WO-2026096589-A1 - DRUG DELIVERY DEVICE AND RELATED METHODS

Abstract

A drug delivery device (10, 100, 200) which includes a housing (12, 112, 212) having a distal end, a proximal end, and an opening adjacent to the distal end, a drug storage container (20) including a delivery member (16) having an insertion end configured to extend at least partially through the opening, a plunger moveable (26) in a distal direction to expel a drug from the drug storage container through the delivery member, a guard member (32, 132, 232) moveable relative to the housing, and a guard extension (37, 137, 237) positioned proximal to the guard member and operably coupled to the guard member. The guard extension may have a first engagement component on an inner surface thereof, and the guard member may have a second engagement component. The first and second engagement components are configured to limit axial movement of the guard extension in a proximal direction when the guard member is in the extended position.

Inventors

• BILLESKOV, Oliver
• LAVMAND MULLER, DAVID
• ELMER JENSEN, Anders
• EILERTSEN, LARS

Assignees

• AMGEN INC.

Dates

Publication Date

20260507

Application Date

20251029

Priority Date

20241030

Claims (20)

1. 1. A drug delivery device comprising: a housing having a distal end, a proximal end, and an opening adjacent to the distal end, the housing extending along a longitudinal axis; a drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening; a plunger moveable in a distal direction to expel a drug from the drug storage container through the delivery member; a guard member moveable relative to the housing, the guard member having an extended position wherein the guard member extends at least partially through the opening in the housing and a retracted position wherein the guard member is positioned away from the extended position toward the housing; a guard extension positioned proximal to the guard member and operably coupled to the guard member, the guard extension having a first engagement component on an inner surface thereof, wherein the guard member includes a second engagement component, and wherein the first and second engagement components are configured to limit axial movement of the guard extension in a proximal direction when the guard member is in the extended position.
2. 2. The drug delivery device of claim 1, wherein the first engagement component includes a pair of grooves, and wherein the second engagement component includes a pair of lock arms.
3. 3. The drug delivery device of claim 2, wherein each lock arm of the pair of lock arms includes a lip portion at a proximal end thereof, wherein the lip portions are movably disposed within the pair of grooves such that the lip portions move axially within the grooves during movement of the guard member between the extended position and the retracted position.
4. 4. The drug delivery device of claim 3, wherein each groove of the pair of grooves includes sidewalls configured to prevent lateral movement of the lip portions.
5. 5. The drug delivery device of claim 3, wherein the lip portions extend radially away from the proximal end of the lock arms.
6. 6. The drug delivery device of claim 2, wherein the guard member includes a cylindrical portion and a pair of arms extending proximally from the cylindrical portion, the pair of arms being at least partially disposed within the housing, wherein the pair of lock arms extend proximally from a distal end of the pair of arms.
7. 7. The drug delivery device of claim 2, wherein each groove of the pair of grooves includes a proximal surface, a distal surface, a pair of sidewalls, and an interface extending between the proximal surface and the distal surface.
8. 8. The drug delivery device of claim 7, further comprising a pair of flanges disposed around a respective one of the pair of grooves, each of the flanges protruding radially towards the longitudinal axis, wherein each flange defines the proximal surface, the distal surface, and the sidewalls of the respective groove. 10923-W001-SEC
9. 9. The drug delivery device of claim 7, wherein at least a portion of the interface extending between the proximal surface and the distal surface is slanted at an angle relative to the longitudinal axis.
10. 10. The drug delivery device of claim 7, wherein each lock arm of the pair of lock arms includes a lip portion at a proximal end thereof, wherein the lip portions are movably disposed within the pair of grooves such that the lip portions engage the interface while moving between the proximal surface and the distal surface.
11. 11. The drug delivery device of claim 10, wherein the lip portions are configured to abut the distal surfaces of the grooves when the guard member is in the extended position to limit or prevent axial movement of the guard extension in the proximal direction.
12. 12. The drug delivery device of claim 10, wherein the lip portions are configured to abut the proximal surfaces of the grooves when the guard member is in the retracted position.
13. 13. The drug delivery device of claim 2, wherein movement of the guard member from the extended position to the retracted position causes the pair of lock arms to move within the pair of grooves and causes the guard extension to move in the proximal direction to activate a drive mechanism.
14. 14. The drug delivery device of claim 2, wherein the pair of grooves are disposed on opposite sides of the inner surface of the guard extension.
15. 15. 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 lgG1 kappa antibody, a drug containing a small interfering RNA (siRNA) that lowers lipoprotein(a), efavaleukin alfa, evolocumab, a drug containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1 R agonist, romiplostim, etanercept, blinatumomab, and tezepelumab.
16. 16. A drug delivery device comprising: a housing having a distal end, a proximal end, and an opening adjacent to the distal end, the housing extending along a longitudinal axis; a flange protruding radially inward from an inner surface of the housing; a drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening; a plunger moveable in a distal direction to expel a drug from the drug storage container through the delivery member; a guard member moveable relative to the housing, the guard member having an extended position wherein the guard member extends at least partially through the opening in the housing and a retracted position wherein the guard member is positioned away from the extended position toward the housing; a guard extension positioned proximal to the guard member and moveable relative to the housing, wherein the guard extension includes an engagement component near a distal end thereof, wherein, when the engagement component abuts the flange of the housing, the flange is configured to limit axial movement of the guard extension in a proximal direction.
17. 17. The drug delivery device of claim 16, wherein the engagement component includes a pair of lock arms. 10923-W001-SEC
18. 18. The drug delivery device of claim 17, wherein the guard extension has a cylindrical body centered about the longitudinal axis, and wherein at least a portion of the lock arms extends radially away from the cylindrical body near the distal end of the guard extension.
19. 19. The drug delivery device of claim 17, wherein each of the lock arms includes a proximally facing surface and a distally facing surface, and wherein the proximally facing surface is configured to moveably abut the flange of the housing.
20. 20. The drug delivery device of claim 19, wherein the distally facing surface of each lock arm includes a slanted surface.

