Coronary disease is the leading cause of hospitalization and death worldwide and prevalence is set to rise 18% by 2030. Although percutaneous coronary interventions today are the most common treatment, there is an increase in patients with complex cases where open-heart surgeries are required. Serious complications happen in 12-15% of major cardiac surgeries and are associated with increased morbidity, longer postoperative stays, higher costs, and increased mortality. To put this into context, postoperative complications in Europe amount to €6 billion annually, indicating the burden on healthcare providers. This healthcare burden may be reduced by applying intra- and post-operative cardiac monitoring to detect a problem before it becomes a serious complication. Cardiaccs is developing a disruptive medical device called ‘CardiSense’, which provides technology for measuring myocardial contractility, a vital parameter for monitoring cardiac function. The patented CardiSense device (as shown in the figure) consists of a miniaturized accelerometer integrated into industry-standard temporary pace leads (TPLs), which are routinely placed at the heart surface during surgery and stay in place for up to 7 days before it is pulled out. CardiSense allows cardiac surgeons to determine abnormal cardiac function before the patient develops serious symptoms. With continuous and accurate monitoring of the cardiac function, intra- and postoperative complications can be avoided, reducing morbidity, mortality, and overall care costs.
Although CardiSense provides a ground-breaking solution for cardiac monitoring, there was a need to develop a more robust and user-friendly solution. The overall objective was therefore to improve the device’s flexibility, sensor encapsulation, and reducing the diameter of the pace lead, which would reduce the risk of bleeding, reduce the exchange of biofluids and toxic materials to and from the device, and improve device placement and removal. Consequently, the results of the MATPASE project would dramatically improve user adoption by cardiac surgeons, maximizing our market impact and eventually improving patient outcomes.
The Cardisense system currently uses an off-the-shelf MEMS sensor for measuring acceleration. This sensor has several features that is not needed for our purpose, and consequently, the size of this sensor is larger than it has to be. By designing a custom MEMS sensor, it is possible to reduce the size substantially, thereby meeting the aforementioned goals.
The Innovation Associate has researched the state-of-the-art materials for the development of the sensor. A report was generated based on the literature review, a candidate material was selected and then suppliers were identified which can provide the material and the services. The Innovation Associate then worked on the design based on the material and process provided by the supplier, a feasibility report with the design specifications and requirements for the performance of the sensor was created with a focus on the miniaturization of the design reducing the size and increasing the sensing capability of the sensor.
