External magnetic detection of physiopathological and other parameters

• US 4,608,992 A
• Filed: 08/18/1983
• Issued: 09/02/1986
• Est. Priority Date: 08/18/1983
• Status: Expired due to Term

• Current Assignee: Carlos A. Hakim, Salomon Hakim
• Original Assignee: Carlos A. Hakim, Salomon Hakim
• Inventors: Hakim, Carlos A., Hakim, Salomon
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): Sykes, Angela D.
• Application Number:
  US06/524,367
• Time in Patent Office: 1,111 Days
• Field of Search: 128/653-654, 128/748, 128/655-658, 73/722, 73/728, 324/246, 324/244, 324/251, 324/259-261
• US Class Current: 600/431
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: G01L 9/14 involving the displacement of magnets, e.g. electromagnets

Abstract

A technique for transmitting from within the body information concerning an internal parameter (e.g., a measurement of a physiopathological parameter or a parameter generated by an implanted pacemaker), without physical connections to the implanted device, without an externally applied or internally generated electromagnetic field, and without implantation of radioactive material. The implanted device generates a magnetic field having an orientation influenced by changes in the internal parameter. The field is generated by one or more permanent magnets in the implanted device. The orientation of the field is detected externally using a viewer that provides a display indicative of the orientation. The display may provide an image of the magnetic field (e.g., a compass needle or magnetometer) that aligns itself with the field in a known manner. The magnetic field can be generated by a rotatable element on which are carried one or more permanent magnets (e.g., a disk of a magnetic alloy such as samarium cobalt on which has been impressed one or more magnetic regions). In some embodiments the image seen in the viewer is in the form of a pointer (e.g., an arrow) and is provided by implanted magnets that have a north/south boundary of the same shape. If the internal parameter is a fluid pressure, the implanted device may include a diaphragm manometer with a rotatable drum (e.g., rotated by levers connected to the diaphragm and arranged to pull a thread wrapped around the drum) on which is mounted the previously mentioned disk with impressed magnetic regions.

Claims

1. The method of transmitting from within the body information regarding an internal parameter, comprising the steps of

surgically implanting a device containing means for generating a magnetic field having a spatial orientation with respect to said device that is influenced by changes in said parameter, and

using an external detection element to detect the spatial orientation of said field with respect to said device, to thereby detect said changes in said parameter.

2. The method of claim 1 wherein said parameter is an intracranial pressure.

3. The method of claim 2 wherein said implanted device comprises a manometer including a diaphragm or bellows and means for translating movement of said diaphragm or bellows into rotation of a member supporting one or more magnets.

4. The method of claim 2 wherein said parameter is the pressure difference across a cerebrospinal fluid shunt valve and wherein said implanted device is a manometer connected in parallel with an implanted said shunt valve.

5. The method of claim 4 further comprising implanting a valve or valves capable of changing connections to said manometer from a first state in which a first port of said manometer is connected upstream of said valve and a second port is connected downstream thereof to a second state in which both said first and second ports are connected upstream of said valve, and wherein said method comprises actuating said valves so as to place said connections in said second state to zero said manometer and then to place said connections in said first state to measure the pressure difference across said valve.

6. The method of claim 4 wherein the pressure reference for said manometer is an atmospheric pressure.

7. The method of claim 6 wherein said atmospheric pressure is provided by a fluid-filled bladder placed subcutaneously.

8. The method of claim 1 wherein said implanted device comprises one or more permanent magnets.

9. The method of claim 8 wherein said permanent magnets are supported on a member that is adapted to move under the influence of said parameter.

10. The method of claim 9 wherein said member is adapted to rotate about an axis.

11. The method of claim 10 wherein said member comprises a magnetic alloy disk on which are impressed permanent magnetic regions forming said magnets.

12. The method of claim 11 wherein the boundary between polar regions of at least one said magnet is adapted to define said orientation.

13. The method of claim 12 wherein the boundary between polar regions has the form of an image for viewing by said detection element.

14. The method of claim 1 wherein said detection element comprises a viewer having means for providing a disply indicative of said orientation.

15. The method of claim 14 wherein said viewer comprises means for displaying an image corresponding to the spatial distribution of said magnetic field.

