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

• US 10,342,924 B2
• Filed: 02/20/2019
• Issued: 07/09/2019
• 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:
  US16/280,488
• Publication Number:
  US 20190175837A1
• Time in Patent Office: 139 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. A method of injecting a medicament, comprising:

removing a medicament delivery device from a case, the medicament delivery device including a prefilled syringe assembly, a piston member, an actuator, and a syringe enclosure,

the prefilled syringe assembly including a syringe body containing the medicament and a needle staked to the syringe body, a proximal end portion of the syringe body including a flange,

the piston member having a distal end configured to move within the syringe body,

the syringe enclosure defining an internal volume within which the proximal end portion of the syringe body is disposed before and during the injecting the medicament, a distal end of the needle extending beyond a distal end surface of the syringe enclosure before and during the injecting the medicament, a proximal end of the syringe enclosure including a first stop surface and a second stop surface, the second stop surface engaging the flange to limit movement of the prefilled syringe assembly within the syringe enclosure, the case obstructing a view of the medicament within the syringe body before the removing;

viewing, after the removing, the medicament within the syringe body;

placing a distal end portion of the medicament delivery device into contact with a target location; and

moving the actuator to cause a force to be exerted on a proximal end of the piston member, the force moving the distal end of the piston member within the syringe body from a first position to a second position to convey a dose of the medicament from the syringe body through the needle into the target location, the first stop surface limiting distal movement of the piston member when the piston member is at the second position within the syringe body.

2. The method of claim 1, wherein the medicament within the syringe body is any one of epinephrine or naloxone.

3. The method of claim 2, wherein the target location is a thigh.

4. The method of claim 1, further comprising:

removing, before the placing, a safety member from the distal end portion of the medicament delivery device, a needle sheath being removed from about the needle during the removing the safety member.

5. The method of claim 4, wherein the needle is inserted into the target location before the distal end of the piston member moves within the syringe body from the first position to the second position.

6. The method of claim 1, wherein:

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

the case obstructs the status aperture before the removing.

7. The method of claim 1, wherein the medicament delivery device produces an audible sound in response to the moving the actuator.

8. The method of claim 1, wherein the medicament delivery device includes a damping member configured to dampen an impact force exerted on the flange when the first stop surface engages the flange.

9. The method of claim 1, wherein:

the medicament delivery device includes an energy storage member configured to produce the force exerted on the proximal end of the piston member; and

the moving the actuator actuates the energy storage member.

10. A method of injecting a medicament, comprising:

removing a medicament delivery device from a case, the medicament delivery device including a prefilled syringe assembly, a piston member, an actuator, and a syringe enclosure,

the prefilled syringe assembly including a syringe body containing the medicament and a needle staked to the syringe body, a proximal end portion of the syringe body including a flange,

the piston member having a distal end configured to move within the syringe body,

the actuator configured to move to initiate the injecting the medicament, the case limiting movement of the actuator before the removing,

the syringe enclosure defining an internal volume within which the proximal end portion of the syringe body is disposed before and during the injecting the medicament, a distal end of the needle extending beyond a distal end surface of the syringe enclosure before and during the injecting the medicament, a proximal end of the syringe enclosure including a first stop surface and a second stop surface, the second stop surface engaging the flange to limit movement of the prefilled syringe assembly within the syringe enclosure;

placing a distal end portion of the medicament delivery device into contact with a target location; and

moving the actuator to cause a force to be exerted on a proximal end of the piston member, the force moving the distal end of the piston member within the syringe body from a first position to a second position to convey a dose of the medicament from the syringe body through the needle into the target location, the first stop surface limiting distal movement of the piston member when piston member is at the second position within the syringe body.

11. The method of claim 10, wherein the case surrounds the actuator before the removing.

12. The method of claim 11, further comprising:

replacing, after the removing and before the placing the moving the actuator, the medicament delivery device back into the case.

13. The method of claim 12, wherein the replacing includes fastening a retention portion of the case to retain the case about the medicament delivery device.

14. The method of claim 10, wherein the case obstructing a view of the medicament within the syringe body before the removing, the method further comprising:

viewing, after the removing, the medicament within the syringe body.

15. The method of claim 14, wherein

the medicament within the syringe body is epinephrine;

the case obstructs a status window when the medicament delivery device is within the case; and

the viewing the epinephrine is performed through the status window.

16. The method of claim 10, wherein, wherein the first stop surface of the syringe enclosure is between the flange and a shoulder of the piston member.

17. The method of claim 10, wherein the medicament within the syringe body is any one of epinephrine or naloxone.

18. A method of injecting a medicament, comprising:

removing a medicament delivery device from a case, the medicament delivery device including a prefilled syringe assembly, a piston member, an actuator, and a syringe enclosure,

the prefilled syringe assembly including a syringe body containing the medicament and a needle staked to the syringe body, a proximal end portion of the syringe body including a flange,

the piston member having a distal end configured to move within the syringe body,

the syringe enclosure defining an internal volume within which the proximal end portion of the syringe body is disposed before and during the injecting the medicament, a distal end of the needle extending beyond a distal end surface of the syringe enclosure before and during the injecting the medicament, a proximal end of the syringe enclosure including a first stop surface and a second stop surface, the second stop surface engaging the flange to limit movement of the prefilled syringe assembly within the syringe enclosure, the case obstructing a view of the medicament within the syringe body before the removing;

viewing, after the removing, the medicament within the syringe body;

placing a distal end portion of the medicament delivery device into contact with a target location; and

actuating the medicament delivery device to cause movement of the distal end of the piston member within the syringe body from a first position to a second position, a dose of the medicament being conveyed from the syringe body through the needle into the target location when the distal end of the piston member moves from the first position to the second position, the first stop surface limiting distal movement of the piston member when piston member is at the second position within the syringe body.

19. The method of claim 18, wherein the actuating includes moving the actuator to cause a force to be exerted on a proximal end of the piston member.

20. The method of claim 18, wherein the first stop surface engages the proximal end of the piston member when piston member is at the second position within the syringe body.

21. The method of claim 18, wherein the medicament within the syringe body is any one of epinephrine or naloxone.

22. The method of claim 18, wherein:

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

the case obstructs the status aperture before the removing.

23. The method of claim 18, further comprising:

removing, before the placing, a safety member from the distal end portion of the medicament delivery device, a needle sheath being removed from about the needle during the removing the safety member.