultaneously inserted center-coupled implementations, the controlled tethers do not extend end-to-end from the catheter proximal end to their anchors and back. Instead, each controlled tether (e.g., the first controlled tether) extends end-to-end from a first tether end (e.g., a first controlled- tether first-end segment) at a proximal end of the implant catheter system (protruding from a proximal, user end of the implant catheter), down along (through or aside) the implant catheter to its distal (implantation) end, through and out of the central body 131 positioned at (and separably connected to) a distal end of the implant catheter system, to the controlled tether’ s respective anchor.

[0640] In some implementations, at the controlled tether’s respective anchor, the controlled tether is affixed to the controlled tether’s respective anchor. Thus, the first controlled tether serially extends from a first controlled- tether first-end segment at a proximal end of the implant catheter system, through a center-body slidable restraint on a central body separably attached to a distal end of the implant catheter system (by a center-body connector), to a first controlled- tether second-end segment affixed to the controlled tether’ s respective anchor.

[0641] In some implementations, at the controlled tether’s respective anchor, it is slidably received by and passes through one or more slidable restraints along a length of the respective anchor, and then back to the central body, to which it fixedly connects. In some implementations, the first controlled tether serially extends from a first controlled-tether first- end segment at a proximal end of the implant catheter system, through a center-body slidable restraint on a central body separably attached to a distal end of the implant catheter system (by a center-body connector), through a slidable restraint on the controlled tether’s respective anchor (e.g., a first slidable restraint on a first leaflet anchor, back to a first controlled-tether second-end segment affixed to the central body.

[0642] In some implementations, each controlled tether can slidingly connect to its respective anchor at one or more locations along the anchor. In some implementations, each tether slidingly connects to the central body 131 at one location along the central body, and to the respective anchor at two locations (as depicted in FIGS. 12-13). This provides a two-point tether connection between each respective anchor and the central body to limit the orientationof the anchor when connected (e.g., when in contact with each other and / or with the central body).

[0643] In some implementations, while the anchor-affixed and center-body-affixed versions reduce both the overall required length of 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 be needed to separate one or more tether segments at the distal end of the controlled tether. The severing of the controlled tethers leaves one or more proximal tether segments for removal from the subject after implantation is complete. The tether cutter can be configured to individually cut each controlled tether, or it can be configured to cut all controlled tethers (that need to be cut) at once.

[0644] In some simultaneously inserted center-coupled implementations, rather than being in the form of a fully flexible cord such as a suture, one or more of the controlled tethers can be in a less flexible form, such as a mechanism or shaft having its bending and torsional flexibility selectively established to allow more flexibility in some degrees of freedom than in others. While limiting free independent movement of the anchors during the relevant periods of implantation, this form of controlled tether might provide some normalizing force to limit the movement and orientation of the anchors with respect to one another and the central body to limit complications from the ebb and flow of the blood during implantation. In some implementations, slack describes the extent to which the controlled tether can flexibly allow movement within its moveable degrees of freedom.

[0645] In some simultaneously inserted center-coupled implementations, the anchor is a T- shaped toggle anchor.

[0646] With reference to FIGS. 20-21, while center bodies of various implementations can be provided with a coaptation element or spacer in a variety of forms, e.g., such as a tubular braided wire formed of a nitinol mesh, a molded component, etc. In some center-coupled implementations, the central body 261 can be a spacer. In some implementations, the spacer can be a resilient spacer, e.g., a spacer formed of a pliant body (material and structure) having a functionally low pliant compressibility with respect to obstructed blood flow, etc. This pliant body can be made of a variety of materials, e.g., a rubber-like material and / or material structure (e.g., combination of materials), having elastomeric properties providing a viscous-likebehavior of low rigidity / high fluidity that leads to deformation rather than compression under a compressive load, wherein the body substantially resumes its original shape when a deforming force is removed). As such, this resilient spacer can be formed as a relatively incompressible, pliant, unitary body that is moldable under compression without significant loss of volume. Example materials can include elastomers such as a medical grade silicone, such as would be appropriate for cosmetic medical use, e.g., polymers that are non-reactive, flexible, temperature-resistant, water-resistant, and biocompatible.

[0647] A functionally low pliant compressibility with respect to obstructed blood flow of a pliant body can comprise a combination of an adequate level of pliancy, and a low enough level of compressibility, to provide for a medically relevant dimensional expansion of the pliant body into the blood flow in response to a functionally available level of force from the mechanism moving the anchors into contact with the spacer (or another type of central body). In some implementations, this can be a force leading to a dimensional expansion that has a medically significant effect on the regurgitation of blood when the pliant body is compressed with a force available from the system and / or mechanism for moving the anchors into contact with and compressing the spacer.

[0648] In some implementations, when compressed with a force between opposing surfaces of the anchors, the resilient spacer is pliant enough to conform to the shape of the anchors, and it is incompressible enough to dimensionally expand to fill in gaps therebetween and (generally) protrude out from between the anchors to the extent the coaptation forces are at a high enough level. This expansion both compliantly maintains the relative positions of the anchors, and can provide a flow-blocking obstruction to prevent or inhibit regurgitation through the valve.

[0649] In some implementations, the pliability of the resilient spacer also provides for the resilient spacer to conformingly hold the anchors in positions relative to one another such that they have a less-than-rigid connection to one another. Therefore, the anchors can move relative to one another in response to forces applied to them by the leaflets and blood flow. Thus, the resilient spacer central body can provide for connected anchors (e.g., anchors in contact with the spacer, central body, etc.) to move relative to one another, thereby adapting to the blood flow and natural movement of the leaflets during the cardiac cycle.

[0650] In some implementations, the resilient spacer material and structure is not simply adapted to be clamped down into a squished shape of reduced volume and dimensions (like existing spacers). Instead, it is sized, structurally formed, and shaped such that when it is mechanically compressed between the anchors, it compressively expands its dimensions to bulge outward and be wider and / or longer than its uncompressed shape. Thereby, potentially the resilient spacer extrudes to extend beyond the anchor opposing surfaces (e.g., in a balloonlike fashion) to fill spaces adjacent to and beyond the boundaries of the anchors in response to forces (e.g., compression forces, actuation forces, movement forces, connection forces, etc.) that are available from the system and / or mechanism (e.g., connection system adjusting connection and position between the anchors and spacer). This effect can occur because of the material and structure’s typically unitary form (e.g., it is not simply a flexible mesh on a frame) and functionally low compressibility.

[0651] In some implementations, when the first, second and third leaflet anchors 213, 215, 217 are drawn to the compliant central body 261 by their respective controlled tethers, the controlled tethers are pulled with a centering force adequate to force the anchors to act as compressive bodies that deform the compliant central body to fill all voids between the anchors, and typically, to protrude past the boundaries of the anchors into the space between the leaflets. In doing so, the leaflets are also drawn further together, which further improves the seal. In some implementations, the anchors are attached to a structural part of the compliant central body directly via the controlled tethers. The structural part can be a central, shaft-shaped catheter around which the spacer forms a pliant periphery.

[0652] Advantageously, this compliant central body allows leaflets to function and move relative to one another more normally during valve operation, particularly as compared to devices that do not use a central body, or ones that use a central body that rigidly hold leaflets.

[0653] The above-described apparatus and systems provide and / or can be used in one or more methods for treating / repairing a native valve of a subject (e.g., a living subject, a simulation, etc.), the valve having a plurality of leaflets (e.g., a first leaflet and a second leaflet, and in some cases a third leaflet). In some implementations, the method entails providing a treatment or repair device 101 mounted at a distal end of a delivery catheter or implant catheter 111. The methods can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc.

[0654] In some implementations, the device 101 includes the first leaflet anchor 113, the second leaflet anchor 115, the first anchor connector 121, and / or the system (e.g., controlled tether system, tether system, coaptation system, actuation system, connection system, etc.). In some implementations, the first anchor connector forms a decouplable / detachable / severable connection between the first leaflet anchor 113 and the delivery or implant catheter 111. In some implementations, the second leaflet anchor is connected to the implant catheter independently of the first anchor connector. In some implementations, the system is actuatable to move the first and second leaflet anchors closer together and / or into contact (e.g., with each other and / or with an optional central body, coaptation element, or spacer), even with the first connection decoupled or detached (e.g., in its decoupled state, detached state, or severed state).

[0655] In some implementations, the method includes the steps of delivering the treatment / repair device mounted on the implant catheter to the valve, positioning the first leaflet anchor 113 at the first leaflet, attaching the first leaflet anchor to the first leaflet, decoupling / detaching / severing the first anchor connector 121, positioning the 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.

[0656] In some implementations, the first anchor connector 121 is decoupled / detached / severed after the first leaflet anchor 113 is attached to the first leaflet. In some implementations, the second leaflet anchor 115 is in turn positioned at the second leaflet after the first anchor connector is decoupled / detached / severed. Once the second leaflet anchor is positioned at the second leaflet, the second leaflet anchor can be attached to the second leaflet.

[0657] In some implementations, after the first and second leaflet anchors are attached to the respective first and second leaflets (and the first anchor connector 121 is decoupled / detached / severed), the first and second leaflet anchors are moved closer together and / or into contact (with each other and / or another portion of the device) using the system (e.g., controlled tether system, tether system, coaptation system, connection system, actuation system, control system, etc.). In some implementations, once they are connected and / or moved into a desired relative position, the device 101 is released from the implant catheter.

[0658] In some implementations, this method can include the use of the anchor-lock. In some implementations, the device 101 includes the anchor-lock, which has a locking mechanism that locks the relative positions of the first and second leaflet anchors (with respect to one another). In some implementations, 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 are locked in their relative positions with respect to one another using the anchor-lock.

[0659] In some implementations, the system can originally be provided without adequate slack for the second leaflet anchor 115 to be positioned at the second leaflet without interference from the connection to the first leaflet. The method can further include controllably releasing slack on the system. In some implementations, this will generally occur after the step of decoupling / detaching / severing the first anchor connector 121, and before the step of attaching the second leaflet anchor to the second leaflet.

[0660] In the case of a valve with three leaflets, the device 101 can include the second anchor connector forming a decouplable / detachable / severable connection between the second leaflet anchor 115 and the implant catheter. In some implementations, a third leaflet anchor is connected to the implant catheter independently of the first and second anchor connectors, and the system is actuatable to move the first, second and third leaflet anchors closer and / or into contact (with each other and / or another portion of the device, e.g., a central body, spacer, edge, surface, etc.) after the first and second decouplable / detachable connections are decoupled / detached / severed.

[0661] In some implementations, after the second leaflet anchor 115 is attached to the second leaflet (of the three leaflets), the second anchor connector is decoupled / detached / severed. In some implementations, the third leaflet anchor is positioned at the third leaflet, and the third leaflet anchor is attached to the third leaflet. In some implementations, in the step of moving, the first, second and third leaflet anchors are moved closer to and / or into contact with one another (or with another portion of the device).

[0662] In some implementations of the methods in which the various systems, devices, apparatuses, etc. herein can be used, including without limitation in the above-described method for treating / repairing a native valve of a subject (e.g., a living subject, a simulation,etc.), the various systems, devices, apparatuses, etc. herein can include one or more anchors that are detached from leaflets and / or reattachable to leaflets, and the methods can include detaching one or more anchors from one or more leaflets and / or reattaching one or more anchors to one or more leaflets.

