Expandable Papillary Scaffold for Endoscopic Stone Access
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Solution Overview
Problem
Standard endoscopic retrograde cholangiopancreatography is ineffective in removing all types of bile duct stones, necessitating the development of alternative medical devices and methods for accessing and enlarging body lumens.
Innovation Solution
A medical device with a flexible elongate member, an expandable scaffold, and an actuator to transition between contracted and radially expanded configurations, facilitating access and dilation of body lumens, such as the sphincter of Oddi, using a handle assembly, cutting wire, and guidewire lumens for enhanced maneuverability and visualization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If standard endoscopic retrograde cholangiopancreatography is used, then the procedure can be performed with conventional equipment, but it is ineffective in removing all types of bile duct stones
Solution Approach 1:
The scaffold is designed to be dynamically expandable, transitioning from a compressed delivery configuration to an expanded deployment configuration. This dynamic structure allows the device to adapt to different anatomical conditions and stone types, resolving the contradiction between reliability and adaptability by enabling the same device to effectively handle various bile duct stone scenarios through controlled expansion.
Solution Approach 2:
The device utilizes parameter changes in the scaffold's radial dimension, transitioning from a small compressed state during delivery to a larger expanded state during deployment. This parameter change enables the scaffold to accommodate different stone sizes and anatomical variations, improving both the effectiveness and adaptability of the procedure without requiring multiple specialized devices.
2Reliability
If an expandable scaffold is introduced to enhance access and dilation capability, then effectiveness in removing bile duct stones improves, but device complexity increases
Solution Approach 1:
The scaffold is segmented into multiple struts arranged in a radial pattern, allowing independent expansion of each segment while maintaining overall structural integrity. This segmentation simplifies the expansion mechanism and reduces the complexity of the actuation system compared to a monolithic expandable structure, as each strut can be independently controlled during deployment.
Solution Approach 2:
The scaffold is nested within the delivery catheter during the delivery phase, with the expandable structure contained within the protective sheath. This nesting arrangement allows the complex expandable scaffold to be delivered through conventional catheters without requiring separate delivery mechanisms, thereby reducing overall device complexity while maintaining enhanced dilation capability.
3Ease of operation
If the scaffold is made expandable to dilate body lumens, then access capability improves, but the device becomes less flexible during delivery
Solution Approach 1:
The scaffold transitions from a flexible compressed state during delivery to a rigid expanded state during deployment. This dynamic property allows the device to maintain flexibility during delivery through the body lumen while providing the necessary rigidity and dilation capability once positioned, resolving the contradiction between ease of operation and device complexity by timing the structural change appropriately.
Solution Approach 2:
The scaffold is pre-compressed to a small diameter before delivery, allowing it to be easily inserted through the body lumen. The expansion action is performed as a preliminary step before the main therapeutic procedure, enabling the device to achieve both ease of delivery and effective dilation capability through staged structural transformation.
Data Source
AI summary
A medical device includes a handle assembly and a flexible elongate member extending distally from the handle assembly. The elongate member includes a first lumen extending from the distal end of the elongate member at least partially along the elongate member toward the proximal end of the elongate member. The first lumen is configured to accept a guidewire. The elongate shaft includes a second lumen extending through at least a portion of the elongate member. A cutting wire extends through the second lumen. A distal end of the cutting wire is connected to the distal end of the elongate member, and a portion of the cutting wire extends external to the outer surface of the elongate member proximal of the distal end. An expandable scaffold is disposed at the distal portion of the elongate member. An actuator is configured to actuate the expandable scaffold between a contracted, delivery configuration and a radially expanded, deployed configuration.