Actively Steerable Sphincterotome for Precise Duct Access

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Solution Overview

Problem

Accessing the papilla of Vater and the common bile duct and pancreatic duct during ERCP procedures is challenging due to their small size, close proximity, and difficult visualization, leading to potential complications like post-ERCP pancreatitis from failed cannulation attempts.

Innovation Solution

A steerable distal tip for medical devices, controlled by a handle with a steering wire and wire filament, allows precise manipulation and access to these ducts, enabling better alignment and entry.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If a rigid, non-steerable sphincterotome is used, then the device structure is simple and easy to manufacture, but the precision of accessing the papilla and ducts is poor, leading to higher complication rates

Engineering Contradiction:

Improveprecision of accessing papilla and ductsVSAvoiddevice structure complexity

Core Design Contradiction:

Manufacturing precisionVSDevice complexity

Solution Approach 1:

The sphincterotome is divided into multiple segments that can be independently controlled. The shaft is segmented to allow steerable articulation, and the distal tip is separated to enable precise positioning. This segmentation allows the device to achieve high precision in accessing the papilla and ducts while maintaining manageable structural complexity through modular design.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The sphincterotome incorporates dynamic steering capabilities with articulation wires and control mechanisms that allow real-time adjustment of the distal tip position and shaft articulation. This dynamic control enables the device to adapt to anatomical variations and achieve precise access to the papilla and ducts, transforming a static rigid structure into an actively steerable system.

Inventive Principle:

Principle #15Dynamics

2Measurement precision

If manual manipulation of the sphincterotome is used, then the device operation is simple, but the precision and control during access attempts is insufficient

Engineering Contradiction:

Improveprecision of duct accessVSAvoidease of device manipulation

Core Design Contradiction:

Measurement precisionVSEase of operation

Solution Approach 1:

Articulation wires serve as intermediaries between the proximal control mechanisms and the distal tip. These wires transmit control inputs through the flexible shaft to precisely position the distal tip. The control mechanism acts as an intermediary system that translates simple operator inputs into precise distal tip movements, maintaining ease of operation while achieving high measurement precision.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces purely manual mechanical manipulation with a hybrid system incorporating articulation wires and control mechanisms. This substitution allows for more precise control of the distal tip position and orientation while maintaining user-friendly operation through intuitive control interfaces that manage the complexity of the steering system.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If multiple failed cannulation attempts are made, then the procedure can be completed, but the risk of post-ERCP pancreatitis increases

Engineering Contradiction:

Improvesafety of procedureVSAvoidcannulation success rate

Core Design Contradiction:

ReliabilityVSProductivity

Solution Approach 1:

The steerable sphincterotome enables preliminary positioning and alignment of the distal tip before attempting cannulation. The articulation capabilities allow the operator to optimize the approach angle and position the tip precisely at the papilla opening, increasing the likelihood of first-attempt success. This preliminary action reduces the number of failed attempts and associated complications.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The device incorporates control mechanisms that provide feedback to the operator about the position and orientation of the distal tip. This feedback allows for real-time adjustment of the articulation and positioning to ensure optimal alignment with the papilla and ducts, increasing cannulation success rate and reducing the need for repeated attempts that could cause pancreatitis.

Inventive Principle:

Principle #23Feedback

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

Enhances the precision and safety of accessing the papilla and ducts, reducing the risk of complications by facilitating controlled entry and minimizing tissue compression.

Implementation Method 1

adjustment of the handle causes tension in the steering wire to adjust the mobile portion of the distal tip relative to the base component of the distal tip

Methodology Applied

Scientific EffectTension: Tension

Implementation Method 2

actuation of the first actuating portion in an axial direction can be configured to cause the distal end of the elongate tube to flex and expose a cutting portion of the wire filament

Methodology Applied

Scientific EffectFlexing: Deformation

Data Source

PatentUS20250331907A1Actively steerable sphincterotome

Publication Date: 2025.10.30 BOSTON SCI MEDICAL DEVICE LTD

AI summary

Devices, systems, and methods for a steerable sphincterotome. A handle includes first and second portions connected respectively to a steering wire and wire filament. A distal tip includes a base component and a mobile component selectively articulated by the steering wire. The wire filament can be selectively articulated and deployed for cutting.