Balloon Catheter for Controlled Bone Cement Injection
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Solution Overview
Problem
Conventional bone cement injection devices face challenges in adjusting or controlling the injection volume or rate in response to cancellous bone volume and density, leading to potential leakage and complications such as soft tissue damage and nerve root pain during bone fracture repair.
Innovation Solution
A medical device comprising a delivery catheter with a conformable member that inflates with reinforcing material, using an optical fiber to harden the material within the bone, ensuring precise placement and minimizing tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional bone cement injection devices are used, then bone fracture repair can be performed, but the injection volume and rate cannot be controlled in real time, leading to leakage and soft tissue damage
Solution Approach 1:
The delivery catheter incorporates a balloon that can be dynamically inflated and deflated to control the injection process. The balloon expansion creates temporary resistance to bone cement flow, allowing real-time adjustment of injection rate and volume. This dynamic control mechanism prevents over-injection and leakage into surrounding soft tissues while ensuring complete filling of the bone defect.
Solution Approach 2:
The system changes the physical state and volume parameters of the balloon during the injection process. By controlling the balloon's inflation state, the device adjusts the internal pressure and flow resistance within the catheter, thereby regulating the bone cement injection rate. This parameter control allows adaptation to different bone density conditions and prevents harmful leakage.
2Adaptability or versatility
If conventional bone cement injection is performed, then bone repair is achieved, but the injection rate cannot be adjusted in response to cancellous bone volume and density, causing potential complications
Solution Approach 1:
The system provides real-time feedback control of the bone cement injection process through balloon pressure monitoring and adjustment. The operator can observe the balloon expansion state and adjust the injection rate accordingly, responding to variations in cancellous bone density and volume. This feedback mechanism prevents excessive pressure that could cause bone cement extrusion into nerve root areas, thereby avoiding nerve compression complications.
3Strength
If internal fixation devices are used, then bone support is provided, but invasive techniques may cause damage to supporting tissues
Solution Approach 1:
The delivery catheter utilizes a flexible balloon that can be collapsed to a small profile for minimally invasive insertion through the skin and soft tissues. Once positioned within the bone, the balloon is inflated to provide adequate support during bone cement injection. The flexible nature of the balloon minimizes trauma to surrounding tissues during insertion and removal while maintaining functional integrity during the procedure.
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 device allows for precise internal bone fixation with minimal invasive techniques, reducing the risk of leakage and tissue damage, while providing strong support for fractured bones through controlled expansion and hardening of the reinforcing material.
Implementation Method 1
activating a light source that is connected to the optical fiber to communicate light energy into the inner lumen of the conformable member such that the at least one reinforcing material is hardened
Data Source
AI summary
Internal bone fixation devices and methods for using the devices for repairing a weakened or fractured bone are disclosed herein. According to aspects illustrated herein, there is provided a device (700) for repairing a fractured bone that includes a delivery (710) having an elongated shaft (701) with a proximal end, a distal end, and a longitudinal axis therebetween, the delivery catheter (710) having an inner void (713) for passing at least one reinforcing material, and an inner lumen (711) for accepting a light pipe (652), wherein a distal end (723) of the inner lumen (711) terminates in an optical lens (754); a conformable member (703) releasably engaging the distal end of the delivery catheter (710), the conformable member (703) moving from a deflated state to an inflated state when the at least one reinforcing material is delivered to the conformable member (703); and an adapter releasably engaging the proximal end of the delivery catheter (710) for receiving the light pipe (652) and the at least one reinforcing material.