Burr-hole flow control valve

• US 4,636,194 A
• Filed: 11/08/1985
• Issued: 01/13/1987
• 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: Bryant, Marga M., East, Gary P., Heindl, Alfons, Schulte, Rudolf R.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Kartchner, Gene B.
• Application Number:
  US06/796,299
• Time in Patent Office: 431 Days
• Field of Search: 604/8-10, 137/522
• US Class Current: 604/9
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves

Abstract

A surgically implantable flow control valve positionable over a burr-hole through a patient'"'"'s skull 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 having a planar valve seat portion, an inlet passageway through the base which terminates at an inlet port situated within the planar valve seat portion of the base, 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 surrounding and covering the inlet port, and an outlet separated from the inlet by the resilient membrane. Radiopaque indicators and markers are provided which 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 positionable upon a burr-hole through a patient'"'"'s skull for controlling the flow of cerebrospinal fluid from the brain ventricles to another portion of the body, said valve comprising:

a substantially rigid base of unitized construction including a valve supporting portion having a planar surface, an inlet connector integral with said supporting portion, and an outlet connector integral with said supporting portion, said supporting portion being situated within a protective well formed by said base;

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 planar surface;

a resilient dome substantially overlying said valve supporting portion of said base to form a reservoir chamber therebetween, said dome having an arch-shape and being deformable toward said base by external pressure so that the extent of deformation is limited by contact between said dome and said base;

an outlet passageway through said base, said outlet passageway originating at an outlet port in open communication with said reservoir chamber and terminating at an open end of said outlet connector;

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 reservoir chamber to support said membrane, said membrane being generally arch-shaped and resiliently biased to contact said planar surface generally along the outer edges of said membrane in a manner surrounding said inlet port and forming a releasable seal between said planar surface and the outer edges of said membrane;

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

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

means for indicating the pressure/flow characteristics of said valve, said indicating means being x-ray detectable after implantation of said valve.

2. 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 rigid base having a planar surface;

a flow control member including a central support and a resilient membrane, said central support being securely attached to said base and extending therefrom to support said resilient membrane, said resilient membrane being generally arch-shaped and resiliently biased to contact said planar surface generally along the outer edges of said membrane in a manner forming a releasable seal between said planar surface and the outer edges of said membrane;

an inlet including an inlet port situated on said planar surface in a position surrounded by the releasable seal between said planar surface and the outer edges of said membrane;

an outlet separated from said inlet by said flow control member; and

a flexible encasement generally surrounding said base.

3. A valve as recited in claim 2, including an inlet connector integral with said base, said inlet connector having a passageway therethrough forming said inlet.

4. A valve as recited in claim 3, including an outlet connector integral with said base, said outlet connector having an outlet passageway therethrough forming said outlet.

5. A valve as recited in claim 4, including 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.

6. A valve as recited in claim 2, wherein said encasement includes means for anchoring said valve in place when surgically implanted.

7. A valve as recited in claim 2, wherein said planar surface is situated within a protective well formed by said base, and wherein a resilient dome forming a portion of said flexible encasement substantially overlies said well to form a reservoir chamber in connection therewith, said dome having an arch-shape and being deformable toward said planar surface by external pressure.

8. A valve as recited in claim 2, wherein said base is formed of a molded plastic, and said membrane is molded of a non-metallic synthetic polymer material different from the material of said base.

9. 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 base of unitized construction including a valve supporting portion having a planar surface, an inlet connector integral with said supporting portion, and an outlet connector integral with said supporting portion;

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 planar surface;

a flow control member including a central support and a resilient membrane, said central support being securely attached to said base and extending therefrom to support said membrane, said membrane being generally arch-shaped and resiliently biased to contact said planar surface generally along the outer edges of said membrane in a manner surrounding said inlet port and forming a releasable seal between said planar surface and the outer edges of said membrane;

an outlet passageway through said base, said outlet passageway originating at an outlet port separated from said inlet port by said flow control member, and terminating at an open end of said outlet connector; and

a flexible encasement generally surrounding said base and including means for anchoring said valve.

10. A valve as recited in claim 9, wherein said encasement is deformable toward said planar surface by external pressure primarily for causing manual flushing of said valve.

11. A valve as recited in claim 10, wherein said encasement includes a resilient dome substantially overlying said valve supporting portion of said base to form a reservoir chamber therebetween.

12. A valve as recited in claim 9, wherein said base provides a protective well within which said resilient membrane is situated.

13. A valve as recited in claim 9, including an inlet radiopaque marker generally encircling a portion of said inlet connector.

14. A valve as recited in claim 9, including an outlet radiopaque marker generally encircling a portion of said outlet connector.

15. A valve as recited in claim 9, including means for indicating the pressure flow characteristics of said valve, said indicating means being x-ray detectable after implantation of said valve.

16. A valve a recited in claim 9, wherein said membrane is molded of a non-metallic synthetic polymer material different from the material of said base.

17. A valve as recited in claim 16, wherein said base is formed of a polypropylene material.

18. A valve as recited in claim 17, wherein said membrane is formed of an elastomer material.

19. 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 rigid base having a planar surface;

a flow control member including a central support and a resilient membrane, said central support being securely attached to said base and extending therefrom to support said resilient membrane, said resilient membrane being generally arch-shaped and resiliently biased to contact said planar surface generally along the outer edges of said membrane in a manner forming a releasable seal between said planar surface and the outer edges of said membrane;

an inlet including an inlet port situated on said planar surface in a position surrounded by the releasable seal between said planar surface and the outer edges of said membrane; and

an outlet separated from said inlet by said flow control member;

wherein said planar surface is situated within a protective well formed by said base, and wherein a resilient dome substantially overlies said well to form a reservoir chamber in connection therewith, said dome having an arch-shape and being deformable toward said planar surface by external pressure.