Methods and apparatus for reducing localized circulatory system pressure

• US 10,207,087 B2
• Filed: 01/13/2014
• Issued: 02/19/2019
• Est. Priority Date: 04/20/2001
• Status: Expired due to Fees

• Current Assignee: V-Wave Ltd.
• Original Assignee: Hemodynamx-Technologies, Ltd.
• Inventors: Keren, Gad, Kesten, Randy
• Primary Examiner(s): Rodriquez, Kari
• Assistant Examiner(s): Nguyen, Camtu
• Application Number:
  US14/154,080
• Publication Number:
  US 20140128795A1
• Time in Patent Office: 1,863 Days
• Field of Search: 604 8- 9, 600 16- 17, 600485-486, 600488
• 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 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: 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 2/2493 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
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: A61M 60/13 by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/165 implantable in, on, or around the heart
• CPC Class Codes: A61M 60/17 inside a ventricle, e.g. intraventricular balloon pumps
• CPC Class Codes: A61M 60/178 drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
• CPC Class Codes: A61M 60/216 including a rotating member acting on the blood, e.g. impeller
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/569 synchronous with the native heart beat
• CPC Class Codes: A61M 60/861 Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
• CPC Class Codes: A61M 60/892 Active valves, i.e. actuated by an external force
• CPC Class Codes: A61M 60/894 Passive valves, i.e. valves actuated by the blood
• CPC Class Codes: A61M 60/896 having flexible or resilient parts, e.g. flap valves

Abstract

The present invention is thus directed to methods and apparatus for decreasing pressure in a first portion of a vessel of the cardiac structure of a patient by implanting a shunt communicating with an area outside said first portion, whereby a volume of blood sufficient to reduce pressure in said first portion is released.

Claims

1. A shunt for reducing left ventricular end diastolic pressure (LVEDP), the shunt comprising;

a body adapted for percutaneous placement across an atrial septum of a human with congestive heart failure, the body having a first end and a second end and a passageway without a valve between the first end and the second end to permit blood to flow between the left atrium and the right atrium;

a first self-expanding end region at the first end that, when expanded, includes a first radial portion and a first circumferential portion such that the first radial portion extends from the first end of the body and connects to the first circumferential portion, the first self-expanding end region having a first planar, circumferential configuration parallel to the atrial septum, the first self-expanding end region adapted to communicate with the left atrium; and

a second self-expanding end region at the second end that, when expanded, includes a second radial portion and a second circumferential portion such that the second radial portion extends from the second end of the body and connects to the second circumferential portion, the second self-expanding end region having a second planar, circumferential configuration parallel to the atrial septum, the second self-expanding end region adapted to communicate with the right atrium,

wherein the shunt is configured to reduce LVEDP by transferring blood from the left atrium to the right atrium through the passageway to thereby treat congestive heart failure.

2. The shunt of claim 1, wherein the first and second self-expanding end regions comprise at least one of nickel-titanium and stainless steel.

3. The shunt of claim 1, wherein the first and second self-expanding end regions are configured to engage opposing sides of the atrial septum.

4. The shunt of claim 1, wherein the shunt is configured for implantation via a delivery catheter.

5. The shunt of claim 4, wherein the first and second self-expanding regions are configured to be compressed into a lumen of the delivery catheter.

6. The shunt of claim 4, wherein the shunt is configured to be coupled to the delivery catheter, and wherein the first and second self-expanding regions are configured to be compressed into a lumen of a sheath such that the delivery catheter delivers the shunt through the sheath.

7. The shunt of claim 1, wherein the body comprises metal and a coating for biocompatibility.

8. The shunt of claim 1, wherein an inside diameter of the body is between 1 and 5 mm.

9. The shunt of claim 1, wherein the shunt is configured to be in fluid communication with an implantable pump.

10. The shunt of claim 9, wherein the implantable pump is configured to move blood from a left ventricle to an aorta of the human.

11. A shunt comprising:

a body adapted for percutaneous placement across an atrial septum of a human with congestive heart failure, the body having a first end and a second end and a passageway without a valve between the first end and the second end to permit blood to flow between the left atrium and the right atrium;

a first self-expanding end region at the first end that, when expanded, includes a first radial portion and a first circumferential portion such that the first radial portion extends from the first end of the body and connects to the first circumferential portion, the first self-expanding end region having a first planar, circumferential configuration parallel to the atrial septum, the first self-expanding end region adapted to engage a side of the atrial septum; and

a second self-expanding end region at the second end that, when expanded, includes a second radial portion and a second circumferential portion such that the second radial portion extends from the second end of the body and connects to the second circumferential portion, the second self-expanding end region having a second planar, circumferential configuration parallel to the atrial septum, the second self-expanding end region adapted to engage an opposing side of the atrial septum,

wherein the body is adapted to permit bloodflow through the passageway between the left atrium and the right atrium to reduce blood pressure in the left atrium to thereby treat congestive heart failure.

12. The shunt of claim 11, wherein the first and second self-expanding end regions comprise at least one of nickel-titanium and stainless steel.

13. The shunt of claim 11, wherein the body comprises metal and a coating for biocompatibility.

14. The shunt of claim 11, wherein the shunt is configured to be in fluid communication with an implantable pump.

15. The shunt of claim 14, wherein the implantable pump is configured to move blood from a left ventricle to an aorta of the human.

16. The shunt of claim 14, wherein the implantable pump is configured to move blood towards the shunt.

17. The shunt of claim 14, wherein the shunt is adapted to be implanted in proximity to a sensor configured to sense cardiac activity.

18. The shunt of claim 17, wherein the implantable pump is electrically coupled to a signal processing unit configured to control operation of the implantable pump.

19. The shunt of claim 18, wherein the signal processing unit is electrically coupled to the sensor and configured to activate the implantable pump responsive to sensed conditions at the sensor.

20. The shunt of claim 14, wherein the implantable pump is configured to move blood to chronically reduce left ventricular end diastolic pressure (LVEDP).

21. The shunt of claim 11, wherein the first self-expanding end region has a first diameter, the second self-expanding end region has a second diameter, and the body has a body diameter, and

wherein the first and second diameters are greater than twice the body diameter.