[0663] In some implementations, after an anchor connector is decoupled / detached / severed, the system (e.g., controlled tether system, tether system, coaptation system, actuation system, connection system, control system, etc.) can be used to connect the respective leaflet anchor to the implant catheter. In some implementations, the implant catheter can be used to reposition the respective anchor with respect to its leaflet (or another leaflet). In some implementations, the leaflet anchor can then be attached in that new position, and the method can proceed as before.

[0664] In some implementations, the method further can include moving the first leaflet anchor and the implant catheter using the system, detaching the first anchor connector from the first location (e.g., detaching from tissue at a first location), and attaching the first leaflet anchor at another location (e.g., a different tissue location).

[0665] The methods described above can be performed on a living subject or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc.

[0666] In some implementations, each of a plurality of leaflet anchors is consecutively inserted into the subject, some of which (a plurality) are separately pulled (independently from one another) toward and to a central body by distinct controlled tethers. Additional details of these implementations can be drawn from similar aspects of the first (simultaneously inserted, center-coupled) implementation. These consecutively inserted implementations are applicable to two- and three-leaflet valves (as is further described) and can incorporate presently used procedures for repairing three-leaflet valves using only two leaflet anchors.

[0667] FIGS. 22-27 illustrate an example of a valve repair system 2200 that includes a valve repair device 2201 with a plurality of tethered anchors 2221 that are controlled by a single actuator 2250. The valve repair device can take a variety of different forms. In some implementations, the valve repair device 2201 includes a central body 2231, a plurality of tethered anchors 2221 , and an actuator end 2251.

[0668] The central body 2231 can take a variety of different forms. In some implementations, the central body 2231 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and / or bases disclosed by this patent application. In some implementations, the central body 2231 includes a bore or passage 2235 that a shaft 2253 of the actuator end 2251 extends through.

[0669] The plurality of tethered anchors 2221 can take a variety of different forms. In some implementations, the plurality of tethered anchors can be any of the anchors disclosed by the present application. In the example illustrated by FIGS. 22-27, the anchors each include a paddle 2215 and an optional gripping member 2233, such as a clasp. In some implementations, a paddle alone can be secured to a native valve leaflet and the optional gripping member 2233 can be omitted.

[0670] The paddle 2215 can take a variety of different forms. In some implementations, the paddle 2215 can be any of the paddles disclosed by the present application. In some implementations, the paddle 2215 includes an inner arm 2260 and an outer arm 2262. The outer arm 2262 can be pivotally and / or flexibly coupled to the inner arm 2260. The outer arm 2262 can move between a closed position (FIG. 22) and an open position (FIG. 24).

[0671] In some implementations, the outer arm 2262 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the closed position and the actuator 2250 moves the outer arm to the open position against the bias. In some implementations, the outer arm 2262 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the open position and the actuator 2250 moves the outer arm to the closed position against the bias. In some implementations, the outer arm 2262 is not biased open or closed.

[0672] In some implementations, the outer arm 2262 is opened and / or closed by moving the actuator end 2251. The outer arm 2262 can be opened and / or closed by the actuator end in a variety of different ways. In some implementations, an arrangement that allows all paddles 2215 that are against the central body 2231 to be opened and / or closed by the single actuator end 2251 can be used.

[0673] In the example illustrated by FIGS. 22-26, the outer arm 2262 includes an actuation extension or link 2264. In some implementations, the actuation extension or link 2264 can be configured such that engagement of the actuation extension or link 2264 by the actuator end2251 moves the outer arm 2262 toward the open or closed position. In the example illustrated by FIGS. 22-26, upward or proximal movement of the actuation extension or link 2264 causes the outer arm 2262 to move toward the open position.

[0674] In some implementations, the inner arm 2260 of each paddle 2215 is coupled to the central body 2231 by one or more control tethers 2241. In some implementations, the one or more control tethers 2241 extend from the inner arm 2260, through the central body 2231, and through a catheter 2272, such as an implant catheter, a steerable catheter, and / or a guide sheath of a delivery system. The one or more control tethers 2241 are used to selectively pull the anchors 2221 toward the central body 2231 and to be selectively slackened to allow the central body to move away from the anchors 2221.

[0675] The actuator 2250 can take a variety of different forms. In some implementations, the actuator 2250 includes a proximal shaft 2280 and the actuator end 2251. The proximal shaft 2280 can be selectively connected and disconnected from the actuator end 2251 at a joint 2283. This allows the actuator end 2251 to be operated by the proximal shaft 2280 during implantation of the valve repair device 2201 and allows the actuator end 2251 to be disconnected at the joint 2283 and left with the remainder of the valve repair device 2201 after the implantation procedure.

[0676] The actuator end 2251 can take a variety of different forms. Any arrangement that allows all paddles 2215 that are against the central body 2231 to be opened and / or closed by the actuator end 2251 can be used. In the example illustrated by FIGS. 22-26, the actuator end 2251 includes the shaft 2253 and an actuation extension, plate, or disc 2284. In some implementations, the actuation extension, plate, or disc 2284 can be configured such that engagement of the actuation extension or link 2264 of the paddle 2215 by the actuation extension, plate, or disc 2284 moves the outer arm 2262 of the paddles toward the open or closed position. In the example illustrated by FIGS. 22-26, upward or proximal movement of actuation extension, plate, or disc 2284 causes the outer arm 2262 to move toward the open position. In some implementations, all paddles 2215 that are against the central body 2231 are moved (i.e., opened or closed) by a single movement of the actuation extension, plate, or disc 2284.

[0677] The optional gripping member 2233 can take a variety of different forms. In some implementations, the optional gripping member 2233 can be any of the gripping members or clasps disclosed herein. In some implementations, the optional gripping member 2233 includes a fixed arm 2290, a movable arm 2292, and a hinge portion 2294 that connects the fixed arm 2290 to the movable arm 2292.

[0678] In some implementations, the gripping member can have optional barbs 2237. In in some implementations, the fixed arm 2290 is fixed to the outer arm 2262 of the paddle 2215. The movable arm 2292 can be moved relative to the fixed arm 2290 between an open position (FIG. 22) and a closed position (FIG. 23). The movable arm 2292 can be moved relative to the fixed arm 2290 in a variety of different ways. In some implementations, a line 2296 (e.g., suture, wire, chord, hypotube, etc.) can be used to move the movable arm 2292. The line 2296 can be attached to the movable arm 2292 and pulled to open the gripping member 2233. In some implementations, the hinge portion 2294 is shape set and / or provides a spring bias to bias the gripping member 2233 to the closed position. Relieving tension or slackening the line 2296 allows the gripping member 2233 to move to the closed position.

[0679] FIGS. 23-27 illustrate implantation of the device 2201 onto native heart valve leaflets 20, 22 or 30, 32, 34. Referring to FIG. 23, the actuator end 2251 is moved in the direction 2300 by the proximal shaft 2280. The actuation extension, plate, or disc 2284 engages the actuation extension or link 2264 of each of the paddles that are against the central body 2231.

[0680] In some implementations, the device 2201 can include two tethered anchors 2221 when the device is configured to treat a mitral valve or two leaflets of a tricuspid valve and the device 2201 can include three tethered anchors 2221 when the device 2201 is configured to treat a tricuspid valve. The device can include any number of tethered anchors 2221.

[0681] In some implementations, the actuation extension, plate, or disc 2284 engages the actuation extension or link 2264 to move the outer arm 2262 of all of the paddles 2215 that are against the central body 2231 toward an open position as indicated by arrows 2302. One or more of the lines 2296 can be pulled in the direction indicated by arrows 2304 to move the movable arm 2292 of the gripping member 2233 toward an open position.

[0682] In some implementations, the device 2201 is moved to position a leaflet 20 in the open gripping member 2233 and the outer arm 2262 of one of the anchors 2221. In some implementations, the line 2296 can then be slackened to close the gripping member 2233 and attach the gripping member 2233 to the first leaflet 20. The actuator end 2251 is moved distally to close the outer arms 2262 of all of the paddles 2215, with the first leaflet secured in the first anchor 2221. The line 2296 can be removed from the gripping member 2233 any at any time after the first leaflet is secured in the first anchor.

[0683] Referring to FIG. 24, the one or more tethers 2241 are slackened to allow the remainder of the device 2201 to be moved away from the first leaflet 20 and the attached first anchor 2221 by one or more catheters 2272 of the valve repair system 2200.

[0684] In some implementations, the actuator end 2251 can be moved again in the direction 2300 by the proximal shaft 2280. The actuation extension, plate, or disc 2284 engages the actuation extension or link 2264 of each of the paddles that that remain against the central body 2231 again. In some implementations, the actuation extension, plate, or disc 2284 engages the actuation extension or link 2264 to move the outer arm 2262 of all of the paddles 2215 that remain against the central body 2231 toward an open position. As shown in FIG. 24, because the anchor holding the leaf is not positioned against the central body 2231 , this anchor remains closed, while the remaining anchors against the central body are opened. One or more of the lines 2296 can be pulled to move the movable arm 2292 of the gripping member 2233 toward an open position.

[0685] In some implementations, the device 2201 is moved to position a second leaflet 22 in the open gripping member 2233 and the outer arm 2262 of a second one of the anchors 2221. The line 2296 can then be slackened to close the gripping member 2233 and attach the gripping member 2233 to the second leaflet 20. The actuator end 2251 is moved distally to close the outer arms 2262 of all of the remaining paddles 2215 (e.g., paddles positioned against the central body 2231), with the second leaflet 22 secured in the second anchor 2221. The line 2296 can be removed from the gripping member 2233 any at any time after the second leaflet is secured in the first anchor.

[0686] Referring to FIG. 25, the one or more tethers 2241 that are attached to the second anchor 2221 can be slackened to allow the remainder of the device 2201 to be moved awayfrom the first leaflet and second leaflets 20, 22 and the attached first and second anchors 2221 by the one or more catheters 2272 of the valve repair system 2200.

[0687] In some implementations, this process for capturing native valve leaflets can be repeated for a third anchor 2221 and any additional anchors that are tethered to the central body to 2231. The actuator end 2251 can be moved again in the direction 2300 by the proximal shaft 2280 for each additional anchor. In some implementations, the actuation extension, plate, or disc 2284 engages the actuation extension or link 2264 of each of the paddles that that remain against the central body 2231.

[0688] In some implementations, the actuation extension, plate, or disc 2284 engages the actuation extension or link 2264 to move the outer arm 2262 of the paddles 2215 that remain against the central body 2231 toward an open position. One or more of the lines 2296 can be pulled to move the movable arm 2292 of the gripping member 2233 toward an open position.

[0689] Referring to FIG. 26, once all of the anchors 2221 are attached to a native valve leaflet (e.g., mitral valve leaflets 20, 22, or tricuspid valve leaflets 30, 32, 34) the tethers 2241 can draw the anchors 2221 back against the central body 2231 . This pulls the native heart valve leaflets toward the central body. The tethers 2241 can be tied, locked or otherwise secured together to hold the anchors 2221 against the central body 2231.

[0690] In some implementations, the anchors can be secured to the central body 2231 by something other than the tethers 2241. For example, the anchors and / or the central body 2231 can include a connection arrangement, fastener, or coupler that secures the anchors 2221 to the central body 2231 when the anchors 2221 are pulled against the central body 2231. The tethers 2241 or portions of the tethers that are proximal to an area where the tethers can be tied, locked or otherwise secured together can be removed.

