Insertion tool for paddle-style electrode

• US 8,606,367 B2
• Filed: 06/28/2012
• Issued: 12/10/2013
• Est. Priority Date: 04/30/2004
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Pianca, Anne M., Kuzma, Janusz A., Thenuwara, Chuladatta
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US13/536,561
• Publication Number:
  US 20120271316A1
• Time in Patent Office: 530 Days
• Field of Search: 607/116, 607/117
• US Class Current: 607/117
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy

Abstract

The present disclosure describes various embodiments of an insertion tool that affords steerability of the paddle-style electrode during implantation without causing damage to the insulation and/or the contacts of the paddle-style electrode. One embodiment is described as having a “pin fork” configuration; another a “shovel” configuration; and yet another has tabs or a lumen on the paddle-style electrode for facilitating the insertion of a stylet. The various embodiments for the insertion tool allow for adjustments of the paddle-style electrode in both the medial/lateral and inferior/superior directions allowing the surgeon to steer the paddle-style electrode to the desired stimulation site within the epidural space of the spinal column.

Claims

1. A system for implanting a paddle-style electrode in a patient without an insertion needle, the system comprising:

a lead comprising

a paddle-style electrode platform including a distal end, a proximal end, a proximal edge, a back surface, an active surface opposite the back surface, a proximal portion of the electrode platform adjacent the proximal edge of the platform, and a plurality of electrode contacts formed in two or more columns and disposed on the active surface, and

a plurality of conductive wires coupled to the plurality of electrode contacts and extending away from the electrode contacts and out of the proximal end of the paddle-style electrode platform; and

an insertion tool to implant the paddle-style electrode platform in the patient without using an insertion needle, the insertion tool including a platform engager comprising a carrier configured and arranged to hold, within the carrier, the proximal portion of the electrode platform to guide the electrode platform during placement of the electrode platform in the patient,

wherein the electrode platform further comprises opposing side surfaces between the active surface and the back surface and extending from the proximal end to the distal end of the electrode platform, wherein the carrier is configured and arranged to, when engaging the electrode platform, extend around the electrode platform from the active surface across at least one of the opposing sides surfaces to the back surface.

2. The system of claim 1, wherein the electrode platform comprises a ridge spaced from the proximal edge of the electrode platform.

3. The system of claim 2, wherein the ridge is disposed on the back surface of the electrode platform.

4. The system of claim 2 wherein the ridge is disposed on the electrode platform closer to the proximal edge than all of the electrode contacts.

5. The system of claim 2, wherein each of the electrodes contacts is coupled to an individual one of the plurality of conductive wires.

6. The system of claim 1, wherein the insertion tool comprises a handle from which the carrier extends.

7. A method of using the system of claim 1 to implant the paddle-style electrode platform in a patient without using an insertion needle, the method comprising:

locating a stimulation site in a patient;

making an incision proximal the stimulation site;

engaging the electrode platform with the insertion tool, wherein engaging the electrode platform with the insertion tool comprises inserting a portion of the electrode platform into the carrier of the insertion tool so that the carrier extends around the portion of the electrode platform from the active surface across at least one of the opposing side surfaces to the back surface;

inserting the insertion tool and electrode platform through the incision without using an insertion needle;

locating an electrode positioning space within the stimulation site;

with the insertion tool, positioning the electrode platform in the positioning space within the stimulation site;

releasing the insertion tool from the electrode platform; and

removing the insertion tool from the patient.

8. A system for implanting a paddle-style electrode in a patient without an insertion needle, the system comprising:

a lead comprising

a paddle-style electrode platform including a distal end, a proximal end, a proximal edge, a back surface, an active surface opposite the back surface, a proximal portion of the electrode platform adjacent the proximal edge of the platform, and a plurality of electrode contacts formed in two or more columns and disposed on the active surface, and

a plurality of conductive wires coupled to the plurality of electrode contacts and extending away from the electrode contacts and out of the proximal end of the paddle-style electrode platform; and

an insertion tool to implant the paddle-style electrode platform in the patient without using an insertion needle, the insertion tool including a platform engager comprising a carrier configured and arranged to hold, within the carrier, the proximal portion of the electrode platform to guide the electrode platform during placement of the electrode platform in the patient,

wherein the electrode platform further comprises opposing side surfaces between the active surface and the back surface and extending from the proximal end to the distal end of the electrode platform, wherein the carrier comprises two arms that are each configured and arranged to, when the carrier engages the electrode platform, wrap around a portion of the electrode platform across one of the opposing side surfaces.

