MEDICAL DEVICES AND METHODS FOR DELIVERY OF CURRENT-BASED ELECTRICAL STIMULATION THERAPY

• US 20100106231A1
• Filed: 10/14/2009
• Published: 04/29/2010
• Est. Priority Date: 10/28/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Michaels, Matthew J., Torgerson, Nathan A.
• Granted Patent: US 9,987,493 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

A medical electrical stimulator provides selective control of stimulation via a combination of two or more electrodes coupled to respective regulated current paths and one or more electrodes coupled to unregulated current paths. Constant current sources may control the current that is sourced or sunk via respective regulated current paths. An unregulated current path may sink or source current to and from an unregulated voltage source that serves as a reference voltage. Unregulated electrodes may function as unregulated anodes to source current from a reference voltage or unregulated cathodes to sink current to a reference voltage.

Claims

1. A method for delivering electrical stimulation therapy to a patient, the method comprising:

selectively coupling two or more of a plurality of electrodes implanted within the patient to respective regulated current paths to deliver electrical stimulation current to the patient; and

selectively coupling at least another of the plurality of electrodes implanted within the patient to an unregulated current path to deliver the electrical stimulation current to the patient.

2. The method of claim 1, wherein the electrodes are located on one or more leads implanted within the patient.

3. The method of claim 1, wherein coupling comprises:

coupling a first electrode to a first regulated current path to deliver a first amount of the electrical stimulation current;

coupling a second electrode to a second regulated current path to deliver a second amount of the electrical stimulation current; and

coupling a third electrode to the unregulated current path to deliver a third amount of the electrical stimulation current approximately equal to a sum of the first and second amounts of the electrical stimulation current, wherein the unregulated current path is coupled to a reference voltage.

4. The method of claim 3, wherein the first amount of the electrical stimulation current is a first regulated source current, the second amount of the electrical stimulation current is a second regulated source current, and the third amount of the electrical stimulation current is an unregulated sink current that is equal to approximately a sum of the first and second regulated source currents.

5. The method of claim 3, wherein the first amount of the electrical stimulation current is a first regulated sink current, the second amount of the electrical stimulation current is a second regulated sink current, and the third amount of the electrical stimulation current is an unregulated source current that is equal to approximately a sum of the first and second regulated sink currents.

6. The method of claim 3, wherein the first amount of the electrical stimulation current is a regulated source current, the second amount of the electrical stimulation current is a regulated sink current less than the first regulated source current, and the third amount of the electrical stimulation current is an unregulated sink current that is equal to approximately a sum of the regulated source current and the regulated sink current, wherein the unregulated sink current is greater than the regulated sink current.

7. The method of claim 3, wherein the first amount of the electrical stimulation current is a regulated source current, the second amount of the electrical stimulation current is a regulated sink current less than the first regulated source current, and the third amount of the electrical stimulation current is an unregulated sink current that is equal to approximately a sum of the regulated source current and the regulated sink current, wherein the reference voltage required to produce the unregulated sink current is less than another voltage required to produce the regulated sink current.

8. The method of claim 3, wherein the first amount of the electrical stimulation current is a regulated sink current, the second amount of the electrical stimulation current is a regulated source current less than the first regulated sink current, and the third amount of the electrical stimulation current is an unregulated source current that is equal to approximately a sum of the regulated sink current and the regulated source current, wherein the unregulated source current is greater than the regulated source current.

9. The method of claim 3, wherein the first amount of the electrical stimulation current is a regulated sink current, the second amount of the electrical stimulation current is a regulated source current less than the first regulated sink current, and the third amount of the electrical stimulation current is an unregulated source current that is equal to approximately a sum of the regulated sink current and the regulated source current, wherein the reference voltage required to produce the third amount of current is greater than another voltage required to produce the second amount of the electrical stimulation current.

10. The method of claim 3, wherein each of the first regulated current path and the second regulated current path comprises a plurality of parallel regulated current paths, and the unregulated current path comprises a plurality of parallel unregulated current paths.

11. The method of claim 1, wherein coupling comprises:

coupling a first electrode to a first regulated current path;

coupling a second electrode to a second regulated current path;

coupling a third electrode to a first unregulated current path; and

coupling a fourth electrode to a second unregulated current path,

wherein the third and fourth electrodes are positioned between the first and second electrodes along the length of one or more implanted leads.

