Implantable neurostimulator supporting trial and chronic modes

• US 20060190048A1
• 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.
• Granted Patent: US 8,774,912 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
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data

Abstract

The disclosure is directed to a chronic implantable neurostimulator that supports trial and chronic modes of operation. The implantable neurostimulator can alternatively include one or more sensors that may or may not function differently in trial and chronic modes. In particular, the device is designed to be used as both a trial neurostimulator and a permanent, or chronic, neurostimulator. A trial neurostimulation period is generally desired to evaluate the efficacy of the therapy. A percutaneous or implantable trial neurostimulator is used for the trial neurostimulation period. In most cases, the trial period is successful, in which case the trial stimulator is explanted and replaced with a permanent, i.e., “chronic,” implantable stimulator. In accordance with the disclosure, an implantable neurostimulator supports both trial neurostimulation and chronic neurostimulation in the event trial stimulation is successful. In this manner, the additional surgery ordinarily required for replacement of the trial stimulator can be avoided. Instead, the implanted neurostimulation device remains implanted and is reconfigured to transition from trial stimulation to chronic stimulation.

Claims

1. A method comprising:

implanting a neurostimulator in a patient;

operating the neurostimulator in a trial mode to evaluate efficacy of the neurostimulator; and

operating the neurostimulator in a chronic mode if the trial mode indicates an acceptable level of efficacy.

2. The method of claim 1, further comprising explanting the neurostimulator from the patient if the trial mode does not indicate the acceptable level of efficacy.

3. The method of claim 1, wherein operating the neurostimulator in a trial mode include operating the neurostimulator over a relatively short trial period.

4. The method of claim 1, wherein the trial period is less than six months.

5. The method of claim 1, wherein the trial period is less than one month.

6. The method of claim 1, wherein the trial period is less than one week.

7. The method of claim 1, wherein operating the neurostimulator in a chronic mode includes operating the neurostimulator for more than six months.

8. The method of claim 1, wherein operating the neurostimulator in a chronic mode includes operating the neurostimulator for more than one year.

9. The method of claim 1, further comprising activating the trial mode in response to a first signal generated by an external programmer and terminating the trial mode in response to a second signal generated by the external programmer.

10. The method of claim 1, further comprising activating the trial mode in response to a first signal generated by an external programmer and terminating the trial mode in response to a second signal generated by the implanted neurostimulator.

11. The method of claim 10, wherein the second signal is generated upon expiration of a timer within the implanted neurostimulator.

12. The method of claim 1, further comprising activating the chronic mode in response to a first signal generated by an external programmer.

13. The method of claim 1, further comprising loading one or more parameters into a memory within the implanted neurostimulator from an external programmer to support the chronic mode.

14. The method of claim 1, further comprising selecting one or more parameters in a memory within the implanted neurostimulator in response to a signal generated by an external programmer to support the chronic mode.

15. The method of claim 1, further comprising permitting a greater scope of parameter adjustments by the patient in the chronic mode than in the trial mode.

16. The method of claim 1, wherein the neurostimulator includes a lead carrying one or more electrodes for delivery of stimulation pulses.

17. The method of claim 1, further comprising operating the neurostimulator to apply neurostimulation therapy for treatment of incontinence, a gastric mobility disorder, pain relief, sexual dysfunction, or interstitial cystitis.

18. An implantable neurostimulator configured to perform the method of claim 1.

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

20. An implantable neurostimulator comprising:

a pulse generator;

a memory storing a trial mode program and a chronic mode program; and

a processor that controls the pulse generator to apply stimulation pulses according to either the trial mode program or the chronic mode program.

21. An implantable neurostimulator comprising:

a pulse generator;

at least one sensor;

a memory storing at least a trial mode program; and

a processor that controls the pulse generator to apply stimulation pulses and monitors data from the at least one sensor according to the trial mode program.