Systems and methods for making and using paddle leads with adjustable spacing between adjacent electrodes

• US 8,494,654 B2
• Filed: 09/07/2011
• Issued: 07/23/2013
• Est. Priority Date: 09/22/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Pianca, Anne Margaret, Sundaramurthy, Priya
• Primary Examiner(s): STOKLOSA, JOSEPH A
• Application Number:
  US13/226,782
• Publication Number:
  US 20120071936A1
• Time in Patent Office: 685 Days
• Field of Search: 607116-119
• US Class Current: 607/117
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy

Abstract

A paddle lead assembly for providing electrical stimulation of patient tissue includes a paddle body having a proximal end, a distal end, and a longitudinal axis. A plurality of spaced-apart electrodes are disposed on the paddle body. The plurality of spaced-apart electrodes include a first electrode and a second electrode. At least one adjustable region is configured and arranged to adjust a center-to-center distance between the first electrode and the second electrode. At least one lead body is coupled to the paddle body. A plurality of terminals are disposed on the at least one lead body. A plurality of conductive wires couple each of the electrodes to at least one of the plurality of terminals.

Claims

1. A paddle lead assembly for providing electrical stimulation of patient tissue, the paddle lead assembly comprising:

a paddle body having a proximal end, a distal end, a longitudinal axis extending from the proximal end to the distal end of the paddle body, and a transverse axis transverse to the longitudinal axis, the paddle body comprising a major surface, the major surface having a longitudinal length along the longitudinal axis of the paddle body and a transverse width along the transverse axis of the paddle body;

a plurality of spaced-apart electrodes disposed on , and exposed at, the major surface of the paddle body, the plurality of spaced-apart electrodes comprising a first electrode and a second electrode;

at least one first adjustable region configured and arranged to adjust a center-to-center distance between the first electrode and the second electrode while leaving the transverse width of the major surface unchanged;

at least one lead body coupled to the paddle body;

a plurality of terminals disposed on the at least one lead body; and

a plurality of conductive wires coupling each of the plurality of electrodes to at least one of the plurality of terminals.

2. The paddle lead assembly of claim 1, wherein the at least one first adjustable region comprises an expandable region disposed between the first electrode and the second electrode such that longitudinally expanding the expandable region causes a corresponding adjustment of the center-to-center distance between the first electrode and the second electrode.

3. The paddle lead assembly of claim 2, wherein the at least one first expandable region comprises a plurality of pleats coupled together in an accordion-like manner.

4. The paddle lead assembly of claim 1, wherein the at least one first adjustable region comprises a first telescoping element and an interconnected second telescoping element that is at least partially nested within the first telescoping element, wherein the second telescoping element is configured and arranged to longitudinally slide relative to the first telescoping element such that sliding the second telescoping element relative to the first telescoping element causes a corresponding adjustment of the center-to-center distance between the first electrode and the second electrode.

5. The paddle lead assembly of claim 1, wherein the at least one first adjustable region comprises a first elongated member coupled to a first support element and a second elongated member coupled to a second support element, wherein the first electrode is coupled to the first support element and the second electrode is coupled to the second support element, and wherein the first elongated member is slidably-coupled to the second elongated member such that longitudinally sliding the first elongated member relative to the second elongated member causes a corresponding adjustment of the center-to-center distance between the first electrode and the second electrode.

6. The paddle lead assembly of claim 1, wherein the at least one first adjustable region comprises a first plate and a second plate that partially overlaps the first plate, wherein the second plate defines a slot extending along the longitudinal axis of the paddle body, wherein the first plate defines a knob that extends through the slot, wherein the first electrode is disposed on the first plate and the second electrode is disposed on the second plate, and wherein the first plate and the second plate are configured and arranged such that movement of the knob along the axis of the slot causes a corresponding adjustment of the center-to-center spacing between the first electrode and the second electrode.

7. An electrical stimulating system comprising:

the paddle lead assembly of claim 1;

a lead extension having a proximal end and a distal end, wherein the distal end of the lead extension is configured and arranged to electrically couple to the at least one lead body of the paddle lead assembly; and

a control module configured and arranged to electrically couple to the proximal end of the lead extension, the control module comprising

a housing, and

an electronic subassembly disposed in the housing.

8. The paddle lead assembly of claim 1, wherein the at least one first adjustable region is configured and arranged to adjust a longitudinal center-to-center distance between the first electrode and the second electrode along the longitudinal axis of the paddle body.

9. The paddle lead assembly of claim 8, further comprising at least one second adjustable region configured and arranged to adjust a transverse center-to-center distance between the first electrode and the second electrode along the transverse axis of the paddle body.

10. The paddle lead assembly of claim 9, wherein the at least one second adjustable region comprises a first plate and a second plate that partially overlaps the first plate, wherein the second plate defines a slot extending along the transverse axis of the paddle body, wherein the first plate defines a knob that extends through the slot, wherein the first electrode is disposed on the first plate and the second electrode is disposed on the second plate, and wherein the first plate and the second plate are configured and arranged such that movement of the knob along the axis of the slot causes a corresponding adjustment of the transverse center-to-center spacing between the first electrode and the second electrode.

