Transhepatic Endoluminal Access for Difficult Pancreaticobiliary Anatomy
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Solution Overview
Problem
Conventional endoscopic procedures face challenges in navigating endoscopes and instruments to deep anatomical regions within patients, particularly in those with surgically altered or difficult anatomy, leading to high failure rates and the need for alternative access routes to the pancreaticobiliary system.
Innovation Solution
A steerable elongate instrument is used for transhepatic access, navigating through a body cavity to the liver and into the pancreaticobiliary system, with AI-based decision systems identifying patient candidacy for retrograde or transhepatic access based on anatomy, and closing the access site with closure means.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If retrograde access via duodenal papilla is used, then conventional endoscopic procedures can access the pancreaticobiliary system, but the procedure fails in patients with surgically altered or difficult anatomy
Solution Approach 1:
The patent inverts the conventional retrograde access approach by implementing antegrade transhepatic access. Instead of approaching the pancreaticobiliary system from the duodenum (retrograde), the instrument approaches from the liver (antegrade), reversing the direction of access to overcome anatomical barriers and surgically altered structures that block retrograde pathways.
Solution Approach 2:
The patent introduces an AI-based decision system as an intermediary that analyzes patient anatomy and determines the appropriate access route. This intermediary evaluates anatomical features and recommends either retrograde or transhepatic access, enabling the system to adapt to individual patient variations and select the most suitable approach.
2Adaptability or versatility
If steerable elongate instrument is used for transhepatic access, then alternative access route is available for non-candidates, but device complexity increases
Solution Approach 1:
The patent employs a steerable elongate instrument with dynamic steering capabilities that allow real-time navigation through the liver and into the pancreaticobiliary system. The instrument's steerability enables it to adapt its path dynamically during the procedure, providing flexibility in accessing difficult anatomical targets while maintaining a relatively simple overall device structure.
3Measurement precision
If AI-based decision system is implemented, then patient candidacy for retrograde or transhepatic access can be identified, but device complexity and procedure time increase
Solution Approach 1:
The AI-based decision system performs preliminary analysis of patient anatomy before the actual access procedure. By evaluating anatomical features and determining candidacy for retrograde versus transhepatic access in advance, the system eliminates the need for time-consuming intraoperative decision-making and trial-and-error approaches, ultimately reducing total procedure time despite the added initial analysis step.
Data Source
AI summary
Systems, devices, and methods for providing an endoluminal transhepatic access to a patient pancreaticobiliary system in an endoscopic procedure are disclosed. An example of a transhepatic access procedure comprises navigating a steerable elongate instrument through a body cavity or channel and exiting to a access site of liver, puncturing the liver from the access site, extending the steerable elongate instrument through the liver and into the pancreaticobiliary system and performing an operation therein. Following the operation, the steerable elongate instrument can be retreated, and the access site of liver can be closed with a closure means. Apparatus and methods of training a machine-learning model and using said model to identify patient candidacy for retrograde access based on images of patient anatomy are also disclosed.