Post Cut Confirmation Device for Bone Alignment Verification
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Solution Overview
Problem
Existing computer-assisted surgical systems face challenges in accurately checking the positional accuracy of bone cuts during procedures like total knee arthroplasty, leading to potential misalignments that can result in poor patient outcomes and increased revision surgeries.
Innovation Solution
A post cut confirmation device with alignment features is used to verify the accuracy of bone cuts by attaching to the bone surface and using a tracked object with a known axis to confirm the orientation of the cut planes against pre-operative data, ensuring alignment with planned cuts.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional registration procedures are used to map surgical plan onto bone position, then the surgical system can prepare bone according to plan, but the positional accuracy of bone cuts cannot be verified in real-time
Solution Approach 1:
Alignment features are pre-defined in the surgical plan with known positions and orientations relative to the bone surface. These features are registered to the surgical system before bone cuts are made, establishing a reference framework for subsequent accuracy verification.
Solution Approach 2:
The surgical system measures the actual positions and orientations of alignment features after bone cuts are performed, then compares these measurements against the pre-defined planned cut parameters. This feedback loop enables real-time verification of cut plane accuracy and allows for corrective action if deviations are detected.
2Manufacturing precision
If multiple planar bone cuts are made to receive femoral prosthesis, then the implant can be properly positioned, but the complexity of ensuring all cuts are correctly aligned increases
Solution Approach 1:
Multiple alignment features are defined within a single coordinate system relative to the bone surface, allowing the surgical system to verify the accuracy of multiple different cut planes (anterior, posterior, distal, chamfer cuts) using a unified reference framework rather than separate alignment procedures for each cut.
3Reliability
If implant alignment is outside clinically acceptable ranges, then patient outcomes worsen and revision surgery increases, but detecting misalignment after bone removal is difficult
Solution Approach 1:
The surgical system replaces manual measurement methods with automated optical or electromagnetic tracking to detect the positions and orientations of alignment features. This enables precise, objective measurement of cut plane accuracy that can detect even small deviations from the planned alignment.
Data Source
AI summary
A device for checking post cut plane accuracy and alignment following bone removal in a bone of a patient during a computer-assisted surgical procedure to create a bone surface is provided. The device includes a body having an axis and adapted to contact the bone surface. One or more alignment features are associated with the body and are accessible when the body is in contact with the bone surface. Each of the one or more alignment features has a known orientation and position relative to the axis. A method for checking post cut plane accuracy and alignment following removal of bone from a patient to create a bone surface during a computer-assisted surgical procedure is also provided. A computer-assisted surgical system is provided that includes a tracking system, a tracked digitizer probe, the aforementioned device, a tracked surgical device, and one or more computers with software for determining the orientation.