Implantable medical device providing adaptive neurostimulation therapy for incontinence

• US 20060190049A1
• Filed: 04/28/2005
• Published: 08/24/2006
• 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.
• Granted Patent: US 8,744,585 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

Abstract

In general, the disclosure is directed to an implantable neurostimulator and system capable of providing adaptive neurostimulation therapy to alleviate 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, in an external programmer, information relating to efficacy of neurostimulation therapy delivered by an implanted neurostimulator to manage urinary incontinence;

sensing, via at least one sensor, information related to efficacy of neurostimulation therapy delivered by an implanted neurostimulator;

adjusting, in a processor, one or more stimulation parameters associated with the neurostimulation therapy based on the received information and the sensed information; and

inputting the adjusted parameters from the programmer to the implanted neurostimulator.

2. The method of claim 1, wherein the received information comprises information from the implanted neurostimulator.

3. The method of claim 2, wherein the received information is information regarding the stimulation parameters of the neurostimulator, the elapsed time since the neurostimulator was implanted, the elapsed time since the settings were adjusted, the battery status, the charging status, the lead impedance, the telemetry status, or some combination thereof.

4. The method of claim 3, wherein the information regarding the settings of the implantable neurostimulator is frequency, amplitude, cycling parameters, identification of electrodes that are being utilized, or some combination thereof.

5. The method of claim 1, wherein the received information comprises information input from the patient.

6. The method of claim 5, wherein the information is information regarding voiding, information regarding comfort, information regarding a need for different settings, or some combination thereof.

7. The method of claim 6, wherein the information regarding voiding is information regarding timing, voiding attempts, voluntary leakage episodes, flow, or some combination thereof.

8. The method of claim 7, wherein the information regarding flow is information regarding strength of flow, stability of flow, amount of flow, or some combination thereof.

9. The method of claim 6, wherein the information regarding comfort is information regarding a subjective rating of the comfort level of the patient.

10. The method of claim 5, wherein the received information includes information regarding the physiological state of the patient

11. The method of claim 10, wherein the information regarding the physiological state of the patient is activity type, activity level, posture, or some combination thereof.

12. The method of claim 1, wherein the received information comprises information from the implantable neurostimulator and information input from the patient.

13. The method of claim 1, wherein the sensed information is information regarding the functioning of the bladder, or any other segment of the patient'"'"'s urinary tract.

14. The method of claim 13, wherein the sensed information relates to bladder pressure, bladder contractile force, urinary sphincter pressure, urine flow rate, urine flow pressure, voiding amount, or some combination thereof.

15. The method of claim 13, wherein the sensed information relates to urine flow velocity, urine or bladder temperature, impedance, urinary pH, or chemical constituency of the urine, or some combination thereof.

16. The method of claim 13, wherein the sensed information relates to a physiological state of the patient.

17. The method of claim 16, wherein the sensed information is cardiac activity, respiratory activity, electromyographic activity, or some combination thereof.

18. The method of claim 16, wherein the sensed information detects a posture or activity level of the patient.

19. The method of claim 1, wherein the processor is associated with the external programmer.

20. The method of claim 1, wherein the processor is associated with the implanted neurostimulator.

21. The method of claim 1, further comprising submitting the adjusted parameters for approval by a clinician.

22. The method of claim 21, wherein the external programmer is in communication with a remote programmer.

23. The method of claim 22, wherein the remote programmer approves the adjusted parameters and the external programmer inputs the adjusted parameters to the implanted neurostimulator via wireless telemetry.

24. A system for performing the method of claim 1 comprising:

an external programmer;

a processor;

at least one sensor; and

an implantable neurostimulator.

25. The system of claim 24, wherein the processor is associated with the external programmer.

26. The system of claim 24, wherein the processor is associated with the implantable neurostimulator.

27. The system of claim 24, wherein at least a part of the adaptive logic is stored in memory associated with the external programmer.

28. The system of claim 24, wherein at least a part of the adaptive logic is stored in memory associated with the implantable neurostimulator.

29. A computer-readable medium comprising instructions to cause one or more processors to perform the method of claim 1.

30. A system comprising:

an implantable neurostimulator configured to deliver neurostimulation therapy to manage urinary incontinence and send information regarding the stimulation parameters of the implantable neurostimulator;

an external programmer configured to receive information from a patient relating to the efficacy of neurostimulation therapy delivered by the implanted neurostimulator and send the received information;

at least one sensor configured to sense information related to efficacy of neurostimulation therapy delivered by an implanted neurostimulator and send the sensed information; and

a processor configured to receive the information from the external programmer, the implantable neurostimulator, and the at least one sensor, and adjust one or more stimulation parameters associated with the neurostimulation therapy based on the received information and adaptive logic.