Adaptive software configuration for a medical device

• US 8,639,346 B2
• Filed: 10/26/2009
• Issued: 01/28/2014
• 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: Seeberger, Michael, Vanderlinde, Scott, Kalgren, James, Lindh, Par, Larsen-Kelly, Kristine M., Lanz, Mitchell, Thompson, Jeffrey M., Dyjach, John A.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): GHAND, JENNIFER LEIGH-STEWAR
• Application Number:
  US12/605,407
• Publication Number:
  US 20100049279A1
• Time in Patent Office: 1,555 Days
• Field of Search: 607/59, 607/60
• 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

A method of operating a medical device comprises 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:

a first external device including;

a communication circuit;

a memory circuit; and

a controller circuit coupled to the memory circuit and communication 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; and

a second external device including;

a communication circuit to allow communication with the first device;

a memory circuit; and

a controller circuit, coupled to the communication circuit and the memory circuit, the controller circuit executing instructions to communicate with the first device,

wherein the first device and the second device include at least one of at least one of an external medical device, or an external device in communication with an implantable medical device, wherein at least one of the memory circuits of the first device and the second device stores a geographic location identifier associated with the first device, wherein at least one of the controller circuits of the first device 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, and wherein at least one of the controller circuits of the first device and the second device is configured to update the status identifier in accordance with the comparison.

2. The system of claim 1, 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.

3. The system of claim 1, 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 the function to indicate that the function is approved.

4. The system of claim 3, 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 function.

5. The system of claim 1, in which the status identifier includes a value to indicate that the at least one function has an approved status during a patient emergency, and wherein the value enables the function.

6. The system of claim 5, wherein at least one of the memory circuits of the first device and the second device stores a geographic location identifier, and wherein the status identifier enables or disables the at least one function during an emergency in accordance with a regulatory approval status of the function during the emergency, wherein the regulatory approval status is associated with a geographic location where at least one of the first device and the second device is located.

7. The system of claim 1, wherein the second device is operable to communicate at least one approved function to the first device and wherein the controller circuit of the first device 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.

8. The system of claim 1, wherein the second device is operable to communicate identifiers associated with the regulatory approval status to the first device.

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

10. The system of claim 1, wherein at least one of the first device 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.

11. The system of claim 1, wherein at least one of the first device 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.

12. 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.

13. The system of claim 1, wherein at least one of the first and second devices are operable to communicate over a network.

14. The system of claim 13, wherein the network includes a wireless communication network.

15. The system of claim 14, wherein the network includes the internet.

16. The system of claim 13, wherein the network includes a wireless telephone network.

17. The system of claim 1, wherein the first device includes at least one of a blood glucose meter, an insulin pump, a urinalysis device, a fetal heart monitoring device, a blood test meter, a sleep apnea detection device, a hypopnea detection device, a sleep apnea therapy device, a blood pressure cuff, or a weight scale.

18. The system of claim 1, wherein the first device is a programmer for the implantable medical device.

19. The system of claim 1, wherein the first device is a repeater to communicate with the implantable medical device.

20. The system of claim 19, wherein at least one of the memory circuits of the first device and the second device stores a geographic location identifier to identify where the implantable medical device 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, wherein the regulatory approval status is associated with a geographic location where the implantable medical device was implanted.