Berlin Heart GmbH and SONOTEC Conclude Project for Joint Development of Non-Invasive Flow Sensors for Application on the New Mobile Driving Unit EXCOR® Active for Paracorporeal, Pulsatile Ventricular Assist Devices Successfully and in Trustful Cooperation

Berlin Heart GmbH and SONOTEC today reports they have once more proven its expertise in managing complex development projects in the medical engineering sector.

The project partners contracted to develop a new type of clamp-on ultrasonic sensor enabling flow measurement for all EXCOR^® cannulae and pump variants in combination with the new mobile driving unit EXCOR^® Active. With its products EXCOR^® Adult and EXCOR^® Pediatric, Berlin Heart GmbH is the only company in the world to support patients of any age and body size – from infants to adults.

The heart support system EXCOR^® is used to mechanically aid the cardiac function for patients suffering from heart failure in later stages. It is the only paracorporeal system with regulatory approval for patients of all ages – from new-borns to adults. In addition to the support of the left heart ventricle, the EXCOR^® system can also be utilized in case of failure of both heart ventricles – the so-called biventricular support. The new mobile driving unit EXCOR^® Active has been specifically designed to optimize treatment for children with serious cardiac insufficiency and excels through a number of outstanding advantages:

• Driving unit as small as a hand luggage, only 15 kg including batteries
• Battery runtime of at least 5 hours even in BVAD mode
• Panel PC with user-friendly touch screen
• Different mobilization options for different ages

Integrated innovative SONOTEC^® clamp-on flow sensor guarantees safety and comfort of the overall device

In the course of the overall development of the mobile driving unit EXCOR^® Active, SONOTEC^® was leading the subproject for developing a new clamp-on ultrasonic sensor designed for direct volume flow measurement on flexible tubes for all cannulae and pump variations of the pulsatile VAD system in combination with the new driving unit.

Apart from usual parameters such as high accuracy and an excellent measuring performance, the sensors were to meet a number of additional requirements such as a compact and low weight product design. Furthermore, the sensors needed to be equipped with a childproof closing mechanism and to be safe in case of the use of defibrillators. Various sensor architectures ensure them to be easily applied to all EXCOR^® cannulae and pump variants. Power supply and communication of the ultrasonic sensor is included to the novel driving system.

The flow sensor is a crucial part of the mobile extracorporeal blood pump EXCOR^® Active, ensuring active flow measurement and constantly performing plausibility checks. Overall, the flow sensors are a key safety feature for this kind of highly complex medical technology products.

“This project took advantage of SONOTEC’s unique miniaturization, integration, low current draw as required by many new portable medical projects,” emphasizes Daniel Thieme, Marketing Manager Non-Invasive Fluid Monitoring at SONOTEC^®. Thieme underlines the topic of miniaturization and tailor-made product development of sensor solutions as one the major strengths of the Germany-based ultrasonic specialist. Over a long period of successfully implemented projects, SONOTEC^® has gained an excellent reputation among manufacturers of dialysis and transfusion devices, heart-lung machines, blood separators, medical pumps and diagnostic systems. The intensive guidance from a very early stage in the product development process, support during verification, prototyping and its expertise in certification processes gives SONOTEC a lasting competitive edge.