CN116847809A - Heart valve repair devices and associated systems and methods - Google Patents

Abstract

Heart valve repair devices and associated systems and methods are disclosed herein. A heart valve repair device configured in accordance with embodiments of the present technology may include, for example, an engagement member configured to be positioned between one or more native leaflets of a heart valve to at least partially fill spaces between the native leaflets. The heart valve repair device may further include one or more securing mechanisms for securing the engagement member in place between the leaflets. A heart valve repair device configured in accordance with additional embodiments of the present technology may include an atrial member and a ventricular member configured to sandwich one or more native leaflets therebetween.

Description

Heart valve repair devices and associated systems and methods

Cross reference to related applications

The present application claims the priority and benefits of (i) U.S. provisional patent application No. 63/116,724 entitled "heart valve repair device and associated systems and methods" filed on 11/20/2020, and (ii) U.S. provisional patent application No. 63/223,923 entitled "heart valve repair device and associated systems and methods" filed on 7/20/2021, both of which are incorporated herein by reference in their entirety.

Technical Field

The present technology relates to devices, systems, and methods for heart valve repair, and more particularly to heart valve repair devices configured to be implanted at a heart valve, such as the mitral or tricuspid valve of a human patient.

Background

Valve regurgitation, valve prolapse, valve stenosis, and/or other adverse conditions may affect the normal function of a heart valve, such as the mitral or tricuspid valve of a human patient. Valve regurgitation occurs when the leaflets of the valve fail to coapt into apposition (appliation) at the peak of systolic pressure, resulting in leakage of blood across the valve (e.g., from the left ventricle across the mitral valve into the left atrium or from the right ventricle across the tricuspid valve into the right atrium). Several structural factors may affect the proper closure of the valve leaflets. For example, the enlargement of the annulus caused by myocardial dilation may prevent the leaflets from properly coapting during systole. Other conditions involve stretching or tearing of chordae tendineae (tendons connecting the papillary muscles with the mitral and tricuspid leaflets), which may also affect the normal closure of the valve leaflets. For example, due to insufficient tension on the leaflets, chordae tendineae rupture may lead to valve leaflet prolapse (e.g., abnormal bulge) into the left or right atrium, which may also lead to valve regurgitation. Abnormal reflux also occurs when papillary muscles are damaged (e.g., due to ischemia) such that the affected papillary muscles do not contract sufficiently to achieve normal closure during systole. The normal function of a heart valve may also be affected by valve stenosis (e.g., narrowing of the orifice), which may, for example, prevent filling of the left or right ventricle during diastole.

Valve regurgitation is often treated with diuretics and/or vasodilators to reduce the amount of blood flowing back to the left or right atrium. Other treatments, such as surgical (open and endovascular), have also been used to repair or replace native heart valves. For example, cinching (fastening) or resecting portions of an expanded annulus (ports) are typical repair procedures. Tightening of the annulus has been accomplished by implantation of a ring or perivalvular ring (peri-annular rings) that is generally fixed to the annulus or surrounding tissue. Other repair procedures also involve suturing or clamping the valve leaflets in partial apposition with each other. Alternatively, more invasive procedures replace the entire valve with a mechanical valve or biological tissue. These invasive procedures are typically accomplished by large open chest surgery, and are therefore very painful, have a high incidence, and require a long recovery period.

However, during many repair and replacement procedures, the durability of the device or improper size of the annuloplasty ring or replacement valve may lead to complications. In addition, many repair procedures rely on the skill of the cardiac surgeon because improper or inaccurate suture placement may affect the success of the procedure.

Brief description of the drawings

Many aspects of the disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Emphasis instead being placed upon clearly illustrating the principles of the present disclosure.

Fig. 1A is a schematic view of a mitral valve and surrounding anatomy of an implantable heart valve repair device in accordance with embodiments of the present technique.

Fig. 1B is a schematic view of the tricuspid valve and surrounding anatomy of an implantable heart valve repair device in accordance with embodiments of the present technique.

Fig. 2A-2D are front, side, rear, and top views, respectively, of a valve repair device implantable in a subject's heart in accordance with embodiments of the present technique.

Fig. 3A-3D are front, side, rear, and top views, respectively, of a valve repair device without a stabilizing member in accordance with embodiments of the present technique.

Fig. 4A-4D are front, side, rear, and top views, respectively, of a valve repair device including a flexible, generally circular stabilizing member in accordance with embodiments of the present technique.

Fig. 5A and 5B are side and rear views, respectively, of a valve repair device including an elongate curved stabilizing member in accordance with embodiments of the present technique.

Fig. 6A-6C are front, side, and back views, respectively, of a valve repair device in accordance with embodiments of the present technique.

Fig. 7A-7C are front, side, and back views, respectively, of a valve repair device in accordance with embodiments of the present technique.

Fig. 8A-8C are front, side, and back views, respectively, of a valve repair device in accordance with embodiments of the present technique.

Fig. 9A-9H are transverse cross-sectional views of a plurality of engagement members in accordance with embodiments of the present technique.

Fig. 10A-10L are side cross-sectional views of a plurality of engagement members in accordance with embodiments of the present technique.

Fig. 11A is a side cross-sectional view of a valve repair device implanted at a mitral valve in accordance with embodiments of the present technique. Fig. 11B and 11C are lateral cross-sectional views of the valve repair device of fig. 11A during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 11D illustrates a plurality of representative side views of the joining member shown in fig. 11B and 11C from a commissure to a commissure angle, in accordance with embodiments of the present technique.

Fig. 12A is a side cross-sectional view of a valve repair device implanted at a mitral valve in accordance with embodiments of the present technique. Fig. 12B and 12C are lateral cross-sectional views of the valve repair device of fig. 12A during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 12D illustrates a plurality of representative side views of the joining member shown in fig. 12B and 12C from a commissure to a commissure angle, in accordance with embodiments of the present technique.

Fig. 13A is a side cross-sectional view of a valve repair device implanted at the tricuspid valve in accordance with embodiments of the present technique. Fig. 13B and 13C are lateral cross-sectional views of the valve repair device of fig. 13A during diastole and systole, respectively, in accordance with embodiments of the present technique.

Fig. 14A is a side cross-sectional view of a valve repair device implanted at the tricuspid valve in accordance with embodiments of the present technique. Fig. 14B and 14C are lateral cross-sectional views of the valve repair device of fig. 14A during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 14D illustrates a plurality of representative side views of the engagement member shown in fig. 14B and 14C in accordance with embodiments of the present technique.

Fig. 15A and 15B are front and side views, respectively, of a valve repair device implanted at a mitral valve in accordance with embodiments of the present technique. Fig. 15C is a side cross-sectional view of the valve repair device of fig. 15A and 15B implanted at a mitral valve in accordance with embodiments of the present technique. Fig. 15D and 15E are lateral cross-sectional views of the valve repair device of fig. 15A-15C, respectively, during diastole and systole, in accordance with embodiments of the present technique.

Fig. 16A is a side cross-sectional view of a valve repair device implanted at a mitral valve in accordance with embodiments of the present technique. Fig. 16B and 16C are lateral cross-sectional views of the valve repair device of fig. 16A during diastole and systole, respectively, in accordance with embodiments of the present technique.

Fig. 17A and 17C are top views of valve repair devices in accordance with embodiments of the present technique. Fig. 17B is a transverse cross-sectional view of the valve repair device of fig. 17A and/or 17C implanted at the tricuspid valve commissure, in accordance with embodiments of the present technique. Fig. 17D is a side cross-sectional view of the valve repair device of fig. 17A-17C implanted at the tricuspid valve in accordance with embodiments of the present technique. Figures 17E and 17F are lateral cross-sectional views of the valve repair device of figures 17A-17D, respectively, during diastole and systole, in accordance with embodiments of the present technique.

Fig. 18A is a side cross-sectional view of a valve repair device implanted at the tricuspid valve in accordance with additional embodiments of the present technique. Fig. 18B and 18C are lateral cross-sectional views of the valve repair device of fig. 18A and 18B, respectively, during diastole and systole, in accordance with embodiments of the present technique.

Fig. 19 is a side view of a valve repair device configured for implantation at, for example, a mitral valve, in accordance with embodiments of the present technique.

Fig. 20 is a top cross-sectional view of a valve repair device implanted at a heart valve in accordance with embodiments of the present technique.

Fig. 21 is a top cross-sectional view of a valve repair device configured in accordance with an embodiment of the present technique.

Fig. 22 is a table of images of a valve repair device including an engagement member having multiple shapes, in accordance with embodiments of the present technique.

Fig. 23A and 23B are top and side perspective views, respectively, of a valve repair device including an expandable engagement member in accordance with embodiments of the present technique. Fig. 23C is a side cross-sectional view of the valve repair device of fig. 23A and 23B implanted at a mitral valve in accordance with embodiments of the present technique. Fig. 23D and 23E are lateral cross-sectional views of the valve repair device of fig. 23A-23C, respectively, during diastole and systole, in accordance with embodiments of the present technique.

Fig. 24A and 24B are top views of a valve repair device in a first and second adjusted position, respectively, in accordance with embodiments of the present technique. Fig. 24C and 24F are side cross-sectional views of the valve repair device of fig. 24A and 24B implanted at the tricuspid and mitral valves, respectively, in accordance with embodiments of the present technique. Fig. 24D and 24E are transverse cross-sectional views of the valve repair device of fig. 24A and 24B implanted at the tricuspid valve, respectively, during diastole and systole, in accordance with embodiments of the present technique. Fig. 24G and 24H are lateral cross-sectional views of the valve repair device of fig. 24A and 24B implanted at the mitral valve MV, during diastole and systole, respectively, in accordance with embodiments of the present technique.

Fig. 25A and 25B are side and top views, respectively, of a valve repair device in an unexpanded position, in accordance with embodiments of the present technique. Fig. 25C and 25D are side and top views, respectively, of the valve repair device of fig. 25A and 25B in an expanded position in accordance with embodiments of the present technique. Figures 25E and 25H are side cross-sectional views of the valve repair device of figures 25A-25D implanted at a mitral valve in an unexpanded position and an expanded position, respectively, in accordance with embodiments of the present technique. Figures 25F and 25G are lateral cross-sectional views of the valve repair device of figures 25A-25D implanted at the mitral valve in an unexpanded position, during diastole and systole, respectively, in accordance with embodiments of the present technique. Figures 25I and 25J are lateral cross-sectional views of the valve repair device of figures 25A-25D implanted at the mitral valve in an expanded position during diastole and systole, respectively, in accordance with embodiments of the present technique.

Fig. 26A and 26B are top views of a valve repair device in an unexpanded position and an expanded position, respectively, in accordance with embodiments of the present technique. Fig. 26C and 26F are side cross-sectional views of the valve repair device of fig. 26A and 26B implanted at a mitral valve in an unexpanded position and an expanded position, respectively, in accordance with embodiments of the present technique. Fig. 26D and 26E are transverse cross-sectional views of the valve repair device of fig. 26A and 26B, respectively, implanted at a mitral valve in an unexpanded position, during diastole and systole, in accordance with embodiments of the present technique. Fig. 26G and 26H are transverse cross-sectional views of the valve repair device of fig. 26A and 26B, respectively, implanted at the mitral valve in an expanded position, in diastole and systole, in accordance with embodiments of the present technique.

Fig. 27A is a top view of a valve repair device in an unexpanded position, in accordance with embodiments of the present technique. Fig. 27B and 27E are side cross-sectional views of the valve repair device of fig. 27A implanted at a mitral valve in an unexpanded position and an expanded position, respectively, in accordance with embodiments of the present technique. Fig. 27C and 27D are transverse cross-sectional views of the valve repair device of fig. 27A implanted at a mitral valve in an unexpanded position during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 27F and 27G are transverse cross-sectional views of the valve repair device of fig. 27A implanted at a mitral valve in an expanded position during diastole and systole, respectively, in accordance with embodiments of the present technique.

Fig. 28A and 28B are side and top views, respectively, of a valve repair device in accordance with embodiments of the present technique. Fig. 28C is a side cross-sectional view of the valve repair device of fig. 28A and 28B implanted at a mitral valve in accordance with embodiments of the present technique. Fig. 28D and 28E are lateral cross-sectional views of the valve repair device of fig. 28A-28C, respectively, during diastole and systole, in accordance with embodiments of the present technique.

Fig. 29A is a side cross-sectional view of a valve repair device with expandable engagement members implanted at the tricuspid valve in accordance with embodiments of the present technique. Fig. 29B and 29C are lateral cross-sectional views of the valve repair device of fig. 29A during diastole and systole, respectively, in accordance with embodiments of the present technique.

Fig. 30 is a side view of a valve repair device in accordance with an embodiment of the present technique.

Fig. 31A is a side cross-sectional view of a valve repair device implanted at a mitral valve in accordance with embodiments of the present technique. Fig. 31B and 31C are lateral cross-sectional views of the valve repair device of fig. 31A during diastole and systole, respectively, in accordance with embodiments of the present technique.

Fig. 32A and 32B are side views of a valve repair device in a first position and a second position, respectively, in accordance with embodiments of the present technique. Fig. 32C is a side cross-sectional view of the valve repair device of fig. 32A and 32B implanted at a mitral valve in a first position in accordance with embodiments of the present technique. Fig. 32D and 32E are lateral cross-sectional views of the valve repair device of fig. 32A and 32B, respectively, during diastole and systole, in accordance with embodiments of the present technique.

Fig. 33A is a side view of a valve repair device in accordance with an embodiment of the present technique. Fig. 33B is a side cross-sectional view of the valve repair device of fig. 33A implanted at a mitral valve in accordance with embodiments of the present technique. Fig. 33C and 33D are lateral cross-sectional views of the valve repair device of fig. 33A and 33B, respectively, during diastole and systole, in accordance with embodiments of the present technique. Fig. 33E is a side cross-sectional view of the valve repair device of fig. 33A implanted at a mitral valve and having a central locking mechanism of a generally circular shape, in accordance with additional embodiments of the present technique. Fig. 33F and 33G are lateral cross-sectional views of the valve repair device of fig. 33E during diastole and systole, respectively, in accordance with embodiments of the present technique.

Fig. 34A and 34B are top and bottom views, respectively, of a valve repair device in accordance with embodiments of the present technique. Fig. 34C is a side cross-sectional view of the valve repair device of fig. 34A and 34B implanted at a mitral valve in accordance with embodiments of the present technique. Fig. 34D and 34E are lateral cross-sectional views of the valve repair device of fig. 34A-34C, respectively, during diastole and systole, in accordance with embodiments of the present technique. Fig. 34F is a side cross-sectional view of another embodiment of the valve repair device of fig. 34A and 34B implanted at a mitral valve in accordance with embodiments of the present technique. Fig. 34G and 34H are transverse cross-sectional views of the valve repair device of fig. 34F during diastole and systole, respectively, in accordance with embodiments of the present technique.

Fig. 35A and 35B are side perspective views of a valve repair device in accordance with embodiments of the present technique.

Fig. 35C is a side cross-sectional view of the valve repair device of fig. 35A and 35B implanted at a mitral valve in accordance with embodiments of the present technique. Fig. 35D and 35E are lateral cross-sectional views of the valve repair device of fig. 35A-35C, in diastole and systole, respectively, in accordance with embodiments of the present technique.

Fig. 36A and 36B are top views of a valve repair device in an unexpanded position and an expanded position, respectively, in accordance with embodiments of the present technique. Fig. 36C is a side cross-sectional view of the valve repair device of fig. 36A and 36B implanted at a mitral valve in accordance with embodiments of the present technique. Fig. 36D and 36E are transverse cross-sectional views of the valve repair device of fig. 36A-36C implanted at a mitral valve in an expanded position during diastole and systole, respectively, in accordance with embodiments of the present technique.

Fig. 37A and 37B are side views of valve repair devices configured in accordance with embodiments of the present technique. Fig. 37C is a side view of the valve repair device of fig. 37A and 37B implanted at the tricuspid valve in accordance with embodiments of the present technique. Fig. 37D is a top view of the valve repair device of fig. 37A-37C during diastole and fig. 37E is a bottom view of the valve repair device of fig. 37A-37C during systole in accordance with embodiments of the present technique.

Fig. 38A is a side cross-sectional view of a valve repair device implanted at the tricuspid valve in accordance with embodiments of the present technique. Fig. 38B and 38C are lateral cross-sectional views of the valve repair device of fig. 38A during diastole and systole, respectively, in accordance with embodiments of the present technique.

Fig. 39A is a side view of a valve repair device implanted at the tricuspid valve in accordance with embodiments of the present technique. Fig. 39B and 39C are top views of the valve repair device of fig. 39A during diastole and systole, respectively, in accordance with embodiments of the present technique.

Fig. 40 is a side cross-sectional view of a valve repair device implanted at the tricuspid valve in accordance with embodiments of the present technique.

41A-41C are top plan views of a valve repair device in systole, top plan view in diastole, and side view in diastole, respectively, in accordance with embodiments of the present technique. Fig. 41D is a side cross-sectional view of the valve repair device of fig. 41A-41C implanted at a mitral valve in accordance with embodiments of the present technique. Fig. 41E and 41F are lateral cross-sectional views of the valve repair device of fig. 41A-41D, respectively, during diastole and systole, in accordance with embodiments of the present technique.

Fig. 42A-42C are perspective side views of a plurality of valve repair devices in accordance with embodiments of the present technique.

Fig. 43A and 43B are a side perspective view and an enlarged side cross-sectional view, respectively, of a valve repair device in accordance with embodiments of the present technique.

Fig. 44 is a side cross-sectional view of a valve repair device and locking mechanism in accordance with embodiments of the present technique.

Fig. 45A is a side perspective view of a valve repair device in accordance with an embodiment of the present technique. 45B-45D are enlarged side cross-sectional views of an unlocking mechanism of the valve repair device of FIG. 45A, in accordance with embodiments of the present technique.

Fig. 46A is a side cross-sectional view of a valve repair device in accordance with an embodiment of the present technique. 46B-46E are side views of a valve repair device during delivery and deployment in accordance with embodiments of the present technique.

Fig. 47A is a side cross-sectional view of a valve repair device implanted at the tricuspid valve in accordance with embodiments of the present technique. Fig. 47B and 47C are lateral cross-sectional views of the valve repair device of fig. 47A during diastole and systole, respectively, in accordance with embodiments of the present technique.

Fig. 48A and 48B are side and enlarged side views, respectively, of a valve repair device in a partially deployed position in accordance with embodiments of the present technique. Fig. 48C is a side view of the valve repair device of fig. 48A and 48B in a fully deployed position, in accordance with embodiments of the present technique.

Fig. 49A and 49B are side and transverse cross-sectional views, respectively, of a valve repair device implanted at the tricuspid valve in accordance with embodiments of the present technique.

Fig. 50A and 50D are side cross-sectional views of a valve repair device implanted at the tricuspid valve in an unexpanded position and an expanded position, respectively, in accordance with embodiments of the present technique. Fig. 50B and 50C are transverse cross-sectional views of the valve repair device of fig. 50A in an unexpanded position during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 50E and 50F are transverse cross-sectional views of the valve repair device of fig. 50D in the expanded position, in diastole and systole, respectively, in accordance with embodiments of the present technique.

Fig. 51A is a perspective side view of a valve repair device in a first position in accordance with embodiments of the present technique. 51B-51D are perspective top, side, and enlarged perspective side views of the valve repair device of FIG. 51A in a second position in accordance with embodiments of the present technique. Fig. 51E is an enlarged cross-sectional view of the valve repair device of fig. 51A-51D secured to a pair of valve leaflets in accordance with an embodiment of the present technique.

Fig. 52A is a perspective side view of a valve repair device in a first position in accordance with embodiments of the present technique. Fig. 52B and 52C are a top perspective view and a side perspective view of the valve repair device of fig. 52A in a second position in accordance with embodiments of the present technique. Fig. 52D is an enlarged cross-sectional view of the valve repair device of fig. 52A-52C secured to a pair of valve leaflets in accordance with an embodiment of the present technique.

FIGS. 53A and 53B are perspective side views of a valve repair device including an atrial member and a ventricular member configured to be sandwiched together ("candwick") and in closed and open positions, respectively, in accordance with embodiments of the present technique. 53C-53F are perspective top views of a plurality of valve repair devices including an atrial member and a ventricular member configured to be sandwiched together in accordance with additional embodiments of the present technique.

54A-54E are perspective side views and FIG. 54F is a perspective top view of a plurality of valve repair devices including atrial and ventricular members configured to sandwich together in accordance with additional embodiments of the present technique.

Fig. 55A-55H are perspective side views of a plurality of valve repair devices including an atrial member and a ventricular member configured to sandwich together in accordance with embodiments of the present technique.

Fig. 56A and 56B are perspective side and bottom views, respectively, of a ventricular member of a valve repair device in a relaxed position in accordance with embodiments of the present technique. Fig. 56C and 56D are perspective side and bottom views, respectively, of the ventricular member of fig. 56A and 56B in an expanded position with the extreme ventricular end compressed in accordance with embodiments of the present technique.

Fig. 57A and 57B are side views of a ventricular member of a valve repair device in a compressed position and an expanded position, respectively, in accordance with embodiments of the present technique.

Fig. 58A is a side cross-sectional view of a valve repair device implanted at the tricuspid valve in accordance with embodiments of the present technique. Fig. 58B and 58C are lateral cross-sectional views of the valve repair device of fig. 58A during diastole and systole, respectively, in accordance with embodiments of the present technique.

Fig. 59A is a side cross-sectional view of a valve repair device implanted at the tricuspid valve in accordance with embodiments of the present technique. Fig. 59B and 59C are transverse cross-sectional views of the valve repair device of fig. 59A during diastole and systole, respectively, in accordance with embodiments of the present technique.

Fig. 60A and 60B are isometric and side views, respectively, of a valve repair device configured in accordance with embodiments of the present technique.

Fig. 61A and 61D are side views of the valve repair device of fig. 30 during a first delivery phase (e.g., an initial phase) and a second delivery phase (e.g., a subsequent phase), respectively, to the mitral valve MV in accordance with embodiments of the present technique. Fig. 61B and 61C are transverse cross-sectional views of a valve repair device during the first delivery stage of fig. 61A and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 61E and 61F are transverse cross-sectional views of a valve repair device during the second delivery phase of fig. 61D and during diastole and systole, respectively, in accordance with embodiments of the present technique.