[0691] Referring to FIG. 27, after the anchors 2221 are secured to the central body 2231, the catheter 2272 and the proximal shaft 2280 can be decoupled from the device 2201. This leaves the device 2201 secured to the native valve leaflets.

[0692] In some implementations, a valve repair device is configured such that tethered anchors are allowed to tilt as the tethered anchors are brought back to a central body. This can reduce stress applied to leaflet tissue as the leaflets and the tethered anchors are pulled towardthe central body. Figures 28-31 illustrate an example of a system where anchors 2821 are allowed to tilt as the anchors are pulled back to a central body 2831. In some implementations, once the anchors 2821 are moved back to the central body 2831, the anchors are rotated or pivoted to a more upright or vertical position against and / or in the central body 2831.

[0693] In the example illustrated by FIGS. 28-31 a valve repair system 2800 includes a valve repair device 2801 with a plurality of tethered anchors 2821 that are controlled by one or more catheters (not shown), such as any of the catheters disclosed herein. The valve repair device can take a variety of different forms. In some implementations, the valve repair device 2801 includes a central body 2831, and a plurality of tethered anchors 2821.

[0694] The central body 2831 can take a variety of different forms. In some implementations, the central body 2831 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and / or bases disclosed by this patent application. In some implementations, the central body 2831 includes a central post 2810, a base or bottom wall 2812, and an outer or retaining wall 2814.

[0695] The central post 2810 can take a variety of different forms. In some implementations, an outer surface of the central post 2810 can be cylindrical or can have other shapes that are compatible with the shape of the native valve leaflets. The central post 2810 can include a plurality of tether passages 2820. In some implementations, the tether passages 2820 extend from an opening 2827 near the bottom wall 2812 to a proximal end 2822 of the central body 2831.

[0696] The base or bottom wall 2812 can take a variety of different forms. In some implementations, the base or bottom wall 2812 extends radially outward from the central post 2810. The retaining wall 2814 can take a variety of different forms. In some implementations, the retaining wall 2814 extends longitudinally from an outer circumference of the base or bottom wall 2812 in a proximal direction.

[0697] The plurality of tethered anchors 2821 can take a variety of different forms. In some implementations, the plurality of tethered anchors can be any of the anchors disclosed by the present application. In the example illustrated by FIGS. 28-31, the tethered anchors 2821 includes an inner arm 2860 and an outer arm 2862.

[0698] In some implementations, the outer arm 2862 can be pivotally and / or flexibly coupled to the inner arm 2860. The outer arm 2862 can move between a closed position and an open position. In some implementations, the outer arm 2862 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the closed position relative to the inner arm 2860. In some implementations, the outer arm 2262 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the open position. In some implementations, the tethered anchors 2821 may not be biased open or closed.

[0699] The tethered anchors 2821 can be opened and closed in a variety of different ways. In some implementations, the inner arm 2860 and the outer arm 2862 can be pulled relatively apart to open and close the tethered anchors 2821.

[0700] In some implementations, the tethered anchors are coupled to the central body 2831 by one or more control tethers 2841. In some implementations, the one or more control tethers 2841 are positioned on the anchors 2821 in a manner that allow the anchors to tilt as the anchors are pulled to the central body 2831.

[0701] In the example illustrated by FIGS. 28-31 , the tethers are attached to a closed or distal end 2823 of the anchors 2821. In some implementations, the one or more control tethers 2841 extend from the closed or distal end 2823 of the anchors 2821, into the openings 2827 and through the tether passages 2820 that are through the central body 2831, and through a catheter (not shown), such as an implant catheter, a steerable catheter, and / or a guide sheath of a delivery system.

[0702] In the example illustrated by FIGS. 28-31, the system 2800 includes an optional tether guide catheter 2852. In some implementations, the optional tether guide catheter 2852 includes guide openings 2854 that the tethers 2841 extend through between the anchors 2821 and the openings 2827. In some implementations, the tether guide catheter 2852 can be moved / positioned such that the tethers 2841 first pull the anchors 2821 toward the central body 2831 and then into the central body (and / or pull the central body 2831 over the anchors 2821). When the optional tether guide catheter 2852 is omitted, the tethers can pull the anchors 2821 past or over the retaining wall 2814 and then down and into the central body 2831.

[0703] In some implementations, the one or more control tethers 2841 are used to selectively pull the anchors 2821 against and into the central body 2831 and / or to be selectively slackened to allow the central body to move away from the anchors 2821.

[0704] In some implementations, the one or more control tethers 2841, the central body 2831, and optionally, the optional tether guide catheter 2852, are configured to pull the anchors toward the central body 2831 in a tilted orientation, and then rotate or pivot the anchors to a more upright or vertical position against the central body 2831. In some implementations, the anchors 2821 remain in the more upright or vertical position against the central body 2831 when the device 2801 is implanted and removed from the delivery system.

[0705] FIGS. 28-31 illustrate implantation of the device 2801 onto native heart valve leaflets 20, 22 or 30, 32, 34 according to one or more implementations of this disclosure. Referring to FIG. 28, the tethered anchors 2821 have already been attached to two native valve leaflets 20, 22. However, the tethered anchors 2821 could be attached to any number of native valve leaflets. For example, three tethered anchors 2821 can be attached to the three leaflets 30, 32, 34 of the native tricuspid valve. The device can include any number of tethered anchors 2821.

[0706] In some implementations, once all of the anchors 2821 are attached to a native valve leaflet (e.g., mitral valve leaflets 20, 22, or tricuspid valve leaflets 30, 32, 34) the tethers 2841 can draw the anchors 2821 against the central body 2831 as indicated by arrows 2870. Referring to FIGS. 28 and 29, in some implementations, the attachment of the tethers 2841 to the closed or distal end 2823 allows the anchors 2821 to tilt (e.g., along with the natural shape of the leaflets) as the tethers 2841 draw the anchors 2821 back against the central body 2831. This can reduce stress (indicated by the arrows next to the leaflets 20, 22) on the leaflets as the leaflets are pulled toward the central body 2831.

[0707] Referring to FIG. 30, in some implementations, once the anchors 2821 are positioned against the central body 2831, the anchors are rotated or pivoted to a more upright or vertical position. The anchors can be rotated or pivoted to a more upright or vertical position in a variety of different ways. For example, in implementations with two tethers such as the example shown in FIGS. 24 and 25, the two tethers 2241 can be independently controlled tofirst allow the anchors to tilt as they are drawn to the central body 2231 and then to rotate or pivot the anchors to a more upright or vertical position against the central body 2231.

[0708] In the example illustrated by FIG. 30, the tethers 2841 are pulled into the openings 2827 to pull the anchors 2821 into the central body 2831 (and / or pull the central body 2831 over the anchors 2821). As the anchors 2821 are pulled into the central body 2831 and / or the central body 2831 is pulled over the anchors 2821, the anchors 2821 are engaged between the retaining wall 2814 and the central post 2810 to rotate or pivot the anchors to a more upright or vertical position.

[0709] When the optional tether guide catheter 2852 is included, the tether guide catheter can be advanced into the central body 2831 as the tethers 2841 are pulled into the openings 2827. As such, the tether guide catheter can assist in the pulling of the anchors 2821 into the central body 2831 (and / or pull the central body 2831 over the anchors 2821).

[0710] In some implementations, the tethers 2841 can be tied, locked or otherwise secured together to hold the anchors 2821 in the central body 2831. In some implementations, the anchors can be secured to the central body 2831 by something other than the tethers 2841 . For example, the anchors and / or the central body 2831 can include a connection arrangement, fastener, or coupler that secures the anchors 2821 to the central body 2831. The tethers 2841 or portions of the tethers that are proximal to an area where the tethers are tied, locked or otherwise secured together can be removed.

[0711] Referring to FIG. 31, in some implementations, after the anchors 2821 are secured in the central body 2831, the device 2801 can be decoupled from the delivery system. For example, locks 3100 can be placed over the tethers 2841 to secure them in place relative to the central body 2831. This leaves the device 2801 secured to the native valve leaflets.

[0712] FIGS. 32-34 illustrate an example of a valve repair device 3401 where anchors 3421 are allowed to tilt as the anchors are pulled back to a central body 3431. In some implementations, as the anchors 3421 engage the central body 3431, the anchors are rotated or pivoted to a more upright or vertical position against and / or on the central body 3431.

[0713] In the example illustrated by FIGS. 32-34 a valve repair system includes a valve repair device 3401 with a plurality of tethered anchors 3421 that are controlled by one or morecatheters (not shown), such as any of the catheters disclosed herein. The valve repair device can take a variety of different forms. In some implementations, the valve repair device 3401 includes a central body 3431, and a plurality of tethered anchors 3421.

[0714] The central body 3431 can take a variety of different forms. In some implementations, the central body 3431 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and / or bases disclosed by this patent application. In some implementations, the central body 3431 includes a central post 3410 and a base or bottom wall 3412. The central post 3410 can take a variety of different forms. An outer surface of the central post 3410 can be cylindrical or can have other shapes that are compatible with the shape of the native valve leaflets. The central post 3410 can include a plurality of tether passages 3420. In some implementations, the tether passages 3420 extend from an opening 3427 near the bottom wall 3412 to a proximal end 3422 of the central body 3431.

[0715] The base or bottom wall 3412 can take a variety of different forms. In some implementations, the base or bottom wall 3412 extends radially outward from the central post 3410.

[0716] The plurality of tethered anchors 3421 can take a variety of different forms. For example, the plurality of tethered anchors can be any of the anchors disclosed by the present application. In the example illustrated by FIGS. 32-34, the tethered anchors 3421 includes an inner arm 3460, an outer arm 3462, and a tilting flange or projection 3463. The outer arm 3462 can be pivotally and / or flexibly coupled to the inner arm 3460. The outer arm 3462 can move between a closed position and an open position. In some implementations, the outer arm 3462 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the closed position relative to the inner arm 3460. In some implementations, the outer arm 3462 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the open position. In some implementations, the tethered anchors 3421 may not be biased open or closed.

[0717] In some implementations, the tethered anchors 3421 can be opened and closed in a variety of different ways. For example, the inner arm 3460 and the outer arm 3462 can be pulled relatively apart to open and close the tethered anchors 3421. In some implementations,the tilting flange or projection 3463 is fixed to and extends from a closed end 3423 of the tethered anchors 3421.

[0718] In some implementations, the tethered anchors are coupled to the central body 3431 by one or more control tethers 3441. In some implementations, the one or more control tethers 3441 are positioned on and / or coupled to the anchors 3421 in a manner that allow the anchors to tilt as the anchors are pulled to the central body 3431. In the example illustrated by FIGS. 32-34, the tethers are attached at or near a closed end 3423 of the anchors 3421. In some implementations, the one or more control tethers 3441 extend from the closed end 3423 of the anchors 3421, into the openings 3427 and through the tether passages 3420 that are through the central body 3431 , and through a catheter (not shown), such as an implant catheter, a steerable catheter, and / or a guide sheath of a delivery system.

[0719] In some implementations, the one or more control tethers 3441 can be used to selectively pull the anchors 3421 against and onto the central body 3431 and / or to be selectively slackened to allow the central body to move away from the anchors 3421. In some implementations, the one or more control tethers 3441 and the central body 3431 are configured to pull the anchors toward the central body 3431 in a tilted orientation.

