Stylet Handle Attachment Device

• US 20090292259A1
• Filed: 11/21/2008
• Published: 11/26/2009
• Est. Priority Date: 11/21/2007
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Wayman, Annica, Delano, Peter George, Wong, Andrew, Meehan, Michael, D'Arrigo, Christina
• Granted Patent: US 9,259,553 B2
• Time in Patent Office: Days
• US Class Current: 604/263
• 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. 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;

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 engagement of the first engagement portion of the needle hub and the second engagement portion of the stylet handle forms a positive lock.

2. The hub assembly of claim 1, wherein the first engagement portion is a recess and the second engagement portion is a protrusion adapted for releasable receipt within the recess.

3. The hub assembly of claim 2, wherein the recess further comprises a shoulder and the protrusion further comprises a restraining end engageable with the shoulder when the needle hub and stylet handle form a positive lock.

4. The hub assembly of claim 2, wherein the restraining end of the protrusion 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.

5. The hub assembly of claim 4, wherein the insertion contact surface extends from at least one of laterally or radially from a longitudinal axis of the protrusion and is inclined in the direction from distal end of the restraining end to the proximal end of the restraining end, and wherein the removal contact surface extends from at least one of laterally or radially from the longitudinal axis of the protrusion and is inclined in the direction from the proximal end of retraining end to the distal end of the restraining end.

6. The hub assembly of claim 4, wherein the recess comprises a first portion for engaging the insertion contact surface of the protrusion during transition of the protrusion from the unlocked position to the positive lock, and a second portion for engaging the removal contact surface of the protrusion during transition of the protrusion from the positive lock to the unlocked position.

7. The hub assembly of claim 2, 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.

8. The hub assembly of claim 7, wherein at least one of the first beam and the second beam is adapted to transition from one of an unlocked position and a positive lock to the other of the unlocked position and the positive lock.

9. The hub assembly of claim 7, wherein the first beam and second beam are deflected toward each other during transition of the protrusion from one of an unlocked position and a positive lock to the other of the unlocked position and the positive lock.

10. The hub assembly of claim 9, wherein each of the first beam and the second beam are adapted to deflect from about 0.005 inch to about 0.010 inch during transition from one of the unlocked position and the positive lock to the other of the unlocked position and the positive lock.

11. The hub assembly of claim 7, wherein the first 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, 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.

12. The hub assembly of claim 11, 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 the 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.

13. The hub assembly of claim 11, wherein the insertion contact surface of the first beam and the insertion contact surface of the second beam extend laterally from a longitudinal axis of the protrusion and are inclined in opposing directions from the distal end of the restraining end to the proximal end of the restraining end.

14. The hub assembly of claim 11, wherein the removal contact surface of the first beam and the removal contact surface of the second beam extend laterally from a longitudinal axis of the protrusion and are inclined in opposing directions from the proximal end of the restraining end to the distal end of the restraining end.

15. The hub assembly of claim 2, wherein the needle hub and the stylet handle are adapted to transition between one of an unlocked position and a 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.

16. The hub assembly of claim 15, 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.

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

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

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

20. The hub assembly of claim 18, wherein the transparent portion has a substantially parabolic curvature.

21. A needle assembly, comprising:

a cannula having 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;

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

wherein engagement of the first engagement portion and the second engagement portion forms a positive lock 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.

22. The needle assembly of claim 21, wherein the first engagement portion is a recess and the second engagement portion is a protrusion adapted for releasable receipt within the recess, wherein the recess further comprises a shoulder and the protrusion further comprises a restraining end engageable with the shoulder when the needle hub and stylet handle form a positive lock.

23. The needle assembly of claim 22, 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.

24. The needle assembly of claim 23, wherein the first beam and second beam are deflected toward each other during transition of the protrusion from one of an unlocked position and a positive lock to the other of the unlocked position and the positive lock.

25. The needle assembly of claim 23, wherein the first 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, 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.

26. The needle assembly of claim 25, 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 the 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.

27. The needle assembly of claim 21, wherein the needle hub and the stylet handle are adapted to transition between one of an unlocked position and a 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.

28. The needle assembly of claim 21, wherein at least one of engagement or disengagement of the first engagement portion the second engagement portion produces an audible, visual or tactual indicator evidencing one of the unlocked position or positive lock of the needle hub and the stylet handle.

29. The needle assembly of claim 21, wherein the disengagement force is less than a drag force of the cannula within a human tissue sample.

30. The needle assembly of claim 21, wherein the cannula is an 18 G needle and the disengagement force is at least greater than 0.25 lbs.

31. The needle assembly of claim 30, wherein the disengagement force is less than 0.45 lbs.

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

33. The needle assembly of claim 32, wherein the disengagement force is less than 0.27 lbs.

34. The needle assembly of claim 21, further comprising a needle guard circumferentially disposed about a portion of the needle and at least partially disposable within a portion of the needle hub.

35. A needle assembly, comprising:

a cannula having 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 the 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;

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 the orientation of the beveled distal end of the stylet;

wherein engagement of the first engagement portion and the second engagement portion is permitted only when the first directional indicator and the second directional indicator are provided in mating orientation.

36. The needle assembly of claim 35, wherein 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.

37. The needle assembly of claim 35, wherein engagement of the first engagement portion and the second engagement portion forms a positive lock.

38. The needle assembly of claim 37, wherein at least one of formation of the positive lock and disengagement of the positive lock produces an audible, visual or tactual indicator evidencing one of the unlocked position or positive lock of the needle hub and the stylet handle.