Fig. 62A is a side view of a valve repair device that may be sequentially delivered to a heart valve in accordance with embodiments of the present technique. Fig. 62B is a side view of the valve repair device of fig. 62A with optional additional engagement members located on the central delivery track at the mitral valve in accordance with embodiments of the present technique. Fig. 62C and 62D are side views of the valve repair device of fig. 62B with the addition of an optional additional engagement member in diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 62e,62h,62k, and 62N are side views of the valve repair device of fig. 62A during first through fourth delivery stages to the tricuspid valve, respectively, in accordance with embodiments of the present technique. Fig. 62F and 62G are transverse cross-sectional views of a valve repair device during the first delivery phase of fig. 62E and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 62I and 62J are transverse cross-sectional views of the valve repair device during the second delivery phase of fig. 62H and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 62L and 62M are transverse cross-sectional views of the valve repair device during the third delivery stage of fig. 62L and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 62O and 62P are transverse cross-sectional views of the valve repair device during the alternative third delivery stage of fig. 62N and during diastole and systole, respectively, in accordance with embodiments of the present technique.

Figures 63a,63D, and 63G are side views, e.g., of any of the valve repair devices of figures 42A-45D or 52A-54F, respectively, during first through third delivery stages to the tricuspid valve in accordance with embodiments of the present technique. Fig. 63B and 63C are transverse cross-sectional views of a valve repair device during the first delivery stage of fig. 63A and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 63E and 63F are transverse cross-sectional views of the valve repair device during the second delivery phase of fig. 63D and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 63H and 63I are transverse cross-sectional views of the valve repair device during the third delivery stage of fig. 63G and during diastole and systole, respectively, in accordance with embodiments of the present technique.

Figures 64a,64D,64g, and 64J are side views, e.g., of any of the valve repair devices of figures 42A-45D or 52A-54F, respectively, during first through fourth delivery stages to the tricuspid valve, in accordance with embodiments of the present technique. Fig. 64B and 64C are transverse cross-sectional views of a valve repair device during the first delivery stage of fig. 64A and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 64E and 64F are transverse cross-sectional views of the valve repair device during the second delivery phase of fig. 64D and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 64H and 64I are transverse cross-sectional views of a valve repair device during the third delivery stage of fig. 64G and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 64K and 64L are transverse cross-sectional views of a valve repair device during the fourth delivery phase of fig. 64J and during diastole and systole, respectively, in accordance with embodiments of the present technique.

Figures 65a,65d,65g,65j, and 65M are side views, respectively, of a valve repair device, such as that of figures 60A and 60B, during first through fifth delivery stages to the tricuspid valve in accordance with embodiments of the present technique. Fig. 65B and 65C are transverse cross-sectional views of a valve repair device during the first delivery stage of fig. 65A and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 65E and 65F are transverse cross-sectional views of the valve repair device during the second delivery stage of fig. 65D and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 65H and 651 are transverse cross-sectional views of the valve repair device during the third delivery stage of fig. 65G and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 65K and 65L are transverse cross-sectional views of a valve repair device during the fourth delivery stage of fig. 65J and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 65M and 65O are transverse cross-sectional views of a valve repair device during the fifth delivery stage of fig. 65M and during diastole and systole, respectively, in accordance with embodiments of the present technique.

Fig. 66A-66C are side views, respectively, of any one of the valve repair devices of, for example, fig. 42A-45D or 52A-54F during first through third retrieval stages of the recovery (recovery) valve repair device from an implantation procedure at the tricuspid valve, in accordance with embodiments of the present technique.

Fig. 67A-67C are perspective side views of a ventricular member of a valve repair device positioned at a heart valve in a first position, a second position, and a third position, respectively, in accordance with embodiments of the present technique. Fig. 67E-67F are top views of the ventricular member of fig. 67A-67C positioned at a heart valve in a first position, a second position, and a third position, respectively, in accordance with embodiments of the present technique.

Fig. 68A and 68B are side and top views, respectively, of a base of the ventricular member of fig. 67A-67F including a fixation mechanism in accordance with embodiments of the present technique.

Fig. 69A is a side view of a base of the ventricular member of fig. 67A-67F including a fixation mechanism in accordance with additional embodiments of the present technique. Fig. 69B is an enlarged side view of a portion of the securing mechanism of fig. 69A in accordance with embodiments of the present technique.

Fig. 70A is a side view of a valve repair device in a delivery configuration, in accordance with embodiments of the present technique. Fig. 70B is a side view of the valve repair device of fig. 70A in a deployed configuration and implanted at a heart valve in accordance with embodiments of the present technique.

Detailed Description

The present technology relates to heart valve repair devices and associated systems and methods. For example, in some embodiments, a heart valve repair device (also referred to herein as a "valve repair device," "coaptation assistance device," "implant device," and iterations thereof) includes features that anchor to one or more native leaflets of a native anatomy of a patient's heart, such as a mitral valve or tricuspid valve of a human patient. For example, a heart valve repair device may include (i) an engagement member (also referred to as an "engagement structure," "space filler," "spacer," "valve endosome," "intermediate structure," and iterations thereof) positioned at least partially between the native leaflets, and (ii) one or more clip mechanisms to secure the engagement member in place relative to the native leaflets. The engagement member may at least partially fill the backflow orifice in the heart valve and provide a new engagement surface for the native leaflet to seal around. The engagement members may also push a portion of the native leaflet outward against the ventricular wall while reducing or minimizing damage to the remaining portion of the native leaflet. The clip mechanism may engage the ventricular side and/or the atrial side of the native leaflet to fix the position of the engagement member relative to the heart valve.

In some embodiments, a heart valve repair device in accordance with additional embodiments of the present technology can include (i) an engagement member positioned between the native valve leaflets, and (ii) one or more anchors and/or support members that secure the engagement member to the heart anatomy other than the native leaflets. For example, the anchors may be secured to the atrial wall, ventricular wall, annulus, ventricular outflow tract, and/or other portions of the patient's cardiac anatomy.

In some embodiments, a heart valve repair device in accordance with additional embodiments of the present technology includes an atrial member and a ventricular member configured to capture one or more native leaflets therebetween (e.g., "sandwich-like"). For example, the atrial and ventricular members may include a plurality of small clips, fingers, arms, or other features that interlock and interleave on the native leaflets. The atrial member and the ventricular member together can at least partially fill a regurgitation port in the heart valve, and in some embodiments, the atrial member and the ventricular member can provide an engagement surface for the native leaflets to seal around.

Specific details of several embodiments of the present technology are described herein with reference to fig. 1A-70B. However, the present technology may be practiced without some of these specific details. In certain instances, well-known structures and techniques commonly associated with catheter-based delivery systems, prosthetic (proshetic) heart valves, and the like have not been shown in detail to avoid obscuring the present technology. The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the disclosure. Although certain terms may be emphasized below; any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined in this detailed description section.

The drawings depict embodiments of the present technology and are not intended to limit its scope. The size of the elements described are not necessarily drawn to scale, and the elements may be arbitrarily enlarged to improve legibility. Where such details are not necessary for a complete understanding of how the present technology may be made and used, the details of the components may be abstracted in the drawings to the exclusion of details such as the location of the components and certain precise connections between the components. Many of the details, dimensions, angles, and other features shown in the figures are merely illustrative of specific embodiments of the disclosure. Thus, other embodiments may have other details, dimensions, angles, and features without departing from the spirit or scope of the present technology.

With respect to the terms "distal" and "proximal" in this description, unless otherwise noted, the terms may refer to locations in the operator and/or vasculature to provide relative positions of portions of the catheter subsystem. Furthermore, as used herein, the designations "rearward", "forward", "upward", "downward", and the like are not meant to limit the components referred to being used in a particular direction. It should be understood that such designations refer to the orientation of the components mentioned as shown in the drawings, and that the system of the present technology may be used in any orientation suitable for the user.

The headings provided herein are for convenience only and should not be construed as limiting the subject matter disclosed.

Many embodiments of a heart valve repair device are described and illustrated herein in the context of one of the tricuspid valve or mitral valve. However, it should be understood that the heart valve repair device of the present technology is not limited to the described/illustrated embodiments thereof, and may be implanted at the tricuspid valve, mitral valve, and/or other valves, unless explicitly stated otherwise.

I.SUMMARY

Fig. 1A is a schematic view of a mitral valve and surrounding anatomy of an implantable heart valve repair device in accordance with embodiments of the present technique. The anterior leaflet has a semi-circular shape and is attached to an annular perimeter of about two-fifths. The motion of the anterior leaflet defines an important boundary between the inflow (diastole) and outflow (systole) tracts of the left ventricle. The posterior leaflet of the mitral valve has a crescent-shaped shape and attaches to an annular perimeter of approximately three-fifths. The posterior leaflet typically has two well-defined indentations that divide the leaflet into three separate sectors, designated P1 (side sector), P2 (middle sector), and P3 (medial sector). Three corresponding segments of the anterior leaflet are designated as A1 (lateral segment), A2 (medial segment), and A3 (medial segment). The small She Aohen aids in opening the posterior leaflet during diastole.

As shown in fig. 1A, the mitral valve has an anterolateral and posterolateral commissure, which defines a unique region in which the anterior and posterior leaflets come together upon insertion into the annulus. Sometimes the commissures exist as well-defined leaflet segments, but typically the region is a hidden microstructure that can be identified using two anatomical landmarks: (a) An axis of the corresponding papillary muscle, and (b) commissure chordae tendineae, which have a particular fan-like configuration. Valve tissue of a few millimeters separates the free edge of the commissure from the annulus.

The mitral valve is an atrioventricular valve that separates the left atrium from the left ventricle. The mitral annulus constitutes an anatomical interface between the left ventricle and the left atrium. The fixed ends of the leaflets attach to the annulus. The anterior portion of the mitral annulus attaches to the fibrous triangle, generally developing better than the posterior annulus. The right fibrous triangle is the dense interface area between the mitral valve, the tricuspid valve, the non-coronary valve of the aortic valve, and the valve space. The left fiber triangle is located at the juncture of the left fiber boundaries of the aortic valve and the mitral valve.

The mitral annulus does not develop well at the insertion site of the posterior leaflet. The segments are not attached to any fibrous structure and the fibrous skeleton in the region is discontinuous. When mitral regurgitation occurs with left atrial or left ventricular dilation, the posterior portion of the annulus tends to increase its perimeter. The mitral annulus has a saddle shape and during systole, the commissure regions move proximally-i.e., toward the top of the atrium-while the annular contraction also narrows the perimeter. Both of these processes help achieve leaflet coaptation, which can be adversely affected by annular dilation and calcification. The mitral annulus is surrounded by several important anatomical structures, including the aortic valve, the coronary sinus, and the circumflex artery. Accordingly, there is a need to locate a cardiac device implanted at the mitral valve to accommodate the asymmetric anatomy of the mitral valve without affecting the surrounding cardiac structure.

Fig. 1B is a schematic view of the tricuspid valve and surrounding anatomy of an implantable heart valve repair device in accordance with embodiments of the present technique. The tricuspid valve is an atrioventricular valve that separates the right atrium from the right ventricle and is located closer to the apex of the heart than the mitral valve. The tricuspid valve is located within the right triangle of the fibrous skeleton of the heart. The tricuspid annulus (fibrous or membranous structure) forms the anatomical interface between the right ventricle and the right atrium and provides a strong support structure for the tricuspid valve. The annulus is less fibrous than the other annuli and slightly larger than the mitral annulus.

The tricuspid valve has an oval shape and includes an anterior leaflet (also known as a funnel leaflet or an anterior superior leaflet), a septal leaflet (also known as an medial leaflet), and a posterior leaflet (also known as a inferior leaflet or an edge leaflet). The anterior leaflet and the septal leaflet are larger than the posterior leaflet. The fixed ends of the leaflets attach to the annulus. The tricuspid valve has (i) a posterior septal commissure that defines a unique region in which the septal and posterior leaflets meet upon insertion into the annulus, (ii) an anterior septal commissure that defines a unique region in which the septal and anterior leaflets meet upon insertion into the annulus, and (iii) an anterior-posterior commissure that defines a unique region in which the anterior and posterior leaflets meet upon insertion into the annulus. The commissures look more like indentations than the true commissures, and valve tissue of a few millimeters separates the free edge of the commissures from the annulus.

The septal leaflet is supported from the fibrous trigones more than the anterior or posterior leaflet. Thus, tricuspid regurgitation due to annular expansion often occurs due to a loss of coaptation between the anterior and posterior leaflets. In addition to annular expansion, leaflet coaptation can also be adversely affected by calcification of the annulus. The tricuspid annulus is surrounded by several important anatomical structures, including the left pulmonary artery, the coronary sinus, and the AV node. Accordingly, it is desirable to position the implanted heart device at the tricuspid valve to accommodate the asymmetric anatomy of the tricuspid valve without affecting the surrounding heart structure.

Fig. 2A-2D are front, side, rear, and top views, respectively, of a tricuspid valve repair device 200 ("device" or "valve repair device") that may be implanted in a heart of a subject (e.g., a human patient), in accordance with embodiments of the present technique. Referring collectively to fig. 2A-2D, the apparatus includes an engagement member 210, a stabilizing member 220 extending from the engagement member 210, and a pair of clip mechanisms 230 (also referred to as "capture clips") movably (e.g., hingedly, pivotably, rotatably) coupled to the engagement member 210. In some embodiments, device 200 may include some features that are substantially similar or identical to one or more of the implantable devices described below: (i) U.S. patent application Ser. No. 16/044,447, entitled "Artificial leaflet device," filed on 7/24/2018; (ii) International patent application number PCT/US2018/061126 entitled "leaflet extension of heart valve leaflets" filed 11/14 in 2018; (iii) U.S. patent application Ser. No. 16/745,246, entitled "implantable coaptation assistance devices with sensor and related systems and methods," filed on 1/16/2020; (iv) U.S. patent application Ser. No. 16/817,464, entitled "heart valve repair device with annuloplasty feature and related systems and methods," filed on 3/12, 2020, and/or (v) U.S. patent application Ser. No. 17/027,681, entitled "valve repair device with coaptation structure and multiple leaflet capturing clips," filed on 9/21, 2020, each of which is incorporated herein by reference in its entirety. Any valve repair device disclosed herein can be delivered intravascularly (e.g., transseptally via the femoral vein or axial vein), transdermally (e.g., transapically), and/or surgically to the tricuspid valve.

In the illustrated embodiment, the engagement member 210 is configured to (i) fill at least a portion of the regurgitation openings between the native leaflets of the heart valve, (ii) replace at least a portion of the one or more native leaflets, and/or (iii) provide a prosthetic engagement surface for the one or more native leaflets. The clip mechanism 230 is configured to be positioned on the ventricular (e.g., under the annulus) side of the valve and extend posteriorly and grasp portions of one or more native leaflets to attach the leaflets to the engagement member 210. The stabilizing member 220 is configured to be at least partially located on the atrial side (e.g., over the annulus) of the valve and contact the atrial side of one or more native leaflets and/or other portions of the heart anatomy (e.g., the atrial wall) to stabilize and fix the position of the engaging member 210 relative to the valve. The stabilizing member 220 may also be used to inhibit or even prevent prolapse of the engaging member 210 during ventricular systole. The stabilizing members 220 may also be used to provide a platform for tissue ingrowth and long term fixation. In the illustrated embodiment, the engagement member 210 has a trapezoidal side cross-sectional shape and an almond-like transverse cross-sectional shape. The engagement member 210 may also include a pair of recesses 211 (fig. 2C) for receiving at least a portion of the clip mechanism 230.

In the illustrated embodiment, the stabilizing member 220 includes a frame 221 having an M-like shape covered by a cover 222. In other embodiments, the frame 221 may have other shapes, such as circular, oval, polygonal, irregular, rectilinear, and the like. The frame 221 may be in the form of a wire, braid, or laser cut stent-like structure formed of a suitable strong biocompatible material, such as stainless steel, nitinol (e.g., nitinol), and/or other suitable stent material. In some aspects of the present technique, the M-like shape of the frame 221 may provide lateral stiffness to the stabilizing member (e.g., side-to-side along the stabilizing member) and maintain torsional and fore-aft stability from transferring loads to/from the engaging member 210. In some embodiments, a covering 222 (e.g., fabric, graft material) may extend over at least a portion of the frame 221 to at least partially enclose the frame 221 and provide a smooth atraumatic surface to contact the atrium (e.g., right atrium or left atrium) and/or other portions of the cardiac anatomy while promoting ingrowth into the annulus and right atrium. In some embodiments, the stabilizing member 220 can have friction elements (not shown) that cooperate with the over-the-annulus tissue and the annulus tissue and provide additional fixation and stability.

In some embodiments, the engagement member 210 may extend away from a downstream portion of the stabilizing member 220 along a flow axis of the device 200, and at least a portion of the engagement member 210 may extend radially inward from the stabilizing member 220 to, for example, fill a portion of a native orifice. In the illustrated embodiment, the stabilizing member 220 is angled or biased outwardly from the engaging member 210 by an angle a (fig. 2B) of between about 10 ° -75 ° (e.g., about 15 °, about 45 °, greater than about 45 °) to, for example, (i) provide rigidity and support to the engaging member 210 and/or (ii) push a portion of an adjacent native leaflet back from the valve opening and approximate the closed position of the native leaflet when the device 200 is implanted at a heart valve. In some embodiments, angle a may be selected to inhibit engagement member 210 from contacting the ventricular wall during the cardiac cycle and particularly during systole. In some embodiments, the engagement member 210 is more centrally located within the orifice. The engagement member 210 may be substantially stationary (e.g., have little movement) during the cardiac cycle such that the position of the engagement member 210 relative to the stabilizing member 220 is at least substantially fixed when the device 200 is deployed at the native valve. Thus, unlike the native leaflets that move back and forth to open and close the native valve, the engagement member 210 may remain stationary during diastole and systole. In some embodiments, the engagement member 210 does experience some movement during the cardiac cycle.

The outer portion 212 of the engagement member 210 can have a smooth atraumatic surface (also referred to as an "engagement surface") for engaging at least a portion of one or more opposing native leaflets, while the opposing inner portion 213 of the engagement member 210 adjacent the clip mechanism 230 can displace and mate with at least a portion of another native leaflet. In some embodiments, the inner portion 213 and/or the outer portion 212 may include friction elements that engage the native leaflets. The engagement member 210 may comprise an internal expandable frame structure (obscured in fig. 2A-2D; e.g., a mesh structure, a laser cut stent frame) made of a plurality of connected struts defining an at least partially hollow interior space when the device 200 is in the deployed state shown. Portions of the frame structure may be disconnected to allow portions of the struts to slide and/or move away from each other to facilitate low profile in the delivery state and/or adjustability of the size of the engagement member 210. In some embodiments, the engagement member 210 or portions thereof may be integral with the stabilizing member 220. In other embodiments, the engagement member 210 is a separate structure that is attached to a portion of the stabilizing member 220 during manufacture using welding, rivets, adhesives, connectors, sutures, and fabrics, and/or other suitable attachment mechanisms.

The engagement member 210 may include one or more access openings 219, such as slits, valves, and/or holes, that provide access to the interior of the engagement member 210 and components therein during delivery and/or retrieval. For example, the access/entry opening 219 may provide access to a delivery system connector that allows manipulation of the engagement member 210 and/or the clip actuation mechanism to open and close the clip mechanism 230. In addition, the cavity of the engagement member 210 may house an extension member, a supplemental clip, and/or other components that may optionally be deployed during the implantation procedure.

The clip mechanism 230 extends from the coaptation member 210 (e.g., the interior portion 213 of the coaptation member) to allow the clip mechanism 230 to extend behind and capture one or more native leaflets located on one or more sides of the coaptation member 210. Referring to fig. 2B and 2C, the clip mechanism 230 may include a base portion 231 (also referred to as a "first portion") attached to the engagement member 210, a free end portion 232 (also referred to as a "second portion") unattached to the engagement member 210, and an articulatable arm member 233 extending from the base portion 231 and forming the free end portion 232. The base portion 231 may be attached to the engagement member 210 by welding, riveting, adhesive, sutures, and/or other coupling mechanisms, or may be an extension of the engagement member frame. The arm member 233 may extend from the base portion 231 along the length of the engagement member 210 in an upstream direction (e.g., toward the stabilizing member 220). For example, the arm member 233 may extend only partially up the engagement member 210 and along the length of the engagement member 210 to the downstream end of the stabilizing member 220. In some embodiments, the arm members 233 may form an inverted U-shape and flare outwardly to form a wider portion where the arm members 233 grip the native leaflet. In other embodiments, the arm member 233 may have other suitable shapes for engaging the leaflets and/or may include an extension at the distal-most end that engages the sub-annular tissue for additional stability and fixation under the annulus.

The arm members 233 may be made of one or more wires, struts, and/or other semi-rigid/rigid structures that are sufficiently rigid to clamp the native leaflets and/or the subannular tissue. In some embodiments, the arm member 233 includes a fabric covering, biocompatible foam or other type of padding (padding), and/or a coating on the rigid member to provide (i) a smooth surface at the root of the arm to reduce trauma to the leaflet and/or surrounding tissue, (ii) additional surface area for leaflet fit, (iii) a platform for tissue ingrowth, and/or (iv) additional friction to prevent the leaflet from sliding out. In some embodiments, the arm members 233 and/or other portions of the clip mechanism 230 may include spikes, teeth, corrugations, or other friction features (not shown) that enhance stability and fixation to the native leaflets.

The clip mechanism 230 may also include an actuation mechanism 234, such as a spring-loaded lever, that acts on the arm member 233 to move it between a closed position (also referred to as a "closed state," "closed configuration," or "first state") and an open position (also referred to as an "open state," "open configuration," or "second state"), as shown in fig. 2A-2D. In the closed state, the arm members 233 are positioned proximate to or against the surface of the engagement member 210 in the respective recess 211, wherein at least a portion of the arm members 233 are pressed against the surface of the engagement member 210 to provide leaflet fit. In the open state, the articulatable arm member 233 extends away from the engagement member 210 (e.g., forms a V-shape or L-shape with a surface of the engagement member 210) to allow the free end portion 232 to extend behind the native leaflet and receive the native leaflet between the arm member 233 and the surface of the engagement member 210. In some embodiments, the actuation mechanism 234 maintains the clip mechanism 230 in a normally closed state (e.g., due to a spring force) such that (i) the clip mechanism 230 is in a closed state during device delivery, and (ii) manipulation of the actuation mechanism 234 moves the clip mechanism 230 to an open state. In other embodiments, the clip mechanism 230 is disposed in a normally open state. The actuation mechanism 234 for the clip mechanism 230 may also have a locking mechanism to prevent clip actuation after deployment.

