Percutaneous lead introducing system and method

• US 4,512,351 A
• Filed: 11/19/1982
• Issued: 04/23/1985
• Est. Priority Date: 11/19/1982
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Pohndorf, Peter J.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US06/442,964
• Time in Patent Office: 886 Days
• Field of Search: 128/753, 128/754, 128/784, 128/786, 128/419 R
• US Class Current: 607/117
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

A method and apparatus for introducing a neural stimulator lead into the epidural space in the spinal cord of a patient includes an introducer into which an epidural needle assembly may be inserted through a cannula in the introducer. The introducer along with the epidural needle assembly, such as a Tuohy needle, are inserted between the vertebrae in the patient'"'"'s spine so that the leading tip of the epidural needle assembly and the introducer are adjacent the epidural space. The epidural needle assembly includes a needle which also has a cannula and an obturator which is inserted in the cannula when the introducer and epidural needle assembly are being inserted between the vertebrae. The obturator is thereafter removed from the cannula of the needle, the needle cannula is filled with a saline solution, and the introducer is further advanced into the epidural space as the needle is withdrawn from the cannula of the introducer. The neural stimulator lead is then inserted through the cannula of the introducer, until it is positioned in the epidural space. Once the electrode of the lead is positioned at its desired location, the introducer is withdrawn along the lead and the introducer is split away from the electrode by a pair of handles and a weakened score line extending longitudinally of the cannula of the introducer.

Claims

1. A method of introducing a flexible member in the epidural space in the spinal column of a patient, comprising the steps of:

percutaneously inserting a longitudinally extending flexible introducer having an epidural needle assembly extending through a cannula in the introducer between vertebrae in the patient'"'"'s spine so that the leading tip of the epidural needle assembly and the introducer are adjacent said epidural space;

withdrawing said epidural needle assembly from the cannula of said introducer;

inserting said flexible member through the cannula of said introducer until the flexible member is positioned in said epidural space;

withdrawing said introducer from the patient while leaving said flexible member in said epidural space; and

splitting said flexible member along the longitudinal axis thereof following withdrawal of said introducer from the patient and removing said split introducer from around said flexible member.

2. The method of claim 1, comprising the additional steps of forming said epidural needle assembly by positioning an obturator in the cannula of an epidural needle, positioning said epidural needle assembly in said cannula of said introducer prior to said percutaneous insertion of said introducer, and withdrawing said obturator from said epidural needle following said percutaneous insertion of said introducer.

3. The method of claim 2, comprising the additional step of filling the cannula of the needle with a saline solution upon removal of the obturator.

4. The method of claim 3, comprising the additional step of advancing said introducer into the epidural space following filling said cannula of said epidural needle with said saline solution.

5. The method of claim 4, comprising the additional step of withdrawing said needle from said introducer while simultaneously advancing said introducer further into the epidural space such that said leading end of said introducer is caused to assume a slight angle.

6. The method of claim 2, wherein said step of forming said needle assembly comprises the step of positioning said obturator in the cannula of a Tuohy needle.

7. The method of claim 1, wherein said step of inserting said member comprises inserting a neural stimulator lead through the cannula of said introducer until said neural stimulator lead is positioned in the epidural space.

8. Apparatus for the introduction of a flexible member into the epidural space in the spinal column of a patient, comprising:

a longitudinally extending introducer comprising a flexible elongate cannula, said introducer being splittable along the longitudinal axis thereof; and

an epidural needle assembly removably inserted in and through said cannula, the tip of said epidural needle assembly extending beyond an end of said elongate cannula, whereby said introducer and epidural needle assembly may be percutaneously inserted together between vertebrae in the patient'"'"'s spine so that the tip of the epidural needle assembly and the end of said elongate cannula are adjacent the epidural space of the patient when the epidural needle assembly is fully inserted into the cannula of said introducer.

9. The apparatus of claim 8, wherein said epidural needle assembly comprises a needle having a cannula and an obturator removably inserted in the cannula of said needle.

10. The apparatus of claim 9, wherein the flexible member comprises a neural stimulator lead and said introducer is dimensioned to encircle said neural stimulator lead, said introducer further including means for splitting said introducer away from said neural stimulator lead after said lead has been inserted in and through said cannula of said introducer, said means for splitting including a weakened portion of said introducer extending longitudinally of said elongate cannula of said introducer, and a pair of handle means attached to the elongate cannula of said introducer adjacent the end thereof opposite the aforementioned end, said weakened portion extending between said handle means.

11. The method of claim 10, wherein said neural stimulator lead includes a terminal on an end thereof opposite the end which is positioned in the epidural space, said terminal being larger in cross-section than the lead, and said introducer may be withdrawn from the patient'"'"'s body along said lead and split away from said lead before said introducer reaches said terminal.

12. The apparatus of claim 8, wherein said epidural needle assembly includes a Tuohy needle having a cannula, and an obturator removably inserted in said cannula of said Tuohy needle such that said cannula is filled by said obturator.

13. The apparatus of claim 8, wherein the flexible member is a neural stimulator lead and said introducer is dimensioned to receive said neural stimulator lead.

14. The apparatus of claim 8, wherein said introducer includes means for splitting said introducer along a longitudinal axis thereof such that said introducer can be removed from said flexible member after said flexible member has been inserted in and through said cannula of said introducer.

15. The apparatus of claim 14, wherein said means for splitting includes a weakened portion of said introducer.

16. The apparatus of claim 15, wherein said weakened portion extends longitudinally of said elongate cannula of said introducer.

17. The apparatus of claim 15, wherein said weakened portion comprises a score line.

18. The apparatus of claim 17, wherein said means for splitting also includes a pair of handles attached to the elongate cannula of said introducer adjacent the end thereof opposite the aforementioned end, said score line extending between said handle.

19. The apparatus of claim 14, wherein said means for splitting includes a pair of handles attached to the elongate cannula of said introducer adjacent the end thereof opposite the aforementioned end.

20. The apparatus of claim 14, wherein said flexible member includes an end thereon opposite the end which is positioned in the epidural space and which is larger in cross-section than the flexible member, and said introducer may be withdrawn from the patient'"'"'s body along said flexible member and split away from said flexible member before said introducer reaches said end.