[0720] In some implementations, the anchors 3421 and the central body 3431 are configured to engage one another and rotate or pivot the anchors to a more upright or vertical position against the central body 3431. In some implementations, the anchors 3421 remain in the more upright or vertical position against the central body 3431 when the device 3401 is implanted and removed from the delivery system.

[0721] FIGS. 32-34 illustrate implantation of the device 3401 onto native heart valve leaflets 20, 22 or 30, 32, 34. Referring to FIG. 32, the tethered anchors 3421 have already been attached to two native valve leaflets 20, 22. However, the tethered anchors 3421 could be attached to any number of native valve leaflets. For example, three tethered anchors 3421 can be attached to the three leaflets 30, 32, 34 of the native tricuspid valve. The device can include any number of tethered anchors 3421 .

[0722] In some implementations, once all of the anchors 3421 are attached to a native valve leaflet (e.g., mitral valve leaflets 20, 22, or tricuspid valve leaflets 30, 32, 34) the tethers 3441 can draw the anchors 3421 against the central body 3431. Referring to FIG. 32, the attachmentof the tethers 3441 to the closed or distal end 3423 allows the anchors 3421 to tilt (e.g., along with the natural shape of the leaflets) as the tethers 3441 draw the anchors 3421 back against the central body 3431. This can reduce stress on the leaflets as the leaflets are pulled toward the central body 3431.

[0723] Referring to FIGS. 33 and 34, as the anchors 3421 are pulled against the central body 3431, the anchors are rotated or pivoted to a more upright or vertical position. In some implementations, the anchors can be rotated or pivoted to a more upright or vertical position in a variety of different ways.

[0724] In the example illustrated by FIGS. 33 and 34, the tethers 3441 are pulled into the openings 3427 to pull the tilting flanges or projections 3463 of the anchors 3421 into engagement with the base or bottom wall 3412 (and / or pull the base or bottom wall 3412 into engagement with the tilting flanges or projections 3463). In some implementations, the engagement between the tilting flanges or projections 3463 and the base or bottom wall 3412 causes the anchors 3421 to rotate or pivot to a more upright or vertical position as illustrated by FIG. 34. That is, once the anchors 3421 are pulled sufficiently close to the central body 3431 , the tilting flanges 3463 of the anchors can interact with and / or engage with the base or bottom wall 3412.

[0725] In some implementations, the tethers 3441 can be tied, locked or otherwise secured together to hold the anchors 3421 on (e.g., against) the central body 3431. In some implementations, the anchors can be secured to the central body 3431 by something other than the tethers 3441. For example, the anchors and / or the central body 3431 can include a connection arrangement, fastener, or coupler that secures the anchors 3421 to the central body 3431. The tethers 3441 or portions of the tethers that are proximal to an area where the tethers are tied, locked or otherwise secured together can be removed.

[0726] Referring to FIG. 34, after the anchors 3421 are secured in the central body 3431, the device 3401 can be decoupled from the delivery system. For example, locks 3490 can be placed over the tethers 3441 to secure them in place relative to the central body 3431. This leaves the device 3401 secured to the native valve leaflets.

[0727] FIG. 35 illustrates an example of valve repair device 3401 that includes a base or bottom wall 3412 with a tapered upper surface 3510. In some implementations, the taperedupper surface 3510 can be shaped to move the anchors 3421 more gradually to the more upright or vertical position and / or to control how upright the anchors 3421 become as the tilting flanges or projections 3463 are moved into engagement with the bottom wall 3412. In some implementations, a shallow or less inclined tapered surface 3510 will move the anchors to a more upright position. In some implementations, a steep or more inclined tapered surface 3510 will move the anchors to a less upright position.

[0728] The anchors 3421 of the FIG. 35 example can take a variety of different forms. In some implementations, the plurality of tethered anchors can be any of the anchors disclosed by the present application. In the example illustrated by FIG. 35, the tethered anchors 3421 include an inner arm 3460 coupled to an inner mounting plate 3461, an outer arm 3462 mounted to an outer mounting plate 3465 that includes the tilting flange or projection 3463, and a hinge portion 3467 that connects the inner and outer arms 3460, 3462. The outer arm 3462 can move between a closed position and an open position. In some implementations, the outer arm 3462 can be biased by the hinge portion 3467 to the closed position relative to the inner arm 3460.

[0729] The tethered anchors 3421 can be opened and closed in a variety of different ways. In some implementations, the anchors 3421 are opened by pressing or pulling on the tilting flange or projection 3463. For example, the outer arm 3462 can be biased by the hinge portion 3467 to the open position relative to the inner arm 3460 and the base or bottom wall 3412 can be moved distally or away from the tilting flange or projection 3463 to allow the outer arm 3462 to open. The base or bottom wall 3412 can be moved back into engagement with the tilting flange or projection 3463 to close the outer arm 3462. This configuration can be implanted in the same or a similar way as shown in the example of FIGS. 22-27.

[0730] FIGS. 36 and 37 are top views of an example of valve repair device 3401 that includes a base or bottom wall 3412 with extensions or petals 3610 and cutouts 3612. The anchors 3421 can be moved to the more upright or vertical position in a variety of different ways. In some implementations, the base or bottom wall 3412 is rotated to move the anchors 3421 between the tilted position and the upright position.

[0731] Referring to FIG. 36, in some implementations, the anchors are free to assume the tilted position when the cutouts 3612 are aligned with the tilting flanges or projections 3463.I l l

[0732] Referring to FIG. 37, in some implementations, rotating the base or bottom wall 3412 such that the extensions or petals 3610 engage the flanges or projections 3463 moves the anchors 3412 to the more upright or vertical position. In some implementations, the flanges or projections 3463 are tapered or inclined such that the rotation of the base or bottom wall 3412 gradually moves the anchors 3421 between the tilted position and the more upright or vertical position.

[0733] The tethered anchors 3421 can be opened and closed in a variety of different ways. In some implementations, the anchors 3421 are opened by pressing or pulling on the tilting flange or projection 3463 when the cut outs 3612 are aligned with the tilting flanges or projections 3463. For example, the outer arm 3462 can be biased by the hinge portion 3467 to the closed position relative to the inner arm 3460. With the extensions or petals 3610 out of the way of the flanges or projections 3463, the outer arm 3462 and / or the tilting flanges or projections 3463 can be pushed or pulled by an actuator to open the anchors 3421.

[0734] In the example illustrated by FIGS. 38-42, a valve repair system 5200 includes a valve repair assembly 5201 with a plurality of anchors 5221 that are controlled by one or more catheters (not shown), such as any of the catheters disclosed herein. The valve repair assembly can take a variety of different forms. In some implementations, the valve repair assembly 5201 includes a center clip 5231, and the plurality of anchors 5221.

[0735] The center clip 5231 can take a variety of different forms. In some implementations, the center clip 5231 can include a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and / or bases disclosed by this patent application. In some implementations, the center clip 5231 includes a central base 5210 and a plurality of clipping arms 5214 or an annular or semi-annular clipping wall. The central base 5210 can take a variety of different forms. An outer surface of the central base 5210 can be cylindrical or can have other shapes that are compatible with the shape of the native valve leaflets.

[0736] The plurality of clipping arms 5214 or an annular or semi-annular clipping wall can take a variety of different forms. In some implementations, the clipping arms 5214 are biased to a closed or clamping configuration (See FIG. 42). The plurality of clipping arms 5214 or anannular or semi-annular clipping wall can be elongated and / or straightened when loaded into a catheter 5252 (See FIG. 38).

[0737] In some implementations, the clipping arms 5214 can be made from a metal, such as steel or ni tinol. Any number of clipping arms can be included. In some implementations, the clipping arms 5214 are evenly spaced around a perimeter of the center base 5210 when the clipping arms are in the closed position. The size, number, and / or spacing of the clipping arms 5214 can be selected to approximate an annular wall around the center base 5210 when the clipping arms are in the closed position.

[0738] In some implementations, the clipping arms 5214 can move between a closed position and an open position. In some implementations, the clipping arms 5214 can be biased (e.g. by shape setting, etc.) to the closed position. The clipping arms can be opened and closed in a variety of different ways.

[0739] Referring to FIG. 38, clipping arms 5214 can be loaded into the catheter 5252 in an open, straightened configuration. Referring to FIGS. 39-42, the clipping arms 5214 can curl toward the closed, curved configuration, as the arms are moved out of the catheter 5252. For instance, the clipping arms 5214 can be biased to the curved configuration such that the clipping arms assume the curved configuration upon exiting the catheter.

[0740] The plurality of anchors 5221 can take a variety of different forms. In some implementations, the plurality of anchors can be any of the anchors disclosed by the present application. In the example illustrated by FIGS. 40-42, the anchors 5221 includes an inner arm 5260 and an outer arm 5262. The outer arm 5262 can be flexibly coupled to the inner arm 5260.

[0741] In some implementations, the outer arm 5262 can move between a closed position and an open position. In some implementations, the outer arm 5262 can be biased (e.g. by shape setting, etc.) to the closed position relative to the inner arm 5260. The anchors 5221 can be opened and closed in a variety of different ways, including but not limited to, any of the ways disclosed in the present application.

[0742] In some implementations, the anchors 5221 are connected to one or more tethers 5241. In some implementations, the one or more tethers 5241 can optionally be positioned on the anchors 5221 in a manner that allow the anchors to tilt as the anchors are pulled toward thecenter clip 5231. In the example illustrated by FIGS. 40-41, the tethers are attached to a closed or distal end 5223 of the anchors 5221. The one or more tethers 5241 can be used to selectively pull the anchors 5221 toward one another.

[0743] FIGS. 38-42 illustrate implantation of the device 5201 onto native heart valve leaflets 20, 22 or 30, 32, 34. In this example, the tethered anchors 5221 have already been attached to two native valve leaflets 20, 22. However, the tethered anchors 2821 could be attached to any number of native valve leaflets. For example, three tethered anchors 2821 can be attached to the three leaflets 30, 32, 34 of the native tricuspid valve. The device can include any number of tethered anchors 2821.

[0744] The anchors 5221 can be attached to the leaflets in a variety of different ways, including but not limited to any of the ways disclosed in this patent application. In some implementations, the tethers 5241 can take the form illustrated by FIG. 40 and the device 5201 can be positioned by the tethers 5241 in the manner shown in FIG. 40.

[0745] In some implementations, once all of the anchors 5221 are attached to a native valve leaflet (e.g., mitral valve leaflets 20, 22, or tricuspid valve leaflets 30, 32, 34) the tethers 5241 can draw the anchors 2821 toward one another. The catheter 5252 can be positioned for deployment with the clipping arms 5214 in the catheter in the elongated configuration (see FIG. 38.).

[0746] Referring to FIG. 40, the center clip 5231 can be pushed out of the catheter 5252 such that the clipping arms curl out of the catheter 5252 and create a space for accepting the anchors 5221. Referring to FIG. 41, the catheter 5252 moves the center clip 5231 to place the anchors 5221 in the clipping arms 5214.

[0747] Referring FIG. 42, the center clip 5231 can be moved further out of the catheter 5252 such that the clipping arms 5214 close to secure the anchors 5221 in the center clip 5231. After the anchors 5221 are secured in the center clip 5231, the device 5201 can be released from the catheter 5252.

