Prosthetic heart valve and systems and methods for delivering the same

A prosthetic heart valve includes a self-expanding wire frame body, a valve disposed in the body, a leaflet clip coupled to the body, and a control element operably coupled to the leaflet clip. The body has a proximal end and a distal end. The leaflet clip is configured to be transitioned between a first configuration in which the prosthetic valve can be inserted into a heart, and a second configuration in which the leaflet clip is disposed to capture a native valve leaflet between the leaflet clip and the wire frame body when the body is disposed in a native annulus of an atrioventricular valve of a heart. The control element extends from the leaflet clip through a ventricle of the heart and out a wall of the ventricle to allow a user to transition the leaflet clip from its first configuration to its second configuration.

BACKGROUND

Embodiments described herein relate generally to prosthetic heart valves, and apparatus, systems, and methods for delivering a prosthetic device into a heart. More particularly, embodiments described herein relate to apparatus, systems, and methods for implanting and manipulating a prosthetic heart valve and associated components into the heart.

The human heart is responsible for pumping blood around the human body. The human heart is separated into four distinct chambers, and is commonly referenced in terms of the right or left side of the heart. The right side of the heart, including the right atrium and the right ventricle, is responsible for receiving de-oxygenated blood from the body, and then pumping the de-oxygenated blood to the lungs in order to oxygenate the blood. The left side of the heart, including the left atrium and left ventricle, is responsible for receiving oxygenated blood from the lungs, and then pumping the oxygenated blood to various parts of the body. The movement of blood within the chambers of the heart is controlled by four valves: aortic, mitral, pulmonic and tricuspid. These valves open and close constantly, and as such, can be subject to wear and tear and other challenges that affect their performance (e.g., mitral valve regurgitation, prolapse, and/or stenosis), and consequently, the entire circulatory system.

Some known devices for repairing the performance of the heart, such as, for example, the performance of a mitral valve of the heart, can include a prosthetic heart valve. The prosthetic heart valve can be implanted and secured to a native annulus of the heart. In such cases, native leaflets of the heart valve can become disposed between the prosthetic heart valve and the myocardium of the heart. Further, when the native valve leaflets are disposed in such a manner, the native valve leaflets can, for example, interfere with blood flow into and out of the left ventricle of the heart (e.g., interfere with left ventricular outflow tract (LVOT), reduction of effective orifice area (EOA) through the prosthetic heart valve). In some cases, this can occur when the native valve leaflets become at least partially disposed in the flow path defined through the orifice area of the prosthetic heart valve and from the atrium to the ventricle of the heart. In addition, over time, the native valve leaflets can stiffen (e.g., change modulus) due to calcification or the like, resulting in undesirable turbulence, eddies, and/or otherwise undesirable flow profiles within the heart. Even more, such degradation and/or stiffening of the native valve leaflets can, in some cases, cause degradation of the prosthetic heart valve leaflets.

Accordingly, there is a need for improved devices, systems and methods for securing, capturing, controlling, or otherwise manipulating native valve leaflets of a heart valve when a prosthetic heart valve is disposed and operating therein.

SUMMARY

Apparatus, systems and methods for securing, capturing, controlling, or otherwise manipulating native heart valve leaflets when a prosthetic heart valve is delivered to, or disposed in, a native annulus of an atrioventricular valve of a heart are described herein. In some embodiments, a prosthetic heart valve includes a self-expanding wire frame body, a valve disposed in the body, a leaflet clip coupled to the body, and a control element operably coupled to the leaflet clip. The body has a proximal end and a distal end. The leaflet clip is configured to be transitioned between a first configuration in which the prosthetic valve can be inserted into a heart, and a second configuration in which the leaflet clip is disposed to capture a native valve leaflet between the leaflet clip and the wire frame body when the body is disposed in a native annulus of an atrioventricular valve of a heart. The control element has a length sufficient to extend from the leaflet clip through a ventricle of the heart and out a wall of the ventricle when the body is disposed in the native annulus of the atrioventricular valve of the heart. The control element is configured to allow a user to transition the leaflet clip from its first configuration to its second configuration when the body is disposed in the native annulus of the atrioventricular valve of the heart.

DETAILED DESCRIPTION

Apparatus, systems, and methods for securing, controlling, capturing, or otherwise manipulating native heart valve leaflets when a prosthetic heart valve is delivered to or disposed in a native annulus of an atrioventricular valve of a heart are described herein.

In some embodiments, a prosthetic heart valve (also referred to herein as a “prosthetic valve”) includes a self-expanding wire frame body (also referred to herein as a “body”), a valve disposed in the body, a leaflet clip coupled to the body, and a control element operably coupled to the leaflet clip. The body has a proximal end and a distal end. The leaflet clip is configured to be transitioned between a first configuration in which the prosthetic valve can be inserted into a heart, and a second configuration in which the leaflet clip is disposed to capture a native valve leaflet between the leaflet clip and the wire frame body when the body is disposed in a native annulus of an atrioventricular valve of a heart. The control element has a length sufficient to extend from the leaflet clip through a ventricle of the heart and out a wall of the ventricle when the body is disposed in the native annulus of the atrioventricular valve of the heart. The control element is configured to allow a user to transition the leaflet clip from its first configuration to its second configuration when the body is disposed in the native annulus of the atrioventricular valve of the heart.

In some embodiments, a method includes delivering to a native annulus of an atrioventricular valve of a heart a prosthetic valve having a self-expanding body having a proximal end and a distal end. A valve is disposed in the body and a leaflet clip is coupled to the body. The leaflet clip is movable between a first configuration and a second configuration, and a control element is operably coupled to the leaflet clip. The leaflet clip and the control element are disposed on a ventricular side of the native annulus. The leaflet clip is disposed in the first configuration, and the body is allowed to self-expand into engagement with the native annulus. A portion of the control element is disposed outside the heart, and with the control element, tension is released to allow the leaflet clip to transition between the first configuration and the second configuration to capture a native valve leaflet between the leaflet clip and the body.

In some embodiments, a system includes a prosthetic heart valve body, a leaflet clip, a control element operably coupled to the leaflet clip, and an elongate member. The body has a proximal end and a distal end. The leaflet clip is configured to be transition between a first configuration during deployment of the body, and a second configuration, in which the leaflet clip captures a native valve leaflet between the leaflet clip and the body when the body is disposed in a native annulus of an atrioventricular valve of a heart. The control element has a length sufficient to extend from the leaflet clip through the ventricle of the heart and out a wall of the ventricle when the body is disposed in the native annulus of the atrioventricular valve of the heart. The control element is configured to allow a user to transition the leaflet clip from its first configuration to its second configuration when the body is disposed in the native annulus of the atrioventricular valve of the heart. The elongate member has a first end and a second end. The first end is configured to be disposed in the ventricle of the heart during deployment of the body and the second end is configured to extend outside the heart. The elongate member defines a control element lumen. The control element is disposable in the control element lumen and extendable out the second end of the elongate member.

In some embodiments, a system for delivering a prosthetic heart valve to a native valve annulus includes a self-expanding wire frame body, a leaflet clip, an elongate member, and a control element. The body has a proximal end and a distal end. The elongate member has a first end and a second end. The first end of the elongate member is configured to be disposed in a ventricle of a heart during deployment of the prosthetic heart valve, and the second end of the elongate member is configured to extend outside the heart. The elongate member defines a control element lumen. The control element has a first end and a second end disposed in the control element lumen and operably coupled to the leaflet clip. The control element has a length sufficient to extend from the leaflet clip through the control element lumen and out a wall of the ventricle when the body is disposed in the native annulus of the atrioventricular valve of the heart. The control element is configured to allow a user to maintain the leaflet clip in a first configuration during deployment of the body, and to allow the user to transition the leaflet clip to a second configuration, in which the leaflet clip captures a native valve leaflet between the leaflet clip and the body when the body is disposed in the native annulus of the atrioventricular valve of the heart.

As used herein, the words “distal” and “proximal” refer to a direction close to and away from, respectively, an operator of, for example, a medical device. Thus, for example, the end of the medical device closest to the patient's body (e.g., contacting the patient's body or disposed within the patient's body) would be the proximal end of the medical device, while the end opposite the proximal end and closest to, for example, the user (or hand of the user) of the medical device, would be the distal end of the medical device.

As used herein, the terms “about” and “approximately” generally mean plus or minus 10% of the value stated. For example, about 0.5 would include 0.45 and 0.55, about 10 would include 9 to 11, about 1000 would include 900 to 1100.

As described herein, when a prosthetic heart valve is implanted and secured to a native heart valve annulus, native valve leaflets can become disposed between the prosthetic heart valve and the myocardium of the heart. When the native valve leaflets are disposed in such a manner, the native valve leaflets can, for example, interfere with operation of the prosthetic heart valve and/or with blood flow through the heart. For example, the native leaflets can obstruct the left ventricular outflow tract (LVOT), thereby reducing the flow of oxygenated blood to the body. The native leaflets can also obstruct the prosthetic heart valve and reduce the effective orifice area (EOA), thereby reducing the flow of blood from the atrium to the ventricle. Furthermore, the native valve leaflets can interfere with proper seating of the prosthetic heart valve in the native valve annulus resulting in improper operation of the prosthetic heart valve. Said another way, if the prosthetic heart valve body does not form a sufficient seal with the native valve annulus, blood can leak around the valve body and the prosthetic heart valve may not function properly.

In some embodiments, a prosthetic heart valve can include a leaflet clip. In use, i.e., during an operation in which the prosthetic heart valve is delivered to a native annulus of an atrioventricular valve of a heart (e.g., mitral valve or a tricuspid valve), the leaflet clip can function to capture (e.g., grab, couple to, connect with, bias, pierce, enclose, etc.) a native valve leaflet. For example, when the prosthetic heart valve is implanted into the native annulus of the heart, the leaflet clip can capture the native valve leaflet such that the native leaflet is disposed between the leaflet clip and a body portion of the prosthetic valve. In this manner, the native leaflet can be selectively positioned, for example, outside of the flow path between the prosthetic heart valve orifice, thereby preserving the EOA of the prosthetic heart valve, limiting and/or reducing LVOT obstruction, blood flow turbulence, eddies, or similar interference by the native leaflet during operation of the prosthetic heart valve. Similarly, over time as the native leaflet stiffens, due to calcification for example, or otherwise changes form, the leaflet clip can retain the native leaflet in a desirable position such that a desirable blood flow profile is maintained. Further, the native leaflet can be selectively positioned and/or enclosed by the leaflet clip to provide sealing between the prosthetic heart valve (e.g., the body of the prosthetic heart valve) and the native annulus of the heart valve, and additionally as a result, between the left ventricle of the heart and the left atrium of the heart.

