# US 10,765,801 B2 · Drug delivery device with proximity sensor > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,765,801 B2 - Document ID: US10765801B2 - Status: Granted - Kind: B2 - Application number: 15/047,853 - Filed: 2016-02-19 - Published: 2016-06-23 - Granted: 2020-09-08 - Earliest claimed: 2014-12-19 - Assignees: Amgen Inc. - Applicants: Amgen Inc. - Inventors: Adam B. McCullough - Web page: https://patentgrep.com/patent/US10765801B2 ## CPC - A61M 5/31501: {Means for blocking or restricting the movement of the rod or piston (A61M5/5013 takes precedence)} - A61M 5/00: Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests (tube connectors, tube couplings, valves or branch units, specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00) - A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body} - A61M 5/14248: {of the skin patch type} - A61M 5/1454: {spring-actuated, e.g. by a clockwork} - A61M 5/20: Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically (A61M5/142 takes precedence) - A61M 5/2033: {Spring-loaded one-shot injectors with or without automatic needle insertion (multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287)} - A61M 5/2053: {Media being expelled from injector by pressurised fluid or vacuum (for infusion A61M5/145, A61M5/155)} - A61M 5/5086: {for indicating if defective, used, tampered with or unsterile} - A61M 5/14526: {the piston being actuated by fluid pressure} - A61M 5/1684: {by detecting the amount of infusate remaining, e.g. signalling end of infusion} - A61M 5/16881: {Regulating valves} - A61M 5/2046: {Media being expelled from injector by gas generation, e.g. explosive charge} - A61M 2005/14252: {with needle insertion means} - A61M 2005/1581: {Right-angle needle-type devices} - A61M 2005/2013: {triggering of discharging means by contact of injector with patient body} - A61M 2005/2073: {preventing premature release, e.g. by making use of a safety lock} - A61M 2205/13: with means for the detection of operative contact with patient, e.g. lip sensor - A61M 2205/33: Controlling, regulating or measuring - A61M 2205/3351: Controlling upstream pump pressure - A61M 2205/50: with microprocessors or computers - A61M 2205/583: by visual feedback - A61M 2205/8225: using incorporated gas cartridges for the driving gas - 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 device, in the form of an injector, may include one of a number of systems for limiting the delivery of a medical fluid or drug product in case of movement of (e.g., removal of) the injector relative to the patient as determined by a proximity sensor. The drug delivery system may in the alternative or in addition include systems for indicating the amount of medical fluid or drug product delivered (or not delivered) in case of movement of (e.g., removal of) the injector relative to the patient as determined by the proximity sensor. The injector may be, for example, an on-body injector or an hand-held autoinjector. ## Claims ### Claim 1 An on-body injector comprising: a reservoir including a bore having a first end and a second end, and a plunger assembly including a plunger moveable within the bore between the first and second ends; a cannula having an operational state wherein the cannula is connected in fluid communication with the reservoir; a drive coupled to the plunger assembly to move the plunger between the first and second ends for moving a drug product out of the reservoir and through the cannula; a housing, wherein the reservoir, the cannula, and the drive are disposed at least partially within the housing; a proximity sensor operably coupled to move relative to the housing, the proximity sensor having a first sensor state wherein the proximity sensor extends from the housing and a second sensor state wherein the proximity sensor is retracted toward the housing relative to the first sensor state; a biasing member configured to bias the proximity sensor toward the first sensor state; and a lock operably coupled to the proximity sensor, the lock having a first position resisting movement of the plunger between the first and second ends of the reservoir when the proximity sensor is in the first sensor state and the lock having a second position permitting movement of the plunger between the first and second ends of the reservoir when the proximity sensor is in the second sensor state. ### Claim 2 (depends on 1) The on-body injector of claim 1, wherein the lock comprises a wall of a plate that moves along a line of motion and is operably coupled to one of the plunger assembly and the drive when the proximity sensor is in the first sensor state. ### Claim 3 (depends on 2) The on-body injector of claim 2, wherein the plate has a first end that defines the wall of the lock and a second end that defines the proximity sensor. ### Claim 4 (depends on 2) The on-body injector of claim 2, wherein: the plunger assembly includes a plunger arm attached to the plunger; the wall of the lock abuts the plunger arm to limit movement of the plunger when the lock is coupled to the plunger assembly; and the proximity sensor is coupled to the wall, where the wall abuts the plunger arm when the proximity sensor is in the first sensor state and the is spaced from the plunger arm when the proximity sensor is in the second sensor state. ### Claim 5 (depends on 4) The on-body injector of claim 4, wherein: the plunger arm has at least one shoulder formed thereon; and the wall of the lock abuts the at least one shoulder of the plunger arm to limit movement of the plunger when the lock is coupled to the plunger assembly. ### Claim 6 (depends on 1) The on-body injector of claim 1, wherein the lock comprises a wall of a lever