Functionally Graded Polymer Knee Implant for Stress-Shielding Reduction

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Solution Overview

Problem

Current metallic and ceramic-based femoral knee implants lead to bone mineral density loss due to stress-shielding, increased risk of implant loosening, and adverse biological reactions, while polyethylene implants cause osteolysis, necessitating the development of materials that mimic native bone properties and promote stable fixation and bone ingrowth.

Innovation Solution

A polymeric-based knee implant with a porous topography and bioactive additives at the bone/implant interface, incorporating wear-resistant materials like PAEKs, and additive manufacturing to enhance bone integration and load transfer, reducing wear rates and stress-shielding effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If metallic and ceramic based implants are used, then mechanical properties and wear-resistance are improved, but bone mineral density loss occurs due to stress-shielding

Engineering Contradiction:
Improvemechanical propertiesVSAvoidbone mineral density loss
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent changes the material parameters from traditional metallic/ceramic to polymeric materials with elastic moduli closer to native bone (2-10 GPa), reducing the mechanical mismatch that causes stress-shielding. This parameter change allows the implant to transfer loads more effectively to the surrounding bone, maintaining bone mineral density while providing adequate mechanical support.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs composite polymeric materials combining base polymers (PEEK, PEKK, PES) with reinforcing fibers (carbon, glass, aramid) and wear-resistant particulates. This composite approach achieves the necessary mechanical strength and wear resistance while maintaining a lower elastic modulus compared to monolithic metallic implants, thereby reducing stress-shielding effects.

Inventive Principle:
Principle #40Composite materials

2Strength

If polyethylene implants are used, then mechanical properties are improved, but osteolysis occurs due to wear debris

Engineering Contradiction:
Improvemechanical propertiesVSAvoidosteolysis
Core Design Contradiction:
StrengthVSObject-generated harmful factors

Solution Approach 1:

The patent transitions from conventional polyethylene to advanced polymeric materials (PEEK, PEKK, PES) with superior wear resistance characteristics. These materials generate significantly less wear debris while maintaining or improving mechanical properties, thereby eliminating the osteolysis pathway associated with polyethylene wear particles.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses composite polymeric materials with wear-resistant particulates (oxides, carbides, nitrides) dispersed in the polymer matrix. This composite structure dramatically reduces wear rates compared to conventional polyethylene, minimizing wear debris generation and the subsequent osteolysis response.

Inventive Principle:
Principle #40Composite materials

3Reliability

If metallic and ceramic based implants are used, then fixation to native bone is achieved, but adverse biological reactions occur

Engineering Contradiction:
ImprovefixationVSAvoidadverse biological reactions
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent incorporates porous structures within the polymeric implant material, providing pathways for bone ingrowth and direct mechanical interlocking with the surrounding native bone. This porous architecture achieves reliable fixation while the biocompatible polymeric material eliminates adverse biological reactions associated with metallic and ceramic implants.

Inventive Principle:
Principle #31Porous materials

Solution Approach 2:

The patent employs composite polymeric materials that combine structural integrity with biocompatibility. The polymeric matrix provides chemical inertness and biocompatibility, while embedded phases (fibers, particulates) provide mechanical reinforcement, achieving reliable fixation without the adverse biological reactions (allergies, toxicity, corrosion) associated with metallic and ceramic materials.

Inventive Principle:
Principle #40Composite materials

4Object-affected harmful factors

If polymeric based materials are used, then biocompatibility and radiotransparency are improved, but wear-resistance decreases

Engineering Contradiction:
ImprovebiocompatibilityVSAvoidwear-resistance
Core Design Contradiction:
Object-affected harmful factorsVSStrength

Solution Approach 1:

The patent uses composite polymeric materials where the polymeric matrix (PEEK, PEKK, PES) provides biocompatibility and radiotransparency, while dispersed wear-resistant particulates (oxides, carbides, nitrides) embedded in the matrix dramatically enhance surface wear resistance. This composite approach simultaneously achieves improved biocompatibility and enhanced wear resistance.

Inventive Principle:
Principle #40Composite materials

5Reliability

If functionally graded structure is implemented, then load transfer and bone integration are improved, but manufacturing complexity increases

Engineering Contradiction:
Improveload transferVSAvoidmanufacturing complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent implements a functionally graded structure where material composition and porosity vary spatially within the implant. The region adjacent to native bone has higher porosity (40-60%) to facilitate bone ingrowth and optimize load transfer, while the articulating surface region has lower porosity (10-30%) and enhanced wear-resistant particulate concentration to withstand contact stresses. This local quality variation optimizes both bone integration and wear resistance.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent employs controlled porous structures with gradient porosity distribution, creating regions of varying pore density and size tailored to specific functional requirements. The porous regions near the bone interface promote osteointegration and load transfer, while the graded structure transitions to denser regions at the articulating surface, managing the complexity through functional optimization.

Inventive Principle:
Principle #31Porous materials

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 solution promotes rapid bone ingrowth, improved load transfer, and longer implant service life by creating a physiological bond between the implant and native bone, reducing wear debris and adverse biological responses, thus maintaining bone mineral density and enhancing implant stability.

Implementation Method 1

a porous topography at the bone/implant interface which promotes bone ingrowth

Methodology Applied
Scientific EffectOsteoconduction:

Implementation Method 2

an articulating surface which comprises wear-resistant additives that reduce wear debris

Methodology Applied
Scientific EffectWear resistance: Wear

Data Source

PatentEP3746139B1Functionally graded polymer knee implant for enhanced fixation, wear resistance, and mechanical properties and the fabrication thereof
Publication Date: 2023.07.05 EVONIK OPERATIONS GMBH
  • EP3746139B1 patent drawingFigure 1~2
  • EP3746139B1 patent drawingFigure 3~4
  • EP3746139B1 patent drawingFigure 5~7

AI summary

The present invention comprises a polymeric based femoral and/or tibial component implant to be used in total knee replacement/arthroplasty procedures serving to provide increased wear resistance, enhanced physiological response at the bone/implant interface, and decreased stress-shielding. The implant can be made via additive manufacturing. The articulating surface of the implant may be implemented in without any additive or in a form containing an additive for improved tribological response. Further, the device disclosed herein contains an interfacial surface which is in contact with the native bone (i.e., bone/implant interface) which may exist in its pure form, containing a bioactive additive. The implant has a porous morphology on the bone/implant interface for improved biological response and improved fixation. The depth of the additives and the topographical morphology therein are controlled via techniques disclosed herein.