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Tactile and Ultrasound Image Fusion for Functional Assessment of the Female Pelvic Floor

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Open Journal of Obstetrics and Gynecology 2021年第6期11卷 674-688页

作者： Vladimir Egorov heather van raalte S. Abbas Shobeiri Advanced Tactile Imaging Trenton NJ USA Princeton Urogynecology Princeton NJ USA INOVA Fairfax Hospital Falls Church VA USA

Introduction: The true etiology of pelvic organ prolapse and urinary incontinence and variations observed among individuals are not entirely understood. Tactile (stress) and ultrasound (anatomy, strain) image fusion may furnish new insights into the female pelvic floor conditions. This study aimed to explore imaging performance and clinical value of vaginal tactile and ultrasound image fusion for characterization of the female pelvic floor. Methods: A novel probe with 96 tactile and 192 ultrasound transducers was designed. Women scheduled for a urogynecological visit were considered eligible for enrollment to observational study. Intravaginal tactile and ultrasound images were acquired for vaginal wall deformations at probe insertion, elevation, rotation, Valsalva maneuver, voluntary contractions, involuntary relaxation, and reflex pelvic muscle contractions. Biomechanical mapping has included tactile/ultrasound imaging and functional imaging. Results: Twenty women were successfully studied with the probe. Tactile and ultrasound images for tissues deformation as well as functional images were recorded. Tactile (stress) and ultrasound (strain) images allowed creation of stress-strain maps for the tissues of interest in absolute scale. Functional images allowed identification of active pelvic structures and their biomechanical characterization (anatomical measurements, contractive mobility and strength). Fusion of the modalities has allowed recognition and characterization of levator ani muscles (pubococcygeal, puborectal, iliococcygeal), perineum, urethral and anorectal complexes critical in prolapse and/or incontinence development. Conclusions:

关键词： Tissue Elasticity Pelvic Support Pelvic Function Ultrasound Tactile Biomechanical Mapping

Cervical Characterization with Tactile-Ultrasound Probe

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Open Journal of Obstetrics and Gynecology 2020年第1期10卷 85-99页

作者： Vladimir Egorov Todd Rosen heather van raalte Viktors Kurtenoks Advanced Tactile Imaging Trenton NJ USA. Department of Obstetrics Rutgers Robert Wood Johnson Medical School New Brunswick NJ USA. Princeton Urogynecology Princeton NJ USA.

Background: Premature cervical softening and shortening may be considered an early mechanical failure that predisposes to preterm birth. Preliminary clinical studies demonstrate that cervical elastography may be able to quantify this phenomenon and predict spontaneous preterm delivery. Objective: To explore a new approach for cervix elasticity and length measurements with tactile-ultrasound probe. Methods: Cervix probe has tactile array and ultrasound transducer designed to apply controllable load to cervix and acquire stress-strain data for calculation of cervical elasticity (Young’s modulus) and cervical length for four cervix sectors. Average values, standard deviations, intraclass correlation coefficients and the 95% limits of agreement (Bland-Altman plots) were estimated. Results: Ten non-pregnant and ten pregnant women were examined with the probe. The study with non-pregnant women demonstrated a reliable acquisition of the tactile signals. The ultrasound signals had a prolonged appearance;identification of the internal os of the cervix in these signals was not reliable. The study with pregnant women with the gestational age of 25.4 ± 2.3 weeks demonstrated reliable data acquisition with real-time visualization of the ultrasound signals. Average values for cervical elasticity and standard deviations of 19.7 ± 15.4 kPa and length of 30.7 ± 6.6 mm were calculated based on two measurements per 4 sectors. Measurement repeatability calculated as intraclass correlation coefficients between two measurements at the same cervix sector on pregnant women was found to be 0.97 for cervical elasticity and 0.93 for the cervical length. The 95% limits of agreement of 1) cervical elasticity were from ?22.4% to +14.9%, and 2) cervical length from ?13.3% to +16.5%. Conclusions: This study demonstrated clinically acceptable measurement performance and reproducibility. The availability of stress-strain data allowed the computation of cervical elasticity and length. This approach h

关键词： Cervical Elasticity Cervical Length Tactile Ultrasound Elastography Premature Cervical Softening Spontaneous Preterm Delivery

Characterization of Perineum Elasticity and Pubic Bone-Perineal Critical Distance with a Novel Tactile Probe: Results of an Intraobserver Reproducibility Study

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Open Journal of Obstetrics and Gynecology 2020年第4期10卷 493-503页

作者： Justin S. Brandt Todd Rosen heather van raalte Viktors Kurtenos Vladimir Egorov Department of Obstetrics Gynecology and Reproductive Sciences Division of Maternal-Fetal Medicine Rutgers Robert Wood Johnson Medical School New Brunswick NJ USA. Princeton Urogynecology Princeton NJ USA. Advanced Tactile Imaging Inc. Trenton NJ USA.

