Medical device function configuration post-manufacturing

• US 8,352,038 B2
• Filed: 10/01/2007
• Issued: 01/08/2013
• Est. Priority Date: 10/01/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Mao, Bor-Jiin, Haerle, Mark L., Crandall, Kathleen U., Graham, Michael Lee, Fuher, Patricia K
• Primary Examiner(s): Bertram, Eric D.
• Assistant Examiner(s): So, Elizabeth K
• Application Number:
  US11/865,294
• Publication Number:
  US 20090088820A1
• Time in Patent Office: 1,926 Days
• Field of Search: 607/5, 607/30, 607/31, 607/59
• US Class Current: 607/59
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware

Abstract

A medical device system and method configure a medical device according to a configuration definition. The configuration definition includes an allowable status and a function status for each of a number of medical device functions. The medical device configuration is updated automatically in response to being interrogated by a programmer configured to update the device configuration. The device configuration is updated by updating the function status for at least one of the medical device functions in response to the allowable status for the medical device function.

Claims

1. A method for configuring a medical device, comprising:

setting a first device configuration of the medical device corresponding to a configuration definition stored in a memory of the medical device comprising both one allowable status field bit and one function status field bit corresponding to each of a plurality of medical device functions, the function status field bit indicating a current status of a respective medical device function as being enabled or disabled and the allowable status field bit indicating whether updates to the function status field bit of the respective medical device function are allowed or not allowed;

interrogating the medical device using a first programmer configuration configured to update the first device configuration;

automatically comparing the first programmer configuration and the first device configuration in response to the interrogating; and

automatically setting a second device configuration of the medical device by updating the function status field bit for at least one of the plurality of medical device functions in response to the comparison of the first programmer configuration and the first device configuration if the allowable status field bit for the at least one of the plurality of medical device functions indicates updates to the respective function status field bit are allowed, wherein the updating comprises switching between an enabled and a disabled status.

2. The method of claim 1 further comprising updating a programmer display field in response to setting the second device configuration.

3. The method of claim 1 further comprising:

interrogating the medical device using a second programmer configuration not configured to update the first device configuration, and

updating a programmer display field in response to the second device configuration.

4. The method of claim 3 wherein the second programmer configuration is further configured to allow operating parameters corresponding to the at least one of the plurality of medical device functions to be programmed in response to the function status field bit for the at least one of the plurality of medical device functions being enabled in the second device configuration.

5. The method of claim 1, further comprising:

interrogating the medical device using a second programmer configuration configured to update the second medical device configuration;

automatically comparing the second programmer configuration and the second device configuration in response to the interrogating;

automatically setting a third device configuration of the medical device by updating the function status field bit for at least one of the plurality of medical device functions in response to the allowable status field bit for the at least one of the plurality of medical device functions.

6. The method of claim 1, wherein the allowable status field bit for each of the plurality of medical device functions is fixed at a time of medical device manufacture and is not updatable.

7. The method of claim 1 wherein the first programmer configuration comprises an update file for updating the first device configuration.

8. A medical device system, comprising:

a programmable medical device comprising a memory and a configuration definition stored in the memory, the configuration definition comprising both one allowable status field bit and one function status field bit corresponding to each of a plurality of medical device functions, the function status field bit indicating a current status of a respective medical device function as being enabled or disabled and the allowable status field bit indicating whether updates to the function status field bit of the respective medical device function are allowed or not allowed;

a first programmer configuration configured to update the configuration definition wherein updating the configuration definition comprises automatically comparing the first programmer configuration and the configuration definition in response to interrogating the medical device using the first programmer configuration and automatically setting an updated configuration definition by updating the function status field bit for at least one of the plurality of medical device functions in response to the comparing of the first programmer configuration and the configuration definition if the allowable status field bit for the at least one of the plurality of medical device functions indicates updates to the respective function status field bit are allowable, wherein the updating comprises switching between an enabled and a disabled status.

9. The system of claim 8 wherein the first programmer configuration comprises a display and wherein the programmer configuration is further configured to update a programmer display field in response to updating the configuration definition.

