# US 12,005,238 B2 · Impact resistant and tamper evident system for prefilled syringe > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,005,238 B2 - Document ID: US12005238B2 - Status: Granted - Kind: B2 - Application number: 16/949,226 - Filed: 2020-10-20 - Published: 2022-04-21 - Granted: 2024-06-11 - Earliest claimed: 2020-10-20 - Assignees: Fresenius Kabi USA, LLC - Applicants: Fresenius Kabi USA, LLC - Inventors: Christopher J. Murray - Web page: https://patentgrep.com/patent/US12005238B2 ## CPC - A61M 5/31501: {Means for blocking or restricting the movement of the rod or piston (A61M5/5013 takes precedence)} - A61M 5/5086: {for indicating if defective, used, tampered with or unsterile} - A61M 5/002: {Packages specially adapted therefor, e.g. packages for syringes or needles or kits for diabetics} - A61M 5/3129: {Syringe barrels (A61M5/3205, A61M5/50 take precedence)} - A61M 5/31505: {Integral with the syringe barrel, i.e. connected to the barrel so as to make up a single complete piece or unit} - A61M 5/31571: {Means preventing accidental administration (for automatic syringes A61M5/20)} - A61M 2005/3101: {Leak prevention means for proximal end of syringes, i.e. syringe end opposite to needle mounting end} - A61M 2005/3103: {Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle} - A61M 2005/3104: {Caps for syringes without needle} - A61M 2005/3142: {Modular constructions, e.g. supplied in separate pieces to be assembled by end-user} - A61M 2205/02: characterised by a particular materials - A61M 2209/06: Packaging for specific medical equipment - 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 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. ## Claims ### Claim 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. ### Claim 2 (depends on 1) The syringe assembly of claim 1, wherein the barrel cover is translucent and/or transparent. ### Claim 3 (depends on 1) 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. ### Claim 4 (depends on 1) The syringe assembly of claim 1, wherein the backstop is configured to snap onto the proximal portion of the barrel cover. ### Claim 5 (depends on 1) 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. ### Claim 6 (depends on 1) The syringe assembly of claim 1, wherein the backstop includes first and second backstop members. ### Claim 7 (depends on 6) The syringe assembly of claim 6, wherein the first and second backstop members are semi-circumferential. ### Claim 8 (depends on 1) 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. ### Claim 9 (depends on 1) 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. ### Claim 10 (depends on 1) 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. ### Claim 11 (depends on 1) 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. ### Claim 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. ### Claim 13 (depends on 12) 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. ### Claim 14 (depends on 12) 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. ### Claim 15 (depends on 12) The syringe assembly of claim 12, wherein the anti-rotation member includes an adhesive or an abrasive surface. ### Claim 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. ### Claim 17 (depends on 16) The method of claim 16, wherein attaching the backstop includes attaching a first backstop member and a second backstop member. ### Claim 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. ### Claim 19 (depends on 18) The syringe assembly of claim 18, wherein the breakage of the frangible connection comprises rotation of the tamper evident cap relative to the collar. ### Claim 20 (depends on 12) The syringe assembly of claim 12, wherein the breakage of the frangible connection comprises rotation of the tamper evident cap relative to the collar. ### Claim 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. ### Claim 22 (depends on 21) The syringe assembly of claim 21, wherein the barrel cover is translucent and/or transparent. ### Claim 23 (depends on 21) 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.