Stimulation therapy including substantially simultaneous bilateral stimulation

• US 8,706,233 B2
• Filed: 01/25/2012
• Issued: 04/22/2014
• Est. Priority Date: 01/28/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Su, Xin, Nelson, Dwight E.
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US13/358,165
• Publication Number:
  US 20120197338A1
• Time in Patent Office: 818 Days
• Field of Search: 607 1- 3, 607 39- 41, 607/46, 607/48, 607 55- 58
• US Class Current: 607/40
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

In some examples, a medical device delivers a first electrical stimulation therapy to a patient, and, upon detecting a trigger event, delivers a second electrical stimulation therapy to the patient. In some examples, the first stimulation therapy includes unilateral stimulation or stimulation delivered to both lateral sides of the patient at different times at a stimulation intensity lower than, equal to, or greater than a threshold intensity level for the patient, or bilateral stimulation delivered substantially simultaneously to both lateral sides of the patient, where one lateral side of the patient receives stimulation at an intensity level that is lower than the threshold intensity level and the other lateral side receives stimulation at an intensity level that is greater than or equal to the threshold intensity level. The second stimulation therapy may include substantially simultaneous bilateral stimulation therapy at an intensity level that at or above the threshold intensity level.

Claims

1. A method comprising:

with a processor, controlling a stimulation generator to deliver a first electrical stimulation therapy to a patient, wherein the first electrical stimulation therapy comprises delivery of electrical stimulation at a first stimulation intensity to a first lateral side of a patient;

after initiating delivery of the first electrical stimulation therapy, detecting a trigger event; and

in response to detecting the trigger event, controlling, with the processor, the stimulation generator to deliver a second electrical stimulation therapy to the patient, wherein the second electrical stimulation therapy comprises electrical stimulation delivered substantially simultaneously to the first lateral side at a second stimulation intensity and a second lateral side of the patient at a third stimulation intensity, wherein the second and third stimulation intensities are each greater than or equal to a threshold stimulation intensity of the patient at which a threshold physiological response is evoked.

2. The method of claim 1, wherein the first stimulation intensity is less than the threshold stimulation intensity of the patient at which the threshold physiological response is evoked.

3. The method of claim 1, wherein the first stimulation intensity is greater than or equal to the threshold stimulation intensity of the patient at which the threshold physiological response is evoked.

4. The method of claim 1, wherein the first electrical stimulation therapy further comprises delivery of electrical stimulation at a fourth stimulation intensity to the second lateral side of the patient, wherein the fourth stimulation intensity is less than the threshold stimulation intensity.

5. The method of claim 4, wherein controlling the stimulation generator to deliver the first electrical stimulation therapy comprises controlling the stimulation generator to deliver electrical stimulation to the first and second lateral sides of the patient at the respective first and fourth stimulation intensities substantially simultaneously.

6. The method of claim 1, wherein controlling the stimulation generator to deliver the first electrical stimulation therapy comprises controlling the stimulation generator to deliver electrical stimulation to the first and second lateral sides of the patient at the respective first and fourth stimulation intensities at different times.

7. The method of claim 1, wherein the first electrical stimulation therapy further comprises delivery of electrical stimulation at a fourth stimulation intensity to the second lateral side of the patient, wherein the fourth stimulation intensity is greater than or equal to the threshold stimulation intensity.

8. The method of claim 7, wherein the first stimulation intensity is less than the threshold stimulation intensity of the patient at which the threshold physiological response is evoked, and controlling the stimulation generator to deliver the first electrical stimulation therapy comprises controlling the stimulation generator to deliver electrical stimulation to the first and second lateral sides of the patient at the respective first and fourth stimulation intensities substantially simultaneously.

9. The method of claim 7, controlling the stimulation generator to deliver the first electrical stimulation therapy comprises controlling the stimulation generator to deliver electrical stimulation to the first and second lateral sides of the patient at the respective first and fourth stimulation intensities at different times.

