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1. WO1997029678 - CATHETER CALIBRATION AND USAGE MONITORING SYSTEM

Note: Text based on automatic Optical Character Recognition processes. Please use the PDF version for legal matters

[ EN ]

CLAIMS

1. A probe for insertion into the body of a subject, said probe having distal and proximal ends, and comprising an electronic microcircuit,
wherein the microcircuit stores information relating to calibration of the probe.

2. A probe in accordance with claim 1, wherein at least a portion of the information on the microcircuit is encrypted.

3. A probe in accordance with claim 2, wherein the microcircuit stores a usage code, which controls availability of the probe to a user thereof.

4. A probe in accordance with claim 3, and including access control circuitry that allows the usage code to be changed so as to reduce the availability of the probe, but not to increase the availability thereof.

5. A probe in accordance with claim 3, wherein the microcircuit stores the usage code in a memory location therein that is controlled by the access circuitry so as to operate in a read access and program only mode.

6. A probe in accordance with claim 5, wherein the mode may be changed by entry of a password to the access control circuitry.

7. A probe in accordance with claim 6, wherein the usage code includes date information.

8. A probe in accordance with claim 1, and comprising a device that generates signals responsive to the position or orientation of the probe, and
wherein the information relating to calibration comprises information relating to calibration of said signal generating device.

9. A probe in accordance with claim 8, wherein said signal generating device is adjacent to the distal end of the probe.

10. A probe in accordance with claim 8, wherein said signal generating device comprises one or more coils.

11. A probe in accordance with claim 10, wherein the information relating to calibration comprises information relating to a gain of at least one of the one or more coils.

12. A probe in accordance with claim 10, wherein information relating to calibration comprises information relating to an angular orientation of at least one of the one or more coils.

13. A probe in accordance with claim 8, wherein the information relating to calibration comprises information relating to a positional displacement of the signal generating device, relative to the distal end of the probe.

14. A probe in accordance with claim 1, and including isolation circuitry, wherein the information relating to calibration comprises information relating to a non-linearity of the isolation circuitry.

15. A probe in accordance with claim 1, wherein the microcircuit is adjacent to the proximal end of the probe.

16. A probe in accordance with claim 15, wherein the probe further comprises a connector at its proximal end, and wherein the microcircuit is contained in the connector.

17. A probe in accordance with any of claims 1-16, and wherein the microcircuit comprises a programmable memory device.

18. A probe in accordance with claim 17, and wherein the programmable memory device comprises an EEPROM device.

19. A probe in accordance with claim 17, and wherein d e programmable memory device comprises a non-volatile RAM device.

20. A probe in accordance with claim 17, and wherein the programmable memory device comprises an EPROM or PROM device.

21. A probe in accordance with claim 17, and wherein the programmable memory device comprises a Flash ROM device.

22. Apparatus for determining the position of a probe in the body of a subject, comprising: a probe in accordance with any of claims 8-13; and
a console, comprising a computer, which receives said position- or orientation-responsive signals and said information relating to calibration and determines therefrom the position of the probe.

23. Apparatus in accordance with claim 22, wherein the microcircuit is adjacent to the proximal end of the probe.

24. Apparatus in accordance with claim 23, wherein the probe further comprises a connector at its proximal end, and wherein the microcircuit is contained in the connector, and wherein the console further comprises a mating receptacle, which is adapted to be coupled with the probe connector.

25. Apparatus in accordance with claim 22, wherein the microcircuit comprises a programmable memory device.

26. Apparatus in accordance with claim 25, wherein the probe includes one or more connections adapted for programming the programmable memory device.

27. Apparatus in accordance with claim 26, wherein the mating receptacle includes means for disabling at least one of the connections for programming the programmable memory device.

28. Apparatus in accordance with claim 25, wherein the programmable memory device comprises an EEPROM device.

29. Apparatus in accordance with claim 25, wherein the programmable memory device comprises a non-volatile RAM device.

30. Apparatus in accordance with claim 25, wherein the programmable memory device comprises an EPROM or PROM device.

31. Apparatus in accordance with claim 25, wherein the programmable memory device comprises a Flash ROM device.

32. Apparatus in accordance with claim 25, wherein the computer is further adapted to program the programmable memory device.

33. Apparatus in accordance with claim 30, wherein the console further comprises EPROM or PROM programming apparatus, which is adapted to program the EPROM or PROM device.

34. A method of calibrating a probe for insertion into the body of a subject, said probe including a programmable microcircuit, comprising:
determining calibration data relating to the probe;
programming the microcircuit so as to record the calibration data in the microcircuit.

35. A method in accordance with claim 34, and comprising encrypting a calibration code and programming the microcircuit therewith.

36. A method in accordance with claim 34, wherein programming the microcircuit includes setting a usage record.

37. A method in accordance with claim 36, wherein the usage record is indicative of a permitted use date of the probe.

38. A method in accordance with claim 36, wherein the usage record is indicative of how many times the probe may be re-used.