16. The method of claim 15 wherein said means for displaying comprises a multiplicity of movable ferromgnetic particles.

17. The method of claim 16 wherein said means for displaying comprises a weakly-ferromagnetic crystal suspension.

18. The method of claim 15 wherein said implanted device includes a rotatable member with at least two permanent magnetic regions, said orientation is a rotational change in the position of said field, said spatial distribution is adapted to provide an indication of the center of said rotation, and a pointer means is provided on said viewer that is adapted to be aligned with said indication of the center and adapted to be rotated into a preselected orientation with said distribution so that a measurement can be made after said alignment and rotation by comparing the position of said pointer means with a scale on said viewer.

19. The method of claim 14 wherein said viewer comprises a magnetic element adapted to align itself in said field in a predetermined relationship to said orientation.

20. The method of claim 19 wherein said magnetic element comprises a rotatable permanent magnet such as a compass needle.

21. The method of claim 14 wherein said implanted device includes at least two permanent magnets having a boundary between adjoining polar regions that defines an image for viewing by said viewer.

22. The method of claim 21 wherein said viewer comprises a scale for directly reading values of said parameter and said image has the shape of a pointing means for indicating a position along said scale.

23. The method of claim 22 wherein said viewer comprises a ferromagnetic suspension with a generally circular display area and said scale comprises markings around the periphery of said circular display area and wherein said implanted device has a rotatable element on which said magnets are arranged to define an image in the form of a pointer with a center of rotation that is aligned with the center of said display area when measurements are made.

24. The method of claim 23 wherein said pointer image has asymmetry so that a full 360°

rotation may be used for reading measurements.

25. The method of claim 21 wherein said at least two permanent magnets have strengths sufficiently similar and shapes adapted to provide said image in generally undistorted form at varying separations between said implanted device and said viewer.

26. The method of claim 14 wherein said viewer comprises a magnetometer adapted to indicate magnetic polarity.

27. The method of claim 1 wherein said step of using a detection element comprises using a means for generating an electrical signal representative of said orientation, and further comprising the step of continuously monitoring said parameter by detecting whether said electrical signal remains in a desired range of values.

28. The method of claim 27 wherein said step of using a means for generating a electrical signal comprises using Hall effect cells or a magnetometer adapted to indicate magnetic polarity.

29. The method of claim 1, wherein said parameter is a physiopathological parameter being measured by said surgically-implanted device.

30. The method of claim 1, wherein said magnetic field generating means within said device is a permanent magnet and said magnet is adapted to move in dependent response to changes in said internal parameter, to thereby produce said variation in the spatial orientation of said magnetic field.

59. The method of claim 25 wherein the pressure reference for said manometer is an atmospheric pressure.

60. The method of claim 59 wherein said atmospheric pressure is provided by a fluid-filled bladder placed subcutaneously.

31. A surgically-implantable device for use as part of apparatus for transmitting from within the body information regarding an internal parameter, said device containing means for generating a magnetic field having a spatial orientation with respect to said device that is influenced by changes in said parameter, said means and device being adapted so that changes in the spatial orientation of said magnetic field with respect to said device are detectable outside of the body.

55. The apparatus of claim 31 or 32 wherein said parameter is a physiopathological parameter being measured by said surgically-implantable device.

56. The apparatus of claim 31 or 32 wherein said magnetic field generating means within said device is a permanent magnet and said magnet is adapted to move in dependent response to changes in said internal parameter, to thereby produce said variation in the spatial orientation of said magnetic field.

32. Apparatus for transmitting from within the body information regarding an internal parameter, comprising

a surgically-implantable device containing means for generating a magnetic field having a spatial orientation with respect to said device that is influenced by changes in said parameter, said means and device being adapted so that changes in the spatial orientation of said magnetic field with respect to said device are detectable outside of the body, and

detection apparatus comprising a detection element with means for detecting the spatial orientation of said magnetic field with respect to said device after said device has been surgically implanted.

33. Apparatus of claim 32 wherein said parameter is an intracranial pressure.

34. The apparatus of claim 33 wherein said implantation device comprises a manometer including a diaphragm or bellows and means for translating movement of said diaphragm or bellows into rotation of a member supporting one or more magnets.

