Instrument and method for delivery of anaesthetic drug

• US 6,973,346 B2
• Filed: 07/02/2002
• Issued: 12/06/2005
• Est. Priority Date: 03/13/2000
• Status: Expired due to Term

• Current Assignee: Arrow International, LLC (Teleflex Incorporated)
• Original Assignee: Arrow International Incorporated (Teleflex Incorporated)
• Inventors: Boezaart, Andre, Syrucek, Michal, Hafer, Fred
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US10/188,605
• Publication Number:
  US 20020198568A1
• Time in Patent Office: 1,253 Days
• Field of Search: 607/3, 607/116, 607/117, 607/118, 607/120, 607/127, 604/21, 604/117, 604/501, 604/503, 604/506, 600/554
• US Class Current: 604/21
• 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 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

A needle and catheter system, including components, is provided such that the position of an epidural needle may be identified after insertion into the body of a patient by electrically stimulating and thus locating a specific nerve.When a specific nerve is located, the catheter is inserted through the needle to a point slightly beyond the distal tip of the needle. The catheter tip may then be manipulated and the optimum position for the catheter tip determined by applying an electrical voltage through the helical wire to the proximal tip of the helical wire, this electrical stimulation being utilized in locating the specific location of the catheter tip within the nerve. Once optimum placement is achieved, the catheter is utilized for continuous administration of anaesthetic. A catheter adapter is utilized to allow easy access to the catheter and introduction of fluid into the nerve of the patient through the catheter tip. The catheter and catheter adapter are also provided with components so that the catheter adapter can be in place for during electrical stimulation of the target nerve.

Claims

1. A method for delivery of an anaesthetic drug into a fascia sheath of a nerve, comprising the steps of:

a. providing a needle assembly comprising a needle capable of conveying a first electrical impulse from a proximal end to a distal tip of the needle and an electrically insulating coating over a portion of an outer surface of the needle between the proximal end and the distal tip;

b. inserting the distal tip of the needle to a position proximate the nerve;

c. applying the first electrical impulse to the proximal end of the needle which first impulse is conveyed to the distal tip of the needle to confirm the appropriate placement of the distal tip;

d. piercing the fascia sheath of the nerve with the distal tip of the needle;

e. providing a wire located within a catheter, the wire capable of conveying a second electrical impulse from the proximal end of the catheter to the distal end of the catheter, a distal end of the wire terminating at an electrically conducting tip that extends beyond the distal end of the catheter, a proximal end of the wire accessible for application of the second electrical impulse;

f. inserting the distal end of the catheter into the proximal end of the needle assembly and advancing the catheter until electrically conducting tip extends distally of the distal tip of the needle, into a space adjacent the nerve and providing a catheter adapter on the proximal end of the catheter, the catheter adapter comprising an electrical contact which allows a source of electrical impulse to be attached through the catheter adapter to the proximal end of the catheter;

g. applying the second electrical impulse through the electrical contact of the catheter adapter to the proximal end of the wire which second impulse is conveyed to the electrically conducting tip and manipulating the location of the electrically conducting tip proximate the nerve to achieve the desired placement of the electrically conducting tip; and

h. administering an anaesthetic through the catheter to the nerve.

2. The method according to claim 1, further including the step of removing the needle assembly.

3. The method according to claim 2, wherein the removal of the needle assembly is accomplished while maintaining the placement of the electrically conducting tip of the catheter proximate the nerve.

4. The method according to claim 2, further including the step of securing the catheter with the electrically conducting tip of the catheter adjacent the nerve.

5. The method of claim 1 wherein:

a. the step of administering an anaesthetic is accomplished through the catheter adapter.

6. The method of claim 1 further comprising the step of:

a. the catheter adapter provides access to an inner lumen of the catheter; and

wherein the step of administering an anaesthetic is accomplished through the catheter adapter.

7. The method of claim 1 further comprising the steps of:

a. manipulating the catheter until the distal tip of the catheter comes into contact with an electrically conducting interior bore of the needle; and

b. conveying the second electrical pulse from the distal tip of the catheter to the electrically conducting interior bore of the needle which second pulse is conveyed to the distal tip of the needle.

