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EP-4736786-A2 - HEART VALVE SEALING DEVICES AND DELIVERY DEVICES THEREFOR

EP4736786A2EP 4736786 A2EP4736786 A2EP 4736786A2EP-4736786-A2

Abstract

An implantable prosthetic device includes a coaption portion, paddles, and clasps. The paddles are moveable from a closed position to an open position. The clasps are also moveable from an open position to a closed position. The implantable prosthetic device can be used to repair a naitive valve, such as a native mitral valve.

Inventors

  • Dixon, Eric R.
  • CHEN, JENSEN
  • MORATORIO, GUILLERMO W.
  • CAO, HENGCHU
  • DOMINICK, DOUGLAS THOMAS
  • DELGADO, Sergio
  • FRESCHAUF, LAUREN R.

Assignees

  • Edwards Lifesciences Corporation

Dates

Publication Date
20260506
Application Date
20180418

Claims (15)

  1. An implantable prosthetic device (100) for helping to seal a native mitral or tricuspid heart valve and prevent or reduce regurgitation therethrough, the prosthetic device (100) comprising: a coaption element (110) configured to be positioned within the native heart valve orifice to help form a more effective seal between the native valve leaflets, thereby reducing or preventing regurgitation; a plurality of paddles (120, 122) configured to be opened and closed to capture the native valve leaflets (42, 44) between the paddles (120, 122) and the coaption element (110); and a plurality of barbed clasps (130) moveable from an open position to a closed position, wherein each barbed clasp can be opened and closed independently by independent actuation of a respective actuation line.
  2. The device of claim 1, wherein the barbed clasps are spring loaded so that in the closed position of the barbed clasps, the barbed clasps continue to provide a pinching force on the captured native leaflets.
  3. The device of any of the preceding claims, wherein the coaption element is adapted to be implanted between the leaflets of the native valve and is slideably attached to an actuation wire or shaft (112), wherein actuation of the actuation wire or shaft opens and closes the paddles.
  4. The device of any of the preceding claims, wherein the coaption element is configured to fill a space between the native valve leaflets.
  5. The device of any of the preceding claims, wherein each barbed clasp comprises a movable arm and a hinge portion, wherein each actuation line is attached to the end of a respective one of the movable arms, wherein each barbed clasp is configured to be opened by applying tension to the respective actuation line, thereby causing the respective moveable arm to pivot on the respective hinge portion.
  6. The device of claim 5, wherein each barbed clasp includes a base or fixed arm that remains stationary when the movable arms are opened to open the barbed clasps.
  7. The device of any of the preceding claims, wherein the device is configured to be maintained in a deployed condition by being biased to remain closed through the use of spring materials, wherein the deployed condition is a condition in which the paddles and the clasps remain in their respective closed positions.
  8. The device of any of the preceding claims, wherein the coaption element has a non-cylindrical shape.
  9. The device of any of the preceding claims, wherein the coaption element is configured to self-expand.
  10. The device of any of the preceding claims, wherein the coaption element is radially expandable.
  11. The device of any of the preceding claims, the device comprising a covering over the coaption element and the paddles, and optionally over the clasps.
  12. The device of any of claims 1 to 10, wherein the coaption element and the paddles are formed from a covering that is a mesh, woven, braided, cloth, shape-memory alloy wire, or other flexible material.
  13. The device of any of the preceding claims, wherein the plurality of paddles comprises inner paddles and outer paddles.
  14. The device of claim 13, wherein the inner paddles and outer paddles are connected between a cap (114) and the coaption element by hinged and/or flexible portions, wherein extending and retracting an actuation wire or shaft (112) increases and decreases the spacing between the coaption element and the cap, thereby opening and closing the paddles.
  15. The device of claim 13 or 14, wherein the outer paddles have a wide curved shape that fits around the curved shape of the coaption element to more securely grip the native valve leaflets.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present application is related to and claims any benefit of U.S. Patent Application No. 15/884,193, filed January 30, 2018, U.S. Patent Application No. 15/909,803, filed March 1, 2018, U.S. Application No. 15/910,951 filed March 2, 2018, U.S. Application No. 15/914,143 filed March 7, 2018, U.S. Application No. 15/927,814 filed March 21, 2018, U.S. Patent Application No. 15/946,604 filed April 5, 2018, U.S. Patent Application No. 15/953,220 filed April 13, 2018, U.S. Patent Application No. 15/953,263 filed April 13, 2018, U.S. Patent Application No. 15/953,283 filed April 13, 2018, U.S. Provisional Application Serial No. 62/486,835, filed on April 18, 2017, titled HEART VALVE SEALING DEVICES AND DELIVERY DEVICES THEREFOR, the disclosure of which is incorporated herein by reference in its entirety. TECHNICAL FIELD The present application relates generally to prosthetic devices and related methods for helping to seal native heart valves and prevent or reduce regurgitation therethrough, as well as devices and related methods for implanting such prosthetic devices. BACKGROUND OF THE INVENTION 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 damaged, and thus 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 damaged valves was surgical repair or replacement of the valve during open heart surgery. However, open heart 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. One particular transvascular technique that is used for accessing the native mitral and aortic valves is the trans-septal technique. The trans septal technique comprises inserting a catheter into the right femoral vein, up the inferior vena cava and into the right atrium. The septum is then punctured and the catheter passed into the left atrium. 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 (also referred to as "ventricular diastole" or "diastole"), 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 (also referred to as "ventricular systole" or "systole"), 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 systolic 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 ventricl