US-12616574-B2 - Device, system, and method for transcatheter treatment of valvular regurgitation

Abstract

The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation assistance element for implantation across the valve; a system including the coaptation assistance element and anchors for implantation; a system including the coaptation assistance element and delivery catheter; and a method for transcatheter implantation of a coaptation element across a heart valve.

Inventors

• Alexander K. Khairkhahan

Assignees

• POLARES MEDICAL INC.

Dates

Publication Date

20260505

Application Date

20220303

Claims (20)

1. 1 . A coaptation assistance element for treating mal-coaptation of a heart valve of a heart, the coaptation assistance element comprising: a first surface and an opposed second surface; a first lateral edge, a second lateral edge, an inferior edge, and a superior edge; and a superior zone and an inferior zone, the superior zone configured to reside within a heart superior to an annulus of the heart valve, the inferior zone extending downward from the superior zone, wherein the inferior zone comprises a leaflet-apposing valve body element, wherein the leaflet-apposing valve body element is configured to overlie and move relative to the opposed second surface to fill a gap between the leaflet-apposing valve body element and a leaflet surface in an expanded state.
2. 2 . The coaptation assistance element of claim 1 , wherein the gap is a lateral gap.
3. 3 . The coaptation assistance element of claim 1 , wherein the gap is an axial gap.
4. 4 . The coaptation assistance element of claim 1 , wherein the gap is a lateral and axial gap.
5. 5 . The coaptation assistance element of claim 1 , wherein the leaflet-apposing valve body element is configured to assist one leaflet.
6. 6 . The coaptation assistance element of claim 1 , wherein the leaflet-apposing valve body element is configured to assist two leaflets.
7. 7 . The coaptation assistance element of claim 1 , wherein the leaflet-apposing valve body element is configured to be positioned along the blood flow path.
8. 8 . The coaptation assistance element of claim 1 , wherein a volume of the coaptation assistance element increases when deployed.
9. 9 . The coaptation assistance element of claim 1 , wherein a thickness of the coaptation assistance element increases when deployed.
10. 10 . A coaptation assistance element for treating mal-coaptation of a heart valve of a heart, the coaptation assistance element comprising: a first surface and an opposed second surface; a first lateral edge, a second lateral edge, an inferior edge, and a superior edge; and a superior zone and an inferior zone, the superior zone configured to reside within a heart superior to an annulus of the heart valve, the inferior zone extending downward from the superior zone, wherein the inferior zone comprises a leaflet-apposing valve body element configured to form a gap between the leaflet-apposing valve body element and the second surface, the leaflet-apposing valve body comprising a conformable structure configured to conform to the geometry of an anterior leaflet allowing coaptation between the anterior leaflet and the coaptation assistance element, wherein the coaptation assistance element is configured to remain within the blood flow path throughout the heart beat cycle.
11. 11 . The coaptation assistance element of claim 10 , wherein the leaflet-apposing valve body element is configured to adjust curvature of a coaptation surface in situ.
12. 12 . The coaptation assistance element of claim 10 , wherein the leaflet-apposing valve body element is configured to conform to the geometry of the anterior leaflet in situ.
13. 13 . The coaptation assistance element of claim 10 , wherein one or more dimensions of the leaflet-apposing valve body element is configured to be adjusted in situ.
14. 14 . The coaptation assistance element of claim 10 , further comprising a radiopaque material or an echo-enhancement material.
15. 15 . The coaptation assistance element of claim 10 , wherein the coaptation assistance element comprises one or more passive anchors.
16. 16 . The coaptation assistance element of claim 10 , wherein the conformable structure is configured to extend laterally across a portion of a width of a valve opening.
17. 17 . A coaptation assistance element for treating mal-coaptation of a heart valve of a heart, the coaptation assistance element comprising: a first surface and an opposed second surface; a first lateral edge, a second lateral edge, an inferior edge, and a superior edge; and a superior zone and an inferior zone, the superior zone configured to reside within a heart superior to an annulus of the heart valve, the inferior zone extending downward from the superior zone, wherein the inferior zone comprises a leaflet-apposing valve body element configured to expand relative to the second surface near the inferior edge, wherein the leaflet-apposing valve body element is configured to expand in systole and contract in diastole.
18. 18 . The coaptation assistance element of claim 17 , wherein the coaptation assistance element only requires annular attachment.
