# US 10,307,541 B2 · Drive mechanism of a 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 10,307,541 B2 - Document ID: US10307541B2 - Status: Granted - Kind: B2 - Application number: 14/783,514 - Filed: 2014-04-08 - Published: 2016-02-04 - Granted: 2019-06-04 - Earliest claimed: 2013-04-10 - Assignees: Sanofi - Applicants: Sanofi - Inventors: Stefan Bayer; Daniel Berning; Philippe Blank; Wolfgang Pelzer; Björn Wilden - Web page: https://patentgrep.com/patent/US10307541B2 ## CPC - A61M 5/31541: {Means preventing setting of a dose beyond the amount remaining in the cartridge} - A61M 5/20: Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically (A61M5/142 takes precedence) - A61M 5/31551: {including axial movement of dose setting member} - A61M 5/31553: {without axial movement of dose setting member} - A61M 5/31583: {the piston rod being moved by the rotational movement of a component directly in contact with it} - A61M 5/3157: {Means providing feedback signals when administration is completed (A61M5/20 takes precedence)} - A61M 2005/3126: {related to dosing} - A61M 2005/3154: {limiting maximum permissible dose} - 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 drive mechanism of a drug delivery device for dispensing of a dose of a medicament includes a housing extending in an axial direction, and a piston rod to operably engage with a piston of a cartridge to displace the piston in an axial distal direction. The drive mechanism further includes a last dose sleeve rotatably supported in the housing and being selectively engageable with a dose setting mechanism for setting of a dose, and a last dose member threadedly engaged to the housing, rotatably locked to the last dose sleeve and axially displaceable relative to the last dose sleeve. ## Claims ### Claim 1 A drive mechanism of a drug delivery device for dispensing a dose of a medicament, the drive mechanism comprising: a housing comprising a radial stop, a piston rod to operably engage with a piston of a cartridge to displace the piston in a distal direction along a longitudinal axis of the housing, a last dose sleeve rotatably supported in the housing and being selectively engageable with a user operable dose setting member for setting of the dose, wherein the last dose sleeve is configured to be coupled to the dose setting member during dose setting and to be decoupled from the dose setting member during dose dispensing, wherein the last dose sleeve is axially fixed relative to the housing, and a last dose member threadedly engaged to and rotatable relative to the housing, rotationally locked to the last dose sleeve, and axially displaceable relative to the last dose sleeve, wherein the last dose member comprises a radial counter stop configured to engage with the radial stop to prevent rotation of the last dose member, wherein the last dose sleeve is hollow, and at least one axially extending clutch member extending through the last dose sleeve is axially displaceable relative to the last dose sleeve for selectively engaging the dose setting member with the last dose sleeve exclusively during the dose setting. ### Claim 2 (depends on 1) The drive mechanism according to claim 1, wherein the last dose member is radially sandwiched between the housing and the last dose sleeve. ### Claim 3 (depends on 1) The drive mechanism according to claim 1, wherein the last dose member is arc-shaped and comprises an outer thread to engage with an inner thread of the housing. ### Claim 4 (depends on 1) The drive mechanism according to claim 1, wherein: one of the last dose member and the last dose sleeve comprises an axially extending groove, the other one of the last dose member and the last dose sleeve comprises a correspondingly shaped radially extending protrusion, and the axially extending groove is configured to receive the correspondingly shaped radially extending protrusion to inhibit relative rotation between the last dose member and the last dose sleeve. ### Claim 5 (depends on 1) The drive mechanism according to claim 1, wherein the radial counter stop extends radially at a circumferential end and is configured to engage with the radial stop during rotation of the last dose member relative to the housing, wherein the radial stop extends radially at an inside facing portion of the housing. ### Claim 6 (depends on 1) The drive mechanism according to claim 1, wherein the last dose sleeve comprises a radially outwardly extending flange portion at an axial end to support the last dose member in an initial assembly configuration. ### Claim 7 (depends on 1) The drive mechanism according to claim 1, wherein the last dose sleeve is axially constrained in the housing between a drive wheel and an insert axially fixed to the housing. ### Claim 8 (depends on 7) The drive mechanism according to claim 7, wherein the drive wheel is threadedly engaged with the piston rod, the piston rod being rotationally locked to the housing. ### Claim 9 (depends on 7) The drive mechanism according to claim 7, wherein the at least one axially extending clutch member is displaceable between a proximal stop position and a distal stop position, the at least one axially extending clutch member being engaged with the last dose sleeve in the proximal stop position such that torque is transferred from the at least one axially extending clutch member to the last dose sleeve and being engaged with the drive wheel in the distal stop position such that torque is transferred from the at least one axially extending clutch member to the drive wheel. ### Claim 10 (depends on 7) The drive mechanism according to claim 7, wherein the at least one axially extending clutch member comprises a crown wheel at its distal end face to engage with a corresponding crown wheel on a proximal end face of the drive wheel. ### Claim 11 (depends on 1) The drive mechanism according to claim 1, wherein the at least one axially extending clutch member comprises radially outwardly extending teeth at a distal end to selectively engage with correspondingly shaped radially inwardly extending teeth of the last dose sleeve. ### Claim 12 (depends on 1) The drive mechanism according to claim 1, wherein the at least one axially extending clutch member is axially displaceable in the distal direction against an action of a spring by means of a dose dispensing button located