Incontinence therapy

• US 9,155,885 B2
• Filed: 04/09/2010
• Issued: 10/13/2015
• Est. Priority Date: 04/24/2009
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Wei, Xuan K., Bonde, Eric H., Miesel, Keith A., Lent, Mark S., Molnar, Gregory F.
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): FAIRCHILD, MALLIKA DIPAYAN
• Application Number:
  US13/265,702
• Publication Number:
  US 20120130444A1
• Time in Patent Office: 2,013 Days
• Field of Search: 607/40, 607/41
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0514 Electrodes for the urinary tract
• 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 1/36128 Control systems
• CPC Class Codes: A61N 1/3614 based on impedance measurement
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data

Abstract

Techniques for managing urinary or fecal incontinence include delivering a first type of therapy to generate a first physiological response and, upon detecting a trigger event, delivering a second type of therapy to generate a second physiological response. The first type of therapy can be delivered on a substantially regular basis, while the second type of therapy is delivered as needed to provide an additional boost of therapy. The trigger event for activating the delivery of the second type of therapy may include input from a sensor that indicates a bladder condition, patient activity level or patient posture, or patient input. In some examples, the therapy is stimulation therapy.

Claims

1. A medical system comprising:

a therapy delivery module configured to generate and deliver a first electrical stimulation therapy to a patient to generate a first physiological effect and a second electrical stimulation therapy to the patient to generate a second physiological effect that is different than the first physiological effect, wherein the first physiological effect comprises inhibiting contraction of a bladder of the patient, and wherein the second physiological effect comprises promoting contraction of one or more of a bladder outlet of the patient, an internal urinary sphincter of the patient, an external urinary sphincter of the patient, or periurethral muscles of the patient; and

a processor configured to control the therapy delivery module to deliver the first electrical stimulation therapy to the patient on a regular basis over a period of time and control, during the period of time, the therapy delivery module to deliver the second electrical stimulation therapy only in response to received input, wherein the first and second electrical stimulation therapies are configured to reduce a likelihood of at least one of urinary voiding events and fecal voiding events.

2. The medical system of claim 1, further comprising a sensor configured to at least one of sense a patient parameter indicative of a bladder condition or a detrusor muscle activity, or generate a signal indicative of patient activity or posture, wherein the processor is configured to receive the input from the sensor.

3. The medical system of claim 1, further comprising a user input mechanism configured to receive input from a user indicative of at least one of an imminent involuntary voiding event of the patient or an increased possibility of an occurrence of an involuntary voiding event of the patient, wherein the processor is configured to receive the input from the user input mechanism.

4. The medical system of claim 1, wherein the received input is indicative of at least one of an imminent involuntary voiding event or an increased possibility of an occurrence of an involuntary voiding event.

5. The medical system of claim 1, wherein the therapy delivery module is configured to deliver the second electrical stimulation therapy by at least delivering a plurality of electrical stimulation signals during a plurality of therapy periods that are separated by a minimum inter-therapy interval to minimize muscle fatigue.

6. The medical system of claim 1, wherein the therapy delivery module is configured to deliver the second electrical stimulation therapy for a therapy period of approximately 10 to approximately 50 seconds.

7. The medical system of claim 1, wherein the therapy delivery module is configured to deliver the second electrical stimulation therapy by at least delivering a stimulation signal comprising an amplitude of approximately two to approximately four times rheobase of a target muscle or nerve, a frequency of approximately 15 Hertz to approximately 66 Hertz, and a pulse width of approximately 100 microseconds to approximately 1000 microseconds.

8. The medical system of claim 1, wherein the therapy delivery module is configured to deliver the second electrical stimulation according to a first set of stimulation parameters for a period of time and according to a second set of stimulation parameters different than the first set of stimulation parameters for a subsequent period of time.

9. The medical system of claim 8, wherein the first set of stimulation parameters is configured to activate fast-twitch muscles of the patient, and the second set of stimulation parameters is configured to activate slow-twitch muscles of the patient.

10. The medical system of claim 1, wherein the processor is configured to control the therapy delivery module to deliver the second electrical stimulation therapy to the patient for a predetermined period of time following the received input.

