Tamper evident tip cap and syringe

• US 9,480,801 B2
• Filed: 08/20/2010
• Issued: 11/01/2016
• Est. Priority Date: 08/21/2009
• Status: Active Grant

• Current Assignee: Becton Dickinson France (Becton, Dickinson & Co)
• Original Assignee: Becton Dickinson France (Becton, Dickinson & Co)
• Inventors: Schiller, Eric, Perot, Frederic
• Primary Examiner(s): FLICK, JASON E
• Application Number:
  US12/859,830
• Publication Number:
  US 20110046550A1
• Time in Patent Office: 2,265 Days
• Field of Search: 604/111
• US Class Current: 1/1
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 5/28 Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
• CPC Class Codes: A61M 5/3134 characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile

Abstract

A pre-filled syringe assembly having a tamper evident tip cap is provided for indicating if the contents of the syringe assembly have been compromised. The syringe barrel has an interior chamber which defines a pressure therein and is sealed at the proximal and distal ends by a first and second seal, respectively, to maintain this pressure. The second seal is formed of a deformable material and a tip cap is located about the second seal and distal end of the syringe barrel. This tip cap includes a viewable indicator representing a change in state of the syringe contents. The indicator has a portion positioned in contact with the second seal such that the first distinguishing feature is viewable through a portion of the cap. Tampering of the contents within the interior chamber causes a change in pressure and movement of the indicator indicating tampering of the syringe assembly.

Claims

1. A tamper evident pre-filled syringe assembly comprising:

a syringe barrel defining an interior chamber, a proximal end, and a distal end terminating in a tip having an opening extending therethrough, said syringe barrel defining a pressure contained within said interior chamber;

at least one seal associated with the syringe assembly; and

an indicator separate and distinct from and in contact with the at least one seal, said indicator configured for changing state upon movement of the at least one seal caused by a change in the pressure within the interior chamber to indicate tampering of contents within the syringe assembly.

2. The syringe assembly of claim 1 wherein the at least one seal comprises a first seal for sealing the interior chamber and a second seal for sealing the opening, the second seal extending through the tip of the distal end of the syringe barrel.

3. The syringe assembly of claim 2, further comprising a plunger assembly including a plunger head extending within the syringe barrel, wherein the plunger head comprises the first seal.

4. The syringe assembly of claim 2 wherein the second seal is positioned about the distal end of the syringe barrel and is formed from a deformable material and wherein tampering of contents within the interior chamber causes a change in the pressure within the interior chamber resulting in a deformation of the second seal.

5. The syringe assembly of claim 4 wherein the indicator is associated with the second seal and wherein deformation of the second seal results in movement of the indicator.

6. The syringe assembly of claim 5 wherein the pressure defined by the interior chamber is a positive pressure and wherein tampering with the syringe contents reduces the pressure within the interior chamber resulting in deformation of the second seal and movement of the indicator toward a proximal end of the syringe assembly.

7. The syringe assembly of claim 5 wherein the pressure defined by the interior chamber is a negative pressure and wherein tampering with the syringe contents increases the pressure within the interior chamber resulting in deformation of the second seal and movement of the indicator toward a distal end of the syringe assembly.

8. The syringe assembly of claim 1 wherein the change in state of the indicator comprises a visual change.

9. The syringe assembly of claim 8 wherein the visual change is a color change, an indicia change, or any visually distinguishable contrast.

10. The syringe assembly of claim 1 including a tip cap located about the distal end of the syringe barrel, said tip cap containing at least a portion of said indicator therein and at least one viewing portion for viewing the change of state of said indicator.

11. The syringe assembly of claim 10 wherein the viewing portion comprises a cut-out portion in a wall of the tip cap.

12. The syringe assembly of claim 10 wherein the viewing portion comprises a transparent portion in the tip cap.

13. The syringe assembly of claim 10 wherein the tip cap is threadedly engaged with the distal end of the syringe barrel.

14. The syringe assembly of claim 1 including a holding member for cooperating with the indicator and for preventing the indicator from returning to an original pre-tampered state.

15. The syringe assembly of claim 14 wherein the holding member comprises flexible fingers or a washer.

16. A tamper evident pre-filled syringe assembly comprising:

a syringe barrel defining an interior chamber, a proximal end, and a distal end having an opening extending therethrough;

a first seal within the interior chamber of the syringe barrel;

a second seal sealing the opening of the distal end of the syringe barrel, said second seal being deformable upon a change in pressure within the interior chamber; and

an indicator separate and distinct from and associated with the second seal and having a first distinguishing feature indicating an untampered state and a second distinguishing feature indicating a tampered state,

wherein the indicator is adapted for movement upon deformation of the second seal caused by a change of pressure within the interior chamber such that the second distinguishing feature is located in a viewable location.

17. The syringe assembly of claim 16, further comprising a plunger assembly comprising a plunger head extending within the syringe barrel, the plunger head forming said first seal within the interior chamber of the syringe barrel.

18. The syringe assembly of claim 16 wherein tampering of contents within the syringe barrel causes the change in pressure within the interior chamber resulting in the deformation of the second seal and movement of the indicator to position the second distinguishing feature in the viewable location.

19. The syringe assembly of claim 16 including a tip cap located about the second seal and the distal end of the syringe barrel, said tip cap including a hollow portion and at least one viewing portion extending therethrough.

20. The syringe assembly of claim 19 wherein the indicator is positioned within the hollow portion of the tip cap and wherein the first distinguishing feature is viewable through the viewing portion when the syringe assembly is in an untampered state and the second distinguishing feature is viewable through the viewing portion when the syringe assembly is in a tampered state.

21. The syringe assembly of claim 20 including biased flexible fingers located in a sidewall of the tip cap and wherein upon movement of the indicator showing a tampered state, said flexible fingers bias into the hollow portion of the tip cap to contact the indicator and prevent a return of the indicator to a pre-tampered position.

22. The syringe assembly of claim 16 wherein the first distinguishing feature and the second distinguishing feature of the indicator comprise a color change, an indicia change, or any visually distinguishable contrast.

23. A tamper evident pre-filled syringe assembly comprising:

a syringe barrel extending between a proximal end and a distal end, the distal end having an opening extending therethrough;

a plunger assembly comprising a plunger head extending within the syringe barrel at a position between the proximal end of the syringe barrel and the opening of the distal end forming an interior chamber therebetween, the plunger head forming a first seal within the interior chamber;

a second seal sealing the interior chamber adjacent the opening of the distal end of the syringe barrel, said second seal being deformable upon a change in pressure within the interior chamber; and

an indicator separate and distinct from and associated with the second seal, the indicator adapted for movement upon deformation of the second seal,

wherein tampering of contents within the interior chamber causes a change in pressure within the interior chamber resulting in a deformation of the second seal and movement of the indicator to provide a visual indication of tampering.

24. The syringe assembly of claim 23 wherein the indicator is a separate member from the second seal.

25. A tamper evident pre-filled syringe assembly comprising:

a syringe barrel defining an interior chamber, a proximal end, and a distal end terminating in a tip having an opening extending therethrough, said syringe barrel defining a pressure contained within said interior chamber;

at least one seal associated with the syringe assembly;

an indicator in contact with the at least one seal, said indicator configured for changing state upon movement of the at least one seal caused by a change in the pressure within the interior chamber to indicate tampering of contents within the syringe assembly; and

a tip cap located about the distal end of the syringe barrel, said tip cap containing at least a portion of said indicator therein and at least one viewing portion for viewing the change of state of said indicator.