Implantable neurostimulator supporting trial and chronic modes

• US 8,774,912 B2
• Filed: 04/28/2005
• Issued: 07/08/2014
• 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.
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US11/116,953
• Publication Number:
  US 20060190048A1
• Time in Patent Office: 3,358 Days
• Field of Search: 607/2, 607/59, 607/60
• US Class Current: 607/2
• 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, wherein the neurostimulator comprises a therapy delivery circuit that generates stimulation energy;

operating the neurostimulator in a trial mode as a first operating mode upon initial implantation of the neurostimulator and before operation of the neurostimulator in any chronic mode to evaluate efficacy of the neurostimulator; and

operating the neurostimulator in a chronic mode as a second operating mode after completion of the trial mode only if the trial mode indicates that the neurostimulator provides an acceptable level of therapeutic efficacy, wherein the neurostimulator operates in the chronic mode according to a set of electrical stimulation parameter values that is different than any set of electrical stimulation parameter values that define operation of the neurostimulator in the trial mode.

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 includes 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 the 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 9, further comprising, after activating the trial mode, receiving the second signal from the external programmer.

11. 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.

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

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

14. 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.

15. The method of claim 14, wherein loading the one or more one or more parameters into the memory comprises loading the one or more one or more parameters into the memory after activating the trial mode.

16. 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.

17. 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.

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

19. 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.

20. The method of claim 1, further comprising terminating the trial mode of the neurostimulator upon expiration of a maximum trial period of time.

21. The method of claim 20, wherein the maximum trial period of time includes a plurality of days.

22. The method of claim 1 further comprising sensing one or more parameters related to the patient during the trial mode and sensing one or more different parameters related to the patient during the chronic mode.

23. The method of claim 1 further comprising unlocking one or more features of the neurostimulator in the chronic mode not available in the trial mode.

24. The method of claim 23, wherein the one or more features comprise at least one of a voiding diary, a different algorithm, or a different stimulation pattern.

25. The method of claim 24, wherein the one or more features comprise a different stimulation pattern.

26. A non-transitory computer-readable medium comprising instructions to cause one or more processors to:

operate a neurostimulator in a trial mode as a first operating mode upon initial implantation of the neurostimulator and before operation of the neurostimulator in any chronic mode to evaluate efficacy of the neurostimulator, wherein the neurostimulator comprises a therapy delivery circuit that generates stimulation energy; and

operate the neurostimulator in a chronic mode as a second operating mode after completion of the trial mode only if the trial mode indicates that the neurostimulator provides an acceptable level of therapeutic efficacy, wherein the one or more processors operate the neurostimulator in the chronic mode according to a set of electrical stimulation parameter values that is different than any set of electrical stimulation parameter values that define operation of the neurostimulator in the trial mode.

27. The computer-readable medium of claim 26, wherein the instructions cause the one or more processors to terminate the delivery of stimulation according to the trial mode program upon expiration of a maximum trial period of time.

28. The computer-readable medium of claim 26, wherein the instructions cause the one or more processors to control one or more sensors to sense one or more parameters related to a patient in which the neurostimulator is implanted, wherein the one or more processors control the one or more sensors to sense one or more parameters in the trial mode that are different than one or more parameters sensed during the chronic mode.

29. A method comprising:

implanting a neurostimulator in a patient;

operating the neurostimulator in a trial mode as a first and only operating mode upon initial implantation of the neurostimulator and before operation of the neurostimulator in a chronic mode to evaluate efficacy of the neurostimulator;

controlling the neurostimulator to operate in the trial mode for a trial period, and controlling the neurostimulator to stop operating after the trial period until authorization to continue operating is received; and

operating the neurostimulator in the chronic mode after completion of the trial mode only if the trial mode indicates that the neurostimulator provides efficacious therapy to the patient, wherein the neurostimulator operates in the chronic mode according to a new program relative to programs that define operation of the neurostimulator in the trial mode.

30. The method of claim 29, further comprising controlling the neurostimulator to generate no electrical stimulation in any chronic mode prior to the generation of electrical stimulation in the trial mode.

31. The method of claim 29, further comprising terminating the trial mode of the neurostimulator upon expiration of a maximum trial period of time.

32. The method of claim 29 further comprising sensing one or more parameters related to the patient during the trial mode and sensing one or more different parameters related to the patient during the chronic mode.

33. A method comprising:

operating an electrical stimulation generator to generate stimulation in a trial mode as a first operating mode upon initial implantation of the electrical stimulation generator to evaluate efficacy of the electrical stimulation generator;

controlling the electrical stimulation generator to operate in the trial mode for a trial period, and controlling the electrical stimulation generator to stop operating after the trial period until authorization to continue operating is received; and

operating the electrical stimulation generator to generate stimulation in a chronic mode according to a new program relative to programs that define stimulation generated during the trial mode, wherein the electrical stimulation generator operates to generate stimulation in the chronic mode after completion of the trial mode and only if the trial mode indicates that the electrical stimulation generator provides efficacious therapy to the patient.