MULTIMODAL NEUROSTIMULATION SYSTEMS AND METHODS

• US 20090149917A1
• Filed: 12/06/2007
• Published: 06/11/2009
• Est. Priority Date: 12/06/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Whitehurst, Todd, Schleicher, Brett D., Carbunaru, Rafael, DiGiore, Andrew, Jaax, Kristen
• Granted Patent: US 9,452,288 B2
• Time in Patent Office: Days
• US Class Current: 607/59
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/3625 External stimulators
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3904 External heart defibrillators [EHD]

Abstract

A system for performing a neurostimulation trial comprises an external trial stimulator capable of delivering stimulation energy to a plurality of electrodes carried by one or more stimulation leads. The external trial stimulator is configurable to operate in a plurality of stimulation energy delivery modes to respectively emulate one of different neurostimulator types. The system may further comprise a programmer capable of configuring the external trial stimulator to operate in one of the stimulation energy delivery modes. The programmer may be capable of generating a first programming screen capable of allowing a first set of stimulation parameters to be defined for the first neurostimulator type, and a second programming screen capable of allowing a second set of stimulation parameters to be defined for a second neurostimulator type.

Claims

1. An external trial stimulator, comprising:

one or more connectors capable of respectively mating with one or more stimulation leads carrying a plurality of electrodes;

a plurality of electrical terminals capable of being electrically coupled to the plurality of electrodes via the one or more connectors;

stimulation circuitry capable of delivering stimulation energy to the plurality of electrical terminals in accordance with a set of stimulation parameters; and

circuitry capable of reconfiguring the stimulation circuitry to selectively emulate different neurostimulator types.

2. The external trial stimulator of claim 1, wherein the one or more connectors comprises a plurality of connectors capable of respectively mating with a plurality of stimulation leads.

3. The external trial stimulator of claim 1, wherein the stimulation parameter set comprises at least one of an electrode combination, a pulse amplitude, a pulse width, a pulse frequency, and a burst pattern.

4. The external trial stimulator of claim 1, wherein the processor is capable of reconfiguring the stimulation circuitry to emulate one of the different neurostimulator types by operating the stimulation circuitry to deliver the stimulation energy to the plurality of electrical terminals at a constant voltage in response to varying impedance at the plurality of electrical terminals, and is capable of reconfiguring the stimulation circuitry to emulate another one of the different neurostimulator types by operating the stimulation circuitry to deliver the stimulation energy to the plurality of electrical terminals at a constant current in response to varying impedance at the plurality of electrical terminals.

5. The external trial stimulator of claim 4, further comprising monitoring circuitry capable of measuring voltage at the plurality of electrical terminals, wherein the stimulation circuitry comprises one or more current sources capable of outputting one or more constant currents to the plurality of electrical terminals, and wherein the processor is capable of operating the stimulation circuitry to deliver the stimulation energy to the plurality of electrical terminals at the constant voltage by varying the one or more current sources as the measured voltage varies.

6. The external trial stimulator of claim 5, wherein the processor is capable of operating the stimulation circuitry to deliver the stimulation energy to the plurality of electrical terminals at the constant current by not varying the one or more constant current sources as the measure voltage varies.

7. The external trial stimulator of claim 6, wherein the one or more current sources comprises a plurality of current sources capable of outputting a plurality of different constant currents to the plurality of electrical terminals.

8. The external trial stimulator of claim 1, wherein the processor is capable of reconfiguring the stimulation circuitry to emulate one of the different neurostimulator types by operating the stimulation circuitry to deliver the stimulation energy at different magnitudes respectively to the plurality of electrical terminals, and is capable of reconfiguring the stimulation circuitry to emulate another one of the different neurostimulator types by operating the stimulation circuitry to deliver the stimulation energy at a single magnitude to the plurality of electrical terminals.

9. The external trial stimulator of claim 1, wherein the processor is capable of reconfiguring the stimulation circuitry to emulate one of the different neurostimulator types by operating the stimulation circuitry to deliver the stimulation energy to the plurality of electrical terminals in accordance with a plurality of stimulation parameter sets, and is capable of reconfiguring the stimulation circuitry to emulate another one of the different neurostimulator types by operating the stimulation circuitry to deliver the stimulation energy to the plurality of electrical terminals in accordance with a single stimulation parameter set.

10. The external trial stimulator of claim 1, wherein the processor is capable of reconfiguring the stimulation circuitry to emulate one of the different neurostimulator types by operating the stimulation circuitry to deliver the stimulation energy between two or more of the plurality of electrical terminals, and is capable of reconfiguring the stimulation circuitry to emulate another one the different neurostimulator types by operating the stimulation circuitry to only deliver the stimulation energy from one or more of the plurality of electrical terminals.

