IP Library › Granted Patent US 12,453,626
Granted Patent B2
US 12,453,626 · App. 17/175,549 · Granted Oct 28, 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 12,453,626
App. No.
17/175,549
Granted
Oct 28, 2025
Kind
B2
Abstract

Systems and methods for implanting a shunt for regulating blood pressure between a patient's left and right atria are provided. The shunt comprises an anchor having a neck region, first and second end regions, and a conduit affixed with the anchor formed of a biocompatible material that is resistant to transmural and translation tissue ingrowth and that reduces a risk of paradoxical embolism. The shunt may be advanced through the sheath until the first region protrudes from the sheath and self-expands within the left atrium. The shunt and the sheath may then be retracted until the first region contacts the left side of the atrial septum. The sheath may further be retracted until the counterforce exerted by shunt tension on the atrial septum overcomes the friction of the retained portions of the shunt such that the second region is exposed from the sheath and self-expands within the second atrium.

Claims (36)

1. A system for treating a heart condition, the system comprising:

a sheath having a lumen and distal end sized and shaped to be positioned through an opening of an atrial septum of a patient;

a shunt comprising an anchor and a conduit, the anchor having a first region, a second region, and a neck region joining the first and second regions, the conduit affixed to the anchor to define a passageway through the shunt, the shunt configured to transition from a contracted delivery state within the lumen of the sheath to an expanded state, wherein the passageway maintains a continuous opening across the atrial septum in the expanded state and inhibits late lumen loss; and

a delivery catheter movably disposed within the lumen of the sheath and configured to advance the shunt through the lumen of the sheath until the first region protrudes from the distal end of the sheath and transitions from the contracted delivery state to the expanded state within a first atrium,

wherein the shunt and the sheath are configured to be retracted towards the atrial septum until the first region in the expanded state engages with the atrial septum within the first atrium, and

wherein the sheath is configured to be further retracted until the second region of the anchor is exposed from the distal end of the sheath and transitions from the contracted delivery state to the expanded state within a second atrium to implant the neck region at the atrial septum.

2. The system of claim 1 , wherein a force required to retract the sheath over the second region in the contracted delivery state is less than a force required to transition the first region from the expanded state to the contract delivery state.

3. The system of claim 2 , wherein the force required to retract the sheath over the second region in the contracted delivery state is less than a yield stress of the atrial septum.

4. The system of claim 1 , wherein the anchor forms a diabolo shape in the expanded state.

5. The system of claim 1 , wherein the first and second regions comprise a superelastic or a shape memory material.

6. The system of claim 1 , wherein a narrowest portion of the neck region is configured to be implanted to contact the atrial septum in the expanded state.

7. The system of claim 1 , wherein the conduit comprises a biocompatible material that encapsulates at least a portion of the anchor.

8. The system of claim 1 , wherein the delivery catheter is configured to be detachably coupled to the shunt in the contracted delivery state within the lumen of the sheath.

9. The system of claim 1 , wherein the delivery catheter is configured to advance the shunt through the lumen of the sheath until the delivery catheter reaches a stopping point such that the first region protrudes from the distal end of the sheath a predetermined distance.

10. The system of claim 9 , wherein the delivery catheter is configured to be retracted from the stopping point such that the sheath causes the first region to transition from the expanded state to the contracted delivery state for retrieval of the shunt.

11. The system of claim 1 , further comprising a guidewire configured to be positioned through the opening of the atrial septum of the patient, and wherein the sheath is configured to be positioned through the opening of the atrial septum over the guidewire.

12. The system of claim 1 , further comprising a dilator configured to be advanced over the guidewire to dilate the opening of the atrial septum, the dilator further configured to be removed through the lumen of the sheath.

13. A method for redistributing blood across a patient's interatrial septum, the method comprising:

positioning a distal end of a sheath through an opening of an atrial septum;

advancing a shunt comprising a conduit affixed to an anchor through the lumen of the sheath via a delivery catheter until a first region of the anchor protrudes from the distal end of the sheath and transitions from a contracted delivery state within the lumen of the sheath to an expanded state within a first atrium;

retracting the shunt and the sheath towards the atrial septum until the first region in the expanded state contacts the atrial septum within the first atrium; and

further retracting the sheath until a second region of the anchor is exposed from the distal end of the sheath and transitions from a contracted delivery state to an expanded state within a second atrium to thereby lock the shunt within the atrial septum,

wherein a passageway through the shunt maintains a continuous opening across the atrial septum in the expanded state and inhibits late lumen loss for shunting blood via the passageway between the first and second atria.

14. The method of claim 13 , wherein advancing the shunt through the lumen of the sheath via the delivery catheter comprises:

advancing the delivery catheter until the delivery catheter reaches a first stopping point wherein the shunt is within 1 to 5 cm from the distal end of the sheath; and

advancing the delivery catheter to a second stopping point such that the first region protrudes from the distal end of the sheath a predetermined distance.

15. The method of claim 14 , further comprising verifying that the distal end of the sheath is positioned within 1 to 3 cm beyond the atrial septum prior to advancing the delivery catheter to the second stopping point.

16. The method of claim 13 , wherein retracting the shunt and the sheath comprises retracting the shunt and the sheath towards the atrial septum until reverse tenting of the atrial septum is observed.

17. The method of claim 13 , wherein further retracting the sheath until the second region is exposed from the distal end of the sheath comprises further retracting the sheath until a counterforce exerted by shunt tension on the atrial septum overcomes a friction of the second region in the contracted delivery state within the sheath.

18. The method of claim 13 , further comprising decoupling the delivery catheter from the shunt prior to further retracting the sheath until the second region is exposed from the distal end of the sheath.

19. The method of claim 13 , further comprising:

injecting an agitated saline via the delivery catheter; and

observing where microbubbles of the agitated saline exit the distal end of the sheath via ultrasonic imaging to confirm a position of the distal end of the sheath within the first atrium.

20. The method of claim 13 , further comprising:

injecting radiographic contrast material via the delivery catheter; and

observing where the radiographic contrast material exits the distal end of the sheath via fluoroscopy to confirm a position of the distal end of the sheath within the first atrium.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 30, 2022
From: EIGLER, NEAL; NAE, NIR; ROSEN, LIOR; HAFELFINGER, WERNER; ROZENFELD, EREZ; WHITING, JAMES S; NITZAN, YAACOV; YACOBY, MENASHE
To: V-WAVE LTD.
Reel/Frame 060940/0078 →
Continuity (9)
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 61425792 · Dec 22, 2010
Provisional Application 61240667 · Sep 9, 2009
Provisional Application 61175073 · May 4, 2009
Related Publication 20210161637A1 · Jun 3, 2021
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