Systems and methods to identify and disable re-used single use devices based on time elapsed from first therapeutic use

• US 6,387,092 B1
• Filed: 09/07/1999
• Issued: 05/14/2002
• Est. Priority Date: 09/07/1999
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Swanson, David K., Burnside, Robert R.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/390,441
• Time in Patent Office: 980 Days
• Field of Search: 606/32, 606/34, 606/39-41, 606/45, 606/49, 607/116, 607/122
• US Class Current: 606/32
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2090/0803 Counting the number of times an instrument is used

Abstract

A medical system for limiting usage of a medical probe, such as, e.g., a catheter or surgical probe, is provided. The medical system includes a medical probe that includes electronic storage componentry for storage of data. The medical system further includes a control unit to which the medical probe is connected. The control unit is configured for writing and reading data to and from the electronic storage componentry of the medical probe when the medical probe is connected to the control unit. The control unit includes a clock that generates a time signal, which is used to determine an initial probe usage time and a reference time. The control unit further includes a control circuit that writes the initial probe usage time to the electronic storage componentry of the medical probe when the medical probe is initially operated. During a subsequent procedure, the control circuit reads the initial probe usage time from the electronic storage componentry. The control circuit determines an elapsed probe usage time based on the initial probe usage time and the reference time. The control circuit then determines whether a predetermined elapsed time limit has expired based on the elapsed probe usage time. The control circuit then prevents operation of the medical probe if the predetermined elapsed time limit has expired.

Claims

1. A method of monitoring usage of a medical probe, comprising:

initially effectively operating the medical probe;

determining a time coincident with the initial effective operation of the medical probe to obtain an initial probe usage time; and

electronically storing the initial probe usage time in the medical probe.

2. The method of claim 1, wherein the initial probe usage time is stored in a non-volatile storage component.

3. The method of claim 1, further comprising electronically storing a predetermined elapsed time limit in the medical probe.

4. The method of claim 3, wherein the predetermined elapsed time limit is selected to be between a minimum elapsed time expected to sterilize the medical probe and a maximum elapsed time expected to perform a procedure on a patient.

5. The method of claim 1, wherein the initial probe usage time is obtained from the medical probe.

6. The method of claim 1, further comprising limiting usage of the medical probe based on the initial probe usage time.

7. The method of claim 1, wherein the initial probe usage time is used to facilitate troubleshooting of the medical probe.

8. The method of claim 1, wherein the medical probe is an RF ablation instrument, and the initial effective operation of the medical probe includes creating a tissue lesion.

40. The method of claim 1, wherein the initial probe usage time is stored substantially permanently in the medical probe.

9. A method of limiting usage of a medical probe having electronically stored therein an initial effective probe usage time, the method comprising:

reading the initial effective probe usage time from the medical probe;

comparing the initial effective probe usage time with a reference time; and

conditionally operating the medical probe based on the time comparison.

10. The method of claim 9, wherein the reference time is a current time, the initial effective probe usage time is subtracted from the current time to determine an elapsed probe usage time, and conditional operation of the medical probe is based on the elapsed probe usage time.

11. The method of claim 10, further comprising determining whether the elapsed probe usage time has expired, wherein operation of the medical probe is prevented if the elapsed probe usage time has expired.

12. The method of claim 11, wherein expiration of the elapsed probe usage time expires if the elapsed probe usage time exceeds a predetermined elapsed time limit.

13. The method of claim 12, wherein the medical probe has electronically stored therein the predetermined elapsed time limit, the method further comprising reading the predetermined elapsed time limit from the medical probe.

14. The method of claim 11, wherein the medical probe is connectable to a control unit, and wherein the expiration of the elapsed probe usage time is determined only once per device connection.

15. The method of claim 11, wherein the medical probe is connectable to a control unit, and wherein the expiration of the elapsed probe usage time is determined periodically during device connection.

16. The method of claim 9, wherein the reference time comprises an absolute time.

41. The method of claim 9, wherein the initial effective probe usage time is electronically stored substantially permanently in the medical probe.

