Anti-tampering apparatus and method for drug delivery devices

• US 8,353,869 B2
• Filed: 03/11/2011
• Issued: 01/15/2013
• Est. Priority Date: 11/02/2010
• Status: Expired due to Fees

• Current Assignee: Baxter Corporation Englewood (Baxter International Inc.)
• Original Assignee: BAXA Corporation (Baxter International Inc.)
• Inventors: Ranalletta, Joseph V., Ward, Brian William, Kingsford, Timothy Lee
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US13/045,742
• Publication Number:
  US 20120109059A1
• Time in Patent Office: 676 Days
• Field of Search: 604/111, 604/110
• US Class Current: 604/111
• CPC Class Codes: A61J 1/18 Arrangements for indicating condition of container contents, e.g. sterile condition
• CPC Class Codes: A61M 2005/3104 Caps for syringes without needle
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3204 Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
• CPC Class Codes: A61M 5/50 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile retractable needles or needle protectors with means for preventing re-use A61M5/321

Abstract

An anti-tampering apparatus and method for drug delivery devices provides for the capture of caps in a manner that restricts repositioning of a captured cap onto a corresponding drug delivery device. The anti-tampering apparatus includes one or more retention members to define a capture region for restrainably capturing a cap. The anti-tampering apparatus further locates an obstruction surface thereof to engage a surface of a drug delivery device and thereby restrict recapping of the device by the captured cap. As such, tampering of a drug delivery device is indicated by the absence of a cap captured within the anti-tampering apparatus.

Claims

1. An anti-tampering apparatus for a drug delivery device having a corresponding cap disposed on a port thereof, comprising:

a frame member; and

,

at least one retention member connected to said frame member for non-removable capture of a cap disposed on a port of a corresponding drug delivery device.

2. An anti-tampering apparatus as recited in claim 1, wherein a cap captured by the anti-tampering apparatus is restricted from replacement on a port of a corresponding drug delivery device after initial removal therefrom.

3. An anti-tampering apparatus as recited in claim 1, wherein said anti-tampering apparatus further comprises:

an obstruction surface for obstructing replacement of a cap captured by the anti-tampering apparatus onto a port of a corresponding drug delivery device after initial removal therefrom.

4. An anti-tampering apparatus as recited in claim 3, wherein said obstruction surface is located on said frame member.

5. An anti-tampering apparatus as recited in claim 4, wherein said obstruction surface is a peripheral edge extending about an opening to an internal area defined by said frame member.

6. An anti-tampering apparatus as recited in claim 5, wherein said peripheral edge is located on a cylindrical portion of said frame member.

7. An anti-tampering apparatus as recited in claim 3, further comprising:

at least one pivot member interconnected to said frame, wherein said at least one pivot member pivots from a first position to a second position when a cap disposed on a corresponding drug delivery device is captured by said anti-tampering apparatus, and wherein said obstruction surface is defined by said pivot member upon removal of a cap captured by the anti-tampering apparatus from a port of a corresponding drug delivery device.

8. An anti-tampering apparatus as recited in claim 1, wherein said frame member defines an internal area and comprises:

an opening to said internal area for receiving a cap disposed on a port of a corresponding drug delivery device, wherein said at least one retention member extends into said internal area to define a capture region rearward from said opening of said frame member.

9. An anti-tampering apparatus as recited in claim 8, wherein a length of said capture region is greater than a length of a cap captured by the anti-tampering apparatus.

10. An anti-tampering apparatus as recited in claim 9, wherein said frame member further comprises:

an obstruction surface extending about said opening for obstructing replacement of a cap captured by the anti-tampering apparatus onto a port of a corresponding drug delivery device after initial removal therefrom.

11. An anti-tampering apparatus as recited in claim 9, wherein at least a portion of a cap disposed on a port of a corresponding drug delivery device is forcibly advanceable in a first direction past the at least one retention member into said capture region and restrained from movement in an opposite second direction by the at least one retention member.

12. An anti-tampering apparatus as recited in claim 9, wherein said at least one retention member comprises:

a detent projecting inward from a sidewall of said frame member.

13. An anti-tampering apparatus as recited in claim 12, wherein said detent is of a barbed configuration having a tapered first surface extending inward from said wall and away from said opening and a second surface for restrainably engaging a cap captured by the anti-tampering apparatus.

14. An anti-tampering apparatus as recited in claim 8, wherein at least a portion of a cap disposed on a port of a corresponding drug delivery device is forcibly advanceable in a first direction past the at least one retention member into said capture region and restrained from movement in an opposite second direction by the at least one retention member.

15. An anti-tampering apparatus as recited in claim 14, wherein at least a portion of at least one of said frame, said at least one retention member and said cap is elastically deformable.

16. An anti-tampering apparatus as recited in claim 8, wherein said at least one retention member is provided to define a minimum cross-dimension within said internal area that is less than a maximum cross-dimension of a cap disposed on a corresponding delivery device.

17. An anti-tampering apparatus as recited in claim 8, wherein said at least one retention member defines a reduced circular opening within the internal area having a diameter less than a maximum cross-dimension of a cap disposed on a corresponding drug delivery device.

18. An anti-tampering apparatus as recited in claim 8, further comprising:

a plurality of retention members interconnected to and extending into said internal area from a sidewall of said frame.

19. An anti-tampering apparatus as recited in claim 18, wherein said plurality of retention members are spaced about said sidewall at equidistances from said opening and from each other.

20. An anti-tampering apparatus as recited in claim 8, further comprising:

a cylindrical sidewall; and

,

an end wall interconnected to said sidewall at an end opposite to said opening.

21. An anti-tampering apparatus as recited in claim 8, wherein said anti-tampering apparatus further comprises:

an obstruction surface for obstructing replacement of a cap captured by the anti-tampering apparatus onto a port of a corresponding drug delivery device after initial removal therefrom.