Method and apparatus for injection of external data within an implantable medical device

• US 20030204147A1
• Filed: 04/30/2002
• Published: 10/30/2003
• Est. Priority Date: 04/30/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Hornberger, Steve R., Condie, Catherine R., Mongeon, Luc R., Cho, Yong Kyun, Brandstetter, John S., Portzline, Gerald A., Nichols, Lucy M.
• Granted Patent: US 7,123,965 B2
• Time in Patent Office: Days
• US Class Current: 600/520
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• 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: A61N 1/37264 Changing the program; Upgrading firmware

Abstract

A method and an apparatus for performing implementing external data into an implantable medical device. A first stress test is performed using an external sensor. External data resulting from the initial stress test is acquired. An external data injection process is performed. The external data injection process includes providing the external data to the implantable medical device. A second stress test is performed, the second stress test being substantially similar to the first stress test. Internal data resulting from the second stress test is acquired. Internal data resulting from the second stress test along with the external data resulting from the first stress test, are processed.

Claims

1. A method for injecting external data into an implantable medical device, comprising the steps of:

performing a first stress test using an external sensor;

acquiring external data resulting from said first stress test;

performing an external data injection process, said external data injection process comprising providing said external data to said implantable medical device;

performing a second stress test, said second stress test being substantially similar to said first stress test;

acquiring internal data resulting from said second stress test; and

processing said internal data resulting from said second stress test along with said external data resulting from said first stress test.

2. The method described in claim 1, wherein the step of performing a first stress test using an external sensor further comprises performing said first stress test on a treadmill.

3. The method described in claim 1, wherein the step of acquiring external data resulting from said initial stress test further comprises acquiring non-physiological data.

4. The method described in claim 3, wherein the step of acquiring external data resulting from said initial stress test further comprises acquiring data from said external accelerometer.

5. The method described in claim 1, wherein the step of performing an external data injection process further comprises:

storing said external data;

transferring said stored external data to an access device capable of communicating with an implantable medical device; and

downloading said external data from said access device into said implantable medical device.

6. The method described in claim 1, wherein the step of acquiring internal data resulting from said second stress test further comprises acquiring data from an internal sensor operatively coupled with an implantable medical device.

7. The method described in claim 6, wherein the step of acquiring internal data resulting from said second stress test further comprises acquiring physiological data.

8. The method described in claim 1, wherein the step of processing said internal data resulting from said second stress test along with said external data resulting from said first stress test further comprises:

blending said internal data with said external data;

calculating a target pacing rate for a delivery of therapy based at least partially upon at least one of said blending of said internal and external data and an initial setpoint therapy target pacing rate;

modifying a therapy delivery rate based upon said target pacing rate;

and

calculating a new setpoint therapy target pacing rate as feedback for calculating a subsequent target pacing rate.

9. The method described in claim 8, wherein the step of blending said internal data with said external data further comprises combining real time physiological data with corresponding stored non-physiological data.

10. The method described in claim 1, wherein the step of processing said internal data resulting from said second stress test along with said external data resulting from said first stress test further comprises validating an operation of an implantable medical device.

11. An apparatus, comprising:

means for performing a first stress test using an external sensor;

means for acquiring external data resulting from said initial stress test;

means for performing an external data injection process;

means for performing a second stress test, said second stress test being substantially similar to said first stress test;

means for acquiring internal data resulting from said second stress test; and

means for processing said internal data resulting from said second stress test along with said external data resulting from said first stress test.

12. An apparatus, comprising:

a processor;

a control logic unit operatively coupled to said processor, said control logic unit generating at least one control signal in response to a command from said processor;

a data acquisition controller operatively coupled with said control logic unit, said data acquisition controller acquiring internal data in response to an assertion of at least one control signal from said control logic unit;

a memory unit operatively coupled with said data acquisition controller, said memory unit storing said acquired physiological data and injected external data;

a telemetry unit operatively coupled with said processor and said memory unit, said telemetry unit receiving external data relating to a first stress test; and

a firmware unit operatively coupled with at least one of said processor, said control unit, and said memory unit, said firmware unit processing internal data resulting from a second stress test with said external data.

13. The apparatus of claim 12, wherein said control logic unit, said processor, said data acquisition controller, said memory unit, said telemetry unit, and said firmware unit are integrated into an implantable medical device.

