DEVICE AND METHOD FOR REGULATING PRESSURE IN A HEART CHAMBER

• US 20140213959A1
• Filed: 03/27/2014
• Published: 07/31/2014
• Est. Priority Date: 05/04/2009
• Status: Active Grant

• Current Assignee: V-Wave Ltd.
• Original Assignee: V-Wave Ltd.
• Inventors: SHMULEWITZ, Ascher, NITZAN, Yaacov, HARARI, Boaz, SIVAN, Tovy
• Granted Patent: US 9,707,382 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 having a length substantially greater than a thickness of the 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 and to flank the atrial septum substantially without contacting the atrial septum, the stent being configured to transition between a collapsed state suitable for percutaneous delivery and an expanded state when deployed across a 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 plurality of rings are sinusoidal and the stent comprises at least five sinusoidal rings.

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 a thickness of the atrial septum.

6. The shunt of claim 1, wherein a length of the stent is greater than twice a 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 rings is located at the neck and has a diameter smaller than at least one of the other 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 substantially greater than a thickness of the 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 and to flank the atrial septum substantially without contacting the atrial septum, the stent being configured to transition between a collapsed state suitable for percutaneous delivery and an expanded state when deployed across a 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. A shunt for regulating blood pressure between a patient'"'"'s left atrium and right atrium, the shunt comprising:

a stent having a length substantially greater than a thickness of the atrial septum and a neck and a conical section, the neck being adaptable to engage the atrial septum, the conical section being adaptable to protrude into the left atrium and to flank the atrial septum substantially without contacting the atrial septum, the stent being configured to transition between a collapsed state suitable for percutaneous delivery and an expanded state when deployed across a patient'"'"'s atrial septum; and

an anchoring element coupled to the neck, the anchoring element being adaptable for placement in the right atrium such that the anchoring element contacts the atrial septum when the shunt is deployed.

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

a shunt body adapted for placement at an atrial septum; and

two or more movable end elements coupled to the shunt body and adapted for placement in a left atrium, each movable end element extending from a distal end of the shunt body to an area adjacent the atrial septum,

wherein the movable end elements are configured to move towards and away from one another to control an amount of blood flow through the shunt body.

16. The shunt of claim 15, wherein the movable end elements comprise sail-like elements configured to deform responsive to pressure change.

17. The shunt of claim 16, wherein each sail-like element has a valve flap extending from the distal end of the shunt body to the area adjacent the atrial septum, and

wherein the valve flaps are configured to move away from one another to increase blood flow through the shunt body when a pressure in the left atrium is above a predetermined threshold.

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

a shunt conduit adapted for placement at an atrial septum, the shunt conduit having a length substantially greater than a thickness of the atrial septum,

wherein the shunt conduit is configured to be collapsible after implantation responsive to pressure changes in the left atrium.

19. The shunt of claim 18, wherein the shunt conduit has a diabolo shape.

20. The shunt of claim 18, wherein an opening through the shunt conduit is configured to change diameter as a function of left atrium pressure change.