Method and apparatus for implanting an electrical stimulation lead using a flexible introducer

• US 20050288759A1
• Filed: 04/29/2005
• Published: 12/29/2005
• Est. Priority Date: 08/08/2003
• Status: Active Grant

• 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., Daglow, Terry
• Granted Patent: US 7,359,755 B2
• 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 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36071 Pain

Abstract

In one embodiment, an introducer is provided for implanting a paddle style electrical stimulation lead to enable electrical stimulation of nerve tissue. The introducer includes an outer sheath and an inner penetrator. The outer sheath may accommodate insertion of the paddle style electrical stimulation lead and may be inserted into a human body near the nerve tissue. The inner penetrator is removably housed within the outer sheath and includes an inner channel configured to accommodate a guide wire, a tip end having a shape and size substantially conforming to that of the guide wire, a body region having a shape and size substantially conforming to that of the outer sheath, and one or more transition regions substantially connecting the tip end with the body region. The inner penetrator may 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 paddle style electrical stimulation lead through the outer sheath into position proximate the nerve tissue. At least a portion of the transition regions of the inner penetrator may flex to substantially follow flexures in the guide wire during advancement of the inner penetrator.

Claims

1. An introducer for implanting a paddle style electrical stimulation lead to enable electrical stimulation of nerve tissue, comprising:

an outer sheath to accommodate insertion of the paddle style electrical stimulation lead through the outer sheath, the outer sheath operable to be inserted into a human body near the nerve tissue; and

an inner penetrator removably housed within the outer sheath and comprising an inner channel configured to accommodate a guide wire, 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 a cross-sectional shape and size of the outer sheath, and one or more transition regions substantially connecting the tip end with the body region; and

wherein 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 substantially in position for insertion of the paddle style electrical stimulation lead through the outer sheath into position proximate the nerve tissue, at least a portion of the one or more transition regions being configured to flex to substantially follow flexures in the guide wire during advancement of the inner penetrator along the guide wire.

2. The introducer of claim 1, wherein the cross-sectional shape and size of the tip end of the inner penetrator are significantly different than the cross-sectional shape and size of the body region of the inner penetrator.

3. The introducer of claim 1, wherein:

the outer sheath and the body region of the inner penetrator have substantially oval or oblong cross-sections; and

the guide wire and the tip end of the inner penetrator have substantially circular cross-sections.

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

5. The introducer of claim 1, wherein both the outer sheath and the inner penetrator are formed from one or more of plastic, silastic, or a polymeric materials.

6. The introducer of claim 1, wherein the one or more transition regions include a tip transition region extending from the tip end of the inner penetrator at least a portion of the distance toward the body region of the inner penetrator, the tip transition region being formed from a particular material and having a wall thickness sufficiently thin such that when the inner penetrator is advanced along the guide wire, the tip transition region may flex to substantially follow flexures in the guide wire.

7. The introducer of claim 6, wherein the wall thickness of tip transition region decreases toward the tip end of the inner penetrator.

8. The introducer of claim 1, wherein the one or more transition regions include a tip transition region extending from the tip end of the inner penetrator at least a portion of the distance toward the body region of the inner penetrator, the tip transition region having a substantially circular cross-section extending along the length of the tip transition region, the substantially circular cross-section having an inner diameter and an outer diameter, both the inner diameter an the outer diameter of the substantially circular cross-section tapering toward the tip end of the tip transition region.

9. The introducer of claim 8, wherein the one or more transition regions further include a body transition region extending from the body region of the inner penetrator at least a portion of the distance toward the tip transition region, the body transition region having a cross-section that transitions from a first end having a substantially oval cross-section to a second end having a substantially circular cross-section.

10. The introducer of claim 1, wherein the one or more transition regions include:

a tip transition region extending from the tip end of the inner penetrator toward the body region of the inner penetrator, the tip transition region having a substantially circular cross-section extending along the length of the tip transition region, the substantially circular cross-section tapering toward the tip end of the inner penetrator;

a body transition region extending from the body region of the inner penetrator toward the tip end of the inner penetrator, the body transition region having a cross-section that transitions from a first end having a substantially oval or oblong cross-section to a second end having a substantially circular cross-section; and

a middle transition connecting the tip transition region with the body transition region, the middle transition having a substantially circular cross-section, the middle transition not being tapered.