8. A method for delivery of an anaesthetic drug to a nerve of a patient, comprising the steps of:

a. providing a needle assembly comprising a needle capable of conveying a first electrical impulse from a proximal end of the needle to a distal tip of the needle and an electrically insulating coating over a portion of an outer surface of the needle between the proximal end and the distal tip;

b. inserting the distal tip of the needle through a first portion of skin of the patient to a position proximate the nerve;

c. applying the first electrical impulse to the proximal end of the needle which first impulse is conveyed to the distal tip of the needle to confirm the appropriate placement of the distal tip;

d. providing a catheter, the catheter capable of conveying a second electrical impulse from a proximal end of the catheter to a distal tip of the catheter and providing a catheter adapter on a proximal end of the catheter, the catheter adapter comprising an electrical contact which allows a source of electrical impulse to be attached through the catheter adapter to the proximal end of the catheter;

e. inserting the distal tip of the catheter into the proximal end of the needle and advancing the catheter until the distal tip of the catheter extends distally of the distal tip of the needle;

f. applying the second electrical impulse through the electrical contact of the catheter adapter to the proximal end of the catheter which second impulse is conveyed to the distal tip of the catheter and manipulating the location of the distal tip of the catheter proximate the nerve to achieve the desired placement of the distal tip of the catheter; and

g. administration of an anaesthetic through the catheter to the nerve.

9. The method according to claim 8, further including the step of removing the needle assembly while maintaining the placement of the distal tip of the catheter proximate the nerve.

10. The method of claim 9, further including the step of securing the catheter in place by:

a. inserting the distal tip of the needle at a second portion of the skin of the patient proximate the first portion of the skin of the patient;

b. advancing the distal tip of the needle to exit the skin of the patient from the inside;

c. feeding the proximal end of the catheter into the distal tip of the needle; and

d. removing the needle from the patient, thus leaving the catheter tunneled subcutaneously between the skin portion where the needle exited and the second skin portion.

11. The method of claim 10 wherein the skin portion where the needle exited and the first portion of skin are identical.

12. The method of claim 9 wherein a portion of the catheter external to patient is covered with a dressing.

13. The method of claim 8 wherein:

a. the catheter adapter comprises

i. a hub for frictionally gripping the catheter; and

ii. an access port fluidly connected to an inner lumen of the catheter, the access port being dimensioned to allow access to the inner lumen of the catheter.

14. The method of claim 13 further including the step of attaching an anaesthetic supply device to the access port of the catheter adapter.

15. The method of claim 13 further comprising the step of actuating the catheter adapter such that the catheter is frictionally gripped by the catheter adapter.

16. The method of claim 15 wherein the step of actuating the catheter adapter further comprising forming electrical connection between the catheter adapter and the proximal end of the catheter.

17. The method of claim 8 further comprising the steps of:

a. manipulating the catheter until the distal tip of the catheter comes into contact with an electrically conducting interior bore of the needle; and

b. conveying the second electrical pulse from the distal tip of the catheter to the electrically conducting interior bore of the needle which second pulse is conveyed to the distal tip of the needle.

18. The method of claim 8 wherein:

a. the step of administering an anaesthetic is accomplished through the catheter adapter.

19. A method for delivery of an anaesthetic drug to a nerve of a patient, comprising the steps of:

a. providing a needle assembly comprising a needle capable of conveying a first electrical impulse from a proximal end of the needle to a distal tip of the needle and an electrically insulating coating over a portion of an outer surface of the needle between the proximal end and the distal tip;

b. inserting the distal tip of the needle into the patient to a position proximate the nerve;

c. applying the first electrical impulse to the proximal end of the needle which first impulse is conveyed to the distal tip of the needle to confirm the appropriate placement of the distal tip;

d. providing a catheter, the catheter capable of conveying a second electrical impulse from a proximal end of the catheter to a distal tip of the catheter;

e. inserting the distal tip of the catheter into the proximal end of the needle;

manipulating the catheter until the distal tip of the catheter comes into contact with an electrically conducting interior bore of the needle;

g. conveying the second electrical pulse from the distal tip of the catheter to the electrically conducting interior bore of the needle which second pulse is conveyed to the distal tip of the needle; and

h. administration of an anaesthetic through the catheter to the nerve.