As described in further detail herein, in some embodiments, the prosthetic heart valve and/or the leaflet clip can be operably coupled to a control element that is configured to allow a user to transition the leaflet clip to capture the native leaflet between the a body portion of the prosthetic heart valve and the leaflet clip.

FIG. 1is a schematic illustration of a prosthetic heart valve system1000. The prosthetic heart valve1000is designed to be disposed in a damaged or diseased native heart valve such as a mitral valve. The prosthetic heart valve1000(also referred to herein as a “prosthetic valve”) includes a prosthetic valve body1100, a first leaflet clip1200a, and optionally a second leaflet clip1200b(referred to collectively as “clips1200”). In some embodiments, additional leaflet clips1200can be included in the prosthetic heart valve1000. The leaflet clips1200are coupled to the prosthetic valve body1100and are configured to be transitioned between a first configuration in which the prosthetic valve1000can be inserted into a heart, and a second configuration in which the leaflet clips1200are disposed to capture one or more native valve leaflets between the leaflet clips1200and the valve body1100when the valve body1100is disposed in a native annulus of an atrioventricular valve of a heart. A control element1300is operably coupled to the leaflet clips1200and has a length sufficient to extend from the leaflet clips1200through a ventricle of the heart and out a wall of the ventricle when the valve body1100is disposed in the native annulus of the atrioventricular valve of the heart. The control element1300is further configured to allow a user to transition the leaflet clips1200from their first configuration to their second configuration (either individually or simultaneously) when the valve body1100is disposed in the native annulus of the atrioventricular valve of the heart.

The prosthetic valve body1100can be formed such that it can be deformed (e.g., compressed and/or expanded) and, when released, return to its original (undeformed) size and shape. To achieve this, the valve body1100can be formed of any suitable material, or combination of materials, such as metals or plastics that have shape memory properties. In some embodiments, the valve body1100can be formed from Nitinol. Other shape memory alloys, such as, for example, Cu—Zn—Al alloys and/or Cu—Al—Ni alloys can be used. The prosthetic valve body1100can be the same as or similar to any of the prosthetic valves described in International Patent Application No. PCT/US14/44047, entitled “Thrombus Management and Structural Compliance Features for Prosthetic Heart Valves,” (“the '047 application”), and International Patent Application No. PCT/US14/40188, entitled “Structure Members for Prosthetic Mitral Valves,” (“the 188 application”), the disclosures of which are incorporated herein by reference in their entirety.

The valve body1100includes a valve (not shown) disposed therein. The valve body1100can be any suitable size, shape, or configuration. In some embodiments, the valve body1100can include an outer frame, and an inner valve assembly that includes an inner frame and leaflets. Further, in some embodiments, the valve body1100can have an upper, proximal end (e.g., at an atrium portion), a lower, distal end (e.g., at a ventricle portion), and a medial portion (e.g., at an annulus portion) therebetween. The medial portion, in such embodiments, can have a perimeter that is configured to fit into an annulus of a native atrioventricular valve (e.g., a mitral valve or a tricuspid valve). The upper end of the outer frame can have a perimeter that is larger than the perimeter of the medial portion. As will be shown in further embodiments, portions of the valve body1100can have a D-shaped cross-section (e.g., the upper end and the medial portion of the outer frame). In this manner, the outer frame can promote a suitable fit into the annulus of the native atrioventricular valve.

As described herein, the leaflet clips1200are operably coupled to the valve body1100. The leaflet clips1200can be coupled to the valve body1100in any suitable manner. In some embodiments, the leaflet clips1200and the valve body1100can be monolithically constructed. In other embodiments, the leaflet clips1200and the valve body1100can be formed separately and then joined together (e.g., using a wire, a screw, an interference fit, a weld, or otherwise any suitable fastener or fastening method). In some embodiments, the leaflet clips1200can be substantially permanently coupled to the valve body1100, while in other embodiments, the leaflet clips1200can be removably coupled to the valve body1100.

In some embodiments, the leaflet clips1200can be coupled to or a part of an outer frame of the valve body1100, while in other embodiments, the leaflet clips1200can be coupled to or a part of an inner frame of the valve body1100. Moreover, the leaflet clips1200can be coupled to the valve body1100at any suitable time. For example, the leaflet clips1200can be coupled to the valve body1100before delivery of prosthetic heart valve1000into a heart, i.e., the leaflet clips1200can be coupled to the valve body1100when the heart valve1000is disposed outside the heart. As another example, the leaflet clips1200can be coupled to the valve body1100after the prosthetic heart valve1000is disposed inside the heart. In this manner, the valve body1100and the leaflet clips1200can be delivered to the heart separately, and coupled to one another after both the valve body1000and the leaflet clips1200are disposed in the heart.

In some embodiments, the first leaflet clip1200acan include a first leaflet covering1210adisposed on at least a portion of the first leaflet clip1200a. Similarly, in some embodiments, the second leaflet clip1200bcan include a second leaflet covering1210bdisposed on at least a portion of the second leaflet clip1200b. The covering1210aand the covering1210b(referred to collectively as “coverings1210”) can be constructed from any suitable material, or any combination of materials such as, for example, stabilized tissue derived from 30 day old bovine, ovine, equine or porcine pericardium, or from animal small intestine submucosa. In some embodiments, the coverings1210can be constructed from a synthetic material including, for example, polyester, polyurethane, polytetrafluoroethylene, or a combination thereof. In use, the coverings1210can enhance the ability to capture, secure, bias, or otherwise contain or manipulate a native valve leaflet. For example, in use, the coverings1210can provide an enhanced surface area configured to at least partially enclose a native leaflet, thereby enhancing management and/or selective control of the native leaflet. In this manner, the coverings1210can prevent at least a portion of one or more native leaflets from protruding through an area defined by the leaflet clips1200, thereby limiting and/or reducing the potential undesirable interference of the one or more native valve leaflets with blood flow, LVOT, EOA, or otherwise proper functioning of the heart and/or the prosthetic heart valve1000. Moreover, in some embodiments the coverings1210can be configured to promote or accelerate desirable in-growth between the coverings1210and/or the valve body1100, and the native leaflets.

In some embodiments, the coverings1210can substantially cover the leaflet clips1200(e.g., substantially the entire area defined by the leaflet clips1200). In other embodiments, the coverings1210can define an aperture, or multiple apertures, to allow blood to flow there-through (e.g., from the atrium to the ventricle during delivery of the prosthetic valve1000, during deployment of the valve body1100, and/or during manipulation of the leaflet clips1200). In this manner, in use, an aperture of the coverings1210can be configured to limit and/or reduce blood flow restriction, and enhance movement and manipulation of the leaflet clips1200and/or the valve body1100. Further to this example, in use, the coverings1210can be configured to allow blood flow there-through when the leaflet clips1200are in a disengaged (i.e., disengaged with respect to a native leaflet; in a “ready state”). Such a configuration can limit and/or prevent undesirable interruption of blood flow (e.g., LVOT obstruction) during delivery and deployment of the prosthetic heart valve1000and the leaflet clips1200. The aperture(s) can be sized and/or shaped in any suitable manner, e.g., to encourage a desirable flow rate there-through. As described herein, in some embodiments, the coverings1210can include multiple materials and/or configurations. In this manner, the coverings1210can be configured to promote in-growth between the coverings1210and/or the valve body1100, and the native leaflets. For example, the coverings1210can include varying porosities configured to promote in-growth and/or allow blood to flow through the varying porosities at varying flow rates.

The leaflet clips1200can be any shape, size or configuration, and can be formed of any suitable material, or combination of materials. In some embodiments, similar to the valve body1100in some instances, the leaflet clips1200can be formed such that they can be deformed (e.g., compressed, expanded, reconfigured, or otherwise biased in some manner), and when released, return to their original sizes, shapes and/or configurations (undeformed).

In some embodiments, the leaflet clips1200can be substantially identical to each other in shape, size, and/or configuration, while in other embodiments, the leaflet clips1200can be different than one another in shape, size, and/or configuration. Various configurations of the leaflet clips1200will be discussed in further detail herein, and illustrated in more detail in further figures.

The leaflet clips1200can function to engage (e.g., capture, bias, couple to, connect with, pierce, enclose, etc.) one or more native leaflets of a heart valve. More specifically, the leaflet clips1200can capture a native leaflet between the leaflet clips1200and the valve body1100. Any number of leaflet clips can be configured to capture any number of native valve leaflets, and at any location of the valve body1100, as discussed in further detail herein. In some embodiments, the leaflet clips1200(i.e., the leaflet clip1200aand the leaflet clip1200b) can be configured to capture a single native valve leaflet. In other embodiments, the leaflet clips1200can be configured to capture multiple native leaflets. For example, the leaflet clip1200acan be configured to capture a native leaflet at an A2 portion (also referred to as “A2 leaflet”) of the heart valve, and the leaflet clip1200bcan be configured to capture a native leaflet at a P2 portion (also referred to as “P2 leaflet”) of the heart valve. Further to this example, in many instances the A2 leaflet has a size and shape different than the P2 leaflet. In such instances, the first leaflet clip1200acan be sized and/or shaped to sufficiently engage and capture the A2 leaflet. Similarly, the second leaflet clip1200bcan be sized and/or shaped to sufficiently engaged and capture the P2 leaflet. In some embodiments, the leaflet clips1200can vary in width based on their configuration or position. For example, the leaflet clips1200can have a first width when disposed in a disengaged position, and a second width when disposed in an engaged configuration, where the second width is greater than the first width.

Moreover, in this manner, one or more native leaflets can be captured and selectively positioned outside of the flow path defined between the prosthetic heart valve1000orifice (e.g., through the valve disposed in the valve body1100), thereby preventing obstruction or reduction of the EOA. Similarly, the leaflet clips1200and the valve body1100can collectively function to position one or more native leaflets to provide sealing between the prosthetic heart valve1000(e.g., an outer portion of the valve body1100) and the native annulus of the atrioventricular valve of the heart.

