Devices and methods for delivery of substances within a prefilled syringe
Inventors
Meyers, Paul F. • Roe, Michael J.
Assignees
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Publication Number
US-12017047-B2
Publication Date
2024-06-25
Expiration Date
Abstract
An apparatus includes a housing, an energy storage member, a carrier, a medicament container, and a delivery control mechanism. The housing defines a gas chamber configured to receive pressurized gas from the energy storage member to pressurize the gas chamber. The carrier has a proximal surface that defines a portion of the gas chamber. The medicament container is coupled to the carrier and has a distal end portion coupled to a delivery member. The medicament container contains a medicament and includes an elastomeric member that seals the medicament within the medicament container. The delivery control mechanism is coupled to a proximal end portion of the medicament container and includes a flow restriction member for regulating a pressure supplied by the gas chamber and entering into the medicament container that acts on the elastomeric member.
Core Innovation
The invention relates to a pistonless gas-powered auto-injector apparatus that dispenses medicament by driving a distal movement of an elastomeric member through a travel stroke in response to pressurized gas. A housing defines a gas chamber, and an actuated energy storage member produces pressurized gas that pressurizes the gas chamber and defines a first gas flow path. A carrier disposed within the housing has a proximal surface that defines a portion of a boundary of the gas chamber, and a medicament container is coupled to the carrier, contains a medicament, and is sealed by an elastomeric member.
A delivery control mechanism governs movement of the elastomeric member by regulating gas pressure in a second gas flow path that is fluidically isolated from the first gas flow path. The delivery control mechanism includes a flow restriction member operably coupled to a proximal end portion of the medicament container, and the flow restriction member defines the second gas flow path in fluid communication with the elastomeric member. The flow restriction member establishes a gas pressure magnitude in the second gas flow path that is less than the gas pressure magnitude within the first gas flow path, and this pressure differential controls at least in part movement of the elastomeric member through the travel stroke.
The apparatus further includes a gas vent assembly positioned at least partially within the gas chamber that selectively connects the gas chamber to an external volume and enables venting behavior through a movable valve member, including venting high-pressure gas to enable needle retraction. The claims also recite a flow restriction retainer with a radially extending flange and coaxial axis relationship, and an expandable assembly positioned at least partially within the gas chamber. In additional embodiments, the apparatus supports dual-container systems where separate medicament containers each include their own elastomeric member, delivery control mechanism, and flow restriction member, with coordinated venting when medicament delivery mechanisms reach a terminal configuration.
Claims Coverage
The independent claims identified are clm-00001, clm-00011, and clm-00015. Across these claims, the inventive features consistently include gas chamber pressurization by an actuated energy storage member, an elastomeric-sealed medicament container coupled to the carrier, and a delivery control mechanism using a flow restriction and a separate second gas flow path to control elastomer movement via a controlled pressure differential.
Gas chamber pressurization via energy storage member
A housing defining a gas chamber, an energy storage member configured to produce a pressurized gas when actuated, and the gas chamber receiving the pressurized gas to pressurize the gas chamber and define a first gas flow path.
Elastomeric medicament container fluidically isolated from first gas flow path
A medicament container coupled to the carrier, containing a medicament and including an elastomeric member that seals the medicament within the medicament container, where the elastomeric member is fluidically isolated from the first gas flow path.
Flow restriction controlled second gas flow path to drive elastomer travel stroke
A delivery control mechanism including a flow restriction member that regulates flow of the pressurized gas that acts on the elastomeric member, the flow restriction member defining a second gas flow path in fluid communication with the elastomeric member, and establishing a gas pressure within the second gas flow path at a magnitude less than a magnitude of the gas pressure within the first gas flow path to control at least in part movement of the elastomeric member through a travel stroke.
Flow restriction retainer and coaxial axis relationship
A delivery control mechanism including a flow restriction retainer and a flow restriction member disposed within the flow restriction retainer, where the flow restriction retainer includes a radially extending flange configured to mount on at least one of the carrier or the proximal end portion of the medicament container, the distal end portion of the flow restriction retainer extends into the proximal end portion of the medicament container, and the flow restriction retainer defines a first axis coaxial with a second axis defined by the medicament container.
Expandable assembly and venting using movable valve to external volume
An expandable assembly positioned at least partially within the gas chamber, and a gas vent assembly positioned at least partially within the gas chamber, where the gas vent assembly includes a movable valve member that selectively connects the gas chamber to an external volume.
The independent claims collectively cover gas chamber pressurization by an actuated energy storage member and a medicament container sealed by an elastomeric member. They require a delivery control mechanism with a flow restriction that defines a second gas flow path fluidically coupled to the elastomeric member, establishing a second-gas pressure magnitude less than the first-gas pressure magnitude to control elastomer movement through a travel stroke. Additional structural refinements include a flow restriction retainer with axis relationship and an expandable assembly with a gas vent assembly using a movable valve to selectively communicate with an external volume.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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