Devices, systems and methods for medicament delivery
Inventors
Edwards, Eric S. • Edwards, Evan T. • Licata, Mark J. • Meyers, Paul F.
Assignees
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Publication Number
US-11590286-B2
Publication Date
2023-02-28
Expiration Date
Abstract
A method includes moving an actuation lock of a medical injector from a first position to a second position. The actuation lock has an extended portion disposed between a shoulder of a housing and the base when the actuation lock is in the first position. The extended portion is spaced apart from the base when the actuation lock is in the second position. A distal end portion of a base, which is movably coupled to an end portion of the housing, is placed into contact with a body. The base is actuated after the placing to release an energy from an energy storage member within the housing to produce a force to move a needle from a first needle position to a second needle position. At least a portion of the needle extends through the base when the needle is in the second needle position.
Core Innovation
An apparatus includes a housing having a distal end portion, a medicament container disposed within the housing, and a needle coupled to the medicament container. A plunger having a distal end is configured to move within the medicament container between a first position and a second position in response to a first force. The needle is covered by a needle sheath, and a sheath retainer is disposed about at least a portion of the needle sheath.
The sheath retainer includes a grip surface configured to be manipulated by a user to move the sheath retainer distally relative to the housing. The sheath retainer further includes at least one retaining tab that engages the needle sheath and transfers a removal force to the needle sheath to remove the needle sheath from about the needle when the sheath retainer is moved distally. A case is configured to contain at least the distal end portion of the housing and to surround the needle when the distal end portion of the housing is within the case.
The device is described with multi-stage operation in which safety/locking features prevent actuation until a needle guard is removed. The described delivery sequence involves triggering energy release to move the needle between retracted and deployed positions, followed by retraction after injection, while fluid isolation between the needle and medicament until injection is maintained through the staged operation.
Claims Coverage
The provided material identifies one independent claim (clm-00001). The main inventive coverage is centered on an apparatus with a user-manipulated, distal-moving sheath retainer having retaining tabs that remove a needle sheath, in combination with a housing/case arrangement and a medicament container with a plunger moving in response to a first force.
User-moved sheath retainer with retaining tabs to remove the needle sheath
A needle sheath covering the needle and a sheath retainer disposed about at least a portion of the needle sheath, the sheath retainer including a grip surface configured to be manipulated by a user to move the sheath retainer distally relative to the housing, the sheath retainer including at least one retaining tab that engages the needle sheath and is configured to transfer a removal force to the needle sheath to remove the needle sheath from about the needle when the sheath retainer is moved distally.
Plunger movement within the medicament container in response to a first force
A plunger having a distal end configured to move within the medicament container between a first position and a second position in response to a first force, where the medicament container and the needle are disposed within the housing.
Housing distal end portion contained by a case surrounding the needle
A case configured to contain at least the distal end portion of the housing, the case surrounding the needle when the distal end portion of the housing is within the case.
Overall, the claim coverage provided is focused on the combination of a medicament container and plunger arrangement for force-responsive needle-delivery, together with a user-manipulated sheath retainer that removes the needle sheath via retaining tabs, and a case/housing configuration that contains the distal end portion and surrounds the needle.
Stated Advantages
Safety/locking features are described as preventing actuation until a needle guard is removed.
Needle guard constructions are described as supporting sterilization or microbial resistance, including microbial-resistance/sterilizability via sterilant gas and/or porous materials.
Manufacturing is described as enabling sterilization after needle cover installation using sterilant gas through porous/valved needle guard constructions.
Fluid isolation between the needle and medicament until injection is described as being maintained.
Additional indicia/order-of-operation indicators are described as supporting correct user removal order.
Documented Applications
Medicinal delivery using an auto-injector apparatus for delivering a medicament through a needle between retracted and deployed positions, including a described example medicament content of epinephrine.
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