10. The method of claim 1, wherein controlling the stimulation generator to deliver the second electrical stimulation therapy comprises controlling the stimulation generator to deliver electrical stimulation substantially simultaneously to a first tissue site on the first lateral side of the patient and a second tissue site on the second lateral side of the patient, wherein the first and second tissue sites are proximate to branches of a same nerve.

11. The method of claim 1, wherein controlling the stimulation generator to deliver the second electrical stimulation therapy comprises controlling the stimulation generator to deliver electrical stimulation substantially simultaneously to a first tissue site on the first lateral side of the patient and a second tissue site on the second lateral side of the patient, wherein the first and second tissue sites are proximate to branches of different nerves.

12. The method of claim 1, wherein controlling the stimulation generator to deliver the second electrical stimulation therapy to the patient comprises controlling the stimulation generator to deliver electrical stimulation to a first tissue site on the first lateral side of the patient via electrodes positioned on the first lateral side of the patient, and controlling the stimulation generator to deliver electrical stimulation to a second tissue site on the second lateral side of the patient via electrodes positioned on the second lateral side of the patient.

13. The method of claim 1, wherein the second and third stimulation intensities are substantially equal.

14. The method of claim 1, wherein the second and third stimulation intensities are different.

15. The method of claim 1, wherein detecting the trigger event comprises detecting the trigger event while the stimulation generator delivers the first electrical stimulation therapy to the patient.

16. The method of claim 1, wherein detecting the trigger event comprises, with the processor, detecting a bladder condition indicative of at least one of an increased possibility of an involuntary voiding event or an imminent involuntary voiding event.

17. The method of claim 1, wherein detecting the trigger event comprises receiving patient input via a user interface.

18. The method of claim 1, wherein detecting the trigger event comprises, with the processor, detecting expiration of a timer.

19. The method of claim 18, further comprising, with the processor, starting the timer when the first electrical stimulation therapy is delivered to the patient.

20. The method of claim 1, further comprising:

with the processor, detecting a voiding event after initiating delivery of the second electrical stimulation therapy, wherein controlling the stimulation generator to deliver the second electrical stimulation therapy comprises controlling the stimulation generator to deliver the second electrical stimulation therapy until the voluntary voiding event is detected; and

with the processor, after detecting the voiding event, terminating delivery of the second electrical stimulation therapy and delivering the first electrical stimulation therapy to the patient.

21. The method of claim 1, wherein controlling the stimulation generator to deliver the second electrical stimulation therapy comprises controlling the stimulation generator to deliver the second electrical stimulation therapy for a predetermined period of time.

22. The method of claim 21, further comprising:

after the stimulation generator delivers the second electrical stimulation therapy for the predetermined period of time, determining, with the processor, whether the trigger event is detected again;

with the processor, controlling the stimulation generator to deliver the second electrical stimulation therapy for the predetermined of time in response to determining the trigger event is detected again; and

with the processor, controlling the stimulation generator to deliver the first electrical stimulation therapy in response to determining the trigger event is not detected again.

23. A system comprising:

a stimulation generator configured to generate and deliver electrical stimulation to a patient; and

a processor configured to control the stimulation generator to deliver

a first electrical stimulation therapy to the patient, wherein the first electrical stimulation therapy comprises delivery of electrical stimulation at a first stimulation intensity to a first lateral side of a patient, and, after initiating delivery of the first electrical stimulation therapy, detect a trigger event, wherein the processor is configured to, in response to detecting the trigger event, control the stimulation generator to deliver a second electrical stimulation therapy to the patient, wherein the second electrical stimulation therapy comprises electrical stimulation delivered substantially simultaneously to the first lateral side at a second stimulation intensity and a second lateral side of the patient at a third stimulation intensity, wherein the second and third stimulation intensities are each greater than or equal to a threshold stimulation intensity of the patient at which a threshold physiological response is evoked.

24. The system of claim 23, wherein the first stimulation intensity is less than the threshold stimulation intensity of the patient at which the threshold physiological response is evoked.

25. The system of claim 23, wherein the first stimulation intensity is greater than or equal to the threshold stimulation intensity of the patient at which the threshold physiological response is evoked.

