Impact resistant and tamper evident system for prefilled syringe

Patent metadata

Field	Value
Publication number	US-12005238-B2
Application number	US-202016949226-A
Country	US
Kind code	B2
Filing date	Oct 20, 2020
Priority date	Oct 20, 2020
Publication date	Jun 11, 2024
Grant date	Jun 11, 2024

Abstract

A syringe assembly and methods of producing the syringe assembly are described. The syringe assembly may include a syringe body, a plunger rod, a barrel cover, and a tamper evident device. The syringe body has a chamber configured to receive a material. The plunger rod moves within the chamber to dispense the material. The barrel cover covers the syringe body. The backstop is attached to the barrel cover to prevent a portion of the plunger rod from moving proximally through the backstop. The tamper evident device includes a tamper evident cap covering a distal portion of the syringe body, a collar attached to the barrel cover, and a frangible connection between the tamper evident cap and the collar.

First claim

What is claimed is:

1. A syringe assembly comprising:
a syringe body having a chamber configured to receive a material;
a plunger rod configured to move within the chamber to dispense the material;
a barrel cover configured to receive the syringe body, the barrel cover extending from a proximal portion to a distal portion;
a backstop configured to attach to the proximal portion of the barrel cover to prevent a portion of the plunger rod from moving proximally through the backstop; and
a tamper evident assembly including:
a collar positioned at the distal portion of the barrel cover, wherein the distal portion of the barrel cover comprises a first attachment feature and the collar comprises a second attachment feature configured to attach to the first attachment feature, and
a tamper evident cap attached to the collar by a frangible connection between the tamper evident cap and the collar.

2. The syringe assembly of claim 1 , wherein the barrel cover is translucent and/or transparent.

3. The syringe assembly of claim 1 , wherein the first attachment feature of the barrel cover is a groove and the second attachment feature of the collar is a ridge that snaps into the groove.

4. The syringe assembly of claim 1 , wherein the backstop is configured to snap onto the proximal portion of the barrel cover.

5. The syringe assembly of claim 1 , wherein the proximal portion of the barrel cover comprises a flange, and the backstop has a slot configured to receive the flange.

6. The syringe assembly of claim 1 , wherein the backstop includes first and second backstop members.

7. The syringe assembly of claim 6 , wherein the first and second backstop members are semi-circumferential.

8. The syringe assembly of claim 1 , wherein the plunger rod includes a stopper at a distal end of the plunger rod, and the backstop is configured to contact the stopper to prevent the stopper from passing through the backstop.

9. The syringe assembly of claim 1 , wherein the backstop is configured to contact an enlarged portion of the plunger rod to prevent the plunger rod from moving proximally through the backstop.

10. The syringe assembly of claim 1 , the syringe body comprises a flange at a proximal portion of the syringe body, and the barrel cover comprises a plurality of ridges supporting the flange of the syringe body.

11. The syringe assembly of claim 1 , further comprising a syringe cap covering a distal portion of the syringe body, wherein the tamper evident cap covers the syringe cap.

12. A syringe assembly comprising:
a syringe body defining a chamber configured to receive a material;
a plunger rod configured to move within the chamber to dispense the material;
a barrel cover configured to receive the syringe body, the barrel cover extending from a proximal portion to a distal portion;
a backstop configured to attach to the proximal portion of the barrel cover to prevent a portion of the plunger rod from passing through the backstop;
a tamper evident assembly including:
a collar configured to attach to the distal portion of the barrel cover, and
a tamper evident cap attached to the collar by a frangible connection between the tamper evident cap and the collar; and

an anti-rotation member on the barrel cover or the collar, the anti-rotation member configured to prevent rotation of the collar relative to the barrel cover during breakage of the frangible connection.

13. The syringe assembly of claim 12 , wherein the anti-rotation member includes a plurality of teeth or grooves on an outer surface of the barrel cover.

14. The syringe assembly of claim 12 , wherein the anti-rotation member includes a plurality of teeth or grooves on an inner surface of the collar.

15. The syringe assembly of claim 12 , wherein the anti-rotation member includes an adhesive or an abrasive surface.

16. A method of assembling a syringe assembly for administering a material, the method comprising:
attaching a tamper evident assembly to a distal portion of a barrel cover, the distal portion of the barrel cover comprising a first attachment feature, wherein the tamper evident assembly comprises a collar that comprises a second attachment feature that is configured to attach to the first attachment feature, and wherein the tamper evident assembly further comprises a tamper evident cap that is connected to the collar by a frangible connection between the tamper evident cap and the collar;
inserting a pre-filled syringe into the barrel cover, the pre-filled syringe comprising a flange and a plunger rod; and
attaching a backstop to a proximal end of the barrel cover and over the flange of the pre-filled syringe to prevent a portion of the plunger rod of the pre-filled syringe from moving proximally through the backstop.

17. The method of claim 16 , wherein attaching the backstop includes attaching a first backstop member and a second backstop member.

18. A syringe assembly comprising:
a syringe body having a chamber configured to receive a material;
a plunger rod configured to move within the chamber to dispense the material;
a barrel cover configured to receive the syringe body, the barrel cover extending from a proximal portion to a distal portion;
a backstop configured to attach to the proximal portion of the barrel cover to prevent a portion of the plunger rod from moving proximally through the backstop;
a tamper evident assembly including:
a collar positioned at the distal portion of the barrel cover, and
a tamper evident cap attached to the collar by a frangible connection between the tamper evident cap and the collar; and

an anti-rotation member on the barrel cover or the collar, the anti-rotation member configured to prevent rotation of the collar relative to the barrel cover during breakage of the frangible connection.

19. The syringe assembly of claim 18 , wherein the breakage of the frangible connection comprises rotation of the tamper evident cap relative to the collar.

20. The syringe assembly of claim 12 , wherein the breakage of the frangible connection comprises rotation of the tamper evident cap relative to the collar.

21. A syringe assembly comprising:
a syringe body having a chamber configured to receive a material;
a plunger rod configured to move within the chamber to dispense the material;
a barrel cover configured to receive the syringe body, the barrel cover extending from a proximal portion to a distal portion, the barrel cover comprises a flange at the proximal portion of the barrel cover;
a backstop configured to attach to the proximal portion of the barrel cover to prevent a portion of the plunger rod from moving proximally through the backstop, the backstop having a slot configured to receive the flange of the barrel cover, the backstop and the flange forming a continuous outer surface with the flange received in the slot; and
a tamper evident assembly including:
a collar configured to attach to the distal portion of the barrel cover, and
a tamper evident cap attached to the collar by a frangible connection between the tamper evident cap and the collar.

22. The syringe assembly of claim 21 , wherein the barrel cover is translucent and/or transparent.

23. The syringe assembly of claim 21 , wherein:
the collar is configured to snap onto the distal portion of the barrel cover, and
the backstop is configured to snap onto the proximal portion of the barrel cover.

Assignees

• Fresenius Kabi Usa Llc

Inventors

• Murray Christopher J

Classifications

• A61M5/002

  Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics (needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001) · CPC title

• A61M2209/06

  Packaging for specific medical equipment · CPC title

• A61M2005/3142

  Modular constructions, e.g. supplied in separate pieces to be assembled by end-user · CPC title

• A61M5/31571

  Means preventing accidental administration (for automatic syringes A61M5/20) · CPC title

• A61M2205/02

  characterised by a particular materials · CPC title