Implantabe trial neurostimulation device

• US 20040215287A1
• Filed: 04/25/2003
• Published: 10/28/2004
• Est. Priority Date: 04/25/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Swoyer, John M., Gerber, Martin T.
• Granted Patent: US 7,065,412 B2
• Time in Patent Office: Days
• US Class Current: 607/48
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/378 Electrical supply
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

The invention provides an implantable trial neurostimulator. The implantable trial neurostimulator may be equipped with limited, short-term battery resources. The limited battery resources are designed to last for a finite period of time, thereby preventing a patient or physician from prolonging the trial neurostimulation period. For example, the implantable trial neurostimulator may be designed to stop functioning after a number of days or weeks, upon exhaustion of the battery resources. Alternatively, the implantable trial neurostimulator may be disabled upon expiration of a timer. The trial neurostimulator may be temporarily implanted in a subdural pocket in which the chronic stimulator is ultimately implanted. In this manner, the trial neurostimulator can be coupled to a chronic lead and avoid any percutaneous connections, reducing the risk of infection and affording greater convenience and comfort to patients.

Claims

1. An implantable trial neurostimulator comprising:

a neurostimulation therapy delivery circuit; and

a battery to deliver power to the circuit, wherein the battery is selected such that the battery is exhausted within a predetermined trial period of time, thereby disabling the circuit.

2. The neurostimulator of claim 1, wherein the battery is selected such that the battery is exhausted within approximately one week of activation of the circuit.

3. The neurostimulator of claim 1, wherein the battery is selected such that the battery is exhausted within approximately one month of activation of the circuit.

4. The neurostimulator of claim 1, wherein the battery is selected such that the battery is exhausted within approximately six months of activation of the circuit.

5. The neurostimulator of claim 1, wherein the battery includes a coin cell battery.

6. The neurostimulator of claim 1, wherein the battery has a power rating of less than or equal to approximately 200 mAh.

7. The neurostimulator of claim 1, wherein the battery has a power rating of less than or equal to approximately 30 mAh.

8. The neurostimulator of claim 1, further comprising a sacral nerve stimulation lead coupled to the circuit.

9. An implantable trial neurostimulator comprising:

a neurostimulation therapy delivery circuit; and

a processor to control the circuit, wherein the processor automatically disables the circuit upon expiration of a trial period of time.

10. The neurostimulator of claim 9, further comprising a timer that indicates the expiration of the trial period of time.

11. The neurostimulator of claim 9, further comprising a battery to power the circuit.

12. The neurostimulator of claim 9, further comprising a telemetry circuit to communicate with a programmer, wherein the telemetry circuit receives an indication of the expiration of the trial period of time from the programmer.

13. The neurostimulator of claim 9, wherein the trial period of time is less than approximately one month.

14. The neurostimulator of claim 9, wherein the trial period of time is less than approximately six months.

15. The neurostimulator of claim 9, further comprising a sacral nerve stimulation lead coupled to the circuit.

16. An implantable trial neurostimulator system comprising:

an implantable neurostimulator including a neurostimulation therapy delivery circuit, and a transcutaneous receiver coil; and

an external power supply including a transcutaneous transmitter coil to deliver power to the circuit via the transcutaneous receiver coil, wherein the power supply automatically terminates the delivery of power by the transcutaneous transmitter coil upon expiration of a trial period of time.

17. The neurostimulator system of claim 16, wherein the power supply includes a timer that indicates the expiration of the trial period of time.

18. The neurostimulator system of claim 16, wherein the trial period of time is less than approximately one month.

19. The neurostimulator system of claim 16, wherein the trial period of time is less than approximately six months.

20. The neurostimulator system of claim 16, further comprising a sacral nerve stimulation lead coupled to the circuit.

21. A method comprising:

implanting a neurostimulation lead in a patient;

implanting a trial neurostimulator in the patient;

coupling the trial neurostimulator to the lead; and

removing the trial neurostimulator from the patient upon expiration of a trial period of time.

22. The method of claim 21, further comprising implanting a chronic neurostimulator in the patient, and coupling the chronic neurostimulator to the lead.

23. The method of claim 22, further comprising implanting the chronic neurostimulator in an implant site used for the implantation of the trial neurostimulator.

24. The method of claim 21, further comprising removing the trial neurostimulator when a battery within the trial neurostimulator is exhausted.

25. The method of claim 21, further comprising removing the trial neurostimulator within approximately one week following the implantation of the trial neurostimulator.

26. The method of claim 21, further comprising removing the trial neurostimulator within approximately one month following the implantation of the trial neurostimulator.

27. The method of claim 21, further comprising removing the trial neurostimulator within approximately six months following the implantation of the trial neurostimulator.

28. The method of claim 21, further comprising remotely disabling the trial neurostimulator upon expiration of the trial period of time.

29. The method of claim 21, further comprising uploading information from the trial neurostimulator, and downloading the information to the chronic neurostimulator.

30. The method of claim 29, wherein the information includes neurostimulation settings.

31. The method of claim 21, further comprising delivering power to the implanted trial neurostimulator transcutaneously, and terminating the delivery of power upon expiration of the trial period of time.

32. The method of claim 21, wherein the lead is a sacral nerve stimulation lead.

33. The method of claim 21, wherein the trial neurostimulator is powered by a battery with a power rating of less than or equal to approximately 200 mAh.

34. The method of claim 21, further comprising implanting a chronic neurostimulator in the patient, removing the lead, replacing the lead with a second lead, and coupling the chronic neurostimulator to the second lead.

35. An implantable trial neurostimulator comprising:

means for delivering neurostimulation therapy to a patient; and

means for automatically disabling the delivery of neurostimulation therapy upon expiration of a trial period of time.

36. The neurostimulator of claim 35, wherein the disabling means includes a battery that power the delivery of neurostimulation therapy, the battery disabling the delivery of neurostimulation therapy upon exhaustion of the battery.

37. The neurostimulator of claim 36, wherein the battery is selected such that the battery is exhausted within approximately one week of activation of the circuit.

38. The neurostimulator of claim 36, wherein the battery is selected such that the battery is exhausted within approximately one month of activation of the circuit.

39. The neurostimulator of claim 36, wherein the battery includes a coin cell battery.

40. The neurostimulator of claim 36, wherein the battery has a power rating of less than or equal to approximately 200 mAh.

41. The neurostimulator of claim 36, wherein the battery has a power rating of less than or equal to approximately 30 mAh.

42. The neurostimulator of claim 35, further comprising a sacral nerve stimulation lead coupled to the circuit.

43. The neurostimulator of claim 35, wherein the disabling means includes a timer that indicates the expiration of the trial period of time, and a controller that disables the neurostimulation therapy in response to the timer.

44. The neurostimulator of claim 35, wherein the disabling means includes a processor to control the delivery of neurostimulation therapy, wherein the processor automatically disables the circuit upon expiration of the trial period of time.

45. The neurostimulator of claim 35, further comprising a telemetry circuit to communicate with a programmer, wherein the telemetry circuit receives an indication of the expiration of the trial period of time from the programmer.

46. The neurostimulator of claim 35, wherein the trial period of time is less than approximately one month.

47. The neurostimulator of claim 35, wherein the trial period of time is less than approximately six months.

48. The neurostimulator of claim 35, further comprising a sacral nerve stimulation lead coupled to the circuit.

49. The neurostimulator of claim 35, further comprising a transcutaneous receiver coil to receive power from an external transcutaneous transmitter coil and power the delivery of neurostimulation therapy, wherein the delivery of power by the transcutaneous transmitter coil is automatically terminated upon expiration of a trial period of time.