Implantable medical device providing adaptive neurostimulation therapy for incontinence

• US 7,580,752 B2
• Filed: 04/28/2005
• Issued: 08/25/2009
• 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): Layno; Carl H
• Assistant Examiner(s): Gedeon; Brian T
• Application Number:
  US11/117,058
• Publication Number:
  US 20060190050A1
• Time in Patent Office: 1,580 Days
• Field of Search: 607/40, 607/41, 607/133, 607/138
• 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 fecal or urinary 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, wherein the received information comprises information input by the patient and information from the implanted neurostimulator, wherein the information input by the patient and the information from the implanted neurostimulator are temporally correlated;

adjusting, in a processor applying adaptation logic, one or more stimulation parameters of the neurostimulation therapy based on the received information; and

inputting the adjusted parameters from the processor to the implanted neurostimulator

wherein the information is temporally correlated in order to evaluate the conditions experienced by a patient at the time of a significant voiding event.

2. The method of claim 1, wherein the information is information regarding voiding, information regarding comfort, information regarding a need for different settings, or some combination thereof.

3. The method of claim 2, wherein the information regarding voiding is information regarding timing, voiding attempts, voluntary leakage episodes, flow, or some combination thereof.

4. The method of claim 3, wherein the information regarding flow is information regarding strength of flow, stability of flow, amount of flow, or some combination thereof.

5. The method according to claim 4, wherein the information that is input was rated by the patient on a relative scale.

6. The method of claim 2, wherein the information regarding comfort is information regarding a subjective rating of the comfort level of the patient.

7. The method according to claim 6, wherein the information that is input was rated by the patient on a relative scale.

8. The method of claim 1, 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.

9. The method of claim 8, 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.

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

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

14. The method of claim 1, wherein the external programmer is a portable programmer carried by the patient.

15. The method of claim 1, wherein the input of the adjusted parameters to the implanted neurostimulator is via wireless telemetry.

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

17. The method of claim 16, wherein the external programmer is in communication with a remote programmer.

18. The method of claim 17, wherein the remote programmer approves the adjusted parameters and the external programmer inputs the adjusted parameters to the implanted neurostimulator via wireless telemetry.

19. The method according to claim 1, wherein the one or more stimulation parameters of the neurostimulation therapy is adjusted based on the evaluation of the conditions.

20. A computer-readable medium programmed with instructions to cause one or more processors to perform the method of claim 1.

21. A system for performing a method the system comprising:

an external programmer, comprising a processor; and

an implantable neurostimulator,

wherein the external programmer is configured to be in wireless contact with the implantable neurostimulator, the external programmer is configured to receive information input by a patient related to efficacy of neurostimulation therapy delivered by the implantable neurostimulator to manage urinary incontinence and information from the implantable neurostimulator, wherein the information input from the patient and the information from the implantable neurostimulator are temporally correlated in order to evaluate the conditions experienced by a patient at the time of a significant voiding event, the processor applying adaptation logic and is configured to adjust one or more stimulation parameters of the neurostimulation therapy based on the received information, and the processor is configured to input the adjusted parameters into the implantable neurostimulator.

22. The system of claim 21, wherein at least a part of the adaptation logic is stored in memory associated with the external programmer.

23. 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 input by a patient, said information relating to efficacy of neurostimulation therapy delivered by the implanted neurostimulator and information from the implantable neurostimulator, wherein the information input from the patient and the information from the implantable neurostimulator are temporally correlated in order to evaluate the conditions experienced by a patient at the time of a significant voiding event, and send the received information; and

a processor applying adaptation logic, that is configured to adjust one or more parameters associated with the neurostimulation therapy based on the information from the implantable neurostimulator and the external programmer.

24. A system for performing a method, the system comprising:

an external programmer; and

an implantable neurostimulator comprising a processor,

wherein the external programmer is configured to be in wireless contact with the implantable neurostimulator, the external programmer is configured to receive information input by a patient, said information related to efficacy of neurostimulation therapy delivered by the implantable neurostimulator to manage urinary incontinence and information from the implantable neurostimulator, wherein the information input from the patient and the information from the implantable neurostimulator are temporally correlated in order to evaluate the conditions experienced by a patient at the time of a significant voiding event, the processor applying adaptation logic and being configured to adjust one or more stimulation parameters of the neurostimulation therapy based on the received information, and the processor is configured to input the adjusted parameters into the implantable neurostimulator.

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