Claims for Patent: 10,183,116

Summary for Patent: 10,183,116

Title:	Devices and methods for delivering medicaments from a multi-chamber container
Abstract:	An apparatus includes a housing, a medicament container, and a movable assembly. The movable assembly includes a first movable member and a second movable member. The second movable member is configured to move relative to the first movable member to move the movable assembly from a first configuration to a second configuration. A distal end portion of the second movable member is configured to move a plunger disposed within the medicament container in a distal direction when the movable assembly is moved to the second configuration. The movable assembly is configured to move between a first position and a second position to move the medicament container within the housing between a first container position and a second container position.
Inventor(s):	Edwards; Eric S. (Moseley, VA), Edwards; Evan T. (Charlottesville, VA), Licata; Mark J. (Doswell, VA), Meyers; Paul F. (Fishers, IN), Blondino; Frank E. (Henrico, VA)
Assignee:	kaleo, Inc. (Richmond, VA)
Application Number:	14/927,668
Patent Claims:	1. An apparatus, comprising: a housing; a medicament container assembly disposed within the housing, the medicament container assembly containing a first substance and a second substance, the medicament container assembly including a first elastomeric member and a second elastomeric member, the first elastomeric member defining a portion of a first volume containing the first substance, a channel defined through the second elastomeric member; an energy storage member configured to produce a force to move the first elastomeric member such that the first substance is conveyed from the first volume via the channel to produce a mixture of the first substance and the second substance within a second volume, the second volume defined at least in part by the second elastomeric member; a mixing actuation member disposed within the housing, the mixing actuation member configured to actuate the energy storage member when moved from a first position to a second position; a safety member removably coupled to a distal end portion of the housing, the safety member including an engagement portion configured to engage a distal end portion of the mixing actuation member such that when the safety member is being removed from the housing the mixing actuation member is moved from the first position to the second position; and an actuator movably coupled the distal end portion of the housing, the actuator including a distal surface configured to be placed against a target, the distal surface defining an opening, the actuator configured to initiate delivery of the mixture of the first substance and the second substance through the opening after the safety member is removed from the housing and when the distal surface is pressed against the target. 2. The apparatus of claim 1, further comprising: a piston having an engagement portion and an actuation portion, the engagement portion of the piston configured to engage a proximal end portion of the mixing actuation member to limit movement of the piston within the housing, the actuation portion configured to move the first elastomeric member in response to the force when the engagement portion of the piston is disengaged from the proximal end portion of the mixing actuation member. 3. The apparatus of claim 2, wherein: the engagement portion of the of the piston includes a protrusion; and the proximal end portion of the mixing actuation member includes a lock surface configured to engage the protrusion to limit movement of the piston within the housing. 4. The apparatus of claim 1, wherein: the medicament container assembly includes a delivery member through which the mixture of the first substance and the second substance is conveyed; and a portion of the delivery member is disposed through the opening during delivery of the mixture of the first substance and the second substance. 5. The apparatus of claim 1, wherein: the medicament container assembly includes a needle through which the mixture of the first substance and the second substance is conveyed, the needle disposed within the housing when the medicament container assembly is in a first medicament container assembly position, a distal end portion of the needle extending through the opening defined by the distal surface of the actuator when the medicament container assembly is in a second medicament container assembly position. 6. The apparatus of claim 1, wherein: the safety member is disposed about the opening when the safety member is coupled to the housing, the opening being exposed after the safety member is removed from the housing. 7. The apparatus of claim 1, wherein: a proximal end portion of the mixing actuation member includes a lock surface configured to engage a surface of a piston to maintain the energy storage member in a storage configuration when the mixing actuation member is in the first position, the lock surface spaced apart from the surface of the piston when the mixing actuation member is in the second position, the piston configured to move the first elastomeric member when the mixing actuation member is in the second position. 8. The apparatus of claim 1, wherein at least a portion of the mixing actuation member is configured to rotate within the housing when the mixing actuation member is moved from the first position to the second position. 9. The apparatus of claim 1, wherein the second substance is 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. 10. The apparatus of claim 1, wherein the first substance is a diluent and the second substance is a substantially dry medicament. 11. The apparatus of claim 1, wherein the energy storage member is a spring disposed between a proximal end surface of the housing and the first elastomeric member. 12. The apparatus of claim 1, wherein the housing defines a status aperture through which a portion of the medicament container assembly can be visually inspected. 13. An apparatus, comprising: a housing having a distal end portion that defines an opening; a medicament container assembly disposed within the housing, the medicament container assembly containing a first substance and a second substance, the medicament container assembly including a first elastomeric member and a second elastomeric member, the first elastomeric member defining a portion of a first volume containing the first substance; an energy storage member configured to produce a force to move the first elastomeric member such that the first substance is conveyed from the first volume to produce a mixture of the first substance and the second substance within a second volume, the second volume defined at least in part by the second elastomeric member; a mixing actuation member disposed within the housing, the mixing actuation member configured to release the energy storage member such that the force is exerted upon the first elastomeric member when at least a portion of the mixing actuation member is rotated within the housing; a safety member coupled to the distal end portion of the housing, the safety member including an outer surface disposed outside of the housing and covering the opening, the safety member including a protrusion disposed within the housing, the protrusion configured to engage a portion of the mixing actuation member such that when the safety member is being removed from the housing, the portion of the mixing actuation member is rotated within the housing and the opening of the housing is exposed; and an actuator movably coupled to the distal end portion of the housing, the actuator configured to initiate delivery of the mixture of the first substance and the second substance through the opening when the actuator is moved relative to the housing and after the safety member is removed from the housing. 