2. Slesarenko S.V.
1. Low lifecycle of the prostheses due to wear off liner (up to 20% of repetitive operations). Wear of the prosthesis liner
provoke serious complications in patients.
2. High cost of liners (10-15% of the prosthesis’ price).
3. There are only two kinds of material to produce liners in the world. Only 2 materials are used as liners (UHMWPE-
85% and biocompatible ceramics-15%). The last major innovation was introduced in orthopedics 50 years ago.
4. UHMWPE material is an extremely difficult material to process.
Introduction to the issue
Antifriction
liner
endoprosthesis
2
3. Slesarenko S.V.
Solution (technology) proposal
Today we have run out of the improvement methods of the materials used as endoprosthesis liner. To solve the issue there should be
implemented a new quality material that has the best features. We have developed a new material with unique properties –
Raflon.
Raflon is a type of a fluoroplastic, exposed to ionizing radiation that leads to major changes of the structure and
morphology of polymer. A new structure is characterized by the best in class physico-mechanical properties compared to
the equivalents:
With an average lifecycle of endoprosthesis of 15 years an increase of durability of the liner and minimization of abrasion products
allows to ensure a lifelong implantation of an endoprosthesis.
3
Nanomodified fluoroplastic
Ultra-high durability
Lowest friction coefficient
Impact-strength
Chemical resistance, biocompatibility
4. Slesarenko S.V.
Competitive advantages
1. Completely eliminate problems with wear, because the new material exceeds the existing
analogues in physical and chemical characteristics (wear resistance increased by 10 times).
2. Raflon is based on polytetrafluoroethylene (PTFE) and is completely inert to the human
body.
3. The cost of the material is less than 1/10 of the cost of the finished liner.
4. The implementation of a new material is possible by using the existing processing
equipment of prosthesis manufacturers. The new material is easier to process than
UHMWPE.
5. The author of the project has registered intellectual property (national patent for
invention and PCT application), has unique equipment and is the only manufacturer of
the above mentioned material in the world.
4
5. Slesarenko S.V.
1. The technology to obtain Raflon was developed and unique technological equipment was created.
2. Laboratory studies of the key physical and mechanical properties of Raflon were conducted: wear resistance, coefficient of
friction, etc.
3. A patent search was conducted, a patent application was drawn up and filed. Received a patent of the Russian Federation. Filed
a PCT application. It is planned to protect intellectual property in the European Union, USA, China, India.
4. This project is highly appreciated by the leadership of Russian orthopedic medical institutions such as FGBU «NMITS TO
them. Priorov», FGBU “Burdenko Central Military Clinical Hospital”, «Clinic of traumatology, orthopedics and joint
pathology of the Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov», received letters of
readiness to assist in the implementation of this project.
Project roadmap
5
6. Comparing of material characteristics
№ Comparative parameter
UHMWPE
(used)
Raflon
1
Wear rate without lubrication in the rod-
disk kinematic scheme (2.5 MPa, 1 m / s),
mm3n-1m-1
(less is better)
(3-6) х 10-6 (1-3) × 10-8
2
Coefficient of friction on steel without
lubrication in the area of moderate loads and
speeds
(less is better)
0.22-0,28 0.05
6Slesarenko S.V.
7. Nanomodification leads to a radical change in the morphology of the fluoroplast:
Instead of the lamellar structure inherent in the original fluoroplast, a spherulite structure is formed. Spherulites are
constructed from a set of nanofibrils radiating from a single common center
Незаполненная
полость
After (spherulitic structure of the fluoropolymer, the disappearance of isolated nanofibrils)
Before (the lamellar structure of the fluoroplast. Both isolated and included in the tapes nanofibrils have a "shish-kebab"
type structure. The characteristic size of the structural element of the nanofibrill is about 10 nm)
А B C
1-micropores,
2-nanopores,
3-isolated nanofibrils,
4-ribbon-like nano-fibrillar structures
Rise: А – 500, B – 20000, С – 100000
А B C
1 - centers of nucleation of spherulites,
2-nanopores,
3 - nanofibrils of spherulites
The mechanism of nanostructuring of fluoroplast:
1) Reduction of melt viscosity as a result of destruction of polymer chains in the conditions of fibrillar-band structure
2) "Collapsing" of pores due to surface tension forces with decreasing viscosity, disappearance of isolated nanofibrils
3) Formation of a spherulite structure with nucleation centers, which are collapsing nanometer-scale pores
7
Nanotechnology part of the project
Slesarenko S.V.
8. Leading orthopedic medical institutions of the
Russian Federation:
1. FGBU “NMITS TO them. Priorov”
2. FGBU “Burdenko Central Military
Clinical Hospital”
3. Federal State Autonomous Educational
Institution of Higher Education I.M.
Sechenov
4. SPB FGBU “CMSH NO. 2”
- highly appreciated the prospects of this
development;
- confirmed readiness to implement this
product.
1
23
4
Recommendations
8Slesarenko S.V.
9. Slesarenko S.V.
1. Patent on an invention №2703615 was obtained, PCT application №2018000739
filed, translation into national phases in China, USA, EU, Japan, India is underway
Patent name: endoprosthesis liner.
Author: Slesarenko S.V.
.
2. Patent for invention №2669841 was obtained, PCT application №2018000513 was
filed, translation into national phases of China №2018800108099, USA №16/484,445,
EU №18845041.5, Japan, India №202017008085 is underway
Patent name : METHOD FOR PRODUCING POLYMER MATERIALS
Author: Slesarenko S.V., Arsentyev M.A
Intellectual property
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10. ▪ Pressing and heat
treatment
Air conditioning, cooling,
unloading
Area of the production of
blanks
Unloading area Machining area
Finished goods
warehouseOutput control
Ionizing radiation treatment on an
electron accelerator
Preparation for irradiation area
Irradiation chamber
Loading blanks into TRC*, air
conditioning, heating.
*TRC – thermal radiation chamber
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Manufacture of the material Raflon
Slesarenko S.V.
