Patient-Specific Surgical Guides for Fluoroscopy-Free Alignment
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Solution Overview
Problem
Existing surgical procedures for total joint replacement rely heavily on intra-operative fluoroscopy, which increases surgery time and exposes patients to ionizing radiation, posing risks and inefficiencies.
Innovation Solution
Customized surgical guides and fixtures are developed using patient-specific imaging data to accurately align orthopedic procedures, reducing the need for fluoroscopy by utilizing patient-specific surgical instruments that conform to the patient's anatomy and any foreign objects, such as implants, to enhance precision and safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If intra-operative fluoroscopy is used to check alignment of intramedullary cavities, then measurement precision is improved, but loss of time increases and object-affected harmful factors increase
Solution Approach 1:
Patient-specific guides are fabricated before surgery based on preoperative imaging data. These guides incorporate patient-specific anatomical surface features and are designed to self-align with the patient's anatomy, eliminating the need for intraoperative fluoroscopy to verify alignment. The alignment determination is performed preliminarily through computer-based planning and manufacturing.
Solution Approach 2:
The patent replaces the mechanical/physical fluoroscopy-based alignment verification system with a computer-based planning and patient-specific guide system. Alignment is determined through digital modeling and custom-fitted guides rather than repeated fluoroscopic imaging during surgery.
2Measurement precision
If intra-operative fluoroscopy is used to check alignment of intramedullary cavities, then measurement precision is improved, but object-affected harmful factors increase
Solution Approach 1:
All alignment measurements and planning are completed before surgery using preoperative imaging (CT or MRI scans). Patient-specific guides are manufactured with predetermined alignment features based on this preliminary data, eliminating the need for repeated fluoroscopic exposure during the surgical procedure.
Solution Approach 2:
The patent substitutes fluoroscopy-based alignment verification with a computer-aided design and patient-specific guide system. Alignment is determined through digital planning and physical guides that conform to patient-specific anatomy, replacing the harmful radiation-based measurement method with a non-ionizing alternative.
3Manufacturing precision
If customized patient-specific guides are used, then manufacturing precision is improved, but device complexity increases
Solution Approach 1:
Patient-specific guides incorporate localized anatomical surface features that are unique to each patient's anatomy. The guides are designed with specific surface contours, landmarks, and geometric features that match the patient's individual bone surfaces, providing precise localization without requiring complex overall device structures.
Solution Approach 2:
The patient-specific guides are created as physical copies or representations of the patient's anatomical surfaces based on preoperative imaging data. The guides replicate key anatomical landmarks and surface features, allowing direct physical comparison and alignment during surgery without complex computational systems in the operating room.
Data Source
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AI summary
A surgical device includes a body having a first side with a first surface that is complementary to a surface of a foreign object disposed within a patient based on preoperative imaging of the patient. The body defines at least one hole positioned relative to the body to facilitate insertion of an elongate device at a predetermined location relative to the foreign object.