17. A control unit for connection to a medical probe, the medical probe having electronic storage componentry, the control unit comprising:

a clock configured for generating a time signal; and

a control circuit electrically coupled to the clock, the control circuit configured to electrically couple to the electronic storage component of the medical probe for deriving an initial probe usage time from the time signal when the medical probe is initially effectively operated, and for writing the initial probe usage time to the electronic storage componentry substantially permanently.

18. The control unit of claim 17, wherein the control circuit includes a microprocessor.

19. The control unit of claim 17, wherein the control circuit is further configured for conditionally generating a control signal based on the initial probe usage time.

20. The control unit of claim 19, wherein the control circuit is further configured for reading the initial probe usage time from the electronic storage componentry when the medical probe is reconnected to the control unit.

21. The control unit of claim 19, wherein the medical probe is prevented from being operated based on the control signal.

42. The control unit of claim 17, wherein the initial probe usage time is written substantially permanently into the electronic storage componentry.

22. A control unit for connection to a medical probe, the medical probe comprising electronic storage componentry having an initial effective probe usage time stored therein, the control unit comprising:

a clock configured for generating a time signal; and

a control circuit electrically coupled to the clock, the control circuit configured to electrically couple to the electronic storage componentry for reading the initial probe usage time stored in the electronic storage componentry, and for conditionally generating a control signal based on the initial probe usage time.

23. The control unit of claim 22, wherein the control circuit is further configured for determining a reference time from the time signal, the conditional control signal being based on the initial effective probe usage time and the reference time.

24. The control unit of claim 23, wherein the control circuit is further configured for determining if a predetermined elapsed time limit has expired based on the initial effective probe usage time and the reference time, and wherein the control signal is generated upon expiration of the predetermined elapsed time limit.

25. The control unit of claim 24, wherein the control circuit is further configured for determining an elapsed probe usage time by subtracting the initial effective probe usage time from the reference time, and wherein the predetermined elapsed time limit expires if the elapsed probe usage time exceeds the predetermined elapsed time limit.

26. The control unit of claim 24, wherein the electronic storage componentry has the predetermined elapsed time limit stored therein, and the control circuit is further configured for reading the predetermined elapsed time limit from the electronic storage componentry.

27. The control unit of claim 24, wherein expiration of the predetermined elapsed time limit is determined only one time per device connection.

28. The control unit of claim 24, wherein the expiration of the predetermined elapsed time limit is determined periodically during device connection.

29. The control unit of claim 24, wherein the conditional control signal generated by the control circuit prevents operation of the medical probe.

30. The control unit of claim 22, further comprising:

an RF power source; and

an interlocking device coupled between the RF power source and the control circuit, wherein the control signal is an interlocking control signal.

31. The control unit of claim 22, wherein the control circuit includes a microprocessor.

43. The control unit of claim 22, wherein the initial probe usage time is stored substantially permanently in the electronic storage componentry.

32. A medical probe, comprising:

an elongate member having a distally located operative element; and

electronic storage componentry having a predetermined elapsed time limit for effective operation stored therein.

33. The medical probe of claim 32, wherein the storage component is non-volatile.

34. The medical probe of claim 32, wherein the electronic storage componentry comprises an EEPROM.

35. The medical probe of claim 32, further comprising a thermocouple having a first temperature-sensing component adjacent the operative element and a second temperature-sensing component adjacent the electronic storage-componentry, wherein the electronic storage componentry is an EEPROM having temperature-sensing capability.

36. The medical probe of claim 32, wherein the electronic storage componentry further has an initial probe usage time stored therein.

37. The medical probe of claim 32, wherein the predetermined elapsed time limit is between a minimum elapsed time expected to sterilize the medical probe and a maximum elapsed time expected to perform a procedure on a patient.

38. The medical probe of claim 32, wherein the elongate member forms a catheter.

39. The medical probe of claim 32, wherein the elongate member forms a surgical probe.