EP-4736817-A2 - WIDE CLIP WITH DEFORMABLE WIDTH

EP4736817A2EP 4736817 A2EP4736817 A2EP 4736817A2EP-4736817-A2

Abstract

Fixation device for fixation of leaflets of a heart valve includes a central assembly and at least one arm moveably coupled relative to the central assembly. The at least one arm includes a deformable frame having a first end and a second end and a longitudinal axis defined therebetween, the second end being moveable between a closed position and an open position. The deformable frame further includes first and second deformable flex portions, each flex portion extending along a respective lateral side of the deformable frame and having a deformed condition and an undeformed condition, and each flex portion having an outer lateral edge. The at least one arm has a maximum deformed arm lateral cross-dimension with the flex portions in the deformed condition.

Inventors

The designation of the inventor has not yet been filed

Assignees

Evalve, Inc.

Dates

Publication Date: 20260506
Application Date: 20201216

Claims (15)

A fixation device for fixation of leaflets of a heart valve comprising: a central assembly; at least one arm moveably coupled relative to the central assembly, the at least one arm comprising: a deformable frame having a first end and a second end and a longitudinal axis defined therebetween, the second end being moveable between a closed position and an open position, the deformable frame further comprising first and second deformable flex portions, each flex portion extending along a respective lateral side of the deformable frame and having a deformed condition and an undeformed condition, each flex portion having an outer lateral edge, wherein the at least one arm has a maximum deformed arm lateral cross-dimension with the flex portions in the deformed condition and a maximum undeformed arm width defined between the outer lateral edge of the first flex portion and the outer lateral edge of the second flex portion in the undeformed condition, wherein the ratio of the maximum deformed arm lateral cross-dimension to the maximum undeformed arm width is at least 1:1.3; and at least one gripping element moveable relative to the at least one arm to capture a native leaflet therebetween, wherein the first flex portion comprises a deformable first flank member extending longitudinally along a first lateral side of the deformable frame and the second flex portion comprises a deformable second flank member extending longitudinally along a second lateral side of the deformable frame, the first and second flank members in the deformed condition being aligned generally parallel with the longitudinal axis, and wherein the deformable frame further comprises a strut assembly disposed between the first flank member and the second flank member.
The fixation device of claim 1, wherein the strut assembly comprises a first strut extending laterally from the first flank member to the second flank member, wherein the first strut comprises a hinge portion having a compressed configuration with the deformable frame in the deformed condition and an extended configuration with the deformable frame in the undeformed condition.
The fixation device of claim 2, wherein the hinge portion is biased toward the extended condition.
The fixation device of claim 2 or claim 3, wherein the deformable frame further comprises an end strut extending laterally from the first flank member to the second flank member at the second end of the deformable frame, the end strut comprising a hinge portion having a compressed configuration with the deformable frame in the deformed condition and an extended configuration with the deformable frame in the undeformed condition, the first strut being spaced longitudinally from the end strut.
The fixation device of any one of claims 2-4, wherein the fixation device further comprises a boss configured to engage and urge the first and second flank members outwardly towards the undeformed condition.
The fixation device of claim 5, wherein the boss is disposed: a) proximate the first end of the arm and below a tissue contact patch area; or b) within a tissue contact patch area.
The fixation device of claim 1, wherein the strut assembly comprises a first strut extending laterally from the first flank member toward the second flank member and a second strut extending laterally from the second flank member toward the first flank member.
The fixation device of claim 7, wherein the deformable frame further comprises an end strut extending laterally from the first flank member to the second flank member at the second end of the deformable frame, the end strut comprising a hinge portion having a compressed configuration with the deformable frame in the deformed condition and an extended configuration with the deformable frame in the undeformed condition.
The fixation device of claim 7 or claim 8, wherein the first and second struts are in overlapping sliding arrangement for movement relative each other between the deformed condition and the undeformed condition.
The fixation device of any one of claims 7-9, wherein the first and second struts are laterally spaced from each other with the deformable frame in the undeformed condition, the fixation device further comprising a middle support member extending parallel with the longitudinal axis between the first and second flank members.
The fixation device of claim 1, wherein the strut assembly comprises a plurality of first struts extending laterally from the first flank member toward the second flank member and a plurality of second struts extending laterally from the second flank member toward the first flank member, the plurality of first struts and the plurality of second struts configured to interlock with each other in the deformed condition and release from each other in the undeformed condition.
The fixation device of any preceding claim, wherein the deformable frame is biased towards the undeformed condition.
The fixation device of any preceding claim, wherein the deformable frame comprises a shape memory material.
A system for fixation of leaflets of a heart valve comprising: a guide catheter having an inner diameter; and a fixation device according to any one of the preceding claims.
The system of claim 14, wherein the maximum deformed arm lateral cross-dimension is less than the inner diameter of the guide catheter, and the maximum undeformed arm width is greater than the inner diameter of the guide catheter.

