Loop Kyphoplasty Balloon Control for Vertebral Fracture Repair
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Solution Overview
Problem
Traditional kyphoplasty procedures face complications such as iatrogenic cortical rim fractures due to lack of control over the distal end of the balloon, leading to uneven expansion and potential vertebral cortical fractures, especially in heterogeneous bone structures.
Innovation Solution
A loop kyphoplasty system using dual trocars and a wire tool to create a loop within the vertebral body, allowing for controlled expansion and inflation of a balloon from both proximal and distal ends, along with deployable stents to maintain cavity height and prevent fractures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional single-ended balloon kyphoplasty is used, then the procedure is simpler to perform, but the distal end of the balloon cannot be controlled leading to uneven expansion and cortical rim fractures
Solution Approach 1:
The balloon catheter is divided into two independent controllable ends (proximal and distal), allowing separate manipulation of each end to achieve uniform expansion while maintaining procedural simplicity
Solution Approach 2:
Different regions of the balloon can be inflated at different rates and pressures through the two separate access points, allowing localized control of expansion to match heterogeneous bone structures and prevent cortical rim fractures
2Device complexity
If traditional unipedicle or bipedicle balloon kyphoplasty is used, then the procedure is less complex, but nonuniform balloon expansion occurs in heterogeneous bone structures leading to cortical fracture
Solution Approach 1:
The system enables different inflation parameters (pressure, rate, volume) to be applied at different locations within the vertebral body through the two trocars, allowing the balloon to adapt to heterogeneous bone density and structure to achieve uniform expansion
Solution Approach 2:
The dual-ended control system allows real-time adjustment of balloon expansion based on resistance feedback from different regions of the vertebral body, enabling the practitioner to detect and respond to heterogeneous bone structures to prevent nonuniform expansion
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 loop kyphoplasty system provides full control over balloon expansion, reducing the risk of vertebral endplate damage and cement leakage, enabling effective vertebral height restoration and pain relief with controlled cement placement.
Implementation Method 1
a balloon that is expandable within the vertebral body to a deployed state
Implementation Method 2
at least one expandable stent compressed onto the balloon in a compressed state, and expandable from the compressed state to a deployed state
Data Source
AI summary
A system and method for percutaneous loop kyphoplasty is described. An apparatus for the treatment of a targeted vertebral bone fracture includes a first trocar having a first lumen, a proximal end and a distal end, wherein the distal end of the first trocar is configured for surgical insertion into a vertebral body at a first location, a second trocar having a second lumen, a proximal and a distal end, wherein the distal end of the second trocar is configured for surgical insertion into the vertebral body at a second location, a wire tool that is slidable within the first trocar, a grasper tool that is slidable within the second trocar and is configured to temporarily couple to the wire tool within the vertebral body, and a non-deployable balloon that is advanced through the first or second trocar into the vertebral body to facilitate expansion within the vertebral body.