In some embodiments, a force can be applied to the leaflet clips1200. In this manner, the leaflet clips1200can be disposed in a first configuration based at least in part on the force. Further, in such embodiments, the leaflet clips1200can be transitioned into a second configuration based at least in part on reduction of the force. Similarly stated, the leaflet clips1200can be disposed in a first configuration for a time period and when the force (e.g., tension) is being applied to the leaflet clips1200. In such embodiments, the leaflet clips1200scan be transitioned from the first configuration to a second configuration after the time period and when the force is reduced or no longer applied (e.g., the tension is released). Further, in some embodiments, the leaflet clips1200can transition from the first configuration to the second configuration based on a force (e.g., generated by a user), as previously discussed above, and alternatively or additionally, the leaflet clips1200can transition from the first configuration to the second configuration based on a material from which the leaflet clips1200are formed (e.g., a material having shape memory properties).

The leaflet clips1200can be operably coupled to the control element1300(e.g., suture, tether, etc.) in any suitable manner. The control element1300can be configured to allow a user to transition the leaflet clips1200from a first configuration (e.g., during delivery, disengaged from native leaflet) to a second configuration (e.g., engaged with the native leaflet). For example, in some embodiments, the control element1300can apply a force to the leaflet clips1200such that the leaflet clips1200are disposed in the first configuration. Further to this example, in some embodiments, the first configuration can include the leaflet clips1200being disposed in a deformed state, e.g., in instances where the leaflet clips1200are formed of shape memory material. In such embodiments, the control element1300can reduce or remove the force to the leaflet clips1200such that the leaflet clips1200transition from the first configuration to the second configuration. The second configuration can include the leaflet clips1200being disposed in an undeformed state, e.g., in instances where the leaflet clips1200are formed of shape memory material. In other embodiments, the force applied by the control element1300can be a first force, and the leaflet clips1200can transition from the first configuration to the second configuration based at least in part on a second force (e.g., a spring, hinge or the like coupled to the valve body1100and operably coupled to the leaflet clips1200). For example, the prosthetic valve1000can include leaflet clip attachment members (not shown) disposed between the leaflet clips1200and the valve body1100. The leaflet clip attachment members can transition the leaflet clips1200from the first configuration to the second configuration. For example, the leaflet clip attachment members can include an energy storage member such as a spring-loaded hinge, a spring, or the like. Further to this example, instead of or in addition to shape memory properties of the leaflet clips1200causing the leaflet clips1200to transition from the first configuration to the second configuration, the energy storage member can promote transition of the leaflet clips1200from the first configuration to the second configuration.

In some embodiments, the leaflet clips1200can be removably coupled to the control element1300. In use, the control element1300can be coupled to the leaflet clips1200during delivery of the prosthetic valve1000to a native annulus of an atrioventricular valve of a heart, and during manipulation of the leaflet clips1200, and selectively decoupled (e.g., by an operator) from the leaflet clips1200thereafter.

Although control element1300is shown inFIG. 1as being operably coupled to both leaflet clip1200aand leaflet clip1200b, in some embodiments, control element1300can include a first control element1300aand a second control element1300b. In such embodiments, the first control element1300aand the second control element1300bcan be monolithically constructed, while in other embodiments, the first control element1300aand the second control element1300bcan be formed separately, and in some cases, attached. In some embodiments, the first control element1300acan be operably coupled to the first leaflet clip1200aand not the second leaflet clip1200b, and the second control element1300bcan be operably coupled to the second leaflet clip1200band not the first leaflet clip1200a. In other embodiments, the first control element1300aand the second control element1300bcan each be operably coupled to both the first leaflet clip1200aand the second leaflet clip1200b.

The first control element1300aand the second control element1300bcan be coupled to one another in any suitable manner (e.g., a knot, a fastener, etc.) such that a user can operate both the first control element1300aand the second control element1300bsubstantially simultaneously, and as such, the user can manipulate both the first leaflet clip1200aand the second leaflet clip1200bsubstantially simultaneously. In use, in some embodiments, the first control element1300acan be coupled to the second control element1300bwithin the heart, while in other embodiments, the first control element1300acan be coupled to the second control element1300boutside the heart.

In some embodiments, the first control element1300aand the second control element1300bcan be configured such that a user can independently operate the first control element1300aand the second control element1300b, and as such, the user can independently manipulate the first leaflet clip1200aand the second leaflet clip1200b. In this manner, a user can transition first leaflet clip1200avia the first control element1300afrom a disengaged configuration (e.g., in which the prosthetic valve can be inserted into the heart) to an engaged configuration (e.g., in which the first leaflet clip1200ais disposed to capture a native valve leaflet between the first leaflet clip1200aand the valve body1100). In a similar manner, a user can transition the second leaflet clip1200bvia the second control element1300bfrom a disengaged configuration (e.g., in which the prosthetic valve can be inserted into the heart) to an engaged configuration (e.g., in which the second leaflet clip1200bis disposed to capture a native valve leaflet between the second leaflet clip1200band the valve body1100).

Moreover, the first leaflet clip1200aand the second leaflet clip1200bcan include a first control portion (not shown) and a second control portion (not shown), respectively (referred to collectively as “control portions”). The control portions1230can be configured to be coupled to the control element1300. In some embodiments, the control portions1230can include an aperture, a ring, a loop, a slot, or otherwise any suitable anchor point for the control element1200to attach to. In some embodiments, the control portions1230and the leaflet clips1200can be monolithically constructed, while in other embodiments, the control portions1230and the leaflet clips1200can be formed separately and then joined together (e.g., using a wire, a weld, or otherwise any suitable fastener or fastening method).

In some embodiments, the leaflet clips1200can be configured to not undesirably interfere with a portion of an atrioventricular valve of a heart. For example, the leaflet clips1200can be sized and shaped such that they do not undesirably interfere with a native annulus of the atrioventricular valve (e.g., when the leaflet clips1200are in an engaged configuration or in the process of transitioning into the engaged configuration). Further to this example, more specifically, the leaflet clips1200can have a first end and a second end having a length that is less than a length of the valve body1100. As such, the leaflet clips1200can be spaced a non-zero distance from the native annulus when the leaflet clips1200are in the engaged configuration. In this manner, the leaflet clips1200can transition between various positions and configurations without undesirably interfering with the native annulus, while having a length sufficient to capture one or more native leaflets. Similarly, the leaflet clips1200can be spaced a non-zero distance from an internal surface of a ventricle (e.g., a ventricular wall) when the leaflet clips1200are in the disengaged configuration, engaged configuration, or any position there between. In this manner, the leaflet clips1200can transition between various positions and configurations without undesirably interfering with portions of the atrioventricular valve, such as, a ventricular wall.

FIGS. 2a-2cshow a prosthetic valve2000according to an embodiment in a first position (FIG. 2a), a second position (FIG. 2b), and a third position (FIG. 2c), respectively. The prosthetic valve2000includes a valve body2100, a first leaflet clip2200aand a second leaflet clip2200b(referred to collectively as “leaflet clips2200”), an anchoring tether2130, and a first control element2300aand a second control element2300b(referred to collectively as “control elements2300”). The valve body2100has a proximal end2110and a distal end2120, and includes multiple self-expanding atrial anchoring elements distributed circumferentially about, and extending radially outwardly from, the proximal end2110of the valve body2100. In this embodiment, the valve body2100and the leaflet clips2200are formed from a laser-cut tube of Nitinol. The anchoring tether2130is coupled to the distal end2120of the valve body2100.

The leaflet clips2200are integrally formed with the valve body2100. The first leaflet clip2200aand the second leaflet clip2200binclude a first leaflet clip covering2210aand a second leaflet clip covering2210b, respectively (referred to collectively as “coverings2210”). As described above, the coverings2210can be constructed from any suitable material, or any combination of materials.

The anchoring tether2130is attached to the distal end2120of the valve body2100. Although not shown, the anchoring tether2130can have a length sufficient to extend from the distal end2120of the valve body2100through the ventricle of a heart and out the wall of the ventricle when the valve body2100is disposed in a native annulus of an atrioventricular valve of the heart. The anchoring tether2130can be configured to anchor the prosthetic valve2000to the heart at a location external to the heart.

As best shown inFIG. 2b, the control elements2300are operably and removably coupled to the leaflet clips2200. In this manner, the control elements2300are configured to transfer a force to the leaflet clips2200such that the leaflet clips2200transition among various positions. Further, the control elements2300are configured to allow a user to transition leaflet clips2200among the various positions.

In use, the leaflet clips2200can be transitioned between several different positions. For ease of illustration, inFIGS. 2a-2c, first leaflet clip2200aand the second leaflet clip2200bare shown in like or matching positions. It should be noted that, in some embodiments, the first leaflet clip2200aand the second leaflet clip2200bcan be transitioned at different times between different positions. For example, the first leaflet clip2200acan be disposed in a first position when second leaflet clip2200bis disposed in a second position. In this manner, a user can manipulate each leaflet clip independently such that the first leaflet clip2200acan capture a native leaflet at a first time, and the second leaflet clip2200bcan capture a native leaflet at a second time after the first time. Such functionality allows for better, more repeatable capture and recapture of native leaflets.

In the first position (FIG. 2a), the leaflet clips2200are in disengaged positions (i.e., disengaged with respect to a native valve leaflet). Said another way, in the first position, the leaflet clips2200are in a “ready state” (i.e., ready to capture a native valve leaflet between the leaflet clips2200and the valve body2100). Further, in the first position, the leaflet clips2200are disposed such that the valve body2100can be inserted into a heart. In this manner, in use, as the valve body2100is delivered to a native annulus of an atrioventricular valve of a heart, the leaflet clips2200can limit and/or provide for minimal undesirable contact and/or interference with portions of the heart (e.g., native chordae tendineae of the heart). Further, in the first position, the leaflet clips2200are in their deformed positions, i.e., not in their at least partially predefined, undeformed positions, e.g., as defined in part by their shape memory properties. Moreover, as shown, a force (tension) is applied by the control elements2300to the leaflet clips2200. In this manner, the control elements2300are configured to maintain the leaflet clips2200in the first position.

