Customized Vaginal Therapeutic Device Fitting via Anatomical Modeling
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Solution Overview
Problem
Current methods for fitting vaginal therapeutic devices (VTDs), such as pessaries, are often based on trial-and-error or best guess, leading to incorrect fittings and inadequate treatment for women with pelvic organ prolapse (POP) and urinary incontinence (UI).
Innovation Solution
A method involving measurement and characterization of individual user anatomical and physiological parameters, followed by an assessment and modeling process to create a customized VTD with defined geometry and material composition, using additive or non-additive manufacturing processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If standard sizes and trial-and-error methods are used for fitting vaginal therapeutic devices, then the device selection process is simplified, but fitting accuracy and treatment efficacy deteriorate
Solution Approach 1:
The system performs preliminary measurement and characterization of user anatomy before device selection, creating a customized anatomical model that guides the fitting process. This preliminary action eliminates the need for trial-and-error by establishing accurate baseline measurements of vaginal dimensions, shape, and tissue properties prior to device insertion.
Solution Approach 2:
The system changes the parameters used for device selection from standardized size categories to customized anatomical parameters including vaginal length, width, shape characteristics, and tissue compliance. This parameter transformation enables precise matching of device geometry to individual user anatomy, improving fitting accuracy while the automated modeling process manages the complexity.
2Adaptability or versatility
If multiple types and sizes of pessaries are available, then adaptability to different user needs is improved, but logistical complexity and device selection difficulty worsen
Solution Approach 1:
The system applies local quality by creating customized anatomical models that capture specific regional characteristics of each user's vaginal anatomy. The measurement and characterization process identifies local variations in tissue properties, shape, and dimensions, enabling selection of device features tailored to specific anatomical regions rather than using uniform sizing approaches.
Solution Approach 2:
The system creates a digital copy or anatomical model of the user's vaginal geometry and tissue properties. This virtual replica allows for simulation and evaluation of different device configurations before physical insertion, enabling high adaptability to individual anatomy while reducing logistical complexity by eliminating the need for physical trial devices.
3Reliability
If best guess and trial-and-error fitting methods are used, then the fitting process is quick to initiate, but treatment efficacy and user comfort deteriorate
Solution Approach 1:
The system replaces the mechanical trial-and-error fitting process with a computational modeling and simulation approach. Instead of physically inserting multiple devices to determine fit, the system uses digital anatomical models to predict optimal device characteristics, significantly improving treatment efficacy while reducing the time required for the fitting process.
Solution Approach 2:
The measurement and characterization system enables self-service capabilities by providing users with a digital representation of their own anatomy. This self-knowledge allows users to participate more actively in the device selection process and understand the rationale for recommended devices, improving treatment efficacy through better user engagement while streamlining the overall fitting timeline.
Data Source
AI summary
A variety of medical and non-medical devices are exploited by users to address a wide range of conditions. However, in the vast majority of instances the device has a limited number of options with respect to its fit for the user and its performance. Further, the determination of target performance and fit are established on a qualitative basis rather than a quantitative basis. In many instances these combinations lead to low user acceptance of the device due to the resulting performance and fit issues. Accordingly, it would enhance performance and user acceptance if a quantitative determination provided a recommended type where options exist, and this determination provided the basis of a custom designed device to the user's specific anatomical and/or performance requirements.