IP Library › Granted Patent US 12,186,176
Granted Patent B2
US 12,186,176 · App. 18/320,108 · Granted Jan 7, 2025

Shunt for redistributing atrial blood volume

Inventors: Neal Eigler (Agoura Hills, CA); Nir Nae (Binyamina, IL); Lior Rosen (Zikhron Ya'akov, IL); Werner Hafelfinger (Thousand Oaks, CA); Erez Rozenfeld (Shoham, IL); James S. Whiting (Los Angeles, CA); Menashe Yacoby (Ramat Gan, IL); Yaacov Nitzan (Hertzelia, IL)
Assignee: V-Wave Ltd.
A61F2/01A61F2/2487A61M27/002A61F2002/249A61F2250/0051A61F2250/0098
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Quick Facts
Patent No.
US 12,186,176
App. No.
18/320,108
Granted
Jan 7, 2025
Kind
B2
Abstract

Interatrial shunts are described herein that are designed to benefit both the left side of the heart and the right side of the heart. The interatrial shunt is anchored in the atrial septum to permit blood to flow between atrial heart chambers across the atrial septum. In accordance with some aspects, the lumen of the shunt has an effective orifice area selected to permit blood flow across the atrial septum to unload the patient's left ventricle with beneficial effects on the patient's right ventricle. The shunts are structured to be suitably anchored at the atrial septum for long-term implantation. Further, the shunts preferably have insignificant late lumen loss. The interatrial shunts are expected to treat pathologies such as heart failure and pulmonary hypertension.

Claims (35)

1. A shunt for regulating blood volume distribution configured for placement in a puncture in a patient's heart between a first heart area and a second heart area, the shunt comprising:

an anchor comprising an hourglass-shaped body having a first region, a second region, a neck region joining the first region to the second region, the anchor configured to transition from a collapsed delivery state to an expanded deployed state in which the first region extends into the first heart area, the second region extends into the second heart area, and the neck region is disposed at the puncture,

wherein the anchor defines a lumen therethrough configured to maintain a continuous opening that permits blood to flow across the puncture via the shunt and inhibits late lumen loss, wherein the lumen has an effective orifice area selected to permit blood flow across the puncture to thereby reduce the patient's left atrial pressure and increase ejection fraction while preserving the patient's right atrial pressure and pulmonary artery pressure.

2. The shunt of claim 1 , wherein the shunt is configured to be implanted in the patient experiencing low ejection fraction from heart failure.

3. The shunt of claim 1 , wherein the effective orifice area is from 11.0 to 30.0 mm 2 .

4. The shunt of claim 1 , wherein the effective orifice area is from 17.7 to 19.1 mm 2 .

5. The shunt of claim 1 , wherein the effective orifice area is from 11.31 to 25.44 mm 2 .

6. The shunt of claim 1 , wherein the lumen at a narrow portion of the neck region has a diameter of 4-6 mm in the expanded deployed state and a coefficient of discharge of 0.9 resulting in the effective orifice area being from 11.31 to 25.44 mm 2 .

7. The shunt of claim 1 , wherein the first region and the second region flare radially outward upon the transition from the collapsed delivery state to the expanded deployed state.

8. The shunt of claim 1 , wherein the neck region's diameter is smaller than the first and second region's diameters in the expanded deployed state.

9. The shunt of claim 1 , further comprising a conduit coupled to the anchor to define the lumen.

10. The shunt of claim 9 , wherein the conduit is formed of expanded-polytetrafluoroethylene (ePTFE).

11. The shunt of claim 9 , wherein the conduit inhibits late lumen loss.

12. The shunt of claim 1 , wherein the shunt further comprises a drug to inhibit late lumen loss.

13. The shunt of claim 1 , wherein ends of the first and/or second regions are configured to protrude by not more than 7 mm into the patient's left and/or right atria in the expanded deployed state.

14. The shunt of claim 1 , wherein the lumen of the shunt is sized and shaped to permit an amount of blood to flow across the patient's interatrial septum to treat the patient's heart failure.