The actuation mechanism 234 may be a spring-loaded rod (e.g., a nitinol wire, laser cut nitinol, or cobalt-chromium sheet) operatively coupled to a portion of a delivery system (not shown) that is operable to move the clip mechanism 230 between an open position and a closed position. For example, tendons (made of suture or nitinol wire) may be attached to the spring-loaded rod 234, extend along or through the body of the engagement member 210, and through the delivery catheter to the external handle assembly. The clinician may pull or otherwise apply tension to the tendon to transfer the force to the lever to move the arm member 233 between the closed and open positions. In other embodiments, the actuation mechanism 234 may have different actuation patterns, such as other springs, clamps, pulleys, engaged threaded members, and/or other actuation mechanisms described in international patent application number PCT/US2018/061126 filed on 11/14 2018. Further, because each clip mechanism 230 includes its own actuation mechanism 234, the clip mechanisms 230 can be actuated independently. As described in detail below, in some embodiments, the device 200 may include more than two clip mechanisms 230 and/or one of the clip mechanisms 230 may be omitted.

In some other embodiments, the valve repair device 200 may omit the stabilizing member 220, the stabilizing member 220 may have a different shape, and/or the number and location of the clip mechanisms 230 may vary. For example, fig. 3A-3D are front, side, rear, and top views, respectively, of a valve repair device 200 with the stabilizing member 220 omitted, in accordance with embodiments of the present technique. For example, fig. 4A-4D are front, side, rear, and top views, respectively, of a valve repair device 200 including a flexible, generally circular stabilizing member 420 in accordance with embodiments of the present technique. In the illustrated embodiment, the stabilizing member 420 includes a frame 421 having a plurality of generally circular rings attached to the engaging member 210 at a portion of its periphery, for example, to provide (i) radial flexibility while minimizing lateral flexibility and (ii) target location for additional continuous fixation to stabilize the rings against the atrial wall. Also for example, fig. 5A and 5B are side and rear views, respectively, of a valve repair device 500 including an elongate curved stabilizing member 520 extending from an engagement member 510, in accordance with embodiments of the present technique. In the illustrated embodiment, the stabilizing member 520 includes a frame 521, the frame 521 having two high wire forms or laser cut structures that bend to move and support the atrial wall, for example, along the shape of the atrial wall. In addition, the engagement member 510 includes only one centrally located clip mechanism 530 depending therefrom.

Fig. 6A-6C are front, side, and back views, respectively, of a valve repair device 600 configured in accordance with embodiments of the present technique. Referring collectively to fig. 6A-6C, the valve repair device 600 includes an engagement member 610, a stabilizing member 620 extending from the engagement member 610, and a clip mechanism 630 movably coupled to the engagement member. In some embodiments, the stabilizing member 620 may extend at an angle a (fig. 6B) between about 90 ° -130 ° (e.g., between about 95 ° -110 °) relative to the engaging member 610. The clip mechanism 630 may include a base 631 and a pair of arms or prongs 633 extending from the base 631. The prongs 633 may each include a first portion 635 extending from the base 631 and a second portion 636 extending from the first portion 635. When the clip mechanism 630 is closed as shown in fig. 6A-6C, the first portion 635 may extend generally parallel to the engagement member 610 and the second portion 636 may extend generally parallel to the stabilizing member 620. In the illustrated embodiment, the engagement member 610 has a concave-convex (jog) or offset and/or tapered shape in a direction from the top to the bottom of the engagement member 610. That is, the engagement member 610 may be wider/thicker toward the top than toward the bottom. In some aspects of the present technique, such a shape of the engagement member 610 may help deflect the engagement member 610 from the heart anatomy and/or stabilize the valve repair device 600 against the ventricular wall when the engagement member 610 is implanted at the heart valve, and also maintain the engagement member 610 substantially centered within the valve. In the illustrated embodiment, the engagement member 610 also includes a curved portion 614 at its bottom that may, for example, reduce the systolic phase by a small She Bodong (flash).

Fig. 7A-7C are front, side, and rear views, respectively, of a valve repair device 700 configured in accordance with embodiments of the present technique. Likewise, fig. 8A-8C are front, side, and back views, respectively, of a valve repair device 800 configured in accordance with embodiments of the present technique. The valve repair devices 700 and 800 of fig. 7A-7C and 8A-8C, respectively, may include some features that are at least substantially similar in structure and function or identical in structure and function to the valve repair device 600 of fig. 6A-6C and the corresponding features of each other. For example, the valve repair device of fig. 7A-7C may include an engagement member 710 having a greater length (e.g., top-to-bottom), having a reduced profile (e.g., front-to-back), and/or having a substantially flat anterior surface 712 than the engagement member 610 of fig. 6A-6C. The valve repair device 800 of fig. 8A-8C may include a pair of separate and individually actuatable clip mechanisms 830 and engagement members 810 that are shorter (reduced length from top to bottom) than the engagement members 610 of fig. 6A-6C.

II.Selected embodiments of a heart valve repair device including an engagement member

In general, a heart valve repair device in accordance with the present technology may include an engagement member having a shape (e.g., transverse cross-sectional shape, side cross-sectional shape, three-dimensional volumetric shape) and size (e.g., volume, area, cross-sectional dimension) selected to correspond to the natural shape of the commissure lines of a heart valve, for example, to fill and/or provide an engagement surface for gaps between one or more native leaflets of the heart valve. For example, all or a portion of the engagement member may be located (e.g., centrally located) between the leaflets, or positioned to be biased toward one or more of the leaflets and/or the heart valve annulus. The position of the engagement member may be set to predominantly displace one or more leaflets and/or to predominantly fill the commissure gap between two or more leaflets. The shape of the engagement member may be selected to assist in leaflet engagement, fill the regurgitation area, secure the leaflets into the clip mechanism, provide an engagement surface, facilitate native engagement in areas that are not in contact with the implant device, minimize movement/deflection of the engagement member during the cardiac cycle, and/or inhibit native leaflet fluctuation. For example, the narrowing shape of the coaptation region can draw the leaflets together, increase the depth of the coaptation along the coaptation line, and create an annuloplasty effect. In contrast, the shape widening along the coaptation region can uniquely fill regurgitation spaces (e.g., fissures) in the expanded anatomy, further create coaptation redundancy, and/or fill spaces left by the native leaflets. In some embodiments, a slight annuloplasty effect approximating a leaflet may be combined with the coaptation redundancy of the coaptation members to produce a generally better valve. In some embodiments, the size and/or orientation of the engagement member may be adjusted by a delivery system for delivering the heart valve repair device prior to the delivery system being removed.

In some embodiments, the shape of the engagement member may be designed to have an atrial-to-ventricular gradient-such as tapered or twisted-that is configured to direct forward flow, minimize cross-valve gradients, maximize pressure recovery, promote native leaflet closure, and/or simulate natural eddies of blood flow throughout the cardiac cycle. The engagement members may be covered with a fabric covering that aids in ingrowth into the leaflets to provide firm long-term fixation, and provides a atraumatic surface for engaging the native leaflets. In some embodiments, the engagement member may include foam under the fabric cover to provide further atraumatic engagement of the leaflets against the engagement member. The engagement members may be supported by braided wires, nitinol wires, superelastic nitinol stent-like frames, expanded sponge-like materials, polymeric balloons, and/or other support structures.

More specifically, for example, fig. 9A-9H are transverse cross-sectional views (e.g., top or atrial, bottom or ventricular views) of a plurality of engagement members 910 in accordance with embodiments of the present technique. As shown in fig. 9A-9H, respectively, the engagement member 910 may have a crescent shape, an oblong shape, an elongated polygonal shape, a triangular or asymmetric hexagonal shape, a semicircular shape, a mushroom shape or umbrella shape, a T-shape, and/or a star shape (e.g., having three or more points). Similarly, fig. 10A-10L are side cross-sectional views (e.g., anterior-posterior view and/or commissure-commissure view) of a plurality of engagement members 1010, in accordance with embodiments of the present technique. As shown in fig. 10A-10L, respectively, the engagement member 1010 may have a triangular shape (e.g., isosceles triangle shape), a curved or fin shape, an oblong shape, an inverted triangle shape, an elongated T shape, an inverted umbrella shape, a trapezoid shape, a semicircle shape, a laterally elongated T shape, a square shape, a circle shape, or a bow tie shape (e.g., including a pair of trapezoid portions extending from the central member). The multiple transverse cross-sectional and side cross-sectional shapes of the engaging members 910 and 1010 may be combined to form engaging members of different shapes and sizes. Likewise, in other embodiments, the engagement members according to the present technology may have other shapes.

The plurality of engagement member shapes shown in fig. 9A-10L may be combined and/or modified based on, for example, the particular anatomy and/or abnormality of the heart valve in which the heart valve repair device is to be implanted. For example, fig. 11A is a side cross-sectional view of a valve repair device 1100 implanted at a mitral valve MV in accordance with embodiments of the present technique. Fig. 11B and 11C are lateral cross-sectional views of the valve repair device 1100 of fig. 11A during diastole and systole, respectively, in accordance with embodiments of the present technique. 11A-11C, the valve repair device 1100 includes an engagement member 1110, the engagement member 1110 having a circular or oblong side cross-sectional shape and an elongated hourglass-like or peanut-like transverse cross-sectional shape. More specifically, the engagement member 1110 can have a first elongate side portion 1111a and a second elongate side portion 1111b positioned adjacent to the posterior leaflet PL and the anterior leaflet AL, respectively. The engagement member 1110 can also include (i) a width W (fig. 11B) that extends between the first and second side portions 1111a-B and perpendicular to an axis that extends between the commissures C between the anterior leaflet AL and the posterior leaflet PL (e.g., in the direction between the leaflets), and (ii) a length L (fig. 11C) that is generally orthogonal to the width W and extends along the axis between the commissures C. The length L may be greater than the width W such that the engagement member has an elongated transverse cross-sectional shape. The shape of the engagement member 1110 may facilitate engagement of the anterior leaflet AL or the posterior leaflet PL of the mitral valve MV against its surface, as shown in fig. 11C. In other embodiments, the engagement member 1110 of the valve repair device 1100 can have any of the side cross-sectional shapes shown in fig. 11D, including, for example, pentagonal, trapezoidal, or bow tie-like shapes.

In the illustrated embodiment, the valve repair device 1100 includes a clip mechanism 1130 (including first and second clip mechanisms 1130a, 1130b, respectively, shown in fig. 11A) configured to secure the valve repair device 1100 to one or both of the anterior leaflet AL or the posterior leaflet PL of the mitral valve MV. More specifically, a first clip mechanism 1130a can extend from the first elongated side portion 1111a to capture the posterior leaflet PL, thereby at least partially securing the posterior leaflet PL against the engagement member 1110, and a second clip mechanism 1130b can extend from the second elongated side portion 1111b and capture the anterior leaflet AL to at least partially secure the anterior leaflet AL against the engagement member 1110.

Fig. 12A is a side cross-sectional view of a valve repair device 1200 implanted at a mitral valve MV in accordance with embodiments of the present technique. Fig. 12B and 12C are lateral cross-sectional views of the valve repair device 1200 of fig. 12A during diastole and systole, respectively, in accordance with embodiments of the present technique. 12A-12C, the valve repair device 1200 includes an engagement member 1210 having (i) a double-fin cross-sectional shape including, for example, a first fin portion 1215 (FIG. 12A) having a concave surface facing the posterior leaflet PL and a second fin portion 1216 (FIG. 12A) having a concave surface facing the anterior leaflet AL and (ii) an elongated oblong or skewed hourglass-like transverse cross-sectional shape. In some embodiments, the engagement member 1210 may bend between the oblique hourglass shape shown in fig. 12B and the oblong shape of fig. 12C to facilitate engagement of the anterior leaflet AL or posterior leaflet PL of the mitral valve MV against its surface, as shown in fig. 12C. In other embodiments, the engagement member 1210 has a constant shape during diastole and systole. In some embodiments, the engagement member 1210 of the valve repair device 1200 can have any of the side cross-sectional shapes shown in fig. 12D, including, for example, a trapezoid, a horn, or a curved rectangle, or a rectangular shape. The valve repair device 1200 may be secured in place relative to the mitral valve MV via one or more clip mechanisms, locking mechanisms, anchors, and/or other securing features (not shown) described herein.

Fig. 13A is a side cross-sectional view of a valve repair device 1300 implanted at a tricuspid valve TV in accordance with embodiments of the present technique. Fig. 13B and 13C are lateral cross-sectional views of the valve repair device 1300 of fig. 13A during diastole and systole, respectively, in accordance with embodiments of the present technique. Referring collectively to fig. 13A-13C, the valve repair device 1300 includes an engagement member 1310, the engagement member 1310 having a generally circular side cross-sectional shape and an oblong transverse cross-sectional shape. In the illustrated embodiment, the engagement member 1310 can be secured to and/or against a first leaflet L1, such as a posterior leaflet, of the tricuspid valve TV via one or more clip mechanisms, anchors, and/or other securing features (not shown) described herein. In other embodiments, the engagement member 1310 may additionally or alternatively be secured to and/or against the second leaflet L2 (e.g., anterior leaflet) and/or the third leaflet L3 (e.g., septal leaflet). The engagement member 1310 provides an engagement surface for the first leaflet L2 and the second leaflet L3, as shown in fig. 13C, for example.

Fig. 14A is a side cross-sectional view of a valve repair device 1400 implanted at a tricuspid valve TV in accordance with embodiments of the present technique. Fig. 14B and 14C are lateral cross-sectional views of the valve repair device of fig. 14A during diastole and systole, respectively, in accordance with embodiments of the present technique. Referring together to fig. 14A-14C, the valve repair device 1400 includes an engagement member 1410 having a generally pentagonal side cross-sectional shape and a tri-cusp transverse cross-sectional shape. In the illustrated embodiment, the valve repair device 1400 may be secured between the leaflets L1-L3 of the tricuspid valve TV via one or more clip mechanisms, locking mechanisms, anchors, and/or other securing features (not shown) described herein. As shown in fig. 14B and 14C, the star-like transverse cross-sectional shape of the engagement member 1410 may be oriented such that each tip of the star is directed generally toward a corresponding one of the commissures between the leaflets L1-L3 to, for example, facilitate engagement of the leaflets L1-L3 against the surface of the engagement member 1410. In other embodiments, the engagement member 1410 of the valve repair device 1400 may have any side cross-sectional shape shown in fig. 14D, including, for example, a curved pentagon, square-semicircle, or rectangular shape. Additionally, the relative size of the engagement features may be varied to meet user needs by features within the engagement surface, and may be actuated by a delivery system as described herein.

Fig. 15A and 15B are front and side views, respectively, of a valve repair device 1500 implanted at a mitral valve in accordance with embodiments of the present technique. Fig. 15C is a side cross-sectional view of the valve repair device 1500 of fig. 15A and 15B implanted at the mitral valve MV, in accordance with embodiments of the present technique. Fig. 15D and 15E are lateral cross-sectional views of the valve repair device 1500 of fig. 15A-15C, respectively, during diastole and systole, in accordance with embodiments of the present technique. 15A-15E, the valve repair device 1500 includes an engagement member 1510 having an inverted umbrella-like side cross-sectional shape and an elongated curved rectangular or oblong transverse cross-sectional shape. In the illustrated embodiment, the engagement member 1510 is narrower at the juncture line and widens below the mitral valve MV within the anterior-posterior (AP) tendinous window. More specifically, the engagement member 1510 can include a lower portion 1513 having a semicircular cross-sectional shape, an upper portion 1512 having a rectangular or cylindrical cross-sectional shape, a first side portion 1511a configured to be positioned adjacent (e.g., facing) the posterior leaflet PL, and a second side portion 1511b configured to be positioned adjacent (e.g., facing) the anterior leaflet AL.

In the illustrated embodiment, the valve repair device 1500 includes a clip mechanism 1530 (labeled as a first clip mechanism 1530a and a second clip mechanism 1530b, respectively) and a locking mechanism 1540 (labeled as a first locking mechanism 1540a and a second locking mechanism 1540b, respectively) extending from the engagement member 1510. The clip mechanism 1530 is configured to be positioned on the ventricular side of the mitral valve MV and capture the posterior and anterior leaflets PL, AL for securing the leaflets against the coaptation member 1510. For example, as described in more detail below with reference to fig. 31A-40D, the locking mechanism 1540 (which may also be referred to as a "locking clip," "stabilizing member," "stabilizing feature," and iterations thereof) may be generally similar to the clip mechanism 1530, but configured to be positionally disposed on the atrial side of the mitral valve MV (or another heart valve) and to engage the posterior leaflet PL, anterior leaflet AL, and/or the atrial side of other portions of the heart anatomy, for example, to help secure the engagement member 1510 in a selected position relative to the mitral valve MV. In the illustrated embodiment, the first and second clip mechanisms 1530a, 1530b extend from first and second side portions 1511-a-b, respectively, of the upper portion 1512. Likewise, first lock mechanism 1540a and second lock mechanism 1540b extend from first and second side portions 1511-a-b, respectively, of upper portion 1512. In some embodiments, the locking mechanism 1540 can be generally aligned over the clip mechanism 1530 and can nest within the clip mechanism 1530, causing the anterior and posterior leaflets AL, PL to fold around the interlocking features of the device 1500. In some embodiments, after capturing the leaflet with the clip mechanism 1530, the locking mechanism 1540 can be simultaneously released (e.g., actuated) to align with the clip mechanism 1530 and press onto the atrial side of the leaflet to provide further leaflet fixation.

Fig. 16A is a side cross-sectional view of a valve repair device 1600 implanted at a mitral valve MV in accordance with embodiments of the present technique. Fig. 16B and 16C are lateral cross-sectional views of the valve repair device 1600 of fig. 16A and 16B, respectively, at diastole and systole, in accordance with embodiments of the present technique. Referring collectively to fig. 16A-16C, the valve repair device 1600 includes features substantially similar to the valve repair device of fig. 15A-15E, including, for example, an engagement member 1610, a clip mechanism 1630, and a locking mechanism 1640. However, in the illustrated embodiment, the engagement member 1610 has a generally trapezoidal or rectilinear side cross-sectional shape. As shown in fig. 16B and 16C, in some embodiments, the clip mechanism 1630 and the locking mechanism 1640 can cooperate to fold the valve leaflet (e.g., anterior leaflet AL and posterior leaflet PL) independent of the shape of the engagement member 1610.

Fig. 17A is a top view of a valve repair device 1700 in accordance with embodiments of the present technique. Fig. 17B is a side cross-sectional view of the valve repair device 1700 of fig. 17A implanted at the tricuspid valve TV, in accordance with embodiments of the present technique. Fig. 17C and 17D are lateral cross-sectional views of the valve repair device of fig. 17A and 17B, respectively, during diastole and systole, in accordance with embodiments of the present technique. 17A-17D, the valve repair device 1700 includes an engagement member 1710 having a generally triangular (e.g., tear drop, oval, guitar pick) side cross-sectional shape and a transverse cross-sectional shape. The valve repair device 1700 further includes a securing mechanism 1750 extending from one or more edges of the engagement member 1710 and configured to secure the engagement member 1710 to two or more leaflets of the tricuspid valve, such as leaflets L1 and L2 of tricuspid valve TV. In some embodiments, the fixation mechanism 1750 may be substantially similar or identical to any of the atrial and ventricular "sandwich" members described in detail below with reference to fig. 42A-60B. In other embodiments, the fixation mechanism 1750 may include one or more clip mechanisms, locking mechanisms, anchors, and/or other fixation features described herein for securing the device to the valve leaflet. Thus, the engagement member 1710 can (i) be located at the commissure between the leaflets, (ii) extend to the center of the tricuspid valve TV, and (iii) be shaped to fill the regurgitation orifice and prevent regurgitation. In some embodiments, the engagement member 1710 can be biased toward the annulus a of the tricuspid valve TV to help fill regurgitation space in the valve.

Fig. 18A is a side cross-sectional view of a valve repair device 1800 implanted at the tricuspid valve TV in accordance with embodiments of the present technique. Fig. 18B and 18C are lateral cross-sectional views of the valve repair device 1800 of fig. 18A during diastole and systole, respectively, in accordance with embodiments of the present technique. 18A-18C, the valve repair device includes features generally similar to the valve repair device 1700 of FIGS. 17A-17D, including, for example, engagement members 1810 secured to the leaflets L1 and L2. However, in the illustrated embodiment, the engagement member 1810 has a fixation mechanism that includes (i) a clip mechanism 1830 configured to engage the ventricular side of the leaflets L1 and L2 and (ii) a locking mechanism 1840 configured to engage the atrial side of the leaflets L1 and L2. Additionally, the engagement member 1810 has been oriented opposite the valve repair device 1700 of fig. 17A-17D, with the narrow portion of the surface of the engagement member 1810 oriented toward the commissures between the leaflets. Thus, in some aspects of the present technique, the engaging members 1810 may be oriented and/or placed between the leaflets in a general manner. In general, multiple engagement members of the present technology may be optionally placed in different orientations, depending on the particular application of the valve and valve repair device.

In some embodiments, the engaging member 1810 is expandable. For example, the engaging member 1810 may include an inflatable bladder or means for mechanically expanding the engaging member 1810. In some aspects of the present technique, the engaging member 1810 may be further expanded into the orifice of the tricuspid valve TV. For example, the engaging member 1810 may be selectively expanded by a physician or other operator until regurgitation of the tricuspid valve TV is substantially reduced.

Fig. 19 is a side view of a valve repair device 1900 configured for implantation at, for example, a mitral valve, in accordance with embodiments of the present technique. In the illustrated embodiment, the valve repair device 1900 includes posterior and anterior clips 1930a and 1930b, respectively, for securing the engagement members 1910 (e.g., the baffles) to the posterior and anterior leaflets PL and AL of the mitral valve. The engagement member 1910 can include a tab or point 1917 configured (e.g., shaped, sized) to fit the anterior leaflet above the anterior clip 1930 b.

