Adaptive software configuration for a medical device

• US 20060074463A1
• Filed: 10/05/2004
• Published: 04/06/2006
• Est. Priority Date: 10/05/2004
• Status: Active Grant

• 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
• Granted Patent: US 7,167,755 B2
• Time in Patent Office: Days
• US Class Current: 607/60
• 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:

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, the regulatory approval status corresponding to at least one function performable by the medical device; and

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

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

comparing a geographical jurisdiction of a regulatory approval to a geographical location of the medical device; and

updating the regulatory approval status of the function in accordance with the comparison.

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

4. The method of claim 2, wherein the medical device is an implantable medical device (IMD).

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

6. The method of claim 4, wherein the IMD is a cardiac rhythm management device.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

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

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

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

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

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

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

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

20. The method of claim 18, wherein the validating includes verifying that functions do not contain conflicting parameters.

21. The method of claim 18, wherein the validating includes validating using the medical device.

22. The method of claim 18, wherein the validating includes validating using the second device.

23. 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.

24. The method of claim 23, 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.

25. The method of claim 23, wherein at least one device is an implantable medical device (IMD), and wherein providing notification of the update includes providing notification using the IMD.

26. The method of claim 23, wherein at least one device is an external device, and wherein providing notification of the update includes providing notification using the external device.

27. The method of claim 23, wherein providing notification of the update includes providing the notification over a communication network.

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

29. A system comprising:

an implantable medical device (IMD) including;

a communication circuit;

a memory circuit; and

a controller circuit coupled to the at least one memory circuit and communication circuit, the memory circuit storing instruction code executable by the controller circuit to perform at least one function and to enable or disable the at least one function; and

a second device including;

a communication circuit;

a memory circuit; and

a controller circuit coupled to the at least one memory circuit and the communication circuit, the controller circuit executing instructions to communicate with the IMD;

wherein at least one of the memory circuits of the IMD and the second device stores a status identifier corresponding to a regulatory approval status of the at least one function, the status identifier used to enable or disable the at least one function.

30. The system of claim 29, wherein at least one of the memory circuits of the IMD and the second device stores a geographic location identifier to identify where the IMD was implanted, and wherein the status identifier enables or disables the function in accordance with a regulatory approval status of the at least one function, the approval status associated with the geographic location where the IMD was implanted.

31. The system of claim 29, wherein at least one of the memory circuits of the IMD and the second device stores a geographic location identifier stored in the memory circuit to identify where the IMD is deemed to be located, and wherein the status identifier enables or disables the function in accordance with a regulatory approval status of the at least one function, the approval status associated with the geographic location where the IMD is deemed to be located.

32. The system of claim 29, in which the status identifier includes a first value used to disable a function to indicate that the function is not approved, and a second value used to enable a function to indicate that the function is approved.

33. The system of claim 32, in which the status identifier includes a third value indicating that the function is approved for a clinical study purpose, and wherein the third value is used to enable the corresponding function.

34. The system of claim 29, in which the status identifier includes a value to indicate that the function has an approved status during a patient emergency, and wherein the value enables the corresponding function.

35. The system of claim 34, wherein at least one of the memory circuits of the IMD and the second device stores a geographic location identifier, and wherein the status identifier enables or disables the function during an emergency in accordance with a regulatory approval status of the function during an emergency, wherein the regulatory approval status is associated with the geographic location.

36. The system of claim 29, wherein at least one of the IMD and the second device further includes a timing circuit coupled to its controller circuit, wherein the controller circuit is operable to enable or disable a function during a timed duration associated with a regulatory approval status.

37. The system of claim 29, wherein at least one of the IMD and the second device further includes a clock circuit coupled to the controller circuit, wherein the controller circuit is operable to enable or disable a function in relation to a time and/or date associated with a regulatory approval status.

38. The system of claim 29, wherein the IMD further includes at least one cardiac signal sensing circuit operable to detect cardiac signals, and wherein the at least one function includes a diagnostic test.

39. The system of claim 29, wherein the IMD further includes a therapy circuit coupled to the controller circuit, and wherein the at least one function includes a therapy delivered to a patient.

