Flow control device having selectable alternative fluid pathways

• US 5,167,615 A
• Filed: 05/02/1991
• Issued: 12/01/1992
• Est. Priority Date: 05/15/1990
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Pudenz-Schulte Medical Research Corporation (Medtronic Plc)
• Inventors: Watson, David A., East, Gary P.
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US07/694,896
• Time in Patent Office: 579 Days
• Field of Search: 604/8-10, 604/247, 604/186, 137/854
• US Class Current: 604/9
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: Y10T 137/789 Central mount

Abstract

A flow control device for use in a subcutaneously implanted physiological shunt system includes a relatively rigid base and a resiliently flexible encasement which defines a fluid flow path therethrough from an inlet to an outlet. Two valves for controlling the flow of fluid through the device are situated within the fluid flow path between the inlet and the outlet. The fluid flow path includes a first fluid conduit which directs fluid through both valves, and a second fluid conduit which bypasses the first valve and directs fluid only through the second valve. The first valve is constructed to provide a greater resistance to flow through the device than the second valve, and when the second fluid conduit is unobstructed, fluid will tend to flow through the second fluid conduit and bypass the first valve. A pivotable plug is provided within the encasement for selectively occluding a portion of the second fluid conduit. The position of the plug is determined by a magnetically polarized, percutaneously manipulable cam also provided within the encasement. The plug and the cam are attached such that rotation of the cam in one direction causes the plug to occlude the second fluid conduit, and rotation of the cam in another direction opens the second fluid conduit to fluid flow. A siphon control device is provided adjacent to the outlet to prevent fluid flow in response to negative downstream hydrostatic pressure on the outlet of the device.

Claims

1. A fluid flow control device, comprising:

a housing having an inlet and an outlet;

a first fluid flow pathway through the housing from the inlet to the outlet, the first fluid flow pathway having first means including a first valve for resisting fluid flow therethrough;

a second fluid flow pathway through the housing from the inlet to the outlet, the second fluid flow pathway having second means including a second valve for resisting fluid flow therethrough, wherein the first fluid flow pathway directs fluid through the first and second valves, and the second fluid flow pathway bypasses the first valve and directs fluid through the second valve; and

means for selectively directing fluids through one of the first or the second fluid flow pathways, the fluid directing means being actuable by percutaneous manipulation of the device when subcutaneously implanted.

2. A fluid flow control device as set forth in claim 1, wherein the first and second valves each comprise a base including a valve passageway therethrough and a valve seat surrounding a portion of the valve passageway, and a flow control member contacting the valve seat in a manner normally occluding the valve passageway but selectively opening to permit controlled unidirectional flow therethrough.

3. A fluid flow control device as set forth in claim 2, wherein each flow control member includes a central support and a resilient membrane, the central support being attached to the respective base and extending therefrom to support the resilient membrane, the resilient membrane being generally arch-shaped and having a portion thereof capable of engaging the respective valve seat to occlude the respective valve passageway.

4. A fluid flow control device as set forth in claim 1, wherein the first valve provides a greater resistance to flow than the second valve.

5. A fluid flow control device as set forth in claim 1, wherein the means for selectively directing fluids through either the first or the second fluid flow pathways includes means for occluding the second fluid flow pathway.

6. A fluid flow control device as set forth in claim 5, wherein the means for occluding the second fluid flow pathway includes a selectively positionable plug movable between a first position wherein the second fluid flow pathway is open to fluid flow therethrough, and a second position wherein the second fluid flow pathway is closed to fluid flow therethrough.

7. A fluid flow control device as set forth in claim 6, wherein the means for occluding the second fluid flow pathway includes a magnetically polarized, percutaneously manipulable cam rotatable between a first position and a second position, the plug having an occluder at one end and a cam rider at another end, wherein the cam rider interacts with the cam such that rotation of the cam between its first and second positions simultaneously moves the plug between its first and second positions.

8. A fluid flow control device as set forth in claim 1, including a pump between the inlet and the outlet, wherein the pump provides means for flushing fluid from the fluid flow control device by application of percutaneous manual pressure to the device.

9. A fluid flow control device as set forth in claim 8, including means for temporarily occluding a portion of the fluid flow pathways adjacent to the inlet by application of percutaneous manual pressure to the housing such that actuation of the pump flushes fluid distally through the device.

10. A fluid flow control device as set forth in claim 8, including means for temporarily occluding a portion of the fluid flow pathways adjacent to the outlet by application of percutaneous manual pressure to the housing such that actuation of the pump flushes fluid proximally through the device.

11. A fluid flow control device as set forth in claim 1, including siphon control device means situated adjacent to the outlet and forming a portion of the fluid flow pathways, for preventing fluid flow through the device in the presence of negative hydrostatic pressure at the outlet.

