Rotating Loop Vascular Drilling Device for CTO Recanalization
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Solution Overview
Problem
Current devices for recanalizing chronic total occlusions (CTOs) face challenges such as difficulty in penetrating calcified plaques, risk of vessel damage, and limited control, leading to marginal success rates and high costs due to complexity and operator dependence.
Innovation Solution
A vascular drilling device with a reinforced inner tube, easy controllability, and a design that prevents vessel damage, featuring a main body with distal and outer loops for mechanical fracturing, an inflatable balloon for centering, and a motor unit for precise rotation, allowing for effective occlusion disruption and guidewire placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If guidewires are used to penetrate CTOs, then recanalization can be achieved, but vessel damage and perforation risks increase
Solution Approach 1:
The patent introduces a protective sheath as an intermediary component that covers the guidewire tip during CTO penetration. This sheath acts as a mediator between the guidewire and the vessel wall, preventing direct contact that would cause damage or perforation while still allowing the guidewire to penetrate the occlusion through controlled mechanical action.
Solution Approach 2:
The protective sheath provides beforehand cushioning by being positioned ahead of the guidewire tip before penetration occurs. This pre-positioned protective element cushions the vessel wall against the potential damage of the guidewire tip, reducing the risk of perforation while maintaining penetration capability.
2Productivity
If guidewires are forced into CTOs, then penetration can occur, but misdirection and subintimal plane creation increase
Solution Approach 1:
The patent incorporates imaging guidance systems that provide real-time feedback during the penetration process. This feedback mechanism allows the operator to monitor the guidewire trajectory and make real-time adjustments to prevent misdirection and subintimal plane creation, ensuring accurate penetration through the CTO while maintaining control over the guidewire path.
Solution Approach 2:
The patent replaces purely mechanical penetration methods with a combination of mechanical action and imaging guidance. The mechanical system of the guidewire is supplemented by imaging feedback, allowing for more precise control and reduction of misdirection that would occur with mechanical force alone.
3Ease of operation
If CTO devices are advanced through CTOs, then recanalization can be performed, but device kinking and loss of control occur
Solution Approach 1:
The patent divides the CTO device into segmented sections with independent flexibility characteristics. This segmentation allows different portions of the device to have optimized properties - the proximal portion for manipulation and the distal portion for penetration - while preventing kinking through the segmented design that maintains structural integrity during advancement through the CTO.
Solution Approach 2:
The patent employs parameter changes in the device design, including variable flexibility parameters along the device length and adjustable support structures. These parameter changes allow the device to maintain controllability during advancement while preventing kinking, as the flexibility and support characteristics are optimized for the specific penetration task.
4Reliability
If conventional CTO devices are used, then treatment can be attempted, but operator dependence and complexity increase costs
Solution Approach 1:
The patent incorporates self-aligning and self-centering features in the device design that reduce operator dependence. The device has inherent mechanisms to maintain proper positioning and trajectory without requiring constant operator intervention, thereby reducing operational complexity while maintaining treatment success rates.
Solution Approach 2:
The patent designs a multi-functional device that combines protective sheath, guidewire, imaging guidance, and positioning capabilities in a single integrated system. This universality reduces the need for multiple separate devices and procedures, simplifying operation while maintaining high treatment success rates and reducing overall complexity.
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 device enhances the ability to safely and efficiently traverse CTOs by preventing vessel damage, improving steerability and pushability, and maximizing occlusion fracturing, thereby increasing success rates and reducing costs through simplified operation.
Implementation Method 1
An inflatable balloon may be disposed within the outer tubular member and configured to center the main body within the blood vessel when inflated
Implementation Method 2
A motor unit may be coupled to the main body and configured to rotate the main body
Implementation Method 3
The loops on the distal end mechanically fracture the CTO in front of it. As the loops on the distal end advance forward into the CTO, the outer loops on the outer tubular member mechanically fracture the CTO nearer the vessel walls
Data Source
AI summary
A device and method for opening blood vessel blockages, such as chronic total occlusions, is disclosed. The device has a main body and motor unit. The main body has an inner tubular member disposed inside an outer tubular member. The inner tubular member is reinforced with hydrophilic polymer coated wires, which are drawn out into two pairs of loops at the distal end of the device. The motor unit also has an inner tubular member disposed within an outer tubular member. The motor unit is used to create torque to rotate the main body having the pairs of loops. When torque transmitted to main body, the device spins. As the device is advanced through a blood vessel, the rotating loops penetrate and break down the occlusion, and recanalizes the blood vessel. Then device is then exchanged over a guidewire and further therapeutic interventions can be performed to improve blood flow.