Invented by Julien Penders, Michiel ROOIJAKKERS, Eric Dy, Marco Altini, Bloom Technologies Nv

The market for systems and methods for monitoring uterine activity and assessing pre-term birth risk has witnessed significant growth in recent years. With the increasing prevalence of pre-term births and the associated health risks for both mothers and babies, there is a growing need for effective monitoring and assessment tools to identify high-risk pregnancies and provide timely interventions. Pre-term birth, defined as delivery before 37 weeks of gestation, is a major global health concern. According to the World Health Organization (WHO), approximately 15 million babies are born prematurely each year, accounting for nearly 1 in 10 births worldwide. These premature babies are at a higher risk of developing various health complications, including respiratory distress syndrome, neurological disorders, and even death. To address this issue, healthcare providers are increasingly relying on advanced systems and methods for monitoring uterine activity and assessing the risk of pre-term birth. These technologies aim to detect and analyze changes in uterine contractions, cervical length, and other relevant parameters to identify women at risk of pre-term labor. One of the key factors driving the market growth is the increasing adoption of non-invasive monitoring techniques. Traditional methods, such as manual palpation and fetal heart rate monitoring, have limitations in accurately predicting pre-term labor. However, with the advent of advanced technologies like transvaginal ultrasound, electrohysterography, and uterine activity monitoring devices, healthcare professionals can obtain more precise and reliable data for risk assessment. Transvaginal ultrasound, for instance, allows for the measurement of cervical length, which has been identified as a strong predictor of pre-term birth. By regularly monitoring cervical length throughout pregnancy, healthcare providers can identify women with a short cervix, indicating an increased risk of pre-term labor. This enables timely interventions, such as cervical cerclage or progesterone supplementation, to help prevent pre-term birth. Electrohysterography (EHG) is another promising technology that has gained traction in recent years. EHG measures the electrical activity of the uterine muscles, providing valuable insights into uterine contractions and their patterns. By analyzing these signals, healthcare professionals can assess the strength, frequency, and duration of contractions, helping to identify abnormal uterine activity associated with pre-term labor. Furthermore, advancements in wearable devices and remote monitoring solutions have revolutionized the way uterine activity is monitored. These devices allow pregnant women to track their contractions and other relevant parameters in the comfort of their homes, providing real-time data to healthcare providers for continuous monitoring and risk assessment. This not only improves convenience for pregnant women but also enables early detection of any concerning changes in uterine activity. The market for systems and methods for monitoring uterine activity and assessing pre-term birth risk is highly competitive, with numerous players offering a wide range of innovative solutions. Key market players include medical device manufacturers, research institutions, and healthcare technology companies. These companies are investing heavily in research and development to introduce more advanced and accurate monitoring tools and techniques. In conclusion, the market for systems and methods for monitoring uterine activity and assessing pre-term birth risk is witnessing significant growth due to the increasing prevalence of pre-term births and the associated health risks. Advanced technologies such as transvaginal ultrasound, electrohysterography, and wearable devices are revolutionizing the way uterine activity is monitored, enabling early detection of high-risk pregnancies and timely interventions. With ongoing advancements in this field, it is expected that these monitoring systems and methods will continue to evolve, ultimately improving outcomes for both mothers and babies.

The Bloom Technologies Nv invention works as follows

A method of assessing over time a pre-term birth risk of a pregnant female may include: calculating a baseline pre-term birth risk score based on a user input; acquiring, over time, a signal from a sensor; analyzing the signal to extract a parameter of interest, such that the parameter of interest comprises a physiological parameter; and calculating an instant preterm birth rate score based, at least in part, on the extracted and analyzed parameter of interest and the user input. The method for assessing the pre-term risk of a female pregnant over time may include the following: calculating the baseline pre-term risk score using a user’s input; acquiring a signal over time from a sensor, analyzing the data to extract a parameter, where the parameter is a physiological parameter, and calculating the instant pre-term risk score, based at least in part on the parameter and the user’s input.

Background for Systems and Methods for Monitoring Uterine Activity and Assessing Pre-Term Birth Risk

1. Field

This invention is a general field of obstetrics and, more specifically, new and useful methods and systems for monitoring uterine activities and assessing the risk of pre-term delivery.

2. “2.

The pregnancy period can be a very stressful time for a mother. She must learn to distinguish between changes in her body that are indicative of her body preparing for labour (e.g. Braxton Hicks contractions), and changes that actually indicate labor (e.g. real labor-inducing contractions). It can be difficult for a mother to distinguish between Braxton-Hicks and real labor-inducing contracts, especially when she is a first time mother. An expectant mother, for example, may not notice or feel Braxton Hicks contractions. When labor-inducing labor contractions begin, she may be unable to tell if she’s in labor or just experiencing Braxton Hicks. An expectant mother, for instance, may have painful or frequent Braxton-Hicks contractions causing her to worry about labor. An expectant mother might mistakenly believe that her contractions were Braxton-Hicks, when they were actually pre-term labor or term labor-inducing.

