Devices and methods for delivering a lyophilized medicament

Inventors

Blondino, Frank E. • Edwards, Eric S. • Edwards, Evan T. • Meyers, Paul F.

Assignees

kaleo Inc

Abstract

An apparatus includes a housing, an actuator, a lock mechanism, and a medicament container. The lock mechanism selectively engages a portion of the housing such that (1) the lock mechanism is maintained in a substantially fixed position when the housing is in a first orientation and (2) the lock mechanism is removable from the housing when the housing is in a second orientation. The medicament container is moved in a proximal direction when the lock mechanism is removed from the housing to mix a first medicament portion contained within the medicament container with a second medicament portion contained within the medicament container. The actuator can be moved from a first position to a second position when the lock mechanism is removed from the housing to release energy stored within an energy storage member such that the medicament container is moved in a distal direction.

Core Innovation

The invention relates to medicament delivery devices that use a housing gas chamber and an energy storage member configured to produce pressurized gas within the gas chamber when actuated. The pressurized gas directly contacts a surface of an elastomeric member disposed within a container body of a medicament container assembly, and the elastomeric member moves within the container body to deliver a dose of medicament via a needle that extends from the housing in response to distal movement of the container assembly.

The apparatus includes a sealing assembly coupled to the medicament container assembly and disposed within the housing, where a proximal surface of the sealing assembly defines a portion of the boundary of the gas chamber. The sealing assembly moves within the housing from a first sealing assembly position to a second sealing assembly position in response to a force exerted by the pressurized gas, and the apparatus is devoid of a rigid member configured to transfer the force produced by the pressurized gas onto the surface of the elastomeric member.

To control force management during delivery and retraction, the invention includes a vent assembly with a vent opening defined by the housing. The vent opening vents a portion of the pressurized gas to reduce at least the force to a magnitude less than a retraction force exerted on the sealing assembly by a bias member, and venting is initiated during delivery of a final portion of the dose so that needle retraction occurs in response to proximal movement of the container assembly.

Claims Coverage

The partial content provides three independent claims. Together, they cover a pressurized-gas, elastomer-actuated delivery apparatus with a sealing assembly boundary for the gas chamber and no rigid force-transfer member, force-managed delivery using venting through a housing-defined vent opening to reduce force below a bias retraction force, and a method that initiates venting during a final portion of dose delivery and then retracts the needle in response to a retraction spring.

Across the independent claims, the core coverage is a pressurized-gas injector apparatus in which pressurized gas directly contacts an elastomeric member within a medicament container to move and deliver the dose, with the gas-chamber boundary shared between the elastomeric-member surface and a sealing assembly. The claims further require force management by venting through a housing-defined vent opening to reduce pressurized-gas force below a retraction force, and in the method, the venting is initiated during delivery of a final portion so that needle retraction occurs afterward in response to the retraction spring.

Stated Advantages

Documented Applications