12. A subcutaneously implantable shunt system, comprising:

a shunt inlet;

a shunt outlet;

first valve means for controlling fluid flow from the shunt inlet to the shunt outlet;

second valve means for controlling fluid flow from the shunt inlet to the shunt outlet;

first fluid conduit means for directing fluid through the first and second valve means as the fluid passes through the shunt system;

second fluid conduit means for directing fluid through the second valve means and bypassing the first valve means as the fluid passes through the shunt system; and

means for selectively directing fluid either through the first or second fluid conduit means, the fluid directing means including a selectively positionable plug movable between a first position wherein the second fluid conduit is open to fluid flow therethrough and a second position wherein the second fluid conduit is closed to fluid flow therethrough, and a magnetically polarized, percutaneously manipulable cam rotatable between a first position and a second position, the plug having means for occluding the second fluid conduit at one end and a cam rider at another end, wherein the cam rider interacts with the cam such that rotation of the cam between its first and second positions simultaneously moves the plug between its first and second positions.

13. A shunt system as set forth in claim 12 including a pump situated between the shunt inlet and the shunt outlet, wherein the pump provides means for flushing fluid through the shunt system by application of manual percutaneous pressure to the pump.

14. A shunt system as set forth in claim 12, including means for occluding a portion of the shunt system adjacent to the inlet by application of manual percutaneous pressure to the shunt system, and means for occluding a portion of the shunt system adjacent to the outlet by application of manual percutaneous pressure to the shunt system.

15. A shunt system as set forth in claim 12, including siphon control device means situated between the second valve means and the outlet, for preventing fluid flow through the device in the absence of negative hydrostatic pressure at the outlet.

16. A shunt system as set forth in claim 12, wherein the first and second valve means each include a base having a fluid passageway therethrough and a valve seat surrounding a portion of the fluid passageway, and a flow control member which contacts the valve seat in a manner normally occluding the fluid passageway but selectively opening to permit controlled unidirectional flow therethrough.

17. A shunt system as set forth in claim 16, wherein each flow control member includes a central support and a resilient membrane, the central support being attached to the respective base and extending therefrom to support the resilient membrane, the resilient membrane being generally arch-shaped and having a portion thereof capable of engaging the respective valve seat to occlude the respective fluid passageway.

18. A shunt system as set forth in claim 13, wherein the fluid directing means is situated within the pump, the first valve means is situated between the shunt inlet and he pump, and the second valve means is situated between the pump and the shunt outlet.

19. A flow control device having selectable alternative fluid pathways, for use in a subcutaneously implanted physiological shunt system, the flow control device comprising:

a housing having an inlet and an outlet;

a flushing reservoir situated between the inlet and the outlet and having an overlying, resiliently deformable dome forming a portion of the housing, the flushing reservoir providing means for flushing fluid through the flow control device by application of percutaneous manual pressure to the device to depress the dome;

a first valve situated between the inlet and the flushing reservoir, for controlling fluid flow from the inlet to the outlet;

a second valve situated between the flushing reservoir and the outlet, for controlling fluid flow from the inlet to the outlet;

first fluid conduit means for directing fluid through the first and second valves as the fluid passes through the flow control device;

second fluid conduit means for directing fluid through the second valve and bypassing the first valve as the fluid passes through the flow control device; and

means for selectively directing fluid either through the first or second fluid conduit means, the fluid directing means including a selectively positionable plug movable between a first position wherein the second fluid conduit is open to fluid flow therethrough and a second position wherein the second fluid conduit is closed to fluid flow therethrough, and a magnetically polarized, percutaneously manipulable cam rotatable between a first position and a second position, the plug having means for occluding the second fluid conduit at one end and a cam rider at another end, wherein the cam rider interacts with the cam such that rotation of the cam between its first and second positions simultaneously moves the plug between its first and second positions.

20. A flow control device as set forth in claim 19, wherein the first and second valve means each include a base having a fluid passageway therethrough and a valve seat surrounding a portion of the fluid passageway, and a flow control member which contacts the valve seat in a manner normally occluding the fluid passageway but selectively opening to permit controlled unidirectional flow therethrough.

21. A flow control device as set forth in claim 19, including a siphon control device adjacent to the outlet, which prevents fluid flow through the flow control device in the absence of positive upstream fluid pressure through the device or in response to negative hydrostatic downstream pressure on the device.

22. A flow control device as set forth in claim 19 including means for occluding a portion of the flow control device adjacent to the inlet by application of manual percutaneous pressure to the flow control device.

23. A fluid flow control device, comprising:

a housing having an inlet and an outlet;

a first fluid flow pathway through the housing from the inlet to the outlet, the first fluid flow pathway having first means for resisting fluid flow therethrough;

a second fluid flow pathway through the housing from the inlet to the outlet, the second fluid flow pathway having second means for resisting fluid flow therethrough; and

means for selectively directing fluids through one of the first or the second fluid flow pathways, the fluid directing means being actuable by percutaneous manipulation of the device when subcutaneously implanted;

wherein the means for selectively directing fluids through either the first or the second fluid flow pathways includes means for occluding the second fluid flow pathway, comprising a selectively positionable plug movable between a first position wherein the second fluid flow pathway is open to fluid flow therethrough, and a second position wherein the second fluid flow pathway is closed to fluid flow therethrough.

24. A fluid flow control device as set forth in claim 23, wherein the means for occluding the second fluid flow pathway includes a magnetically polarized, percutaneously manipulable cam rotatable between a first position and a second position, the plug having an occluder at one end and a cam rider at another end, wherein the cam rider interacts with the cam such that rotation of the cam between its first and second positions simultaneously moves the plug between its first and second positions.