DEVICE AND METHOD FOR REGULATING PRESSURE IN A HEART CHAMBER

• US 20110306916A1
• Filed: 05/16/2011
• Published: 12/15/2011
• Est. Priority Date: 05/04/2009
• Status: Active Grant

• Current Assignee: V-Wave Ltd.
• Original Assignee: V-Wave Ltd.
• Inventors: Harari, Boaz, Shmulewitz, Ascher, Sivan, Tovy, Nitzan, Yaacov
• Granted Patent: US 8,696,611 B2
• Time in Patent Office: Days
• 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 a plurality of sinusoidal rings interconnected by longitudinally extending struts, the stent 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 across the stent, 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 stent comprises a neck and first and second flared end regions, the neck disposed between the first and second end regions and having a smaller diameter than the first or second flared end regions.

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

6. The shunt of claim 4, wherein the neck engages the patient'"'"'s atrial septum and the first and second end regions flank the atrial septum but do not contact the atrial septum.

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

8. 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.

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

10. 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 a plurality of sinusoidal rings interconnected by longitudinally extending struts, the stent 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 across the stent, the tissue valve configured to shunt blood flow from the left atrium to the right atrium when subjected to a predetermined pressure differential.

11. The method of claim 10, wherein the tissue valve comprises pericardium tissue.

12. The method of claim 11, wherein the pericardium tissue is porcine, equine, or bovine.

13. The method of claim 10, wherein the stent comprises a neck and first and second flared end regions, the neck disposed between the first and second end regions and having a smaller diameter than the first or second flared end regions.

14. The method of claim 13, wherein the neck is between 4 and 6 mm in diameter.

15. The method of claim 13, wherein the neck engages the patient'"'"'s atrial septum and the first and second end regions flank the atrial septum but do not contact the atrial septum.

16. The method of claim 10, wherein a flow rate capacity of the shunt increases with an increase in pressure of the left atrium.

17. The method of claim 10, 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.

18. The method of claim 10, wherein the tissue valve is configured to prevent blood flow from the right atrium to the left atrium.