Vacuum Formed Biocompatible Polymer Auricular Scaffolds

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Solution Overview

Problem

Current methods for reconstructing auricles in microtia cases using autologous cartilage are limited by symmetry issues, donor site morbidity, unpredictable cosmetic results, and the lack of structural integrity in crushed cartilage grafts, while 3D-printed scaffolds face challenges in representing anatomic features and are costly.

Innovation Solution

A method involving vacuum forming of biocompatible polymer sheets over customized molds created from patient-specific data, using materials like PLGA or PLLA, to produce auricular scaffolds that can be packed with crushed cartilage, offering improved symmetry and cost-effectiveness.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If 3D printing is used to create auricular scaffolds, then structural integrity and shape accuracy are improved, but manufacturing cost increases and anatomic feature representation is limited due to resolution constraints

Engineering Contradiction:

Improveanatomic feature representationVSAvoidmanufacturing cost

Core Design Contradiction:

Manufacturing precisionVSEase of manufacture

Solution Approach 1:

The patent uses vacuum forming to create a precise copy of the auricular cartilage anatomy by forming a polymer sheet over a master model or 3D scan. This copying approach achieves superior anatomic feature representation compared to direct 3D printing, while the vacuum forming process itself is more cost-effective than high-resolution medical-grade 3D printing.

Inventive Principle:

Principle #26Copying

Solution Approach 2:

The patent changes the manufacturing parameter from additive layer-by-layer deposition (3D printing) to thermal forming (vacuum forming). By heating the biocompatible polymer sheet to its glass transition temperature and then applying vacuum, the material becomes pliable and conforms precisely to the mold, achieving high manufacturing precision at lower cost.

Inventive Principle:

Principle #35Parameter changes

2Reliability

If autologous costal cartilage is harvested for reconstruction, then tactile fidelity is improved, but donor site morbidity and surgical complexity increase

Engineering Contradiction:

Improvetactile fidelityVSAvoiddonor site morbidity

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces a biocompatible polymer scaffold as an intermediary structure that provides the structural framework and tactile properties needed for auricular reconstruction. This scaffold serves as a mediator between the need for structural integrity and the desire to avoid donor site morbidity, eliminating the need for cartilage harvesting while maintaining tactile fidelity.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent uses porous biocompatible polymer materials for the scaffold construction. These porous materials allow for tissue ingrowth and provide appropriate mechanical properties that mimic native cartilage, achieving tactile fidelity without requiring autologous cartilage harvest. The porosity also facilitates integration with surrounding tissues.

Inventive Principle:

Principle #31Porous materials

3Object-affected harmful factors

If crushed autologous cartilage grafts are used, then donor site morbidity is reduced, but structural integrity and shape maintenance are compromised

Engineering Contradiction:

Improvedonor site morbidityVSAvoidstructural integrity

Core Design Contradiction:

Object-affected harmful factorsVSStrength

Solution Approach 1:

The patent employs a nested structure where crushed autologous cartilage grafts are placed inside the biocompatible polymer scaffold. The scaffold acts as an outer container that provides structural integrity and shape maintenance, while the crushed cartilage fills the internal space. This nesting approach allows the use of less invasive cartilage harvesting while maintaining the structural strength needed for proper auricular reconstruction.

Inventive Principle:

Principle #7Nested doll (Nesting)

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 provides auricular scaffolds that accurately represent anatomic features, reduce donor site morbidity, and improve cosmetic outcomes while being more cost-effective than traditional 3D printing methods, enhancing the structural integrity and symmetry of reconstructed auricles.

Implementation Method 1

A biocompatible polymer sheet is then heated to a first temperature

Methodology Applied

Scientific EffectHeating: Heating

Implementation Method 2

A vacuum is then applied to the biocompatible polymer sheet that was heated to draw the biocompatible polymer sheet over the mold

Methodology Applied

Scientific EffectVacuum: Vacuum

Implementation Method 3

The biocompatible polymer sheet that was drawn over the mold is then cooled below the first temperature to fix the shape representing the auricular cartilage in the polymer sheet

Methodology Applied

Scientific EffectCooling: Cooling

Data Source

PatentUS20220338993A1Vacuum forming of thermoplastic bioabsorbable scaffolds for use in auricular reconstruction

Publication Date: 2022.10.27 JOHNS HOPKINS UNIVERSITY

AI summary

Provided is a polymeric auricular scaffold for use in auricular implants and methods for making them. The disclosed polymeric auricular scaffold is formed using a biocompatible polymer sheet that is vacuumed formed into a shape representing auricular cartilage using a vacuum forming mold.