Dual-Access Incising Catheter for Small-Vessel Lesion Fracturing
Solution Overview
Problem
Existing angioplasty devices are too large for below-the-knee or small vessel angioplasty, lacking sufficient pressure to effectively treat calcified or fibrous lesions, and often result in vessel recoil.
Innovation Solution
A dual-access catheter system with a type-1 catheter featuring a blade or needle protrusion and a type-2 angioplasty balloon, allowing controlled incision or fracturing of lesions through a guidewire-assisted dual-access method, using a 3-6 French catheter with a 0.1-2 mm blade or needle projections, and a complementary balloon for force application.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If conventional balloons are used to treat calcified or fibrous lesions, then the procedure can be performed with standard equipment, but the balloons do not supply enough outward pressure to fully expand the lesions
Solution Approach 1:
The system divides the force application into two segments: a cutting component (blade or needle) that fractures the lesion and a balloon component that expands the vessel. The cutting component is segmented from the balloon, allowing independent optimization of each function - the blade provides focused mechanical cutting force while the balloon provides radial expansion force.
Solution Approach 2:
The catheter system acts as an intermediary device that combines multiple functions (cutting and expansion) in a single platform. The guide wire serves as an intermediary to deliver both the cutting component and balloon through the vasculature, enabling coordinated action of the blade and balloon on the target lesion.
2Force
If slicing or cutting technologies are used to treat BTK lesions, then the lesions can be fractured, but the devices are too large for below-the-knee or small vessel angioplasty
Solution Approach 1:
The cutting component (blade or needle) is nested within the catheter shaft, and the balloon is nested within the catheter tip. This nested arrangement allows the cutting and expansion functions to be contained within a small profile catheter that can navigate below-the-knee vessels while still providing sufficient cutting force through the blade and expansion force through the balloon.
Solution Approach 2:
The system transitions from axial force application (pushing the entire catheter through the lesion) to radial force application (expanding the balloon outward from the catheter tip). This dimensional change allows cutting and expansion forces to be applied perpendicular to the catheter axis, enabling effective lesion treatment without requiring a large catheter profile.
3Adaptability or versatility
If fixed blades or wires are bonded to balloons or deployment arms, then the cutting function is integrated, but the device complexity increases and the profile becomes larger
Solution Approach 1:
The cutting component is designed to be movable relative to the catheter shaft, allowing it to be advanced or retracted as needed. The blade or needle can be dynamically positioned to contact the lesion only when required, rather than being permanently fixed. This dynamic design reduces device complexity by eliminating the need for complex fixed mounting mechanisms while still providing integrated cutting functionality.
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 system provides controlled incision depths and effective treatment of calcified or fibrous lesions in smaller vessels, minimizing vessel damage and enabling drug delivery post-treatment.
Implementation Method 1
The balloon is inflated using inflation fluid. As the balloon inflates, it presses against the vessel wall and radially expands or effaces the lumen
Implementation Method 2
This technology uses some sort of aid or force focusing device to cut or crack a target lesions
Data Source
AI summary
Dual-access site catheter systems with a blade or scoring functionality entering through a first access site and a balloon functionality for manipulating or driving the blade or scoring functionality through a different site. The blade or scoring functionality also sometimes provides needle or fluid delivery functionality to an atherosclerotic lesion.