Variable extension combined spinal/epidural needle set and method for its use

• US 6,245,044 B1
• Filed: 07/17/1998
• Issued: 06/12/2001
• Est. Priority Date: 07/17/1998
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Marsh, Ronald W., Daw, Sean P.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/118,269
• Time in Patent Office: 1,061 Days
• Field of Search: 604/158-167, 604/256, 604/264, 604/272-274
• US Class Current: 604/158
• 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 2017/347 Locking means, e.g. for locking instrument in cannula
• CPC Class Codes: A61M 2025/0007 Epidural catheters

Abstract

An epidural needle has an elongate tube defining a longitudinal axis having a proximal end, a distal end and an axial hollow bore having an inside diameter therethrough. The needle has a hub with a proximal end, a distal end and an open passageway having an inside diameter substantially similar to the hollow bore therethrough, the distal end of the hub being fixedly attached to the proximal end of the elongate tube so that the hollow bore of the elongate tube is in fluid communication and substantial axial alignment with the open passageway. The hub further has a cavity disposed between the proximal end and the distal end of the hub. There is a resilient member with an opening therethrough that has an inner diameter substantially similar to the inside diameter of the hollow bore disposed in the cavity so that the opening is substantially axially aligned and in fluid communication with the open passageway. The hub of the epidural needle of the invention has a clamp with a releasable latch disposed about the resilient member. The clamp is selectively movable between an open position wherein the inner diameter of the resilient member is substantially unaffected, a clamp position wherein the clamp causes a strain to the resilient member and thereby reduces the inner diameter of the opening through the resilient member. The clamp also has a latch position where the latch releasably retains the clamp in the clamp position.

Claims

1. An epidural needle having a hollow bore therethrough useful for releasably fixing a position of a spinal needle disposed within the bore of the epidural needle comprises:

an elongate tube defining a longitudinal axis having a proximal end, a distal end and an axial hollow bore having an inside diameter therethrough;

a hub having a proximal end, a distal end and an open passageway having an inside diameter substantially similar to said hollow bore therethrough, said distal end of said hub being fixedly attached to said proximal end of said elongate tube so that said hollow bore of said elongate tube is in fluid communication and substantial axial alignment with said open passageway, said hub further having a cavity therein disposed between said proximal end and said distal end of said hub;

a resilient member having an opening therethrough with an inner diameter, substantially similar to said inside diameter of said hollow bore, said resilient member disposed in said cavity so that said opening is substantially axially aligned and in fluid communication with said open passageway; and

a clamp having a releasable latch disposed about said resilient member, said clamp being selectively movable between an open position wherein said inner diameter of said resilient member is substantially unaffected, a clamp position wherein said clamp causes a strain to at least a portion of said resilient member thereby reducing said inner diameter of said opening through at least a portion of said resilient member, and a latch position wherein said latch releasably retains said clamp in said clamp position; and

wherein a practitioner using said epidural needle to position a spinal needle having an outside diameter less than said inside diameter of said hollow tube may freely axially move the spinal needle within said hollow bore with respect to said epidural needle and fix a position of the spinal needle relative to said epidural needle by said reduction of said inner diameter of said opening through said resilient member to a diameter less than the outside diameter of the spinal needle by movement of said clamp to said clamp position and said latch position thereby to grasp releasably the spinal needle sufficiently to fix the relative position of the spinal needle.

2. The epidural needle of claim 1 wherein said distal end of said elongate tube comprises a point suitable for penetration of mammalian tissue.

3. The epidural needle of claim 1 wherein said at least a portion of said clamp projects outwardly from said hub to facilitate the practitioner'"'"'s selective movement of said clamp between said open position, said clamp position and said latch position.

4. The epidural needle of claim 3 wherein said portion of said clamp that projects outwardly from said hub is sized and shaped to allow the practitioner to apply digital pressure for said selective movement of said clamp between said open position, said clamp position and said latch position.

5. The epidural needle of claim 4 wherein said portion of said clamp that projects outwardly from said hub further includes said releasable latch for selectively retaining said clamp in said clamp position.

6. The epidural needle of claim 1 wherein said hub further includes at least one outwardly projecting wing substantially transverse to said axis, said at least one wing being useful to facilitate the practitioner'"'"'s placement of said epidural needle.

7. The epidural needle of claim 1 wherein said resilient member is formed from a resilient material selected from the group consisting of natural rubber, synthetic rubber, silicone rubber, polyurethane and ethylene propylene diene monomer (EPDM).

