Ultrasound catheter calibration system

• US 7,090,639 B2
• Filed: 05/29/2003
• Issued: 08/15/2006
• Est. Priority Date: 05/29/2003
• Status: Active Grant

• Current Assignee: Biosense, Inc. (Cardinal Health, Inc.)
• Original Assignee: Biosense, Inc. (Cardinal Health, Inc.)
• Inventors: Govari, Assaf
• Primary Examiner(s): Jaworski, Francis J.
• Application Number:
  US10/447,940
• Publication Number:
  US 20040254458A1
• Time in Patent Office: 1,174 Days
• Field of Search: 600/437, 600/443, 600/459, 600466- 7, 73/17.9, 73/18.2, 73/18.6, 310/334, 128/899
• US Class Current: 600/437
• CPC Class Codes: A61B 2017/00725 Calibration or performance testing
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/062 using magnetic field
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4254 using sensors mounted on the probe
• CPC Class Codes: A61B 8/58 Testing, adjusting or calibrating the diagnostic device
• CPC Class Codes: H01F 2005/027 wound on formers for receiving several coils with perpendicular winding axes, e.g. for antennae or inductive power transfer

Abstract

Apparatus is provided for calibrating a probe having a position sensor and an ultrasonic transducer. The apparatus includes a test fixture, which includes an ultrasonic target disposed therein at a known position. A computer is adapted to receive a position signal generated by the position sensor while the transducer is in alignment with the ultrasonic target, determine an orientation of the probe in a frame of reference of the test fixture, and determine calibration data for the probe responsive to the orientation of the probe.

Claims

1. A method for calibration, comprising:

placing a probe that includes a distal tip, a position sensor and an ultrasonic transducer in a test fixture that includes an ultrasonic target disposed therein at a known position;

manipulating the probe in the test fixture while operating the ultrasonic transducer until an output signal of the transducer indicates that the transducer is in alignment with the ultrasonic target;

measuring a position signal generated by the position sensor while the transducer is in alignment with the ultrasonic target, so as to determine an orientation of the probe in a frame of reference of the test fixture;

measuring a displacement of the ultrasonic transducer relative to the distal tip and;

determining calibration data for the probe responsive to the orientation of the probe and determining the measure of displacement.

2. A method according to claim 1, wherein the calibration data include an alignment of the ultrasonic transducer with respect to an axis of the probe, and wherein determining the calibration data comprises determining the alignment.

3. A method according to claim 1, wherein the calibration data include an alignment of the ultrasonic transducer with respect to the position sensor, and wherein determining the calibration data comprises determining the alignment.

4. A method according to claim 1, wherein the calibration data include an alignment of the ultrasonic transducer with respect to the position sensor and an alignment of the ultrasound transducer with respect to an axis of the probe, and wherein determining the calibration data comprises determining the alignments.

5. A method according to claim 1, wherein determining the calibration data comprises determining the calibration data for the probe responsive to the orientation of the probe and the known position of the ultrasonic target relative to the test fixture.

6. A method according to claim 1, wherein manipulating the probe comprises varying a rotational axis of the probe selected from the set consisting of:

a roll of the probe, a yaw of the probe, and a pitch of the probe.

7. A method according to claim 1, wherein manipulating the probe comprises manipulating the probe in the test fixture while operating the ultrasonic transducer, so as to form an image of the ultrasonic target, until the output signal indicates that the transducer is in alignment with the ultrasonic target.

8. A method according to claim 1, wherein manipulating the probe comprises manipulating the probe manually.

9. A method according to claim 1, wherein manipulating the probe comprises manipulating the probe in an automated manner.

10. A method according to claim 1, wherein measuring the position signal comprises generating at least two magnetic fields in the test fixture.

11. A method according to claim 1, wherein the position sensor includes at least two coils, and wherein measuring the position signal comprises measuring a coil signal for each of the coils.

12. A method according to claim 1, wherein manipulating the probe comprises rotating the probe about a long axis of the probe.

