RF Polymerized 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, which can lead to complications like pulmonary embolism and adjacent vertebral fractures, due to the lack of precise control over the introduction and distribution of bone cement.
Innovation Solution
A system utilizing RF energy in combination with an electrically conductive bone fill material to polymerize the surface of the inflow plume, controlling the geometry and flow direction of the fill material, and sealing tissue to prevent migration of monomers and emboli, thereby ensuring controlled permeation and interdigitating with cancellous bone to restore vertebral height.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If bone cement is injected into the vertebral body to restore vertebral height, then vertebral height restoration is improved, but cement leakage risk increases
Solution Approach 1:
The system performs preliminary actions by creating a polymerized surface layer on the bone cement before complete injection. The RF energy source initiates polymerization at the cement-bone interface, forming a controlled surface that prevents subsequent cement leakage while allowing continued height restoration through controlled injection.
Solution Approach 2:
The system changes the physical state of the bone cement by controlling polymerization progression. RF energy transforms the cement from a fully flowable state to a partially polymerized state with controlled viscosity gradients, enabling precise control over cement distribution and preventing leakage while maintaining injection capability.
2Force
If high pressure is applied to inject bone cement into compacted cancellous bone, then vertebral height restoration is improved, but cement leakage and emboli formation increase
Solution Approach 1:
The system changes the viscosity parameter of the bone cement through controlled RF polymerization. By creating a gradient from polymerized surface to less viscous interior, the system allows high pressure injection to proceed while the polymerized surface acts as a barrier preventing cement and emboli from leaking into the bloodstream.
Solution Approach 2:
The bone cement becomes a composite material with dual characteristics: a polymerized solid surface layer providing containment, and a less viscous interior maintaining injectability. This composite structure enables high pressure injection while preventing harmful leakage and emboli formation.
3Quantity of substance
If bone cement is allowed to flow freely into cancellous bone, then vertebral body filling is improved, but control over cement geometry and distribution is lost
Solution Approach 1:
The system controls the viscosity parameter of bone cement through spatially and temporally controlled RF polymerization. By adjusting polymerization degree in different regions, the system guides cement flow into desired geometric patterns while maintaining precise control over distribution and preventing unwanted leakage.
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 allows for controlled introduction and distribution of bone cement, reducing the risk of leakage and improving vertebral height restoration, while preventing emboli and enhancing the structural integrity of the vertebrae.
Implementation Method 1
utilizing Rf energy in combination with a conductive bone fill material for polymerizing surface portions of the inflow plume
Implementation Method 2
bone fill material that carries an electrically conductive filler
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. An exemplary system utilizes Rf energy in combination a conductive bone fill material for polymerizing the surface of the inflow plume to control the geometry of the fill material and the application of force caused by inflows of fill material. In another embodiment, method of treating bone includes injecting a volume of fill material into a bone and selectively modifying a viscosity of a selected portion 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 as it flows out of the introducer.