THE SURECALL® LABOR MONITOR®
An innovative new monitor, measuring uterine contractions via skin electrodes to accurately detect true labor and monitor the induction of labor.
The SureCALL® Labor Monitor® non-invasively, detects changes in the electrical signals in the uterus to identify the onset of true labor. Compared to the currently used tocodynamometer technology, this device is significantly more accurate, more convenient for the clinicians and more comfortable for the patient. Prototypes developed under NIH grants have been used in research studies to record over 1,700 patient sessions. Based on these studies, transabdominal uterine electromyography predicts delivery with 24 hours at term and within 4 days preterm. This methodology offers many advantages and benefits that are not available with other uterine monitoring systems.
A revolutionary application of technology allowing for accurate monitoring in the comfort of your own home or on the go.
The SureCALL® Labor Monitor® Wireless Model provides uterine activity monitoring from a small, portable unit wirelessly to a cell phone application, which then remotely transmits to a monitoring service center or a preset clinic.
AN ACCURATE MEDICAL DEVICE TO DIAGNOSE THE ONSET OF TRUE LABOR
The SureCALL® Labor Monitor® Is…
- A Non-Invasive Labor Monitor Device
- Cleared by the FDA to Monitor Term Labor
- Replaces the Tocodynamometer and Intrauterine Pressure Catheter
- A Scientific Breakthrough Technology
- Developed by Scientists and Engineers at the University of Texas Medical Branch, Galveston, Texas
- Engineered with Advanced Electronics and Software in Collaboration with Scientists and Engineers from Texas A&M University, College Station, Texas
- A Proven Technology that Measures, Records, and Displays Uterine Muscle Contractions from Abdominal Recordings of Electrical Signals
- Has Successfully Recorded Over 1,700 Patient Monitoring Sessions
- Protected by Over Ten United States and Worldwide Issued and Pending Patents Based on or Derived from SureCALL Technology
The SureCALL® Labor Monitor® Does…
- ACCURATELY “CALL” – the Onset of True Labor Versus False Labor
- ACCURATELY MONITOR – the Induction of Labor
The SureCALL® Labor Monitor® Will…
Become A MAJOR ADVANCEMENT IN OBSTETRICS and Will Make a Meaningful Contribution in the Reduction of the Problems Associated with Labor and Delivery
THE SURECALL® LABOR MONITOR® IS INTENDED FOR USE BY HEALTHCARE PROFESSIONALS IN A CLINICAL SETTING TO MONITOR WOMEN WHO ARE AT TERM WITH SINGLETON PREGNANCIES.
The SureCALL® LABOR MONITOR® was developed by Scientists and Engineers at The University of Texas Medical Branch at Galveston, Texas (“UTMB”). Advanced electronics and software were developed in collaboration with Engineers from Texas A&M University, College Station, Texas.
The SureCALL® Labor Monitor® technology is named for its ability to accurately “call” the onset of true labor. Uterine Electromyography (“EMG”) Labor Monitoring detects and analyzes uterine smooth muscle contractions from abdominal recordings of electrical signals generated in the uterus. Published studies by UTMB Scientists and others have presented convincing data that uterine EMG activity can be measured by abdominal surface electrodes and that EMG can be used to predict true labor with high levels of confidence.
While several methods have been adopted to identify, monitor, and predict labor, they are subjective and rarely accurately predict true labor. The methods range in complexity from simple patient self-awareness to complex electronic pressure sensors. Of the current methods, intrauterine pressure catheters provide perhaps the best information concerning the state of the pregnancy, but the invasive instrument used can increase the risk of infection or cause more serious complications.
Tocodynamometers are external pressure measurement devices that are used to measure the contractions of the uterus and are the primary type of external monitor. The patient wears the device on a tightly attached belt, which must maintain a constant pressure on a pressure-sensing device (usually a donut shaped strain gauge). As the uterus contracts, a strain gauge measures the pressure which the abdomen exerts on the device. External Tocodynamometer monitoring devices are used in over 90% of all hospital births in the USA.
