Steerable Vertebroplasty Needle Deflection for Cement Placement
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Solution Overview
Problem
Current bone cement delivery systems for vertebroplasty and kyphoplasty procedures are limited by the need for rapid and controllable deployment of bone cement to effectively treat vertebral compression fractures, with existing systems facing challenges in achieving precise placement and stability, leading to potential complications such as bone marrow/PMMA ejection through micro-fractures.
Innovation Solution
A steerable vertebroplasty device and system featuring a deflectable injection needle with a cement dispensing pump and mixing nozzle, allowing for controlled injection of bone cement with varying particle concentrations, enabling precise placement and stabilization of the vertebral body through a two-step injection process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a standard injection needle is used for bone cement delivery, then the device structure is simple, but the placement precision and controllability are insufficient leading to potential complications
Solution Approach 1:
The injection needle is divided into multiple segments including a proximal shaft, a deflectable distal section, and a tip section. The deflectable section can be independently controlled to change orientation, allowing precise placement while maintaining a relatively simple overall structure. This segmentation enables controlled deflection without requiring complex mechanical systems throughout the entire needle.
Solution Approach 2:
The distal section of the needle is designed to be deflectable rather than rigid, allowing it to dynamically adjust its orientation during injection. This dynamic capability enables the needle to navigate and position itself precisely within the vertebral body while maintaining structural simplicity through elastic deformation rather than complex mechanical joints.
2Productivity
If bone cement is injected rapidly to stabilize the vertebra, then the productivity is improved, but the control over cement distribution is reduced leading to potential ejection through micro-fractures
Solution Approach 1:
The deflectable distal section allows the injection needle to dynamically adjust its orientation during the injection process. This enables the operator to control cement distribution by adjusting the needle angle in real-time, preventing ejection through micro-fractures while maintaining rapid injection speeds for productivity.
Solution Approach 2:
The system provides tactile and visual feedback to the operator about needle position and cement flow characteristics. This feedback mechanism allows real-time adjustment of injection parameters and needle orientation, ensuring reliable cement distribution control even during rapid injection procedures.
3Strength
If a two-step injection process with varying particle concentrations is used, then the structural stability is improved, but the procedure time and complexity increase
Solution Approach 1:
The bone cement is segmented into different particle concentration formulations. The first injection uses cement with higher particle concentration for structural framework, while the second injection uses cement with lower particle concentration for filling and stabilization. This segmentation of material properties enables improved structural stability while the rapid injectable formulation minimizes procedure time.
Solution Approach 2:
The particle concentration parameter of the bone cement is changed between the two injection steps. By optimizing the particle size distribution and concentration in each step, the system achieves rapid setting times for both injections, reducing overall procedure time while improving structural stability through the graduated particle concentration approach.
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
The system enables precise and controlled delivery of bone cement, forming a stable shell to prevent bone marrow/PMMA ejection, effectively stabilizing the vertebral body and reducing the risk of complications, with the cement hardening within minutes to provide structural support.
Implementation Method 1
When the powder and liquid monomer are mixed, an exothermic polymerization takes place resulting in the formation of a 'dough-like' material
Data Source
AI summary
Methods and devices for augmenting bone, such as in performing vertebroplasty are disclosed. A bone cement injection needle is provided, having a laterally deflectable distal end. Systems are also disclosed, including the steerable injection needle, introducer and stylet. The system may additionally include a cement delivery gun, one-time use disposable cement cartridges and a cement mixing chamber. Methods are also disclosed.