# US 11,439,758 B2 · Devices and methods for precision dose delivery > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,439,758 B2 - Document ID: US11439758B2 - Status: Granted - Kind: B2 - Application number: 17/354,850 - Filed: 2021-06-22 - Published: 2021-10-28 - Granted: 2022-09-13 - Earliest claimed: 2019-06-05 - Assignees: Regeneron Pharmaceuticals, Inc. - Applicants: Regeneron Pharmaceuticals, Inc. - Inventors: Trevor Langley; Justin Bechstein; Jeremy Odegard; Sibgat Ulla; Daniel Halbig; Bryan Grygus; Prithvi Singh; Andrew Dumont; David Nett; Tasha Gillum; Ryan Ainsworth - Web page: https://patentgrep.com/patent/US11439758B2 ## CPC - A61M 5/31505: {Integral with the syringe barrel, i.e. connected to the barrel so as to make up a single complete piece or unit} - A61M 5/3135: {characterised by constructional features of the proximal end} - A61M 5/3137: {with finger grip means, e.g. for easy manipulation of the syringe rod} - A61M 5/3146: {Priming, e.g. purging, reducing backlash or clearance} - A61M 5/31536: {Blocking means to immobilize a selected dose, e.g. to administer equal doses} - A61M 5/31583: {the piston rod being moved by the rotational movement of a component directly in contact with it} - A61F 9/0008: {Introducing ophthalmic products into the ocular cavity or retaining products therein (putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00)} - A61M 2005/3139: {Finger grips not integrally formed with the syringe barrel, e.g. using adapter with finger grips} - A61M 2005/31508: {provided on the piston-rod} - A61M 2005/3154: {limiting maximum permissible dose} - A61M 2205/584: having a color code - 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)} - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) ## Abstract Disclosed herein are devices and methods for delivering a predetermined volume of a drug substance or other product including a fluid. An exemplary device may include a body configured to receive a drug substance therein, and a plunger rod disposed at least partially inside the body to distally move a stopper in the body. The device may include a component configured to regulate distal movement of the plunger rod in a priming step and in a subsequent delivery step, so that the device may be accurately primed and may accurately dispense a predetermined volume of a drug substance. ## Claims ### Claim 1 A drug delivery device, comprising: a body; a plunger rod including a proximal end portion and a distal end portion disposed partially inside the body, wherein the proximal end portion has a diameter greater than a diameter of the distal end portion; a protrusion extending from an outer surface of the proximal end portion of the plunger rod; and a blocking component coupled to a proximal end portion of the body, wherein the blocking component is a flange piece that includes a channel with an open distal end and a slot with a closed distal end, wherein, when the protrusion is in a first position relative to the blocking component, the protrusion is misaligned with the slot and the blocking component restricts distal movement of the plunger rod through the open distal end to a first stopping point, and when the protrusion is in a second position relative to the blocking component, the protrusion is aligned with the slot and the blocking component restricts distal movement of the plunger rod through the open distal end to a second stopping point when the protrusion abuts against the closed distal end. ### Claim 2 (depends on 1) The drug delivery device of claim 1, further comprising: a stopper disposed in the body, wherein distal movement of the plunger rod distally moves the stopper; and a drug substance disposed in the body in between the stopper and a distal end of the body, wherein distal movement of the plunger rod to the first stopping point primes the drug delivery device, and distal movement of the plunger rod to the second stopping point dispenses a predetermined volume of the drug substance from a distal end of the device. ### Claim 3 (depends on 1) The drug delivery device of claim 1, wherein moving the protrusion from the first position to the second position includes twisting the plunger rod relative to the blocking component, such that the protrusion is positioned external to the blocking component when in the second position. ### Claim 4 (depends on 1) The drug delivery device of claim 1, wherein the slot is positioned on a proximal side of the blocking component, the slot is sized and configured to receive a distal end of the protrusion, such that a proximal end of the protrusion is positioned external to the slot when the distal end is received within the slot, wherein when the protrusion is in the second position relative to the blocking component, the distal end of the protrusion is positioned proximally from the slot and disengaged from the proximal side of the blocking component, such that distal movement of the plunger rod moves the distal end of the protrusion into the slot. ### Claim 5 (depends on 4) The drug delivery device of claim 4, wherein the slot is a first slot and the protrusion is a first protrusion, and further comprising: a second slot in a proximal side of the blocking component, the second slot sized and configured to receive a second protrusion extending from the outer surface of the proximal end portion of the plunger rod, wherein the first and second slots are located on opposite sides of a central longitudinal axis of the drug delivery device. ### Claim 6 (depends on 4) The drug delivery device of claim 4, wherein, when the protrusion is in the first position relative to the blocking component, the proximal side engages the distal end of the protrusion and restricts distal movement of the plunger rod to the first stopping point; and when the protrusion is in the second position relative to the blocking component, the distal end of the protrusion aligns with the slot and is disengaged from the proximal side. ### Claim 7 (depends on 6) The drug delivery device of claim 6, wherein the plunger rod further includes a pair of extensions protruding distally from an actuation portion of the proximal end portion, and the blocking component includes a pair of openings; and wherein a portion of each extension is configured to be received by one of the pair of openings, prior to the plunger rod moving to the first stopping point, to restrict proximal movement of the plunger rod relative to the blocking component. ### Claim 8 (depends on 7) The drug delivery device of claim 7, wherein the blocking component includes one or more indents formed along a bottom wall of the blocking component; and wherein a portion of each extension is configured to be received by the one or more indents upon distal movement of the plunger rod relative to the blocking component to allow distal movement of the plunger rod to the second stopping point. ### Claim 9 (depends on 7) The drug delivery device of claim 7, wherein the blocking component includes a pair of internal grooves formed along a sidewall of the blocking component; and wherein a portion of each extension is configured to be received by at least one of