26. The system of claim 23, wherein the processor is configured to control the stimulation generator to deliver the first electrical stimulation therapy by at least controlling the stimulation generator to deliver electrical stimulation at the first stimulation intensity to the first lateral side of the patient and deliver electrical stimulation at a fourth stimulation intensity to the second lateral side of the patient, wherein the fourth stimulation intensity is less than the threshold stimulation intensity.

27. The system of claim 26, wherein the processor is configured to control the stimulation generator to deliver electrical stimulation to the first and second lateral sides of the patient at the respective first and fourth stimulation intensities substantially simultaneously.

28. The system of claim 26, wherein the processor is configured to control the stimulation generator to deliver electrical stimulation to the first and second sides of the patient at the respective first and fourth stimulation intensities at different times.

29. The system of claim 23, wherein the processor is configured to control the stimulation generator to deliver the first electrical stimulation therapy by at least controlling the stimulation generator to deliver electrical stimulation at the first stimulation intensity to the first lateral side of the patient and deliver electrical stimulation at a fourth stimulation intensity to the second lateral side of the patient, wherein the fourth stimulation intensity is greater than or equal to the threshold stimulation intensity.

30. The system of claim 29, wherein the first stimulation intensity is less than the threshold stimulation intensity of the patient at which the threshold physiological response is evoked, and the processor controls the stimulation generator to deliver stimulation to the first and second lateral sides of the patient at the respective first and fourth stimulation intensities substantially simultaneously.

31. The system of claim 29, wherein the processor is configured to control the stimulation generator to deliver electrical stimulation to the first and second lateral sides of the patient at the respective first and fourth stimulation intensities at different times.

32. The system of claim 23, further comprising a first set of electrodes positioned on the first lateral side of the patient and a second set of electrodes positioned on the second lateral side of the patient, wherein the stimulation generator is configured to deliver the second electrical stimulation therapy by at least delivering electrical stimulation to a first tissue site on the first lateral side of the patient via the first set of electrodes and delivering electrical stimulation to a second tissue site on the second lateral side of the patient via the second set of electrodes, wherein the first and second tissue sites are proximate to branches of a same nerve.

33. The system of claim 23, wherein the second and third stimulation intensities are substantially equal.

34. The system of claim 23, wherein the second and third stimulation intensities are different.

35. The system of claim 23, wherein the processor is configured to detect the trigger event while the stimulation generator is delivering the first stimulation therapy to the patient.

36. The system of claim 23, further comprising a sensor configured to generate a signal indicative of a physiological parameter of the patient, wherein the processor is configured to detect the trigger event by at least detecting, based on the signal, a bladder condition indicative of at least one of an increased possibility of an involuntary voiding event or an imminent involuntary voiding event.

37. The system of claim 23, further comprising a user interface, wherein the processor is configured to detect the trigger event by at least receiving patient input via the user interface.

38. The system of claim 23, wherein the processor is configured to detect the trigger event by at least detecting expiration of a timer.

39. The system of claim 38, wherein the processor is configured to start the timer when the first electrical stimulation therapy is delivered to the patient.

40. The system of claim 23, wherein the processor is configured to detect a voiding event after initiating delivery of the second electrical stimulation therapy, control the stimulation generator to deliver the second electrical stimulation therapy until the voluntary voiding event is detected, and, after detecting the voiding event, control the stimulation generator to terminate delivery of the second electrical stimulation therapy and deliver the first electrical stimulation therapy to the patient.

41. The system of claim 23, wherein the processor is configured to control the stimulation generator to deliver the second electrical stimulation therapy for predetermined period of time.

42. The system of claim 41, where the processor is configured to determine, after the stimulation generator delivers the second electrical stimulation therapy to the patient for the predetermined period of time, whether the trigger event is detected again, and deliver the second electrical stimulation therapy for the predetermined of time in response to determining the trigger event is detected again and deliver the first electrical stimulation therapy in response to determining the trigger event is not detected again.

