Melt-Stabilized UHMWPE Antioxidant Coating Nitrogen Atmosphere

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Solution Overview

Problem

Highly crosslinked ultra-high molecular weight polyethylene (UHMWPE) used in orthopedic implants experiences high wear rates due to free radical burden, leading to osteolysis and implant failure, and current melt-stabilization methods in oxygen-containing environments result in oxidation and waste of material.

Innovation Solution

A method involving coating UHMWPE with antioxidants like vitamin E and heating in an oxygen-containing environment to melt and stabilize the material, reducing free radical concentration and minimizing oxidation, thereby preventing the formation of an oxidized surface layer.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If highly crosslinked UHMWPE is heat stabilized by raising the material temperature above the melting point in an oxygen-containing environment, then the free radical burden is reduced, but an oxidized layer forms on the exterior of the material

Engineering Contradiction:
Improvefree radical burden reductionVSAvoidoxidized layer formation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces nitrogen gas as an intermediary atmosphere during the melt stabilization process. The nitrogen atmosphere acts as a mediator that allows the UHMWPE to be heated above its melting point for free radical reduction while preventing oxygen from diffusing into the molten material and forming an oxidized layer. This resolves the contradiction by providing a protective intermediate environment.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent employs an inert nitrogen atmosphere during the heat stabilization process. By replacing the oxygen-containing environment with nitrogen, the process eliminates the harmful oxidation that would otherwise occur during melting, while still allowing the temperature to rise above the melting point to reduce free radical burden through recombination.

Inventive Principle:
Principle #39Inert atmosphere (Inert environment)

2Reliability

If the oxidized surface layer is removed during fabrication to prevent contamination, then implant contamination is prevented, but material waste increases

Engineering Contradiction:
Improveimplant contamination preventionVSAvoidmaterial waste
Core Design Contradiction:
ReliabilityVSLoss of substance

Solution Approach 1:

The patent converts the potential harm of oxidation into a benefit by using nitrogen atmosphere control. The inert nitrogen environment prevents oxidized layer formation during the critical melt stabilization process, transforming what would be a harmful byproduct into a controlled process outcome. This eliminates the need for subsequent oxidized layer removal and reduces material waste.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

3Reliability

If UHMWPE is crosslinked by high energy irradiation to reduce wear rate, then wear rate is reduced significantly, but free radical burden increases causing oxidation in-vivo

Engineering Contradiction:
Improvewear rate reductionVSAvoidfree radical burden
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent applies preliminary melt stabilization treatment after irradiation crosslinking. By heating the irradiated UHMWPE above its melting point in a nitrogen atmosphere, the process enables free radicals to recombine before the implant is introduced into the body. This preliminary action reduces the free radical burden that would otherwise cause oxidation in-vivo, while preserving the wear reduction benefits of crosslinking.

Inventive Principle:
Principle #10Preliminary action

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The method effectively reduces free radical concentration and prevents oxidation, resulting in a stable UHMWPE implant with reduced wear rates and cost savings by minimizing material waste and avoiding the need for oxygen-free environments.

Implementation Method 1

The UHMWPE includes a first concentration of free-radicals... The UHMWPE in the melt-stabilized material includes a second concentration of free-radicals. The second concentration of free-radicals is less than the first concentration of free-radicals

Methodology Applied
Scientific EffectFree radical scavenging: Absorption (physical)

Implementation Method 2

The heating is sufficient to melt at least part of the UHMWPE

Methodology Applied
Scientific EffectMelting: Melting

Implementation Method 3

This oxidized layer is removed during fabrication of the implant to prevent contamination of the implant with oxidatively degraded UHMWPE

Methodology Applied
Scientific EffectDiffusion: Diffusion

Implementation Method 4

coating at least part of the solid material with a liquid composition including at least one antioxidant

Methodology Applied
Scientific EffectOxidation prevention: Oxidation

Data Source

PatentUS10184031B2Melt-stabilized ultra high molecular weight polyethylene and method of making the same
Publication Date: 2019.01.22 ZIMMER INC
  • US10184031B2 patent drawing
  • US10184031B2 patent drawing
  • US10184031B2 patent drawing

AI summary

Various embodiments disclosed relate to melt-stabilized materials including ultra high molecular weight polyethylene (UHMWPE), methods of making the same, and medical implants including the same. In various embodiments, the present invention provides a method of melt-stabilizing a material including UHMWPE. The method includes obtaining or providing a solid material including UHMWPE including a first concentration of free-radicals. The method includes coating at least part of the solid material with a liquid composition including at least one antioxidant, to provide a coated solid material. The method includes heating the coated solid material in an environment including oxygen, the heating being sufficient to melt at least part of the UHMWPE, to provide a heated material. The method also includes solidifying the heated material, to provide a melt-stabilized material including UHMWPE including a second concentration of free-radicals, wherein the second concentration of free-radicals is less than the first concentration of free-radicals.