Methods and apparatus for reducing localized circulatory system pressure

• US 20110218477A1
• Filed: 05/13/2011
• Published: 09/08/2011
• Est. Priority Date: 04/20/2001
• Status: Active Grant

• Current Assignee: V-Wave Ltd.
• Original Assignee: V-Wave Ltd.
• Inventors: Keren, Gad, Kesten, Randy
• Granted Patent: US 8,235,933 B2
• Time in Patent Office: Days
• US Class Current: 604/9
• 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. Preferably, the first portion comprises the left ventricle and the pressure reduced is the end diastolic pressure, which is accomplished by having the shunt communicate with the left ventricle so a small volume of blood is released from the left ventricle to reduce the end diastolic pressure. Most preferably, the shunt selectively permits flow when a pressure differential between the left ventricle and another chamber of a heart above a threshold pressure, whereby shunting is prevented during left ventricular systole, or, alternatively, selectively permits flow when a pressure differential between the left ventricle and another chamber of a heart is between a lower threshold and a higher threshold, whereby shunting is again prevented during left ventricular systole. In certain embodiments a semi-passive check-valve is controlled and actuated by an external signal, either using a signal generated by an intra-corporeal electrical battery or an externally coupled energy source. In certain embodiments, the shunt has a pump with an input connected to the left ventricle, or other portion with excessive pressure, and an output connected to a volume of lower pressure. The preferred method of implanting the shunt to effect the present invention is by deploying a tubular element having two ends and a tissue affixation element disposed at each of said ends via a catheter, preferably, the fixation element is a shape retaining metallic material that returns to its original shape as part of the retention aspect of its function. In preferred embodiments of the apparatus, the tubular element is comprised of a biologically inert non-metallic material.

Claims

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

a shunt element defining a passageway between the right atrium and the left atrium through the atrial septum;

a valve element disposed within the shunt element and configured to regulate blood flow between the left atrium and the right atrium through the shunt element; and

a fixation element configured to retain the shunt and valve elements in position relative to the atrial septum.

2. The device of claim 1, wherein the shunt element is tubular.

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

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

5. The device of claim 1, wherein the fixation element comprises first and second flanges.

6. The device of claim 5, wherein the first and second flanges are annular.

7. The device of claim 5, wherein the first and second flanges are configured to respectively engage first and second sides of the atrial septum.

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

9. The device of claim 1, wherein the valve element is configured to be disposed within the septum.

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

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

12. The device of claim 1, wherein the valve element comprises a duckbill valve.

13. The device of claim 1, wherein the valve allows blood flow through the shunt element when the pressure in the left atrium exceeds the pressure in the right atrium.

14. The device of claim 1, wherein the valve allows blood flow through the shunt element when the pressure in the left atrium exceeds 12 mmHg.