Patent Description:
The present technology is generally related to devices for repairing a heart valve. Particularly, the present technology is generally related to devices for treating heart valve regurgitation.

Various types of clips and surgical sutures (e.g. an Alfieri stitch) are utilized to provide an edge-to-edge mitral valve repair. These techniques are used to reduce the regurgitation of a diseased mitral valve by clipping the anterior and posterior leaflets together in one or more locations. <insert new page 1A>.

The present disclosure provides alternative devices and methods for edge-to-edge heart valve repair.

It is common to treat a diseased mitral valve by securing anterior and posterior leaflets together in one or more locations with one or more ligating devices for edge-to-edge heart valve repair to treat heart valve regurgitation. The present disclosure provides numerous devices and methods, the methods being not claimed , for delivering edge-to-edge heart valve repair.

In one aspect, the present disclosure provides a device including a capsule having an interior and a clamp assembly including a plurality of clamps. Each clamp includes a first arm having a first free end and a second arm having a second free end. The clamp assembly includes a compacted state in which the plurality of clamps are compressed within the capsule and a deployed state in which at least the free ends of the plurality of clamps are positioned outside of the interior of the capsule. The first free end is closer to the second free end in the compacted state as compared to the deployed state. The device further includes a push rod.

Document <CIT> relates to a method and apparatus for percutaneously delivery and deployment of a cardiac valve.

Document <CIT> relates to methods and devices for capturing and fixing leaflets in valve repair.

Document <CIT> relates to a mitral valve spacer device.

Document <CIT> relates to heart valve repair.

Document <CIT> relates to a valve clip device.

Document <CIT> relates to a valve clip. releasably secured to the clamp assembly. In some examples, the device further includes a delivery rod releasably secured to the capsule.

Specific embodiments of the present disclosure are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. The terms "distal" and "proximal" are used in the following description with respect to a position or direction relative to the treating clinician. "Distal" or "distally" are a position distant from or in a direction away from the clinician. "Proximal" and "proximally" are a position near or in a direction toward the clinician.

<FIG> collectively illustrate a device <NUM>. Generally, the device <NUM> includes a clamp assembly <NUM> deliverable within a capsule <NUM> and then deployable from the capsule <NUM> to engage heart valve leaflets L1, L2 and pull the leaflets into the capsule <NUM> where the leaflets L1, L2 will be compressively secured and clamped together. In this example, the capsule <NUM> has an open proximal end <NUM>, a closed distal end <NUM> and an interior <NUM>. In one embodiment, the proximal end <NUM> is flared or tapers away from a central axis of the capsule <NUM>. The capsule <NUM> is releasably secured to a delivery rod <NUM>, which can control proximal and distal movement of the capsule <NUM>. In some embodiments, the capsule <NUM> can include one or more slits <NUM> along a length of the capsule <NUM>. As shown, the capsule <NUM> can include two slits <NUM> approximately <NUM> degrees from each other (+/- <NUM> degrees). The capsule <NUM> can, in some examples, be a shape memory material. In various embodiments, the capsule <NUM> and/or the clamp assembly <NUM> include a polymer coating.

The clamp assembly <NUM> includes a plurality of clamps <NUM>. In the illustrated example, the clamp assembly <NUM> includes two clamps <NUM>. In one embodiment, each clamp <NUM> is identically configured and includes a first arm <NUM> having a first free end <NUM> and a second arm <NUM> having a second free end <NUM> (only one clamp <NUM> is full labeled for ease of illustration in <FIG> but it will be understood that each clamp <NUM> can be identically configured and operate in an identical manner). Each arm <NUM>, <NUM> defines an engagement surface <NUM>, <NUM> configured to contact opposing sides or surfaces of a valve leaflet (see <FIG>). The engagement surface <NUM>, <NUM> can optionally be textured as will be discussed and shown with respect to <FIG>, below. The device <NUM> further includes a push rod <NUM> releasably secured to the clamp assembly <NUM> and positioned co-axially over the delivery rod <NUM>. The push rod <NUM> at least partially serves to actuate movement of the clamp assembly <NUM> with respect to the capsule <NUM>. The clamp assembly <NUM> includes a compacted state (<FIG>) in which the plurality of clamps <NUM> are compressed within the interior <NUM> of the capsule <NUM> and a deployed state (<FIG>) in which the plurality of clamps <NUM> are positioned outside of the interior <NUM> of the capsule <NUM>. The first free end <NUM> is closer to the second free end <NUM> in the compacted state as compared to the deployed state.

