Flow control valve

• US 4,560,375 A
• Filed: 01/30/1984
• Issued: 12/24/1985
• Est. Priority Date: 06/30/1983
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Pudenz-Schulte Medical Research Corporation
• Inventors: East, Gary P., Heindl, Alfons, Schulte, Rudolf R., Bryant, Marga M.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Kartchner, Gene B.
• Application Number:
  US06/575,165
• Time in Patent Office: 694 Days
• Field of Search: 604/8-10, 137/522
• US Class Current: 604/9
• CPC Class Codes: A61M 2039/0045 Radiopaque indicia
• CPC Class Codes: A61M 2039/0238 having means for locating the implanted device to insure proper injection, e.g. radio-emitter, protuberances, radio-opaque markers
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276

Abstract

A surgically implantable flow control valve is provided for use in shunt systems for controlling the release of entrapped body fluids. The valve includes a relatively rigid, unitized molded plastic base separating an inlet chamber from an outlet chamber and including one or more apertures passing from the inlet chamber to the outlet chamber, and a resilient membrane which is molded of a material different from the material of the plastic base and which is secured to the base in a manner covering the apertures through the base on the outlet chamber side of the base. Fluid flow occluders on the base facilitate both proximal and distal flushing, and radiopaque indicators and markers permit a surgeon to ascertain specific information about the device and the functioning of the shunt system which would otherwise be unavailable without additional surgery.

Claims

1. A surgically implantable flow control valve for controlling the flow of fluid from one portion of the human body to another, said valve comprising:

a substantially rigid polypropylene base of utilized construction including a plate having an inlet surface and an outlet surface, a tubular inlet connector integral with said plate, and a tubular outlet connector integral with said plate;

an inlet passageway through said base, said inlet passageway originating at an open end of said inlet connector and terminating at an inlet port situated on said inlet surface of said plate;

an outlet passageway through said base, said outlet passageway originating at an outlet port adjacent said outlet surface and terminating at an open end of said outlet connector;

a resilient dome substantially overlying said base and said inlet port, said dome having an arch-shape similar to one-half of a sphere, the inner surface of said dome being smooth and forming a seal against an upper surface of said base to create an inlet chamber between said dome and said base, said dome being deformable toward said base by external pressure so that the extent of deformation is limited by contact between said dome and said base;

a mounting pad generally underlying said base and interacting with the edges of said dome to substantially encase said base in connection with said dome;

an outlet chamber between said outlet surface and said outlet port;

a plate passageway permitting fluid communication between said inlet chamber and said outlet chamber;

a flow control member including a central support and a resilient membrane, said central support being securely attached to said base and extending therefrom into said outlet chamber to support said membrane, said membrane being generally arch-shaped and resiliently biased to normally contact said outlet surface generally along the outer edges of said membrane in a manner surrounding said plate passageway and forming a releasable seal between said outlet surface and the outer edges of said membrane, said outlet surface being sufficiently rigid to maintain a proper valve seat for the outer edges of said membrane despite pressure applied to said inlet surface caused by contact of said dome with said inlet surface when said dome is fully deformed, said membrane being formed of an elastomer material to prevent sticking with said polypropylene base;

means for occluding said inlet port in a manner permitting deformation of said dome to cause fluid contained in said inlet chamber to pass through said plate passageway into said outlet chamber and finally through said outlet passageway, said inlet port occluding means useful for flushing said valve in a distal direction;

means for occluding said plate passageway in a manner permitting deformation of said dome to cause fluid contained in said inlet chamber to pass through said inlet port into said inlet passageway, said plate passageway occluding means useful for flushing said valve in a proximal direction;

a radiopaque indicator situated on the upper surface of said dome, said indicator being X-ray detectable after implantation of said valve in the body for indicating the proximal-to-distal flow path through said valve;

an inlet radiopaque marker generally encircling a portion of said inlet connector; and

an outlet radiopaque marker generally encircling a portion of said outlet connector.

2. A valve as recited in claim 1, including means for determining the pressure/flow characteristics of said valve by X-ray photography/after implantation of said valve in the body.

3. A surgically implantable flow control valve for controlling the flow of fluid from one portion of the human body to another, said valve comprising:

an inlet;

an outlet;

a relatively rigid base forming a wall separating said inlet from said outlet;

an aperture through said wall for permitting flow of the fluid through said valve from said inlet to said outlet;

a flow control member, including a central support and a resilient membrane, said central support being securely attached to said wall adjacent said aperture and extending therefrom on the outlet side of said wall to support said membrane, said membrane being generally arch-shaped and resiliently biased to normally contact the outlet side of said wall generally along the outer edges of said membrane in a manner surrounding said aperture and forming a releasable seal between the outlet side of said wall and the outer edges of said membrane;

means for indicating the proximal-to-distal flow path through said valve, said indicating means being X-ray detectable after implantation of said valve in the body;

an inlet radiopaque marker generally situated adjacent a portion of said inlet; and

an outlet radiopaque marker generally situated adjacent a portion of said outlet.