9. The system of claim 8, wherein the carrier comprises a central portion from which the two arms extend.

10. The system of claim 9, wherein the central portion is configured and arranged to receive a portion of the active surface of the electrode platform with the two arms wrapping around the electrode platform across the one of the opposing side surfaces to the back surface of the electrode platform.

11. The system of claim 9, wherein the central portion is configured and arranged to receive a portion of the back surface of the electrode platform with the two arms wrapping around the electrode platform across the one of the opposing side surfaces to the active surface of the electrode platform.

12. A method of using the system of claim 8 to implant the paddle-style electrode platform in a patient without using an insertion needle, the method comprising:

locating a stimulation site in a patient;

making an incision proximal the stimulation site;

engaging the electrode platform with the insertion tool, wherein engaging the electrode platform with the insertion tool comprises inserting the electrode platform into the carrier of the insertion tool so that each of he arms of the carrier wraps around a portion of the electrode platform across a one of the opposing side surfaces;

inserting the insertion tool and electrode platform through the incision without using an insertion needle;

locating an electrode positioning space within the stimulation site;

with the insertion tool, positioning the electrode platform in the positioning space within the stimulation site;

releasing the insertion tool from the electrode platform; and

removing the insertion tool from the patient.

13. The method of claim 12, wherein the carrier comprises a central portion from which the two arms extend and engaging the electrode platform with the insertion tool comprises inserting the electrode platform into the carrier of the insertion tool so that the central portion receives a portion of the active surface of the electrode platform with the two arms wrapping around the electrode platform across the one of the opposing side surfaces to the back surface of the electrode platform.

14. The method of claim 12, wherein the carrier comprises a central portion from which the two arms extend and engaging the electrode platform with the insertion tool comprises inserting the electrode platform into the carrier of the insertion tool so that the central portion receives a portion of the back surface of the electrode platform with the two arms wrapping around the electrode platform across the one of the opposing side surfaces to the active surface of the electrode platform.

15. A system for implanting a paddle-style electrode in a patient without insertion needle, the system comprising:

a lead comprising

a paddle-style electrode platform including a distal end, a proximal end, a proximal edge, a back surface, an active surface opposite the back surface, a proximal portion of the electrode platform adjacent the proximal edge of the platform, and a plurality of electrode contacts formed in two or more columns and disposed on e active surface, wherein the electrode platform comprises a ridge spaced from the proximal edge of the electrode platform, and

a plurality of conductive wires coupled to the plurality of electrode contacts and extending away from the electrode contacts and out of the proximal end of the paddle-style electrode platform; and

an insertion tool to implant the paddle-style electrode platform in the patient without using an insertion needle, the insertion tool including a platform engager comprising a carrier configured and arranged to hold, within the carrier, the proximal portion of the electrode platform to guide the electrode platform during placement of the electrode platform in the patient,

wherein the ridge is configured and arranged to limit insertion of the electrode platform into the carrier of the insertion tool to prevent contact between the insertion tool and the electrode contacts of the electrode platform.

16. A method of using the system of claim 15 to implant the paddle-style electrode platform in a patient without using an insertion needle, the method comprising:

locating a stimulation site in a patient;

making an incision proximal the stimulation site;

engaging the electrode platform with the insertion tool, wherein engaging the electrode platform with the insertion tool comprises inserting the electrode platform into the carrier of the platform engager starting at the proximal edge of the electrode platform with the ridge limiting how far the electrode platform can be inserted into the carrier;

inserting the insertion tool and electrode platform through the incision without using an insertion needle;

locating an electrode positioning space within the stimulation site;

with the insertion tool, positioning the electrode platform in the positioning space within the stimulation site;

releasing the insertion tool from the electrode platform; and

removing the insertion tool from the patient.

17. The method of claim 16, wherein the ridge is disposed on the electrode platform closer to the proximal edge than all of the electrode contacts to prevent contact between the insertion tool and the electrode contacts of the electrode platform.