Fig. 20 is a top cross-sectional view of a valve repair device 2000 implanted at a heart valve in accordance with embodiments of the present technique. In the illustrated embodiment, the valve repair device 2000 includes an engagement member 2010 having a rear surface defining a pair of recesses 2011, the recesses 2011 each configured to receive a corresponding clip mechanism 2030 or a corresponding portion of the clip mechanism 2030. The clip mechanism 2030 may secure the engagement member 2010 to the leaflets L of the heart valve. In some aspects of the present technique, locating the clip mechanism 2030 in the recess 2011 may increase staggering of the leaflets L between the clip mechanism 2030 and the engagement member 2010. That is, for example, the valve repair device 2000 may be configured such that the leaflets traverse a more tortuous path relative to the engagement member 2010 to improve stability (e.g., by inhibiting or even preventing excessive deflection of the engagement member 2010) and fixation of the valve repair device 2000 at the heart valve.

Fig. 21 is a top cross-sectional view of a valve repair device 2100 configured in accordance with an embodiment of the present technique. In the illustrated embodiment, the valve repair device 2100 includes an engagement member 2110 having a bean-like shape (e.g., curved into a crescent shape) that includes a recess 2111 at its rear surface. Similar to the embodiment shown in fig. 21, the location of one or more clip mechanisms (not shown) may be provided in the recess 2111, for example, to increase the staggering of the leaflets of a heart valve (not shown) between the one or more clip mechanisms and the engagement member 2110.

Fig. 22 is a table of images of a valve repair device including an engagement member having multiple shapes, in accordance with embodiments of the present technique.

III.Selected implementations of a heart valve repair device including an engagement member configured to move and/or expand Example(s)

In some embodiments, a heart valve repair device in accordance with the present technology may include an engagement member configured to pivot, expand, or otherwise move, for example, to facilitate positioning the engagement member at a desired location relative to and/or within a heart valve.

For example, fig. 23A and 23B are top and side perspective views, respectively, of a valve repair device 2300 including an expandable engagement member 2310 in accordance with embodiments of the present technique. Fig. 23C is a side cross-sectional view of the valve repair device 2300 of fig. 23A and 23B implanted at the mitral valve MV, in accordance with embodiments of the present technique. Fig. 23D and 23E are lateral cross-sectional views of the valve repair device 2300 of fig. 23A-23C, respectively, during diastole and systole, in accordance with embodiments of the present technique. Referring together to fig. 23A-23E, the engagement member 2310 includes a static central portion 2318 and a pair of expandable side portions 2319 extending from the central portion 2318 (e.g., coupled to the central portion 2318, integrally formed with the central portion 2318). In the illustrated embodiment, the expandable side portions 2319 protrude from the central portion 2318 into the commissure-commissure (C-C) direction. The expandable side portion 2319 may include a stent-like structure, a balloon, and/or other expandable structures. In some embodiments, the protrusion of the side portion 2319 in the C-C direction may be adjusted (e.g., fine tuned) by, for example, controlling the amount of expansion of the side portion 2319. For example, the side portions 2319 may expand independently of each side of the static central portion 2318. In some embodiments, the side portions 2319 may be covered with a fabric (e.g., a non-woven fabric) such as expanded polytetrafluoroethylene (ePTFE) to allow atraumatic engagement of the native leaflets against the side portions 2319. Valve repair device 2300 may include a pair of clip mechanisms 2330 for capturing leaflets of a valve. In some embodiments, the valve repair device 2300 may further include an atrial-side locking mechanism 2340 configured to engage the leaflet over the clip mechanism 2330.

Fig. 24A and 24B are top views of a valve repair device 2400 in a first position (e.g., a first configuration, an initial position) and a second position (e.g., a second configuration, a deployed position), respectively, in accordance with embodiments of the present technique. Fig. 24C and 24F are side cross-sectional views of the valve repair device 2400 of fig. 24A and 24B implanted at the tricuspid valve TV and mitral valve MV, respectively, in accordance with embodiments of the present technique. Fig. 24D and 24E are transverse cross-sectional views of the valve repair device 2400 of fig. 24A and 24B implanted at the tricuspid valve TV, respectively, at diastole and systole, in accordance with embodiments of the present technique. Fig. 24G and 24H are lateral cross-sectional views of the valve repair device 2400 of fig. 24A and 24B implanted at the mitral valve MV, respectively, during diastole and systole, in accordance with embodiments of the present technique. 24A-24H, the valve repair device includes features generally similar to the valve repair device of FIGS. 23A-23E, including, for example, an engagement member 2410 including a central portion 2418 and a pair of expandable side portions 2419, and a clip mechanism 2430 and a locking mechanism 2440 coupled to the engagement member 2410. However, in the illustrated embodiment, the side portions 2419 may move (e.g., be rotatable, pivotable) relative to the central portion 2418 and the clip mechanism 2430 and locking mechanism 2440. Thus, the side portions 2419 may be rotated relative to, for example, the anterior and posterior positions of the clip mechanism 2430 to treat non-central valve regurgitation. That is, the side portion 2419 may be selectively rotated to fill the valve regurgitation area. In some embodiments, the rotation or pivoting of the side portion 2419 may be actively controlled by a physician or other operator via the mechanisms of the associated activation system. In other embodiments, the side portion 2419 is configured to passively rotate to align with the commissure lines of the native leaflets. In some embodiments, the side portions 2419 and/or other portions of the engagement members 2410 may be modular to allow for placement of the native valve leaflets (e.g., anterior leaflet AL and posterior leaflet PL of the mitral valve MV) after they are initially clamped.

Fig. 25A and 25B are side and top views, respectively, of a valve repair device 2500 in an unexpanded position (e.g., first position, first configuration, initial position), in accordance with embodiments of the present technique. Fig. 25C and 25D are side and top views, respectively, of the valve repair device 2500 of fig. 25A and 25B in an expanded position (e.g., second position, second configuration, deployed position), in accordance with embodiments of the present technique. Fig. 25E and 25H are side cross-sectional views of the valve repair device 2500 of fig. 25A-25D implanted at the mitral valve MV in an unexpanded position and an expanded position, respectively, in accordance with embodiments of the present technique. Fig. 25F and 25G are transverse cross-sectional views of the valve repair device 2500 of fig. 25A-25D implanted at the mitral valve MV in unexpanded position, in diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 25I and 25J are transverse cross-sectional views of the valve repair device 2500 of fig. 25A-25D implanted at the mitral valve MV in an expanded position, in diastole and systole, respectively, in accordance with embodiments of the present technique.

Referring together to fig. 25A-25J, the valve repair device 2500 includes an engagement member 2510 having a pair of hinged side portions 2519 that facilitate expansion of the engagement member 2510 in, for example, a C-C direction. That is, the engagement member 2510 may be opened from an unexpanded position to an expanded position to increase the C-C width of the device 2500. In some embodiments, the side portions 2519 are semi-circular and include pointed ridges extending in the C-C direction, allowing the tapered surfaces to contact the engagement surfaces of the device 2500. The C-C expansion may be binary (e.g., expanded or unexpanded), or the device 2500 may include features configured to facilitate gradual expansion of the side portion 2519, such as a corset (corset) like cord (not shown) coupled to the side portion 2519. The valve repair device 2500 may be secured in place relative to the native valve via one or more clip mechanisms 2530, locking mechanisms 2540, anchors, and/or other securing features described herein.

Fig. 26A and 26B are top views of valve repair device 2600 in an unexpanded position and an expanded position, respectively, in accordance with embodiments of the present technique. Fig. 26C and 26F are side cross-sectional views of the valve repair device 2600 of fig. 26A and 26B implanted at the mitral valve MV in an unexpanded position and an expanded position, respectively, in accordance with embodiments of the present technique. Fig. 26D and 26E are lateral cross-sectional views of the valve repair device 2600 of fig. 26A and 26B, respectively, implanted at the mitral valve MV in an unexpanded position, in diastole and systole, in accordance with embodiments of the present technique. Fig. 26G and 26H are transverse cross-sectional views of the valve repair device 2600 of fig. 26A and 26B, respectively, implanted at the mitral valve MV in an expanded position, in diastole and systole, in accordance with embodiments of the present technique.

26A-26H, the valve repair device 2600 includes an engagement member 2610 having an expandable central portion 2618 and tapered side portions 2619 extending from the central portion 2618. The central portion 2618 may have parallel sides configured to extend in the C-C direction. Thus, the expansion may come from the central portion 2618, maintaining the most C-C shape. In some embodiments, the valve repair device 2600 includes a pair of clip mechanisms 2630 aligned with the central portion 2618. In some embodiments, the central portion 2618 may further expand in other directions, such as front-to-back (a-P) dimensions, further filling the engagement distance and increasing the force with which the clip mechanism 2630 mates with the central portion 2618. That is, the expansion of the central portion 2618 may further fill any distance between native leaflet coaptations in two directions or all four directions (oval and circular). In some embodiments, the valve repair device 2600 may include more than two clip mechanisms 2630 to ensure adequate securement of the engagement member 2610, such as when the engagement member 2610 is wider.

Fig. 27A is a top view of valve repair device 2700 in an unexpanded position in accordance with embodiments of the present technique. Fig. 27B and 27E are side cross-sectional views of the valve repair device 2700 of fig. 27A implanted at the mitral valve MV in an unexpanded position and an expanded position, respectively, in accordance with embodiments of the present technique. Fig. 27C and 27D are lateral cross-sectional views of the valve repair device 2700 of fig. 27A implanted at the mitral valve MV in an unexpanded position, in diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 27F and 27G are transverse cross-sectional views of the valve repair device 2700 of fig. 27A implanted at the mitral valve MV in an expanded position, in diastole and systole, respectively, in accordance with embodiments of the present technique.

Referring together to fig. 27A-27G, valve repair device 2700 includes an engagement member 2710 configured to extend in the C-C direction and a clip mechanism 2730 and/or locking mechanism 2740 extending from engagement member 2710 for securing native valve leaflets (e.g., anterior leaflet AL and posterior leaflet PL) against engagement member 2710. In the illustrated embodiment, valve repair device 2700 includes a corset-type feature 2752 that can be actuated to (i) decrease the width (e.g., a-P distance) of engagement member 2710, (ii) increase the length of engagement member 2710 along the C-C dimension, and/or (iii) increase the volume of engagement member 2710 along the A1/P1 and A3/P3 directions. That is, the corset feature 2752 may reduce the distance between the clip mechanisms 2730, increase the length in the engagement dimension, and increase the width parallel to the clip mechanisms 2730. In some embodiments, engagement member 2710 may have a stent form or a braided form, and may be covered by atraumatic engagement materials described herein.

Fig. 28A and 28B are side and top views, respectively, of a valve repair device 2800 in accordance with embodiments of the present technique. Fig. 28C is a side cross-sectional view of the valve repair device 2800 of fig. 28A and 28B implanted at the mitral valve MV, in accordance with embodiments of the present technique. Fig. 28D and 28E are transverse cross-sectional views of the valve repair device 2800 of fig. 28A-28C, respectively, during diastole and systole, in accordance with embodiments of the present technique. Referring together to fig. 28A-28E, valve repair device 2800 includes an engagement member 2810 having a central portion 2818 and a pair of tapered side portions 2819 extending in the C-C direction from central portion 2818. The valve repair device 2800 may also include a clip mechanism 2830 and a locking mechanism 2840 for securing one or more leaflets L of the mitral valve MV against the engagement member 2810 (e.g., against the central portion 2818). In some embodiments, the tapered side portions 2819 are configured to individually rise or fall in the atrial-ventricular direction to increase or decrease the amount of the engagement member 2810 (e.g., filler) in the C-C direction. In some embodiments, the valve repair device 2800 may also include features to lock the tapered side portions 2819 in place to prevent the side portions of the engagement member 2610 from moving after deployment.

In some embodiments, the engagement member of the heart valve device (and/or another atrial portion of the device) may comprise a flexible (e.g., nitinol) frame cut from a tube having a plurality of struts connected at the extreme ends of the atrium and the extreme ends of the ventricle. The frame may include a central thread or locking nut cut and formed into the frame. The delivery system may be configured to compress the atrial portion of the frame, reducing the overall height, while increasing the diameter of the struts, thereby increasing the diameter of the engagement surface filling the existing engagement gap. The device may be asymmetrically shaped to expand in an elliptical or other non-circular manner, or may include a plurality of central adjustable components for localized height changes and diameter increases.

IV.Comprising a clip mechanism and/or locking mechanism for securing the engagement member at and/or near the heart valve Selected embodiments of the manufactured heart valve repair device

In some embodiments, a heart valve repair device according to the present technology may include an implant fixation mechanism for securing the device in the local native anatomy of the heart valve via, for example, anchoring to or against the native atrium or ventricle wall, against the annulus, and/or the leaflet itself. As described in detail above, the implant fixation mechanism may include one or more clip mechanisms and one or more locking mechanisms. The clip mechanism (also referred to as a "clip," "capture mechanism," and iterations thereof) is configured to be positioned on the ventricular side of the heart valve and capture one or more leaflets of the valve for securing the leaflets against, for example, engagement members coupled to the clip mechanism and the locking mechanism. The locking mechanism (also referred to as a "clip," "locking clip," "stabilizing member," "stabilizing feature," and iterations thereof) may be generally similar to the clip mechanism, but configured to be positionally disposed on the atrial side of the heart valve to engage the atrial side of the valve leaflets and/or other portions of the heart anatomy, for example, to help secure the engagement member in a selected position relative to the valve and/or to provide additional leaflet fixation. The clip mechanism and locking mechanism may or may not require a particular orientation.

In some embodiments, the clip mechanism may be located (i) on an opposite side of the engagement member, (ii) on one side of the engagement member, and/or (iii) below the mating surface of the engagement member. In some embodiments, the clip mechanism and/or locking mechanism may be movable, expandable, and/or otherwise adjustable. In some embodiments, the clip mechanism may be a narrow feature configured to guide chordae close to the valve and/or minimize leaflet damage (e.g., allow forward flow) during diastole, while the locking mechanism may be a wide feature on the atrial side to minimize leaflet fluctuation during systole and provide additional flow resistance. In some embodiments, the clip mechanism and the locking mechanism may operate independently of each other and may be repositioned. Further, the clip mechanism and locking mechanism (e.g., arms thereof) may (i) have a plurality of shapes that support the shape of the native leaflets, (ii) be angled to mimic a natural leaflet engagement angle, and/or (iii) be configured to capture only the free edges of one or more leaflets.

In some embodiments, the implant fixation mechanism may include features configured to enhance leaflet fixation, such as (i) interlocking features configured to increase small She Shezhou (indication), (ii) materials or features that increase surface area in contact with the leaflet, (iii) friction elements (e.g., cleats, barbs, textures) that increase friction against the leaflet, (iv) features that pierce the leaflet, and/or (v) combinations thereof. For valve repair devices having clips on the atrial and ventricular sides of the device, features (e.g., locking mechanisms) on the atrial side of the leaflets can fit within the spaces of the features under the annulus. The fixed feature may be a gear drive, hydraulic, superelastic, or spring-loaded. The features contacting the leaflets can be widened to distribute the closing force to a wider area. Some stabilization features may use flared, angled, or wide fixation mechanisms to increase the stability of the device and to facilitate the natural angle of engagement of the native valve. In some embodiments, the clip mechanism and/or locking mechanism may include a Patent Foramen Ovale (PFO) closure device configured as an atrial anchor.

In some embodiments, the clip mechanism and/or locking mechanism may be in the form of hooks so as not to pull the leaflet tightly onto the engagement member, but only to bring it close to the engagement member. This configuration may allow the captured leaflets to open more during diastole, thereby reducing the pressure gradient. When multiple (e.g., two) ventricular clip mechanisms are in the form of hooks, atrial ring support and/or fixation members in the form of anchors, barbs, or splints, etc., may be included to inhibit migration of the device into the ventricle. In some embodiments, the clip mechanism may include one or more clip expandable arms that work effectively in treating wide mitral regurgitation jets without the need for an engagement member with a C-C protrusion.

Fig. 29A is a side cross-sectional view of a valve repair device 2900 implanted at the tricuspid valve TV in accordance with embodiments of the present technique. Fig. 29B and 29C are lateral cross-sectional views of the valve repair device 2900 of fig. 29A during diastole and systole, respectively, in accordance with embodiments of the present technique. 29A-29C, the valve repair device 2900 may include features substantially similar to the valve repair device 2300 of FIGS. 23A-23E, for example, including an engagement member 2910 and a clip mechanism 2930. In the illustrated embodiment, the valve repair device 2900 includes an engagement member 2910 having three triangular portions 2919 (e.g., side portions), which together impart a star-shaped transverse cross-sectional shape to the engagement member 2910. In some embodiments, one or more triangular portions 2919 may be independently expandable from an unexpanded position (not shown). In the illustrated embodiment, the valve repair device 2900 is secured between the leaflets L1-L3 of the tricuspid valve TV via a clip mechanism 2930 extending from the engagement member 2910, and, for example, interspersed or staggered between the triangular portions 2919 of the engagement member 2910. As can be seen in fig. 29B and 29C, each triangular portion 2919 may be oriented to protrude toward a corresponding one of the commissures between the leaflets L1-L3 to facilitate, for example, engagement of the leaflets L1-L3 with the surface of the engagement member 2910. In some embodiments, valve repair device 2900 may also include a locking mechanism (not shown) configured to further secure valve repair device 2900 at tricuspid valve TV.

Fig. 30 is a side view of a valve repair device 3000 in accordance with embodiments of the present technique. In the illustrated embodiment, the valve repair device 3000 includes a central engagement member 3010 configured to provide an engagement surface to one or more native leaflets of a heart valve. The valve repair device 3000 further includes a pair of gear-driven clip mechanisms 3030 configured to capture, for example, a medial sector P2 of the posterior leaflet PL and a medial segment A2 of the anterior leaflet AL of the mitral valve MV. Clip mechanism 3030 can be independently operated to help optimize the angle and amount of clip closure during capture of anterior and posterior leaflets AL, PL. In some embodiments, valve repair device 3000 further includes a spring-loaded locking mechanism 3040, which may also be gear-driven, for example.

In some embodiments, clip mechanism 3030 is held in proximity by central track 3054. The engagement member 3010 can be inserted onto the track 3054 and slid down into place-e.g., into the space between the anterior leaflet AL and the posterior leaflet PL. In some embodiments, the engagement member 3010 may be replaced if a larger size is needed to block the reflux leak. In some embodiments, after installation of the selected engagement member 3010 during the delivery procedure, the locking mechanism 3040 may be operated simultaneously or independently to lock onto the immobilized leaflet. In some embodiments, the joint member 3010 may be modular-have multiple segments to allow posterior, anterior, medial, lateral, spacing, and/or other segment segmentation to be added to the joint member 3010 or to alter the level of joint along the ventricular axis.

Fig. 31A is a side cross-sectional view of a valve repair device 3100 implanted at a mitral valve MV in accordance with embodiments of the present technique. Fig. 31B and 31C are lateral cross-sectional views of the valve repair device 3100 of fig. 31A during diastole and systole, respectively, in accordance with embodiments of the present technique. Referring together to fig. 31A-31C, the valve repair device 3100 includes a rotatable engagement member 3110, a pair of clip mechanisms 3130 (labeled front clip mechanism 3130a and rear clip mechanism 3130b, respectively) extending from the engagement member 3110, and a locking mechanism 3140 extending from the engagement member 3110. In the illustrated embodiment, the engagement member 3110 includes a rearwardly biased tab 3151. The posterior clip mechanism 3130b is positioned below the posterior annulus and grips the posterior leaflet PL. The anterior clip mechanism 3130a grasps the anterior leaflet AL from the ventricular side, securing, for example, the A2 leaflet against the engagement member 3110. The engagement member 3110 can be rotated with the mating feature (e.g., tab 3151) locked down onto the posterior clip mechanism 3130b and the mating feature (e.g., locking mechanism 3140) on the anterior side further mated with the anterior leaflet. Thus, in the illustrated embodiment, the engagement member 3110 is biased rearward and doubles as a rear locking mechanism. Front clip mechanism 3130a may nest within the front surface of engagement member 3110 and its use may be optional. In other embodiments, the posterior clip mechanism 3130b may have a locking clip feature that falls onto the atrial surface of the posterior leaflet prior to placement of the tab 3151 on the posterior leaflet.

Fig. 32A and 32B are side views of valve repair device 3200 in a first position and a second position, respectively, in accordance with embodiments of the present technique. Fig. 32C is a side cross-sectional view of the valve repair device 3200 of fig. 32A and 32B implanted at the mitral valve MV in a first position, in accordance with embodiments of the present technique. Fig. 32D and 32E are transverse cross-sectional views of the valve repair device 3200 of fig. 32A-32C, respectively, during diastole and systole, in accordance with embodiments of the present technique. Referring together to fig. 32A-32E, valve repair device 3200 includes an optional engagement member 3210, a pair of clip mechanisms 3230 coupled to engagement member 3210, and an articulating locking mechanism 3240 coupled to engagement member 3210. Clip mechanism 3230 captures and secures anterior leaflet AL and posterior leaflet PL, respectively. The locking mechanism 3240 on the small She Xinfang side is a locking clip hinged in the center of the a-P dimension. The hinge is located on the ventricular side of the central engagement member 3210 forming a V-shape. The angle of the V-opening of the locking mechanism 3240 is adjustable such that the angle of the clip mechanism 3230 varies at the discretion of the user. In some embodiments, the optional engagement member 3210 may be adjusted in the anterior-posterior dimension such that the distance of the locking mechanism 3240 varies at the discretion of the user and fills any remaining gap in the engagement surface. In some embodiments, the optional engagement member 3210 may be adjusted in the C-C dimension (e.g., perpendicular to the clip mechanism 3230 and/or horizontally aligned with the head of the clip mechanism 3230) to fill any remaining gaps in the engagement surface or plane along the C-C direction.

