Implantable Microwell Device for Localized Drug Sensitivity Testing
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Solution Overview
Problem
Current clinical treatments for diseases like cancer often fail to account for patient-specific molecular and genetic factors, leading to ineffective drug responses, as they follow standard guidelines rather than personalized approaches.
Innovation Solution
Development of devices with microwells for local delivery of microdose active agents to tissues, allowing for in vivo analysis of drug sensitivity, which can be implanted and retrieved, and equipped with features like fiber optics and sensors for real-time data collection and drug release control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If standard-of-care guidelines are followed for clinical treatments, then treatment protocols are established and manageable, but patient-specific molecular and genetic factors are not accounted for, leading to ineffective drug responses
Solution Approach 1:
The device segments the treatment evaluation process by dividing it into multiple microwells, each containing different active agents or dosages. This allows simultaneous testing of multiple drug regimens in a single implantation, enabling personalized treatment selection without requiring multiple separate procedures or complex systemic testing protocols
Solution Approach 2:
The invention applies local quality by delivering discrete microdose quantities of active agents to specific locations within the tissue via individual microwells. Each well creates a localized treatment zone that can be independently evaluated, allowing the tissue to respond locally to different drug formulations while the overall device remains a single implantable unit
2Object-affected harmful factors
If discrete microdose quantities of active agents are locally delivered to tissues, then personalized treatment evaluation is enabled without systemic toxicity, but the device requires complex features for implantation, retrieval, and data collection
Solution Approach 1:
The device employs nesting by placing multiple microwells within a single support structure that can be delivered through a catheter or cannula. The entire array of drug-containing wells is nested within the delivery device, allowing implantation of multiple treatment zones through a single access point while maintaining the ability to retrieve the entire structure intact for tissue analysis
Solution Approach 2:
The device enables self-service through its design that allows the tissue itself to serve as the evaluation medium. After implantation, the surrounding tissue naturally responds to the delivered active agents, and upon retrieval with the device, the tissue spatially positioned relative to the discrete dosages provides direct in vivo sensitivity data without requiring additional external testing procedures
3Measurement precision
If in vivo analysis of drug sensitivity is performed, then accurate prediction of drug response is achieved, but the methodology requires sophisticated device capabilities for real-time data collection and control
Solution Approach 1:
The device performs preliminary action by delivering all necessary active agents and dosages simultaneously during the initial implantation procedure. The tissue is pre-exposed to the complete array of treatment options before retrieval, allowing comprehensive in vivo sensitivity testing to occur naturally over time without requiring sequential interventions or complex real-time data collection systems
Solution Approach 2:
The invention uses copying by creating a spatial map of drug responses directly in the tissue surrounding the device. The tissue architecture and cellular distribution serve as a natural template that is copied onto the device structure during retrieval, preserving the spatial relationship between different drug dosages and their corresponding tissue responses for subsequent analysis
Data Source
AI summary
Devices for the local delivery of microdose amounts of one or more active agents, alone or in combination, in one or more dosages, to selected tissue of a patient are described. The devices generally include multiple microwells arranged on or within a support structure. The microwells contain one or more active agents, alone or in combination, in one or more dosages and/or release pharmacokinetics. In an exemplary embodiment, the device has a cylindrical shape, having symmetrical wells on the outside of the device, each well containing one or more drugs, at one or more concentrations, sized to permit placement using a catheter, cannula, or stylet. Optionally, the device has a guidewire, and fiber optics, sensors and/or interactive features such as remote accessibility (such as WiFi) to provide for in situ retrieval of information and modification of device release properties. In the most preferred embodiment, the fiber optics and/or sensors are individually accessible to discrete wells.