Medicament delivery devices for administration of a medicament within a prefilled syringe

• US 10,238,806 B2
• Filed: 07/20/2015
• Issued: 03/26/2019
• Est. Priority Date: 01/26/2011
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: Edwards, Eric S., Edwards, Evan T., Licata, Mark J., Meyers, Paul F.
• Primary Examiner(s): Desanto, Matthew F
• Application Number:
  US14/803,821
• Publication Number:
  US 20160045670A1
• Time in Patent Office: 1,345 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 2005/208 Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin
• CPC Class Codes: A61M 2005/2086 having piston damping means, e.g. axially or rotationally acting retarders
• CPC Class Codes: A61M 5/20 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 Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/2066 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/315 Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
• CPC Class Codes: A61M 5/3202 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 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: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

An apparatus includes a housing, a medicament container and a movable member. The medicament container is configured to move within the housing between a first position and a second position in response to a force produced by an energy storage member. A proximal end portion of the medicament container includes a flange and has a plunger disposed therein. A first shoulder of the movable member is configured to exert the force on the flange to move the medicament container from the first position to the second position. A portion of the first shoulder deforms when the medicament container is in the second position such that at least a portion of the force is exerted upon the plunger. A second shoulder of the movable member is configured to exert a retraction force on the flange to move the medicament container from the second position towards the first position.

Claims

1. An apparatus, comprising:

a cover member;

a prefilled syringe assembly including a syringe body, an elastomeric member disposed within the syringe body, and a needle staked to a distal end portion of the syringe body, a proximal end portion of the syringe body including a flange;

a piston member having a distal end configured to move within the syringe body between a first position and a second position to convey a dose of a medicament from the syringe body through the needle during an injection event; and

a syringe enclosure removably disposed within the cover member, the syringe enclosure defining an internal volume within which the proximal end portion of the syringe body is disposed before and during the injection event, the medicament within the syringe body being visible through the syringe enclosure when the syringe enclosure is removed from the cover member, the cover member obstructing the view of the medicament within the syringe body when the syringe enclosure is within the cover member, a distal end of the needle extending beyond a distal end surface of the syringe enclosure before and during the injection event, a proximal end of the syringe enclosure including a first stop surface and a second stop surface, the first stop surface configured to limit distal movement of the piston member when piston member is at the second position within the syringe body, the second stop surface configured to engage the flange to limit movement of the prefilled syringe assembly within the syringe enclosure; and

an actuator operably coupled to the piston member, movement of the actuator causing a force to be exerted on a proximal end portion of the piston member.

2. The apparatus of claim 1, wherein the prefilled syringe assembly contains any one of epinephrine or naloxone.

3. The apparatus of claim 2, wherein:

the medicament within the prefilled syringe assembly is viewable through a status aperture; and

the cover member obstructs the status aperture when the syringe enclosure is within the cover member.

4. The apparatus of claim 1, further comprising:

an energy storage member configured to produce a force to move the piston member in response to the movement of the actuator.

5. The apparatus of claim 4, wherein the energy storage member is a pressurized gas container.

6. The apparatus of claim 1, wherein the distal end portion of the syringe body extends beyond the distal end surface of the syringe enclosure before, during, and after the injection event.

7. The apparatus of claim 1, further comprising:

a damping member configured to dampen a force exerted on the flange when the first stop surface engages the flange.

8. The apparatus of claim 1, wherein

the cover member limits movement of the actuator when the syringe enclosure is within the cover member, the syringe enclosure is configured to be removed from within the cover member to allow movement of the actuator.

9. An apparatus, comprising:

a prefilled syringe assembly including a syringe body, a needle staked to the syringe body, and an elastomeric member disposed within the syringe body, the syringe body including a flange;

a piston member having a distal end configured to move within the syringe body between a first position and a second position to convey a dose of a medicament from the syringe body through the needle during an injection event;

an actuator operably coupled to the piston member, movement of the actuator causing a force to be exerted on a proximal end of the piston member to move the distal end of the piston member within the syringe body;

a syringe enclosure defining an internal volume within which a proximal end portion of the prefilled syringe assembly is disposed before and during the injection event, a distal end portion of the prefilled syringe assembly extending beyond a distal end surface of the syringe enclosure, a proximal end portion of the syringe enclosure including a first stop surface and a second stop surface, the first stop surface configured to limit distal movement of the piston member within the syringe body when the piston member has reached the second position during the injection event, the second stop surface configured to engage a proximal surface of the flange to limit movement of the prefilled syringe assembly within the syringe enclosure; and

a case configured to contain the syringe enclosure and the prefilled syringe assembly, the case limiting movement of the actuator when the syringe enclosure is within the case, the syringe enclosure and the prefilled syringe assembly configured to be removed from within the case to allow movement the actuator.

10. The apparatus of claim 9, wherein:

the prefilled syringe assembly contains epinephrine;

the case obstructs a status window when the syringe enclosure is within the case; and

the epinephrine within the prefilled syringe assembly is viewable through the status window when syringe enclosure is removed from case.

11. The apparatus of claim 9, further comprising:

an energy storage member configured to produce the force in response to movement of the actuator.

12. The apparatus of claim 9, wherein the prefilled syringe assembly contains naloxone.

13. The apparatus of claim 9, wherein the first stop surface of the syringe enclosure is between the flange and a shoulder of the piston member.