Systems and methods for making and using a tool for steering a paddle lead of an electrical stimulation system

• US 9,289,601 B2
• Filed: 12/06/2013
• Issued: 03/22/2016
• Est. Priority Date: 12/18/2012
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Lacey, Natalie, Howard, Joshua Dale
• Primary Examiner(s): Tyson, Melanie
• Application Number:
  US14/098,994
• Publication Number:
  US 20140171961A1
• Time in Patent Office: 837 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• 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 kit includes a paddle lead and an insertion kit. The paddle lead includes a stylet lumen defined in a paddle body. The insertion tool includes a stylet channel defined along the insertion tool. A stylet is disposed in the stylet channel and transitions between a refracted position and an extended position. When the stylet is in the retracted position, the stylet is disposed completely within the stylet channel. When the stylet is in the extended position, the stylet extends outwardly from the stylet channel and is insertable into the stylet lumen of the paddle lead. A slide assembly is coupled to the stylet and controls transitioning of the stylet between the retracted position and the extended position.

Claims

1. A paddle lead insertion kit, the paddle lead insertion kit comprising:

a paddle lead comprising

a paddle body having a proximal end,

at least one stylet lumen defined in the paddle body with each stylet lumen having an entrance at the proximal end of the paddle body,

at least two lead bodies, each lead body having a distal end portion and a proximal end portion, wherein the distal end portion of each of the at least two lead bodies is coupled to the paddle body, wherein the entrance of at least one of the at least one stylet lumen is disposed between two of the at least two lead bodies,

a plurality of electrodes disposed on the paddle body,

a plurality of terminals disposed along the proximal end portion of each of the at least two lead bodies, and

a plurality of conductors, each conductor of the plurality of conductors electrically coupling each of the plurality of terminals to at least one of the plurality of electrodes; and

an insertion tool configured and arranged for facilitating insertion of the paddle lead into a patient, the insertion tool comprising

an insertion tool body comprising an insertion end portion, a handling end portion, an outer surface, and a longitudinal length,

a stylet channel extending along the longitudinal length of the insertion tool body from the insertion end portion to the handling end portion,

a stylet at least partially disposed in the stylet channel, the stylet configured and arranged for transitioning between a retracted position and an extended position, the stylet having a first end portion and an opposing second end portion, wherein when the stylet is in the retracted position the first end portion of the stylet is disposed completely within the stylet channel, wherein when the stylet is in the extended position the first end portion of the stylet extends outwardly from a first end of the stylet channel and is configured and arranged for insertion into at least one of the at least one stylet lumen of the paddle lead, and

a slide assembly disposed along the handling end portion of the insertion tool body and coupled to the stylet, the slide assembly configured and arranged to control transitioning of the stylet between the retracted position and the extended position.

2. The paddle lead insertion kit of claim 1, further comprising an insertion tool handle disposed along the handling end portion of the insertion tool body, the insertion tool handle configured and arranged for being held in a hand of a user of the insertion tool.

3. The paddle lead insertion kit of claim 1, wherein the stylet has a rectangular cross-section.

4. The paddle lead insertion kit of claim 1, wherein the first end portion of the stylet has a rectangular cross-section and the second end portion of the stylet has a round cross-section.

5. The paddle lead insertion kit of claim 1, wherein the stylet channel has an oval-shaped cross-section.

6. The paddle lead insertion kit of claim 1, wherein the stylet channel comprises a metal tube.

7. The paddle lead insertion kit of claim 6, wherein the metal tube is laser cut in a spiral configuration to facilitate bending of the metal tube.

8. The paddle lead insertion kit of claim 1, wherein the handling end portion of the insertion tool body has a cross-section that is larger than a cross-section of the insertion tool body at the insertion end portion.

9. The paddle lead insertion kit of claim 1, wherein the insertion tool body comprises at least one curve along the longitudinal length of the insertion tool body.

10. The paddle lead insertion kit of claim 1, wherein the insertion tool body comprises at least two curves, the at least two curves oppositely oriented from one another to form an S-shape along the longitudinal length of the insertion tool body.

11. The paddle lead insertion kit of claim 1, wherein the insertion tool body is configured and arranged for bending by a user of the insertion tool prior to insertion of the first end portion of the stylet into the paddle body.

12. The paddle lead insertion kit of claim 1, wherein the slide assembly comprises

an actuator slit defined along the outer surface of the insertion tool body and extending along at least a portion of the longitudinal length of the insertion tool body;

an actuator handle disposed external to the insertion tool body and over the actuator slit, the actuator handle configured and arranged for moving along the actuator slit; and

an actuator strut extending through the actuator slit and coupling the actuator handle to the second end portion of the stylet;

wherein movement of the actuator handle along the actuator slit causes a corresponding movement of the stylet along the stylet channel.

13. The paddle lead insertion kit of claim 1, wherein the insertion end portion of the insertion tool is configured and arranged to rotate independently from the handling end portion.

14. The paddle lead insertion kit of claim 13, wherein the insertion tool further comprises a rotational actuator configured and arranged for controlling the independent rotation of the handling end portion of the insertion tool.

15. The paddle lead insertion kit of claim 1, wherein the stylet is a first stylet and the stylet channel is a first stylet channel, and wherein the insertion tool further comprises a second stylet that is disposed in a second stylet channel defined in the insertion tool body.

16. The paddle lead insertion kit of claim 15, wherein the slide assembly is a first slide assembly, and wherein the insertion tool further comprises a second slide assembly configured and arranged to control transitioning of the second stylet between the retracted position and the extended position independently from the first stylet.

17. An electrical stimulating system comprising:

the paddle lead insertion kit of claim 1;

a control module coupleable to the paddle lead of the paddle lead insertion kit, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector for receiving the paddle lead, the connector having a proximal end, a distal end, and a longitudinal length, the connector comprising

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

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

18. A method of inserting an electrical stimulation lead into a patient, the method comprising:

providing the paddle lead insertion kit of claim 1;

inserting the first end portion of the stylet of the insertion tool of the paddle lead insertion kit into the stylet lumen defined in the paddle body of the paddle lead of the paddle lead insertion kit;

using the insertion tool to guide the paddle lead to a target stimulation location;

retracting the stylet to remove the stylet from the stylet lumen of the paddle body; and

removing the stylet from the patient.

19. The method of claim 18, wherein retracting the stylet to remove the stylet from the stylet lumen comprises removing the stylet from the stylet lumen of the paddle body without causing corresponding movement of the paddle lead within the patient.

20. The paddle lead insertion kit of claim 1, wherein the paddle body has a lateral width and each of the at least two lead bodies has a lateral diameter, wherein the lateral width of the paddle body is greater than a combination of the lateral diameters of at least two of the at least two lead bodies.