US-12616795-B2 - Drug delivery device and methods of delivering a drug

US12616795B2US 12616795 B2US12616795 B2US 12616795B2US-12616795-B2

Abstract

A drug delivery device and a method of using the drug delivery device may include a housing having an opening and a drug storage container including a delivery member. The drug storage container may be coupled with the housing such as to substantially prevent relative movement between the drug storage container and the housing. A guard may be positioned adjacent to the opening and operably coupled with a plunger biasing member such that a relative movement between the guard and the housing permits release of the plunger biasing member to urge a plunger in to expel a drug from the drug storage container. A lock component may be configured to resist the relative movement between the guard and the housing until the lock component is released by a user force, whereafter the user force drives the housing and the drug storage container toward an injection site.

Inventors

Emil Finkelstein
Soren Forbech Skall
Lars Eilertsen
Rasmus Øhlenschlæger
Joshua J. Dudman
Anders Grove Sund
Steve Sanchez

Assignees

AMGEN INC.

Dates

Publication Date: 20260505
Application Date: 20200929

Claims (20)

1 . A drug delivery device comprising: a housing defining a longitudinal axis and having an opening; a drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening during a delivery state, the drug storage container coupled with the housing such as to substantially prevent relative movement between the drug storage container and the housing; a plunger moveable in a distal direction with respect to the drug storage container to expel a drug from the drug storage container through the delivery member; a plunger biasing member configured to urge the plunger in the distal direction; a guard positioned adjacent to the opening, the guard operably coupled with the plunger biasing member such that a relative movement between the guard and the housing along the longitudinal axis permits release of the plunger biasing member; and a lock component configured to resist the relative movement between the guard and the housing until the lock component is released by a user force, wherein resistance from the lock component is configured to induce a user to increase the user force and when the lock component is released the user force is configured to drive the housing and the drug storage container toward an injection site, wherein at least a portion of the lock component is rotatable with respect to the housing about the longitudinal axis, at least the portion of the lock component having a first position where at least the portion of the lock component resists the relative movement between the guard and the housing and a second position where at least the portion of the lock component does not resist or offers less resistance to the relative movement between the guard and the housing.
2 . The drug delivery device of claim 1 , wherein at least the portion of the lock component includes a lock ring.
3 . The drug delivery device of claim 2 , wherein the lock ring includes a lock arm having a base and a deflectable end, wherein deflection of the deflectable end permits the lock ring to rotate between the first position and the second position.
4 . The drug delivery device of claim 3 , wherein the deflectable end includes a lock ridge.
5 . The drug delivery device of claim 3 , wherein the guard includes an inertial rib configured to engage the lock ring and resist rotational movement of the lock ring relative to the housing.
6 . The drug delivery device of claim 5 , wherein the inertial rib is configured to engage the deflectable end of the lock arm and resist movement of the lock ring from the first position to the second position.
7 . The drug delivery device of claim 6 , wherein the guard further includes a camming rib configured to engage a first camming surface of the lock ring and urge the lock ring towards the second position.
8 . The drug delivery device of claim 7 , wherein the lock ring further includes: a second camming surface configured to engage the guard and urge the lock ring towards a third position; and a stop ridge configured to selectively engage the guard and limit or resist relative movement between the guard and the lock ring along the longitudinal axis when the lock ring is in the third position.
9 . The drug delivery device of claim 2 , wherein: the guard includes a first proximally-facing camming surface, the housing includes a first distally-facing camming surface, and the lock ring includes a first distally-facing camming surface and a first proximally-facing camming surface configured to engage respectively the first proximally-facing camming surface of the guard and the first distally-facing camming surface of the housing when the lock ring is in the first position to resist proximal movement of the guard.
10 . The drug delivery device of claim 9 , wherein one or more of the first proximally-facing camming surface of the guard and the first distally-facing camming surface of the housing is configured to urge the lock ring to rotate from the first position toward the second position during the proximal movement of the guard.
11 . The drug delivery device of claim 9 , wherein any two or combination of the following are parallel to each other: the first proximally-facing camming surface of the guard, the first distally-facing camming surface of the housing, the first distally-facing camming surface of the lock ring, and the first proximally-facing camming surface of the lock ring.
12 . The drug delivery device of claim 9 , wherein the lock ring includes a radially outwardly extending protrusion and the radially outwardly extending protrusion includes the first distally-facing camming surface.
13 . The drug delivery device of claim 2 , further comprising a lock ring biasing member disposed axially between the lock ring and the guard, wherein the lock ring biasing member is configured to exert a biasing force to urge the lock ring and the guard away from each other.
14 . The drug delivery device of claim 2 , wherein a distal end of the lock ring is at least partially disposed within the guard.
15 . The drug delivery device of claim 2 , wherein the lock ring includes a camming surface, wherein the camming surface is non-parallel to the longitudinal axis such that the camming surface is configured to convert translational movement of the guard into rotational movement of the lock ring.
16 . The drug delivery device of claim 1 , wherein the drug storage container is filled or pre-filled with the drug, and wherein the drug comprises one of: a drug containing a human IgG1 kappa antibody, a drug containing a small interfering RNA (siRNA) that lowers lipoprotein (a), erenumab, etanercept, Tezepelumab, efavaleukin alfa, evolocumab, and a drug containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist.
