Custom Vaginal Therapeutic Fitting for Quantitative Anatomy Match
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Solution Overview
Problem
Existing vaginal therapeutic devices, such as pessaries, are often fitted using a trial-and-error approach, lacking a quantitative basis for determining the appropriate size and type, leading to inefficiencies and frustration in treating conditions like pelvic organ prolapse and urinary incontinence.
Innovation Solution
A method involving user-specific measurements and characterization, followed by anatomical modeling and additive or non-additive manufacturing processes, to create customized vaginal therapeutic devices tailored to individual anatomical requirements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a vaginal therapeutic device is inserted into a patient's vagina, then the device can deliver therapeutic effects, but the device may cause discomfort, pain, or injury to the patient due to improper fitting
Solution Approach 1:
The system performs preliminary actions by measuring vaginal anatomy parameters (depth, width, curvature) before device insertion and using these measurements to pre-configurate the device dimensions and insertion trajectory. This preliminary measurement and configuration ensures the device fits properly the first time, preventing discomfort and injury while maintaining therapeutic effectiveness.
Solution Approach 2:
The device utilizes expandable balloons that change their physical parameters (volume, diameter) upon insertion. The balloons start in a compressed state for easy insertion and then expand to their therapeutic dimensions, allowing the same device to accommodate varying vaginal anatomy while delivering consistent therapeutic effects.
2Object-affected harmful factors
If a vaginal therapeutic device is customized to fit individual patient anatomy, then patient comfort and safety improve, but the complexity of device selection and fitting procedures increases
Solution Approach 1:
The system enables self-service by providing patients with home measurement kits that allow them to independently measure their vaginal anatomy parameters. This eliminates the need for complex clinical measurements and device fitting procedures, reducing overall system complexity while maintaining personalized device selection based on patient-specific dimensions.
Solution Approach 2:
The patent replaces complex mechanical measurement and fitting procedures with digital measurement tools and automated device selection algorithms. Instead of manual clinical assessment and trial-and-error fitting, the system uses digital sensors and computational algorithms to determine the optimal device configuration, simplifying the overall process.
3Ease of manufacture
If standard-sized vaginal devices are used for all patients, then device manufacturing and inventory simplification is achieved, but device effectiveness decreases for patients with atypical vaginal anatomy
Solution Approach 1:
The device system is segmented into modular components with adjustable dimensions. Instead of manufacturing entirely different devices for different patient sizes, the system uses a modular platform where balloons, stems, and applicators can be independently configured to match patient anatomy, maintaining manufacturing simplicity while achieving customization.
Solution Approach 2:
The device incorporates dynamic, adjustable components that can adapt to different vaginal anatomy dimensions. Expandable balloons and adjustable positioning mechanisms allow a single device platform to effectively serve patients with varying anatomical characteristics, eliminating the need for multiple standardized device sizes.
Data Source
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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.