In one example, the device <NUM> is delivered with the clamp assembly <NUM> in the compacted state of <FIG> to a heart valve V as is shown in <FIG>. In the delivery state, the device <NUM> includes clamp assembly <NUM> in a compacted state, wherein the clamps <NUM> are housed within the interior <NUM> to prevent snagging as the device <NUM> is delivered through a patient's vasculature to the heart valve V to be repaired (e.g., a defective native mitral valve). Once the capsule <NUM> is inserted antegrade through an annulus A of the valve V such that the proximal end <NUM> of the capsule <NUM> is distal with respect to the valve annulus A, the push rod <NUM> can be proximally withdrawn to pull the clamps <NUM> from the interior <NUM> as is shown in <FIG>. The clamps <NUM> are positioned adjacent the leaflets L1, L2. Then, the capsule <NUM> can be proximally pulled to engage and compress the first and second arms <NUM>, <NUM> of the clamps <NUM>, so that the clamps <NUM> each clamp onto one leaflet L1, L2, while drawing both the clamps <NUM> and the leaflets L1, L2 into the interior <NUM> of the capsule <NUM> as is shown in <FIG>. In this way, the leaflets L1, L2 are compressively joined together with the clamps <NUM> and capsule <NUM>. The push rod <NUM> can then be disconnected from the clamp assembly <NUM> and the delivery rod <NUM> can be disconnected from the capsule <NUM> and withdrawn from the patient in the same manner as the push rod <NUM> and delivery rod <NUM> were delivered leaving the capsule <NUM> and clamps <NUM> securing the leaflets L1, L2 together as is shown in <FIG>. It is envisioned that the releasable connection between the delivery rod <NUM> and the capsule <NUM> or between the push rod <NUM> and the clamp assembly <NUM> can be achieved in many ways. A few examples are discussed below with respect to <FIG>.

In one example, as shown in <FIG>, a device <NUM>' includes a clamp assembly <NUM>' having a plurality of clamps <NUM>' each having a first arm <NUM>' with a free end <NUM>' and a second arm <NUM>' having a free end <NUM>'. In this embodiment, each arm <NUM>', <NUM>' has an engagement surface <NUM>', <NUM>', at least one of which has a textured or serrated engagement surface <NUM>' to assist in gripping the respective leaflet L1, L2. As indicated with like reference numbers, the device <NUM>' of <FIG> can otherwise be similarly configured and operate similarly as compared to that of <FIG> except as explicitly stated.

Referring now in addition to <FIG>, which illustrate an alternate device <NUM>. In this example, the device <NUM> includes a clamp assembly <NUM> and a capsule <NUM>. The capsule <NUM> has an open proximal end <NUM>, a closed distal end <NUM> and an interior <NUM>. The clamp assembly <NUM> is movably secured to the capsule <NUM> and is connected to a push rod <NUM>, which can control proximal and distal movement of the clamp assembly <NUM> with respect to the capsule <NUM>. As in prior disclosed embodiments, the capsule <NUM> can optionally include one or more slits along a length of the capsule <NUM> (see <FIG>) through a material, which can be any of the type disclosed with respect to other embodiments. In various embodiments, the capsule <NUM> and/or the clamp assembly <NUM> include a polymer coating.

The clamp assembly <NUM> includes a plurality of clamps <NUM>. In the illustrated example, the clamp assembly <NUM> includes two clamps <NUM>. Each clamp <NUM> includes a first arm <NUM> having a first free end <NUM> and a second arm <NUM> having a second free end <NUM>. In this example, the first arm <NUM> is hingedly connected to the second arm <NUM>. In addition, each second arm <NUM> can be V-shaped defining a first portion <NUM> and a second portion <NUM> and a connection point <NUM> where the first and second portions <NUM>, <NUM> converge. The second arm <NUM> is hingedly secured to the first arm <NUM> at the connection point <NUM>. As referenced in <FIG>, the second portion <NUM> of each second arm <NUM> can include a slot <NUM> engaged with a pin <NUM> extending outwardly from the push rod <NUM>, which allows the respective second portion <NUM> to vary an angle between the ends <NUM> and the push rod <NUM> as the first arm <NUM> transitions from a compacted state to a deployed state. The compacted state is one in which the plurality of clamps <NUM> are compressed within the interior <NUM> of the capsule <NUM> (<FIG>) and the deployed state being one in which the plurality of clamps <NUM> are positioned outside of the interior <NUM> of the capsule <NUM> (<FIG>). The device <NUM> also includes intermediate states (e.g., <FIG> and <FIG>). Each first free end <NUM> is closer to the corresponding second free end <NUM> in the compacted state as compared to the deployed state. In one example, each arm <NUM>, <NUM> can define a leaflet engagement surface similar to that disclosed with respect to <FIG>. A releasable connection between the push rod <NUM> and the clamp assembly <NUM> can be achieved in any of the ways disclosed herein. The clamp assembly <NUM> can be slidably secured to the capsule <NUM> with a bracket <NUM>. In this example, the clamps <NUM> are further interconnected with the bracket <NUM> proximate connection points <NUM>.

