Systems and methods for enhancing paddle lead placement

• US 9,402,993 B2
• Filed: 04/04/2012
• Issued: 08/02/2016
• Est. Priority Date: 04/11/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Howard, Joshua Dale, Pianca, Anne Margaret, Pandit, Aditya Vasudeo
• Primary Examiner(s): Wu, Eugene
• Application Number:
  US13/439,077
• Publication Number:
  US 20120259396A1
• Time in Patent Office: 1,581 Days
• Field of Search: 607/116, 607/117, 607/132
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

A paddle lead assembly for providing electrical stimulation of patient tissue includes a paddle body; a plurality of electrodes disposed on the paddle body; 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 couples one of the electrodes to at least one terminal of at least one of the terminal arrays. The paddle lead assembly further includes an implantation aid configured and arranged to fit over a portion of at least one of the lead bodies to provide additional stiffness proximal to the paddle body for aiding in implantation of the paddle body into a patient.

Claims

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

a paddle body;

a plurality of electrodes disposed on the paddle body;

a plurality of lead bodies coupled to the paddle body;

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

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; and

an implantation aid disposed on a portion of at least two of the lead bodies proximate to the paddle body to provide additional stiffness proximal to the paddle body for aiding in implantation of the paddle body into a patient, wherein the implantation aid is removable from the at least two of the lead bodies and the paddle body, wherein a material of the implantation aid has a higher durometer than a material of the paddle body, wherein the implantation aid defines a plurality of lumens, each lumen configured and arranged for fitting over a portion of one of the lead bodies.

2. 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 the 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.

3. A method for stimulating tissue, the method comprising:

providing the paddle lead assembly of claim 1, wherein the implantation aid is fit over a portion of at least one of the lead bodies and disposed proximate to the paddle body to provide additional stiffness proximal to the paddle body for aiding in implantation of the paddle body into a patient;

implanting the paddle body of the paddle lead assembly into tissue a patient such that at least some of the electrodes are disposed in proximity to tissue to be stimulated; and

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

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

a paddle body;

a plurality of electrodes disposed on the paddle body;

a plurality of lead bodies coupled to the paddle body;

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

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; and

an implantation aid disposed on a portion of at least two of the lead bodies proximate to the paddle body to provide additional stiffness proximal to the paddle body for aiding in implantation of the paddle body into a patient, wherein the implantation aid is removable from the at least two of the lead bodies and the paddle body and the implantation aid comprises at least one of the suture feature for suturing the implantation aid to tissue of the patient, wherein the implantation aid defines a plurality of lumens, each lumen configured and arranged for fitting over a portion of one of the lead bodies.

5. The paddle lead assembly of claim 4, wherein the implantation aid comprises an aid body, the aid body comprising a plurality of cylindrical portions and at least one connecting portion, wherein the at least one connecting portion couples the plurality of cylindrical portions together, each of the cylindrical portions defining at least one of the lumens.

6. The paddle lead assembly of claim 4, wherein the implantation aid comprises an aid body and the at least one suture feature comprises at least one suture tab extending from the aid body.

7. The paddle lead assembly of claim 6, wherein the at least one suture tab comprises a first suture tab and a second suture tab, wherein the first and second suture tabs extend from opposite sides of the aid body and from near opposite ends of the aid body.

8. The paddle lead assembly of claim 6, wherein the at least one suture feature further compromises at least one suture groove formed in an exterior of the aid body.

9. The paddle lead assembly of claim 4, wherein the implantation aid comprises an aid body and the at least one suture feature comprises at least one suture groove formed in an exterior of the aid body.

10. The paddle lead assembly of claim 4, wherein the implantation aid is slidable over the lead bodies.

11. The paddle lead assembly of claim 4, wherein the implantation aid and paddle body are both made of silicone or both made of polyurethane.

12. The paddle lead assembly of claim 4, wherein the implantation aid is cylindrical.

13. An electrical stimulating system comprising:

the paddle lead assembly of claim 4;

at least one control module configured and arranged to electrically couple to each of the electrodes, each of the 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.

14. The electrical stimulating system of claim 13, wherein the Connector assembly is disposed on the control module.

15. The electrical stimulating system of claim 13, further including a lead extension having a distal end and at least one proximal end, the connector assembly disposed on the distal end of the lead extension.

16. The electrical stimulating system of claim 15, wherein at least one of the proximal ends of the lead extension is configured and arranged for insertion into another connector.

17. A method for stimulating tissue, the method comprising:

providing the paddle lead assembly of claim 4, wherein the implantation aid is fit over a portion of at least one of the lead bodies and disposed proximate to the paddle body to provide additional stiffness proximal to the paddle body for aiding in implantation of the paddle body into a patient;

implanting the paddle body of the paddle lead assembly into tissue a patient such that at least some of the electrodes are disposed in proximity to tissue to be stimulated; and

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

18. The method of claim 17, further comprising suturing the paddle lead assembly to the tissue of the patient with sutures disposed, at least in part, around the implantation aid.

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

a paddle body;

a plurality of electrodes disposed on the paddle body;

a plurality of lead bodies coupled to the paddle body;

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

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; and

an implantation aid disposed on a portion of at least two of the lead bodies proximate to the paddle body to provide additional stiffness proximal to the paddle body for aiding in implantation of the paddle body into a patient, wherein the implantation aid is removable from the at least two of the lead bodies and the paddle body and the implantation aid comprises an aid body and at least one suture tab extending from the aid body for suturing the implantation aid to tissue of the patient, wherein the at least one suture tab comprises a first suture tab and a second suture tab, wherein the first and second suture tabs extend from opposite sides of the aid body and from near opposite ends of the aid body.