Automated Contrast Agent Dose Preparation System
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Solution Overview
Problem
Current X-ray contrast media exhibit undesirable clinical side effects such as Contrast Induced Nephropathy and adverse cardiac events, and there is a need for customizable doses based on individual patient factors like type of examination, age, and physical health to improve safety and reduce costs.
Innovation Solution
An automated system for preparing patient-tailored doses of contrast agents using sealed containers with information carriers, a receiving device, and software instructions to calculate and mix constituents, allowing for precise concentration and volume adjustments based on patient-specific data.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If standard pre-set doses of contrast media are used for all patients, then the imaging procedure is simple and efficient, but the diagnostic quality and patient safety are compromised due to inability to tailor doses to individual patient needs
Solution Approach 1:
The contrast media is divided into multiple separate containers, each containing a specific constituent (API, excipients, diluent). This segmentation allows the automated system to precisely control the composition and concentration of the final contrast dose by selectively combining these segmented components according to patient-specific requirements.
Solution Approach 2:
The system dynamically adjusts the concentration and volume parameters of the contrast media by varying the amounts of each constituent transferred from separate containers. This enables precise tailoring of the contrast dose to individual patient factors such as kidney function, age, and examination type, thereby improving both diagnostic quality and patient safety.
2Manufacturing precision
If higher concentrations of contrast media are used to improve image quality, then diagnostic quality increases, but adverse effects such as Contrast Induced Nephropathy and cardiac events increase
Solution Approach 1:
The system optimizes the concentration parameter of the contrast media by precisely controlling the ratio of API to diluent based on patient-specific factors. This allows the use of the minimum effective concentration required for diagnostic quality imaging, thereby reducing the risk of Contrast Induced Nephropathy and cardiac events while maintaining image quality.
Solution Approach 2:
The system incorporates patient-specific data (kidney function, age, examination type) to dynamically adjust the contrast media concentration. This feedback mechanism ensures that each patient receives a customized dose that achieves sufficient image quality while minimizing adverse effects, rather than using fixed high concentrations for all patients.
3Reliability
If customized doses of contrast media are prepared for each patient, then patient safety and diagnostic quality improve, but the preparation time and system complexity increase
Solution Approach 1:
The contrast media constituents are pre-prepared and stored in separate sealed containers with information carriers containing composition data. This preliminary preparation eliminates the need for time-consuming mixing and compounding procedures during patient preparation, allowing the automated system to quickly assemble customized doses by simply transferring predetermined amounts from the pre-prepared containers.
Solution Approach 2:
The containers are equipped with information carriers that automatically provide composition and quantity data to the automated preparation system. This self-service feature eliminates the need for manual verification and measurement, enabling the system to rapidly prepare customized contrast doses with minimal human intervention and reduced preparation time.
4Manufacturing precision
If multiple constituents are stored in separate sealed containers, then dose customization and quality control improve, but the device complexity and handling requirements increase
Solution Approach 1:
The automated preparation system is designed with multi-functional capabilities to handle multiple container types and perform various operations (identification, verification, transfer, mixing) through a single integrated platform. This universality reduces the complexity of handling multiple separate constituents, as the system can automatically manage the entire process from receiving different container types to assembling the final customized dose.
Solution Approach 2:
The information carrier on each container acts as an intermediary that provides standardized data about the constituent's composition and quantity. This intermediary interface allows the automated system to efficiently manage multiple different constituents without requiring complex manual identification and handling procedures, thereby reducing overall handling complexity while maintaining dose customization capabilities.
Data Source
AI summary
Disclosed herein are novel procedures, systems and excipient solutions for in situ provision of a contrast media at a user defined concentrations. An automated procedure according to embodiments of the current invention provides increased user safety, flexibility and user friendliness.