11. The medical system of claim 1, wherein the processor configured to control the delivery of the second electrical stimulation therapy by the therapy delivery module based on the received input by at least determining whether the input is indicative of a trigger event for the second electrical stimulation therapy, determining whether a number of trigger events detected within a predetermined interval of time is greater than or equal to a threshold value, and controlling the therapy delivery module to deliver the second electrical stimulation therapy to the patient in response to determining the number of trigger events detected within the predetermined interval of time is not greater than or equal to the threshold value.

12. The medical system of claim 11, wherein the processor is configured to generate a patient notification in response to determining the number of trigger events detected within the predetermined interval of time is greater than or equal to the threshold value.

13. The medical system of claim 1, further comprising a sensor configured to generate a signal, wherein the processor is configured to determine whether the signal is indicative of a trigger event for the second electrical stimulation therapy, generate a patient notification that indicates prospective delivery of the second electrical stimulation therapy in response to determining the signal is indicative of the trigger event, receive patient input after generating the patient notification, and control the therapy delivery module to suspend the delivery of the second electrical stimulation therapy upon receiving the patient input.

14. The medical system of claim 1, wherein the processor is configured to control the therapy delivery module to deliver the second electrical stimulation therapy based on received input by at least determining whether a first received input is indicative of a trigger event for the second electrical stimulation therapy and controlling the therapy delivery module to deliver the second electrical stimulation therapy for a first therapy period in response to determining the first received input is indicative of the trigger event, wherein after the first therapy period, the processor is configured to determine whether a second received input is indicative of the trigger event, the second received input being received after the first received input, control the therapy delivery module to deliver the second electrical stimulation therapy to the patient for a second therapy period in response to determining the second received input is indicative of the trigger event, and control the therapy delivery module to deactivate the second electrical stimulation therapy in response to determining the second received input is not indicative of the trigger event.

15. The medical system of claim 1, wherein the processor is configured to control the therapy delivery module to deliver the second electrical stimulation therapy based on received input by at least determining whether the second electrical stimulation therapy was delivered to the patient within an immediately preceding period of time, controlling the therapy delivery module to deliver the second electrical stimulation therapy in response to determining the second electrical stimulation therapy was not delivered to the patient within the immediately preceding period of time, adjusting the second electrical stimulation therapy in response to determining the stimulation therapy was delivered to the patient within the immediately preceding period of time, and controlling the therapy delivery module to deliver the adjusted second electrical stimulation therapy to the patient.

16. The medical system of claim 15, wherein the second electrical stimulation therapy includes first stimulation pulses and second electrical stimulation pulses having a lower frequency than the first stimulation pulses, wherein the processor is configured to control the therapy delivery module to deliver the second electrical stimulation therapy by controlling the therapy delivery module to deliver the first stimulation pulses for a first period of time and cease delivering the first stimulation pulses and deliver the second electrical stimulation pulses for a second period of time, and wherein the processor is configured to adjust the second electrical stimulation therapy by adjusting at least one of the first period of time or the second period of time.

17. The medical system of claim 1, wherein the processor is configured to control the therapy delivery module to deliver the second electrical stimulation therapy to the patient by controlling the therapy delivery module to at least gradually increase or decrease a first stimulation parameter value defined by the first electrical stimulation therapy to a second electrical stimulation parameter value defined by the second electrical stimulation therapy according to a predetermined rate of change or over a predetermined duration of time.

18. The medical system of claim 1, wherein the first electrical stimulation therapy defines a first value of a first stimulation parameter and a second value of a second electrical stimulation parameter and the second electrical stimulation therapy defines a third value of the first stimulation parameter and a fourth value of the second electrical stimulation parameter, wherein the processor is configured to control the therapy delivery module to deliver the second electrical stimulation therapy to the patient by controlling the therapy delivery module to at least instantaneously shift stimulation delivery from the second value to the fourth value of the second electrical stimulation parameter upon receipt of the input and gradually shift from the first value to the third value of the first stimulation parameter value according to a predetermined rate of change or over a predetermined duration of time.

