Adjustable Balloon Catheter for Tortuous Vessel Treatment
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Solution Overview
Problem
Balloon dilatation catheters face challenges in navigating tortuous anatomy, crossing tight lesions, and treating lesions of varying lengths, as they lack adjustability, pushability, and maneuverability, especially when dealing with bifurcation lesions.
Innovation Solution
A rapid exchange balloon catheter system with an adjustable balloon length, featuring a main elongated element, a balloon with an inflation lumen, a distal connecting element for guidewire reception, and a longitudinally movable sheath with a tapered end for reduced diameter entry, along with a core wire and radiopaque markers for enhanced pushability and visibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a balloon catheter is designed with fixed length, then the structure is simple, but it cannot treat lesions of varying lengths or multiple lesions simultaneously
Solution Approach 1:
The balloon catheter is divided into multiple separate balloons positioned at different locations along the catheter shaft. Each balloon can be independently inflated or deflated, allowing treatment of multiple lesions of varying lengths simultaneously or sequentially, while maintaining a relatively simple overall catheter structure
Solution Approach 2:
The balloon catheter incorporates an adjustable balloon length mechanism that allows the operator to dynamically change the length of the balloon or the number of active balloons during the procedure. This dynamic adjustment capability enables adaptation to different lesion configurations without requiring multiple different catheter sizes
2Reliability
If a balloon catheter uses standard diameter throughout, then manufacturing is simple, but it cannot effectively navigate tortuous anatomy or cross tight lesions
Solution Approach 1:
The catheter incorporates sections with different diameters and stiffness characteristics at specific locations. The distal portion may have a smaller diameter and higher flexibility for navigating tortuous anatomy, while proximal sections maintain larger diameter for strength and operator control. This localized variation in properties enables both navigation through complex anatomy and effective lesion treatment
3Reliability
If a balloon catheter lacks focused force capability, then the design is simple, but it cannot effectively treat tight or calcified lesions
Solution Approach 1:
The balloon catheter system combines multiple therapeutic modalities in a single device, including traditional balloon inflation, integrated atherectomy elements for plaque removal, and potentially laser or other energy-based treatments. This merging of functions provides focused force and mechanical plaque modification capabilities while maintaining a unified catheter system rather than requiring separate devices
4Adaptability or versatility
If a balloon catheter does not address bifurcation lesions, then the design is simple, but it cannot treat vessels with branch points
Solution Approach 1:
The catheter incorporates multiple balloons positioned at different angular orientations and locations, including balloons specifically positioned to address bifurcation points. These segmented balloon elements can be selectively inflated to treat the main vessel and branch vessels simultaneously, providing comprehensive bifurcation lesion treatment
Solution Approach 2:
The catheter design extends into multiple spatial dimensions with balloons positioned not only along the longitudinal axis but also at different angular positions to accommodate vessel bifurcations. This three-dimensional balloon arrangement allows treatment of complex vessel geometries including T-junctions and other bifurcation configurations
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 enables effective navigation and treatment of lesions of varying lengths, providing focused force and maneuverability through tortuous vessels, while allowing for precise positioning and adjustable balloon length to address bifurcation lesions effectively.
Implementation Method 1
the exposed portion of the balloon expands when fluid is delivered to the balloon through the inflation lumen
Implementation Method 2
one or more radiopaque markers to indicate the position of the device within the vessel and a rotational orientation
Data Source
AI summary
A device for introduction into a body vessel includes a main elongated element, a balloon positioned at the main elongated element distal end, a distal connecting element positioned at the distal end of the balloon to receive a guidewire during use, and a longitudinally movable sheath positioned external to the main elongated element, a position of the sheath distal end with respect to the balloon defining an exposed portion of the balloon that expands when fluid is delivered to the balloon through the inflation lumen.