Implantable medical device providing adaptive neurostimulation therapy

• US 9,192,763 B2
• Filed: 06/02/2014
• Issued: 11/24/2015
• 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:
  US14/293,863
• Publication Number:
  US 20140277251A1
• Time in Patent Office: 540 Days
• Field of Search: None
• US Class Current: 1/1
• 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:

obtaining, in an external programmer during application of neurostimulation therapy, information that relates to efficacy of the neurostimulation therapy being delivered to the patient by an implanted neurostimulator;

adjusting, in a processor, one or more stimulation parameters associated with the neurostimulation therapy being applied to the patient by applying a set of adaptive logic to the obtained information to formulate an adjustment of a stimulation parameter;

submitting the adjusted parameters for approval by a clinician;

if approval is received, then inputting the adjusted parameters from the programmer to the implanted neurostimulator, and otherwise stopping without inputting the adjusted parameters to the implanted neurostimulator.

2. The method of claim 1, wherein the obtained information comprises at least one of information from the implanted neurostimulator, information sensed by a sensor, and information input to the external programmer by a patient.

3. The method of claim 2, wherein the received information from the implanted neurostimulator comprises 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 obtained information is provided by the patient via a user input device in communication with the external programmer.

6. The method of claim 5, wherein the information provided by the patient 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 obtained 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 obtained information is information regarding the functioning of the bladder, or any other segment of the patient'"'"'s urinary tract.

13. The method of claim 1, wherein the obtained information relates to bladder pressure, bladder contractile force, urinary sphincter pressure, urine flow rate, urine flow pressure, voiding amount, or some combination thereof.

14. The method of claim 1, wherein the obtained information relates to urine flow velocity, urine or bladder temperature, impedance, urinary pH, or chemical constituency of the urine, or some combination thereof.

15. The method of claim 1, wherein the obtained information relates to a physiological state of the patient.

16. The method of claim 1, wherein the obtained information is cardiac activity, respiratory activity, electromyographic activity, or some combination thereof.

17. The method of claim 1, wherein the obtained information detects a posture or activity level of the patient.

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

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

20. The method of claim 1, wherein submitting the adjusted parameters for approval by a clinician comprises providing a web page to a clinician terminal wherein the web page provides the adjusted parameters.

21. The method of claim 1, wherein the external programmer is in communication with a remote programmer.

22. The method of claim 21, wherein the remote programmer approves the adjusted parameters and the external programmer inputs the adjusted parameters to the implanted neurostimulator via wireless telemetry.

23. The method of claim 1, wherein submitting the adjusted parameters for approval by a clinician comprises providing an email notification to a clinician terminal wherein the email notification provides the adjusted parameters.

24. A system comprising:

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

an external programmer configured to obtain information that relates to the efficacy of neurostimulation therapy delivered by the implanted neurostimulator;

a processor configured to adjust one or more stimulation parameters associated with the neurostimulation therapy based on adaptive logic applied to information including at least the obtained information, and wherein the adaptive logic employs weighting to the information and employs safety ranges for the information with the safety ranges being weighted most heavily.

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 system for adjusting stimulation parameters associated with neurostimulation therapy comprising:

an implantable neurostimulator adapted to deliver neurostimulation therapy;

an external programmer adapted to obtain information that relates to efficacy of neurostimulation therapy delivered by the implantable neurostimulator; and

a processor adapted to adjust a stimulation parameter associated with the neurostimulation therapy by applying a set of adaptive logic to information including the obtained information, wherein the processor submits the adjusted parameters for approval by a clinician and upon receiving an approval adjusts the stimulation parameters.

30. The system of claim 29, wherein the processor adjusts the stimulation parameters incrementally over a period of time to implement the adjustment formulated by application of the adaptive logic until the adaptive logic no longer indicates a need for a change to the stimulation parameters.

31. The system of claim 29, wherein the adaptive logic employs weighting to the information and employs safety ranges for the information with the safety ranges being weighted most heavily.