How a physician and researcher created a new technology to monitor a patient’s vital signs, continuously, and out of the hospital bed.
Jeffrey Joseph was in the habit of taking his 90-year old father’s vital signs – blood pressure, heart rate, respiratory rate, lung sounds – every weekend when he’d visit. One afternoon he noticed a dangerous spike in blood pressure. “If I hadn’t been checking, I’m not certain that he’d be alive today,” said Dr. Joseph, a researcher and anesthesiologist at Jefferson.
Now Dr. Joseph is working with a team of scientists and engineers to develop non-invasive wearable and long-term implantable sensors that continuously monitor the vital signs of patients like his father, from the comfort of their home. “It’s similar to a Fitbit or Apple Watch, but will give clinicians more precise and detailed information, accurate enough to diagnose a problem and/or adjust the dose of medication in a more timely and effective manner.”
The wearable and implantable sensors are being combined with a machine learning (artificial intelligence) computer algorithm capable of analyzing the trend information from the vital-signs sensors in real-time; and alert the patient of a significant change in their health. Important vital sign data would also be transmitted via cell phone to a central monitoring station for advanced analysis by a computer and clinician. For example, the real-time vital sign monitoring system’s algorithm would be able to detect and report changes that could indicate an impending heart attack, stroke, heart failure, or sudden death.
In addition, patients could observe their real-time vital sign data on their cell phone and paramedics, physicians, and nurses could easily download recorded information during an emergency or office visit.
Dr. Joseph, who has worked at Jefferson for over 30 years as an anesthesiologist and medical device entrepreneur, is currently working on a variety of innovations. One of his earlier inventions, an automated glucose monitoring and insulin delivery system for patients with diabetes, was successfully acquired by Johnson & Johnson in 2004, but he hasn’t stopped there. He continues innovating medical devices designed to improve the lives of patients with diabetes. He frequently mentors students and other faculty who want to learn how to translate a great idea into a company- leading to products that can help people.
For Dr. Joseph, one of the first steps was bringing on veteran business partners with experience in industry and start-ups. In 2014, RTM Vital Signs LLC, which stands for Real-Time Monitoring of a patient’s vital signs, was born with co-founders Nance Dicciani, PhD, and Denise Devine, MBA. Focusing on different aspects of the business, the three are now working through the research, development, regulatory, and financial steps needed to manufacture and test the vital-signs devices and bring them to market.
Although real-time vital sign monitoring in the hospital is commonly used to detect a significant change in a patient’s health, there is great clinical need to extend continuous real-time monitoring into the outpatient setting. RTM’s wearable and implantable sensors are being designed for ease-of patient use and robust communication with a cell phone and central monitoring station. More than 1,000 people die suddenly every day in the United States, and many these deaths may be preventable by more timely diagnosis and intervention. “Our goal is to recognize a significant change in a patient’s typical vital sign pattern during daily living and provide an alert/alarm to the patient and the patient’s physicians prior to a serious cardiovascular event,” said Dr. Joseph. In contrast with traditional telemedicine where patients are monitored intermittently, high-risk patients could be continuously monitored and vital-sign data interpreted in real-time, to enhance the accuracy and timeliness of diagnosis and treatment leading to improved clinical outcomes and decreased costs.
If I hadn’t been checking, I’m not certain that he’d be alive today.
— Jeff Joseph
Jefferson and RTM are currently focused on the development of a long-term implantable sensor that continuously monitors an ambulatory patient’s blood pressure, including the arterial blood pressure waveform. The next-generation sensor will continuously monitor a patient’s electrocardiogram, respiratory rate, tidal volume, hemoglobin oxygen saturation, temperature, sounds of the upper airway, heart, and lungs, body position and activity level. Dr. Joseph and his team are engineering the devices for easy implantation as a same-day outpatient procedure that would require local anesthesia and sedation, similar to implantation of a pacemaker. “If all goes well, it’s possible the implantable blood pressure monitoring system could be on the market in three to five years,” says Dr. Joseph.
In addition, Jefferson and RTM are also developing a wearable sensor that could help prevent opioid overdose. The group is building on their previous work by adding a miniature microphone and accelerometer that continuously monitors an ambulatory patient’s respiratory rate, tidal volume, body position and activity level. The system utilizes a novel machine-learning algorithm on a cell phone that accurately detects and predicts the onset of respiratory depression due to an opioid overdose, with automatic alerts and alarms to the patient, caregiver, and emergency personnel. As a sign of early success, the team was recently awarded an National Institutes of Health (NIH) grant to validate and optimize the diagnostic algorithms and sensor design. The first clinical trial to test the system is set to begin October 2019.