During surgery, an anaesthetic is typically inserted into the throat via a tube, which allows the anaesthetist to continue ventilating the lungs for the duration of the procedure. The problem occurs when the surgeon and anaesthetist both need to access the same upper airway, as the system is then open and the lungs cannot be inflated and deflated by a regular ventilator.
“Essentially the problem was how to pump air in and out of the lungs in an open system,” said Peter Rossegger, Former CEO of Carl Reiner GMBH. “It is rather like inflating and deflating a balloon, with a tube keeping the balloon open all the time, through which instruments and lasers can move.”
Carl Reiner needed a more technical piece of equipment that would pump an accurate concentration of oxygenated air, with accurate pressure for different patients, whilst allowing the anaesthetist and surgeon to operate safely in tandem.
They sought a failsafe product and an end-to-end solution to bring the design to production. How to design it and solve the technical challenge was up to ESCATEC’s R&D team.
Previous design was not conducive to specific surgery
Components needed optimising for accurate oxygen and pressure
Specifications required technical input
An end-to-end solution, from design to manufacture, was required
Whilst Carl Reiner had the ideal specifications and parameters, this complex device required technical input alongside extensive monitoring electronics and software design features, including computer-monitored supervision, safety regulators and temperature control monitored in real-time.
Former Head of Global R&D at ESCATEC, Daniel Pfeifer, said:
“Designing such a device really makes you think outside the box. You have to consider what would happen if something went wrong. If 3.5 bar of pressure was suddenly applied inside the patient’s lungs, it would do tremendous damage so you have to build in all kinds of safety protocols to meet every possible ‘what if’ scenario.”
ESCATEC was contracted to offer a comprehensive end-to-end solution to optimise the respiratory system while meeting ISO regulatory medical requirements. Collaboration with the R&D team meant that quality was assured from the outset with an efficient design ready for mass production.
We chose ESCATEC because they could provide us with a complete solution from designing how the product would work right through to the manufacture of the final products, all conforming to the ISO standard for medical equipment – ISO13485. This is an extremely complex device that people’s lives depend on, so it is vital that it designed and built to the highest standards.
The Twinstream™ Multi Mode Respirator was created with ESCATEC’s custom pneumatic model at its heart.
The respirator blends air (21% oxygen [O2]) and 100% O2 into a gas mixture with a defined O2 concentration accuracy of +/-3%. The embedded pressure controller is also integral for applying accurate pressure to patients with varying lung sizes and elasticity.
The system was designed with safety at the forefront, in accordance with the regulatory standard for medical equipment, ISO 13485.
“We are used to operating to these very exacting standards which are vitally important, as patients’ lives depend on the equipment working correctly all the time.” Daniel Pfeifer, Former Head of Global R&D at ESCATEC
Every safety measure was carefully implemented. An independent microcontroller system supervises all the safety-relevant functions of a second controller system, measuring temperatures, pressures, O2, CO2, electrical voltages and currents. These functions are implemented on a powerful embedded computer with the Windows CE operating system. As this system is not safety-relevant, the patient can still be ventilated in case of breakdown.
The second embedded system is based on a DSP without an operating system to implement all safety-relevant functions while the third, smallest controller can be powered through a 9V battery for use during blackouts.
This end-to-end process, centred on precision and quality, removes the gap between design and manufacture that can typically cause friction. This means that the product could be safely and efficiently optimised for mass production from the outset, keeping costs low and removing unnecessary production delays. Working this way also ensured that Carl Reiner remained in control of design with full IP.
We are very proud to have designed a unique product that is saving lives on a daily basis in many leading hospitals around the world.
