Burr-hole flow control device

• US 5,800,376 A
• Filed: 04/07/1997
• Issued: 09/01/1998
• Est. Priority Date: 09/29/1995
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Vaskelis, Paul S., Watson, David A.
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US08/826,782
• Time in Patent Office: 512 Days
• Field of Search: 604/8, 604/9, 604/10
• 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 device 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 device includes a rigid base including an inlet port and a valve seat which surrounds the inlet port, and a flow control member secured to the base. The flow control member has an asymmetric membrane which is resiliently biased to contact the valve seat in a manner forming a releasible seal therebetween, to provide controlled resistance to proximal-to-distal fluid flow through the device. The membrane includes a septum portion overlying the inlet port and a relatively thin portion responsive to fluid pressure differentials on inlet and outlet sides thereof. A membrane shield overlies an outlet side of the membrane and includes a needle guide aperture in alignment with the septum portion of the membrane and the inlet port.

Claims

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

a base including an inlet port and a valve seat surrounding the inlet port; and

a flow control member secured to the base and including an asymmetric membrane resiliently biased to contact the valve seat in a manner forming a releasable seal therebetween to provide controlled resistance to proximal-to-distal fluid flow through the device, the membrane including a thickened septum portion overlying the inlet port and a relatively thin portion responsive to fluid pressure differentials on inlet and outlet sides thereof.

2. The flow control device of claim 1, including an outlet separated from the inlet port by the flow control member.

3. The flow control device of claim 2, including a flexible encasement which, in connection with the base, defines a fluid reservoir between the inlet port and the outlet.

4. The flow control device of claim 3, wherein the encasement includes means for anchoring the device in place when surgically implanted.

5. The flow control device of claim 3, including a membrane shield within the fluid reservoir.

6. The flow control device of claim 5, wherein the membrane shield overlies the outlet side of the membrane and includes a needle guide aperture therethrough over the septum portion.

7. The flow control device of claim 6, wherein the needle guide aperture is aligned with the inlet port.

8. The flow control device of claim 6, including an alignment plug fixed to the septum portion and extending through the needle guide aperture.

9. The flow control device of claim 8, wherein the alignment plug comprises an elastomeric adhesive.

10. A surgically implantable flow control device for controlling the flow of fluid from one portion of a body to another, the device comprising:

a base including an inlet port and a valve seat surrounding the inlet port;

an inlet connector integral with the base and having a passageway therethrough terminating at the inlet port;

a flow control member secured to the base and including a membrane resiliently biased to contact the valve seat in a manner forming a releasable seal therebetween to provide controlled resistance to proximal-to-distal fluid flow through the device, the membrane including a thickened septum portion overlying the inlet port and a relatively thin portion responsive to fluid pressure differentials on inlet and outlet sides thereof;

an outlet separated from the inlet port by the flow control member; and

an outlet connector integral with the base and having a passageway therethrough forming the outlet.

11. The flow control device of claim 10, including an alignment plug fixed to the membrane and extending through the needle guide aperture.

12. The flow control device of claim 11, wherein the alignment plug comprises an elastomeric adhesive.

13. The flow control device of claim 10, wherein the membrane is disposed between the inlet port and the needle guide aperture.

14. The flow control device of claim 10, wherein the membrane shield includes prongs which engage the base to hold the membrane shield in place.

15. The flow control device of claim 10, including a flexible encasement which, in connection with the base, defines a fluid reservoir between the inlet port and the outlet, wherein the encasement includes means for anchoring the device when surgically implanted.

22. The flow control device of claim 10, including a membrane shield overlying the membrane and including a needle guide aperture therethrough in alignment with the inlet port.

16. A surgically implantable flow control device for controlling the flow of fluid from one portion of a body to another, the device comprising:

a base including an inlet port and a valve seat surrounding the inlet port;

a flow control member secured to the base and including an asymmetric membrane resiliently biased to contact the valve seat in a manner forming a releasable seal therebetween to provide controlled resistance to proximal-to-distal fluid flow through the device, the membrane including a thickened septum portion overlying the inlet port and a relatively thin portion responsive to fluid pressure differentials on inlet and outlet sides thereof; and

means for guiding a needle inserted into the flow control device when subcutaneously implanted, through the septum portion of the membrane.

17. The flow control device of claim 16, wherein the needle guide aperture is aligned with the inlet port, and further including an alignment plug fixed to the septum portion and extending through the needle guide aperture.

18. The flow control device of claim 16, wherein the alignment plug comprises an elastomeric adhesive.

20. The flow control device of claim 16, including an outlet separated from the inlet port by the flow control member, an inlet connector integral with the base and have having a passageway therethrough terminating at the inlet port, and an outlet connector integral with the base and having a passageway therethrough forming the outlet.

21. The flow control device of claim 20, including a flexible encasement which, in connection with the base, defines a fluid reservoir between the inlet port and the outlet.

23. The flow control device of claim 16, wherein the needle guiding means includes a membrane shield overlying the membrane and including a needle guide aperture therethrough over the septum portion.

19. The flow control device of claim wherein the membrane shield includes prongs which engage the base to hold the membrane shield in place.