17 . A drug delivery device comprising: a housing defining a longitudinal axis and having an opening; a drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening during a delivery state, the drug storage container coupled with the housing such as to substantially prevent relative movement between the drug storage container and the housing; a plunger moveable in a distal direction with respect to the drug storage container to expel a drug from the drug storage container through the delivery member; a plunger biasing member configured to urge the plunger in the distal direction; a guard positioned adjacent to the opening such that the housing has a first position with respect to the guard where the plunger biasing member is locked and a second position with respect to the guard where the plunger biasing member is unlocked; and a lock component configured to maintain the housing in the first position until the lock component is released by a user force, wherein resistance from the lock component is configured to induce a user to increase the user force and when the lock component is released the user force is configured to drive the housing and the drug storage container toward an injection site, wherein at least a portion of the lock component is rotatable with respect to the housing about the longitudinal axis, at least the portion of the lock component having a first position where at least the portion of the lock component resists a relative movement between the guard and the housing and a second position where at least the portion of the lock component does not resist or offers less resistance to the relative movement between the guard and the housing.
18 . The drug delivery device of claim 17 , wherein at least the portion of the lock component includes a lock ring.
19 . The drug delivery device of claim 18 , wherein the lock ring includes a lock arm having a base and a deflectable end, wherein deflection of the deflectable end permits the lock ring to rotate between the first position of the lock ring and the second position of the lock ring.
20 . The drug delivery device of claim 19 , wherein the deflectable end includes a lock ridge.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS The present application claims the priority of U.S. Provisional Application No. 62/908,504, filed Sep. 30, 2019, entitled, “Drug Delivery Device,” U.S. Provisional Application No. 62/960,996, filed Jan. 14, 2020, entitled, “Drug Delivery Device and Methods of Delivering a Drug,” and U.S. Provisional Application No. 62/962,042, filed Jan. 16, 2020, entitled, “Drug Delivery Device and Methods of Delivering a Drug,” each of which is incorporated by reference. FIELD OF DISCLOSURE The present disclosure relates to drug delivery devices and methods of delivering a drug, and, more particularly, devices and methods for automatically injecting a drug into a patient. BACKGROUND A general aversion to exposed needles, as well as health and safety issues, have led to the development of drug delivery devices which conceal a needle or other insertion member prior to use and which automate various aspects of an injection process. Such devices offer a variety of benefits as compared with traditional forms of drug delivery including, for example, delivery via a conventional syringe. A drug delivery device may incorporate various mechanisms to implement various automated features. Such features may include automatically covering a needle in a pre-delivery and/or post-delivery state, automatically inserting a needle and/or a cannula into a user, automatically activating a drive mechanism, automatically indicating to the user that drug delivery is complete, among other features. Typically a drug delivery device will incorporate a separate or independently operable mechanism to realize each of its automated features. As a consequence, with each added feature, the mechanical complexity of the device tends to increase. This, in turn, can increase the size of the device, which can make it cumbersome for the user to handle, as well as increase manufacturing costs and timeframes. As the demand grows for drug delivery devices with greater ease of use and safety, finding a way to incorporate more automated features without adding undue complexity to the drug delivery device presents various design and manufacturing challenges. The present disclosure sets forth drug delivery devices embodying advantageous alternatives to existing drug delivery devices, and that may address one or more of the challenges or needs mentioned herein. SUMMARY One aspect of the present disclosure provides a drug delivery device including a housing defining a longitudinal axis and having an opening and a drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening, the drug storage container coupled with the housing such as to substantially prevent relative movement therebetween. The device may further include a plunger moveable in a distal direction with respect to the drug storage container to expel a drug from the drug storage container through the delivery member and a plunger biasing member configured to urge the plunger in the distal direction. The device may also include a guard positioned adjacent to the opening of the housing that is operably coupled with the plunger biasing member such that a relative movement between the guard and the housing along the longitudinal axis permits release of the plunger biasing member. The device may further include a lock component configured to resist the relative movement between the guard and the housing until the lock component is released by a user force. Resistance from the lock component may induce (e.g., encourage) the user to increase the user force and when the lock component is released the user force may drive the housing and the drug storage container toward an injection site. In at least some embodiments, release of the lock component may allow for utilization of inertial forces from the user force to drive the housing and the drug storage container toward the injection site. The lock component may include a lock ring rotatable with respect to the housing about the longitudinal axis. The lock ring may have a first position where the lock ring resists the relative movement between the guard and the housing and a second position where the lock ring does not resist the relative movement between the guard and the housing. The lock ring may additionally or alternatively include a lock arm having a base and a deflectable end, where deflection of the deflectable end permits the lock ring to rotate between the first position and the second position. The lock arm may also include a lock ridge. The guard may include an inertial rib configured to engage the lock ring and to resist rotational movement of the lock ring relative to the housing. The guard may further include an inertial rib configured to engage the deflectable end of the lock arm and resist movement of the lock ring from the first position to the second position. The guard may include a camming rib configured to engage a camming surface of