15. The shunt of claim 1 , wherein the lumen of the shunt is sized and shaped to permit an amount of blood to flow across the patient's interatrial septum to treat the patient's pulmonary hypertension.

16. The shunt of claim 1 , wherein the lumen of the shunt is sized and shaped to permit an amount of blood to flow across the patient's interatrial septum while preventing right ventricle (RV) overload.

17. The shunt of claim 1 , wherein the lumen of the shunt is sized and shaped to permit an amount of blood to flow across the patient's interatrial septum to lower blood pressure in the patient's left atrium.

18. The shunt of claim 1 , wherein the anchor is configured to self-expand to the expanded deployed state.

19. The shunt of claim 1 , wherein the anchor is formed of superelastic material.

20. The shunt of claim 1 , wherein the lumen of the anchor has a coefficient of discharge of 0.7 or greater.

21. The shunt of claim 1 , wherein the anchor is laser cut from a single tube of nitinol.

22. The shunt of claim 1 , wherein the lumen at a narrow portion of the neck region has a diameter of 3-6 mm in the expanded deployed state.

23. The shunt of claim 1 , wherein the first heart area is a left atrium and the second heart area is a right atrium.

24. The shunt of claim 1 , wherein the first heart area is a left atrium and the second heart area is a coronary sinus.

25. The shunt of claim 1 , wherein the anchor exhibits an outward radial force sufficient to maintain a fixed diameter for the lumen.

26. The shunt of claim 25 , wherein the outward radial force is greater than 10 Newton.

27. The shunt of claim 1 , further comprising an ePTFE conduit coupled to the anchor that defines the lumen and defines a lumen wall that is resistant to transmural and translational tissue growth.

28. The shunt of claim 1 , further comprising an ePTFE conduit coupled to the anchor that has a first end configured to extend from the neck region a first distance of at least 3 mm into the patient's left atrium and a second end configured to extend from the neck region a second distance of at least 3 mm into the patient's right atrium, thereby preventing pannus formation from narrowing the lumen in the neck region.

29. The interatrial shunt of claim 28 , wherein the ePTFE conduit is configured so that when implanted the second end of the ePTFE conduit is located out of a natural circulation flow path of blood entering into the patient's right atrium from an inferior vena cava, thereby reducing a risk of emboli entrained in flow from the inferior vena cava being directed into the second end of the ePTFE conduit.

30. A method for regulating blood volume distribution between a patient's first heart area and the patient's second heart area, the method comprising:

implanting a shunt at a puncture in a heart to treat a heart condition, the shunt comprising:

an anchor comprising an hourglass-shaped body having a first region, a second region, a neck region joining the first region to the second region, the anchor configured to transition from a collapsed delivery state to an expanded deployed state in which the first region extends into the first heart area, the second region extends into the second heart area, and the neck region is disposed at the puncture,

wherein the anchor defines a lumen therethrough configured to maintain a continuous opening that permits blood to flow across the puncture via the shunt and inhibits late lumen loss, wherein the lumen has an effective orifice area selected to permit blood flow across the puncture to thereby reduce the patient's left atrial pressure and increase ejection fraction while preserving the patient's right atrial pressure and pulmonary artery pressure.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 27, 2023
From: EIGLER, NEAL; NAE, NIR; ROSEN, LIOR; HAFELFINGER, WERNER; ROZENFELD, EREZ; WHITING, JAMES S.; NITZAN, YAACOV; YACOBY, MENASHE
To: V-WAVE LTD.
Reel/Frame 064088/0182 →
Continuity (12)
Continuation In Part 17823047 · Aug 29, 2022
Continuation 17175549 · Feb 12, 2021
Continuation In Part 16130988 · Sep 13, 2018
Continuation 15449834 · Mar 3, 2017
Continuation In Part 14712801 · May 14, 2015
Division 13193335 · Jul 28, 2011
Continuation In Part PCTIL2010000354 · May 4, 2010
Provisional Application 63365018 · May 19, 2022
Provisional Application 61425792 · Dec 22, 2010
Provisional Application 61240667 · Sep 9, 2009
Provisional Application 61175073 · May 4, 2009
Related Publication 20230285133A1 · Sep 14, 2023
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