Fig. 33A is a side view of a valve repair device 3300 in accordance with embodiments of the present technique. Fig. 33B is a side cross-sectional view of the valve repair device 3300 of fig. 33A implanted at the mitral valve MV, in accordance with embodiments of the present technique. Fig. 33C and 33D are lateral cross-sectional views of the valve repair device 3300 of fig. 33A and 33B, respectively, during diastole and systole, in accordance with embodiments of the present technique. Referring together to fig. 33A-33D, the valve repair device 3300 includes an engagement member 3310, a pair of clip mechanisms 3330 coupled to the engagement member 3310, and a central locking mechanism 3340 coupled to the engagement member 3310. Clip mechanism 3330 captures and secures anterior leaflet AL and posterior leaflet PL, respectively. In the illustrated embodiment, the locking mechanism 3340 is nested on top of the engagement member 3310 and clip mechanism 3330 and is configured to be pulled further into the valve leaflet to provide a slight annuloplasty effect. In some embodiments, the diameter of the central locking mechanism 3340 is greater than the distance between the clip mechanisms 3330. In the illustrated embodiment, the central locking mechanism 3340 has a generally elongated oval or rectangular shape. In other embodiments, the central locking mechanism may have other shapes. For example, fig. 33E is a side cross-sectional view of the valve repair device 3300 of fig. 33A implanted at the mitral valve MV and having a central locking mechanism 3340, in accordance with embodiments of the present technique. Fig. 33F and 33G are lateral cross-sectional views of the valve repair device 3300 of fig. 33E during diastole and systole, respectively, in accordance with embodiments of the present technique.

Fig. 34A and 34B are top and bottom views, respectively, of a valve repair device 3400 in accordance with embodiments of the present technique. Fig. 34C is a side cross-sectional view of the valve repair device 3400 of fig. 34A and 34B implanted at the mitral valve MV in accordance with embodiments of the present technique. Fig. 34D and 34E are lateral cross-sectional views of the valve repair device 3400 of fig. 34A-34C, respectively, in diastole and systole, in accordance with embodiments of the present technique. 34A-34E, the valve repair device 3400 includes an engagement member 3410, a pair of clip mechanisms 3430 coupled to the engagement member 3410, and a pair of locking mechanisms 3440 coupled to the engagement member 3410. The clip mechanism 3430 captures and secures the anterior leaflet AL and the posterior leaflet PL, respectively. The locking mechanism 3440 engages the atrial side of the anterior leaflet AL and posterior leaflet PL above the clip mechanism 3430. In the illustrated embodiment, the clip mechanism 3430 has a narrower profile (e.g., width) than the locking mechanism 3440, which can help minimize leaflet damage during diastole, allowing forward flow. The relatively wide geometry of the locking mechanism 3440 may help minimize leaflet wobble during systole and provide additional flow resistance.

In some embodiments, the valve repair device 3400 may include a plurality of narrow clip mechanisms 3430 extending below the corresponding locking mechanisms 3440. For example, fig. 34F is a side cross-sectional view of another embodiment of the valve repair device 3400 of fig. 34A and 34B implanted at the mitral valve MV in accordance with embodiments of the present technique. Fig. 34G and 34H are lateral cross-sectional views of the valve repair device 3400 of fig. 34F in diastole and systole, respectively, in accordance with embodiments of the present technique. 34F-34H, the valve repair device 3400 may include two pairs of clip mechanisms 3430-each pair extending from opposite sides of the engagement member 3410 and aligned under a wider locking mechanism 3440.

Fig. 35A and 35B are side perspective views of a valve repair device 3500 in accordance with embodiments of the present technique. Fig. 35C is a side cross-sectional view of the valve repair device 3500 of fig. 35A and 35B implanted at the mitral valve MV in accordance with embodiments of the present technique. Fig. 35D and 35E are lateral cross-sectional views of the valve repair device 3500 of fig. 35A-35C, in diastole and systole, respectively, in accordance with embodiments of the present technique. Referring together to fig. 35A-35E, valve repair device 3500 includes an engagement member 3510, a clip mechanism 3530 and a locking mechanism 3540 extending from engagement member 3510, and an expandable support 3553 extending from engagement member 3510. The expandable support 3553 may extend below and support the posterior leaflet PL and may be made of a stent structure, a braided structure, an expandable balloon, and/or another expandable element. In some embodiments, expandable support 3553 may be covered with fabric to allow ingrowth into the posterior lower annular space. In some embodiments, the expandable support 3553 can be held in place by a corresponding expandable locking clip (not shown) on the atrial side of the leaflet, e.g., extending toward the annulus within the P2 portion of the posterior leaflet PL. Clip mechanism 3530 and locking mechanism 3540 can be aligned with each other and respectively engage the ventricular side and the atrial side of anterior leaflet AL to capture and close anterior leaflet AL.

Fig. 36A and 36B are top views of a valve repair device 3600 in an unexpanded position and an expanded position, respectively, in accordance with embodiments of the present technique. Fig. 36C is a side cross-sectional view of the valve repair device 3600 of fig. 36A and 36B implanted at the mitral valve MV, in accordance with embodiments of the present technique. Fig. 36D and 36E are lateral cross-sectional views of the valve repair device 3600 of fig. 36A-36C implanted at the mitral valve MV in an expanded position, in diastole and systole, respectively, in accordance with embodiments of the present technique. 36A-36E, the valve repair device 3600 includes an engagement member 3610, and a clip mechanism 3630 and (optionally) locking mechanism 3640 extending from the engagement member 3610 for engaging and capturing the anterior and posterior leaflets AL, PL. In the illustrated embodiment, the clip mechanisms 3630 each include a plurality of movable fingers 3638 that can be independently expanded to increase the amount of leaflet area captured. For example, fingers 3638 can fan out in the second position shown in fig. 36b,36d, and 36E to increase the amount of leaflet area captured. In some embodiments, the valve repair device 3600 may be delivered to the mitral valve MV with the clip mechanism 3630 in the narrowed first position and then released to fan out in one or both directions under the leaflet after placement at the mitral valve MV. In other embodiments, the engagement member 3610 may be omitted and the expandable fingers 3638 may work effectively in treating wide mitral regurgitant jet without the need for an engagement member having, for example, a C-C protrusion. In other embodiments, the expandable fingers 3638 can be individually actuated to pop out of the engagement member 3610 if additional fixation or leaflet stabilization is desired.

Fig. 37A and 37B are side views of a valve repair device 3700 configured in accordance with embodiments of the present technology. Fig. 37C is a side view of the valve repair device 3700 of fig. 37A and 37B implanted at the tricuspid valve TV in accordance with embodiments of the present technique. Fig. 37D is a top view of the valve repair device 3700 of fig. 37A-37C during diastole and fig. 37E is a bottom view of the valve repair device 3700 of fig. 37A-37C during systole in accordance with embodiments of the present technique. Referring collectively to fig. 37A-37E, valve repair device 3700 includes an engagement member 3710 and one or more clip mechanisms 3730 coupled to engagement member 3710. The engagement member 3710 includes an enlarged top portion 3717 configured to be positioned over the tricuspid valve TV (e.g., at the annulus and/or in the right atrium). Clip mechanism 3730 extends behind engagement member 3710 and contacts a portion of one or more leaflets of tricuspid valve TV below top portion 3717. Thus, the top portion 3717 of the engagement member 3710 can serve as a surface against which the leaflets are pressed and held by the ventricular located clip mechanism 3730. The clip mechanism 3730 can capture one or more leaflets to orient the face 3712 of the coaptation surface toward any free leaflet to expand leaflet function by filling the regurgitant leakage space. In some embodiments, the surface of the engagement member 3710 may be slightly rounded to accommodate a variety of positional arrangements and displacements caused by multiple systolic pressures.

Fig. 70A is a side view of a valve repair device 7000 in a delivery configuration (e.g., a compressed configuration) in accordance with an embodiment of the present technique. Fig. 70B is a side view of the valve repair device 7000 of fig. 70A in a deployed configuration (e.g., an expanded configuration) and implanted at a heart valve, in accordance with embodiments of the present technique. Referring to fig. 70A and 70B together, the valve repair device 7000 includes a central member 7050, a pair of clip mechanisms 7030, and a pair of locking mechanisms 7040. In the deployed configuration, the clip mechanism 7030 and the locking mechanism 7040 can cooperate to capture one or more leaflets L of the heart valve therebetween. In the illustrated embodiment, (i) the clip mechanisms 7030 each include a first link 7031 and a second link 7032, (ii) the anchor mechanisms 7040 similarly include a third link 7041 and a fourth link 7042, and (iii) the valve repair device 7000 further includes a drive link 7052. The first link 7031 is hingedly coupled (e.g., at a first end portion) to the central member 7050 and hingedly coupled (e.g., at a second end portion) to the second link 7032 (e.g., to a first end portion of the second link 7032). The second link 7031 is further hingedly coupled (e.g., at a second end portion) to the drive link 7052. The third link 7031 is hingedly coupled (e.g., at a first end portion) to the drive link 7052 and hingedly coupled (e.g., at a second end portion) to the fourth link 7042 (e.g., coupled to a first end portion of the second link 7032). In some embodiments, the fourth link 7042 is hingedly coupled (e.g., at the second end portion) to the central member 7050 and/or another component of the valve repair device 7000.

In the delivery configuration shown in fig. 70A, the first, second, third, fourth, and drive links 7031, 7032, 7041, 7042, and 7052 (collectively, links 7031-7052) are folded longitudinally such that, for example, the links 7031-7052 extend generally parallel to the central member 7050. Thus, in the delivery configuration, the clip mechanism 7030 and the anchor mechanism 7400 are radially compressed so that, for example, the valve repair device 7000 can be advanced through an associated delivery catheter. In the deployed configuration shown in fig. 70B, the links 7031-7052 are folded radially outward such that the second link 7032 of each clip mechanism 7030 and the third link 7041 of the associated anchor mechanism 7040 generally face each other to capture one of the leaflets L therebetween. More specifically, the second link 7032 can engage the ventricular side of the leaflet L and the third link 7041 can engage the atrial side of the leaflet L to capture the leaflet L therebetween. In some aspects of the present technique, the links 7031-7052 provide a robust locking arrangement in the deployed configuration. To move the valve repair device 7000 between the delivery and deployed configurations, one or more of the links 7031-7052 can be actuated (e.g., driven longitudinally) to drive the plurality of links 7031-7052 to pivot between the delivery and deployed configurations.

V.Including non-clips and/or thereof for securing the engagement members at and/or near the heart valve Selected embodiments of his mechanism's heart valve repair device

In some embodiments, a heart valve repair device according to the present technology may include an implant fixation mechanism in addition to the clip and/or locking mechanism for securing the device into the heart anatomy. In some embodiments, the implant fixation mechanism may include a support (e.g., a bracing) member for securing the engagement member at the heart valve such that the engagement member "floats" within the valve between the native leaflets. For example, the implant fixation mechanism may include a rolled or tapered form anchored in the atrium, right ventricle, right atrium, right ventricular outflow tract, coronary sinus, atrial appendage, and/or other anatomical region not directly adjacent the device.

Fig. 38A is a side cross-sectional view of a valve repair device 3800 implanted at a tricuspid valve TV in accordance with an embodiment of the present technique. Fig. 38B and 38C are lateral cross-sectional views of the valve repair device 3800 of fig. 38A at diastole and systole, respectively, in accordance with embodiments of the present technique. Referring together to fig. 38A-38C, valve repair device 3800 includes an engagement member 3810 and an under-the-valve support member 3860 configured to engage a ventricle (e.g., a ventricular wall) and apply an outward force thereto to support engagement member 3810 at the valve between the native leaflets. In some embodiments, the device 3800 can optionally include one or more small She Gazi (not shown) configured to secure the leaflets to the engagement member 3810 for additional stability, to reduce regurgitation, and/or to provide annuloplasty effects. In other embodiments, the position of the support member 3860 may be disposed in the atrium to engage the atrial wall to support the engagement member 3810. In some embodiments, such an atrial support member can support the subannular leaflet She Gazi. The support member 2860 may be made of a superelastic material such as nitinol.

Fig. 39A is a side view of a valve repair device 3900 implanted at the tricuspid valve TV in accordance with embodiments of the present technique. Fig. 39B and 39C are top views of the valve repair device 3900 of fig. 39A, in diastole and systole, respectively, in accordance with embodiments of the present technique. 39A-39C, the valve repair device 3900 includes an engagement member 3910 and a plurality of fingers or anchors (e.g., three anchors) 3961 that extend ventricles under the leaflets to engage the annulus of the tricuspid valve TV to secure (e.g., anchor, attach) the engagement member 3910 between the leaflets of the tricuspid valve TV. In some embodiments, anchor 3961 may be hinged at hinge 3962 such that anchor 3961 extends downward under the leaflet into the ventricle and then upward to the annulus. Hinge 3962 may be mobile or stationary.

Fig. 40 is a side cross-sectional view of a valve repair device 4000 implanted at the tricuspid valve TV in accordance with embodiments of the present technique. In the illustrated embodiment, the valve repair device 4000 includes an engagement member 4010 that is movably secured to one or more native leaflets via hooks 4063 and anchors 4064. More specifically, (i) the anchor 4064 may extend from the engagement member 4010 to another portion of the septum or cardiac anatomy (e.g., the cardiac anatomy on the annulus) and (ii) the hook 4063 may extend from the engagement member 4010 around the ventricular side of one or more leaflets. The hook and anchor system may allow one or more leaflets to remain moving during the cardiac cycle and, for example, inhibit upward movement of the one or more leaflets, thereby inhibiting leaflet waving and regurgitation. The anchor 4064 may be delivered complementarily after placement of the engagement member 4010.

VI.Heart valve repair device including mechanism for movably securing engagement member at heart valve Selected embodiment of (2)

In some embodiments, a heart valve repair device in accordance with the present technology may be movably secured at or near the heart valve, for example, to facilitate selective movement of the device during the cardiac cycle. For example, fig. 41A-41C are top plan views of a valve repair device 4100 in systole, top plan view in diastole, and side view in diastole, respectively, in accordance with embodiments of the present technique. Fig. 41D is a side cross-sectional view of the valve repair device 4100 of fig. 41A-41C implanted at the mitral valve MV, in accordance with embodiments of the present technique. Fig. 41E and 41F are transverse cross-sectional views of the valve repair device 4100 of fig. 41A-41D, respectively, at diastole and systole, in accordance with embodiments of the present technique. Referring together to fig. 41A-41F, the valve repair device 4100 includes an engagement member 4110 that includes a central portion 4118 and a pair of hinge portions 4119 extending from the central portion 4118. The valve repair device 4100 also includes a pair of clip mechanisms 4130 for securing the engagement member 4110 to one or more leaflets of the mitral valve MV, as described in detail above with reference to, for example, fig. 29A-37E. The hinge portion 4119 is hingedly (e.g., movably, pivotably, rotatably) coupled to the central portion 4118 and is configured to (i) open by a systolic flow in the C-C direction to occlude the flow and (ii) be urged closed during diastole. In some embodiments, one or both of the hinge portions 4119 may include a piezoelectric or other power generating component configured to utilize and reuse mechanical movement generated by blood flow.

VII.Including a valve or valves configured toThe membrane leaflets capture the heart of the atrial and ventricular members therebetween Selected embodiments of valve repair devices

In some embodiments, a heart valve repair device in accordance with the present technology may include an atrial member and a ventricular member configured to capture one or more native leaflets therebetween (e.g., "sandwich"). For example, the atrial and ventricular members may include a plurality of small clips or other features that interlock and interleave on the native leaflets. The atrial member and the ventricular member together can at least partially fill a backflow orifice in a leaking heart valve (e.g., mitral valve or tricuspid valve). In some embodiments, the atrial member and ventricular member can provide an engagement surface for the native leaflets to seal around. The ventricular members may be designed such that they are tolerant of a leaflet not being captured. In such embodiments, the ventricular member may be designed to allow engagement with non-captured leaflets.

Fig. 42A-42C are perspective side views of a plurality of valve repair devices 4200a-4200C (collectively, valve repair devices 4200), respectively, in accordance with embodiments of the present technique. Referring together to fig. 42A-42C, the valve repair device 4200 may include substantially similar features, including, for example, an atrial member 4270 (also referred to as an "upper member," "first member," "upper annulus member," "atrial disk," "atrial half," "top plate," and iterations thereof) and a ventricular member 4280 (also referred to as a "lower member," "second member," "lower annulus member," "ventricular disk," "ventricular half," and iterations thereof). One or both of the atrial member 4270 and the ventricular member 4280 can be slidably coupled to the central member 4290 (e.g., an elongated central member) and configured to be pressed together (e.g., slid along the central member toward each other, "sandwiched together," compressed) to capture one or more native leaflets therebetween. That is, one or both of the atrial member 4270 and the ventricular member 4280 can be moved toward each other along the central member 4290 to reduce the distance between the atrial member 4270 and the ventricular member 4280, thereby capturing the one or more native leaflets therebetween. In some embodiments, the atrial member 4270 can comprise atrial mating features 4271 and/or the ventricular member 4280 can comprise ventricular mating features 4281. The mating features 4271, 4281 may comprise clips, fingers, and/or securing features and may be positioned around the edge of the atrial member 4270 and/or the ventricular member 4280. The mating features 4271, 4281 may interlock with each other and interleave on the leaflet at the junction line, and/or the atrial member 4270 and the ventricular member 4280 may be locked in place by a central member 4290 passing through each of the atrial member 4270 and the ventricular member 4280 (e.g., similar to a button). That is, the atrial member 4270 can be nested within the ventricular member 4280. More generally, the atrial member 4270 can be positioned within, between, or on top of the ventricular mating features 4281 of the ventricular member. In some embodiments, the ventricular member 4280 may have a claw or multi-prong shape to navigate through the paravalvular chordae and secure one or more leaflets to the atrial member 4270 and provide space for chordae motion.

When mated together, the atrial member 4270 and the ventricular member 4280 can be shaped to dampen fluctuations and fill in the coaptation gap in the heart valve. In some embodiments, the atrial member 4270 and the ventricular member 4280 can be substantially annular (e.g., such that they are independent of a particular alignment of the valve), while in other embodiments, the atrial member 4270 and the ventricular member 4280 can have other shapes. In some embodiments, the atrial member 4270 and the ventricular member 4280 can provide an engagement surface for one or more native valve leaflets. In some embodiments, the atrial member 4270 and the ventricular member 4280 can be angled to mimic the natural angle of engagement of the leaflets. In some embodiments, the atrial member 4270 can radially expand or contract after the ventricular member 4280 is attached—this can pull in more leaflets and provide optional annuloplasty effects.

In some embodiments, the device 4200 may be sequentially deployed to provide a reduced delivery profile and to help verify a leaky solution prior to full deployment. For example, the atrial member 4270 can be deployed before the ventricular member 4280, allowing a solution to verify leakage before the ventricular member 4280 is deployed and locked into the atrial member 4270. In other embodiments, the balloon may be deployed into the region of the blowby to verify placement prior to deployment of the device 4200.

Fig. 43A and 43B are a side perspective view and an enlarged side cross-sectional view, respectively, of a valve repair device 4300 in accordance with embodiments of the present technique. Referring first to fig. 43A, the valve repair device 4300 includes an atrial member 4370 and a ventricular member 4380 that are (i) coupled together via a central member 4290 and (ii) configured to be pressed together to sandwich one or more native leaflets therebetween. In the illustrated embodiment, the atrial member 4370 comprises a plurality of interconnecting struts 4372, and the ventricular member 4380 also comprises a plurality of interconnecting struts 4382. The struts 4372, 4382 may enable the valve repair device 4300 to collapse/expand to facilitate sheathing, delivery, and/or recapture. The struts 4372, 4382 may be formed of stainless steel, nitinol (e.g., nitinol), and/or other suitable biocompatible materials, and may be in the form of laser cut patterns or lines. The valve repair device 4300 may be centrally located relative to the valve or offset along one or more commissure lines. In some aspects of the present technique, the atrial member 4370 and the ventricular member 4380 act as a two-piece space filler between the native leaflets, while the double-layer structure of the device 4300 can provide strength and sealing, and in some embodiments, contain coagulum. Referring to fig. 43B, the valve repair device 4300 may include a wedge 4391 or other mating feature for anchoring to the leaflet. In some embodiments, the outer sides of the atrial member 4370 and the ventricular member 4380 can comprise a material 4392, such as a knitted or woven polyester, to promote bio-incorporation into the leaflets. In some embodiments, the material 4392 may also include PTFE or ePTFE to help provide an atraumatic surface for bonding to occur.

Fig. 44 is a side cross-sectional view of a valve repair device 4480 in accordance with an embodiment of the present technique. In the illustrated embodiment, the valve repair device 4470 includes an atrial member 4470 and a ventricular member 4480 that are (i) coupled together via a central threaded member 4490 (e.g., a threaded stud) and (ii) configured to be pressed together to sandwich one or more native leaflets therebetween. More specifically, the atrial member 4470 can be threadably coupled to the threaded member 4490 via a captive nut (captivut) 4473, while the ventricular member 4480 is fixedly (e.g., non-rotatably) coupled to the threaded member 4490. Thus, rotation of the threaded member 4490 can move (e.g., translate) the atrial member 4470 toward or away from the ventricular member 4480. Threaded member 4490 may be rotated by a torque shaft or other component of an associated delivery system. In some aspects of the present technique, the valve repair device 4400 allows the leaflets to be released via movement of the atrial member 4470 along the threaded member 4490 away from the ventricular member 4480 after capture (e.g., if insufficient leaflet capture is determined). In some embodiments, the atrial member 4470 and/or the ventricular member 4480 can each comprise a wedge or other mating feature 4471, 4481 (e.g., at an edge thereof) for anchoring onto a leaflet.

Fig. 45A is a side perspective view of a valve repair device 4500 in accordance with an embodiment of the present technology. In the illustrated embodiment, valve repair device 4500 includes an atrial member 4570 and a ventricular member 4580 that (i) are coupled together via a central post member 4590 (e.g., a locking post) and (ii) are configured to be pressed together to sandwich one or more valve leaflets therebetween. Atrial member 4570 can be movably coupled to post member 4590 via, for example, an unlocking mechanism 4574. Fig. 45B is an enlarged side cross-sectional view of unlocking member 4574 in accordance with an embodiment of the present technique. 45A and 45B, the associated delivery system may be actuated to unlock the unlocking mechanism 4574, thereby moving the atrial member 4570 along the post member 4590 toward the ventricular member 4580 to capture one or more leaflets therebetween. In some embodiments, the delivery system may include an unlocking cable 4593 that may be actuated to pull in teeth 4575 of unlocking mechanism 4574, thereby unlocking atrial member 4570 from post member 4590 and allowing atrial member 4570 to move freely. That is, the unlocking mechanism 4574 may comprise a "ratchet" mechanism. Thus, the unlocking cable 4593 may be actuated to facilitate movement of the atrial member 4570 away from the ventricular member 4580, allowing release of the leaflet from between the atrial member 4570 and the ventricular member 4580, for example if insufficient leaflet capture is determined.

