BILATERAL ELECTRICAL STIMULATION THERAPY FOR BLADDER DYSFUNCTION

• US 20120197337A1
• Filed: 01/25/2012
• Published: 08/02/2012
• 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.
• Granted Patent: US 8,706,232 B2
• Time in Patent Office: Days
• US Class Current: 607/41
• 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 1/3614 based on impedance measurement
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters

Abstract

A medical device is configured to deliver a first stimulation therapy to a patient, and, upon detecting a trigger event, deliver a second stimulation therapy to the patient. In some examples, the first stimulation therapy includes bilateral stimulation in which stimulation is delivered at different times to two lateral sides of the patient and the second stimulation therapy includes substantially simultaneous bilateral stimulation therapy to two lateral sides of the patient. In some examples, the second stimulation therapy may elicit a stronger inhibitory physiological response related to incontinence (e.g., inhibition of bladder contractions) than the first stimulation therapy. The trigger event may include, for example, any one or more of detection of a physiological condition indicative of an increased possibility of an involuntary voiding event or an imminent involuntary voiding event, input from the patient, a predetermined time of day, or expiration of a timer.

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 to a first lateral side of the patient and a second lateral side of the patient at different times;

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

in response to detecting the trigger event, with the processor, controlling the stimulation generator to deliver a second electrical stimulation therapy to the patient, wherein the second electrical stimulation therapy comprises delivery of electrical stimulation substantially simultaneously to the first and second lateral sides of the patient.

2. The method of claim 1, wherein controlling the stimulation generator to deliver the first electrical stimulation therapy comprises controlling the stimulation generator to alternate delivery of electrical stimulation to the first and second lateral sides of the patient.

3. The method of claim 1, wherein controlling the stimulation generator to deliver at least one of the first or second electrical stimulation therapies comprises controlling the stimulation generator to deliver substantially balanced electrical stimulation to the first and second lateral sides of the patient.

4. The method of claim 3, wherein controlling the stimulation generator to deliver the substantially balanced electrical stimulation to the first and second lateral sides of the patient comprises controlling the stimulation generator to deliver electrical stimulation at substantially equal intensity levels to the first and second lateral sides of the patient.

5. The method of claim 3, wherein controlling the stimulation generator to deliver the substantially balanced electrical stimulation to the first and second lateral sides of the patient comprises controlling the stimulation generator to deliver electrical stimulation to the first and second lateral sides of the patient for substantially equal durations of time.

6. The method of claim 1, wherein controlling the stimulation generator to deliver at least one of the first or second electrical stimulation therapies comprises controlling the stimulation generator to deliver imbalanced electrical stimulation to the first and second lateral sides of the patient.

7. The method of claim 6, wherein controlling the stimulation generator to deliver the imbalanced electrical stimulation comprises controlling the stimulation generator to deliver electrical stimulation to the first lateral side of the patient at a first stimulation intensity level and controlling the stimulation generator to deliver electrical stimulation to the second lateral side of the patient at a second stimulation intensity level that is different than the first stimulation intensity level.

8. The method of claim 6, wherein controlling the stimulation generator to deliver the substantially imbalanced electrical stimulation to the first and second lateral sides of the patient comprises controlling the stimulation generator to deliver electrical stimulation to the first and second lateral sides of the patient for substantially different durations of time.

9. The method of claim 1, wherein controlling the stimulation generator to deliver at least one of the first or second electrical stimulation therapies 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 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, wherein the first and second tissue sites are proximate to branches of a same nerve.

10. The method of claim 1, wherein controlling the stimulation generator to deliver at least one of the first or second electrical stimulation therapies 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 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, wherein the first and second tissue sites are proximate to branches of different nerves.

11. The method of claim 1, wherein detecting the trigger event comprises detecting the trigger event while the first electrical stimulation therapy is being delivered to the patient.

12. 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.

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

14. The method of claim 1, wherein detecting the trigger event comprises, with the processor, at least one of detecting a predetermined time of day or detecting expiration of a timer.

15. The method of claim 14, further comprising, with the processor, starting the timer when the first electrical stimulation therapy is delivered to the patient.

16. The method of claim 1, further comprising:

detecting a voiding event after initiating delivery of the second electrical stimulation therapy; and

after detecting the voiding event, controlling the stimulation generator to terminate delivery of the second electrical stimulation therapy and deliver the first electrical stimulation therapy to the patient.

17. 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 predetermined period of time.

18. The method of claim 17, further comprising:

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

controlling the stimulation generator to deliver the second electrical stimulation therapy for the predetermined of time in response to detecting the trigger event again; and

controlling the stimulation generator to deliver the first electrical stimulation therapy in response to not detecting the trigger event again.

