Adaptive electrical stimulation therapy for fecal incontinence

• US 8,190,262 B2
• Filed: 02/24/2009
• Issued: 05/29/2012
• Est. Priority Date: 02/23/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin T., Rondoni, John C.
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US12/391,846
• Publication Number:
  US 20090163975A1
• Time in Patent Office: 1,190 Days
• Field of Search: 607/3, 607/9, 607/41, 607/46, 607/48
• US Class Current: 607/41
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

In general, the disclosure is directed to an implantable neurostimulator and system capable of providing adaptive neurostimulation therapy to alleviate urinary or fecal incontinence. The neurostimulator operates according to a set of stimulation parameters stored in memory. During operation, information is obtained from the patient, the implanted neurostimulator, one or more implanted sensors, or some combination thereof. A processor analyzes the information to automatically generate proposed adjustments to the stimulation parameters applied by the neurostimulator. The adjustments provide an adaptive neurostimulation therapy that supports or enhances therapeutic efficacy based on the information.

Claims

1. A method comprising:

receiving information sensed by a sensor relating to efficacy of electrical stimulation therapy delivered to a patient by an implanted neurostimulator to manage fecal incontinence, wherein the received information includes information regarding a physiological state of the patient at the time of a voiding event, the information regarding the physiological state of the patient comprising at least one of patient activity type at the time of the voiding event or patient posture at the time of the voiding event;

with a processor, adjusting one or more stimulation parameters of the electrical stimulation therapy based on the received information regarding the physiological state of the patient at the time of the voiding event and adaptation logic; and

providing the adjusted parameters to the implanted neurostimulator.

2. The method of claim 1, further comprising:

receiving information input from the patient relating to efficacy of electrical stimulation therapy delivered by the implanted neurostimulator to manage fecal incontinence; and

with the processor, adjusting the one or more stimulation parameters of the electrical stimulation therapy based on the received information regarding the physiological state of the patient at the time of the voiding event, the received information input from the patient, and the adaptation logic.

3. The method of claim 2, wherein the information input from the patient comprises at least one of information regarding fecal voiding, information regarding comfort, or information regarding a need for different settings.

4. The method of claim 3, wherein the information regarding comfort indicates a subjective rating of the comfort level of the patient.

5. The method of claim 3, wherein the information regarding fecal voiding comprises at least one of fecal voiding attempts, involuntary fecal voiding, timing of fecal voiding, or characteristics of a fecal bolus.

6. The method of claim 2, wherein the adaptation logic comprises a function that weighs the information sensed by the sensor and the information input from the patient to determine an adjustment to the one or more stimulation parameters.

7. The method of claim 6, further comprising determining an efficacy of the stimulation therapy based on a weighted sum of the information sensed by the sensor and the information input from the patient, wherein adjusting one or more stimulation parameters of the electrical stimulation therapy comprises adjusting one or more stimulation parameters if the efficacy deviates from a desired range.

8. The method of claim 1, wherein adjusting one or more stimulation parameters of the electrical stimulation therapy comprises adjusting one or more stimulation parameters via a plurality of incremental increases until the adaptation logic no longer indicates an adjustment to the one or more stimulation parameters is needed.

9. The method of claim 1, wherein the sensor comprises an accelerometer.

10. The method of claim 1, wherein the information regarding the physiological state of the patient further comprises an activity level of the patient at the time of the voiding event.

11. A system comprising:

an implantable neurostimulator that delivers electrical stimulation therapy to a patient to manage fecal incontinence;

a sensor that senses information relating to efficacy of the electrical stimulation therapy delivered by the implantable neurostimulator, wherein the information includes information regarding a physiological state of the patient at the time of a voiding event, the information regarding the physiological state of the patient comprising at least one of patient activity type at the time of the voiding event or patient posture at the time of the voiding event; and

a processor that receives the information sensed by the sensor, adjusts one or more stimulation parameters of the electrical stimulation therapy based on the received information and adaptation logic, and provides the adjusted parameters to the implantable neurostimulator.

12. The system of claim 11, wherein the processor receives input from the patient relating to efficacy of the electrical stimulation therapy delivered by the implantable neurostimulator to manage fecal incontinence and adjusts the one or more stimulation parameters of the electrical stimulation therapy based on the received information, the input from the patient, and the adaptation logic.

13. The system of claim 12, wherein the information input from the patient comprises at least one of information regarding fecal voiding, information regarding comfort, information regarding a need for different settings.

14. The system of claim 13, wherein the information regarding comfort indicates a subjective rating of the comfort level of the patient.

15. The system of claim 13, wherein the information regarding fecal voiding comprises at least one of fecal voiding attempts, involuntary fecal voiding, timing of fecal voiding, or characteristics of a fecal bolus.

16. The system of claim 12, wherein the adaptation logic comprises a function that weighs the information sensed by the sensor and the information input from the patient to determine an adjustment to the one or more stimulation parameters.

17. The method of claim 16, wherein the processor determines an efficacy of the electrical stimulation therapy based on a weighted sum of the information sensed by the sensor and the information input from the patient, and adjusts the one or more stimulation parameters of the electrical stimulation therapy if the efficacy deviates from a desired range.

18. The system of claim 11, wherein the processor adjusts the one or more stimulation parameters of the electrical stimulation therapy via a plurality of incremental increases until the adaptation logic no longer indicates an adjustment to the one or more stimulation parameters is needed.

19. The system of claim 11, further comprising a medical device programmer that comprises the processor.

20. The system of claim 11, wherein the implantable neurostimulator comprises the processor.

21. The system of claim 11, wherein the sensor comprises an accelerometer.

22. The system of claim 11, wherein the information regarding the physiological state of the patient further comprises an activity level of the patient at the time of the voiding event.

23. A system comprising:

means for delivering electrical stimulation therapy to a patient to manage fecal incontinence;

means for sensing information relating to efficacy of the electrical stimulation therapy delivered by the means for delivering electrical stimulation therapy, wherein the information includes information regarding a physiological state of the patient at the time of a voiding event, the information regarding the physiological state of the patient comprising at least one of patient activity type at the time of the voiding event or patient posture at the time of the voiding event;

means for adjusting one or more stimulation parameters of the electrical stimulation therapy based on the information regarding at least one of patient activity type at the time of the voiding event, activity level at the time of the voiding event or patient posture at the time of the voiding event sensed by the means for sensing information and adaptation logic; and

means for providing the adjusted parameters to the means for delivering electrical stimulation therapy.

24. The system of claim 23, further comprising means for receiving input from the patient relating to efficacy of the electrical stimulation therapy delivered by the implantable neurostimulator to manage fecal incontinence, wherein the means for adjusting one or more stimulation parameters adjusts the one or more stimulation parameters based on the information regarding at least one of patient activity type at the time of the voiding event, activity level at the time of the voiding event or patient posture at the time of the voiding event, the input from the patient, and the adaptation logic.

25. The system of claim 24, wherein the information input from the patient comprises at least one of information regarding fecal voiding, information regarding comfort, or information regarding a need for different settings.

26. The system of claim 23, wherein the information regarding the physiological state of the patient further comprises an activity level of the patient at the time of the voiding event.