In other embodiments, atrial member 4570 can be unlocked from post member 4590 via other mechanisms besides unlocking cable 4593. For example, fig. 45C and 45D are enlarged views of the valve repair device of fig. 45A and an enlarged side cross-sectional view of the unlocking member 4574 in accordance with additional embodiments of the present technique. Referring to fig. 45A, 45C, and 45D together, device 4500 may utilize hydraulic tubing 4576, sealing piston 4577, and compression spring 4578 to facilitate unlocking of atrial member 4570 from post member 4590. More specifically, compression spring 4579 can keep tines 4575 normally closed to allow tines 4575 to engage on post member 4590-facilitating advancement of atrial member 4570 toward ventricular member 4580. Unlocking mechanism 4574 may be pressurized to pull teeth 4575 inward against the biasing force of compression spring 4578 and allow atrial member 4570 to move freely along post member 4590.

Fig. 46A is a side cross-sectional view of a valve repair device 5700 in accordance with embodiments of the present technique. Fig. 46B-46E are side views of a valve repair device 5700 during delivery and deployment in accordance with embodiments of the present technique. Referring first to fig. 46A, a valve repair device 4600 includes an atrial member 4670 and a ventricular member 4680 coupled to a threaded post 4690. Similar to the embodiments described in detail above with reference to fig. 44-46D, the atrial member 4670 is movably coupled to the threaded post 4690 (e.g., via a tether nut 4673), while the ventricular member 4680 may be fixedly attached to the threaded post 4690 such that rotation of the post 4690 moves the atrial member 4670 relative to the ventricular member 4680. In the illustrated embodiment, the atrial member 4670 and the ventricular member 4680 each comprise two or more hinged wings (labeled atrial wings 4679 and ventricular wings 4689). With additional reference to fig. 46B-46E, the wings 4679, 4689 can pivot toward each other and the threaded member 4490, for example, to facilitate sheathing (e.g., a compact delivery position) within the delivery catheter C (fig. 46B and 46C). After de-sheathing, the wings 4679, 4689 can be toggled open as shown in fig. 46C and 46E, and the atrial member 4670 can be moved toward the ventricular member 4680 (e.g., via rotation of a torque shaft coupled to the post 4690) to capture one or more leaflets L therebetween.

Fig. 47A is a side cross-sectional view of a valve repair device 4700 implanted at the tricuspid valve TV in accordance with embodiments of the present technique. Fig. 47B and 47C are lateral cross-sectional views of the valve repair device 4700 of fig. 47A during diastole and systole, respectively, in accordance with embodiments of the present technique. Referring together to fig. 47A-47C, the valve repair device 4700 includes a ventricular member 4780 and an atrial member 4770 configured to sandwich two or more leaflets of the tricuspid valve TV therebetween (e.g., each of the leaflets L1-L3). In the illustrated embodiment, the ventricular member 4780 includes a plurality of narrow fingers 4781 (e.g., mating features) configured to rotate about a central axis of the device 4700, allowing the fingers 4781 to navigate through chordae and collapse together as the path permits, collectively creating a wider point of contact upon meeting the atrial member 4770. When sandwiched together, the atrial member 4770 and the ventricular member 4780 act as a space filler between the leaflets L1-L3. The device 4700 may be centrally located within the valve as shown in fig. 47A-47C, or may be biased to one side of the valve.

Fig. 48A and 48B are side and enlarged side views, respectively, of valve repair device 4800 in a partially deployed position in accordance with embodiments of the present technique. Fig. 48C is a side view of the valve repair device 4800 of fig. 48A and 48B in a fully deployed position in accordance with embodiments of the present technique. Referring collectively to fig. 48A-48C, valve repair device 4800 includes a ventricular member 4880 and an atrial member 4870 configured to sandwich one or more valve leaflets therebetween. In the illustrated embodiment, the ventricular member 4880 includes a plurality of fingers 4881 (also referred to as "arms"; e.g., six evenly spaced fingers) connected by a circular base 4883 and configured to navigate through the paravalvular chordae. The atrial member 4870 can be flexible and can be formed from, for example, an ePTFE-covered foam 4892, which can fill in the fingers 4881 of the ventricular member 4880 and between the fingers 4881 of the ventricular member 4880 when the atrial member 4870 and the ventricular member 4880 are sandwiched together, thereby pulling in the leaflets while also expanding through the fingers 4881 of the ventricular member 4880. Thus, the flexible atrial member 4870 secures the native leaflets in place after they are captured by the fingers 4881. The atrial member 4870 can also serve as a space filler between the leaflets, and in some embodiments, provide a prosthetic engagement surface for one or more, particularly if all of the leaflets are not captured.

In some embodiments, the underlying device structure is a stent-like structure cut from a single tube (e.g., nitinol tube) and/or from a nitinol wire form. Ventricular finger 4881 can be shaped in a deployed configuration and covered with ePTFE or another atraumatic material that also promotes tissue ingrowth. As can be seen in fig. 48B, the atrial member may include a plurality of vertical struts 4872 cut from the same tube as the ventricular fingers 4881 and shaped in a flat configuration such that the struts, when deployed, protrude at least up to or beyond the ventricular surface of the ventricular fingers 4881. Struts 4872 can be covered with a highly compressible foam 4892 that is further covered with an atraumatic ePTFE layer. In the deployed state (fig. 48C), the ventricular fingers 4881 and atrial member 4870 together grip the leaflets and secure the device 4800 in place. If no leaflets are captured around a portion of the perimeter of the device 4800, the ventricular fingers 4881 can sink into the foam 4892 of the atrial member 4870 and provide a relatively continuous atraumatic engagement surface for one or more of the leaflets that are not captured.

To deliver the device 4800 to, for example, the tricuspid valve, the position of the device 4800 can be centered over the tricuspid valve in the right atrium, and then advanced into the right ventricle. Then, when the position of the device 4800 is set below the leaflet leading edge in the right ventricle, the ventricular fingers 4881 can be deployed (e.g., unsheathed or released from the catheter). Next, the device 4800 can be retracted to capture some or all of the leaflets of the tricuspid valve. When some or all of the leaflets are captured, the atrial member 4870 can be deployed by first loosening or extracting the ePTFE/foam cover 4892, and then compressing or flattening the underlying vertical struts 4872 using threaded rods 4890 that pass through nuts 4873 attached to the proximal end of the underlying device structure. In other embodiments, the atrial member 4870 can be deployed by releasing pins that hold it in an elongated configuration or by releasing uniform cinch sutures that hold the ePTFE/foam cover 4892 in place during grasping of the leaflets. In some embodiments of the fork, vertical strut 4872 may be replaced by a braided or laser cut structure (e.g., as described in detail with reference to fig. 62A and 62B). Alternatively, the atrial member 4870 can be composed of a balloon or foam-filled balloon instead of a metallic structure. In some embodiments, the ePTFE covering and foam of atrial member 4870 can have slots that align with ventricular fingers 4881 such that fingers 4881 sink completely into foam 4892 if no leaflets are captured.

Fig. 49A and 49B are side and transverse cross-sectional views, respectively, of a valve repair device 4900 implanted at the tricuspid valve TV in accordance with embodiments of the present technique. Referring to fig. 49A and 49B together, valve repair device 4900 includes a ventricular member 4980 and an atrial member 4970, the ventricular member 4980 including fingers 4981, the atrial member 4970 being formed of a braided structure. The atrial member 4970 and the ventricular member 4980 are configured to sandwich one or more leaflets (e.g., leaflets L1 and L3) of the tricuspid valve TV therebetween. In the illustrated embodiment, the device 4900 further includes an engagement member 4910 coupled to the atrial member 4970 and/or the ventricular member 4980 and configured to provide a smooth engagement surface around an edge of the device 4900 for any leaflets (e.g., uncaptured leaflets L2) that are not captured during deployment of the ventricular fingers 4981 and the atrial member 4970. In some embodiments, the engagement member 4910 may comprise a foam/ePTFE covered stent structure, a braided structure, and/or a balloon. In some embodiments, the engagement member 4910 can be preformed to enclose the edges of the deployed atrial member 4970 and/or ventricular member 4980, as can be seen in fig. 49A. The shape of the engagement member 4910 may be selected based on, for example, the native anatomy and the extent of the one or more leaflets that are not captured. In some embodiments, the engagement member 4910 is elongated, sheathed, and fed over the central delivery shaft 4990 prior to deployment, with the delivery shaft 4990 still attached to the device 4900. The engagement member 4910 may then be rotationally aligned based on an echocardiogram or other imaging, and unsheathed and deployed with a screw mechanism or pusher (not shown). In some embodiments, a deployment mechanism may be used to compress the engagement member 4910, further increasing the width and coverage of the atrial member 4970, further filling the residual engagement gap and providing an engagement surface for any non-captured leaflets.

Fig. 50A and 50D are side cross-sectional views of a valve repair device 5000 implanted at the tricuspid valve TV in an unexpanded position and an expanded position, respectively, in accordance with embodiments of the present technique. Fig. 50B and 50C are transverse cross-sectional views of the valve repair device 5000 of fig. 50A in an unexpanded position, in diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 50E and 50F are transverse cross-sectional views of the valve repair device 5000 of fig. 50D in the expanded position, in diastole and systole, respectively, in accordance with embodiments of the present technique. Referring together to fig. 50A-50F, the valve repair device 5000 includes an atrial member 5070 and a ventricular member 5080 configured to sandwich together to capture one or more leaflets of the tricuspid valve TV. In the illustrated embodiment, the atrial member 5070 can be expandable between, for example, an unexpanded position and an expanded position. Thus, the atrial member 5070 can be expanded to fill and block any residual leakage that may exist prior to expansion of the atrial member 5070. For example, after initially setting the position of the device 5000 to the unexpanded position of the atrial member 5070, it is determined that there is still leakage through the tricuspid valve TV, and then the atrial member 5070 may be expanded during the delivery procedure.

Fig. 51A is a perspective side view of a valve repair device 5100 in a first position in accordance with embodiments of the present technique. 51B-51D are a top perspective view, a side perspective view, and an enlarged side perspective view of the valve repair device 5100 of FIG. 51A in a second position in accordance with embodiments of the present technique. Fig. 51E is an enlarged cross-sectional view of the valve repair device 5100 of fig. 51A-51D secured to a pair of valve leaflets L in accordance with an embodiment of the present technique. Referring together to fig. 51A-51E, the valve repair device 5100 includes an atrial member 5170 and a ventricular member 5180 coupled together via a central member 5190 and configured to be sandwiched together. In the illustrated embodiment, the ventricular member 5180 includes a plurality of fingers 5181 and the atrial member 5170 defines a recess 5194 configured to receive one or more fingers 5181 in the second position. That is, the fingers 5181 can nest and secure within the recess 5194 of the atrial member 5170. As can be seen in fig. 51E, the device 5100 is configured to capture the leaflets between the atrial member 5170 and the ventricular member 5180 such that the leaflets L flex about the tips of the fingers 5181 and into the recesses 5194 of the atrial member 5170, providing radial folding of the leaflets L to enhance fixation.

Fig. 52A is a perspective side view of the valve repair device 5200 in a first position in accordance with an embodiment of the present technique. Fig. 52B and 52C are a top perspective view and a side perspective view of the valve repair device 5200 of fig. 52A in a second position in accordance with an embodiment of the present technique. Fig. 52D is an enlarged cross-sectional view of the valve repair device 5200 of fig. 52A-52C secured to a pair of valve leaflets L in accordance with an embodiment of the present technique. Referring together to fig. 52A-52D, the valve repair device 5200 includes an atrial member 5270 and a ventricular member 5280 coupled together via a central member 5290 and configured to be sandwiched together. In the illustrated embodiment, the ventricular member 5280 includes a plurality of fingers 5281 and the atrial member 5270 has a trapezoid or tapered shape configured to be received within the interior space defined between the fingers 5281. That is, all or a portion of the atrial member 5270 can be nested and secured between the fingers 5281. As can be seen in fig. 52D, the device 5200 is configured to capture the leaflet L between the atrial member 5270 and the ventricular member 5280 such that the leaflet L extends around the lower surface (e.g., curved or sloped lower surface) of the atrial member 5270 such that the leaflet L maintains a substantially natural angle of coaptation.

Fig. 53A and 53B are perspective side views of a valve repair device 5300a including an atrial member and a ventricular member configured to be sandwiched together and in closed and open positions, respectively, in accordance with embodiments of the present technique. Figures 53C-53F are perspective top views of a plurality of valve repair devices 5300b-5300e, respectively, including an atrial member and a ventricular member configured to be sandwiched together, in accordance with additional embodiments of the present technique. In the illustrated embodiment, the atrial and ventricular members of each valve repair device 5300a-e include a plurality of fingers that, when sandwiched together, may be staggered or interdigitated, for example, (i) to fold the leaflets thereby captured, (ii) to provide a uniform engagement surface for the uncaptured leaflets, and/or (iii) to pinch the leaflets with a desired capture force.

54A-54E are perspective side views and 54F is a perspective top view of a plurality of valve repair devices 5400a-5400F, respectively, each including an atrial member and a ventricular member configured to be sandwiched together, in accordance with embodiments of the present technique. In the illustrated embodiment, the ventricular member includes a plurality of fingers, and the atrial member is configured to be positioned within, between, and/or on top of the ventricular fingers.

Fig. 55A-55H are perspective side views of a plurality of valve repair devices 5500a-5500f, respectively, each including an atrial member 5570 (fig. 55G and 55H) and a ventricular member 5580 (fig. 55G and 55H) configured to sandwich together, in accordance with embodiments of the present technology. In the illustrated embodiment, the ventricular member 5580 includes a plurality of fingers 5581, and the atrial member 5570 includes foam or other flexible material configured to be positionally disposed within the fingers 5581 and to protrude through the fingers 5581. The use of foam or other flexible material may help collapse the leaflets into the seat provided by the ventricular fingers 5581, and the protrusion of foam through the fingers 5581 may provide a smooth engagement surface for the uncaptured leaflets along the length of the devices 5500 a-h. In some embodiments, the atrial member 5570 comprises a flexible frame (e.g., formed of nitinol) covered with foam and ePTFE to provide a recess for the ventricular fingers 5581 and an atraumatic engagement surface for the uncaptured leaflets. The recess for the ventricular finger 5581 may enhance leaflet fixation.

Fig. 56A and 56B are perspective side and bottom views, respectively, of a ventricular member 5680 of a valve repair device in a first (e.g., relaxed) position in accordance with embodiments of the present technique. Fig. 56C and 56D are perspective side and bottom views, respectively, of the ventricular member 5680 of fig. 56A and 56B in a second (e.g., compressed, expanded) position in accordance with embodiments of the present technique. Referring collectively to fig. 56A-56D, the ventricular member 5680 is configured to lock to (e.g., sandwich) the atrial member, as described in detail above with reference to, for example, fig. 42A-55H. The ventricular member 5680 can be formed from a flexible material (e.g., nitinol) and can include a plurality of fingers 5681 extending from a base 5683. The base 5683 may have a V-shaped pattern of interconnecting struts that allow the base 5683 to flex radially inward from a first position to a second position-thereby driving the fingers 5681 at the atrial end of the ventricular member 5680 radially outward. More specifically, in the illustrated embodiment, the base 5683 includes a plurality of perforations 5684 at least partially around a perimeter thereof and configured to receive a suture 5695 (fig. 56A and 56B; e.g., of a delivery system) therethrough. The position of the aperture 5684 is disposed at or near the ventricular end of the ventricular member 5680 such that pulling (e.g., collapsing, tightening, cinching) of the suture 5695 compresses the ventricular end of the base 5683 to drive (e.g., expand) the fingers 5681 radially outward. In some embodiments, the sutures 5695 may be released to aid in leaflet capture and fixation, or the sutures 5695 may be secured to and/or within the valve repair device to lock the ventricular member 5680 in the second position.

Fig. 57A and 57B are side views of a ventricular member 5780 of a valve repair device in a first (e.g., compressed) position and a second (e.g., expanded) position, respectively, in accordance with embodiments of the present technique. 57A and 57B, the ventricular member 5780 is configured to lock to (e.g., sandwich to) the atrial member, as described in detail above with reference to, for example, FIGS. 42A-55H. The ventricular member 5780 may include a central support rod 5780 coupled to (i) a hollow threaded rod 5785 and (ii) a base 5783 having a plurality of fingers 5781 (also referred to as "arms") extending therefrom. Cam 5786 is rotatably coupled to threaded rod 5785 such that rotation of rod 5785 advances cam 5786 toward base 5783 (e.g., between fingers 5781) or away from base 5783. In operation, threaded rod 5785 may be rotated to move cam 5786 toward base 5783, thereby advancing cam 5786 between fingers 5781 to urge finger 5781 (e.g., a lower portion thereof) to spread finger 5781 more widely from the first position toward the second position as cam 5786 advances toward base 5783.

Fig. 58A is a side cross-sectional view of a valve repair device 5800 implanted at the tricuspid valve TV in accordance with embodiments of the present technique. Fig. 58B and 58C are lateral cross-sectional views of the valve repair device 5800 of fig. 58A during diastole and systole, respectively, in accordance with embodiments of the present technique. 58A-58C, the valve repair device 5800 includes a mesh-grid 5842, such as an Amplatzer-type mesh-grid or filter. In other embodiments, a stent-like structure or other structure may be used instead of a woven mesh. In the illustrated embodiment, the mesh includes an upper (e.g., first, atrial) disk or leaf portion 5841, a lower (e.g., second, ventricular) disk or leaf portion 5843, and a connecting portion 5844 (e.g., waist) extending between the upper disk portion 5841 and the lower disk portion 5843. In some embodiments, the upper disc portion 5841 and the lower disc portion 5843 may each have an oblong lateral cross-sectional shape and a rounded transverse cross-sectional shape, and the connecting portion 5844 may have a generally cylindrical shape. The shape of the mesh can draw the native leaflets together and help improve coaptation between the native leaflets. In some embodiments, the mesh may be fully or partially covered with a non-porous fabric (e.g., comprising Polytetrafluoroethylene (PTFE) and/or expanded PTFE (ePTFE)) for occluding regurgitant jet flow between the native leaflets. The mesh braid (e.g., connecting portion 5844) may be centrally located along the commissure lines of the native leaflets or offset along one or more commissure lines. In some embodiments, the mesh may include additional friction elements, clip mechanisms, and/or locking mechanisms (not shown) configured to increase the fixation of the device 5800 to the native leaflet and/or another anatomical structure surrounding the tricuspid valve TV.

In other embodiments, the mesh may have a different shape and/or size. For example, fig. 59A is a side cross-sectional view of a valve repair device 5900 implanted at the tricuspid valve TV in accordance with additional embodiments of the present technique. Fig. 59B and 59C are transverse cross-sectional views of the valve repair device 5900 of fig. 59A, in diastole and systole, respectively, in accordance with embodiments of the present technique. 59A-59C, the valve repair device 5900 includes a woven mesh having an upper disc portion 5941 and a lower disc portion 5943, each having a curved (e.g., concave) side cross-sectional shape and a circular transverse cross-sectional shape. The mesh braid may also include a connecting portion 5944 having a generally cylindrical shape between the upper disc portion 5941 and the lower disc portion 5943.

Fig. 60A and 60B are isometric and side views, respectively, of a valve repair device 6000 in accordance with embodiments of the present technique. Referring to fig. 60A and 60B together, valve repair device 6000 may include a ventricular member 6080 having a plurality of ventricular fingers 6081 and an atrial member 6070 (obscured in fig. 60B) having a plurality of atrial fingers 6071. In the illustrated embodiment, the atrial finger 6071 and the ventricular finger 6081 may be coupled together via a connecting member 6096. The attachment member 6096 may include a biasing member (e.g., a coil spring), a band or ring, or the like. In other embodiments, atrial finger 6071 and ventricular finger 6081 may be integrally formed. Atrial finger 6071 and ventricular finger 6081 may be formed of a flexible and/or shape memory material such as nitinol. In the illustrated embodiment, ventricular finger 6081 is configured to extend from connecting member 6096 toward the ventricle before bending upward in the atrial direction toward atrial finger 6071. As described in more detail below with reference to fig. 65A-65P, the ventricular fingers 6081 may be initially unflexed (e.g., elongated, straight) in a delivery state within the delivery catheter prior to deployment from the delivery catheter, and may be flexed back toward the atrial member 6070 to capture one or more leaflets therebetween during deployment. In some embodiments, valve repair device 6000 may also include engagement members 6010 (e.g., "tops") that may be positioned between atrial fingers 6071; omitted from fig. 60A for clarity. In the illustrated embodiment, the engagement member 6010 includes a recess 6097 configured to receive one or more ventricular fingers 6081 therein (e.g., those of the fingers 6081 that are not used to engage leaflets). In some embodiments, the valve repair device 6000 may also include a central ridge (not shown) that allows compression between the components, locking the valve repair device 6000 in a wider profile to further block regurgitant leakage.

VIII.Selected embodiments of methods of delivering and/or retrieving a heart valve repair device

In some embodiments, valve repair devices according to the present technology may include features configured to enable sequential delivery of the device to a target valve and/or to render the leaflet capture process reversible. For example, in cases where leaflet capture is deemed insufficient, an unlocking feature in the device and/or associated delivery system may facilitate multiple capture attempts and/or complete re-capture of the device.

For example, fig. 61A and 61D are side views of the valve repair device 3000 of fig. 30 during a first delivery phase (e.g., an initial phase) and a second delivery phase (e.g., a subsequent phase) to the mitral valve MV, respectively, in accordance with embodiments of the present technique. Fig. 61B and 61C are transverse cross-sectional views of a valve repair device 3000 during the first delivery phase of fig. 61A and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 61E and 61F are transverse cross-sectional views of valve repair device 3000 during the second delivery phase of fig. 61D and during diastole and systole, respectively, in accordance with embodiments of the present technique. Referring first to fig. 61A-61C together, the position of valve repair device 3000 may initially be set at mitral valve MV, and gear-driven clip mechanism 3030 may capture anterior leaflet AL and posterior leaflet PL. In some embodiments, the clip mechanism 3030 may operate independently to optimize the angle of the central engagement member 3010a relative to the anterior leaflet AL and the posterior leaflet PL. At this stage, the locking mechanism 3040 has not yet been deployed.

