Shunt for redistributing atrial blood volume

• US 10,076,403 B1
• Filed: 03/03/2017
• Issued: 09/18/2018
• 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:
  US15/449,834
• Publication Number:
  US 20180243071A1
• Time in Patent Office: 564 Days
• 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 device for regulating blood volume distribution configured for placement in an interatrial septum between a patient'"'"'s left atrium and patient'"'"'s right atrium, the device comprising:

an anchor 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 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 contacts the interatrial septum;

a conduit affixed to the anchor and having a lumen wall defining a lumen, the lumen wall resistant to transmural and translational tissue growth, the conduit having 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.

2. The device of claim 1, wherein the conduit is configured so that when implanted 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.

3. The device of claim 2, wherein the second end is configured to extend into the right atrium a distance of at least 5 mm when implanted.

4. The device of claim 1, wherein the second end is configured so that when implanted the neck region engages a fossa ovalis of the patient'"'"'s interatrial septum and the second end protrudes a distance of between 3 mm to 15 mm into the patient'"'"'s right atrium.

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

6. The device of claim 1, wherein at least the first region is flared.

7. The device 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.

8. The device 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.

9. The device of claim 1, wherein a length of the anchor is different than a length of the conduit.

10. The device 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.

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

an anchor having, in a deployed state, a first region configured to be disposed in the patient'"'"'s left atrium, a second region configured to be disposed in a right atrium, and a neck region disposed between the first and second regions, the neck region configured to engage a fossa ovalis of an atrial septum;

a conduit affixed to the anchor and having a lumen that extends through the first region, the second region and the neck region, the conduit configured so that when implanted an end of the conduit 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.

12. The device of claim 11, wherein the distance is greater than or equal to 5 mm.

13. The device of claim 11, wherein a wall of the conduit is resistant to transmural and translational tissue growth and 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.

14. The device of claim 11, wherein at least one of the first region and the second region is flared.

15. The device of claim 11, wherein the conduit encapsulates the anchor.

16. The device of claim 11, wherein the anchor has a diameter in the expanded deployed state larger than a diameter of the conduit, such that the anchor is configured to fill a larger opening in the interatrial septum than needed to accommodate the conduit.

17. The device of claim 11, wherein conduit has a length different than a length of the anchor.

18. The device of claim 11, wherein the anchor comprises, in the expanded deployed state, a filter that excludes emboli from entering the lumen.

19. The device of claim 11, wherein the anchor comprises a plurality of longitudinal struts, a subset of the longitudinal struts having eyelets configured to engage a delivery device.

20. The device of claim 19, wherein a subset of the longitudinal struts include radiopaque markers.

21. The device of claim 19, wherein the anchor further comprises a plurality of circumferential sinusoidal struts interconnecting the longitudinal struts, and the conduit encapsulates the anchor except for a portion defining cutouts adjacent to the end of the conduit.