Unfortunately, the Tocodynamometer is widely recognized to be lacking in accuracy and in comfort. Many different variables affect the pressure measurement, such as instrument placement, the amount of fat, and uterine wall pressure. Also, body movements, gastric activity and other non-labor induced stresses on the device can be mistaken for labor contractions. As a result, the Toco crudely and indirectly measures uterine contractions and therefore cannot distinguish true labor contractions. The data the Tocodynamometer monitors provide is largely subjective. Experienced examiners can analyze single patient records and arrive at different diagnoses. The devices themselves are also uncomfortable and inconvenient for the patient. They are not adaptable or suitable for ambulatory applications and have not proven to be very effective for home uterine monitoring. Cost, instrument reliability and patient mobility are also issues. Yet, the advantages of a non-invasive method to provide uterine contraction data have led to widespread adoption of the Tocodynamometer despite these drawbacks.
The SureCALL® Labor Monitor® Technology:
Scientists at UTMB have been able to successfully extract, isolate and analyze uterine EMG signals from all other electrical signals such as maternal cardiac, musculoskeletal, and gastrointestinal activity. Research Grants funded by the United States Federal Government National Institutes of Health (“NIH”) have enabled these Scientists to conduct patient studies at UTMB, and collect and characterize uterine EMG signals from over 1,000 pregnant women using Uterine EMG instruments coupled with computers. The detection, recording and analysis of uterine EMG signals takes advantage of current electrode and electrode amplifier technologies as well as the powerful processing capabilities of currently available personal computing devices. Filtering of the EMG signals removes irregular or discordant random signals (“noise”) and artifacts arising from patient movement, respiration, and other imperfections in the electrical signals generated by the patient and in the electrical leads applied to the patient.
Data processing programs are used to perform frequency analysis, spectral filtering, spectral temporal mapping functions, and other analytical techniques to specifically identify electrical signals (action potentials) from uterine muscle. These signals are the result of ion changes in the muscle that directly produce uterine contractions. Measurement of EMG from the uterus is similar to measurement of heart ECG (electrocardiography) as electrical signals of the heart are also directly responsible for muscle contractions. The difference is that the signals in the heart have a completely different configuration than those from the uterus and thus different devices and methods are needed for signal detection. The development of ECG, the most common instrument used today to detect cardiac problems, completely revolutionized heart function testing and led to effective treatments for the heart.
Changes in uterine myoelectric activity have been associated with the progression of pregnancy and the onset of labor during studies performed in UTMB clinics and laboratories. The following research conclusions were reached:
- Measurable increases in the following parameters occur during the gestational period leading to labor: amplitude and power of bursts, high frequency content of action potential waveforms, rate of burst production and duration of bursts.
- Increases in energy of the electrical activity and a rise in the high-frequency content of the action potentials are favored by the changes that occur in the electrical properties of the myometrium during labor to increase current flow (and contractile force) in the myometrial smooth muscle.
- Measurable differences in the electrical signals that originate from true and false labor have been shown to distinguish the two types of signal from one another.
- These increases occur abruptly during the last few days before delivery and accompany other changes in the muscle that convert the uterus from a quiescent state to an active and forcefully contractile condition.
SureCALL® Clinic Model:
Advanced Maternity Innovations has taken the core technology of the research prototype SureCALL® models and streamlined it for clinical use and integrated it into a stand-alone clinical cart system for bedside operation in a hospital or clinic environment. Features include:
- Accurate, Comfortable, and Noninvasive
- Dual Monitors for Simultaneous Patient Monitoring and Patient Data Entry
- Integrated Fetal Heart Rate Monitor
- Integrated Strip Chart Printer
- Digital Storage Space for Thousands of Patient Records
- Lockable Supply Drawers
- Adjustable Cart Height
- Stable Work Surface
- Locking Wheels
- Retractable Keyboard and Trackball
SureCALL® Wireless Remote Model:
Advanced Maternity Innovations has miniaturized the hardware processing of the SureCALL® technology into the form of a comfortable, wearable monitoring device. This model will couple wirelessly to a nearby cellular phone where a custom application will transmit patient recordings directly to a clinic or monitoring service. Features include:
- Accurate, Comfortable, and Noninvasive
- Portable, Light, and Easily Wearable
- Wireless Connection to Cellular Phone
- Remote Monitoring, Only Limited by Cellular Coverage