11. The paddle lead assembly of claim 1, wherein the at least one first adjustable region is configured and arranged to adjust a transverse center-to-center distance between the first electrode and the second electrode along the transverse axis of the paddle body.

12. The paddle lead assembly of claim 11, further comprising at least one second adjustable region configured and arranged to adjust a longitudinal center-to-center distance between the first electrode and the second electrode along the longitudinal axis of the paddle body, the at least one second adjustable region comprising a first plate and a second plate that partially overlaps the first plate, wherein the second plate defines a slot extending along the longitudinal axis of the major surface, wherein the first plate defines a knob that extends through the slot, wherein the first electrode is disposed on the first plate and the second electrode is disposed on the second plate, and wherein the first plate and the second plate are configured and arranged such that movement of the knob along the axis of the slot causes a corresponding adjustment of the longitudinal center-to-center spacing between the first electrode and the second electrode.

13. A paddle lead assembly for providing electrical stimulation of patient tissue, the paddle lead assembly comprising:

a paddle lead comprising

a paddle body having a proximal end, a distal end, and a longitudinal axis extending from the proximal end to the distal end of the paddle body, and a transverse axis transverse to the longitudinal axis, the paddle body comprising a major surface, the major surface having a longitudinal length along the longitudinal axis of the paddle body and a transverse width along the transverse axis of the paddle body;

a plurality of spaced-apart electrodes disposed along the major surface of the paddle body, the plurality of spaced-apart electrodes comprising a first electrode and a second electrode

at least one elongated member disposed on the major surface of the paddle body, the at least one elongated member having a first end and a second end opposite to the first end, wherein the first electrode is coupled to the first end of the at least one elongated member and the second electrode is coupled to the second end of the at least one elongated member, wherein the at least one elongated member is formed from at least one shape memory material, and wherein the at least one elongated member is configured and arranged to bend or straighten independently from the paddle lead upon activation by exposure to at least one of heat or current, the bending or straightening of the at least one elongated member causing an adjustment in center-to-center spacing between the first electrode and the second electrode along a first axis,

a plurality of lead bodies coupled to the paddle body,

at least one terminal disposed on each of the plurality of lead bodies, and

a plurality of conductive wires coupling each of the plurality of electrodes to at least one of the plurality of terminals.

14. The paddle lead assembly of claim 13, wherein the plurality of electrodes are arranged into a plurality of rows and a plurality of columns, wherein the plurality of rows of electrodes extend perpendicular to the longitudinal axis of the paddle body and the plurality of columns of electrodes extend parallel to the longitudinal axis of the paddle body.

15. The paddle lead assembly of claim 14, wherein the first electrode and the second electrode are disposed in at least one of the same row of electrodes or the same column of electrodes.

16. The paddle lead assembly of claim 14, further comprising a third electrode, wherein the first electrode and the second electrode are disposed in different rows of electrodes, and wherein the first electrode and the third electrode are both in the same row of electrodes.

17. The paddle lead assembly of claim 16, wherein the paddle body comprises a first plate and a second plate that partially overlaps the first plate, wherein the second plate defines a slot with an axis that is perpendicular to the first axis of the paddle body and the first plate defines a knob that extends through the slot, wherein the first electrode is disposed on the first plate and the third electrode is disposed on the second plate, and wherein the first plate and the second plate are configured and arranged such that movement of the knob along the axis of the slot causes a corresponding adjustment of center-to-center spacing between he first electrode and the third electrode.

18. A paddle lead assembly for providing electrical stimulation of patient tissue, the paddle lead assembly comprising:

a paddle body having a proximal end, a distal end, a longitudinal axis extending from the proximal end to the distal end of the paddle body, and a transverse axis transverse to the longitudinal axis, the paddle body comprising a major surface, the major surface having a longitudinal length along the longitudinal axis of the paddle body and a transverse width along the transverse axis of the paddle body;

a plurality of spaced-apart electrodes disposed on, and exposed at, the major surface of the paddle body, the plurality of spaced-apart electrodes comprising a first electrode and a second electrode;

at least one adjustable region configured and arranged to adjust a center-to-center distance between the first electrode and the second electrode while leaving each of the longitudinal length and the transverse width of the major surface unchanged;

at least one lead body coupled to the paddle body;

a plurality of terminals disposed on the at least one lead body; and

a plurality of conductive wires coupling each of the plurality of electrodes to at least one of the plurality of terminals.

19. The paddle lead assembly of claim 18, wherein the at least one adjustable region is configured and arranged to adjust a transverse center-to-center distance between the first electrode and the second electrode along the transverse axis of the paddle body.

20. The paddle lead assembly of claim 18, wherein the at least one adjustable region is configured and arranged to adjust a longitudinal center-to-center distance between the first electrode and the second electrode along the longitudinal axis of the paddle body.