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-11801008-B2
Publication Date
2023-10-31
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 assessment system and methods for analyzing cervical tissue through a dedicated probe device within the vaginal canal. This probe integrates ultrasound (US), viscoelastic (VE), and photoacoustic (PA) imaging to obtain cervical biomarker information, such as the collagen to water ratio, tissue hydration, blood oxygen saturation, and hemoglobin content, which are indicative of the risk of preterm delivery in expectant mothers.
Conventional ultrasound measurement of cervical length fails to detect the majority of cases at risk for preterm delivery due to its sensitivity limitations—less than 40% of mothers delivering preterm are detected via this method. The present system addresses this problem by enabling combined structural, molecular, and biomechanical characterization of cervical tissue, thereby providing detection of cervical changes even in cases where cervical length remains normal but the tissue begins remodeling, such as increased water content or collagen network degradation.
The system comprises a probe device communicatively linked with an ultrasound machine and processor, capable of transmitting and receiving US, PA, and VE signals. The PA signals are tunable laser pulses, and VE imaging uses the cervix as a medium for viscoelastic assessment. Real-time image and biomarker computation reveal parameters like the collagen to water ratio, tissue hydration, oxygenation, elasticity, and viscosity. This allows clinicians to assess cervical remodeling beyond anatomical changes and supports improved identification and risk prediction for preterm birth.
Claims Coverage
The independent claim defines a system for risk of preterm labor assessment during delivery with multiple distinctive inventive features.
Integrated multi-modal imaging system for cervical assessment
A system comprising one or more processors, memory modules, an ultrasound machine with a display, and a probe device communicatively coupled to the ultrasound machine. The system executes machine-readable instructions to: - Transmit ultrasound (US), photoacoustic (PA), and viscoelastic (VE) signals from the probe device toward cervical tissue after the probe is inserted into the vaginal canal; the PA signals are laser pulses tunable by wavelength, and the cervical tissue serves as the VE medium. - Receive reflected US, PA, and VE signals back into the probe device. - Transmit the received signals to the ultrasound machine. - Generate real-time multi-modal images and biomarker parameters of the cervical tissue based on the combined signals, including the collagen to water ratio. - Generate a risk parameter for preterm delivery based on these biomarker parameters; an elevated water-to-collagen ratio above a threshold indicates increased risk. - Display both the generated images and risk parameter on the ultrasound machine display.
The claim covers a system that integrates real-time US, PA, and VE imaging for cervical biomarker assessment, enabling risk evaluation for preterm delivery based on multi-parametric tissue characterization, especially focusing on the collagen to water ratio.
Stated Advantages
Provides a more sensitive and accurate detection of women at risk for preterm birth by evaluating structural, molecular, and biomechanical cervical biomarkers beyond cervical length measurement.
Allows real-time, multi-parametric, and non-invasive assessment using a single probe device, minimizing risk and discomfort to the fetus and mother and not significantly increasing examination time.
Facilitates the acquisition of advanced microstructural, functional, and biomechanical information from cervical tissue to better stratify risk and potentially reduce false positives compared to ultrasound alone.
Documented Applications
Assessment of risk for preterm delivery in expectant mothers through real-time cervical tissue analysis using multi-modal imaging.
Screening and diagnosis of cervical remodeling by analyzing collagen to water ratio, tissue hydration, oxygenation, elasticity, and viscosity using a multi-modal probe during pregnancy.
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