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EP-3595587-B1 - DEVICE, SYSTEM, AND METHOD FOR TRANSCATHETER TREATMENT OF VALVULAR REGURGITATION

EP3595587B1EP 3595587 B1EP3595587 B1EP 3595587B1EP-3595587-B1

Inventors

  • KHAIRKHAHAN, ALEXANDER K.
  • ROBINSON, JANINE C.
  • KLENK, ALAN R.
  • PATEL, ANUJA
  • TUN, ZAYA
  • QUINTOS, ROBERT
  • SNYDER, BRETT

Dates

Publication Date
20260506
Application Date
20180312

Claims (15)

  1. A coaptation assistance element (400; 500; 600; 700) for treating mal-coaptation of a heart valve of a heart, the coaptation assistance element comprising: a first coaptation surface (460; 560; 660; 760) and an opposed second surface (405; 505; 605; 705); a first lateral edge (470; 570; 670; 770), a second lateral edge (475; 575; 675; 775), an inferior edge (480; 580; 680; 780), and a superior edge (440; 540; 640; 740); and a superior zone and an inferior zone, the superior zone comprising a hub (420; 520; 620; 720) spaced inward from each of the first lateral edge, the second lateral edge, the inferior edge, and the superior edge, the superior zone configured to reside in the plane of an annulus of the heart valve, the inferior zone comprising the first coaptation surface and the opposed second surface, wherein the inferior zone comprises a laminate layer such that a thickness of the inferior zone is greater than a thickness of a portion of the superior zone.
  2. The coaptation assistance element of Claim 1, wherein the laminate layer comprises ePTFE.
  3. The coaptation assistance element of Claim 1, wherein the thickness of the inferior zone is at least about 25% thicker than the thickness of the portion of the superior zone.
  4. The coaptation assistance element of Claim 1, wherein the thickness of the inferior zone is at least about 50% thicker than the thickness of the portion of the superior zone.
  5. The coaptation assistance element of Claim 1, wherein the peripheral edge of the coaptation assistance element comprises a raised atraumatic edge surrounding only partially around the coaptation assistance element.
  6. The coaptation assistance element of Claim 5, wherein the peripheral edge of the coaptation assistance element comprises a raised atraumatic edge surrounding only the inferior zone of the coaptation assistance element.
  7. The coaptation assistance element of Claim 1, further comprising: an active anchor (800) configured to couple to the hub (420; 520; 620; 720) and configured to be rotated relative to the hub to selectively deploy the active anchor at a first target location; and a plurality of struts (430; 530; 630; 730) spaced around the hub and extending outward from the hub, the plurality of struts comprising at least a first strut configured to be implanted within the heart and a second strut configured to be implanted within the heart such that the first coaptation surface coapts with a first leaflet of the heart valve and the opposed second surface overlays a second leaflet of the heart valve.
  8. The coaptation assistance element of Claim 1, wherein the hub is configured to facilitate attachment to a delivery system (2200), wherein the delivery system comprises a primary anchor housing (2202) configured to be disposed around the hub.
  9. The coaptation assistance element of Claim 1, further comprising an anchor (800), wherein the anchor is configured to be driven by a primary anchor driver (2204) comprising two extensions (2262, 2264).
  10. The coaptation assistance element of Claim 1, further comprising release wires (2206, 2208) configured to rigidly hold a primary anchor housing (2202) against the hub (420; 520; 620; 720) of the coaptation assistance element.
  11. The coaptation assistance element of Claim 1, further comprising release wires (2206, 2208) extending underneath the coaptation assistance element.
  12. The coaptation assistance element of Claim 1, further comprising release wires (2206, 2208) configured to maintain the connection between the coaptation assistance element and a primary anchor (800) and a primary anchor driver (2204).
  13. The coaptation assistance element of Claim 1, further comprising release wires (2206, 2208) configured to maintain the connection between the coaptation assistance element and secondary anchor tethers (2250, 2252, 2254, 2256).
  14. The coaptation assistance element of Claim 1, wherein the coaptation assistance element is configured to be delivered via a delivery catheter (1402).
  15. The coaptation assistance element of Claim 1, wherein the location of an anchor (800) and the hub (420; 520; 620; 720) are at a neutral center to prevent swinging of the coaptation assistance element when the coaptation assistance element is held by the hub.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 62/470684, filed on March 13, 2017. 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 options would be desirable. For example, pharmacologic agents (such as diuretics and vasodilators) can be used with patients having mild mitral valve regurgitation to help reduce the amount of blood flowing back into the left atrium. However, medications can suffer from lack of patient compliance. A significant number of patients may occasionally (or even regularly) fail to take medications, despite the potential seriousness of chronic and/or progressively deteriorating mitral valve regurgitation. Pharmacological therapies of mitral valve regurgitation may also be inconvenient, are often ineffective (especially as the condition worsens), and can be associated with significant side effects (such as low blood pressure). A variety o