Retractable Inflatable Bone Tamp for Kyphoplasty
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Solution Overview
Problem
Conventional inflatable bone tamps used in kyphoplasty procedures face challenges with radial tears during inflation, leading to difficulties in removing the balloon due to snagging on the cannula, which can result in material separation and incomplete removal.
Innovation Solution
An inflatable bone tamp with a retractable inflatable structure coupled between an outer and a movable inner shaft, allowing the structure to be retracted into the outer shaft, reducing the risk of snagging and enabling secure removal, featuring a retraction controller for precise positioning and sealing elements to prevent fluid leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the balloon is inflated within the vertebral body to create a cavity, then the cavity provides containment for bone filler material and restores vertebral height, but the balloon may suffer radial tears during inflation making removal difficult due to snagging on the cannula
Solution Approach 1:
The balloon is nested within an outer catheter that provides a protective sheath during insertion and removal. The outer catheter receives the balloon in a deflated state, allows inflation within the vertebral body, and then receives the deflated balloon during removal, preventing snagging on the cannula edge.
Solution Approach 2:
The balloon is pre-positioned within the outer catheter before insertion into the vertebral body. This preliminary positioning ensures the balloon is protected during insertion and can be smoothly retrieved through the outer catheter after deflation, preventing the harmful effect of snagging on the cannula.
2Volume of stationary object
If the balloon is made larger to create adequate cavity volume for bone filler containment, then the cavity provides better support and containment, but the balloon becomes more difficult to remove if it tears due to increased snagging risk
Solution Approach 1:
The outer catheter provides a protective sheath that accommodates the balloon in all states (deflated and inflated). This nesting structure allows the balloon to achieve adequate size for cavity creation while ensuring smooth removal through the outer catheter, eliminating the correlation between balloon size and removal difficulty.
3Manufacturing precision
If the balloon is inflated to restore vertebral body height, then the vertebral height is restored and bone filler is contained, but material may separate from the balloon during removal if radial tears occur
Solution Approach 1:
The outer catheter provides a protected pathway for balloon insertion and removal. The balloon inflates to restore vertebral height, then deflates and is retrieved through the outer catheter, preventing material separation that would occur if the balloon tore while passing through the cannula edge.
Solution Approach 2:
The outer catheter acts as a protective cushion during balloon removal. By providing a smooth inner surface and containing the deflated balloon, it prevents the balloon material from catching on the sharp cannula edge, ensuring complete removal without material separation.
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 retractable design minimizes the risk of balloon snagging and material separation, facilitating easier removal and reducing recovery issues associated with radial tears, while maintaining effective cavity creation and bone filler containment for vertebral stabilization.
Implementation Method 1
an inflatable structure, an inner shaft disposed at least partially within the outer shaft, wherein the inflatable structure is coupled between a distal end region of the outer shaft and a distal end region of the inner shaft
Implementation Method 2
By providing an inflatable bone tamp having an inflatable structure coupled between an outer shaft and a movable inner shaft capable of retracting the inflatable structure into the outer shaft
Implementation Method 3
In various embodiments, the inflatable bone tamp can include a sealing element to prevent leakage of inflation fluid from within the outer shaft around the internal shaft
Data Source
AI summary
An inflatable bone tamp for performing a minimally invasive surgical procedure includes an outer shaft defining an internal lumen, an inflatable structure coupled to the outer shaft, and an inner shaft movably disposed within the internal lumen and coupled to a distal end region of the inflatable structure. The internal lumen is sized to receive the inflatable structure, such that by moving the inner shaft relative to the outer shaft, the inflatable structure can be retracted into the internal lumen (and likewise can be extended from within the internal lumen for deployment in bone). This retraction capability can beneficially protect the inflatable structure during positioning/removal, and can also enhance recovery from radial tears of the inflatable structure.