4. A valve as recited in claim 3, including means for determining the pressure/flow characteristics of said valve by X-ray photography after implantation of said valve in the body.

5. A valve is recited in claim 3, wherein said membrane is formed of an elastomer material and said base is formed of a polypropylene material.

6. A valve as recited in claim 3, wherein said base includes a rigid plate which provides a planar valve seat to facilitate the formation of a releasable seal between the outer edges of said membrane and said plate, said plate having an inlet surface in communication with said inlet and an outlet surface in communication with said outlet.

7. A valve as recited in claim 6, including a flexible encasement generally surrounding said base, said encasement being deformable toward said inlet surface by external pressure primarily to facilitate manual flushing of said valve.

8. A valve as recited in claim 7, wherein said central support carries said membrane adjacent said outlet surface in a manner permitting deformation of said encasement without affecting the normal operation of said membrane.

9. A valve as recited in claim 3, further including a resilient dome secured to said base over the inlet side of said wall to form an inlet chamber in communication with said inlet, said dome being deformable toward said wall by external pressure, and said indicating means being situated on the upper surface of said dome.

10. A valve as recited in claim 9, wherein said dome includes a first wing and a second wing situated over said base, said first wing providing means for occluding said inlet in a manner permitting deformation of said dome to cause fluid contained in said inlet chamber to pass through said aperture into said outlet, said second wing providing means for occluding said aperture in a manner permitting deformation of said dome to cause fluid contained in said inlet chamber to be expelled from said valve through said inlet.

11. A surgically implantable flow control valve for controlling the flow of fluid from one portion of the human body to another, said valve comprising:

an inlet including an inlet chamber;

an outlet including and outlet chamber;

a base of unitized construction including a rigid plate which resists deformation, said plate having an inlet surface in communication with said inlet chamber and an outlet surface in communication with said outlet chamber;

an aperture through said plate for permitting flow of the fluid through said valve from said inlet chamber to said outlet chamber;

a flow control member including a central support and a resilient membrane, said central support being securely attached to said outlet surface and extending therefrom to support said resilient membrane, said resilient membrane being generally arch-shaped so that the outer edges of said membrane normally contact said outlet surface in a manner surrounding said aperture;

means for occluding said inlet; and

means for occluding said aperture in a manner preventing fluid communication between said inlet chamber and said outlet chamnber.

12. A valve as recited in claim 11, further including a resilient dome secured to said base over a portion of said inlet to form said inlet chamber, said dome being deformable toward said base by external pressure and having a radiopaque indicator situated on the upper surface of said dome, said indicator being X-ray detectable after implantation of said valve in the body for indicating the proximal-to-distal flow path through said valve.

13. A valve as recited in claim 12, including means for determining the pressure/flow characteristics of said valve by X-ray photography after implantation of said valve in the body.

14. A valve as recited in claim 11, further including an inlet radiopaque marker generally encircling a portion of said inlet and an outlet radiopaque marker generally encircling a portion of said outlet.

15. A valve as recited in claim 11, wherein said member is molded of a non-metallic synthetic polymer material different from the material of said base.

16. A valve as recited in claim 15, wherein said base is formed of a polypropylene material and said member is formed of an elastomer material.

42. A valve as recited in claim 11, including an inlet connector forming a portion of said inlet and an outlet connector forming a portion of said outlet, said inlet and outlet connectors being integrally formed with said base.

17. A surgically implantable flow control valve for controlling the flow of fluid from one portion of the human body to another, said valve comprising:

an inlet;

an outlet;

a base including a plate having an inlet surface in communication with said inlet and an outlet surface in communication with said outlet;

an aperture through said plate permitting said inlet to communicate with said outlet;

a flow control member including a central support and a resilient membrane, said central supporting being securely attached to said outlet surface and extending therefrom to supporting said resilient membrane, said resilient membrane being generally arch-shaped so that the outer edges of said membrane normally contact said outlet surface in a manner surrounding said aperture;

an inlet radiopaque marker situated adjacent a portion of said inlet; and

an outlet radiopaque marker situated ajacent a portion of said outlet.

18. A valve as recited in claim 17, including a resilient dome secured to said base over said inlet surface, said dome cooperating with said inlet surface to form an inlet chamber in communication with said inlet, said dome being deformable toward said inlet surface by external pressure.

19. A valve is recited in claim 18, further including a radiopaque indicator situated on the upper surface of said dome, said indicator being X-ray detectable after implantation of said valve in the body for indicating the proximal-to-distal flow path through said valve.

20. A valve as recited in claim 17, wherein said membrane is carried adjacent said outlet surface in a manner permitting deformation of said dome without affecting the normal operation of said membrane.

21. A valve as recited in claim 17, including means for determining the pressure/flow characteristics of said valve by X-ray photography after implantation of said valve in the body.

