RAFLON

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

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INTRODUCTION TO THE ISSUE

In the area of large joint replacement, there are the following problems:

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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.

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HIGH COST OF LINERS (10-15% OF THE PROSTHESIS’ PRICE)

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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.

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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

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COMPETITIVE ADVANTAGES

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

LOW COST

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.

 

MATERIALS COMPARSION

Comparison of Raflon materials with common materials

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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

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A

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B

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C

 

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

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A

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B

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C

Rise: А – 500, B – 20000, С – 100000

 

MANUFACTURE OF THE MATERIAL

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RECOMENDATIONS

Leading orthopedic medical institutions of the Russian Federation

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FGBU “NMITS TO THEM. PRIOROV”

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FGBU “BURDENKO CENTRAL MILITARY CLINICAL HOSPITAL”

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FEDERAL STATE AUTONOMOUS EDUCATIONAL INSTITUTION OF HIGHER EDUCATION I.M. SECHENOV

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SPB FGBU “CMSH NO. 2”

- Highly appreciated the prospects of this development;
- Confirmed readiness to implement this product.

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

CONTACTS

Sergey Slesarenko

+7 926 450 – 58 – 43