40. The system of claim 29, wherein the at least one function includes a frequency of operation used in communication between the IMD and the second device.

41. The system of claim 29, wherein at least the memory circuit of the IMD stores the status identifier, wherein the second device is operable to communicate at least one approved function to the IMD, and wherein the IMD controller circuit is operable to compare at least one performable function to the approved function and update at least one status identifier in accordance with an outcome of a comparison.

42. The system of claim 29, wherein at least the memory circuit of the second device stores the status identifier, and wherein the second device is operable to communicate at least one identifier associated with the regulatory approval status to the IMD.

43. The system of claim 29, wherein the memory circuit of the second device stores the status identifier, and wherein the second device is operable to enable or disable the at least one function in accordance with the regulatory approval status.

44. The system of claim 29, wherein the memory circuit of the IMD stores the status identifier, and wherein the IMD is operable to communicate an enabled or disabled status of the at least one function to the second device.

45. The system of claim 29, wherein the second device is another IMD.

46. The system of claim 29, wherein the second device is an external device further including a user interface.

47. The system of claim 29, wherein the second device is operable to communicate over a network.

48. The system of claim 47, wherein the network includes a wireless communication network.

49. The system of claim 48, wherein the network includes the internet.

50. 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.

51. The method of claim 50, 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.

52. The method of claim 51, wherein assigning values to the status identifiers includes assigning a third value to indicate an approval during clinical trials.

53. The method of claim 50, wherein updating the first and second status identifiers according to the at least one rule includes deeming the function approved.

54. The method of claim 53, wherein deeming the function approved includes indicating the availability of the function using the second device.

55. The method of claim 50, wherein updating the first and second status identifiers according to the at least one rule includes deeming the function unapproved.

56. The method of claim 55, wherein deeming the function unapproved includes preventing access to the first device using the second device.

57. The method of claim 55, wherein deeming the function unapproved includes triggering an alarm with the second device.

58. The method of claim 50, wherein updating the first and second status identifiers according to at least one rule includes deeming the function approved for clinical use.

59. The method of claim 50, 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.

60. The method of claim 50, 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.

61. The method of claim 50, wherein the first device is an implantable medical device (IMD).

62. The method of claim 61, wherein the second device is an IMD.

63. A system comprising:

a first external device including;

at least one memory circuit; and

a controller circuit coupled to the at least one memory circuit, the memory circuit storing instruction code executable by the controller circuit to perform at least one function and storing a corresponding status identifier used to enable or disable the function in accordance with a regulatory approval status of the function;

a communication circuit coupled to the controller circuit; and

a second external device operable to communicate the regulatory approval status to the first device, the second device including;

a communication circuit to allow communication with the first device;

a memory circuit to store information about one or more functions performable by the first device along with one or more corresponding current status identifiers indicative of a most current regulatory approval status of the corresponding function; and

a controller circuit, coupled to the communication circuit and the memory circuit, the controller circuit executing instructions to communicate the most current regulatory approval status to the first device.

64. The system of claim 63, wherein the first device further includes a geographic location identifier stored in the memory circuit to identify where the first device is deemed to be located, and wherein the status identifier enables or disables the function in accordance with a regulatory approval status of the at least one function, the approval status associated with the geographic location where the first device is deemed to be located.

65. The system of claim 63, in which the status identifier includes a first value to disable a function to indicate that the function is not approved, and a second value to enable a function to indicate that the function is approved.

66. The system of claim 65, in which the status identifier includes a third value indicating that the function is approved for a clinical study purpose, and wherein the third value enables the corresponding function.

67. The system of claim 63, wherein the second device is operable to communicate at least one approved function to the first device and wherein the controller circuit is operable to compare a set of performable functions to the approved function and update status identifiers in accordance with an outcome of a comparison.

68. The system of claim 63, wherein the second device is operable to communicate identifiers associated with the regulatory approval status to the first device.

69. The system of claim 63, wherein the at least one function includes a frequency of operation used in communication between the first device and the second device.

70. The system of claim 63, wherein at least one of the first and second devices are operable to communicate over a network.

71. The system of claim 70, wherein the network includes a wireless communication network.

72. The system of claim 71, wherein the network includes the internet.