that moves about a pivot and is operably coupled to one of the plunger assembly and the drive when the proximity sensor is in the first sensor state. ### Claim 7 (depends on 6) The on-body injector of claim 6, wherein the lever has a first end disposable within the housing and defining the wall of the lock, and a second end disposable outside of the housing and defining the proximity sensor. ### Claim 8 (depends on 1) The on-body injector of claim 1, wherein the drive comprises a spring. ### Claim 9 (depends on 8) The on-body injector of claim 8, wherein the lock is selectively coupled to one of the plunger and the spring when the proximity sensor is in the first sensor state. ### Claim 10 (depends on 9) The on-body injector of claim 9, wherein a wall of the lock abuts the spring to limit movement of the plunger when the lock is coupled to the plunger assembly; and the proximity sensor is attached to the wall, where the wall abuts the spring when the proximity sensor is in the first sensor state and the wall is spaced from the spring when the proximity sensor is in the second sensor state. ### Claim 11 (depends on 1) The on-body injector of claim 1, wherein the drive comprises a gas source and the lock comprises a vent operably coupled to the gas source to exhaust positive pressure from the gas source when the proximity sensor is in the first sensor state. ### Claim 12 (depends on 11) The on-body injector of claim 11, further comprising a chamber disposed between and connecting the gas source and the reservoir, the vent disposed in a wall of the chamber. ### Claim 13 (depends on 11) The on-body injector of claim 11, wherein the vent comprises a seal and a vent cannula, wherein the vent cannula pierces the seal when the proximity sensor is in the first sensor state. ### Claim 14 (depends on 13) The on-body injector of claim 13, further comprising a vent lever having a first end connected to the vent cannula and a second end connected to the proximity sensor such that movement of the proximity sensor is transmitted to the vent cannula via the vent lever. ### Claim 15 (depends on 1) The on-body injector of claim 1, wherein the lock comprises a valve disposed between the reservoir and the cannula, the valve being movable between open and closed states and occupying the closed state when the proximity sensor is in the first sensor state. ### Claim 16 (depends on 15) The on-body injector of claim 15, further comprising a controller coupled to the proximity sensor and the valve for positioning the valve in the closed state when the proximity sensor is in the first sensor state. ### Claim 17 (depends on 15) The on-body injector of claim 15, further comprising a fluid line disposed between and connecting the reservoir and the cannula, the valve disposed on the fluid line. ### Claim 18 (depends on 1) The on-body injector of claim 1, further comprising a flexible fluid line disposed between the reservoir and the cannula. ### Claim 19 (depends on 18) The on-body injector of claim 18, comprising a movable plate, wherein the movable plate comprises an aperture through which the flexible fluid line is disposed. ### Claim 20 (depends on 1) The on-body injector of claim 1, wherein the lock comprises a wall and a first end of the cannula resides within the wall and out of fluid communication with the reservoir when the proximity sensor is in the first sensor state. ### Claim 21 (depends on 20) The on-body injector of claim 20, further comprising a biasing member biasing the first end of the cannula to reside within the wall. ### Claim 22 (depends on 20) The on-body injector of claim 20, wherein the first end of the cannula penetrates the wall and is in fluid communication with the reservoir when the proximity sensor is in the second sensor state. ### Claim 23 (depends on 1) The on-body injector of claim 1, further comprising an indicator selectively coupled to the plunger assembly when the proximity sensor is in the second sensor state and selectively de-coupled from the plunger assembly when the proximity sensor is in the first sensor state. ### Claim 24 (depends on 23) The on-body injector of claim 23, wherein the indicator is mechanically coupled to the plunger assembly when the proximity sensor is in the second sensor state. ### Claim 25 (depends on 24) The on-body injector of claim 24, wherein the plunger assembly comprises a plunger arm attached to the plunger, the indicator being selectively mechanically coupled to the plunger arm through a gear train having at least one gear that is moveable into and out of engagement with the plunger arm, and the proximity sensor is coupled to the at least one gear to move the at least one gear out of engagement with the plunger arm and decouple the indicator from the plunger arm with the proximity sensor in the first sensor state. ### Claim 26 (depends on 1) The on-body injector of claim 1, comprising an indicator disposed at an exterior surface of the housing, the indicator being operable to track movement of the plunger within the bore of the reservoir when the proximity sensor is in the second sensor state and not being operable to track movement of the plunger within the bore of the reservoir when the proximity sensor is in the first sensor state. ### Claim 27 (depends on 26) The on-body injector of claim 26, wherein moving the proximity sensor from the second sensor state to the first sensor state decouples the indicator from the plunger such that the indicator does not track movement of the plunger within the bore of the reservoir. ### Claim 28 (depends on 1) The on-body injector of claim 1, the proximity sensor comprising a lever having a first end and a second end, the first end of