22. A valve as recited in claim 17, further including means for occluding said inlet in a manner permitting deformation of said dome to cause fluid contained in said inlet chamber to pass through said aperture into said outlet, said inlet occluding means useful for flushing said valve in a distal direction.

23. A valve as recited in claim 17, further including means for occluding said aperture in a manner permitting deformation of said dome to cause fluid contained in said inlet chamber to pass through said inlet, said aperture occluding means useful for flushing said valve in a proximal direction.

43. A valve as recited in claim 17, wherein said base is formed of a polypropylene material and said flow control member is formed of a non-metallic synthetic polymer material.

24. A surgically implantable flow control valve for controlling the flow of fluid from one portion of the human body to another, said valve comprising:

a base of unitized construction, including a substantially rigid plate having an inlet surface and an outlet surface, an inlet connector integral with said plate, and an outlet connector integral with said plate, said inlet surface of said plate having a first surface and a second surface;

an inlet passageway through said base, said inlet passageway originating at an open end of said inlet connector and terminating at an inlet port on said first surface;

an outlet passageway through said base, said outlet passageway originating at an outlet port adjacent said outlet surface and terminating at an open end of said outlet connector;

an inlet chamber adjacent said inlet surface, said inlet chamber communicating with said inlet passageway at said inlet port;

an outlet chamber adjacent said outlet surface, said outlet chamber communicating with said outlet passageway at said outlet port;

a plate passageway permitting fluid communication between said inlet chamber and said outlet chamber;

a flow control member including a central support and a resilient membrane, said central support being securely attached to said base plate and extending therefrom into said outlet chamber to support said membrane, said membrane being generally arch-shaped and resiliently biased to normally contact said outlet surface generally along the outer edges of said membrane in a manner surrounding said plate passageway; and

means for indicating the proximal-to-distal flow path through said valve, said indicating means being X-ray detectable after implantation of said valve in the body.

25. A valve as recited in claim 24, including a resilient dome secured to said base generally over said inlet surface, said dome cooperating with said inlet surface to form said inlet chamber, said dome being deformable toward said inlet surface by external pressure for primarily causing manual flushing of said valve, said indicating means being situated generally on the upper surface of said dome.

26. A valve as recited in claim 25, including means for occluding said inlet port in a manner permitting deformation of said dome to cause fluid contained in said inlet chamber to pass through said plate passageway into said outlet chamber and finally through said outlet passageway.

27. A valve as recited in claim 26, wherein a first portion of said dome resiliently covers said first surface in a manner permitting said first portion of said dome to interact with said first surface to occlude said inlet port.

28. A valve as recited in claim 25, including means for occluding said plate passageway in a manner permitting deformation of said dome to cause fluid contained in said inlet chamber to pass through said inlet port into said inlet passageway.

29. A valve as recited in claim 28, wherein a second portion of said dome covers said second surface in a manner permitting said second portion of said dome to be resiliently pressed against said second surface to occlude said plate passageway.

30. A valve as recited in claim 24, including an inlet radiopaque marker situated on said inlet connector near said open end of said inlet connector.

31. A valve as recited in claim 24, including an oulet radiopaque marker situated on said outlet connector near said open end of said outlet connector.

32. A valve as recited in claim 24, including means for determining the pressure/flow characteristics of said valve by X-ray photography after implantation of said valve in the body.

33. A surgically implantable flow control valve for controlling the flow of fluid from one portion of the human body to another, said valve comprising:

an inlet;

an outlet;

a base including a plate having an inlet surface in communication with said inlet and an outlet surface in communication with said outlet;

an aperture through said plate permitting said inlet to communicate with said outlet; and

a flow control member including a central support and a resilient membrane, said central support being securely attached to said outlet surface and extending therefrom to support said resilient membrane, said resilient membrane being generally arch-shaped so that the outer edges of said membrane contact said outlet surface in a manner surrounding said aperture.

34. A valve as recited in claim 33 wherein said membrane is molded of a non-metallic synthetic polymer material different from the material of said base.

35. A valve as recited in claim 34 wherein said base is formed of a polypropylene material.

36. A valve as recited in claim 35 wherein said membrane is formed of an elastomer material.

37. A valve as recited in claim 33 including a flexible encasement generally surrounding said base.

38. A valve as recited in claim 37 wherein said encasement is deformable toward said inlet surface by external pressure primarily to facilitate manual flushing of said valve.

39. A valve as recited in claim 38 wherein said central support holds said membrane adjacent said outlet surface in a manner permitting full deformation of said encasement toward said inlet surface without affecting the seal between the outer edges of said membrane and said plate.

40. A valve as recited in claim 38 wherein said base is sufficiently rigid to maintain a proper valve seat for said membrane on said outlet surface despite external pressure applied to said inlet surface when said encasement is fully deformed.

41. A valve as recited in claim 33 further including a resilient dome secured to said base over the inlet side of said plate to form an inlet chamber in communication with said inlet, said dome being deformable toward said plate by external pressure.