Techniques for providing a replacement valve and transseptal communication

Patent metadata

Field	Value
Publication number	US-11298117-B2
Application number	US-202016738516-A
Country	US
Kind code	B2
Filing date	Jan 9, 2020
Priority date	Feb 16, 2016
Publication date	Apr 12, 2022
Grant date	Apr 12, 2022

Abstract

A method is provided, including (1) identifying the subject as having mitral valve regurgitation; (2) during a medical procedure, in response to identifying the subject as having mitral valve regurgitation, implanting a prosthetic valve at a mitral valve site of the heart; and (3) during the same medical procedure, implanting a therapeutic septal device at a septum of the heart. Other embodiments are also described.

First claim

The invention claimed is:

1. A method for use with a heart of a subject, comprising:
identifying the subject as having mitral valve regurgitation;
during a medical procedure, in response to identifying the subject as having mitral valve regurgitation, implanting a prosthetic valve at a mitral valve site of the heart; and
during the same medical procedure, implanting a shunt including a check valve at a septum of the heart such that the check valve facilitates one-way blood flow from a chamber of a left side of the heart, via the shunt, to a chamber of a right side of the heart.

2. The method according to claim 1 , wherein implanting the prosthetic valve and implanting the shunt respectively comprise implanting the prosthetic valve and implanting the shunt in an absence of an identification of the subject as having heart failure.

3. The method according to claim 1 , wherein the septum is an interatrial septum of the heart, and wherein implanting the shunt at the septum comprises implanting the shunt at the interatrial septum.

4. The method according to claim 1 , wherein the septum is an interventricular septum of the heart, and wherein implanting the shunt at the septum comprises implanting the shunt at the interventricular septum.

5. The method according to claim 1 , wherein the subject is an adult subject, and wherein the method is performed on the adult subject.

6. The method according to claim 1 , further comprising making a fenestration in the septum of the heart, and delivering the prosthetic valve transfemorally to the heart and through the fenestration to the mitral valve site, and wherein implanting the shunt comprises implanting the shunt in the fenestration.

7. The method according to claim 6 , further comprising transfemorally delivering the shunt to the septum.

8. The method according to claim 6 , wherein making the fenestration comprises making the fenestration transfemorally.

9. The method according to claim 1 , further comprising transapically making a fenestration in the septum of the heart, wherein implanting the shunt comprises implanting the shunt in the fenestration.

10. The method according to claim 1 , further comprising transapically delivering the prosthetic valve to the mitral valve site.

11. The method according to claim 1 , wherein implanting the shunt comprises implanting the shunt after implanting the prosthetic valve.

12. The method according to claim 1 , wherein implanting the shunt comprises implanting the shunt before implanting the prosthetic valve.

13. A method for use with a heart of a subject, comprising:
identifying the subject as having mitral valve regurgitation;
during a medical procedure, in response to identifying the subject as having mitral valve regurgitation, implanting a prosthetic valve at a mitral valve site of the heart; and
during the same medical procedure, implanting a shunt at a septum of the heart, the shunt being shaped to define a lumen and including a membrane that regulates blood flow through the lumen, wherein:
the membrane:
has a closed position in which the membrane inhibits blood flow through the lumen, and an open position in which the inhibiting of the blood flow by the membrane is reduced,
resides in the closed position while a blood pressure difference across the membrane is lower than a threshold blood pressure difference,
moves from the closed position into the open position in response to the blood pressure difference exceeding the threshold blood pressure difference, and
is configured such that the threshold blood pressure difference is 4-6 mmHg, and

implanting the shunt that is shaped to define the lumen and includes the membrane comprises implanting the shunt that is shaped to define the lumen and includes the membrane that:
has the closed position and the open position,
resides in the closed position while the blood pressure difference across the membrane is lower than the threshold blood pressure difference,
moves from the closed position into the open position in response to the blood pressure difference exceeding the threshold blood pressure difference, and
is configured such that the threshold blood pressure difference is 4-6 mmHg.

14. The method according to claim 13 , wherein the membrane is configured to move from the closed position into the open position in response to the blood pressure difference exceeding the threshold blood pressure difference in either direction across the membrane, and wherein implanting the shunt that includes the membrane comprises implanting the shunt that includes the membrane that is configured to move from the closed position into the open position in response to the blood pressure difference exceeding the threshold blood pressure difference in either direction across the membrane.

15. The method according to claim 13 , wherein the membrane is transected by intersecting slits, and wherein implanting the shunt comprises implanting the shunt that includes the membrane that is transected by intersecting slits.

16. The method according to claim 13 , wherein implanting the prosthetic valve and implanting the shunt respectively comprise implanting the prosthetic valve and implanting the shunt in an absence of an identification of the subject as having heart failure.

17. The method according to claim 13 , wherein the septum is an interatrial septum of the heart, and wherein implanting the shunt at the septum comprises implanting the shunt at the interatrial septum.

18. The method according to claim 13 , wherein the septum is an interventricular septum of the heart, and wherein implanting the shunt at the septum comprises implanting the shunt at the interventricular septum.

19. The method according to claim 13 , wherein the subject is an adult subject, and wherein the method is performed on the adult subject.

20. The method according to claim 13 , further comprising making a fenestration in the septum of the heart, and delivering the prosthetic valve transfemorally to the heart and through the fenestration to the mitral valve site, and wherein implanting the shunt comprises implanting the shunt in the fenestration.

21. The method according to claim 20 , further comprising transfemorally delivering the shunt to the septum.

22. The method according to claim 20 , wherein making the fenestration comprises making the fenestration transfemorally.

23. The method according to claim 13 , further comprising transapically making a fenestration in the septum of the heart, wherein implanting the shunt comprises implanting the shunt in the fenestration.

24. The method according to claim 13 , further comprising transapically delivering the prosthetic valve to the mitral valve site.

25. The method according to claim 13 , wherein implanting the shunt comprises implanting the shunt after implanting the prosthetic valve.

26. The method according to claim 13 , wherein implanting the shunt comprises implanting the shunt before implanting the prosthetic valve.

Assignees

• Cardiovalve Ltd

Inventors

• Hariton Ilia
• Reich Tal
• Kaye Paul

Classifications

• A61B2017/00606

  Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening · CPC title

• A61F2/2436

  Deployment by retracting a sheath · CPC title

• A61B2017/00575

  for closure at remote site, e.g. closing atrial septum defects · CPC title

• A61F2/2427

  Devices for manipulating or deploying heart valves during implantation · CPC title

• A61F2/2412

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title