Device and method for regulating pressure in a heart chamber

• US 9,707,382 B2
• Filed: 03/27/2014
• Issued: 07/18/2017
• Est. Priority Date: 05/04/2009
• Status: Active Grant

• Current Assignee: V-Wave Ltd.
• Original Assignee: V-Wave Ltd.
• Inventors: Sivan, Tovy, Nitzan, Yaacov, Harari, Boaz, Shmulewitz, Ascher
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): Zimbouski, Ariana
• Application Number:
  US14/227,982
• Publication Number:
  US 20140213959A1
• Time in Patent Office: 1,209 Days
• 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 having a length greater than a thickness of the patient'"'"'s atrial septum and comprising at least five sinusoidal rings interconnected by struts, the sinusoidal rings and struts defining a neck and first and second conical sections, 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 without contacting the atrial septum other than in a vicinity of the neck, the stent being configured to transition between a collapsed state suitable for percutaneous delivery and an expanded state when deployed across the patient'"'"'s atrial septum.

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

3. The shunt of claim 1, wherein the stent is coated with expanded-polytetrafluoroethylene (ePTFE).

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

5. The shunt of claim 1, wherein the neck has a length and a diameter, the neck length being greater than the thickness of the atrial septum.

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

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

8. The shunt of claim 1, wherein one of the at least five sinusoidal rings is located at the neck and has a diameter smaller than at least one other sinusoidal rings of the at least five sinusoidal rings.

9. 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 having a length greater than a thickness of the patient'"'"'s atrial septum and comprising a plurality of rings interconnected by struts, the rings and struts defining a neck and first and second conical sections, 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 without contacting the atrial septum other than in a vicinity of the neck, the stent being configured to transition between a collapsed state suitable for percutaneous delivery and an expanded state when deployed across the patient'"'"'s atrial septum.

10. The method of claim 9, wherein the neck is between 4 and 6 mm in diameter.

11. The method of claim 9, wherein a flow rate capacity of the shunt increases with an increase in pressure of the left atrium.

12. The method of claim 9, wherein the stent is between 10 and 18 mm in length in the collapsed state.

13. The method of claim 9, wherein the plurality of rings are sinusoidal and the struts extend longitudinally.

14. The method of claim 9, wherein the stent is coated with expanded-polytetrafluoroethylene (ePTFE).

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

a diabolo-shaped stent having a length greater than a thickness of the patient'"'"'s atrial septum and comprising a plurality of rings interconnected by struts, the rings and struts defining a neck and first and second conical sections, the neck being adaptable to engage the atrial septum and being between 4 and 6 mm in diameter, the first and second conical sections being adaptable to protrude respectively into the left and right atria without contacting the atrial septum other than in a vicinity of the neck, the stent being configured to transition between a collapsed state suitable for percutaneous delivery and an expanded state when deployed across the patient'"'"'s atrial septum.

16. The shunt of claim 15, wherein a flow rate capacity of the shunt increases with an increase in pressure of the left atrium.

17. The shunt of claim 15, wherein the plurality of rings are sinusoidal and the stent comprises at least five sinusoidal rings.

18. The shunt of claim 15, wherein the stent is coated with expanded-polytetrafluoroethylene (ePTFE).

19. The shunt of claim 15, wherein the neck has a length greater than the thickness of the atrial septum.

20. The shunt of claim 15, wherein the length of the stent is greater than twice the thickness of the atrial septum.

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

22. The shunt of claim 15, wherein one of the rings is located at the neck and has a diameter smaller than at least one of the other rings.