Systems and methods for making and using paddle lead assemblies for electrical stimulation systems

• US 9,061,138 B2
• Filed: 06/02/2014
• Issued: 06/23/2015
• Est. Priority Date: 09/16/2010
• 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
• Primary Examiner(s): PATTON, AMANDA K
• Application Number:
  US14/294,063
• Publication Number:
  US 20140277320A1
• Time in Patent Office: 386 Days
• Field of Search: 607/116, 607/117, 607/148, 607/158
• US Class Current: 1/1
• 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. The paddle body includes tour columns of electrodes, each column including at least one electrode. The columns include two outer columns flanking two inner columns. The paddle lead assembly further includes a plurality of lead bodies coupled to the paddle body. At least one terminal is disposed on each of the plurality of lead bodies. 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 lead comprising:

a paddle body having a longitudinal length;

a plurality of electrodes disposed along the paddle body and arranged into four columns that each comprise at least two electrodes and that each extend along the longitudinal length of the paddle body, wherein the four columns of electrodes includes two outer columns flanking two inner columns;

an extension element having a longitudinal length, a first end, and an opposing second end, the first end of the extension element coupled to the paddle body;

a plurality of lead bodies coupled to the second end of the extension element, the plurality of lead bodies comprising a first lead body and a second lead body;

a plurality of terminals arranged into a plurality of terminal arrays disposed along the plurality of lead bodies, the plurality of terminal arrays comprising a first terminal array disposed along the first lead body and a second terminal array disposed along the second lead body; and

a plurality of conductive wires extending along the longitudinal length of the extension element and coupling the plurality of electrodes to the plurality of terminals, the plurality of conductive wires divided up into a plurality of distinct wire groupings with each of the plurality of distinct wire groupings having different conductive wires of the plurality of conductive wires from the remaining distinct wire groupings, the plurality of distinct groupings comprising a first distinct wire grouping and a second distinct wire grouping, wherein the first distinct grouping is coupled to the first terminal array and the second distinct grouping is coupled to the second terminal array.

2. The paddle lead assembly of claim 1, wherein each of the four columns of electrodes comprises eight electrodes.

3. The paddle lead assembly of claim 1, wherein the number of lead bodies is equal to the number of columns of electrodes.

4. The paddle lead assembly of claim 1, wherein the longitudinal length of the extension element is substantially greater than lengths of each of the plurality of lead bodies.

5. The paddle lead assembly of claim 1, wherein at least one of the plurality of lead bodies has a length that is different from a length of at least one other of the plurality of lead bodies.

6. The paddle lead assembly of claim 1, wherein each lead body of the plurality of lead bodies has a different length from the remaining lead bodies of the plurality of lead bodies.

7. The paddle lead assembly of claim 1, wherein each of the plurality of lead bodies is coupled to at least one adjacent lead body by at least one weakened region configured and arranged to permit manual separation of the coupled lead bodies.

8. The paddle lead assembly of claim 1, wherein a number of distinct wire groupings is equal to a number of columns of electrodes.

9. The paddle lead assembly of claim 1, wherein each terminal array of the plurality of terminal arrays is coupled to a different column of electrodes than the remaining terminal arrays.

10. The paddle lead assembly of claim 1, wherein each distinct wire grouping extending along the extension element is separated from the remaining distinct wire groupings by at least one divider that extends along at least a portion of the longitudinal length of the extension element and that divides at least a portion of the extension element into at least two distinct co-axial regions.

11. The paddle lead assembly of claim 10, wherein the at least two distinct co-axial regions comprise an inner region and an outer region that is concentric to the inner region along the longitudinal length of the extension element.

12. The paddle lead assembly of claim 1, further comprising at least one lead splitter.

13. The paddle lead assembly of claim 12, wherein the at least one lead splitter comprises a splitter connector and at least two splitter lead bodies, and wherein the splitter connector is configured and arranged to receive at least one of the plurality of lead bodies.

14. The paddle lead assembly of claim 1, further comprising a junction disposed at the second end of the at least one extension element, the junction coupling the extension element to each of the plurality of lead bodies.

15. The paddle lead assembly of claim 14, wherein the plurality of lead bodies comprises two lead bodies, and wherein the two lead bodies are coupled to the junction such that the plurality of lead bodies are arranged in a side-by-side configuration.

16. The paddle lead assembly of claim 14, wherein the plurality of lead bodies comprises at least three lead bodies, and wherein the plurality of lead bodies are coupled to the junction such that the plurality of lead bodies are arranged into a single layer in a side-by-side configuration that comprises at least one inner lead body flanked by two outer lead bodies.

17. The paddle lead assembly of claim 16, wherein the electrodes of each of the outer columns are electrically coupled to the terminal arrays disposed along the two outer lead bodies and the electrodes of each of the inner columns are electrically coupled to the at least one terminal array disposed along the at least one inner lead body.

18. The paddle lead assembly of claim 14, wherein the plurality of lead bodies comprises four lead bodies, and wherein the plurality of lead bodies are coupled to the junction such that the plurality of lead bodies are stacked into a plurality of layers, each layer comprising at least two lead bodies arranged in a side-by-side configuration.

19. An electrical stimulating system comprising:

the paddle lead assembly of claim 1;

at least one control module configured and arranged to electrically couple to each of the plurality of lead bodies, each of the at least one control modules comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector configured and arranged for receiving the plurality of lead bodies, the connector comprising

a connector housing defining a plurality of ports configured and arranged for receiving a portion of each of the plurality of lead bodies, and

a plurality of connector contacts disposed in each of the plurality of ports defined by the connector housing, the plurality of connector contacts configured and arranged to couple to the plurality of terminal arrays disposed along the plurality of the lead bodies.

20. The electrical stimulating system of claim 19, further comprising at least one lead extension coupling each of the plurality of lead bodies to the at least one control module.