RF-Heated Conductive Bone Cement for Vertebral Height Restoration
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Solution Overview
Problem
Current treatments for vertebral compression fractures, such as vertebroplasty and kyphoplasty, face challenges with uncontrolled augmentation of vertebral body height and high risks of cement leakage, leading to complications like pulmonary embolism and adjacent vertebral fractures due to the use of high-pressure cement injection and balloon-tamped procedures.
Innovation Solution
The use of RF energy in combination with conductive bone fill material to selectively increase the viscosity of the cement, allowing for controlled flow and geometry of the fill material within the cancellous bone, thereby preventing migration and enhancing vertebral height restoration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Shape
If high-pressure cement injection is used to restore vertebral body height, then vertebral height restoration is improved, but cement leakage risk increases
Solution Approach 1:
The patent changes the physical parameter of the cement from liquid to gel state through controlled polymerization. The cement composition includes polymer beads that swell and gelify the cement matrix, transforming it from a flowable liquid to a semi-solid gel that can be injected at low pressure while maintaining structural support capability and preventing leakage
Solution Approach 2:
The patent performs preliminary polymerization of the cement before injection by mixing polymer beads with the cement monomer to create a pre-gelified composition. This preliminary action allows the cement to maintain gel structure during injection, eliminating the need for high-pressure injection and subsequent polymerization after injection
2Shape
If balloon-tamped procedures are used to augment vertebral body height, then vertebral height restoration is improved, but adjacent vertebral fractures risk increases
Solution Approach 1:
The patent replaces the mechanical balloon-tamping system with a chemical gelification system. Instead of using mechanical force from balloon inflation to restore vertebral height, the patent uses the swelling and gelification of polymer beads to gradually augment the vertebral body, distributing forces evenly and avoiding concentrated mechanical loads that could cause adjacent fractures
3Ease of operation
If low-viscosity cement is used for injection, then ease of injection is improved, but cement migration risk increases
Solution Approach 1:
The patent creates a dynamic viscosity system where the cement transitions from liquid to gel state during and after injection. The polymer beads continuously swell and gelify the cement matrix, allowing easy injection of low-viscosity precursor material that transforms to high-viscosity gel in situ, preventing migration while maintaining ease of injection
Solution Approach 2:
The patent performs preliminary polymerization by pre-mixing polymer beads with cement monomer before injection. This creates a pre-gelified composition that maintains adequate flowability for injection while already having initiated polymerization, reducing the risk of migration compared to fully liquid cement
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
This approach reduces the risk of cement leakage, improves control over vertebral height restoration, and minimizes complications by ensuring the bone cement interdigitates with cancellous bone without compacting it, thus providing a safer and more effective treatment for vertebral compression fractures.
Implementation Method 1
Rf energy in combination a conductive bone fill material for polymerizing the surface of the inflow plume
Implementation Method 2
polymerizing the surface of the inflow plume to control the geometry of the fill material
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 fill material introduced into cancellous bone. A method of treating bone includes injecting a volume of fill material into a bone and selectively modifying a viscosity of the bone filler to control the direction of flow of the fill material within the bone. A system for treating bone using this method includes an introducer for delivering fill material into the bone and an energy source selectively coupleable to the fill material to alter the viscosity of the fill material via an energy emitter in the introducer.