Local in-device memory feature for electrically powered medical equipment

• US 5,400,267 A
• Filed: 12/08/1992
• Issued: 03/21/1995
• Est. Priority Date: 12/08/1992
• Status: Expired due to Fees

• Current Assignee: Hemostatix Corporation
• Original Assignee: Hemostatix Corporation
• Inventors: Weller, Albert E. III, Denen, Dennis J., Eggers, Philip E., Shaw, Robert F.
• Primary Examiner(s): Voeltz, Emanuel T.
• Assistant Examiner(s): PIPALA, EDWARD J
• Application Number:
  US07/986,967
• Time in Patent Office: 833 Days
• Field of Search: 364/413.07, 364/413.01, 364/480, 364/483, 364/550, 364/552, 365/226, 365/244, 439/909, 128/908, 323/911, 307/11, 307/31, 307/38, 307/39, 307/154
• US Class Current: 702/59
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• 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 2090/0803 Counting the number of times an instrument is used
• CPC Class Codes: A61B 90/10 for stereotaxic surgery, e.g. frame-based stereotaxis
• CPC Class Codes: H02J 2310/23 The load being a medical device, a medical implant, or a life supporting device
• CPC Class Codes: H02J 3/00 Circuit arrangements for ac mains or ac distribution networks
• CPC Class Codes: Y10S 128/908 Patient protection from electric shock
• CPC Class Codes: Y10S 323/911 Medical electronics

Abstract

A non-volatile memory disposed within electrically powered medical equipment is described. The non-volatile memory may be preprogrammed to store utilization limits and parametric data for the equipment. An external control module may be programmed to store the utilization history for the equipment in the non-volatile memory on an on-going basis. The control module compares the utilization limits and utilization history during each use, and disables the equipment if a utilization limit is exceeded. The control module may also use the parametric data stored in the non-volatile memory to regulate the power supplied to the equipment.

Claims

1. In a medical device selected from a plurality of different types of medical devices, the medical device to be connected to a power supply that supplies an output to the medical device during use, the output of the power supply having selectable voltage and current parameters specific to each one of the plurality of different types of medical devices, the improvement comprising memory means disposed in the medical device for storing identification data identifying the type of medical device connected to the power supply, the selection of the voltage and current parameters of the output determined responsive to the identification data.

2. A medical device as defined in claim 1 wherein the memory means comprises a device having a non-volatile memory.

3. A medical device as defined in claim 1 wherein the identification data comprises data from the group consisting of:

serial number, model number and power supply parametric data.

4. A medical device as defined in claim 3 wherein the power supply parametric data comprises data from the group consisting of:

voltage limits, current limits, instrument impedance, voltage setpoints, current setpoints, voltage ranges, current ranges and scale factors.

5. A medical device as defined in claim 3 wherein the identification data comprises limit data.

6. A medical device as defined in claim 5 wherein the limit data pertains to use of the medical device in individual procedures, the limit data comprising data from the group consisting of:

maximum procedure count, maximum actuation count, maximum accumulated actuation time, maximum sterilization count and maximum fault count.

7. A medical device as defined in claim 1 wherein the information pertaining to the medical device stored in the memory means further comprises utilization data reflecting the most recent use of the medical device.

8. A medical device as defined in claim 7 wherein the utilization data pertains to use of the medical device in individual procedures, the utilization data comprising data from the group consisting of:

accumulated procedure count after the most recent procedure, accumulated actuation count after the most recent actuation, accumulated actuation time after the most recent actuation, accumulated sterilization count after the most recent sterilization and accumulated fault count for the medical device during a current surgical procedure.

9. A medical device as defined in claim 1 wherein the memory means is disposed in a reusable portion of the medical device.

10. A medical device as defined in claim 2 wherein the memory means comprises a device selected from the group consisting of:

ROM, PROM, EPROM, flash memory, non-volatile RAM, battery-backed-up RAM, EEPROM, magnetic data storage apparatus and optical data storage apparatus.

11. A system of tracking the utilization of a medical device selected from a plurality of different types of medical devices, the medical device connected to a power supply that supplies an output to the medical device during use, the output of the power supply having selectable voltage and current parameters specific to each one of the plurality of different types of medical devices, the system comprising:

memory means disposed in the medical device for storing identification data identifying the type of medical device;

control means for receiving the information stored in the memory means, the control means setting the voltage and current parameters of the output responsive to the identification data stored in the memory means; and

connecting means for coupling the memory means to the control means when the medical device is connected to the power supply.

12. The system as defined in claim 11 wherein the memory means comprises a device having a non-volatile memory.

13. The system as defined in claim 11 wherein the identification data comprises data from the group consisting of:

serial number, model number and power supply parametric data.

14. The system as defined in claim 13 wherein the power supply parametric data comprises data from the group consisting of:

voltage limits, current limits, instrument impedance, voltage setpoints, current setpoints, voltage ranges, current ranges and scale factors.

15. The system as defined in claim 13 wherein the identification data comprises limit data.

16. The system as defined in claim 15 wherein the limit data pertains to use of the medical device in individual procedures, the limit data comprising data from the group consisting of:

maximum procedure count, maximum actuation count, maximum accumulated actuation time, maximum sterilization count and maximum fault count.

17. The system as defined in claim 11 wherein the control means tracks utilization data reflecting the most recent use of the medical device, and second non-volatile memory means for storing the utilization data.

18. The system as defined in claim 17 wherein the utilization data pertains to use of the medical device in individual procedures, the utilization data comprising data from the group consisting of:

accumulated procedure count after the most recent procedure, accumulated actuation count after the most recent actuation, accumulated actuation time after the most recent actuation, accumulated sterilization count after the most recent sterilization and accumulated fault count for the medical device during a current procedure.