13. A method according to claim 1, wherein measuring the position signal comprises modifying a temperature of the probe.

14. A method according to claim 13, wherein modifying the temperature of the probe comprises heating the probe.

15. A method according to claim 13, wherein modifying the temperature of the probe comprises cooling the probe.

16. A method according to claim 1, wherein the probe includes a programmable microcircuit, and wherein determining the calibration data comprises recording the calibration data in the microcircuit.

17. A method according to claim 16, wherein recording the calibration data comprises encrypting a calibration code.

18. A method according to claim 1, wherein the test fixture includes a clamp assembly, and wherein placing the probe in the test fixture comprises placing the probe in the clamp assembly.

19. A method according to claim 18, wherein the clamp fixture is shaped to define a groove, and wherein placing the probe in the test fixture comprises placing the probe in the groove.

20. A method according to claim 1,

wherein the test fixture includes at least two radiator coils fixed in known positions,

wherein placing the probe comprises aligning the probe in a known orientation relative to the radiator coils,

wherein measuring the position signal comprises activating the radiator coils so as to generate known magnetic fields in the test fixture, and measuring a position-sensor-calibration position signal generated by the position sensor, so as to determine a position-sensor orientation of the position sensor with respect to an axis of the probe, and

wherein determining the calibration data comprises determining position-sensor calibration data for the probe responsive to the orientation of the position sensor.

21. A method according to claim 20, wherein the probe includes a distal tip, and wherein determining the position-sensor calibration data comprises determining a measure of displacement of the position sensor relative to the distal tip.

22. A method according to claim 20,

wherein measuring the position signal comprises measuring the position signal so as to determine an orientation of the ultrasonic transducer relative to the position sensor, and

wherein determining the calibration data for the probe comprises determining an alignment of the ultrasonic transducer with respect to the axis of the probe, responsive to the orientation of the ultrasonic transducer relative to the position sensor, and responsive to the position-sensor orientation with respect to the axis of the probe.

23. A method according to claim 20, wherein the position sensor includes at least two coils, and wherein measuring the position-sensor-calibration position signal comprises measuring a coil-calibration signal for each of the coils.

24. A method according to claim 23, wherein determining the position-sensor calibration data for the probe comprises calibrating a gain of each coil.

25. A method according to claim 23, wherein determining the position-sensor calibration data for the probe comprises determining, for each coil, a deviation of the coil from alignment with the axis of the probe.

26. A method for calibration, comprising:

placing a probe that includes a distal tip, a position sensor and an imaging device in a test fixture, which comprises an imaging target disposed therein at a known position;

manipulating the probe in the test fixture while operating the imaging device until an output signal of the imaging device indicates that the imaging device is in alignment with the imaging target;

measuring a position signal generated by the position sensor while the imaging device is in alignment with the imaging target, so as to determine an orientation of the probe in a frame of reference of the test fixture;

measuring a displacement of the imaging device relative to the distal tip;

determining calibration data for the probe responsive to the orientation of the probe and determining the measure of displacement.

27. Apparatus for calibrating a probe having a distal tip, a position sensor and an ultrasonic transducer, the apparatus comprising:

a test fixture, which comprises an ultrasonic target disposed therein at a known position; and

a computer, adapted to;

receive a position signal generated by the position sensor while the transducer is in alignment with the ultrasonic target,

determine an orientation of the probe in a frame of reference of the test fixture,

measuring a displacement of the ultrasonic transducer relative to the distal tip;

determine calibration data for the probe responsive to the orientation of the probe; and

determine the measure of displacement.

28. Apparatus according to claim 27, wherein the calibration data include an alignment of the ultrasonic transducer with respect to an axis of the probe, and wherein the computer is adapted to determine the alignment.

29. Apparatus according to claim 27, wherein the calibration data include an alignment of the ultrasonic transducer with respect to the position sensor, and wherein the computer is adapted to determine the alignment.