19. 19 . The coaptation assistance element of claim 17 , wherein the coaptation assistance element does not require ventricular attachment.
20. 20 . The coaptation assistance element of claim 17 , wherein during diastole, the at least one surface is configured to return to an initial position.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a continuation application of U.S. application Ser. No. 16/685,338 filed Nov. 15, 2019, which is a continuation application of U.S. application Ser. No. 16/275,665 filed Feb. 14, 2019, which is a continuation-in-part application of U.S. application Ser. No. 16/129,194 filed Sep. 12, 2018, which is a continuation-in-part application of U.S. application Ser. No. 15/918,988 filed Mar. 12, 2018, which claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 62/470,684, filed on Mar. 13, 2017. Each of the foregoing applications of which are hereby incorporated by reference in their entireties. Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application, are hereby incorporated by reference in their entirety under 37 CFR 1.57. BACKGROUND Field The present disclosure generally provides improved medical devices, systems, and methods, typically for treatment of heart valve disease and/or for altering characteristics of one or more valves of the body. Embodiments include implants for treatment of mitral valve regurgitation. The human heart receives blood from the organs and tissues via the veins, pumps that blood through the lungs where the blood becomes enriched with oxygen, and propels the oxygenated blood out of the heart to the arteries so that the organ systems of the body can extract the oxygen for proper function. Deoxygenated blood flows back to the heart where it is once again pumped to the lungs. The heart includes four chambers: the right atrium (RA), the right ventricle (RV), the left atrium (LA) and the left ventricle (LV). The pumping action of the left and right sides of the heart occurs generally in synchrony during the overall cardiac cycle. The heart has four valves generally configured to selectively transmit blood flow in the correct direction during the cardiac cycle. The valves that separate the atria from the ventricles are referred to as the atrioventricular (or AV) valves. The AV valve between the left atrium and the left ventricle is the mitral valve. The AV valve between the right atrium and the right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary artery and thence to the lungs; blood returns to the left atrium via the pulmonary veins. The aortic valve directs flow through the aorta and thence to the periphery. There are normally no direct connections between the ventricles or between the atria. The mechanical heartbeat is triggered by an electrical impulse, which spreads throughout the cardiac tissue. Opening and closing of heart valves may occur primarily as a result of pressure differences between chambers, those pressures resulting from either passive filling or chamber contraction. For example, the opening and closing of the mitral valve may occur as a result of the pressure differences between the left atrium and the left ventricle. At the beginning of ventricular filling (diastole) the aortic and pulmonary valves are closed to prevent back flow from the arteries into the ventricles. Shortly thereafter, the AV valves open to allow unimpeded flow from the atria into the corresponding ventricles. Shortly after ventricular systole (i.e., ventricular emptying) begins, the tricuspid and mitral valves normally shut, forming a seal, which prevents flow from the ventricles back into the corresponding atria. Unfortunately, the AV valves may become damaged or may otherwise fail to function properly, resulting in improper closing. The AV valves are complex structures that generally include an annulus, leaflets, chordae and a support structure. Each atrium interfaces with its valve via an atrial vestibule. The mitral valve has two leaflets; the analogous structure of the tricuspid valve has three leaflets, and apposition or engagement of corresponding surfaces of leaflets against each other helps provide closure or sealing of the valve to prevent blood flowing in the wrong direction. Failure of the leaflets to seal during ventricular systole is known as malcoaptation, and may allow blood to flow backward through the valve (regurgitation). Heart valve regurgitation can have serious consequences to a patient, often resulting in cardiac failure, decreased blood flow, lower blood pressure, and/or a diminished flow of oxygen to the tissues of the body. Mitral regurgitation can also cause blood to flow back from the left atrium to the pulmonary veins, causing congestion. Severe valvular regurgitation, if untreated, can result in permanent disability or death. Description of the Related Art A variety of therapies have been applied for treatment of mitral valve regurgitation, and still other therapies may have been proposed but not yet actually used to treat patients. While several of the known therapies have been found to provide benefits for at least some patients, still further opt