19. The medical system of claim 1, wherein the first electrical stimulation therapy defines a first value of a first stimulation parameter and a second value of a second electrical stimulation parameter and the second electrical stimulation therapy defines a third value of the first stimulation parameter and a fourth value of the second electrical stimulation parameter, wherein the processor is configured to control the therapy delivery module to deliver the second electrical stimulation therapy to the patient by controlling the therapy delivery module to at least gradually shift from the first value to the third value of the first stimulation parameter value according to a first predetermined rate of change or over a first predetermined duration of time and gradually shift from the second value to the fourth value of the second electrical stimulation parameter value according to a second predetermined rate of change or over a second predetermined duration of time, wherein the first and second predetermined rates of change are different and the first and second predetermined durations of time are different.

20. The medical system of claim 1, wherein the first electrical stimulation therapy defines a first value of a first stimulation parameter and a second value of a second electrical stimulation parameter and the second electrical stimulation therapy defines a third value of the first stimulation parameter and a fourth value of the second electrical stimulation parameter, wherein the processor is configured to control the therapy delivery module to deliver the second electrical stimulation therapy to the patient by controlling the therapy delivery module to at least gradually transition therapy delivery from the first value to the third value of the first stimulation parameter value and subsequently gradually transition therapy delivery from the second value to the fourth value of the second electrical stimulation parameter value.

21. The medical system of claim 1, wherein the processor is configured to control the therapy delivery module to deliver a prestimulus before delivering the second electrical stimulation therapy.

22. The medical system of claim 21, wherein the prestimulus comprises at least one stimulation pulse comprising an amplitude of about 0.10 to about 0.50 of an amplitude of a stimulation signal defined by the second electrical stimulation therapy.

23. The medical system of claim 21, wherein the processor is configured to control the therapy delivery module to deliver the prestimulus about 1 millisecond to about 25 milliseconds before delivering the second electrical stimulation therapy.

24. The medical system of claim 1, wherein the processor is configured to control the therapy delivery module to deliver stimulation to block nerve conduction while delivering the second electrical stimulation therapy.

25. The medical system of claim 1, wherein the processor is configured to control the therapy delivery module to deliver a third electrical stimulation therapy to produce paresthesia while the therapy delivery module delivers the second electrical stimulation therapy.

26. The medical system of claim 1, wherein the therapy delivery module comprises a first therapy delivery module, the medical system further comprising a second therapy delivery module configured to deliver a third electrical stimulation therapy to the patient to produce paresthesia while the first therapy delivery module delivers the second electrical stimulation therapy.

27. The medical system of claim 1, wherein the first and second electrical stimulation therapies are configured to reduce, during delivery of the first and second electrical stimulation therapies to the patient, respectively, a likelihood of at least one of urinary voiding events and fecal voiding events.

28. The medical system of claim 1, wherein the therapy delivery module is configured to overlap delivery of the second electrical stimulation therapy with delivery of the first electrical stimulation.

29. The medical system of claim 1, wherein the processor is configured to control the therapy delivery module to deliver the first electrical stimulation during one or more first time slots and deliver the second electrical stimulation therapy during one or more second time slots different than the first time slots.

30. A method comprising:

controlling, by a processor, a therapy module to deliver first electrical stimulation therapy to a patient on a regular basis over a period of time to generate a first physiological effect;

receiving input from the patient or a sensor; and

controlling, by the processor and during the period of time, the therapy module to deliver second electrical stimulation therapy to the patient only in response to the input from the patient or the sensor, wherein the delivery of the second electrical stimulation therapy generates a second physiological effect that is different than the first physiological effect, wherein the first and second electrical stimulation therapies are configured to reduce a likelihood of at least one of urinary voiding events and fecal voiding events, wherein the first physiological effect comprises inhibiting contraction of a bladder of the patient, and wherein the second physiological effect comprises promoting contraction of one or more of a bladder outlet of the patient, an internal urinary sphincter of the patient, an external urinary sphincter of the patient, or periurethral muscles of the patient.

31. The method of claim 30, wherein the input from the patient or the sensor is indicative of at least one of an imminent involuntary voiding event or an increased possibility of an occurrence of an involuntary voiding event.

32. The method of claim 30, wherein controlling the therapy module to deliver the second electrical stimulation therapy comprises controlling the therapy module to deliver a plurality of electrical stimulation signals during a plurality of therapy periods that are separated by a minimum inter-therapy interval to minimize muscle fatigue.

