Methods and apparatuses for implanting and removing an electrical stimulation lead

• US 20050288758A1
• Filed: 04/29/2005
• Published: 12/29/2005
• Est. Priority Date: 08/08/2003
• Status: Abandoned Application

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Jones, Timothy S., Hegi, Peter B., Hickman, Thomas K.
• Application Number:
  US11/118,718
• Publication Number:
  US 20050288758A1
• Time in Patent Office: Days
• US Class Current: 607/116
• 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: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36071 Pain

Abstract

In one embodiment, a lead introducer kit for preparing to implant an electrical stimulation lead for electrical stimulation of nerve tissue is provided. The lead introducer kit includes a needle, a guide wire, a lead blank having a similar shape and size as an electrical stimulation, and an introducer. The lead blank is configured for insertion into the human body to determine whether the electrical stimulation lead may be inserted into position proximate nerve tissue to be stimulated. The introducer includes an inner penetrator removably housed within an outer sheath and including an inner channel configured to accommodate the guide wire. The inner penetrator is configured to be advanced along the guide wire to a desired location relative to the nerve tissue and removed from the outer sheath leaving the outer sheath in position for insertion of the lead blank to determine whether the electrical stimulation lead may be inserted into position proximate the nerve tissue to be stimulated.

Claims

1. A lead introducer kit for preparing to implant an electrical stimulation lead for electrical stimulation of nerve tissue, comprising:

a needle;

a guide wire;

a lead blank having a similar shape and size as an electrical stimulation lead to be inserted proximate the nerve tissue, the lead blank configured for insertion into the human body to determine whether the electrical stimulation lead may be inserted into position proximate nerve tissue to be stimulated; and

an introducer comprising an outer sheath and an inner penetrator, the outer sheath operable to be inserted into a human body near nerve tissue to be stimulated, the inner penetrator removably housed within the outer sheath and comprising an inner channel configured to accommodate the guide wire, the inner penetrator configured to be advanced along the guide wire to a desired location relative to the nerve tissue and removed from the outer sheath leaving the outer sheath substantially in position for insertion of the lead blank through the outer sheath to determine whether the electrical stimulation lead may be inserted into position proximate the nerve tissue to be stimulated.

2. The lead introducer kit of claim 1, wherein the electrical stimulation lead is not included in the lead introducer kit.

3. The lead introducer kit of claim 1, wherein:

the nerve tissue comprises spinal nerve tissue and the desired location comprises an epidural space of the human; and

the lead blank is configured for insertion into the epidural space to determine whether the electrical stimulation lead may fit into position in the epidural space proximate nerve tissue to be stimulated.

4. The lead introducer kit of claim 1, wherein the lead blank is a paddle style lead blank.

5. The lead introducer kit of claim 1, wherein at least a portion of the lead blank is notched to provide additional flexibility to the lead blank.

6. The lead introducer kit of claim 1, wherein at least a portion of the lead blank has a scalloped shape to provide additional flexibility to the lead blank.

7. The lead introducer kit of claim 1, wherein the lead blank includes a marker that may be detected by one or more medical imaging techniques such that the location of the lead blank in the human body may be determined.

8. The lead introducer kit of claim 1, wherein the outer sheath has a substantially oval or oblong cross-section.

9. The lead introducer kit of claim 8, wherein the inner penetrator of the introducer includes a tip end having a cross-sectional shape and size substantially conforming to a cross-sectional shape and size of the guide wire, a body region having a cross-sectional shape and size substantially conforming to the substantially oval or oblong cross-section of the outer sheath, and one or more transition regions located between the tip end and the body region, the one or more transition regions transitioning between the cross-section of the tip end and the cross-section of the body region.

10. The lead introducer kit of claim 1, wherein the outer sheath and inner penetrator of the introducer are configured from one or more flexible materials such that the introducer may flex to navigate around physical structures in the body.

11. The lead introducer kit of claim 10, wherein both the outer sheath and the inner penetrator are formed from one or more of plastic, silastic, or a polymeric materials.

12. A method of removing an electrical stimulation lead from a human body, comprising:

positioning a stimulation lead introducer over a body portion of an electrical stimulation lead that is at least partially implanted in a human body, the stimulation lead introducer including an outer sheath and an inner penetrator removably housed within the outer sheath and comprising an inner channel, a tip region of the inner penetrator extending out from the outer sheath, the stimulation lead introducer being positioned such that the body portion of the electrical stimulation lead is at least partially disposed within the inner channel of the inner penetrator;

advancing the stimulation lead introducer along the body portion of the electrical stimulation lead until the tip region of the inner penetrator is located adjacent a stimulating portion of the electrical stimulation lead;

advancing the outer sheath relative to the inner penetrator until the outer sheath covers at least a portion of the stimulating portion of the electrical stimulation lead; and

removing the outer sheath, the inner penetrator, and the electrical stimulation lead from the human body.

13. The method of claim 12, comprising advancing the outer sheath relative to the inner penetrator until the outer sheath completely covers the stimulating portion of the electrical stimulation lead.

14. The method of claim 12, comprising:

advancing the outer sheath relative to the inner penetrator until the outer sheath partially covers the stimulating portion of the electrical stimulation lead; and

removing the outer sheath, the inner penetrator, and the electrical stimulation lead from the human body with the outer sheath partially covering the stimulating portion of the electrical stimulation lead.

15. The method of claim 12, wherein the outer sheath, the inner penetrator, and the electrical stimulation lead are removed from the human body together at the same time.

16. The method of claim 12, wherein the electrical stimulation lead is a paddle style lead and the stimulation portion of the electrical stimulation lead has a paddle shape.

17. The method of claim 16, wherein the outer sheath has a substantially oval or oblong cross-section configured to receive the paddle shaped stimulating portion of the electrical stimulation lead.

18. The method of claim 12, further including inserting a stylet into a channel formed in the lead, the stylet providing rigidity to the electrical stimulation lead such that when the stimulation lead introducer advances along a flexure in the body of the electrical stimulation lead, the tip region of the inner penetrator flexes to substantially follow the flexure in the body of the electrical stimulation lead rather than displacing the body of the electrical stimulation lead.

19. The method of claim 12, wherein the outer sheath and inner penetrator of the introducer are configured from one or more flexible materials such that the introducer may flex to navigate around physical structures in the body.

20. The method of claim 19, wherein both the outer sheath and the inner penetrator are formed from one or more of plastic, silastic, or a polymeric materials.