Implantable neurostimulator supporting trial and chronic modes

• US 8,768,452 B2
• Filed: 04/28/2005
• Issued: 07/01/2014
• 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:
  US11/116,932
• Publication Number:
  US 20060195152A1
• Time in Patent Office: 3,351 Days
• Field of Search: 607/2, 607/59
• US Class Current: 607/2
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• 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 1/37252 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. An implantable neurostimulator comprising:

a neurostimulation generator;

a processor that controls the neurostimulation generator to generate neurostimulation in a trial mode as a first operating mode upon initial implantation of the neurostimulator and before generation of electrical stimulation in any chronic mode by the neurostimulation generator, to evaluate efficacy of the neurostimulator; and

one or more sensors that sense one or more parameters related to a patient during the trial mode,

wherein the processor controls the neurostimulation generator to generate neurostimulation in the chronic mode after completion of the trial mode and only if the trial mode indicates that the neurostimulator provides efficacious therapy to the patient, wherein the processor controls the neurostimulation generator to generate neurostimulation in the chronic mode according to a set of electrical stimulation parameter values that is different than any sets of electrical stimulation parameter values that define neurostimulation generated during the trial mode.

2. The implantable neurostimulator of claim 1, wherein the processor is configured to operate the neurostimulator in the trial mode for a period of less than six months, and is configured to operate the neurostimulator in the chronic mode for a period of more than six months.

3. The implantable neurostimulator of claim 1, wherein the one or more parameters related to the patient comprise bladder pressure, bladder contractile force, urinary sphincter pressure, urine flow rate, urine flow pressure, voiding amount, urine flow velocity, urine temperature, bladder temperature, impedance, urinary pH, or chemical constituency of the urine.

4. The implantable neurostimulator of claim 1, wherein the one or more parameters related to the patient comprise cardiac activity, respiratory activity, electromyographic activity, a posture or activity level of the patient.

5. The implantable neurostimulator of claim 1, wherein the processor is configured to activate the trial mode in response to a first signal generated by an external programmer and terminate the trial mode in response to a second signal generated by the external programmer.

6. The implantable neurostimulator of claim 1, wherein the processor is configured to activate the trial mode in response to a first signal generated by an external programmer and terminate the trial mode in response to a second signal generated by the implanted neurostimulator.

7. The implantable neurostimulator of claim 1, wherein the processor is configured to control the one or more sensors to sense one or more patient parameters during the chronic mode.

8. The implantable neurostimulator of claim 7, wherein the one or more patient parameters comprise bladder pressure, bladder contractile force, urinary sphincter pressure, urine flow rate, urine flow pressure, voiding amount, urine flow velocity, urine or bladder temperature, impedance, urinary pH, or chemical constituency of the urine.

9. The implantable neurostimulator of claim 7, wherein the one or more patient parameters comprise cardiac activity, respiratory activity, electromyographic activity, posture or activity level of the patient.

10. The implantable neurostimulator of claim 7, wherein the processor is configured to control the one or more sensors to sense one or more patient parameters in the trial mode that are different than the one or more parameters related to the patient sensed during the chronic mode.

11. The implantable neurostimulator of claim 7, wherein the processor is configured to control the one or more sensors to sense one or more patient parameters in the trial mode at a different frequency than the one or more parameters sensed in the chronic mode.

12. The implantable neurostimulator of claim 2, wherein the period includes a plurality of days.

13. The implantable neurostimulator of claim 1, wherein the processor is configured to permit a greater scope of stimulation parameter adjustments by the patient in the chronic mode than in the trial mode.

14. The implantable neurostimulator of claim 1, wherein the neurostimulator includes a lead carrying one or more electrodes for delivery of stimulation pulses, and wherein the neurostimulator is configured to apply neurostimulation for treatment of incontinence, a gastric mobility disorder, pain relief, sexual dysfunction, or interstitial cystitis.

15. The implantable neurostimulator of claim 1, wherein the processor terminates the trial mode upon expiration of a maximum trial period of time.

16. The implantable neurostimulator of claim 1, wherein the processor is configured to unlock one or more features of the neurostimulation generator in the chronic mode not available in the trial mode.

17. The implantable neurostimulator of claim 16, wherein the one or more features comprise at least one of a voiding diary, a different algorithm, or a different stimulation pattern.

18. The implantable neurostimulator of claim 17, wherein the one or more features comprise a different stimulation pattern.

19. An implantable neurostimulator comprising:

a pulse generator;

one or more sensors configured to sense one or more parameters related to a patient;

a memory storing a trial mode program and a chronic mode program that is different than the trial mode program; and

a processor that controls the pulse generator to apply stimulation pulses according to the trial mode program in a first operating mode upon initial implantation of the neurostimulator to evaluate efficacy of the neurostimulator, wherein the first operating mode occurs prior to operation of the neurostimulator in any chronic mode, and apply stimulation pulses according to the chronic mode program as a second mode after completion of the trial mode only if the trial mode indicates that the neurostimulator provides efficacious therapy to the patient, wherein the chronic mode program is different than any sets of electrical stimulation parameter values that define stimulation applied during the trial mode, and controls the one or more sensors to sense one or more patient parameters during the trial mode.

20. The implantable neurostimulator according to claim 19, wherein the processor also controls the one or more sensors during the chronic mode.

21. The implantable neurostimulator according to claim 20, wherein the one or more sensors are controlled differently by the processor during the trial mode and the chronic mode.

22. The implantable neurostimulator of claim 19, wherein the processor terminates the delivery of stimulation according to the trial mode program upon expiration of a maximum trial period of time.

23. An implantable electrical stimulator comprising:

an electrical stimulation generator;

a processor that controls the electrical stimulation generator to generate electrical stimulation in a trial mode as a first mode following implantation of the electrical stimulator and before generation of stimulation in any chronic mode; and

one or more sensors that sense one or more parameters related to a patient during the trial mode,

wherein the processor controls the electrical stimulation generator to generate electrical stimulation in the chronic mode after completion of the trial mode only if the trial mode indicates that the electrical stimulator provides efficacious therapy to the patient, and controls the electrical stimulation generator to generate no electrical stimulation in any chronic mode prior to the generation of electrical stimulation in the trial mode, and wherein the processor controls the electrical stimulation generator to generate electrical stimulation in the chronic mode according to a new program relative to programs that define neurostimulation generated during the trial mode, and

wherein the processor controls the electrical stimulation generator to operate in the trial mode for a trial period, and controls the electrical stimulation generator to stop operating after the trial period until authorization to continue operating is received.

24. The system implantable electrical stimulator of claim 23, wherein the processor controls the electrical stimulation generator to stop generating stimulation according to the trial mode upon expiration of a maximum trial period of time.

25. The implantable electrical stimulator of claim 23, wherein the trial period is prescribed.

26. An implantable neurostimulator comprising:

an electrical stimulation generator; and

a processor that controls the electrical stimulation generator to generate neurostimulation in a trial mode as a first operating mode upon initial implantation of the neurostimulator to evaluate efficacy of the neurostimulator and controls the neurostimulation generator to generate neurostimulation in a chronic mode according to a new program relative to programs that define neurostimulation generated during the trial mode, wherein the processor controls the neurostimulation generator to generate neurostimulation in the chronic mode after completion of the trial mode and only if the trial mode indicates that the neurostimulator provides efficacious therapy to the patient, and wherein the processor controls the electrical stimulation generator to operate in the trial mode for a trial period, and controls the electrical stimulation generator to stop operating after the trial period until authorization to continue operating is received.