Incremental Inflation Tool for ERCP Extraction Balloons
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Solution Overview
Problem
Current syringe devices for inflating extraction balloons in ERCP procedures lack the ability to provide incremental inflation and accurate sizing to match the specific anatomy of patients, limiting the number of achievable balloon diameters and precision.
Innovation Solution
An inflation system comprising a syringe with a first component having a longitudinal arm with positioning members that correspond to incremental inflation increments, allowing the balloon to be inflated to specific diameters by advancing the plunger and component distally to engage different positioning members.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a syringe with predetermined markings is used to control balloon inflation volume, then the number of achievable balloon sizes is limited, but the device structure remains simple
Solution Approach 1:
The syringe barrel is segmented into multiple discrete inflation increments, each marked with a positioning member. This segmentation allows the clinician to select from multiple predetermined balloon sizes (e.g., 18mm, 20mm, 22mm, 24mm, 26mm, 28mm, 30mm) while maintaining a relatively simple syringe structure. The segmentation is achieved through physical markers such as holes, protrusions, or visual indicators at specific volumes along the barrel.
Solution Approach 2:
The inflation tool incorporates a movable component that can be positioned at different locations along the syringe barrel, allowing dynamic adjustment of the inflation volume. The positioning members (such as a movable indicator or adjustable stop) enable the system to adapt to different clinical needs by selecting from multiple predetermined volumes, transforming a static syringe into a dynamically adjustable inflation device.
2Measurement precision
If the syringe barrel includes multiple markings for different balloon sizes, then the precision of balloon sizing improves, but the markings become less visible and accurate due to size constraints and dimensional tolerances
Solution Approach 1:
An intermediary positioning indicator or movable marker is introduced as a mediator between the syringe barrel markings and the clinician's visual assessment. This intermediary component can be positioned at different locations along the barrel corresponding to different desired balloon sizes, providing a clear, unified visual reference point that is not constrained by the size or precision limitations of individual barrel markings. The intermediary marker amplifies the precision of volume selection by providing a single, easily visible target position.
Solution Approach 2:
The positioning members or markings on the syringe barrel utilize color coding or color-changing materials to enhance visibility and precision. Different colors can indicate different inflation increments or size ranges, making it easier for the clinician to accurately select the desired balloon size. Color changes or high-contrast markings compensate for dimensional tolerances and ensure that the intended volume is clearly identifiable.
3Ease of operation
If the syringe allows full plunger travel for maximum inflation volume, then the balloon can reach its maximum diameter, but the clinician cannot easily control or stop inflation at intermediate diameters
Solution Approach 1:
The syringe is pre-configured with positioning members and markings that indicate predetermined inflation volumes corresponding to specific balloon diameters. These preliminary markers guide the clinician to stop plunger advancement at the desired intermediate diameter, eliminating the need to calculate or estimate volumes during the procedure. The preliminary markings enable precise control at multiple intermediate stages before reaching maximum inflation.
Solution Approach 2:
The positioning members on the syringe barrel provide visual feedback to the clinician during the inflation process. As the plunger is advanced, the clinician can observe the position relative to the markings and stop at the desired increment. This immediate visual feedback loop allows for precise control of balloon diameter at intermediate stages, enabling the clinician to achieve exactly the required size without over-inflation.
Data Source
AI summary
Inflation systems and methods for inflating a balloon member are provided. The inflation system includes an inflation tool. The inflation tool includes a first component having a first arm where the first arm extends longitudinally along an axis of movement of the first component. The first arm includes a first and a second positioning member, the first positioning member is longitudinally spaced apart from the second positioning member. The first component is adapted to advance distally for inflation of the balloon member. Each positioning member corresponds to an inflation increment for the balloon member.