DEVICE AND METHOD FOR CONTROLLING IN-VIVO PRESSURE

• US 20110218481A1
• Filed: 05/16/2011
• Published: 09/08/2011
• Est. Priority Date: 04/20/2001
• Status: Abandoned Application

• Current Assignee: V-Wave Ltd.
• Original Assignee: V-Wave Ltd.
• Inventors: Keren, Gad, Shmulewitz, Ascher, Rozy, Yoram, Rottenberg, Dan, Braun, Ori, Aba Zakay, Avraham
• Application Number:
  US13/108,850
• Publication Number:
  US 20110218481A1
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2476 Valves implantable in the body not otherwise provided for
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices
• 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

Abstract

A differential pressure regulating device is provided for controlling in-vivo pressure in a body, and in particularly in a heart. The device may include a shunt being positioned between two or more lumens in a body, to enable fluids to flow between the lumens, and an adjustable flow regulation mechanism being configured to selectively cover an opening of the shunt, to regulate the flow of fluid through the shunt in relation to a pressure difference between the body lumens. In some embodiments a control mechanism coupled to the adjustable flow regulation mechanism may be provided, to remotely activate the adjustable flow regulation mechanism.

Claims

1. A method for reducing elevated left atrial pressure, the method comprising:

providing a device comprising a shunt element configured to define a passageway between the left atrium and right atrium through the atrial septum of a heart, and a support structure configured to support the shunt element in a hole through the atrial septum, the device having a contracted delivery configuration and an expanded deployment configuration;

forming a hole through the atrial septum;

delivering the device, in the contracted delivery configuration, through the hole in the atrial septum; and

expanding the delivered device to the expanded deployment configuration.

2. The method of claim 1, wherein said shunt element comprises a valve element configured to regulate blood flow between the left atrium and the right atrium through the shunt element.

3. The method of claim 2, wherein said shunt element allows flow from the left atrium to the right atrium responsive to a pressure differential between the left atrium and the right atrium.

4. The method of claim 2, wherein the valve element comprises a leaflet.

5. The method of claim 2, wherein the valve element comprises a plurality of leaflets.

6. The method of claim 2, wherein the valve element comprises a duckbill valve.

7. The method of claim 2, wherein the valve element is coupled to the support structure by stitching.

8. The method of claim 1, wherein the shunt element is cylindrical.

9. The method of claim 1, wherein the support structure comprises a plurality of flanges.

10. The method of claim 1, wherein the support structure comprises first and second flanges.

11. The method of claim 10, wherein the first and second flanges are annular.

12. The method of claim 10, further comprising engaging first and second sides of the atrial septum with the first and second flanges.

13. The method of claim 12, wherein at least one of the first and second flanges comprises a curved portion that does not contact the atrial septum when deployed.

14. The method of claim 12, wherein at least one of the first and second flanges comprises a straight portion that is parallel to and in contact with the atrial septum when deployed.

15. The method of claim 10, wherein the first and second flanges are substantially the same size as one another.

16. The method of claim 1, further comprising mounting the device, in the contracted delivery configuration, within a catheter.

17. The method of claim 1, further comprising imaging the device during deployment in the hole in the atrial septum.