Drug delivery device having a needle guard mechanism with a tunable threshold of resistance to needle guard movement

Patent metadata

Field	Value
Publication number	US-11872374-B2
Application number	US-202016951987-A
Country	US
Kind code	B2
Filing date	Nov 18, 2020
Priority date	Feb 27, 2015
Publication date	Jan 16, 2024
Grant date	Jan 16, 2024

Abstract

A device and method for drug delivery includes a casing for housing a drug storage container, the container including a dose delivery member, at least a portion of the dose delivery member extending through an opening in the casing; a guard movable relative to the casing between extended and retracted positions; an interference arrangement for providing selected threshold of resistance to movement of the guard from the extended position to the retracted position during insertion of the dose delivery member into body tissue at an injection site, the arrangement having a first member and a second member, the first and second members engaging one another to retain the guard in the extended position, one of the first and second members moving if the selected threshold of resistance is exceeded to allow the members to slide past one another to allow the guard to move into the retracted position.

First claim

What is claimed is:

1. A drug delivery device comprising:
a housing having an opening;
a drug storage container including a body portion having a proximal end and a distal end and a delivery member positioned at the distal end of the body portion, the delivery member having an insertion end configured to extend at least partially through the opening during drug delivery;
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 drive positioned at least partially within the housing and storing energy for moving the plunger in the distal direction;
a guard positioned adjacent to the opening and movable relative to the housing between an extended position and a retracted position, the delivery member, prior to operation of the drug delivery device when the guard is in the extended position, extending through the opening in the housing such that at least a first portion of the delivery member is inside of the housing and at least a second portion of the delivery member including the insertion end of the delivery member is outside of the housing;
a guard biasing member configured to urge the guard in the distal direction, wherein at least a portion of the guard biasing member is distal to the proximal end of the body portion of the drug storage container; and
an arrangement configured to resist relative movement between the guard and the housing until a threshold of resistance is exceeded by a force applied to the guard in a proximal direction, wherein the arrangement includes a first member and a second member coupled with the guard to move jointly with the guard when the guard moves between the extended position and the retracted position, the first member being disposed entirely within the guard and configured to rotate as a result of the force applied to the guard in the proximal direction, the second member comprising a protrusion protruding at least partially in a radially inward direction with respect to at least a portion of the guard that is distal to the protrusion, wherein the radially inward direction is at least substantially perpendicular to a longitudinal axis of the drug delivery device, and wherein the first member contacts at least the protrusion to resist relative movement between the guard and the housing until the threshold of resistance is exceeded by the force applied to the guard in the proximal direction.

2. The drug delivery device of claim 1 , wherein at least one of the first member and the second member is configured to move if the threshold of resistance is exceeded by the force applied to the guard in the proximal direction to allow the first member and the second member to slide against one another and the guard to move into the retracted position.

3. The drug delivery device of claim 2 , wherein the first member is configured to rotate when the first member and the second member slide against one another.

4. The drug delivery device of claim 3 , wherein the first member is configured to rotate with respect to a portion of the housing when the first member and the second member slide against one another.

5. The drug delivery device of claim 1 , wherein one of the first member and the second member comprises a cam and the other one of the first member and the second member comprises a cam follower.

6. The drug delivery device of claim 5 , wherein the first member comprises the cam follower and the second member comprises the cam.

7. The drug delivery device of claim 1 , wherein the threshold of resistance is a selected threshold of resistance.

8. The drug delivery device of claim 7 , wherein the selected threshold of resistance depends on at least one of: a geometric shape of the arrangement, a dimension of the arrangement, and a modulus of elasticity of the arrangement.

9. The drug delivery device of claim 1 , wherein the second member is integrally formed with the guard.

10. The drug delivery device of claim 1 , wherein the insertion end of the delivery member is surrounded by the guard in the extended position and the insertion end of the delivery member being at least partially exposed when the guard is in the retracted position.

11. The drug delivery device of claim 1 , wherein the proximal end of the drug storage container and the distal end of the drug storage container are arranged at respective positions along an axis, and wherein the first member is configured to move at least partially in a direction that is not parallel to the axis as a result of the force applied to the guard in the proximal direction.

12. The drug delivery device of claim 1 , wherein the plunger is configured to move along the longitudinal axis of the drug delivery device when moving in the distal direction with respect to the drug storage container to expel the drug from the drug storage container.

13. The drug delivery device of claim 12 , wherein at least a portion of the protrusion comprises a surface facing at least partially in the proximal direction and configured to slidably engage the first member.

14. The drug delivery device of claim 1 , wherein a radial distance between the first member and the longitudinal axis of the drug delivery device is substantially the same when the guard is in the extended position and when the guard is in the retracted position.

15. A method of delivering a drug to a user, the method comprising:
providing a drug delivery device comprising a housing having an opening, a drug storage container having a delivery member having an insertion end, 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 drive positioned at least partially within the housing and storing energy for moving the plunger in the distal direction, a guard coupled with the housing, a guard biasing member positioned at least partially distal to a proximal end of the drug storage container, and an arrangement configured to resist relative movement between the guard and the housing until a threshold of resistance is exceeded by a force applied to the guard in a proximal direction, the arrangement including a first member and a second member coupled with the guard to move jointly with the guard when the guard moves between an extended position and a retracted position, the first member being disposed entirely within the guard, the second member comprising a protrusion protruding at least partially in a radially inward direction with respect to at least a portion of the guard that is distal to the protrusion, wherein the radially inward direction is at least substantially perpendicular to a longitudinal axis of the drug delivery device, the delivery member, prior to operation of the drug delivery device when the guard is in the extended position, extending through the opening in the housing such that at least a first portion of the delivery member is inside of the housing and at least a second portion of the delivery member including the insertion end of the delivery member is outside of the housing;
positioning the guard in contact with a user at an injection site; and
applying the force to the guard in the proximal direction sufficient to exceed the threshold of resistance and permit relative movement between the guard and the housing,
wherein the first member contacts at least the protrusion and rotates as a result of the force being applied to the guard in the proximal direction.

16. The method of claim 15 , wherein at least one of the first member and the second member moves if the t

Assignees

• Amgen Inc

Inventors

• Gibson Scott R
• Moberg Sheldon

Classifications

• A61M5/20 Primary

  Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically (A61M5/142 {, A61M5/46} take precedence; {hypodermic projectiles F42B12/54}) · CPC title

• A61M5/24

  Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic {(ampoules or carpules A61J1/06)} · CPC title

• A61M5/3243

  being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel (devices for protecting guide needles in combination with catheters A61M25/0612) · CPC title

• A61M5/3202

  Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001) · CPC title

• A61M2005/2013

  triggering of discharging means by contact of injector with patient body · CPC title