Tissue stimulation method and apparatus

• US 9,387,318 B2
• Filed: 09/21/2007
• Issued: 07/12/2016
• Est. Priority Date: 09/26/2006
• Status: Active Grant

• Current Assignee: Medtronic Bakken Research Center B.V. (Medtronic Plc)
• Original Assignee: Medtronic Bakken Research Center B.V. (Medtronic Plc)
• Inventors: Martens, Hubert Cecile Francois, Decre, Michel Marcel Jose, Cantatore, Eugenio
• Primary Examiner(s): Moran, Edward
• Assistant Examiner(s): Carey, Michael
• Application Number:
  US12/442,862
• Publication Number:
  US 20100030298A1
• Time in Patent Office: 3,217 Days
• Field of Search: 607115-118, 607/45, 607/139, 607/152
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0472 Structure-related aspects
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation

Abstract

A stimulation apparatus includes a stimulation lead (102), a multiplexer (114), a stimulation signal generator (116), and a signal detector (120). The stimulation lead (102) includes a plurality of stimulation electrodes (112) disposed in an array about a distal portion of the lead body (110). The arrangement of the electrodes (112) facilitates the controlled steering of stimulating electrical field (118) in three dimensions. Four dimensional field steering may also be provided.

Claims

1. An apparatus comprising:

a lead having a longitudinal axis, the lead configured to be inserted in a tissue in a direction substantially parallel to the longitudinal axis; and

a plurality of electrodes carried on a portion of the lead and disposed about the longitudinal axis in a two-dimensional array on the portion of the lead, each electrode having an n-fold rotational symmetry, n being an integer greater than or equal to three, wherein the portion of the lead on which the plurality of electrodes are carried has a substantially constant width along the longitudinal axis, and

wherein a field generated by delivery of electrical stimulation via the electrodes is steerable in three dimensions.

2. The apparatus of claim 1, wherein the two-dimensional array includes a close-packed array.

3. The apparatus of claim 1, wherein n is an integer greater than or equal to six.

4. The apparatus of claim 1, wherein the two-dimensional array includes an irregular array.

5. The apparatus of claim 1 further comprising

a fiducial marker carried by the lead, wherein the fiducial marker identifies a rotational orientation of the lead.

6. The apparatus of claim 5, wherein the fiducial marker is configured to be visible during imaging when the lead is implanted in the tissue.

7. The apparatus of claim 1, wherein the lead includes a substantially circular exterior cross-section and the tissue is neural tissue.

16. The apparatus of claim 1, wherein the electrodes are each hexagonal in shape.

17. The apparatus of claim 1, further comprising a stimulation generator configured to generate the electrical stimulation delivered via the electrodes and a controller configured to control the steering of the field generated by the delivery of the electrical stimulation.

18. The apparatus of claim 17, further comprising an implantable medical device configured to be coupled to the lead, wherein the implantable medical device includes at least one of the stimulation generator or the controller.

19. The apparatus of claim 17, wherein the controller is configured to control the steering of the field by at least applying an electrical stimulus via a first stimulating electrode of the plurality of electrodes to generate an electric field, and varying an electrical stimulus applied to at least first and second shielding electrodes of the plurality of electrodes to vary a distribution of the electric field in three spatial dimensions.

20. The apparatus of claim 1, wherein the lead has a substantially circular cross-section in a plane substantially orthogonal to the longitudinal axis, and wherein the substantially constant width comprises a substantially constant diameter.

26. The apparatus of claim 1, wherein the field is steerable in a temporal dimension.

27. The apparatus of claim 1, wherein the two-dimensional array includes a regular array.

28. The apparatus of claim 5, wherein the fiducial marker includes a rotationally asymmetric portion adapted to engage a stereotactic head frame.

29. The apparatus of claim 1, further comprising means for electrically stimulating the electrodes according to a spatially and temporally varying electrical stimulation scheme.

30. The apparatus of claim 29, wherein the stimulation scheme is longitudinally asymmetric.

31. The apparatus of claim 1, further comprising means for selectively exciting the electrodes according to a unipolar and a bipolar electrical stimulation pattern.

32. The apparatus of claim 1, further comprising a flexible circuit substrate and wherein at least one of said electrodes is carried by the substrate.

33. The apparatus of claim 1 further comprising a flexible monolithic electrical circuit carried by the lead and in operative electrical communication with at least one of said electrodes.

