Implantable medical device providing adaptive neurostimulation therapy for incontinence

• US 7,415,308 B2
• Filed: 04/28/2005
• Issued: 08/19/2008
• 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:
  US11/117,062
• Publication Number:
  US 20060190051A1
• Time in Patent Office: 1,209 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 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 a processor an operation information from an implantable neurostimulator for delivery of a neurostimulation therapy to manage urinary incontinence, the delivery of the neurostimulation therapy being based on a plurality of stimulation parameters;

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

wirelessly transmitting the sensed information from the sensor to the processor;

selecting, using adaptation logic, at lease one parameter from the plurality of stimulation parameters based on the sensed information and the operation information from the implantable neurostimulator;

determining, in the processor, an adjustment of the at least one parameter;

proposing a modified at least one parameter to a user based, at least in part, on the adjustment of the at least one parameter;

the user choosing a disposition for the modified at least one parameter;

inputting the modified at least one parameter from the processor to the implanted neurostimulator based on the disposition.

2. The method of claim 1, wherein the operation information from the implantable neurostimulator 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.

3. The method of claim 2, 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.

4. 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.

5. The method of claim 4, 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.

6. The method of claim 4, 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.

7. The method of claim 4, wherein the sensed information relates to a physiological state of the patient.

8. The method of claim 7, wherein the sensed information is cardiac activity, respiratory activity, electromyographic activity, or some combination thereof.

9. The method of claim 7, wherein the sensed information detects a posture or activity level of the patient.

10. The method of claim 1, wherein the processor is associated with the at least one sensor.

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

12. The method of claim 1, wherein the sensed information, the operation information from the implantable neurostimulator, or some combination thereof is sent via wireless telemetry.

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

14. The method as in claim 1, wherein the processor is an external processor.

15. A system for delivering therapy to a patient, comprising:

an implantable neurological stimulator, comprising;

a therapy delivery circuit delivering therapy based on a plurality of stimulation parameters;

a memory module storing said plurality of stimulation parameters and an operating information; and

an implantable neurological stimulator wireless telemetry interface operatively coupled to said memory module;

an implantable sensor, comprising;

a sensing element obtaining sensed information related to efficacy of said therapy; and

a sensor wireless telemetry interface operatively coupled to said sensing element; and

a processor receiving said sensed information by way of said sensor wireless telemetry interface and said operating information by way of said implantable neurological stimulator wireless telemetry interface; and

a user interface operatively coupled with said processor;

wherein said processor is configured to select, using adaptation logic, at least one parameter from said plurality of parameters based on said sensed information and said operating information;

wherein the processor is further configured to determine an adjustment of said at least one parameter;

wherein said user interface displays a modified at least one parameter to a user based, at least in part, on said adjustment of said at least one parameter;

wherein said user interface is configured to allow said user to select a disposition for said modified at least one parameter; and

wherein said modified at least one parameter is stored in said memory module based on said disposition.

16. The system as in claim 15:

further comprising an external programmer having an external wireless telemetry interface in wireless communication with said sensor wireless telemetry interface and said implantable stimulator wireless telemetry interface; and

wherein said processor is a component of said external programmer.

17. The system as in claim 15:

wherein said processor is a component of said implantable neurological stimulator, said processor operatively coupled with said implantable neurological stimulator wireless telemetry interface; and

said implantable neurological stimulator wireless telemetry interface operatively coupled with said sensor wireless telemetry interface.

18. The system as in claim 16, wherein said external programmer comprises an external programmer network link operatively coupled to said external wireless telemetry interface and connecting said external programmer to the internet.

19. The system as in claim 18, further comprising a remote monitor, comprising:

a remote network link, operatively coupled via the internet to said external programmer network link;

a server, said server receiving and storing said sensed information by way of said remote network link, adjusting said at least one stimulation parameter based on said sensed information, and storing said at least one stimulation parameter in said memory module.

20. The system as in claim 19:

further comprising a plurality of said remote stations;

wherein each individual one of said plurality of said remote stations is operatively coupled to other individual ones of said plurality of remote stations via said remote network link.

21. The system as in claim 20 wherein individual ones of said plurality of remote stations is operatively coupled to said external programmer via said remote network link.

22. The system as in claim 15, wherein the processor is an external processor.