Separable Microneedle Arrays for Controlled Drug Release
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Solution Overview
Problem
Existing microneedle drug delivery systems face challenges with the separation of microneedles from their substrates after insertion into biological tissues, leading to discomfort and inconvenience for patients. Additionally, these systems lack the ability to control drug release kinetics effectively, limiting the range of release profiles that can be achieved.
Innovation Solution
The development of drug delivery devices with separable microneedles, which include a substrate with a microneedle side and a supporting layer on the opposing back side. The device features an array of microneedles that can be separated from the substrate upon application of a force, allowing for controlled drug release and improved insertion and separation processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If microneedles are associated with a substrate to facilitate handling during production and application, then ease of operation is improved, but the device complexity increases and patient comfort deteriorates due to the substrate remaining on the tissue surface
Solution Approach 1:
The microneedle array is segmented from the substrate through a frangible connection that allows the microneedles to separate after insertion. This segmentation enables the substrate to be removed while microneedles remain in tissue, resolving the contradiction between ease of handling (substrate provides handling advantage) and device complexity/patient comfort (substrate remaining causes discomfort).
Solution Approach 2:
The frangible connection is pre-designed to break under specific force conditions during application. This preliminary action ensures that the microneedles automatically separate from the substrate at the appropriate moment, eliminating the need for manual separation and ensuring patient comfort without compromising handling ease during the application process.
2Manufacturing precision
If microneedles are made small to target specific tissue layers and provide controlled drug release, then manufacturing precision and drug delivery control are improved, but ease of operation deteriorates due to difficulty in handling
Solution Approach 1:
The microneedles are merged with a substrate to form a single handleable unit during production and application. This merging allows precise, small microneedles (which would be difficult to handle individually) to be easily manipulated as part of a larger array structure, while still maintaining their ability to target specific tissue layers and provide controlled drug release.
3Reliability
If the substrate remains on the tissue surface after microneedle insertion to maintain microneedle position, then reliability is improved, but patient comfort and ease of operation worsen due to discomfort and inconvenience
Solution Approach 1:
The system is segmented into two functional parts: the substrate that provides initial stability and the microneedles that deliver the drug. The frangible connection allows these segments to separate after insertion, enabling the substrate to be removed for patient comfort while microneedles remain in place for reliable drug delivery.
Solution Approach 2:
The frangible connection is designed to break automatically under the force applied during normal application. This preliminary action ensures that the substrate separates from the microneedles at the appropriate moment, providing both initial stability during insertion and subsequent patient comfort during drug release.
4Device complexity
If conventional microneedle configurations are used without separation capability, then device complexity is reduced, but the ability to control drug release kinetics and provide additional release control techniques is limited
Solution Approach 1:
The separable microneedle design segments the drug delivery system into removable substrate and retained microneedles. This segmentation enables additional control techniques such as controlling the region of microneedles from which drug is released and directing the direction of drug diffusion, thereby increasing adaptability without requiring complex additional mechanisms.
Data Source
AI summary
Drug delivery devices and methods are provided for delivering one or more drugs into a biological tissue. The devices include microneedles that may be separable from the drug delivery devices, control drug release rate and/or direction, or a combination thereof. When the microneedles are separable, a force applied to the drug delivery devices may be effective to penetrate a biological tissue with the microneedles and then to separate the microneedles from the drug delivery devices. The drug delivery devices may be capable of achieving discrete periods of drug release. Methods for delivery drug with microneedles also are provided.