Needle-Mounted Balloon System for Bone Cavity Creation
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Solution Overview
Problem
Current methods for creating space within bones for therapeutic purposes, such as vertebroplasty and kyphoplasty, require separate cannula and balloon devices, which are complex and time-consuming, leading to increased procedural time and patient discomfort.
Innovation Solution
A needle-mounted balloon system that integrates a cannula and expandable balloon member, allowing for a single component to create space within the bone by inflating and deflating to facilitate the injection of filler materials like bone cement, reducing the number of steps and components needed.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate cannula and balloon devices are used, then the procedure can be performed with standard components, but the device complexity increases and procedural time increases
Solution Approach 1:
The patent combines the cannula and balloon device into a single integrated needle-mounted balloon system. The cannula serves dual purposes: as the delivery vehicle for the balloon and as the injection channel for cement after balloon deflation. This merging eliminates the need for separate components, reducing procedural complexity while maintaining therapeutic effectiveness.
Solution Approach 2:
The integrated needle-mounted balloon system performs multiple functions: (1) acts as a needle for bone penetration, (2) serves as a balloon for cavity creation through inflation, and (3) functions as a cement delivery catheter after deflation. This multi-functionality reduces the number of components needed while maintaining all necessary procedural capabilities.
2Reliability
If separate cannula and balloon devices are used, then each component can be optimized independently, but the procedural time increases
Solution Approach 1:
By integrating the cannula and balloon into a single device, the patent eliminates the time required to exchange components during the procedure. The balloon can be inflated and deflated in place within the same needle, streamlining the workflow and reducing overall procedural time while maintaining the benefits of optimized component design.
3Reliability
If separate cannula and balloon devices are used, then standard procedures can be followed, but patient discomfort increases
Solution Approach 1:
The integrated design reduces the number of component exchanges and procedural steps, thereby reducing the total duration of needle penetration and manipulation within the bone. This minimized exposure time to the needle and balloon inflation/deflation cycles reduces patient discomfort and anxiety during the procedure.
4Device complexity
If an integrated needle-mounted balloon system is used, then the number of components is reduced, but the device must perform multiple functions
Solution Approach 1:
The needle-mounted balloon system is designed to perform multiple functions: it penetrates bone as a needle, creates a cavity through balloon inflation, and delivers cement through the same needle channel after deflation. This functional versatility is achieved through careful design of the lumen configuration and balloon positioning, allowing a single device to replace multiple specialized tools.
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
This integrated system simplifies the procedure, reduces procedural time, and minimizes patient discomfort and costs by allowing for easier and more efficient placement of filler materials within the bone cavity.
Implementation Method 1
a balloon is first inserted into the fractured bone through the hollow needle and then inflated to create a cavity or space
Implementation Method 2
The stylet includes a stylet hub and a stylet needle extending distally from the stylet hub. The stylet needle is slidably disposable within the lumen of the cannula tube portion.
Implementation Method 3
The cement is injected into the cavity once the balloon is removed
Data Source
AI summary
Devices and methods for creating space within a body structure for therapeutic purposes include an expandable member disposed on the distal end portion of a catheter. Such devices and methods can be used, for example, for creating space within bone, and for injecting a filler material such as cement into the space to strengthen, repair, or otherwise enhance the bone structure.