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

• US 10,226,583 B2
• Filed: 12/09/2016
• Issued: 03/12/2019
• 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 L
• Application Number:
  US15/374,389
• Publication Number:
  US 20170151393A1
• Time in Patent Office: 823 Days
• 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. A method, comprising:

moving a medicament container having a first elastomeric member, a second elastomeric member and a third elastomeric member disposed therein from a first position to a second position relative to a carrier of a medicament delivery device such that a needle of the carrier pierces a stopper coupled to a distal end portion of the medicament container to place a vent volume in fluid communication with the needle, the vent volume defined, in part, between the third elastomeric member and the stopper and by a second portion of the medicament container;

moving the second elastomeric member within the medicament container to convey a gas from a solid medicament volume to the vent volume, the solid medicament volume defined, in part, by the third elastomeric member and the second elastomeric member and by a first portion of the medicament container; and

moving the medicament container to a third position relative to the carrier such that the needle of the carrier pierces the third elastomeric member to place the solid medicament volume in fluid communication with the needle;

wherein the stopper includes 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 the first position, 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.

2. The method of claim 1, wherein a time period of the moving the second elastomeric member overlaps a time period of the moving the medicament container to the second position.

3. The method of claim 1, wherein the moving the second elastomeric member and the moving the medicament container to the second position are performed in response to a force applied to the first elastomeric member.

4. The method of claim 1, wherein:

the moving the medicament container to the second position includes deforming at least one of the first retention portion or the first portion of the carrier.

5. The method of claim 1, wherein:

the moving the medicament container to the third position includes deforming at least one of the second retention portion or the second portion of the carrier.

6. 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;

a third elastomeric member disposed within the medicament container, the second elastomeric member, a first portion of the medicament container and the third 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 third 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 needle 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.

7. The apparatus of claim 6, 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 collective 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.

8. The apparatus of claim 6, 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.

9. An apparatus, comprising:

a housing having a proximal end portion and a distal end portion;

a medicament container within the housing;

a delivery member coupled to the medicament container, the delivery member configured to extend from the distal end portion of the housing;

a movable assembly including a first movable member, a second movable member, and a mixing spring, the mixing spring configured to exert a force on the second movable member to move a first elastomeric member within the medicament container to produce a mixture of a first substance and a second substance within the medicament container when the mixing spring is released;

a mixing actuator member disposed within the housing, the mixing actuator member including a retention portion, the retention portion configured to move within a portion of the first movable member between a first position and a second position to release the mixing spring; and

a safety lock at the distal end portion of the housing, the safety lock configured to selectively engage the mixing actuator member such that movement of the safety lock in a distal direction moves the retention portion of the mixing actuator member to the second position.

10. The apparatus of claim 9, wherein:

the safety lock includes a safety lock actuator configured to move with the safety lock such that movement of the safety lock in the distal direction moves the safety lock actuator in the distal direction.

11. The apparatus of claim 10, wherein:

the safety lock is configured to selectively engage the mixing actuator member through the safety lock actuator such that movement of the safety lock in the distal direction moves the safety lock actuator in the distal direction to move the retention portion of the mixing actuator member to the second position.

12. The apparatus of claim 9, wherein

the distal end portion of the housing defines an opening through which a portion of the delivery member is disposed;

and

the safety lock is disposed about the opening at the distal end portion of the housing.

13. The apparatus of claim 12, wherein:

the safety lock is configured to be removed from the housing to expose the opening at the distal end portion of the housing.

14. The apparatus of claim 13, wherein:

the safety lock is configured to move in the distal direction when removed from the housing to expose the opening.

15. The apparatus of claim 12, wherein the opening is a first opening, the apparatus further comprising:

a base movably coupled to the distal end portion of the housing, the base including a surface configured to be placed against a target surface, the surface defining a second opening through which at least a portion of the delivery member is disposed;

the safety lock disposed about the surface of the base when the safety lock is coupled to the housing, the safety lock configured to be removed from the housing to expose the second opening.

16. The apparatus of claim 9, wherein the delivery member includes a one of a needle, a nozzle, or a tube.

17. The apparatus of claim 9, wherein the medicament container 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.

18. The apparatus of claim 9, wherein the safety lock is coupled to the housing, the safety lock further including:

an outer surface disposed outside of the housing; and

a protrusion disposed within the housing, the protrusion configured to selectively engage the mixing actuator member upon movement of the safety lock in the distal direction.