Magnetically-adjustable cerebrospinal fluid shunt valve

• US 4,595,390 A
• Filed: 12/08/1983
• Issued: 06/17/1986
• Est. Priority Date: 07/21/1983
• Status: Expired due to Term

• Current Assignee: DePuy Orthopaedics Incorporated (Johnson & Johnson)
• Original Assignee: Carlos A. Hakim, Salomon Hakim
• Inventors: Hakim, Carlos A., Hakim, Salomon
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Kaechele, Karen
• Application Number:
  US06/559,864
• Time in Patent Office: 922 Days
• Field of Search: 604/8-10, 128/1.3-1.5, 128/DIG. 25, 137/530, 137/537, 251/65, 310/103
• US Class Current: 604/9
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: H02K 37/00 Motors with rotor rotating step by step and without interrupter or commutator driven by the rotor, e.g. stepping motors
• CPC Class Codes: Y10T 137/7906 Cam means for adjusting and fixing bias

Abstract

A surgically-implantable shunt valve in which the popping pressure is adjusted in finite increments by application of an external magnetic field.

Claims

1. A surgically-implantable shunt valve for venting cerebrospinal fluid in the treatment of hydrocephalus and for shunting other body fluids, said valve comprising

a housing constructed of a surgically-implantable material,

an inlet and outlet chamber within said housing,

said housing including inlet and outlet ports communicating with said inlet and outlet chambers respectively for connecting said inlet and outlet chambers to external catheters or other fluid conduits,

an aperture communicating between said chambers, said aperture having a circular periphery forming a circular valve seat,

a valve element of diameter larger than said circular valve seat,

spring means for biasing said valve element against the circular valve seat so as to keep said aperture closed until the cerebrospinal fluid pressure in said inlet chamber exceeds a preselected popping pressure and so as to open said aperture when said popping pressure is exceeded so as to vent cerebrospinal fluid through said aperture into said outlet chamber, and

incremental magnetic adjustment means for increasing or decreasing the amount of said bias in finite increments in response to pulses of a magnetic field applied from outside the body ao as thereby to increase or decrease said popping pressure in finite increments, said incremental magnetic adjustment means comprising

a primary member adapted to cooperate with said spring means so as to increase or decrease said bias when said primary member is moved, said primary member not being itself susceptible to movement by said external magnetic field, and

a secondary member susceptible to said applied magnetic field and mounted and positioned with respect to said primary member so as to be capable of movement relative to said primary member and so as to cause no more than an incremetal movement of said primary member for each pulse of said magnetic field.

2. The valve of claim 1 wherein said spring means comprises a three-arm spring having two flanking arms and a central arm, one end of said central arm being positioned to bias said ball against said circular valve seat, and the other end of said central arm being said portion of said spring means.

3. The valve of claim 1 wherein spring means are provided for returning said escapement element and arm to a neutral position.

4. The valve of claim 3 wherein said arm, escapement element, gear and spring means are adapted so that application of a varying magnetic field that rises and then decays has the effect of moving said arm through a cycle consisting of movement in one direction from said neutral position to a stop position and then back again and so that as the result of said movement said gear rotates through a finite angle, said spring portion is raised or lowered a finite distance, and said popping pressure is varied by a finite amount.

5. The valve of claim 4 wherein said escapement element is mounted on an arm, said arm is pivoted about an axis, and a ferromagnetic or permanently magnetic material is attached to said arm at a radial location further from said pivot than said escapement element.

6. The valve of claim 5 wherein more than ten such cycles are required to raise said popping pressure from its minimum to its maximum.

7. The valve of claim 1 wherein there are two said escapement elements engaging said gear at different angular positions about the gear.

8. The valve of claim 7 wherein said two escapement elements are each connected to a permanent magnet and each escapement/magnet pair is pivoted about an axis passing between the two poles of the magnet.

9. The valve of claim 8 wherein the angular locations of he axes of rotation of said escapement elements are separated angularly around said gear by a whole number of gear teeth plus one half of a tooth.

10. The valve of claim 9 wherein said two escapement elements are positioned about 180°

apart around said gear.

11. The valve of claim 10 wherein for each said magnet the line connecting the poles of said magnet is generally parallel to said line on the other of said magnets.

12. The valve of claim 9 wherein said two escapement elements are positioned about 90°

apart around said gear.

13. The valve of claim 12 wherein for each said magnet the line connecting the poles of said magnet is generally normal to said line on the other of said magnets.

14. The valve of claim 13 wherein said escapement elements are positioned so that an external magnetic field can be applied in a first location such that the field provides a stronger turning moment on one said escapement than the other, and so that if said external field is applied in a second location a stronger turning moment will be provided to the other of said escapements.