33. The method of claim 30, wherein controlling the therapy module to deliver the second electrical stimulation therapy comprises controlling the therapy module to deliver the second electrical stimulation therapy for a therapy period of approximately 10 seconds to approximately 50 seconds.

34. The method of claim 30, wherein controlling the therapy module to deliver the second electrical stimulation therapy comprises controlling the therapy module to deliver a stimulation signal comprising an amplitude of approximately two to approximately four times rheobase of a target muscle or nerve, a frequency of approximately 15 Hertz to approximately 66 Hertz, and a pulse width of approximately 100 microseconds to approximately 1000 microseconds.

35. The method of claim 30, wherein controlling the therapy module to deliver the second electrical stimulation therapy comprises controlling the therapy module to deliver the second electrical stimulation therapy according to a first set of stimulation parameters for a period of time and to deliver the second electrical stimulation therapy according to a second set of stimulation parameters different that the first set of stimulation parameters for a subsequent period of time.

36. The method of claim 35, wherein the first set of stimulation parameters is configured to activate fast-twitch muscles of the patient, and the second set of stimulation parameters is configured to activate slow-twitch muscles of the patient.

37. The method of claim 30, wherein controlling the therapy module to deliver the second electrical stimulation therapy to the patient based on the input from the patient or the sensor comprises controlling the therapy module to deliver the second electrical stimulation therapy for a period of time based on the patient input.

38. The method of claim 30, wherein controlling the therapy module to deliver the second electrical stimulation therapy to the patient based on the input from the patient or the sensor comprises:

determining whether the input is indicative of a trigger event for the second electrical stimulation therapy;

determining whether a number of trigger events detected within a predetermined interval of time is greater than or equal to a threshold value; and

controlling the therapy module to deliver the second electrical stimulation therapy to the patient in response to determining the number of trigger events detected within the predetermined interval of time is not greater than or equal to the threshold value.

39. The method of claim 38, further comprising generating a patient notification in response to determining the number of trigger events detected within the predetermined interval of time is greater than or equal to the threshold value.

40. The method of claim 30, wherein the method comprises receiving input from the sensor, and wherein the sensor generates a signal indicative of at least one of bladder contraction activity, detrusor muscle activity, patient activity level, patient posture, bladder impedance, a sacral or pudendal afferent nerve signal or activity of a muscle in a pelvic region of the patient.

41. The method of claim 30, wherein the input includes sensor input, the method further comprising:

determining whether the sensor input is indicative of a trigger event for the second electrical stimulation therapy;

generating a patient notification that indicates prospective delivery of the second electrical stimulation therapy in response to determining the sensor input is indicative of the trigger event;

receiving patient input after generating the patient notification; and

suspending the delivery of the second electrical stimulation therapy based on the patient input.

42. The method of claim 30, wherein the input comprises a first input, and controlling the therapy module to deliver the second electrical stimulation therapy to the patient based on the first input from the patient or the sensor comprises:

determining whether the first input is indicative of a trigger event for the second electrical stimulation therapy;

controlling the therapy module to deliver the second electrical stimulation therapy to the patient for a first therapy period in response to determining the first input is indicative of the trigger event;

receiving a second input;

after the first therapy period, determining whether the second input is indicative of the trigger event;

controlling the therapy module to deliver the second electrical stimulation therapy to the patient for a second therapy period in response to determining the second input is indicative of the trigger event; and

controlling the therapy module to deactivate the second electrical stimulation therapy in response to determining the second input is not indicative of the trigger event.

43. The method of claim 30, wherein controlling the therapy module to deliver the second electrical stimulation therapy to the patient based on the input from the patient or the sensor comprises:

determining whether the second electrical stimulation therapy was delivered to the patient within an immediately preceding period of time;

controlling the therapy module to deliver the second electrical stimulation therapy to the patient in response to determining the second electrical stimulation therapy was not delivered to the patient within the immediately preceding period of time; and

adjusting the second electrical stimulation therapy and controlling the therapy module to deliver the adjusted second electrical stimulation therapy to the patient in response to determining the second electrical stimulation therapy was delivered to the patient within the immediately preceding period of time.

