# US 12,109,402 B2 · Hard-packaged safety needle device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,109,402 B2 - Document ID: US12109402B2 - Status: Granted - Kind: B2 - Application number: 17/315,873 - Filed: 2021-05-10 - Published: 2021-11-18 - Granted: 2024-10-08 - Earliest claimed: 2020-05-12 - Assignees: Becton, Dickinson and Company - Applicants: Becton, Dickinson and Company - Inventors: Amit Uday Limaye - Web page: https://patentgrep.com/patent/US12109402B2 ## 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 5/3213: {Caps placed axially onto the needle, e.g. equipped with finger protection guards (axially-extensible protective sleeves A61M5/3243)} - A61M 5/3216: {Caps placed transversally onto the needle, e.g. pivotally attached to the needle base} - A61M 5/3245: {Constructional features thereof, e.g. to improve manipulation or functioning} - A61M 5/34: Constructions for connecting the needle {, e.g. to syringe nozzle or needle hub (connecting catheter tubes to hubs A61M25/0014)} - A61M 5/345: {Adaptors positioned between needle hub and syringe nozzle} - A61M 5/346: {friction fit (A61M5/344 takes precedence)} - A61M 5/348: {snap lock, i.e. upon axial displacement of needle assembly (A61M5/344 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 5/321: {Means for protection against accidental injuries by used needles} - A61M 5/3293: {characterised by features of the needle hub} - A61M 2005/3109: {Caps sealing the needle bore by use of, e.g. air-hardening adhesive, elastomer or epoxy resin} - A61M 2205/6063: Optical identification systems - 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 hard-packaged safety needle device comprises a needle hub comprising a distal portion and a proximal portion, a needle cannula extending from the distal portion of the needle hub, and a hard needle enclosure comprising a needle cover, an adapter and a cap. The needle cover is configured to house the needle cannula, and the adapter has a tapered aperture configured to create an interference fit and a sterility barrier with the tapered outer surface of the needle cover. The caps includes a distal opening defining a first cavity, the cap being configured to interdigitate with the adapter by the first cavity of the cap receiving a proximal portion of the adapter. ## Claims ### Claim 1 A hard-packaged safety needle device comprising: a needle hub configured to couple to a syringe comprising a distal portion and a proximal portion; a needle cannula extending from the distal portion of the needle hub; and a hard needle enclosure comprising a needle cover, an adapter and a cap, the needle cover configured to house the needle cannula and the distal portion of the needle hub, the needle cover having a tapered cylindrical outer surface, the adapter having a cylindrical body including a proximal portion, a distal portion and an outside surface, the distal portion having a tapered aperture configured to create an interference fit and a sterility barrier with the tapered cylindrical outer surface of the needle cover, the proximal portion having a proximal cavity in communication with the tapered aperture, and the cap having a first cavity, the cap being configured to interdigitate with the adapter by the first cavity of the cap receiving the proximal portion of the adapter, and the cap having a second cavity having an inside surface, the second cavity of the cap being configured to interdigitate with the adapter. ### Claim 2 (depends on 1) The hard-packaged safety needle device of claim 1, wherein the outside surface creates an interference fit and a sterility barrier with an inside surface of the first cavity when the adapter is connected with the first cavity. ### Claim 3 (depends on 1) The hard-packaged safety needle device of claim 1, wherein the tapered aperture of the adapter is configured to interdigitate with a conventional needles or a commercially available needle. ### Claim 4 (depends on 1) The hard-packaged safety needle device of claim 1, further comprising a hinge having a distal connection to the outside surface of the adapter and a proximal connection to an outside surface of the cap. ### Claim 5 (depends on 4) The hard-packaged safety needle device of claim 4, wherein the hard needle enclosure is opened with one handed operation by applying a proximal force F against the outside surface of the adapter opposite the hinge. ### Claim 6 (depends on 1) The hard-packaged safety needle device of claim 1, wherein a proximal opening and a distal opening are removably bonded together with adhesive. ### Claim 7 (depends on 1) The hard-packaged safety needle device of claim 1, further comprising a label disposed on a wall of the first cavity of the cap. ### Claim 8 (depends on 7) The hard-packaged safety needle device of claim 7, wherein the label indicates that the hard needle enclosure has been opened or used. ### Claim 9 (depends on 7) The hard-packaged safety needle device of claim 7, the label includes in indicia, words, numbers or symbols. ### Claim 10 (depends on 7) The hard-packaged safety needle device of claim 7, the label includes a biohazard symbol. ### Claim 11 (depends on 1) The hard-packaged safety needle device of claim 1, wherein the adapter and the first cavity are configured to be releasably connected and the adapter and the second cavity are configured to be connected in a locked configuration. ### Claim 12 (depends on 11) The hard-packaged safety needle device of claim 11, the adapter further comprises a ledge having a triangular shape, wherein a right face the ledges is located opposite a sloped surface of the ledge, the ledges of the adapter are disposed on the outside surface of the adapter. ### Claim 13 (depends on 12) The hard-packaged safety needle device of claim 12, wherein the first cavity of the cap comprises a holding tab configured to removably snap-fit with locking surface of the ledge of the adapter upon insertion of the adapter into the first cavity of the cap. ### Claim 14 (depends on 13) The hard-packaged safety needle device of claim 13, wherein the cap further comprises a ledge including a locking surface disposed on the inside surface of the second cavity, the ledge of the cap having a triangular shape, wherein a right angle face of the ledge of the cap is located opposite a sloped surface of the ledge of the cap, the ledge of the cap being configured to create a non-removable snap fit with the ledge of the adapter upon insertion of the adapter into the second cavity of the adapter. ### Claim 15 (depends on 14) The hard-packaged safety needle device of claim 14, wherein first cavity comprises indicia indicating that the safety needle device has been used. ### Claim 16 (depends on 15) The hard-packaged safety needle device of claim 15, wherein the second cavity comprises indicia indicating that the safety needle device is ready for use.