[0748] The tethered anchors and central bodies or bases can be moved toward and away from one another in a variety of different ways. FIG. 43 illustrates an example of a system 3800 where anchors 3821 are selectively moved toward and away from a central member or body3831. In the example illustrated by FIG. 43, the system 3800 includes a plurality of anchors 3821, a plurality of tethers 3841, center member or body 3831, an implant catheter 3850, and a plurality of tether control members 3852.

[0749] The central body 3831 can take a variety of different forms. In some implementations, the central body 3831 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and / or bases disclosed by this patent application. In some implementations, the central body 3831 includes a central post 3810 and optional coupling features 3812.

[0750] The central post 3810 can take a variety of different forms. In some implementations, an outer surface of the central post 3810 can have recesses 3811 that accept the anchors 3821. In some implementations, the recesses 3811 extend along a height of the center post 3810.

[0751] The plurality of tethered anchors 3821 can take a variety of different forms. In some implementations, the plurality of tethered anchors can be any of the anchors disclosed by the present application. In the example illustrated by FIG. 43, the tethered anchors 3821 includes an inner arm 3860, and an outer arm 3862. In some implementations, the outer arm 3862 can be pivotally and / or flexibly coupled to the inner arm 3860. The outer arm 3862 can move between a closed position and an open position.

[0752] In some implementations, the outer arm 3862 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the closed position relative to the inner arm 3860. In some implementations, the outer arm 3862 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the open position. In some implementations, the tethered anchors 3821 are not biased open or closed.

[0753] The tethered anchors 3821 can be opened and closed in a variety of different ways. In some implementations, the inner arm 3860 and the outer arm 3862 can be pulled relatively apart to open and close the tethered anchors 3821. In some implementations, an optional tilting flange or projection 3863 is fixed to and extends from a closed end 3823 of the tethered anchors 3821.

[0754] In some implementations, the tethered anchors are coupled to the implant catheter 3850 by the control tethers 3841. The control tethers 3841 can take a variety of different forms. In some implementations, the control tethers 3841 can be sutures, wires, tubes such as hypo tubes, etc.

[0755] In some implementations, the control tethers 3841 are shaped and / or shapeset to extend away from the implant catheter 3850 and / or the central body 3831 when the control tethers 3841 are unconstrained.

[0756] In some implementations, the one or more control tethers 3841 are positioned on the anchors 3821 in a manner that allow the anchors to tilt as the anchors are pulled to the central body 3831 and / or the implant catheter 3850. In the example illustrated by FIG. 43, the tethers 3841 are attached at or near a closed or distal end 3823 of the anchors 3821.

[0757] In some implementations, the one or more control tethers 3841 extend from the closed or distal end 3823 of the anchors 3821 , into slots or channels 3827 that extend along the implant catheter 3850. In some implementations, the tethers 3841 are sized to be able to move laterally and / or longitudinally int and out of the slots or channels 3827.

[0758] The plurality of tether control members 3852 can take a variety of different forms. In some implementations, the tether control members 3852 comprise tubes, such as hypo tubes, plastic tubes, etc. In some implementations, the tether control members 3852 are sized to fit in and slide within the slots or channels 3827, but are too large to be pulled laterally out of the slots.

[0759] In some implementations, by distally advancing the tether control members 3852 in the slots or channels, the tethers 3841 are pulled into the slots or channels 3827. This pulls the anchors 3821 toward the implant catheter 3850. Conversely, proximately retracting the tether control members 3852 allows the tethers 3841 to flex and extend out of the slots or channels 3827. This allows the implant catheter 3850 and the anchors 3821 to move relatively apart.

[0760] In some implementations, pulling the tethers 3841 into the slots or channels 3827 moves the anchors 3821 into the recesses 3811 of the central post 3810. In some implementations, the coupling features 3812 couple the anchors 3821 to the central post 3810 when the anchors 3821 are pulled into the recesses 3811. In some implementations, thecoupling features 3812 can comprise female-type sockets while the anchors comprise a corresponding male terminal. In some implementations, the coupling features 3812 can comprise a male-terminal, while the anchors comprise a female-type socket. Other types of coupling features, including fasteners and the like can be used without departing from the scope of this disclosure.

[0761] In some implementations, an actuator is configured to both open the paddles and close the paddles and / or that is configured to increase a range of movement or stroke of the paddles. FIGS. 44-48 illustrate an example of a valve repair system that includes a valve repair device 3901 with a plurality of tethered anchors 3921 that are controlled by a single actuator 3950. In some implementations, the anchors 3921 and the actuator 3950 are configured to both open and close the anchors.

[0762] The valve repair device can take a variety of different forms. In some implementations, the valve repair device 3901 includes a central body 3931 (FIG. 44), a plurality of tethered anchors 3921, and an actuator end 3951.

[0763] The central body 3931 can take a variety of different forms. In some implementations, the central body 3931 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and / or bases disclosed by this patent application. In some implementations, the central body 3931 includes passages 3939 that tethers 3941 extend through. In some implementations, the central body 3931 includes a bore or passage 3935 that a shaft 3953 of the actuator end 3951 extends through.

[0764] The plurality of tethered anchors 3921 can take a variety of different forms. In some implementations, the plurality of tethered anchors can be any of the anchors disclosed by the present application. In the examples illustrated by FIGS. 44-48, the anchors can each include a paddle 3915, a base member 3962. In some implementations, the anchors can each include an optional gripping member 3933, such as a clasp (See FIGS. 47-48). In some implementations, a paddle alone can be secured to a native valve leaflet and the optional gripping member 3933 can be omitted.

[0765] The paddle 3915 can take a variety of different forms. In some implementations, the paddle 3915 can be any of the paddles disclosed by the present application. In someimplementations, the paddle 3915 includes a single arm 3960 coupled to a base member 3962 of the anchor 3921.

[0766] In some implementations, the single arm 3960 can be pivotally and / or flexibly coupled to the base member 3962 of the anchor 3921. The single arm 3960 can move between a closed position and an open position. In some implementations, the single arm 3960 is not biased open or closed. However, in some implementations the single arm can be biased to the closed position or the open position.

[0767] In some implementations, the single arm 3960 is opened and / or closed by moving the actuator end 3951. The single arm 3960 can optionally be opened and / or closed by the actuator end 3951 in a variety of different ways. In some implementations, the actuator end 3951 can be configured to both open and close all paddles 3915 of all the anchors that are against the central body 3931.

[0768] In the examples illustrated by FIGS. 44-48, the paddle 3915 includes an upper actuation extension or link 3964 and a lower extension or link 3965. In some implementations, the upper actuation extension or link 3964 and the lower extension or link 3965 can be configured such movement of the actuator end 3951 in a proximal direction moves the single arm 3960 toward the open position. In some implementations, the upper actuation extension or link 3964 and the lower extension or link 3965 can be configured such movement of the actuator end 3951 in a distal direction moves the single arm 3960 toward the closed position.

[0769] In some implementations, the anchors 3921 are coupled to the central body 3931 by one or more control tethers 3941. In some implementations, the one or more control tethers 3941 can be configured to bring the anchors 3921 into contact with the central body 3931. The one or more control tethers 3941 can be configured to bring the anchors 3921 into contact with the central body 3931 in any manner disclosed herein.

[0770] In some implementations, the one or more control tethers optionally extend through the central body 3931 , and through a catheter, such as an implant catheter, a steerable catheter, and / or a guide sheath of a delivery system. Thus, pulling the tethers bring the anchors 3921 into contact with the central body 3931.

[0771] In some implementations, the one or more control tethers 3941 are configured to bring the anchors 3921 toward the central body in the same manner as the example illustrated by FIG. 43. The one or more control tethers 3941 are used to selectively pull the anchors 3921 against the central body 3931 and to be selectively slackened to allow the central body to move away from the anchors 3921.

[0772] The single actuator 3950 can take a variety of different forms. In some implementations, the single actuator 3950 includes a proximal shaft 3980 and the actuator end 3951. The proximal shaft 3980 can be selectively connected and disconnected from the actuator end 3951. This allows the actuator end 3951 to be operated by the proximal shaft during implantation of the valve repair device 3901 and allows the actuator end 3951 to be disconnected and left with the remainder of the valve repair device 3901 after the implantation procedure.

[0773] The actuator end 3951 can take a variety of different forms. Any arrangement that allows all paddles 3915 that are against the central body 3931 to be opened and closed by the single actuator end 3951 can be used.

[0774] In the examples illustrated by FIGS. 44-48, the actuator end 3951 includes the shaft 3953, a lower actuation extension, plate, or disc 3984, and an upper actuation extension, plate, or disc 3985. The lower actuation extension, plate, or disc 3984, and the upper actuation extension, plate, or disc 3985 can be configured such that engagement of the upper actuation extension or link 3964 an / or the lower extension or link 3965 by the lower actuation extension, plate, or disc 3984, and / or the upper actuation extension, plate, or disc 3985 moves the single arm 3960 of the paddles toward the open or closed position.

[0775] In the examples illustrated by FIGS. 44-48, upward or proximal movement of the lower actuation extension, plate, or disc 3984, and the upper actuation extension, plate, or disc 3985 causes the single arm 3862 to move toward the open position. For example, the lower actuation extension, plate, or disc 3984 engages the lower extension or link 3965 and the upper actuation extension, plate, or disc 3985 engages the upper actuation extension or link 3964 when the actuator end 3951 is moved proximally as indicated by arrow 3991. This opens the single paddle arm 3960.

[0776] In the examples illustrated by FIGS. 44-48, downward or distal movement of the lower actuation extension, plate, or disc 3984, and the upper actuation extension, plate, or disc 3985 causes the single arm 3862 to move toward the closed position. For example, the upper actuation extension, plate, or disc 3985 engages the lower extension or link 3965 when the actuator end 3951 is moved distally (opposite of arrow 3991). This closes the single paddle arm 3960. In some implementations, all paddles 3915 that are against the central body 3931 are moved (i.e., opened or closed) by a single movement of the actuator end 3951.

[0777] Referring to FIGS. 47 and 48, the optional gripping member 3933 can take a variety of different forms. In some implementations, the optional gripping member 3933 can be any of the gripping members or clasps disclosed herein. In the example illustrated by FIG. 47, the optional gripping member 3933 includes a gripping arm 4290, an actuating arm 4292, and a pivoting portion 4294 that connects the gripping arm 4290 to the actuating arm 4292.

[0778] In the example illustrated by FIG. 48, the optional gripping member 3933 includes a first arm 3990, a second arm 3992, and a hinge portion 3994 that connects the first arm 3990 to the second arm 3992. In some implementations, the gripping members can have optional barbs 3937. In in some implementations, the gripping member 3933 is pivotally connected to the base member 3962 of the anchor 3921.

[0779] In the example illustrated by FIG. 47, the gripping member 3933 is configured to capture a leaflet between the single paddle arm 3960 and the gripping arm 4290. In some implementations, the closed position is when the gripping arm is as close as possible to the single paddle arm 3960.

[0780] In the example illustrated by FIG. 48, the gripping member 3933 is configured to capture a leaflet between the first arm 3990 and the second arm 3992. In some implementations, the closed position is when the second arm 3992 is as close as possible to the first arm 3990. The second arm 3992 can be moved relative to the first arm 3990 between an open position and a closed position.

