Internal Bone Fixation Device with Integrated Cement Mixer
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Solution Overview
Problem
Conventional bone cement injection devices are cumbersome, time-consuming, and prone to leakage, with the mixing process introducing air bubbles and monomer vapor, leading to complications such as soft tissue damage and respiratory issues during bone fracture repair.
Innovation Solution
A system comprising a delivery catheter with an expandable internal bone fixation device that mixes two-component bone cement in situ, minimizing air exposure and leakage, using a mixing element with a spinning mechanism to ensure uniform mixing and curing within the device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional bone cement mixing and transfer process is used, then bone cement can be delivered to fracture site, but significant amounts of monomer liquid vapor are introduced into ambient air causing respiratory issues
Solution Approach 1:
The mixing element is inserted through the delivery catheter into the mixing vessel, creating a nested configuration where the mixing element is contained within the catheter which is contained within the mixing vessel. This nested structure allows mixing to occur in a closed system, preventing monomer vapor escape into the ambient air while enabling complete bone cement delivery to the fracture site.
Solution Approach 2:
The delivery catheter creates a closed, isolated environment for bone cement mixing and transfer. By maintaining this closed system throughout the mixing and transfer process, the catheter prevents ambient air contamination and monomer vapor escape, effectively creating a protected environment that eliminates respiratory exposure risks.
2Productivity
If bone cement is manually transferred from mixing vessel to injection device cartridge, then bone cement can be delivered, but the process is cumbersome, time-consuming and prone to mishandling
Solution Approach 1:
The delivery catheter combines the mixing vessel and injection device cartridge into a single integrated system. The mixing element can be inserted through the catheter into the mixing vessel, mixed, and then the entire catheter with contained bone cement can be advanced directly to the fracture site for injection. This merging eliminates the separate transfer step, reducing both time and handling complexity.
Solution Approach 2:
The mixing element is pre-loaded into the delivery catheter before entering the mixing vessel. This preliminary preparation allows the mixing element to be immediately deployed into the bone cement upon catheter insertion, eliminating setup time and enabling continuous operation from mixing through delivery without interruption or manual transfer.
3Ease of operation
If bone cement is delivered from injection device, then fracture site can be treated, but great effort is required on the device plunger due to thick and viscous bone cement
Solution Approach 1:
The system replaces manual plunger force with a mechanical delivery mechanism. The delivery catheter is advanced over a guidewire to the fracture site, and bone cement is delivered through the catheter using controlled mechanical advancement rather than manual plunger compression. This substitution eliminates the need for great manual effort while maintaining effective bone cement delivery to the fracture site.
4Ease of manufacture
If mixing element is withdrawn from bone cement, then mixing is complete, but large surface area of cement is exposed to room air introducing monomer vapor
Solution Approach 1:
The mixing element remains nested within the delivery catheter throughout the mixing process. After mixing is complete, the mixing element is simply withdrawn through the catheter, and the catheter is immediately advanced to the fracture site for injection. This nested configuration ensures the bone cement surface area is never exposed to room air, preventing monomer vapor introduction while maintaining mixing completion.
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 repairs fractured bones by minimizing air bubbles and leakage, reducing procedural complexity, and providing a hardened internal fixation device that supports bone healing while minimizing complications.
Implementation Method 1
a spinning mechanism engaged to a rotatable shaft, wherein the spinning mechanism is inserted into the internal bone fixation device
Implementation Method 2
the bone cement components are delivered to the internal bone fixation device and mixed within the internal bone fixation device
Data Source
AI summary
Systems and methods for repairing a weakened or fractured bone are disclosed herein. A system for repairing a fractured bone includes a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, wherein the delivery catheter has an inner void for passage of bone cement components and an inner lumen for passage of a mixing element; an internal bone fixation device releasably engaging the distal end of the delivery catheter, wherein the internal bone fixation device moves from a first compact state to a second expanded state when the bone cement components are delivered to the internal bone fixation device and mixed within the internal bone fixation device; and a spinning mechanism engaged to a rotatable shaft, wherein the spinning mechanism is inserted into the internal bone fixation device.