In one example, the device <NUM> is delivered in the compacted state (<FIG>). In the compacted state, the clamps <NUM> are fully housed within the interior <NUM> of the capsule <NUM> to prevent snagging as the device <NUM> is delivered through a patient's vasculature to a heart valve to be repaired (e.g., a defective native mitral valve, see also <FIG>, for example). Once the capsule <NUM> is inserted in an antegrade direction through the annulus of the valve such that the proximal end <NUM> of the capsule <NUM> is distal with respect to the valve annulus, the push rod <NUM> can be proximally withdrawn to pull the clamps <NUM> from the interior <NUM> so that the first and second arms <NUM>, <NUM> can splay away from either other on either sides of one leaflet L1, L2 as is shown in <FIG>. In one example, each clamp <NUM> is configured to be biased (e.g., spring biased) in the expanded position of <FIG> so that an angle between the first and second arms <NUM>, <NUM> is greater than when the first and second arms <NUM>, <NUM> are compressed within the interior <NUM> of the capsule <NUM>. The clamps <NUM> are positioned so that one arm <NUM>, <NUM> is positioned on each side of the leaflets L1, L2 and then, a delivery rod <NUM> (only shown in <FIG> for ease of illustration), which is connected to the capsule <NUM>, can be proximally advanced so that the clamps <NUM> engage and clamp onto the leaflets L1, L2, while drawing both the clamps <NUM> and the leaflets L1, L2 into the interior <NUM> of the capsule <NUM> as is generally shown in <FIG>. In this way, the leaflets L1, L2 are compressively joined together with the clamps <NUM> and capsule <NUM>. The push rod <NUM> can then be disconnected from the clamp assembly <NUM> and the delivery rod <NUM> can be disconnected from the capsule <NUM> in any manner disclosed herein. The push rod <NUM> and delivery rod can then be withdrawn from the patient leaving the capsule <NUM> and clamp assembly <NUM> securing the leaflets L1, L2 together. The push rod <NUM> can be configured to be releasably connected to the clamp assembly <NUM> in a variety of ways. A few examples are disclosed below with respect to FIGS. The delivery rod <NUM> can be configured to be releasably connected to the capsule <NUM> in a variety of ways. A few examples are disclosed below with respect to FIGS. It is further noted that although the delivery rod <NUM> is shown as being biaxial with respect to the push rod <NUM>, it is envisioned that the delivery rod <NUM> may be positioned coaxial with respect to the push rod <NUM> in other embodiments.

Referring in addition to <FIG>, which illustrate an alternate device <NUM>. In this example, the device <NUM> includes a clamp assembly <NUM> and a capsule <NUM>. In various embodiments, the capsule <NUM> and/or the clamp assembly <NUM> include a polymer coating. As in prior disclosed embodiments, the capsule <NUM> can optionally include one or more slits along a length of the capsule <NUM> (see also <FIG>), which can be any of the type disclosed with respect to other embodiments. The capsule <NUM> has an open proximal end <NUM>, a closed distal end <NUM> and an interior <NUM>. The clamp assembly <NUM> is movably secured to the capsule <NUM> and is connected to a push rod or shaft <NUM>, which can control proximal and distal movement of the clamp assembly <NUM> with respect to the capsule <NUM>. Extending coaxially within the push rod <NUM> is a delivery rod, shaft, or wire <NUM>, which is connected to the capsule <NUM> and can control movement of the capsule <NUM> with respect to the clamp assembly <NUM>. The push rod <NUM> and the delivery rod <NUM> are proximally and distally movable with respect to each other. The wire <NUM> can also allow for rotation of the capsule <NUM>, as desired. In various embodiments, a hypotube <NUM> maintains at least a portion of the wire <NUM> and the push rod <NUM>, within respective lumens 266a, 266b. The first lumen 266a is D-shaped and receives the wire <NUM>. In the illustrated example, the wire <NUM> correspondingly also has a D-shaped cross section to lock the capsule <NUM> and clamp assembly <NUM> orientation and allow for additional torque of the device <NUM> to be applied via the push rod <NUM>. The push rod <NUM> can be inserted through the second lumen 266b. Control of the state of the clamp assembly <NUM> can be actuated with a handle assembly <NUM> shown in <FIG>. In this non-limiting example, the handle assembly <NUM> includes a first actuator 272a, such as a sliding button or the like, to control the position of the clamp assembly <NUM>. The handle assembly <NUM> can also include a second actuator 272b, such as a lever connected to the first actuator 272a, configured to open and close the clamps <NUM>.

