Method and Tools for Clearing the Epidural Space in Preparation for Medical Lead Implantation

• US 20130261653A1
• Filed: 01/29/2013
• Published: 10/03/2013
• Est. Priority Date: 03/30/2012
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Skubitz, Sean P.
• Granted Patent: US 9,687,265 B2
• Time in Patent Office: Days
• US Class Current: 606/190
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 2017/00946 malleable
• CPC Class Codes: A61B 2017/320044 Blunt dissectors
• CPC Class Codes: A61B 2017/320056 Tunnelers
• CPC Class Codes: A61M 2025/0007 Epidural catheters
• CPC Class Codes: A61M 25/0169 Exchanging a catheter while keeping the guidewire in place
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

An epidural space is cleared of fat and scar tissue in preparation for implantation of a medical lead by utilizing a clearing tool. The clearing tool has a flexible body that allows the clearing tool to deflect when entering the epidural space through a window in the vertebral bone and ligaments. The clearing tool is guided into the epidural space and to a target site by a guidewire present in the epidural space. Upon removal of the guidewire and clearing tool, the medical lead is inserted through the window and cleared epidural space until reaching the target site. The clearing tool may include a distal tip with a shape and size that aids in the clearing of the epidural space. The distal tip may be integral to the clearing tool or may be removable so as to allow for different sizes of the distal tip to be installed as needed.

Claims

1. A method of implanting a paddle lead into an epidural space, comprising:

passing a guidewire through a window to the epidural space created within the spinal column;

passing a tool through the window and into the epidural space by passing the guidewire through a lumen of the tool;

cleaning the epidural space by moving the tool further into the epidural space and then retracting the tool;

removing guidewire and tool from the epidural space; and

after removing the guidewire and tool from the epidural space, inserting the paddle lead through the window and into a desired position within the epidural space.

2. The method of claim 1, wherein the guidewire has a pre-formed tip that is curved to enter the epidural space and turn approximately parallel to a dura covering a spinal cord.

3. The method of claim 1, wherein the tool has an elongated body and a distal tip and where the distal tip has a width greater than a diameter of the elongated body.

4. The method of claim 3, wherein the distal tip is integral with the elongated body.

5. The method of claim 3, wherein the distal tip is removable from the elongated body.

6. The method of claim 1, wherein the tool has a flexible elongated body.

7. An apparatus for cleaning an epidural space prior to paddle lead implantation, comprising:

a flexible elongated body having an inner lumen;

a guidewire present within the inner lumen; and

a distal tip present on a distal end of the elongated body, the distal tip having a width greater than a diameter of the elongated body.

8. The apparatus of claim 7, further comprising a hub on a proximal end of the guidewire.

9. The apparatus of claim 7, further comprising a hub on a proximal end of the flexible elongated body.

10. The apparatus of claim 7, wherein the distal tip includes a lumen and wherein the guidewire is present within the lumen of the distal tip.

11. The apparatus of claim 7, wherein the distal tip is integral to the flexible elongated body.

12. The apparatus of claim 7, wherein the distal tip is removable from the flexible body.

13. The apparatus of claim 12, wherein the distal tip includes two tabs with each tab defining an opening with a diameter greater than the lead body, wherein the lead body includes a distal end with a diameter greater than the lead body but less than the opening of each tab.

14. The apparatus of claim 7, wherein a distal region of the flexible elongated body has less flexibility than a more proximal region.

15. A tool for cleaning an epidural space prior to paddle lead implantation, comprising:

a flexible elongated body having an inner lumen and a distal end with a diameter greater than the lead body;

a distal tip present on the distal end of the elongated body, the distal tip having a width greater than the distal end of the elongated body, the distal tip being removable from the elongated body by having two tabs with each tab defining an opening with a diameter greater than the distal end of the elongated body, the tabs having a resting state such that the openings of the tabs are eccentrically aligned to lock the distal tip to the distal end, the distal tip being removable upon pressuring the tabs to force the openings of the tabs to become concentric and pass over the distal end.

16. The tool of claim 15, wherein the distal tip includes a lumen.

17. The tool of claim 15, further comprising a hub on a proximal end of the elongated body.

18. The tool of claim 15, wherein a distal region of the flexible elongated body has less flexibility than a more proximal region.

19. The tool of claim 15, wherein the distal tip has a domed shape.

20. The tool of claim 15, wherein the elongated body and the distal tip are constructed of polymers.

21. A method cleaning an epidural space prior to paddle lead implantation, comprising:

passing a guidewire through a window to the epidural space created within the spinal column;

passing a tool through the window and into the epidural space by passing the guidewire through a lumen of the tool;

cleaning the epidural space by moving the tool further into the epidural space causing a body of the tool to deflect within the epidural space in proximity to the window and then retracting the tool; and

removing the guidewire and the tool from the epidural space, the body of the tool continuing to deflect as the tool is being removed.