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EP-4740910-A2 - HEART VALVE SEALING DEVICES

EP4740910A2EP 4740910 A2EP4740910 A2EP 4740910A2EP-4740910-A2

Abstract

This disclosure pertains 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. In some cases, a spacer having a single anchor can be implanted within a native heart valve. In some cases, a spacer having dual anchors can be implanted within a native heart valve. In some cases, devices can be used to extend the effective length of a native heart valve leaflet.

Inventors

  • CHAU, MARK
  • OBA, TRAVIS
  • DELGADO, Sergio
  • TAFT, ROBERT C.
  • ROWE, STANTON J.
  • COOPER, ALEXANDER H

Assignees

  • Edwards Lifesciences Corporation

Dates

Publication Date
20260513
Application Date
20130830

Claims (15)

  1. A prosthetic device comprising: a spacer body (602), wherein the spacer body (602): is configured to be positioned within the native mitral or tricuspid valve orifice to help create a more effective seal between the native leaflets to prevent or minimize regurgitation; and comprises a structure that is impervious to blood and that allows the native leaflets to close around the sides of the spacer body (602) during ventricular systole to block blood from flowing from the left ventricle back into the left atrium; and a plurality of anchors (604, 606) such that the spacer body (602) can be clipped to more than one native leaflet; wherein the device is configured to effectively couple two or more native leaflets to one another and is thus useable to bring the native leaflets closer to one another and restrict their mobility in order to help increase the chance of or extent of coaptation between the leaflets.
  2. The device of claim 1, wherein the spacer body (602) has an atrial or upper end positioned in or adjacent to atrium, a ventricular or lower end positioned in or adjacent to the ventricle, and an annular side surface that extends between the native leaflets.
  3. The device of claim 2, wherein each anchor attaches to the spacer body (602) at a location adjacent the ventricular end of the spacer.
  4. The device of claim 3, wherein the anchors extend along opposite sides of the spacer body (602) toward the atrial end of the spacer body (602).
  5. The device of any one of the preceding claims, wherein each anchor is configured to be positioned behind a native leaflet when implanted such that the leaflet is captured between the anchor and the spacer body.
  6. The prosthetic device of any one of the preceding claims, wherein the spacer body (602) has a circular cross-sectional shape.
  7. The prosthetic device of any one of the preceding claims, wherein the spacer body (602) does not comprise a prosthetic valve structure.
  8. The prosthetic device of any one of the preceding claims, wherein, when the device is clipped onto the native mitral or tricuspid leaflets, the device divides the native mitral or tricuspid orifice into at least two orifices during diastole through which blood can flow from the atrium to the ventricle.
  9. The prosthetic device of any one of the preceding claims, wherein the spacer body (602) is covered in a blood impermeable fabric material (822).
  10. The prosthetic device of any one of the preceding claims, wherein the anchors (604, 606) are covered in a blood impermeable fabric material (822).
  11. The prosthetic device of any one of the preceding claims, wherein the spacer body (602) comprises a solid block of material.
  12. The prosthetic device of any one of claims 1-10, wherein the spacer body (602) is hollow or filled with material.
  13. The prosthetic device of any one of the preceding claims, wherein the anchors (604, 606) can be splayed apart so that gaps exist between the anchors (604, 606) and the spacer body (602).
  14. The prosthetic device of claim 13, wherein the device is configured to be introduced into the region of the patient's native valve in a closed configuration with the anchors (604, 606) against the side of the spacer body (602).
  15. The prosthetic device of any one of the preceding claims, wherein the anchors (604, 606) are fabricated from separate pieces of material from the spacer body (602) and coupled to the spacer body (602) using a coupling mechanism.

Description

FIELD This disclosure pertains 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 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. Other prior techniques include the use of a spacer implanted between the native mitral valve leaflets. Despite these prior techniques, there is a continuing need for improved devices and methods for treating mitral valve regurgitation. SUMMARY This disclosure pertains 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. In some embodiments, a prosthetic device for treating heart valve regurgitation comprises a radially compressible and radially expandable body having a first end, a second end, and an outer surface extending from the first end to the second end and an anchor having a connection portion and a leaflet capture portion, wherein the connection portion is coupled to the body s