In some embodiments, after positioning the valve repair device 3000 at the mitral valve MV, the operator may determine that residual leakage still exists, as shown in fig. 61C. In some such embodiments, the operator may modularly deliver another engagement member 3010b having a larger size, for example, to facilitate better engagement and sealing of the anterior and posterior leaflets AL, PL therewith. The additional engagement member 3010b can slide into place along (i) the delivery track 6102 (fig. 61A) and (ii) the central track 3054 of the device, and can be used in addition to or in place of the smaller engagement member 3010 a. That is, the smaller engagement member 3010a may be removed from the track 3054 before the location of the larger engagement member 3010b is provided, or the larger engagement member 3010b may slide over the smaller engagement member 3010 a. In other embodiments, the initial engagement member 3010a may be replaced with a smaller engagement member, a differently shaped engagement member, and so forth.

61D-61F, in a second stage, the locking mechanism 3040 is deployed to help lock the position of the engagement member 3010b relative to the anterior and posterior leaflets AL, PL. After final positioning of the engagement member 3010b and deployment of the locking mechanism 3040, the delivery track (fig. 61A-) and any other components of the delivery system may be removed, as shown in fig. 61D-61F.

Fig. 62A is a side view of a valve repair device 6200 that may be sequentially delivered to a heart valve in accordance with embodiments of the present technique. Fig. 62B is a side view of the valve repair device 6200 of fig. 62A at the mitral valve with optional additional engagement members 6210 located on the central delivery track 6202, in accordance with embodiments of the present technique. Fig. 62C and 62D are side views of the valve repair device 6200 of fig. 62B with the addition of an optional additional engagement member 6210, in diastole and systole, respectively, in accordance with embodiments of the present technique. Referring together to fig. 62A-62D, in the illustrated embodiment, the valve repair device 6200 includes (i) a first clip assembly 6244a including a first clip mechanism 6230a coupled to a first elongate member 6245a and first locking mechanisms 6240a and (ii) a second clip assembly 6244b including a second clip mechanism 6230b coupled to a second elongate member 6245 b. The valve repair device 6200 can further include an optional engagement member 6210 that can be coupled to the first and/or second clip assemblies 6244a-b by, for example, sliding the engagement member 6210 along the first and/or second elongate members 6245 a-b.

Fig. 62e,62h,62k, and 62N are side views of the valve repair device 6200 of fig. 62A during first through fourth delivery stages to the tricuspid valve TV, respectively, in accordance with embodiments of the present technique. Fig. 62F and 62G are lateral cross-sectional views of a valve repair device 6200 during the first delivery phase of fig. 62E and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 62I and 62J are lateral cross-sectional views of valve repair device 6200 during the second delivery phase of fig. 62H and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 62L and 62M are transverse cross-sectional views of the valve repair device 6200 during the third delivery stage of fig. 62L and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 62O and 62P are transverse cross-sectional views of the valve repair device 6200 during the alternative third delivery stage of fig. 62N and during diastole and systole, respectively, in accordance with embodiments of the present technique.

Referring first to fig. 62E-62G together, in a first delivery phase, a first clip assembly 6244a can be advanced through a delivery catheter 6204 (and/or another component of an associated delivery system) and used to capture a first leaflet (e.g., leaflet L1) of the tricuspid valve TV between a first clip mechanism 6230a and a first locking mechanism 6240 a. Referring next to fig. 62H-62J together, in a second delivery phase, a second clip assembly 6244b can be advanced through the delivery catheter 6204 and used to capture a second leaflet (e.g., leaflet L3) of the tricuspid valve TV between the second clip mechanism 6230b and the second locking mechanism 6240 b. Referring next to fig. 62K-62M together, in a third delivery phase, the engagement member 6210 can optionally be delivered to the tricuspid valve TV (e.g., as shown in fig. 62B-62D) by, for example, advancing the engagement member 6210 between the first and second clip assemblies 6244a-B over the first and second elongate members 6245 a-B. The size and shape of the engagement members 6210 can be selected to fill the spaces between the leaflets, and the position of the engagement members 6210 can be adjusted along a-P and/or C-C to block any leakage. In some embodiments, the engagement member 6210 can be delivered with the second clip assembly 6244b in a single delivery stage. Referring next to fig. 62N-62P together, an alternative third delivery phase may include juxtaposing or nearly juxtaposing the first and second clip assemblies 6244a-b to reduce the gap between the first leaflet L1 and the third leaflet L3, either in place of the deployment engagement member 6210 or in addition to the deployment engagement member 6210. That is, an operator may selectively adjust the space between the first and second clamp assemblies 6244 a-b.

Thus, in some aspects of the present technique, the small She Gazi assemblies are sequentially deployed, capturing one leaflet within a double-sided clip before diverting the delivery system to the opposing leaflet for capture within a second double-sided clip. Sequential deployment and capture may allow for a narrow delivery profile. Alternatively, leaflet capture may not require capture clip pairs to be directly juxtaposed to each other, allowing the user to specify the necessary space between clip assemblies.

Fig. 63a,63D, and 63G are side views, e.g., of any of the valve repair devices of fig. 42A-45D or 52A-54F, respectively, during first through third delivery phases to tricuspid valve TV in accordance with embodiments of the present technique. Fig. 63B and 63C are transverse cross-sectional views of a valve repair device during the first delivery stage of fig. 63A and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 63E and 63F are transverse cross-sectional views of the valve repair device during the second delivery phase of fig. 63D and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 63H and 63I are transverse cross-sectional views of the valve repair device during the third delivery stage of fig. 63G and during diastole and systole, respectively, in accordance with embodiments of the present technique.

63A-63C, in a first delivery phase, the central member 6390 of the valve repair device and the coupled ventricular member 6380 including fingers 6381 may be advanced from a delivery catheter 6304 (and/or another component of an associated delivery system) within the right atrium RA, through the tricuspid valve TV, and into the right ventricle RV. In some embodiments, the atrial member 6370 of the valve repair device can remain compressed within the delivery catheter 6304 during advancement of the ventricular member 6380 during the first delivery phase. Referring next to fig. 63D-63F together, in a second delivery phase, ventricular member 6380 can be retracted proximally toward the leaflets of tricuspid valve TV, for example, to focus one or more leaflets (e.g., each of leaflets L1-L3) within fingers 6381. Next, referring collectively to fig. 63G-63I, the atrial member 6370 can be advanced distally from the delivery catheter 6304 (fig. 63A and 63D) along the central member 6390 toward the ventricular member 6380 to secure the leaflets between the fingers 6381 of the ventricular member 6380 and the outer surface of the atrial member 6370 (e.g., clamped as a sandwich). As can be seen in fig. 63I, the atrial member 6370 and/or the ventricular member 6380 can provide a smooth coaptation surface for one or more native leaflets L1-L3.

Figures 64a,64D,64g, and 64J are side views, e.g., of any of the valve repair devices of figures 42A-45D or 52A-54F, respectively, during first through fourth delivery phases to tricuspid valve TV in accordance with embodiments of the present technique. Fig. 64B and 64C are transverse cross-sectional views of a valve repair device during the first delivery stage of fig. 64A and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 64E and 64F are transverse cross-sectional views of the valve repair device during the second delivery phase of fig. 64D and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 64H and 64I are transverse cross-sectional views of a valve repair device during the third delivery stage of fig. 64G and during diastole and systole, respectively, in accordance with embodiments of the present technique. Fig. 64K and 64L are transverse cross-sectional views of a valve repair device during the fourth delivery phase of fig. 64J and during diastole and systole, respectively, in accordance with embodiments of the present technique.

Referring first to fig. 64A-64C together, in a first delivery phase, a ventricular member 6480 of the valve repair device can be constrained (e.g., compressed) within a first delivery catheter 6404, and the first delivery catheter 6404 can be advanced from a second delivery catheter 6405 within the right atrium RA, through the tricuspid valve TV, and into the right ventricle RV. Referring next to fig. 64D-64F together, the atrial member 6470 of the valve repair device can be advanced through the second delivery catheter 6405 and over the first delivery catheter 6404 to the atrial side of the tricuspid valve TV. Next, referring together to fig. 64G-64I, in a third delivery phase, ventricular member 6480 may be released (I) from within first delivery catheter 6404, allowing fingers 6481 of ventricular member 6480 to expand, and then (ii) retracted proximally toward leaflets of tricuspid valve TV and atrial member 6470, for example, to gather one or more leaflets (e.g., each of leaflets L1-L3) within fingers 6481. Finally, referring to fig. 64J-64L together, in a fourth delivery phase, the ventricular member 6480 can be retracted along the central member 6490 of the valve repair device to secure the leaflets between the fingers 6481 of the ventricular member 6480 and the outer surface of the atrial member 6470 (e.g., clamped as a sandwich).

Fig. 65a,65d,65g,65j, and 65M are side views, respectively, of valve repair device 6000, e.g., fig. 60A and 60B, during first through fifth delivery phases to tricuspid valve TV in accordance with embodiments of the present technique. Fig. 65B and 65C are transverse cross-sectional views of a valve repair device 6000 in accordance with embodiments of the present technique during the first delivery stage of fig. 65A and during diastole and systole, respectively. Fig. 65E and 65F are transverse cross-sectional views of a valve repair device 6000 in accordance with embodiments of the present technique during the second delivery phase of fig. 65D and during diastole and systole, respectively. Fig. 65H and 65I are transverse cross-sectional views of a valve repair device 6000 in accordance with embodiments of the present technique during the third delivery stage of fig. 65G and during diastole and systole, respectively. Fig. 65K and 65L are transverse cross-sectional views of a valve repair device 6000 in accordance with embodiments of the present technique during the fourth delivery stage of fig. 65J and during diastole and systole, respectively. Fig. 65M and 65O are transverse cross-sectional views of a valve repair device 6000 in accordance with embodiments of the present technique during the fifth delivery stage of fig. 65M and during diastole and systole, respectively.

Referring first to fig. 65A-65C together, in a first delivery phase, valve repair device 6000 may be constrained (e.g., compressed) within delivery catheter 6504, and delivery catheter 6504 may finally be advanced partially from within right atrium RA, through the annulus of tricuspid valve TV, and at least partially into right ventricle RV. In the constrained position, the ventricular finger 6081 may straighten/elongate within the delivery catheter 6504.

65D-65F, valve repair device 6000 can be advanced distally through delivery catheter 6504 to first expose ventricular fingers 6081 within right ventricle RV, allowing ventricular fingers 6081 to expand and buckle (e.g., bend) in the atrial direction below the leaflets. In some embodiments, as shown in fig. 65G-65I, the delivery catheter 6504 can be retracted proximally toward the tricuspid valve TV after the ventricular finger 6081 expands to capture one or more leaflets. In some embodiments, ventricular fingers 6081 may be deployed parallel to the annulus and pass through chordae tendineae, or in a slight arc to gather chordae tendineae and leaflets within ventricular fingers 6081.

Figures 65J-65L illustrate deployment of the connecting member 6096 from the delivery catheter 6504. In the illustrated embodiment, the connecting member 6096 is a coil spring that can elongate when constrained within the delivery catheter 6504 to facilitate separate (e.g., sequential) deployment of the ventricular member 6080 and the atrial member 6070. Fig. 65M-65O illustrate the continued deployment of atrial fingers 6071 (obscured in fig. 65M-65O) within the right atrium RA and deployment of engagement members 6010 between and/or around atrial fingers 6071. In some embodiments, atrial member 6070 and ventricular member 6080 can compress one or more leaflets therebetween to secure engagement member 6010 between the leaflets. In some embodiments, the attachment member 6096 may also apply a biasing force to the atrial member 6070 and the ventricular member 6080 to pull the atrial member 6070 and the ventricular member 6080 toward each other to compress the leaflets therebetween.

Fig. 66A-66C are side views of a valve repair device, such as any of fig. 42A-45D or 52A-54F, respectively, during first through third retrieval stages of retrieving (e.g., removing) the valve repair device from an implantation procedure at the tricuspid valve TV, in accordance with embodiments of the present technique. Referring first to fig. 66A, in a first retrieval phase, the position of the ventricular member 6680 of the valve repair device is disposed in the right ventricle and unconstrained by the first delivery catheter 6604. The first delivery catheter 6604 can be advanced through the second delivery catheter 6605, and the atrial member 6670 of the valve repair device can be constrained within the first delivery catheter 6604. In the illustrated embodiment, the valve repair device includes one or more constraining features 6698 (e.g., tethers, sutures, lasso) that bring the fingers 6681 of the ventricular member 6680 together. More specifically, the constraining feature 6698 may extend through (e.g., loop through) an aperture 6684 formed at an atrial end of the finger 6681. Referring next to fig. 66B, (i) the constraining feature 6698 may be pulled (e.g., tensioned) to radially collapse the finger 6681, and (ii) the first delivery catheter 6604 (and/or another component of the associated delivery system) may be advanced toward the ventricular member 6680. In the illustrated embodiment, the position of the ventricular member 6680 collapses to a compressed or narrow-profile position when disposed in the right ventricle RV. In some aspects of the present technique, collapsing the ventricular member 6680 in the right ventricle RV can help minimize the interaction of the ventricular member 6680 with chordae tendineae of the tricuspid valve TV. In other embodiments, the ventricular member 6680 can collapse in the right atrium RA. Referring finally to fig. 66C, the first delivery catheter 6604 may be fully advanced over the ventricular member 6680, and the first delivery catheter 6604 and captured ventricular member 6680 may be withdrawn through the second delivery catheter 6605.

In some embodiments, the atrial member 6670 of the valve repair device (shown compressed within the second delivery catheter in fig. 66A) can include features (e.g., perforations) for receiving corresponding constraining features configured to narrow the profile of the atrial element 6670. In some embodiments, one or more constraining features may be used to narrow the atrial and/or ventricular elements 6670, 6680 to facilitate repositioning of the valve repair device relative to the tricuspid valve TV. Similarly, when the valve repair device includes an engagement member, the atrial member 6670, and/or the ventricular member 6680 can include features configured to facilitate narrowing of the device to enable the device to be retrieved and/or repositioned.

Fig. 67A-67C are perspective side views of a ventricular member 6780 of a valve repair device positioned at a heart valve in a first position, a second position, and a third position, respectively, in accordance with embodiments of the present technique. Fig. 67D-67F are top views of the ventricular member 6780 of fig. 67A-67C positioned at a heart valve in a first position, a second position, and a third position, respectively, in accordance with embodiments of the present technique. 67A-67F, the ventricular member 6780 is configured to lock to (e.g., sandwich) the atrial member, as described in detail above with reference to, for example, FIGS. 42A-60B. The ventricular member 6780 includes a plurality of fingers 6781 extending from a base 6783 (also referred to as a "hub"). In some embodiments, the ventricular member 6780 includes chordae tendineae clearing sutures 6799 configured to facilitate retrieval and removal of the ventricular member 6780 from the heart valve prior to final release of the valve repair device during the delivery procedure. In some embodiments, tensioning suture 6798 (e.g., a separate suture or a portion of a tendon clearing suture) may be coupled to tendon clearing suture 6799. In the illustrated embodiment, in a first position, chordae tendineae clearance sutures 6799 (i) extend through the eyelets 6784 at the ventricular end of each finger 6781, and (ii) extend down each finger 6781 toward the base 6783 (e.g., toward the root of each finger 6781), wherein the chordae tendineae clearance sutures 6799 are releasably held in place by a securing mechanism 6888 (obscured in fig. 67A-67F; shown in fig. 68A and 68B) coupled to the base 6783. Thus, in the first position, one or more chordae C around the heart valve may extend between the fingers 6781.

To retrieve the ventricular member 6780 from the heart valve, the securing mechanism 6888 (fig. 68A and 68B) can be actuated or otherwise moved to release the chordae tendineae clearing suture 6799 from the base 6783. Releasing the chordae tendineae cleaning suture 6799 from the base 6783 allows the chordae tendineae cleaning suture 6799 to move outwardly away from the base 6783 to the second position shown in fig. 67B and 67E. To clear any chordae C from between the fingers 6781, the tensioning suture 6798 may be pulled to move the chordae clearing suture 6799 to the third position shown in FIGS. 67C and 67F. As the tendon cleaning suture 6799 moves (e.g., straightens) outwardly from the base 6783, it pushes and cleans the tendon C from between the fingers 6781. In some embodiments, further pulling of tensioning suture 6798 may collapse fingers 6781 radially toward base 6782 to allow ventricular member 6780 to be pulled back into a delivery catheter (not shown). In some aspects of the present technique, removal of chordae C from between the fingers 6781 may inhibit or even prevent tangling or trapping of chordae C between the fingers 6781 as the heart valve device is resheathed and removed.

Fig. 68A and 68B are side and top views, respectively, of a base 6783 of the ventricular member of fig. 67A-67F including a securing mechanism 6888 in accordance with embodiments of the present technique. Referring together to fig. 67A-68B, the securing mechanism 6888 may include (i) a movable sleeve 6846 and (ii) a plurality of U-shaped channels or grooves 6847 in the base 6783 corresponding to each finger 6781 in which a chordae tendineae cleaning suture 6799 may be located. The chordae tendineae clearance suture 6799 remains captured in the passage 6847 by the movable sleeve 6846, which can be actuated to allow the chordae tendineae clearance suture 6799 to be released and moved outwardly to the third position shown in fig. 67C and 67F for device retrieval.

Fig. 69A is a side view of a base of the ventricular member of fig. 67A-67F including a securing mechanism 6988 in accordance with additional embodiments of the present technique. Fig. 69B is an enlarged side view of a portion of the securing mechanism 6898 of fig. 69A in accordance with embodiments of the present technique. Referring collectively to fig. 67A-67f,69a, and 69B, the securing mechanism 6988 can include a plurality of posts 6907 coupled to, secured to, and/or integrally formed with the base 6783 and corresponding to each finger 6781. Each post 6907 may include an aperture 6908 extending therethrough. In the illustrated embodiment, chordae clearance sutures 6799 are wrapped around each post 6907 and remain captured by pins, sutures, and/or other locking structures 6909 extending through each eyelet 6908. When the locking structure 6909 is removed from the eyelet 6908, the chordae tendineae cleaning suture 6799 is free to slide off the post 6907 and straighten to the third position shown in fig. 67C and 67F.

IX.Additional examples

The following examples are illustrative of several embodiments of the present technology:

1. a valve repair device for repairing a heart valve comprising a first native leaflet and a second native leaflet, the valve repair device comprising:

an engagement member configured to be positioned at least partially between the first native leaflet and the second native leaflet, wherein the engagement member has a first portion configured to face the first native leaflet and a second portion configured to face the second native leaflet;

A first clip mechanism extending from the first portion and configured to engage a ventricular side of the first native leaflet;

a first anchoring mechanism extending from the first portion and configured to engage an atrial side of the first native leaflet, wherein the first clip mechanism and the first anchoring mechanism are configured to cooperate to at least partially secure a portion of the first native leaflet therebetween;

a second clip mechanism extending from the second portion and configured to engage a ventricular side of the second native leaflet; and

a second anchoring mechanism extending from the second portion and configured to engage an atrial side of the second native leaflet, wherein the second clip mechanism and the second anchoring mechanism are configured to cooperate to at least partially secure a portion of the second native leaflet therebetween.

2. The valve repair device of example 1, wherein the first clip mechanism is aligned over the first anchor mechanism.

3. The valve repair device of example 1 or example 2, wherein the first clip mechanism is aligned over the first anchoring mechanism, and wherein the second clip mechanism is aligned over the second anchoring mechanism.

4. The valve repair device of any of examples 1-3, wherein the engagement member comprises an upper portion having a first shape and a lower portion having a second shape, wherein the first clip mechanism and the first anchor mechanism extend from the upper portion, and wherein the second clip mechanism and the second anchor mechanism extend from the upper portion.

5. The valve repair device of example 4, wherein the first shape is a cylindrical side cross-sectional shape, and wherein the second shape is a semi-circular side cross-sectional shape.

6. The valve repair device of any one of examples 1-5, wherein the engagement member has a generally trapezoidal side cross-sectional shape.

7. The valve repair device of any one of examples 1-5, wherein the engagement member has a substantially rectangular side cross-sectional shape.

8. The valve repair device of any of examples 1-7, wherein the heart valve is a mitral valve, wherein the first native leaflet is a posterior leaflet of the mitral valve, and wherein the second native leaflet is an anterior leaflet of the mitral valve.

9. The valve repair device of any of examples 1-8, wherein the first clip mechanism comprises a locking mechanism configured to lock the first clip mechanism in a deployed position, wherein the first clip mechanism engages a ventricular side of the first native leaflet, and wherein the second clip mechanism comprises a locking mechanism configured to lock the second clip mechanism in a deployed position, wherein the second clip mechanism engages a ventricular side of the second native leaflet.

10. The valve repair device of any one of examples 1-9, wherein

The first clip mechanism and the first anchor mechanism are movable from a closed position, in which the first clip mechanism and the first anchor mechanism cooperate to at least partially secure a portion of the first native leaflet therebetween, to an open position, in which the first clip mechanism and the first anchor mechanism are configured to be spaced apart to release the portion of the first native leaflet; and

the second clip mechanism and the second anchor mechanism are movable from a closed position in which the second clip mechanism and the second anchor mechanism cooperate to at least partially secure a portion of the second native leaflet therebetween to an open position in which the second clip mechanism and the second anchor mechanism are configured to be spaced apart to release a portion of the second native leaflet.

11. The valve repair device of example 10, wherein the first clip mechanism and the first anchoring mechanism are movable between the closed position and the open position independently of the second clip mechanism and the second anchoring mechanism, and wherein the second clip mechanism and the second anchoring mechanism are movable between the closed position and the open position independently of the first clip mechanism and the first anchoring mechanism.

12. A method of repairing a heart valve comprising a first native leaflet and a second native leaflet, the method comprising:

deploying an engagement member of a valve repair device at least partially between the first native leaflet and the second native leaflet, and such that a first portion of the valve repair device faces the first native leaflet and a second portion of the valve repair device faces the second native leaflet;

mating a ventricular side of the first native leaflet with a first clip mechanism extending from a first portion of the valve repair device;

engaging an atrial side of the first native leaflet with a first anchoring mechanism extending from a first portion of the valve repair device to at least partially secure a portion of the first native leaflet between the first clip mechanism and the first anchoring mechanism;

Mating the ventricular side of the second native leaflet with a second clip mechanism extending from a second portion of the valve repair device; and

the atrial side of the second native leaflet is mated with a second anchoring mechanism extending from a second portion of the valve repair device to at least partially secure a portion of the second native leaflet between the second clip mechanism and the second anchoring mechanism.

