Catheter calibration and usage monitoring system

• US 6,266,551 B1
• Filed: 02/17/1999
• Issued: 07/24/2001
• Est. Priority Date: 02/15/1996
• Status: Expired due to Term

• Current Assignee: Biosense, Inc. (Cardinal Health, Inc.)
• Original Assignee: Biosense, Inc. (Cardinal Health, Inc.)
• Inventors: Fried, Shlomo, Ben-Haim, Shlomo, Osadchy, Daniel, Fenster, Maier
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): MANTIS MERCADER, ELENI M
• Application Number:
  US09/117,840
• Time in Patent Office: 888 Days
• Field of Search: 600/424, 600/300, 600/407, 128/898, 128/899, 341/50, 341/65, 341/78
• US Class Current: 600/424
• CPC Class Codes: A61B 1/00016 using wireless means
• CPC Class Codes: A61B 1/0002 provided with data storages
• CPC Class Codes: A61B 1/00059 provided with identification means for the endoscope
• CPC Class Codes: A61B 2017/00482 with a code
• CPC Class Codes: A61B 2017/00725 Calibration or performance testing
• CPC Class Codes: A61B 2018/00178 Electrical connectors
• CPC Class Codes: A61B 2018/00988 Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/363 Use of fiducial points
• CPC Class Codes: A61B 2090/3929 Active markers
• CPC Class Codes: A61B 2090/3958 emitting a signal
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 2560/028 Arrangements to prevent overuse, e.g. by counting the number of uses
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 2562/085 combined with means for recording calibration data
• 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 5/283 Invasive
• CPC Class Codes: A61B 90/36 Image-producing devices or illumination devices not otherwise provided for
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61B 90/98 : using electromagnetic means, e.g. transponders
• 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

A probe (20) for insertion into the body of a subject, the probe (20) having distal (22) and proximal ends, and including an electronic microcircuit (90), which stores information relating to calibration of the probe (20). Preferably, the microcircuit (90) stores a calibration code, which is encrypted. Alternatively or additionally, the microcircuit (90) stores a usage code, which controls availability of the probe (20) to a user thereof. Preferably, the probe (20) includes access control circuitry (90) that allows the usage code to be changed so as to reduce the availability of the probe (20), but not to increase the availability thereof.

Claims

1. A method of calibrating a probe for insertion into the body of a subject, comprising:

providing a probe having a programmable microcircuit and a distal end, the distal end including a functional portion adjacent to a distal tip of the distal end for performing diagnostic and/or therapeutic functions, the distal end also including a position signal generating device for generating signals used to determine the position of the probe within the subject'"'"'s body;

determining calibration data for the position signal generating device with respect to the distal tip of the probe; and

programming the microcircuit so as to record the calibration data in the microcircuit.

2. A method in accordance with claim 1, and comprising encrypting a calibration code and programming the microcircuit therewith.

3. A method in accordance with claim 2 comprising:

reading the encrypted code; and

notifying a user of the probe if the encrypted code does not match a predetermined code.

4. A method in accordance with claim 3 comprising:

reading the encrypted code; and

ceasing operating of the probe if the encrypted code does not match a predetermined code.

5. A method in accordance with claim 1, wherein programming the microcircuit includes setting a usage record.

6. A method in accordance with claim 5, wherein the usage record is indicative of a permitted use date of the probe.

7. A method in accordance with claim 5, wherein the usage record is indicative of how many times the probe may be re-used.

8. A method in accordance with claim 5, wherein the usage record is indicative of a duration of time during which the probe may be operated.

9. A method in accordance with claim 5, 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.

10. A method in accordance with claim 9, 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.

11. A method in accordance with claim 1, wherein restricting access to the usage record comprises setting a password.

12. A method in accordance with claim 1, wherein the calibration data relate to the position signal generating device, which generates signals responsive to the position or orientation of the probe.

13. A method in accordance with claim 12, wherein the signal generating device has a gain, and the calibration data include data relating to the gain of the device.

14. A method in accordance with claim 12, wherein the calibration data include data relating to an angular orientation of the signal generating device.

15. A method in accordance with claim 12, wherein the calibration data include date relating to a positional displacement of the signal generating device, relative to the probe.

16. A method for programming a probe for insertion into the body of a subject, the method comprising the steps of:

providing a probe having a programmable microcircuit and a distal end, the distal end including a functional portion adjacent to a distal tip of the distal end for performing diagnostic and/or therapeutic functions, the distal end also including a position signal generating device for generating signals used to determine the position of the probe within the subject'"'"'s body; and

programming the microcircuit with an expiration date and time.

17. The method according to claim 16, including determining a pre-set interval for the expiration date and time based on the actual date and time when the probe is first used.

18. A method for programming and tracking usage of a probe for insertion into the body of a subject, the method comprising the steps of:

providing a probe having a programmable microcircuit and a distal end, the distal end including a functional portion adjacent to a distal tip of the distal end for performing diagnostic and/or therapeutic functions, the distal end also including a position signal generating device for generating signals used to determine the position of the probe within the subject'"'"'s body;

programming the microcircuit with a number of times that the probe may be used; and

tracking with the microcircuit the number of times that the probe is used.

19. The method according to claim 18, further comprising wherein the number of times defines a minimum value and preventing further operation of the probe upon reaching the minimum value.

20. The method according to claim 19, further comprising displaying a message to the user that the probe is unsuitable for further use upon reaching the minimum value.

21. A method for programming and tracking the usage of a probe for insertion into the body of a subject, the method comprising the steps of:

providing a probe having a programmable microcircuit and a distal end, the distal end including a functional portion adjacent to a distal tip of the distal end for performing diagnostic and/or therapeutic functions, the distal end also including a position signal generating device for generating signals used to determine the position of the probe within the subject'"'"'s body;

storing a record in the microcircuit corresponding to a duration of use for the probe, the record including a minimum value;

reducing the record for each use of the probe; and

preventing further operation of the probe when the record reaches the minimum value.