EP-4740911-A2 - BIASED DISTAL ASSEMBLIES WITH LOCKING MECHANISM

EP4740911A2EP 4740911 A2EP4740911 A2EP 4740911A2EP-4740911-A2

Abstract

System for fixation of native leaflets of a heart valve including an implantable fixation device including a center portion defining a longitudinal axis. The implantable fixation device further includes a first distal assembly having a first distal strut pivotally-coupled with the center portion and a first distal element pivotally-coupled with the first distal strut. The first distal assembly is configured to move between a closed position and an extended position. The implantable fixation device further includes a second distal assembly having a second distal strut pivotally-coupled with the center portion and a second distal element pivotally-coupled with the second distal strut. The second distal assembly is configured to move between a closed position and an extended position. The implantable fixation device further includes a locking mechanism configured to lock the first distal assembly and second distal assembly in a selected locked position between the closed position and the extended position.

Inventors

The designation of the inventor has not yet been filed

Assignees

Evalve, Inc.

Dates

Publication Date: 20260513
Application Date: 20210924

Claims (16)

A system for fixation of native leaflets of a heart valve comprising: an implantable fixation device comprising: a center portion defining a longitudinal axis; a first distal assembly comprising a first distal strut pivotally-coupled with the center portion and a first distal element pivotally-coupled with the first distal strut, the first distal assembly configured to move between a closed position with the first distal strut folded proximate the center portion and the first distal element folded proximate the first distal strut, and an extended position with the first distal strut extending distally from the center portion and the first distal element extending distally from the first distal strut; a second distal assembly comprising a second distal strut pivotally-coupled with the center portion and a second distal element pivotally-coupled with the second distal strut, the second distal assembly configured to move between a closed position with the second distal strut folded proximate the center portion and the second distal element folded proximate the second distal strut, and an extended position with the second distal strut extending distally from the center portion and the second distal element extending distally from the second distal strut; a first proximal element having a first gripping portion, the first gripping portion being moveable relative to the first distal assembly to capture native leaflet tissue therebetween; a second proximal element having a second gripping portion, the second gripping portion being moveable relative to the second distal assembly to capture native leaflet tissue therebetween; and a locking mechanism configured to lock the first distal assembly and second distal assembly in a selected locked position between the closed position and the extended position, wherein each of the first and second distal assemblies comprises a plurality of metal components having at least one rivet attachment.
The system of any preceding claim, wherein the plurality of metal components are stamped metal components.
The system of any preceding claim, wherein each of the first and second distal assemblies comprises three rivet attachments.
The system of any preceding claim, wherein: the implantable fixation device further comprises an actuator shaft operatively connected to the first and second distal assemblies; the first distal strut is pivotally-coupled with the center portion by a first rivet attachment, the first distal element is pivotally-coupled with the first distal strut by a second rivet attachment, and the first distal element is pivotally-coupled with the actuator shaft by a third rivet attachment; and the second distal strut is pivotally-coupled with the center portion by a fourth rivet attachment, the second distal element is pivotally-coupled with the second distal strut by a fifth rivet attachment, and the second distal element is pivotally-coupled with the actuator shaft by a sixth rivet attachment.
The system of any preceding claim, wherein the first distal assembly is biased towards the closed position and the second distal assembly is biased towards the closed position.
The system of claim 5, wherein the first and second distal assemblies are biased towards the closed position by at least one spring.
The system of claim 6, wherein the at least one spring produces between about 0.44 Newtons and 2.22 Newtons (between about 0.10 lbf and 0.50 lbf) of closure force at each of the first and second distal struts, measured proximate a location of coupling between the first and second distal struts and the first and second distal elements.
The system of claim 6, wherein: the implantable fixation device further comprises an actuator shaft operatively connected to the first and second distal assemblies, and the at least one spring is an axial spring operatively connected to the actuator shaft; or the at least one spring is a torsion spring operatively connected to at least one pivot point of each of the first and second distal assemblies.
The system of any of claims 5-8, wherein a strain energy biasing the first and second distal assemblies is at a lowest-strain energy state when the distal assemblies are fully closed and is at an additional lowest-strain energy state when the distal assemblies are fully extended.
The system of any preceding claim, wherein each of the first and second distal assemblies comprises a flexural member configured to bias each of the first and second distal assemblies towards the closed position, wherein the flexural member is made of nitinol and comprises a beam structure selected from the group consisting of a slotted beam, a solid beam, and a hinged beam.
The system of claim 10, wherein each of the flexural members comprises a living hinge at a pivot point of the first and second distal assemblies, respectively.
The system of any preceding claim, wherein: each of the first and second proximal elements is attached to the center portion; or the first proximal element is attached to the first distal strut and the second proximal element is attached to the second distal strut.
The system of any preceding claim, wherein the locking mechanism comprises a binding plate configured to lock each of the first and second distal assemblies when the binding plate is at an angled orientation relative to the longitudinal axis and further configured to unlock each of the first and second distal assemblies when the binding plate is at a perpendicular orientation relative to the longitudinal axis.
The system of any preceding claim, further comprising a delivery device releasably attached to the implantable fixation device, the delivery device comprising an actuator rod, wherein the implantable fixation device is releasably attached to the implantable fixation device at a distal end of the actuator rod.
The system of claim 14, wherein the actuator rod is rotatable and comprises a threaded fastener at the distal end thereof, the threaded fastener configured to connect to the implantable fixation device by a threaded connection.
The system of claim 14, wherein distal movement of the actuator rod moves each of the first and second distal assemblies towards the extended position, and proximal movement of the actuator rod moves each of the first and second distal assemblies towards the closed position.

Description

Cross-Reference to Related Applications This application claims priority to United States Provisional Application Serial No. 63/092,110 filed October 15, 2020, 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 system for fixation of native leaflets of a heart valve including an implantable fixation device including a center portion defining a longitudinal axis. The implantable fixation device further includes a first distal assembly having a first distal strut pivotally-coupled with the center portion and a first distal element pivotally-coupled with the first distal strut. The first distal assembly is configured to move between a closed position with the first distal strut folded proximate the center portion and the first distal element folded proximate the first distal strut, and an extended position with the first distal strut extending distally from the center portion and the first distal element extends distally from the first distal strut. The first distal assembly is biased towards the closed position. The implantable fixation device further includes a second distal assembly having a second distal strut pivotally-coupled with the center portion and a second distal element pivotally-coupled with the second distal strut. The second distal assembly is configured to move between a closed position with the second distal strut folded proximate the center portion and the second distal element folded proximate the second distal strut, and an extended