面对疫情，KNF在行动
隔膜泵是用于抗击2019新冠肺炎医疗设备中的关键部件
了解详情
人的心脏是大自然的奇迹。它每天连续不断地跳动多达 100000 次，对于一个健康的人而言，这是理所当然。然而，对于急需新心脏的心脏病患者，情况则完全不同。他们的存活机会很大程度上取决于能否找到合适的捐献者心脏。但是等待人的名单很长。心室辅助装置（VAD）可以帮助病人度过临时过渡期。 Berlin Heart 的 EXCOR® 儿科心室辅助装置是全世界唯一被批准用于儿童和婴儿的心室辅助装置。KNF为其固定驱动器提供高度专业的隔膜气泵。
From a start-up to the European market leader for ventricular assist devices
The international medical technology manufacturer Berlin Heart GmbH has its headquarters in Berlin and is a real Berlin story itself. It began in the late 80s in the form of a spin-off company of the German Heart Center in Berlin. In 1996, conceptualized by clinicians and developers and supported by Fehling Medical, Berlin Heart was founded in its present form. Since then, the company has become the European pioneer and market leader for ventricular assist devices and now employs more than 200 people.
图像出处说明：Berlin Heart GmbH
Mechanical blood pump simulates cardiac function for people with cardiac insufficiency
The company’s core product is the EXCOR® blood pump, a double-chamber pump that takes over the cardiac functions for patients with cardiac insufficiency. The pump is placed on the outside of the patient’s body; cannulas connect it with the heart and the blood vessels. A pneumatic drive unit generates pressure and vacuum, which powers a three-layer diaphragm that separates the air chamber from the blood chamber, moving the membrane in a pulsating manner to create blood flow.
In the 90s, Berlin Heart developed the first heart pump for the treatment of children – a global breakthrough. For the related stationary drive unit Ikus, the company was looking for a reliable partner to develop a suitable compressor. In 1993, Berlin Heart found this partner – the diaphragm pump manufacturer KNF.
Berlin Heart 出品的Ikus 驱动单元。图像出处说明：Berlin Heart GmbH
Controlled quality and reliability allow for a quick project implementation
As therapies may take months or even years, EXCOR® and all its components are designed for long-term use. Therefore, the medical technology manufacturer provided clear guidelines for the development of the KNF diaphragm gas pumps for the drive unit. In addition to performance and durability, the most important factor was low-noise operation to improve the patient’s quality of life during therapy. After reviewing all aspects of the project, the developers at Berlin Heart determined that the diaphragm pump technology from KNF could fulfill all requirements.
The collaboration benefited from the proven “modular KNF system” – a system that draws from pre-approved KNF pump components to facilitate speedy response and pump development. The pump was further adjusted to the individual project requirements from Berlin Heart. “Despite our special requirements, a complete redevelopment of the diaphragm pumps was not necessary”, said Daniel Hartmann, Team Leader Sustaining Engineering at Berlin Heart. “Instead, we could draw on the already proven and reliably tested components from the modular KNF system. That also complied with our wish to develop a reliable drive system within a short period of time.”
Together, Berlin Heart and the KNF development team optimized the parameters using the modular system. Starting with the existing series model “N 023.1.2”, this pump was perfectly adjusted to the customer requirements. Among other modifications, specially adapted intermediate plates and special silicon wiring were implemented. Due to the careful harmonization of all components, Berlin Heart's EXCOR® Pediatric product received premarket approval (PMA) for the US market.
N 023.1.2 系列型号使用 KNF 模块化系统来适应外部心脏支持系统的特定要求。
Saving lives – the driver of business success
Since 1994, the EXCOR® Pediatric remains the only VAD approved for children, infants and babies and has saved more than 2,500 lives. “With each positive feedback on the successful use from the market, especially for children is always providing renewed strength and happiness, and this is exactly our main driver at Berlin Heart”, says Hartmann. Over the years, the company has opened up more and more markets. In 2005, the subsidiary Berlin Heart Inc. was founded in the USA where, in 2017, EXCOR® Pediatric also received premarket approval (PMA) from the FDA. In 2015, the first patients in Japan were successfully treated with the new system. Today, Asia is one of the biggest markets for the EXCOR® Pediatric artificial heart, and it has now been used successfully throughout the world.
Opening new markets requires continuous development
Opening new markets also changes the requirements for the heart pump. For example, the drive system's voltage needs to be changed depending on the country. Here, Berlin Heart could also rely on the KNF expertise. Through the years, KNF has continually developed the solution according to the new requirements. “We now offer five different voltages. This way, our system can be used almost anywhere in the world,” Hartmann explains. “KNF has considered our problems and interests throughout the project, and has proactively dealt with them. Furthermore, they always gave us the feeling of really appreciating our application. Still today, working with them is a big pleasure!”
