Stylet handle attachment device

• US 9,259,553 B2
• Filed: 11/21/2008
• Issued: 02/16/2016
• Est. Priority Date: 11/21/2007
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Delano, Peter George, Wong, Andrew, Meehan, Michael, D'Arrigo, Christina, Wayman, Annica
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): PATEL, SHEFALI DILIP
• Application Number:
  US12/275,636
• Publication Number:
  US 20090292259A1
• Time in Patent Office: 2,643 Days
• Field of Search: 604/164.07, 604/164.01, 604/158, 604/165.03, 604/162, 604/164.06, 604/164.08, 604/165.01, 604/165.02, 604/165.04, 600/567, 600/564
• US Class Current: 1/1
• 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 2017/00455 Orientation indicators, e.g. recess on the handle
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters

Abstract

A hub assembly, such as for long needles, is disclosed. The hub assembly includes a needle hub having a proximal end and a distal end, having a cannula extending therethrough and protruding from the distal end, with the needle hub having a first engagement portion. The hub assembly also includes a stylet handle having a stylet extending therefrom. The stylet is adapted to be received within a portion of the cannula, with the stylet handle having a second engagement portion. An engagement of the first engagement portion of the needle hub and the second engagement portion of the stylet handle forms a positive lock in which at least a portion of one of the first and second engagement portions is held within the other of the first and second engagement portions in an unbiased state.

Claims

1. A hub assembly, comprising:

a needle hub having a proximal end and a distal end, having a cannula extending therethrough and protruding from the distal end, the needle hub having a first engagement portion; and

a stylet handle having a stylet extending therefrom, the stylet adapted to be received within a portion of the cannula, the stylet handle having a second engagement portion;

wherein an engagement of the first engagement portion of the needle hub and the second engagement portion of the stylet handle forms a positive lock, which restricts the first engagement portion from separating from the second engagement portion in a longitudinal direction,

wherein the first engagement portion is a recess and the second engagement portion is a protrusion for releasable receipt within the recess,

wherein the protrusion comprises a first beam and a second beam spaced apart from the first beam, the second beam extending along and substantially parallel to the first beam,

wherein the first beam comprises an insertion contact surface adjacent a distal end of the stylet handle and a removal contact surface proximally spaced from the insertion contact surface, and the second beam comprises an insertion contact surface adjacent the distal end of the stylet handle and a removal contact surface proximally spaced from the insertion contact surface of the second beam, the removal contact surface of the first beam and the removal contact surface of the second beam being inclined relative to a longitudinal axis of the protrusion,

wherein the recess further comprises a shoulder and the protrusion further comprises a restraining end engageable with the shoulder when the needle hub and the stylet handle form the positive lock, and

wherein the recess comprises a first portion for engaging the insertion contact surface of the first beam and the insertion contact surface of the second beam during transition of the protrusion from an unlocked position to the positive lock, and a second portion for engaging the removal contact surface of the first beam and the removal contact surface of the second beam during transition of the protrusion from the positive lock to the unlocked position.

2. The hub assembly of claim 1, wherein the insertion contact surface of the first beam and the insertion contact surface of the second beam extends from at least one of laterally or radially from the longitudinal axis of the protrusion and is are inclined in a direction from a distal end of the restraining end to a proximal end of the restraining end, and wherein the removal contact surface of the first beam and the removal contact surface of the second beam extend from at least one of laterally or radially from the longitudinal axis of the protrusion and are inclined in a direction from the proximal end of the restraining end to the distal end of the restraining end.

3. The hub assembly of claim 1, wherein at least one of the first beam and the second beam is adapted to transition from one of the unlocked position and the positive lock to the other of the unlocked position and the positive lock.

4. The hub assembly of claim 1, wherein the first beam and the second beam are deflected toward each other during transition of the protrusion from one of the unlocked position and the positive lock to the other of the unlocked position and the positive lock.

5. The hub assembly of claim 4, wherein each of the first beam and the second beam is adapted to deflect from about 0.005 inches to about 0.010 inches during transition from one of the unlocked position and the positive lock to the other of the unlocked position and the positive lock.

6. The hub assembly of claim 1, wherein the insertion contact surface of the first beam and the insertion contact surface of the second beam extend laterally from the longitudinal axis of the protrusion and are inclined in opposing directions from a distal end of the restraining end to a proximal end of the restraining end.

7. The hub assembly of claim 1, wherein the removal contact surface of the first beam and the removal contact surface of the second beam extend laterally from the longitudinal axis of the protrusion and are inclined in opposing directions from a proximal end of the restraining end to a distal end of the restraining end.

8. The hub assembly of claim 1, wherein the needle hub and the stylet handle are adapted to transition between one of the unlocked position and the positive lock and the other of the unlocked position and the positive lock, and wherein the protrusion is in a non-deflected orientation in both the unlocked position and the positive lock.

9. The hub assembly of claim 8, wherein the protrusion is deflected against a portion of the recess during transition from one of the unlocked position and the positive lock to the other of the unlocked position and the positive lock.

10. The hub assembly of claim 1, wherein the first engagement portion is oriented on a first side of the needle hub and the second engagement portion is oriented on a first side of the stylet handle, such that the needle hub and the stylet handle may only form the positive lock when the first side of the needle hub and the first side of the stylet handle are aligned adjacent each other.

11. The hub assembly of claim 1, wherein at least one of the engagement or a disengagement of the first engagement portion and the second engagement portion produces an audible, visual or tactual indicator evidencing one of the unlocked position or the positive lock of the needle hub and the stylet handle.

12. The hub assembly of claim 1, wherein the needle hub further comprises a transparent portion to indicate fluid flow through the cannula.

