Patient-Specific Fibula Malleolus Cap for Osteotomy Guide Alignment

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Solution Overview

Problem

Current methods for jaw reconstruction using fibula free flaps face challenges with sliding and rotational errors due to the geometric variations of the fibula and soft tissue interference, leading to inaccuracies in positioning the fibula harvest guide.

Innovation Solution

The development of patient-specific fibula malleolus caps connected to osteotomy guides via connecting bars, which are designed to fit the morphology of the lateral malleolus and reduce errors by providing precise alignment and angulation during fibula harvesting.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional measurement methods from lateral malleolus are used to locate fibula harvest guide, then the surgical procedure is simple to perform, but sliding and rotational errors occur leading to positioning inaccuracy

Engineering Contradiction:
Improvepositioning accuracy of fibula harvest guideVSAvoidcomplexity of surgical device
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The surgical device is segmented into distinct functional components: a malleolus cap that fits the lateral malleolus, a connecting bar for rigid attachment, and an osteotomy guide for precise cutting. This segmentation allows each component to perform its specific function optimally while maintaining overall positioning accuracy.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The malleolus cap acts as an intermediary element between the lateral malleolus and the osteotomy guide. It provides a stable reference point on the rounded malleolus surface, eliminating direct measurement errors from the irregular malleolus geometry while transmitting positional information accurately to the guide.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Manufacturing precision

If fibula harvest guide is positioned without patient-specific morphology fitting, then the device is easier to manufacture, but sliding errors occur due to geometric variations of fibula

Engineering Contradiction:
Improvefitting precision to lateral malleolusVSAvoidease of manufacturing malleolus cap
Core Design Contradiction:
Manufacturing precisionVSEase of manufacture

Solution Approach 1:

The malleolus cap is designed with local quality specific to each patient's anatomy. The inner surface morphology is customized to match the patient's lateral malleolus geometry, providing optimal fit and stability at the specific location while the rest of the device can be manufactured using standard processes.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The device incorporates patient-specific parameters obtained from preoperative imaging (CT or MRI scans). These parameters define the unique geometry of the lateral malleolus, allowing the malleolus cap to be customized for each patient while maintaining manufacturability through digital modeling and additive manufacturing technologies.

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If conventional osteotomy guide positioning is used, then the surgical workflow is simpler, but rotational errors occur due to rounded shape of fibula cross-section

Engineering Contradiction:
Improveangular accuracy of osteotomyVSAvoidease of positioning osteotomy guide
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The malleolus cap is pre-positioned on the lateral malleolus to establish a stable reference frame before the osteotomy guide is attached. This preliminary action eliminates rotational degrees of freedom and ensures correct angular orientation of the subsequent osteotomy cuts according to the virtual surgical plan.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The connecting bar serves as a mediator that rigidly connects the pre-positioned malleolus cap to the osteotomy guide. This intermediary component ensures that the angular relationship established by the cap is accurately transmitted to the guide, preventing rotational errors during osteotomy while maintaining ease of operation.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP4082453B1Surgical device with patient-specific fibula malleolus cap
Publication Date: 2025.06.11 VERSITECH LTD
  • EP4082453B1 patent drawingFigure 1A~1F
  • EP4082453B1 patent drawingFigure 2A~2C
  • EP4082453B1 patent drawingFigure 2D~2F

AI summary

Described are fibula malleolus caps and surgery devices with fibula malleolus caps. The fibula malleolus caps may be patient-specific fibula malleolus caps. The devices with patient-specific fibula malleolus caps overcome the sliding and rotational errors during fibula flap harvesting. A comparative clinical study demonstrates that the fibula malleolus cap enhances the accuracy of fibula flap harvesting, leading to accurate location and angulation of simultaneous dental implants.