# US 12,178,991 B2 · Wearable injector with sterile adhesive patch > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,178,991 B2 - Document ID: US12178991B2 - Status: Granted - Kind: B2 - Application number: 17/359,825 - Filed: 2021-06-28 - Published: 2022-01-13 - Granted: 2024-12-31 - Earliest claimed: 2017-08-18 - Assignees: Amgen Inc. - Applicants: Amgen Inc. - Inventors: Ali Nekouzadeh; Jerome Olivas; Joshua Merilos; Matthew Wayne Janke; Justin Harris; Marc Orloff; Edward Stapleford Nielsen; Chitra Nadig; Yasaman Damestani; Guojie Song; Bryton De Guia - Web page: https://patentgrep.com/patent/US12178991B2 ## CPC - A61M 5/14248: {of the skin patch type} - A61M 5/20: Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically (A61M5/142 takes precedence) - A61M 2005/14252: {with needle insertion means} - A61M 2005/14264: {with means for compensating influence from the environment} - A61M 2205/0205: Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent - A61M 2205/0238: the material being a coating or protective layer - A61M 2205/50: with microprocessors or computers - A61M 2205/58: Means for facilitating use, e.g. by people with impaired vision - A61M 2205/587: Lighting arrangements - 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 adhesive patch for a drug delivery device with a bacteria impermeable sterility margin surrounding an edge surface of the adhesive patch is disclosed, as well as a drug delivery device fixed to such an adhesive patch and a method of assembling a drug delivery device with such an adhesive patch. In some arrangements, the sterility margin is attached to or integral with a lower liner on a lower surface of the adhesive patch. In other arrangements, the sterility margin is attached to or integral with an upper liner on an upper surface of the adhesive patch. ## Claims ### Claim 1 A method of preparing a drug delivery device for use, the method comprising: providing an adhesive patch, the adhesive patch including an area contained within an outer perimeter, the area having an upper surface, an adhesive lower surface, and an edge surface at the outer perimeter between the upper surface and the lower surface, a bacteria impermeable lower liner on the lower surface, and a bacteria impermeable sterility margin surrounding the edge surface and including a sealing edge, physically coupling to or abutting the edge surface, that forms a seal between the bacteria impermeable sterility margin and the edge surface; providing a sub-assembly of a drug delivery device comprising an insertion mechanism; adhering the upper surface of the adhesive patch to the drug delivery device or the sub-assembly of the drug delivery device. ### Claim 2 (depends on 1) The method of claim 1, further comprising aligning a hole in the adhesive patch with the insertion mechanism of the sub-assembly of the drug delivery device prior to adhering the adhesive patch to the drug delivery device or the sub-assembly of the drug delivery device. ### Claim 3 (depends on 1) The method of claim 1, further comprising sterilizing the adhesive patch and the sub-assembly of the drug delivery device after adhering the adhesive patch to the drug delivery device or the sub-assembly of the drug delivery device. ### Claim 4 (depends on 1) The method of claim 1, further comprising filling a container of the drug delivery device in a sterile fill line. ### Claim 5 (depends on 1) The method of claim 1, further comprising connecting the sub-assembly of the drug delivery device to additional parts of the drug delivery device in an environment that is sterile or non-sterile. ### Claim 6 (depends on 1) The method of claim 1, further comprising removing a portion of an upper liner from the top surface of the adhesive patch prior to adhering the upper surface of the adhesive patch to the drug delivery device or the sub-assembly of the drug delivery device. ### Claim 7 (depends on 1) The method of claim 1, further comprising removing the bacteria impermeable sterility margin prior to use. ### Claim 8 (depends on 1) The method of claim 1, wherein removing the bacteria impermeable sterility margin comprises removing the sterility margin simultaneously with removing a lower liner from the lower surface of the adhesive patch. ### Claim 9 (depends on 1) The method of claim 1, wherein removing the bacteria impermeable sterility margin comprises removing the sterility margin simultaneously with removing an upper liner from the upper surface of the adhesive patch. ### Claim 10 (depends on 1) The method of claim 1, wherein removing the bacteria impermeable sterility margin comprises removing the sterility margin after and separately of removing a lower liner from the lower surface of the adhesive patch. ### Claim 11 (depends on 1) The method of claim 1, wherein removing the bacteria impermeable sterility margin comprises removing the sterility margin after and separately of removing an upper liner from the upper surface of the adhesive patch. ### Claim 12 (depends on 1) The method of claim 1, further comprising sealing the insertion mechanism to a bottom wall of the drug delivery device so that the contact between the bottom wall and the insertion mechanism is bacteria impermeable.