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Developing new MATerial solutions for cardiac PAce lead and SEnsor encapsulation

Periodic Reporting for period 1 - MATPASE (Developing new MATerial solutions for cardiac PAce lead and SEnsor encapsulation)

Reporting period: 2019-12-31 to 2020-12-30

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.
The project started with the hiring of an Innovation Associate in the company with expertise within research and development of next-generation sensor design. At the start of the project, the specifications and requirements for the new sensor were highlighted which were determined by the extensive experience, diagnostics studies, data collected from previously performed cardiac surgeries, and animal trials. These requirements and specifications outlined the performance enhancement, sensitivity, and size characteristics for the development of the next-generation sensor for Cardisense system. The performance parameters were determined in the early stages of the project and in view of these parameters, the IA researched the suitable materials for the fabrication of the next-generation sensor for the CardiSense system. The suitable materials were identified by an in-depth study of the literature review and availability in the market. The processes involved in the fabrication of the sensor were thoroughly studied, reports were documented for the advantages, and compliances were checked for biocompatibility. This study helped the IA to identify the suitable material for the fabrication of the next generation sensor, the process involved in the fabrication of the sensor was associated with a supplier within the country of residence. The selected supplier was then assessed for conformity with the international standards and the special operating procedures and quality control maintained by Cardiaccs.

In the final stage of the project, a 3-axis sensor was designed and documented. The design of the new sensor was theoretically formulated based on the set parameters and requirements from the early stages of the project. Analytical calculations were performed, and the design was analyzed through computer-aided design software subjected to the performance and sensitivity parameters. The new design was analytically characterized for the sensitivity, signal outputs, feasibility, and adoption to the selected material and fabrication process. The design specifications were shared and verified by the expert team of the selected supplier. A feasibility report was documented for the new design sensor with its performance, sensitivity characteristics, and execution analyzing the integration with the overall electrical system of the Cardisense. It was found that the new sensor will provide enhanced sensitivity for patient heart signal, will be biocompatible, and will reduce the overall cost of the system by exploiting the batch fabrication techniques provided by the material and process supplier.
This project provided a unique opportunity for Cardiaccs to develop a state-of-the-art sensor utilizing set industrial fabrication processes. The new sensor developed during this project brings higher prospects for Cardiaccs to be a market leader in cardiac diagnostic systems by focusing on better performance, sensitivity output, and lower the cost of the overall system utilizing the industrial batch fabrication techniques. Currently, the cost of the CardiSense system has improvement potential as Cardiaccs is highly dependent on the suppliers for providing components. By developing its own unique sensor, made possible due to the research done by the funding provided in this project, Cardiaccs is a step further in the process of manufacturing the sensor in-house. The in-house capability will provide economic opportunities for the new talent and local suppliers available in the country of residence, reducing the overall cost of the system bringing affordability to the masses and its impact on the estimated 5 million heart surgeries undergone globally each year. Additionally, the improved design will potentially improve patient safety in that it will lower the risk of bleeding, increase successful placement and extraction of the device, and reduce the chance of dislodgment. These factors will in turn increase the adoption among clinicians as the difference between CardiSense and traditional pace leads become minimal.
Image showing the CardiSense