Containment and delivery systems for cryogenic storage
Inventors
Laurence, Lawton E. • Lyness, Alex • Rouin, Geoffrey T. • Evans, Christopher
Assignees
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Publication Number
US-12162649-B2
Publication Date
2024-12-10
Expiration Date
Abstract
Various systems for the containment or delivery of a product are provided. The systems allow for the storage of products at low temperatures and include a container closure inserted into a container (10). The container closure may have an elastomeric body (12) and include a material (14) having a negative coefficient of thermal expansion. In other systems, the material having a negative coefficient of thermal expansion may be inserted between the elastomeric container closure and a seal. Other systems may include an insert at least partially embedded within the elastomeric body of a container closure, an actuator having a distal end movably attached to the insert, and a resilient element between the distal end of the actuator and the insert, wherein the resilient material expands radially upon displacing the distal end of the actuator toward the insert.
Core Innovation
The described invention relates to cryogenic containment or delivery of biologics or pharmaceuticals using a container and a container closure. The closure includes an elastomeric body and a material having a negative coefficient of thermal expansion (NCTE), arranged so that the outer surface of the elastomeric body contacts an inner surface of the container while maintaining sealing integrity at very low temperatures.
The disclosed architectures place the NCTE material within the elastomeric container closure to counter elastomer contraction at freezing temperature regimes. In one implementation, NCTE material is blended or encapsulated in the elastomeric closure, optionally within chambers, to reduce contraction. In another implementation, an embedded insert and an actuator displace a distal end so that a resilient sealing element expands radially toward the container inner surface, and the resilient element comprises NCTE material.
Additional embodiments focus on vial stopper and needle-access configurations. A vial stopper includes an NCTE insert located between stopper surfaces and a surrounding seal, including shaped inserts such as rings or bladders and embodiments with axial versus radial expansion features to preserve axial retention under crimped seals. Needle-access configurations include an internal through-hole configured to receive a needle puncturing the elastomeric body while avoiding exposure of the product to NCTE material, and barrier films are optionally included to prevent leaching of the NCTE material.
The NCTE material is described in multiple forms and phases, including solid, liquid, and gel, with temperature-related regimes at or below cryogenic thresholds. The disclosure also describes optional component-level manufacturing and sterilization at the closure or component level, and it discusses use of elastomer and container materials together with inert barrier films such as fluoropolymer, PTFE, or ETFE.
Claims Coverage
The independent claims cover four distinct containment/delivery system architectures grounded in NCTE-containing container closures. Across the independent claims, the inventive features total four NCTE integration structures.
Needle-access closure with NCTE material defining an internal through-hole
A system with a container and a container closure having an elastomeric body with a negative coefficient of thermal expansion material disposed within an outer surface, where the outer surface contacts the container inner surface and the material defines an internal through-hole configured to receive a needle puncturing the elastomeric body.
Actuated radial expansion using NCTE resilient element
A system with a container and a container closure including an elastomeric body, an insert embedded in the elastomeric body, an actuator with a distal end movably attached to the insert, and a resilient element between the distal end of the actuator and the insert, wherein the resilient element expands radially toward the inner surface upon displacement of the actuator distal end toward the insert and the resilient element comprises a material having a negative coefficient of thermal expansion.
Vial stopper system with NCTE insert between stopper surface and seal surface
A system with a vial having an inner surface and a neck portion, a stopper comprising an elastomeric body with an outer surface, an insert comprising a material having a negative coefficient of thermal expansion, and a seal around an outer periphery of the stopper and at least a portion of the neck portion, wherein the insert is located between a surface of the stopper and a surface of the seal.
Ribbed elastomeric closure with NCTE material in a same plane as ribs
A system with a container and a container closure configured to be received in the container to close the container, where the closure has a plurality of ribs each extending radially in a plane perpendicular to a centerline axis and contacting at least a portion of the container inner surface, and the closure comprises an elastomeric body with a material having a negative coefficient of thermal expansion disposed within the elastomeric body in the same plane as one or more of the plurality of ribs.
Overall claim coverage requires an elastomeric container closure that includes a material having a negative coefficient of thermal expansion, with distinct mechanical and structural arrangements to preserve containment or sealing integrity at cryogenic conditions, including a needle-access internal through-hole, actuated radial expansion, vial stopper insert positioning between stopper and seal surfaces, and a ribbed closure with NCTE material co-planar with the ribs.
Stated Advantages
Maintains sealing integrity at very low temperatures.
Reduces elastomer contraction at freezing temperature regimes.
Avoids exposure of the product to NCTE material in needle-access configurations.
Preserves axial retention under crimped seals.
Prevents leaching of the NCTE material.
Documented Applications
Cryogenic containment or delivery of biologics/pharmaceuticals using a container and container closure with an NCTE material to maintain sealing integrity at very low temperatures.
Needle-access configurations for receiving a needle puncturing the elastomeric body via an internal through-hole.
Vial stopper systems with sealing around the stopper outer periphery and at least a portion of the vial neck portion, including crimped metal seal contexts.
Containment/delivery system configurations where the container closure includes radially extending ribs that contact the container inner surface, including implementations identified as syringe/plunger in dependent claims.
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