Image-Guided Atherectomy Catheter With Magnetic Cutter Drive
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Solution Overview
Problem
Current atherectomy devices face challenges such as the need for large vessel access, rigid distal assemblies, unpredictable cut length and depth, limited tissue collection, complexity, and lack of real-time image guidance, which hinder their effectiveness in treating eccentric lesions and complex anatomy.
Innovation Solution
Atherectomy catheters with independently controlled imaging and non-contact magnetic drive systems, featuring a longitudinally actuated cutter and pull-wire mechanism for deflection, allowing precise cutting and imaging without sterility compromise, and a guidewire re-entry system for navigating complex vasculature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If traditional atherectomy devices are used, then plaque removal is achieved, but large vessel access is required and device complexity increases
Solution Approach 1:
The catheter is divided into multiple functional segments including a flexible distal tip section, a mid-section with imaging elements, and a proximal drive shaft. The cutter assembly is separately positioned and independently controlled, allowing each segment to be optimized for its specific function while reducing overall device complexity
Solution Approach 2:
The cutter assembly is nested within the catheter body and can be deployed from a retracted position. The imaging elements are positioned within the catheter wall or lumen, and the drive shaft components are nested concentrically, allowing compact packaging that reduces vessel access requirements
2Stability of the object's composition
If rigid distal assemblies are used, then structural stability is maintained, but adaptability to complex anatomy is reduced
Solution Approach 1:
The distal tip assembly is designed with flexible materials and articulated joints that allow dynamic adaptation to vessel curvature and eccentric lesions. The catheter can bend and conform to complex anatomical paths while maintaining cutter positioning accuracy through active control mechanisms
Solution Approach 2:
Different sections of the catheter have different stiffness properties - the distal tip is more flexible for navigation, the mid-section provides structural support for imaging, and the proximal section maintains rigidity for operator control. This gradient of mechanical properties allows both adaptability and stability
3Ease of operation
If contact-based drive systems are used, then mechanical control is achieved, but sterility is compromised
Solution Approach 1:
A magnetic coupling system acts as an intermediary between the external drive mechanism and the internal cutter assembly. Magnets in the catheter tip interact with magnets or electromagnetic coils in the external driver, transmitting rotational and axial control forces through the catheter wall without physical penetration, thereby maintaining sterility while enabling precise mechanical control
Solution Approach 2:
The traditional mechanical drive shaft that requires physical connection is replaced with a magnetic field-based actuation system. This substitution eliminates the need for sterile barriers while maintaining full mechanical control capability for cutter rotation and positioning
4Measurement precision
If real-time imaging is added, then lesion visualization is improved, but device complexity increases
Solution Approach 1:
The catheter integrates multiple functions into a single device: the imaging elements serve both as diagnostic tools for lesion visualization and as guidance systems for cutter positioning. The same flexible distal tip that enables navigation also houses the imaging sensors, reducing the need for separate components
Solution Approach 2:
The imaging system is merged with the catheter structure itself - sensors are positioned within the catheter wall or lumen, sharing the same physical space as other components. The drive shaft that controls cutter rotation also drives imaging element rotation, combining actuation functions and reducing overall system complexity
5Manufacturing precision
If cutter exposure is improved, then cutting precision is enhanced, but tissue trauma increases
Solution Approach 1:
The cutter assembly can dynamically adjust its exposure level based on the procedural needs. The cutter rotates within a controlled range of motion, exposing the cutting edge only when needed for plaque removal while retracting to minimize contact with healthy tissue. This dynamic control allows precise cutting with reduced vessel trauma
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 provides safe, precise, and efficient plaque removal in eccentric lesions and complex anatomy, reducing vessel trauma and improving procedural outcomes by enabling real-time visualization and sterility maintenance.
Implementation Method 1
non-contact magnetic drive systems for controlling motion (e.g., rotation of the cutting and/or imaging elements) of the catheter without contacting catheter
Data Source
AI summary
Described herein are atherectomy catheters, systems and methods of use. The atherectomy catheters may include a driveshaft within an elongate body. An optical fiber may run through the driveshaft and have a distal end that is attached to an opening of a cutter at distal end of the driveshaft. The cutter and the optical fiber may be rotated respect to the elongate body by rotating the driveshaft with respect to the elongate body. The driveshaft may be longitudinally displaced to expose a distal cutting edge of the cutter for cutting tissue or plaque from a vessel lumen. Images of the vessel lumen collected through the opening of the cutter may be captured in real time with the optical fiber.