# US 10,441,725 B2 · Dose setting mechanism for a drug delivery device and drug delivery device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,441,725 B2 - Document ID: US10441725B2 - Status: Granted - Kind: B2 - Application number: 15/313,905 - Filed: 2015-05-27 - Published: 2017-07-06 - Granted: 2019-10-15 - Earliest claimed: 2014-05-28 - Assignees: Sanofi-Aventis Deutschland GmbH - Applicants: Sanofi-Aventis Deutschland GmbH - Inventors: Matthew Meredith Jones; Samuel Keir Steel; Neal Alexander Blundred; Joseph Butler; Robert Frederick Veasey; David Plumptre - Web page: https://patentgrep.com/patent/US10441725B2 ## CPC - A61M 5/31596: {comprising means for injection of two or more media, e.g. by mixing} - A61M 5/19: having more than one chamber - A61M 5/2448: {comprising means for injection of two or more media, e.g. by mixing} - A61M 5/3146: {Priming, e.g. purging, reducing backlash or clearance} - A61M 5/31528: {by means of rotational movements, e.g. screw-thread mechanisms} - A61M 5/31538: {Permanent blocking, e.g. by medical personnel} - A61M 5/31551: {including axial movement of dose setting member} - A61M 5/31575: {using scaling up or down transmissions, e.g. gearbox} - A61M 5/31591: {Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means} - A61M 5/31593: {Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir} - A61M 5/3295: {Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel} - A61M 2005/1787: {Syringes for sequential delivery of fluids, e.g. first medicament and then flushing liquid} - A61M 2005/3126: {related to dosing} - A61M 2205/581: by audible feedback - 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 dose setting mechanism for a drug delivery device includes a primary drug delivery assembly and a secondary drug delivery assembly. The dose setting mechanism includes a primary dose dial component for setting a dose in the primary drug delivery assembly and a secondary dose dial component for setting a dose in the secondary drug delivery assembly. The primary dose dial component and the secondary dose dial component are configured to rotate during dose setting. A gear mechanism is configured such that in a first phase of the dose setting, rotation of the primary dose dial component is transferred to the secondary dose dial component and such that in a second phase of the dose setting, the secondary dose dial component is decoupled from the primary dose dial component such that rotation of the primary dose dial component is prevented from being transferred to the secondary dose dial component. ## Claims ### Claim 1 A dose setting mechanism for a drug delivery device, the dose setting mechanism comprising: a primary dose dial component for setting a primary dose in a primary drug delivery assembly of the drug delivery device; and a secondary dose dial component for setting a secondary dose in a secondary drug delivery assembly of the drug delivery device, wherein the primary dose dial component and the secondary dose dial component are configured to rotate during dose setting; and a gear mechanism configured such that rotation of the primary dose dial component is transferred to the secondary dose dial component during a first phase of the dose setting, and the secondary dose dial component is decoupled from the primary dose dial component during a second phase of the dose setting, thereby inhibiting rotation of the primary dose dial component from being transferred to the secondary dose dial component, for further setting the primary dose in the primary drug delivery assembly without changing the secondary dose in the secondary drug delivery assembly. ### Claim 2 (depends on 1) The dose setting mechanism according to claim 1, wherein the gear mechanism comprises a first gear coupled to the primary dose dial component such that the primary dose dial component is rotationally locked to the first gear during the first phase of the dose setting, and the primary dose dial component is rotationally decoupled from the first gear during the second phase of the dose setting. ### Claim 3 (depends on 2) The dose setting mechanism according to claim 2, wherein the gear mechanism comprises a second gear that is in meshed engagement with the first gear and that is rotationally coupled to the secondary dose dial component during the dose setting. ### Claim 4 (depends on 2) The dose setting mechanism according to claim 2, wherein the first gear comprises a boss engaged with a track on the primary dose dial component to transfer rotation between the primary dose dial component and the first gear. ### Claim 5 (depends on 4) The dose setting mechanism according to claim 4, wherein: the track comprises a first section and a second section, the boss is engageable with the first section until a predetermined dose is set with the primary dose dial component or the secondary dose dial component, and the boss is engageable with the second section after the predetermined dose is dialed with the primary dose dial component or the secondary dose dial component. ### Claim 6 (depends on 5) The dose setting mechanism according to claim 5, wherein the second section is engageable with the boss to rotationally decouple the primary dose dial component from the first gear. ### Claim 7 (depends on 5) The dose setting mechanism according to claim 5 wherein the second section extends along a helical path on the primary dose dial component. ### Claim 8 (depends on 1) The dose setting mechanism according to claim 1, wherein: the primary dose dial component is rotationally fixed to a primary drive sleeve that is in threaded engagement with a primary lead screw via a primary first thread, and the primary lead screw is in threaded engagement with a housing assembly via a primary second thread. ### Claim 9 (depends on 8) The dose setting mechanism according to claim 8, wherein: the secondary dose dial component is in threaded engagement with a secondary lead screw via a secondary first thread, and the secondary lead screw is in threaded engagement with the housing assembly via a secondary second thread. ### Claim 10 (depends on 9) The dose setting mechanism according to claim 9, wherein a pitch of a thread between