Development of technology for the manufacture of medical devices based on honeycomb carbon adsorbents for extracorporeal blood purification
Tech Area / Field
- MED-DRG/Drug Discovery/Medicine
3 Approved without Funding
Kazakh National University / Combustion Problems Institute, Kazakstan, Almaty
- Nazarbaev University, Kazakstan, Astana
- MAST Carbon International Ltd, UK, Basingtoke\nUniversity of Brighton, UK, Brighton
Project summaryThe aim of the project is to develop medical device, composed of a haemoperfusion column with monolithic carbon sorbent of honeycomb structure which is noted for lack of dust particles formation during blood flow and enhanced sorption capacity towards high molecular protein bound uraemic toxins in order to reduce adverse outcomes for patients with chronic kidney disease and improve their quality of life. An innovative and original technology for manufacturing of activated carbon sorbents for haemoperfusion will be developed, which has no analogues among existing methods.
Objectives that have to be addressed in the course of the project realization:
- Manufacture of monolithic carbosorption block of honeycomb structure by means of extrusion of mixtures of milled rice husk with different fractions and different binders
- Investigation of structural and textural characteristics of obtained blocks by means of physical and physic-chemical methods of analysis.
- Investigation the methods of the porous structure development and the surface modification of the obtained blocks in order to improve the textural characteristics and sorption selectivity with respect to various toxins;
- Development of the haemosorbents fabrication technology and model tests on haemosorption on laboratory animals in vivo;
- Patenting of the medical device in Kazakhstan and filing of application for international patent
- Design and engineering works and producing of experimental batch of columns for haemoperfusion
- Development of technical documentation with the purpose of filing for permission for preclinical trials
- Preparation and optimization of methods of synthesis of nanostructured carbon monoliths from rice husk and binding components for the production of a pilot lot monoliths laminar type for use in haemoperfusion
- Learning efficiency of removal of toxins from the blood of animals in the conditions in vivo and blood under in vitro derived monoliths, no cytotoxicity and good hemocompatibility.
This problem will be solved by launching domestic manufacture of haemoperfusion columns from rice husk, a unique material with minimum content of toxic substances, which is essential for carbon adsorbents for medical purposes. Kazakhstan has large amount of rice husk – large-scale renewable pollution-free vegetable raw material..
Proposed project offers manufacturing new medical device complete with bloodlines (AV-set), thus reducing costs of blood detoxification using haemoperfusion, which in turn, increases effective demand. This will bring Kazakhstan to the level of global leading manufacturers of haemosorbents of new generation.
The sorbent will be produced using innovative technology developed in this project. The scientific and practical impact of the project is highly significant. For the first time production of a novel medical sorbent made from local raw materials will be launched in Kazakhstan. It will be used for the removal of high molecular uraemic toxins from the blood of patients with chronic kidney disease.
Currently used granular haemosorbents are produced only abroad from synthetic polymers and are expensive. Companies engaged in the manufacture or design of the equipment are presented by the following trademarks: SKN, Ukraine; VNIITU-1, Russian Federation; MARS, Germany; Norit, The Netherlands; Adsorbate (Gambro), Sweden; Dali (Fresenius), Germany; Kaneka, Japan.
Republic of Kazakhstan has an urgent need for the creation of domestic sorbent production which will remove import dependence. We established that the negative side effects of haemoperfusion processes can be reduced in case of the use of a haemosorbent of honeycomb structure with narrow channels, in which laminar blood flow is realized, as blood is purified. Preliminary tests confirmed that assumption.
On the other hand, Kazakhstan has a large amount of rice husk (RH) as a waste material, which has no current commercially viable use. In terms of other potential advantages, it is a renewable bioavailable material with a minimal amount of toxic substances as opposed to synthetic polymers. The team at Institute of Combustion Problems (ICP) has developed technology for carbonisation and activation of carbon materials produced from rice husk. Starting material, rice husk, is a unique material in terms of availability, large-scale world production (over 120 million tons annually), as well as the presence of nanoscale silica phytoliths, which serve as a template to create additional meso/macropore space within the nanoscale range. It is these nanopores, which will optimise the adsorption of middle molecular size uraemic toxins.
Potential customers and end-users of the nanostructured sorbents are pharmaceutical companies, health care centers, research organisations, dialysis centres and medical-biological services of the Republic of Kazakhstan.