12. The method of claim 1, wherein coupling comprises:

coupling a first electrode to a first regulated current path;

coupling a second electrode to a second regulated current path;

coupling a third electrode to a first unregulated current path; and

coupling a fourth electrode to a second unregulated current path,

wherein the first and second electrodes are positioned between the third and fourth electrodes along the length of one or more implanted leads.

13. The method of claim 1, wherein coupling two or more of the electrodes to the regulated current paths comprises selectively coupling the respective electrode to regulated current sources or regulated current sinks, and coupling at least another of the electrodes to an unregulated current path comprises selectively coupling the respective electrode to a reference voltage via a switch, wherein the reference voltage comprises a low reference voltage when the unregulated current path sinks current and a high reference voltage when the unregulated current path sources current.

14. The method of claim 1, wherein coupling comprises:

coupling a first electrode to a first regulated current path;

coupling a second electrode to a second regulated current path; and

coupling a third electrode to a third regulated current path.

15. The method of claim 1, further comprising coupling the electrodes to the regulated and unregulated current paths on a selective basis to form different electrode configurations.

16. A device for delivering electrical stimulation therapy to a patient, the device comprising:

a plurality of implantable electrodes;

two or more regulated current paths;

one or more unregulated current paths; and

a stimulation controller that selectively couples two or more of the electrodes to respective ones of the regulated current paths to deliver electrical stimulation current to the patient, and selectively couples at least another of the electrodes to one of the unregulated current paths to deliver the electrical stimulation electrical stimulation current to the patient.

17. The device of claim 16, further comprising one or more implantable leads, wherein at least some of the electrodes are located on the one or more leads.

18. The device of claim 16, wherein the stimulation controller is configured to:

couple a first electrode to a first regulated current path to deliver a first amount of the electrical stimulation current;

couple a second electrode to a second regulated current path to deliver a second amount of the electrical stimulation current; and

couple a third electrode to the unregulated current path to deliver a third amount of the electrical stimulation current approximately equal to a sum of the first and second amounts of the electrical stimulation current, wherein the unregulated current path is coupled to a reference voltage.

19. The device of claim 18, further comprising:

a first regulated current source that sources the first amount of electrical stimulation current via the first regulated current path; and

a second regulated current source that sources the second amount of the electrical stimulation current via the second regulated current path,

wherein the unregulated current path sinks the third amount of the electrical stimulation current to the reference voltage.

20. The device of claim 18, further comprising:

a first regulated current sink that sinks the first amount of electrical stimulation current via the first regulated current path; and

a second regulated current sink that sinks the second amount of the electrical stimulation current via the second regulated current path,

wherein the unregulated current path sources the third amount of the electrical stimulation current from the reference voltage.

21. The device of claim 18, further comprising:

a first regulated current source that sources the first amount of the electrical stimulation current via the first regulated current path; and

a second regulated current sink that sinks the second amount of the electrical stimulation current via the second regulated current path, wherein the second amount of electrical stimulation current is less than the first amount of electrical stimulation current, and

wherein the unregulated current path sinks the third amount of the electrical stimulation current to the reference voltage, and wherein the third amount of the electrical stimulation current is greater than the second amount of the electrical stimulation current.

22. The device of claim 18, further comprising:

a first regulated current source that sources the first amount of the electrical stimulation current via the first regulated current path; and

a second regulated current sink that sinks the second amount of the electrical stimulation current via the second regulated current path, wherein the second amount of electrical stimulation current is less than the first amount of electrical stimulation current, and

wherein the unregulated current path sinks the third amount of the electrical stimulation current to the reference voltage, and wherein the reference voltage required to produce the unregulated sink current is less than another voltage required to produce the regulated sink current.

23. The device of claim 18, further comprising:

a first regulated current sink that sinks the first amount of the electrical stimulation current via the first regulated current path; and

a second regulated current source that sources the second amount of the electrical stimulation current via the second regulated current path, wherein the second amount of electrical stimulation current is less than the first amount of electrical stimulation current, and

wherein unregulated current path sources the third amount of the electrical stimulation current from the reference voltage, and the third amount of the electrical stimulation current is greater than the second amount of the electrical stimulation current.

