Patient-Specific Spinal Implants for Safe Pedicle Screw Fixation
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Solution Overview
Problem
Existing spinal implants, particularly pedicle screws, face challenges such as neurovascular injuries, construct loosening, and poor fixation due to mismatched sizes and suboptimal insertion trajectories, especially in osteoporotic bone, leading to increased surgical complications and prolonged recovery.
Innovation Solution
A process for creating patient-specific spinal fixation devices that match the three-dimensional geometry of the patient's target zone, using computer-aided design to produce implants with tailored dimensions and features, such as threadless or threaded designs, to enhance biomechanical stability and safety during implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If standard-sized generic implants are used, then manufacturing cost and availability are improved, but implant fit and biomechanical stability deteriorate due to size discrepancies with target zones
Solution Approach 1:
The patent applies parameter changes by customizing implant dimensions (length, diameter, curvature) based on patient-specific anatomical measurements obtained through imaging. This allows the implant to precisely match the target zone geometry while maintaining manufacturability through standardized manufacturing processes that accommodate variable parameters.
Solution Approach 2:
The patent implements local quality by creating implants with non-uniform dimensions that specifically adapt to the local anatomical variations of the patient's target zone. The implant geometry is customized to match the specific curvature, size, and shape characteristics of the individual patient's anatomy rather than using uniform standard sizes.
2Strength
If larger diameter screws are used to increase fixation strength, then pullout strength is improved, but the risk of cutting through pedicle walls and causing neurovascular injury increases
Solution Approach 1:
The patent applies parameter changes by determining the optimal screw diameter based on the patient's specific pedicle dimensions measured through imaging. This ensures the screw is large enough to provide adequate fixation strength while small enough to fit safely within the pedicle boundaries, avoiding neurovascular structures.
Solution Approach 2:
The patent implements preliminary action by performing preoperative imaging and 3D reconstruction to accurately measure pedicle dimensions before surgery. This allows the surgeon to select the appropriate screw size in advance, ensuring optimal fixation strength while minimizing the risk of injuring neurovascular structures during implantation.
3Object-affected harmful factors
If smaller diameter screws are used to reduce neurovascular injury risk, then safety is improved, but fixation strength and holding power deteriorate
Solution Approach 1:
The patent applies parameter changes by optimizing screw diameter based on the patient's specific anatomy. Rather than using smaller screws for all patients, the system calculates the precise diameter needed to achieve adequate fixation strength while maintaining safety margins from neurovascular structures, ensuring each patient receives the minimum necessary screw size for their specific anatomy.
Solution Approach 2:
The patent implements preliminary action by performing preoperative planning that calculates the optimal screw diameter for each patient based on their pedicle measurements. This allows selection of the smallest screw diameter that still provides adequate fixation strength for that specific patient's bone quality and anatomy, avoiding both oversized and undersized implants.
4Stability of the object's composition
If pedicle screw instrumentation is used to increase spinal stability, then construct stability and healing environment are improved, but the risk of damaging nearby nerves, blood vessels and bones increases
Solution Approach 1:
The patent implements preliminary action by performing preoperative imaging, 3D reconstruction, and virtual implantation planning before surgery. This allows the surgeon to identify safe trajectories that avoid neurovascular structures, select appropriate screw sizes, and plan the optimal insertion path, thereby achieving spinal stability while minimizing the risk of damaging nerves, blood vessels, and bones.
Solution Approach 2:
The patent applies parameter changes by customizing screw dimensions, insertion angles, and trajectories based on the patient's specific anatomy obtained through imaging. This allows optimization of the fixation construct to provide maximum stability while adapting to individual anatomical variations and avoiding critical neurovascular structures.
5Strength
If threaded screw designs are used to improve fixation, then holding power is improved, but the complexity of insertion and risk of trajectory alteration increase
Solution Approach 1:
The patent implements preliminary action by performing virtual implantation planning that determines the optimal insertion trajectory and depth before surgery. This preplanning ensures that threaded screws are inserted along the safest and most effective path, reducing the risk of trajectory alteration during insertion while maintaining optimal holding power.
Data Source
AI summary
The present invention is a process of making a patient-specific implant for a patient. The current process is adaptable to manufacture spinal and other implants for insertion into the patient.