Proximal catheter assembly having a self-limiting aspiration valve

• US 20030187391A1
• Filed: 10/21/2002
• Published: 10/02/2003
• Est. Priority Date: 03/29/2002
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated
• Inventors: Hogendijk, Michael
• Granted Patent: US 7,004,931 B2
• Time in Patent Office: Days
• US Class Current: 604/119
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61M 1/7413 by changing the cross-section of the line
• CPC Class Codes: A61M 1/7415 by deformation of the fluid passage
• CPC Class Codes: A61M 2025/0078 for fluid inflow from the body into the catheter lumen

Abstract

The present invention is directed to a proximal catheter assembly configured to facilitate natural or suction-assisted aspiration through a catheter lumen. The proximal catheter assembly comprises a multi-function valve configured to perform functions associated with conventional check valves and relief valves. The valve is configured to regulate the direction of fluid flow, and further configured to regulate the rate of suction-assisted aspiration provided through the lumen of the catheter. When the rate of suction-assisted aspiration exceeds a predetermined threshold, the valve opens to allow fluid to be drawn from tubing coupled to the proximal catheter assembly, thereby mitigating excessively high rates of aspiration imposed upon the patient'"'"'s vessel.

Claims

1. Apparatus suitable for regulating the rate of suction-assisted aspiration provided to a working lumen of a catheter, the apparatus comprising:

a hub having an inlet, an outlet, an aspiration port, a bore in fluid communication with the inlet, the outlet and the aspiration port, wherein the inlet of the hub is coupled to the catheter so that the bore is in fluid communication with the working lumen of the catheter; and

a valve in fluid communication with the inlet, the outlet and the aspiration port,

wherein the valve is configured to regulate the direction of fluid flow between the inlet and the outlet, and further to regulate the rate of suction-assisted aspiration provided by the aspiration port to the working lumen of the catheter.

2. The apparatus of claim 1 wherein the valve is configured to provide partial communication between the outlet and the aspiration port when an aspiration threshold is exceeded.

3. The apparatus of claim 1 wherein the valve comprises a frame and at least one flap affixed to an interior surface of the frame.

4. The apparatus of claim 3 wherein the frame comprises a circular configuration.

5. The apparatus of claim 4 wherein the frame is disposed within a valve housing having a circular configuration.

6. The apparatus of claim 3 further comprising at least one pivot pin coupled to the frame, the pivot pin configured to permit partial rotation of the frame with respect to a valve housing.

7. The apparatus of claim 6 further comprising proximal and distal stops coupled to an interior surface of the valve housing, the proximal and distal stops configured to limit rotation of the frame.

8. The apparatus of claim 3 further comprising at lease one hinge coupled to the frame, the hinge configured to permit partial rotation of the frame with respect to a valve housing.

9. The apparatus of claim 8 further comprising an inner ring coupled to an interior surface of the valve housing, the inner ring configured to limit rotation of the frame with respect to the valve housing.

10. The apparatus of claim 3 wherein the flaps are formed from a membrane having at least one slit.

11. The apparatus of claim 3 wherein the flaps are provided with a predetermined rigidity.

12. The apparatus of claim 1 wherein the valve comprises an open position that enables flow from the inlet to the outlet, and a closed position that inhibits flow between the inlet and the outlet when suction is applied via the aspiration port.

13. A method for regulating the rate of suction-assisted aspiration provided to a working lumen of a catheter, the method comprising:

providing apparatus comprising a hub having an inlet, an outlet, an aspiration port, and a bore in fluid communication with the inlet, the outlet and the aspiration port, the inlet of the hub in fluid communication with the working lumen of the catheter;

providing a valve in fluid communication with the inlet, the outlet and the aspiration port;

using the valve to regulate the direction of fluid flow between the inlet and outlet; and

when a rate of suction-assisted aspiration provided by the aspiration port exceeds a predetermined threshold, transitioning the valve to an open state wherein fluid from the outlet is directed through the valve and toward the aspiration port.

14. The method of claim 13 further comprising returning the valve to a closed state when the rate of suction-assisted aspiration is reduced below the predetermined threshold.

15. The method of claim 13 wherein using the valve to regulate the direction of fluid flow comprises enabling fluid flow from the inlet into the outlet when suction-assisted aspiration is not provided via the aspiration port.

16. The method of claim 13 wherein using the valve to regulate the direction of fluid flow comprises inhibiting fluid flow from the outlet into the inlet when a rate of suction-assisted aspiration provided by the aspiration port is below the predetermined threshold.

17. The method of claim 13 wherein providing a valve comprises providing apparatus wherein the valve comprises at least one flap having a predetermined rigidity.

18. The method of claim 17 wherein providing a valve comprises providing apparatus wherein the predetermined rigidity of the flap is proportional to the predetermined threshold.

19. The method of claim 17 further comprising varying the predetermined rigidity of the flap by varying the material properties of the flap.

20. The method of claim 17 further comprising varying the predetermined rigidity of the flap by varying the configuration of the flap.