Ablation Imaging Catheter With Fluid-Cleared Lesion Mapping
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Solution Overview
Problem
Conventional imaging modalities for body lumens, such as the heart, face challenges due to the displacement of surrounding tissue by inflated balloons, pressure changes, and the presence of opaque fluids like blood, leading to unsteady imaging conditions and difficulty in assessing tissue conditions for diagnosis and therapy.
Innovation Solution
A tissue imaging and manipulation apparatus with a deployment catheter and expandable imaging hood that uses a transparent fluid to displace blood, allowing clear visualization and stabilization, combined with mechanisms for tissue engagement and real-time data acquisition, including electrocardiogram gating to account for tissue movement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If an inflatable balloon is used for imaging, then the imaging area is created and stabilized, but the balloon displaces surrounding tissue and interferes with fine positioning
Solution Approach 1:
The imaging system is divided into separate functional components: a non-inflatable imaging catheter with imaging elements (optical fibers, sensors) that can be positioned precisely against the tissue, while a separate balloon component is used only for stabilizing the imaging field by displacing blood, not for direct tissue contact imaging. This segmentation allows independent optimization of positioning precision and imaging stability.
Solution Approach 2:
A clear fluid (saline or contrast agent) is introduced as an intermediary medium between the imaging catheter and the tissue surface. This fluid displaces opaque blood from the imaging field while allowing transparent optical pathways, enabling clear imaging without requiring the imaging catheter itself to be inflated or to directly contact the tissue in a way that disrupts positioning.
2Area of stationary object
If an inflatable balloon is used for imaging, then a working area is created, but the working area becomes cramped and limited in size
Solution Approach 1:
The system separates the blood-displacing function (performed by the inflatable balloon component) from the imaging function (performed by the imaging catheter). This allows the imaging catheter to maintain a smaller, more flexible profile while the balloon provides the necessary working space by clearing blood from the field, thereby increasing working area flexibility without sacrificing imaging area.
Solution Approach 2:
The imaging system utilizes dynamic positioning capabilities where the imaging catheter can be moved, rotated, and repositioned independently within the cleared field. The system adapts to different anatomical configurations by allowing real-time adjustment of catheter position and orientation, enhancing working area versatility while maintaining a compact imaging head design.
3Reliability
If an inflatable balloon is used for imaging, then imaging is enabled, but the balloon is susceptible to pressure changes during systolic and diastolic cycles
Solution Approach 1:
The system separates pressure-sensitive components (the balloon used for blood displacement) from pressure-sensitive imaging components. The imaging catheter itself is designed to be pressure-resistant and maintain its structural integrity and positioning stability despite cardiac pressure cycles, while the balloon component absorbs pressure variations by expanding and contracting without affecting imaging quality.
Solution Approach 2:
The clear fluid acts as a pressure-buffering intermediary between the balloon and the imaging field. This fluid absorbs and dampens pressure transmissions from cardiac cycles, providing a more stable optical environment for imaging while allowing the balloon to undergo volume changes without directly transmitting pressure variations to the imaging catheter or tissue interface.
4Reliability
If an inflated balloon is used for imaging, then imaging is possible, but poor or blurred images are produced if the balloon is not firmly pressed against the tissue surface
Solution Approach 1:
The clear fluid serves as a contact-mediated intermediary that fills the gap between the imaging catheter and tissue surface, displacing opaque blood and creating a transparent optical pathway. This eliminates the need for firm mechanical contact while maintaining optical contact, thereby ensuring high image quality without compromising positioning stability or requiring excessive contact force.
Solution Approach 2:
The system replaces reliance on mechanical contact stability with optical clarity achieved through fluid displacement. Instead of requiring the imaging catheter to be firmly pressed against the tissue to exclude blood, the system uses fluid dynamics to displace blood from the imaging field, substituting a mechanical contact-based solution with a fluid-based optical clearing solution that maintains image quality while improving contact stability.
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
Enables real-time, clear visualization and accurate assessment of tissue regions within body lumens, facilitating effective diagnosis and treatment by minimizing fluid intake and synchronizing data acquisition with tissue movement.
Implementation Method 1
uses a transparent fluid to displace blood, allowing clear visualization
Implementation Method 2
including electrocardiogram gating to account for tissue movement
Data Source
AI summary
A method of imaging a tissue region may comprise visualizing one or more lesions in vivo over a tissue region within a body through an imaging catheter. The method may further comprise measuring a temperature or an electrical potential of the one or more lesions. The method may further comprise overlaying a gradient indicative of the temperature or the electrical potential upon a visual image of the one or more lesions captured in vivo. The method may further comprise registering ablation parameters to the visual image of the one or more lesions and displaying the visual image with the overlaid gradient and the registered ablation parameters.