Expandable Instrument Accessory for Precise Bile Duct Cannulation
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Solution Overview
Problem
Endoscopic procedures, such as ERCP, face challenges in cannulating the bile duct due to difficulties in positioning and stabilizing the endoscope within the duodenum, exacerbated by peristaltic movements and the tightly contracted musculature of the duodenal papilla, leading to compromised effectiveness and efficiency.
Innovation Solution
An instrument accessory device with an expandable member that can be expanded within the body lumen to stabilize the endoscope, featuring an inner and outer layer with an instrument lumen and apertures for fluid communication, allowing for frictional contact and stabilization, and comprising a mechanism for expanding and collapsing the member.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the endoscope is maneuvered through the tightly contracted musculature of the duodenal papilla, then cannulation of the bile duct can be achieved, but the precision required is extremely high and the procedure becomes difficult and time-consuming
Solution Approach 1:
The expandable member acts as an intermediary device that is deployed around the endoscope within the duodenum. When expanded, it provides a stable platform that mediates between the moving endoscope and the contracted duodenal papilla, allowing for precise positioning without requiring extreme manual dexterity.
Solution Approach 2:
The expandable member changes its physical parameters (radius, surface area) by transitioning from a compressed to an expanded state. This parameter change allows it to engage with the duodenal wall and provide stabilization, transforming the operational conditions from difficult to manageable.
2Measurement precision
If the endoscope position is stabilized against peristaltic movements, then cannulation precision improves, but the procedure time increases due to the complexity of positioning
Solution Approach 1:
The expandable member is deployed and expanded before the critical cannulation maneuver is attempted. This preliminary action establishes a stable base of support that prevents peristaltic movement from disrupting the positioning, allowing the operator to proceed with confidence and efficiency.
Solution Approach 2:
The expandable member serves as a mediator between the peristaltic movements of the duodenum and the endoscope. By expanding within the duodenal lumen, it creates a stable interface that isolates the endoscope from harmful movements, enabling precise positioning without repeated adjustments.
3Measurement precision
If the expandable member is expanded within the body lumen, then the endoscope is stabilized and positioning precision improves, but the device complexity increases
Solution Approach 1:
The expandable member is designed with a nested structure where the expandable framework is contained within an outer sheath during delivery. Once positioned, the expandable member is deployed from within the sheath, allowing the complex structure to be delivered in a compact form and then expanded only when needed at the target site.
Solution Approach 2:
The expandable member transitions from a static, compressed state during delivery to a dynamic, expanded state during use. This dynamic characteristic allows the device to adapt its complexity - simple during delivery, complex only when needed for stabilization - thereby reducing the overall burden of device complexity.
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
Enhances the precision, accuracy, and ease of endoscopic procedures by maintaining the endoscope's position within the body lumen, facilitating successful cannulation of the bile duct and improving procedural outcomes.
Implementation Method 1
The instrument lumen may be configured to maintain frictional contact with the instrument when the expandable member is in a collapsed condition
Implementation Method 2
The outer layer may comprise a compliant elastic material
Data Source
AI summary
The present disclosure, in its various aspects, is directed to instrument accessory devices, implementation methods, and related delivery systems. Embodiments according to the present disclosure, including as described herein, may increase the effectiveness and efficiency of endoscopy procedures, such as ERCP. In one example, an embodiment includes an instrument accessory device with an expandable member, the device configured to receive an instrument through an instrument lumen, wherein the expandable member comprises an aperture on the inner surface and outer surface, and the outer surface is in fluid communication with the inner surface.