Implant Body with Gas-Phase Release Control Layer

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Solution Overview

Problem

Current implant technologies face challenges such as rejection reactions, poor ingrowth, infection risks due to bacterial contamination, and instability of antimicrobial substances during sterilization, leading to high healthcare costs and regulatory hurdles.

Innovation Solution

An implant body with a surface layer system comprising an active substance carrier layer and a release control layer, where the release control layer reduces the pore opening diameter of the active substance carrier layer without closing the pores, allowing for controlled and prolonged release of antimicrobial agents like antibiotics directly at the implant site.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional sterilization methods (gamma sterilization, high curing temperatures, UV radiation) are used, then sterilization is achieved, but active ingredients are destroyed or changed

Engineering Contradiction:
Improvesterilization effectivenessVSAvoidactive ingredient stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The coating is divided into two distinct layers: a lower active substance carrier layer containing the antibiotic, and an upper release control layer that is sterilization-resistant. This segmentation allows each layer to have optimized properties - the active ingredient layer can be loaded with sensitive substances while the release control layer provides sterilization stability

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The release control layer acts as an intermediary between the sterilization process and the active ingredient layer. It protects the antibiotic-containing layer from direct exposure to damaging sterilization methods while still allowing the implant to be sterilized, thereby preserving the active ingredient's effectiveness

Inventive Principle:
Principle #24Intermediary (Mediator)

2Duration of action of moving object

If active ingredients are fixed on surfaces by modifying with fatty acid, then long-lasting release is achieved, but mechanical abrasion resistance is low

Engineering Contradiction:
Improverelease durationVSAvoidmechanical abrasion resistance
Core Design Contradiction:
Duration of action of moving objectVSStrength

Solution Approach 1:

The coating combines two different materials with complementary properties: the active substance carrier layer (which can be polymer-based for good mechanical properties and abrasion resistance) and the release control layer (which provides controlled release functionality). This composite structure achieves both long-lasting release and mechanical durability

Inventive Principle:
Principle #40Composite materials

3Reliability

If pores are closed to control release, then release control is improved, but active substance release is completely stopped

Engineering Contradiction:
Improverelease control precisionVSAvoidactive substance release amount
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The release control layer is designed with spatially varying properties - it has different thicknesses and densities in different regions, creating zones with different release rates. This allows precise control of where and how fast the active substance is released, while still maintaining overall controlled release functionality

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The release control layer itself is designed as a porous structure with controlled porosity. The pores allow active substance diffusion while the layer's overall structure controls the release rate. This porous design enables release control without completely blocking the pores

Inventive Principle:
Principle #31Porous materials

4Ease of manufacture

If active substance is distributed inhomogeneously, then manufacturing is simpler, but uniform effect is not achieved

Engineering Contradiction:
Improveloading simplicityVSAvoidactive substance distribution uniformity
Core Design Contradiction:
Ease of manufactureVSManufacturing precision

Solution Approach 1:

The manufacturing process utilizes changes in physical parameters (such as concentration gradients, temperature gradients, or pressure gradients) during the loading process to achieve uniform distribution. By controlling these parameters, the active substance is evenly distributed throughout the carrier layer while maintaining manufacturing simplicity

Inventive Principle:
Principle #35Parameter changes

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

This solution enables localized and sustained release of antimicrobial agents, reducing infection risks and eliminating the need for lengthy approval processes, while allowing for sterilization methods that might otherwise damage active ingredients, thus reducing healthcare costs and ensuring effective implant integration.

Implementation Method 1

the delivery control layer being a layer separated from the gas phase

Methodology Applied
Scientific EffectPhysical Vapour Deposition: Physical Vapour Deposition

Implementation Method 2

the pore opening diameter of pores on an implant body is reduced without closing them

Methodology Applied
Scientific EffectCapillary Pressure: Capillary Pressure

Data Source

PatentEP3432941B1Implant body with active substance carrier layer and release control layer
Publication Date: 2020.07.01 FRAUNHOFER GESELLSCHAFT ZUR FORDERUNG DER ANGEWANDTEN FORSCHUNG EV
  • EP3432941B1 patent drawingFigure 1
  • EP3432941B1 patent drawingFigure 2
  • EP3432941B1 patent drawingFigure 3

AI summary

The invention relates to an implant body comprising a substrate (3) and, on the surface thereof, a layer system consisting of an active substance carrier layer (2) and a release control layer (1) arranged on same, said active substance carrier layer having a plurality of open pores (4), and said release control layer (1) being a layer that is deposited from the gas phase and that reduces the area of the pore opening of the pores (4) of the active substance carrier layer (2) without closing them.