Applicator for applying a microneedle device to skin
Inventors
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Assignees
Member
Kindeva Drug DeliveryKindeva Drug Delivery is a contract development and manufacturing organization specializing in advanced drug delivery systems including pulmonary, nasal, injectable, transdermal, and intradermal therapies. Services range from formulation and analytical development to commercial-scale, Annex 1-compliant GMP manufacturing across global facilities. The company brings integrated expertise in regulatory strategy, device engineering, process and technology transfer, and quality assurance, with a focus on sustainable solutions such as low-GWP propellants and microneedle patch platforms. Kindeva supports complex, patient-centric, and environmentally optimized therapies from product conception through commercialization.
Kindeva Drug Delivery is a contract development and manufacturing organization specializing in advanced drug delivery systems including pulmonary, nasal, injectable, transdermal, and intradermal therapies. Services range from formulation and analytical development to commercial-scale, Annex 1-compliant GMP manufacturing across global facilities. The company brings integrated expertise in regulatory strategy, device engineering, process and technology transfer, and quality assurance, with a focus on sustainable solutions such as low-GWP propellants and microneedle patch platforms. Kindeva supports complex, patient-centric, and environmentally optimized therapies from product conception through commercialization.
Publication Number
US-12290672-B2
Publication Date
2025-05-06
Expiration Date
Abstract
Various embodiments of an applicator and a method for applying a microneedle device to skin are disclosed. The applicator can include a housing and a reciprocating support structure slidably engaged with the housing. The reciprocating support structure can have a plurality of alignment feet. The applicator can have a lockout mechanism that prevents actuation if any of the plurality of the alignment feet are not evenly aligned. The applicator can include a device life indicator that is capable of counting a number of use cycles that the applicator has undergone and providing feedback to a user. The applicator can include a dose timer capable of determining a time that has elapsed after the actuation of the applicator and providing feedback to the user.
Core Innovation
The invention relates to an applicator for applying a microneedle device. The applicator includes a housing having a first open end configured to accept the microneedle device and a second end configured as a graspable handle, with a driving element contained within the housing and coupled with the microneedle device. An actuation button is in mechanical or electrical engagement with the driving element.
A device life indicator is in mechanical or electrical engagement with at least one of the driving element or the actuation button. The device life indicator counts a number of use cycles that the applicator has undergone and provides feedback to a user as to a use status of the applicator based on the number of use cycles. The feedback can include READY, WARNING, or INOPERABLE.
The applicator further includes a lockout mechanism configured to unlock or prevent unlocking of the driving element based on predetermined acceptance criteria. In embodiments, the unlock behavior is tied to whether the number of use cycles meets predetermined acceptance criteria, and additional acceptance criteria can include a check of battery life. The applicator may also include a dose timer that provides user feedback on how long the microneedle device has been on the skin surface.
Claims Coverage
The document includes two independent claims (clm-00001 and clm-00019). Across these claims, there are three inventive features centered on cycle-counting device life indication, use-status feedback, and lockout/unlock behavior conditioned on predetermined acceptance criteria, with an additional cycle-count and battery-life criteria check in the second independent claim.
Cycle-counted device life indicator with user status feedback
A device life indicator in mechanical or electrical engagement with at least one of the driving element or the actuation button, capable of counting a number of use cycles and providing feedback to a user as to a use status of the applicator based on the number of use cycles.
Lockout mechanism unlocked only when acceptance criteria are met
A lockout mechanism configured to unlock the driving element if the number of use cycles meets predetermined acceptance criteria.
Combined cycle count and battery life readiness check for unlocking
The applicator is configured to check a cycle count from the device life indicator, check a battery life, direct the device life indicator to provide feedback to the user of a ready use status if the cycle count and the battery life meet predetermined criteria, and unlock the lockout mechanism if the cycle count and the battery life meet the predetermined criteria.
Together, the independent claims cover an applicator that counts use cycles to drive a user-facing device life indicator, and a lockout mechanism that unlocks based on predetermined acceptance criteria tied to the counted use cycles. A further independent claim adds a combined check of cycle count and battery life to determine ready status feedback and to unlock the lockout mechanism only when both criteria meet predetermined thresholds.
Stated Advantages
Provides feedback to a user as to a use status of the applicator based on the number of use cycles.
Enables lockout/unlock behavior based on predetermined acceptance criteria linked to use cycles.
Supports a ready use status based on predetermined criteria including cycle count and battery life.
Prevents unlocking of the driving element unless predetermined criteria are met.
Documented Applications
Use-status management for a microneedle device applicator, including feedback of device use status and locking behavior to control actuation based on counted use cycles and, in some embodiments, battery life.
Optional dose-timer feedback indicating elapsed time after actuation and how long the microneedle device has been on the skin surface.
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