Syringe with disabling mechanism

• US 7,972,302 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: Odell, Robert, Caizza, Richard J.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): FLICK, JASON E
• Application Number:
  US12/137,732
• Publication Number:
  US 20090048560A1
• 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. According to one or more embodiments, the syringe assembly comprises a barrel, plunger rod and stopper wherein the plunger rod further comprises a locking protrusion that locks the plunger rod within the barrel. Certain embodiments further include a frangible portion on the plunger rod that breaks when reuse is attempted. One or more embodiments include a plunger rod and stopper attachment that prevents disassembly of the syringe assembly prior to use. 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, said sidewall including 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;

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, the distal end including a stopper-engaging portion, the plunger rod further including 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 and the plunger rod further including at least one frangible portion;

a stopper having a proximal end, a distal end and a peripheral edge that forms a seal with the interior surface of the barrel having a diameter greater than the diameter of the barrel at the rib, the stopper attached to the stopper-engaging portion of the plunger rod, the stopper being 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 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, the stopper-engaging portion comprising a visual indicator that is fully visible before an initial distally directed force is applied to the plunger rod.

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

3. The syringe assembly of claim 2, further comprising a peripheral lip at a proximal end of the stopper boss.

4. The syringe assembly of claim 2, wherein the stopper-engaging portion of the plunger rod further comprises a retainer to retain the peripheral lip of the stopper.

5. The syringe assembly of claim 1, wherein the protrusion is tapered to facilitate distal movement.

6. The syringe assembly of claim 1, wherein the stopper-engaging portion of the plunger rod is connected to the stopper such that upon 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.

7. The syringe assembly of claim 6, wherein the stopper-engaging portion of the plunger rod is connected to the stopper such that upon 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.

8. The syringe assembly of claim 7, wherein the stopper-engaging portion of the plunger rod is connected to the stopper such that 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.

9. The syringe assembly of claim 8, 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, thereby allowing the protrusion to advance distally past the rib in the barrel and lock the plunger rod in the barrel to prevent reuse of the syringe assembly.

10. The syringe assembly of claim 1, wherein application of a proximally directed force to the plunger, after the protrusion has advanced distally past the rib, causes the at least one frangible portion of the plunger rod to break.

11. 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.

12. The syringe assembly of claim 3, wherein a continuous proximally directed force on the plunger rod causes the frangible connection to break.

13. The syringe assembly of claim 1, wherein the proximal end of the barrel further comprising a flange.

14. The syringe assembly of claim 1, wherein the barrel further comprising a needle cannula attached to the opening of the barrel.

15. The syringe assembly of claim 10, further comprising a second frangible point.

16. The syringe assembly of claim 1, wherein the visual indicator is not visible when 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.

17. The syringe assembly of claim 1, further comprising a visual marker disposed on the barrel and aligned with 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 visual marker on the barrel to indicate the plunger rod is locked in the barrel.

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, 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 first and second inner diameters, and a diameter transition region extending between the locking rib and the increased diameter region;

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, a main body portion extending between the distal and proximal ends of the plunger rod, an annular protrusion extending radially from the plunger rod having an outer diameter greater than the second inner diameter and the plunger rod further including at least one frangible portion;

a stopper having a proximal end and a distal, the stopper attached to the stopper-engaging portion of the plunger rod, the stopper being distally and proximally movable a pre-selected axial distance 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 annular 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; and

a use detection system including a visual display disposed on the stopper-engaging portion of the plunger rod, the visual display being fully visible before an initial distally directed force is applied to the plunger rod.

19. The syringe assembly of claim 18, wherein the stopper further comprises a stopper boss at the proximal end of the stopper and a frangible connection connecting said stopper to the plunger rod.

20. The syringe assembly of claim 19, further comprising a peripheral lip at a proximal end of the stopper boss.

21. The syringe assembly of claim 20, wherein the stopper-engaging portion of the plunger rod further comprises a retainer to retain the peripheral lip of the stopper.

22. The syringe assembly of claim 18, wherein the annular protrusion is tapered to facilitate distal movement past the locking rib.

23. The syringe assembly of claim 18, wherein the stopper-engaging portion of the plunger rod is connected to the stopper such that 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.

24. The syringe assembly of claim 23, 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.

25. The syringe assembly of claim 24, wherein the stopper-engaging portion of the plunger rod is connected to the stopper such that 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.

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 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, thereby allowing the annular protrusion 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.

27. The syringe assembly of claim 18, wherein application of a proximally directed force to the plunger, after the protrusion has advanced distally past the rib, causes the at least one frangible portion of the plunger rod to break.

28. The syringe assembly of claim 27, wherein the stopper has a diameter greater than the second inner diameter.

29. The syringe assembly of claim 28, wherein, 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 disengage from the stopper.

30. The syringe assembly of claim 21, wherein the stopper has a diameter greater than the second inner diameter.

31. The syringe assembly of claim 30, wherein, 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 proximal end of the barrel further comprising a flange.

33. The syringe assembly of claim 18, wherein the barrel further comprising a needle cannula attached to the opening of the barrel.

34. The syringe assembly of claim 27, further comprising a second frangible point.

35. The syringe assembly of claim 18, wherein the visual indicator is not visible when 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.

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

37. 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, the stopper being distally and proximally movable relative to the stopper-engaging portion;

means for locking the plunger rod in 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;

means for separating at least a portion of the plunger rod from the main body upon application of sufficient proximal force to the plunger rod;

means for separating the stopper from the stopper-engaging portion of the plunger rod upon application of sufficient proximal force on the plunger rod; and

indicator means for indicating that the plunger rod is locked in the barrel.

38. The syringe assembly of claim 37, wherein the means for separating at least a portion of the plunger rod is located adjacent the proximal end of the plunger rod and is operable to break a portion of the plunger rod when the plunger rod is locked in the barrel.

39. The syringe assembly of claim 37, wherein the stopper-engaging portion of the plunger rod is connected to the stopper such that application of an initial proximally directed force to the plunger rod, while holding the barrel, causes the plunger rod to move in a proximal direction within the barrel, while the stopper remains stationary.

40. The syringe assembly of claim 39, 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.

41. The syringe assembly of claim 40, wherein the stopper-engaging portion of the plunger rod is connected to the stopper such that 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 in the distal direction within the barrel.

42. The syringe assembly of claim 41, 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, thereby engaging the means for locking the plunger rod to prevent reuse of the syringe assembly.