The clamp assembly <NUM> includes a plurality of clamps <NUM>. In the illustrated example, the clamp assembly <NUM> includes two clamps <NUM>, only one of which is fully referenced for ease of illustration but it is to be understood that each clamp <NUM> can be identically configured and operate in an identical manner. Each clamp <NUM> includes a first arm <NUM> having a first free end <NUM> and a second arm <NUM> having a second free end <NUM>. In this example, the first arm <NUM> is hingedly connected to the second arm <NUM>. In addition, each second arm <NUM> can be V-shaped defining a first portion <NUM> and a second portion <NUM> and a connection point <NUM>, where the first arm <NUM> is connected with the second arm <NUM> and the first and second portions <NUM>, <NUM> converge. The second arm <NUM> is hingedly secured to the first arm <NUM> at the connection point <NUM>. As shown in <FIG>, the first portion <NUM> of each second arm <NUM> can include a slot <NUM> engaged with a pin <NUM> extending outwardly from the push rod <NUM>, which allows the respective second portion <NUM> to vary an angle between the first portion <NUM> and the push rod <NUM> as the clamp <NUM> transitions from a compacted state to a deployed state. The compacted state is one in which the plurality of clamps <NUM> are compressed within the interior <NUM> of the capsule <NUM> and the deployed state being one in which the plurality of clamps <NUM> are positioned outside of the interior <NUM> of the capsule <NUM>. Each first free end <NUM> is closer to the corresponding second free end <NUM> in the compacted state as compared to the deployed state. In one example, each arm <NUM>, <NUM> can define a leaflet engagement surface similar to that disclosed with respect to <FIG>. A releasable connection between the push rod <NUM> and the clamp assembly <NUM> as well as the delivery rod or wire <NUM> and the capsule <NUM> can be achieved in any of the ways disclosed herein. This device <NUM> operates in a similar manner to that of <FIG> in that respective leaflets can be grasped by clamps <NUM> and then at least partially drawn into the capsule <NUM> to secure the leaflets together. Then, the push rod <NUM> and delivery rod <NUM> can be disengaged form the clamp assembly <NUM> and capsule <NUM> and withdrawn from the patient in the same manner as delivered leaving the capsule <NUM> and clamp assembly <NUM> interconnecting the leaflets. The push rod <NUM> and delivery rod <NUM> can be releasably connected in any manner disclosed herein with respect to other embodiments.

As shown in <FIG>, the device of <FIG> can be modified slightly for procedures via a trans-apical approach. In this example, the ligating device <NUM> includes a clamp assembly <NUM> and a capsule <NUM>, which is shown as transparent for ease of illustration. In various embodiments, the capsule <NUM> and/or the clamp assembly <NUM> include a polymer coating. As in prior disclosed embodiments, the capsule <NUM> can optionally include one or more slits along a length of the capsule <NUM> (see <FIG>) through a material, which can be any of the type disclosed with respect to other embodiments. The capsule <NUM> has an open proximal end <NUM>, a generally closed distal end <NUM> and an interior <NUM>. In one example, the proximal end <NUM> is flared or tapered outwardly as compared to the distal end <NUM>. The clamp assembly <NUM> is movably secured to the capsule <NUM> and is connected to a push rod <NUM>, which can control proximal and distal movement of the clamp assembly <NUM> with respect to the capsule <NUM>. A delivery rod or wire <NUM> is connected to the capsule <NUM> and can control movement of the capsule <NUM> with respect to the clamp assembly <NUM>. As with the embodiment of <FIG>, the push rod <NUM> and delivery rod <NUM> can be housed in a hypotube <NUM> having first and second lumens 366a, 366b. The first lumen 366a is D-shaped and receives the wire <NUM>. In the illustrated example, the wire <NUM> correspondingly also has a D-shaped cross section to lock the capsule <NUM> and clamp assembly <NUM> orientation and allow for additional torque of the device <NUM> to be applied via the push rod <NUM>. The push rod <NUM> can be inserted through the second lumen 366b. Control of the state of the clamp assembly <NUM> can be actuated with a handle assembly <NUM> shown in <FIG>. In this non-limiting example, the handle assembly <NUM> includes a first actuator 372a, such as a sliding button or the like, to control the position of the clamp assembly <NUM>. The handle assembly <NUM> can also include a second actuator 372b, such as a lever connected to the first actuator 372a, configured to open and close the clamps <NUM>.

