A balloon catheter designed for deployment inside a target luminal organ. The balloon catheter having at least one detection element, the detection element configured to collect and send data about the balloon and/or luminal organ to a user operated control device. The control device may then analyze the received data to calculate the status of the luminal organ, such as diameter. The control device may also be configured to notify the user when the luminal organ is in a certain condition.

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.

A cervical dilation reading apparatus and method of use to accurately and precisely determine cervical dilation measurements during labor and delivery. The apparatus includes a measuring device having a length with a first end and a second end, a fixed attachment configured to couple with a first finger and fixedly engage the first end of the measuring device, and a slidable attachment configured to couple with a second finger and slidably engage the measuring device along the length between the first and second ends. The method includes providing a cervical dilation reading apparatus, inserting the first and second fingers into the vaginal introitus and locating the cervix and cervical os, placing the first finger on a first side of the cervical os and extending the second finger away from the first finger to a second side, opposite the first side, of the cervical Os, thereby extending the length of the measuring device between the first and second fingers to a substantially extended state, removing the first and second fingers, and determining a diameter of the cervical os by the length of the measuring device in the substantially extended state between the fixed attachment and slidable attachment.

A device for measuring the elastic deformability of soft tissue has a probe head having the form of a cup with a cavity, side walls and a bottom wall, a first probe channel, a pressure unit and a control unit, the first probe channel being configured to connect the pressure unit, that provides a vacuum inside first probe channel and that is controlled by the control unit with the probe head. The first probe channel has a distal end leading through the bottom wall into the cavity. The device further has a second probe channel having a distal end leading through the bottom wall into the cavity and being connected with a pressure sensor provided to determine the pressure in the cavity and to communicate it to the control unit to determine a point in time, when deformed tissue closes the distal end of the first probe channel based on a pressure difference in the two probe channels.

There is provided a computer implemented method of training a machine learning model for prediction of unplanned Cesarean Delivery (uCD), comprising: creating or receiving a multi-record training dataset, wherein a record comprises: at least one fetal biometric parameter of a sample fetus obtained by an ultrasonography device, at least one personal parameter of a sample mother of the sample fetus, and a ground truth indicating whether a birth of the sample fetus by the sample mother was a uCD, and training the machine learning model on the multi-record training dataset for generating an outcome indicating likelihood of uCD for a target mother in response to an input of at least one fetal biometric parameter of a target fetus of the target mother and at least one personal parameter of the target mother.

The present invention may be embodied as a retrievable device capable of sensing one or more properties of an individual (e.g., chemical or physical parameters, etc.) In use, the retrievable device can continuously determine the chemical concentrations within the vaginal tract. An embodiment of the retrievable device comprises a first housing having a light source and an image capture device, a second housing removably connected to the first housing and having a sensor, and a fitting for retrieving the device. The sensor may be an analyte sensor configured to obtain at least one measurement of a concentration of an analyte in a fluid. The analyte sensor comprises a sensor substance in a sol-gel material so the sensor substance reversibly interacts with an analyte of interest. In addition, the retrievable device can be configured to determine different physical parameters and re-implanted.

A micro-device and system for monitoring cervical tissue includes micro-circuitry for simulating electrochemical impedance spectroscopy and a system for monitoring the physiological condition of the cervical tissue.

A cervical dilation reading apparatus and method of use to accurately and precisely determine cervical dilation measurements during labor and delivery. The apparatus includes a measuring device having a length with a first end and a second end, a fixed attachment configured to couple with a first finger and fixedly engage the first end of the measuring device, and a slidable attachment configured to couple with a second finger and slidably engage the measuring device along the length between the first and second ends. The method includes providing a cervical dilation reading apparatus, inserting the first and second fingers into the vaginal introitus and locating the cervix and cervical os, placing the first finger on a first side of the cervical os and extending the second finger away from the first finger to a second side, opposite the first side, of the cervical os, thereby extending the length of the measuring device between the first and second fingers to a substantially extended state, removing the first and second fingers, and determining a diameter of the cervical os by the length of the measuring device in the substantially extended state between the fixed attachment and slidable attachment.

A pessary for the prevention of preterm birth, and in particular two pathological conditions of pregnancy known as isthmico-cervical incontinence and cervical shortening, both of which are associated with increased risks for pregnancy loss and/or premature deliveries of babies. The pessary includes a sleeve supported within a ring by an annular member. The sleeve is intended to contact the cervix and maximize the length of the cervix while the annular member and ring contact the vagina. The pessary may be fabricated from a pliable medical-grade silicon, and the pessary may include one or more sensors to measure various patient parameters indicative of a premature cervical contraction. The sleeve may be wirelessly powered from a charging device, such as a pillow, a table-top device, or a pelvic belt.

An apparatus to protect the tissues, muscles and nerves of the female pelvic floor from trauma during vaginal childbirth, the apparatus having a softly expansible intravaginal component capable of insertion into a vaginal canal and under a fetal head while in either a folded or rolled up configuration and to unfold or unroll into a deployed configuration in the vaginal canal and under the fetal head, and a support component with a handle capable of attachment to the intravaginal component, of deploying and inflating the intravaginal, preferably with pressurized air or liquid, and further sized and shaped to provide support and stabilization to at least one from among a perineal, perianal, and anal region when maintained against a female perineal body and perianal region while attached to the intravaginal device that is deployed beneath the fetal head within the vaginal canal, or, in cases of obstructed vaginal childbirth, being subsequently detached, temporarily leaving in situ within the vagina the deployed, inflated intravaginal component for the purpose of preventing or mitigating the subsequent development of abnormal fistulous communications between the vagina and either the urinary bladder or the rectum or both.