Adaptive software configuration for a medical device

• US 7,167,755 B2
• Filed: 10/05/2004
• Issued: 01/23/2007
• Est. Priority Date: 10/05/2004
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Lindh, Par, Kalgren, James, Vanderlinde, Scott, Dyjach, John A., Thompson, Jeffrey M., Seeberger, Michael, Larsen-Kelly, Kristine M., Lanz, Mitchell
• Primary Examiner(s): Pezzuto; Robert
• Assistant Examiner(s): Lee; Yun Haeng
• Application Number:
  US10/958,628
• Publication Number:
  US 20060074463A1
• Time in Patent Office: 840 Days
• Field of Search: 607/30, 607/32, 607/59
• US Class Current: 607/59
• CPC Class Codes: A61N 1/37254 Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass
• CPC Class Codes: H04W 4/021 Services related to particular areas, e.g. point of interest [POI] services, venue services or geofences

Abstract

This document describes, among other things, a method of operating a medical device comprising updating a regulatory approval status stored in at least one of the medical device or a second device operable to communicate with the medical device, and enabling or disabling the at least one function in the medical device based on the regulatory approval status. The regulatory approval status corresponds to at least one function performable by the medical device.

Claims

1. A method of configuring a medical device, the method comprising:

automatically comparing a geographical jurisdiction of a regulatory approval to a geographical location identifier stored in at least one of the medical device or a second device operable to communicate with the medical device;

updating a regulatory approval status, stored in at least one of the medical device or the second device, in accordance with the comparison, the regulatory approval status corresponding to least one function performable by the medical device; and

enabling or a disabling the at least one function in the medical device based on the regulatory approval status.

2. The method of claim 1, wherein a geographical location of the medical device includes a location where the medical device is deemed to be located.

3. The method of claim 1, wherein the medical device is an implantable medical device (IMD).

4. The method of claim 3, wherein a geographical location of the IMD includes a location where the IMD was implanted.

5. The method of claim 3, wherein the IMD is a cardiac rhythm management device.

6. The method of claim 1, wherein enabling or disabling the function includes setting a status identifier corresponding to the function to a first value indicating that the function is not approved, wherein the first value disables the function, or setting the status identifier to a second value indicating that the function is approved, wherein the second value enables the function, the status identifier stored in at least one of the medical device and the second device.

7. The method of claim 1, wherein updating a regulatory approval status includes:

updating a regulatory approval status stored in the second device; and

communicating at least one identifier associated with the regulatory approval status to the medical device;

and wherein enabling or disabling the at least one function in accordance with the regulatory approval status includes enabling or disabling the function using the medical device.

8. The method of claim 1, wherein updating a regulatory approval status includes updating a regulatory approval status stored in the second device, and wherein enabling or disabling the at least one function in accordance with the regulatory approval status includes enabling or disabling the function using the second device.

9. The method of claim 1, wherein updating a regulatory approval status includes:

communicating at least one approved function to the medical device using the second device;

comparing at least one performable function to the approved function using the medical device; and

updating a regulatory approval status stored in the medical device in accordance with an outcome of a comparison.

10. The method of claim 1, wherein enabling or disabling the performable function based on the regulatory approval status includes enabling the function when the medical device is deemed a clinical-use device.

11. The method of claim 1, wherein enabling or disabling the performable function in the medical device based on the regulatory approval status includes enabling the function during a patient emergency.

12. The method of claim 11, enabling the function during a patient emergency includes wherein enabling the function for a timed duration.

13. The method of claim 1, wherein the at least one function includes performing a diagnostic test.

14. The method of claim 1, wherein the at least one function includes providing a therapy to a patient.

15. The method of claim 1, wherein the at least one function includes communicating using an approved communication frequency.

16. The method of claim 1, wherein the at least one function includes performing a sensing function.

17. The method of claim 1, wherein the method further includes validating the at least one function having updated approval status.

18. The method of claim 17, wherein the validating includes error-checking of information associated with the function and stored in the medical device.

19. The method of claim 17, wherein the validating includes verifying that functions do not contain conflicting parameters.

20. The method of claim 17, wherein the validating includes validating using the medical device.

21. The method of claim 17, wherein the validating includes validating using the second device.

22. The method of claim 1, wherein the method further includes providing notification of an update of a set of active functions of the medical device.

23. The method of claim 22, wherein providing notification of an update of a set of active functions of the medical device includes providing notification of an update to a third device.

24. The method of claim 22, wherein at least one device is an implantable medical device (IMD), and wherein providing notification of the update includes providing notification using the IMD.

25. The method of claim 22, wherein at least one device is an external device, and wherein providing notification of the update includes providing notification using the external device.

26. The method of claim 22, wherein providing notification of the update includes providing the notification over a conmmnication network.

27. The method of claim 26, wherein providing the notification over a communication network includes providing the notification to a central database.

29. The method of claim 27, wherein using approval status identifiers includes assigning values to the status identifiers, wherein assigning a first value indicates an approved status and assigning a second value indicates an unapproved status.

31. The method of claim 27, wherein updating the first and second status identifiers according to the at least one rule includes deeming the function approved.

32. The method of claim 31, wherein deeming the function approved includes indicating the availability of the function using the second device.

33. The method of claim 27, wherein updating the first and second status identifiers according to the at least one rule includes deeming the function unapproved.

34. The method of claim 32, wherein deeming the function unapproved includes preventing access to the first device using the second device.

35. The method of claim 33, wherein deeming the function unapproved includes triggering an alarm with the second device.

28. A method of adjusting whether a function of a first medical device is active, the method comprising:

storing regulatory approval information in a second device operable to communicate with the first device, the approval information including regulatory approval by geographic location;

storing in the first device geographic location information associated with the first device, and storing in the second device geographic location information associated with the second device;

using approval status identifiers to enable or disable at least one function of the first device, wherein a first status identifier value is stored in the first device to represent a first regulatory approval status of the function, and wherein a second status identifier value is stored in the second device to represent a second regulatory approval status of the function; and

updating the first and second status identifiers according to at least one rule, wherein the at least one rule is applied to stored information including the stored geographical information and the status identifiers.

30. The method of claim 28, wherein assigning values to the status identifiers includes assigning a third value to indicate an approval during clinical trials.

36. The method of claim 28, wherein updating the first and second status identifiers according to at least one rule includes deeming the function approved for clinical use.

37. The method of claim 28, wherein updating the first and second status identifiers according to at least one rule includes updating to effect the most restrictive use of the at least one function subject to approval.

38. The method of claim 28, wherein updating the first and second status identifiers according to at least one rule includes updating to effect the least restrictive use of the at least one function subject to approval.

39. The method of claim 28, wherein the first device is an implantable medical device (IMD).

40. The method of claim 39, wherein the second device is an IMD.