Decellularized Tissue Layer for Implant Biocompatibility

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Solution Overview

Problem

Active implants, such as cochlear implants and cardiac pacemakers, often face issues with tissue rejection and scarring, leading to reduced functionality and the need for explantation or replacement, as the body recognizes these implants as foreign and forms scar tissue, which interferes with their sensitivity and operation.

Innovation Solution

A decellularized tissue layer is formed around the implant, composed of extracellular matrix from biological origin, which is immunologically compatible and reduces tissue rejection, providing a matrix for neurite ingrowth and minimizing scar tissue formation, thereby improving implant integration and functionality.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a synthetic implant is used, then the implant provides structural support and functionality, but the body recognizes it as foreign and forms scar tissue, leading to reduced sensitivity and functionality

Engineering Contradiction:
Improveimplant functionalityVSAvoidscar tissue formation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A decellularized tissue layer is introduced as an intermediary between the synthetic implant and the host tissue. This biologic layer serves as a mediator that prevents direct recognition of the synthetic implant as foreign, thereby reducing scar tissue formation while maintaining structural support and implant functionality.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The implant system combines synthetic materials (for structural support) with decellularized biologic tissue (for biocompatibility). This composite structure integrates the advantages of both material types: the synthetic component provides mechanical strength and functionality, while the biologic component reduces immune recognition and scar tissue formation.

Inventive Principle:
Principle #40Composite materials

2Stability of the object's composition

If the implant is firmly integrated with tissue through ingrowth, then the implant provides stable support, but explantation or replacement becomes difficult and disruptive

Engineering Contradiction:
Improveimplant integrationVSAvoidexplantation difficulty
Core Design Contradiction:
Stability of the object's compositionVSEase of repair

Solution Approach 1:

The decellularized tissue layer creates a localized interface with distinct properties: it allows controlled tissue integration at the implant-tissue interface while maintaining a clear boundary that prevents fibrotic encapsulation. This local differentiation enables stable integration where needed while preserving ease of explantation by preventing disruptive scar tissue formation.

Inventive Principle:
Principle #3Local quality

3Measurement precision

If electrodes are placed close to tissue for high sensitivity, then the implant detects signals accurately, but unwanted interactions between stimulation channels occur during neurite ingrowth

Engineering Contradiction:
Improveelectrode sensitivityVSAvoidchannel interactions
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The decellularized tissue layer acts as an intermediary barrier between electrodes and host tissue, enabling close placement of electrodes for high sensitivity while preventing direct tissue ingrowth that would cause channel interactions. This intermediate layer maintains electrical sensitivity while providing physical separation during the neurite ingrowth process.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP3582818B1Decellularised implant coverings
Publication Date: 2023.10.04 FRAUNHOFER GESELLSCHAFT ZUR FORDERUNG DER ANGEWANDTEN FORSCHUNG EV
  • EP3582818B1 patent drawingFigure 1

AI summary

The invention relates to devices and methods for improving the functionality of implants. In particular, the present invention relates to a decellularised tissue of biological origin that is formed into a layer covering an implant. The invention further relates to an implant that is covered by a layer of decellularised tissue, and the use of a decellularised tissue to cover an implant. Finally, the invention relates to a method for improving the functionality of an exchangeable implant while maintaining biocompatibility, comprising the steps of providing a decellularised tissue of biological origin and covering the implant with said decellularised tissue.