# US 8,784,377 B2 · Anti-tampering apparatus and method for drug delivery devices

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- Number: US 8,784,377 B2
- Document ID: US8784377B2
- Status: Granted
- Kind: B2
- Application number: 13/737,518
- Filed: 2013-01-09
- Published: 2013-07-25
- Granted: 2014-07-22
- Earliest claimed: 2010-11-02
- Assignees: Baxter Corporation Englewood
- Applicants: Baxa Corporation
- Inventors: Joseph Vincent Ranalletta; Brian William Ward; Timothy Lee Kingsford
- Web page: https://patentgrep.com/patent/US8784377B2

## CPC

- A61J 1/18: Arrangements for indicating condition of container contents, e.g. sterile condition
- A61M 5/3202: {Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; protectors for sharps A61B50/3001)}
- 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)}
- A61M 5/3204: {Needle cap removers, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices}
- A61M 2005/3104: {Caps for syringes without needle}
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## 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

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 2)

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.

### Claim 4 (depends on 3)

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.

### Claim 5 (depends on 4)

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.

### Claim 6 (depends on 4)

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.

### Claim 7 (depends on 6)

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.

### Claim 8 (depends on 3)

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.

### Claim 9 (depends on 8)

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.

### Claim 10 (depends on 7)

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.

### Claim 11 (depends on 1)

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.

### Claim 12 (depends on 11)

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.

### Claim 13 (depends on 1)

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.

### Claim 14 (depends on 13)

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

### Claim 15 (depends on 13)

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

### Claim 16 (depends on 1)

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.

### Claim 17 (depends on 16)

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.

### Claim 18 (depends on 16)

A method as recited in claim 16, further comprising:
completing said capturing step at said second location.

### Claim 19 (depends on 1)

A method as recited in claim 1, further comprising:
packaging said drug delivery device and said cap at a first location.

### Claim 20 (depends on 19)

A method as recited in claim 19, further comprising:
sterilizing said drug delivery device and said cap at said first location.

### Claim 21 (depends on 19)

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.

### Claim 22 (depends on 18)

A method as recited in claim 18, further comprising:
completing said filling step, said positioning step, and said capturing step at said second location.

### Claim 23 (depends on 22)

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.