DEVICES AND METHODS FOR DELIVERING A LYOPHILIZED MEDICAMENT

• US 20180304018A1
• Filed: 03/24/2016
• Published: 10/25/2018
• Est. Priority Date: 03/24/2015
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: BLONDINO, Frank E., EDWARDS, Eric S., EDWARDS, Evan T., MEYERS, Paul F.
• Granted Patent: US 10,695,495 B2
• Time in Patent Office: Days
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2005/2093 including concentration setting means
• CPC Class Codes: A61M 2005/3123 having air entrapping or venting means, e.g. purging channels in pistons
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/80 voice-operated command
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 5/2053 Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• CPC Class Codes: A61M 5/2066 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/24 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 Class Codes: A61M 5/2425 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/28 Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
• CPC Class Codes: A61M 5/31501 Means for blocking or restricting the movement of the rod or piston A61M5/5013 takes precedence
• CPC Class Codes: A61M 5/3204 Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
• CPC Class Codes: G09B 23/285 for injections, endoscopy, bronchoscopy, sigmoidscopy, insertion of contraceptive devices or enemas
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

An apparatus includes a housing, an actuator, a lock mechanism, and a medicament container. The lock mechanism selectively engages a portion of the housing such that (1) the lock mechanism is maintained in a substantially fixed position when the housing is in a first orientation and (2) the lock mechanism is removable from the housing when the housing is in a second orientation. The medicament container is moved in a proximal direction when the lock mechanism is removed from the housing to mix a first medicament portion contained within the medicament container with a second medicament portion contained within the medicament container. The actuator can be moved from a first position to a second position when the lock mechanism is removed from the housing to release energy stored within an energy storage member such that the medicament container is moved in a distal direction.

Claims

1. An apparatus, comprising:

a housing configured to contain at least a portion of a medicament container, the housing including a housing surface defining a lock chamber;

a safety member coupled to the housing and configured to be moved relative to the housing between a first position and a second position, the safety member configured to limit delivery of a contents of the medicament container when the safety member is in the first position, an outer surface of the safety member disposed outside of the housing, a lock protrusion of the safety member disposed within the lock chamber of the housing when the safety member is in the first position, the lock protrusion disposed outside of the lock chamber when the safety member is in the second position; and

a lock member disposed within the lock chamber of the housing and configured to move along the housing surface when an orientation of the longitudinal axis of the medicament container changes, the lock member positioned in contact with the lock protrusion of the safety member to limit movement of the safety member from the first position to the second position when the longitudinal axis of the medicament container is in a first orientation, the lock member spaced apart from the lock protrusion when the longitudinal axis of the medicament container is in a second orientation.

2. The apparatus of claim 1, wherein the safety member is removed from the housing when the safety member is in the second position.

3. The apparatus of claim 1, the lock protrusion of the safety member defines a recessed portion configured to receive the lock member when the longitudinal axis of the medicament container is in the first orientation.

4. The apparatus of claim 1, wherein:

the lock protrusion of the safety member is one of a plurality of lock protrusions; and

the housing defines a plurality of openings, each lock protrusion from the plurality of lock protrusions configured to be disposed through a corresponding opening from the plurality of openings and within the lock chamber of the housing when the lock member is in the first position.

5. The apparatus of claim 1, wherein:

the housing surface defining the lock chamber is angularly offset from a longitudinal axis of the medicament container,

the housing surface is a first housing surface;

the housing includes a second housing surface that forms a nonzero angle with the first housing surface; and

the lock member is configured to move along one of the first housing surface or the second housing surface when the orientation of the longitudinal axis of the medicament container changes.

7. The apparatus of claim 1, wherein the outer surface of the safety member is configured to be manipulated to move the safety member from the first position to the second position when the longitudinal axis of the medicament container is in the second orientation.

8. The apparatus of claim 1, wherein the lock member has a spherical shape and is configured to roll along the housing surface.

9. The apparatus of claim 1, wherein:

the housing surface is a conical surface; and

the lock member has a spherical shape and is configured to roll along the conical surface of the lock chamber.

10. The apparatus of claim 1, wherein:

the housing surface is a first conical surface;

the housing includes a second conical surface opposite the first conical surface that forms a nonzero angle with the first surface; and

the lock member is configured to roll between the first conical surface and the second conical surface when the orientation of the longitudinal axis of the medicament container changes.

12. The apparatus of claim 1, further comprising:

a movable member coupled to the medicament container, the movable member configured to move within housing to deliver the contents from the medicament container, the movable member including a retention portion engaged with the safety member to limit movement of the movable member when the safety member is in the first position.

13. The apparatus of claim 1, wherein the safety member defines a volume within which a portion of the housing is contained when the safety member is in the first position.

14. The apparatus of claim 1, wherein:

the medicament container is coupled to a delivery member through which the contents are delivered, the delivery member being aligned with the longitudinal axis; and

the longitudinal axis and an upward vertical axis form angle of between about 25 degrees and −

25 degrees.

