Steerable Catheter Arcuate Shape for Biliary Access

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Solution Overview

Problem

Current endoscopic ultrasound-guided biliary drainage techniques face challenges such as difficulty in accessing the biliary duct due to rigid needle designs, complex anatomy, and the need for prolonged and labor-intensive procedures, which can lead to tissue trauma and complications like pancreatitis.

Innovation Solution

A maneuverable catheter assembly with an adjustable distal section that transitions to a pre-defined arcuate shape, allowing for improved directional control and navigation within the biliary duct, along with steerable functionality and cutting elements to facilitate access and treatment of blockages.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If rigid needle designs are used for biliary access, then structural strength is maintained, but ease of operation deteriorates due to difficulty in accessing the biliary duct

Engineering Contradiction:
Improvestructural strengthVSAvoidease of operation
Core Design Contradiction:
StrengthVSEase of operation

Solution Approach 1:

The catheter assembly incorporates a distal section that can dynamically change its configuration between a constrained linear state (within the delivery system) and a deployed arcuate shape (upon release), enabling the device to adapt its form for optimal navigation and access to the biliary duct while maintaining structural integrity during delivery

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The catheter utilizes a flexible membrane or thin-walled structure in the distal section that allows bending and shaping into pre-defined arcuate configurations, providing maneuverability for navigating complex biliary anatomy while maintaining sufficient strength for effective access and drainage

Inventive Principle:
Principle #30Flexible shells and thin films

2Reliability

If complex navigation maneuvers are performed to access the biliary duct, then access success rate improves, but tissue trauma increases

Engineering Contradiction:
Improveaccess success rateVSAvoidtissue trauma
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The catheter is pre-formed with a distal section configured in a pre-defined arcuate shape that is designed to naturally align with and follow the anatomical pathway of the biliary duct, eliminating the need for complex navigation maneuvers and reducing mechanical trauma to surrounding tissues during access

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The catheter's distal section adopts a curved arcuate geometry that mimics the natural curvature of the biliary duct anatomy, allowing the device to navigate the ductal system more smoothly and with less force, thereby reducing tissue trauma while maintaining high access success rates

Inventive Principle:
Principle #14Spheroidality (Curvature)

3Reliability

If prolonged procedures are performed to achieve biliary access, then access completeness improves, but procedural complexity increases

Engineering Contradiction:
Improveaccess completenessVSAvoidprocedural complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The catheter assembly is divided into distinct functional segments: a proximal delivery system portion and a distal access portion with pre-configured arcuate shape, allowing the device to self-navigate to the target location without requiring complex procedural maneuvers or multiple device exchanges, thereby simplifying the overall procedure while ensuring complete access

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP3000422B1Endoscopic ultrasound-guided biliary access system
Publication Date: 2021.10.27 COVIDIEN LP
  • EP3000422B1 patent drawingFigure 1
  • EP3000422B1 patent drawingFigure 2
  • EP3000422B1 patent drawingFigure 3

AI summary

The present disclosure provides an access system having a maneuverable catheter assembly configured for providing access to and navigating a desired vessel for subsequent treatment thereof. The access system includes an adjustable delivery handle assembly and an access catheter subassembly having a maneuverable access catheter configured to be delivered to desired site (e.g., within duodenum) to assist in treatment of a condition (e.g., drainage of a bile ducts via Endoscopic Ultrasound Guided Biliary Drainage (EUS-BD) techniques). The access catheter includes at least a distal section having an adjustable portion along a length thereof configured to transition to a pre-defined arcuate shape to provide directional control over the distal end of the catheter as it is navigated through a vessel (e.g., bile duct). The handle assembly includes additional elements configured to allow a clinician to maneuver and manipulate the distal end of the access catheter.