8. The epidural needle of claim 7 wherein said resilient material has a Shore A durometer between about 30 and about 80.

9. The epidural needle of claim 7 wherein said resilient member forms a substantially air and fluid tight seal between said epidural needle hub and an outside surface of said spinal needle when said clamp is positioned in said clamp position and said latch position.

10. The epidural needle of claim 1 wherein said proximal end of said hub further comprises an attachment for a fluid handling device.

11. The epidural needle of claim 10, wherein said resilient member is disposed in said hub so that said bore of said epidural needle is in substantially fluid tight communication with said attachment for said fluid handling device.

12. The epidural needle of claim 10 wherein said attachment for the fluid handling device comprises a female luer fitting.

13. The epidural needle of claim 1 wherein said hub further comprises a first portion and a second portion, said portions being joined together after placement of said resilient member in said cavity.

14. A method for releasably fixing a position of a spinal needle disposed within the bore of an epidural needle comprises:

providing an epidural needle including an elongate tube defining a longitudinal axis, said tube having a proximal end, a distal end and an axial hollow bore having an inside diameter therethrough, a hub having a proximal end, a distal end and an open passageway having an inside diameter substantially similar to said hollow bore therethrough, said distal end of said hub being fixedly attached to said proximal end of said elongate tube so that said hollow bore of said elongate tube is in fluid communication and substantial axial alignment with said open passageway and wherein said open hub further having a cavity disposed between said proximal end and said distal end of said hub, a resilient member having an opening therethrough with an inner diameter, substantially similar to said inside diameter of said hollow bore, said resilient member disposed in said cavity so that said opening is substantially axially aligned and in fluid communication with said open passageway, and a clamp having a releasable latch disposed about said resilient member, said clamp being selectively movable between an open position wherein said inner diameter of said resilient member is substantially unaffected, a clamp position wherein said clamp causes a strain to said resilient member thereby reducing said inner diameter of said opening through said resilient member, and a latch position wherein said latch releasably retains said clamp in said clamp position;

placing a spinal needle having an outside diameter less than said inside diameter of within said hollow bore of said epidural needle;

selecting a position of said spinal needle relative to said epidural needle; and

fixing a position of said spinal needle relative to said epidural needle by moving of said clamp to said clamp position and said latch position thereby releasably fixing said position of said spinal needle relative to said epidural needle.

15. A combined spinal epidural needle set comprises:

an epidural needle including an elongate tube defining a longitudinal axis having a proximal end, a distal end and an axial hollow bore having an inside diameter therethrough, said epidural needle having a hub having a proximal end, a distal end and an open passageway having an inside diameter substantially similar to said hollow bore therethrough, said distal end of said hub being fixedly attached to said proximal end of said elongate tube so that said hollow bore of said elongate tube is in fluid communication and substantial axial alignment with said open passageway and wherein said hub further having a cavity disposed between said proximal end and said distal end of said hub, a resilient member having an opening therethrough with an inner diameter, substantially similar to said inside diameter of said hollow bore, said resilient member disposed in said cavity so that said opening is substantially axially aligned and in fluid communication with said open passageway, and a clamp having a releasable latch disposed about said resilient member, said clamp being selectively movable between an open position wherein said inner diameter of said resilient member is substantially unaffected, a clamp position wherein said clamp causes a strain to said resilient member thereby reducing said inner diameter of said opening through said resilient member, and a latch position wherein said latch releasably retains said clamp in said clamp position; and

a spinal needle having an outside diameter less than said inside diameter of said hollow tube disposed within said hollow bore, and wherein a practitioner using said epidural needle to position said spinal needle may freely axially move said spinal needle within said hollow bore with respect to said epidural needle and fix a position of said spinal needle relative to said epidural needle by said reduction of said inner diameter opening through said resilient member to a diameter less than said outside diameter of the spinal needle by movement of said clamp to said clamp position and said latch position thereby to grasp releasably the spinal needle sufficiently to fix the position.

16. The combined spinal epidural needle set of claim 15 further comprising a stylet sized and shaped to fit removably within and substantially occlude said hollow bore of said epidural needle.

17. The combined spinal epidural needle set of claim 15 further comprising a stylet sized and shaped to fit removably within and substantially occlude a bore of said spinal needle.

18. The combined spinal epidural needle set of claim 17 wherein each of said hub of said epidural needle, a hub of said spinal needle, a hub of said epidural needle stylet and a hub of said spinal needle stylet have a size and shape and are disposed to be engaged with one another to facilitate a practitioner'"'"'s manipulation of said set during a procedure.

19. The combined spinal epidural needle set of claim 15 being placed in a package formed from materials substantially resistant to the passage of microorganisms and exposed to conditions that render substantially any microorganisms inside said package non-viable.