Methods and systems for vaginal therapeutic device fitting
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Publication Number
US-11826162-B2
Publication Date
2023-11-28
Expiration Date
Abstract
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.
Core Innovation
The invention relates to a quantitative, user-specific process for providing a vaginal therapeutic device (VTD) for a user. The process derives one or more user specific results by performing a characterization process upon the user to obtain at least one measurement of a plurality of measurements of the user, and the user specific results are used to generate an anatomical model based on a vagina, support tissues surrounding the vagina, and pelvic organs surrounding the vagina.
The process generates the anatomical model by performing a modelling process which applies the one or more user specific results of the characterization process to the anatomical model. The VTD is then designed by performing at least one of computational modelling, finite element analysis, and three-dimensional modelling upon the anatomical model, and the VTD comprises at least one structure of a plurality of structures having a defined geometry and a defined material composition.
The invention further fabricates the VTD by performing at least one processing step comprising an additive manufacturing step of creating a physical version of the at least one structure of the plurality of structures of the VTD. The design output includes VTD forms including a ring shaped pessary, a disk shaped pessary, and a space-filling pessary, and the characterization process includes options using sensor devices or an ultrasonic assessment characterization process.
Claims Coverage
The provided material includes three independent claims, each covering a user-specific method to derive measurements, generate an anatomical model of a vagina and surrounding tissues/organs, design a VTD using computational modelling/finite element analysis/three-dimensional modelling with defined geometry and material composition, and fabricate the VTD using additive manufacturing. Across the independent claims, inventive coverage focuses on anatomical-model-to-design parameterization, sensor-based characterization options, and ultrasonic balloon characterization.
User-specific characterization to anatomical model parameterization
Deriving one or more user specific results by performing a characterization process upon the user to obtain at least one measurement of a plurality of measurements of the user; generating an anatomical model by performing a modelling process which applies the one or more user specific results of the characterization process to the anatomical model.
Computational modelling and defined geometry and material composition design
Designing the VTD by performing at least one of computational modelling, finite element analysis, and three-dimensional modelling upon the anatomical model, wherein the VTD comprises at least one structure of a plurality of structures having a defined geometry and a defined material composition.
Additive manufacturing of a physical version of the designed structure
Fabricating the at least one structure of the plurality of structures of the VTD by performing at least one processing step comprising an additive manufacturing step of creating a physical version of the at least one structure of the plurality of structures of the VTD.
Sensor device characterization option with selectable sensor types
The characterization process is performed with a first device comprising a first predetermined portion for insertion into a vagina of the user, a second predetermined portion electrically coupled to the first predetermined portion, and at least one sensor selected from photoplethysmography, laser Doppler imaging, phonomyography, pressure sensing, force sensing, pH sensing, flow rate sensing, and temperature sensing.
Highly elastic and deformable sensor body characterization option
The characterization process is performed with a second device comprising a body formed from a highly elastic and deformable material, a plurality of sensors disposed upon the surface of the body to measure local deformation of the body, and a plurality of contacts electrically connected to each sensor.
Ultrasonic balloon characterization with predetermined fluid and processing circuit
Disposing a balloon within a vagina of the user; coupling the balloon to a measurement device comprising a plurality of ultrasonic transducers; transmitting and receiving ultrasonic signals through a predetermined fluid within the balloon; and processing the received ultrasonic signals with a processing circuit within the measurement device.
Across the independent claims, the coverage centers on producing a user-specific VTD by using user measurements to generate an anatomical model, designing the VTD with computational modelling, finite element analysis, or three-dimensional modelling, and fabricating the resulting structure via additive manufacturing. Additional coverage specifies characterization using selectable sensors, a highly elastic deformable sensor body, or an intravaginal balloon with ultrasonic transducers and signal processing.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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