# US 10,118,000 B2 · Pen needle installation and removal safety cover and pen needle assembly utilizing the same > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,118,000 B2 - Document ID: US10118000B2 - Status: Granted - Kind: B2 - Application number: 14/689,500 - Filed: 2015-04-17 - Published: 2015-10-22 - Granted: 2018-11-06 - Earliest claimed: 2014-04-21 - Assignees: Stat Medical Devices, Inc. - Applicants: Stat Medical Devices, Inc. - Inventors: Steven Schraga - Web page: https://patentgrep.com/patent/US10118000B2 ## CPC - A61M 5/3202: {Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; protectors for sharps A61B50/3001)} - A61M 5/002: {Packages specially adapted therefor, e.g. packages for syringes or needles or kits for diabetics} - A61M 5/3293: {characterised by features of the needle hub} - A61M 5/34: Constructions for connecting the needle {, e.g. to syringe nozzle or needle hub (connecting catheter tubes to hubs A61M25/0014)} - A61M 5/3205: {Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles (for sharps A61B50/362; disintegrating apparatus in general B02C, e.g. B02C19/0075, B23H9/001; disposal of medical waste in general B09B3/00; receptacles for refuse disposal in general B65F1/00)} - A61M 5/3213: {Caps placed axially onto the needle, e.g. equipped with finger protection guards (axially-extensible protective sleeves A61M5/3243)} - 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 needle tip assembly for a pre-loaded syringe or a pen needle injection device. The needle tip assembly includes a body comprising a double-ended needle and being installable and removable from the pre-loaded syringe or pen needle injection device. A needle cap is configured to cover a skin puncturing end of the double-ended needle and is removable to exposed the skin puncturing end. An outer cover is structured and arranged to at least install the body onto the pre-loaded syringe or pen needle injection device and remove the body from the pre-loaded syringe or pen needle injection device after the outer cover is re-installed. The body is lockable to the outer cover upon one of re-installation of the outer cover and prior to the body being removed from the pre-loaded syringe or pen needle injection device. ## Claims ### Claim 1 A needle tip assembly for a pre-loaded syringe or pen needle injection device, the needle tip assembly comprising: a body comprising a double-ended needle and being installable and removable from the pre-loaded syringe or pen needle injection device, wherein the body comprises outwardly deflectable teeth engageable with threads on the pre-loaded syringe or pen needle injection device; a needle cap configured to cover a skin puncturing end of the double-ended needle and being removable to expose the skin-puncturing end; and an outer cover structured and arranged to at least: install onto the body of the needle-tip assembly device; be re-installable and non-releasably locked to the body while the body remains installed on the pre-loaded syringe or pen needle injection device, wherein, when the outer cover is re-installed to the body, the outwardly deflectable teeth outwardly deflect to disengage the outwardly deflectable teeth from the threads; and remove the body from the pre-loaded syringe or pen needle injection device after the outer cover is re-installed to the body; wherein, after re-installation of the outer cover and removal of the body from the pre-loaded syringe or pen needle injection device, the double-ended needle is positioned inside the outer cover without use of the needle cap, thereby preventing puncturing by a user of the double-ended needle. ### Claim 2 (depends on 1) The needle tip assembly of claim 1, wherein the outer cover is structured and arranged to contain therein the body and the needle cap in a prior use and sterile package condition. ### Claim 3 (depends on 1) The needle tip assembly of claim 1, wherein the body is a one-piece body. ### Claim 4 (depends on 1) The needle tip assembly of claim 1, wherein the outer cover is a one-piece body. ### Claim 5 (depends on 1) The needle tip assembly of claim 1, wherein the needle cap is a one-piece body. ### Claim 6 (depends on 1) The needle tip assembly of claim 1, wherein the outer cover has an axial length that is greater than an axial length of the body and a closed front end. ### Claim 7 (depends on 1) The needle tip assembly of claim 1, wherein the outer cover has an axial length that is greater than an axial length of the needle cap. ### Claim 8 (depends on 1) The needle tip assembly of claim 1, wherein installation of the needle tip assembly to the pre-loaded syringe or pen needle injection device is by sliding. ### Claim 9 (depends on 1) The needle tip assembly of claim 1, wherein removal of the body from the pre-loaded syringe or pen needle injection device is by sliding off or by unthreading of the body from the pre-loaded syringe or pen needle injection device. ### Claim 10 (depends on 1) The needle tip assembly of claim 1, wherein the outer cover has a visual indicator to a user that a needle is disposed within the outer cover, has been used, and should not be used again.