Development and Clinical Testing of Oxygenators (Artificial Lungs).
Tech Area / Field
- MED-DID/Diagnostics & Devices/Medicine
3 Approved without Funding
Research Institute of Technology, Russia, Leningrad reg., Sosnovy Bor
- Military Medical Academy named after S.M.Kirov, Russia, St Petersburg
Project summaryThe project's objective is the development and clinical test of oxygenators and their small-lot production for clinical test needs.
To do surgery on a human heart, devices for saturating blood with oxygen (i.e. oxygenators) are required. This type of devices falls in the category of full-flow oxygenators.
Annual purchase of oxygenators (mostly from foreign firms) makes no more than 5% of the required quantity and about 50% of the quantity which medical institutions can use in their operations on heart. The development is based on the mass exchange technique protected by two Russian Patents. The method is relatively simple for implementation.
Preliminary model testing of mass exchange devices under donor's blood oxygenation conditions gave good results.
The Project implementation will involve:
- a sequence of laboratory physicochemical and medicobiological investigations to find the optimum parameters of oxygenators mass exchange chambers and the best modes of blood saturation with oxygen;
- construction of inpidual blocks and assemblies of oxygenators, their functional and technological connections and lay-out;
- development of manufacturing equipment and acquisition of equipment for small-lot production of oxygenators to provide for clinical tests;
- manufacture of oxygenators and conducting an adequate number of medicobiological tests so that a decision on the possibility of clinical testing be taken;
- conducting clinical tests to the extent sufficient for the RF Public Health Ministry to authorize application of the developed oxygenators.
Implementation of the Project would provide for build up of commercial production of full-flow oxygenators for medical institutions in Russia and CIS states. Thus, the quantity of oxygenators (including ones purchased from abroad) can be brought to the level of potential of medical institutes doing heart surgery.
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