Patient-Specific Interbody Implants for Vertebral Fit and Fixation
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Solution Overview
Problem
Traditional orthopedic implants, particularly interbody implants used in spinal fusion surgeries, often fail to provide an optimal fit due to insufficient contact and load transfer between the implant and vertebrae, leading to inadequate fixation, micro- and macro-motions, and increased risk of implant failure, as they are typically selected intraoperatively from a limited set of standard sizes and shapes without consideration for individual patient anatomy.
Innovation Solution
Patient-specific interbody implants are designed using preoperative imaging and surgical planning software to accurately match the negative space between vertebrae, incorporating personalized geometry and internal features for optimal fit and bone integration, reducing the need for intraoperative trialing and minimizing radiation exposure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If standard sizes and shapes of implants are used, then device complexity and inventory management are simplified, but implant fit and contact with vertebrae are insufficient
Solution Approach 1:
Patient-specific implants are designed and manufactured before surgery based on preoperative imaging data (CT or MRI scans). The negative space between vertebrae is measured and the implant is customized to match these dimensions exactly, eliminating the need for intraoperative trial-and-error selection of standard sizes.
Solution Approach 2:
Each implant is tailored to the specific local anatomy of the patient's spine at the target vertebral level. The implant geometry is customized to match the unique negative space, endplate orientations, and vertebral characteristics of that specific location, providing optimal contact and fit for that particular site.
2Adaptability or versatility
If multiple standard implant sizes are stocked, then intraoperative selection flexibility is improved, but logistical burden and costs increase
Solution Approach 1:
The appropriate implant size and geometry are determined before surgery through preoperative planning. This eliminates the need to stock multiple standard sizes, as only the specific patient-matched implant is required, significantly reducing inventory requirements.
Solution Approach 2:
The implant design is created as a custom copy of the patient's specific negative space geometry obtained from imaging data. This unique copy replaces the need for multiple standard implant variants, providing the necessary adaptability without the inventory burden.
3Loss of time
If standard implants are used, then surgical procedure time is reduced, but radiation exposure from intraoperative trialing increases
Solution Approach 1:
Implant selection and sizing are completed during preoperative planning using non-ionizing imaging modalities (CT or MRI). This eliminates the need for intraoperative C-arm fluoroscopy and trial implantation, thereby removing the radiation exposure component while the actual implantation remains efficient.
Solution Approach 2:
The mechanical trial-and-error process involving physical trial implants and C-arm imaging is replaced with a computational design process using preoperative imaging data and surgical planning software. This substitution eliminates radiation exposure while maintaining surgical efficiency.
Data Source
AI summary
A system and computer-implemented method for manufacturing an orthopedic implant involves segmenting features in an image of anatomy. Anatomic elements can be isolated. Spatial relationships between the isolated anatomic elements can be manipulated. Negative space between anatomic elements is mapped before and/or after manipulating the spatial relationships. At least a portion of the negative space can be filled with a virtual implant. The virtual implant can be used to design and manufacture a physical implant.