Orbital Floor Template and Implant Kit

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Solution Overview

Problem

Current craniofacial implant surgery practices involve wastefulness as a separate, high-quality implant is used as a sizing template, which cannot be charged for, due to insurance or patient billing limitations.

Innovation Solution

An orbital floor implant and template kit where the template and implant are packaged together in a single sterile package, with the template made from the same biocompatible high-density polyethylene material as the implant, allowing for sizing without the need for a second implant.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a separate implant is used as a sizing template during surgery, then accurate sizing can be achieved, but material waste and costs increase

Engineering Contradiction:
Improvesizing accuracyVSAvoidimplant material waste
Core Design Contradiction:
Measurement precisionVSLoss of substance

Solution Approach 1:

The implant system is divided into two functional segments: a reusable template component and a disposable implant component. The template is specifically designed for sizing and planning purposes, while the implant is intended for final placement. This segmentation allows the template to be used repeatedly across multiple patients without compromising the sterility or integrity of the actual implant materials.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A template that replicates the geometry and key features of the actual implant is created. This template copy allows surgeons to perform sizing, shaping, and planning procedures without using the expensive, sterile implant material. The template accurately reproduces the implant's form factor and critical dimensions, enabling precise measurement and customization before the actual implant is opened and used.

Inventive Principle:
Principle #26Copying

2Measurement precision

If a second implant is pulled from stock for sizing purposes, then proper sizing can be determined, but surgical workflow efficiency decreases

Engineering Contradiction:
Improveimplant sizingVSAvoidsurgical workflow efficiency
Core Design Contradiction:
Measurement precisionVSProductivity

Solution Approach 1:

The template is prepared in advance and made available in the surgical suite before the actual implant is opened. All sizing, shaping, and planning activities are completed using this pre-prepared template, eliminating the need to pause surgery to retrieve and prepare a second implant from stock. This preliminary preparation of the template streamlines the surgical workflow and maintains efficiency.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The template serves as an intermediary tool between the surgeon's planning needs and the actual implant. Rather than directly using the implant for sizing (which would require opening sterile packaging and risking contamination), the template mediates this interaction by providing all necessary sizing and shaping functions in a non-sterile, reusable format.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Loss of substance

If a non-implant grade material is used for the template, then cost is reduced, but patient safety may be compromised

Engineering Contradiction:
Improvematerial costVSAvoidadverse material introduction
Core Design Contradiction:
Loss of substanceVSObject-affected harmful factors

Solution Approach 1:

The template is constructed from the same biocompatible, implant-grade high-density polyethylene material as the actual implant. This material homogeneity ensures that if any template material were to inadvertently contact the patient (through debris, particles, or contamination), it would be biocompatible and safe. Using the same material for both template and implant eliminates the risk of adverse reactions from non-implant grade materials while still maintaining the template's reusable, cost-effective nature.

Inventive Principle:
Principle #33Homogeneity

Data Source

PatentEP3941543B1Orbital floor template
Publication Date: 2023.12.06 PORIFEROUS
  • EP3941543B1 patent drawingFigure 1~2

AI summary

An orbital floor template packaged along with an implant. The two components are provided together in a single sterile package. This allows the surgeon to pull a single package and have the implant and a pre-sized template available during surgery. This avoids the need to pull a second implant from the operating room materials shelf for sizing purposes only. The template is used during surgery and prevents the need to use a separate, new, sterile, separately-packaged actual implant for sizing purposes.