Systems and methods for preventing automatic identification of re-used single use devices

• US 6,237,604 B1
• Filed: 09/07/1999
• Issued: 05/29/2001
• Est. Priority Date: 09/07/1999
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Swanson, David K., Burnside, Robert R., Wand, Bruce
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US09/391,109
• Time in Patent Office: 630 Days
• Field of Search: 128/898, 128/897, 606/1, 606/10-12, 606/32-35, 606/41-42, 606/45-50, 600/300
• US Class Current: 128/897
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/148 having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
• 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 2090/0803 Counting the number of times an instrument is used
• CPC Class Codes: A61B 2090/0814 Preventing re-use
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags

Abstract

A medical system for limiting the re-use of a medical probe, such as, e.g., a catheter or a surgical probe, is provided. The medical system includes a medical probe that includes an electronic storage component for storing a probe identification code. The medical probe further includes a disabling circuit, the activation of which disables the electronic storage component. The medical system further includes a control unit, such as, e.g., an RF generator, for connection to the medical probe. The control unit includes control circuit that is configured for automatically reading the probe identification code from the electronic storage component and preventing the medical probe from being operated if the probe identification code is not approved. The control circuit is also configured for determining if the medical probe has been previously used. If the medical probe has been previously used, the control circuit prevents operation of the medical probe and activates the disabling circuitry to disable the electronic storage component in the medical probe. Thus, when the medical probe is reconnected to the control unit, the control circuitry will attempt to read the probe identification code from the disable electronic storage component. Alternatively, the disabling circuitry internally determines whether the medical probe has been previously used and disables the electronic storage component.

Claims

1. A method of limiting usage of a medical probe, the medical probe including an electronic storage component for storing a probe identification code that can be read by a control unit, the method comprising:

determining if the medical probe has been previously used; and

disabling the electronic storage component so that the probe identification code can no longer be read by the control unit if the medical probe is determined to have been previously used.

2. The method of claim 1, wherein the electronic storage component is disabled by modifying the probe identification code.

3. The method of claim 2, wherein the probe identification code is modified by clearing the probe identification code from the electronic storage component.

4. The method of claim 1, wherein the electronic storage component is disabled by modifying a function of the electronic storage component.

5. The method of claim 4, wherein the function of the electronic storage component is modified by shorting the electronic storage component.

6. The method of claim 1, wherein the determination of whether the medical probe has been previously used is based on an elapsed time since an initial operation of the medical probe.

7. The method of claim 1, wherein the determination of whether the medical probe has been previously used is based on a number of times the medical probe has been operated.

8. The method of claim 1, wherein the determination of whether the medical probe has been previously used is based on determining whether there has been a previous operation of the medical probe and a sterilization of the medical probe.

9. The method of claim 1, wherein the probe identification code is a unique serial number.

10. The method of claim 1, wherein the probe identification code identifies a characteristic of the medical probe.

11. A medical probe, comprising:

an elongate member having a distally located functional component;

an electronic storage component having stored therein a probe identification code that can be read by a control unit; and

disabling circuitry electrically coupled to the electronic storage component, the disabling circuitry configured for detecting whether the medical probe has been previously used, and for disabling the electronic storage component so that the probe identification code can no longer be read by the control unit if the medical probe is determined to have been previously used.

12. The medical probe of claim 11, wherein the disabling circuitry disables the electronic storage component by shorting the electronic storage component.

13. The medical probe of claim 11, wherein the electronic storage component comprises one or more resistors.

14. The medical probe of claim 11, wherein the electronic storage component comprises a semiconductor device.

15. The medical probe of claim 11, wherein the disabling circuitry detects whether the medical probe has been previously used by sensing a disable signal transmitted from a source external to the medical probe.

16. The medical probe of claim 11, wherein the probe identification code is a unique serial number.

17. The medical probe of claim 11, wherein the probe identification code identifies a characteristic of the medical probe.

18. The medical probe of claim 11, wherein the elongate member forms a catheter.

19. The medical probe of claim 11, wherein the elongate member forms a surgical probe.

20. A control unit for connection to a medical probe, the medical probe having an electronic storage component for storing a probe identification code that can be read by the control unit, the control unit comprising:

control circuitry configured to electrically couple to the electronic storage component for determining if the medical probe has been previously used, and for disabling the electronic storage component so that the probe identification code can no longer be read by the control unit if the medical probe is determined to have been previously used.

21. The control unit of claim 20, wherein the electronic storage component is disabled by modifying the probe identification code.

22. The control unit of claim 20, wherein the electronic storage component is disabled by modifying a functioning of the electronic storage component.

23. The control unit of claim 20, wherein the determination of whether the medical probe has been previously used is based on an elapsed time since an initial operation of the medical probe.

24. The control unit of claim 20, wherein the determination of whether the medical probe has been previously used is based on a number of times the medical probe has been operated.

25. The control unit of claim 20, wherein the determination of whether the medical probe has been previously used in based on determining whether that has been an initial operation and sterilization of the medical probe.

26. The control unit of claim 20, wherein the probe identification code is a unique serial number.

27. The control unit of claim 20, wherein the control circuitry comprises a microprocessor.

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

an RF power source; and

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

29. A method of limiting usage of a medical probe, the medical probe including an electronic storage component for storing a probe identification code, the method comprising:

determining if the medical probe has been previously used; and

disabling the electronic storage component if the medical probe is determined to have been previously used;

wherein the electronic storage component is disabled by clearing the probe identification code from the electronic storage component.

30. A medical probe, comprising:

an elongate member having a distally located functional component;

an electronic storage component having stored therein a probe identification code that can be read by a control unit;

a usage counter that can be read by the control unit; and

disabling circuitry electrically coupled to the electronic storage component, the disabling circuitry configured for detecting the state of the usage counter, and for disabling the electronic storage component so that the probe identification code can no longer be read by the control unit if the usage counter exceeds a threshold value.

31. The medical probe of claim 30 wherein the usage counter is incremented each time the medical probe is used therapeutically.

32. The medical probe of claim 30 wherein the usage counter is incremented each time the probe is used and a predetermined period of time elapses.

33. The medical probe of claim 32 wherein the predetermined period of time is greater than the maximum time expected to perform a therapeutic procedure with the medical probe and less than the minimum time expected to complete a sterilization cycle on the medical probe.

34. The medical probe of claim 30 wherein the usage counter is incremented each time the medical probe is sterilized.