The clamp assembly <NUM> includes a plurality of clamps <NUM>. In the illustrated example, the clamp assembly <NUM> includes two clamps <NUM>, only one of which is fully referenced for ease of illustration but it is to be understood that each clamp <NUM> can be identically configured and operate in an identical manner. Each clamp <NUM> includes a first arm <NUM> having a first free end <NUM> and a second arm <NUM> having a second free end <NUM>. In this example, the first arm <NUM> is hingedly connected to the second arm <NUM>. In addition, each second arm <NUM> can be V-shaped defining a first portion <NUM> and a second portion <NUM> and a connection point <NUM>, where the first arm <NUM> is connected with the second arm <NUM> and the first and second portions <NUM>, <NUM> converge. The second arm <NUM> is hingedly secured to the first arm <NUM> at the connection point <NUM>. The first portion <NUM> of each second arm <NUM> can include a slot <NUM> engaged with a pin <NUM> extending outwardly from the push rod <NUM>, which allows the respective second portion <NUM> to vary its angle with respect to the push rod <NUM> as the clamp <NUM> transitions from a compacted state in which the clamps <NUM> are fully positioned within the interior <NUM> of the capsule <NUM> to a deployed state in which the clamps <NUM> are positioned outside of the interior <NUM> as is shown in <FIG>. In various examples, each clamp <NUM> can be secured to a bracket <NUM>, which supports the clamp assembly <NUM> and push rod <NUM> and is further interconnected to the delivery rod <NUM>. Each first free end <NUM> is closer to the corresponding second free end <NUM> in the compacted state as compared to the deployed state. In one example, one or more arms <NUM>, <NUM> can define a leaflet engagement surface similar to that disclosed with respect to <FIG>. A releasable connection between the push rod <NUM> and the clamp assembly <NUM> as well as the delivery rod <NUM> and the capsule <NUM> can be achieved in any of the ways disclosed herein or in other ways. This device <NUM> operates in a similar manner to that of <FIG> in that respective leaflets can be grasped by clamps <NUM> and then at least partially drawn into the capsule <NUM> to secure the leaflets together. Then, the push rod <NUM> and delivery rod <NUM> can be disengaged form the clamp assembly <NUM> and capsule <NUM> and withdrawn from the patient in the same manner as delivered leaving the capsule <NUM> and clamp assembly <NUM> interconnecting the leaflets.

Referring now in addition to <FIG>, which collectively illustrate yet another device <NUM> that is particularly suitable for delivery to a heart valve via a trans-femoral approach. In this embodiment, the device <NUM> includes a clamp assembly <NUM> connected to a capsule <NUM> having a closed distal end <NUM> and an open proximal end <NUM> that is open to an interior <NUM> of the capsule <NUM>. In the illustrated example, the capsule <NUM> includes a rigid support <NUM> that releasably interconnects the proximal end <NUM> to a delivery rod <NUM>. The clamp assembly <NUM> has a plurality of clamps <NUM>. In this example, the clamp assembly <NUM> can include four clamps <NUM>, which are equidistantly spaced <NUM> degrees. In one embodiment, each clamp <NUM> is identically configured to include a first arm <NUM> having a first free end <NUM> pivotally connected to a second arm <NUM> having a second free end <NUM> (only one clamp <NUM> is fully labeled for ease of illustration in <FIG>). Each arm <NUM>, <NUM> defines an engagement surface <NUM>, <NUM>. One or more of the engagement surfaces <NUM>, <NUM> can be textured as will be discussed and shown with respect to <FIG>, above. In one example, the textured engagement surfaces <NUM>, <NUM> on corresponding arms <NUM>, <NUM> include ridges and grooves configured to mate with each other when the clamp assembly <NUM> is in the compacted state. In the illustrated example, the push rod <NUM> extends through a central aperture <NUM> (<FIG>) between opposing second arms <NUM>. In various embodiments, the capsule <NUM> and/or the clamp assembly <NUM> include a polymer coating.