34. The apparatus of claim 1, wherein the array includes first and second longitudinally displaced columns, the first and second columns include a longitudinal pitch, and the first and second columns are offset by a distance which is less than the pitch.

8. A method comprising:

applying an electrical stimulus to a first stimulating electrode of a plurality of electrodes of a lead implanted in tissue to generate an electric field, wherein the plurality of electrodes are carried on a portion of the lead and disposed angularly about a longitudinal axis of the lead, each electrode having an n-fold rotational symmetry, n being an integer greater than or equal to three, wherein the portion of the lead on which the plurality of electrodes are carried has a substantially constant width along the longitudinal axis; and

varying the electrical stimulus applied to at least first and second shielding electrodes to vary a distribution of the electric field in three spatial dimensions.

9. The method of claim 8, wherein the lead carries a fiducial marker which identifies a rotational orientation of the lead and wherein the method further comprises applying the electrical stimulus based on a location of the fiducial marker.

10. The method of claim 8, wherein a proximal portion of the lead carries a fiducial marker which provides at least one of a tactile or visual indication of a rotational orientation of the lead and wherein the method further comprises using the fiducial marker to determine a position of the lead in relation to the tissue.

11. The method of claim 8 further comprising using at least one of the plurality of electrodes to sense a biological signal.

12. The method of claim 8, wherein the tissue is brain tissue.

21. The method of claim 8, wherein the lead has a substantially circular cross-section in a plane substantially orthogonal to the longitudinal axis, and wherein the substantially constant width comprises a substantially constant diameter.

35. The method of claim 8, wherein the lead includes a hexagonally-shaped electrode.

36. The method of claim 35, wherein the electrodes are disposed in a close-packed two dimensional array.

37. The method of claim 8, wherein the electrodes are disposed in a two dimensional array including at least first and second adjacent, longitudinally displaced rows, the first and second rows include an angular spacing, and the first and second rows are angularly offset by a non-zero fraction of the angular array spacing.

38. The method of claim 8, further comprising varying the electrical stimulus applied to at least one of the first and second shielding electrodes to vary a temporal distribution of the electric field.

39. The method of claim 8, further comprising varying an electrical stimulus applied to the plurality of electrodes to generate an electric field which rotates about the longitudinal axis, wherein the electric field exhibits rotational symmetry.

40. The method of claim 8, further comprising determining a rotational orientation of the lead in relation to the tissue and using the determined orientation to select the first stimulating electrode.

13. An apparatus comprising:

a lead having a longitudinal axis, wherein the lead includes a substantially rotationally symmetric exterior cross section; and

a plurality of electrodes carried on a portion of the lead and disposed about the longitudinal axis in a two-dimensional close-packed array on the portion of the lead, each electrode having an n-fold rotational symmetry, n being an integer greater than or equal to three, wherein the portion of the lead on which the plurality of electrodes are carried has a substantially constant width along the longitudinal axis.

14. The apparatus of claim 13 further comprising fiducial marking means for indicating a rotational orientation of the lead.

15. The apparatus of claim 13 further comprising means for determining a location of one of the plurality of electrodes within tissue and selectively applying an electrical stimulus to the electrode based on the determined location.

22. The apparatus of claim 13, further comprising a stimulation generator configured to generate electrical stimulation delivered via the electrodes and a controller configured to control steering of a stimulation field generated by the delivery of the electrical stimulation.

23. The apparatus of claim 22, further comprising an implantable medical device configured to be coupled to the lead, wherein the implantable medical device includes at least one of the stimulation generator or the controller.

24. The apparatus of claim 22, wherein the controller is configured to control the steering of the stimulation field by at least applying an electrical stimulus via a first stimulating electrode of the plurality of electrodes to generate a stimulating electric field, and varying an electrical stimulus applied to at least first and second shielding electrodes of the plurality of electrodes to vary a distribution of the stimulating electric field in three spatial dimensions.

25. The apparatus of claim 13, wherein the lead has a substantially circular cross-section in a plane substantially orthogonal to the longitudinal axis, and wherein the substantially constant width comprises a substantially constant diameter.

41. The apparatus of claim 13, wherein the electrodes are each hexagonal in shape.

42. The apparatus of claim 13, wherein the array includes first and second longitudinally displaced columns, the first and second columns include a longitudinal pitch, and the first and second columns are offset by a distance which is less than the pitch.