Balloon Catheter Blade Depth Control for Aortic Valve Stenosis
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Solution Overview
Problem
Current methods for treating aortic valve stenosis lack control over incision depth, leading to ineffective dilation or damage to underlying tissues during procedures like balloon valvuloplasty, which can result in complications such as heart failure.
Innovation Solution
A catheter with an elongated balloon and attached blades, where the blades are inclined relative to the balloon axis upon inflation, allowing for controlled incisions by a cutting edge that is protected by a non-incising surface to limit the incision depth, ensuring precise tissue incision and dilation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional balloon valvuloplasty is used to treat aortic valve stenosis, then the procedure is less invasive compared to valve replacement, but the incision depth cannot be controlled leading to potential damage to underlying tissues
Solution Approach 1:
The balloon is segmented into multiple inflation zones (proximal, intermediate, and distal sections) that can be selectively inflated to control blade deployment and incision depth. The blade itself is segmented with a cutting edge portion and a non-cutting protected portion, allowing precise control over how much of the blade engages the tissue.
Solution Approach 2:
The balloon acts as an intermediary mechanism that translates inflation pressure into controlled blade deployment. By inflating the balloon to different pressures in different sections, the operator can control the extent to which the blade is pushed against the aortic valve, thereby controlling incision depth without direct mechanical contact.
2Productivity
If the incision is made deeper to effectively dilate the conduit lumen, then dilation effectiveness improves, but damage to underlying tissue such as vital organs and nerves increases
Solution Approach 1:
The incision depth is controlled by changing the inflation parameter of the balloon. By adjusting the inflation pressure and the distribution of inflation across different balloon sections, the operator can precisely control the depth to which the blade engages the tissue, achieving effective dilation without excessive depth that would cause damage.
Solution Approach 2:
The blade deployment is dynamic rather than fixed. The balloon can be inflated in a controlled sequence (e.g., proximal section first, then intermediate, then distal) to progressively deploy the blade to the desired depth. This dynamic control allows the operator to stop inflation at any point, preventing over-penetration and damage to underlying structures.
3Object-affected harmful factors
If the incision is made shallower to protect underlying tissue, then tissue safety improves, but the incision becomes ineffective in promoting dilation of the conduit lumen
Solution Approach 1:
The system provides visual feedback through radiopaque markers on the balloon and blade that allow the operator to monitor the deployment and incision depth in real-time during the procedure. This feedback mechanism ensures that the incision reaches the necessary depth for effective dilation while providing early warning if the depth approaches levels that could cause damage to underlying tissue.
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 solution enables controlled, precise incisions within the aortic valve, effectively treating aortic valve stenosis by maintaining a consistent incision depth, reducing the risk of damage to surrounding tissues and improving blood flow.
Implementation Method 1
inflating the balloon to a predetermined pressure
Implementation Method 2
making incisions in the aortic valve with a controlled, pre-selected incision depth
Data Source
AI summary
A device for incising tissue to a pre-selected incision depth within a body conduit of a patient includes an elongated balloon catheter and at least one elongated straight blade that is mounted on the balloon. To control the incision depth, each blade has a blunt section formed with a non-incising surface and a cutting edge positioned distally to the blunt section. A proximal portion of the blade is attached to a proximal balloon section, and in operation, the balloon/blade combination is advanced into the body conduit and positioned distal to the target tissue/stenosis. The balloon is then inflated. With this inflation, the blade is inclined relative to the axis of the catheter with an increasing distance between the blade and the axis in a distal direction. The device is then withdrawn, proximally, to incise the tissue/stenosis.