Systems and methods to identify and disable re-use single use devices based on detecting environmental changes

• US 6,611,793 B1
• Filed: 09/07/1999
• Issued: 08/26/2003
• 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): Hoff; Marc S.
• Assistant Examiner(s): Charioui; Mohamed
• Application Number:
  US09/391,122
• Time in Patent Office: 1,449 Days
• Field of Search: 702/183,127,104,52 128/897 385/125 606/10 604/22 600/549 250/370 377/15
• US Class Current: 702/183
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• 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 2090/0803 Counting the number of times an instrument is used
• CPC Class Codes: A61B 2090/0813 Accessories designed for easy sterilising, i.e. re-usable

Abstract

A medical system for limiting usage of a medical probe, such as, e.g., a catheter or a surgical probe, is provided. The medical system comprises a medical probe that includes an electronic storage component for storage of data. The electronic storage component has environmental sensing capabilities and detects an environmental condition to which the medical probe is exposed. If the detected environmental condition is associated with a sterilization cycle, the electronic storage component stores a probe sterilization indicator indicating that the medical probe has been sterilized. The medical system further includes a medical probe control unit to which the medical probe is connected. The medical probe control unit is configured for writing and reading data to and from the electronic storage component of the medical probe when the medical probe is connected to the control unit. The medical probe control unit comprises a control circuit that prevents operation of the medical probe based on the presence of the probe sterilization indicator. Prevention of the medical probe operation is also based on a probe usage indicator, which is employed to distinguish between legitimate and illegitimate sterilization of medical probes.

Claims

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

detecting an environmental condition to which the medical probe is exposed;

electronically storing a probe sterilization indicator in the medical probe if the detected environmental condition indicates exposure of the medical probe to a sterilization cycle;

electronically storing a probe usage indicator in the medical probe if the medical probe is operated;

determining whether the probe sterilization indicator and probe usage indicator are present; and

conditionally operating the medical probe based on the presence of the probe sterilization indicator and probe usage indicator.

2. The method of claim 1, further comprising:

electronically storing an actual probe sterilization date in the medical probe when the medical probe is sterilized; and

determining the actual probe sterilization date of the medical probe.

3. The method of claim 2, wherein operation of the medical probe is prevented if the difference between actual probe sterilization date and a reference date exceeds a predetermined period of time.

4. The method of claim 3, wherein the predetermined period of time is a shelf-life of the medical probe.

5. The method of claim 1, wherein operation of the medical probe is allowed if the probe sterilization indicator is present and the probe usage indicator is absent.

6. The method of claim 5, wherein the probe sterilization indicator is cleared from the medical probe and the probe usage indicator is stored in the medical probe if the probe sterilization indicator is present and the probe usage indicator is absent.

7. The method of claim 1, further comprising:

electronically storing an estimated probe sterilization date in the medical probe when the medical probe is manufactured;

electronically storing an actual probe sterilization date in the medical probe when the medical probe is sterilized; and

determining the estimated probe sterilization date of the medical probe and the actual probe sterilization date of the medical probe.

8. The method of claim 7, wherein operation of the medical probe is prevented if the actual probe sterilization date is later than the estimated probe sterilization date.

9. The method of claim 1, wherein operation of the medical probe is prevented if the probe sterilization indicator and the probe usage indicator are present.

10. The method of claim 1, wherein operation of the medical probe is prevented if the probe sterilization indicator and the probe usage indicator are present.

11. The method of claim 1, wherein operation of the medical probe is allowed if the probe sterilization indicator is absent and the probe usage indicator is present.

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

control circuitry configured to electrically couple to the electronic storage componentry for reading data from the electronic storage componentry, and for conditionally operating the medical probe based on a presence of a probe sterilization indicator in the data and a presence of a probe usage indicator.

13. The control unit of claim 12, wherein operation of the medical probe is allowed if the probe sterilization indicator is present and the probe usage indicator is absent.

14. The control unit of claim 13, wherein the probe sterilization indicator is cleared from the electronic storage componentry and the probe usage indicator is stored in the electronic storage componentry when the medical probe is operated if the probe sterilization indicator is present and the probe usage indicator is absent.

15. The control unit of claim 13, wherein the probe sterilization indicator is cleared from the electronic storage componentry and the probe usage indicator is stored in the electronic storage componentry when the medical probe is effectively operated if the probe sterilization indicator is present and the probe usage indicator is absent.

16. The control unit of claim 12, wherein operation of the medical probe is prevented if the probe sterilization indicator and the probe usage indicator are present.

17. The control unit of claim 12, wherein operation of the medical probe is prevented if the probe sterilization indicator and the probe usage indicator are absent.

18. The control unit of claim 12, wherein operation of the medical probe is allowed if the probe sterilization indicator is absent and the probe usage indicator is present.

19. The control unit of claim 12, wherein the control circuitry comprises a microprocessor.

20. The control unit of claim 12, further comprising:

an RF power source; and

an interlocking device electrically coupled between the RF power source and the control circuitry.

21. A medical probe, comprising:

an elongate member having a distally located operative element; and

electronic storage componentry configured for detecting an environmental condition to which the medical probe is exposed and electronically storing a probe sterilization indicator in the medical probe if the detected environmental condition indicates exposure of the medical probe to a sterilization cycle, and configured for storing a probe usage indicator in the medical probe only if an initial operation of the medical probe is detected.

22. The medical probe of claim 21, wherein the electronic storage componentry is non-volatile.

23. The medical probe of claim 21, wherein the electronic storage componentry comprises non-volatile RAM coupled to a battery.

24. The medical probe of claim 21, wherein the electronic storage componentry comprises an EEPROM coupled to a battery.

25. The medical probe of claim 21, wherein the environmental condition is temperature-based.

26. The medical probe of claim 21, wherein the environmental condition is moisture-based.

27. The medical probe of claim 21, wherein the environmental condition is pressure-based.

28. The medical probe of claim 21, wherein the environmental condition is chemical-based.

29. The medical probe of claim 21, wherein the elongate member forms a catheter.

30. The medical probe of claim 21, wherein the elongate member forms a surgical probe.

31. A method of monitoring sterilization and usage of a medical probe, comprising:

detecting an environmental condition to which the medical probe is exposed;

electronically storing a probe sterilization indicator in the medical probe if the detected environmental condition indicates exposure of the medical probe to a sterilization cycle;

electronically storing a probe usage indicator in the medical probe only if initial operation of the medical probe is detected; and

determining whether the probe sterilization indicator and probe usage indicator are present.

32. The method of claim 31, wherein the environmental condition is temperature-based.

33. The method of claim 31, wherein the environmental condition is moisture-based.

34. The method of claim 31, wherein the environmental condition is pressure-based.

35. The method of claim 31, wherein the environmental condition is chemical-based.

36. The method of claim 31, further comprising preventing usage of the medical probe based on a presence of the probe sterilization indicator and a presence of the probe usage indicator.

37. The method of claim 31, wherein a presence of the probe sterilization indicator and probe usage indicator are determined when the medical probe is connected to a control unit.