Three medical devices were showcased in Cleveland Clinic’s Top 10 Medical Innovations for 2021. The devices have the potential to change health care and enhance healing in the coming year. The innovations, which were selected by a panel of distinguished clinicians and researchers at Cleveland Clinic, include a smartphone-connected pacemaker, a bubble CPAP (continuous positive airway pressure) for premature babies, and a vacuum-induced tamponade device.
Smartphone-Connected Pacemaker Devices
A pacemaker is an implantable device designed to regulate the electrical impulses of the heart. They are used to correct uneven heartbeats. Millions of patients have pacemaker implants to treat arrhythmia or heart failure. However, many patients do not understand how these devices function. This smartphone-connected pacemaker device was designed to give patients insight into their cardiac treatment.
The pacemaker connects to the patient’s phone, where their information is displayed in a mobile app. In the app, patients can access information about the implant, such as the battery longevity and device information, but it also engages the patient in their treatment plan. The app includes a symptom journal to share with their doctors and educational resources.
Pacemakers have been able to wirelessly transmit data for some time now. However, previous technology required additional monitoring equipment. Generally, patients would store the equipment in their bedrooms. The previous devices did allow patients to transmit information to their doctors, but the devices did not let patients access the data.
Medtronic published a study in May 2020 demonstrating that the mobile apps better engaged patients in monitoring their heart health. The usage of the Medtronic MyCareLink Heart (MCLH) mobile app was compared to traditional bedside monitoring devices. The study found that the patients using the MCLH completed 94.6 percent of their scheduled remote monitoring transmissions to their health care provider. In comparison, the results of those using the traditional bedside monitor ranged from 56.3 percent to 87.1 percent. Medtronic tested three different bedside devices that it manufactures.
Increased remote reporting has many benefits. The information can detect potential medical issues earlier. It is not surprising, then, that the use of remote monitoring is associated with long-term patient survival. Remote monitoring also reduces the number of necessary in-person clinic visits. Rob Kowal, a doctor working for Medtronic, said in a press release that “Remote monitoring for cardiac health is associated with better patient outcomes and is playing an important role in the care of patients during the COVID-19 pandemic as in-person clinic visits are restricted.”
Technology is fast becoming a way for patients to engage in their treatment plans. For the first time, patients with pacemakers can access data about their heart health. This interaction is an important step to better engage patients in their treatment plans. Cleveland Clinic believes that this technology will change the way patients track, understand and engage with their heart health.
Bubble CPAP for Premature Infants
Premature infants are fragile and require special medical attention. In particular, premature infants are at risk of infant respiratory distress syndrome (IRDS). Traditionally, IRDS has been treated with a combination of surfactants and mechanical ventilation. Although these treatments have been successful, mechanical ventilation can injure premature infant’s lungs and cause lasting damage.
Bubble CPAP (b-CPAP) offers a new way to treat premature infants with IRDS. Instead of an invasive ventilation strategy, b-CPAP uses positive airway pressure noninvasively. Infant-sized nose prongs are placed in the infant’s nostrils to deliver humidified oxygen blended with air. The pressure is maintained with water pressure. The end of the expiratory tube is submerged in water. The amount of pressure in the CPAP circuit is controlled by how deep the expiratory tube is submerged in the water.
There are several advantages to b-CPAP over mechanical ventilation. Cleveland Clinic stated on its website, “the oscillating, rather than constant, pressure provided by b-CPAP plays a role in its safety and efficacy of volume retention in an infant’s lungs. Its physiologic advantages include optimally matched blood and airflow in the lungs, increased functional residual lung capacity, and maintenance of inflation of alveoli—the functional unit of lung tissue.”
Due to these benefits, the World Health Organization recommends the use of b-CPAP for infants with IRDS. Six clinical trials, with 355 premature infants, found a 48 percent reduction in in-hospital mortality when using CPAP technology. Another study of 773 infants, published in Pediatric Research, found that only 6.4 percent of premature infants who received b-CPAC developed chronic lung disease (CLD). For a subset of 196 infants who could be compared to a benchmark sample from a network of worldwide hospitals, the rate of CLD was 4.8 percent versus 28.6 percent for the latter.
The most exciting feature of b-CPAP technology is how affordable and accessible it is. The machine does not require compressed oxygen or air sources; it can utilize room air. A sterile water bottle can be used to make the bubbler, although commercial options are available. Medical practitioners require little equipment and resources to use b-CPAP technology. This has made the device particularly well suited for developing nations.
Although the research into b-CPAP has been explored for years, its use is just now becoming widespread. The combination of the recent adoption and the accessibility of the technology earned it a spot on Cleveland Clinic’s Top 10 Medical Innovations.
Vacuum-Induced Uterine Tamponade Device for Postpartum Hemorrhage
Postpartum hemorrhage (PPH) remains a worldwide complication of childbirth. One to five percent of women will experience excessive bleeding after childbirth. Women in developing nations are at higher risk, but all women are susceptible to PPH.
After birth, if a woman’s uterus does not strongly contract, the blood vessels that were attached to the placenta can remain open. This is the most common cause of PPH. It is an extremely dangerous condition that can require blood transfusions, drugs, medical procedures, and even an emergency hysterectomy.
One treatment for PPH has been the use of a uterine balloon tamponade. It is a device that is inserted into the uterus and expanded. The balloon applies pressure to the blood vessels to stop the bleeding. However, this is an invasive procedure.
A vacuum uterine tamponade uses negative pressure instead of positive pressure to stop bleeding. The device is inserted into the uterus. Then the vacuum creates negative pressure in the uterus, which causes the uterus to collapse and shrink. As the uterus shrinks, the blood vessels contract, stopping the bleeding. The vacuum mimics the natural process of the body with the uterus contracting after birth.
A study with 107 women, published in Obstetrics & Gynecology, tested the effectiveness of vacuum uterine tamponades. Bleeding was stopped within three minutes in 94 percent of cases. They reported, “The short duration of time the device is in-dwelling may limit rates of device-related complications such as infection while also reducing resource utilization and cost by decreasing time spent on the labor and delivery unit.”
This medical device is particularly promising because of its simple design. It is made of soft silicone with an intrauterine loop that houses 20 vacuum pores. An expandable cervical seal, which is filled with sterile fluid, creates a seal. The end of the device attaches to a vacuum source.
Many startup companies have made medical devices, but few have grappled with the challenges of treating PPH. The simple design and successful clinical trials made this device stand out as a top medical device for 2021. This device promises to make the complications of PPH worldwide a thing of the past.