15. The valve of claim 1 wherein stop means are provided for stopping movement of said primary member at a position corresponding to a known popping pressure, to thereby permit pressure adjustments to be made by first causing said member to move against said stop and then incrementally moving said member away from said stop.

16. The shunt valve of claim 1 in combination with apparatus for providing a pulsed magnetic field to adjust the said shunt valve, said apparatus comprising an electromagnet and means for orienting said apparatus and thereby said magnet in a predetermined orientation with respect to said valve so that energization of said electromagnet will have a predictable effect on the popping pressure of said valve.

17. The apparatus of claim 16 wherein said means for orienting comprises a recess shaped to fit over the protrusion formed on the skin surface by said valve when implanted.

18. The apparatus of claim 17 wherein said means for orienting comprises an arrow or other indicia indicating the direction of fluid flow so that the user can orient said apparatus so that said arrow points in the direction of spinal fluid flow through said valve.

19. The apparatus of claim 16 wherein said apparatus comprises two electromagnets, each separately energizeable and each oriented differently than the other so that upward adjustment of said popping pressure is achieved by energizing one of said electromagnets and so that downward adjustment is achieved by energizing the other of said electromagnets.

20. The shunt valve of claim 1 wherein

said spring means comprises a spring having a low spring rate to make said popping pressure substantially independent of changes in fluid flow rate, and

said incremental magnetic adjustment means comprises means for increasing or decreasing said bias without substantially affecting the spring rate of said spring.

21. The shunt valve of claim 1 wherein

said spring means comprises a three-arm spring having two flanking arms and a central arm, one end of said central arm being positioned to bias said valve element against said circular valve seat, and

said magnetic adjustment means comprises means for raising or lowering the other end of said central arm with respect to said valve element so as thereby to increase or decrease said bias on said valve element and thus said popping pressure.

22. The shunt valve of claim 1 wherein

said spring means comprises a three-arm spring having two flanking arms and a central arm, one end of said central arm being positioned to bias said valve element against said circular valve seat, and the ends of said flanking arms being retained by a yoke that extends over the upper surfaces of said ends to retain said ends against upward movement, and

said magnetic adjustment means comprises means for raising or lowering the other end of said central arm with respect to said valve element so as thereby to increase or decrease said bias on said valve element and thus said popping pressure.

23. The valve of claim 22 wherein said yoke extends from below said ends of said flanking arms, past the inward edges of said arms, and over said ends, thereby to retain said ends against sideward as well as upward movement.

24. The valve of claim 23 wherein said yoke is U-shaped so as to pass between said central arm and said flanking arms.

25. The valve of claim 24 wherein each of said ends of said flanking arms have a notch receiving that portion of said yoke passing said inward adges of said arms, thereby to retain said spring against longitudinal movement as well as upward and sideward movement.

26. The valve of claim 23 wherein said yoke is not fastened to said ends of said flanking arms but fits loosely thereover.

27. The valve of claim 1 wherein said primary member comprises a toothed gear mounted for rotation and said secondary member comprises an escapement element engaging the teeth of said gear and a permanent magnet for moving said escapement element in response to said applied pulsed magnetic field to thereby rotate said toothed gear.

28. The valve of claim 22 wherein said cam or screw means comprises a screw extending through said spring portion.

29. The valve of claim 22 wherein said cam or screw means comprises a cam surface adapted to lift said spring portion as said gear is rotated.

30. The valve of claim 22 wherein said escapement element has blunt teeth of a shape that mates with the teeth of said gear.

31. The valve of claim 22 wherein said escapement element has teeth in the form of long, thin elements adapted for piercing through debris collected between the teeth of said gear.

32. The valve of claim 22 wherein said escapement element has two teeth.

33. A surgically-implantable shunt valve for venting cerebrospinal fluid in the treatment of hydrocephalus and for shunting other body fluids, said valve comprising

a housing constructed of a surgically-implantable material,

an inlet and outlet chamber within said housing,

said housing including inlet and outlet ports communicating with said inlet and outlet chambers respectively for connecting said inlet and outlet chambers to external catheters or other fluid conduits,

an aperture communicating between said chambers, said aperture having a circular periphery forming a circular valve seat,

a valve element of diameter larger than said circular valve seat,

spring means for biasing said valve element against the circular valve seat so as to keep said aperture closed until the cerebrospinal fluid pressure in said inlet chamber exceeds a preselected popping pressure and so as to open said aperture when said popping pressure is exceeded so as to vent cerebrospinal fluid through said aperture into said outlet chamber, and

incremental magnetic adjustment means for increasing or decreasing the amount of said bias in finite increments in response to pulses of an applied magnetic field so as thereby to increase or decrease said popping pressure in finite increments,

said incremental magnetic adjustment means comprising an element adapted to rotate in response to an external magnetic field and wherein said valve further comprises a cam in the shape of a circular staircase and wherein said spring means includes one arm supported on said staircase.