39. A method in accordance with claim 36, wherein the usage record is indicative of a duration of time during which the probe may be operated.

40. A method in accordance with claim 36, wherein programming the microcircuit includes restricting access to the usage record, so that availability of the probe to a user thereof may be reduced, but not increased.

41. A method in accordance with claim 40, wherein restricting access to the usage record comprises allowing one or more bits in the record to be changed from a first value to a second value thereof, but not from the second value to the first value.

42. A method in accordance with claim 40 or 41, wherein restricting access to the usage record comprises setting a password.

43. A method in accordance with claim 34, wherein the calibration data relate to a signal generating device, which generates signals responsive to the position or orientation of the probe.

44. A method in accordance with claim 43, wherein the position- or orientation-responsive signal generating device has a gain, and the calibration data include data relating to the gain of the device.

45. A method in accordance with claim 43, wherein the calibration data include data relating to an angular orientation of the position- or orientation-responsive signal generating device.

46. A method in accordance with claim 43, wherein the calibration data include data relating to a positional displacement of the position- or orientation-responsive signal generating device, relative to the probe.

47. A method of determining the position or orientation of a probe, comprising:
determining calibration data relating to the probe and programming a microcircuit in the probe, in accordance with any of claims 43-46; and
computing the position or orientation of the probe inside the body based on the position- or orientation-responsive signals and on the calibration data.

48. A method of controlling a usage of a probe having an encrypted code stored therein, comprising:
reading the encrypted code; and
notifying a user of the probe if the encrypted code does not match a predetermined code.

49. A method of controlling a usage of a probe having an encrypted code stored therein, comprising:
reading the encrypted code; and
ceasing operating of the probe if the encrypted code does not match a predetermined code.

50. A method of controlling a usage of a probe having an encrypted code stored therein, comprising:
reading the encrypted code; and
ceasing operating of the probe if the encrypted code is not within a given range of values.

51. A method according to any of claims 48-50, comprising updating a usage record on the probe

52. A method of calibrating a probe for insertion into the body of a subject, comprising:
providing a probe having a locatable portion and a signal generating device, which device generates signals responsive to the position or orientation of the probe;
fixedly coupling said signal generating device and said locatable portion in one or more predetermined positions and orientations;
applying predetermined magnetic fields to the probe, which magnetic fields are known at the vicinity of the signal generating device and which magnetic fields cause the signal generating device to generate the position- or orientation-responsive signals; and receiving signals generated by the signal generating device.

53. A method in accordance with claim 52, wherein at least some of the calibration data are determined by applying substantially uniform magnetic fields to the probe.

54. A method in accordance with claim 52, wherein at least some of the calibration data are determined by applying spatially variable magnetic fields to the probe.

55. A method in accordance with claim 52, wherein the position- or orientation-responsive signals generated by the signal generating device have an amplitude, which is characterized by a proportionality to a directional component of the magnetic fields applied thereto, and the calibration data include data relating to said proportionality.

56. A method in accordance with claim 52, wherein the calibration data include data relating to an angular orientation of the position- or orientation-responsive signal generating device.

57. A method in accordance with claim 52, wherein the calibration data include data relating to a positional displacement of the position- or orientation-responsive signal generating device, relative to the probe.

58. A method in accordance with any of claims 52-57, and comprising heating the probe.

59. A method in accordance with claim 58, wherein heating the probe comprises heating the probe to approximately 37°C.

60. A method in accordance with any of claims 52-57, comprising storing the calibration data on the probe.

61. Apparatus for calibration of a probe having a position sensing device therein, comprising: a plurality of coils, wherein the coils define three substantially orthogonal axes and a central region, and are adapted to generate substantially uniform magnetic fields along the directions of the three axes in the central region, and
means for fixing the distal end of the probe in the central region.

62. Apparatus in accordance with claim 61, wherein the coils include three orthogonal pairs of mutually parallel coils.

63. Apparatus in accordance with claim 61 or claim 62, and comprising a clamp for holding the probe in a fixed position and orientation in the central region.

64. Apparatus for calibration of a probe, having a position sensing device therein, comprising: a jig, including a plurality of receptacles adapted for insertion of the probe thereinto, each said receptacles defining a different predetermined position and orientation of the probe; and
a plurality of coils, wherein the coils generate magnetic fields that are different for the different predetermined positions and orientations.

65. Apparatus in accordance with any of claims 61-62 or 64, and comprising a heater, which heats the probe.

66. Apparatus in accordance with claim 65, and comprising a temperature sensor, which senses the temperature of the probe.

67. A wireless catheter comprising:
an elongate flexible body having a distal end and a proximal end;
a signal generating portion at the distal end of the body; and
a transmitter which transmits signals generated by the signal generation portion to an extemal receiver.

68. A catheter according to claim 67, wherein the transmitter comprises a receiver, which receives transmissions from an extemal transmitter.