Cervical Probe Combining Tactile and Ultrasound Elasticity Sensing
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Solution Overview
Problem
Current methods for predicting spontaneous preterm birth are unreliable due to subjective and descriptive assessments of cervical elasticity, leading to poor diagnostic accuracy, and there is a need for an objective and biomechanical characterization of the cervix to identify women at high risk.
Innovation Solution
A Cervix Monitor (CM) device using a tactile sensor array and ultrasound transducers to measure cervical elasticity and length, integrating stress and strain data to calculate cervix elasticity and length, and predict preterm birth based on a strain-to-stress ratio and cervical length.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If clinical risk factor-based assessment is used to predict spontaneous preterm birth, then the assessment can be performed without specialized equipment, but the diagnostic accuracy is poor and unreliable
Solution Approach 1:
The patent replaces subjective clinical assessment with objective biomechanical measurements using a tactile sensor array that quantifies cervical elasticity through stress-strain analysis. This substitution transforms qualitative clinical judgment into quantitative mechanical data, significantly improving diagnostic accuracy while maintaining clinical accessibility.
Solution Approach 2:
The invention changes the assessment parameters from subjective clinical descriptors to objective biomechanical parameters including stress, strain, elasticity modulus, and cervical length. This parameter transformation enables precise, repeatable measurements that directly correlate with preterm birth risk.
2Device complexity
If subjective clinical evaluation of cervical elasticity is used, then the assessment is simple and descriptive, but the measurement precision and objectivity are insufficient
Solution Approach 1:
The patent replaces subjective tactile evaluation with an objective tactile sensor array that measures cervical stress and strain distributions. The sensor array quantifies elasticity through computational analysis of mechanical responses, transforming subjective assessment into precise, objective biomechanical data while maintaining procedural simplicity.
Solution Approach 2:
The tactile sensor array acts as an intermediary between the clinician and the cervix, translating complex biomechanical properties into quantifiable stress-strain data. This intermediary device bridges the gap between simple clinical examination and complex biomechanical characterization.
3Adaptability or versatility
If conventional ultrasound imaging alone is used for cervical assessment, then the equipment is already available in clinical settings, but the biomechanical characterization capability is insufficient
Solution Approach 1:
The patent merges conventional ultrasound imaging with tactile sensor array measurements to create a comprehensive assessment system. The ultrasound provides anatomical visualization and length measurement, while the tactile sensors provide biomechanical elasticity data, combining structural and functional information for improved predictive accuracy.
Solution Approach 2:
The integrated system performs multiple functions: conventional ultrasound imaging for anatomical assessment, tactile sensing for biomechanical characterization, and computational analysis for elasticity calculation. This multi-functional approach maximizes the utility of existing clinical infrastructure.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Provides an objective and real-time assessment of cervical biomechanical properties, enabling timely medical intervention and reducing the risk of preterm birth, with potential long-term benefits for maternal and fetal outcomes.
Implementation Method 1
measuring stress applied to an anterior surface of the cervix with a tactile sensor array with pressure sensors
Implementation Method 2
measuring cervical strain by calculating a time-of-flight of an ultrasound pulses reflected from cervical canal and posterior boundary to the cervix
Implementation Method 3
provide B-mode ultrasound image of the cervix
Data Source
AI summary
A cervical probe, equipped with both a tactile sensor array and an ultrasound transducer array, is engineered for the simultaneous acquisition of stress and ultrasound strain data from cervical sectors, as well as for the measurement of cervical length. The collected stress and strain data from various cervical sectors are transmitted to a data processor. This processor calculates cervical elasticity using a strain-to-stress ratio. Subsequently, the arithmetic mean of the stress-to-strain ratios is compared with a predetermined cutoff value, and the measured cervical length is evaluated against another predetermined value, to predict preterm birth during gestational weeks 24-28.