Pre-loaded Spring Impact Device for Hard Plaque Penetration
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Solution Overview
Problem
Current devices struggle to penetrate hard calcified plaque in blood vessels, particularly the proximal cap of Chronic Total Occlusions (CTOs), which are often too hard for guidewires and crossing devices to traverse, leading to limited options for restoring blood flow in about 20% of peripheral CTO patients.
Innovation Solution
A device with a distal pre-loaded spring that stores energy and releases an impact force to penetrate hard plaque, allowing percutaneous insertion over a standard guidewire, with an optional centering balloon to aim the impactor and facilitate penetration of the occlusion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a thin guidewire is used to cross the occlusion, then the device can be inserted percutaneously, but the guidewire cannot penetrate hard calcified plaque in about 20% of peripheral CTO patients
Solution Approach 1:
The spring is pre-loaded in a compressed state within the device, storing mechanical energy that is released at the moment of impact with the plaque. This preliminary energy storage enables the impactor to deliver sufficient force to penetrate hard calcified plaque that would otherwise be impenetrable to standard guidewires
Solution Approach 2:
The device transitions from a static insertion mode to a dynamic impact mode. The spring mechanism allows the impactor to move from a retracted position to a forward impacting position, creating a dynamic force application that enables penetration of hard plaque while maintaining percutaneous insertion capability
2Reliability
If expensive lumen reentry devices or retrograde techniques are used to cross hard CTO proximal caps, then penetration can be achieved, but the procedure becomes more complex and costly
Solution Approach 1:
The invention extracts the essential function of plaque penetration from complex reentry devices and retrograde techniques, isolating it to a simple pre-loaded spring mechanism. This extraction allows standard guidewires to achieve penetration capability without requiring expensive specialized equipment or complex procedural techniques
Solution Approach 2:
The spring mechanism is self-activating through a simple trigger action. Once the operator pulls the trigger, the pre-loaded spring automatically propels the impactor forward without requiring complex control systems, imaging guidance, or specialized maneuvering techniques
3Reliability
If standard crossing devices are used without a pre-loaded spring mechanism, then the device structure remains simple, but the ability to penetrate hard plaque is insufficient
Solution Approach 1:
The spring is pre-loaded during device assembly, storing mechanical energy that is released at the moment of impact with the plaque. This preliminary energy storage enables the impactor to deliver sufficient force to penetrate hard calcified plaque that would otherwise be impenetrable to standard guidewires
Solution Approach 2:
The spring acts as an intermediary energy transfer mechanism between the operator's trigger action and the impactor. This intermediary component amplifies the operator's input force, converting a simple trigger pull into the high-impact force needed to penetrate hard plaque
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 effective penetration of hard plaque and CTO proximal caps, allowing further advancement of guidewires and subsequent use of balloon angioplasty and stents to open the occlusion, thereby improving blood flow and reducing the need for complex reentry devices or retrograde techniques.
Implementation Method 1
The distal biasing device located at the device distal tip can store energy and release it as an impact force in order to penetrate or break through hard plaque blocking blood path in blood vessels. The distal biasing device is preferably a pre-loaded spring, allowing storage of high energy level for impact.
Implementation Method 2
The distal biasing device located at the device distal tip can store energy and release it as an impact force in order to penetrate or break through hard plaque blocking blood path in blood vessels
Data Source
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AI summary
Devices and methods are described for penetrating hard plaque that partially or completely occludes blood vessels and disturbs blood flow through the blood vessel. The device includes a distal pre-loaded spring that can store energy and release it as impact at the device distal tip, in order to penetrate or break through hard plaque that is blocking blood path in blood vessels.