Device and method for controlling in-vivo pressure

• US 8,070,708 B2
• Filed: 02/03/2005
• Issued: 12/06/2011
• Est. Priority Date: 02/03/2004
• Status: Active Grant

• Current Assignee: V-Wave Ltd.
• Original Assignee: V-Wave Ltd.
• Inventors: Rottenberg, Dan, Braun, Ori, Aba Zakay, Avraham, Shmulewitz, Ascher, Rozy, Yoram, Keren, Gad
• Primary Examiner(s): Deak, Leslie
• Assistant Examiner(s): SU, SUSAN SHAN
• Application Number:
  US10/597,666
• Publication Number:
  US 20070282157A1
• Time in Patent Office: 2,497 Days
• Field of Search: 623/2.2, 623/1.26, 604/8, 137 1522- 1525
• 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 17/11 for performing anastomosis; Buttons for anastomosis
• 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: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2476 Valves implantable in the body not otherwise provided for
• 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

Abstract

A differential pressure regulating device is provided for controlling in-vivo pressure in a body, and in particularly in a heart. The device may include a shunt being positioned between two or more lumens in a body, to enable fluids to flow between the lumens, and an adjustable flow regulation mechanism being configured to selectively cover an opening of the shunt, to regulate the flow of fluid through the shunt in relation to a pressure difference between the body lumens. In some embodiments a control mechanism coupled to the adjustable flow regulation mechanism may be provided, to remotely activate the adjustable flow regulation mechanism.

Claims

1. A differential pressure regulating device, the device comprising:

a shunt being for positioning in the septum of a heart between a left atrium and a right atrium, to enable fluids to flow between said left atrium and said right atrium, and an adjustable flow regulating mechanism configured for setting a blood flow rate through said shunt as function of a pressure differential between said left atrium and said right atrium such that an increase in said pressure differential within a first pressure differential range results in a different blood flow rate increase through said shunt as compared to an identical increase in said pressure differential within a second pressure differential range;

wherein said first pressure differential range is approximately 12-20 mmHg.

2. The pressure regulating device of claim 1, wherein said shunt is configured for protruding into said left atrium and/or said right atrium when positioned within said septum.

3. The pressure regulating device of claim 1, comprising a control mechanism to remotely control said flow regulating mechanism.

4. The pressure regulating device of claim 3, wherein said control mechanism includes one or more mechanisms selected from the group consisting of:

wires, lines, springs, pins, cables, magnets, hooks, latches, electric mechanisms, pressure transducers, telemetry mechanisms, wireless mechanisms, pneumatic mechanisms, and motors.

5. The pressure regulating device of claim 1, wherein said second differential range has an upper limit of approximately 12 mmHg or a lower limit of approximately 20 mmHg.

6. The differential pressure regulating device, of claim 1 further comprising

a control mechanism to be coupled to said adjustable flow regulating mechanism, said control mechanism being remotely activatable to adjust said adjustable flow regulating mechanism.

7. The pressure regulating device of claim 6, wherein said control mechanism includes one or more mechanisms selected from the group consisting of one or more wires, lines, springs, pins, cables, magnets, hooks, latches, electric mechanisms, pressure transducers, wireless mechanisms, telemetry mechanisms, pneumatic mechanisms, and motors.

8. A method of regulating pressure in a heart chamber comprising:

implanting a shunt in a septum between a left atrium and a right atrium of a heart in a body of a subject in need, wherein said shunt comprises an adjustable flow regulating mechanism configured for setting a blood flow rate within said shunt as function of a pressure differential between said left atrium and said right atrium; and

deploying said adjustable flow regulating mechanism, thereby regulating pressure in said left atrium;

wherein said adjustable flow regulating mechanism sets a blood flow rate through said shunt as function of a pressure differential between said left atrium and said right atrium such that an increase in said pressure differential within a first pressure differential range results in a higher blood flow rate increase through said shunt as compared to an identical increase in said pressure differential within a second pressure differential range.

9. The pressure control method of claim 8, comprising remotely controlling said adjustable flow regulating mechanism.

10. A method of regulating pressure in a heart chamber comprising:

implanting a shunt in a septum between a left atrium and a right atrium of a heart in a body of a subject in need, wherein said shunt comprises a valve configured for setting a blood flow rate within said shunt as function of a pressure differential between said left atrium and said right atrium; and

deploying said valve, thereby regulating pressure in said left atrium;

wherein said valve sets a blood flow rate through said shunt as function of a pressure differential between said left atrium and said right atrium such that an increase in said pressure differential within a first pressure differential range results in a higher blood flow rate increase through said shunt as compared to an identical increase in said pressure differential within a second pressure differential range.