Insertion tool for implanting a paddle lead and methods and systems utilizing the tool

• US 9,956,000 B2
• Filed: 12/29/2015
• Issued: 05/01/2018
• Est. Priority Date: 01/13/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Gardanier, Lauren, Howard, Joshua Dale
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US14/982,669
• Publication Number:
  US 20160199096A1
• Time in Patent Office: 854 Days
• Field of Search: 606129
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• 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 insertion tool includes an insertion tool body having a delivery end portion, a delivery end portion, and a slider slit; a slider partially disposed within the slider slit; extenders coupled to the slider and extending to the delivery end portion to receive a paddle body between or upon the extenders; and a center push piece coupled to the slider and disposed between the extenders to push against a proximal end of the paddle body. The slider moves between an insertion position and a delivery position. The insertion tool extends the extenders and center push piece when the slider moves from the insertion position to the delivery position to extend a paddle body received by the insertion tool. The insertion tool retracts the extenders without retracting the center push piece when the slider moves from the delivery position towards the insertion position.

Claims

1. A paddle lead insertion tool, comprising:

an insertion tool body comprising a delivery end portion and a slider slit;

a slider comprising a portion disposed within the slider slit;

a plurality of extenders coupled to the slider and each of the extenders extending to the delivery end portion and configured and arranged to receive a paddle body of a paddle lead between the extenders or upon the extenders; and

a center push piece coupled to the slider and disposed between the extenders and configured and arranged to directly engage and directly push against a proximal end of the paddle body of the paddle lead;

wherein the slider is configured and arranged to move between an insertion position and a delivery position, wherein the insertion tool is configured and arranged to extend the extenders and center push piece when the slider moves from the insertion position to the delivery position to extend the paddle body received by the insertion tool, wherein the insertion tool is further configured and arranged to retract the extenders without retracting the center push piece when the slider moves from the delivery position towards the insertion position.

2. The insertion tool of claim 1, wherein the extenders each comprise a vertical or curved rail configured and arranged to be disposed adjacent sides of the paddle body.

3. The insertion tool of claim 1, wherein the extenders each comprise a horizontal platform configured and arranged to be at least partially disposed beneath a portion of the paddle body.

4. The insertion tool of claim 1, further comprising a crosspiece coupling ends of the extenders.

5. The insertion tool of claim 1, further comprising cabling coupled to the slider and to distal end portions of the extenders and configured and arranged to cooperate with the slider and the extenders for steering the paddle body.

6. The insertion tool of claim 5, wherein the slider comprises a rotatable slider wheel coupled to the cabling and configured and arranged to rotate and pull the distal end portion of one of the extenders for steering the paddle body.

7. The insertion tool of claim 1, wherein the slider is configured and arranged to move along a first direction between the insertion position and the delivery position, wherein the delivery end portion of the insertion tool body comprises a curved delivery ramp configured and arranged to deliver the paddle body received by the insertion tool at an angle, defined between the paddle body and the first direction, in a range of 80 to 100 degrees.

8. The insertion tool of claim 7, wherein the angle is in a range from 85 to 95 degrees.

9. An insertion kit, comprising:

the insertion tool of claim 1; and

a paddle lead comprising a paddle body, at least one lead body extending from the paddle body, a plurality of electrodes disposed on the paddle body, and a plurality of terminals disposed along the at least one lead body and electrically coupled to the electrodes.

10. A method of implanting a paddle lead, the method comprising:

disposing a paddle body of the paddle lead between or upon the extenders of the insertion tool of claim 1;

inserting the insertion tool and paddle body into the patient;

advancing the slider to the delivery position to extend the extenders, the center push piece, and the paddle body toward an implantation site within the patient;

retracting the slider to retract the extenders without retracting the center push piece to deliver the paddle body at the implantation site; and

removing the insertion tool leaving the paddle body at the implantation site.

16. The insertion tool of claim 5, wherein the slider comprises a rotatable slider wheel coupled to the cabling and configured and arranged to rotate and pull the distal end portion of one of the extenders for steering the paddle body.

11. A paddle lead insertion tool, comprising:

an insertion tool body comprising a delivery end portion and a slider slit;

a slider comprising a portion disposed within the slider slit and configured and arranged to move along a first direction between an insertion position and a delivery position, wherein the delivery end portion of the insertion tool body comprises a curved delivery ramp configured and arranged to deliver a paddle body of a paddle lead received by the insertion tool at an angle, defined between the paddle body and the first direction, in a range of 70 to 260 degrees; and

two extenders coupled to the slider and each of the two extenders extending to the delivery end portion and configured and arranged to receive the paddle body of the paddle lead between the two extenders with the two extenders disposed opposite each other along opposing sides of the paddle body;

wherein the slider is configured and arranged to move between an insertion position and a delivery position, wherein the insertion tool is configured and arranged to extend the extenders when the slider moves from the insertion position to the delivery position to extend the paddle body received by the insertion tool, wherein the insertion tool is configured and arranged to retract the extenders when the slider moves from the delivery position towards the insertion position.

12. The insertion tool of claim 11, further comprising a center push piece coupled to the slider and disposed between the extenders and configured and arranged to directly engage and directly push against a proximal end of the paddle body of the paddle lead, wherein the insertion tool is configured and arranged to extend the extenders and center push piece when the slider moves from the insertion position to the delivery position to extend the paddle body received by the insertion tool, wherein the insertion tool is further configured and arranged to retract the extenders without retracting the center push piece when the slider moves from the delivery position towards the insertion position.

13. The insertion tool of claim 11, wherein the angle is in a range from 80 to 100 degrees.

14. The insertion tool of claim 11, wherein the angle is in a range from 85 to 95 degrees.

15. The insertion tool of claim 11, further comprising cabling coupled to the slider and to distal end portions of the extenders and configured and arranged to cooperate with the slider and the extenders for steering the paddle body.

17. The insertion tool of claim 11, wherein the extenders each comprise a vertical or curved rail configured and arranged to be disposed adjacent the opposing sides of the paddle body.

18. The insertion tool of claim 11, wherein the extenders each comprise a horizontal platform configured and arranged to be at least partially disposed beneath a portion of the paddle body.

19. An insertion kit, comprising:

the insertion tool of claim 11; and

a paddle lead comprising a paddle body, at least one lead body extending from the paddle body, a plurality of electrodes disposed on the paddle body, and a plurality of terminals disposed along the at least one lead body and electrically coupled to the electrodes.

20. A method of implanting a paddle lead, the method comprising:

disposing a paddle body of the paddle lead between or upon the extenders of the insertion tool of claim 11;

inserting the insertion tool and paddle body into the patient;

advancing the slider to the delivery position to extend the extenders and the paddle body toward an implantation site within the patient;

retracting the slider to retract the extenders to deliver the paddle body at the implantation site; and

removing the insertion tool leaving the paddle body at the implantation site.