VOIDING EVENT IDENTIFICATION BASED ON PATIENT INPUT

• US 20080300651A1
• 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 8,121,691 B2
• Time in Patent Office: Days
• US Class Current: 607/41
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/202 Assessing bladder functions, e.g. incontinence assessment
• CPC Class Codes: A61B 5/204 Determining bladder volume
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile

Abstract

An implantable medical device (IMD) is configured to operate as an automatic voiding diary for logging urinary and/or fecal voiding events. The IMD detects urinary and/or fecal voiding events and generates data that identifies detected events as voluntary or involuntary events. In particular, the IMD generates the identification data based on a patient defined action. In one embodiment, the patient defined action is the patient tapping on the skin located above the IMD. The IMD may generate the identification data based on one or more characteristics of the tapping, e.g., the number, frequency, duration, or pattern of taps. The IMD may also generate the identification data based on a lack of input during a specific range of time after a detected voiding event. In some embodiments, the identification data may be used to identify a false positive, i.e., an event that was incorrectly detected by the IMD.

Claims

1. A method comprising:

receiving a sensor signal that varies as a function of a parameter associated with a voiding event of a patient;

determining whether the voiding event occurred based on the sensor signal;

receiving input from the patient, wherein the input comprises a patient defined action that is received via a device implanted within the patient; and

associating the input with an occurrence of the voiding event.

2. The method of claim 1, wherein the device is implanted within subcutaneous tissue of the patient, and wherein receiving input from the patient comprises receiving one or more taps through the skin of the patient proximate to the device.

3. The method of claim 1, wherein the parameter associated with the voiding event comprises at least one of nerve activity, bladder volume, bladder pressure, bladder impedance, sphincter pressure, bowel pressure, motion of a portion of an intestine, motion of a sigmoid colon, motion of a rectum or a sound associated with the voiding event.

4. The method of claim 1, further comprising determining whether the voiding event was a controlled event or an involuntary event based on the input associated with the voiding event.

5. The method of claim 4, wherein the device is implanted within subcutaneous tissue of the patient, and wherein the patient defined action comprises one or more taps on the skin of the patient proximate to the device, and wherein determining whether the voiding event was a controlled event or an involuntary event based on the input associated with the voiding event comprises determining a characteristic of the tapping, and the characteristic comprising at least one of a number, frequency, pattern or duration of the tapping.

6. The method of claim 4, further comprising generating identification data that indicates whether the voiding event was the controlled event or the involuntary event and storing the identification data in a memory.

7. The method of claim 6, wherein storing the identification data in the memory comprises transmitting the identification data to an external device via wireless telemetry, wherein the external device comprises the memory.

8. The method of claim 7, further comprising presenting the identification data to a user via a display of the external device.

9. The method of claim 6, wherein generating the identification data comprises generating an indicator that identifies the voiding event associated with the input as a false positive.

10. The method of claim 9, wherein generating the indicator that identifies the voiding event as the false positive comprises generating the data that identifies the voiding event associated with the input as the false positive when the input is not received within a pre-determined time after the voiding event is detected.

11. The method of claim 4, further comprising adjusting one or more therapy parameters based on the determination of whether the voiding event was the controlled event or the involuntary event.

12. The method of claim 11, wherein the therapy parameters comprises at least one of a 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.

13. The method of claim 4, further comprising controlling the delivery of therapy to the patient based on the determination of whether the voiding event was the controlled event or the involuntary event.

14. The method of claim 13, wherein delivering therapy to the patient comprises delivering electrical stimulation to the patient or delivering a fluid to the patient.

15. The method of claim 1, wherein the method further comprising delivering therapy to the patient and evaluating efficacy of the therapy based on the identification data.

16. The method of claim 1, further comprising receiving confirmation from the patient that the determination of whether the voiding event was the controlled event or the involuntary event is valid or invalid.

17. The method of claim 1, wherein the signal comprises a first signal and the device comprises an accelerometer, wherein receiving the input comprises detecting a movement of the device via a second signal generated by at least one of the accelerometer or a microphone.

18. The method of claim 1, wherein determining whether the voiding event occurred based on the sensor signal comprises comparing a sample of the sensor signal to a signal template.

19. The method of claim 18, further comprising generating an example sensor signal during an actual voiding event, wherein the signal template is defined based on one or more characteristics of a portion of the example sensor signal.

20. The method of claim 1, wherein receiving the input from the patient comprises receiving the input within a pre-determined period of time following the determination that the voiding event occurred.

21. A system comprising:

a sensor that generates an electrical signal that varies as function of a parameter associated with a voiding event of a patient;

a processor that processes the electrical signal to detect the voiding event; and

an implantable input mechanism configured to receive an input from the patient, the input comprising a patient defined action,

wherein the processor associates the input with the detected voiding event.

22. The system of claim 21, wherein the patient defined action comprises a tapping action by the patient at a location proximate to an implant site for the implantable medical device.

23. The system of claim 21, wherein the parameter comprises at least one of nerve activity, bladder volume, bladder pressure, bladder impedance, sphincter pressure, bowel pressure, motion of a portion of an intestine, motion of a sigmoid colon, motion of a rectum or a sound associated with the voiding event.

24. The system of claim 21, wherein the processor determines whether the detected voiding event was a controlled event or an involuntary event based on the patient defined action.

25. The system of claim 24, wherein the patient defined action comprises a tapping action by the patient at a location proximate to an implant site for the implantable medical device, and wherein the processor determines whether the detected voiding event was the controlled event or the involuntary event based on one or more characteristics of the tapping action, the characteristics comprising at least one of number, a frequency, a pattern or a duration of the tapping action.

26. The system of claim 24, further comprising a memory, wherein the processor generates identification data that indicates whether the voiding event was the controlled event or the involuntary event and stores the identification data in the memory.

27. The system of claim 26, further comprising a medical device programmer comprising the memory.

28. The system of claim 26, wherein processor generates the identification data if the input mechanism receives the input within a predetermined period of time following the detected voiding event.

29. The system of claim 26, wherein the identification data identifies the detected voiding event as a false positive based on the input.

30. The system of claim 29, wherein the processor generates identification data that identifies the detected voiding event as the false positive when the input mechanism does not receive the input within a pre-determined period of time following the detected voiding event.

31. The system of claim 21, wherein the input mechanism comprises at least one of a single-axis accelerometer or a multiple-axis accelerometer, and wherein the patient defined action results in a movement of the input mechanism.

32. The system of claim 21, further comprising a therapy delivery module and one or more therapy elements coupled to the therapy delivery module to deliver therapy to the patient, wherein the therapy comprises at least one of electrical stimulation or drug therapy.

33. The system of claim 21, wherein the sensor, the processor, and the implantable input mechanism are enclosed in a common housing.

34. The system of claim 21, wherein the input mechanism comprises a microphone.

35. A computer-readable medium comprising instructions that cause a processor to:

receive a sensor signal that varies as a function of a parameter associated with a voiding event of a patient;

determine whether the voiding event occurred based on the sensor signal;

receive input from the patient via a patient defined action that is received via a device implanted within the patient; and

determine whether the voiding event was a controlled event or an involuntary event based on the input.