44. The method of claim 43, wherein controlling the therapy module to deliver the second electrical stimulation therapy comprises controlling the therapy module to deliver first stimulation pulses for a first period of time and to deliver second electrical stimulation signals having a lower frequency than the first stimulation signals for a second period of time, wherein adjusting the second electrical stimulation therapy comprises adjusting the duration of one of the first period of time and the second period of time.

45. The method of claim 30, further comprising controlling the therapy module to deliver a prestimulus before delivering the second electrical stimulation therapy.

46. The method of claim 45, wherein controlling the therapy module to deliver the prestimulus comprises at least one of controlling the therapy module to deliver the prestimulus about 1 millisecond to about 25 milliseconds before delivering the second electrical stimulation therapy or delivering at least one stimulation pulse comprising an amplitude of about 0.10 to about 0.50 of an amplitude of a stimulation signal defined by the second electrical stimulation therapy.

47. The method of claim 30, further comprising controlling the therapy module to deliver stimulation to block nerve conduction while controlling the therapy module to deliver the second electrical stimulation therapy.

48. The method of claim 47, wherein controlling the therapy module to deliver the second electrical stimulation therapy to the patient comprises controlling the therapy module to deliver the second electrical stimulation therapy to a target nerve, the stimulation to block nerve conduction comprising the stimulation delivered to the target nerve.

49. The method of claim 30, further comprising controlling the therapy module to deliver a third electrical stimulation therapy to minimize discomfort to the patient while delivering the second electrical stimulation therapy.

50. The method of claim 49, wherein controlling the therapy module to deliver second electrical stimulation therapy to the patient comprises controlling the therapy module to deliver the second electrical stimulation therapy to a target nerve and wherein controlling the therapy module to deliver the third electrical stimulation therapy comprises controlling the therapy module to deliver the third electrical stimulation therapy to a dermatome associated with the target nerve.

51. A medical system comprising:

means for generating and delivering first electrical stimulation therapy to a patient on a regular basis over a period of time to generate a first physiological effect;

means for receiving input from the patient or a sensor; and

means for delivering, during the period of time, second electrical stimulation therapy to the patient to generate a second physiological effect that is different than the first physiological effect only in response to the input from the patient or the sensor, wherein the first and second electrical stimulation therapies are configured to reduce a likelihood of at least one of urinary voiding events and fecal voiding events, wherein the first physiological effect comprises inhibiting contraction of a bladder of the patient, and wherein the second physiological effect comprises promoting contraction of one or more of a bladder outlet of the patient, an internal urinary sphincter of the patient, an external urinary sphincter of the patient, or periurethral muscles of the patient.

52. The medical system of claim 51, further comprising a therapy delivery module that comprises the means for delivering the first electrical stimulation therapy and the means for delivering the second electrical stimulation therapy, the system further comprising a processor that controls the therapy delivery module to at least one of deliver a prestimulus to the patient before delivery of the second electrical stimulation therapy, deliver stimulation to block nerve conduction during delivery of the second electrical stimulation therapy or deliver a third electrical stimulation therapy to produce paresthesia to minimize discomfort to the patient during delivery of the second electrical stimulation therapy.

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

control a therapy module to deliver first electrical stimulation therapy to a patient on a regular basis over a period of time to generate a first physiological effect;

receive input from a patient or a sensor; and

control, during the period of time, the therapy module to deliver second electrical stimulation therapy to the patient only in response to the input from the patient or the sensor, wherein the second electrical stimulation therapy is configured to generate a second physiological effect that is different than the first physiological effect, wherein the first and second electrical stimulation therapies are configured to reduce a likelihood of at least one of urinary voiding events and fecal voiding events, wherein the first physiological effect comprises inhibiting contraction of a bladder of the patient, and wherein the second physiological effect comprises promoting contraction of one or more of a bladder outlet of the patient, an internal urinary sphincter of the patient, an external urinary sphincter of the patient, or periurethral muscles of the patient.

54. The non-transitory computer-readable medium of claim 53, further comprising instructions that cause the programmable processor to control the therapy module to at least one of deliver a prestimulus to the patient before delivery of the second electrical stimulation therapy, deliver stimulation to block nerve conduction during delivery of the second electrical stimulation therapy or deliver a third electrical stimulation therapy to produce paresthesia to minimize discomfort to the patient during delivery of the second electrical stimulation therapy.