Claims for Patent: 9,522,235

Summary for Patent: 9,522,235

Title:	Devices and methods for delivering medicaments from a multi-chamber container
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.
Inventor(s):	Edwards; Eric S. (Moseley, VA), Edwards; Evan T. (Gordonsville, VA), Licata; Mark J. (Doswell, VA), Meyers; Paul F. (Fishers, IN), Blondino; Frank E. (Henrico, VA)
Assignee:	kaleo, Inc. (Richmond, VA)
Application Number:	13/827,582
Patent 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.

Details for Patent 9,522,235

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2039-02-26
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2039-02-26
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2039-02-26
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2039-02-26
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	09/14/2017		2039-02-26
Immunex Corporation	ENBREL	etanercept	Injection	103795			2039-02-26