11. The introducer of claim 1, further comprising a locking device including a first locking portion coupled to the outer sheath and a second locking portion coupled to the inner penetrator, the first locking portion and second locking portion being configured to interact to lock the inner penetrator within the outer sheath.

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

14. A method of implanting a paddle style electrical stimulation lead to enable electrical stimulation of nerve tissue, comprising:

inserting a needle into tissue;

positioning a guide wire through the needle into a desired location relative to the nerve tissue;

removing the needle;

forming a tract for the paddle style electrical stimulation lead by advancing an introducer along the guide wire to a desired location, the introducer comprising an outer sheath and inner penetrator removably housed within the outer sheath, the inner penetrator including 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 a cross-sectional shape and size of the outer sheath, and one or more transition regions substantially connecting the tip end with the body region, at least a portion of the one or more transition regions flexing to substantially follow flexures in the guide wire during advancement of the inner penetrator along the guide wire;

removing the inner penetrator;

leaving the outer sheath substantially in position; and

inserting the paddle style electrical stimulation lead through the outer sheath until the paddle style electrical stimulation lead is positioned proximate the nerve tissue.

15. The method of claim 14, wherein the introducer flexes to navigate around physical structures in the body during advancement of the introducer along the guide wire.

16. The method of claim 14, wherein:

the guide wire and the tip end of the inner penetrator have substantially circular cross-sections; and

the outer sheath and the body region of the inner penetrator have substantially oval cross-sections.

17. The method of claim 14, wherein:

the one or more transition regions include a tip transition region extending from the tip end of the inner penetrator at least a portion of the distance toward the body region of the inner penetrator; and

during the advancement of the introducer along the guide wire, the tip transition region flexes to substantially follow flexures in the guide wire, the tip transition region being formed from a particular material and having a wall thickness that decreases toward the tip end of the inner penetrator.

18. The method of claim 14, wherein the one or more transition regions include a tip transition region extending from the tip end of the inner penetrator at least a portion of the distance toward the body region of the inner penetrator, the tip transition region having a substantially circular cross-section extending along the length of the tip transition region, the substantially circular cross-section having an inner diameter and an outer diameter, both the inner diameter an the outer diameter of the substantially circular cross-section tapering toward the tip end of the tip transition region.

19. The method of claim 14, wherein the one or more transition regions include a tip transition region, a body transition region, and a middle transition connecting the tip transition region with the body transition region, the tip transition region and the body transition region being tapered, and the middle transition not being tapered.

20. A system for implanting a paddle style electrical stimulation lead for electrical stimulation of a human'"'"'s spinal nerve tissue, comprising:

a needle;

a guide wire;

an introducer comprising an outer sheath and an inner penetrator;

the outer sheath configured to accommodate insertion of the paddle style electrical stimulation lead through the outer sheath, the outer sheath operable to be inserted through the human'"'"'s skin and into the human'"'"'s epidural space;

the inner penetrator removably housed within the outer sheath and comprising an inner channel configured to accommodate a guide wire, 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 a cross-sectional shape and size of the outer sheath, and one or more transition regions substantially connecting the tip end with the body region;

the inner penetrator configured to be advanced along the guide wire until an end of the inner penetrator is positioned in the epidural space at a desired location relative to spinal nerve tissue to be stimulated such that the outer sheath forms an insertion tract for the paddle style electrical stimulation lead as the inner penetrator advances along the guide wire, a tip transition region of the inner penetrator being formed from a particular material and having a wall thickness sufficiently thin such that during advancement of the inner penetrator along the guide wire, the tip transition region may flex to substantially follow flexures in the guide wire, the inner penetrator configured to be removed from the outer sheath leaving the outer sheath substantially in position in the epidural space for insertion of the paddle style electrical stimulation lead through the outer sheath into position proximate the spinal nerve tissue to be stimulated; and

an implantable generator to power the paddle style electrical stimulation lead.

13. The introducer of claim 20, wherein:

the marker on the outer sheath is a radio-opaque marker; and

the inner penetrator includes a radio-opaque marker having a different radiopacity than the radio-opaque marker on the outer sheath such that the marker on the inner penetrator may be distinguishable from the marker on the outer sheath using the one or more medical imaging techniques such that the location of the inner penetrator relative to the outer sheath may be determined.