43. A system comprising:

means for delivering a first electrical stimulation therapy to a patient, wherein the first electrical stimulation therapy comprises delivery of electrical stimulation at a first stimulation intensity to a first lateral side of a patient;

means for detecting a trigger event after initiation of delivery of the first electrical stimulation therapy; and

means for delivering a second electrical stimulation therapy to the patient in response to detection of the trigger event, wherein the second electrical stimulation therapy comprises electrical stimulation delivered substantially simultaneously to the first lateral side at a second stimulation intensity and a second lateral side of the patient at a third stimulation intensity, wherein the second and third stimulation intensities are each greater than or equal to a threshold stimulation intensity of the patient at which a threshold physiological response is evoked.

44. The system of claim 43, wherein the first stimulation intensity is less than the threshold stimulation intensity of the patient at which the threshold physiological response is evoked.

45. The system of claim 43, wherein the first stimulation intensity is greater than or equal to the threshold stimulation intensity of the patient at which the threshold physiological response is evoked.

46. The system of claim 43, wherein the first electrical stimulation therapy further comprises delivery of electrical stimulation at a fourth stimulation intensity to the second lateral side of the patient, wherein the fourth stimulation intensity is less than the threshold stimulation intensity.

47. The system of claim 43, wherein the first electrical stimulation therapy further comprises delivery of electrical stimulation at a fourth stimulation intensity to the second lateral side of the patient, wherein the fourth stimulation intensity is greater than or equal to the threshold stimulation intensity.

48. The system of claim 47, wherein the first stimulation intensity is less than the threshold stimulation intensity of the patient at which the threshold physiological response is evoked, and the means for delivering the first electrical stimulation therapy delivers electrical stimulation to the first and second lateral sides of the patient at the respective first and fourth stimulation intensities substantially simultaneously.

49. The system of claim 47, wherein the means for delivering the first electrical stimulation therapy delivers electrical stimulation to the first and second lateral sides of the patient at the respective first and fourth stimulation intensities at different times.

50. The system of claim 43, wherein the trigger event comprises at least one of detection of a bladder condition indicative of at least one of an increased possibility of an involuntary voiding event or an imminent involuntary voiding event, patient input, or expiration of a timer.

51. A computer-readable medium comprising instructions that, when executed by a processor, cause the processor to:

control a stimulation generator to deliver a first electrical stimulation therapy to a patient, wherein the first electrical stimulation therapy comprises delivery of electrical stimulation at a first stimulation intensity to a first lateral side of a patient;

detect a trigger event after the first electrical stimulation therapy is initiated; and

in response to detecting the trigger event, control the stimulation generator to deliver a second electrical stimulation therapy to the patient, wherein the second electrical stimulation therapy comprises electrical stimulation delivered substantially simultaneously to the first lateral side at a second stimulation intensity and a second lateral side of the patient at a third stimulation intensity, wherein the second and third stimulation intensities are each greater than or equal to a threshold stimulation intensity of the patient at which a threshold physiological response is evoked.

52. The computer-readable medium of claim 51, wherein the first electrical stimulation therapy further comprises delivery of electrical stimulation at a fourth stimulation intensity to the second lateral side of the patient, wherein the fourth stimulation intensity is less than the threshold stimulation intensity.

53. The computer-readable medium of claim 51, wherein the first stimulation intensity is less than the threshold stimulation intensity of the patient at which the threshold physiological response is evoked and the first electrical stimulation therapy further comprises delivery of electrical stimulation at a fourth stimulation intensity to the second lateral side of the patient, wherein the fourth stimulation intensity is greater than or equal to the threshold stimulation intensity, and wherein the instructions cause the processor to control the stimulation generator to deliver electrical stimulation to the first and second lateral sides of the patient at the respective first and fourth stimulation intensities substantially simultaneously.

54. The computer-readable medium of claim 53, wherein the first electrical stimulation therapy further comprises delivery of electrical stimulation at a fourth stimulation intensity to the second lateral side of the patient, wherein the fourth stimulation intensity is greater than or equal to the threshold stimulation intensity, and wherein the instructions cause the processor to control the stimulation generator to deliver electrical stimulation to the first and second lateral sides of the patient at the respective first and fourth stimulation intensities at different times.