# US 12,005,235 B2 · Drug delivery systems including displaceable closures > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,005,235 B2 - Document ID: US12005235B2 - Status: Granted - Kind: B2 - Application number: 17/772,304 - Filed: 2020-11-13 - Published: 2022-12-22 - Granted: 2024-06-11 - Earliest claimed: 2019-11-19 - Assignees: Eli Lilly and Company - Applicants: Eli Lilly and Company - Inventors: Gavin Miles McKeown - Web page: https://patentgrep.com/patent/US12005235B2 ## CPC - A61M 5/24: Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic - A61M 5/2455: {with sealing means to be broken or opened} - A61M 5/2466: {by piercing without internal pressure increase (A61M5/2429 takes precedence)} - A61M 5/3293: {characterised by features of the needle hub} - A61M 2005/2407: {from the rear} - A61M 2005/247: {with fixed or steady piercing means, e.g. piercing under movement of ampoule} - A61M 2205/582: by tactile feedback - 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 drug delivery system includes a drug containing device and a drug delivery device. The drug containing device includes a chamber carrying a fluid drug and an outlet in fluid communication with the chamber. A first closure initially inhibits the fluid drug from exiting the drug containing device via the outlet. The drug delivery device includes a fluid passageway and a stem having an inlet in fluid communication with the fluid passageway. The stem displaces the first closure from the outlet and enters the outlet to provide fluid communication between the chamber and the fluid passageway and thereby facilitates delivery of the fluid drug to the drug delivery device. A second closure is coupled to the stem, and the second closure engages the first body at the outlet when the stem enters the outlet to inhibit the fluid drug from exiting the drug containing device around the stem. ## Claims ### Claim 1 A system including: a drug container having a tip end defined by a tip body, the tip body having an outlet, and a pop-in seal disposed at the outlet to contain a medication, and a drug device having a device body and a device inlet in fluid communication with a fluid path extending within the device body away from the device inlet, the device body including a stem extending within a recess defined in the device body, the stem defining the device inlet and including a protruding stem body with a contact tip opposite a floor of the recess, the stem including a sealing portion comprising a circumferentially extending lobe positioned along the protruding stem body, wherein a portion of the fluid path extends through the contact tip and the stem body, wherein the drug container is removably coupled to the drug device, wherein in a coupled configuration, the tip body of the drug container is slidably inserted into the recess of the drug device and a sealing edge of the outlet is in sealing engagement with the circumferentially extending lobe of the sealing portion of the stem subsequent to the contact tip engaging the pop-in seal to forcibly remove the pop-in seal from sealing engagement with the sealing edge. ### Claim 2 (depends on 1) The system of claim 1, wherein, when the sealing edge is engaged with the sealing portion of the stem, an axial end surface of the tip end is in a spaced relationship with the floor of the recess. ### Claim 3 (depends on 1) The system of claim 1, wherein an outer cross-sectional area of the tip body is similar to an inner cross-sectional area of the recess to allow for a snug fit. ### Claim 4 (depends on 1) The system of claim 1, wherein an edge of the pop-in seal has a lobed configuration configured to provide tactile and/or audible feedback. ### Claim 5 (depends on 1) The system of claim 1, wherein the drug container is configured to be decoupled from the drug device, after delivery of the medication from the drug container, where the sealing edge is disengaged from the sealing portion of the stem such that the outlet of the drug container is removed from the recess of the drug device. ### Claim 6 (depends on 1) The system of claim 1, further comprising a cap or plug to close off an entrance of the fluid path at the contact tip. ### Claim 7 A drug delivery system comprising: a drug containing device comprising: a first body comprising a chamber carrying a fluid drug, and an outlet in fluid communication with the chamber, the first body having an outer cross-sectional area; and a first closure detachably carried by the first body at the outlet and configured to inhibit the fluid drug from exiting the drug containing device via the outlet; and a drug delivery device comprising: a second body including a recess defined therein and a fluid passageway defined therein, the recess having an inner cross-sectional area sized similar to the outer cross-sectional area to allow for a snug fit when the recess receives the first body; a stem extending within the recess from the second body and defining an inlet, the stem configured to displace the first closure from the outlet and enter through the outlet, wherein the inlet is configured to fluidly interconnect the chamber and the fluid passageway and thereby facilitate delivery of the fluid drug from the drug containing device to the drug delivery device; a second closure associated with the stem, the second closure configured to engage the first body at the outlet when the stem enters the outlet to inhibit the fluid drug from exiting the drug containing device between the first body and the stem; and a drug delivery element in fluid communication with the fluid passageway. ### Claim 8 (depends on 7) The system of claim 7, wherein the stem further comprises: a contact portion configured to engage and displace the first closure from the outlet, the contact portion having a first cross-sectional dimension; and a sealing portion carrying the second closure, the sealing portion having a second cross-sectional dimension, the second cross-sectional dimension being greater than the first cross-sectional dimension. ### Claim 9 (depends on 8) The system of claim 8, wherein the first cross-sectional dimension is a first diameter and the second cross-sectional dimension is a second diameter. ### Claim 10 (depends on 8) The system of claim 8, wherein the contact portion comprises the inlet. ### Claim 11 (depends on 7) The system of claim 7, wherein the first closure comprises an upper lobe configured to initially sealingly engage the drug containing device within the chamber. ### Claim 12 (depends on 7) The system of claim 7, wherein the first closure comprises a lower lobe configured to initially sealingly engage the drug containing device outside of the chamber. ### Claim 13 (depends on 7) The system of claim 7, wherein the second closure comprises an upper lobe configured to sealingly engage the drug containing device within the chamber when the stem enters the outlet. ### Claim 14 (depends on 7) The system of claim 7, wherein the second closure comprises a lower lobe configured to sealingly engage the drug containing device outside of the chamber when the stem enters the outlet. ### Claim 15 (depends on 7) The system of claim 7, wherein the stem is monolithically formed with the second body. ### Claim 16 A drug delivery system having an uncoupled configuration and a coupled configuration, the drug delivery system comprising: a drug containing device comprising: a first body comprising a chamber carrying a fluid drug and an outlet in fluid communication with the chamber; and a first closure detachably carried by the first body at the outlet; and a drug delivery device comprising: a second body comprising a fluid passageway; a stem coupled to the second body and comprising an inlet in fluid communication with the fluid passageway; a second closure coupled to the stem; and a drug delivery element in fluid communication with the fluid passageway; wherein: in the uncoupled configuration, the first closure is carried by the first body at the outlet to inhibit the fluid drug from exiting the drug containing device via the outlet; and in the coupled configuration, the first closure is displaced from the outlet by the stem, the second closure is engaged with the first body at the outlet, and the fluid drug is permitted to travel from the chamber to the fluid passageway via the inlet, for delivery to the drug delivery element. ### Claim 17 (depends on 16) The system of claim 16, wherein the first closure comprises an upper lobe that sealingly engages the drug containing device within the chamber in the uncoupled configuration. ### Claim 18 (depends on 16) The system of claim 16, wherein the first closure comprises a lower lobe that sealingly engages the drug containing device outside of the chamber in the uncoupled configuration. ### Claim 19 (depends on 16) The system of claim 16, wherein the second closure comprises an upper lobe that sealingly engages the drug containing device within the chamber in the coupled configuration. ### Claim 20 (depends on 16) The system of claim 16, wherein the second closure comprises a lower lobe that sealingly engages the drug containing device outside of the chamber in the coupled configuration.