6. (canceled)

11. (canceled)

15. (canceled)

16. (canceled)

17. An apparatus, comprising:

a housing configured to contain at least a portion of a medicament container;

an energy storage member disposed within the housing, the energy storage member configured to produce a force to convey a contents of the medicament container when the energy storage member is actuated to release a potential energy stored therein; and

a safety member coupled to the housing, a first portion of the safety member configured to actuate the energy storage member when the safety member is moved relative to the housing between a first position and a second position, a second portion of the safety member configured to engage a lock member within the housing to limit movement of the safety member from the first position to the second position when the longitudinal axis of the medicament container is in a first orientation, the second portion of the safety member spaced apart from the lock member when the longitudinal axis of the medicament container is in a second orientation.

18. The apparatus of claim 17, further comprising:

the lock member configured to move within the housing when an orientation of a longitudinal axis of the medicament container changes.

19. The apparatus of claim 17, further comprising:

the medicament container, the medicament container including a first elastomeric member and a second elastomeric member, the first elastomeric member disposed within a proximal end portion of the medicament container and defining, at least in part, a first volume containing a first substance, the second elastomeric member disposed distally from the first elastomeric member, the second elastomeric member, the first elastomeric member, and a portion of the medicament container collectively defining a second volume containing a second substance, the contents of the medicament container including a gas from the second volume.

20. The apparatus of claim 19, wherein the first substance is a liquid diluent and the second substance is a lyophilized medicament.

21. The apparatus of claim 20, wherein the lyophilized medicament includes glucagon.

22. The apparatus of claim 17, wherein the energy storage member is a first energy storage member, the first energy storage member being any of a gas container, a chemical energy storage member, a spring, or an electrical energy storage member,

the force is a first force, the potential energy is a first potential energy, the contents are a first contents, the apparatus further comprising:

a second energy storage member configured to produce a second force to convey a second contents of the medicament container when the second energy storage member is actuated to release a second potential energy stored therein; and

an actuator configured to actuate the second energy storage member when the actuator is moved relative to the housing, the safety member configured to limit movement of the actuator when the safety member is in the first position.

24. The apparatus of claim 19, further comprising:

a mixing protrusion disposed within the housing, at least a portion of the force produced by the energy storage member exerted by the mixing protrusion onto the first elastomeric member to convey the contents of the medicament container.

25. The apparatus of claim 17, wherein the housing includes a housing surface defining at least a portion of a lock chamber, the housing surface being angularly offset from a longitudinal axis of the medicament container, the apparatus further comprising:

the lock member disposed within the lock chamber of the housing and configured to move along the housing surface when the orientation of the longitudinal axis of the medicament container changes, the lock member positioned in contact with a lock protrusion of the safety member to limit movement of the safety member from the first position to the second position when the longitudinal axis of the medicament container is in the first orientation, the lock member spaced apart from the lock protrusion when the longitudinal axis of the medicament container is in the second orientation, and

the lock protrusion of the safety member defines a recessed portion configured to receive the lock member when the longitudinal axis of the medicament container is in the first orientation.

23. (canceled)

26. (canceled)

27. (canceled)

28. An apparatus, comprising:

a safety member configured to be coupled to a housing of a medicament delivery device, the safety member configured to be moved relative to the housing between a first position and a second position,

a lock portion of the safety member configured to be disposed within a lock chamber defined by the housing when the lock member is in the first position, the lock portion configured to engage a lock member within the lock chamber to limit movement of the safety member from the first position to the second position when a longitudinal axis of the housing is in a first orientation, the lock portion spaced apart from the lock member when the longitudinal axis of the medicament container is in a second orientation,

an actuation portion of the safety member configured to actuate an energy storage member of the medicament delivery device when the safety member is moved from the first position to the second position, the energy storage member configured to produce a force to convey a contents from a medicament container of the medicament delivery device when the energy storage member is actuated.

29. The apparatus of claim 28, wherein:

the safety member is removed from the housing when the safety member is in the second position; and

the lock portion of the safety member includes as curved surface configured to receive the lock member when the longitudinal axis of the medicament container is in the first orientation.

31. The apparatus of claim 28, wherein:

the lock portion includes a plurality of lock protrusions, each lock protrusion from the plurality of lock protrusions configured to be disposed through a corresponding opening from a plurality of openings defined by the housing and within the lock chamber of the housing when the safety member is in the first position; and

the plurality of lock protrusions collectively define a volume within which the lock member is disposed when the safety member is in the first position and when the longitudinal axis of the medicament container is in the first orientation.

33. The apparatus of claim 28, wherein the medicament delivery device is any one of a single-use auto-injector, a reusable auto-injector, a pen injector, or an inhaler.

34. The apparatus of claim 28, wherein:

the medicament delivery device is a medical injector having a needle through which the contents from the medicament container is conveyed; and

a needle sheath engagement portion of the safety member configured to be coupled to a needle sheath covering the needle when the needle sheath engagement portion is in the first position, the needle sheath engagement portion configured to remove the needle sheath from about the needle when the safety member is moved from the first position to the second position.

37. The apparatus of claim 28, wherein the safety member includes a side wall defining an internal volume, the side wall surrounding an end portion of the housing of the medicament delivery device when the safety member is in the first position.

30. (canceled)

32. (canceled)

35. (canceled)

36. (canceled)

38-66. -66. (canceled)