GI Tract Occlusion Device for Endoscopic Ultrasound Imaging
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Solution Overview
Problem
Current endoscopic ultrasound guided procedures, such as entero-enterostomy, are limited by poor ultrasound imaging quality and limited lumen distensibility due to rapid fluid egress from the gastrointestinal tract, which can lead to metabolic disturbances with excessive fluid infusion.
Innovation Solution
A device and method for at least partially occluding a bodily lumen, specifically a GI tract, during an endoscopy procedure, using a flow reducing device with a flexible member that can be expanded to block the lumen, allowing for improved imaging and intervention by reducing fluid egress.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If large quantities of liquid are infused into the bowel to counter fluid egress, then imaging quality and lumen distensibility are improved, but metabolic disturbances occur due to excessive liquid infusion
Solution Approach 1:
The device segments the GI tract lumen by placing an occlusion balloon at the distal end of the infusion site, creating a isolated segment where liquid can be retained. This segmentation allows imaging to be performed in a contained environment without requiring excessive liquid infusion throughout the entire bowel, thereby improving imaging quality while avoiding metabolic disturbances from over-infusion.
Solution Approach 2:
The occlusion balloon acts as an intermediary device between the infused liquid and the rest of the GI tract. It mediates the retention of liquid at the target site, allowing sufficient liquid to be present for high-quality imaging without requiring large quantities to be infused systemically, thus preventing metabolic disturbances while achieving the desired imaging conditions.
2Duration of action of moving object
If large quantities of liquid are infused into the bowel to maintain lumen distensibility, then imaging time is extended, but metabolic disturbances occur
Solution Approach 1:
By segmenting the GI tract with the occlusion balloon, the device creates a contained environment where liquid can be retained for extended periods. This allows imaging procedures to be performed over longer durations without requiring continuous large-volume infusion, thereby extending imaging time while avoiding the metabolic disturbances associated with excessive liquid infusion.
Solution Approach 2:
The occlusion balloon is deployed in advance to establish liquid retention before imaging begins. This preliminary action ensures that the lumen remains distended with sufficient liquid for the entire imaging procedure duration, eliminating the need for continuous large-volume infusion and thereby extending imaging time without causing metabolic disturbances.
3Shape
If liquid is rapidly infused to counter fluid egress, then lumen distensibility is maintained, but imaging quality is limited by rapid fluid passage
Solution Approach 1:
The occlusion balloon segments the GI tract to create a closed system at the infusion site. This segmentation maintains lumen distensibility by preventing rapid fluid passage downstream, allowing the liquid to remain in contact with the bowel wall long enough to provide high-quality ultrasound imaging while maintaining the necessary distension for targeted intervention.
Solution Approach 2:
The occlusion balloon serves as an intermediary that prevents rapid fluid egress from the infusion site. It mediates between the infused liquid and the downstream GI tract, allowing sufficient liquid to be present for high-quality imaging and maintained lumen distensibility without requiring rapid continuous infusion that would otherwise be needed to counteract fast fluid passage.
Data Source
AI summary
Described herein are devices and related methods for occluding at least a portion of a bodily lumen during a procedure. In some embodiments, the device includes an inner shaft defining a lumen therethrough and a first aperture; and an outer shaft including a flexible member and defining a lumen therethrough and a second aperture positioned proximally on the outer shaft relative to the flexible member. The inner shaft extends through the lumen of the outer shaft, such that at least a portion of the outer shaft is axially translatable toward and away from the distal portion of the inner shaft. The flexible member is movable between an unexpanded configuration and an expanded configuration when at least a portion of the outer shaft is translated axially toward or away from the distal portion of the inner shaft. In some embodiments, the device and methods are used for endoscopy procedures.