at a proximal end of the housing. ### Claim 13 (depends on 1) The drive mechanism according to claim 1, wherein the last dose member is configured to jointly rotate with the last dose sleeve and to move axially relative to the last dose sleeve during the dose setting. ### Claim 14 (depends on 1) The drive mechanism according to claim 1, wherein the last dose member and the last dose sleeve are configured to be axially fixed relative to the housing during the dose dispensing. ### Claim 15 (depends on 1) The drive mechanism according to claim 1, wherein the radial stop and the radial counter stop extend in both a radial direction and an axial direction, and the radial stop is configured to engage with the radial counter stop in a circumferential direction such that further rotation of the last dose sleeve and further rotation the last dose member are prevented when a last dose stop configuration of the drive mechanism has been reached. ### Claim 16 A drug delivery device for dispensing a dose of a medicament, the drug delivery device comprising: a housing comprising a radial stop; a cartridge at least partially filled with the medicament and being arranged in the housing or in a cartridge holder fixed to the housing; and a drive mechanism comprising a piston rod to operably engage with a piston of the cartridge to displace the piston in a distal direction along a longitudinal axis of the housing, a last dose sleeve rotatably supported in the housing and being selectively engageable with a user operable dose setting member for setting the dose, wherein the last dose sleeve is configured to be coupled to the dose setting member during dose setting and to be decoupled from the dose setting member during dose dispensing, wherein the last dose sleeve is axially fixed relative to the housing, and a last dose member threadedly engaged and rotatable relative to the housing, rotationally locked to the last dose sleeve, and axially displaceable relative to the last dose sleeve, wherein the last dose member comprises a radial counter stop configured to engage with the radial stop to prevent rotation of the last dose member; wherein the last dose sleeve is hollow, and at least one axially extending clutch member extending through the last dose sleeve is axially displaceable relative to the last dose sleeve for selectively engaging the dose setting member with the last dose sleeve exclusively during the dose setting. ### Claim 17 (depends on 16) The drug delivery device according to claim 16, wherein: the last dose member is radially sandwiched between the housing and the last dose sleeve, and the last dose sleeve is axially constrained in the housing between a drive wheel and an insert axially fixed to the housing. ### Claim 18 (depends on 16) The drug delivery device according to claim 16, wherein the last dose member is configured to jointly rotate with the last dose sleeve and to move axially relative to the last dose sleeve during the dose setting. ### Claim 19 (depends on 16) The drug delivery device according to claim 16, wherein the last dose member and the last dose sleeve are configured to be axially fixed relative to the housing during the dose dispensing. ### Claim 20 (depends on 16) The drug delivery device according to claim 16, wherein the radial stop and the radial counter stop extend in both a radial direction and an axial direction, and the radial stop is configured to engage with the radial counter stop in a circumferential direction such that further rotation of the last dose sleeve and further rotation of the last dose member are prevented when a last dose stop configuration of the drive mechanism has been reached. ### Claim 21 A method of operating a drug delivery device, the method comprising: setting a dose of medicament to be dispensed by the drug delivery device by operating a dose setting member, thereby causing a last dose sleeve axially fixed relative to a housing of the drug delivery device to rotate through the housing of the drug delivery device while a last dose member threadedly engaged to the housing of the drug delivery device, rotatable relative to the housing of the drug delivery device, and rotatably locked to the last dose sleeve advances axially through the housing of the drug delivery device, the last dose member being configured to inhibit rotation of the last dose sleeve to inhibit the dose from exceeding an amount of medicament remaining in the drug delivery device, a radial counter stop of the last dose member being configured to abut a radial stop on the housing of the drug delivery device, thereby inhibiting rotation of the last dose sleeve relative to the housing of the drug delivery device, wherein the last dose sleeve is hollow, and at least one axially extending clutch member extending through the last dose sleeve is axially displaceable relative to the last dose sleeve for selectively engaging the dose setting member with the last dose sleeve exclusively during dose setting; and dispensing the dose without causing the last dose member to advance axially through the housing while the last dose member is decoupled from the dose setting member. ### Claim 22 (depends on 21) The method according to claim 21, wherein setting the dose comprises rotating the dose setting member, wherein the last dose member is configured to inhibit rotation of the dose setting member to inhibit the dose from exceeding the amount of medicament remaining in the drug delivery device. ### Claim 23 (depends on 22) The method according to claim 22, wherein rotating the dose setting member causes rotation of a drive sleeve in a dose incrementing direction to set the dose, and dispensing the dose comprises depressing a dose dispensing button to disengage the dose setting member from the drive sleeve and to enable rotation of the drive sleeve in a dose decrementing direction to dispense the dose. ### Claim 24 (depends on 21) The method according to claim 21, wherein the radial stop and the radial counter stop extend in both a radial direction and an axial direction, and the radial stop is configured to engage with the radial counter stop in a circumferential direction such that further rotation of the last dose sleeve and rotation of the last dose member are prevented when a last dose stop configuration of the drug delivery device has been reached.