Retractor and tools for implantation of electrical stimulation leads and methods of using and manufacture

• US 9,931,109 B2
• Filed: 02/09/2016
• Issued: 04/03/2018
• Est. Priority Date: 02/13/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Burckhardt, Laura, Govea, Michael X.
• Primary Examiner(s): SEVILLA, CHRISTIAN ANTHONY
• Application Number:
  US15/019,848
• Publication Number:
  US 20160235394A1
• Time in Patent Office: 784 Days
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators

Abstract

A retractor for implanting a paddle lead of an electrical stimulation system includes a shaft defining a length, an interior lumen, a first end for receiving tools or paddle lead, and a second end opposite the first end and configured and arranged for insertion into tissue of a patient; a handle coupled to the shaft; and at least one divider disposed within the interior lumen and dividing a portion of the interior lumen into at least two compartments, wherein the at least one divider extends from at or near the first end of the shaft and no more than 70% of the length of the shaft. At least one of the compartments is sized for implantation of a paddle lead of an electrical stimulation system therethrough.

Claims

1. An implantation kit, comprising:

a retractor for implanting a paddle lead of an electrical stimulation system, the retractor comprising;

a shaft defining a length, an interior lumen, a first end for receiving tools or the paddle lead, and a second end opposite the first end and configured and arranged for insertion into tissue of a patient;

a handle coupled to the shaft; and

at least one divider disposed within the interior lumen and dividing a portion of the interior lumen into at least two compartments, wherein the at least one divider extends from at or near the first end of the shaft and no more than 70% of the length of the shaft; and

a paddle lead, comprising;

a paddle body,

at least one lead body having a distal end portion, a proximal end portion, and a longitudinal length, the distal end portion of each of the at least one lead body coupled to the paddle body,

a plurality of electrodes disposed in at least two columns on the paddle body,

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

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

wherein at least one of the compartments of the retractor is sized for implantation of the paddle lead therethrough.

2. The implantation kit of claim 1, wherein the at least one divider extends at least 40% of the length of the shaft.

3. The implantation kit of claim 1, wherein the at least one divider is two dividers that divide the portion of the interior lumen into three compartments.

4. The implantation kit of claim 3, wherein the three compartments form two side ports and a central port disposed between the two side ports.

5. The implantation kit of claim 4, wherein the central port is larger than either of the two side ports and the central port is sized for implantation of the paddle lead of the electrical stimulation system therethrough.

6. The implantation kit of claim 1, wherein the handle is removable.

7. The implantation kit of claim 1, further comprising a filler configured and arranged for insertion into the shaft of the retractor, the filler comprising a handle and a plurality of filler fingers coupled to the handle and configured and arranged to substantially fill the shaft of the retractor, wherein the filler fingers are separated by at least one gap configured and arranged to align with the at least one divider of the retractor when the filler is inserted into the retractor.

8. The implantation kit of claim 1, further comprising at least one blade tool, each blade tool comprising an actuator, a rod coupled to the actuator, and a blade movably coupled to the rod and configured and arranged to move back and forth in response to the actuator, wherein each blade tool is configured and arranged so that the blade and rod can be inserted through the first end of the shaft into one of the compartments of the shaft of the retractor and the blade can be extended out of the second end of the shaft.

9. The implantation kit of claim 8, wherein the at least one divider is two dividers that divide the portion of the interior lumen into three compartments and the at least one blade tool is two blade tools.

10. The implantation kit of claim 1, further comprising an actuator tool configured and arranged for insertion through the first end of the shaft of the retractor into one of the compartments of the shaft of the retractor;

and

at least one blade tool, each blade tool comprising a handle, a rod coupled to the handle, and a blade movably coupled to the rod and configured and arranged to move back and forth in response to the actuator tool, wherein each blade tool is configured and arranged so that the blade and rod can be inserted through the first end of the shaft into one of the compartments of the shaft of the retractor and the blade can be extended out of the second end of the shaft.

11. The implantation kit of claim 10, wherein the blade of each of the at least one blade tool has a first magnetic polarity and the actuator tool has a second magnetic polarity opposite the first magnetic polarity.

12. The implantation kit of claim 11, wherein the at least one divider is two dividers that divide the portion of the interior lumen into three compartments and the at least one blade tool is two blade tools.

13. The implantation kit of claim 1, further comprising a control module coupleable to the paddle lead.

14. The implantation kit of claim 1, further comprising a series of introducers, wherein each introducer in the series has a diameter larger than a preceding one of the introducers in the series.

15. A method of implanting an electrical stimulation lead, the method comprising:

providing the implantation kit of claim 1;

inserting the second end of the retractor into tissue of the patient; and

implanting the paddle body of the paddle lead into the patient through one of the at least two compartments of the retractor.