10. The system of claim 8 further comprising:

a second programmer configuration not configured to update the configuration definition,

the second programmer configuration comprising a display and being configured to update a display field in response to the updated configuration definition.

11. The system of claim 10 wherein the second programmer configuration is further configured to allow operating parameters corresponding to the at least one of the plurality of medical device functions to be programmed in response to the function status field bit for the at least one of the plurality of medical device functions being enabled in the updated configuration definition.

12. The system of claim 10, wherein updating a display field comprises one of inhibiting a display of a disabled function and labeling a display of a disabled function in response to the updated configuration definition comprising a function status field bit corresponding to a disabled status.

13. The system of claim 8 further comprising a second programmer configuration configured to update the updated configuration definition by updating the function status field bit for at least one of the plurality of medical device functions in response to the allowable status field bit for the at least one of the plurality of medical device functions.

14. The system of claim 8 wherein the allowable status field bit for each of the plurality of medical device functions is fixed at a time of medical device manufacture and is not updatable.

15. The system of claim 8 wherein the first programmer configuration comprises an update file for updating the first device configuration.

16. A non-transitory computer-readable medium for storing a set of instructions which when implemented in a medical device system cause the system to:

set a first device configuration of a medical device corresponding to a configuration definition stored in a device memory and comprising both one allowable status field bit and one function status field bit corresponding to each of a plurality of medical device functions, the function status field bit indicating a current status of a respective medical device function as being enabled or disabled and the allowable status field bit indicating whether updates to the function status field bit of the respective medical device function are allowed or not allowed;

automatically compare a first programmer configuration and the first device configuration in response to interrogating the medical device using the first programmer configuration; and

automatically set a second device configuration of the medical device by updating the function status field bit for at least one of the plurality of medical device functions in response to comparing of the first programmer configuration and the first device configuration if the allowable status field bit for the at least one of the plurality of medical device functions indicates updates to the function status field bit are allowed, wherein the updating comprises switching between an enabled and a disabled status.

17. An implantable medical device, comprising:

a memory;

a device configuration definition stored in the memory, the device configuration definition comprising both one allowable status field bit and one function status field bit corresponding to each of a plurality of medical device functions, the function status field bit indicating a current status of a respective medical device function as being enabled or disabled and the allowable status field bit indicating whether updates to the function status field bit of the respective medical device function are allowed or not allowed;

telemetry circuitry for establishing a communication link with a programmer and for receiving an update instruction for updating the device configuration definition; and

a processor for updating the function status field bit for at least one of the plurality of medical device functions in response to the allowable status field bit for the at least one of the plurality of medical device functions indicating updates to the function status field bit are allowed and the update instruction, wherein the updating comprises switching between an enabled and a disabled status.

18. The implantable medical device of claim 17 wherein the allowable status field bit for each of the plurality of medical device functions is fixed at a time of implantable medical device manufacture and is not updatable.

19. A medical device system, comprising:

a plurality of programmable medical devices each comprising a memory and a device configuration definition stored in the memory, the configuration definition comprising both one allowable status field bit and one function status field bit corresponding to each of the plurality of medical device functions, the function status field bit indicating a current status of a respective medical device function as being enabled or disabled and the allowable status field bit indicating whether updates to the function status field bit of the respective medical device function are allowed or not allowed;

a programmer comprising a memory and an update file stored in the memory for updating the configuration definition wherein updating the configuration definition comprises automatically comparing the update file and the configuration definition in response to interrogating one of the plurality of the medical devices using the programmer and automatically updating the configuration definition of the one of the plurality of medical devices by updating the function status field bit for at least one of the plurality of medical device functions in response to the comparing of the update file and the configuration definition if the allowable status field bit indicates updates to the function status field bit are allowed for the at least one of the plurality of medical device functions, wherein the updating comprises switching between an enabled and a disabled status;

wherein the plurality of programmable medical devices comprises a first set of devices having a first configuration definition comprising a first allowable status field and a second set of devices having a second configuration definition wherein the second configuration definition includes a second allowable status field defined uniquely different than the first allowable status field.