Device and method for regulating pressure in a heart chamber

• US 8,696,611 B2
• Filed: 05/16/2011
• Issued: 04/15/2014
• Est. Priority Date: 05/04/2009
• Status: Active Grant

• Current Assignee: V-Wave Ltd.
• Original Assignee: V-Wave Ltd.
• Inventors: Nitzan, Yaacov, Harari, Boaz, Shmulewitz, Ascher, Sivan, Tovy
• Primary Examiner(s): Wiest, Philip R
• Assistant Examiner(s): Zimbouski, Ariana
• Application Number:
  US13/108,880
• Publication Number:
  US 20110306916A1
• Time in Patent Office: 1,065 Days
• Field of Search: 604/8, 604/9, 623/1.1, 623/1.11, 623/1.12, 623/1.13, 623/1.24, 623/1.302, 623/903
• US Class Current: 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 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2002/249 Device completely embedded in the heart wall
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves

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 left 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

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

a diabolo-shaped stent comprising intersecting first and second conical sections that intersect at a plane to define a neck, the stent having a length substantially greater than a thickness of the atrial septum and comprising a plurality of sinusoidal rings interconnected by longitudinally extending struts, the neck being adaptable to engage the atrial septum, the first and second conical sections being adaptable to protrude respectively into the left and right atria and to flank the atrial septum substantially without contacting the atrial septum, the stent being configured to transition between a collapsed state suitable for percutaneous delivery and an expanded state when deployed across a patient'"'"'s atrial septum; and

a tissue valve disposed wholly within either the first or second conical sections, the tissue valve configured to shunt blood flow from the left atrium to the right atrium when subjected to a predetermined pressure differential.

2. The shunt of claim 1, wherein the tissue valve comprises pericardium tissue.

3. The shunt of claim 2, wherein the pericardium tissue is porcine, equine, or bovine.

4. The shunt of claim 1, wherein the neck is between 4 and 6 mm in diameter.

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

6. The shunt of claim 1, wherein the tissue valve is configured to remain closed below a first threshold pressure differential, to open slightly between the first threshold pressure differential and a second pressure differential, and to fully open between the second pressure differential and a third pressure differential.

7. The shunt of claim 1, wherein the tissue valve is configured to prevent blood flow from the right atrium to the left atrium.

15. The shunt of claim 1, wherein the stent is between 10 and 18 mm in length in the collapsed state.

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

18. The shunt of claim 1, wherein the neck has a length greater than twice the thickness of the atrial septum.

19. The shunt of claim 1, wherein the neck has a length and a diameter, the neck length being greater than the neck diameter.

20. The shunt of claim 1, wherein the tissue valve is disposed wholly within the second conical section and is adapted to be disposed within the right atrium.

8. A method of regulating blood pressure between a patient'"'"'s left atrium and right atrium, the method comprising:

deploying a device in a hole in the patient'"'"'s atrial septum,

the device comprising a diabolo-shaped stent comprising intersecting first and second conical sections that intersect at a plane to define a neck, the stent having a length substantially greater than a thickness of the atrial septum and comprising a plurality of sinusoidal rings interconnected by longitudinally extending struts, the neck being adaptable to engage the atrial septum, the first and second conical sections being adaptable to protrude respectively into the left and right atria and to flank the atrial septum substantially without contacting the atrial septum, the stent being configured to transition between a collapsed state suitable for percutaneous delivery and an expanded state when deployed in the hole in the patient'"'"'s atrial septum,

the device further comprising a tissue valve disposed wholly within either the first or second conical sections, the tissue valve configured to shunt blood flow from the left atrium to the right atrium when subjected to a predetermined pressure differential.

9. The method of claim 8, wherein the tissue valve comprises pericardium tissue.

10. The method of claim 9, wherein the pericardium tissue is porcine, equine, or bovine.

11. The method of claim 8, wherein the neck is between 4 and 6 mm in diameter.

12. The method of claim 8, wherein a flow rate capacity of the shunt increases with an increase in pressure of the left atrium.

13. The method of claim 8, wherein the tissue valve is configured to remain closed below a first threshold pressure differential, to open slightly between the first threshold pressure differential and a second pressure differential, and to fully open between the second pressure differential and a third pressure differential.

14. The method of claim 8, wherein the tissue valve is configured to prevent blood flow from the right atrium to the left atrium.

16. The method of claim 8, wherein the stent is between 10 and 18 mm in length in the collapsed state.