13. The hub assembly of claim 12, wherein the transparent portion has a substantially parabolic curvature.

14. A needle assembly, comprising:

a cannula having a distal end adapted to penetrate a tissue sample, a proximal end, and a lumen extending between the distal end and the proximal end;

a needle hub connected to the proximal end of the cannula, the needle hub having a first engagement portion;

a stylet having a distal end and a proximal end, the stylet adapted to be received through the lumen; and

a stylet handle connected to the proximal end of the stylet, the stylet handle having a second engagement portion;

wherein an engagement of the first engagement portion and the second engagement portion forms a positive lock, which restricts the first engagement portion from separating from the second engagement portion in a longitudinal direction, the positive lock being formed between the needle hub and the stylet handle such that a disengagement force required to release the positive lock is greater than a force applied to the stylet during insertion of the distal end of the cannula in the tissue sample,

wherein the first engagement portion is a recess and the second engagement portion is a protrusion for releasable receipt within the recess,

wherein the protrusion comprises a first beam and a second beam spaced apart from the first beam, the second beam extending along and substantially parallel to the first beam,

wherein the first beam comprises an insertion contact surface adjacent a distal end of the stylet handle and a removal contact surface proximally spaced from the insertion contact surface, and the second beam comprises an insertion contact surface adjacent the distal end of the stylet handle and a removal contact surface proximally spaced from the insertion contact surface of the second beam, the removal contact surface of the first beam and the removal contact surface of the second beam being inclined relative to a longitudinal axis of the protrusion,

wherein the recess further comprises a shoulder and the protrusion further comprises a restraining end engageable with the shoulder when the needle hub and the stylet handle form the positive lock, and

wherein the recess comprises a first portion for engaging the insertion contact surface of the first beam and the insertion contact surface of the second beam during transition of the protrusion from an unlocked position to the positive lock, and a second portion for engaging the removal contact surface of the first beam and the removal contact surface of the second beam during transition of the protrusion from the positive lock to the unlocked position.

15. The needle assembly of claim 14, wherein the first beam and the second beam are deflected toward each other during transition of the protrusion from one of the unlocked position and the positive lock to the other of the unlocked position and the positive lock.

16. The needle assembly of claim 14, wherein the needle hub and the stylet handle are adapted to transition between one of the unlocked position and the positive lock and the other of the unlocked position and the positive lock, and wherein the protrusion is in a non-deflected orientation in both the unlocked position and the positive lock, and the protrusion is deflected against a portion of the recess during transition from one of the unlocked position and the positive lock to the other of the unlocked position and the positive lock.

17. The needle assembly of claim 14, wherein at least one of the engagement or a disengagement of the first engagement portion and the second engagement portion produces an audible, visual or tactual indicator evidencing one of the unlocked position or the positive lock of the needle hub and the stylet handle.

18. The needle assembly of claim 14, wherein the disengagement force is less than a drag force of the cannula within a human tissue sample.

19. The needle assembly of claim 14, wherein the cannula is an 18 G needle and the disengagement force is at least greater than 0.25 lbs.

20. The needle assembly of claim 14, wherein the disengagement force is less than 0.45 lbs.

21. The needle assembly of claim 14, wherein the cannula is a 22 G needle and the disengagement force is at least greater than 0.09 lbs.

22. The needle assembly of claim 14, wherein the disengagement force is less than 0.27 lbs.

23. The needle assembly of claim 14, further comprising a needle guard circumferentially disposed about a portion of the cannula and at least partially disposable within a portion of the needle hub.

24. A needle assembly, comprising:

a cannula having a beveled distal end adapted to penetrate a tissue sample, a proximal end, and a lumen extending between the distal end and the proximal end;

a needle hub connected to the proximal end of the cannula, the needle hub having a first engagement portion including a first directional indicator corresponding to an orientation of the beveled distal end of the cannula;

a stylet having a beveled distal end and a proximal end, the stylet adapted to be received through the lumen; and

a stylet handle connected to the proximal end of the stylet, the stylet handle having a second engagement portion including a second directional indicator corresponding to an orientation of the beveled distal end of the stylet;

wherein an engagement of the first engagement portion and the second engagement portion forms a positive lock, which restricts the first engagement portion from separating from the second engagement portion in a longitudinal direction, and is permitted only when the first directional indicator and the second directional indicator are provided in a mating orientation,

wherein the first engagement portion is a recess and the second engagement portion is a protrusion for releasable receipt within the recess,

wherein the protrusion comprises a first beam and a second beam spaced apart from the first beam, the second beam extending along and substantially parallel to the first beam,

wherein the first beam comprises an insertion contact surface adjacent a distal end of the stylet handle and a removal contact surface proximally spaced from the insertion contact surface, and the second beam comprises an insertion contact surface adjacent the distal end of the stylet handle and a removal contact surface proximally spaced from the insertion contact surface of the second beam, the removal contact surface of the first beam and the removal contact surface of the second beam being inclined relative to a longitudinal axis of the protrusion,

wherein the recess further comprises a shoulder and the protrusion further comprises a restraining end engageable with the shoulder when the needle hub and the stylet handle form the positive lock, and

wherein the recess comprises a first portion for engaging the insertion contact surface of the first beam and the insertion contact surface of the second beam during transition of the protrusion from an unlocked position to the positive lock, and a second portion for engaging the removal contact surface of the first beam and the removal contact surface of the second beam during transition of the protrusion from the positive lock to the unlocked position.

25. The needle assembly of claim 24, wherein the mating orientation of the first directional indicator and the second directional indicator substantially aligns the beveled distal end of the stylet with the beveled distal end of the cannula.

26. The needle assembly of claim 24, wherein at least one of a formation of the positive lock and a disengagement of the positive lock produces an audible, visual or tactual indicator evidencing one of the unlocked position or the positive lock of the needle hub and the stylet handle.