Syringe with disabling mechanism

• US 7,972,303 B2
• Filed: 06/12/2008
• Issued: 07/05/2011
• Est. Priority Date: 06/12/2007
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Wayman, Brian H., Caizza, Richard, Odell, Robert B.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): FLICK, JASON E
• Application Number:
  US12/137,854
• Publication Number:
  US 20090076450A1
• Time in Patent Office: 1,118 Days
• Field of Search: 604/110
• US Class Current: 604/110
• CPC Class Codes: A61M 2005/31516 reducing dead-space in the syringe barrel after delivery
• CPC Class Codes: A61M 2005/5026 allowing single filling of syringe
• CPC Class Codes: A61M 2005/5073 by breaking or rupturing the connection parts
• CPC Class Codes: A61M 5/502 for blocking the piston
• CPC Class Codes: A61M 5/5066 Means for preventing re-use by disconnection of piston and piston-rod

Abstract

Syringe assemblies having a passive disabling system to prevent reuse are provided. In one embodiment, the passive disabling system activates after completion of an injection cycle. An exemplary syringe assembly incorporates a stopper and plunger rod attached in a manner to prevent users from disassembling the syringe prior to completion of the injection cycle. The barrel may also include an annular extension or collar that extends from the proximal end of the barrel. In a specific configuration, the annular extension at least partially envelopes a portion of the thumb press to prevent the user from accessing the thumb press and moving the plunger rod in a proximal direction Syringe assemblies of one or more embodiments also include visual indicators or markers indicating whether a syringe assembly is used or the plunger rod is locked within the barrel.

Claims

1. A syringe assembly comprising:

a barrel including a cylindrical sidewall having an interior surface defining a chamber for retaining fluid, an open proximal end and a distal end including a distal wall having an opening therethrough in fluid communication with said chamber;

an elongate plunger rod including a proximal end, a distal end, and a main body extending between the proximal and distal end, the plunger rod being distally and proximally movable within said chamber, the proximal end including a thumb press having proximal end, a distal end, and a diameter, the distal end of the plunger rod including a stopper-engaging portion;

an annular extension protruding proximally from the proximal end of the barrel having a diameter greater than the diameter of the thumb press; and

a stopper having a proximal end and a distal end, the stopper attached to the stopper-engaging portion of the plunger rod and distally and proximally movable relative to the stopper-engaging portion for a pre-selected axial distance, such that when the distal end of the stopper is in contact with the distal wall of the barrel, the thumb press is permitted to advance distally into the annular extension and the annular extension at least partially envelopes a portion of the thumb press to prevent the user from accessing the thumb press and moving the plunger rod in a proximal direction, the stopper-engaging portion comprising a visual indicator being fully visible when the stopper-engaging portion is proximally moved relative to the stopper.

2. The syringe assembly of claim 1, wherein the annular extension fully envelopes the length of the thumb press.

3. The syringe assembly of claim 1, wherein the diameter of the thumb press decreases from the distal end of the thumb press to the proximal end of the thumb press.

4. The syringe assembly of claim 1, wherein the annular extension further comprises a detent and the thumb press further comprises a retaining ring, the detent configured to engage the retaining ring to lock the thumb press at the proximal end of the barrel when the distal end of the thumb press is permitted to advance distally into the annular extension.

5. The syringe assembly of claim 1, wherein the barrel further comprises a rib adjacent said proximal end and a diameter transition region having an axial length extending from the rib towards said proximal end such that the diameter of the barrel increases along the transition region from the rib towards the proximal end.

6. The syringe assembly of claim 5, wherein the plunger rod further comprises a protrusion between the thumb press and the main body, the protrusion having a diameter greater than the diameter of the barrel at the rib such that when the distal end of the stopper is in contact with the distal wall of the barrel, the protrusion is permitted to advance distally past the rib in the barrel and lock the plunger rod in the barrel to prevent reuse of the syringe assembly.

7. The syringe assembly of claim 6, wherein the protrusion is tapered to facilitate distal movement.

8. The syringe assembly of claim 1, wherein the application of an initial proximally directed force to the plunger rod, while holding the barrel, causes the plunger rod to move the length of the axial distance in a proximal direction within the barrel, while the stopper remains stationary.