The device <NUM> further includes a push rod <NUM> releasably secured to the clamp assembly <NUM> and positioned co-axially over the delivery rod <NUM>. The push rod <NUM> at least partially serves to actuate movement of the clamp assembly <NUM> with respect to the capsule <NUM>. The clamp assembly <NUM> includes a compacted state (not shown) in which the plurality of clamps <NUM> are compressed and completely positioned within the interior <NUM> of the capsule <NUM> and a deployed state (<FIG>) in which the plurality of clamps <NUM> are positioned outside of the interior <NUM> of the capsule <NUM>. It will be understood that intermediate states will exist between the compacted state and the deployed state in which the clamps <NUM> are partially positioned within the interior <NUM>. The first free end <NUM> is closer to the respective second free end <NUM> in the compacted state as compared to the deployed state. In one example, the arms <NUM>, <NUM> are biased to the deployed state so that upon freeing the arms <NUM>, <NUM> from the confines of the capsule <NUM>, the arms <NUM>, <NUM> spring apart so that a leaflet (e.g., L1 or L2) can be placed between the respective arms <NUM>, <NUM>. In one example, two clamps <NUM> may be engaged with one leaflet and two clamps <NUM> may be engaged with another leaflet.

The device <NUM> of <FIG> is used in a largely similar manner as compared to that of <FIG>. In a delivery state, the clamps <NUM> are housed within the interior <NUM> of the capsule <NUM> to prevent snagging as the device <NUM> is delivered through a patient's vasculature via a transfemoral approach to the heart valve to be repaired (e.g., a defective native mitral valve). Once the capsule <NUM> is inserted in an antegrade direction through an annulus of the valve such that the proximal end <NUM> of the capsule <NUM> is distal with respect to the valve annulus, the push rod <NUM> can be proximally withdrawn to pull the clamps <NUM> from the interior <NUM>. The clamps <NUM> are positioned adjacent two leaflets. Then, the capsule <NUM> can be proximally pulled to engage and compress the first and second arms <NUM>, <NUM> of each clamp <NUM>, so that the clamps <NUM> each clamp onto one leaflet, while drawing both the clamps <NUM> and the leaflets into the interior <NUM> of the capsule <NUM> (only one clamp <NUM> is fully referenced for ease of illustration, however, all other clamps <NUM> can be identically configured). In this way, the leaflets are compressively joined together with the clamps <NUM> and capsule <NUM>. The push rod <NUM> can then be disconnected from the clamp assembly <NUM> and the delivery rod <NUM> can be disconnected from the support <NUM> and withdrawn from the patient in the same manner as the push rod <NUM> and delivery rod <NUM> were delivered leaving the capsule <NUM> and clamps <NUM> securing the leaflets together. It is envisioned that the push rod <NUM> can be releasably connected to the clamp assembly <NUM> in a variety of ways. It is also envisioned that the delivery rod <NUM> can be releasably connected to the support <NUM> in a variety of ways.

Yet another device <NUM> is illustrated in <FIG>. Generally, the device <NUM> includes a clamp assembly <NUM> deliverable within a capsule <NUM> and then deployable from the capsule <NUM> to engage heart valve leaflets and pull the leaflets into the capsule <NUM> where the leaflets will be compressively secured and clamped together as similarly shown in prior figures with respect to similar embodiments. In this example, the capsule <NUM> is shown as the type of <FIG> and has an open proximal end <NUM>, a closed distal end <NUM> and an interior <NUM> (see <FIG>). The capsule <NUM> can be configured and vary as disclosed with respect to capsule <NUM> or other capsules disclosed herein. The capsule <NUM> is secured to a delivery rod <NUM>, which can control proximal and distal movement of the capsule <NUM>. In various embodiments, the capsule <NUM> and/or the clamp assembly <NUM> include a polymer coating.

In the illustrated example, the clamp assembly <NUM> includes two clamps <NUM>, According to the invention, the device includes a plurality of clamps. Only one clamp <NUM> is fully referenced in <FIG> for ease of illustration, however, it will be understood that each clamp <NUM> can be identically configured and operate in an identical manner. In one embodiment, each clamp <NUM> is identically configured and includes a first arm <NUM> having a first free end <NUM> and a second arm <NUM> having a second free end <NUM> (only one clamp <NUM> is full labeled for ease of illustration in <FIG>). Each arm <NUM>, <NUM> defines an engagement surface <NUM>, <NUM>, which is arranged to contact one leaflet. One or more engagement surfaces <NUM>, <NUM> can be textured or serrated as also disclosed with respect to <FIG>, for example. The device <NUM> further includes a base <NUM> positioned co-axially over the delivery rod <NUM> and slidable along a length of the delivery rod <NUM>. The base <NUM> is connected to the clamp assembly <NUM> and interconnects the plurality of clamps <NUM>. In various embodiments, each clamp <NUM> can be pivotally connected to the base <NUM>.

