Cervical Stiffness Measurement Probe for Preterm Birth Risk
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Solution Overview
Problem
Current methods for predicting preterm birth, such as cervical length measurements, are inadequate and do not provide a satisfactory correlation with the risk of preterm birth, necessitating a more reliable and accessible method for risk assessment.
Innovation Solution
Measuring cervical stiffness using biomechanical devices that apply compression or expansion to quantify cervical tissue stiffness, providing a cervical stiffness score to assess preterm birth risk.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If cervical length measurement is used to predict preterm birth risk, then the procedure is simple and widely available, but the prediction accuracy is insufficient
Solution Approach 1:
The patent replaces the traditional mechanical/visual cervical length measurement method with a biomechanical stiffness measurement system. The system uses a probe with sensors to measure cervical tissue stiffness through controlled compression, substituting the simple length measurement approach with a more sophisticated mechanical property assessment that provides better prediction accuracy.
Solution Approach 2:
The invention changes the measured parameter from cervical length to cervical stiffness. By measuring the force required to compress the cervix by a specific distance (or the distance compressed under a specific force), the system captures different biomechanical properties of the cervix that are more strongly correlated with preterm birth risk.
2Reliability
If transvaginal ultrasound is performed on high-risk patients to measure cervical length, then risk assessment can be conducted, but low-risk patients with no known factors are not monitored despite many delivering preterm
Solution Approach 1:
The cervical stiffness measurement system is designed to be integrated into routine obstetric examinations, allowing for self-service monitoring during regular prenatal visits. The probe can be easily inserted and measurements taken during standard check-ups without requiring separate specialized procedures, enabling universal application across all pregnant patients regardless of risk status.
3Measurement precision
If cervical stiffness measurement is performed using compression or expansion devices, then accurate quantitative measurements can be obtained, but the procedure becomes more complex than simple length measurement
Solution Approach 1:
The patent uses a probe with a balloon or expandable element as an intermediary to apply controlled force to the cervix. This intermediary device allows for precise measurement of cervical stiffness by measuring the pressure required to expand the balloon or the force required to compress the tissue, providing accurate quantitative data while maintaining patient comfort and safety.
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
The cervical stiffness measurement system allows for accurate and accessible prediction of preterm birth risk, offering a more reliable indicator than cervical length, and can be performed during routine check-ups without speculum use, ensuring patient comfort and safety.
Implementation Method 1
a cinching or cuffing mechanism that will wrap around the cervical tissue and compress the cervix with added air or liquid pressure, or with the cinching of a loop, squeezing the cervical tissue to a predetermined displacement
Implementation Method 2
Expanding devices that measure the force needed for the expansion of cervical tissue are also disclosed
Data Source
AI summary
A system and method for determining cervical stiffness in a patient, to help identify the risk of preterm birth in pregnant patients, based on abnormal changes in cervical stiffness during pregnancy. A probe is inserted to engage the patient's cervix and activated to deform the cervix a predetermined amount. The amount of force needed for the probe to deform the cervix the predetermined amount is measured and a cervical stiffness value can be displayed, based on how much force was needed to deform the cervix the predetermined amount. The probe can include a piston, cuff or loop or an expanding head to deform the cervix. The probe can include the related electronics to activate the probe and display the results as well as preterm birth risk warnings.


