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

• US 8,774,941 B2
• Filed: 09/02/2011
• Issued: 07/08/2014
• 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:
  US13/224,681
• Publication Number:
  US 20120071952A1
• Time in Patent Office: 1,040 Days
• Field of Search: 607116- 17, 607/148, 607/152
• 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. The paddle body includes four 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 comprising four columns of electrodes, wherein each of the four columns comprises a plurality of electrodes, wherein the four columns of electrodes includes two outer columns flanking two inner columns;

at least one elongated extension element having a first end and an opposing second end, the first end of the at least one extension element coupled directly to the paddle body;

a plurality of lead bodies coupled to the second end of the least one extension element, wherein the number of lead bodies is equal to the number of columns of electrodes;

a different plurality of terminals disposed on each lead body of the plurality of lead bodies;

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

wherein for each of the different pluralities of terminals, the terminals are electrically coupled to a different column of electrodes of the four columns of electrodes than the terminals of the remaining different pluralities of terminals.

2. 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 at least one extension element to each of the plurality of lead bodies, wherein the plurality of conductive wires extend along the at least one extension element to the junction, wherein the plurality of conductive wires are divided up into a plurality of distinct groupings in the junction, and wherein a different one of the groupings of conductive wires extends along each of the plurality of lead bodies.

3. The paddle lead assembly of claim 2, wherein the plurality of lead bodies couple 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.

4. The paddle lead assembly of claim 2, wherein the plurality of lead bodies couple 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.

5. The paddle lead assembly of claim 4, wherein the at least one electrode of each of the outer columns is electrically coupled to the at least one terminal disposed on the two outer lead bodies and the at least one electrodes of each of the inner columns is electrically coupled to the at least one terminal disposed on each of the two inner lead bodies.

6. The paddle lead assembly of claim 4, 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.

7. The paddle lead assembly of claim 6, wherein the conductive wires extending along the extension element are divided into distinct groupings of conductive wires, and wherein a number of distinctive groupings is equal to a number of different columns of electrodes.

8. The paddle lead assembly of claim 2, wherein each distinct grouping of conductive wires extending along the extension element is separated from the other distinct groupings of conductive wires by one or more dividers extending along a length of the extension element.

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

10. The paddle lead assembly of claim 9, 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.

11. The paddle lead assembly of claim 1, wherein each of the four columns of electrodes comprises eight electrodes and each of the plurality of lead bodies comprises eight terminals.

12. The paddle lead assembly of claim 11, wherein for each of the four columns of electrodes the electrodes are coupled to the terminals of one of the plurality of lead bodies such that a proximal-most electrode is electrically coupled to a proximal-most terminal and a distal-most electrode is electrically coupled to a distal-most terminal.

13. The paddle lead assembly of claim 11, wherein for each of the four columns of electrodes the electrodes are coupled to the terminals of one of the plurality of lead bodies such that a proximal-most electrode is electrically coupled to a distal-most terminal and a distal-most electrode is electrically coupled to a proximal-most terminal.

14. The paddle lead assembly of claim 1, wherein the plurality of lead bodies each has a different length.

15. The paddle lead assembly of claim 1, wherein at least one distinct marker is disposed on or in at least one of the plurality of lead bodies.

16. 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 module comprising

a housing, and

an electronic subassembly disposed in the housing; and

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

a connector housing defining at least one port at a distal end of the connector, the at least one port configured and arranged for receiving a portion of at least one of the plurality of lead bodies, and

at least one connector contact disposed in each of the at least one ports defined by the connector housing, the at least one connector contact configured and arranged to couple to the at least terminal disposed on each of the plurality of the lead bodies.

17. The electrical stimulating system of claim 16, further comprising at least one lead extension coupling each of the plurality of lead bodies to the at least one control module.

18. A method for implanting a paddle lead, the method comprising:

inserting the paddle lead assembly of claim 6 into a patient,

separating the weakened region between a first proximal element and an adjacent second proximal element such that the terminals of the first proximal element are separated from terminals disposed on the second proximal element; and

inserting the terminals of the first proximal element into a connector electrically coupled to an implantable pulse generator.