Devices for reconstituting and delivering lyophilized drugs
Inventors
BAKER, Alexander Joseph • Gibson, Luke Andrew • Patel, Hemant Thakorbhai • Roberts, Ariel Marie
Assignees
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Publication Number
US-12329939-B2
Publication Date
2025-06-17
Expiration Date
Abstract
The present disclosure relates to drug delivery devices, and in particular, to drug delivery devices configured to reconstitute a lyophilized drug powder into liquid form prior to delivery into a patients body. In some embodiments, such devices include a flexible drug reservoir having a proximal reservoir component storing a liquid diluent and a distal reservoir component storing a lyophilized drug powder, wherein the two compartments are separated by a frangible seal. A compression member may be positioned above the reservoir and held up by a releasable mechanism. When released, the compression member may be driven downwards to compress the proximal compartment so as to break the frangible seal and allow the diluent to mix with the drug powder and form a liquid drug mixture, and then to eject the liquid drug mixture from the reservoir.
Core Innovation
The invention relates to a drug-delivery device assembly that has a housing with an interior surface, a proximal end, and a distal end, and a flexible drug reservoir disposed on the interior surface. The reservoir includes a proximal reservoir compartment storing a liquid diluent and a distal reservoir compartment storing a lyophilized drug powder, separated by a frangible seal.
The device uses a releasable mechanism positioned in the housing, including a rigid pivoting member configured to rotate about a central spindle with at least a first arm and a second arm. A compression member having a proximal end and a distal end is disposed proximate the drug reservoir, with the proximal end attached to a hinge and the distal end secured by the first arm of the pivoting member, and a biasing member applies pressure to the compression member.
In response to actuation, the releasable mechanism rotates the pivoting member so that the plane of the first arm no longer directly contacts the compression member, allowing the compression member to rotate about the hinge. The compression member then compresses the proximal reservoir compartment to force liquid diluent through the frangible seal into the distal reservoir compartment, where the diluent mixes with the lyophilized drug powder to form a drug mixture, and compresses the distal reservoir compartment to expel the drug mixture.
During the same actuation, rotation of the pivoting member causes the second arm no longer to engage the injection needle, so the injection needle moves from a storage position to an injection position under the biasing force from the injection spring. The described actuation sequence links reconstituting the lyophilized drug mixture with expelling the drug mixture and moving the injection needle.
Claims Coverage
The partial content provides one independent claim (clm-00001). The claim includes three main inventive feature groupings: the housed flexible reservoir with a frangible seal and compartments, the pivoting releasable mechanism with a hinge-mounted compression member and biasing member for mixing and expulsion, and the coupled needle movement sequence controlled by engagement and disengagement with pivoting member arms.
Flexible reservoir with frangible seal between diluent and lyophilized drug compartment
A housing includes a flexible drug reservoir disposed on the interior surface with a proximal reservoir compartment storing a liquid diluent and a distal reservoir compartment storing a lyophilized drug powder, separated by a frangible seal.
Pivoting releasable mechanism controlling hinged compression member
A releasable mechanism includes a rigid pivoting member configured to rotate about a central spindle with at least a first arm and a second arm, wherein a compression member disposed proximate the reservoir has a proximal end attached to a hinge and a distal end secured by the first arm, and a biasing member biases the distal end toward the interior surface while being prevented from moving toward the interior surface by direct contact with a plane of the first arm.
Actuation sequence for reconstitution, expulsion, and needle positioning
In response to actuation, the pivoting mechanism rotates until the plane of the first arm no longer directly contacts the compression member so the compression member first compresses the proximal reservoir compartment to force liquid diluent through the frangible seal into the distal reservoir compartment for mixing with the lyophilized powder, and then compresses the distal reservoir compartment to expel the drug mixture, while rotation also disengages the second arm from the injection needle so the injection needle moves to the injection position under an injection spring force.
Across the single independent claim, the coverage centers on a hinged compression member driven by a pivoting releasable mechanism, a flexible proximal liquid diluent compartment separated by a frangible seal from a distal lyophilized drug powder compartment, and a coupled actuation sequence that mixes and expels the reconstituted drug mixture while moving the injection needle from storage to injection position.
Stated Advantages
Documented Applications
Not explicitly described in patent.
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