Steerable Catheter Imaging Hood for Fluid-Cleared Tissue Manipulation
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Solution Overview
Problem
Conventional imaging modalities for body lumens, such as the heart, are hindered by opaque bodily fluids like blood, leading to inadequate real-time imaging and limited therapeutic procedures due to tissue displacement, cramped working areas, and susceptibility to pressure changes.
Innovation Solution
A tissue imaging and manipulation apparatus with an expandable imaging hood deployed via a catheter, using a biocompatible fluid to displace blood and provide clear visualization, combined with articulatable mechanisms for precise positioning and therapeutic tools.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of information
If an inflatable balloon is used to create a working area for imaging, then a clear visualization field can be obtained, but the balloon displaces surrounding tissue and interferes with fine positioning
Solution Approach 1:
The imaging system is segmented into multiple independent components: a non-displacing imaging balloon for visualization, separate positioning mechanisms (articulatable catheter, magnetic navigation), and selective fluid delivery systems. This allows the imaging function to be isolated from the positioning function, enabling clear imaging without tissue displacement interfering with fine positioning.
Solution Approach 2:
A clear fluid (saline or contrast agent) is introduced as an intermediary medium between the imaging balloon and the tissue. This fluid displaces blood from the imaging field without requiring the balloon itself to displace surrounding tissue, thereby maintaining both image quality and positioning precision.
2Loss of information
If an inflatable balloon is used for imaging, then a visualization field is created, but the working area becomes cramped and limited in size
Solution Approach 1:
The system transitions from a two-dimensional balloon surface imaging approach to a three-dimensional volumetric imaging approach using multiple imaging planes and angles. This dimensional expansion creates a larger effective working area by utilizing space in multiple dimensions rather than being constrained to a single cramped plane.
Solution Approach 2:
The imaging system is designed with multi-functionality to perform various therapeutic procedures (ablation, biopsy, drug delivery) within the imaging field. By integrating multiple functions into a single system, the working area is optimized to accommodate diverse procedures without requiring separate cramped spaces for each function.
3Loss of information
If an inflated balloon is used for imaging, then a clear field is obtained, but the balloon is susceptible to pressure changes during systolic and diastolic cycles
Solution Approach 1:
The system employs a counterbalancing pressure mechanism where a compliant membrane or adjustable pressure system compensates for the pressure changes occurring during cardiac cycles. This counterpressure maintains the balloon volume and positioning stability despite the dynamic pressure environment of the beating heart.
Solution Approach 2:
The balloon system incorporates adjustable parameters including variable inflation pressure, flexible membrane materials with different compliance characteristics, and dynamic volume control. These parameter changes allow the system to adapt to pressure variations during systole and diastole while maintaining stable imaging conditions.
4Loss of information
If conventional imaging modalities are used in body lumens, then imaging can be performed, but opaque bodily fluids like blood obstruct the image acquisition
Solution Approach 1:
The system converts the harmful effect of blood opacity into a beneficial imaging contrast mechanism. By introducing clear fluid that displaces blood and using contrast agents that enhance tissue visibility against the clear background, the presence of blood is transformed from an obstacle into part of the contrast mechanism itself.
Solution Approach 2:
A clear fluid (saline or contrast agent) serves as an intermediary medium that replaces opaque blood within the imaging field. This intermediary fluid is transparent to the imaging modality and allows unobstructed visualization of tissue structures that would otherwise be hidden by blood.
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, undistorted imaging and therapeutic procedures within body lumens by maintaining a stable imaging field despite fluid dynamics, allowing for procedures like trans-septal access and valve treatments.
Implementation Method 1
using a biocompatible fluid to displace blood and provide clear visualization
Implementation Method 2
maintaining a stable imaging field despite fluid dynamics
Data Source
AI summary
A tissue imaging assembly includes a steerable sheath and a steerable catheter deployable within the sheath. The tissue imaging assembly also includes an imaging hood at a distal end of the steerable catheter. The imaging hood is independently translatable with respect to the steerable sheath and the steerable catheter. The steerable catheter includes an imaging element and a lumen for delivering an elongate instrument out a distal region of the steerable catheter.


