Medical agent dispensing systems, methods, and apparatuses
Inventors
Kamen, Dean • Zeira, Eitan C. • Demers, Jason A. • Tracey, Brian D. • Rosa, Michel A. • MacLeod, Jack
Assignees
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Abstract
A medical agent delivery device may comprise a laminate of a number of layers coupled together. The medical agent delivery device may further comprise a collapsible reservoir within the laminate. The medical agent delivery device may further comprise a sharp bearing body having at least one microneedle. The medical agent delivery device may further comprise a collar element attached to the sharp bearing body. The medical agent delivery device may further comprise a removable cover assembly including a microneedle encasing body coupled to the sharp bearing body and to a release liner. The microneedle encasing body may be attached more weakly to the sharp bearing body than to the release liner.
Core Innovation
The invention relates to a patch-type medical agent delivery device that includes a laminate having a cavity defined therein. A collapsible reservoir is formed between a second stratum and a third stratum that are coupled to one another, with the reservoir at least partially seated within the cavity. The collapsible reservoir is described as a variable-volume reservoir configured to house a medical agent for delivery through sharp features.
The device further includes a sharp bearing body having at least one delivery sharp with a delivery lumen, where the sharp bearing body includes a peripheral surface coupled to the third stratum around a hole in the third stratum. A removable sharp encasing body encases the at least one delivery sharp and inhibits flow out of the delivery lumen from an interior volume of the reservoir. Collar element structures are coupled to the third stratum or laminate to define a receptacle in which the sharp bearing body is disposed.
The laminated reservoir is described with multi-layer constructions, including SiOx layers positioned as interior wall layers of the reservoir, and barrier/agent-compatible and antimicrobial layers in some configurations. Reservoir structures are described using welded or form-fill-seal reservoir formations, and the delivery is activated by manually rupturing a weakened/score-line portion of a membrane or by using a temperature-activated bimetallic actuator. Microneedle geometry and arrangement are described, including spacing arrays and a polygonal prism pointed wedge microneedle geometry with an offset delivery lumen.
Claims Coverage
The provided claim set includes three independent claims (clm-00001, clm-00016, clm-00032). Each independent claim covers a laminate-based medical agent delivery device with a collapsible reservoir, a sharp bearing body with delivery lumens, a removable sharp encasing body that inhibits flow, and a collar element that positions the sharp bearing body within a receptacle.
Collapsible reservoir in a laminate cavity
A second stratum and a third stratum coupled to one another form a collapsible reservoir therebetween, the reservoir being at least partially seated within a cavity defined in a first stratum; in another formulation, a collapsible reservoir is at least partially seated within a cavity defined in a laminate of a plurality of strata.
Sharp bearing body with delivery lumen
A sharp bearing body having at least one delivery sharp with a delivery lumen, where the sharp bearing body includes a peripheral surface coupled to the third stratum around a hole in the third stratum.
Removable sharp encasing body inhibiting flow through delivery lumen
A removable sharp encasing body encasing the at least one delivery sharp and inhibiting flow out of the delivery lumen of each of the at least one delivery sharp from an interior volume of the reservoir (or inhibiting flow through the delivery lumen of each of the at least one delivery sharp).
Collar element receptacle disposition
A collar element coupled to the third stratum (or laminate) in a region surrounding at least a portion of the reservoir, wherein the sharp bearing body is disposed within a receptacle of the collar element.
Across the independent claims, the core claim coverage is a laminate-based device that combines a collapsible reservoir seated in a cavity with a sharp bearing body providing delivery lumens and a removable sharp encasing body that inhibits flow, while a collar element couples to the laminate or third stratum to provide a receptacle that positions the sharp bearing body.
Stated Advantages
Dose sparing and injection sparing are discussed for vaccine payload delivery.
The device is described as suited for shallow/intradermal delivery.
Documented Applications
Medical agent delivery as a patch-type medical agent delivery device, including delivery of vaccine payloads suited for shallow/intradermal delivery, with example inclusion of a SARS-CoV-2 vaccine.
Puncture-depth signaling and indicator/window concepts are discussed for the delivery device.
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