11. The external trial stimulator of claim 1, further comprising memory for storing the stimulation parameter set.

12. The external trial stimulator of claim 1, further comprising telemetry circuitry capable of receiving instructions from a programmer, wherein the processor is capable of reconfiguring the stimulation circuitry to selectively emulate different neurostimulator types in response to the instructions.

13. A system for performing a neurostimulation trial, comprising:

one or more stimulation leads carrying a plurality of electrodes; and

an external trial stimulator capable of delivering stimulation energy to the plurality of electrodes carried by the one or more stimulation leads, wherein the external trial stimulator is configurable to operate in a plurality of stimulation energy delivery modes to respectively emulate one of different neurostimulator types.

14. The system of claim 13, wherein external trial stimulator is capable of delivering stimulation energy to the plurality of electrodes at a constant voltage when reconfigured to operate in a first one of the stimulation energy delivery modes, and is capable of delivering stimulation energy to the plurality of electrodes at a constant current when reconfigured to operate in a second one of the stimulation energy delivery modes.

15. The system of claim 13, wherein external trial stimulator is capable of independently delivering stimulation energy to the plurality of electrodes when reconfigured to operate in a first one of the stimulation energy delivery modes, and is capable of uniformly delivering stimulation energy to the plurality of electrodes when reconfigured to operate in a second one of the stimulation energy delivery modes.

16. The system of claim 13, wherein external trial stimulator is capable of delivering stimulation energy to the plurality of electrodes over multiple channels when reconfigured to operate in a first one of the stimulation energy delivery modes, and is capable of delivering stimulation energy to the plurality of electrodes over a single channel when reconfigured to operate in a second one of the stimulation energy delivery modes.

17. The system of claim 13, wherein external trial stimulator is capable of delivering stimulation energy to the plurality of electrodes in a multipolar manner when reconfigured to operate in a first one of the stimulation energy delivery modes, and is capable of delivering stimulation energy to the plurality of electrodes in a monopolar manner when reconfigured to operate in a second one of the stimulation energy delivery modes.

18. The system of claim 13, further comprising a programmer capable of reconfiguring the external trial stimulator to operate in one of the stimulation energy delivery modes.

19. The system of claim 18, wherein the external trial stimulator is capable of modifying the stimulation energy delivered to the plurality of electrodes during emulation of each of the different implantable neurostimulator types, and wherein the programmer is capable of controlling the modification of the stimulation energy.

20. The system of claim 18, wherein the programmer is capable of performing a therapeutic comparative analysis between the different neurostimulator types based on the emulation of the different neurostimulator types by the external trial stimulator.

21. The system of claim 18, wherein the programmer is capable of wirelessly reconfiguring the external trial stimulator.

22. The system of claim 18, wherein the programmer is capable of reconfiguring the external trial stimulator in response to a user entry.

23. The system of claim 13, wherein the one or more stimulation leads are not directly matable to the external trial stimulator, the system further comprising a lead adapter capable of mating the one or more stimulation leads to the external trial stimulator.

24. The system of claim 13, wherein the external trial stimulator is capable of delivering ablation energy to the plurality of electrodes, and wherein the programmer is capable of initiating delivery of the ablation energy from the external trial stimulator to the plurality of electrodes.

25. A method of performing a neurostimulation trial, comprising:

introducing one or more stimulation leads carrying a plurality of electrodes into a patient;

coupling an external trial stimulator to the one or more stimulation leads;

configuring the external trial stimulator to emulate a first neurostimulator type while delivering stimulation energy from the external trial stimulator to the plurality of electrodes; and

configuring the external trial stimulator to emulate a second neurostimulator type while delivering stimulation energy from the external trial stimulator to the plurality of electrodes.

26. The method of claim 25, wherein the external trial stimulator is operated to deliver the stimulation energy to the plurality of electrodes at a constant voltage to emulate the first neurostimulator type, and is operated to deliver the stimulation energy to the plurality of electrodes at a constant current to emulate the second neurostimulator type.

27. The method of claim 25, wherein the external trial stimulator is operated to independently deliver the stimulation energy to the plurality of electrodes to emulate the first neurostimulator type, and is operated to uniformly deliver the stimulation energy to the plurality of electrodes to emulate the second neurostimulator type.

28. The method of claim 25, wherein the external trial stimulator is operated to deliver the stimulation energy to the plurality of electrodes over a multiple of channels to emulate the first neurostimulator type, and is operated to deliver the stimulation energy to the plurality of electrodes over a single channel to emulate the second neurostimulator type.

29. The method of claim 25, wherein the external trial stimulator is operated to deliver the stimulation energy to the plurality of electrodes in a multipolar manner to emulate the first neurostimulator type, and is operated to deliver the stimulation energy to the plurality of electrodes in a monopolar manner to emulate the second neurostimulator type.