To move the leaflet clips2200from the first position (FIG. 2a) to the second position (FIG. 3), tension applied to the leaflet clips2200by the control elements2300is partially released. As shown inFIG. 2b, in the second position, the leaflet clips2200are in intermediate states. Similarly stated, the leaflet clips2200are in partially engaged positions, i.e., in a position to contact a native valve leaflet of the heart.

To move the leaflet clips2200from the second position (FIG. 2b) to the third position (FIG. 2c), tension applied to the leaflet clips2200by the control elements2300is released further. In the third position (FIG. 2c), the leaflet clips2200are in fully engaged positions. In this manner, the leaflet clips2200are disposed to capture one or more native valve leaflets (not shown) between the leaflet clips2200and the valve body2100when the valve body2100is disposed in a native annulus of an atrioventricular valve of a heart (not shown). Thus, the leaflet clips2200are configured to retain one or more native valve leaflets when the leaflet clips2200are in the third position such that one or more native valve leaflets do not undesirably interfere with flow through the valve body2100(e.g., through a prosthetic valve disposed in the valve body2100).

Although the leaflet clips2200are shown as rotating and/or bending about an axis when transitioning between positions (FIGS. 2a-2c), in other embodiments, the leaflet clips2200can be configured to transition between positions in any suitable manner to capture and/or bias one or more native valve leaflets. For example, the leaflet clips2200can be configured to slide and/or otherwise translate between positions (e.g., from the first position to the third position) to capture one or more native valve leaflets.

Although the transition of the leaflet clips2200from the first position (disengaged; deformed) to the second position (intermediate; partially engaged and deformed) and to the third position (engaged, undeformed) has been described above as resulting at least in part from a release or reduction of tension via the control elements2300, in other embodiments, leaflet clips2200can be transitioned between positions in or by any suitable manner. For example, the leaflet clips2200can be configured to transition from a disengaged, undeformed position, to an engaged position, at least in part in response to receiving a force from control elements2300. In this manner, a force can be applied to the leaflet clips2200to cause the leaflet clips2200to transition from their disengaged position to their engaged position (i.e., disposed to capture one or more native valve leaflets between the leaflet clips2200and the valve body2100when the valve body2100is disposed in a native annulus of an atrioventricular valve of a heart).

In use, the force applied to and released from the leaflet clips2200can be produced and released in any suitable manner, e.g., the force can be produced and reduced manually by a user. For example, a user can apply or release tension at a distal end portion (not shown) of the control elements2300. Further to this example, the distal end portion of the control elements2300can be disposed outside the heart.

As described herein, the leaflet clips2200are configured to capture native leaflets of a heart valve. In doing so, the leaflet clips2200can be moved throughout the ventricle of a native heart valve. In some embodiments, the leaflet clips2200can be configured to limit or avoid undesirable interference with portions of the heart valve (e.g., interference with the native chordae tendineae of the heart, or a wall of the heart), and to promote sufficient capture and/or containment of one or more native leaflets. For example, the leaflet clips2200can have one or more axis or points of rotation. In this manner, in use, as the leaflet clips2200are transitioned through various positions within the heart, the leaflet clips2200can be maintained in profiles suitable for avoidance of undesirable interference with portions of the native heart valve, and suitable for sufficient capture of one or more native leaflets.

Further to this example, as shown inFIGS. 3 and 4, the leaflet clips2200can have a single point of rotation (FIG. 3) or two points of rotation (FIG. 4), respectively. As shown inFIG. 3, the leaflet clip2200can have a single point of rotation, i.e., rotation point2240. In use, the leaflet clip2200can be transitioned between various positions and configurations, shown by arrow A, by being rotated about the rotation point2240. Further, the leaflet clip2200can have distal end disposed at a maximum distance D1measured from that distal end to an axis defined by an end of the valve body2100when the leaflet clip2200is being transitioned from a disengaged configuration to an engaged configuration. As another example, as shown inFIG. 4, the leaflet clip2200can have two points of rotation, i.e., a first point of rotation2240and a second point of rotation2250. In use, the leaflet clip2200can be transitioned between various positions and configurations, shown by arrow B, by being rotated about the rotation point2240and the rotation point2250. Further to this example, the leaflet clip2200can have a distal end disposed at a maximum distance D2measured from that distal end to an axis defined by an end of the valve body2100when the leaflet clip2200is being transitioned from a disengaged configuration to an engaged configuration. As shown, distance D1is greater than distance D2. Thus, the additional rotation point, i.e., rotation point2250, can reduce or limit the leaflet clips2200profile, thereby promoting avoidance of undesirably interference with portions of the native heart valve. In addition, the additional rotation point can promote suitable capture of one or more native leaflets. Although the leaflet clip2200shown inFIG. 4has only two rotation points, in some embodiments, the leaflet clip2200can have any suitable number rotation points (e.g., 3, 4, 5 or more).

FIGS. 5-7show a valve body3100and leaflet clips3200, of a prosthetic heart valve3000, in an undeformed, initial state, i.e., as laser-cut, and in a rolled configuration (FIG. 5), a flat sheet of the same for ease of illustration (FIG. 6), and a side view with the leaflet clips3200in an engaged position (FIG. 7), according to an embodiment. As shown inFIG. 5, the leaflet clips3200and the valve body3100are formed and laser-cut from the same piece of Nitinol. As such, the leaflet clips3200are integral to the valve body3100.

The prosthetic valve3000includes a first leaflet clip3200aand a second leaflet clip3200b(referred to collectively as “leaflet clips3200”). The leaflet clips3200can be configured the same as or similar to the leaflet clips described in any other embodiments described herein (e.g., the leaflet clips1200and/or the leaflet clips2200). The leaflet clips3200can be any suitable shape, size, or configuration to capture a native valve leaflet. The first leaflet clip3200aand the second leaflet clip3200bare configured to collectively capture a native valve leaflet (e.g., an A2 leaflet). The first leaflet clip3200aincludes a leaflet control portion3230aconfigured to operably couple to a control element (not shown). Similarly, the second leaflet clip3200bincludes a leaflet control portion3230bconfigured to operably couple to the control element (not shown). The leaflet control portion3230aand the leaflet control portion3230bare referred to collectively as “control portions3230.” The leaflet control portions3230each define an aperture. In some embodiments, the leaflet control portions3230can define any suitable number of apertures, and in any suitable size, shape or configuration.

Moreover, in some embodiments, control element (not shown) can include a tether configured to be routed through the apertures defined by the control portions3230. In this manner, in use, the control element can cause the leaflet clips3200to transition between various positions (e.g., the same or similar positions discussed above with respect to prosthetic heart valve2000).

Although the control portions3230each define an aperture, in other embodiments, the control portions3230can be any suitable shape, size, or configuration. For example, the control portions3230can include a protrusion, a fastener, a clasp, or the like, i.e., any suitable feature to allow for attachment of or control/manipulation by control element (e.g., a user of control element).

As best shown inFIG. 7, the first leaflet clip3200aand second leaflet clip3200bare each disposed on a single side portion of the valve body3100, e.g., an A2 portion of the valve body3100. In this manner, the first leaflet clip3200aand second leaflet clip3200bcan be configured to capture a single native valve leaflet when prosthetic heart valve3000is disposed in a native atrioventricular valve of a heart. The leaflet clips3200can include coverings (not shown) the same as or similar to the coverings described above with respect to leaflet clips1210and/or leaflet clips2210.

Although many of the leaflet clips discussed herein are integral to their respective valve bodies, in some embodiments, one or more leaflet clips can be formed separately from a valve body, and then joined together in any suitable manner (e.g., using any suitable fastener or fastening method, a screw, wire, an interference fit, laser welding, etc.). In addition, in some embodiments, one or more leaflet clips can include a pivot portion configured to provide an axis about which the clip can fold over and/or otherwise capture a native valve leaflet. Said another way, the pivot portion of the leaflet clip can delineate an axis across the leaflet clip such that a portion of the leaflet clip disposed on one side of the axis is configured to contact a proximal portion of the native leaflet, and a portion of the leaflet clip disposed on the opposite side of the axis is configured to contact a distal portion of the native leaflet. In some embodiments, a leaflet clip can include multiple points of rotation (e.g., two points of rotation).

In some embodiments, the leaflet clips described herein can include a clip attachment portion configured to allow the leaflet clip to be coupled to a valve body. For example, as shown inFIGS. 8a-10b, a leaflet clip4200defines a clip attachment portion4250, a pivot portion4260, and a leaflet control portion4230. The leaflet clip4200is configured to be coupled to the valve body4100at the clip attachment portion4250. As shown inFIGS. 8a, 9a, and 10a, the leaflet attachment portion4250defines multiple apertures configured to allow for the leaflet clip4200to be coupled to the valve body4100in any suitable manner (e.g., any suitable fastener, a screw, a wire, a tether, laser weld, etc.). The number of apertures defined by the leaflet attachment portion4250inFIGS. 8a, 9a, and 10aare illustrative examples. In other embodiments, any suitable number of apertures can be defined and/or used.

In use, the leaflet clip4200is configured to capture a native valve leaflet.FIGS. 8a, 9a, and 10ashow leaflet clip4200in a first configuration (“ready state”, disengaged).FIGS. 8b, 9b, and 10bshow the leaflet clip4200in a second configuration (engaged), i.e., disposed to capture native leaflet L between either end of the leaflet clip4200, the ends being defined in part by the pivot portion4260.

Further shown inFIGS. 8a-10bare examples of various shapes, sizes, and configurations of the leaflet clip4200.FIGS. 8aand 8b, for example, show the leaflet clip4200as having a fork-like shape, i.e., a shape having two prongs spaced apart in a suitable manner by a width configured to promote suitable capturing of a native valve leaflet. Similarly,FIGS. 9aand 9b, show the leaflet clip4200as having a similar two-prong structure, however, the prongs have a width larger than a width of the prongs illustrated inFIGS. 8aand 8b. As another example,FIGS. 10aand 10bshow the leaflet clip4200as having a U-shape.