19. 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 to a first lateral side of the patient and a second lateral side of the patient at different times, and wherein the processor is further configured to detect a trigger event after initiating delivery of the first electrical stimulation therapy 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 delivery of electrical stimulation substantially simultaneously to the first and second lateral sides of the patient.

20. The system of claim 19, wherein the processor is configured to control the stimulation generator to deliver the first electrical stimulation therapy by at least alternating delivery of electrical stimulation to the first and second lateral sides of the patient.

21. The system of claim 19, wherein at least one of the first or second electrical stimulation therapies comprises delivery of substantially balanced electrical stimulation therapy to the first and second lateral sides of the patient.

22. The system of claim 21, wherein the substantially balanced electrical stimulation therapy comprises delivery of electrical stimulation at substantially equal intensity levels to the first and second lateral sides of the patient.

23. The system of claim 21, wherein the substantially balanced electrical stimulation therapy comprises delivery of electrical stimulation to the first and second lateral sides of the patient for substantially equal durations of time.

24. The system of claim 19, wherein at least one of the first or second stimulation therapies comprises delivery of imbalanced electrical stimulation therapy to the first and second lateral sides of the patient.

25. The system of claim 24, wherein the processor controls the stimulation generator to deliver the imbalanced electrical stimulation therapy by at least delivering electrical stimulation to the first lateral side of the patient at a first stimulation intensity level and delivering electrical stimulation to the second lateral side of the patient at a second stimulation intensity level that is different than the first stimulation intensity level.

26. The system of claim 24, wherein the substantially balanced electrical stimulation therapy to the first and second lateral sides of the patient comprises delivery of electrical stimulation to the first and second lateral sides of the patient for substantially different durations of time.

27. The system of claim 19, further comprising a first set of electrodes configured to be positioned on the first lateral side of the patient and a second set of electrodes configured to be positioned on the second lateral side of the patient, wherein the stimulation generator is configured to deliver at least one of the first or second electrical stimulation therapies 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.

28. The system of claim 19, 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.

29. The system of claim 19, further comprising a user interface, wherein the processor is configured to detect the trigger event by at least receiving input via the user interface.

30. The system of claim 19, wherein the processor is configured to detect the trigger event by at least one of detecting a predetermined time of day or detecting expiration of a timer.

31. The system of claim 30, wherein the processor is configured to start the timer when the first stimulation therapy is delivered to the patient.

32. The system of claim 19, wherein the processor is configured to detect a voiding event after initiating delivery of the second stimulation therapy, control the stimulation generator to deliver the second 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 stimulation therapy and deliver the first stimulation therapy to the patient.

33. The system of claim 19, wherein the processor is configured to control the stimulation generator to deliver the second stimulation therapy for predetermined period of time.

34. The system of claim 33, wherein the processor is configured to determine, after the stimulation generator delivers the second stimulation therapy to the patient for the predetermined period of time, whether the trigger event is detected again, and control the stimulation generator to deliver the second stimulation therapy for the predetermined of time in response to determining the trigger event is detected again and control the stimulation generator to deliver the first stimulation therapy in response to determining the trigger event is not detected again.

35. A system comprising:

means for delivering electrical stimulation therapy to a patient;

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

means for controlling the means for delivering electrical stimulation therapy, wherein the means for controlling is configured to control the means for delivering electrical stimulation therapy to deliver a first electrical stimulation therapy to a patient, wherein the first electrical stimulation therapy comprises delivery of electrical stimulation to a first lateral side of the patient and a second lateral side of the patient at different times, the means for controlling being further configured to, in response to detection of the trigger event, control the means for delivering electrical stimulation therapy to deliver a second electrical stimulation therapy to the patient, wherein the second electrical stimulation therapy comprises delivery of electrical stimulation substantially simultaneously to the first and second lateral sides of the patient.

36. The system of claim 35, wherein at least one of the first or second electrical stimulation therapies comprises delivery of substantially balanced electrical stimulation to the first and second lateral sides of the patient.

37. The system of claim 35, wherein at least one of the first or second electrical stimulation therapies comprises delivery of imbalanced electrical stimulation to the first and second lateral sides of the patient.

38. The system of claim 35, wherein the trigger event comprises at least one 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, detection of a predetermined time of day, or expiration of a timer.

39. 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 to a first lateral side of the patient and a second lateral side of the patient at different times;

detect a trigger event after the first 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 delivery of electrical stimulation substantially simultaneously to the first and second lateral sides of the patient.

40. The computer-readable medium of claim 39, wherein at least one of the first or second electrical stimulation therapies comprises delivery of substantially balanced electrical stimulation to the first and second lateral sides of the patient.

41. The computer-readable medium of claim 39, wherein at least one of the first or second electrical stimulation therapies comprises delivery of imbalanced electrical stimulation to the first and second lateral sides of the patient.

42. The computer-readable medium of claim 39, wherein the trigger event comprises at least one 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, a predetermined time of day, or expiration of a timer.