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EP-4734878-A1 - PROSTHETIC HEART VALVES FOR DEPLOYMENT TO A MITRAL VALVE

EP4734878A1EP 4734878 A1EP4734878 A1EP 4734878A1EP-4734878-A1

Abstract

Improved features of medical devices. Implants that may include self-expanding portions and portions that are expandable with an inflatable body. A portion expandable with an inflatable body may dock with a portion that is self-expanding. A portion expandable with an inflatable body may be coupled to a portion that is self-expanding. Delivery apparatuses for deployment of both a self-expanding portion and a portion expandable with an inflatable body may be disclosed.

Inventors

  • YOUSEF, Abdorruhman, M.
  • SAIDUDDIN, ADEEB
  • ELTAL, Munir, Hicham
  • ROMERO, Anthony, Michael

Assignees

  • Edwards Lifesciences Corporation

Dates

Publication Date
20260506
Application Date
20240627

Claims (20)

  1. 1. A system for deployment to a native heart valve, the system comprising: a self-expanding stent configured to be deployed to the native heart valve and including a proximal portion, a distal portion, and a central portion having a smaller diameter than the proximal portion and the distal portion, the proximal portion comprising a flange extending radially outward from the central portion and having a conical shape from the central portion to a proximal end of the self-expanding stent, the self-expanding stent surrounding an interior cavity; and a valve body configured to be expanded with an inflatable body and configured to be positioned within the interior cavity of the self-expanding stent and couple to the central portion, the valve body including one or more prosthetic valve leaflets.
  2. 2. The system of claim 1, wherein the distal portion extends radially outward from the central portion in a direction towards a distal end of the self-expanding stent.
  3. 3. The system of claim 1 or claim 2, wherein the distal portion bows radially outward.
  4. 4. The system of any of claims 1-3, wherein the distal portion has a curved bulb shape.
  5. 5. The system of any of claims 1-4, wherein the central portion has a uniform diameter.
  6. 6. The system of any of claims 1-5, further comprising one or more distal prongs for engaging chordae of a heart.
  7. 7. The system of claim 6, wherein each of the distal prongs forms a hook extending proximally.
  8. 8. The system of any of claims 1-7, wherein the self-expanding stent includes a stent frame.
  9. 9. The system of claim 8, wherein the stent frame is made of a shape memory material.
  10. 10. The system of any of claims 1-9, wherein the self-expanding stent includes a skirt.
  11. 11. The system of any of claims 1-10, wherein the self-expanding stent includes a sealing band positioned at the central portion.
  12. 12. The system of any of claims 1-11, wherein the valve body includes a stent frame.
  13. 13. The system of claim 12, wherein the stent frame of the valve body has a cylindrical shape.
  14. 14. The system of any of claims 1-13, wherein the self-expanding stent has an inner surface and an outer surface facing radially outward from the inner surface, and the valve body is configured to couple to the inner surface.
  15. 15. The system of claim 14, wherein the valve body includes a skirt configured to contact the inner surface of the self-expanding stent.
  16. 16. The system of any of claims 1-15, wherein the valve body is configured to dock with the self-expanding stent.
  17. 17. The system of claim 16, wherein the self-expanding stent has an inner surface and an outer surface facing radially outward from the inner surface, and the valve body is configured to press against the inner surface to dock with the self-expanding stent.
  18. 18. The system of any of claims 1-17, further comprising one or more couplers coupling the valve body to the self-expanding stent.
  19. 19. The system of any of claims 1-18, wherein the valve body comprises a prosthetic aortic heart valve.
  20. 20. The system of any of claims 1-19, wherein the system is configured to be deployed to a native mitral heart valve or a native tricuspid heart valve.

Description

PROSTHETIC HEART VALVES FOR DEPLOYMENT TO A MITRAL VALVE CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Application No. 63/523,693, filed June 28, 2023, the entire contents of which are incorporated herein by reference. BACKGROUND Field [0002] Certain examples disclosed herein relate generally to implantable medical devices and may relate to implantable prosthetic valves such as those which may be used in place of native heart valves. Background [0003] A variety of maladies may affect an individual’s body. Such maladies may be of the individual’s heart, and may include maladies of the individual’s native heart valves, including the aortic, mitral, tricuspid, and pulmonary valves. Stenosis, for example, is a common and serious valve disease that may affect the operation of the heart valves and an individual’s overall well-being. [0004] Implants may be provided that may replace or repair portions of a patient’ s heart. Prosthetic implants, such as prosthetic valves, may be provided to replace or repair a portion of a patient’s heart. Prosthetic aortic, mitral, tricuspid, and even pulmonary valves may be provided. [0005] Implants may be deployed to the desired portion of the patient’s body percutaneously, in a minimally invasive manner. Such deployment may occur transcatheter, in which a catheter may be deployed through the vasculature of an individual. [0006] Deployment to a mitral or tricuspid valve may pose challenges. The shape of the mitral or tricuspid valve annulus may be irregular. The presence of chordae may need to be addressed. Variations in the shape of the mitral or tricuspid valve among different patients may be significant. SUMMARY [0007] Features of examples disclosed herein may be directed to improved features of medical devices. The features may include implants that may include self-expanding portions and portions that are expandable with an inflatable body. In examples, a portion expandable with an inflatable body may dock with a portion that is self-expanding. In examples, one or more couplers may be utilized that may couple the portion expandable with an inflatable body to the portion that is self-expanding. Variations may be provided. [0008] Aspects of the present disclosure may include a system for deployment to a native heart valve. [0009] The system may include a self-expanding stent configured to be deployed to the native heart valve and including a proximal portion, a distal portion, and a central portion having a smaller diameter than the proximal portion and the distal portion, the proximal portion comprising a flange extending radially outward from the central portion and having a conical shape from the central portion to a proximal end of the self-expanding stent, the self-expanding stent surrounding an interior cavity. [0010] The system may include a valve body configured to be expanded with an inflatable body and configured to be positioned within the interior cavity of the self-expanding stent and couple to the central portion, the valve body including one or more prosthetic valve leaflets. [0011] Aspects of the present disclosure may include a delivery system for deployment of a prosthetic system to a native heart valve. [0012] The delivery system may include an elongate shaft. [0013] The elongate shaft may include a first implant retention area comprising an inflatable body for a first implant to be positioned upon, the inflatable body configured to expand to deploy the first implant to the native heart valve from the elongate shaft. [0014] The elongate shaft may include a second implant retention area comprising a retaining body configured to retain a second self-expanding implant to the elongate shaft in a compressed configuration, the retaining body configured to release from the second selfexpanding implant to allow the second self-expanding implant to deploy to the native heart valve from the elongate shaft. [0015] Aspects of the present disclosure may include a method. [0016] The method may include deploying a prosthetic system to a native heart valve. [0017] The prosthetic system may include a self-expanding stent including a proximal portion, a distal portion, and a central portion having a smaller diameter than the proximal portion and the distal portion, the proximal portion comprising a flange extending radially outward from the central portion and having a conical shape from the central portion to a proximal end of the self-expanding stent, the self-expanding stent surrounding an interior cavity. [0018] The prosthetic system may include a valve body configured to be expanded with an inflatable body and configured to be positioned within the interior cavity of the self-expanding stent and couple to the central portion, the valve body including one or more prosthetic valve leaflets. [0019] Aspects of the present disclosure may include a method. [0020] The method may include deploying a prosthetic system t