Methods and apparatus for reducing localized circulatory system pressure

• US 8,235,933 B2
• Filed: 05/13/2011
• Issued: 08/07/2012
• Est. Priority Date: 04/20/2001
• Status: Expired due to Term

• Current Assignee: V-Wave Ltd.
• Original Assignee: V-Wave Ltd.
• Inventors: Keren, Gad, Kesten, Randy
• Primary Examiner(s): Bianco, Patricia
• Assistant Examiner(s): NGUYEN, CAMTU TRAN
• Application Number:
  US13/107,832
• Publication Number:
  US 20110218477A1
• Time in Patent Office: 452 Days
• Field of Search: 604 8- 9, 623/1.15, 623/1.18, 623 124- 126
• US Class Current: 604/8
• 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 directed to methods and apparatus for decreasing pressure in the left atrium of a patient by implanting a valved shunt through the atrial septum, whereby a volume of blood sufficient to reduce pressure in said left atrium is released to the right atrium.

Claims

1. A device for decreasing blood pressure in the left atrium of a heart of a human with congestive heart failure, the device comprising:

a shunt tube element configured for percutaneous placement across an atrial septum of the human with congestive heart failure so as to define a passageway between the right atrium and the left atrium through the atrial septum;

a valve element disposed within the shunt tube element and configured to open to permit blood to flow from the left atrium to the right atrium through the shunt tube element only when the blood pressure in the left atrium exceeds the blood pressure in the right atrium; and

a fixation element comprising first and second self-expanding end regions configured to retain the shunt tube element within the atrial septum,

the device being configured such that the first self-expanding end region communicates with the left atrium and the second self-expanding end region communicates with the right atrium and reduces the blood pressure in the left atrium by transferring blood from the left atrium to the right atrium through the shunt tube element responsive to a predetermined differential atrial pressure.

2. The device of claim 1, wherein the first and second self-expanding end regions of the fixation element comprise first and second flanges.

3. The device of claim 2, wherein the first and second flanges are annular.

4. The device of claim 2, wherein the first and second flanges are configured to respectively engage first and second sides of the atrial septum.

5. The device of claim 1, wherein the valve element comprises at least two leaflets.

6. The device of claim 1, wherein the shunt tube element is cylindrical.

7. The device of claim 1, wherein the valve comprises a passive check-valve that allows blood flow only above a given threshold pressure.

8. The device of claim 1, wherein the fixation element surrounds and positions the shunt tube element.

9. The device of claim 1, wherein the valve element comprises a plurality of leaflets.

10. The device of claim 1, wherein the valve element comprises a leaflet.