RF-Controlled Bone Cement for Vertebral Height Restoration
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Solution Overview
Problem
Current vertebroplasty and kyphoplasty procedures for treating vertebral compression fractures lack control over cement introduction and vertebral body height restoration, leading to complications such as leakage, pulmonary embolism, and incomplete fracture reduction due to high pressure balloon inflation and uncontrolled cement distribution.
Innovation Solution
A system utilizing RF energy with conductive bone cement and a controller to selectively polymerize the cement inflow plume, controlling its geometry and flow direction, thereby preventing leakage and enhancing vertebral body height restoration by distributing forces evenly across the endplates.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Shape
If high pressure balloon inflation is used to restore vertebral body height, then vertebral height restoration is achieved, but cement leakage and pulmonary embolism occur
Solution Approach 1:
The balloon is inflated first to restore vertebral body height and create space, then cement is injected into the pre-created cavity. This preliminary action prevents uncontrolled cement distribution and leakage while achieving height restoration.
Solution Approach 2:
The balloon acts as an intermediary tool that first restores vertebral height and then serves as a template for controlled cement injection. The balloon cavity confines the cement, preventing leakage while maintaining the restored shape.
2Productivity
If uncontrolled cement distribution is used to fill vertebral body, then filling efficiency is improved, but incomplete fracture reduction and height loss occur
Solution Approach 1:
The system uses real-time monitoring of cement injection parameters and balloon expansion to control cement distribution. Feedback control ensures precise cement placement while maintaining filling efficiency, achieving both speed and accuracy.
Solution Approach 2:
The balloon is dynamically adjusted during the procedure - inflated to restore height, then used as a dynamic constraint during cement injection. This dynamic control enables both efficient filling and precise fracture reduction.
3Speed
If rapid cement injection is used to prevent polymerization, then injection speed is improved, but cement distribution control and leakage prevention worsen
Solution Approach 1:
The balloon cavity is created first, providing a pre-defined space for cement injection. This allows slower, more controlled injection rates while preventing polymerization issues, as the cement has a confined space to distribute evenly.
Solution Approach 2:
The balloon cavity serves as an intermediary containment space that enables controlled cement injection at optimal speeds. The cavity walls guide cement distribution, maintaining geometric control while allowing sufficient injection speed to prevent premature polymerization.
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 effectively prevents cement leakage, seals tissue to prevent emboli, and achieves controlled vertebral body height restoration by altering the viscosity of the cement in real-time, reducing complications and improving treatment outcomes.
Implementation Method 1
A bone treatment system utilizes an Rf energy source in combination a conductive bone cement and a controller for controlling cement inflow parameters and energy delivery parameters for selectively polymerizing the cement inflow plume
Implementation Method 2
A bone treatment system utilizes an Rf energy source in combination a conductive bone cement
Data Source
AI summary
The present invention relates in certain embodiments to medical devices for treating osteoplasty procedures such as vertebral compression fractures. More particularly, embodiments of the invention relate to instruments and methods for controllably restoring vertebral body height by controlling the geometry of bone cement introduced into the interior of a vertebra. An exemplary system utilizes Rf energy in combination a conductive bone cement for polymerizing the inflow plume to control the geometry of the fill material and the application of force caused by inflows of cement. In another embodiment, a method of treating bone includes utilizing a controller to control (i) bone cement inflow parameters and (ii) energy delivery parameters selectively modify the viscosity of a selected portion of bone cement as it is introduced. A system for treating bone includes an introducer for delivering bone and an energy source selectively coupleable to the bone cement to alter the viscosity of the fill material as it flows out of the introducer. One method includes pulsing the inflows of bone cement and further applying pulsed aspiration forces to the interior of the vertebra to relieve interior pressures to prevent emboli from migrating into the venous system.