Innovative material of endoprosthesis liner of major joints
Raflon is a line of fluoropolymer (PTFE) materials of a new level of antifriction, tribotechnical and sealing purposes, retaining all the advantages of known fluoropolymers and having unique physicochemical properties
INTRODUCTION TO THE ISSUE
In the area of large joint replacement, there are the following problems:
LOW LIFECYCLE OF THE PROSTHESES DUE TO WEAR OFF LINER (UP TO 20% OF REPETITIVE OPERATIONS). WEAR PRODUCTS OF THE PROSTHESIS LINER PROVOKE SERIOUS COMPLICATIONS IN PATIENTS.
HIGH COST OF LINERS (10-15% OF THE PROSTHESIS’ PRICE)
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.
UHMWPE MATERIAL IS AN EXTREMELY DIFFICULT MATERIAL TO PROCESS
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
NO PROBLEMS WITH WEAR
Completely eliminate problems with wear, because the new material exceeds the existing analogues in physical and chemical characteristics (wear resistance increased by 10 times)
INERT TO THE HUMAN BODY
RAFLON is based on polytetrafluoroethylene (PTFE) and is completely inert to the human body
The cost of the material is less than 1/10 of the cost of the finished liner
EASIER TO PROCESS
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.
Comparison of Raflon materials with common materials
NANOTECHNOLOGY PART OF THE PROJECT
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.
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).
1 - micropores,
2 - nanopores,
3 - isolated nanofibrils,
4 - ribbon-like nano-fibrillar structures
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.
After (spherulitic structure of the fluoropolymer, the disappearance of isolated nanofibrils)
1 - centers of nucleation of spherulites,
2 - nanopores,
3 - nanofibrils of spherulites
Rise: А – 500, B – 20000, С – 100000
MANUFACTURE OF THE MATERIAL
Leading orthopedic medical institutions of the Russian Federation
FGBU “NMITS TO THEM. PRIOROV”
FGBU “BURDENKO CENTRAL MILITARY CLINICAL HOSPITAL”
FEDERAL STATE AUTONOMOUS EDUCATIONAL INSTITUTION OF HIGHER EDUCATION I.M. SECHENOV
SPB FGBU “CMSH NO. 2”
- Highly appreciated the prospects of this development;
- Confirmed readiness to implement this product.