[0781] In the example illustrated by FIG. 47, the gripping arm 4290 can be moved to the open position in a variety of different ways. In some implementations, a line 4296 (e.g., suture, wire, chord, hypotube, etc.) can be used to hold the base member 3962 while a catheter 4297 is advanced in direction 4298. This advancing of the catheter 4297 engages the actuating arm4292 to open the gripping member 3933. In some implementations, a biasing member 4299, such as a spring, can provide a spring bias to bias the gripping member 3933 to the closed position. Retracting the catheter 4297 allows the gripping member 3933 to move to the closed position.

[0782] In the example illustrated by FIG. 48, The second arm 3992 can be moved to the open position in a variety of different ways. For example, a line 3996 (e.g., suture, wire, chord, hypotube, etc.) can be used to move the second arm 3992. The line 3996 can be attached to the second arm 3992 and pulled to open the gripping member 3933. In some implementations, the hinge portion 3994 is shape set and / or provides a spring bias to bias the gripping member 3933 to the closed position. Relieving tension or slackening the line 3996 allows the gripping member 3933 to move to the closed position.

[0783] The device 3901 can be implanted onto native heart valve leaflets 20, 22 or 30, 32, 34. The actuator end 3951 is moved in the direction 3991 by the proximal shaft. The lower actuation extension, plate, or disc 3984 engages the lower extension or link 3965 and the upper actuation extension, plate, or disc 3985 engages the upper actuation extension or link 3964 of each of the paddles that are against the central body 3931 when the actuator end 3951 is moved proximally as indicated by arrow 3991.

[0784] In some implementations, the device 3901 can include two tethered anchors 3921 when the device is configured to treat a mitral valve or two leaflets of a tricuspid valve and the device 3901 can include three tethered anchors 3921 when the device 3901 is configured to treat a tricuspid valve. The device can include any number of tethered anchors 3921. In some implementations, all of the paddles 3915 that are against the central body 3931 are moved toward an open position when the actuator end 3951 is moved proximally.

[0785] In the example illustrated by FIG. 47, the line 4296 can be pulled while the catheter 4297 is advanced to engage the actuating arm 4292 and move the gripping arm 4290 of the gripping member 3933 toward the open position, away from the single paddle arm 3960. The gripping member 3933 can be biased to the closed position in the FIG. 47 example.

[0786] In the example illustrated by FIG. 48, one or more of the lines 3996 can be pulled to move the second arm 3992 of the gripping member 3933 toward to the open position, awayfrom the first arm 3990. The gripping member 3933 can be biased to the closed position in the FIG. 48 example.

[0787] In some implementations, the device 3901 can be implanted by being moved to position a leaflet 20 in the open paddle arm 3960 and / or the optional open gripping member 3933. When the gripping member 3933 is biased closed, the catheter 4297 can be retracted (FIG. 47) or the line 3996 can be slackened (FIG. 48) to close the gripping member 3933 and attach the gripping member 3933 to the first leaflet 20. In some implementations, the actuator end 3951 can optionally be moved distally to close the first arm 3960 of all of the paddles 3915, with the first leaflet secured in the first anchor 3921. The catheter 4297 or the line 3996 can be removed from the gripping member 3933 any at any time after the first leaflet is secured in the first anchor.

[0788] In some implementations, the one or more tethers 3941 are slackened to allow the remainder of the device 3901 to be moved away from the first leaflet 20 and the attached first anchor 3921 by one or more catheters of the valve repair system. This process can be repeated to attach all the anchors 3921 to the leaflets.

[0789] In some implementations, once all the anchors 3921 are attached to a native valve leaflet (e.g., mitral valve leaflets 20, 22, or tricuspid valve leaflets 30, 32, 34) the tethers 3941 can draw the anchors 3921 back against the central body 3931. This pulls the native heart valve leaflets toward the central body 3931.

[0790] In some implementations, the tethers 3941 can be tied, locked or otherwise secured together to hold the anchors 3921 against the central body 3931. In some implementations, the anchors can be secured to the central body 3931 by something other than the tethers 3941. For example, the anchors and / or the central body 3931 can include a connection arrangement, fastener, or coupler that secures the anchors 3921 to the central body 3931 when the anchors 3921 are pulled back against the central body 3931. The tethers 3941 or portions of the tethers that are proximal to an area where the tethers are tied, locked or otherwise secured together can be removed.

[0791] In some implementations, after the anchors 3921 are secured to the central body 3931 , the actuator end 3951 is moved distally (opposite of arrow 3991). This movement causes the upper actuation extension, plate, or disc 3985 to engage the lower extensions or links 3965of all of the paddle arms 3960 to close all of the paddle arms. In some implementations, the actuator end 3951 can be secured in place to set the closed position of the paddle arms. The delivery system components can be decoupled from the device 3901, leaving the device 3901 secured to the native valve leaflets.

[0792] FIGS. 49-56 illustrate an example of a valve repair system 4400 that includes a valve repair device 4401 and a delivery system 4403. The valve repair device 4401 includes a plurality of tethered anchors 4421 that are controlled by a plurality of spools 4450. The valve repair device can take a variety of different forms. In some implementations, the valve repair device 4401 includes a central body 4431 , a plurality of tethered anchors 4421 , and the plurality of spools 4450.

[0793] The central body 4431 can take a variety of different forms. In some implementations, the central body 4431 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and / or bases disclosed by this patent application. In some implementations, the central body 4431 includes a bore 4435 that the spools 4450 are rotatably disposed in. The central body 4431 can accept one or more shafts 4453 that are configured to rotate the spools 4450.

[0794] The plurality of tethered anchors 4421 can take a variety of different forms. In some implementations, the plurality of tethered anchors can be any of the anchors disclosed by the present application. In the example illustrated by FIGS. 49-56, the anchors 4421 each include a gripping member 4433, such as a clasp.

[0795] In some implementations, the tethered anchors 4421 can optionally be connected to the central body 4431 by an optional biasing member 4432, such as a spring, a shape set arm or wire, etc. The biasing member can bias the tethered anchors to a selected position. For example, the optional biasing member 4432 can bias the anchors 4421 away from the central body 4431 (see the anchor 4421 on the right in FIG. 50).

[0796] In some implementations, the optional biasing member 4432 can bias the anchors 4421 toward from the central body 4431. When the optional biasing member 4432 is configured to bias the anchors 4421 toward from the central body 4431, the central body 4431 can be moved away from the anchors 4421 due to attachment of the anchors to the leaflets and / or due to movement of the leaflets.

[0797] The gripping member 4433 can take a variety of different forms. In some implementations, the gripping member 4433 can be any of the gripping members or clasps disclosed herein. In some implementations, the gripping member 4433 includes a fixed arm 4490, a movable arm 4492, and a hinge portion 4494 that connects the fixed arm 4490 to the movable arm 4492. The gripping member can have optional barbs 4437.

[0798] In in some implementations, the fixed arm 4490 is fixed to the biasing member 4432. The movable arm 4492 can be moved relative to the fixed arm 4490 between an open position (left anchor in FIG. 50) and a closed position (right anchor in FIG. 50).

[0799] The movable arm 4492 can be moved relative to the fixed arm 4490 in a variety of different ways. In some implementations, further tensioning of tethers 4441 by the spools 4450 after the anchors 4421 are pulled up to the central body 4431 can cause the movable arm 4492 to open. The tethers 4441 can be attached to the movable arm 4492 and pulled to open the gripping member 4433.

[0800] In some implementations, the hinge portion 4494 is shape set and / or provides a spring bias to bias the gripping member 4433 to the closed position. Relieving tension or slackening the tether 4441 allows the gripping member 4433 to move to the closed position. Further slackening of the tether 4441 after the gripping member 4433 has moved to the closed position allows the anchor 4421 and the central body 4431 to be moved relatively apart.

[0801] In some implementations, the anchors 4421 are coupled to the central body 4431 by one or more control tethers 4441. The one or more control tethers 4441 can extend from the movable arm 4492, into the central body 4431, and are wrapped around the spools 4450.

[0802] In some implementations, the one or more control tethers 4441 can be used to selectively pull the anchors 4421 against the central body 4431. In some implementations, once the anchors 4421 are against the central body 4431, the control tethers 4441 can be further pulled to move the anchors 4421 to the open position. The tethers 4441 can also be slackened to allow the anchors to close and allow the central body to move away from the anchors 4421.

[0803] The delivery system 4403 for implanting the device 4401 on a native heart valve can take a variety of different forms. In the example illustrated by FIGS. 49-56, the deliverysystem includes a catheter 4480 and a plurality of shafts 4453 that are configured to rotate the spools 4450.

[0804] In some implementations, the catheter 4480 can be releasably coupled to the central body 4431 of the device 4401. In some implementations, the plurality of shafts 4453 can be concentric shafts. A smallest of the shafts 4453 can be extended into the central body 4431 and to a distal one of the spools 4450, through any spools that are proximal to the distal spool. A middle sized one of the shafts 4453 can be extended into the central body 4431 and to a middle one of the spools, through any spools that are proximal to the middle spool. A largest sized one of the shafts 4453 can be extended into the central body 4431 and into a proximal one of the spools. The system 4400 can have any number of spools 4450 and associated shafts 4453. When the device 4401 includes two spools 4450, there is no middle spool or associated shaft. When the device 4401 includes more than three spools and shafts, the device includes more than one middle spool.

[0805] In some implementations ,when a shaft 4453 is engaged with its respective spool 4450, the shaft can rotate the spool in a first direction to selectively pull the anchors 4421 against the central body 4431 and then to pull the anchors 4421 to the open position. The tethers 4441 can rotate the spool 4450 in a second direction to selectively slacken the tethers to allow the anchors to close and then allow the central body to move away from the anchors 4421.

[0806] FIGS. 51-56 illustrate implantation of the device 4401 onto native heart valve leaflets 20, 22 or 30, 32, 34. Referring to FIG. 51, a middle one of the spools 4450 is rotated by the middle one of the shafts 4453. However, the spools can be used in any order. Rotation of the spool 4450 pulls on the corresponding tether 4441.

[0807] In some implementations, the tether 4441 pulls on the movable arm 4492 to open the anchor 4421. The device 4401 is moved by the delivery system 4403 to position a leaflet 20 in the open gripping member 4433 either before or after the anchor 4421 is opened.

[0808] Referring to FIG. 52, the tether 4441 can then be slackened by rotating the spool in the opposite direction (opposite to the direction that opened the gripping member) to close the gripping member 4433 and attach the gripping member 4433 to the first leaflet 20.

[0809] Referring to FIG. 53, the tether(s) 4441 of the anchor connected to the leaflet 20 is slackened to allow the remainder of the device 4401 to be moved away from the first leaflet 20 and the attached first anchor 4421 by the delivery system 4403. In some implementations, the optional biasing member 4432 biases the anchor 4421 attached to the first leaflet 20 away from the central body 4431 when the tether 4441 is slackened.

[0810] Referring to FIG. 53, a distal one of the spools 4450 is rotated by an inner or smallest one of the shafts 4453. Again, the spools can be used in any order. Rotation of the spool 4450 pulls on the corresponding tether 4441. The tether 4441 pulls on the movable arm 4492 to open the anchor 4421. The device 4401 is moved by the delivery system 4403 to position a leaflet 22 in the open gripping member 4433.

