Patient-Matched Modular Implants for Precise Spinal Placement
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Solution Overview
Problem
Existing surgical procedures face challenges in accommodating the unique and irregular anatomical features of patients, particularly in orthopedic surgeries, leading to difficulties in implant placement and risk of damaging sensitive anatomical structures like para-spinal nerves during minimally invasive spinal surgery.
Innovation Solution
Development of patient-specific or patient-matched surgical devices, including modular implants and instruments, that are customized based on MRI or CT data to conform to individual patient anatomy, allowing precise placement and orientation, and incorporating augmented reality systems for enhanced surgical planning and execution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If standard implants and instruments are used in surgical procedures, then device availability and ease of manufacture are improved, but the ability to accommodate unique and irregular anatomical features of patients deteriorates
Solution Approach 1:
Patient-specific anatomical data is acquired through imaging (CT, MRI) before surgery, and 3D models are created in advance. This preliminary action allows the surgical plan and implant design to be customized based on the patient's unique anatomy before the actual surgical procedure, resolving the contradiction between standard device availability and anatomical adaptability
Solution Approach 2:
The implant system is divided into modular components including patient-specific instruments and standard implant components. The patient-specific portion is customized to match anatomical features, while standard components maintain manufacturing efficiency. This segmentation allows combination of customized and standardized elements
2Adaptability or versatility
If patient-specific customized devices are created based on MRI or CT data, then the ability to accommodate unique anatomical features is improved, but device complexity and manufacturing difficulty increase
Solution Approach 1:
Only the portions of the surgical system that directly contact or interact with patient-specific anatomy are customized (e.g., guide templates, positioning devices). Other portions use standard components, thereby achieving local customization where it is most needed while minimizing overall device complexity
Solution Approach 2:
The patient-specific instruments are designed to perform multiple functions within the surgical workflow (guiding, positioning, measuring) rather than requiring separate specialized tools for each function. This multi-functionality reduces the number of complex custom components needed
3Adaptability or versatility
If multiple device configurations are used to accommodate different anatomical features, then adaptability is improved, but surgical time and costs increase
Solution Approach 1:
The optimal implant configuration and surgical approach are determined in advance through 3D modeling and virtual surgical planning. This preliminary determination eliminates the need to decide among multiple configurations during surgery, thereby reducing surgical time while maintaining adaptability to patient-specific anatomy
Solution Approach 2:
Patient-specific guide templates and positioning devices serve as intermediaries that translate the pre-planned implant configuration into precise physical placement. These guides ensure that the predetermined configuration is accurately executed without requiring multiple trial devices or adjustments during surgery
4Ease of operation
If standard surgical approaches are used, then ease of operation is improved, but the risk of damaging sensitive anatomical structures increases
Solution Approach 1:
The precise trajectory and positioning of surgical instruments are predetermined through 3D modeling and virtual surgical planning based on patient-specific anatomy. This preliminary planning identifies safe zones and critical structures, allowing surgeons to follow pre-determined safe trajectories without complex intraoperative adjustments, thereby maintaining ease of operation while reducing nerve damage risk
Solution Approach 2:
Patient-specific guide templates and positioning devices act as intermediaries that physically constrain and guide surgical instruments along pre-calculated safe trajectories. These guides prevent inadvertent deviation into dangerous zones near nerves and critical structures, providing passive safety without complicating the surgical procedure
Data Source
AI summary
The following relates to patient-specific or patient-matched, customized apparatus for use in surgical procedures, including various interbody procedures. The patient-matched apparatus may be a modular implant, a monolithic implant, and may include an instrument for use in procedures involving a modular or monolithic implant. One or more patient-matched apparatus described herein may be configured for use with a guide, with robotic instrumentation, or with augmented reality system.