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

• US 9,084,849 B2
• Filed: 01/25/2012
• Issued: 07/21/2015
• 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:
  US13/357,935
• Publication Number:
  US 20130023825A1
• Time in Patent Office: 1,273 Days
• Field of Search: 604/110, 604/189, 604/131, 604/135, 604/197, 604/198
• US Class Current: 1/1
• 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 housing;

a medicament container 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 including a flange and having a plunger disposed therein; and

a movable member configured to move within the housing, the movable member being monolithically constructed and including a first shoulder, a second shoulder, and a retraction spring, the first shoulder of the movable member configured to exert at least a portion of the force on a proximal surface of the flange to move the medicament container from the first position to the second position, a portion of the first shoulder configured to deform when the medicament container is in the second position such that (1) the first shoulder is at least partially disposed in the medicament container and (2) the portion of the force is exerted upon the plunger, the second shoulder of the movable member configured to exert a retraction force produced by the retraction spring on a distal surface of the flange to move the medicament container from the second position towards the first position.

2. The apparatus of claim 1, further comprising:

a damping member disposed between the first shoulder of the movable member and the flange of the medicament container.

3. The apparatus of claim 1, further comprising:

a damping member disposed between the second shoulder of the movable member and the flange of the medicament container.

4. The apparatus of claim 1, wherein the medicament container is configured to move from the first position to the second position in a first direction, the retraction spring configured to produce the retraction force to move the movable member in a second direction.

5. The apparatus of claim 1, further comprising:

the energy storage member, the energy storage member being any one of a spring, a container configured to produce a pressurized gas or a device configured to store electrical energy.

6. The apparatus of claim 1, wherein the movable member includes a piston portion disposed within the medicament container, the piston portion spaced apart from the plunger when the medicament container is in the first position, the piston portion configured to move with the medicament container when the medicament container moves from the first position to the second position, the piston portion configured to move relative to the medicament container to contact the plunger such that a medicament is expelled from the medicament container after the portion of the first shoulder is deformed.

7. The apparatus of claim 1, further comprising:

a piston coupled to the movable member, at least a portion of the piston disposed within the medicament container, the portion of the piston disposed apart from the plunger when the medicament container is in the first position, the portion of the piston in contact with the plunger after the portion of the first shoulder is deformed.

8. The apparatus of claim 1, wherein the movable member is a first movable member, the apparatus further comprising:

a second movable member configured to move with the medicament container when the medicament container moves from the first position to the second position, the second movable member configured to move relative to the medicament container to expel a medicament from the medicament container after the portion of the first shoulder is deformed.

9. The apparatus of claim 1, wherein the movable member is configured to move with the medicament container when the medicament container moves from the first position to the second position, the movable member configured to move relative to the medicament container to expel a medicament from the medicament container after the portion of the first shoulder is deformed.

10. The apparatus of claim 1, wherein the medicament container is a prefilled syringe containing at least one of influenza A vaccine, influenza B vaccine, influenza A (H1N1) vaccine, hepatitis A vaccine, hepatitis B vaccine, haemophilus influenza Type B (HiB) vaccine, measles vaccine, mumps vaccine, rubella vaccine, polio vaccine, human papilloma virus (HPV) vaccine, tetanus vaccine, diphtheria vaccine, pertussis vaccine, bubonic plague vaccine, yellow fever vaccine, cholera vaccine, malaria vaccine, smallpox vaccine, pneumococcal vaccine, rotavirus vaccine, varicella vaccine, rabies vaccine, meningococcus vaccine, epinephrine, salicylic acid, naloxone, naltrexone, buprenorphine, diazepam, lorazepam, midazolam, testosterone, vitamin D, vitamin B12, diphenhydramine, hydroxyzine, risperidone, haloperidol, hyaluronidase, sumatriptan, methotrexate, insulin, glucagon, exenatide, C1 esterase inhibitor, kallikrein inhibitor, bradykinin B2 inhibitor, human growth hormone (HGH), erythropoietin alfa/epoetin alfa, imiglucerase, darbepoetin alfa, denosumab, golimumab, adalimumab, certolizumab, ustekinumab, canakinumab, interferons (interferon-alpha-2a, interferon-alpha-2b, interferon-beta 1a, interferon-beta-1b, and their pegylated forms) etanercept, pegfilgrastim, enoxaparin, semuloparin, or dalteparin.