the lever being pivotably attached within the housing, the second end of the lever extending outside of the housing in the first sensor state. ### Claim 29 (depends on 28) The on-body injector of claim 28, the first end of the lever being pivotally attached at a pivot within the housing, the biasing member being configured to exert a biasing force on the first end of the lever at a distance away from the pivot. ### Claim 30 (depends on 29) The on-body injector of claim 29, the biasing member comprising a spring. ### Claim 31 (depends on 30) The on-body injector of claim 30, the spring being linearly compressible. ### Claim 32 (depends on 1) The on-body injector of claim 1, wherein the lock mechanically resists movement of the plunger between the first and second ends of the reservoir when the proximity sensor is in the first sensor state. ### Claim 33 An on-body injector comprising: a reservoir including a bore having a first end and a second end, and a plunger assembly including a plunger moveable within the bore between the first and second ends; a cannula having an operational state wherein the cannula is connected in fluid communication with the reservoir; a drive coupled to the plunger assembly to move the plunger between the first and second ends for moving a drug product out of the reservoir and through the cannula; a housing, wherein the reservoir, the cannula, and the drive are disposed at least partially within the housing; a proximity sensor operably coupled to move relative to the housing, the proximity sensor having a first sensor state wherein the proximity sensor extends from the housing and a second sensor state wherein the proximity sensor is retracted toward the housing relative to the first sensor state; and an indicator disposed at an exterior surface of the housing, the indicator being operable to track movement of the plunger within the bore of the reservoir when the proximity sensor is in the second sensor state and not being operable to track movement of the plunger within the bore of the reservoir when the proximity sensor is in the first sensor state. ### Claim 34 (depends on 33) The on-body injector of claim 33, wherein moving the proximity sensor from the second sensor state to the first sensor state decouples the indicator from the plunger such that the indicator does not track movement of the plunger within the bore of the reservoir. ### Claim 35 An on-body injector comprising: a reservoir including a bore having a first end and a second end, and a plunger assembly including a plunger moveable within the bore between the first and second ends and a plunger arm attached to the plunger; a cannula having an operational state wherein the cannula is connected in fluid communication with the reservoir; a drive coupled to the plunger assembly to move the plunger between the first and second ends for moving a drug product out of the reservoir and through the cannula; a housing, wherein the reservoir, the cannula, and the drive are disposed at least partially within the housing; a proximity sensor operably coupled to move relative to the housing, the proximity sensor having a first sensor state wherein the proximity sensor extends from the housing and a second sensor state wherein the proximity sensor is retracted toward the housing relative to the first sensor state; a gear train including at least one gear that is moveable into and out of engagement with the plunger arm; and an indicator mechanically coupled to the plunger arm via the at least one gear when the proximity sensor is in the second sensor state, the proximity sensor being coupled to the at least one gear to move the at least one gear out of engagement with the plunger arm and mechanically decouple the indicator from the plunger arm when the proximity sensor is in the first sensor state. ### Claim 36 An on-body injector comprising: a reservoir including a bore having a first end and a second end, and a plunger assembly including a plunger moveable within the bore between the first and second ends; a volume of a drug product disposed in the reservoir, the drug product comprising a granulocyte colony-stimulating factor (G-CSF); a cannula having an operational state wherein the cannula is connected in fluid communication with the reservoir; a drive coupled to the plunger assembly to move the plunger between the first and second ends for moving the drug product out of the reservoir and through the cannula; a housing, wherein the reservoir, the cannula, and the drive are disposed at least partially within the housing; a proximity sensor operably coupled to move relative to the housing, the proximity sensor having a first sensor state wherein the proximity sensor extends from the housing and a second sensor state wherein the proximity sensor is retracted toward the housing relative to the first sensor state; an indicator selectively coupled to the plunger assembly when the proximity sensor is in the second sensor state and selectively de-coupled from the plunger assembly when the proximity sensor is in the first sensor state, wherein the indicator is mechanically coupled to the plunger assembly when the proximity sensor is in the second sensor state; and wherein the plunger assembly comprises a plunger arm attached to the plunger, the indicator being selectively mechanically coupled to the plunger arm through a gear train having at least one gear that is moveable into and out of engagement with the plunger arm, and the proximity sensor is coupled to the at least one gear to move the at least one gear out of engagement with the plunger arm and decouple the indicator from the plunger arm with the proximity sensor in the first sensor state.