Auto-injectors for administration of a medicament within a prefilled syringe

• US 10,576,206 B2
• Filed: 06/30/2016
• Issued: 03/03/2020
• Est. Priority Date: 06/30/2015
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: Edwards, Eric S., Edwards, Evan T., Meyers, Paul F.
• Primary Examiner(s): Mendez, Manuel A
• Application Number:
  US15/738,008
• Publication Number:
  US 20180304017A1
• Time in Patent Office: 1,342 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 2005/3139 Finger grips not integrally formed with the syringe barrel, e.g. using adapter with finger grips
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 5/178 Syringes
• 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 5/2046 Media being expelled from injector by gas generation, e.g. explosive charge
• 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 5/31 Details
• 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: A61M 5/3221 Constructional features thereof, e.g. to improve manipulation or functioning
• CPC Class Codes: A61M 5/3234 Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
• CPC Class Codes: A61M 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user

Abstract

An apparatus includes a housing, a carrier, and an expandable assembly. The housing defines an opening configured to selectively place a gas chamber of the housing in fluid communication with an exterior volume. The carrier is movably disposed within the housing and is coupled to a medicament container. A proximal surface of the carrier defines a portion of a boundary of the gas chamber. The expandable assembly has a first member and a second member. The first member is coupled to an elastomeric member disposed within the medicament container, and the second member includes a valve portion. The expandable assembly transitions from a collapsed configuration to an expanded configuration when the elastomeric member moves within the medicament container. The valve portion moves relative to the opening when the expandable assembly transitions from the first to the second configuration, placing the gas chamber in fluid communication with the exterior volume.

Claims

1. An apparatus, comprising:

a housing defining a gas chamber, a side wall of the housing defining an opening configured to selectively place the gas chamber in fluid communication with an exterior volume;

a carrier configured to be movably disposed within the housing, the carrier configured to be coupled to a medicament container, a proximal surface of the carrier defining a portion of a boundary of the gas chamber; and

an expandable assembly having a first member and a second member, the first member coupled to an elastomeric member disposed within the medicament container, the second member including a valve portion, the expandable assembly configured to transition from a collapsed configuration to an expanded configuration when the elastomeric member moves within the medicament container, the valve portion configured to move relative to the opening when the expandable assembly transitions from the collapsed configuration to the expanded configuration to place the gas chamber in fluid communication with the exterior volume.

2. The apparatus of claim 1, wherein the valve portion of the second member defines a gas release path, the valve portion disposed within the opening of the housing such that the gas release path is fluidically isolated from the gas chamber via a seal member when the expandable assembly is in the collapsed configuration.

3. The apparatus of claim 1, wherein:

the carrier is configured to move from a first carrier position to a second carrier position in response to a pressurized gas being conveyed into the gas chamber such that a needle coupled to the medicament container moves from a first needle position, in which the needle is disposed within the housing, to a second needle position, in which a portion of the needle extends from the housing.

4. The apparatus of claim 3, wherein:

the housing includes a first stop surface and a second stop surface, the first stop surface configured to limit proximal movement of the carrier when the carrier is in the first carrier position, the second stop surface configured to limit distal movement of the carrier when the carrier is in the second carrier position.

5. The apparatus of claim 1, wherein an outer surface of the carrier includes a seal in sliding contact with an inner surface of the housing, the seal fluidically isolating the gas chamber from the exterior volume.

6. The apparatus of claim 1, further comprising:

the medicament container, the medicament container being a prefilled syringe having a needle staked to a distal end portion of a container body.

7. The apparatus of claim 6, wherein the medicament container contains the medicament, the medicament being any one of a drug or a biologic product.

8. The apparatus of claim 1, wherein the expandable assembly has a first length when in the collapsed configuration and a second length when in the expanded configuration, a ratio of the second length to the first length being greater than about 2.0.

9. The apparatus of claim 1, wherein:

the elastomeric member is configured to move a stroke distance within medicament container to expel a medicament contained therein in response to a pressurized gas being conveyed into the gas chamber; and

the expandable assembly has a first length when in the collapsed configuration, a ratio of the first length to the stroke distance being less than about 1.2.

10. The apparatus of claim 1, wherein:

the first member and the second member are each rigid; and

the first member defines an opening within which a portion of the second member slides when the expandable assembly moves from the collapsed configuration to the expanded configuration.

11. An apparatus, comprising:

a housing defining a gas chamber;

an energy storage member disposed within the housing, the energy storage member configured to produce a pressurized gas within the gas chamber;

a medicament container assembly disposed within the housing, the medicament container assembly including a container body and an elastomeric member disposed within the container body, the medicament container assembly including a needle coupled to a distal end portion of the container body; and

a carrier coupled to the medicament container assembly, a proximal surface of the carrier defining a portion of a boundary of the gas chamber, the carrier configured to move within the housing from a first carrier position to a second carrier position in response to a force exerted by the pressurized gas on the proximal surface of the carrier, the carrier including a first seal member and a second seal member, the first seal member in sliding contact with an inner surface of the housing to fluidically isolate the gas chamber, the second seal member in contact with a proximal end portion of the container body, the first seal member in a fixed position relative to the second seal member.

12. The apparatus of claim 11, wherein the first seal member is disposed about an outer surface of the carrier distally from the second seal member.

13. The apparatus of claim 11, wherein

a proximal end portion of the container body includes a flange;

and

the second seal member is an o-ring disposed between a shoulder of the carrier and the flange.

14. The apparatus of claim 11, wherein:

the carrier defines a first groove surrounding an outer surface of the carrier and a second groove surrounding an inner surface of the carrier;

a proximal end portion of the container body includes a flange;

the first seal member is disposed within the first groove; and

the second seal member is disposed within the second groove between the proximal surface of the carrier and the flange.

15. The apparatus of claim 11, wherein the needle moves from a first needle position, in which the needle is disposed within the housing, to a second needle position, in which a portion of the needle extends from the housing, when the carrier moves from the first carrier position to the second carrier position.

16. The apparatus of claim 11, further comprising:

a retraction spring configured to move the carrier towards the first carrier position in response to the pressurized gas being conveyed out of the gas chamber via an opening defined by the housing.

17. The apparatus of claim 11, wherein the carrier defines an opening within which a portion of the medicament container assembly is disposed.

18. The apparatus of claim 11, wherein the medicament container assembly is a prefilled syringe, the needle being staked to the distal end portion of the container body.

19. The apparatus of claim 11, wherein the housing defines an opening configured to selectively place the gas chamber in fluid communication with an exterior volume, the apparatus further comprising:

an expandable assembly having a first member and a second member, the first member coupled to the elastomeric member disposed within the container body, the second member including a valve portion, the expandable assembly configured to transition from a collapsed configuration to an expanded configuration when the elastomeric member moves within the container body, the valve portion configured to move relative to the opening when the expandable assembly transitions from the collapsed configuration to the expanded configuration to place the gas chamber in fluid communication with the exterior volume.

20. The apparatus of claim 11, wherein:

the housing includes a first stop surface and a second stop surface, the first stop surface configured to limit proximal movement of the carrier when the carrier is in the first carrier position, the second stop surface configured to limit distal movement of the carrier when the carrier is in the second carrier position.