The device <NUM> includes a compacted delivery state (<FIG>) in which the plurality of clamps <NUM> are compressed within a delivery sheath <NUM>. In one example, the proximal end <NUM> of the capsule <NUM> can receive and maintain a portion of the clamp assembly <NUM> and a portion of the delivery sheath <NUM> in the compressed state but most of the clamp assembly <NUM> is housed in the delivery sheath <NUM>. The device <NUM> can transition to a partially deployed state shown in <FIG> in which the delivery sheath <NUM> is proximally withdrawn. The delivery sheath <NUM> is further proximally withdrawn so that the distal ends <NUM>, <NUM> of the arms <NUM>, <NUM> are freed from and distal to the delivery sheath <NUM> so that they transition to their natural biased deployed arrangement in which the arms <NUM>, <NUM> are splayed outwardly, away from each other to receive a leaflet therebetween as is shown in <FIG>. Therefore, the first free end <NUM> is closer to the second free end <NUM> of each clamp <NUM> in the compacted state as compared to the deployed state. Once a leaflet is positioned between each pair of engagement surfaces <NUM>, <NUM>, the delivery rod <NUM> can be pulled proximally to position the capsule <NUM> over the clamps <NUM>, compressing the clamps <NUM> and the leaflets within the interior <NUM> to the degree desired. As is best seen in <FIG>, the device <NUM> can optionally incorporate a ratchet assembly <NUM> (generally referenced) having a plurality of tines <NUM> extending inwardly within the interior <NUM>. To prevent the clamps <NUM> from opening and re-cinching, the capsule <NUM> can be pulled proximally with the delivery rod <NUM> so that the base <NUM> is pulled past one or more of the tines <NUM>, which will then prevent the base <NUM> from moving proximally with respect to the capsule <NUM>. In one example, the base <NUM> is configured similar to a ring that has an outer diameter that is greater than an outer diameter of the deliver rod <NUM>.

In one example, the device <NUM> is delivered in the compacted state of <FIG> to a heart valve (see also, <FIG>, for example). In the compacted state, the clamps <NUM> are housed within the delivery catheter <NUM> to prevent snagging as the device <NUM> is delivered through a patient's vasculature to the heart valve to be repaired (e.g., a defective native mitral valve). Once the capsule <NUM> is inserted in an antegrade direction through an annulus of the valve such that the proximal end <NUM> of the capsule <NUM> is distal with respect to the valve annulus, the delivery sheath <NUM> can be proximally withdrawn to free the clamps <NUM> as is shown in <FIG>. The clamps <NUM> are positioned adjacent the leaflets so that each clamp <NUM> has arms <NUM>, <NUM> on opposing sides of the leaflet. Then, the capsule <NUM> can be proximally pulled to engage and compress the first and second arms <NUM>, <NUM> of the clamps <NUM>, so that the clamps <NUM> each clamp onto one leaflet, while drawing both the clamps <NUM> into the interior <NUM> of the capsule <NUM>. In this way, the leaflets are compressively joined together with the clamps <NUM> and capsule <NUM>. In embodiments where the capsule <NUM> includes the ratchet assembly <NUM>, example methods, not claimed , include restricting movement of the clamp assembly <NUM> with respect to the capsule <NUM> with the ratchet assembly <NUM>. Once the leaflets and clamp assembly <NUM> are sufficiently clamped together and retained within the interior <NUM> to the level desired, the delivery rod <NUM> can be disconnected from the capsule <NUM> and withdrawn from the patient in the same manner as the delivery rod <NUM> was delivered, thus leaving the capsule <NUM> and clamps <NUM> securing the leaflets together.

