Systems and methods for making and using electrode configurations for paddle leads

• US 9,162,055 B2
• Filed: 09/02/2011
• Issued: 10/20/2015
• 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, Peterson, David Karl Lee
• Primary Examiner(s): PATTON, AMANDA K
• Application Number:
  US13/224,817
• Publication Number:
  US 20120071948A1
• Time in Patent Office: 1,509 Days
• Field of Search: 607116-117, 607/148, 607/152
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections

Abstract

A paddle lead assembly for providing electrical stimulation of patient tissue includes a paddle body having a longitudinal axis and a lateral axis transverse to the longitudinal axis. The paddle body includes a plurality of electrodes disposed into at least four columns extending parallel with the longitudinal axis. The at least four columns include two lateral columns and at least two medial columns disposed therebetween. The electrodes of the at least two medial columns are arranged into rows aligned along the transverse axis. The electrodes of the two lateral columns are each longitudinally offset from the rows of electrodes of the at least two medial columns. An array of terminals are disposed on each of at least one lead body coupled to the paddle body. A plurality of conductive wires couple each of the electrodes to at least one terminal of the terminal arrays.

Claims

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

a paddle body having a length along a longitudinal axis and a width along a lateral axis transverse to the longitudinal axis, wherein the width of the paddle body is no more than nine millimeters;

a plurality of electrodes, the plurality of electrodes arranged into at least four columns extending parallel with the longitudinal axis of the paddle body, the at least four columns comprising two lateral columns and at least two medial columns disposed therebetween with the two lateral columns flanking the at least two medial columns, wherein the electrodes of the at least two medial columns are arranged into rows aligned along the transverse axis, wherein the electrodes of the two lateral columns are each longitudinally offset from the rows of electrodes of the at least two medial columns, wherein each of the at least four columns of electrodes has an equal number of electrodes, and wherein each of the at least four columns of electrodes comprises at least five electrodes;

a plurality of lead bodies coupled to the paddle body;

an array of terminals disposed on each of the plurality of lead bodies; and

a plurality of conductive wires, each conductive wire coupling one of the electrodes to at least one terminal of at least one of the terminal arrays.

2. Th paddle lead assembly of claim 1, wherein the electrodes of the paddle body are arranged into four columns.

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

4. The paddle lead assembly of claim 1, wherein at least one of the electrodes of each of the at least two medial columns is configured and arranged to function as one of a cathode or an anode.

5. The paddle lead assembly of claim 1, wherein each of the columns of electrodes has equal longitudinal center-to-center spacing between longitudinally-adjacent electrodes.

6. The paddle lead assembly of claim 5, wherein the longitudinal center-to-center spacing between longitudinally-adjacent electrodes is greater than six millimeters.

7. The paddle lead assembly of claim 6, wherein each of the at least hour columns comprises eight electrodes.

8. The paddle lead assembly of claim 1, wherein the plurality electrodes comprises thirty-two electrodes, and wherein a total number of terminals disposed collectively on each of the arrays of terminals is thirty-two terminals.

9. The paddle lead assembly of claim 1, wherein at least two of the plurality of lead bodies are coupled to one another along at least one perforated region.

10. The paddle lead assembly of claim 1, wherein the paddle body has a length along the lateral axis that is no greater than 12millimeters.

11. The paddle lead assembly of claim 1, wherein the plurality of electrodes comprises thirty-two electrodes arranged into four columns each having eight electrodes, and wherein each of the four columns of electrodes has equal longitudinal center-to-center spacing between longitudinally-adjacent electrodes.

12. 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 electrodes, each of he at least one control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector assembly for receiving at least one of the lead bodies, the connector assembly comprising

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

a plurality of connector contacts disposed in the connector housing, the connector contacts configured and arranged to couple to at least one of the plurality of terminals disposed on each of the at least one of the lead bodies.

13. The electrical stimulating system of claim 12, wherein the at least one control module has 32 independently programmable stimulation channels for delivering constant current stimulus pulses.

14. The electrical stimulating system of claim 12, wherein the housing of the at least one control module is programmable to be an anode (ON) or be programmed OFF.

15. The electrical stimulating system of claim 12, wherein the connector is disposed on the control module.

16. The electrical stimulating system of claim 12, further including a lead extension having a distal end and at least one proximal end, the connector disposed on the distal end of the lead extension.

17. The electrical stimulating system of claim 16, wherein at least one of the proximal ends of the lead extension is configured and arranged for insertion into another connector.

18. The electrical stimulating system of claim 12, wherein the paddle lead assembly comprises two lead bodies, each of the two lead bodies having 16 terminals and two lead splitters, wherein each of the two lead splitters comprises two splitter lead bodies, and wherein each of the two lead splitter bodies comprises eight terminals.

19. The electrical stimulating system of claim 12, wherein the paddle lead assembly comprises an intermediate extension element coupling the paddle body to a junction, and wherein the four lead bodies are each coupled to the junction.

20. The electrical stimulating system of claim 19, wherein a plurality of intermediate-extension-element conductors extend along it length of the intermediate extension element, and wherein the intermediate extension element comprises at least one divider extending along the length of the intermediate extension, the at least one divider configured and arranged to separate the plurality of intermediate-extension-element conductors into at least two groupings of intermediate-extension-element conductors.

21. A method for treating middle or upper back pain, the method comprising:

providing the paddle lead assembly of claim 1;

inserting the paddle body of the paddle lead assembly into an epidural space of a patient with at least some of the electrodes disposed in proximity to the thoracic region of the patient'"'"'s spine; and

providing current to at least some of the electrodes from an electrically coupled pulse generator.

22. The method of claim 21, wherein inserting the paddle body of the paddle lead assembly into the epidural space of the patient comprise inserting the paddle body into the epidural space of the patient such that the longitudinal axis of the paddle body aligns with the patient'"'"'s spinal cord.

23. The method of claim 21, wherein providing current to at least some of the electrodes from an electrically coupled pulse generator comprises providing current to at least one of the rows of electrodes disposed in the at least two medial columns such that those electrodes operate as cathodes, and providing current to at least one electrode of each of the lateral columns such that those electrodes operate as anodes, and wherein the electrodes operating as anodes are longitudinally offset along the paddle body from the electrodes operating as cathodes.

24. The method of claim 21, wherein providing current to at least one of the rows of electrodes disposed in the at least two medial columns such that those electrodes operate as cathodes comprises providing current to a first cathode and a second cathode of one of the rows of electrodes such that the first cathode receives a different level of current than the second cathode.

25. The method of claim 21, wherein inserting the paddle body of the paddle lead assembly into the epidural space of the patient with at least some of the electrodes disposed in proximity to the thoracic region of the patient'"'"'s spine comprises inserting the paddle body of the paddle lead assembly into the epidural space of the patient with at least some of the electrodes disposed in proximity to the T8level of the patient'"'"'s spine.