Three stage valve

• US 4,776,838 A
• Filed: 07/10/1987
• Issued: 10/11/1988
• Est. Priority Date: 12/08/1983
• Status: Expired due to Term

• Current Assignee: NMT NeuroSciences (International), Inc.
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Hooven, Michael D., Sainte-Rose, Christian
• Primary Examiner(s): Cohan, Alan
• Application Number:
  US07/070,680
• Time in Patent Office: 459 Days
• Field of Search: 604/9, 604/10, 604/129, 604/247, 137/508, 137/504, 137/496, 137/503
• US Class Current: 604/9
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: Y10T 137/7783 Valve closes in responses to reverse flow
• CPC Class Codes: Y10T 137/7792 Movable deflector or choke
• CPC Class Codes: Y10T 137/7834 Valve seat or external sleeve moves to open valve

Abstract

An implantable valve for allowing the passage of cerebrospinal fluid (CSF) from a ventricle of the brain to a suitable drainage location in the body includes a movable diaphragm, one side of which is in pressure communication with the drainage location of the body and the other side of which is in pressure communication with the ventricular spaces of the brain. A valve assembly, actuable by displacement of the diaphragm in response to a pressure differential applied thereto, regulates passage of CSF from the ventricular spaces to the drainage location. When differential pressure is relatively small, the valve is actuated to a constant pressure mode in which a predetermined differential pressure across the valve is maintained. In response to a sudden increase in differentail pressure, the valve mechanism is actuated to a constant flow mode in which a desired relatively constant rate of fluid flow is maintained. Above a predetermined pressure differential, the valve is actuated once again to a constant pressure mode in which differential pressure above a predetermined maximum is prevented.

Claims

1. A surgically implantable valve for controlling the passage of cerebrospinal fluid from a ventricle in the brain, wherein the fluid is normally subject to pressure variations within a predetermined nominal range, and abnormally subject to pressure variations in excess thereof extending to a predetermined maximum allowable level, to a drain location in the body which is of a relatively constant pressure, comprising:

a housing having first and second interior chambers;

inlet port means for establishing fluid communication between said first interior chamber and the source location;

outlet port means for establishing fluid communication between said second interior chamber and the drain location;

valving means for regulating fluid flow between said first and second chambers, said valving means providing a first condition in which fluid flow between said first and second chambers is prevented, a second condition in which fluid flow between said first and second chambers is regulated to maintain a first substantially constant predetermined pressure in said first chamber, a third condition in which fluid flow between said first and second chambers is maintained at a substantially constant rate, and a fourth condition in which fluid flow between said first and second chambers is regulated to maintain a second substantially constant predetermined pressure in said first chamber; and

valve actuator means in said housing, responsive to the pressure differential between said first and second interior chambers for substantially actuating said valving means from said first condition through said second and third conditions to said fourth condition whereby, in response to an increasing pressure differential between fluid at the source location and fluid at the drain location, said valving means in said first condition prevents the passage of fluid between the source location and the drain location when the source pressure falls below the nominal range, said valving means in said second condition maintains a constant fluid pressure differential between the source location and the drain location when the source pressure is in the nominal range, said valving means in said third condition maintains a desired constant rate of fluid flow between the source location and the drain location when the source pressure is greater than the nominal range but less than the maximum allowable level, and said valving means in said fourth condition maintains said maximum allowable pressure level at the source location.

2. A surgically implantable valve as defined in claim 1 wherein said valving means further comprise:

valve closure means mounted within said housing; and

fluid flow restrictor means mounted in said housing opposite said valve closure means and spaced apart therefrom.

3. A flow regulating valve as defined in claim 2 wherein said valve actuator means comprise a diaphragm separating said first and second chambers.

4. A flow regulating valve as defined in claim 3 wherein said valve seat means are carried on said diaphragm.

5. A surgically implantable valve as defined in claim 2 wherein said valve closure means comprise a spherical surface.

6. A surgically implantable valve as defined in claim 5 wherein said fluid flow restrictor means comprise a generally cylindrical member mounted to an interior surface of said housing.

7. A surgically implantable valve as defined in claim 6 wherein said orifice is tapered such that the narrowest region of said orifice is nearest said valve closure member and the widest region of said orifice is nearest said cylindrical member.

21. A surgically implantable valve as defined in claim 2, wherein said orifice of said valve seat means is dimensioned to allow the passage of said restrictor means therethrough, said valve seat means being disposed between said valve closure means and said restrictor means and mounted for movement from a first position in which said valve seat means move into closing relationship with said valve closure means thereby closing said valving means, to a second position in which said restrictor means extend into said orifice of said valving means to control fluid flow therethrough.

8. A surgically implantable cerebrospinal fluid control valve for regulating the passage of cerebrospinal fluid from a source location in the brain to a drain location in the body, wherein the cerebrospinal fluid is normally subject to pressure variations within a predetermined nominal range, and abnormally subject to pressure variations in excess thereof extending to a predetermined maximum allowable level, comprising:

a bio-compatible housing;

means including a flexible diaphragm within said housing for dividing the interior thereof into first and second interior chambers, said diaphragm including a central portion having a position within said housing dependent on the fluid pressure differential between said chambers;

a bio-compatible valve seat forming a part of said central portion of said diaphragm for movement therewith and defining a passageway opening from said first interior chamber into said second interior chamber;

inlet port means for communicating said first interior chamber with cerebrospinal fluid from the source location;

outlet port means for communicating cerebrospinal fluid from said second interior chamber to the drain location in the body;

bio-compatible valve closure means in said first interior chamber arranged for operative association with said valve seat upon positioning of said diaphragm in response to the fluid pressure differential between said first chamber and said second chamber falling below a first predetermined threshold level corresponding to the minimum nominal source pressure to establish a first valving condition by closing said passageway to prevent fluid flow between said first and second chambers; and

bio-compatible fluid flow restrictor means mounted within said housing and in operative association with said valve seat throughout multiple positioning of said diaphragm in response to said pressure differential, said restrictor means with said valve seat to provide a second valving condition wherein a first predetermined pressure differential is maintained when the source pressure is within the nominal range, a third valving condition wherein a constant flow rate is maintained when the source pressure is greater than the nominal range but less than the maximum level, and a fourth valving condition wherein a second predetermined pressure differential is maintained when the source pressure equals the maximum allowable level.

