Ultrasound, photoacoustic, and viscoelastic imaging systems and methods for cervical analysis to assess risk of preterm delivery
Inventors
Mehrmohammadi, Mohammad • Hassan, Sonia S. • Hernandez-Andrade, Edgar • Yan, Yan • Basij, Maryam • Gomez-Lopez, Nardhy
Assignees
Publication Number
US-12364432-B2
Publication Date
2025-07-22
Expiration Date
2039-10-22
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Abstract
Methods and system are described for multi-modal, multi-parametric, non-invasive, and real-time assessment of cervical tissue through a multi-modal probe device for use within a vaginal canal and an associated imaging system to assess a risk of preterm delivery of an expectant mother. The multi-modal system may include ultrasound (US) imaging, viscoelastic (VE) imaging, and/or photoacoustic (PA) imaging of the cervical issue to determine cervical biomarker information indicative of parameters including, but not limited to, a collagen to water ratio such that a more water dominant ratio is indicative of a risk of preterm delivery.
Core Innovation
The invention provides a multi-modal, multi-parametric, non-invasive, and real-time system and method for assessment of cervical tissue through a multi-modal probe device used within a vaginal canal. This system integrates ultrasound (US) imaging, viscoelastic (VE) imaging, and photoacoustic (PA) imaging to acquire detailed biomarker information indicative of cervical tissue parameters including a collagen to water ratio. The system assesses the risk of preterm delivery in expectant mothers by deriving functional, molecular, structural, and biomechanical data from the cervix that go beyond conventional cervical length measurement.
The problem addressed is the lack of highly sensitive and accurate diagnostic modalities to predict preterm delivery risk. Conventional ultrasound systems primarily measure cervical length, but less than 40% of preterm deliveries are detected using this biomarker, indicating insufficient sensitivity. The invention solves this by combining US imaging for microstructural data, PA imaging for functional and molecular composition including collagen and water content, and VE imaging for biomechanical properties such as tissue elasticity and viscosity. This multi-modal approach offers improved detection of cervical remodeling and ripening, which may not be captured by length alone, thus enabling earlier and more reliable identification of patients at risk of preterm birth.
The multi-modal probe device comprises a transvaginal US transducer paired with an optical fiber assembly for delivering tunable laser pulses for PA imaging. The device acquires interleaved signals of US, PA, and VE modalities that are processed to generate real-time images and biomarker parameters. The system evaluates bi-planar US images (sagittal and transverse planes) to detect anisotropy related to collagen fiber organization, while PA imaging spectroscopically determines collagen-to-water ratio and oxygen saturation, and VE imaging quantifies cervical tissue elasticity and viscosity. Together, these biomarkers provide a comprehensive analysis of cervical tissue status and enable the generation of a risk parameter indicative of preterm delivery.
Claims Coverage
The patent contains one independent method claim focusing on the multi-modal, non-invasive, real-time assessment of cervical tissue for preterm labor risk, encompassing novel combinations and uses of US, PA, and VE signals and analyses.
Multi-modal signal transmission and reception
Transmitting US, PA, and VE signals from a probe device toward cervical tissue upon insertion into a vaginal birth canal, wherein the PA signals comprise tunable laser pulses and the cervical tissue serves as a medium for VE signals, and receiving reflected signals of all three modalities into the device.
Real-time generation of cervical images and biomarker parameters
Generating one or more images and biomarker parameters of the cervical tissue in real-time based on the reflected US, PA, and VE signals, including specifically measuring a collagen to water ratio indicative of cervical tissue status.
Risk parameter generation based on biomarker thresholds
Generating a risk parameter for preterm delivery based on biomarker parameters such as an increased water to collagen ratio above a predetermined threshold, with the risk parameter indicative of risk of preterm delivery.
Probe device configuration for signal delivery
Utilizing a probe device comprising an optical fiber assembly communicatively coupled to a laser for PA signals and an active surface communicatively coupled to a transducer for US signals.
Distinct signal sources for US and PA
Transmitting US signals as sound wave pulses from the active surface and PA signals as laser pulse signals from the optical fiber assembly.
Inclusion of multiple biomarker parameters
Including biomarker parameters such as water content, oxygen saturation, and hemoglobin content of cervical tissue derived from the multi-modal signals.
Bi-planar imaging and collagen degradation assessment
Generating orthogonal sagittal and transverse plane views of the cervix and deriving a collagen degradation parameter based on comparisons between these planes, with the collagen degradation serving as a biomarker for cervical ripening and preterm delivery risk.
Viscoelastic biomarker measurement
Using VE signals to generate biomarker parameters including elasticity and viscosity of the cervical tissue.
The independent claims cover a method employing a multi-modal probe device transmitting and receiving US, PA, and VE signals to generate real-time cervical images and biomarker parameters, including collagen to water ratio and tissue elasticity/viscosity, and deriving a risk parameter for preterm delivery based on these measurements.
Stated Advantages
Improved sensitivity and specificity over conventional ultrasound cervical length measurements in detecting patients at risk of preterm delivery.
Non-invasive and real-time assessment of cervical tissue composition, structure, and biomechanics.
Ability to detect cervical remodeling through functional and molecular biomarkers such as collagen disorganization and tissue hydration.
Combination of US, PA, and VE imaging to provide comprehensive evaluation of cervical status without increasing fetal or maternal risk or scan time.
Enhanced clinical translatability and reliability in early detection of cervical insufficiency potentially leading to preterm delivery.
Documented Applications
Assessment of risk of preterm delivery in expectant mothers by imaging cervical tissue through a vaginal canal.
Real-time monitoring of cervical tissue biomarkers including collagen to water ratio, tissue oxygenation, hemoglobin content, elasticity, and viscosity.
Multi-parametric screening tool integrating ultrasound, photoacoustic, and viscoelastic imaging for improved clinical diagnostics in obstetrics.
Use of bi-planar ultrasound imaging to assess cervical collagen fiber organization and degradation.
Spectroscopic photoacoustic imaging to evaluate molecular composition such as collagen and water content in the cervix.
Viscoelastic imaging for detailed biomechanical assessment of cervical tissue stiffness and viscosity.
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