Patient-Specific Skull Base Prostheses with Rigid Core and Flexible Edges

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Solution Overview

Problem

Current skull base reconstruction techniques face challenges in conforming to the specific three-dimensional variations of large defects, leading to instability and a high risk of post-operative cerebrospinal fluid leaks due to the flexibility of materials used in existing methods.

Innovation Solution

A patient-specific prosthetic device with a rigid core and flexible edges, designed using 3D printing and intraoperative neuronavigation, allowing for precise fitting and alignment, and featuring handles for easy maneuvering, is developed to provide a watertight seal and stability during reconstruction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If flexible materials are used for skull base reconstruction, then the material can conform to the defect shape, but the reconstruction becomes unstable and prone to dislodgement

Engineering Contradiction:

Improveconformability to defect shapeVSAvoidreconstruction stability

Core Design Contradiction:

Adaptability or versatilityVSStability of the object's composition

Solution Approach 1:

The invention uses a composite structure combining rigid material (titanium or PEEK) for the core support with flexible material (fascia lata graft) for the sealing surface. This composite approach allows the prosthesis to maintain structural stability while providing conformability to the defect edges, resolving the contradiction between flexibility and stability.

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The prosthesis design applies different material properties to different regions: the central portion uses rigid material for stability and structural support, while the peripheral edges use flexible material for conformability and sealing. This local differentiation of material properties allows each region to perform its specific function optimally.

Inventive Principle:

Principle #3Local quality

2Stability of the object's composition

If rigid materials are used for skull base reconstruction, then structural stability is improved, but the material cannot conform to specific three-dimensional variations of defects

Engineering Contradiction:

Improvestructural stabilityVSAvoidconformability to defect variations

Core Design Contradiction:

Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The prosthesis is custom-designed and manufactured before surgery based on preoperative imaging and defect assessment. This preliminary customization allows the rigid prosthesis to be precisely shaped to match the patient's specific three-dimensional defect variations, ensuring both stability and conformability.

Inventive Principle:

Principle #10Preliminary action

3Manufacturing precision

If custom 3D printed prostheses are manufactured, then precision and fit are improved, but manufacturing complexity increases

Engineering Contradiction:

Improveprosthetic fit precisionVSAvoidmanufacturing process complexity

Core Design Contradiction:

Manufacturing precisionVSDevice complexity

Solution Approach 1:

The invention utilizes advanced 3D printing technologies that can vary material parameters during manufacturing. By changing material properties (from rigid to flexible) at different locations and layers, the complex composite structure is manufactured as an integrated piece, simplifying the overall manufacturing process while achieving high precision.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The 3D printing process serves multiple functions: it shapes the rigid prosthesis body, creates the flexible peripheral components, and integrates all elements into a single customized device. This multi-functionality of the manufacturing process handles the complexity internally while delivering a precise, ready-to-implant prosthesis.

Inventive Principle:

Principle #6Universality (Multi-functionality)

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 solution effectively addresses the challenge of reconstructing complex skull base defects by providing a stable, watertight seal and minimizing the risk of cerebrospinal fluid leaks, while allowing for precise placement and alignment through its flexible and rigid design.

Implementation Method 1

A three-dimensional (3D) printed model of the prosthetic device is created

Methodology Applied

Scientific Effect3D Printing: 3D Printing

Data Source

PatentUS10881513B2Prostheses using individual-specific 3D printed model

Publication Date: 2021.01.05 THE BRIGHAM & WOMEN S HOSPITAL INC

AI summary

A prosthetic device includes a first material and a second material that surrounds a least a portion of the perimeter of the first material. The first material and the second material have a resting shape that is configured to fit a body part on which the prosthetic devices is to be implanted. The second material is deformable to fit the prosthetic device through an opening of the subject smaller than the resting shape to reach the body part. A prosthetic device can be produced by obtaining image data corresponding to a body part of the subject, generating and refining one or more models of a body part based on the image data, and producing the prosthetic device as a three-dimensional print of the refined model.