Ingestible Medical Device Microarray for Localized Drug Delivery
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Solution Overview
Problem
Current point of care devices for monitoring biological macromolecular activity and drug concentration levels are limited by the need for pre-processing of whole blood, making them costly and inconvenient, and they often require systemic administration of drugs which can have unwanted effects on healthy parts of the body.
Innovation Solution
A medical device comprising a microarray with a bioactive agent, a therapeutic agent reservoir, and microchips for scanning and releasing agents, capable of interacting with disease marker analytes and facilitating localized treatment, powered by an energy source and using biostable polymers for implantation or wearability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If pre-processing steps are integrated into the point of care device to enable whole blood analysis, then the device can accurately monitor biological macromolecular activity, but the device cost increases significantly
Solution Approach 1:
The device separates the pre-processing function into a distinct module that isolates analytes of interest from whole blood components. This segmentation allows the complex task of whole blood analysis to be divided into manageable steps: sample introduction, selective isolation of target analytes, and detection, thereby achieving accurate monitoring without proportionally increasing overall device complexity and cost.
Solution Approach 2:
The patent introduces an intermediary substance or mechanism that selectively binds to or isolates the target analyte from whole blood components. This intermediary acts as a mediator between the complex whole blood matrix and the detection system, enabling accurate analyte monitoring while simplifying the detection process and reducing device complexity.
2Adaptability or versatility
If systemic administration of drug agents is used to treat the body, then the drug can reach all parts of the body, but unwanted effects occur on healthy parts not intended to be treated
Solution Approach 1:
The device enables localized drug delivery by positioning the therapeutic agent reservoir and release mechanism directly at the disease site. This local quality approach ensures that the drug is administered precisely where needed, achieving effective treatment coverage while minimizing exposure of healthy tissues to the therapeutic agent and thereby reducing side effects.
Solution Approach 2:
The device incorporates autonomous control mechanisms that enable it to self-regulate drug release based on real-time analyte monitoring. The system automatically adjusts therapeutic agent delivery without external intervention, maintaining optimal drug concentrations at the treatment site while preventing excessive systemic exposure and associated side effects.
3Ease of operation
If a wearable device is designed to repeatedly and automatically monitor bodily fluids, then convenience is improved, but the device must be small enough for wearability while maintaining functionality
Solution Approach 1:
The device employs a nested structure where smaller functional components are integrated within larger housing structures. The microarray, reservoir, and detection elements are arranged in a compact, space-efficient configuration that allows the device to maintain full monitoring functionality while achieving a small overall size suitable for wearability.
Solution Approach 2:
The device utilizes thin-film technology and flexible materials for its construction, particularly for the microarray substrate and device housing. This approach significantly reduces the device volume while maintaining structural integrity and functional performance, enabling the device to be small enough for comfortable wearability without sacrificing automated monitoring capabilities.
Data Source
AI summary
The invention relates to an ingestible, implantable or wearable medical device comprising a microarray which comprises a bioactive agent capable of interacting with a disease marker biological analyte; a reservoir which comprises at least one therapeutic agent and is capable of releasing the therapeutic agent(s) from the medical device; and a plurality of microchips comprising a microarray scanning device capable of obtaining physical parameter data of an interaction between the disease marker biological analyte with the bioactive agent; a biometric recognition device capable of comparing the physical parameter data with an analyte interaction profile; optionally a therapeutic agent releasing device capable of controlling release of the therapeutic agent from the reservoirs; an interface device capable of facilitating communications between the microarray scanning device, biometric recognition device and the therapeutic agent releasing device; and an energy source to power the medical device. Specifically, the invention relates to a medical device capable of detecting an analyte in a bodily fluid comprising at least one microneedle capable of obtaining a sample of a bodily fluid, a first microchannel through which the sample flows and is in fluid communication with the at least one microneedle, a second microchannel in fluid communication with the first microchannel, through which a buffer flows, wherein the second channel comprises a microarray with a bioactive agent, a microarray scanning device to detect an interaction between the bioactive agent and the analyte in the bodily fluid; and an interface device.