Flexible Sheet Microneedle Applicator for Controlled Skin Insertion
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Solution Overview
Problem
Existing methods for applying microneedle arrays to the skin face challenges in effectively inserting needles to a desired depth and protecting delicate microneedles, with limited ability to transport therapeutic molecules through the skin due to the stratum corneum barrier.
Innovation Solution
A flexible sheet-based applicator with a raised central area that undergoes a stepwise motion perpendicular to its plane, driving the microneedle device into the skin, providing a low-profile, easy-to-use, and cost-effective solution for applying microneedle arrays, with optional supporting members and adhesive attachments for secure placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If microneedles are pressed against the skin to pierce the stratum corneum, then therapeutic agents can be delivered through the skin, but the microneedles may not reach the desired depth or may damage the delicate structure
Solution Approach 1:
The flexible sheet is designed to undergo dynamic deformation when force is applied to the raised central area, transitioning from a convex to a concave orientation. This dynamic motion drives the microneedle device against the skin with controlled force, ensuring precise insertion depth while protecting the delicate microneedle structures from damage.
Solution Approach 2:
The application device utilizes changes in the physical state of the flexible sheet (from relaxed convex state to deformed concave state) to control the application force. This parameter change allows for consistent, controlled delivery of the microneedle array to the skin surface without excessive force that could damage the microneedles.
2Reliability
If a traditional applicator design is used, then the device structure is simple, but it cannot provide consistent controlled insertion or protect the microneedles effectively
Solution Approach 1:
The applicator employs a flexible sheet with a raised central area as its core structural element. This flexible film design provides the necessary compliance to protect microneedles during handling while enabling controlled deformation during application. The flexibility allows the sheet to undergo convex-to-concave transformation, ensuring consistent microneedle insertion depth and force distribution across the array.
3Productivity
If force is applied to insert microneedles into the skin, then therapeutic delivery is achieved, but nerve stimulation and discomfort may occur
Solution Approach 1:
The flexible sheet design distributes the application force across the entire microneedle array simultaneously, ensuring that each individual needle delivers only the necessary partial force required for effective insertion. This prevents excessive force on any single needle that could cause nerve stimulation or discomfort, while collectively achieving complete therapeutic delivery across all insertion points.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The applicator ensures consistent and controlled insertion of microneedles into the skin, facilitating transdermal delivery of therapeutic agents, including large molecules, while minimizing discomfort and nerve stimulation, with adjustable force and velocity to accommodate varying skin conditions.
Implementation Method 1
a flexible sheet having a raised central area wherein motion of the raised central area in a direction perpendicular to the plane of the flexible sheet drives the microneedle device against the skin
Data Source
AI summary
An applicator (100) used to apply microneedle arrays (10) to a mammal. In particular, an application device for applying a microneedle device (120) to a skin surface comprising a flexible sheet (110) having a raised central area (115) attached to the microneedle device and a supporting member at or near the periphery of the flexible sheet, wherein the flexible sheet is configured such that it will undergo a stepwise motion in the direction orthogonal to the major plane of the sheet.