[0811] Referring to FIG. 54, the tether 4441 can then be slackened to close the gripping member 4433 and attach the gripping member 4433 to the second leaflet 22. The tether 4441 of the anchor connected to the leaflet 22 can be slackened to allow the remainder of the device 4401 to be moved away from the second leaflet 20 to allow the device to capture any additional leaflets. This process can be repeated for each spool, shaft and native valve leaflet.

[0812] Referring to FIG. 55, once all of the anchors 4421 are attached to a native valve leaflet (e.g., mitral valve leaflets 20, 22, or tricuspid valve leaflets 30, 32, 34) shafts 4453 can be rotated, to rotate the spools 4450, and pull on the tethers 4441 to draw the anchors 4421 back against the central body 4431. In some implementations the spools are not rotated so far that the anchors start to reopen. In some implementations, there can be a tactile indicator provided to an operator (e.g., increased resistance in the tether) that indicates the that further rotation of the spool can cause the anchors to reopen. In this manner, the tethers 4441 pull the native heart valve leaflets toward the central body. The spools 4450 can be locked or otherwise secured to hold the anchors 4421 against the central body 4431.

[0813] Referring to FIG. 56, after the anchors 4421 are secured to the central body 4431, the delivery system 4403 can be decoupled from the device 4401. This leaves the device 4401 secured to the native valve leaflets.

[0814] In some implementations, anchors are movable toward and away from on another by attaching the anchors to an expandable / expansion member 21018. The expandable / expansion member 21018 can take a variety of different forms. Referring to FIG.57A, an example of a valve repair device 5701 includes an expandable / expansion member 21018 and a plurality of anchors 5721.

[0815] The expandable / expansion member 21018 can take a variety of different forms. In some implementations, the expandable / expansion member 21018 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and / or bases disclosed by this patent application. In some implementations, the expandable / expansion member 21018 can include structure configured to mount an actuation mechanism 21020 (FIG. 59) within the expandable / expansion member 21018.

[0816] In some implementations, the proximal end portion 21022 (FIGS. 57-63) of the expandable / expansion member 21018 includes a first pair of radially opposed openings 21036, and a second pair of radially opposed openings 21038 distal to the first pair of radially opposed openings 21036 and the distal end portion 21024 of the expandable / expansion member 21018 includes a third pair of radially opposed openings 21040.

[0817] In some implementations, the actuation mechanism 21020 is configured as a threaded connection. Referring to FIG. 59, the example actuation mechanism 21020 includes a distal member 21042 (e.g., tube, body, shaft, etc.) configured to threadably couple with a proximal member 21044 (e.g., tube, body, shaft, etc.). The distal member 21042 and the proximal member 21044 can be configured in a variety of ways. In the illustrated example, the distal member 21042 is formed as a cylindrical tube having a circular cross section. In some implementations, however, the distal member 21042 can have a shape other than cylindrical (e.g., a cross section that is oval, rectangular, elliptical, or other suitable shape).

[0818] In some implementations, the distal member 21042 includes a proximal end 21046, a distal end 21048 opposite the proximal end 21046, and an inner passage 21050 extending through the distal member 21042 from the proximal end 21046 to the distal end 21048. The inner passage 21050 includes female threads 21052 (FIGS. 60-61) for threadably coupling with the proximal member 21044.

[0819] In some implementations, the distal member 21042 is sized to be received within the passage 21027 of the expandable / expansion member 21018. In some implementations, the distal member 21042 includes structure for fixing the distal member 21042 in position within the passage 21027 relative to the expandable / expansion member 21018. In the illustratedexample, the distal end 21048 includes a pair of opposed projections 21054 configured to be received within the third pair of radially opposed openings 21040, as shown in FIGS. 60-63.

[0820] In some implementations, the proximal member 21044 is formed as a cylindrical tube having a circular cross section. In some implementations, the proximal member 21044 can have a shape other than cylindrical (e.g., a cross section that is oval, rectangular, elliptical, or other suitable shape).

[0821] In some implementations, the proximal member 21044 includes a proximal end 21056, a distal end 21058 opposite the proximal end 21056, and an inner passage 21059 extending through the proximal member 21044 from the proximal end 21056 to the distal end 21058.

[0822] In some implementations, the proximal member 21044 can include male threads 21060 (FIGS. 60-61) extending along at least a portion of the exterior of the proximal member 21044. The male threads 21060 are configured to mate with the female threads 21052 of the distal member 21042.

[0823] In some implementations, the proximal member 21044 is sized to be received within the passage 21027 of the expandable / expansion member 21018. In some implementations, the actuation mechanism 21020 can include structure for restricting axial movement of the proximal member 21044 within the passage 21027 relative to the expandable / expansion member 21018.

[0824] In some implementations, the structure restricts axial movement of the proximal member 21044 within the passage 21027 relative to the expandable / expansion member 21018 while allowing rotational movement of the proximal member 21044 relative to the expandable / expansion member 21018. The structure for restricting axial movement of the proximal member 21044 can be configured in a variety of ways.

[0825] In some implementations, the actuation mechanism 21020 includes a circumferential, radially extending ridge 21062 at the proximal end 21056. In some implementations, the ridge 21062 is configured to engage with a stop 21064 and an end cap 21066 to restrict axial movement of the proximal member 21044 within the passage 21027. The stop 21064 can be configured in a variety of ways. In some implementations, the stop21064 is configured to inhibit movement of the proximal member 21044 distally within the passage 21027.

[0826] In some implementations, the stop 21064 is formed as a ring having a central passage 21068 sized to receive a portion of the proximal member 21044 therethrough. In some implementations, the stop 21064 is further sized to be received within the passage 21027.

[0827] In some implementations, the stop 21064 can include structure configured to fix the position of the stop 21064 relative to the expandable / expansion member 21018. In some implementations, the stop 21064 includes a pair of opposed projections 21070 configured to be received within the second pair of radially opposed openings 21038 of the expandable / expansion member 21018, as shown in FIGS. 60-63.

[0828] The end cap 21066 can be configured in a variety of ways. In some implementations, the end cap 21066 is configured to inhibit movement of the proximal member 21044 proximally within the passage 21027. In some implementations, the end cap 21066 is formed as a ring having a distal end 21072, a proximal end 21074 opposite the distal end 21072, and a central passage 21076 extending through the end cap 21066 from the distal end 21072 to the proximal end 21074.

[0829] In some implementations, the central passage 21076 is sized to receive at least a portion of the proximal end 21056 of the proximal member 21044. In some implementations, the proximal end 21056 of the proximal member 21044 can further include one or more engagement surfaces 21077 accessible through the central passage 21076 of the end cap 21066. In some implementations, the one or more engagement surfaces 21077 are configured to be engaged to rotate the proximal member 21044.

[0830] In some implementations, the end cap 21066 is further sized to be received within the passage 21027. In some implementations, the end cap 21066 can include structure configured to fix the position of the end cap 21066 relative to the expandable / expansion member 21018.

[0831] In some implementations, the end cap 21066 includes a pair of opposed projections 21078 at the distal end 21072 that are configured to be received within the first pair of radiallyopposed openings 21036 of the expandable / expansion member 21018, as shown in FIGS. 60- 63.

[0832] In some implementations, the end cap 21066 can include a radial flange 21080 at the proximal end 21074 configured to inhibit over insertion of the end cap 21066 into the passage 21076.

[0833] Referring to FIGS. 60-63, in some implementations, when assembled, the actuation mechanism 21020 can move the expandable / expansion member 21018 between the first and the second configurations. In particular, the distal member 21042 is received within the passage 21027 of the expandable / expansion member 21018.

[0834] In some implementations, the pair of opposed projections 21054 on the distal member 21042 are received within the third pair of radially opposed openings 21040 thus both axially and rotationally fixing the distal member 21042 relative to the expandable / expansion member 21018.

[0835] In some implementations,...

Claims

1. What is claimed is:

1. A valve repair device comprising: a central body; a plurality of anchors, each anchor comprising: a mounting plate having a first alignment feature for engaging a corresponding second alignment feature of the central body; and a paddle, wherein the paddle is attached to the mounting plate; wherein each of the plurality of anchors can be individually released from the central body and re-engaged with the central body; and wherein the first alignment feature engages the second alignment feature of the central body to align the anchor in a desired position relative to the central body.

2. The valve repair device of claim 1 , wherein the first alignment feature comprises a protrusion and the second alignment feature comprises an opening.

3. The valve repair device of claim 2, wherein the first alignment feature comprises a rectangular protrusion or a cross-shaped protrusion and the second alignment feature comprises a rectangular opening or a cross-shaped opening.

4. The valve repair device of claim 2, wherein the first alignment feature comprises at least a portion of a cylinder and the second alignment feature comprises a rounded groove in the central body.

5. The valve repair device of claim 1, wherein the first alignment feature comprises an opening and the second alignment feature comprises a protrusion.

6. The valve repair device of claim 4, wherein the first alignment feature comprises a rectangular opening or a cross-shaped opening and the second alignment feature comprises a rectangular protrusion or a cross-shaped protrusion.

7. The valve repair device of claim 1, wherein the first alignment feature comprises a locking eyelet extending from the mounting plate and wherein the second alignment feature comprises an opening in the central body for receiving the locking eyelet.

8. The valve repair device of any of claims 1-7, further comprising: one or more tethers extending from the central body to the mounting plate of an anchor of the plurality of anchors, wherein releasing tension on a tether of the one or more tethers allows the anchor to move away from the central body, and wherein applying tension to the tether pulls the anchor into engagement with the central body.

9. The valve repair device of claim 8, wherein the central body comprises a central bore and the one or more tethers extend through the central bore and out of an opening in the central body that is arranged proximal of the second alignment feature.

10. The valve repair device of any of claims 8, wherein the central body comprises a central bore and the one or more tethers extend through the central bore and out of an opening in the central body that is arranged distal of the second alignment feature.

11. The valve repair device of any of claims 8, wherein the central body comprises a central bore and the one or more tethers extend through the central bore and out of an opening in the central body that is arranged to one side of the second alignment feature.

12. The valve repair device of any of claims 8 or 11, wherein the central body comprises a central bore and one or more tethers extend through the central bore and out of openings in the central body that are arranged on two sides of the second alignment feature.

13. The valve repair device of any of claims 8-12, further comprising: a locking member; a locking surface of the central body; wherein the one or more tethers extend between the locking member and the locking surface; and wherein the one or more tethers are locked by compressing the one or more tethers between the locking member and the locking surface.

14. The valve repair device of claim 13, wherein the locking member and the locking surface have a tapered shape.

15. The valve repair device of any of claims 13-14, wherein the locking member and the locking surface have a frustoconical shape.

16. The valve repair device of any of claims 8-15, wherein a single tether extends from the central body, through the mounting plate of the anchor, and back into the central body.

17. The valve repair device of any of claims 1—16, wherein the paddles of the anchors are independently opened by actuation elements engaging each of the paddles.

18. The valve repair device of claim 17, wherein each of the anchors further comprise a gripping member, the gripping member comprising a first arm connected to a second arm by a hinge portion, wherein the first arm of the gripping member is attached to the mounting plate.

