Guided programming with feedback

• US 8,010,203 B2
• Filed: 03/23/2007
• Issued: 08/30/2011
• Est. Priority Date: 03/23/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: DeMulling, Delight D., McConnell, Debbie A., Herman, Cari C., Goetz, Steven M., Dewing, Wende L.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): SARCIONE, JESSICA LYNN
• Application Number:
  US11/690,655
• Publication Number:
  US 20080027514A1
• Time in Patent Office: 1,621 Days
• Field of Search: 607/30, 607/31, 607/59
• US Class Current: 607/59
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36014 External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/3688 configured for switching the pacing mode, e.g. from AAI to DDD
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware

Abstract

Techniques that involve generating test stimulation programs based upon specific patient feedback to guide the programming process for stimulation therapy are described. The patient describes positive effects and adverse effects of the test stimulation by listing and/or rating specific types of effects, both positive and adverse, and the location of each effect. In this manner, a programming device, i.e. a programmer, uses the feedback to generate subsequent test stimulation programs. Initially, programs with unipolar electrode configurations are tested, but the programmer may generate bipolar electrode configurations to test if the patient rates the unipolar electrode combinations poorly. After the stimulation programs are tested and rated, the programmer sorts the tested programs based upon the feedback and presents the tested programs to the user. The user selects the best tested program to use for chronic stimulation therapy. Additionally, the patient may utilize the guided programming technique for continued therapy optimization.

Claims

1. A method comprising:

providing test stimulation to a patient according to a plurality of programs, wherein each of the plurality of programs comprise an electrode combination;

for at least one of the plurality of programs, receiving a positive input via a user interface that indicates a positive effect resulting from provision of stimulation according to the program;

for at least one of the plurality of programs, receiving a negative input via the user interface that indicates an adverse effect resulting from provision of stimulation according to the program; and

automatically sorting the plurality of tested programs based upon the positive input, the negative input, and a therapy window for each of the plurality of tested programs, wherein the therapy window is characterized by a minimum therapeutic threshold that indicates a magnitude of a stimulation parameter at which positive effects on the patient are noted via the positive input, and wherein the therapy window is characterized by a maximum therapeutic threshold that indicates a magnitude of the stimulation parameter at which adverse effects on the patient are noted via the negative input.

2. The method of claim 1, wherein providing test stimulation according to a plurality of programs comprises providing test stimulation via a plurality of unipolar electrode combinations.

3. The method of claim 1, further comprising automatically generating at least one program that comprises a bipolar electrode configuration when none of a plurality of tested unipolar programs reach a threshold positive effect rating.

4. The method of claim 1, further comprising automatically generating at least one program that comprises a bipolar electrode configuration when all of a plurality of tested unipolar programs reach a threshold adverse effect rating.

5. The method of claim 1, further comprising automatically generating another program based upon the positive input and the negative input.

6. The method of claim 5, wherein at least one of the positive input and the negative input indicates an anatomical region of the patient.

7. The method of claim 5, wherein the automatically generated other program does not include at least one electrode associated with the adverse effect.

8. The method of claim 5, wherein the automatically generated other program includes at least one electrode associated with the positive effect.

9. The method of claim 1, wherein:

receiving the positive input further comprises rating at least one positive effect associated with at least one of the plurality of programs; and

receiving the negative input further comprises rating at least one adverse effect associated with at least one of the plurality of programs.

10. The method of claim 1, further comprising receiving a selection input selecting at least one of the plurality of tested programs for providing chronic stimulation therapy.

11. The method of claim 1, wherein each of the plurality of programs comprise a pulse rate, a pulse width, and at least one of a voltage amplitude or a current amplitude.

12. The method of claim 1, wherein providing test stimulation comprises providing stimulation from a lead that comprises at least two electrodes located at different positions around a periphery of the lead.

13. The method of claim 12, wherein the lead comprises a plurality of electrode levels, each of the electrode levels comprising a plurality of electrodes located at different positions around a periphery of the lead, and providing test stimulation comprises:

iteratively providing test stimulation via each of the levels with all of the electrodes at the level activated; and

after iteratively providing test stimulation via each of the levels, iteratively providing test stimulation via the electrodes of a selected one of the levels.

14. The method of claim 1, wherein at least one of the positive input and the negative input is associated with at least one of tremors, muscle tone, motor speed, balance, or gait of the patient.

15. The method of claim 1, wherein providing test stimulation comprises increasing an amplitude of at least one of the programs until at least one adverse effect is intolerable for the patient to identify the maximum therapeutic threshold.

16. The method of claim 1, further comprising sorting the plurality of tested programs based upon device longevity.

17. The method of claim 1, wherein automatically sorting the plurality of tested programs further comprises:

weighting each of the positive input and the negative input; and

automatically sorting the plurality of tested programs based upon the weighted positive input and weighted negative input.

18. The method of claim 1, further comprising automatically sorting the plurality of tested programs based on a difference between the maximum therapeutic threshold and the minimum therapeutic threshold.

19. The method of claim 1, wherein the stimulation parameter includes at least one of an amplitude of the stimulation, a pulse rate of the stimulation, or a pulse width of the stimulation.

20. The method of claim 1, wherein the maximum therapeutic threshold is one of a voltage or current amplitude at which positive effects are noted by the patient via the positive input, and wherein the minimum therapeutic threshold is one of a voltage or current amplitude at which negative effects are noted by the patient via the negative input.