36. The apparatus of claim 32 wherein said implantable device comprises one or more permanent magnets.

37. The apparatus of claim 42 wherein said permanent magnets are supported on a member that is adapted to move under the influence of said parameter.

38. The apparatus of claim 37 wherein said member is adapted to rotate about an axis.

39. The apparatus of claim 38 wherein said member comprises a magnetic alloy disk on which are impressed permanent magnetic regions forming said magnets.

40. The apparatus of claim 39 wherein the boundary between polar regions of at least one said magnet is adapted to define said orientation.

41. The apparatus of claim 40 wherein the boundary between polar regions has the form of an image for viewing by said detection element.

42. The apparatus of claim 32 wherein said detection element comprises a viewer having means for providing a display indicative of said orientation.

43. The apparatus of claim 42 wherein said viewer comprises means for displaying an image corresponding to the spatial distribution of said magnetic field.

44. The apparatus of claim 43 wherein said means for displaying comprises a multiplicity of movable ferromagnetic particles.

45. The apparatus of claim 44 wherein said means for displaying comprises a weakly-ferromagnetic crystal suspension.

46. The apparatus of claim 43 wherein said implantable device includes a rotatable member with at least two permanent magnetic regions, said orientation is a rotational change in the position of said field, said spatial distribution is adapted to provide an indication of the center of said rotation, and a pointer means is provided on said viewer that is adapted to be aligned with said indication of the center and adapted to be rotated into a preselected orientation with said distribution so that a measurement can be made after said alignment and rotation by comparing the position of said pointer means with a scale on said viewer.

47. The apparatus of claim 42 wherein said viewer comprises a magnetic element adapted to align itself in said field in a predetermined relationship to said orientation.

48. The apparatus of claim 47 wherein said magnetic element comprises a rotatable permanent magnet such as a compass needle.

49. The apparatus of claim 42 wherein said implantable device includes at least two permanent magnets having a boundary between adjoining polar regions that defines an image for viewing by said viewer.

50. The apparatus of claim 49 wherein said viewer comprises a scale for directly reading values of said parameter and said image has the shape of a pointing means for indicating a position along said scale.

51. The apparatus of claim 50 wherein said viewer comprises a ferromagnetic suspension with a generally circular display area and said scale comprises markings around the periphery of said circular display area and wherein said implantable device has a rotatable element on which said magnets are arranged to define an image in the form of a pointer with a center of rotation that is aligned with the center of said display area when measurements are made.

52. The apparatus of claim 51 wherein said pointer image has asymmetry so that a full 360°

rotation may be used for reading measurements.

53. The apparatus of claim 49 wherein said at least two permanent magnets have strengths sufficiently similar and shapes adapted to provide said image in generally undistorted form at varying separations between said implantable device and said viewer.

54. The apparatus of claim 42 wherein said detection element comprises means for generating an electrical signal representative of said orientation, magnetic polarity being indicated by Hall effect cells or a magnetometer.

35. The apparatus 33 wherein said parameter is the pressure difference across a cerebrospinal fluid shunt valve and wherein said implantion is a manometer connected in parallel with an implantion device said shunt valve.

57. The method of measuring cerebrospinal fluid pressure comprising the steps of

implanting a shunt valve in a conduit connecting the cerebral ventricle to a drainage site, and

implanting a manometer with first and second pressure ports connected in parallel with said shunt valve so that said first pressure port of said manometer is connected upstream of said valve and said second pressure port is connected downstream of said valve, thereby providing that said manometer measures the pressure difference across said valve.

58. The method of claim 57 wherein said method further comprises implanting a valve or valves capable of changing the connections to said manometer from a first state in which said first port of said manometer is connected upstream of said valve and said second port is connected downstream thereof to a second state in which both said first and second ports are connected upstream of said valve, and wherein said method comprises actuating said valves so as to place said connections in said second state to zero said manometer and then to place said connections in said first state to measure the pressure difference across said valve.

61. The method of claim 57 wherein the pressure reference for said manometer is the right atrium of the heart.