Devices and methods for precision dose delivery

Patent metadata

Field	Value
Publication number	US-11439758-B2
Application number	US-202117354850-A
Country	US
Kind code	B2
Filing date	Jun 22, 2021
Priority date	Jun 5, 2019
Publication date	Sep 13, 2022
Grant date	Sep 13, 2022

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.

First claim

What is claimed is:

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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

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.

13. 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.

Assignees

• Regeneron Pharma

Inventors

• Langley Trevor
• Bechstein Justin
• Odegard Jeremy
• Ulla Sibgat
• Halbig Daniel
• Grygus Bryan
• Singh Prithvi
• Dumont Andrew
• NETT David
• Gillum Tasha
• Ainsworth Ryan

Classifications

• A61M2005/3154

  limiting maximum permissible dose · CPC title

• A61F9/0008

  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) · CPC title

• A61M5/31583

  based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod · CPC title

• A61M5/31591

  Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means · CPC title

• A61M5/3153

  by single stroke limiting means · CPC title