21. A system comprising:

a stimulation signal generator that provides test stimulation to a patient according to a plurality of programs, wherein each of the plurality of programs comprise an electrode combination;

a lead coupled to the stimulation signal generator;

a user interface; and

a processor that;

receives a positive input via the user interface that indicates a positive effect resulting from provision of stimulation according to the program for at least one of the plurality of programs;

receives a negative input via the user interface that indicates an adverse effect resulting from provision of stimulation according to the program for at least one of the plurality of programs; and

automatically sorts the plurality of tested programs based upon the positive input, the negative input, and a therapy window for each of the plurality of tested programs, wherein the therapy window is characterized by a minimum therapeutic threshold that indicates a magnitude of a stimulation parameter at which positive effects on the patient are noted via the positive input, and wherein the therapy window is characterized by a maximum therapeutic threshold that indicates a magnitude of the stimulation parameter at which adverse effects on the patient are noted via the negative input.

22. The system of claim 21, wherein the stimulation signal generator provides test stimulation via at least one program that comprises a unipolar electrode combination.

23. The system of claim 21, wherein the processor automatically generates at least one program that comprises a bipolar electrode configuration when none of a plurality of tested unipolar programs reach a threshold positive effect.

24. The system of claim 21, wherein the processor automatically generates at least one program that comprises a bipolar electrode configuration when all of a plurality of tested unipolar programs reach a threshold adverse effect.

25. The system of claim 21, wherein the processor automatically generates another program based upon the positive input and the negative input.

26. The system of claim 25, wherein at least one of the positive input and the negative input indicates an anatomical region of the patient.

27. The system of claim 25, wherein the automatically generated other program does not include at least one electrode associated with the adverse effect.

28. The system of claim 25, wherein the automatically generated other program includes at least one electrode associated with the positive effect.

29. The system of claim 21, wherein:

the positive input rates at least one positive effect associated with at least one of the plurality of programs; and

the negative input rates at least one adverse effect associated with at least one of the plurality of programs.

30. The system of claim 21, wherein the processor receives a selection input selecting at least one of the plurality of tested programs for providing chronic stimulation therapy.

31. The system of claim 21, wherein each of the plurality of programs comprise, a pulse rate, a pulse width, and at least one of a voltage amplitude and a current amplitude.

32. The system of claim 21, wherein the lead comprises at least two or more electrodes located at different positions around a periphery of the lead, wherein the test stimulation is delivered to the patient via the lead.

33. The system of claim 21, wherein at least one of the positive input and the negative input is associated with at least one of tremors, muscle tone, motor speed, balance, or gait of the patient.

34. The system of claim 21, wherein the processor instructs the stimulation signal generator to provide test stimulation by increasing an amplitude of at least one of the programs until at least one adverse effect is intolerable for the patient to identify the maximum therapeutic threshold.

35. The system of claim 21, wherein the processor sorts the plurality of tested programs based upon device longevity.

36. The system of claim 21, wherein the processor:

weights each of the positive input and the negative input; and

automatically sorts the plurality of tested programs based upon the weighted positive input and weighted negative input.

37. The system of claim 21, wherein the processor automatically sorts the plurality of tested programs based on a difference between the maximum therapeutic threshold and the minimum therapeutic threshold.

38. The system of claim 21, wherein the stimulation parameter includes at least one of an amplitude of the stimulation, a pulse rate of the stimulation, or a pulse width of the stimulation.

39. The system of claim 21, wherein the maximum therapeutic threshold is one of a voltage or current amplitude at which positive effects are noted by the patient via the positive input, and wherein the minimum therapeutic threshold is one of a voltage or current amplitude at which negative effects are noted by the patient via the negative input.

40. A non-transitory computer-readable medium comprising instructions that cause a processor to:

provide test stimulation to a patient according to a plurality of programs, wherein each of the plurality of programs comprise an electrode combination;

for at least one of the plurality of programs, receive a positive input via a user interface that indicates a positive effect resulting from provision of stimulation according to the program;

for at least one of the plurality of programs, receive a negative input via the user interface that indicates an adverse effect resulting from provision of stimulation according to the program; and

automatically sort the plurality of tested programs based upon the positive input, the negative input, and a therapy window for each of the plurality of tested programs, wherein the therapy window is characterized by a minimum therapeutic threshold that indicates a magnitude of a stimulation parameter at which positive effects on the patient are noted via the positive input, and wherein the therapy window is characterized by a maximum therapeutic threshold that indicates a magnitude of the stimulation parameter at which adverse effects on the patient are noted via the negative input.

41. The computer-readable medium of claim 40, further comprising instructions that cause the processor to automatically generate at least one program that comprises a unipolar electrode configuration.

42. The computer-readable medium of claim 40, further comprising instructions that cause the processor to automatically generate at least one program that comprises a bipolar electrode configuration when none of a plurality of tested unipolar programs reach a threshold positive effect rating.

43. The computer-readable medium of claim 40, further comprising instructions that cause the processor to automatically generate at least one program that comprises a bipolar electrode configuration when all of a plurality of tested unipolar programs reach a threshold adverse effect rating.

44. The computer-readable medium of claim 40, further comprising instructions that cause the processor to automatically generate another program based upon the positive input and the negative input.

45. The computer-readable medium of claim 40, wherein:

the positive input rates at least one positive effect associated with at least one of the plurality of programs; and

the negative input rates at least one adverse effect associated with at least one of the plurality of programs.

46. The computer-readable medium of claim 40, further comprising instructions that cause the processor to receive a selection input selecting at least one of the plurality of tested programs for providing chronic stimulation therapy.

47. The computer-readable medium of claim 40, wherein at least one of the positive input and the negative input is associated with at least one of tremors, muscle tone, motor speed, balance, or gait of the patient.

48. The computer-readable medium of claim 40, wherein the instructions that cause the processor to provide test stimulation comprise instructions that cause the processor to increase an amplitude of at least one of the programs until at least one adverse effect is intolerable for the patient to identify the maximum therapeutic threshold.

49. The computer-readable medium of claim 40, further comprising instructions that cause the processor to sort the plurality of tested programs based upon device longevity.