Additively Manufactured Fixation Device with Porous Elements
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Solution Overview
Problem
Existing fixation devices for spinal surgeries face challenges such as poor stability, flexibility, accuracy, and customization, leading to high failure rates and complications due to inadequate bone integration and anatomical mismatch, particularly in complex surgical procedures.
Innovation Solution
A fixation device with porous elements or fenestrations is developed, additively manufactured using biocompatible materials, which facilitates osteo-integration and includes a porosity gradient tailored to patient-specific anatomy, enhancing stability and accuracy through bony ingrowth and customizable design.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If fixation devices are made with solid structure to ensure strength and stability, then mechanical strength is improved, but bone integration and osteo-integration are hindered
Solution Approach 1:
The fixation device incorporates porous elements and fenestrations throughout its structure, allowing bone tissue to infiltrate and integrate with the implant. This porous architecture enables osteo-integration while maintaining sufficient mechanical strength through optimized pore size, distribution, and interconnectivity, resolving the contradiction between solid structural integrity and bone integration capability.
Solution Approach 2:
The device combines solid and porous regions within a single construct, creating a composite structure where solid portions provide mechanical strength and porous portions facilitate bone ingrowth. This composite approach allows simultaneous optimization of both mechanical properties and biological integration, eliminating the need to choose between solid or porous structures.
2Manufacturing precision
If fixation devices are designed with customized features for patient-specific anatomy, then accuracy and adaptability are improved, but device complexity and manufacturing difficulty increase
Solution Approach 1:
The fixation device incorporates adjustable parameters including variable pitch threads, modifiable fenestration patterns, and adjustable porous element distributions that can be customized for different patient anatomies. These parameter changes allow the device to adapt to patient-specific requirements while maintaining a standardized base design, balancing customization with manufacturing complexity.
Solution Approach 2:
The device includes dynamic or adjustable features such as expandable porous elements, reconfigurable fenestrations, or adjustable thread patterns that can be modified during or after implantation to match patient anatomy. This dynamic capability enables customization without requiring entirely different device designs for each patient, reducing overall device complexity.
3Ease of manufacture
If fixation devices lack fenestrations and porous elements to simplify structure, then manufacturing ease is improved, but osteo-integration and stability are reduced
Solution Approach 1:
The fixation device incorporates porous elements and fenestrations throughout its structure, allowing bone tissue to infiltrate and integrate with the implant. This porous architecture enables osteo-integration while maintaining sufficient mechanical strength through optimized pore size, distribution, and interconnectivity, resolving the contradiction between solid structural integrity and bone integration capability.
Solution Approach 2:
The device includes dynamic or adjustable features such as expandable porous elements, reconfigurable fenestrations, or adjustable thread patterns that can be modified during or after implantation to match patient anatomy. This dynamic capability enables customization without requiring entirely different device designs for each patient, reducing overall device complexity.
4Ease of manufacture
If fixation devices are made with standard designs to simplify production, then manufacturing ease is improved, but adaptability to different anatomies and patient needs is reduced
Solution Approach 1:
The fixation device is designed as a universal platform with standardized interfaces and modular components that can be adapted to multiple anatomical locations and patient requirements. The standardized porous architecture and fenestration patterns provide multi-functionality across different applications, enabling a single device design to serve multiple purposes while maintaining ease of manufacture.
Solution Approach 2:
The device includes adjustable parameters such as variable thread pitch, modifiable fenestration patterns, and adjustable porous element distributions that can be customized for different patient anatomies. These parameter changes allow the device to adapt to patient-specific requirements while maintaining a standardized base design, balancing customization with manufacturing complexity.
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 device improves mechanical stability, reduces loosening risks under dynamic loading, and allows for precise placement and orientation, minimizing complications and enhancing surgical efficiency by promoting bony integration and matching patient anatomy.
Implementation Method 1
facilitates osteo-integration and includes a porosity gradient tailored to patient-specific anatomy, enhancing stability and accuracy through bony ingrowth
Data Source
AI summary
The present disclosure includes fixation devices, such as an orthopedic screw or implant, that comprises one or more porous elements or fenestrations to aid in osteo-integration of the fixation device. The fixation device may be additively manufactured using biocompatible materials such that the solid and porous aspects of the screw are fused together into a single construct. In yet another aspect, the fixation device comprises at least a portion or section incorporating a porous structure, which enables bony ingrowth through the porous section/portion of the screw, and thereby facilitates biocompatibility and improve mechanical characteristics. Methods for using the fixation device are also described herein.