Sphincterotome Device With Multiple Lumens for ERCP

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Solution Overview

Problem

Current sphincterotome devices require removal and reinsertion during the 'double-wire' technique in ERCP procedures, making the process longer and more invasive, and increasing the risk of post-ERCP pancreatitis due to complex guidewire manipulation.

Innovation Solution

A sphincterotome device design that allows simultaneous manipulation of the biliary duct and insertion of a second guidewire without removing the device, facilitating easier access to both the pancreatic and biliary ducts by providing multiple lumens and adjustable cutting wires for improved angulation and reduced need for invasive procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the sphincterotome device is removed and reinserted during the double-wire technique, then guidewire manipulation can be performed, but the procedure time increases and invasiveness increases

Engineering Contradiction:
Improveguidewire manipulationVSAvoidprocedure time
Core Design Contradiction:
Ease of operationVSLoss of time

Solution Approach 1:

The patent combines the sphincterotome device with multiple guidewire lumens integrated into its structure, allowing the device to remain in place while multiple guidewires are manipulated simultaneously. This eliminates the need to remove and reinsert the device, resolving the contradiction between ease of guidewire manipulation and procedure time.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The sphincterotome device is designed with multiple lumens that can accommodate different guidewires and perform multiple functions (biliary access, pancreatic access, cutting) without requiring device removal or replacement, enabling the single device to serve multiple purposes throughout the procedure.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Ease of operation

If the sphincterotome device is removed and reinserted during the double-wire technique, then guidewire manipulation can be performed, but the invasiveness increases and risk of post-ERCP pancreatitis increases

Engineering Contradiction:
Improveguidewire manipulationVSAvoidrisk of post-ERCP pancreatitis
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

By integrating multiple guidewire lumens into the sphincterotome device structure, the patent allows continuous device presence during guidewire manipulation, eliminating repeated insertions and reductions in invasiveness that lower the risk of post-ERCP pancreatitis.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The device is designed with pre-configured lumens and pathways that allow guidewires to be advanced through predetermined routes, reducing the need for complex, repeated manipulations that increase invasiveness and complication risk.

Inventive Principle:
Principle #10Preliminary action

3Adaptability or versatility

If multiple lumens and adjustable cutting wires are provided, then access to pancreatic and biliary ducts is improved, but device complexity increases

Engineering Contradiction:
Improveaccess to ductsVSAvoiddevice structure
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The sphincterotome device is divided into multiple functional lumens, each dedicated to specific purposes (guidewire passage, cutting wire, fluid injection), allowing complex functionality to be achieved through modular segmentation rather than a monolithic complex structure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different portions of the device have specialized properties - certain lumens are designed for guidewire passage, others for cutting wire deployment, with specific angulations and configurations optimized for accessing either biliary or pancreatic ducts, allowing adaptability through localized functional differentiation.

Inventive Principle:
Principle #3Local quality

Data Source

PatentUS11213348B2Sphincterotome device and methods and uses thereof
Publication Date: 2022.01.04 CITY OF HOPE
  • US11213348B2 patent drawing
  • US11213348B2 patent drawing
  • US11213348B2 patent drawing

AI summary

A sphincterotome device can be used to achieve appropriate positioning within the biliary duct during cannulation. The sphincterotome device enables performance of a “double-wire” or multiple wire procedure without the need for removal and reintroduction of the sphincterotome device, thereby allowing for a shorter procedure.