EP-4740908-A2 - RETRIEVABLE TISSUE GRASPING DEVICES, SPACERS, ARTIFICIAL VALVES AND RELATED METHODS

EP4740908A2EP 4740908 A2EP4740908 A2EP 4740908A2EP-4740908-A2

Abstract

A clip for immobilizing leaflets of a cardiac or venous valve includes a hub having a pair of tangle resistant spring-biased outer arms coupled to an inferior end of the hub. A pair of tangle- resistant spring-biased inner arms lies adjacent to the outer arms and is coupled to a superior end of the hub. The clip may incorporate adjustable spacers and retrievable post implantation. A delivery catheter is used to position the valve clip adjacent a target valve while the outer and inner arms are biased in an opened position relative to each other. After the valve leaflets are located between the opened outer and inner arms, the biasing forces may be released to allow the clip to self-close over the valve leaflets.

Inventors

BASUDE, RAGHUVEER
BASUDE, Shri Krishna

Assignees

Basude, Raghuveer
Basude, Shri Krishna

Dates

Publication Date: 20260513
Application Date: 20190423

Claims (14)

A system for implanting a closure device on a patient's mitral valve, the system comprising: a closure device comprising at least a first pair of capture springs, wherein each pair of the at least one pair of capture springs comprises an atrial capture spring and an opposed ventricular capture spring, and wherein each capture spring of the each pair of capture springs has: a base end, wherein the base ends of each capture spring of the each pair of capture springs are coupled together; and a free end wherein the free ends are configured to close together when unconstrained and to elastically separate in response to a separating force; a delivery catheter configured to constrain the closure device in a lumen of the delivery catheter, wherein a distal end of the delivery catheter is configured to be positioned adjacent to the patient's mitral valve; wherein the atrial and ventricular capture springs are in a straightened configuration in the lumen of the delivery catheter during delivery, wherein the atrial capture spring is configured to be released from the lumen of the delivery catheter to engage an atrial surface of the mitral valve leaflet, and wherein the ventricular capture spring is configured to be released from the lumen of the delivery catheter to engage a ventricular surface of a mitral valve leaflet, wherein the atrial and ventricular capture springs self-close over the mitral valve leaflet to affix to the mitral valve leaflet.
The system of claim 1, wherein the closure device further comprises at least a second pair of capture springs comprising an atrial capture spring and an opposed ventricular capture spring.
The system of claim 2, wherein the first and second pairs of capture springs are fixed together at their respective bases prior to constraining the closure device in the lumen of a delivery catheter so the atrial and posterior capture springs of both pairs are straightened and adjacent to each other in the lumen prior to releasing.
The system of claim 2, wherein the first pair of capture springs is configured to be released to capture a first mitral valve leaflet and the second pair of capture springs is configured to be released to capture a second mitral valve leaflet, wherein the first pair of capture springs and the second pair of capture springs are configured to be coupled together at their respective bases after each pair of capture springs is secured to its respective mitral valve leaflet.
The system of claim 1, wherein the delivery catheter is configured to be positioned through a septum from a right atrium to a left atrium and through the mitral valve.
The system of claim 1, wherein the delivery catheter is configured to be positioned through a septum from a right ventricle to a left ventricle and through the mitral valve.
The system of claim 1, wherein the delivery catheter is configured to be positioned through an aortic valve to a left ventricle and through the mitral valve.
The system of claim 1, wherein the delivery catheter is configured to be positioned through an apex of the left ventricle to a left ventricle and through the mitral valve.
The system of claim 1, wherein the closure device consists essentially of only the first pair of capture springs to capture only a single mitral valve leaflet, wherein the closure device is configured to prevent regurgitant blood flow during systole and diastole.
The system of claim 2, wherein the first and second pairs of capture springs are configured to be released sequentially to capture the first and second mitral valve leaflets
The system of claim 2, wherein the first and second pairs of capture springs are configured to be released simultaneously to capture the first and second mitral valve leaflets
The system of claim 1, further comprising a capturable feature on the closure device configured to be captured to retrieve the closure device.
The system of claim 1, further comprising a spacer configured to be deployed to reduce or eliminate or mitigate valve regurgitation.
The system of claim 13, wherein the spacer is one or more of expandable, collapsible, compressible, inflatable, solid, hollow, porous, non-porous, and incompressible.

Description

CROSS-REFERENCE TO RELATED APPLICATION This application claims the benefit of U.S. provisional patent application no. 62/662,152, filed on April 24, 2018, the full disclosure of which is incorporated herein by reference. BACKGROUND OF THE INVENTION This disclosure pertains generally to medical devices and related methods for helping to seal native heart valves and/or augment and/or replace their function using retrievable tissue grasping devices, spacers, annulus reshaping devices, artificial valves, to prevent or reduce regurgitation there through, as well as delivery devices and related methods for implanting such prosthetic devices. More particularly, the present invention relates to methods and devices for the repair of mitral and tricuspid heart valves, venous valves, and other tissue structure through minimally invasive and other procedures. The native heart valves (i.e., the aortic, pulmonary, tricuspid and mitral valves) serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system. These heart valves can be rendered less effective by congenital malformations, inflammatory processes, infectious conditions or disease. Such damage to the valves can result in serious cardiovascular compromise or death. For many years, the definitive treatment for such disorders was the surgical repair or replacement of the valve during open heart surgery. However, such surgeries are highly invasive and are prone to many complications. Therefore, elderly and frail patients with defective heart valves often went untreated. More recently, transvascular techniques have been developed for introducing and implanting prosthetic devices in a manner that is much less invasive than open heart surgery. Such transvascular techniques have increased in popularity due to their high success rates. A healthy heart has a generally conical shape that tapers to a lower apex. The heart is four-chambered and comprises the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall generally referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomy than other native heart valves. The mitral valve includes an annulus portion, which is an annular portion of the native valve tissue surrounding the mitral valve orifice, and a pair of cusps, or leaflets extending downward from the annulus into the left ventricle. The mitral valve annulus can form a "D" shaped, oval, or otherwise out-of-round cross-sectional shape having major and minor axes. The anterior leaflet can be larger than the posterior leaflet, forming a generally "C" shaped boundary between the abutting free edges of the leaflets when they are closed together When operating properly, the anterior leaflet and the posterior leaflet function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates, the oxygenated blood that is collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract, the increased blood pressure in the left ventricle urges the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back to the left atrium and is instead expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, a plurality of fibrous cords called chordae tendineae tether the leaflets to papillary muscles in the left ventricle. Mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows into the left atrium from the left ventricle during the systole phase of heart contraction. Mitral regurgitation is the most common form of valvular heart disease. Mitral regurgitation has different causes, such as leaflet prolapse, dysfunctional papillary muscles and/or stretching of the mitral valve annulus resulting from dilation of the left ventricle. Mitral regurgitation at a central portion of the leaflets can be referred to as central jet mitral regurgitation and mitral regurgitation nearer to one commissure (i.e., location where the leaflets meet) of the leaflets can be referred to as eccentric jet mitral regurgitation. Some prior techniques for treating mitral regurgitation include stitching portions of the native mitral valve leaflets directly to one another. The most common treatments for mitral valve regurgitation rely on valve replacement or repair including leaflet and annulus remodeling. The only FDA approved catheter based device (MitraClip by Abbott) is large (24Fr) owing to complex design and multiple components