Sometimes a doctor needs to measure his or her patient’s cardiac activity for longer than a brief ECG reading would record. In this instance, a physician might prescribe a Holter monitor to record long-term vital signs during normal physical activity, but these devices can have some drawbacks. They might be bulky to wear and could cause itchiness and skin irritations where they are attached to the body. And they don’t provide information in real time.
Umana Medical Technologies has developed products that aim to make wearing a heart monitor more convenient for patients and offer the ability of being able to transmit information as it occurs. For instance, the T1 system, currently in patient trials in Europe, includes a tattoo sensor, a monitor, and an app that work together to gather and analyze clinical-grade data in real time using advanced algorithms.
Krystle Attard Trevison, the company’s cofounder and director, tells MD+DI that the tattoo sensor uses a specially developed adhesive-like applicator to release its nanomaterial conductive ink directly onto the skin. It does not need conductive gel, and it integrates seamlessly with the top epidermal layer of skin. The sensor can be worn for up to five days if it is not subjected to harsh treatment, such as scrubbing while showering. A protective film helps make the tattoo sensor waterproof and last longer.
The T1 monitor attaches to the sensor, either by the patient for real-time measurements, or by a doctor when in Holter mode, meaning it captures raw data on a microSD card for later retrieval. It weighs less than 17 g and is less than 0.8-mm thick. It is worn passively throughout daily activities and gathers ECG activity to provide heart rate, long-term heart rate, ECG-derived respiratory rate, and constant systolic blood pressure measurements. Abnormalities in ECG are detected, as well as physical activity, including falls, and can inform both patient and another contact person through SMS or email if this occurs.
A patient using the device in monitoring mode can select a medical professional to receive his or her data either through the app during registration or from an online user control center. Medical professionals can apply to be registered in the database through the online control center. All applications are vetted by Umana scientific personnel, and if approved, the applicant will be given access.
Captured and stored data can be retrieved from the monitor using a Bluetooth connection to a tablet, which through an Internet connection uploads it to the cloud where it can be downloaded for processing and analysis. The company is also testing 4G and NFC as future connection technologies.
A hub system is also available, enabling nursing homes to monitor up to 300 patients in real time, from one tablet. “This system makes it very easy for the nurse on duty to monitor all patients at a distance, and if there is an abnormality or a patient falls, our tattoo and monitor would automatically generate a notification on the T1 hub interface and send a text message to a predefined mobile number,” says Attard Trevison, in an interview with MD+DI.
The T1 system is currently being used for investigational purposes in patient trials. It will start shipping to its partners in Portugal, UK, Italy, Malta, and Turkey once CE certification is finalized, which the company expects to be very shortly.