Virtual Patient Fitting With Automated Device Alignment and Fit Checks
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Solution Overview
Problem
Current methods for designing and evaluating medical devices require extensive and costly clinical testing, which is time-consuming and prone to errors, especially when assessing fit in patients with elastic tissues, and lack standardized automated virtual testing systems.
Innovation Solution
A system and method for virtually evaluating the fit of medical devices using computer-based virtual patient models, which are generated from patient data, automatically identify device location, align the device model, and perform collision and anatomical measurements to assess fit, enabling population-based evaluations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual steps are used for virtual patient model reconstruction and device positioning, then flexibility in handling complex cases is maintained, but time consumption increases and results become non-comparable
Solution Approach 1:
The patent creates a standardized virtual patient model that copies the anatomical structure from real patient imaging data. This virtual model serves as a reusable template that can be automatically populated with device information, eliminating the need for manual reconstruction and positioning while ensuring consistent results across different patients and testers.
Solution Approach 2:
The patent replaces manual mechanical operations (physician performing reconstruction and positioning) with an automated computer-based system. The system automatically processes imaging data, reconstructs the virtual patient model, positions the medical device, and evaluates fit, thereby eliminating manual labor and ensuring reproducible, comparable results.
2Productivity
If automated virtual testing is implemented, then time and cost are reduced, but reliability of fit evaluation decreases due to lack of expert judgment
Solution Approach 1:
The virtual patient model serves itself by automatically receiving and processing imaging data, reconstructing its own anatomy, and evaluating device fit without requiring manual intervention. The system self-adjusts to different patient geometries and automatically determines suitability, maintaining both speed and reliability through consistent algorithmic evaluation.
Solution Approach 2:
The patent changes the evaluation parameters from subjective expert judgment to objective quantitative measurements. The system automatically measures anatomical dimensions, device dimensions, and spatial relationships, then compares them against predefined criteria to determine fit. This parameter-based approach ensures reliable, reproducible results while maintaining high productivity.
3Reliability
If clinical testing is performed to ensure device safety and fit, then reliability of device performance is improved, but development time and cost increase significantly
Solution Approach 1:
The patent performs virtual testing as a preliminary action before actual clinical trials. The system evaluates device fit and safety on virtual patient models that replicate real patient anatomy, allowing developers to identify and correct issues beforehand. This preliminary virtual evaluation reduces or eliminates the need for extensive clinical testing, thereby maintaining reliability while significantly reducing development time and cost.
4Reliability
If standardized automated testing is implemented, then comparability of results across patients is improved, but complexity of the testing system increases
Solution Approach 1:
The patent creates a universal virtual patient model framework that can handle multiple patient types, anatomical regions, and device categories through a single standardized system. The model serves multiple functions: it stores patient anatomy, receives device information, performs automatic positioning, and evaluates fit. This multi-functional approach ensures comparability across different test cases while managing system complexity through unified architecture.
Data Source
AI summary
A system for virtually evaluating fit of a medical device in at least one patient comprises means for providing at least one virtual patient model, the virtual patient model being based at least in part on image data retrieved from multiple real patients; means for providing a virtual model of a medical device to be evaluated; means for automatically identifying a medical device location within the at least one virtual patient model; means for aligning the model of the medical device with the at least one virtual patient model at the identified device location; and means for evaluating the fit of the medical device in the at least one virtual patient model by evaluating the fit of the aligned model of the medical device within the at least one virtual patient model.