Intraoperative Bone Strength Measurement for Spinal Fixation
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Solution Overview
Problem
Current methods for assessing bone quality during spine surgery, such as DEXA scans, are inadequate as they cannot be performed intraoperatively and do not provide accurate measurements of bone strength, leading to increased risks of complications in osteoporotic patients.
Innovation Solution
A medical device that measures bone quality and strength intraoperatively by inserting into the bone at the implant fixation site, providing visual, auditory, and tactile feedback based on torque and force sensors, and allowing for direct measurements at multiple sites with orientation consistent with implant loading.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If DEXA scan is used to measure bone density, then bone density can be measured, but it cannot be performed intraoperatively and does not provide accurate measurements of bone strength
Solution Approach 1:
The patent replaces the mechanical DEXA scanning system with a torque-based mechanical measurement system. A torque sensor directly measures the torque required to insert a screw into the bone, providing a direct mechanical measurement of bone strength that can be performed intraoperatively during the surgical procedure itself.
Solution Approach 2:
The patent introduces a torque sensor as an intermediary device between the surgical implant and the bone. This sensor acts as a mediator that captures the mechanical interaction forces during screw insertion and translates them into quantitative bone strength measurements that can guide surgical decision-making.
2Productivity
If surgeons proceed with surgery without knowing exact bone strength, then surgery can be performed, but risks of complications increase in osteoporotic patients
Solution Approach 1:
The patent performs bone strength measurement as a preliminary action before final implant placement. The torque measurement is conducted during the surgical procedure before the surgeon commits to the implantation decision, allowing real-time assessment and adjustment of surgical planning based on actual bone quality at the specific surgical site.
Solution Approach 2:
The patent implements a feedback mechanism where torque measurement results are provided to the surgeon during the procedure. This feedback loop allows the surgeon to adjust surgical decisions, such as selecting different implant types or modifying insertion techniques, based on real-time bone strength data, thereby improving surgical outcome reliability.
3Loss of information
If preoperative DEXA scan is ordered, then bone density information can be obtained, but it is not routinely recommended and may not reflect actual bone quality at surgical site
Solution Approach 1:
The patent applies the local quality principle by measuring bone strength at the specific surgical site where the implant will be placed, rather than using a general DEXA scan of the entire skeleton. The torque sensor provides localized mechanical properties of the bone at the exact location of interest, accounting for local variations in bone density and quality that systemic scans cannot detect.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables surgeons to make informed decisions about orthopedic hardware placement, reducing the risk of complications by ensuring the bone strength meets minimum thresholds, and allowing for real-time adjustments to surgical techniques.
Implementation Method 1
a torque sensor that measures the torque applied during screw insertion
Implementation Method 2
a force sensor that measures the force applied during bone interaction
Data Source
AI summary
Provided are bone quality and/or strength measuring devices. In some embodiments, the devices include a body and a detector disposed therein designed to interact with a bone, determine the quality and/or strength thereof, and communicate an evaluation thereof to a user. The presently disclosed devices can also include a torque and/or force sensor that facilitates placement of the device and/or that is in communication with the detector to cause the detector to evaluate the bone; an output that feedback to a user based on the quality and/or strength of the bone determined by the detector, and/or a piston that interacts with the detector to cause the detector to interact with and thereby evaluate the bone. Also provided are methods for determining if a region of a bone is appropriate for placement of an orthopedic hardware piece and methods for reducing risk of a complication of spinal surgery associated with failure of an orthopedic hardware piece.