14. The apparatus of claim 13, wherein: the actuator includes a distal surface configured to be placed against a target surface to initiate delivery of the mixture of the first substance and the second substance; and the safety member is disposed about the distal surface of the actuator when the safety member is coupled to the housing, the distal surface exposed after the safety member is removed from the housing. 15. The apparatus of claim 14, wherein the actuator is configured to initiate movement of the medicament container assembly within the housing to convey the mixture of the first substance and the second substance when the actuator is moved relative to the housing. 16. The apparatus of claim 14, wherein: the first elastomeric member is configured to move from a first elastomeric member position to a second elastomeric member position to convey the first substance from the first volume; and the actuator is configured to initiate movement of the first elastomeric member from the second elastomeric member position to a third elastomeric member position to convey the mixture of the first substance and the second substance when the actuator is moved relative to the housing. 17. The apparatus of claim 13, wherein: the medicament container assembly includes a needle through which the mixture of the first substance and the second substance is conveyed, the needle disposed within the housing when the medicament container assembly is in a first medicament container assembly position, a distal end portion of the needle extending through the opening when the medicament container assembly is in a second medicament container assembly position. 18. The apparatus of claim 13, further comprising: a piston having an engagement portion and an actuation portion, the engagement portion configured to engage a proximal end portion of the mixing actuation member to limit movement of the piston within the housing, the actuation portion configured to move the first elastomeric member in response to the force when the engagement portion is disengaged from the proximal end portion of the mixing actuation member. 19. The apparatus of claim 13, wherein the second substance is 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. 20. The apparatus of claim 13, wherein the first substance is a diluent and the second substance is a substantially dry medicament. 21. The apparatus of claim 13, wherein the second elastomeric member defines a channel through which the first substance is conveyed into the second volume. 22. An apparatus, comprising: a housing having a distal end portion that defines an opening; a medicament container assembly disposed within the housing, the medicament container assembly containing a first substance and a second substance, the medicament container assembly including a first elastomeric member and a second elastomeric member, the first elastomeric member defining a portion of a first volume containing the first substance; an energy storage member configured to produce a force to move the first elastomeric member such that the first substance is conveyed from the first volume to produce a mixture of the first substance and the second substance within a second volume, the second volume defined at least in part by the second elastomeric member; a mixing actuation member disposed within the housing, the mixing actuation member having a first end portion and a second end portion, the first end portion including a retention surface configured to engage a piston to maintain the energy storage member in a storage configuration when the mixing actuation member is in a first position, the retention surface spaced apart from the piston when the mixing actuation member is in a second position to release the energy storage member such that the force is exerted upon the first elastomeric member; a safety member coupled to the distal end portion of the housing, the safety member including an outer surface disposed outside of the housing and covering the opening, the safety member including a protrusion disposed within the housing, the protrusion configured to engage the second end portion of the mixing actuation member such that when the safety member is removed from the housing, the mixing actuation member is moved from the first position to the second position and the opening is exposed; and an actuator movably coupled to the distal end portion of the housing, the actuator configured to initiate delivery of the mixture of the first substance and the second substance through the opening when the actuator is moved relative to the housing and after the safety member is removed from the housing. 23. The apparatus of claim 22, wherein: the actuator includes a distal surface configured to be placed against a target surface to initiate delivery of the mixture of the first substance and the second substance; and the safety member is disposed about the distal surface of the actuator when the safety member is coupled to the housing, the distal surface exposed after the safety member is removed from the housing. 24. The apparatus of claim 23, wherein the actuator is configured to initiate movement of the medicament container assembly within the housing to convey the mixture of the first substance and the second substance when the actuator is moved relative to the housing. 25. The apparatus of claim 23, wherein: the first elastomeric member is configured to move from a first elastomeric member position to a second elastomeric member position to convey the first substance from the first volume; and the actuator is configured to initiate movement of the first elastomeric member from the second elastomeric member position to a third elastomeric member position to convey the mixture of the first substance and the second substance when the actuator is moved relative to the housing. 26. The apparatus of claim 22, wherein a length of the mixing actuation member is greater than a length of medicament container assembly. 27. The apparatus of claim 22, wherein the second substance is 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. 28. The apparatus of claim 22, wherein the second elastomeric member defines a channel through which the first substance is conveyed into the second volume. 29. The apparatus of claim 22, further comprising: a valve configured to control a flow of the first substance from the first volume into the second volume.

Details for Patent 10,183,116

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2031-01-26
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2031-01-26
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2031-01-26
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2031-01-26
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	09/14/2017		2031-01-26
Immunex Corporation	ENBREL	etanercept	Injection	103795			2031-01-26
Immunex Corporation	ENBREL	etanercept	Injection	103795	03/05/2020		2031-01-26