19. The valve repair device of claim 18, further comprising a second mounting plate attached to the second arm of the gripping member, the second mounting plate comprising a routing flange, wherein an actuation element extends through an opening in the routing flange so that retracting the actuation element in a proximal direction through the central body causes the gripping member to open.

20. The valve repair device of any of claims 1-19, wherein the mounting plate comprises a bore and an actuation element extends through the bore of the mounting plate to engage the paddle.

21. The valve repair device of claim 20, wherein extending the actuation element in a distal direction causes the paddle to open; and wherein retracting the actuation element in a proximal direction causes the paddle to close.

22. The valve repair device of claim 20, wherein rotating the actuation element in a first direction causes the paddle to open; and wherein rotating the actuation element in a second direction causes the paddle to close.

23. A valve repair device comprising: a central body; a plurality of anchors; a plurality of tethers attached to the plurality of anchors, wherein the plurality of tethers are configured to pull the plurality of anchors toward the central body and to allow the plurality of anchors to be spaced apart from the central body; an actuator operatively coupled to the plurality of anchors when the plurality of anchors are pulled against the central body by the tethers; and wherein the actuator is configured to open the plurality of anchors that are against the central body.

24. A valve repair system comprising: a delivery system comprising one or more catheters and a control handle; a valve repair device coupled to the one or more catheters, the valve repair device comprising: a central body; a plurality of anchors;a plurality of tethers attached to the plurality of anchors, wherein the plurality of tethers are configured to pull the plurality of anchors toward the central body and to allow the plurality of anchors to be spaced apart from the central body; and an actuator operatively coupled to the plurality of anchors when the anchors are pulled against the central body by the tethers, wherein the actuator is configured to open the plurality of anchors that are against the central body.

25. A valve repair device comprising: a central body; a plurality of anchors; a plurality of tethers attached to the plurality of anchors; wherein the plurality of tethers are configured to pull the plurality of anchors toward the central body; wherein a connection between each tether and each anchor allows the plurality of anchors to assume a tilted position relative to the central body as the plurality of anchors are pulled toward the central body; and wherein the plurality of anchors and the central body are configured to move the plurality of anchors from the tilted position to a more upright position relative to the central body.

26. A valve repair system comprising: a delivery system comprising one or more catheters and a control handle;a valve repair device coupled to the one or more catheters, the valve repair device comprising: a central body; a plurality of anchors; a plurality of tethers, each tether attached to a corresponding anchor of the plurality of anchors; wherein the plurality of tethers are configured to pull the plurality of anchors toward the central body; wherein a connection between each tether and the corresponding anchor allows the plurality of anchors to assume a tilted position relative to the central body as the plurality of anchors are pulled toward the central body; and wherein the plurality of anchors and the central body are configured to move the plurality of anchors from the tilted position to a more upright position relative to the central body.

27. A valve repair device comprising: a central body; a plurality of spools disposed in the central body; a plurality of anchors; and a plurality of tethers, each tether wound around a corresponding spool of the plurality of spools and each tether attached to a corresponding anchor of the plurality of anchors.

28. A valve repair system comprising: a delivery system comprising one or more catheters and a control handle;a valve repair device coupled to the one or more catheters, the valve repair device comprising: a central body; a plurality of spools disposed in the central body; a plurality of anchors; and a plurality of tethers, each tether of the plurality of tethers wound around a corresponding spool of the plurality of spools and each tether attached to a corresponding anchor of the plurality of anchors.

29. A valve repair device comprising: a center clip; a plurality of anchors; and wherein the center clip is configured to capture the plurality of anchors after the plurality of anchors have been attached to leaflets of a native heart valve.

30. A valve repair system comprising: a delivery system comprising one or more catheters and a control handle; a valve repair device coupled to the one or more catheters, the valve repair device comprising: a center clip; a plurality of anchors; and wherein the center clip is configured to capture the plurality of anchors after the plurality of anchors have been attached to leaflets of a native heart valve.

31. A valve repair device comprising: a central body having a plurality of expandable strips; a plurality of anchors attached to the plurality of expandable strips; and wherein the expandable strips are configured to move the plurality of anchors inward and outward.

32. A valve repair system comprising: a delivery system comprising one or more catheters and a control handle; a valve repair device coupled to the one or more catheters, the valve repair device comprising: a central body having a plurality of expandable strips; a plurality of anchors attached to the plurality of expandable strips; and wherein the expandable strips are configured to move the plurality of anchors inward and outward.

33. A valve repair device comprising: a central body; and a plurality of anchors each anchor comprising a paddle and a gripping member, the paddle connected to the central body, wherein the gripping members are configured to move toward and away from the central body while the paddles are connected to the central body and the gripping members are coupled to the paddles.

34. A valve repair system comprising:a delivery system comprising one or more catheters and a control handle; a valve repair device coupled to the one or more catheters, the valve repair device comprising: a central body; and a plurality of anchors each anchor comprising a paddle and a gripping member, the paddle connected to the central body, wherein the gripping member is configured to move toward and away from the central body while the paddle is connected to the central body and the gripping member is coupled to the paddle.

35. A valve repair device comprising: a first anchor; a second anchor; and a coupling member attached to the first anchor and the second anchor, wherein the coupling member is configured to allow the first anchor to move relatively away from the second anchor during diastole, and wherein the coupling member is configured to pull the first anchor relatively toward the second anchor during systole.

36. A valve repair system comprising: a delivery system comprising one or more catheters and a control handle; a valve repair device coupled to the one or more catheters, the valve repair device comprising:a first anchor; a second anchor; and a coupling member attached to the first anchor and the second anchor, wherein the coupling member is configured to allow the first anchor to move relatively away from the second anchor during diastole, and wherein the coupling member is configured to pull the first anchor relatively toward the second anchor during systole.

37. A valve repair device comprising: a central body; a plurality of tethers coupled to the central body; a plurality of anchors coupled to the central body via the plurality of tethers, wherein the plurality of tethers is configured to pull the plurality of anchors toward the central body; and an actuator coupled to the central body, wherein the actuator is configured to open and / or close anchors of the plurality of anchors that are pulled against the central body.

38. A valve repair device comprising: a central body comprising a bore; an actuation element extending through the bore of the central body, wherein the actuation element comprises a worm gear attached to a distal end of the actuation element;a plurality of anchors, each anchor comprising a paddle, the paddle comprising a first arm that is hingeably attached to a second arm by a hinge portion, wherein the hinge portion comprises an actuation gear that engages the worm gear of the actuation element, and wherein rotation of the actuation gear by the worm gear moves the paddle between an open condition and a closed condition; wherein responsive to rotation of the actuation element in a first direction, the second arm of the paddle moves toward the open condition; and wherein responsive to rotation of the actuation element in a second direction, the second arm of the paddle moves toward the closed condition.

39. A valve repair device comprising: a central body; a plurality of anchors, an anchor of the plurality of anchors comprising a gripping member, the gripping member comprising: a first arm; a second arm; and a hinge portion hingeably connecting the first arm to the second arm; a pivot arm connected to the central body and extending from the central body, through the second arm, and back to the central body; an actuation element extending through a bore of the central body; an actuation arm connected to the actuation element and to the first arm of the gripping member; wherein responsive to movement of the actuation element in a proximal direction, the second arm pivots in an opening direction; andwherein responsive to movement of the actuation element in a distal direction, the second arm pivots in a closing direction.

40. A valve repair device comprising: a central body; a plurality of anchors, an anchor of the plurality of anchors comprising a gripping member, the gripping member comprising: a first arm; a second arm; and a hinge portion hingeably connecting the first arm to the second arm; an actuation element extending through a bore of the central body; an actuation arm connected to the actuation element; and a tether connected to an end portion of the actuation arm and the second arm of the gripping member, wherein movement of the actuation element in a distal direction applies tension to the tether to cause the second arm to pivot in an opening direction, and wherein movement of the actuation element in a proximal direction causes the actuation arm to engage the second arm to pivot the second arm in a closing direction.

41. A valve repair device comprising: a central body; a plurality of anchors, an anchor of the plurality of anchors comprising a gripping member, the gripping member comprising:a first arm, a second arm, and a hinge portion hingeably connecting the first arm to the second arm, wherein the second arm is biased in a closing direction; and an actuation element extending through a bore of the central body and further extending out of an opening of the bore, the opening disposed distally of the hinge portion of the gripping member, wherein retracting the actuation element applies tension to the actuation element to cause the second arm to pivot in an opening direction; and wherein extending the actuation element releases tension on the actuation element to allow the second arm to pivot in the closing direction.

42. A valve repair device comprising: a central body; a plurality of anchors, an anchor of the plurality of anchors comprising a gripping member, the gripping member comprising: a first arm, a second arm, and a hinge portion hingeably connecting the first arm to the second arm; a routing member extending distally beyond the hinge portion of the gripping member, wherein the routing member can be retracted to a retracted position proximal of the hinge portion; and an actuation element extending through a bore of the central body, around the routing member, and to the second arm of the gripping member,wherein retracting the actuation element applies tension to the actuation element to cause the second arm to pivot in an opening direction.

43. A valve repair device comprising: a central body; a plurality of anchors, an anchor of the plurality of anchors comprising a gripping member, the gripping member comprising: a first arm; a catch member arranged on the first arm of the gripping member; a second arm comprising a flexible portion including a head having a barbed end configured to engage the catch member of the first arm while in a closed condition; and a hinge portion hingeably connecting the first arm to the second arm, wherein the second arm is biased toward the closed condition; an actuation element extending through a bore of the central body, and further extending around the hinge portion, and to the head of the second arm of the gripping member, wherein retracting the actuation element, while the anchor is in a closed condition, applies tension to the actuation element to disengage the barbed end of the head of the second arm from the catch member, and wherein further retraction of the actuation element after the barbed end is disengaged causes the second arm to pivot toward an open condition.

44. A valve repair device comprising: a central body;a plurality of anchors, an anchor of the plurality of anchors comprising a gripping member, the gripping member comprising: a first arm; a second arm; a hinge portion hingeably connecting the first arm to the second arm, wherein the second arm is biased toward a closed condition; and a folding barbed portion extending from the second arm, wherein the folding barbed portion is biased away from the second arm; an actuation element extending through a bore of the central body, around the hinge portion, through an opening in the second arm, and to the folding barbed portion; wherein retracting the actuation element applies tension to the actuation element to cause the folding barbed portion to move in toward the second arm, and wherein further retraction of the actuation element in the retraction direction after the folding barbed portion is folded against the second arm causes the second arm to pivot in toward an open condition.

45. A method of repairing a native heart valve comprising: simultaneously opening a plurality of anchors that are disposed against a central body; positioning a first anchor of the plurality of anchors such that a first native heart valve leaflet is in the first anchor; simultaneously closing the plurality of anchors that are disposed against the central body to capture the first leaflet; and moving the central body and a remaining one or more anchors away from the first anchor.

46. A method of repairing a native heart valve comprising: attaching an anchor to a leaflet of the native heart valve; pulling the anchor toward a central body in a tilted orientation relative to the central body; and engaging the anchor with the central body to move the anchor from the tilted orientation to a more upright position relative to the central body.

47. A method of repairing a native heart valve comprising: attaching a plurality of anchors to a plurality of leaflets of the native heart valve; and capturing the plurality of anchors with a center clip after the plurality of anchors have been attached to leaflets of the native heart valve.

Images