Shunt for redistributing atrial blood volume

• US 10,251,740 B2
• Filed: 09/13/2018
• Issued: 04/09/2019
• Est. Priority Date: 05/04/2009
• Status: Active Grant

• Current Assignee: V-Wave Ltd.
• Original Assignee: V-Wave Ltd.
• Inventors: Eigler, Neal, Rosen, Lior, Hafelfinger, Werner, Rozenfeld, Erez, Ben-David, Tamir, Nae, Nir, Yacoby, Menashe, Nitzan, Yaacov
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US16/130,978
• Publication Number:
  US 20190015188A1
• Time in Patent Office: 208 Days
• Field of Search: 604 8, 604 9
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/249 Device completely embedded in the heart wall
• CPC Class Codes: A61F 2250/0051 differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A shunt for regulating blood pressure between a patient'"'"'s left atrium and right atrium comprises an anchor comprising a neck region, first and second end regions, and a conduit affixed with the anchor that formed of a biocompatible material that is resistant to transmural and translation tissue ingrowth and that reduces a risk of paradoxical embolism.

Claims

1. A method for regulating blood volume distribution across a patient'"'"'s interatrial septum between the patient'"'"'s left atrium and the patient'"'"'s right atrium, the method comprising:

forming a puncture through a fossa ovalis of the interatrial septum;

percutaneously delivering an anchor in a contracted delivery state through the puncture of the interatrial septum, the anchor having a first region, a second region, a neck region joining the first region to the second region;

transitioning the anchor from the contracted delivery state to an expanded deployed state in which the first region extends into the patient'"'"'s left atrium, the second region extends into the patient'"'"'s right atrium, and the neck region engages the interatrial septum; and

shunting blood through a lumen of a conduit affixed to the anchor, the conduit comprising a first end that extends from the neck region a first distance of at least 3 mm into the patient'"'"'s left atrium and a second end that extends 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,

wherein the lumen of the conduit is defined by a lumen wall, the lumen wall resistant to transmural tissue growth.

2. The method of claim 1, wherein the lumen wall is resistant to translational tissue growth.

3. The method of claim 1, wherein, when the anchor is in the expanded deployed state, the second end of the 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 conduit.

4. The method of claim 3, wherein the second end of the conduit is configured to extend into the right atrium a distance of at least 5 mm when the anchor is in the expanded deployed state.

5. The method of claim 1, wherein the neck region engages a fossa ovalis of the patient'"'"'s interatrial septum in the expanded deployed state.

6. The method of claim 1, wherein the second end of the conduit protrudes a distance of between 3 mm to 15 mm into the patient'"'"'s right atrium when the anchor is in the expanded deployed state.

7. The method of claim 1, wherein the lumen of the conduit has a smallest diameter in the neck region in a range of 5 mm to 6.5 mm.

8. The method of claim 1, wherein at least one of the first region and the second region is flared.

9. The method of claim 1, wherein the conduit comprises a layer of biocompatible material disposed on the anchor and an exterior surface of the conduit is impermeable to transmural tissue growth and resistant to translational tissue growth.

10. The method of claim 1, wherein the anchor has a diameter in the expanded deployed state larger than a diameter of the conduit, such that when implanted the anchor fills a larger opening in the interatrial septum than is needed to accommodate the conduit.

11. The method of claim 1, wherein a length of the anchor is different than a length of the conduit.

12. The method of claim 1, wherein the anchor, in the expanded deployed state, forms a filter that prevents emboli from entering the second end of the conduit.

13. A method for regulating blood volume distribution between a patient'"'"'s left atrium and the patient'"'"'s right atrium, the method comprising:

forming a puncture through a fossa ovalis of the interatrial septum;

percutaneously delivering an anchor in a contracted delivery state through the puncture of the interatrial septum, the anchor having a first region, a second region, and a neck region disposed between the first and second regions;

transitioning the anchor from the contracted delivery state to an expanded deployed state in which the first region is disposed in the patient'"'"'s left atrium, the second region is disposed in the patient'"'"'s right atrium, and the neck region engages a fossa ovalis of the patient'"'"'s interatrial septum; and

shunting blood through a lumen of a conduit affixed to the anchor, the conduit comprising an end that protrudes into the right atrium a distance sufficient to place the end out of a natural circulation flow path in the right atrium, thereby reducing a risk that thrombus entrained in the natural circulation flow path will be directed into the lumen.

14. The method of claim 13, wherein the distance is greater than or equal to 5 mm.

15. The method of claim 13, wherein a wall of the conduit is resistant to transmural and translational tissue growth.

16. The method of claim 13, wherein the conduit extends into each of the first region and the second region at least 3 mm beyond a location of contact of the anchor to any cardiac structure.

17. The method of claim 13, wherein the conduit encapsulates the anchor.

18. The method of claim 13, wherein the conduit encapsulates the anchor except for a portion defining cutouts adjacent to the end of the conduit.

19. The method of claim 13, Wherein conduit has a length different than a length of the anchor.

20. The method of claim 13, wherein the anchor comprises a plurality of longitudinal struts, a subset of the longitudinal struts having eyelets configured to engage a delivery device.