As described above, the leaflet clips can have any suitable configuration and can be disposed at any suitable location on the valve body. For example, as shown inFIG. 11, the leaflet clip5200can be symmetrical with respect to an axis, i.e., axis A, defined by the valve body5100of a prosthetic valve5000. In some embodiments, as shown for example inFIG. 12, the leaflet clip5200can be offset, i.e., asymmetric with respect to axis A defined by the valve body5100. In some embodiments, such as the asymmetric configuration shown inFIG. 12, the leaflet clip5200can promote desirable capturing of a native leaflet. Further to this example, in use, an asymmetric configuration, i.e., asymmetric with respect to axis A, can be configured to dispose the leaflet clip5200in a substantially symmetric fashion with respect to a centerline axis of a native leaflet (not shown) when the valve body5100is disposed in a native annulus of an atrioventricular valve of a heart. In this manner, the leaflet clip5200can be disposed at a radial position of the valve body5100based at least in part on a location of a target native valve leaflet so as to promote suitable capture and/or control of the native valve leaflet.

FIG. 13shows a side view of a prosthetic heart valve6000having a valve body6100and a leaflet clip6200disposed in an engaged configuration, according to an embodiment. The leaflet clip6200includes a covering6210that defines a passageway6215configured to allow blood to flow there-though when the prosthetic heart valve6000is being delivered to a native heart valve. In this manner, the passageway6215can allow blood to flow there-through when the leaflet clip6200is disposed in a disengaged “ready state” position (not shown) during delivery, thereby limiting and/or reducing potential blood flow restriction, and enhancing movement and manipulation of the leaflet clip6200and the valve body6100during delivery thereof. Although the passageway6215of the leaflet clip6200is shown as oval-shaped aperture, in other embodiments, passageway6215can be any suitable shape, size, or configuration, and can include any suitable number of apertures, windows, passageways or varying porosities. For example, the passageway6215can define multiple distinct passageways (e.g., 2, 3, 4 or more). In other embodiments, the passageway6215can define multiple passageways operably coupled to one another (e.g., in fluid communication).

FIG. 14shows a first leaflet clip7200aand a second leaflet clip7200b(referred to collectively as “clips7200”) having a curved shape, according to an embodiment. The curved shape of the leaflet clips7200can be configured to facilitate delivery and deployment of the valve body (not shown) and the leaflet clips7200. More specifically, the leaflet clips7200can be configured to limit or avoid undesirable interference and/or contact between the leaflet clips7200and native chordae tendineae of a heart. Although shown as having an S-shape, in other embodiments, the leaflet clips7200can have any suitable shape to limit interference with the native chordae tendineae.

FIGS. 15-18show a prosthetic heart valve8000in side view (FIG. 15), in front view (FIG. 16), in detailed view (FIG. 17), and in perspective view (FIG. 18), according to an embodiment. The prosthetic heart valve8000has a valve body8100, a first leaflet clip8200aand a second leaflet clip8200b(referred to collectively as “clips8200”). The leaflet clips8200are operably coupled to the valve body8100. The valve body8100has a native leaflet retention portion8140(also referred to herein as “retention portion”) configured to receive a native leaflet and/or the leaflet clips8200when the valve body8100is disposed within a native annulus of an atrioventricular valve of a heart. The valve body8100further includes a first sealing portion8150aand a second sealing portion8150b(referred to collectively as “sealing portions8150”), both of which are configured to provide a fluid seal between the valve body8100and a native leaflet when the native leaflet is disposed between the leaflet clips8200and the valve body8100.

The retention portion8140can be any suitable size and/or shape, and can be located at any suitable portion of the valve body8100. For example, the retention portion8140can be sized and/or shaped to correspond to (e.g., by shape, size, surface design, texture, etc.) a portion of the leaflet clips8100and/or the native leaflets. In this manner, in use, the retention portion8140and the leaflet clips8100can cooperatively function to substantially maintain one or more native leaflets when the leaflet clips8200are disposed in an engaged configuration, i.e., when the leaflet clips8200are disposed to capture the one or more native leaflets between the leaflet clips8200and the retention portion8140of the valve body8100when the valve body8100is disposed in a native annulus of an atrioventricular valve of a heart.

As best shown inFIGS. 15 and 17, the retention portion8140can have a diameter smaller than a diameter of a portion of the valve body8100proximal to the retention portion8140. In this manner, the retention portion8140can be configured to receive the leaflet clips8200such that a diameter of the leaflet clips8200(i.e., from an exterior surface of the first leaflet clip8200ato an exterior surface of the second leaflet clip8200b) is not larger than the diameter of the portion of the valve body8100proximal to the retention portion8140. Said another way, as shown inFIG. 17, the leaflet clips8200define a plane LP, and the portion of the valve body8100proximal to the retention portion8140defines a plane BP. As shown best inFIG. 17, a distance D1between the plane LP and a centerline axis A of valve body8100is less than a distance D2between the plane BP and the centerline axis A. Such a configuration allows for and promotes the sealing by the sealing portions8150, thereby promoting desirable containment of the native leaflet between the valve body8100and the leaflet clips8200. In this manner, the sealing portions8150and the leaflet clips8200are collectively configured to limit blood flow outside of the prosthetic heart valve8000and between the atrium and ventricle of the heart. Further, in use, multiple points of contact, i.e., a first point of contact (FP) between the leaflet clips8200, a native leaflet, and the valve body8100, and second point of contact (SP) by the sealing portions8150and the valve body8100, promotes sealing between the atrium and ventricle of the heart.

Moreover, contact at the sealing portions8150between the valve body8100and a native leaflet promotes desirable seating of the prosthetic heart valve8000within the native annulus of the atrioventricular valve. More specifically, in use, a force applied by the leaflet clips8200to the native leaflet and the valve body8100at the sealing portions8150provides a containment force, which promotes sufficient seating of the prosthetic heart valve8000within the native annulus of the atrioventricular valve.

In some embodiments, as best shown inFIG. 18, the leaflet clips8200are disposed between, and not in interference with, the chordae tendineae CT within a ventricle of a heart when the valve body8100is disposed within the native annulus of the atrioventricular valve. In this manner, the leaflet clips8200can transition between various configurations (e.g., between an engaged and disengaged configuration) without undesirable interference with the native chordae tendineae.

Referring now toFIG. 19, a prosthetic heart valve system9000is shown that includes a prosthetic valve body9100, an anchoring tether9400operably coupled to the valve body9100, a first leaflet clip9200aand a second leaflet clip9200b(referred to collectively as “clips9200”) coupled to the valve body9100, and a first control element9300aand a second control element9300b(referred to collectively as “control elements9300”) operably coupled to the first leaflet clip9200aand the second leaflet clip9200b, respectively. The leaflet clips9200are movably coupled to the prosthetic valve body9100and are configured to be transitioned between a first configuration in which the prosthetic valve9000can be inserted into a heart, and a second configuration in which the leaflet clips9200are disposed to capture native valve leaflets between the leaflet clips9200and the valve body9100when the valve body9100is disposed in a native annulus of an atrioventricular valve of a heart.

The control elements9300are operably coupled to the leaflet clips9200. In some embodiments, the control elements9300are removably coupled to the leaflet clips9200. The first control element9300ahas a proximal end9360aand a distal end9370a. The proximal end9360ais configured to be operably coupled to a control portion9230aof the first leaflet clip9200a. Similarly, the second control element9300bhas a proximal end9360band a distal end9370b. The proximal end9360bis configured to be operably coupled to a control portion9230bof the second leaflet clip9200b. The proximal ends9360a,9360bof the control elements9300are referred to collectively as “proximal ends9360” and the distal ends9370a,9370bof the control elements9300are referred to collectively as “distal ends9370.” In some embodiments, the proximal ends9360are configured to be removably coupled to the control portions9230, of the leaflet clips9200. The control elements9300each have a length sufficient to extend from the leaflet clips9200, through a ventricle of the heart, and out a wall of the ventricle (e.g., through myocardium) when the valve body9100is disposed in the native annulus of the atrioventricular valve of the heart. Said another way, the distal ends9370of the control elements9300are disposed outside the heart when the proximal ends9360are coupled to the leaflet clips9200and the valve body9100is disposed in the native annulus of the atrioventricular valve.

As described herein, the control elements9300are configured to allow a user to transition the leaflet clips9200through various configurations. For example, the control elements9300can allow a user to transition the leaflet clips9200from their first configuration (disengaged) to their second configuration (engaged) when the valve body9100is disposed in the native annulus of the atrioventricular valve. More specifically, in use, the user can manipulate the distal ends9370of the control elements9300to manipulate the leaflet clips9200in any suitable manner. For example, the user can move the distal ends9370of the control elements9300distally to transition the leaflet clips9200distally and dispose the leaflet clips9200in a disengaged “ready state.” Further to this example, the user can move the distal ends9370of the control elements9300proximally (or allow the distal ends9370of the control elements9300to move proximally) to transition the leaflet clips9200proximally and allow the leaflet clips9200to capture a native valve leaflet between the leaflet clips9200and the valve body9100.

Moreover, the user can manipulate the leaflet clips9200between various positions and/or configurations (e.g., engaged, partially engaged, disengaged) via the control elements9300any suitable number of times. For example, the user can reposition the leaflet clips9200after the leaflet clips9200have been transitioned to the engaged position, thereby allowing the user to either capture a native leaflet after a failed attempt at capturing the leaflet, or to re-capture the native leaflet.

The anchoring tether9400can be the same as or similar to any anchoring tether described in International Patent Application No. PCT/US14/49218, entitled “Epicardial Anchor Devices and Methods,” and International Patent Application No. PCT/US12/50740, entitled “Improved Delivery Systems and Methods for Transcatheter Prosthetic Valves,” the disclosures of which are incorporated herein by reference in their entirety. The anchoring tether9400is operably coupled to a distal end9120of the valve body9100. The anchoring tether9400can be used to anchor or secure the prosthetic valve body9100when the valve body9100is disposed in a native annulus of an atrioventricular valve of a heart. Further, the anchoring tether9400can be used to position or reposition the prosthetic valve body9100within the heart. The anchoring tether9400has a length sufficient to extend from the distal end9120of the valve body9100through the ventricle of the heart and out the wall of the ventricle when the valve body9100is disposed in a native annulus of the atrioventricular valve of the heart.

