Fracture Mobility Testing for Vertebral Height Restoration
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Solution Overview
Problem
Current vertebral body augmentation procedures face challenges in restoring height to collapsed vertebral bodies, as the fractured portions often fuse during the healing process, making height restoration impossible without invasive methods.
Innovation Solution
A fracture mobility testing system that uses an expandable balloon to assess the mobility of vertebral body endplates, determining if they can be distracted and if height restoration is feasible, allowing for appropriate procedural decisions such as cement augmentation or more invasive techniques.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If vertebral body augmentation procedures are performed to restore height to collapsed vertebral bodies, then height restoration is achieved, but the fractured portions may have already fused during the healing process, making height restoration impossible without invasive methods
Solution Approach 1:
The system performs a preliminary mobility test before the actual augmentation procedure to assess whether the fractured vertebral portions are still mobile or have already fused. This preliminary assessment guides the surgeon in deciding whether to proceed with height restoration techniques or accept the current vertebral height, thereby avoiding unnecessary invasive procedures while ensuring height restoration is attempted only when feasible.
Solution Approach 2:
The system incorporates a mobility testing mechanism that provides real-time feedback on the mobility of fractured vertebral portions. This feedback information is used to determine the appropriate treatment approach, allowing the surgeon to select between invasive height restoration methods and non-invasive cement augmentation based on the actual mobility status of the fracture fragments.
2Manufacturing precision
If an expandable balloon is inserted into the vertebral body to restore height, then the vertebral body height is restored, but the balloon may be removed allowing for possible settling prior to cement injection and curing
Solution Approach 1:
The system uses a balloon catheter with a specific geometry and material properties that allow it to be expanded within the vertebral body to restore height, while its design includes features (such as a removable nature) that prevent settling before cement injection. The local quality of the balloon's expansion and subsequent removal is controlled to ensure height stability is maintained during the cement curing process.
Solution Approach 2:
The balloon is expanded as a preliminary action to restore vertebral height before cement injection. The system is designed so that the balloon can be removed after a controlled period, and the vertebral body is then ready for cement injection without allowing for settling, thereby maintaining height stability throughout the procedure.
3Adaptability or versatility
If a mesh-based system with an expandable mesh graft balloon is used, then material delivery is provided within the vertebral body, but the system complexity increases
Solution Approach 1:
The system employs an expandable mesh graft balloon that serves multiple functions: it acts as a containment device within the vertebral body, provides a scaffold for material delivery, and maintains structural integrity during the augmentation procedure. This multi-functionality reduces the need for separate devices, thereby managing complexity while enhancing adaptability.
Solution Approach 2:
The mesh-based system utilizes porous or permeable containment devices that allow material delivery through their structure. The porous nature of the mesh graft balloon enables it to provide both containment and material delivery capabilities, reducing the need for additional separate components and thus managing system complexity.
4Manufacturing precision
If the balloon is removed after expansion, then the vertebral body may return to its collapsed position, but height restoration is achieved during the procedure
Solution Approach 1:
The balloon is expanded as a preliminary action to restore vertebral height before the cement injection and curing process. The system is designed so that the balloon is removed after a controlled period when height restoration has been achieved, and the subsequent cement curing maintains the restored height, preventing the vertebral body from returning to its collapsed position.
Solution Approach 2:
The system incorporates monitoring mechanisms that provide feedback on the vertebral body position during and after balloon removal. This feedback ensures that the height restoration is maintained and allows for timely intervention if the vertebral body begins to collapse again, thereby maintaining stability while achieving height restoration.
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
Enables surgeons to determine the feasibility of height restoration and choose the best treatment approach, preventing further collapse and stabilizing the vertebral body, while avoiding unnecessary invasive procedures.
Implementation Method 1
an expandable balloon to assess the mobility of vertebral body endplates, determining if they can be distracted
Implementation Method 2
The balloon is removed, leaving a void within the vertebral body
Data Source
AI summary
A fracture mobility testing system is provided for use in surgical procedures for augmenting vertebral bodies having collapsed due to compression fractures. The testing system is utilized to determine if the cortical shell of the vertebral body has begun to heal over the fracture lines to the point at which height restoration is not possible. Depending on the feedback provided by the testing system, the surgeon may elect to proceed with any of a variety of known height restoration techniques if the fractured portions of the vertebral body are still mobile, or may elect for a simple vertebroplasty procedure without height restoration if the feedback from the testing system determines that the cortical outer portions of the fractured vertebral body have fused to one another to the point at which height restoration is no longer an option.