Device and method for controlling in-vivo pressure

• US 9,724,499 B2
• Filed: 05/16/2011
• Issued: 08/08/2017
• Est. Priority Date: 04/20/2001
• Status: Active Grant

• Current Assignee: V-Wave Ltd.
• Original Assignee: V-Wave Ltd.
• Inventors: Aba Sakay, Avraham, Rozy, Yoram, Braun, Ori, Shmulewitz, Ascher, Keren, Gad, Rottenberg, Dan
• Primary Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US13/108,672
• Publication Number:
  US 20110218479A1
• Time in Patent Office: 2,276 Days
• Field of Search: 604 8- 9, 623 115, 623 118, 623 124- 126
• 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 device for treating a heart condition in a patient, the device for implanting into an atrial septum of the patient'"'"'s heart, the device comprising:

a core segment defining a tube having an unobstructed passageway, the core segment comprising a flexible material and configured to transition between a collapsed state having a first diameter suitable for percutaneous delivery and an expanded, deployed state having a second diameter larger than the first diameter, the core segment configured in the deployed state to engage an opening in the atrial septum and to permit flow of blood through the unobstructed passageway across the atrial septum;

a first annular structure comprising a plurality of support arm segments adapted to engage a first surface of the atrial septum; and

a second annular structure comprising a plurality of support arm segments adapted to engage a second surface of the atrial septum,

wherein each of the first annular structure and the second annular structure comprises flexible materials configured to transition between a collapsed delivery state and an expanded deployed state.

2. The device of claim 1, wherein the core segment comprises a superelastic material.

3. The device of claim 2, wherein the core segment comprises a flexible frame.

4. The device of claim 1, wherein the support arm segments are more flexible than the core segment.

5. The device of claim 1, wherein said second annular structure further comprises at least one support arm segment that is longer than said plurality of second support arm segments.

6. A shunt for treating a heart condition in a patient, the shunt configured to be implanted into an atrial septum of the patient'"'"'s heart, the shunt comprising:

a frame defining a tube having an unobstructed passageway, the frame comprising a flexible material and configured to transition between a collapsed state having a first diameter suitable for percutaneous delivery and an expanded, deployed state having a second diameter larger than the first diameter, the frame configured in the deployed state to engage an opening in the atrial septum and to permit flow of blood through the unobstructed passageway across the atrial septum;

a first annular structure adapted to engage a first wall of the atrial septum; and

a second annular structure adapted to engage a second wall of the atrial septum,

wherein each of the first annular structure and the second annular structure comprises flexible materials configured to transition between a collapsed delivery state and an expanded deployed state.

7. The shunt of claim 6, wherein the frame comprises a flexible metal.

8. The shunt of claim 7, wherein the frame comprises Nitinol or Nitinol wire.

9. The shunt of claim 6, wherein the frame comprises a helical shape.

10. The shunt of claim 6, wherein the first and second annular structures are integrally formed with the frame.

11. The shunt of claim 6, wherein the first and second annular structures each comprises a curved portion when deployed.

12. The shunt of claim 6, wherein the first and second annular structures comprise curved arms at opposing ends of the frame.

13. The shunt of claim 6, wherein the frame is configured for percutaneous delivery in a delivery tube.