Implantable adjustable fluid flow control valve

• US 5,637,083 A
• Filed: 01/19/1996
• Issued: 06/10/1997
• Est. Priority Date: 01/19/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Pudenz-Schulte Medical Research Corporation (Medtronic Plc)
• Inventors: Bertrand, William J., Watson, David A.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): O YONG, KI
• Application Number:
  US08/588,822
• Time in Patent Office: 508 Days
• Field of Search: 604/8-10, 604/247, 604/248
• US Class Current: 604/9
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves

Abstract

A subcutaneously implantable and percutaneously adjustable fluid flow control device includes a magnetically adjustable valve for controlling fluid flow from an inlet to an outlet. The valve includes a housing having a fluid passageway therethrough, a valve element designed to bear upon a valve seat to close the passageway to fluid flow, and a spring which biases the valve element against the valve seat so as to keep the passageway closed until a fluid pressure differential between the inlet and the outlet exceeds a selected valve opening pressure. A fixed dual concentric stair-step array and an overlying rotor assembly permit the amount of bias applied to the valve element by the spring to be adjusted. The rotor assembly is adapted to rotate in response to an external or percutaneously-applied magnetic field. In one embodiment, the rotor assembly may be locked into one of several possible rotational positions relative to the stair-step array to prevent rotation thereof.

Claims

1. A subcutaneously implantable and percutaneously adjustable fluid flow control device, comprising:

an inlet for the control device;

an outlet for the control device spaced from the inlet; and

a valve apparatus for controlling fluid flow from the inlet to the outlet, the valve apparatus comprising;

a valve housing including a fluid passageway therethrough having a peripheral surface forming a valve seat;

a valve element adjacent to the valve seat;

means for biasing the valve element against the valve seat to keep the fluid passageway closed until a fluid pressure differential between the inlet and the outlet exceeds a selected valve opening pressure; and

means for adjusting a bias applied to the valve element by the biasing means, the adjusting means including a fixed dual concentric stair-step array and an overlying rotor assembly having a first surface which supports the biasing means and a second surface which is supported by the dual concentric stair-step array, wherein the rotor assembly is rotatable in response to a percutaneously-applied magnetic field and such rotation of the rotor assembly permits selected seating of the second surface on the stair-step array to raise or lower the rotor assembly with respect to the stair-step array.

2. The fluid flow control device of claim 1, wherein the dual concentric stair-step array includes a central rotor pivot, a plurality of inner steps surrounding the rotor pivot, and a plurality of outer steps extending peripherally about the inner steps, and wherein the rotor assembly includes a magnet imbedded within a base having an inner leg adapted to bear against a selected one of the plurality of inner steps, an outer leg disposed diametrically opposite the inner leg and adapted to bear against a selected one of the plurality of outer steps, and a central aperture through which the rotor pivot extends.

3. The fluid flow control device of claim 2, wherein the rotor assembly further includes a rotor cap fixed to the base on a side thereof opposite the inner and outer legs, the rotor cap providing the first surface of the rotor assembly and including a central aperture aligned with the central aperture of the base, through which the rotor pivot extends.

4. The fluid flow control device of claim 1, wherein the valve apparatus further includes a spring having one end bearing against a portion of the valve housing adjacent to the fluid passageway, and another end bearing against the first surface of the rotor assembly.

5. The fluid flow control device of claim 1, wherein the valve housing includes a flow regulator insert which defines the fluid passageway, threaded into an aperture of the valve housing.

6. The fluid flow control device of claim 1, including means for locking the rotor assembly into one of several possible rotational positions relative to the stair-step array, and means for disengaging the locking means to permit rotation of the rotor assembly in response to the magnetic field.

7. The fluid flow control device of claim 6, wherein the locking means comprises a pin having a first end that engages one of a plurality of detents in an outer peripheral surface of the rotor assembly, and wherein the disengaging means comprises pin actuating means for moving the pin between a first position wherein the first end of the pin engages one of the plurality of detents, and a second retracted position.

8. The fluid flow control device of claim 7, wherein the pin actuating means comprises a pivotable lever including a shaft that engages a second end of the pin, and a manually actuated lever which is biased to urge the pin into its first position.

9. The fluid flow control device of claim 1, including a pump situated between the inlet and the valve means, wherein the pump provides means for flushing fluid through the fluid flow control device by the percutaneous application of pressure to the pump.