a secondary drive sleeve and the secondary lead screw is equal to a pitch of a thread between the primary dose dial component and the primary lead screw divided by a gear ratio between a first gear and a second gear. ### Claim 11 (depends on 1) The dose setting mechanism according to claim 1, wherein: the secondary dose dial component comprises a helical track engaged by a thread feature of a housing assembly, the secondary dose dial component comprises at least one angled track intersecting the helical track, the at least one angled track being arranged such that after the dose setting the thread feature is guided along the at least one angled track under an axial force applied to the secondary dose dial component. ### Claim 12 (depends on 11) The dose setting mechanism according to claim 11, wherein the helical track comprises at least one detent feature arranged between the at least one angled track and the helical track. ### Claim 13 (depends on 12) The dose setting mechanism according to claim 12, wherein the thread feature overrides the at least one detent feature when a predetermined dose is dialed. ### Claim 14 (depends on 1) The dose setting mechanism according to claim 1, further comprising: a clutch that is rotationally fixed to the primary dose dial component during the dose setting, a clicker assembly configured to engage the clutch in such a way that relative rotation between the clutch and the clicker assembly produces a click sound and/or a tactile feedback, the clicker assembly engaging a housing assembly such that the clutch rotates with the clicker assembly during the first phase and relative to the clicker assembly during the second phase. ### Claim 15 (depends on 14) The dose setting mechanism according to claim 14, wherein: the clicker assembly is configured to move proximally during the dose setting and comprises a key that engages an axially extending groove on the housing assembly, and the axially extending groove has at least one intermediate section that allows the clicker assembly to disengage from the axially extending groove. ### Claim 16 (depends on 1) The dose setting mechanism of claim 1, wherein: the gear mechanism comprises a first gear coupled to the primary dose dial component, the first gear comprising a boss engaged with a track on the primary dose dial component to transfer rotation between the primary dose dial component and the first gear, and a second gear that is in meshed engagement with the first gear and that is rotationally coupled to the secondary dose dial component during the dose setting, the track comprises a first section and a second section, the boss is configured to engage with the first section during the first phase of the dose setting such that the primary dose dial component is rotationally locked to the first gear and rotation of the primary dose dial component is transferred to the secondary dose dial component such that the secondary dose in the secondary drug delivery assembly is automatically set until a predetermined dose is set with the primary dose dial component or the secondary dose dial component, and the boss is configured to engage with the second section after the predetermined dose is dialed, wherein the second section is adapted such that engagement of the boss with the second section rotationally decouples the primary dose dial component from the first gear such that rotation of the primary dose dial component is prevented from being transferred to the secondary dose dial component during the second phase of the dose setting. ### Claim 17 A drug delivery device comprising: a primary drug delivery assembly for delivery of a primary medicament; and a secondary drug delivery assembly for delivery of a secondary medicament, and a dose setting mechanism comprising a primary dose dial component for setting a primary dose in the primary drug delivery assembly; and a secondary dose dial component for setting a secondary dose in the secondary drug delivery assembly, wherein the primary dose dial component and the secondary dose dial component are configured to rotate during dose setting, and a gear mechanism configured such that rotation of the primary dose dial component is transferred to the secondary dose dial component during a first phase of the dose setting, and the secondary dose dial component is decoupled from the primary dose dial component during a second phase of the dose setting, thereby inhibiting rotation of the primary dose dial component from being transferred to the secondary dose dial component, for further setting the primary dose in the primary drug delivery assembly without changing the secondary dose in the secondary drug delivery assembly. ### Claim 18 A method of operating a drug delivery device, the method comprising: setting a dose of a primary medicament to be delivered from the drug delivery device and a dose of a secondary medicament to be delivered from the drug delivery device, the dose of the primary medicament being adjustable and the dose of the secondary medicament being fixed, wherein the dose of the primary medicament and the dose of the secondary medicament are set during a first phase of dose setting; adjusting the dose of the primary medicament during a second phase of the dose setting; and dispensing a combined dose from the drug delivery device, the combined dose including the dose of the primary medicament and the dose of the secondary medicament, wherein the first phase of dose setting includes causing the rotation of a primary dose dial component to transfer to a secondary dose dial component, and wherein the second phase of dose setting includes causing the secondary dose dial component to decouple from the primary dose dial component such that rotation of the primary dose dial component is inhibited from being transferred to the secondary dose dial component, for further setting the dose in a primary drug delivery assembly without changing the dose in a secondary drug delivery assembly. ### Claim 19 (depends on 18) The method according to claim 18, wherein setting the dose of the primary medicament and the dose of the secondary medicament comprises operating a single dose setting device.