11. The apparatus of claim 1, wherein a distal end portion of the medicament container is coupled to a needle, the needle disposed within the housing when the medicament container is in the first position, at least a portion of the needle is disposed outside of the housing when the medicament container is in the second position, the retraction force exerted by the second shoulder of the movable member on the flange of the medicament container being operable to retract at least a portion of the needle into the housing when the medicament container is moved towards the first position.

12. The apparatus of claim 1, wherein:

the medicament container is configured to move from the first position to the second position in a first direction; and

the movable member includes a protrusion configured to engage a portion of the housing when the medicament container is in the first position to limit movement of the medicament container in a second direction.

13. The apparatus of claim 1, wherein the movable member defines a recess, at least the portion of the first shoulder configured to be disposed in the recess when the medicament container is in the second position such that the portion of the force is exerted upon the plunger.

14. The apparatus of claim 1, wherein the movable member is a first movable member, the apparatus further comprising:

a second movable member configured to move with the medicament container when the medicament container moves from the first position to the second position, the second movable member configured to be disengaged from the first movable member after the medicament container is placed in the second position such that the retraction force exerted by the first movable member on the flange moves the medicament container from the second position towards the first position.

15. An apparatus, comprising:

a housing;

a medicament container 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 including a flange and having a plunger disposed therein; and

a movable member configured to exert at least a portion of the force on the medicament container to move the medicament container from the first position to the second position, the movable member including a piston portion, an engagement portion, and a retraction portion, the piston portion including a piston surface and an outer surface, the outer surface defining a recess,

the engagement portion configured to be transitioned between a first configuration and a second configuration, the engagement portion being partially disposed outside of the recess defined by the outer surface of the piston portion when the engagement portion is in the first configuration to limit movement of the piston portion relative to the plunger when the medicament container moves from the first position to the second position such that the piston surface is spaced apart from the plunger, the engagement portion being disposed within the recess when the engagement portion is in the second configuration and the medicament container is in the second position to place the piston surface in contact with the plunger,

the retraction portion configured to produce a retraction force to move the movable member and the medicament container towards the first position.

16. The apparatus of claim 15, wherein the movable member includes a first shoulder configured to exert the force on a proximal surface of the flange of the medicament container to move the medicament container from the first position to the second position, and a second shoulder configured to exert the retraction force on a distal surface of the flange to move the medicament container from the second position towards the first position.

17. The apparatus of claim 15, further comprising:

a damping member disposed between the movable member and the flange of the medicament container.

18. The apparatus of claim 15, wherein the force produced by the energy storage member moves the medicament container in a first direction, the retraction portion forming a retraction spring configured to produce the retraction force to move the movable member in a second direction.

19. The apparatus of claim 15, wherein the movable member is a first movable member, the apparatus further comprising:

a second movable member configured to move with the medicament container when the medicament container moves from the first position to the second position, and configured to move relative to the medicament container to expel a medicament from the medicament container after the engagement portion of the movable member is deformed, the second movable member configured to be disengaged from the first movable member after the medicament is expelled from the medicament container.

20. The apparatus of claim 15, wherein the movable member is a first movable member, the apparatus further comprising:

a second movable member configured to selectively engage the first movable member, the second movable member defining a longitudinal axis that is offset from a longitudinal axis of the first movable member.

21. An apparatus, comprising:

a housing;

a medicament container 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 including a flange and having a plunger disposed therein;

a first movable member configured to move within the housing, the first movable member including a latch portion, a first shoulder and a second shoulder, the latch portion operably coupled to the energy storage member such that the first shoulder of the first movable member is configured to exert at least a portion of the force on the flange to move the medicament container from the first position to the second position, a portion of the first movable member configured to be at least partially disposed within the medicament container when the medicament container is in the second position such that at least a portion of the force is exerted upon the plunger to move the plunger within the medicament container, a second shoulder of the first movable member configured to exert a retraction force on the flange to move the medicament container from the second position toward the first position after the plunger is moved within the medicament container; and

a second movable member coupled to the energy storage member and selectively engaged with the latch portion of the first movable member, the second movable member configured to transfer the force produced by the energy storage member to the latch portion to move the first movable member such that the medicament container is moved from the first position to the second position, the second movable member configured to move the first movable member relative to the medicament container to move the plunger within the medicament container, the second movable member configured to be disengaged from the latch portion after the plunger is moved within the medicament container such that the retraction force exerted on the flange by the second shoulder moves the medicament container from when the second position toward the first position.