Background: Tactile imaging provides biomechanical mapping of soft tissues. Objective biomechanical and anatomical assessment of critical structures within the vagina and pelvis may allow development and validation of a clinical tool that could assist with clinical decisions regarding obstetrical procedures and mode of delivery. Objective: To assess intraobserver reproducibility of measurements of perineal elasticity and pubic bone-perineal critical distance with a novel tactile probe in pregnant women. Methods: An Antepartum Tactile Imager (ATI) was designed with a vaginal probe resembling a fetal skull. The probe comprises 128 tactile sensors on a double curved surface and measures 46 mm in width and 72 mm in length. The probe has a motion tracking sensor that allows acquisition of 3D tactile images. There were two arms of the study. In the first arm, biomechanical mapping of the perineum and pelvic bone location was performed in 10 non-pregnant women for purposes of demonstrating safety and feasibility. In the second arm, biomechanical mapping was performed in 10 pregnant women to explore intraobserver reproducibility. Each subject had two standardized examinations over 3 - 5 minutes by the same observer. Examination comfort and pain levels were assessed by post-procedure survey. Reproducibility was analyzed by intraclass correlation coefficients (ICC) with 95% confidence intervals and Bland-Altman plots. Bias and the 95% limits of agreement were also calculated. Results: The safety and feasibility arm of the study demonstrated high degree of safety and tolerability and reliable acquisition of tactile signals. In the reproducibility arm, 10 pregnant women were recruited at mean gestational age of 34.2 ± 6.5 weeks. The mean perineum elasticity (Young’s modulus, E) was 9.8 ± 5.9 kPa, and the mean pubic bone-perineal critical distance (D) at 20 kPa load was 34.6 ± 6.2 mm. The ICC was 0.97 [95% confidence interval (CI) 0.91, 0.99] and 0.82 [CI 0.44, 0.95] for E and D

关键词： Perineal Elasticity Tactile Imaging Elastography Antepartum Predictive Model Delivery Mode Perineum Maternal Birth Trauma

Biomechanical Mapping of the Female Pelvic Floor: Prolapse versus Normal Conditions

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Open Journal of Obstetrics and Gynecology 2018年第10期8卷 900-924页

作者： Vladimir Egorov S. Abbas Shobeiri Peter Takacs Lennox Hoyte Vincent Lucente heather van raalte Artann Laboratories Trenton USA INOVA Fairfax Hospital Falls Church USA Eastern Virginia Medical School Norfolk USA The Pelvic Floor Institute Tampa USA The Institute for Female Pelvic Medicine & Reconstructive Surgery Allentown USA Princeton Urogynecology Princeton USA

Background: Quantitative biomechanical characterization of pelvic supportive structures and functions in vivo is thought to provide insight into pathophysiology of pelvic organ prolapse (POP). An innovative approach—vaginal tactile imaging—allows biomechanical mapping of the female pelvic floor to quantify tissue elasticity, pelvic support, and pelvic muscle functions. The Vaginal Tactile Imager (VTI) records high definition pressure patterns from vaginal walls under an applied tissue deformation and during pelvic floor muscle contractions. Objective: To explore an extended set of 52 biomechanical parameters for differentiation and characterization of POP relative to normal pelvic floor conditions. Methods: 96 subjects with normal and POP conditions were included in the data analysis from multi-site observational, case-controlled studies;42 subjects had normal pelvic floor conditions and 54 subjects had POP. The VTI, model 2S, was used with an analytical software package to calculate automatically 52 biomechanical parameters for 8 VTI test procedures (probe insertion, elevation, rotation, Valsalva maneuver, voluntary muscle contractions in 2 planes, relaxation, and reflex contraction). The groups were equalized for subject age and parity. Results: The ranges, mean values, and standard deviations for all 52 VTI parameters were established. 33 of 52 parameters were identified as statistically sensitive (p 0.05;t-test) to the POP development. Among these 33 parameters, 11 parameters show changes (decrease) in tissue elasticity, 8 parameters show deteriorations in pelvic support and 14 parameters show weakness in muscle functions for POP versus normal conditions. Conclusions: The biomechanical mapping of the female pelvic floor with the VTI provides a unique set of parameters characterizing POP versus normal conditions. These objectively measurable biomechanical transformations of pelvic tissues, support structures, and functions under POP may be used in future research

关键词： Biomechanical Mapping Female Pelvic Floor Prolapse Tissue Elasticity Pelvic Support Pelvic Function Tactile Imaging Elastography