In use, in some embodiments, the valve body9100can be delivered to, deployed, and/or disposed within a native annulus of an atrioventricular valve of a heart when the leaflet clips9200are in a disengaged configuration. Similarly stated, the leaflet clips9200can remain in the disengaged position until the valve body9100is properly seated within the native heart, and/or disposed in a position suitable for manipulation of the leaflet clips9200. After the valve body9100is disposed in the native annulus of the atrioventricular valve, which can be verified using fluoroscopy, or any other imaging technique, the leaflet clips9200can be deployed in any suitable manner.

In some embodiments, the valve body9100can be repositioned to allow for suitable deployment of the leaflet clips9200(e.g., to allow movement of the leaflet clips9200within the ventricle of the heart without undesirable interference by a wall of the heart). Similarly stated, the valve body9100can be offset from an axis (now shown) defined by a tensioned anchoring tether9400before deployment of the one or more of the leaflet clips9200. For example, the valve body9100can be canted away from a posterior wall of the heart to allow adequate space for movement of one of the leaflet clips9200. In use, once the valve body9100is disposed in a proper position for a user to transition one or more of the leaflet clips9100from a disengaged position to an engaged position, the user can manipulate one of the control elements9300to thereby manipulate one of the leaflet clips9200. Once one of the leaflet clips9200is transitioned into the engaged position such that it properly captures a native leaflet, the valve body9100can be repositioned to allow for adequate space for movement of another one of the leaflet clips9200.

Moreover, in use, the valve body9100can be repositioned (e.g., offset from the axis defined by the anchoring tether9400) in any suitable manner. For example, the anchoring tether9400can be manipulated outside the heart by a user, thereby resulting in movement or canting of the valve body9100. In some embodiments, an elongate member (not shown; can be similar to elongate member12350or any other elongate member described herein) defining a lumen configured to receive the anchoring tether9400can be used to reposition the valve body9100to allow for proper deployment of the leaflet clips9200. For example, in use, after the valve body9100is seated within the native annulus of the atrioventricular valve, the elongate member (not shown) can be introduced into the heart and moved proximally towards the distal end9120of the valve body9100. In this manner, a user can manipulate a distal end of the elongate member (not shown) to reposition the valve body9100, thereby allowing for adequate space for deployment of the leaflet clips9200. In some embodiments, the elongate member (not shown) can be operably coupled to the distal end9120of the valve body9100to promote adequate control of the valve body9100by the elongate member (or by a user of the elongate member). In some embodiments, a base member (not shown), defining a tether passageway through which a portion of the anchoring tether9400extending from the valve9100and outside the heart can be received there-through, can be used to assess a position of and/or reposition the valve body9100when the valve body9100is disposed in the native annulus of an atrioventricular valve. The base member (not shown) can be the same as or similar to any of the base members described in International Patent Application PCT/US14/49218, entitled “Epicardial Anchor Devices and Methods,” the disclosure of which is incorporated herein by reference in its entirety.

Referring now toFIGS. 20aand 20b, a prosthetic heart valve system10000is shown that includes a prosthetic valve body10100, leaflet clips10200, control elements10300, and an anchoring tether10400. The components of the prosthetic heart valve system10000(e.g., the valve body10100, the leaflet clips10200, and the control elements10300) can be substantially similar to and/or the same as the components of the prosthetic heart valve system9000described above with reference toFIG. 19. Thus, the valve body10100, the leaflet clips10200, and the control elements10300are not described in further detail herein and should be considered the same as the valve body9100, the leaflet clips9200, and the control elements9300unless expressly stated otherwise. As described herein, the anchoring tether10400can be used to anchor or secure the prosthetic valve body10100in the same or similar manner as described above for previous embodiments. As shown inFIG. 20b, the anchoring tether10400defines a lumen10410through which the control elements10300can be disposed. The lumen10410has a proximal end10412and a distal end10414, and can be any suitable size and shape configured to receive the control elements10300. In some embodiments, additional lumens10410(not shown) can be included in the anchoring tether10400. For example, the anchoring tether10400can define a first lumen10410aconfigured to receive a first control element10300a, and a second lumen10410bconfigured to receive a second control element10300b.

In use, the control elements10300can be disposed in the lumen10410of the anchoring tether10400. More specifically, the control elements10300can be routed into the proximal end10412of the anchoring tether10400and out of the distal end10414of the anchoring tether10400when the valve body10100is disposed within a native annulus of an atrioventricular valve of a heart. Such a configuration consolidates the control elements10300and the anchoring tether10400thereby reducing or limiting the footprint and friction of the control elements10300and the anchoring tether10400within the ventricle of the heart. In this manner, undesirable interference or contact between the control elements10300and the anchoring tether10400, and native chordae tendineae of the heart can be reduced or limited.

Moreover, in use, the anchoring tether10400and the control elements10300are partially disposed outside the heart such that they can be secured, manipulated, or otherwise used by a user. More specifically, as shown inFIG. 20a, the anchoring tether10400and the control elements10300extend through a puncture site PS of a wall V of a heart. Thus, disposing the control elements10300within the anchoring tether10400can reduce or limit the size of the puncture site PS, thereby reducing a patient's recovery time associated with the puncture site PS.

FIGS. 21aand 21bshow an embodiment of a prosthetic heart valve system11000that includes an elongate member11350having a first end11352configured to be disposed in a ventricle of the heart during deployment of the valve body11100, and a second end11354configured to extend outside the heart. The prosthetic heart valve system11000includes a prosthetic valve body11100, an anchoring tether11400, leaflet clips11200, and control elements11300, which can be configured the same as or similar to the prosthetic valve body9100, the leaflet clips9200, the control elements9300, and the anchoring tether9400, respectively, described above with reference toFIG. 19. Thus, the valve body11100, the leaflet clips11200, the control elements11300, and the anchoring tether11400are not described in further detail herein and should be considered the same as the valve body9100, the leaflet clips9200, the control elements9300, and the anchoring tether9400unless expressly stated otherwise.

The elongate member11350defines an anchoring tether lumen11356, a first control element lumen11358aand a second control element lumen11358b(referred to collectively as “control element lumens11358”), and a first leaflet clip attachment portion11380aand a second leaflet clip attachment portion11380b(referred to collectively as “leaflet clip attachment portions11380”). The tether lumen11356can be any suitable shape or size configured to receive at least a portion of the anchoring tether11400. The control element lumen11358can be any suitable shape or size configured to receive at least a portion of the control elements11300. The leaflet clip attachment portions11380can be any suitable size or shape configured to receive, and be operably and removably coupled to a control portion11230aof the first leaflet clip11200aand a control portion11230bof the second leaflet clip11200b(referred to collectively as “control portions11230”).

In use, the anchoring tether11400is disposed in the anchoring tether lumen11356and extends out the second end11354of the elongate member11350. Similarly, the control elements11300are disposed in the control element lumens11358and extend out the second end11354of the elongate member11350. Further, the leaflet clips11200can be held in a disengaged “ready state” position (first configuration) via the leaflet clips attachment portion11360of the elongate member11350and the control elements11300. More specifically, in the first configuration, as shown inFIG. 21a, the control portions11230of the leaflet clips11200are removably coupled to the elongate member11356and the control elements11300. Further, the control elements11300extend from the control portions11230to the second end11354of the elongate member11356and outside the heart.

To transition the leaflet clips11200from the disengaged configuration (first position) to the engaged configuration (second position; not shown), the control elements11300can be decoupled from the leaflet clips11200, thereby releasing the leaflet clips11200and allowing the leaflet clips1200to transition to the engaged configuration. The control elements11300can be decoupled from the leaflet clips11200in any suitable manner. For example, a portion of control element11300can be moved distally (e.g., pulled by a user), resulting in separation of the control elements from the leaflet clips11200. In this manner, the leaflet clips11200can be transitioned from the first configuration to the second configuration, for example, due to shape memory properties of the leaflet clips11200, when the control elements11300are decoupled from the leaflet clips11200. In some embodiments, the leaflet clips11200can be transitioned from the first configuration to the second configuration in response to movement of the elongate member11350. For example, a user can move the elongate member11350distally such that the leaflet clips11200are separated from, or otherwise no longer disposed within, the leaflet clip attachment portion11360. In this manner, the leaflet clips11200can be released from the leaflet clip attachment portion11360, such that the leaflet clips11200are no longer contained or otherwise restricted in the first configuration by the elongate member11350. In some embodiments, after the leaflet clips11200are decoupled from the elongate member11350, the leaflet clips can transition, without manipulation by the control elements11300, from the disengaged configuration to the engaged configuration. In other embodiments, after the leaflet clips11200are decoupled from the elongate member11350, the leaflet clips can be manipulated between configurations by the control elements11300. In the second configuration, the leaflet clips11200are disposed to capture one or more native valve leaflets between the leaflet clips11200and the valve body11100when the valve body11100is disposed in a native annulus of an atrioventricular valve.

Although the elongate member11350defines control element lumens11358, in other embodiments, the elongate member11350can instead, or in addition, define control element channels (not shown) along the outside of the elongate member11350. In this manner, the control element channels can function the same and/or similar to the control element lumens11358described herein.

Referring now toFIGS. 22a-23b, a prosthetic heart valve system12000is shown that includes a prosthetic valve body12100, a first leaflet clip12200aincluding a control portion12230aand a second leaflet clip12200bincluding a control portion12230b(referred to collectively as “leaflet clips12200”), a first control element12300aand a second control element12300b(referred to collectively as “control elements12300”), anchoring tether12400, and an elongate member12350. The components of the prosthetic heart valve system12000(e.g., the valve body12100, the leaflet clips12200, and the control elements12300) can be substantially similar to and/or the same as the components of the prosthetic heart valve system11000described above with reference toFIGS. 21aand 21b. Thus the valve body12100, the leaflet clips12200, and the control elements12300are not described in further detail herein and should be considered the same as the valve body11100, the leaflet clips11200, and the control elements11300unless expressly stated otherwise. As described herein the anchoring tether12400can be used to anchor or secure the prosthetic heart valve body12100in the same or similar manner as described above for previous embodiments.

The elongate member12350defines a first control element lumen12358a, a second control element lumen12358b, a third control element lumen12358c, and a fourth control element lumen12358d(referred to collectively as “control element lumens12358,” all through which the control elements12300can be disposed, and a tether lumen12356configured to receive the anchoring tether12400. The control element lumens12358have proximal ends12412and distal ends12414, and can be any suitable size and shape configured to receive at least a portion of the control elements12300. In some embodiments, additional lumens (not shown) can be included in the elongate member12350, for example, to accommodate additional control elements.