9. A surgically implantable cerebrospinal fluid control valve as defined in claim 8 wherein said passageway is of generally circular cross section and is tapered such that the narrowest region of said passageway faces said first interior chamber and the widest region of said passageway faces said second interior chamber.

10. A surgically implantable cerebrospinal fluid control valve as defined in claim 9 wherein said fluid flow restrictor means are dimensioned to pass through said narrowest region of said passageway.

11. A surgically implantable cerebrospinal fluid control valve as defined in claim 10 wherein said fluid flow restrictor means enters said widest region of said passageway when said pressure differential exceeds said first predetermined threshold and exits said narrowest region when said pressure differential exceeds a second higher predetermined threshold.

12. A surgically implantable cerebrospinal fluid control valve as defined in claim 11 wherein the taper of said passageway and the dimension of said restrictor means are such that the rate of fluid flow through said passageway is substantially constant when said pressure differential is greater than said first predetermined threshold and less than said second higher predetermined threshold.

13. A surgically implantable cerebrospinal fluid control valve as defined in claim 12 wherein said valve further comprises adjustment means for adjusting the position of said valve closure means relative to said diaphragm such that said first predetermined threshold level can be adjusted.

14. A surgically implantable cerebrospinal fluid control valve for controlling the passage of cerebrospinal fluid from one location in the brain to another location in the body, comprising:

a housing having first and second interior chambers;

inlet port means for establishing fluid communication between said first chamber and the one location;

outlet port means for establishing fluid communication between said second chamber and the other location;

valving means for regulating fluid flow between said first and second chambers, said valving means providing a first condition in which fluid flow between said first and second chambers is prevented, a second condition in which fluid flow between said first and second chambers is sufficient to maintain a first substantially constant predetermined pressure in said first chamber, a third condition in which fluid flow between said first and second chambers is of a substantially constant rate, and a fourth condition in which fluid flow between said first and second chambers is sufficient to maintain a second substantially constant predetermined pressure in said first chamber;

partition means in said housing including a diaphragm separating said first and second chambers and movable in response to the pressure differential therebetween, said diaphragm being operatively associated with said valving means such that motion of said diaphragm in response to an increasing pressure differential between fluids in said first and second chambers sequentially conditions said valving means from said first condition through said second and third conditions to said fourth condition whereby in response to an increasing pressure differential between fluid at the one location and fluid at the other location, the valve sequentially prevents the passage of fluid between the one location and the other location, maintains a constant fluid pressure differential between the one location and the other location, maintains a desired constant rate of fluid flow between the one location and the other location, and maintains a second constant fluid pressure differential between the one location and the other location; and

said valving means further comprising valve closure means mounted within said housing, fluid flow restrictor means comprising a generally cylindrical member mounted in said housing and aligned with said valve closure means, and valve seat means forming a part of said diaphragm and having an orifice therethrough, said orifice being dimensioned as to allow the passage of said restrictor means therethrough, said valve seat means being positioned relative to said valve closure means and said restrictor means and mounted for movement by said diaphragm from said first condition in which said valve seat means move into closing relationship with said valve closure means, to said second, third and fourth conditions in which said restrictor means approach and extend into said orifice of said valving means to partially restrict fluid flow therethrough.

15. A surgically implantable cerebrospinal fluid control valve as defined in claim 14 wherein said orifice is a frusto-conical configuration presenting a progressively increasing diameter toward said restrictor means.

16. A surgically implantable cerebrospinal fluid control valve as defined in claim 14 wherein said valve closure means include a spherical surface directed towards said valve seat means.

17. A surgically implantable cerebrospinal fluid control valve as defined in claim 14 wherein said valve closure means are adjustable toward and away from said valve seat means.

18. A surgically implantable cerebrospinal fluid control valve as defined in claim 15 wherein said valve closure means are adjustable toward and away from said valve seat means.

19. A surgically implantable cerebrospinal fluid control valve for controlling the passage of cerebrospinal fluid from one location in the body to another location, comprising:

a housing having first and second interior chambers;

inlet port means for establishing fluid communication between said first chamber and the one location;

outlet port means for establishing fluid communication between said second chamber and the other location;

valving means in said housing to control passage of body fluids between said first and second chambers, said valving means including a valve seat means and at least one fluid flow restrictor means with at least one of said valving means being movable relative to at least another of said valving means into and out of positions which establish a first condition in which fluid communication between said first and second chambers is prevented, a second condition in which fluid communication is provided between said first and second chambers at a flow rate sufficient to maintain a substantially constant desired first pressure in said first chamber, a third condition in which fluid communication is provided between said first and second chamber sufficient to maintain a desired substantially constant flow rate of fluid between said first and second chambers, and a fourth condition in which fluid communication is provided between said first and second chambers at a flow rate sufficient to maintain a substantially constant desired second pressure in said first chambers; and

partition means in said housing including a movable member separating said first and second chambers and movable in response to the pressure differential therebetween, said movable member retaining said valve seat means.

20. A surgically implantable cerebrospinal fluid control valve as defined in claim 19 wherein said valve seat means define a fluid flow passageway of frusto-conical configuration presenting a progressively increasing diameter toward said second chamber.