Anti-tampering apparatus and method for drug delivery devices

• US 8,784,377 B2
• Filed: 01/09/2013
• Issued: 07/22/2014
• Est. Priority Date: 11/02/2010
• Status: Active Grant

• Current Assignee: Baxter Corporation Englewood (Baxter International Inc.)
• Original Assignee: Baxter Corporation Englewood (Baxter International Inc.)
• Inventors: Ranalletta, Joseph Vincent, Ward, Brian William, Kingsford, Timothy Lee
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US13/737,518
• Publication Number:
  US 20130190713A1
• Time in Patent Office: 559 Days
• Field of Search: 604/110, 604/111
• US Class Current: 604/110
• 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. A method for handling a drug delivery device comprising:

filling the drug delivery device with a predetermined amount of a liquid medication;

positioning a cap on a port of said drug delivery device after said filling step; and

,

capturing said cap disposed on said port of said drug delivery device within at least a portion of an anti-tampering apparatus, wherein said cap is non-removable from said anti-tampering apparatus after said capturing step.

2. A method as recited in claim 1, further comprising:

removing said cap from said port of said drug delivery device, wherein said anti-tampering apparatus maintains capture of said cap; and

,

restricting repositioning of said cap onto said port of said drug delivery device.

3. A method as recited in claim 2, wherein said restricting step comprises:

providing an at least one obstructive surface on said anti-tampering apparatus located to engage a surface of said drug delivery device and thereby obstruct repositioning of the cap on said port of said drug delivery device.

4. A method as recited in claim 3, wherein said at least one obstruction surface is located in an initial position prior to said capturing step, and wherein said at least one obstruction surface is automatically located in an obstruction position different from said initial position after said removing step.

5. A method as recited in claim 4, further comprising:

first moving said at least one obstruction surface from said initial position to another position in response to said capturing step; and

,

second moving said at least obstruction surface from said another position to said obstruction position in response to said removing step.

6. A method as recited in claim 4, wherein said at least one obstruction surface is located on a pivot member interconnected to a frame of said anti-tampering apparatus, and further comprising:

pivoting said pivot member relative to said frame to at least partially position said obstruction surface from said initial position to said obstruction position in response to said capturing step.

7. A method as recited in claim 6, wherein at least a portion of at least one of said pivot member and/or said frame is elastically deformed after said capturing step and prior to said removing step, wherein said pivot member applies a spring force against said drug delivery device after said capturing step and prior to said removing step, and wherein the method further comprises:

advancing said obstruction surface to said obstruction position in conjunction with said removing step in response to said spring force.

8. A method as recited in claim 3, wherein said at least one obstruction surface and said cap are located in a first relative position after said capturing step and prior to said removing step, wherein said at least one obstruction surface and said cap are positioned or positionable in a second relative position after said removing step, and wherein said obstruction surface restricts repositioning of said cap onto said port of said drug delivery device when said obstruction surface and said cap are positioned in said second relative position.

9. A method as recited in claim 8, wherein said anti-tampering apparatus includes an opening and a capture region to receive and capture of said cap, respectively, and further comprising:

moving said cap within said capture region in a direction away from opening after said removing step to locate said cap and said obstruction surface in said second relative position.

10. A method as recited in claim 7, wherein at least a portion of said anti-tempering apparatus is elastically deformed to apply a spring force against said drug delivery device after said capturing step and prior to said removing step, and further comprising:

moving said obstruction surface in conjunction with said removing step in response to said spring force, wherein said obstruction surface and said cap are automatically located in said second relative position.

11. A method as recited in claim 1, wherein said capturing step comprises:

advancing at least a portion of said cap forcibly past at least one retention member provided on said anti-tampering apparatus, wherein said cap is restrainably disposed within a capture region of said anti-tampering apparatus.

12. A method as recited in claim 11, further comprising:

flexing at least a portion of at least one of said cap and said anti-tampering apparatus during said capturing step.

13. A method as recited in claim 1, further comprising:

advancing linearly said port of said drug delivery device to successively complete said positioning and capturing steps.

14. A method as recited in claim 13, wherein said advancing step is completed manually.

15. A method as recited in claim 13, wherein said advancing step is completed in an automated manner.

16. A method as recited in claim 1, further comprising:

completing said filling step and said positioning step at a first location; and

,

removing said cap from said port of said drug delivery device at a second location, remote from said first location, wherein said anti-tampering apparatus maintains capture of said cap.

17. A method as recited in claim 16, further comprising:

completing said capturing step at said first location; and

,

labeling said drug delivery device at said first location to provide an identification indication corresponding with at least one of said liquid medication and a corresponding intended recipient of said liquid medication.

18. A method as recited in claim 16, further comprising:

completing said capturing step at said second location.

19. A method as recited in claim 1, further comprising:

packaging said drug delivery device and said cap at a first location.

20. A method as recited in claim 19, further comprising:

sterilizing said drug delivery device and said cap at said first location.

21. A method as recited in claim 19, further comprising:

unpackaging said drug delivery device and said cap at a second location, remote from said first location.

22. A method as recited in claim 18, further comprising:

completing said filling step, said positioning step, and said capturing step at said second location.

23. A method as recited in claim 22, further comprising:

providing said anti-tampering apparatus to said second location separate from said drug delivery device and said cap.