The releasable connection between the delivery rod <NUM> and the capsule <NUM> can be achieved in any of the ways disclosed herein with respect to other embodiments. In one example, device <NUM> includes a releasable connection assembly <NUM> as is best shown in <FIG>. In this example, the releasable connection assembly <NUM> includes a protrusion <NUM> that is secured within the interior <NUM> of the capsule <NUM> (see also <FIG>). The protrusion <NUM> can be ball shaped, for example. The releasable connection assembly <NUM> further includes an engagement portion <NUM> having first and second jaws 586a, 586b that are pivotally connected with respect to each other and a tube <NUM> on which they are mounted. The engagement portion <NUM> is configured to have an engaged configuration (<FIG>) in which the jaws 586a, 586b are positioned around the protrusion <NUM> so that the capsule <NUM> is secured to and can be controlled with the tube <NUM>. The engagement portion <NUM> is also configured to have a disengaged configuration (<FIG>) in which the jaws 586a, 586b expand to release the protrusion <NUM> so that the capsule <NUM> is disconnected from the tube <NUM>. In one example, an outer sheath <NUM> is provided over the tube <NUM> and in the engaged configuration, the outer sheath <NUM> is advanced at least partially over the jaws 586a, 586b. When the outer sheath <NUM> is proximally retracted as is shown in <FIG>, a wedge <NUM> on the inner diameter of the outer sheath <NUM> forces the jaws 586a, 586b away from each other so that the protrusion <NUM> is released. It will be understood that any of the capsules disclosed herein can be released from their respective delivery rods in a similar manner. It will be further understood that any of the clamp assemblies disclosed herein can be similarly disclosed from their respective push rods in a similar manner.

Other release mechanisms are also envisioned. Referring now in addition to <FIG>, which illustrates an alternate releasable connection assembly <NUM>'. In this example, the releasable connection assembly <NUM>' includes the protrusion <NUM> that is secured within the interior <NUM> of the capsule <NUM> (see also <FIG>). The protrusion <NUM> can be ball shaped, for example. The releasable connection assembly <NUM>' further includes an engagement portion <NUM>' having first and second jaws 586a', 586b' that are pivotally connected with respect to each other and a tube <NUM>' on which they are mounted. The engagement portion <NUM>' is configured to have an engaged configuration (<FIG>) in which the jaws 586a', 586b' are positioned around the protrusion <NUM> so that the capsule <NUM> is secured to and can be controlled with the tube <NUM>'. The engagement portion <NUM>' is also configured to have a disengaged configuration (<FIG>) in which the jaws 586a', 586b' expand to release the protrusion <NUM> so that the capsule <NUM> is disconnected from the tube <NUM>'. In one example, an outer sheath <NUM>' is provided over the tube <NUM>' and in the engaged configuration, the outer sheath <NUM>' is advanced at least partially over the jaws 586a', 586b'. When the outer sheath <NUM>' is proximally retracted as is shown in <FIG>, links <NUM>' on an outer diameter of the outer sheath <NUM>' pulls the jaws 586a', 586b' and forces the jaws 586a', 586b' away from each other so that the protrusion <NUM> is released. It will be understood that any of the capsules disclosed herein can be released from their respective delivery rods in a similar manner. It will be further understood that any of the clamp assemblies disclosed herein can be similarly disclosed from their respective push rods in a similar manner.

Other mechanisms for releasing the capsules disclosed herein from their respective delivery rods are envisioned and can be utilized. It is further envisioned that the clamp assemblies disclosed herein can otherwise releasably connected from their respective push rods in other ways and the present disclosure is not intended to be limited to any such configuration.

It is also to be understood that any of the embodiments disclosed herein can be configured for either antegrade or retrograde approach/delivery depending on what valve is to be treated and the desired delivery route. Any trans-apical device or system configuration could also be used for a transfemoral artery route to treat a mitral valve, wherein the delivery route would include passing through the aortic valve and into the left ventricle. Any disclosed trans-apical device or system configuration could also be used for a direct aortic or subclavian artery route, which would also include passing through the aortic valve and into the left ventricle.

Claim 1:
A ligating device (<NUM>) comprising:
a capsule (<NUM>) having an interior (<NUM>);
a clamp assembly (<NUM>) including a plurality of clamps (<NUM>), each clamp (<NUM>) including a first arm (<NUM>) having a first free end (<NUM>) and a second arm (<NUM>) having a second free end (<NUM>), wherein the clamp assembly (<NUM>) includes a compacted state in which the plurality of clamps (<NUM>) are compressed within the capsule (<NUM>) and a deployed state in which at least the free ends (<NUM>, <NUM>) of the plurality of clamps (<NUM>) are positioned outside of the interior (<NUM>) of the capsule (<NUM>), wherein the first free end (<NUM>) is closer to the second free end (<NUM>) in the compacted state as compared to the deployed state;
a push rod (<NUM>) releasably secured to the clamp assembly (<NUM>), wherein the push rod (<NUM>) is configured to transition the plurality of clamps (<NUM>) from the compacted arrangement to the deployed arrangement; and
wherein the clamp assembly (<NUM>) is configured to be deliverable within the capsule (<NUM>) and to be deployable from the capsule (<NUM>) to engage heart valve leaflets (L1, L2) and to pull the leaflets into the capsule (<NUM>) where the leaflets (L1, L2) will be compressively secured and clamped together.