Devices, systems and methods for determining proper placement of epidural catheters

• US 6,190,370 B1
• Filed: 02/26/1999
• Issued: 02/20/2001
• Est. Priority Date: 07/25/1997
• Status: Expired due to Term

• Current Assignee: Pajunk GmbH & Co. KG Besitzverwaltung, Arrow International, LLC (Teleflex Incorporated)
• Original Assignee: Arrow International Incorporated (Teleflex Incorporated)
• Inventors: Tsui, Ban C. H.
• Primary Examiner(s): Nguyen, Anhtuan T.
• Application Number:
  US09/269,155
• Time in Patent Office: 725 Days
• Field of Search: 604/117, 604/20, 604/164.01, 604/164.09, 604/158, 604/162, 604/503, 604/505, 604/508, 604/512, 604/22, 604/164.11, 607/117, 607/101, 128/898, 606/41, 606/42
• US Class Current: 604/508
• 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: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36021 for treatment of pain

Abstract

Methods and systems for determining the proper placement of an epidural catheter prior to administration of anesthetic is described. In a preferred embodiment, an aqueous fluid is introduced into an epidural catheter that has been inserted into the spine of a subject. Motor reactions by the subject in response to electrical current applied through the aqueous solution is monitored. By monitoring the motor response with respect to electrical stimulation, the proper placement of an epidural catheter can be differentiated from the placement of the catheter in subarachnoid, subcutaneous or epidural intravascular placement. Additionally, in the preferred embodiment, a wire is disposed within the catheter tube to facilitate the passage of electric current. However, to avoid electrochemical reaction of the wire with the aqueous solution and/or the subject'"'"'s dural tissue, the wire does not extend completely to the distal end of the catheter tube.

Claims

1. A method for confirming the placement of a catheter in an epidural space of a spine of a subject, comprising:

(A) providing;

(i) a subject in need of having a catheter inserted in the spine;

(ii) a catheter having first and second ends;

(iii) an aqueous solution capable of conducting electricity and suitable for administration in the epidural space of said spine of said subject; and

(iv) an electrical conduction means;

(B) contacting the epidural space of said spine of said subject with said first end of said catheter,

(C) attaching said electrical conduction means to said second end of said catheter;

(D) administering said aqueous solution through said catheter into said epidural space; and

(E) conducting electricity with said electrical conduction means under conditions such that said aqueous solution conducts electricity to said epidural space.

2. The method of claim 1, further comprising the step f) measuring the motor response of said subject caused by said conducting of electricity.

3. The method of claim 1, wherein said electrical conduction means comprises a connector configured for attachment to said second end of said catheter and having a conductive element in communication with a source of electricity.

4. The method of claim 1, wherein said subject is unable to communicate.

5. The method of claim 4, wherein said subject is unconscious.

6. The method of claim 1, wherein said aqueous solution comprises a saline solution.

7. The method of claim 1, wherein said aqueous solution comprises an epimorphine solution.

8. A method for confirming the placement of a catheter in an epidural space of a spine of a subject, comprising:

(A) providing;

(i) a subject in need of having a catheter inserted in the spine;

(ii) a non-metal-containing catheter having first and second ends;

(iii) an aqueous solution capable of conducting electricity and suitable for administration in the epidural space of said spine of said subject; and

(iv) a connector configured for attachment to said second end of said catheter, said connector having a conductive element in communication with a source of electricity;

(B) contacting the epidural space of said spine of said subject with said first end of said catheter;

(C) attaching said connector to said second end of said catheter;

(D) administering said aqueous solution through said catheter into said epidural space;

(E) conducting electricity with said conductive element of said connector under conditions such that said aqueous solution conducts electricity to said epidural space; and

(F) measuring the motor response of said subject caused by said conducting of electricity.

9. The method of claim 8, further comprising the step g) administering anesthetic to said subject.

10. The method of claim 8, wherein said subject is unable to communicate.

11. The method of claim 10, wherein said subject is unconscious.

12. The method of claim 8, wherein said aqueous solution comprises a saline solution.

13. The method of claim 8, wherein said aqueous solution comprises epimorphine solution.

14. A method for confirming the placement of a catheter in an epidural space of a spine of a subject, comprising:

(A) providing;

(i) a subject in need of having a catheter inserted in the spine;

(ii) a catheter having first and second ends, said catheter comprising a metal element disposed the length of said catheter and housed completely within said catheter such that no metal is exposed outside said first end of said catheter;

(iii) an aqueous solution capable of conducting electricity and suitable for administration in the epidural space of said spine of said subject; and

(iv) a connector configured for attachment to said second end of said catheter, said connector having a conductive element in communication with a source of electricity;

(B) contacting the epidural space of said spine of said subject with said first end of said catheter;

(C) attaching said connector to said second end of said catheter;

(D) administering said aqueous solution through said catheter into said epidural space;

(E) conducting electricity with said conductive element of said connector under conditions such that said aqueous solution conducts electricity to said epidural space; and

(F) measuring the motor response of said subject caused by said conducting of electricity.

15. The method of claim 14, further comprising the step g) administering an anesthetic to said subject.

16. The method of claim 14, wherein said metal comprises a wire disposed within said catheter.

17. The method of claim 16, wherein said wire contacts said connector.

18. The method of claim 14, wherein said subject is unable to communicate.

19. The method of claim 18, wherein said subject is unconscious.

20. The method of claim 14, wherein said aqueous solution comprises a saline solution.

21. The method of claim 14, wherein said aqueous solution comprises epimorphine solution.

22. The method as claimed in claim 14 wherein the metal element is comprised of a removable hollow needle such that fluids may be conducted therethrough to a distal end of the needle, wherein the distal end of the needle defines the distal end of the catheter for contacting the epidural space of the spine of the subject and wherein the conducting step is comprised of conducting electricity to the distal end of the catheter via aqueous solution.

29. The method as claimed in claim 14 wherein the catheter is comprised of a hollow needle such that fluids may be conducted therethrough to a distal end of the needle, wherein the distal end of the needle defines the distal end of the catheter for contacting the epidural space of the spine of the subject and wherein the conducting step is comprised of conducting electricity to the distal end of the needle via aqueous solution.

30. The method as claimed in claim 29 wherein the needle includes an insulating coating about at least a portion of the needle.

31. The method as claimed in claim 30 wherein the subject is unable to communicate.

32. The method as claimed in claim 31 wherein the subject is unconscious.

23. A method for confirming the placement of a catheter in an epidural space of a spine of a subject, the catheter having a proximal end and a distal end, the method comprising the steps of:

(A) inserting the distal end of the catheter into the spine of the subject for contact with the epidural space;

(B) injecting into the epidural space an aqueous solution capable of conducting electricity and suitable for administration in the epidural space;

(C) conducting electricity to the distal end of the catheter under conditions such that the aqueous solution conducts the electricity to the epidural space; and

(D) observing an involuntary motor response of the subject caused by conducting the electricity to the distal end of the catheter in order to confirm the placement of the catheter in the epidural space.

24. The method as claimed in claim 23 further comprising the step of administering an anesthetic to the subject.

25. The method as claimed in claim 23 wherein electricity is conducted to the distal end of the catheter at least in part by electrical conduction means.

26. The method as claimed in claim 25 wherein the electrical conduction means is comprised of a conductive element in communication with a source of electricity.

27. The method as claimed in claim 26 wherein the conductive element is comprised of a metal element disposed within the catheter.

28. The method as claimed in claim 23 further comprising the step of adjusting the position of the catheter such that the distal end of the catheter contacts the epidural space of the spine of the subject.