ADAPTIVE SOFTWARE CONFIGURATION FOR A MEDICAL DEVICE

• US 20070100397A1
• Filed: 11/16/2006
• Published: 05/03/2007
• 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, Vanderlinde, Scott, Seeberger, Michael, Lanz, Mitchell, Dyjach, John, Thompson, Jeffrey, Kalgren, James, Larsen-Kelly, Kristine
• Granted Patent: US 7,630,773 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 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; and

wherein at least one of the memory circuits of the IMD and the second device stores a geographical location identifier, and wherein at least one of the IMD and the second device is configured to automatically compare the geographic location identifier to a geographic jurisdiction of a regulatory approval of the at least one function.

2. The system of claim 1, 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.

3. The system of claim 1, 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.

4. The system of claim 1, 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.

5. The system of claim 4, 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.

6. The system of claim 1, 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.

7. The system of claim 6, 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.

8. The system of claim 1, 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.

9. The system of claim 1, 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.

10. The system of claim 1, 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.

11. The system of claim 1, 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.

12. The system of claim 1, wherein the at least one function includes a frequency of operation used in communication between the IMD and the second device.

13. The system of claim 1, 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.

14. The system of claim 1, 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.

15. The system of claim 1, 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.

16. The system of claim 1, 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.

17. The system of claim 1, wherein the second device is another IMD.

18. The system of claim 1, wherein the second device is an external device further including a user interface.

19. The system of claim 1, wherein the second device is operable to communicate over a network.

20. The system of claim 19, wherein the network includes a wireless communication network.

21. The system of claim 20, wherein the network includes the internet.