In use, the control elements12300can be disposed in the control element lumens12358. More specifically, the first control element12300acan be routed proximally through the first control element lumen12358afrom its distal end12414a(not shown) to its proximal end12412a(not shown), operably coupled to the control portion12230aof the first leaflet clip12200a(e.g., looped through an aperture defined by the control portion12230a), then routed distally through the second control element lumen12358bfrom its proximal end12412bto its distal end12414band extending outside the heart. In this manner, a user can manipulate the first leaflet clip12200a, and subsequently remove the first control element from the leaflet clip12200aand the patient's body. Similarly, the second control element12300bcan be routed proximally through the third control element lumen12358cfrom its distal end12414cto its proximal end12412c, operably coupled to the control portion12230bof the second leaflet clip12200b(e.g., looped through an aperture defined by the control portion12230b), then routed distally through the fourth control element lumen12358dfrom its proximal end12412dto its distal end12414dand extending outside the heart. In this manner, a user can independently manipulate the second leaflet clip12200a, and subsequently remove the first control element from the leaflet clip12200aand the patient's body.

Moreover, in use, the control elements12300can be moved distally outside the heart such that the leaflet clips12200are transitioned into a disengaged “ready state,” shown best inFIG. 22a. Further, the control elements12300can be moved proximally (e.g., released) from outside the heart such that the leaflet clips12200are transitioned into an engaged configuration, shown best inFIG. 23a. After the leaflet clips12200are transitioned into the engaged configuration, the positioning of the leaflet clips can be verified using fluoroscopy, or any other imaging technique. If any of the leaflet clips12200are not properly positioned (e.g., one or more leaflet clips12200have not adequately captured a native valve leaflet), one or more control elements12300can be moved distally outside the heart to transition the leaflet clip(s)12200back to the disengaged configuration to allow repositioning of the valve body12100or additional attempts at capturing the native valve leaflets.

After the leaflet clips12200have captured the native leaflets and their positioning verified, the control elements12300can be removed from the ventricle of the heart by pulling a first end of the control elements12300, and releasing a second end of the control elements12300. For example, the control elements12300(e.g., sutures) can include four free ends disposed outside the heart. To decouple the control elements12300from the leaflet clips12200, two free ends from the four free ends can be moved distally outside the heart. In this manner, the remaining two free ends will translate proximally through two of the control element lumens12358, and then distally through the two remaining control element lumens12358, thereby allowing for decoupling of the control elements12300from the leaflet clips12200and removal of the control elements12300from the ventricle of the native heart valve.

In other embodiments, the prosthetic heart valve system12000can include additional control elements (not shown). For example, the prosthetic heart valve system1200can include the first control element12300a, the second control element12300b, a third control element, and a fourth control element. In such embodiments, the control elements can include four distinct elements (e.g., four distinct sutures). Further, the first leaflet clip12200acan include a first control portion12230aand a second control portion. Similarly, the second leaflet clip12200bcan include a first control portion12230band a second control portion. The first control portion12230aand the second control portion of the first leaflet clip12200acan be configured to be operably and removably coupled to the first control element12300aand the third control element, respectively. Similarly, the first control portion12230band the second control portion of the second leaflet clip12200bcan be configured to be operably and removably coupled to the second control element12300band the fourth control element, respectively. In use, the control elements described in this embodiment can be routed individually from the leaflet clips12200through the control element lumens11358, and outside the heart.

Referring now toFIGS. 24-26d, a prosthetic heart valve system13000is shown that includes a prosthetic valve body13100, leaflet clips13200, control elements13300, an elongate member13350, and an anchoring tether13400. The components of the prosthetic heart valve system13000(e.g., the valve body13100, the leaflet clips13200, the elongate member13350, and the control elements13300) can be substantially similar to and/or the same as the components of the prosthetic heart valve system12000described above with reference toFIGS. 23aand 23b. Thus, the valve body13100, the leaflet clips13200, the elongate member13350, and the control elements13300are not described in further detail herein and should be considered the same as the valve body12100, the leaflet clips13200, and the control elements12300unless expressly stated otherwise. As described herein the anchoring tether13400can be used to anchor or secure the prosthetic valve body13100in the same or similar manner as described above for previous embodiments.

The elongate member13350has a proximal end13352configured to be disposed in a ventricle of the heart during deployment of the valve body13100, and a distal end13354configured to extend outside the heart and be operably coupled to a tubular body13600. The elongate member13350can be coupled to the tubular body13600in any suitable manner (e.g., using any suitable fastener or fastening method, a screw, wire, an interference fit, laser welding, etc.). For example, as shown inFIG. 24, the elongate member13350can receive a proximal end13620of the tubular body13600. As best shown inFIGS. 25aand 25b, the elongate member13350defines a first control element lumen13358a, a second control element lumen13358b, a third control element lumen13358c, and a fourth control element lumen13358d(referred to collectively as “control element lumens13358”) all through which the control elements13300can be disposed. The elongate member13350further defines a tether lumen13356there-through configured to receive the anchoring tether13400. The control element lumens13358can be any suitable size and shape configured to receive at least a portion of the control elements13300. In some embodiments, additional lumens (not shown) can be included in the elongate member13350.

As best shown inFIGS. 26a, each of the control elements13300are coupled to a mandrel13700. The tubular body13600has a proximal end13620and a distal end13630, and defines a first mandrel slot13610aat a first radial location, and a second mandrel slot13610band a second radial location, and a lumen13650extending from the proximal end13620to the distal end13630. The first and second slots13610a,13610bare referred to collectively as “mandrel slots13610” and are configured to receive the mandrels13700in any suitable manner (e.g., a keyed joint) to removably couple the control elements13300to the tubular body13600(FIG. 26d). Moreover, a retaining element (not shown) can be disposed on the tubular body13600to retain the mandrels13700in the mandrel slots13610until the control elements13300are ready to be used to deploy the leaflet clips13200.

In some embodiments, some or all of the components described herein (e.g., the elongate member13350, the tubular body13600, etc.) can be provided separately and joined together in preparation for delivery and deployment of the prosthetic valve13000(referred to as “loading the valve”). For example, to load the valve, the elongate member13350can be slidably disposed about the anchoring tether13400. Similarly stated, the anchoring tether13400can be disposed in the tether lumen13356of the elongate member13350. The proximal end13620of the tubular member13600can be coupled to the distal end13354of the elongate member13350such that the anchoring tether13400extends from the proximal end13352of the elongate member13350, through the tether lumen13356of the elongate member13350, and continuing through the tether lumen13650of the tubular member13600from its proximal end13620to its distal end13610. A first end of each control element13300can be coupled to each mandrel13700and a second end of each control element13300can be coupled to any suitable location within the elongate member13350. For example, as best shown inFIG. 25a, one end of the control element13300can be disposed in and coupled to the control element lumen13358aof the elongate member13350, while the other end of the control element13300can be coupled to the mandrel13700. Further to this example, the mandrel13700can be routed distally through the control portion13200aof the leaflet clip13200a, and then proximally through the control element lumen13358bfrom the proximal end13352of the elongate member13350to the distal end13354of the elongate member13350, and then into the mandrel slot13610a. In this manner, each mandrel13700can be operably coupled to a leaflet clip13200, and can be disposed in the mandrel slots13610of the tubular member13600until the control elements13300are ready to be used to deploy the leaflet clips13200.

In use, each mandrel13700can be released from their respective mandrel slots13610in any suitable manner (e.g., both mandrels13700can be released substantially simultaneously, or at distinct times). In this manner, the leaflet clips13200can be manipulated together or separately. Once released, each mandrel13700can be routed through a control element lumen13358from the distal end13354to the proximal end13352of the elongate member13350. For example, the elongate member13350can be pulled distally such that each mandrel13700translates through a control element lumen13358and out from the proximal end13352of the elongate member13350. As the mandrels13700translate proximally towards the proximal end13352of the elongate member13350, the leaflet clips13200can transition positions between a disengaged position and an engaged position, thereby capturing one or more native leaflets. After the leaflet clips13200are disposed in a suitable position (e.g., after leaflet capture), the control elements13200, elongate member13350, tubular member13600, and mandrels13700can be decoupled from the valve body13100and removed from a patient's heart. During removal, in some embodiments, the mandrels13700can be routed through the control portions13200of the leaflet clips13200. In other embodiments, the mandrels13700can be decoupled from the control elements13300(e.g., cut away).

Referring now toFIG. 27, a leaflet clip retrieval member14800(also referred to as “retrieval member14800”) is shown that includes an elongate member14810having a proximal end14820, a distal end14830, and defining a tether lumen14840there-through. The retrieval member14800also includes a leaflet contact portion14850(also referred to as “contact portion14850) coupled to, or disposed at, the proximal end14820of the elongate member14810. In some embodiments, the elongate member14810and the contact portion14850can be monolithically constructed. In other embodiments, the elongate member14810and the contact portion14850can be formed separately and then joined together (e.g., using any suitable fastener or fastening method, such as a screw, a wire, an interference fit, laser welding, etc.). In some embodiments, a portion of the contact portion14850can be disposed in the elongate member14810. For example, the elongate member14810can define a contact portion lumen (not shown) configured to receive at least a portion of the contact portion14850. The contact portion lumen (not shown) can be distinct from the tether lumen14840.

The retrieval member14800is configured to manipulate one or more leaflet clips (e.g., any of the leaflet clips described in any of the embodiments herein). Further, the retrieval member14800is configured to be inserted through a puncture site (not shown) in a wall of a heart (not shown), translate proximally towards a prosthetic heart valve (e.g., any of the prosthetic heart valves described in any of the embodiments herein) such that the contact portion14850can be coupled to a leaflet clip to manipulate a leaflet clip. In this manner, the retrieval member14800can be configured to manipulate a leaflet clips from an engaged configuration to a disengaged configuration. In use, during retrieval of a prosthetic heart valve from within a native annulus of an atrioventricular valve of a heart, the retrieval member14800can manipulate the leaflet clips such that the leaflet clips are in a favorable position for removal from the heart (e.g., without a native leaflet disposed between the leaflet clip and the prosthetic valve body). The contact portion14850of the retrieval member14800can be any suitable size, shape or configuration suitable to attach to and manipulate a leaflet clip. For example, the contact portion14850can be hook-shaped and configured to be operably coupled to a leaflet clip (e.g., a control portion of a leaflet clip). As another example, the contact portion14850can be configured to pierce a covering of a leaflet clip, and thereby grab the leaflet clip for subsequent manipulation thereof.

