Systems and methods for percutaneously implanting into a patient a paddle lead of an electrical stimulation system

• US 9,604,050 B2
• Filed: 02/13/2015
• Issued: 03/28/2017
• Est. Priority Date: 02/20/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Barker, John Michael
• Primary Examiner(s): Patton, Amanda
• Application Number:
  US14/622,210
• Publication Number:
  US 20150231388A1
• Time in Patent Office: 774 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• 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: A61B 2017/00946 malleable
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy

Abstract

A multi-needle paddle lead introducer includes a needle assembly, a hub assembly, and a sheath. The needle assembly includes at least one primary needle and at least one secondary needle. The secondary needle is coupled to the primary needle along a portion of the longitudinal length of the needle assembly such that the primary needle and the secondary needle are arranged in a side-by-side configuration. The secondary needle is configured and arranged to move relative to the primary needle along the longitudinal length of the needle assembly. The hub assembly includes a primary needle hub coupled to a proximal end portion of the primary needle and a secondary needle hub coupled to a proximal end portion of the primary needle. The sheath is configured and arranged for disposing over a portion of an outer surface of the needle assembly and for sliding along the longitudinal length of the needle assembly.

Claims

1. A multi-needle paddle lead introducer comprising:

a needle assembly having an outer surface and a longitudinal length, the needle assembly comprising

at least one primary needle having an outer surface, a longitudinal length, a proximal end portion, a distal end portion, and a sharpened distal tip, the at least one primary needle comprising a lumen extending along the longitudinal length of the at least one primary needle; and

at least one secondary needle coupled to the at least one primary needle along at least a portion of the longitudinal length of the needle assembly such that the at least one primary needle and the at least one secondary needle are arranged in a side-by-side configuration, the at least one secondary needle having an outer surface, a longitudinal length, a proximal end portion, a distal end portion, and a sharpened distal tip, the at least one secondary needle comprising a lumen extending along the longitudinal length of the at least one secondary needle, wherein the at least one secondary needle is configured and arranged to move relative to the at least one primary needle along the longitudinal length of the needle assembly;

a hub assembly coupled to the needle assembly, the hub assembly comprising

at least one primary needle hub coupled to the proximal end portion of the at least one primary needle, and

at least one secondary needle hub coupled to the proximal end portion of the at least one secondary needle; and

a sheath having an outer surface and a longitudinal length, the sheath configured and arranged for disposing over at least a portion of the outer surface of the needle assembly and for sliding along the longitudinal length of the needle assembly.

2. The multi-needle paddle lead introducer of claim 1, further comprising at least one tab extending outwardly from the at least one primary needle hub, the at least one tab defining a slot.

3. The multi-needle paddle lead introducer of claim 2, wherein the at least one secondary needle extends through the slot defined in the at least one tab.

4. The multi-needle paddle lead introducer of claim 3, wherein the slot defined in the at least one tab prevents the distal tip of the at least one secondary needle from extending distally beyond the distal tip of the at least one primary needle.

5. The multi-needle paddle lead introducer of claim 1, further comprising a bend of at least 5°

permanently formed along the distal end portion of the at least one primary needle.

6. The multi-needle paddle lead introducer of claim 1, further comprising a plurality of cuts defined along the outer surface of the distal end portion of the at least one secondary needle, the plurality of cuts facilitating bending of the at least one secondary needle.

7. The multi-needle paddle lead introducer of claim 1, wherein the at least one secondary needle is coupled by an interlocking connection to the at least one primary needle.

8. The multi-needle paddle lead introducer of claim 7, wherein the interlocking connection forms a solid structure between the at least one primary needle and the at least one secondary needle, the solid structure preventing patient tissue from getting caught between the at least one primary needle and the at least one secondary needle during insertion of the needle assembly into a patient.

9. The multi-needle paddle lead introducer of claim 1, wherein the outer surface of the needle assembly comprises opposing flat surfaces.

10. The multi-needle paddle lead introducer of claim 1, wherein at least one of the lumen of the at least one primary needle or the lumen of the at least one secondary needle is configured and arranged to receive a stylet to prevent coring of patient tissue when the needle assembly is inserted into a patient.

11. The multi-needle paddle lead introducer of claim 1, further comprising a plurality of cuts defined along the outer surface of the sheath, the plurality of cuts facilitating bending of the sheath.

12. The multi-needle paddle lead introducer of claim 1, wherein the sheath has a non-round profile along a plane transverse to the longitudinal length of the sheath.

13. The multi-needle paddle lead introducer of claim 1, wherein the at least one secondary needle comprises two secondary needles flanking the at least one primary needle.

14. The multi-needle paddle lead introducer of claim 1, wherein the at least one primary needle comprises two primary needles coupled to one another along the entire longitudinal length of the needle assembly.

15. An insertion kit comprising:

the multi-needle paddle lead introducer of claim 1; and

a paddle lead configured and arranged for insertion into a patient using the lead introducer, the paddle lead comprising;

at least one lead body having a distal end portion, a proximal end portion, and a longitudinal length,

a paddle body attached to the distal end portion of the at least one lead body,

a plurality of electrodes disposed along the paddle body,

a plurality of terminals disposed along the proximal end portion of the at least one lead body, and

a plurality of conductors electrically coupling the plurality of electrodes to the plurality of terminals.

16. An electrical stimulating system comprising:

the insertion kit of claim 15;

a control module coupleable to the paddle lead of the 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 comprising

a connector housing defining a port configured and arranged for receiving the proximal end portion of the at least one lead body 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 along the proximal end portion of the at least one lead body.

17. A method of implanting a paddle lead into a patient, the method comprising:

providing the multi-needle paddle lead introducer of claim 1;

inserting the at least one primary needle of the multi-needle paddle lead introducer into the patient;

advancing the distal tip of the at least one primary needle to a target insertion location in proximity to a target stimulation location within the patient;

advancing the at least one secondary needle of the multi-needle paddle lead introducer relative to the at least one primary needle until the distal tip of the at least one secondary needle is disposed at the target insertion location;

advancing a distal end portion of the sheath of the multi-needle paddle lead introducer to the target insertion location along the longitudinal lengths of the at least one primary needle and the at least one secondary needle;

removing the at least one primary needle and the at least one secondary needle from the patient while leaving the distal end portion of the sheath inserted into the target insertion location;

advancing a paddle lead along a lumen of the sheath to the target insertion location; and

removing the sheath from the patient leaving the paddle lead disposed in the patient.

18. The method of claim 17, further comprising inserting a stylet into a lumen of the at least one primary needle prior to inserting the at least one primary needle into the patient.

19. The method of claim 18, further comprising removing the stylet from the lumen of the at least one primary needle subsequent to advancing the distal tip of the at least one primary needle to the target insertion location.

20. The method of claim 17, further comprising performing a loss-of-resistance test prior to advancing the distal end portion of the sheath to the target insertion location.