Description

Cross-Reference to Related Applications This application claims priority to United States Provisional Application Serial No. 62/949,563 filed on December 18, 2019, the contents of which are hereby incorporated by reference in its entirety. Field of Disclosed Subject Matter The disclosed subject matter is directed to medical devices for the endovascular, percutaneous or minimally invasive surgical treatment of bodily tissues, such as tissue approximation or valve repair. More particularly, the present disclosure relates to repair of valves of the heart and venous valves. Surgical repair of bodily tissues can involve tissue approximation and fastening of such tissues in the approximated arrangement. When repairing valves, tissue approximation includes coapting the leaflets of the valves in a therapeutic arrangement which can then be maintained by fastening or fixing the leaflets. Such coaptation can be used to treat regurgitation, which commonly occurs in the mitral valve and in the tricuspid valve. Mitral valve regurgitation is characterized by retrograde flow from the left ventricle of a heart through an incompetent mitral valve into the left atrium. During a normal cycle of heart contraction (systole), the mitral valve acts as a check valve to prevent flow of oxygenated blood back into the left atrium. In this way, the oxygenated blood is pumped into the aorta through the aortic valve. Regurgitation of the mitral valve can significantly decrease the pumping efficiency of the heart, placing the patient at risk of severe, progressive heart failure. Mitral valve regurgitation can result from a number of different mechanical defects in the mitral valve or the left ventricular wall. The valve leaflets, the valve chordae which connect the leaflets to the papillary muscles, the papillary muscles or the left ventricular wall can be damaged or otherwise dysfunctional. Commonly, the valve annulus can be damaged, dilated, or weakened limiting the ability of the mitral valve to close adequately against the high pressures of the left ventricle. Description of Related Art Treatments for mitral valve regurgitation rely on valve replacement or repair including leaflet and annulus remodeling, the latter generally referred to as valve annuloplasty. Another technique for mitral valve repair, which relies on suturing adjacent segments of the opposed valve leaflets together is referred to as the "bow-tie" or "edge-to-edge" technique. Preferably, the use of devices and systems should not require open chest access and, rather, be capable of being performed either endovascularly, i.e., using devices, such as a catheter, which are advanced to the heart from a point in the patient's vasculature remote from the heart. Furthermore, such devices and systems should allow for repositioning and optional removal of a fixation device (i.e., valve repair clip) prior to fixation to ensure optimal placement. Such devices and systems likewise can be useful for repair of tissues in the body other than heart valves. Summary The purpose and advantages of the disclosed subject matter will be set forth in and apparent from the description that follows, as well as will be learned by practice of the disclosed subject matter. Additional advantages of the disclosed subject matter will be realized and attained by the methods and systems particularly pointed out in the written description and claims hereof, as well as from the appended drawings. To achieve these and other advantages and in accordance with the purpose of the disclosed subject matter, as embodied and broadly described, the disclosed subject matter is directed to a fixation device for treating a patient. In accordance with the disclosed subject matter, a fixation device for fixation of leaflets of a heart valve includes a central assembly and at least one arm moveably coupled relative to the central assembly. The at least one arm includes a deformable frame having a first end and a second end and a longitudinal axis defined therebetween, the second end being moveable between a closed position and an open position. The deformable frame further includes first and second deformable flex portions, each flex portion extending along a respective lateral side of the deformable frame and having a deformed condition and an undeformed condition, and each flex portion having an outer lateral edge. The at least one arm has a maximum deformed arm lateral cross-dimension with the flex portions in the deformed condition and a maximum undeformed arm width defined between the outer lateral edge of the first flex portion and the outer lateral edge of the second flex portion in the undeformed condition. The ratio of the maximum deformed arm lateral cross-dimension to the maximum undeformed arm width is at least 1:1.3. The fixation device further includes at least one gripping element moveable relative to the at least one arm to capture a native leaflet therebetween. In accordance with the disclosed subject ma