Medical Supplies

Engesserstraße 4 A
79108 Freiburg
Germany
Postfach 10 01 26
79120 Freiburg

Phone: (+49-761)7661-0
Fax: (+49-761)7661-100

Company Contacts
Department/ Name Address

Jan Mokros seleon gmbh, Engesserstr. 4a, 79108 Freiburg
seleon@seleon.de

Company Figures
Number of employees 50-99
Sales volume 1-9 Mio US $
Export content max. 25%
Year of foundation 1998
Area of business Components, Parts, Original Equipment Manufacturers

Design, Research and Development Services

Electrical and Electronic Components

Filtration

Instrumentation Control and QC

Manufacturing Services

Tubing

Language: German Language: English Company Profile

seleon gmbh: your work is done when we start the job
seleon designs, develops and manufactures devices, hardware components, assemblies and software for medical technology and life science industries.
We carry out or support the entire product development process - from conception to market launch. Our range of services includes electronics, sensor technologies, precision mechanics, software development, prototypes, manufacturing, design, industrial property rights, clinical studies and trials and international regulatory affairs and approvals.

seleon is ISO 9001:2000 and ISO 13485:2003 certified according to medical product laws.

ComPaMED Hall 8a / Stand L 26 - www.seleon.de.

Product Information
06.17 Product design and development
TNI® 20– Treatment with Nasal Insufflation 12.09.2007

The TNI® 20 device is used to treat sleep-related breathing disorders and is a unique product on the world market. It is a much more comfortable alternative to the breathing therapy devices that are currently on the market.

Requirements:
A considerable technical challenge was to design, develop and manufacture an “open system” which does not use a mask or nasal pillows.
seleon found a solution to the leakage problems that other devices commonly have.
An additional challenge was to prevent the patient’s nose from drying out.
Maintaining a low noise level when the device is in operation was another limiting factor.

Results:
seleon designed and manufactured the TNI®20 device, which consists of three components: a blower, a humidifier and an applicator.
The initial clinical tests were conducted on adults and children at Johns Hopkins University Hospital (JHU) in Baltimore (USA). For adults, the best results were obtained for patients with mild to moderate sleep-related breathing disorders. Additionally, some patients with severe breathing disorders were successfully treated.
For children, all tests conducted so far have proven to be effective and efficient in the therapy, so that no restrictions relative to the degree of severity were observed. Currently several studies are running on various applications of the TNI® in Germany and the USA.
Furthermore, acceptance studies found that even healthy test subjects fell asleep easily with the TNI®20 device and did not feel noticeably disturbed by the device. In addition, the warm, humid airflow was found to be comfortable.

Advantages:
This treatment method is internationally patented.
High patient acceptance for the therapy was achieved largely due to TNI®20’ s unique applicator.
- Practically no resistance is felt when exhaling due to the device’s “open system.”
- Normal sleeping positions, such as sleeping on one’s side or stomach can be maintained.
- There are no places where air can enter or escape due to mask slippage and therefore no leakage problems exist.
- The thin tube does not disturb the patient.
- The humidifier unit prevents the patient’s nose from drying out.
Because it has a separate blower unit, the TNI®20 device operates very quietly.
TNI®20 is very easy and logical to operate and the pressure does not need to be manually set.
The TNI®20 device is easy to use and clean.