# US 9,517,308 B2 · Dose setting mechanism and method of setting a dose > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,517,308 B2 - Document ID: US9517308B2 - Status: Granted - Kind: B2 - Application number: 13/878,762 - Filed: 2011-10-11 - Published: 2013-11-07 - Granted: 2016-12-13 - Earliest claimed: 2010-10-13 - Assignees: Sanofi-Aventis Deutschland GmbH - Applicants: David Moore; Joseph Butler; David Martin Leak - Inventors: David Moore; Joseph Butler; David Martin Leak - Web page: https://patentgrep.com/patent/US9517308B2 ## CPC - A61M 5/31535: {Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose} - A61M 5/24: Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic - A61M 5/31525: {Dosing (burettes, pipettes B01L3/02)} - A61M 5/31551: {including axial movement of dose setting member} - A61M 5/31585: {the component being manually operated or triggered by an axially moving actuator operated by user, e.g. an axially movable injection button} - 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 comprises a drug delivery device housing and a dual state track provided within the housing that is axially and rotationally fixed with respect to the housing. A dose dial component is positioned in the housing and rotatable during dose setting and dose delivery. A clutch is rotatable during dose setting and non-rotatable during dose delivery. A clutch plate is rotationally fixed relative to the housing; and a clutch blocker is in threaded engagement with the clutch plate and has a radial key engaged with the dual state track. The mechanism may comprise a biasing member positioned between the clutch blocker and clutch plate. ## Claims ### Claim 1 Dose setting mechanism for a drug delivery device, the mechanism comprising: a drug delivery device housing; a dose dial component positioned at least partly in the housing and rotatable during dose setting and dose delivery, characterized by at least one dual state track within the housing that is axially and rotationally fixed with respect to the housing, which comprises a first track, a second track, and a third track; a clutch plate rotationally fixed relative to the housing; and a clutch blocker in threaded engagement with the clutch plate and having at least one radial key engaged with the at least one dual state track, wherein the radial key is engaged with the first track during dose setting until a predetermined minimum dose is dialed with the dose dial component and with the second track after a predetermined minimum dose is dialed with the dose dial component. ### Claim 2 (depends on 1) Mechanism according to claim 1 further comprising a biasing member positioned between the clutch blocker and clutch plate. ### Claim 3 (depends on 1) Mechanism according to claim 1 wherein the clutch blocker comprises a distal end and the clutch plate comprises a proximal end, wherein the distal end of the clutch blocker is separated from the proximal end of the clutch plate by a given distance during dose setting and by a distance less than the given distance during dose delivery. ### Claim 4 (depends on 1) Mechanism according to claim 1 wherein the clutch plate has at least one radial key splined to the housing to prevent rotation during dose setting and dose delivery. ### Claim 5 (depends on 1) Mechanism according to claim 1 wherein the clutch blocker and clutch plate are configured to prevent delivery of a dose when a set dose is less than a minimum predetermined dose. ### Claim 6 (depends on 5) Mechanism according to claim 5 wherein the clutch blocker and clutch plate are configured to prevent delivery of the dose when the set dose is less than the minimum predetermined dose but allows the delivery of the set dose if the set dose is less than a predetermined maximum priming dose. ### Claim 7 (depends on 1) Mechanism according to claim 1 wherein the dual state track has an axial length that is proportional to a predetermined minimum dose. ### Claim 8 (depends on 1) Mechanism according to claim 1 further comprising a fourth track wherein the clutch blocker key is engaged with the fourth track when a dose of zero to a predetermined maximum priming dose is dialed. ### Claim 9 (depends on 1) Mechanism according to claim 1 wherein the dual state track, the clutch plate and the clutch blocker are configured to prevent a relative axial and/or a relative rotational movement between the clutch plate and the clutch blocker when a set dose is less than a minimum predetermined dose. ### Claim 10 (depends on 1) Mechanism according to claim 1 wherein the clutch plate is a sleeve-like or ring-like component comprising means for rotationally coupling the clutch plate to a clutch member. ### Claim 11 (depends on 1) Mechanism according to claim 1 wherein the clutch blocker is a sleeve-like component which is at least partly surrounded by the clutch plate. ### Claim 12 (depends on 1) Mechanism according to claim 1 further comprising a drive sleeve being rotatable during dose setting and axially displaceable during dose delivery. ### Claim 13 (depends on 12) Mechanism according to claim 12 wherein the drive sleeve is rotationally locked to a clutch member and wherein the drive sleeve comprises means supporting the clutch blocker in the distal direction. ### Claim 14 A method of setting at least a predetermined minimum dose of a medicament comprising the steps of providing a drug delivery device housing; axially and rotationally fixing a dual state track within the housing with respect to the housing, wherein the dual state track comprises a first track, a second track, and a third track; positioning a dose dial component at least partly in the housing, the dose dial component being rotatable during dose setting and dose delivery, providing a clutch member that is rotatable during dose setting and non-rotatable during dose delivery; rotationally fixing a clutch plate relative to the housing; engaging a clutch blocker with the clutch plate by way of a thread; and engaging a radial key of the clutch blocker with the dual state track wherein the radial key runs in the first track until a predetermined minimum dose has been dialed.