20. The method according to claim 19, further comprising the step of providing a catheter adapter comprising a receptacle for receiving and holding the proximal end of the catheter, a connection portion for attaching an anaesthetic supply device to the catheter adapter and a bore connecting the connection portion and receptacle such that the anaesthetic drug may flow from the connection portion, through the receptacle and into the catheter.

21. The method according to claim 19, further comprising the step of:

a. providing a catheter adapter comprising a hub for frictionally gripping the catheter and an access port fluidly connected to an inner lumen of the catheter, the access port being dimensioned to allow access to the inner lumen of the catheter; and

the method further comprising the step of;

b. actuating the catheter adapter such that the catheter is frictionally gripped by the catheter adapter.

22. The method according to claim 19, further including the step of removing the needle assembly.

23. The method according to claim 19 further comprising the step of providing a catheter adapter comprising an electrical contact which allows a source of electrical impulse to be attached through the catheter adapter to the proximal end of the catheter.

24. The method according to claim 19, further comprising the steps of:

a. advancing the catheter until the distal tip of the catheter extends distally of the distal tip of the needle; and

b. manipulating the location of the distal tip of the catheter proximate the nerve to achieve the desired placement of the distal tip of the catheter.

25. A method for delivery of an anaesthetic drug to a nerve of a patient, comprising the steps of:

a. providing a needle assembly comprising a needle and an electrically insulating coating over a portion of an outer surface of the needle between a proximal end and a distal tip of the needle;

b. inserting the distal tip of the needle into the patient to a position proximate the nerve;

c. providing a catheter, the catheter capable of conveying an electrical impulse from a proximal end of the catheter to a distal tip of the catheter;

d. connecting a catheter adapter to the proximal end of the catheter, the catheter adapter comprising an electrical contact which allows a source of electrical impulse to be attached through the catheter adapter to the proximal end of the catheter, the catheter adapter also providing access to the lumen of the catheter;

e. inserting the distal tip of the catheter into the proximal end of the needle;

f. applying the electrical impulse through the electrical contact of the catheter adapter to the proximal end of the catheter which impulse is conveyed to the distal tip of the catheter; and

g. administration of an anaesthetic through the catheter adapter and the catheter, to the nerve.

26. The method according to claim 25, further comprising the step of:

a. advancing the catheter until the distal tip of the catheter is in electrically conducting contact with an electrically conducting central bore of the needle, such that the second electrical impulse applied to the proximal end of the catheter is conveyed to the distal tip of the needle.

27. The method according to claim 25, further comprising the steps of:

a. advancing the catheter until the distal tip of the catheter extends distally of the distal tip of the needle; and

b. manipulating the location of the distal tip of the catheter proximate the nerve to achieve the desired placement of the distal tip of the catheter.

28. The method according to claim 25, wherein the catheter adapter comprising a receptacle for receiving and holding the proximal end of the catheter, a connection portion for attaching an anaesthetic supply device to the catheter adapter and a bore connecting the connection portion and receptacle such that the drug may flow from the connection portion, through the receptacle and into the catheter.

29. The method according to claim 25, wherein the catheter adapter comprising a hub for frictionally gripping the catheter and an access port fluidly connected to tan inner lumen of the catheter, the access port being dimensioned to allow access to the inner lumen of the catheter;

and the method further comprising the step of;

a. actuating the catheter adapter such that the catheter is frictionally gripped by the catheter adapter.

30. The method according to claim 25, further including the step of removing the needle assembly.

31. The method according to claim 30, wherein the removal of the needle assembly is accomplished while maintaining the placement of the distal tip of the catheter within the fascia sheath of the nerve.