13. The method of example 12, wherein the heart valve has a regurgitant orifice, and wherein deploying the engagement member at least partially between the first native leaflet and the second native leaflet comprises deploying the engagement member at least partially within the regurgitant orifice.

14. The method of example 12 or example 13, wherein the heart valve is a mitral valve, wherein the first native leaflet is a posterior leaflet of the mitral valve, and wherein the second native leaflet is an anterior leaflet of the mitral valve.

15. The method of any of examples 12-14, wherein mating the ventricular side of the first native leaflet with the first clip mechanism comprises independently actuating the first clip mechanism relative to the first anchor mechanism, and wherein mating the atrial side of the first native leaflet with the first anchor mechanism comprises independently actuating the first anchor mechanism relative to the first clip mechanism.

16. The method of example 15, wherein engaging the ventricular side of the second native leaflet with the second clip mechanism comprises independently actuating the second clip mechanism relative to the second anchor mechanism, and wherein engaging the atrial side of the second native leaflet with the second anchor mechanism comprises independently actuating the second anchor mechanism relative to the second clip mechanism.

17. The method of any of examples 12-16, wherein mating the atrial side of the first native leaflet with the first anchoring mechanism includes aligning the first anchoring mechanism over the first clip mechanism to sandwich a portion of the first native leaflet therebetween.

18. The method of example 17, wherein mating the atrial side of the second native leaflet with the second anchoring mechanism comprises aligning the second anchoring mechanism over the second clip mechanism to clip a portion of the second native leaflet therebetween.

19. A valve repair device for repairing a heart valve comprising an annulus, a first native leaflet, and a second native leaflet, the valve repair device comprising:

an engagement member configured to be positioned between the first native leaflet and the second native leaflet, wherein the engagement member has a first side portion configured to be positioned adjacent to the first native leaflet and a second side portion configured to be positioned adjacent to the second native leaflet, wherein the engagement member has an elongated shape along a transverse cross-section of an annulus, wherein the elongated shape comprises a width extending in a direction between the first side portion and the second side portion and a length extending generally orthogonal to the width, and wherein the length is greater than the width;

A first clip mechanism extending from the first side portion and configured to engage the first native leaflet to at least partially secure the first native leaflet between the first clip mechanism and the engagement member; and

a second clip mechanism extends from the second side portion and is configured to engage the second native leaflet to at least partially secure the second native leaflet between the second clip mechanism and the engagement member.

20. The valve repair device of example 19, wherein the width varies along a length of the engagement member such that the elongated shape is an elongated hourglass shape.

21. The valve repair device of example 19 or example 20, wherein the engagement member has a pentagonal side cross-sectional shape.

22. The valve repair device of example 19 or example 20, wherein the engagement member has a trapezoid side cross-sectional shape.

23. The valve repair device of example 19 or example 20, wherein the engagement member has a bow-tie-like side cross-sectional shape.

24. The valve repair device of any of examples 19-23, wherein the heart valve is a mitral valve, wherein the first native leaflet is a posterior leaflet of the mitral valve, and wherein the second native leaflet is an anterior leaflet of the mitral valve.

25. The valve repair device of any one of examples 19-24, wherein the first clip mechanism and the second clip mechanism each comprise (a) a base portion coupled to the engagement member, (b) a free end portion unattached to the engagement member, and (c) an arm member extending between the base portion and the free end portion.

26. The valve repair device of example 25, wherein

The arm member of the first clip mechanism is movable from a closed position in which the free end portion of the first clip mechanism is configured to be positioned proximate to the surface of the first side portion of the engagement member to an open position in which the free end portion of the first clip mechanism is positioned away from the surface of the first side portion of the engagement member, and

the arm member of the second clip mechanism is movable from a closed position in which the free end portion of the second clip mechanism is configured to be positioned proximate to a surface of the second side portion of the engagement member to an open position in which the free end portion of the second clip mechanism is positioned away from the surface of the second side portion of the engagement member.

27. A valve repair device, comprising:

a central member;

an atrial member coupled to the central member and configured to mate with an atrial side of at least one native leaflet of a heart valve; and

a ventricular member coupled to the central member and configured to engage a ventricular side of the at least one native leaflet, wherein the atrial member and the ventricular member are configured to cooperate to at least partially secure a portion of the at least one native leaflet therebetween, and wherein at least one of the atrial member and the ventricular member is movable along the central member in a direction toward the at least one native leaflet.

28. The valve repair device of example 27, wherein the ventricular member comprises a plurality of fingers extending upward toward the atrial member.

29. The valve repair device of example 27 or example 28, wherein the ventricular member is fixed to the central member, and wherein the atrial member is movable toward the ventricular member to sandwich portions of the at least one native leaflet therebetween.

30. The valve repair device of any one of examples 27-29, wherein the atrial member is formed of a flexible material.

31. The valve repair device of any one of examples 27-30, wherein the ventricular member comprises a plurality of fingers extending upward toward the atrial member, and wherein the atrial member is formed of a flexible material configured to at least partially flex between the fingers of the ventricular member.

32. The valve repair device of any one of examples 27-31, wherein the ventricular member comprises a plurality of fingers extending upward toward the atrial member, and wherein the atrial member comprises a plurality of recesses, each positioned to receive a corresponding one of the fingers.

33. The valve repair device of any one of examples 27-32, wherein the atrial member and the ventricular member are each formed from a plurality of interconnected struts.

34. The valve repair device of any one of examples 27-33, wherein the central member is threaded, wherein the atrial member is coupled to the central member via a nut, and wherein rotation of the nut is configured to move the atrial member along the central member toward the ventricular member.

35. The valve repair device of any of examples 27-34, wherein the heart valve is a tricuspid valve.

36. The valve repair device of any of examples 27-35, wherein the heart valve is a mitral valve.

37. The valve repair device of any one of examples 27-36, wherein the at least one native leaflet comprises two native leaflets.

38. The valve repair device of any one of examples 27-37, wherein the atrial member has an engagement surface configured to engage with at least one other native leaflet of the heart valve.

39. The valve repair device of any one of examples 27-38, wherein the ventricular member has an engagement surface configured to engage with at least one other native leaflet of the heart valve.

40. The valve repair device of any one of examples 27-39, wherein the atrial member and the ventricular member together define an engagement surface configured to engage with at least one other native leaflet of the heart valve.

41. A method of repairing a heart valve having a regurgitant orifice, the method comprising:

positioning a ventricular member of a valve repair device at least partially under a regurgitant orifice, wherein the ventricular member is coupled to a central member extending through the regurgitant orifice;

Positioning an atrial member of the valve repair device at least partially over the regurgitant orifice, wherein the atrial member is coupled to the central member; and

advancing the atrial member, ventricular member, or both the atrial member and ventricular member along the central member toward the regurgitant orifice to secure at least one native valve leaflet of a heart valve between the atrial member and the ventricular member.

42. The method of example 41, wherein the method comprises advancing the atrial member along the central member toward the ventricular member to secure the at least one native leaflet between the atrial member and the ventricular member.

43. The method of example 41 or example 42, wherein setting the position of the ventricular member comprises advancing the ventricular member through a delivery catheter in a compressed state, and wherein setting the position of the atrial member comprises advancing the atrial member through the delivery catheter in a compressed state.

44. The method of example 43, wherein the heart valve is a tricuspid valve, and wherein the method further comprises advancing the delivery catheter into the right atrium above the tricuspid valve.

45. The method of example 43 or example 44, wherein the ventricular member comprises a plurality of fingers, wherein the fingers are substantially straightened within the delivery catheter in the compressed state, and wherein positioning the ventricular member comprises advancing the ventricular member out of the delivery catheter below the regurgitant flap to allow the fingers to bend back toward the regurgitant flap.

46. The method of any of examples 41-45, wherein the ventricular member comprises a plurality of fingers, and wherein positioning the ventricular member comprises releasing a suture coupled to the fingers to allow the fingers to expand from a compressed state to an expanded state.

47. The method of example 46, wherein the method further comprises, after releasing the suture, tensioning the suture to move the fingers from the expanded state to the compressed state to facilitate repositioning of the ventricular member relative to the heart valve.

48. The method of any of examples 41-47, wherein the atrial member comprises a flexible material, and wherein the ventricular member comprises a plurality of fingers.

49. The method of example 48, wherein the method includes advancing the flexible material toward the fingers such that (a) the at least one native leaflet is captured between the flexible material and a portion of the fingers and (b) the flexible material flexes between another portion of the fingers.

50. The method of any of examples 41-49, wherein setting the position of the ventricular member comprises advancing the ventricular member in a compressed state through a delivery catheter to an exterior of the delivery catheter to allow the ventricular member to expand from the compressed state to a deployed state, and wherein the method further comprises

At least partially recapturing ventricular members within the delivery catheter; and

the ventricular member is again advanced from the delivery catheter to reposition the ventricular member relative to the regurgitant orifice.

Conclusion(s)

The above detailed description of embodiments of the present technology is not intended to be exhaustive or to limit the technology to the precise form disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. For example, although steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but that well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context allows, singular or plural terms may also include the plural or singular terms, respectively.

Furthermore, unless the term "or" is expressly defined to mean only a single item in a list of two or more items that does not include other items, the use of "or" in such a list should be interpreted to include any single item in the list (a), (b) all items in the list, or (c) any combination of items in the list. In addition, the term "comprising" throughout means that at least one or more of the stated features are included, such that additional types of any greater number of the same features and/or other features are not excluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Moreover, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need exhibit such advantages to fall within the scope of the technology. Accordingly, the present disclosure and related techniques may include other embodiments not explicitly shown or described herein.

Claims (50)

1. A valve repair device for repairing a heart valve comprising a first native leaflet and a second native leaflet, the valve repair device comprising:

an engagement member configured to be positioned at least partially between the first native leaflet and the second native leaflet, wherein the engagement member has a first portion configured to face the first native leaflet and a second portion configured to face the second native leaflet;

a first clip mechanism extending from the first portion and configured to engage a ventricular side of the first native leaflet;

a first anchoring mechanism extending from the first portion and configured to engage an atrial side of the first native leaflet, wherein the first clip mechanism and the first anchoring mechanism are configured to cooperate to at least partially secure a portion of the first native leaflet therebetween;

a second clip mechanism extending from the second portion and configured to engage a ventricular side of the second native leaflet; and

a second anchoring mechanism extending from the second portion and configured to engage an atrial side of the second native leaflet, wherein the second clip mechanism and the second anchoring mechanism are configured to cooperate to at least partially secure a portion of the second native leaflet therebetween.

2. The valve repair device of claim 1, wherein the first clip mechanism is aligned over the first anchoring mechanism.

3. The valve repair device of claim 1, wherein the first clip mechanism is aligned over the first anchoring mechanism, and wherein the second clip mechanism is aligned over the second anchoring mechanism.

4. The valve repair device of claim 1, wherein the engagement member comprises an upper portion having a first shape and a lower portion having a second shape, wherein the first clip mechanism and the first anchor mechanism extend from the upper portion, and wherein the second clip mechanism and the second anchor mechanism extend from the upper portion.

5. The valve repair device of claim 4, wherein the first shape is a cylindrical side cross-sectional shape, and wherein the second shape is a semi-circular side cross-sectional shape.

6. The valve repair device of claim 1, wherein the engagement member has a generally trapezoidal side cross-sectional shape.

7. The valve repair device of claim 1, wherein the engagement member has a substantially rectangular side cross-sectional shape.

8. The valve repair device of claim 1, wherein the heart valve is a mitral valve, wherein the first native leaflet is a posterior leaflet of the mitral valve, and wherein the second native leaflet is an anterior leaflet of the mitral valve.

9. The valve repair device of claim 1, wherein the first clip mechanism comprises a locking mechanism configured to mechanically lock the first clip mechanism in a deployed position, wherein the first clip mechanism engages a ventricular side of the first native leaflet, and wherein the second clip mechanism comprises a locking mechanism configured to mechanically lock the second clip mechanism in a deployed position, wherein the second clip mechanism engages a ventricular side of the second native leaflet.

10. The valve repair device of claim 1 wherein

The first clip mechanism and the first anchor mechanism are movable from a closed position, in which the first clip mechanism and the first anchor mechanism cooperate to at least partially secure a portion of the first native leaflet therebetween, to an open position, in which the first clip mechanism and the first anchor mechanism are configured to be spaced apart to release the portion of the first native leaflet; and

The second clip mechanism and the second anchor mechanism are movable from a closed position in which the second clip mechanism and the second anchor mechanism cooperate to at least partially secure a portion of the second native leaflet therebetween to an open position in which the second clip mechanism and the second anchor mechanism are configured to be spaced apart to release a portion of the second native leaflet.

11. The valve repair device of claim 10, wherein the first clip mechanism and the first anchoring mechanism are movable between the closed position and the open position independently of the second clip mechanism and the second anchoring mechanism, and wherein the second clip mechanism and the second anchoring mechanism are movable between the closed position and the open position independently of the first clip mechanism and the first anchoring mechanism.

12. A method of repairing a heart valve comprising a first native leaflet and a second native leaflet, the method comprising:

deploying an engagement member of a valve repair device at least partially between the first native leaflet and the second native leaflet, and such that a first portion of the valve repair device faces the first native leaflet and a second portion of the valve repair device faces the second native leaflet;

Mating a ventricular side of the first native leaflet with a first clip mechanism extending from a first portion of the valve repair device;

engaging an atrial side of the first native leaflet with a first anchoring mechanism extending from a first portion of the valve repair device to at least partially secure a portion of the first native leaflet between the first clip mechanism and the first anchoring mechanism;

mating the ventricular side of the second native leaflet with a second clip mechanism extending from a second portion of the valve repair device; and

the atrial side of the second native leaflet is mated with a second anchoring mechanism extending from a second portion of the valve repair device to at least partially secure a portion of the second native leaflet between the second clip mechanism and the second anchoring mechanism.

13. The method of claim 12, wherein the heart valve has a regurgitant orifice, and wherein deploying the engagement member at least partially between the first and second native leaflets comprises deploying the engagement member at least partially within the regurgitant orifice.

14. The method of claim 12, wherein the heart valve is a mitral valve, wherein the first native leaflet is a posterior leaflet of the mitral valve, and wherein the second native leaflet is an anterior leaflet of the mitral valve.

15. The method of claim 12, wherein engaging the ventricular side of the first native leaflet with the first clip mechanism comprises independently actuating the first clip mechanism relative to the first anchor mechanism, and wherein engaging the atrial side of the first native leaflet with the first anchor mechanism comprises independently actuating the first anchor mechanism relative to the first clip mechanism.

16. The method of claim 15, wherein mating the ventricular side of the second native leaflet with the second clip mechanism comprises independently actuating the second clip mechanism relative to the second anchor mechanism, and wherein mating the atrial side of the second native leaflet with the second anchor mechanism comprises independently actuating the second anchor mechanism relative to the second clip mechanism.

17. The method of claim 12, wherein mating the atrial side of the first native leaflet with the first anchoring mechanism comprises aligning the first anchoring mechanism over the first clip mechanism to sandwich a portion of the first native leaflet therebetween.

18. The method of claim 17, wherein mating the atrial side of the second native leaflet with the second anchoring mechanism comprises aligning the second anchoring mechanism over the second clip mechanism to sandwich a portion of the second native leaflet therebetween.

19. A valve repair device for repairing a heart valve comprising an annulus, a first native leaflet, and a second native leaflet, the valve repair device comprising:

an engagement member configured to be positioned between the first native leaflet and the second native leaflet, wherein the engagement member has a first side portion configured to be positioned adjacent to the first native leaflet and a second side portion configured to be positioned adjacent to the second native leaflet, wherein the engagement member has an elongated shape along a transverse cross-section of an annulus, wherein the elongated shape comprises a width extending in a direction between the first side portion and the second side portion and a length extending generally orthogonal to the width, and wherein the length is greater than the width;

a first clip mechanism extending from the first side portion and configured to engage the first native leaflet to at least partially secure the first native leaflet between the first clip mechanism and the engagement member; and

a second clip mechanism extends from the second side portion and is configured to engage the second native leaflet to at least partially secure the second native leaflet between the second clip mechanism and the engagement member.

20. The valve repair device of claim 19, wherein the width varies along a length of the engagement member such that the elongated shape is an elongated hourglass shape.

21. The valve repair device of claim 19, wherein the engagement member has a pentagonal side cross-sectional shape.

22. The valve repair device of claim 19, wherein the engagement member has a trapezoid side cross-sectional shape.

23. The valve repair device of claim 19, wherein the engagement member has a bow-tie-like side cross-sectional shape.

24. The valve repair device of claim 19, wherein the heart valve is a mitral valve, wherein the first native leaflet is a posterior leaflet of the mitral valve, and wherein the second native leaflet is an anterior leaflet of the mitral valve.

25. The valve repair device of claim 19, wherein the first and second clip mechanisms each comprise (a) a base portion coupled to the engagement member, (b) a free end portion unattached to the engagement member, and (c) an arm member extending between the base portion and the free end portion.

26. The valve repair device of claim 25 wherein

The arm member of the first clip mechanism is movable from a closed position in which the free end portion of the first clip mechanism is configured to be positioned proximate to the surface of the first side portion of the engagement member to an open position in which the free end portion of the first clip mechanism is positioned away from the surface of the first side portion of the engagement member, and

the arm member of the second clip mechanism is movable from a closed position in which the free end portion of the second clip mechanism is configured to be positioned proximate to a surface of the second side portion of the engagement member to an open position in which the free end portion of the second clip mechanism is positioned away from the surface of the second side portion of the engagement member.

27. A valve repair device, comprising:

a central member;

an atrial member coupled to the central member and configured to mate with an atrial side of at least one native leaflet of a heart valve; and

a ventricular member coupled to the central member and configured to engage a ventricular side of the at least one native leaflet, wherein the atrial member and the ventricular member are configured to cooperate to at least partially secure a portion of the at least one native leaflet therebetween, and wherein at least one of the atrial member and the ventricular member is movable along the central member in a direction toward the at least one native leaflet.

28. The valve repair device of claim 27 wherein the ventricular member comprises a plurality of fingers extending upward toward the atrial member.

29. The valve repair device of claim 27, wherein the ventricular member is fixed to the central member, and wherein the atrial member is movable toward the ventricular member to sandwich portions of the at least one native leaflet therebetween.

30. The valve repair device of claim 27 wherein the atrial member is formed of a flexible material.

31. The valve repair device of claim 27, wherein the ventricular member comprises a plurality of fingers extending upward toward the atrial member, and wherein the atrial member is formed of a flexible material configured to at least partially flex between the fingers of the ventricular member.

32. The valve repair device of claim 27, wherein the ventricular member comprises a plurality of fingers extending upward toward the atrial member, and wherein the atrial member comprises a plurality of recesses, each positioned to receive a corresponding one of the fingers.

33. The valve repair device of claim 27, wherein the atrial member and the ventricular member are each formed from a plurality of interconnected struts.

34. The valve repair device of claim 27, wherein the central member is threaded, wherein the atrial member is coupled to the central member via a nut, and wherein rotation of the nut is configured to move the atrial member along the central member toward the ventricular member.

35. The valve repair device of claim 27, wherein the heart valve is a tricuspid valve.

36. The valve repair device of claim 27 wherein the heart valve is a mitral valve.

37. The valve repair device of claim 27, wherein the at least one native leaflet comprises two native leaflets.

38. The valve repair device of claim 27, wherein the atrial member has an engagement surface configured to engage with at least one other native leaflet of the heart valve.

39. The valve repair device of claim 27, wherein the ventricular member has an engagement surface configured to engage with at least one other native leaflet of the heart valve.

40. The valve repair device of claim 27, wherein the atrial member and the ventricular member together define an engagement surface configured to engage with at least one other native leaflet of the heart valve.

41. A method of repairing a heart valve having a regurgitant orifice, the method comprising:

positioning a ventricular member of a valve repair device at least partially under a regurgitant orifice, wherein the ventricular member is coupled to a central member extending through the regurgitant orifice;

positioning an atrial member of the valve repair device at least partially over the regurgitant orifice, wherein the atrial member is coupled to the central member; and

advancing the atrial member, ventricular member, or both the atrial member and ventricular member along the central member toward the regurgitant orifice to secure at least one native valve leaflet of a heart valve between the atrial member and the ventricular member.

42. The method of claim 41, wherein the method comprises advancing the atrial member along the central member toward the ventricular member to secure the at least one native leaflet between the atrial member and the ventricular member.

43. The method of claim 41, wherein positioning the ventricular member comprises advancing the ventricular member through a delivery catheter in a compressed state, and wherein positioning the atrial member comprises advancing the atrial member through the delivery catheter in a compressed state.

44. The method of claim 43, wherein the heart valve is a tricuspid valve, and wherein the method further comprises advancing the delivery catheter into the right atrium above the tricuspid valve.

45. The method of claim 43, wherein the ventricular member comprises a plurality of fingers, wherein the fingers are substantially straightened within the delivery catheter in the compressed state, and wherein positioning the ventricular member comprises advancing the ventricular member out of the delivery catheter under the regurgitant orifice to permit the fingers to flex back toward the regurgitant orifice.

46. The method of claim 41, wherein the ventricular member comprises a plurality of fingers, and wherein positioning the ventricular member comprises releasing a suture coupled to the fingers to allow the fingers to expand from a compressed state to an expanded state.

47. The method of claim 46, further comprising, after releasing the suture, tensioning the suture to move the fingers from the expanded state to the compressed state to facilitate repositioning of the ventricular member relative to the heart valve.

48. The method of claim 41, wherein the atrial member comprises a flexible material, and wherein the ventricular member comprises a plurality of fingers.

49. The method of claim 48, wherein the method comprises advancing the flexible material toward the fingers such that (a) the at least one native leaflet is captured between the flexible material and a portion of the fingers and (b) the flexible material flexes between another portion of the fingers.

50. The method of claim 41, wherein positioning the ventricular member comprises advancing the ventricular member in a compressed state through a delivery catheter to an exterior of the delivery catheter to allow the ventricular member to expand from the compressed state to an expanded state, and wherein the method further comprises

At least partially recapturing ventricular members within the delivery catheter; and

the ventricular member is again advanced from the delivery catheter to reposition the ventricular member relative to the regurgitant orifice.