3D Image Registration for Guided ERCP Cannulation
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Solution Overview
Problem
Cannulation during endoscopic retrograde cholangiopancreatography (ERCP) is challenging due to the inability to visualize the position or trajectory of the common bile duct and pancreatic duct, leading to prolonged procedures, increased risk of post-ERCP pancreatitis, and the need for tertiary care in failed cases.
Innovation Solution
A system for 3D image registration using a medical device with an imaging and position sensing system to capture and process images, generate a 3D surface map, and overlay a graphical user interface (GUI) to guide cannulation, providing real-time visual guidance for inserting devices into the correct duct.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of information
If fluoroscopy is used to visualize the biliary or pancreatic ductal systems, then the operator can identify the cause of stricture, but the operator cannot visualize the position or trajectory of the common bile duct and pancreatic duct for accurate cannulation
Solution Approach 1:
The patent applies endoscopic imaging to provide a third-dimensional view of the papilla and ductal openings, complementing the two-dimensional fluoroscopy. This multi-dimensional approach allows operators to visualize both the surface anatomy (endoscopy) and the internal ductal trajectory (fluoroscopy), enabling accurate alignment and cannulation by integrating information from multiple imaging planes and perspectives
2Reliability
If multiple cannulation attempts are made to successfully cannulate the duct, then the procedure may eventually succeed, but the risk of post-ERCP pancreatitis increases
Solution Approach 1:
The system performs preliminary visualization of the papilla and ductal openings using endoscopic imaging before attempting cannulation. By pre-identifying the target duct opening and its spatial relationship to surrounding structures, the operator can plan the cannulation trajectory in advance, reducing the need for repeated attempts and minimizing tissue trauma that could lead to pancreatitis
Solution Approach 2:
The integrated imaging system provides real-time feedback during the cannulation procedure, allowing the operator to continuously monitor the position of the catheter relative to the ductal opening and adjust the approach accordingly. This immediate feedback loop enables precise cannulation on the first or second attempt, preventing the cumulative tissue damage associated with multiple failed attempts
3Productivity
If the procedure is performed without 3D image registration, then the procedure can be completed, but the procedure duration is prolonged due to difficulty in visualizing duct trajectory
Solution Approach 1:
The patent merges endoscopic imaging with fluoroscopic imaging through 3D image registration, creating a unified navigational system that displays both modalities in spatially correlated views. This integration allows the operator to simultaneously see the endoscopic view of the papilla and the fluoroscopic projection of the ductal trajectory, eliminating the need to switch between separate imaging systems and significantly reducing the time required to achieve accurate cannulation
Data Source
AI summary
A system includes a medical device and computer-readable media storing instructions that, when executed by a processor, cause operations to be performed, including: receiving a three-dimensional (3D) image of anatomy, processing the 3D image to extract a 3D model identifying anatomical structures of interest, receiving images captured by an imaging device of the medical device as the medical device is navigated through a body lumen to a target site, including a current image of the target site, receiving medical device spatial information from a position sensing system including a transmitter/receiver in or on the medical device, processing the images and spatial information to generate a 3D surface map of the body lumen, registering the 3D model to the patient using the map and spatial information, and generating and displaying a graphical user interface overlaying a representation of a position/trajectory of the anatomical structures of interest on the current image.