SYSTEMS AND METHODS OF CONTROLLING FLOW OF BODILY FLUIDS

• US 20120232461A1
• Filed: 03/09/2012
• Published: 09/13/2012
• Est. Priority Date: 03/11/2011
• Status: Active Grant

• Current Assignee: Arkis BioSciences, Inc. (Integra LifeSciences Holdings Corporation)
• Original Assignee: Arkis BioSciences, Inc. (Integra LifeSciences Holdings Corporation)
• Inventors: SEAVER, Chad, ARNOTT, Chris, KILLEFFER, James Alexander
• Granted Patent: US 9,393,388 B2
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61B 5/0017 transmitting optical signals transmission by light H04B10/00
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61M 2205/3337 Controlling, regulating pressure or flow by means of a valve by-passing a pump
• 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

Systems and methods to regulate flow of bodily fluids, such as cerebrospinal fluid (CSF), including a fluid chamber, an inlet port to receive the bodily fluid into the fluid chamber, an outlet port to remove the bodily fluid from the chamber, and a pressure element to regulate the amount of fluid flowing from the inlet port to the outlet port based on a pressure of the bodily fluid against an absolute pressure reference.

Claims

1. A control system to regulate fluid flow in a patient, comprising:

a fluid chamber having an inlet port to receive a bodily fluid and an outlet port to discharge the received bodily fluid;

a pressure element to sense a first pressure of the bodily fluid in the fluid chamber and a second pressure opposing the first pressure; and

a valve member to regulate the amount of fluid discharged from the outlet port based on a comparison of the first pressure to the second pressure.

2. The control system of claim 1, wherein the valve member is normally closed to close the outlet port, and wherein the pressure element causes the valve member to open the outlet port when the first pressure reaches a threshold relative to the second pressure regardless of a pressure difference between the inlet port and the outlet port.

3. The control system of claim 1, wherein the first pressure corresponds to volumetric changes of bodily fluid in the fluid chamber facing a first surface of the pressure element, and the second pressure corresponds to a back pressure facing a second surface of the pressure element opposite to the first surface.

4. The control system of claim 3, wherein the control system comprises an adjustable member to adjust a pressure reference of the pressure element, the adjustable member being selectively controllable with respect to the pressure element to selectively adjust the second pressure by changing a characteristic of the adjustable member.

5. The control system of claim 4, wherein the adjustable member includes a compression member disposed between the adjustable member and the pressure element, and the change in characteristic corresponds to a change in compression of the compression member.

6. The control system of claim 4, wherein the adjustable member is spaced apart from the pressure element to define a pressure chamber having a volume between the pressure element and the adjustable member, and the pressure element moves with respect to the adjustable member when the valve is opened and closed such that the volume of the pressure chamber is changed when the valve is opened relative to when the valve is closed.

7. The control system of claim 4, wherein the characteristic is adjusted by one or more of heat, control signal, and compression.

8. The control system of claim 6, further comprising a vent member to ventilate pressure of the pressure chamber when the valve is opened and/or closed.

9. The control system of claim 6, further comprising a position sensor to sense a position of the pressure element, and a control unit to calculate a pressure and/or flow rate of fluid discharged from the outlet port based on the position of the pressure element.

10. The control system of claim 9, wherein the position sensor senses a position and/or temperature of the adjustable member, and the control unit calculates the second pressure based on the position and/or temperature of the adjustable member.

11. The control system of claim 4, further comprising a position sensor to sense a position of the adjustable member and/or pressure element to generate a control signal to open or close the valve.

12. The control system of claim 4, wherein the second pressure is a substantially vacuum pressure opposing the first pressure.

13. The control system of claim 1, further comprising a calibration unit to calibrate the comparison between the first and second pressure based on an external environmental pressure.

14. The control system of claim 4, wherein the fluid chamber and the adjustable member are separated by one or more of a diaphragm, a piston, and a bellows.

15. A shunt control system to regulate flow of bodily fluid in a patient, comprising:

a first catheter to receive the bodily fluid from a predetermined region of the patient;

a second catheter to direct the bodily fluid to a fluid compatible region of the patient away from the predetermined region;

a connection path to communicate the bodily fluid from the first catheter to the second catheter;

a valve assembly interposed between the first and second catheter to regulate a flow rate and/or pressure of the bodily fluid communicated by the connection path, the valve assembly comprising;

a fluid chamber having an inlet port to receive the bodily fluid from the first catheter, and an outlet port to discharge the received bodily fluid to the connection path;

a pressure element to sense a first pressure of the bodily fluid in the fluid chamber and a second pressure opposing the first pressure; and

a master control unit coupled to the connection path; and

a valve member to regulate the amount of fluid discharged from the outlet port, under the control of the master control unit, based on a comparison of the first pressure to the second pressure.

16. The shunt control system of claim 15, wherein the connection path comprises a fluid drain path integrated with an electrical communication path to form a monolithic tube structure to deliver the bodily fluid and electrical and/or mechanical control signals along the connection path, respectively.

17. The control system of claim 15, wherein the valve member is normally closed to close the outlet port, and wherein the pressure element causes the valve member to open the outlet port when the first pressure reaches a threshold relative to the second pressure regardless of a pressure difference between the inlet port and the outlet port.

18. A method of regulating fluid flow in a patient, comprising:

providing a fluid chamber having an inlet port to receive a bodily fluid and an outlet port to discharge the received bodily fluid;

sensing a first pressure of the bodily fluid in the fluid chamber;

sensing a second pressure of the pressure element opposing the first pressure; and

opening and closing the outlet port based on a comparison of the first pressure to the second pressure.

19. The method of claim 18, further comprising:

opening the outlet port when the first pressure reaches a threshold relative to the second pressure regardless of a pressure difference between the inlet port and the outlet port.

20. A shunt control system to regulate flow of cerebrospinal fluid (CSF) in a patient, comprising:

a fluid chamber having an inlet port to receive the CSF and an outlet port to remove the received CSF from the fluid chamber;

a pressure element to sense a first pressure of the bodily fluid in the fluid chamber and a second pressure opposing the first pressure; and

a valve member connected between the inlet port and outlet port to open and close the outlet port based on a comparison between the first and second pressure.