10. The fluid flow control device of claim 9, including means for occluding a portion of a fluid flow path through the fluid flow control device adjacent to the inlet by the percutaneous application of pressure to the device, and means for occluding a portion of the fluid flow path adjacent to the outlet by the percutaneous application of pressure to the device.

11. The fluid flow control device of claim 1, including siphon control device means situated between the valve means and the outlet, for preventing fluid flow through the device in the absence of negative hydrostatic pressure at the outlet.

12. A subcutaneously implantable and percutaneously adjustable fluid flow control device, comprising:

an inlet for the control device;

an outlet for the control device spaced from the inlet;

a valve apparatus for controlling fluid flow from the inlet to the outlet, the valve apparatus comprising;

a valve housing including a fluid passageway therethrough having a peripheral surface forming a valve seat;

a valve element adjacent to the valve seat; and

means for biasing the valve element against the valve seat to keep the fluid passageway closed until a fluid pressure differential between the inlet and the outlet exceeds a selected valve opening pressure, the biasing means including a fixed stair-step array and an adjacent rotor assembly adapted to rotate relative to the stair-step array in response to a percutaneously-applied magnetic field, wherein such rotation raises or lowers the rotor assembly with respect to the stair-step array; and

a pump situated between the inlet and the valve means, wherein the pump provides means for flushing fluid through the device by the percutaneous application of pressure to the pump.

13. The fluid flow control device of claim 12, including siphon control device means situated between the valve means and the outlet, for preventing fluid flow through the device in the absence of negative hydrostatic pressure at the outlet.

14. The fluid flow control device of claim 12, wherein the stair-step array includes a central rotor pivot, a plurality of inner steps surrounding the rotor pivot, and a plurality of outer steps extending peripherally about the inner steps, and wherein the rotor assembly includes a magnet imbedded within a base having an inner leg adapted to bear against a selected one of the plurality of inner steps, an outer leg disposed diametrically opposite the inner leg and adapted to bear against a selected one of the plurality of outer steps, and a central aperture through which the rotor pivot extends.

15. The fluid flow control device of claim 14, wherein the biasing means includes a spring disposed between the valve element and the rotor assembly.

16. The fluid flow control device of claim 15, wherein the rotor assembly includes a rotor cap fixed to the base on a side thereof opposite the inner and outer legs, and a central aperture aligned with the central aperture of the base, through which the rotor pivot extends.

17. The fluid flow control device of claim 14, wherein the valve apparatus further includes a spring having one end bearing against a portion of the valve housing surrounding the fluid passageway, and another end bearing against the rotor assembly.

18. The fluid flow control device of claim 17, including a flow regulator insert threaded into an aperture of the valve housing to define the fluid passageway.

19. The fluid flow control device of claim 12, including means for locking the rotor assembly into one of several possible rotational positions relative to the stair-step array, and means for disengaging the locking means to permit rotation of the rotor assembly in response to the magnetic field, wherein the locking means comprises a pin having a first end that engages one of a plurality of detents in an outer peripheral surface of the rotor assembly, and wherein the disengaging means comprises pin actuating means for moving the pin between a first position wherein the first end of the pin engages one of the plurality of detents, and a second retracted position.

20. The fluid flow control device of claim 19, wherein the pin actuating means comprises pivotable lever including a shaft that engages a second end of the pin, and a manually actuated lever disposed within the pump and biased so as to urge the pin into its first position.

21. A subcutaneously implantable and percutaneously adjustable fluid flow control device, comprising:

an inlet for the control device;

an outlet for the control device spaced from the inlet;

valve means for controlling fluid flow from the inlet to the outlet, the valve means comprising;

a valve housing having a threaded aperture and a flow regulator insert threaded into the threaded aperture to define a fluid passageway therethrough, the fluid passageway having a peripheral surface forming a valve seat;

a valve element adjacent to the valve seat;

first spring means for biasing the valve element against the valve seat to keep the fluid passageway closed until a fluid pressure differential between the inlet and the outlet exceeds a selected valve opening pressure;

