Automatic validation techniques for validating operation of medical devices

• US 8,280,517 B2
• Filed: 08/26/2009
• Issued: 10/02/2012
• Est. Priority Date: 09/19/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Skelton, Dennis M., Darne, Emmanuel R., Mairs, Nicholas S., Sorenson, Brian, Kemp, Justin
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US12/548,227
• Publication Number:
  US 20100076525A1
• Time in Patent Office: 1,133 Days
• Field of Search: 607/19, 607/48, 607/63
• US Class Current: 607/48
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware

Abstract

Techniques for validating operation of a medical device are disclosed. A data collection phase utilizes a first sensor carried by a patient to record patient parameter values indicative of conditions experienced by the patient (e.g, posture states.) Therapy parameter values describing therapy adjustments requested by the patient in response to the conditions are also recorded. Associations formed between the therapy parameter values and the patient parameter values are used to develop a closed-loop algorithm for control of an IMD having a sensor similar to the first sensor. An automated device such as a robotic arm uses the recorded patient parameter values to automatically reproduce, and to subject the IMD to, conditions present during the data collection phase. Therapy delivered by the IMD while under control of the closed-loop algorithm and while being subjected to the conditions is compared to the recorded therapy parameter values e to validate IMD operation.

Claims

1. A method of testing a medical device, comprising:

recording therapy parameter values describing therapy being delivered to a patient;

recording a sequence of patient parameter values indicative of at least one of posture and activity of the patient occurring while the therapy is being delivered;

controlling an automated device to reproduce the sequence of patient parameter values; and

validating that the medical device is delivering therapy in accordance with the recorded therapy parameter values while the medical device is experiencing conditions resulting from controlling of the automated device.

2. The method of claim 1, further comprising utilizing an accelerometer to record the sequence of patient parameter values.

3. The method of claim 2, wherein recording the sequence of patient parameter values is performed by sensor logic carried by the patient.

4. The method of claim 1, wherein recording therapy parameter values is performed by a programmer.

5. The method of claim 4, wherein the programmer is receiving the patient parameter values from a sensor and is executing a closed-loop algorithm to control the therapy while the therapy parameter values are being recorded.

6. The method of claim 1, wherein the medical device is an implantable medical device for generating neurostimulation therapy.

7. The method of claim 1, further comprising:

recording in an eDiary conditions indicative of the sequence of patient parameter values; and

utilizing the recorded conditions to verify the sequence of patient parameter values.

8. The method of claim 1, wherein controlling the automated device to reproduce the sequence of patient parameter values comprises:

attaching the medical device to the automated device;

providing the recorded sequence of patient parameter values to control the automated device; and

reproducing, by the automated device, conditions that resulted in sensing the sequence of patient parameter values.

9. The method of claim 8, wherein reproducing the conditions comprises orienting the medical device in one or more predetermined positions.

10. The method of claim 8, wherein reproducing the conditions comprises reproducing one or more predetermined activity states.

11. The method of claim 1, further comprising verifying that the sequence of patient parameter values is being reproduced accurately.

12. The method of claim 11, wherein verifying that the sequence of patient parameter values is being reproduced accurately comprises:

utilizing an accelerometer to record a second sequence of patient parameter values during the reproducing step; and

comparing the second sequence of patient parameter values to the sequence of patient parameter values.

13. The method of claim 1, wherein validating that the medical device is delivering therapy in accordance with the recorded therapy parameter values comprises comparing second therapy parameter values describing the therapy delivered by the medical device to the recorded therapy parameter values.

14. The method of claim 13, wherein validating that the medical device is delivering therapy in accordance with the recorded therapy parameters comprises delivering, by the medical device, therapy in response to a closed-loop algorithm.

15. The method of claim 14, wherein recording therapy parameter values comprises operating the medical device in response to an open-loop algorithm.

16. The method of claim 13, further comprising at least one of measuring by the medical device the therapy parameter values and measuring by the medical device the second therapy parameter values.

17. The method of claim 1, wherein the medical device comprises a sensor, and wherein validating that the medical device is delivering therapy in accordance with the recorded therapy parameter values comprises causing the sensor to substantially generate the sequence of patient parameter values.

18. The method of claim 17, further comprising delivering, by the medical device, therapy according to a closed-loop algorithm in response to the generated sequence of patient parameter values.

19. The method of claim 1, further comprising automatically providing therapy adjustments to the medical device that correspond to the recorded therapy parameter values while reproducing the sequence of patient parameter values.

20. The method of claim 1, wherein the medical device is an implantable medical device, and wherein recording therapy parameter values describing therapy being delivered to a patient comprises transferring the therapy parameter values to a storage device external to the patient.

21. A system for testing a medical device, comprising:

means for recording therapy parameter values describing therapy being delivered to a patient;

means for recording a sequence of patient parameter values indicative of at least one of posture and activity of the patient occurring while the therapy is being delivered;

means for controlling an automated device to reproduce the sequence of patient parameter values; and

means for validating that the medical device is delivering therapy in accordance with the recorded therapy parameter values while the medical device is experiencing conditions resulting from controlling of the automated device.

22. The system of claim 21, wherein the means for recording the sequence of patient parameter values comprises an accelerometer.

23. The system of claim 21, wherein the means for recording the sequence of patient parameter values comprises sensor logic carried by the patient.

24. The system of claim 21, wherein the means for recording therapy parameter values comprises a programmer.

25. The system of claim 24, wherein the programmer is configured to receive the patient parameter values from a sensor and to execute a closed-loop algorithm to control the therapy while the therapy parameter values are being recorded.

26. The system of claim 21, wherein the means for controlling an automated device comprises means for controlling the automated device to reproduce conditions that resulted in sensing the sequence of patient parameter values.

27. The system of claim 26, wherein the means for controlling an automated device comprises means for causing the automated device to orient the medical device in one or more predetermined positions.

28. The system of claim 21, further comprising means for verifying that the sequence of patient parameter values is being reproduced accurately.

29. A system for testing a medical device, comprising:

a storage device configured to record therapy parameter values describing therapy being delivered to a patient;

a storage device configured to record a sequence of patient parameter values indicative of at least one of posture and activity of the patient occurring while the therapy is being delivered;

an automated device controlled to reproduce the sequence of patient parameter values; and

logic configured to validate that the medical device is delivering therapy in accordance with the recorded therapy parameter values while the medical device is experiencing conditions resulting from controlling of the automated device.

30. The system of claim 29, further comprising sensor logic configured to detect the sequence of patient parameter values.

31. The system of claim 29, wherein the storage device that is configured to record therapy parameter values and the storage device that is configured to record the sequence of patient parameter values is a same storage device.

32. The system of claim 29, further comprising a processor configured to receive the patient parameter values from a sensor and to execute a closed-loop algorithm to control delivery of the therapy while the therapy parameter values are being recorded in the storage device.

33. The system of claim 32, further comprising a programmer comprising the processor.

34. The system of claim 29, wherein the logic configured to validate that the medical device is delivering therapy in accordance with the recorded therapy parameter values comprises logic configured to automatically orient the medical device in multiple positions.

35. The system of claim 29, wherein the logic configured to validate that the medical device is delivering therapy in accordance with the recorded therapy parameter values comprises logic configured to automatically orient the medical device to reproduce the sequence of patient parameter values.