9. The syringe assembly of claim 8, wherein the stopper-engaging portion of the plunger rod is connected to the stopper where in the application of a continuous proximally directed force to the plunger rod, while holding the barrel, causes the stopper and the plunger rod to move together in a proximal direction within the barrel.

10. The syringe assembly of claim 9, wherein the stopper-engaging portion of the plunger rod is connected to the stopper where in the application of an initial distally directed force to the plunger rod after application of a proximally directed force to the plunger rod, while holding the barrel, causes the stopper to remain stationary and the plunger to move the length of the axial distance in the distal direction within the barrel.

11. The syringe assembly of claim 10, wherein the stopper-engaging portion of the plunger rod is connected to the stopper where in the application of a continuous distally directed force to the plunger rod causes the stopper and plunger rod to move together in the distal direction within the barrel until the stopper reaches the distal end of the barrel.

12. The syringe assembly of claim 1, wherein the visual indicator is not visible when the stopper-engaging portion is distally moved relative to stopper.

13. The syringe assembly of claim 1, further comprising a visual marker disposed on the barrel.

14. The syringe assembly of claim 6, further comprising a visual marker disposed on the barrel.

15. The syringe assembly of claim 1, wherein the stopper further comprises a stopper boss at the proximal end of the stopper, a frangible connection connecting said stopper to the plunger rod and a peripheral lip at a proximal end of the stopper boss.

16. The syringe assembly of claim 1, wherein application of a continuous proximally directed force on the plunger rod causes the stopper-engaging portion to disengage from the stopper.

17. The syringe assembly of claim 1, wherein the proximal end of the barrel further comprising a flange and the annular extension protrudes in a proximal direction beyond the flange.

18. A syringe assembly comprising:

a barrel including a cylindrical sidewall having an interior surface defining a chamber for retaining fluid, an open proximal end and a distal end including a distal wall having an opening therethrough in fluid communication with said chamber, the chamber further having a first inner diameter;

an elongate plunger rod having a proximal end, a distal end, a stopper-engaging portion located at the distal end of the plunger rod, a thumb press having a proximal end, a distal end, a diameter and a length at the proximal end of the plunger rod, a main body portion extending between the distal and proximal ends of the plunger rod;

an annular extension protruding proximally from the proximal end of the barrel configured to form a nestable arrangement with at least a portion of the length of the thumb press at the distal end of the thumb press; and

a stopper having a proximal end and a distal end, the stopper attached to the stopper-engaging portion of the plunger rod and distally and proximally movable relative to the stopper-engaging portion such that when the distal end of the stopper is in contact with the distal wall of the barrel, the thumb press is permitted to advance distally and nestably engage with the annular extension to prevent the user from engaging the thumb press to move the plunger rod in a proximal direction, the stopper-engaging portion comprising a visual indicator being fully visible when the stopper-engaging portion is proximally moved relative to the stopper.

19. The syringe assembly of claim 18, wherein the annular extension provides a nesting area for the thumb press and a flange at the proximal end of the barrel, wherein the annular extension protrudes in a proximal direction beyond the flange.

20. The syringe assembly of claim 18, wherein the diameter of the thumb press decreases from the distal end of the thumb press to the proximal end of the thumb press.

21. The syringe assembly of claim 18, wherein the thumbpress further comprises a retaining ring and the annular extension further comprises a detent and is configured to engage the retaining ring when the thumb press is permitted to advance distally and the annular extension forms a nested arrangement with the thumb press to lock the thumb press at the proximal end of the barrel.

22. The syringe assembly of claim 18, wherein the barrel further comprises a locking rib adjacent to the open proximal end having a second inner diameter, wherein the second inner diameter is less than the first inner diameter, an increased diameter region located proximally from the locking rib having a third inner diameter greater than the second inner diameters, and a diameter transition region extending between the locking rib and the increased diameter region.

23. The syringe assembly of claim 22, wherein the plunger rod further comprises a protrusion extending radially from the plunger rod having an outer diameter greater than the second inner diameter such that when the distal end of the stopper is in contact with the distal wall of the barrel, the protrusion is permitted to advance distally past the locking rib in the barrel and lock the plunger rod in the barrel to prevent reuse of the syringe assembly.

