Microneedle enclosure and applicator device for microneedle array based continuous analyte monitoring device
Inventors
Mansfield, III, George Albert • Morelock, David Michael • BRISTER, Mark Christopher • Balcom, Nathan Thomas • DOAN, Joshua David • WARNER, Joshua Andrew • Faucher, Paul Daniel
Assignees
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Publication Number
US-11654270-B2
Publication Date
2023-05-23
Expiration Date
Abstract
An applicator for an analyte monitoring device may include an actuatable housing having a body defining a cavity therein and having a distal opening and a side opening. A cuff and a shuttle are received within the cavity and are separately translatable relative to the housing body. A base may removable engage the housing body at the distal opening. The housing body, the cuff, the shuttle, and/or the base may be engaged with one another with one or more releasable coupling features. The base may be removed from an engagement with the housing body, causing the cuff and the shuttle to be aligned and positioned in a configuration in which the analyte monitoring device, held by the shuttle, is ready for insertion into the skin.
Core Innovation
The applicator for an analyte monitoring device includes a housing defining a cavity and a distal opening, a cuff slidably received within the cavity and comprising a lumen, and a shuttle slidably received within the lumen configured to releasably retain the device. A first biasing element is arranged between the housing and the cuff, and a second biasing element is arranged between the housing and the shuttle.
The applicator also comprises a microneedle enclosure releasably engaged with the analyte monitoring device, configured to enclose a portion of the device, and comprising a third biasing element coupled to a releasably engaged base. The enclosure uses a capsule, clamp, and seal to protect the microneedle array and maintain a sterile environment. Relative movement of the housing, cuff, and shuttle transitions the assembly from collapsed to extended and released configurations to insert the microneedle array into skin and release the adherent device.
Claims Coverage
The supplied relevant claims identify one independent claim, which covers six inventive features.
Housing with a cavity and distal opening
The applicator comprises a housing with a body defining a cavity therein and a distal opening.
Slidable cuff with a lumen
A cuff is slidably received within the cavity and comprises a lumen therethrough.
Slidable shuttle retaining the device
A shuttle is slidably received within the lumen and configured to releasably retain the analyte monitoring device.
First and second biasing elements
A first biasing element is arranged between the housing and the cuff, and a second biasing element is arranged between the housing and the shuttle.
Microneedle enclosure with a third biasing element
A microneedle enclosure is releasably engaged with the analyte monitoring device, is configured to enclose a portion of the device when engaged, and comprises a third biasing element.
Releasably engaged base
A base is releasably engaged with the housing and coupled to the microneedle enclosure.
The independent claim covers an applicator combining all elements of the claim, including the housing, sliding cuff and shuttle, three biasing elements, microneedle enclosure, and releasably engaged base.
Stated Advantages
The separately biased cuff and shuttle provide control of actuation force and insertion velocity.
The microneedle enclosure protects the microneedle array and maintains a sterile environment.
Documented Applications
Deploying an analyte monitoring device toward skin using an applicator to release the device for skin insertion, wherein the microneedle array of the device can puncture the skin and the device can adhere.
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