19. The system as defined in claim 15 wherein the control means tracks utilization data reflecting the most recent utilization of the medical device, the utilization data comprising data corresponding to the limit data for the most recent use of the medical device, and second non-volatile memory means for storing the utilization data.

20. The system as defined in claim 19 wherein the utilization data pertains to use of the medical device in individual procedures, the utilization data comprising data from the group consisting of:

accumulated procedure count after the most recent procedure, accumulated actuation count after the most recent actuation, accumulated actuation time after the most recent actuation, accumulated sterilization count after the most recent sterilization and accumulated fault count for the medical device during a current procedure.

21. The system as defined in claim 19 wherein the control means compares the limit data to the corresponding utilization data to determine whether the medical device will exceed a limit value.

22. The system as defined in claim 12 wherein the memory means comprises a device selected from the group consisting of:

ROM, PROM, EPROM, flash memory, non-volatile .RAM, battery-backed-up RAM, EEPROM, magnetic data storage apparatus and optical data storage apparatus.

23. The system as defined in claim 11 wherein the the memory means further stores utilization data reflecting the most recent use of the medical device, and the control means tracks and updates the utilization data stored in the memory means.

24. The system as defined in claim 23 wherein the identification data comprises data from the group consisting of:

serial number, model number and power supply parametric data.

25. The system as defined in claim 23 wherein the identification data comprises limit data.

26. The system as defined in claim 24 wherein the power supply parametric data comprises data from the group consisting of:

voltage limits, current limits, instrument impedance, voltage setpoints, current setpoints, voltage ranges, current ranges and scale factors.

27. The system as defined in claim 25 wherein the limit data pertains to use of the medical device in individual procedures, the limit data comprising data from the group consisting of:

maximum procedure count, maximum actuation time, maximum accumulated actuation count, maximum sterilization count and maximum fault count.

28. The system as defined in claim 23 wherein the utilization data pertains to use of the medical device in individual procedures, the limit data comprising data from the group consisting of:

accumulated procedure count after the most recent procedure, accumulated actuation count after the most recent actuation, accumulated actuation time after the most recent actuation, accumulated sterilization count after the most recent sterilization and accumulated fault count for the medical device during a current procedure.

29. The system as defined in claim 25 wherein the control means compares the limit data to the corresponding utilization data to determine whether the medical device will exceed a limit value.

30. The system as defined in claim 27 wherein the memory means comprises a device selected from the group consisting of:

non-volatile RAM, battery-backed-up RAM, EEPROM, magnetic data storage apparatus and optical data storage apparatus.

31. The system as defined in claim 29 wherein the control means disables the medical device when the utilization data equals the corresponding limit data.

32. The system as defined in claim 11 wherein the memory means stores preprogrammed utilization limit data for each of a plurality of parameters and the control means measures each of a plurality of parameters corresponding to the preprogrammed utilization limit data during a current use of the medical device, and decrements the preprogrammed utilization limit data stored in the memory means to reflect usage of the medical device during the current use.

33. The system as defined in claim 32 wherein the control means disables the medical device when the at least one of the preprogrammed utilization limits has been decremented to zero.

34. The system as defined in claim 32 wherein the preprogrammed utilization limit data pertains to use of the medical device in individual procedures, the programmed utilization limit data comprising data from the group consisting of:

maximum procedure count, maximum actuation count, maximum accumulated actuation time, maximum sterilization count and maximum fault count.

35. The system as defined in claim 13 wherein the identification data comprises power supply parametric data and the control means reads the power supply parametric data stored in the memory means;

and regulates the power supplied to the medical device in accordance with the power supply parametric data.

36. The system as defined in claim 35 wherein the parametric data comprises data from the group consisting of:

maximum current, maximum voltage, instrument impedance, power supply scale factors for limiting the power supplied to the medical device to an acceptable range, voltage setpoints and current setpoints.

37. The system as defined in claim 11, wherein the control means stores a preprogrammed list of identification codes for each one of the plurality of different types of medical devices compatible with the power supply, receives the identification data from the memory means, compares the identification data received from the memory means to the preprogrammed list of identification codes and

disables the medical device if the identification data does not correspond to any identification code.

38. The system as defined in claim 13, wherein the identification data further comprises a maximum fault limit for faults occurring during use and the control means counts the number of faults occurring during a current use, receives the identification data from the memory means, compares the identification data received from the memory means to the number of faults counted during the current use and

prevents the medical device from being reset if the number of faults counted during the current use exceeds the maximum fault limit.

39. The system as defined in claim 11 wherein the control means comprises a microprocessor.

40. The system as defined in claim 11 wherein the control means further comprises random access memory means.

41. The system as defined in claim 11 wherein the control means is disposed within the power supply.

42. The system as defined in claim 17 wherein the second non-volatile memory means comprises a device selected from the group consisting of:

non-volatile RAM, battery-backed-up RAM, EEPROM, magnetic data storage apparatus and optical data storage apparatus.

43. The system as defined in claim 21 wherein the control means disables the medical device when the utilization data equals the corresponding limit data.

44. The system as defined in claim 19 wherein the second non-volatile memory means comprises a device selected from the group consisting of:

non-volatile RAM, battery-backed-up RAM, EEPROM, magnetic data storage apparatus and optical data storage apparatus.

45. The system as defined in claim 21 wherein the control means issues a change equipment advisory before the medical device has exceeded a limit value.

46. The system as defined in claim 29 wherein the control means issues a change equipment advisory before the medical device has exceeded a limit value.