Non-Papillary Steerable Catheter Access for Biliary and Pancreatic Strictures
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Solution Overview
Problem
Existing medical devices face challenges in accessing and treating strictures along the biliary and pancreatic tract, particularly due to difficulties in deep cannulation and the risk of inadvertently cannulating the pancreatic duct during endoscopic procedures, which can lead to complications such as pancreatitis.
Innovation Solution
A medical device system comprising a handle with translational carriages, a steerable catheter shaft, and a needle for non-papillary access, allowing for antegrade stricture crossing by piercing through the digestive tract wall and steering into the biliary or pancreatic tract, followed by guidewire insertion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional endoscopic devices are used for stricture treatment, then deep cannulation can be achieved, but the risk of inadvertently cannulating the pancreatic duct increases
Solution Approach 1:
The device is divided into functionally independent segments: a steerable catheter shaft for navigation, a separate needle for piercing, and a guidewire for tract establishment. This segmentation allows each component to be optimized for its specific function while reducing the risk of pancreatic duct injury through controlled, stepwise progression.
Solution Approach 2:
A steerable catheter shaft acts as an intermediary between the operator and the target ducts. The catheter's steerable design with external steering members provides visual and tactile feedback, allowing the operator to distinguish between biliary and pancreatic ducts before committing to cannulation, thereby reducing inadvertent pancreatic duct entry.
2Measurement precision
If a steerable catheter shaft with external steering members is used, then precise navigation across strictures is enabled, but the device complexity increases
Solution Approach 1:
The catheter shaft incorporates dynamic steering capabilities through externally accessible steering members that can be manipulated during the procedure. This dynamic control allows real-time adjustment of catheter orientation and positioning, enabling precise navigation across strictures while maintaining a relatively simple overall device architecture.
Solution Approach 2:
Steering members are positioned at specific locations along the catheter shaft where they provide maximum leverage and control. This localized steering approach allows precise navigation without requiring complex steering mechanisms throughout the entire device, thereby reducing overall device complexity while maintaining positioning precision.
3Ease of operation
If a needle is used for piercing through tissue, then access to the biliary tract can be achieved, but the risk of tissue damage increases
Solution Approach 1:
The device performs preliminary actions by first advancing a guidewire through the tissue and establishing a safe tract before deploying the needle for final piercing. This stepwise approach allows gradual tissue penetration with continuous visualization, reducing the risk of uncontrolled tissue damage while maintaining the ability to pierce through challenging tissues.
Solution Approach 2:
A guidewire serves as an intermediary that is advanced through the tissue before the needle is deployed. The guidewire establishes a controlled pathway and provides a safety buffer, allowing the needle to pierce tissue with reduced risk of uncontrolled damage while maintaining piercing capability.
Data Source
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AI summary
Systems and methods for treating a stricture, for example along the biliary and/or pancreatic tract, are disclosed. An example system may include a handle (14) having a base, a first carriage (26) translatable relative to the base, and a second carriage (24) translatable relative to the base. A sheath (16) may be coupled to the first carriage. The system may also include a catheter shaft (12) having a proximal end region and a steerable distal end region. The proximal end region may be coupled to the second carriage. A needle may be releasably coupled to the handle. The needle may be configured to pass through tissue into a position along the biliary and/or pancreatic tract. The system may also include a steering member (44) having a first end coupled to the steerable distal end region of the catheter shaft and a second end disposed adjacent to the handle.