30. Apparatus according to claim 27, wherein the calibration data include an alignment of the ultrasonic transducer with respect to the position sensor and an alignment of the ultrasound transducer with respect to an axis of the probe, and wherein the computer is adapted to determine the alignments.

31. Apparatus according to claim 27, wherein the computer is adapted to determine the calibration data for the probe responsive to the orientation of the probe and the known position of the ultrasonic target relative to the test fixture.

32. Apparatus according to claim 27, wherein the ultrasonic target comprises a bubble comprising an ultrasound-reflecting material.

33. Apparatus according to claim 27, wherein the position sensor includes at least two coils, and wherein the computer is adapted to receive the position signal responsive to current in the coils.

34. Apparatus according to claim 27, wherein the test fixture comprises a heating element, adapted to heat the probe.

35. Apparatus according to claim 27, wherein the ultrasonic target is adapted to be movable within the test fixture.

36. Apparatus according to claim 27, wherein the probe includes a programmable microcircuit, and wherein the computer is adapted to record the calibration data in the microcircuit.

37. Apparatus according to claim 36, wherein the computer is adapted to encrypt a calibration code.

38. Apparatus according to claim 27, wherein the test fixture comprises a clamp assembly, adapted to hold the probe.

39. Apparatus according to claim 38, wherein the clamp assembly is adapted to allow an orientation of the probe to be varied on a rotational axis of the probe selected from the set consisting of:

a roll of the probe, a yaw of the probe, and a pitch of the probe.

40. Apparatus according to claim 38, wherein the clamp assembly is shaped to define a groove, adapted to hold the probe.

41. Apparatus according to claim 38, wherein the clamp assembly is adapted to manipulate the probe in an automated manner.

42. Apparatus according to claim 27, wherein the test fixture comprises at least two radiator coils fixed in known positions.

43. Apparatus according to claim 42, wherein the test fixture comprises three mutually-orthogonal pairs of parallel radiator coils.

44. Apparatus according to claim 42, wherein the radiator coils are adapted to generate respective magnetic fields in the test fixture, and wherein the computer is adapted to receive the position signal generated by the position sensor responsive to the magnetic fields.

45. Apparatus according to claim 42, wherein the computer is adapted to:

receive a position-sensor-calibration position signal generated by the position sensor while the probe is aligned in a known orientation relative to the radiator coils,

determine a position-sensor orientation of the position sensor with respect to an axis of the probe, and

determine position-sensor calibration data for the probe responsive to the orientation of the position sensor.

46. Apparatus according to claim 45, wherein the probe includes a distal tip, wherein the position-sensor calibration data include a measure of a displacement of the position sensor relative to the distal tip, and wherein the computer is adapted to determine the measure of displacement.

47. Apparatus according to claim 45,

wherein the calibration data for the probe include an alignment of the ultrasonic transducer with respect to the axis of the probe, and

wherein the computer is adapted to:

determine an orientation of the ultrasonic transducer relative to the position sensor, and

determine the alignment of the ultrasonic transducer with respect to the axis of the probe, responsive to the orientation of the ultrasonic transducer relative to the position sensor, and responsive to the position-sensor orientation with respect to the axis of the probe.

48. Apparatus according to claim 45, wherein the position sensor comprises at least two coils, and wherein the computer is adapted to measure a coil-calibration signal for each of the coils.

49. Apparatus according to claim 48, wherein the computer is adapted to calibrate a gain of each coil.

50. Apparatus according to claim 48, wherein the computer is adapted to determine, for each coil, a deviation of the coil from alignment with the axis of the probe.

51. Apparatus for calibrating a probe having a distal tip, a position sensor and an imaging device, the apparatus comprising:

a test fixture, which comprises an imaging target disposed therein at a known position; and

a computer, adapted to;

receive a position signal generated by the position sensor while the imaging device is in alignment with the imaging target,

determine an orientation of the probe in a frame of reference of the test fixture,

determine a displacement of the imaging device relative to the distal tip;

determine calibration data for the probe responsive to the orientation of the probe; and

determine the measurement of displacement.