EVALUATING PATIENT INCONTINENCE

• US 20080300449A1
• Filed: 05/30/2007
• Published: 12/04/2008
• Est. Priority Date: 05/30/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin T., Rondoni, John C.
• Granted Patent: US 8,204,597 B2
• Time in Patent Office: Days
• US Class Current: 600/30
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

Systems and methods for determining a number of interruptions in a sleep state of a patient attributable to an urge or need to void during a sleep event include monitoring an activity level of the patient. The urge or need to void may be attributable to fecal or urinary incontinence. The patient activity level may be determined with one or more sensors that detect motion and/or one or more sensors that monitor a physiological parameter of the patient that varies as a function of patient activity. In one embodiment, a clinician selects a therapy parameter set for the patient based on the severity of the patient'"'"'s incontinence. In another embodiment, the number of interruptions in the sleep state is associated with a therapy parameter set that was implemented during the sleep state in order to evaluate the efficacy of the therapy parameter set. In another embodiment, a medical device automatically adjusts a therapy parameter to treat the incontinence if the number of interruptions in the sleep state exceeds a threshold.

Claims

1. A method comprising:

detecting a sleep state of a patient afflicted with sleep event voiding;

monitoring an activity level of the patient via an implanted medical device; and

determining a number of interruptions in the sleep state of the patient based on the monitored activity level to evaluate the sleep event voiding.

2. The method of claim 1, further comprising adjusting a therapy parameter to control the sleep event voiding based on the number of interruptions in the sleep state.

3. The method of claim 2, wherein the therapy parameter comprises at least one of voltage or current amplitude of electrical stimulation, pulse width of electrical stimulation, pulse frequency of electrical stimulation, a drug dosage, or a frequency of a delivery of a drug.

4. The method of claim 1, further comprising selecting a therapy parameter set to treat sleep event voiding based on the number of interruptions in the sleep state.

5. The method of claim 1, further comprising storing the number of interruptions in the sleep state of the patient in a memory of the implanted medical device.

6. The method of claim 1, wherein detecting the sleep state of the patient comprises receiving an indication from the patient that the patient is attempting to sleep via a user interface.

7. The method of claim 1, wherein detecting the sleep state comprises determining whether the patient is in the sleep state based on the activity level of the patient.

8. The method of claim 1, wherein monitoring the activity level comprises monitoring at least one signal that indicates posture of the patient, and detecting the sleep state of the patient comprises determining whether the patient is recumbent.

9. The method of claim 1, wherein monitoring the activity level comprises monitoring at least one signal that indicates a posture of the patient, and wherein determining the number of interruptions in the sleep state of the patient comprises determining a change in the posture of the patient.

10. The method of claim 1, wherein determining the number of interruptions in the sleep state of the patient comprises:

comparing the activity level to an activity level threshold; and

determining when the activity level exceeds the activity level threshold.

11. The method of claim 10, wherein when the activity level exceeds the activity level threshold and a subsequent activity level falls below the activity level threshold within a predetermined range of time, the method comprises recording an awake count, wherein each awake count represents an interruption in the sleep state.

12. The method of claim 1, wherein monitoring the activity level of the patient comprises monitoring a plurality of physiological parameters of the patient, and wherein determining the number of interruptions in the sleep state of the patient comprises:

determining a value of at least one metric that is indicates a probability that the patient is asleep or awake based on at least one of the physiological parameters; and

comparing the metric to a threshold.

13. The method of claim 1, wherein monitoring the activity level comprises determining the activity level based on a signal indicative of a physiological parameter of the patient, the physiological parameter comprising at least one of posture, heart rate, respiration rate, respiratory volume, core temperature, blood pressure, blood oxygen saturation, partial pressure of oxygen within blood, partial pressure of oxygen within cerebrospinal fluid, muscular activity, arterial blood flow or galvanic skin response.

14. The method of claim 1, monitoring the activity level comprises determining the activity level based on a signal generated by at least one of an accelerometer, a bonded piezoelectric crystal, a mercury switch or a gyro.

15. The method of claim 1, further comprising associating the number of interruptions in the sleep state with a therapy parameter set.

16. The method of claim 15, wherein the sleep state is a first sleep state, the number of interruptions is a first number of interruptions, and the therapy parameter set is a first therapy parameter set, the method further comprising:

detecting a second sleep state of the patient;

determining a second number of interruptions in the second sleep state of the patient based on the monitored activity level;

associating the second number of interruptions in the second sleep state with a second therapy parameter set; and

ranking the first and second therapy parameter sets according to the respective first and second number of interruptions.

17. The method of claim 15, wherein the sleep state is a first sleep state, the number of interruptions is a first number of interruptions, and the therapy parameter set is a first therapy parameter set, the method further comprising:

detecting a second sleep state of the patient;

determining a second number of interruptions in the second sleep state of the patient based on the monitored activity level;

associating the second number of interruptions in the second sleep state with a second therapy parameter set; and

selecting one of the first or second therapy parameter sets according to the respective first and second number of interruptions.

18. A method comprising:

detecting a sleep state of a patient;

monitoring an activity level of the patient via a medical device;

determining a number of interruptions in the sleep state of the patient based on the monitored activity level; and

adjusting a therapy parameter to control sleep event voiding based on the number of interruptions in the sleep state.