24. The device of claim 18, further comprising:

a first regulated current sink that sinks the first amount of the electrical stimulation current via the first regulated current path; and

a second regulated current source that sources the second amount of the electrical stimulation current via the second regulated current path, wherein the second amount of electrical stimulation current is less than the first amount of electrical stimulation current, and

wherein unregulated current path sources the third amount of the electrical stimulation current from the reference voltage, and wherein reference voltage required to produce the third amount of the electrical stimulation current is greater than another voltage required to produce the second amount of the electrical stimulation current.

25. The device of claim 18, wherein each of the first regulated current path and the second regulated current path comprises a plurality of parallel regulated current paths, and the unregulated current path comprises a plurality of parallel unregulated current paths.

26. The device of claim 16, wherein the electrodes comprise:

a first electrode coupled to a first regulated current path;

a second electrode coupled to a second regulated current path;

a third electrode coupled to a first unregulated current path; and

a fourth electrode coupled to a second unregulated current path,

wherein the third and fourth electrodes are positioned between the first and second electrodes along the length of one or more implantable leads.

27. The device of claim 16, wherein the electrodes comprise:

a first electrode coupled to a first regulated current path;

a second electrode coupled to a second regulated current path;

a third electrode coupled to a first unregulated current path; and

a fourth electrode coupled to a second unregulated current path,

wherein the first and second electrodes are positioned between the third and fourth electrodes along the length of one or more implantable leads.

28. The device of claim 16, wherein the stimulation controller is configured to selectively couple two or more of the electrodes to the regulated current paths via regulated current sources or regulated current sinks, and couple at least another of the electrodes to the unregulated current path via a reference voltage and a switch, wherein the reference voltage comprises a low reference voltage when the unregulated current path sinks current and a high reference voltage when the unregulated current path sources current.

29. The device of claim 16, wherein the stimulation controller is configured to couple one of the electrodes to a first regulated current path, a second one of the electrodes to a second regulated current path, and a third one of the electrodes to a third regulated current path.

30. The device of claim 16, wherein the stimulation controller is configured to selectively couple the electrodes to the regulated and unregulated current paths on a selective basis to form different electrode configurations.

31. A device for delivering electrical stimulation therapy to a patient, the device comprising:

means for selectively coupling two or more of a plurality of implantable electrodes to respective regulated current paths to deliver electrical stimulation current to the patient; and

means for selectively coupling at least another of the plurality of implantable electrodes to an unregulated current path to deliver the electrical stimulation current to the patient.

32. The device of claim 31, further comprising one or more implantable leads, wherein at least some of the electrodes are located on the one or more leads.

33. The device of claim 31, wherein the means for coupling comprise:

means for coupling a first electrode to a first regulated current path to deliver a first amount of the electrical stimulation current;

means for coupling a second electrode to a second regulated current path to deliver a second amount of the electrical stimulation current; and

means for coupling a third electrode to the unregulated current path to deliver a third amount of the electrical stimulation current approximately equal to a sum of the first and second amounts of the electrical stimulation current, wherein the unregulated current path is coupled to a reference voltage.

34. The device of claim 33, wherein the first amount of the electrical stimulation current is a first regulated source current, the second amount of the electrical stimulation current is a second regulated source current, and the third amount of the electrical stimulation current is an unregulated sink current that is equal to approximately a sum of the first and second regulated source currents.

35. The device of claim 33, wherein the first amount of the electrical stimulation current is a first regulated sink current, the second amount of the electrical stimulation current is a second regulated sink current, and the third amount of the electrical stimulation current is an unregulated source current that is equal to approximately a sum of the first and second regulated sink currents.

36. The device of claim 33, wherein the first amount of the electrical stimulation current is a regulated source current, the second amount of the electrical stimulation current is a regulated sink current less than the first regulated source current, and the third amount of the electrical stimulation current is an unregulated sink current that is equal to approximately a sum of the regulated source current and the regulated sink current, wherein the unregulated sink current is greater than the regulated sink current.