The tether lumen14840can be any suitable size, shape or configuration suitable to receive an anchoring tether (e.g., any of the anchoring tethers described in any of the embodiments herein). In use, the retrieval member14800can be moved proximally towards a prosthetic valve body disposed in a native annulus of an atrioventricular valve. More specifically, the retrieval member14800can be moved along an anchoring tether (not shown) disposed within the tether lumen14840of the elongate member14810. In this manner, the anchoring tether can serve as a guide for the retrieval member14800. During removal of the prosthetic valve, a user can translate the retrieval member14800proximally along the anchoring tether, thereby allowing the contact portion14850to contact and manipulate a leaflet clip (e.g., disengage the leaflet clip), and then translate the retrieval member14800distally such that the retrieval member14800can be removed from the heart.

Referring now toFIGS. 28 and 29, a prosthetic heart valve system15000is shown that includes a prosthetic valve body15100, an anchoring tether15400operably coupled to the valve body15100, a first leaflet clip15200aand a second leaflet clip15200b(referred to collectively as “clips15200”) coupled to the valve body15100, a control element15300operably coupled to the first leaflet clip15200aand the second leaflet clip15200b. The leaflet clips15200are movably coupled to the prosthetic valve body15100and are configured to be transitioned between a first configuration in which the prosthetic valve15000can be inserted into a heart, and a second configuration in which the leaflet clips15200are disposed to capture native valve leaflets between the leaflet clips15200and the valve body15100when the valve body15100is disposed in a native annulus of an atrioventricular valve of a heart.

The control element15300is operably and removably coupled to the leaflet clips15200, and configured to be slidably disposed about the anchoring tether15400. The control element15200defines a lumen15210there-through configured to receive the anchoring tether15400and the leaflet clips15200. As described herein the control element15300is configured to allow a user to transition the leaflet clips15200through various positions. For example, the control element15300can allow a user to transition the leaflet clips15200from their first configuration (disengaged), as shown inFIG. 28, to their second configuration (engaged), as shown inFIG. 29, when the valve body15100is disposed in the native annulus of the atrioventricular valve. More specifically, in use, the user can manipulate the control element15300to manipulate the leaflet clips15200in any suitable manner. For example, the user can move the control element15300distally to transition the leaflet clips15200from their disengaged configuration to their engaged configuration, thereby allowing the leaflet clips15200to capture a native valve leaflet between the leaflet clips15200and the valve body15100. More specifically, the leaflet clips15200can be in a deformed, disengaged configuration when disposed within the lumen15210of the control element15200, for example, during delivery of the prosthetic heart valve15000. To capture the native leaflets, the control element15200can be moved distally, or otherwise separated from the leaflet clips15200, thereby allowing the leaflet clips15200return to their undeformed, engaged configuration, and allowing the leaflet clips15200to capture a native valve leaflet between the leaflet clips15200and the valve body15100. In some embodiments, the prosthetic heart valve15000can include additional control elements (e.g., control elements9300, or any other suitable control element described herein).

Referring now toFIGS. 30 and 31, a prosthetic heart valve system16000is shown that includes a prosthetic valve body16100, an anchoring tether16400operably coupled to the valve body16100, a control element16300operably coupled to the anchoring tether16400, and a first leaflet clip16200aand a second leaflet clip16200b(referred to collectively as “clips16200”) coupled to the control element16300. The leaflet clips16200are movably coupled to the control element16300and are configured to be transitioned between a first configuration (FIG. 30) in which the leaflet clips are not in contact with native leaflet clips, and a second configuration (FIG. 31) in which the leaflet clips16200are disposed to capture native valve leaflets between the leaflet clips16200and the valve body16100when the valve body16100is disposed in a native annulus of an atrioventricular valve of a heart.

The control element16300is operably the leaflet clips16200, and configured to be slidably disposed about the anchoring tether16400. The control element16300defines a lumen16210there-through configured to receive the anchoring tether16400. As described herein the control element16300is configured to allow a user to transition the leaflet clips16200through various positions. For example, the control element16300can allow a user to transition the leaflet clips16200from their first configuration (disengaged), as shown inFIG. 30, to their second configuration (engaged), as shown inFIG. 31, when the valve body16100is disposed in the native annulus of the atrioventricular valve. More specifically, in use, the user can manipulate the control element16300to manipulate the leaflet clips16200in any suitable manner. For example, the user can move the control element16300distally to transition the leaflet clips16200from their disengaged configuration to their engaged configuration, thereby allowing the leaflet clips16200to capture a native valve leaflet (not shown) between the leaflet clips16200and the valve body16100. In use, the leaflet clips16200can be in an undeformed, disengaged configuration when disposed within the atrium of a heart valve, for example, during delivery of the prosthetic heart valve16000. To capture the native leaflets, the control element16200can be moved distally to allow the leaflet clips16200to engage one or more native leaflets (not shown) such that the leaflet clips16200can capture a native valve leaflet between the leaflet clips16200and the valve body16100. In some embodiments, the control element16300and the leaflet clips16200can be delivered to the native valve substantially simultaneously with delivery of the prosthetic valve body16100to the native annulus of the valve. In other embodiments, the control element16300and the leaflet clips can be delivered to the native valve subsequent to delivery and/or seating of the prosthetic valve body16100within the native annulus of the valve.

In some embodiments, the prosthetic heart valve16000can include additional control elements (e.g., control elements9300, or any other suitable control element described herein). For example, referring now toFIGS. 32aand 32b, in addition to control element16300(referred to in this example as first control element16300a), the prosthetic valve16000can include a second control element16300boperably coupled to the second leaflet clip16200b, and configured to manipulate the second leaflet clip16200bin any suitable manner (e.g., between engaged, disengaged, deformed, and undeformed configurations). In some embodiments, the second control element16300bcan be removably coupled to the second leaflet clip16200b. In some embodiments, the prosthetic valve16000can include a third control element (not shown) operably coupled to the first leaflet clip16200a, and configured to manipulate the first leaflet clip16200ain any suitable manner (e.g., between engaged, disengaged, deformed, and undeformed configurations).

Referring now also toFIG. 32b, the second leaflet clip16200bis shown coupled to the second control element16300b. The second leaflet clip16200bdefines a first control portion lumen16230aand a second control portion lumen16230b(referred to collectively as “control portion lumens16230”). The control portion lumens16230are configured to receive a portion of the second control element16300b. In use, a first portion16310aof the second control element16300bcan be routed through the first control portion lumen16230a, and a second portion16310bof the second control element16300bcan be routed through the second control portion lumen16230b. In this manner, in use, the first portion16310aand the second portion16310bcan be collectively manipulated to manipulate the second leaflet clip16200bbetween various positions and/or configurations. Further, to decouple the second control element16300bfrom the second leaflet clip16200b, the first portion16310aof the second control element16300bcan be moved through the first control portion lumen16230aand the second control portion lumen16230a distance sufficient to remove the second element16300bfrom both the lumen16230aand the lumen16230b.

Referring now toFIGS. 33a-34, a prosthetic heart valve system17000is shown that includes a prosthetic valve body17100having a leaflet clip delivery portion17110, an anchoring tether17400operably coupled to the valve body17100, a control element (not shown) optionally operably coupled to the anchoring tether17400, and a first leaflet clip17200aand a second leaflet clip17200b(referred to collectively as “clips17200”) operably coupled to the control element (not shown) and movably and slideably coupled to the leaflet clip delivery portion17110. The leaflet clips17200are configured to be transitioned between a first configuration (FIG. 33a) in which the leaflet clips17200are not in contact with native leaflet clips, and a second configuration (FIG. 33b) in which the leaflet clips17200are disposed to capture native valve leaflets between the leaflet clips17200and the valve body17100when the valve body17100is disposed in a native annulus of an atrioventricular valve of a heart.

The leaflet clips17200are configured to transition between a disengaged configuration (FIG. 33a) and an engaged configuration (FIG. 33b). In use, the leaflet clips17200can be translated between configurations via the leaflet clip delivery portion17110. In this manner, the leaflet clips17200can transition distally from the disengaged configuration (FIG. 33a) to the engaged configuration (FIG. 33b), thereby allowing the leaflet clips17200to capture a native valve leaflet NL between the leaflet clips17200and the valve body17100.

Referring now toFIG. 34, the leaflet clip17200ais shown, accordingly to another embodiment. The leaflet clip17200ahas a fork-like or claw-like shape configured to capture a native leaflet in a volume V defined therein. For example, the leaflet clip17200acan be configured to receive a portion of a native leaflet NL and a portion of the valve body17100. In this manner, the leaflet clip17200can secure the native leaflet NL between the leaflet clip17200and the valve body17100. In use, as described herein, the leaflet clip17200acan be disposed in the engaged configuration such that the native leaflet NL and a portion of the valve body17100are disposed in volume V. In some embodiments, an interior portion of the leaflet clip17200acan have any suitable configuration (e.g., any suitable surface design) suitable to receive and/or retain a native leaflet when the leaflet clip17200ais disposed in an engaged configuration.

While various embodiments have been particularly shown and described, various changes in form and details may be made. While embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Although various embodiments have been described as having particular features and/or combinations of components, other embodiments are possible having any combination or sub-combination of any features and/or components from any of the embodiments described herein. Moreover, any suitable combination of components described herein can be physically and/or operably coupled together to form prosthetic heart valve with leaflet clips configured, for example, to capture native valve leaflets and provide an improved seal between the prosthetic heart valve and the native valve annulus.

The specific configurations of the various components can also be varied. For example, the size and specific shape of the various components can be different from the embodiments shown, while still providing the functions as described herein. More specifically, the size and shape of the various components can be specifically selected depending on native valve annulus size and/or native valve leaflet size or position.

Where methods and/or events described above indicate certain events and/or procedures occurring in certain order, the ordering of certain events and/or procedures may be modified. Additionally, certain events and/or procedures may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above.