Device and method for controlling in-vivo pressure

• US 10,463,490 B2
• Filed: 08/03/2017
• Issued: 11/05/2019
• Est. Priority Date: 02/03/2004
• Status: Active Grant

• Current Assignee: V-Wave Ltd.
• Original Assignee: V-Wave Ltd.
• Inventors: Rottenberg, Dan, Braun, Ori J., Aba Zakay, Avraham, Shmulewitz, Ascher, Rozy, Yoram, Keren, Gad
• Primary Examiner(s): Schall, Matthew W
• Application Number:
  US15/668,622
• Publication Number:
  US 20170325956A1
• Time in Patent Office: 824 Days
• 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 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 comprising:

a first annular structure comprising a first plurality of support arms;

a second annular structure comprising a second plurality of support arms, at least one of the second plurality of support arms comprising a distal end adapted to be, when deployed, substantially parallel with a septal wall of the patient'"'"'s atrial septum and to contact the septal wall, wherein the at least one of the second plurality of support arms includes a first curved section that extends into the patient'"'"'s atrium so as to define a space between the at least one of the second plurality of support arms and the septal wall when deployed and a second curved section that extends from the first curved section toward the septal wall and the distal end of the at least one of the second plurality of support arms; and

a shunt coupled to the first and second annular structures, the shunt defining a continuous opening in the atrial septum to permit passage of blood through the atrial septum via the shunt.

2. The device of claim 1, further comprising a coating to increase bio-compatibility.

7. The device of claim 1, wherein the device comprises a flexible metal.

8. The device of claim 7, wherein the flexible metal comprises Nitinol or Nitinol wire.

9. The device of claim 1, wherein the device comprises a shape-memory material.

10. The device of claim 1, further comprising an adjustable flow regulation mechanism to regulate the flow of blood through the shunt in relation to a pressure difference between the patient'"'"'s atrium and the patient'"'"'s other atrium.

11. The device of claim 1, wherein the device is configured to be contracted in a delivery catheter for percutaneous delivery to the atrial septum and to expand after deployment from the delivery catheter.

12. The device of claim 11, wherein the device is configured to be deployed in a puncture made in the atrial septum.

3. A device for implanting in an opening of an atrial septum, the device comprising:

a first annular structure comprising a first proximal end and a first plurality of support arms extending distally away therefrom, each of the first plurality of support arms comprising a first distal end;

a second annular structure comprising a second proximal end and a second plurality of support arms extending distally away therefrom, each of the second plurality of support arms comprising a second distal end substantially parallel with a respective first distal end of the first plurality of support arms when deployed; and

a shunt defining a continuous opening in the atrial septum to permit passage of blood through the atrial septum via the shunt,

wherein the first proximal end and the second proximal end are contiguous to define the shunt having spaced apart apertures, the shunt adapted to maintain atraumatic contact with the opening of the atrial septum.

4. The device of claim 3, further comprising a coating to increase bio-compatibility.

13. The device of claim 3, wherein the device comprises a flexible metal.

14. The device of claim 3, wherein the device comprises a shape-memory material.

15. The device of claim 3, wherein the device is configured to be contracted in a delivery catheter for percutaneous delivery to the atrial septum and to expand after deployment from the delivery catheter.

16. The device of claim 15, wherein the device is configured to be deployed in a puncture that forms the opening of the atrial septum.

5. A device for implanting in an opening of an atrial septum, the device comprising:

a first annular structure comprising a first plurality of support arms, each of the first plurality of support arms adapted to contact a first wall of the atrial septum;

a second annular structure comprising a second plurality of support arms, each of the second plurality of support arms adapted to contact a second wall of the atrial septum; and

a shunt coupled to the first and second annular structures, the shunt defining a continuous opening in the atrial septum to permit passage of blood through the atrial septum via the shunt.

6. The device of claim 5, further comprising a coating to increase bio-compatibility.

17. The device of claim 5, wherein the device comprises a flexible metal.

18. The device of claim 5, wherein the device comprises a shape-memory material.

19. The device of claim 5, wherein the device is configured to be contracted in a delivery catheter for percutaneous delivery to the atrial septum and to expand after deployment from the delivery catheter.

20. The device of claim 19, wherein the device is configured to be deployed in a puncture that forms the opening of the atrial septum.