means for adjusting a bias applied to the valve element by the first spring means, the adjusting means including a fixed dual concentric stair-step array and an overlying rotor assembly having a first surface which supports an end of the first spring means, and a second surface which is supported by the dual concentric stair-step array, wherein the rotor assembly is rotatable in response to a magnetic field and such rotation of the rotor assembly permits selected seating of the second surface on the stair-step array to raise or lower the rotor assembly with respect to the stair-step array, the dual concentric stair-step array including a central rotor pivot, a plurality of inner steps surrounding the rotor pivot, and a plurality of outer steps extending peripherally about the inner steps, the rotor assembly including a magnet embedded within a base having an inner leg adapted to bear against a selected one of the plurality of inner steps, an outer leg disposed diametrically opposite the inner leg and adapted to bear against a selected one of the plurality of outer steps, a central aperture through which the rotor pivot extends, and a rotor cap fixed to the base on a side thereof opposite the inner and outer legs, the rotor cap providing the first surface of the rotor assembly and including a central aperture aligned with the central aperture of the base through which the rotor pivot extends; and

second spring means having one end bearing against a portion of the valve housing and another end bearing against the first surface of the rotor assembly; and

a pump situated between the inlet and the valve means, wherein the pump provides means for flushing fluid through the device by the percutaneous application of pressure to the pump.

22. The fluid flow control device of claim 21, including siphon control device means situated between the valve means and the outlet, for preventing fluid flow through the device in the absence of negative hydrostatic pressure at the outlet.

23. The fluid flow control device of claim 21, including means for locking the rotor assembly into one of several possible rotational positions relative to the stair-step array, and means for disengaging the locking means to permit rotation of the rotor assembly in response to the magnetic field, wherein the locking means comprises a pin having a first end that engages one of a plurality of detents in an outer peripheral surface of the rotor assembly, and wherein the disengaging means comprises pin actuating means for moving the pin between a first position wherein the first end of the pin engages one of the plurality of detents, and a second retracted position.

24. The fluid flow control device of claim 23, wherein the pin actuating means comprises pivotable lever including a shaft that engages a second end of the pin, and a manually actuated lever disposed within the pump and biased so as to urge the pin into its first position.

25. A subcutaneously implantable and percutaneously adjustable fluid flow control device, comprising:

an inlet for the control device;

an outlet for the control device spaced from the inlet; and

a valve apparatus for controlling fluid flow from the inlet to the outlet, the valve apparatus comprising;

a valve housing including a fluid passageway therethrough having a peripheral surface forming a valve seat;

a valve element adjacent to the valve seat; and

an assembly for biasing the valve element against the valve seat to keep the fluid passageway closed until a fluid pressure differential between the inlet and the outlet exceeds a selected valve opening pressure, the biasing assembly including a fixed stair-step array and an adjacent rotor assembly adapted to rotate relative to the stair-step array in response to a percutaneously-applied magnetic field, wherein such rotation raises or lowers the rotor assembly with respect to the stair-step array.

26. The fluid flow control device of claim 25, wherein the stair-step array includes a central rotor pivot, a plurality of inner steps surrounding the rotor pivot, and a plurality of outer steps extending peripherally about the inner steps, and wherein the rotor assembly includes a magnet imbedded within a base having an inner leg adapted to bear against a selected one of the plurality of inner steps, an outer leg disposed diametrically opposite the inner leg and adapted to bear against a selected one of the plurality of outer steps, and a central aperture through which the rotor pivot extends.

27. The fluid flow control device of claim 26, wherein the rotor assembly further includes a rotor cap fixed to the base on a side thereof opposite the inner and outer legs, the rotor cap providing the first surface of the rotor assembly and including a central aperture aligned with the central aperture of the base, through which the rotor pivot extends.

28. The fluid flow control device of claim 25, wherein the valve apparatus further includes a spring having one end bearing against a portion of the valve housing adjacent to the fluid passageway, and another end bearing against the first surface of the rotor assembly.

29. The fluid flow control device of claim 25, including a device for locking the rotor assembly into one of several possible rotational positions relative to the stair-step array, and a device for disengaging the locking device to permit rotation of the rotor assembly in response to the magnetic field, wherein the locking device comprises a pin having a first end that engages one of a plurality of detents in an outer peripheral surface of the rotor assembly, and wherein the disengaging device comprises pin actuating means for moving the pin between a first position wherein the first end of the pin engages one of the plurality of detents, and a second retracted position.

30. The fluid flow control device of claim 29, including a pump situated between the inlet and the valve apparatus, wherein the pump provides means for flushing fluid through the device by the percutaneous application of pressure to the pump, and wherein the pin actuating means comprises pivotable lever including a shaft that engages a second end of the pin, and a manually actuated lever disposed within the pump and biased so as to urge the pin into its first position.