Reusable Microneedle Applicator With Alignment Lockout
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Solution Overview
Problem
Existing microneedle devices for transdermal drug delivery face limitations due to the barrier properties of the stratum corneum, and existing applicators are typically used once and then discarded, lacking features for reuse and effective application control.
Innovation Solution
An applicator with a housing, driving element, and reciprocating support structure that allows for multiple uses, featuring a device life indicator and dose timer to ensure proper alignment and application, ensuring safe and controlled deployment of microneedles.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If microneedle devices are pressed against skin to pierce the stratum corneum, then transdermal drug delivery is enabled, but the barrier properties of skin limit the number of molecules that can be effectively delivered
Solution Approach 1:
The patent changes the physical state and properties of microneedles by using dissolvable materials that transition from solid to dissolved state, enabling controlled drug release. The microneedles are designed with specific dissolution rates and drug loading concentrations that can be adjusted to optimize delivery efficiency and consistency for different therapeutic needs
2Reliability
If applicators are designed for single use, then safety is improved by preventing reuse, but device cost and waste increase
Solution Approach 1:
The applicator is divided into separable components: a reusable applicator body and disposable microneedle arrays. This segmentation allows the expensive, complex applicator mechanism to be reused while only the contaminated microneedle arrays are discarded, reducing overall waste and cost
Solution Approach 2:
The applicator body is designed as a universal platform that can accommodate multiple different microneedle array types and configurations. This multi-functionality allows a single applicator to serve multiple uses with different drug formulations and treatment protocols, reducing the need for multiple specialized devices
3Ease of operation
If microneedle arrays are coated with active components, then direct delivery is enabled, but control over delivery timing and dosage is reduced
Solution Approach 1:
The microneedle system transitions from a static coated structure to a dynamic dissolving structure. The microneedles maintain their structural integrity during application, then dynamically dissolve at a controlled rate after penetration, providing both ease of application and controlled delivery timing through the dissolution process
Solution Approach 2:
The active components are pre-loaded into the microneedle structure during manufacturing, and the microneedles are pre-configured with specific dissolution rates. This preliminary preparation simplifies the application process while maintaining controlled delivery through the pre-engineered dissolution characteristics
4Productivity
If the stratum corneum is made more permeable through various treatment methods, then drug delivery is enhanced, but the complexity of the treatment protocol increases
Solution Approach 1:
The patent extracts and addresses the specific barrier function of the stratum corneum by using dissolvable microneedles that physically penetrate and dissolve within this layer. This targeted approach eliminates the need for complex multi-step treatment protocols by directly overcoming the stratum corneum barrier through a single application
Solution Approach 2:
The dissolvable microneedles are designed as disposable, single-use elements that are discarded after one application. This approach simplifies the overall system by eliminating the need for complex cleaning, sterilization, or maintenance protocols associated with reusable devices, reducing treatment protocol complexity
Data Source
AI summary
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.