the pair of internal grooves upon rotation of the plunger rod relative to the blocking component to expand the extensions radially-outward from a compressed state to a relaxed state. ### Claim 10 (depends on 1) The drug delivery device of claim 1, wherein the blocking component is slidably coupled to the body and includes a cavity and a pair of ribs that extend into the cavity, wherein the body includes a top flange and the pair of ribs are configured to engage the top flange received in the cavity; and wherein the pair of internal ribs are configured to apply a distally-directed force onto the top flange. ### Claim 11 (depends on 1) The drug delivery device of claim 1, wherein the blocking component is slidably coupled to the body and includes a pair of moveable tabs that are configured to engage the body; and wherein the pair of moveable tabs are laterally deflectable upon receiving the body in the blocking component and are configured to apply a radially-inward directed force onto the body. ### Claim 12 A drug delivery device, comprising: a body; a plunger rod having a distal end contacting a stopper inside the body, and a proximal end including an actuation portion with a thumb pad; a plurality of protrusions extending from the thumb pad and along the actuation portion; and a blocking component disposed on the body, the blocking component including a proximal collar having a proximal-facing surface, a channel with an open distal end, and a plurality of slots extending past the proximally-facing surface, each of the plurality of slots including a closed distal end; wherein, when the protrusions and the slots are in a first configuration relative to one another, the plunger rod is moveable relative to the blocking component until the proximally-facing surface abuts against the plurality of protrusions and the blocking component restricts distal movement of the plunger rod through the open distal end to a first stopping point, wherein, in the first configuration, the plurality of protrusions are misaligned with the plurality of slots; and wherein, when the protrusions and the slots are in a second configuration, the proximally-facing surface is separated from the plurality of protrusions and the plunger rod is moveable relative to the blocking component until the blocking component restricts distal movement of the plunger rod through the open distal end to a second stopping point, wherein, in the second configuration, the slots are aligned with the protrusions and configured to receive the protrusions until each of the protrusions abuts against the closed distal end of the slots. ### Claim 13 (depends on 12) The drug delivery device of claim 12, wherein the protrusions and the slots are moveable from the first stopping point to the second stopping point by rotation of the actuation portion about a longitudinal axis in relation to the blocking component, and translation of the plunger rod relative to the blocking component; wherein when the protrusions and the slots are at the second stopping point, the protrusions and the slots are not rotatable. ### Claim 14 (depends on 12) The drug delivery device of claim 12, wherein a longitudinal difference between the first stopping point and the second stopping point is equivalent to a distance that the stopper must travel to expel a predetermined volume of a drug product from a distal end of the body, the distance defined by a depth of the slots from the proximally-facing surface of the blocking component, and wherein the plunger rod is prevented from moving from the second stopping point to the first stopping point. ### Claim 15 (depends on 12) The drug delivery device of claim 12, wherein the drug delivery device is changeable: (a) from a pre-use state to a primed state, by longitudinally moving the plunger rod until the plunger rod reaches the first stopping point; (b) from the primed state to a delivery state by rotating the plunger rod in relation to the blocking component until the protrusions and the blocking component are in the second configuration; and (c) from the delivery state to a used state by longitudinally moving the plunger rod until the plunger reaches the second stopping point, and wherein the drug delivery device is not changeable from the used state to the delivery state, from the delivery state to the primed state, or from the primed state to the pre-use state. ### Claim 16 (depends on 15) The drug delivery device of claim 15, wherein the plunger rod includes a neck disposed distally from the actuation portion, wherein the neck interfaces with an opening in the blocking component to prevent proximal movement of the plunger rod. ### Claim 17 (depends on 16) The drug delivery device of claim 16, wherein the neck further interfaces with the opening in the blocking component to prevent movement of the drug delivery device from the delivery state to the primed state. ### Claim 18 (depends on 12) The drug delivery device of claim 12, wherein when the plunger rod is at the second stopping point, the stopper does not contact a distal end of the body. ### Claim 19 A drug delivery device, comprising: a body; a plunger rod extending along a longitudinal axis, including: a distal portion contacting a stopper inside the body; a proximal end including a generally cylindrical actuation portion and a thumb pad disposed outside of the body, the thumb pad positioned proximal to the generally cylindrical actuation portion; and two protrusions extending from opposite sides of the actuation portion in a symmetrical configuration, wherein distally-facing surfaces of the two protrusions are located at a same longitudinal position along the longitudinal axis; and a blocking component coupled to the body, the blocking component including: a collar having a channel with an open proximal end configured to accept a distal part of the actuation portion, and an open distal end configured to accept the distal portion of the plunger rod; and two slots in the collar having closed distal ends, wherein each slot is configured to accept a distal portion of one of the two protrusions; wherein the plunger rod is longitudinally moveable and rotatable about a longitudinal axis relative to the blocking component, and wherein, when the drug delivery device is in a pre-use state, the protrusions and the slots are not longitudinally aligned such that the plunger rod is moveable relative to the open distal end until the distally-facing surfaces abut against the collar, and when the drug delivery device is in a delivery state, the protrusions and the slots are longitudinally aligned such that the plunger rod is moveable relative to the open distal end until the distally-facing surfaces abut against the closed distal ends. ### Claim 20 (depends on 19) The drug delivery device of claim 19, wherein the plunger rod further includes: two extensions protruding distally from the actuation portion; and a plurality of openings in the collar of the blocking component, wherein a portion of each extension is configured to be received by one of the plurality of openings upon distal movement of the plunger rod relative to the blocking component.