37. The device of claim 33, wherein the first amount of the electrical stimulation current is a regulated source current, the second amount of the electrical stimulation current is a regulated sink current less than the first regulated source current, and the third amount of the electrical stimulation current is an unregulated sink current that is equal to approximately a sum of the regulated source current and the regulated sink current, wherein the reference voltage required to produce the unregulated sink current is less than another voltage required to produce the regulated sink current.

38. The device of claim 31, wherein the means for coupling two or more of the electrodes to respective regulated current paths comprises:

means for coupling a first electrode to a first regulated current path to deliver a first amount of the electrical stimulation current;

means for coupling a second electrode to a second regulated current path to deliver a second amount of the electrical stimulation current; and

means for coupling a third electrode to a third regulated current path to deliver a third amount of the electrical stimulation current.

39. The device of claim 38, wherein the first amount of the electrical stimulation current is a regulated sink current, the second amount of the electrical stimulation current is a regulated source current less than the first regulated sink current, and the third amount of the electrical stimulation current is an unregulated source current that is equal to approximately a sum of the regulated sink current and the regulated source current, wherein the unregulated source current is greater than the regulated source current.

40. The device of claim 38, wherein the first amount of the electrical stimulation current is a regulated sink current, the second amount of the electrical stimulation current is a regulated source current less than the first regulated sink current, and the third amount of the electrical stimulation current is an unregulated source current that is equal to approximately a sum of the regulated sink current and the regulated source current, wherein the reference voltage required to produce the unregulated sink current is less than another voltage required to produce the regulated sink current.

41. A device for programming a medical electrical stimulator to deliver electrical stimulation therapy to a patient, the device comprising:

a user interface configured to receive programming information from a user;

a processor configured to define electrical stimulation programs based at least in part on the programming information; and

a communication interface configured to communicate the programs to the medical electrical stimulator,

wherein at least some of the electrical stimulation programs cause the medical electrical stimulator to generate electrical stimulation current for delivery to the patient via implantable, selectively couple two or more of the electrodes to respective regulated current paths, and selectively couple at least another of the electrodes to an unregulated current path to deliver the electrical stimulation current to the patient.

42. The device of claim 41, wherein at least some of the electrodes are located on one or more implantable leads.

43. The device of claim 41, wherein at least some of the electrical stimulation programs cause the electrical stimulator to couple a first electrode to a first regulated current path to deliver a first amount of the electrical stimulation current, couple a second electrode to a second regulated current path to deliver a second amount of the electrical stimulation current, and couple a third electrode to the unregulated current path to deliver a third amount of the electrical stimulation current approximately equal to a sum of the first and second amounts of the electrical stimulation current, wherein the unregulated current path is coupled to a reference voltage.

44. The device of claim 43, wherein the programming information includes information defining a first amount of electrical stimulation current delivered by a first electrode, a second amount of electrical stimulation current delivered by a second electrode, and a third amount of electrical stimulation current delivered by a third electrode, and the processor is configured to define, based on the programming information, an electrical stimulation program that causes the medical electrical stimulator to couple the first electrode to the first regulated current path, the second electrode to the second regulated current path, and the third electrode to the unregulated current path.

45. A computer-readable storage medium comprising instructions that, when executed by a processor, cause the processor to:

selectively couple two or more of a plurality of electrodes implanted within the patient to respective regulated current paths to deliver electrical stimulation current to the patient; and

selectively couple at least another of the plurality of electrodes implanted within the patient to an unregulated current path to deliver the electrical stimulation current to the patient.

46. The computer-readable storage medium of claim 45, wherein the electrodes are located on one or more leads implanted within the patient.

47. The computer-readable storage medium of claim 45, wherein the instructions that, when executed by the processor, cause the processor to couple further comprise instructions that, when executed by the processor, cause the process to:

couple a first electrode to a first regulated current path to deliver a first amount of the electrical stimulation current;

couple a second electrode to a second regulated current path to deliver a second amount of the electrical stimulation current; and

couple a third electrode to the unregulated current path to deliver a third amount of the electrical stimulation current approximately equal to a sum of the first and second amounts of the electrical stimulation current, wherein the unregulated current path is coupled to a reference voltage.

48. The computer-readable storage medium of claim 47, wherein the first amount of the electrical stimulation current is a first regulated source current, the second amount of the electrical stimulation current is a second regulated source current, and the third amount of the electrical stimulation current is an unregulated sink current that is equal to approximately a sum of the first and second regulated source currents.