24. The syringe assembly of claim 23, wherein the protrusion is tapered to facilitate distal movement past the locking rib.

25. The syringe assembly of claim 18, wherein the application of an initial proximally directed force to the plunger rod while holding the barrel, causes the plunger rod to move the length of an axial distance in a proximal direction within the barrel, while the stopper remains stationary.

26. The syringe assembly of claim 25, wherein the stopper-engaging portion of the plunger rod is connected to the stopper such that application of a continuous proximally directed force to the plunger rod, while holding the barrel, causes the stopper and the plunger rod to move together in a proximal direction within the barrel and applying an initial distally directed force to the plunger rod after application of a proximally directed force to the plunger rod, while holding the barrel, causes the stopper to remain stationary and the plunger to move the length of the axial distance in the distal direction within the barrel.

27. The syringe assembly of claim 26, wherein the stopper-engaging portion of the plunger rod is connected to the stopper such that application of a continuous distally directed force to the plunger rod causes the stopper and plunger rod to move together in the distal direction within the barrel until the stopper reaches the distal end of the barrel.

28. The syringe assembly of claim 22, wherein the stopper has a diameter greater than the second inner diameter and, upon application of a continuous proximally directed force on the plunger rod, the locking rib prevents proximal movement of the stopper and causes the stopper-engaging portion to detach from the stopper.

29. The syringe assembly of claim 28, wherein the stopper further comprises a stopper boss at the proximal end of the stopper, a frangible connection connecting said stopper to the plunger rod and a peripheral lip at a proximal end of the stopper boss.

30. The syringe assembly of claim 29, wherein the stopper-engaging portion of the plunger rod further comprises a retainer to retain the peripheral lip of the stopper.

31. The syringe assembly of claim 29, wherein the stopper has a diameter greater than the second inner diameter and, upon application of a continuous proximally directed force on the plunger rod, the locking rib prevents proximal movement of the stopper and causes the frangible connection to break.

32. The syringe assembly of claim 18, wherein the visual indicator is not visible when the stopper-engaging portion is moved distally relative to the stopper.

33. The syringe assembly of claim 18, further comprising a visual marker disposed on the barrel and aligned with a visual alignment marker disposed on the plunger rod so that when the distal end of the stopper is in contact with the distal wall of the barrel, the position of the visual alignment marker moves from being positioned proximally adjacent to the visual marker to distally adjacent to the visual marker to indicate the plunger rod is locked in the barrel.

34. The syringe assembly of claim 18, wherein the proximal end of the barrel further comprises a flange and the annular extension protrudes in a proximal direction beyond the flange.

35. A syringe assembly comprising:

a barrel including a cylindrical sidewall having an interior surface defining a chamber for retaining fluid, an open proximal end and a distal end including a distal wall having an opening therethrough in fluid communication with said chamber;

an elongate plunger rod having a proximal end, a distal end, a stopper-engaging portion located at the distal end of the plunger rod, a thumb press at the proximal end of the plunger rod, and a main body portion extending between the distal and proximal ends of the plunger rod;

a stopper having a proximal end and a distal end, the stopper attached to the stopper-engaging portion of the plunger rod and distally and proximally movable relative to the stopper-engaging portion, the stopper-engaging portion comprising a visual indicator being fully visible when the stopper-engaging portion is proximally moved relative to the stopper,

means for preventing removal of the plunger rod from the barrel to prevent reuse of the syringe assembly when the distal end of the stopper is in contact with the distal wall of the barrel and distal force is applied to the thumb press; and

means for separating stopper from the stopper-engaging portion upon application of sufficient proximal force to the plunger rod.

36. The syringe assembly of claim 35, wherein the means for preventing removal of the plunger rod from the barrel comprises a nestable thumb press disposed at the proximal end of the plunger rod configured to advance into the chamber of the barrel in a nested configuration with the barrel.

37. The syringe assembly of claim 35, wherein the means for preventing removal of the plunger rod from the barrel comprises a collar for locking the thumb press at the proximal end of the barrel.

38. The syringe assembly of claim 35, further comprising means indicating the stopper is in contact with the distal wall of the barrel and distal force is has been applied to the thumb press.