Angioplasty Balloon With Movable Cutting Element
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Solution Overview
Problem
Current treatments for atherosclerotic plaque, such as PTA with standard balloons, often fail to achieve long-term patency due to plaque redistribution issues, restenosis, and vessel damage, and require multiple catheter exchanges for switching between standard and cutting/scoring balloons.
Innovation Solution
A PTA balloon catheter with a moveable cutting or scoring element that can be alternately positioned to perform either standard dilation or controlled cutting/scoring, allowing for flexible treatment options without the need for multiple catheters.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a standard dilation balloon is used for PTA, then the procedure is simple and the vessel lumen can be dilated, but the plaque redistribution is insufficient and restenosis occurs frequently
Solution Approach 1:
The patent combines a cutting element and a scoring element on the same balloon catheter, integrating multiple plaque modification functions into a single device. This allows the operator to perform cutting, scoring, or standard dilation all with one catheter, improving long-term patency through more effective plaque redistribution while avoiding the need for multiple catheter exchanges.
Solution Approach 2:
The cutting element is designed to be movable between a deployed position (where it cuts the plaque) and a retracted position (where it does not interfere with standard dilation). This dynamic configuration allows the same device to adapt its function based on the treatment phase, providing both cutting capability and standard dilation capability without requiring separate devices.
2Reliability
If a cutting or scoring balloon is used, then controlled plaque cutting improves long-term patency, but the risk of vessel wall damage increases
Solution Approach 1:
The cutting element is designed to contact and cut only the atherosclerotic plaque, while the scoring element creates controlled superficial scores in the plaque. The balloon itself provides a protective barrier between the cutting/scoring elements and the healthy vessel wall, localizing the harmful effect to the plaque only and preventing damage to the underlying healthy tissue.
Solution Approach 2:
The balloon acts as an intermediary between the cutting/scoring elements and the vessel wall. It allows the cutting elements to engage the plaque effectively while maintaining a protective distance from the healthy vessel wall, thus mediating the interaction to achieve plaque modification without excessive vessel wall damage.
3Adaptability or versatility
If multiple catheters are used for different treatment options, then treatment flexibility is improved, but the procedure time and complexity increase
Solution Approach 1:
The catheter is designed with multi-functionality, incorporating a balloon, a movable cutting element, and a scoring element all in one device. This universal design allows the operator to perform standard dilation, cutting, or scoring all with the same catheter, providing treatment flexibility without the need to exchange between multiple specialized catheters, thus reducing procedure time and complexity.
4Reliability
If balloon dilation is performed alone, then the procedure is simple, but plaque redistribution is inadequate and restenosis occurs
Solution Approach 1:
The cutting element or scoring element is deployed before or during the balloon inflation to pre-modify the plaque structure. This preliminary action of cutting or scoring the plaque creates controlled fractures that facilitate more effective plaque redistribution when the balloon is inflated, thereby improving restenosis prevention while maintaining a relatively simple single-step 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
Enables selective and controlled plaque redistribution, reducing restenosis and vessel damage, while allowing for customized treatment approaches and minimizing the need for multiple catheter exchanges.
Implementation Method 1
an elastic member positioned within the catheter shaft and radially expandable to an engaged position in which the elastic member engages the atherosclerotic plaque and radially compresses the plaque to a compressed state sufficient to cause controlled cracking or fracturing of the plaque
Implementation Method 2
The inflated angioplasty balloon applies a radial pressure to the inner wall of the vessel in the area of the atherosclerotic lesion. This results in redistribution of the plaque to a more favorable configuration
Data Source
Figure 1A~1B
Figure 2A~2C
Figure 3
AI summary
Balloon angioplasty catheters having cutting or scoring members that are moveable in at least one direction between a stowed position (away from the angioplasty balloon) and an operative position (on the angioplasty balloon). A balloon catheter of the present invention alternately useable to perform balloon dilation of a body lumen with and without concurrent cutting or scoring.