Pre-mixed Bone Substitute for Vertebral Fracture Treatment
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Solution Overview
Problem
Current bone cement and filler materials require immediate mixing before use, leading to complications such as errors in timing and handling issues, and have limited workability, which complicates their application in treating vertebral fractures and other bone-related conditions.
Innovation Solution
Development of pre-mixed, pre-filled bone substitute compositions comprising a mineral component that hardens in an aqueous environment and a non-aqueous component with an aqueous replacement characteristic, allowing for extended workability and simplified delivery without the need for immediate mixing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If bone cement and filler materials require immediate mixing before use, then the materials can be activated and applied, but the workability or handling characteristics are limited to less than 30 minutes
Solution Approach 1:
The bone substitute material is pre-mixed and pre-filled into the delivery device before use. The mineral component and non-aqueous component are combined in advance during manufacturing, eliminating the need for immediate mixing at the point of use. This preliminary action extends the workability duration while reducing the complexity of on-site mixing operations.
2Reliability
If two component materials are mixed immediately prior to use in syringes, then the materials can be applied, but errors in timing and measurement are introduced
Solution Approach 1:
The precise mixing of mineral and non-aqueous components is performed in advance during the manufacturing process under controlled conditions. This eliminates timing errors that would occur if mixing were performed immediately before use, as the pre-mixed material is ready for application without requiring on-site timing coordination.
Solution Approach 2:
The pre-mixed bone substitute material is self-contained within the delivery device, eliminating the need for separate mixing operations. The material brings its own activated state, removing the source of timing and measurement errors associated with on-site mixing of multiple components.
3Reliability
If bone cement is injected into fractured vertebral body to stabilize segments, then pain relief is achieved, but cement extravasation into spinal canal or venous system may occur
Solution Approach 1:
The bone substitute material utilizes parameter changes in its setting mechanism, transitioning from a flowable non-aqueous state for injection to a hardened state upon contact with aqueous body fluids. This controlled parameter change allows the material to maintain stability during injection while ensuring proper setting only in the target bone cavity, reducing the risk of harmful extravasation.
Data Source
AI summary
The present invention relates to novel bone substitute compositions and methods of use. It further encompasses the use of these novel bone substitute compositions for bone augmentation and the treatment of disease conditions. The invention also contemplates a kit including bone substitute compositions and a percutaneous delivery device.