49. The computer-readable storage medium of claim 47, wherein the first amount of the electrical stimulation current is a first regulated sink current, the second amount of the electrical stimulation current is a second regulated sink current, and the third amount of the electrical stimulation current is an unregulated source current that is equal to approximately a sum of the first and second regulated sink currents.

50. The computer-readable storage medium of claim 47, wherein the first amount of the electrical stimulation current is a regulated source current, the second amount of the electrical stimulation current is a regulated sink current less than the first regulated source current, and the third amount of the electrical stimulation current is an unregulated sink current that is equal to approximately a sum of the regulated source current and the regulated sink current, wherein the unregulated sink current is greater than the regulated sink current.

51. The computer-readable storage medium of claim 47, wherein the first amount of the electrical stimulation current is a regulated source current, the second amount of the electrical stimulation current is a regulated sink current less than the first regulated source current, and the third amount of the electrical stimulation current is an unregulated sink current that is equal to approximately a sum of the regulated source current and the regulated sink current, wherein the reference voltage required to produce the unregulated sink current is less than another voltage required to produce the regulated sink current.

52. The computer-readable storage medium of claim 47, wherein the first amount of the electrical stimulation current is a regulated sink current, the second amount of the electrical stimulation current is a regulated source current less than the first regulated sink current, and the third amount of the electrical stimulation current is an unregulated source current that is equal to approximately a sum of the regulated sink current and the regulated source current, wherein the unregulated source current is greater than the regulated source current.

53. The computer-readable storage medium of claim 47, wherein the first amount of the electrical stimulation current is a regulated sink current, the second amount of the electrical stimulation current is a regulated source current less than the first regulated sink current, and the third amount of the electrical stimulation current is an unregulated source current that is equal to approximately a sum of the regulated sink current and the regulated source current, wherein the reference voltage required to produce the third amount of current is greater than another voltage required to produce the second amount of the electrical stimulation current.

54. The computer-readable storage medium of claim 47, wherein each of the first regulated current path and the second regulated current path comprises a plurality of parallel regulated current paths, and the unregulated current path comprises a plurality of parallel unregulated current paths.

55. The computer-readable storage medium of claim 45, wherein the instructions that, when executed by the processor, cause the processor to couple further comprise instructions that, when executed by the processor, cause the process to:

couple a first electrode to a first regulated current path;

couple a second electrode to a second regulated current path;

couple a third electrode to a first unregulated current path; and

couple a fourth electrode to a second unregulated current path,

wherein the third and fourth electrodes are positioned between the first and second electrodes along the length of one or more implanted leads.

56. The computer-readable storage medium of claim 45, wherein the instructions that, when executed by the processor, cause the processor to couple further comprise instructions that, when executed by the processor, cause the process to:

couple a first electrode to a first regulated current path;

couple a second electrode to a second regulated current path;

couple a third electrode to a first unregulated current path; and

couple a fourth electrode to a second unregulated current path,

wherein the first and second electrodes are positioned between the third and fourth electrodes along the length of one or more implanted leads.

57. The computer-readable storage medium of claim 45, wherein the instructions that, when executed by the processor, cause the processor to couple two or more of the electrodes to the regulated current paths further comprise instructions that, when executed by the processor, cause the processor to selectively couple the respective electrode to regulated current sources or regulated current sinks, and

wherein the instructions that, when executed by the processor, cause the processor to couple at least another of the electrodes to an unregulated current path further comprises instructions that, when executed by the processor, cause the processor to selectively coupling the respective electrode to a reference voltage via a switch, wherein the reference voltage comprises a low reference voltage when the unregulated current path sinks current and a high reference voltage when the unregulated current path sources current.

58. The computer-readable storage medium of claim 45, wherein the instructions that, when executed by the processor, cause the processor to couple further comprise instructions, that when executed by the processor, cause the processor to:

couple a first electrode to a first regulated current path;

couple a second electrode to a second regulated current path; and

couple a third electrode to a third regulated current path.

59. The computer-readable storage medium of claim 45, further comprising instructions that, when executed by the processor, cause the processor to couple the electrodes to the regulated and unregulated current paths on a selective basis to form different electrode configurations.