IP Library › Granted Patent US 12,005,214
Granted Patent B2
US 12,005,214 · App. 16/866,377 · Granted Jun 11, 2024

Device and method for regulating pressure in a heart chamber

Inventors: Yaacov Nitzan (Hertzelia, IL); Boaz Harari (Tel-Aviv, IL); Ascher Shmulewitz (Tel-Aviv, IL); Tovy Sivan (Kfar-Saba, IL)
Assignee: V-Wave Ltd.
A61M27/002A61F2/2412A61F2/2418A61M27/006A61F2002/249A61F2220/0058A61F2220/0066A61F2230/0013A61F2230/0078
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Quick Facts
Patent No.
US 12,005,214
App. No.
16/866,377
Granted
Jun 11, 2024
Kind
B2
Abstract

A device for regulating blood pressure in a heart chamber is provided. The device includes a shunt positionable within a septum of the heart. The shunt is designed for enabling blood flow between a loft heart chamber and a right heart chamber, wherein the flow rate capacity of the device is mostly a function of pressure in the left heart chamber.

Claims (28)

1. A shunt for regulating blood pressure between a patient's left atrium and right atrium, the shunt comprising:

a shunt conduit configured to be implanted at an atrial septum of the patient to dilate an opening in the atrial septum, the shunt conduit having an outer surface along a length greater than a thickness of the atrial septum, the shunt conduit configured to transition between a collapsed state suitable for percutaneous delivery and an expanded state when deployed across the patient's atrial septum such that the shunt conduit has a smallest diameter where the outer surface traverses the atrial septum and has a larger diameter at the outer surface where an end region of the shunt conduit extends into an atrium, wherein the shunt conduit has a diabolo shape and is configured to be collapsible after implantation.

2. The shunt of claim 1 , further comprising an anchor configured to anchor the shunt conduit to the atrial septum when deployed.

3. The shunt of claim 1 , wherein a flow rate capacity of the shunt conduit increases with an increase in pressure of the left atrium.

4. The shunt of claim 1 , wherein the shunt conduit is configured to be expanded to a predetermined diameter using a balloon catheter.

5. The shunt of claim 1 , wherein the diabolo shape of the shunt conduit is configured to prevent migration of the shunt conduit through the atrial septum when deployed.

6. The shunt of claim 1 , wherein the shunt conduit is coated with expanded-polytetrafluoroethylene (ePTFE).

7. The shunt of claim 1 , wherein the length of the shunt conduit is greater than twice the thickness of the atrial septum.

8. The shunt of claim 1 , wherein the shunt conduit comprises a plurality of sinusoidal rings interconnected by a plurality of struts.

9. The shunt of claim 8 , wherein the sinusoidal rings and struts further define a neck where the outer surface traverses the atrial septum between conical sections of the shunt conduit.

10. The shunt of claim 9 , wherein the neck is between 4 and 6 mm in diameter.

11. The shunt of claim 1 , wherein the shunt conduit is constructed from a nitinol frame.

12. The shunt of claim 1 , wherein the shunt conduit defines a neck where the outer surface traverses the atrial septum between conical sections.

13. The shunt of claim 12 , wherein the neck and the conical sections are collapsible.

14. The shunt of claim 12 , wherein the neck is between 4 and 6 mm in diameter.

15. A method for regulating blood pressure between a patient's left atrium and right atrium, the method comprising:

implanting a shunt conduit at an atrial septum of the patient to dilate an opening in the atrial septum, the shunt conduit having an outer surface along a length greater than a thickness of the atrial septum, the shunt conduit configured to transition between a collapsed state suitable for percutaneous delivery and an expanded state when deployed across the patient's atrial septum such that the shunt conduit has a smallest diameter where the outer surface traverses the atrial septum and has a larger diameter at the outer surface where an end region of the shunt conduit extends into an atrium, wherein the shunt conduit has a diabolo shape and is configured to be collapsible after implantation.

16. The method of claim 15 , further comprising expanding the shunt conduit to a predetermined diameter using a balloon catheter.

17. The method of claim 15 , wherein the shunt conduit defines a neck where the outer surface traverses the atrial septum between conical sections.

18. The method of claim 17 , wherein the neck and the conical sections are collapsible.

19. The method of claim 17 , wherein the neck is between 4 and 6 mm in diameter.

20. The method of claim 15 , further comprising shunting blood through the atrial septum via the shunt conduit to treat heart failure.

21. The shunt of claim 1 , wherein the end region of the shunt conduit, when implanted in the expanded state, is configured to be disposed in the atrium and to not contact the atrial septum.

22. The shunt of claim 21 , wherein the shunt conduit further comprises a second end region at an opposing end of the shunt conduit and having a larger diameter when deployed than the smallest diameter,

wherein the second end region of the shunt conduit, when implanted in the expanded state, is configured to be disposed in an opposing atrium and to not contact the atrial septum.

23. The method of claim 15 , wherein the end region of the shunt conduit, when implanted in the expanded state, is disposed in the atrium and does not contact the atrial septum.

24. The method of claim 23 , wherein the shunt conduit further comprises a second end region at an opposing end of the shunt conduit and having a larger diameter when deployed than the smallest diameter,

wherein the second end region of the shunt conduit, when implanted in the expanded state, is disposed in an opposing atrium and does not contact the atrial septum.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 24, 2020
From: NITZAN, YAACOV; HARARI, BOAZ; SHMULEWITZ, ASCHER; SIVAN, TOVY
To: V-WAVE LTD.
Reel/Frame 053311/0658 →
Continuity (7)
Continuation 15650783 · Jul 14, 2017
Division 14227982 · Mar 27, 2014
Continuation 13108880 · May 16, 2011
Continuation PCTIL2010000354 · May 4, 2010
Provisional Application 61240667 · Sep 9, 2009
Provisional Application 61175073 · May 4, 2009
Related Publication 20200261705A1 · Aug 20, 2020
Cited By (4)
US 12,502,272 US 12,599,756 US 12,691,267 US 12,746,110