Surgical retractor for implanting leads and methods of making and using

• US 9,986,989 B2
• Filed: 01/03/2017
• Issued: 06/05/2018
• Est. Priority Date: 01/08/2016
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Roche, Julia A., Govea, Michael X.
• Primary Examiner(s): Philogene, Pedro
• Assistant Examiner(s): Comstock, David C
• Application Number:
  US15/397,693
• Publication Number:
  US 20170196548A1
• Time in Patent Office: 518 Days
• Field of Search: 600204, 600208, 600214, 600219, 600224, 600226, 600227, 600233
• CPC Class Codes: A61B 17/0206 with antagonistic arms as supports for retractor elements
• 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 17/0293 with ring member to support retractor elements
• CPC Class Codes: A61B 2017/00221 with wireless transmission of data, e.g. by infrared radiation or radiowaves
• CPC Class Codes: A61B 2017/00407 Ratchet means
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• 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 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula

Abstract

A retractor for implanting a lead of an electrical stimulation system includes multiple retractor teeth defining an implantation lumen; multiple pin arrangements that each include a base coupled to one of the retractor teeth and at least one pin extending from the base; a spiral track having multiple spiral indentations and multiple spiral ridges separating the spiral indentations with at least one pin of each of the pin arrangements engaging one of the spiral indentations of the spiral track; and a handle coupled to the spiral track to rotate the spiral track. The retractor is configured and arranged to radially move the retractor teeth as the spiral track is rotated.

Claims

1. A retractor for implanting a lead of an electrical stimulation system, the retractor comprising:

a plurality of retractor teeth defining an implantation lumen;

a plurality of pin arrangements, each pin arrangement comprising a base coupled to one of the retractor teeth and a plurality of pins extending from the base;

a spiral track comprising a plurality of spiral indentations and a plurality of spiral ridges separating the spiral indentations, wherein at least one of the pins of each of the pin arrangements engages one of the spiral indentations of the spiral track and the pins of each pin arrangement are spaced apart to permit simultaneous engagement of two of the pins of the pin arrangement with two different ones of the spiral indentations; and

a handle coupled to the spiral track and configured and arranged to rotate the spiral track, wherein the retractor is configured and arranged to radially move the retractor teeth as the spiral track is rotated.

2. The retractor of claim 1, wherein each of the retractor teeth comprises a distal end, wherein each of the retractor teeth is tapered toward the distal end.

3. The retractor of claim 1, wherein a number of the pin arrangements is equal to a number of the spiral indentations and each of the spiral indentations extends at least 360 degrees around the spiral track.

4. The retractor of claim 1, wherein the spiral track comprises a gear arrangement formed on a surface of the spiral track opposite the spiral indentations.

5. The retractor of claim 4, wherein the handle further comprises a gear that engages the gear arrangement of the spiral track to couple the handle to the spiral track.

6. The retractor of claim 1, wherein the retractor further comprises a hub arrangement, the hub arrangement comprising a hub housing that houses the spiral track, a lid disposed over the spiral track and engaged with the hub housing, and a bottom portion attached to the hub housing and engaging the pin arrangements.

7. The retractor of claim 6, wherein the hub housing comprises a base, a sidewall coupled to the base, and a plurality of slots, wherein the pins of each of the pin arrangements are configured and arranged to slide along the slots.

8. The retractor of claim 6, wherein the bottom portion comprises a plurality of channels, wherein each of the pin arrangements is disposed in a different one of the channels and is configured and arranged to slide along the channel.

9. The retractor of claim 1, wherein the retractor teeth and pin arrangements are formed of metal or rigid plastic.

10. The retractor of claim 9, wherein the spiral track is formed of a plastic material having a lower coefficient of friction than the metal or rigid plastic.

11. The retractor of claim 1, further comprising a second handle coupled to the spiral track.

12. The retractor of claim 1, wherein each of the retractor teeth comprises a lighting element.

13. An implantation kit, comprising:

the retractor of claim 1; and

an electrical stimulation lead having a distal portion and a proximal portion, the lead comprising;

a plurality of electrodes disposed along the distal portion of the lead,

a plurality of terminals disposed along the proximal portion of the lead, and

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

14. The implantation kit of claim 13, wherein the lead further comprises

a paddle body disposed along the distal portion of the lead, and

at least one lead body extending from the paddle body,

wherein the electrodes are disposed in at least two columns on the paddle body.

15. The implantation kit of claim 13, further comprising a control module coupleable to the electrical stimulation lead.

16. The implantation kit of claim 13, further comprising a series of dilators, wherein each dilator in the series has a diameter larger than a preceding one of the dilators in the series.

17. The implantation kit of claim 13, further comprising an expandable sleeve configured and arranged to fit around the retractor teeth of the retractor.

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

providing the implantation kit of claim 13;

inserting the retractor teeth into tissue of the patient;

rotating the spiral track to radially separate the retractor teeth; and

implanting the electrical stimulation lead into the patient through the implantation lumen defined by the retractor teeth.

19. The method of claim 18, further comprising

after implanting, rotating the spiral track to bring the retractor teeth closer together;

and

removing the retractor teeth from the tissue of the patient.

20. The retractor of claim 1, wherein the handle, pin arrangements, and spiral track are configured and arranged to rotate the spiral track at least 360 degrees.