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

• US 7,359,755 B2
• Filed: 04/29/2005
• Issued: 04/15/2008
• Est. Priority Date: 08/08/2003
• Status: Expired due to Term

• 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
• Primary Examiner(s): Evanisko; George R.
• Assistant Examiner(s): HOLMES, REX R
• Application Number:
  US11/119,438
• Publication Number:
  US 20050288759A1
• Time in Patent Office: 1,082 Days
• Field of Search: 607/115, 607/116, 607/117, 607/118, 607/122, 604/164.1, 604/164, 604/171
• US Class Current: 607/117
• 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. 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. 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. 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, 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;

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.

2. The method of claim 1, wherein the introducer flexes to navigate around physical structures in the body during advancement of the introducer along the guide wire.

3. The method of claim 1, 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.

4. The method 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 and the outer diameter of the substantially circular cross-section tapering toward the tip end of the tip transition region.

5. The method of claim 1, 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.

6. A method of implanting a paddle style electrical stimulation lead within an epidural space of a patient to enable electrical stimulation of nerve tissue, comprising:

inserting a needle into tissue to access the epidural space;

positioning a guide wire through the needle into a desired location within the epidural space;

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 a plurality of flexing transition regions substantially connecting the tip end with the body region, at least a portion of the plurality of transition regions flexing to substantially follow flexures in the guide wire during advancement of the introducer along the guide wire, wherein the outer sheath, the inner penetrator, and the plurality of transition regions allow the introducer, during entry within the epidural space, to assume a shape where a distal first portion of the introducer possesses a substantially linear shape within the epidural space and a second portion of the introducer exhibits a curve to allow the introducer to exit from the patient'"'"'s body;

removing the inner penetrator and guide wire;

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.

7. The method of claim 6, wherein the introducer flexes to navigate around physical structures in the body during advancement of the introducer along the guide wire.

8. The method of claim 6, 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.

9. The method of claim 6, wherein:

the plurality of 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.

10. The method of claim 6, wherein the plurality of 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 and the outer diameter of the substantially circular cross-section tapering toward the tip end of the tip transition region.

11. The method of claim 6, wherein the plurality of 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.

12. A method of implanting a paddle style electrical stimulation lead into the epidural space of a patient, comprising:

inserting a needle into tissue to access the epidural space;

positioning a guide wire through the needle into a desired location within the epidural space;

removing the needle;

placing an introducer over the guide wire, the introducer comprising an outer sheath and an inner penetrator, 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 flexing transition regions substantially connecting the tip end with the body region, wherein the tip end of the inner penetrator comprises (i) a needle nose segment that possesses an approximately constant outer diameter, the needle nose segment comprising an aperture for providing an interference fit with the guide wire and (ii) a transition segment that transitions from the shape of the needle nose segment to the shape of the body portion of the inner penetrator;

forming a tract for the paddle style electrical stimulation lead by advancing the introducer along the guide wire to a desired location within the epidural space, wherein the tip end of the introducer, the body region, and outer sheath flex substantially follow flexures in the guide wire without substantially dislocating the guide wire during the advancing, the advancing continuing until a distal portion of the introducer within the epidural space is approximately parallel with the spinal column and a medial portion of the introducer within the epidural space is curved to allow the introducer to exit from the epidural space at an angle;

removing the inner penetrator and guide wire while 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 to nerve tissue.

13. The method of claim 12 wherein the needle nose segment is more flexible than the transition segment and the transition segment is more flexible than the body portion of the inner penetrator.