Devices and methods for delivering medicaments from a multi-chamber container

• US 9,522,235 B2
• Filed: 03/14/2013
• Issued: 12/20/2016
• Est. Priority Date: 05/22/2012
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: Edwards, Eric S., Edwards, Evan T., Licata, Mark J., Meyers, Paul F., Blondino, Frank E.
• Primary Examiner(s): Schmidt, Emily
• Application Number:
  US13/827,582
• Publication Number:
  US 20130317477A1
• Time in Patent Office: 1,377 Days
• US Class Current: 1/1
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61M 2005/3123 having air entrapping or venting means, e.g. purging channels in pistons
• CPC Class Codes: A61M 2005/3132 having flow passages for injection agents at the distal end of the barrel to bypass a sealing stopper after its displacement to this end due to internal pressure increase
• CPC Class Codes: A61M 2205/0216 Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61M 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• 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 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/2466 by piercing without internal pressure increase A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/31536 Blocking means to immobilize a selected dose, e.g. to administer equal doses
• CPC Class Codes: A61M 5/31596 comprising means for injection of two or more media, e.g. by mixing
• 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: G09B 23/285 for injections, endoscopy, bronchoscopy, sigmoidscopy, insertion of contraceptive devices or enemas

Abstract

An apparatus includes a medicament container, a first elastomeric member, a second elastomeric member and a stopper. The first and second elastomeric members are disposed within the medicament container. The first elastomeric member, a first portion of the medicament container and the second elastomeric member collectively define a medicament volume. The stopper is coupled to a distal end portion of the medicament container. The second elastomeric member, a second portion of the medicament container and the stopper collectively define a vent volume. A first retainer of the stopper is configured to engage a first portion of a carrier to limit movement of the medicament container when in a first position. A second retainer of the stopper is configured to engage a second portion of the carrier to limit movement of the medicament container when in a second position.

Claims

1. An apparatus, comprising:

a medicament container configured to be movably coupled to a carrier of a medicament delivery device, the carrier including a needle;

a first elastomeric member disposed within a proximal end portion of the medicament container;

a second elastomeric member disposed within the medicament container, the first elastomeric member, a first portion of the medicament container and the second elastomeric member collectively defining, at least in part, a medicament volume; and

a stopper coupled to a distal end portion of the medicament container, the second elastomeric member, a second portion of the medicament container and the stopper collectively defining, at least in part, a vent volume, the stopper having a first retention portion and a second retention portion, the first retention portion configured to engage a first portion of the carrier to limit movement of the medicament container relative to the carrier when the medicament container is in a first position relative to the carrier, the second retention portion configured to engage a second portion of the carrier to limit movement of the medicament container relative to the carrier when the medicament container is in a second position relative to the carrier, the stopper configured to fluidically isolate the needle from the vent volume when the medicament container is in the first position, the needle is disposed through a portion of the stopper to fluidically couple the vent volume to the needle when the medicament container is in the second position, the needle is disposed through a portion of the second elastomeric member to fluidically couple the medicament volume to the needle when the medicament container is in a third position relative to the carrier.

2. The apparatus of claim 1, wherein:

the stopper defines a needle volume within which the needle is disposed when the medicament container is in the first position; and

the first retention portion and the first portion of the carrier collectively form a substantially fluid-tight seal such that the needle volume is fluidically isolated from a volume outside of the medicament container when the medicament container is in the first position.

3. The apparatus of claim 1, wherein at least one of the first retention portion or the first portion of the carrier is configured to deform when the medicament container moves from the first position to the second position.

4. The apparatus of claim 1, wherein at least one of the second retention portion or the second portion of the carrier is configured to deform when the medicament container moves from the second position to the third position relative to the carrier.

5. The apparatus of claim 1, wherein at least one of the second elastomeric member or the medicament container defines a flow path between the medicament volume and the vent volume such that when a force is exerted on the first elastomeric member, a gas within the medicament volume flows into the vent volume via the flow path.

6. The apparatus of claim 1, wherein the medicament container defines a bypass, the second elastomeric member disposed within the medicament container such that when a force is exerted on the first elastomeric member, a gas within the medicament volume flows into the vent volume via the bypass.

