Arcuate Nitinol Needle for Vertebral Fracture Stabilization
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Solution Overview
Problem
Current spinal kyphoplasty procedures face challenges in precisely accessing and stabilizing vertebral fractures due to the need for repeated fluoroscopic guidance and trial-and-error methods, which interrupt and delay the procedure.
Innovation Solution
A kyphoplasty device featuring a straight cannula with a nitinol needle having an arcuate distal end that can be inserted through the cannula and return to its curved shape, allowing for precise placement of an inflatable bone tamp and subsequent delivery of bone cement to inaccessible regions of the vertebral body.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a straight cannula is used to access the vertebral body, then the procedure is simpler, but it cannot reach inaccessible regions near the cortical rim
Solution Approach 1:
The needle is designed with a curved distal end portion that allows it to navigate around the cortical rim and reach inaccessible regions of the vertebral body. The curvature enables the needle to follow a non-linear path through the bone, accessing areas that a straight cannula cannot reach while maintaining procedural simplicity.
Solution Approach 2:
The access system is divided into a straight cannula for initial insertion and a separate curved needle for reaching inaccessible regions. This segmentation allows each component to perform its specific function optimally - the straight cannula provides simple initial access while the curved needle extends reach to hidden areas.
2Measurement precision
If fluoroscopic guidance is used repeatedly for positioning, then placement accuracy is improved, but procedural time increases due to repeated interruptions
Solution Approach 1:
The curved needle is pre-formed with the appropriate arcuate shape before insertion, eliminating the need for repeated fluoroscopic adjustments during positioning. The pre-configured geometry ensures accurate placement in a single action, reducing procedural interruptions while maintaining precision.
Solution Approach 2:
The needle's resilient material allows it to self-maintain its arcuate shape after insertion, automatically positioning itself correctly without requiring continuous external guidance or adjustment. The material's memory effect ensures the needle returns to and maintains its intended configuration.
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 precise stabilization and reinforcement of vertebral bodies with reduced procedural interruptions, improving the efficiency and accuracy of vertebral fracture stabilization.
Implementation Method 1
a needle having an arcuate end portion that is flexible enough to be inserted through the channel provided by the straight cannula and resilient enough to return to its arcuate shape upon exiting the straight channel provided through the cannula
Data Source
AI summary
A kyphoplasty device and method offers access and serves as a channel to radially locate sites in the vertebral body using a curved needle made of a material, such as nitinol, which recovers its shape after passing through a straight cannula. The needle serves as a channel facilitating precise positioning of an inflatable bone tamp. The bone tamp creates a void when inflated at the proper location within a nonlinear, arcuate-shaped channel defined by the shape of the needle within the vertebral body. After the bone tamp is deflated and removed, the needle serves as a conduit for delivery of cement into the cavity formed by the bone tamp, without repositioning the needle.