Description

10923-W001-SEC DRUG DELIVERY DEVICE AND RELATED METHODS CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application claims priority to U.S. Provisional Patent Application No. 63/713,767, filed October 30, 2024. FIELD OF DISCLOSURE [0002] The present disclosure relates to drug delivery devices, and, more particularly, devices for automatically injecting a drug into a patient. BACKGROUND [0003] A general aversion to exposed needles, as well as health and safety issues, have led to the development of drug delivery devices, such as injectors and autoinjectors, which conceal a needle or other insertion member prior to use and which automate or semi-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. [0004] A drug delivery device may incorporate various mechanisms to implement various automated or semi-automated features. Such features may include automatically covering a needle in a pre-deli very and/or post-delivery state, automatically activating a drive mechanism, automatically indicating to the user that drug delivery is complete, among other features. Certain such features are activated by the application of an external force, for example, by a user. Such features may be prone to premature or inadvertent activation in cases where the drug delivery device is subjected to a sudden unintended force or motion during manufacture, transport, storage, and/or other handling of the device. [0005] For example, a drug delivery device may experience a substantial impact force when it is dropped from a height and strikes a stationary surface such as the ground. The impact force has the potential to cause displacement of one or more components of the drug delivery device, which may result in premature activation of the automated or semi-automated features. In addition, the impact force has the potential to cause structural damage to one or more components of the drug delivery device. The likelihood of such problems is increased if the drug delivery device has recently been removed from cold storage, which is required for drug delivery devices containing certain drugs. In a cold state, various components of the drug delivery device may be relatively brittle and thus vulnerable to fracture or damage as the result of a sudden impact. Accordingly, there is a need for an improved drug delivery device that increases drop robustness, reduces the likelihood of displacement of components of the drug delivery device, and minimizes the likelihood of premature or inadvertent activation. [0006] The present disclosure sets forth drug delivery devices embodying advantageous alternatives to existing drug delivery devices, and device housing features, and that may address one or more of the challenges or needs mentioned herein. [0007] The present disclosure sets forth drug delivery devices and related methods to address one or one of the needs and challenges mentioned herein and other related needs and challenges. SUMMARY [0008] One aspect of the present disclosure provides a drug delivery device comprising a housing having a distal end, a proximal end, and an opening adjacent to the distal end, the housing extending along a longitudinal axis, a drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening, a plunger moveable in a distal direction to expel a drug from the drug storage container through the delivery member, a guard member moveable relative to the housing, and a guard extension positioned proximal to the guard member and operably coupled to the guard member. The guard member has an extended position wherein the guard member extends at least partially through the opening in the housing and a retracted position wherein the guard member is positioned away from the extended position toward the housing. The guard extension has a first engagement component on an inner surface thereof. The guard member includes a second engagement component. The first and second engagement components are configured to limit axial movement of the guard extension in a proximal direction when the guard member is in the extended position. 10923-W001-SEC [0009] In some embodiments, the first engagement component may include a pair of grooves, and the second engagement component may include a pair of lock arms. In some embodiments, each lock arm of the pair of lock arms may include a lip portion at a proximal end thereof, and the lip portions may be movably disposed within the pair of grooves such that the lip portions move axially within the grooves during movement of the guard member between the extended position and the retracted position. In some embodiments, each groove of the pair of grooves may include sidewalls configured to prevent lateral movement of the lip portions. In some embodiments, the lip portions ma