Early contraction monitoring devices such as Home Uterine Activity Monitors were cumbersome. The patient had to remember to wear it daily for a short period of time, collect data and then transmit data to a central location. These devices also did not give feedback to the woman, which could cause her to worry about the results of the monitoring. The Home Uterine activity monitors were designed for women at high risk of preterm labour, to be able to monitor the onset of preterm birth from home. Multiple studies have shown that these monitors do not improve outcomes. Most health insurance companies no longer cover these devices, and the American College of Obstetrics and Gynecology casts doubt on their efficacy. Other devices designed to correct these deficiencies focused on a more continuous monitoring uterine muscle activity and frequency-based algorithm to detect abnormal uterine activity. However, they failed to differentiate Braxton Hicks from labor-inducing movements.

Other systems to monitor labor include invasive devices or probes inserted in the uterus or on the cervical area (post membrane rupture), which are used to monitor uterine contractions. These systems are not intended for use continuously and are not appropriate for use at home or by individuals (i.e. without a healthcare professional).

The Bishop score, the cervical length measurement and tocodynamometry are other systems and methods that are currently in use. The Bishop score is a combination of cervical dilation and cervical effacement as well as cervical consistency, cervical positioning, and fetal position measured during a vaginal exam. Transvaginal sonography, for example, uses vaginal ultrasound images to estimate the length of the cervical cervix. A shorter cervix is associated with a greater risk of preterm labor. TOCO also uses an external probe to measure contractions. TOCO is used to measure the frequency and length of contractions, but does not capture any information on the amplitude. TOCO can also be affected by probe placement and measurement artifacts, such as fetal movement. These systems and methods are useful for a clinician to estimate the contraction or labor status, but they do not capture the true physiological phenomenon that occurs behind contractions. This is the electrical activity in the uterine muscles. They fail to differentiate Braxton-Hicks from labor-inducing contractions or preterm and term.

In other situations, a premature baby may suffer from intellectual and developmental delays or disabilities and/or have health conditions and problems. A premature baby can experience delays or disabilities in areas such as physical development, social skills, learning and breathing disorders. Some of the long-term conditions or disabilities caused by premature birth include: anxiety, autism, behavioral problems, breathing disorders, asthma or bronchopulmonary disorders, intestinal disorders and decreased immunity to infections. To improve neonatal wellbeing and future healthcare costs, it is important to assess and manage pre-term birth risks.

Current systems and methods of assessing preterm birth risks include, among others, measuring biomarkers in the pregnant woman, assessing her health history or lifestyle, and monitoring contractions that indicate preterm labor. These systems and methods are based on parameters that cannot be changed by a female pregnant to improve the pre-term risk score. These systems and methods don’t allow the pregnant woman to alter different physiological, behavioral and/or biochemical characteristics to improve pre-term risk, or give feedback to her or the healthcare provider in order to adjust therapy or consultation.

The need to detect contractions outside of clinical or laboratory settings, and specifically to differentiate Braxton-Hicks from labor inducing contractions, as well as assess the risk of preterm birth, is evident.

SUMMMARY

The following is an incomplete listing of aspects of the current techniques. These and other aspects will be described in the disclosure.

The system includes a number of sensors attached to the belly of a pregnant woman; a processor that is communicatively connected to the sensors; and an executable computer-readable medium containing non-transitory instructions. Execution of the instructions causes a processor to perform the following method: acquiring signals from the sensors during uterine contractions, processing those signals to extract a variety of uterine electric activity characteristics; analyzing these uterine characteristics; and classifying uterine contractions as a

In some embodiments, at least two characteristics of uterine electric activity are included: a frequency of uterine activity, an amplitude of uterine activity over time and duration of uterine activity over time.

In some embodiments the directionality or speed of uterine electric activity can be determined by detecting a uterine activity movement or propagation in time between three sensors.

In some embodiments, machine learning techniques are used to analyze the various characteristics of uterine electric activity.

The method may include: “processing the plurality signals to extract a matern characteristic during the uterine activities; correlating the maternal characteristics with the plurality uterine electric activity characteristics. Wherein the uterine activities are classified as: a Braxton Hicks contraction or a Braxton preterm contraction based, at least in part, on the plurality uterine electronic activity characteristics and the mother characteristic.

In some embodiments, maternal characteristics include one or more of the following: maternal heart rate (or variability), maternal respiration rate (or intensity), maternal galvanic response to skin, or maternal body temperature.

In some embodiments, a method performed by a processor includes analyzing uterine electric activity characteristics over time in order to identify changes and correlating a maternal characteristic with those changes.

The method may include: correlating the deformation in the belly area with the uterine electrical characteristics. This is done based on at least a part of the uterine electrical characteristics and the deformation.

In some embodiments, deformation in the abdomen region can be measured using an inertial or piezoelectric sensor.

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