Steerable Instrument RF Puncture for Pancreaticobiliary Access

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Solution Overview

Problem

Conventional endoscopic systems lack the capability for automated navigation guidance based on a patient's unique anatomy, making it difficult to access the pancreaticobiliary region, especially in patients with altered surgical anatomy or invasive tumors, and are less effective in the hands of less experienced operators.

Innovation Solution

A steerable elongate instrument with a working head that can deliver radio-frequency (RF) energy or apply mechanical force to create an opening in the stricture, guided by a machine-learning model to identify the optimal access approach, either RF-based or mechanical puncture-based, for accessing the pancreaticobiliary region.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Extent of automation

If conventional endoscopic systems are used for pancreaticobiliary access, then the procedure can be performed with standard equipment, but the navigation guidance lacks automation and success rate decreases in patients with altered anatomy

Engineering Contradiction:

Improvenavigation guidance automationVSAvoidaccess success rate

Core Design Contradiction:

Extent of automationVSReliability

Solution Approach 1:

The patent replaces manual mechanical navigation with an automated image-guided system that uses real-time imaging and computer-assisted navigation to guide the endoscope and puncture needle to the target pancreaticobiliary region, eliminating reliance on operator experience alone

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The system incorporates real-time imaging feedback and position monitoring that continuously provides information about the instrument's location relative to the target, allowing for dynamic adjustment of the navigation path and improving access success rate

Inventive Principle:

Principle #23Feedback

2Productivity

If direct cutting methods are used for stricture access, then the opening can be created quickly, but the risk of complications increases

Engineering Contradiction:

Improveopening creation speedVSAvoidprocedure risk

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces a staged access approach where a guidewire and dilating catheter serve as intermediaries between the external environment and the pancreaticobiliary system, allowing gradual dilation of the stricture rather than immediate cutting, thereby reducing complications

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The system performs preliminary imaging and planning before the puncture procedure, identifying the optimal access path and entry point in advance, which allows for more precise and safer stricture crossing with reduced risk of inadvertent injury

Inventive Principle:

Principle #10Preliminary action

3Ease of operation

If manual operator skill is relied upon for pancreaticobiliary access, then the procedure can be performed without automated systems, but effectiveness decreases in less experienced operators

Engineering Contradiction:

Improveoperator independenceVSAvoidprocedure effectiveness

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The automated navigation system performs many of the navigation and positioning tasks that would otherwise require skilled operator judgment and manual dexterity, allowing the system to guide itself to the target based on imaging data, thereby equalizing performance across operators of different experience levels

Inventive Principle:

Principle #25Self-service

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This approach improves access to the pancreaticobiliary region, reducing procedure complexity and time, and enhances the success rate of ERCP procedures while minimizing risks associated with direct cutting methods.

Implementation Method 1

delivering radio-frequency (RF) energy to an entry site of the stricture via a working head of the steerable elongate instrument to produce an opening to the pancreaticobiliary region

Methodology Applied

Scientific EffectRadio-frequency energy: Dielectric Heating

Data Source

PatentUS20230363628A1Wire puncture of stricture for pancreaticobiliary access

Publication Date: 2023.11.16 OLYMPUS CORPORATION(JP)

AI summary

Systems, devices, and methods for endoscopic access to a target region in a patient pancreaticobiliary system from an entry site of a stricture is disclosed. The stricture can be opened up using an radio-frequency (RF)-based approach by delivering RF energy to a working head of a steerable elongate instrument positioned at the entry site, or a mechanical puncture-based approach by applying force to a working head made of material with substantial stiffness. A machine learning (ML) model can be trained to determine a proper pancreaticobiliary access method for the patient, such as between the RF-based approach and the mechanical puncture-based approach. At least a distal portion of the steerable elongate instrument can be advanced into the pancreaticobiliary region to perform a diagnostic or therapeutic operation therein.