22. The apparatus of claim 21, wherein:

the force produced by the energy storage member moves the medicament container in a first direction, and

the first movable member includes a retraction spring configured to produce the retraction force to move the movable member in a second direction.

23. The apparatus of claim 21, wherein the first movable member is monolithically constructed and includes a retraction spring configured to produce the retraction force.

24. The apparatus of claim 21, wherein a longitudinal axis of the second movable member is offset from a longitudinal axis of the first movable member.

25. The apparatus of claim 21, wherein the second movable member is placed in contact with a protrusion of the housing when the medicament container is placed in the second position, the protrusion configured to deform a portion of the second movable member to disengage the second movable member from the latch portion of first movable member.

26. An apparatus, comprising:

a movable member configured to be disposed within a housing of a medical device, the movable member being monolithically constructed to include a first engagement portion, a second engagement portion, and a retraction portion, the first engagement portion configured to be operably coupled to an energy storage member,

the second engagement portion configured to engage a flange of a medicament container such that a first shoulder of the second engagement portion exerts a first force produced by the energy storage member on the flange to move the medicament container within the housing in a first direction from a first position to a second position, at least a portion of the movable member being moved within the medicament container when the medicament container is in the second position to expel a medicament from the medicament container,

the retraction portion configured to produce a second force, a second shoulder of the second engagement portion configured to exert the second force produced by the retraction member on the flange to move the medicament container within the housing in a second direction from the second position towards the first position.

27. The apparatus of claim 26, wherein the first engagement portion is configured to be releasably coupled to the energy storage member by a latch portion.

28. The apparatus of claim 27, wherein, the first engagement portion is configured to be disengaged from the energy storage member when the medicament container is in the second position.

29. The apparatus of claim 26, wherein the first shoulder of the second engagement portion is configured deform to allow the portion of the movable member to be moved within the medicament container.

30. The apparatus of claim 26, wherein the retraction portion forms a spring.

31. The apparatus of claim 26, the second engagement portion is configured to deform when the medicament container is in the second position such that a piston surface of the movable member is placed in contact with a plunger disposed in the medicament container to move the plunger within the medicament container.

32. An apparatus, comprising:

a housing;

a medicament container 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 including a flange and having a plunger disposed therein; and

a movable member including a piston portion having a first surface, a second surface, a first engagement portion, and a second engagement portion, the first engagement portion extending from the first surface and configured to be transitioned between a first configuration and a second configuration, the first engagement portion in contact with a proximal surface of the flange of the medicament container when in the first configuration to maintain a distance between the second surface of the piston portion and the plunger as the medicament container is moved from the first position to the second position, the first engagement portion configured to be transitioned from the first configuration to the second configuration when the medicament container is in the second position such that the first engagement portion is disposed in a recess defined by the first surface of the piston portion, the second surface of the piston portion configured to be placed in contact with the plunger when the first engagement portion is in the second configuration, the second engagement portion configured to exert a retraction force on a distal surface of the flange to move the medicament container from the second position towards the first position after the piston portion moves the plunger within the medicament container.

33. The apparatus of claim 32, wherein the piston portion is at least partially disposed in the medicament container and is movable within the medicament container between a first piston position and a second piston position, the first engagement portion disposed in the recess when in the second configuration such that the first engagement portion and the recess are disposed in the medicament container when the piston portion is in the second position.

34. The apparatus of claim 32, wherein the first engagement portion is configured to exert at least a portion of the force produced by the energy storage member on the flange to move the medicament container from the first position to the second position.

35. The apparatus of claim 32, wherein the movable member includes a third engagement portion, the third engagement portion releasably coupled to the energy storage member, the third engagement portion configured to be disengaged from the energy storage member when the medicament container is in the second position.

36. The apparatus of claim 32, wherein the first engagement portion is configured to be plastically deformed when transitioned from the first configuration to the second configuration.