7. The apparatus of claim 1, wherein the medicament volume includes a medicament selected from the group consisting of adalimumab, atropine, buprenorphine, certolizumab, cetirizine, diazepam, diphenhydramine, epinephrine, etanercept, exenatide, glucagon, haloperidol, hydroxyzine, insulin, ketorolac, lixisenatide, lorazepam, methotrexate, midazolam, obidoxime chloride, pralidoxime chloride, and combinations thereof.

8. The apparatus of claim 1, wherein:

the first retention portion and the first portion of the carrier collectively form a substantially fluid-tight seal such that a needle volume is fluidically isolated from a volume outside of the medicament container when the medicament container is in the first position; and

the second retention portion is within the volume outside of the medicament container.

9. The apparatus of claim 1, wherein:

the first retention portion is formed by an inner surface of the stopper; and

the second retention portion is formed by an outer surface of the stopper.

10. The apparatus of claim 1, wherein the first retention portion is longitudinally spaced apart from the second retention portion.

11. An apparatus, comprising:

a medicament container configured to be movably coupled to a carrier of a medicament delivery device, the carrier including a needle;

a first elastomeric member disposed within a proximal end portion of the medicament container;

a second elastomeric member disposed within the medicament container, the first elastomeric member, a first portion of the medicament container and the second elastomeric member collectively defining, at least in part, a medicament volume; and

a stopper coupled to a distal end portion of the medicament container, the second elastomeric member, a second portion of the medicament container and the stopper collectively defining, at least in part, a vent volume, a retention portion of the stopper configured to engage a portion of the carrier to limit movement of the medicament container relative to the carrier when the medicament container is in a first position relative to the carrier, the stopper defining a needle volume that is fluidically isolated from the vent volume and within which the needle is disposed when the medicament container is in the first position, the retention portion and the portion of the carrier collectively forming a substantially fluid-tight seal such that the needle volume is fluidically isolated from a volume outside of the medicament container when the medicament container is in the first position, the needle being disposed through a portion of the stopper to fluidically couple the vent volume to the needle when the medicament container is in a second position relative to the carrier, the needle being disposed through a portion of the second elastomeric member to fluidically couple the medicament volume to the needle when the medicament container is in a third position relative to the carrier.

12. The apparatus of claim 11, wherein at least one of the second elastomeric member or the medicament container defines a flow path between the medicament volume and the vent volume such that when a force is exerted on the first elastomeric member, a gas within the medicament volume flows into the vent volume via the flow path.

13. The apparatus of claim 11, wherein at least one of the retention portion of the stopper or the portion of the carrier is configured to deform when the medicament container moves from the first position to the second position.

14. The apparatus of claim 11, wherein:

the portion of the carrier is a first portion;

the retention portion of the stopper is a first retention portion; and

the stopper has a second retention portion configured to engage a second portion of the carrier to limit movement of the medicament container relative to the carrier when the medicament container is in the second position relative to the carrier.

15. The apparatus of claim 11, wherein the medicament container defines a bypass, the second elastomeric member disposed within the medicament container such that when a force is exerted on the first elastomeric member, a gas within the medicament volume flows into the vent volume via the bypass.

16. An apparatus, comprising:

a medicament container configured to be movably coupled to a carrier of a medicament delivery device, the carrier including a needle;

a first elastomeric member disposed within a proximal end portion of the medicament container;

a second elastomeric member disposed within the medicament container, the first elastomeric member, a first portion of the medicament container and the second elastomeric member collectively defining, at least in part, a medicament volume; and

a stopper coupled to a distal end portion of the medicament container, the second elastomeric member, a second portion of the medicament container and the stopper collectively defining, at least in part, a vent volume, the stopper having a first retention portion and a second retention portion, the first retention portion is formed by an inner surface of the stopper and is configured to engage a first portion of the carrier to limit movement of the medicament container relative to the carrier when the medicament container is in a first position relative to the carrier, the second retention portion is formed by an outer surface of the stopper and is configured to engage a second portion of the carrier to limit movement of the medicament container relative to the carrier when the medicament container is in a second position relative to the carrier.