19. The method of claim 18, wherein the medical device is implanted within the patient.

20. The method of claim 18 wherein detecting the sleep state of the patient comprises receiving an indication from the patient that the patient is attempting to sleep.

21. The method of claim 18, wherein detecting the sleep state comprises determining whether the patient is in the sleep state based on the activity level of the patient.

22. The method of claim 18, wherein monitoring the activity level comprises monitoring at least one signal that indicates a posture of the patient, and wherein determining the number of interruptions in the sleep state of the patient comprises determining a change in the posture of the patient

23. The method of claim 18, wherein determining the number of interruptions in the sleep state of the patient comprises:

comparing the activity level to an activity level threshold; and

determining when the activity level exceeds the activity level threshold.

24. The method of claim 18, wherein monitoring the activity level comprises monitoring a plurality of physiological parameters of the patient, and determining the number of interruptions in the sleep state of the patient comprises:

determining a value of at least one metric that is indicates a probability that the patient is asleep or awake based on at least one of the physiological parameters; and

comparing the sleep metric to a threshold.

25. The method of claim 18, wherein adjusting the therapy parameter comprises:

comparing the number of interruptions in the sleep state to a quality of life threshold; and

adjusting the therapy parameter if the number of interruptions exceeds the quality of life threshold.

26. A system comprising:

an implantable activity sensor that generates a signal that varies as a function of activity of a patient; and

at least one processor that receives the signal from the activity sensor, detects a sleep state of the patient, determines a first number of interruptions in the sleep state of the patient based signal, and determines a second number of sleep event voiding events based on the number of interruptions in the sleep state of the patient.

27. The system of claim 26, wherein the processor further adjusts a therapy parameter to treat sleep event voiding based on the number of interruptions in the sleep state.

28. The system of claim 27, further comprising a memory, wherein the processor compares the number of interruptions in the sleep state to a quality of life threshold stored in the memory and adjusts the therapy parameter if the number of interruptions exceeds the quality of life threshold.

29. The system of claim 26, wherein the processor further selects a therapy parameter set to treat sleep event voiding based on the number of interruptions in the sleep state.

30. The system of claim 26, wherein the processor detects the sleep state of the patient by receiving an indication from the patient that the patient is attempting to sleep.

31. The system of claim 26, wherein the processor detects the sleep state of the patient based on the signal from the activity sensor.

32. The system of claim 26, further comprising a memory, wherein the processor determines the number of interruptions in the sleep state of the patient by comparing the activity level to an activity level threshold stored in the memory, and determining when the activity level exceeds the activity level threshold.

33. The system of claim 26, further comprising a memory, wherein implantable activity sensor senses a physiological parameter to the signal, wherein the processor determines the number of interruptions in the sleep state of the patient by determining a value of at least one metric that is indicates a probability that the patient is asleep or awake based the signal, and comparing the metric to a threshold stored in the memory.

34. The system of claim 26, wherein the signal is indicative of a physiological parameter of the patient, the physiological parameter comprising at least one of posture, heart rate, respiration rate, respiratory volume, core temperature, blood pressure, blood oxygen saturation, partial pressure of oxygen within blood, partial pressure of oxygen within cerebrospinal fluid, muscular activity, arterial blood flow, and galvanic skin response.

35. The system of claim 26, wherein the implantable activity sensor comprises at least one of an accelerometer, a bonded piezoelectric crystal, a mercury switch or a gyro.

36. The system of claim 26, further comprising a therapy module configured to delivery a therapy to the patient via a therapy parameter set, wherein the processor associates the number of interruptions in the sleep state with the therapy parameter set.

37. The system of claim 36, wherein the sleep state is a first sleep state, the number of interruptions is a first number of interruptions, and the therapy parameter set is a first therapy parameter set, wherein the processor further:

detects a second sleep state of the patient;

determines a second number of interruptions in the second sleep state of the patient based on the signal;

associates the second number of interruptions in the second sleep state with a second therapy parameter set.

38. The system of claim 37, further comprising an external programming device including a display that receives information identifying the first and second therapy parameter sets and the first and second number of interruptions in the sleep state associated with the respective first and second therapy parameter sets from the implantable medical device, and presents a list of the first and second therapy parameter sets and the associated first and second number of interruptions in the sleep state to a user via the display.

39. A system comprising:

an activity sensor that generates a signal that varies as a function of activity of a patient;

a therapy delivery module configured to deliver a therapy to the patient to control sleep event voiding; and

a processor that receives the signal from the activity sensor, detects a sleep state of the patient, determines a number of interruptions in the sleep state of the patient based on the signal, and adjusts a parameter of the therapy based on the number of interruptions in the sleep state.

40. The system of claim 39, wherein the activity sensor is implantable.

41. The system of claim 39, wherein the therapy parameter comprises at least one of voltage or current amplitude, pulse width or pulse frequency of electrical stimulation, or a drug dosage or a frequency of a delivery of a drug.

42. The system of claim 39, wherein the processor compares the number of interruptions in the sleep state to a quality of life threshold, and adjusts the therapy parameter if the number of interruptions exceeds the quality of life threshold.