30. The method of claim 25, further comprising modifying the stimulation energy delivered from the external trial stimulator to the plurality of electrodes during emulation of each of the first and second neurostimulator types.

31. The method of claim 25, further comprising performing a therapeutic comparative analysis between the first and second neurostimulator types based on the emulation of the first and second neurostimulator types by the external trial stimulators.

32. The method of claim 31, further comprising:

selecting one of the first and second neurostimulator types based on the therapeutic comparative analysis; and

permanently implanting a neurostimulator corresponding to the selected neurostimulator type into the patient.

33. A computer executable software program stored on a medium, comprising:

a first neurostimulator programming module capable of generating at least a first set of stimulation parameters for use by a first neurostimulator type;

a second neurostimulator programming module capable of generating at least a second set of stimulation parameters for use by a second neurostimulator type; and

a therapeutic device selection module configured for selecting one of the first and second neurostimulator programming modules in response to a user input.

34. The software program of claim 33, wherein the at least first stimulation parameter set defines a stimulation current value of at least one electrode, and the at least second stimulation parameter set defines a stimulation voltage value for at least one electrode.

35. The software program of claim 33, wherein the first stimulation parameter set defines independent stimulation amplitude values for a plurality of electrodes, and the second stimulation parameter set defines a single stimulation amplitude value for a plurality of electrodes.

36. The software program of claim 33, wherein the at least first stimulation parameter set defines multiple channels for a plurality of electrodes, and wherein the at least second stimulation parameter set defines a single channel for a plurality of electrodes.

37. The software program of claim 33, wherein the at least first stimulation parameter set defines a multipolar electrode configuration, and the at least second stimulation parameter set defines a monopolar electrode configuration.

38. The software program of claim 33, wherein the first and second neurostimulator programming modules are capable of generating the first and second stimulation parameter sets in response to user inputs.

39. The software program of claim 33, wherein the first and second neurostimulator programming modules are capable of generating the first and second stimulation parameter sets in accordance with user-defined inputs.

40. The software program of claim 33, further comprising a comparative therapeutic analysis module capable of performing a therapeutic comparative analysis between the first and second neurostimulator types based on stimulation energy delivered to a patient by the first and second neurostimulator types in accordance with the respective first and second stimulation parameter sets.

41. The software program of claim 33, further comprising a therapeutic ablation module capable of generating a set of ablation parameters for use by an ablation device, wherein the therapeutic device selection module is capable of selecting the therapeutic ablation module in response to another user input.

42. The software program of claim 33, further comprising a drug pump programming module capable of generating a set of drug delivery parameters for use by an implantable drug pump, wherein the therapeutic device selection module is capable of selecting the drug pump programming module in response to another user input.

43. A programmer for multimodal neurostimulator, comprising:

a user interface having a display and an input device;

a processor capable of generating a first programming screen for a first neurostimulator type for display on the monitor, and generating a second programming screen for a second neurostimulator type for display on the monitor;

wherein the first programming screen is capable of allowing a first set of stimulation parameters to be defined via the input device for the first neurostimulator type, and the second programming screen is capable of allowing a second set of stimulation parameters to be defined for the second neurostimulator type; and

output circuitry for transmitting the first and second stimulation parameter sets.

44. The programmer of claim 43, wherein the first programming screen only allows a stimulation current value to be defined via the input device for the first neurostimulator type, and the second programming screen only allows a stimulation voltage value to be defined via the input device for the second neurostimulator type.

45. The programmer of claim 43, wherein the first programming screen allows stimulation amplitude values to be independently defined via the input device for the first neurostimulator type, and the second programming screen only allows a stimulation amplitude value to be uniformly defined via the input device for the second neurostimulator type.

46. The programmer of claim 43, wherein the first programming screen allows multiple channels to be defined via the input device for the first neurostimulator type, and the second programming screen only allows a single channel to be defined via the input device for the second neurostimulator type.

47. The programmer of claim 43, wherein the first programming screen allows a multipolar configuration to be defined via the input device for the first neurostimulator type, and the second programming screen only allows a monopolar configuration to be defined via the input device for the second neurostimulator type.

48. The programmer of claim 43, wherein the processor is capable of generating a therapeutic ablation screen for display on the monitor, and wherein the therapeutic ablation screen allows a set of ablation parameters to be defined via the input device for an ablation device.

49. The programmer of claim 43, wherein the processor is capable of generating a drug delivery programming screen for display on the monitor, and wherein drug delivery programming screen allows a set of drug delivery parameters to be defined via the input device for a drug delivery device.

50. The programmer of claim 43, wherein the output circuitry comprises telemetry circuitry.