Steerable Crossing Catheter With Ultrasound-Guided Occlusion Navigation
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Solution Overview
Problem
Existing medical devices face challenges in efficiently crossing venous occlusions without causing damage to the vessel wall, as these occlusions tend to blend with the vessel and are tough like scar tissue, making navigation difficult.
Innovation Solution
A steerable crossing catheter system with a steerable distal end, a penetrating member, and a sensing assembly that uses ultrasound transducers to estimate the device's location within the vessel, allowing precise navigation and avoidance of vessel contact.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a penetrating member is used to cross venous occlusions, then the ability to cross tough occlusions is improved, but the risk of causing damage to the vessel wall increases
Solution Approach 1:
The patent incorporates a sensing assembly with ultrasound transducers that provide real-time feedback on the catheter's position relative to the vessel wall and occlusion. This feedback enables the operator to adjust the catheter position dynamically, allowing the penetrating member to cross the occlusion while avoiding contact with and damage to the vessel wall through continuous monitoring and adjustment.
Solution Approach 2:
The patent replaces reliance on purely mechanical navigation with an acoustic field-based sensing system. The ultrasound transducers create and detect acoustic signals to map the catheter's position and the occlusion's location, substituting mechanical sensing with acoustic field interaction to achieve more precise control and reduce mechanical damage to the vessel wall.
2Ease of operation
If the catheter is made steerable to navigate around the occlusion, then the ease of navigation is improved, but the device complexity increases
Solution Approach 1:
The catheter is divided into functional segments including a steerable distal end region with a steering member, a core, and a sensing assembly. The steering member can be independently actuated to change the catheter's trajectory, while the sensing assembly remains positioned to monitor the distal end. This segmentation allows the steerable portion to be controlled separately from the sensing and penetrating components, managing complexity through modular functional separation.
Solution Approach 2:
The sensing assembly is disposed adjacent to the distal end of the core, and the core is disposed within the lumen of the catheter shaft. The steering member is integrated into the distal end region. This nested arrangement allows multiple functions (sensing, steering, penetrating) to be compactly integrated within the catheter structure, reducing overall device complexity while maintaining ease of operation.
3Measurement precision
If the sensing assembly is positioned adjacent to the distal end to accurately locate the core, then the measurement precision is improved, but the device complexity increases
Solution Approach 1:
The sensing assembly with ultrasound transducers is merged with the core and distal end region of the catheter. The transducers are disposed adjacent to the distal end of the core, combining the sensing function with the structural components. This merging allows the sensing assembly to accurately estimate the core's location while minimizing the overall device complexity by integrating multiple functions into a unified structure rather than adding separate complex subsystems.
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 efficient crossing of venous occlusions by accurately positioning the catheter and penetrating tip, minimizing vessel wall damage during the procedure.
Implementation Method 1
the sensing assembly includes an ultrasound transducer
Implementation Method 2
estimating the position of the medical device system within the vein using the sensing assembly includes emitting ultrasonic energy with the ultrasound transducer
Data Source
AI summary
Medical devices as well as methods for making and using medical devices are disclosed. An example medical device may include a steerable crossing catheter system. The steerable crossing catheter system may include an elongate catheter shaft having a proximal end region, a steerable distal end region, and a lumen extending therethrough. A core may be disposed within the lumen. The core may have a distal end. A penetrating member may be coupled to the distal end. A sensing assembly may be disposed adjacent to the distal end. The sensing assembly may be configured to estimate the location of the core within a body lumen.