Radio-Opaque Markers in 3D Printed Implants

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Solution Overview

Problem

Radiolucent materials used in 3D printing of implantable medical devices, such as PEEK and PEKK, are not visible on medical images, requiring additional radio-opaque markers that can weaken the implant structure and provide inadequate information about its features and orientation.

Innovation Solution

A 3D printing method that integrates radio-opaque markers made from materials like barium, iodine, or tantalum with thermoplastic materials during the printing process, allowing for visible markers on medical imaging without compromising the implant's strength.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If radio-opaque markers are added to the implant after manufacturing, then the implant becomes visible on medical images, but the additional holes drilled into the implant weaken the structure

Engineering Contradiction:

Improvevisibility on medical imagesVSAvoidstructural strength

Core Design Contradiction:

ReliabilityVSStrength

Solution Approach 1:

The patent combines the radio-opaque marker integration with the implant manufacturing process itself, merging two separate operations (manufacturing and marker addition) into one. The markers are deposited directly during 3D printing, eliminating the need for post-manufacturing hole drilling and marker insertion, thereby preserving structural strength while achieving visibility on medical images

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The patent performs the marker integration action in advance during the manufacturing process rather than afterward. By incorporating radio-opaque materials into the thermoplastic material before or during printing, the markers are positioned and secured without requiring subsequent structural modifications that would compromise implant integrity

Inventive Principle:

Principle #10Preliminary action

2Reliability

If traditional radio-opaque pins are used, then the implant becomes visible on medical images, but inadequate information about functions, features, and orientation is provided

Engineering Contradiction:

Improvevisibility on medical imagesVSAvoidinformation about functions, features, and orientation

Core Design Contradiction:

ReliabilityVSLoss of information

Solution Approach 1:

The patent applies different properties to different parts of the implant by strategically placing radio-opaque markers at specific locations corresponding to important features, functions, and orientation indicators. This localized approach allows various implant characteristics to be visualized on medical images without requiring uniform marker distribution throughout the entire implant

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The patent uses variations in radio-opaque material deposition to create different marker densities and patterns that encode information about implant features and orientation. By varying the concentration, shape, and arrangement of radio-opaque markers, rich information is conveyed on medical images without adding physical complexity to the implant structure

Inventive Principle:

Principle #32Color changes

3Ease of manufacture

If PEEK or PEKK materials are used for 3D printing, then complex implant structures can be manufactured, but the materials are radiolucent and do not appear on medical images

Engineering Contradiction:

Improvecomplex structure manufacturingVSAvoidvisibility on medical images

Core Design Contradiction:

Ease of manufactureVSReliability

Solution Approach 1:

The patent creates a composite material system by combining radiolucent thermoplastic materials (PEEK or PEKK) with radio-opaque materials. The thermoplastic provides the structural framework and biocompatibility, while the radio-opaque materials embedded within or on the surface provide visibility on medical images, achieving both manufacturing flexibility and imaging capability

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The patent modifies the material properties by changing the composition of the thermoplastic material to include radio-opaque additives. This parameter change allows the material to maintain its excellent mechanical properties and 3D printability while gaining the ability to be visualized on medical images through the incorporated radio-opaque components

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

The method enables clear visualization of implant features and orientation on medical images, enhancing positioning and post-operative assessment without compromising the structural integrity of the implant.

Implementation Method 1

A variety of three-dimensional (3D) printing processes may be used to create 3D objects, such as implantable medical devices

Methodology Applied

Scientific Effect3D Printing: 3D Printing

Data Source

PatentUS11523910B2Radio-opaque markers in additively manufactured implants

Publication Date: 2022.12.13 WARSAW ORTHOPEDIC INC

AI summary

An approach is provided for a three-dimensional (3D) printing method for forming a 3D object. The approach provides for printing a structure of the 3D object by depositing a thermoplastic material, in which the thermoplastic material is radiolucent. The approach provides for printing one or more radio-opaque markers by depositing another material, which includes at least a radio-opaque material. The approach integrates the one or more radio-opaque markers with the structure of the 3D object.