14. The apparatus of claim 12, wherein firmware unit comprises:

means for blending said internal data with said external data;

means for calculating a target pacing rate for a delivery of therapy based at least partially upon at least one of said blending of said internal and external data and an initial setpoint therapy target pacing rate;

means for modifying a therapy delivery rate based upon said target pacing rate; and

means for calculating a new setpoint therapy target pacing rate as feedback for calculating a subsequent target pacing rate.

15. A system for controlling an implantable medical device, comprising:

an external sensor device acquiring external data resulting from a first stress test;

an implantable medical device adapted to acquire data related to a patient'"'"'s body and provide a therapy in response to said data, said implantable medical device storing said external data, acquiring internal data relating to a second stress test, and processing said external and internal data to validate the operation of said implantable medical device;

an access device transferring data from said external sensor device to said implantable medical device; and

at least one sensor operatively coupled to said implantable medical device, said sensor providing said internal data to said implantable medical device.

16. The system of claim 15, wherein said implantable medical device comprises:

a processor;

a control logic unit operatively coupled to said processor, said control logic generating at least one control signal in response to a command from said processor;

a data acquisition controller operatively coupled with said control logic unit, said data acquisition controller acquiring internal data in response to an assertion of at least one control signal from said control logic unit;

a memory unit operatively coupled with said data acquisition controller, said memory unit storing said acquired physiological data and injected external data;

a telemetry unit operatively coupled with said processor and said memory unit, said telemetry unit receiving external data relating to a first stress test; and

a firmware unit operatively coupled with at least one of said processor, said control unit, and said memory unit, said firmware unit processing internal data resulting from a second stress test with said external data.

17. The system of claim 15, wherein said external sensor device is an accelerometer.

18. The system c~f claim 15, wherein said sensor is an activity sensor.

19. A computer readable program storage device encoded with instructions that, when executed by a computer, performs a method, comprising:

performing a first stress test using an external sensor;

acquiring external data resulting from said initial stress test;

performing an external data injection process, said external data injection process comprising providing said external data to said implantable medical device;

performing a second stress test, said second stress test being substantially similar to said first stress test;

acquiring internal data resulting from said second stress test; and

processing said internal data resulting from said second stress test along with said external data resulting from said first stress test.

20. The computer readable program storage device encoded with instructions that, when executed by a computer, performs the method described in claim 19, wherein performing a first stress test using an external sensor further comprises performing said first stress test on a treadmill.

21. The computer readable program storage device encoded with instructions that, when executed by a computer, performs the method described in claim 19, wherein acquiring external data resulting from said initial stress test further comprises acquiring non-physiological data.

22. The computer readable program storage device encoded with instructions that, when executed by a computer, performs the method described in claim 21, wherein acquiring external data resulting from said initial stress test further comprises acquiring data from said external accelerometer.

23. The computer readable program storage device encoded with instructions that, when executed by a computer, performs the method described in claim 19, wherein performing an external data injection process further comprises:

storing said external data;

transferring said stored external data to an access device capable of communicating with an implantable medical device; and

downloading said external data from said access device into said implantable medical device.

24. The computer readable program storage device encoded with instructions that, when executed by a computer, performs the method described in claim 19, wherein acquiring internal data resulting from said second stress test further comprises acquiring data from an internal sensor operatively coupled with an implantable medical device.

25. The computer readable program storage device encoded with instructions that, when executed by a computer, performs the method described in claim 24, wherein acquiring internal data resulting from said second stress test further comprises acquiring physiological data.

26. The computer readable program storage device encoded with instructions that, when executed by a computer, performs the method described in claim 19, wherein processing said internal data resulting from said second stress test along with said external data resulting from said first stress test further comprises:

blending said internal data with said external data;

calculating a target pacing rate for a delivery of therapy based at least partially upon at least one of said blending of said internal and external data and an initial setpoint therapy target pacing rate;

modifying a therapy delivery rate based upon said target pacing rate; and

calculating a new setpoint therapy target pacing rate as feedback for calculating a subsequent target pacing rate.

27. The computer readable program storage device encoded with instructions that, when executed by a computer, performs the method described in claim 26, wherein blending said internal data with said external data further comprises combining real time physiological data with corresponding stored non-physiological data.

28. The computer readable program storage device encoded with instructions that, when executed by a computer, performs the method described in claim 19, wherein processing said internal data resulting from said second stress test along with said external data resulting from said first stress test further comprises validating an operation of an implantable medical