Biliary Diagnostic Sensor for Non-Fluoroscopic Endoscope Navigation

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Solution Overview

Problem

Conventional endoscopes face challenges in navigating to difficult-to-reach anatomical locations, often resulting in increased time and cost, and risk of tissue damage, particularly in duodenoscopy procedures where accurate navigation is crucial, and there is a need to avoid radiation exposure from fluoroscopy.

Innovation Solution

The development of biliary diagnostic devices equipped with sensors that analyze biological matter to guide endoscopes to specific anatomical areas, such as the common bile duct, using electrical properties to differentiate between liver bile and pancreatic ducts, thereby facilitating non-fluoroscopy navigation and identifying conditions leading to stone formation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If conventional endoscopes are used to navigate to difficult-to-reach anatomical locations, then the ability to access these locations is maintained, but the time required increases and tissue damage risk increases

Engineering Contradiction:
Improvenavigation to anatomical locationsVSAvoidtime to navigate endoscope
Core Design Contradiction:
Ease of operationVSLoss of time

Solution Approach 1:

The sensor analyzes biological matter ahead of the endoscope to identify anatomical features and bile presence in advance, allowing the operator to anticipate the correct path and make proactive navigation decisions rather than reactively adjusting after insertion

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The sensor acts as an intermediary between the operator and the complex anatomy by translating biological matter composition into interpretable signals that guide endoscope navigation, reducing the operator's cognitive burden and decision-making time

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If conventional endoscopes are used to navigate to difficult-to-reach anatomical locations, then access is possible, but the risk of tissue damage increases

Engineering Contradiction:
Improvenavigation to anatomical locationsVSAvoidtissue damage risk
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The sensor provides real-time feedback about bile presence and anatomical features, allowing continuous monitoring and adjustment of the navigation path to avoid sensitive tissues and confirm correct duct entry

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent replaces mechanical navigation reliance (operator skill and visual inspection) with a sensor-based detection system that objectively identifies anatomical features, reducing human error and tissue trauma from repeated probing

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Measurement precision

If fluoroscopy is used to facilitate navigation, then navigation accuracy improves, but radiation exposure increases

Engineering Contradiction:
Improvenavigation accuracyVSAvoidradiation exposure
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent substitutes the fluoroscopy-based detection method with a sensor-based electrical property detection system that analyzes biological matter composition, eliminating radiation exposure while maintaining the ability to identify anatomical features and guide navigation

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The invention changes the detection parameter from visual/radiographic imaging to electrical property analysis of biological matter, fundamentally altering how anatomical features are identified without using ionizing radiation

Inventive Principle:
Principle #35Parameter changes

4Reliability

If biliary diagnostic devices with sensors are used, then navigation accuracy and safety improve, but device complexity increases

Engineering Contradiction:
Improvenavigation accuracy and safetyVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The sensor serves multiple functions: identifying bile presence, detecting anatomical features, and guiding navigation decisions, allowing a single device component to address multiple navigation challenges without proportionally increasing complexity

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

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

The biliary diagnostic devices enhance navigation accuracy, reduce the risk of tissue damage, and provide insights into conditions causing stone formation, enabling more effective treatment plans without the need for fluoroscopy, thus improving procedural efficiency and patient safety.

Implementation Method 1

a first biliary diagnostic sensor comprising a first electrode configured to analyze biological matter in contact with the tubular body

Methodology Applied
Scientific EffectElectrical conductivity analysis: Conduction (electrical)

Data Source

PatentUS12256906B2Medical devices with biliary diagnostic devices
Publication Date: 2025.03.25 GYRUS ACMI INC
  • US12256906B2 patent drawing
  • US12256906B2 patent drawing
  • US12256906B2 patent drawing

AI summary

A biliary diagnostic device comprises a tubular body comprising an outer wall and an internal lumen, and a biliary diagnostic sensor comprising for analyzing biological matter in contact with the tubular body. A method of guiding an endoscope to a bile duct comprises inserting the endoscope into a duodenum, engaging a sensor with biological matter, electrically analyzing biological matter with the sensor to identify an electrical parameter, identifying liver bile in the biological matter from the electrical parameter, and guiding the endoscope through the duodenum based on the bile. A method of identifying biological matter comprises engaging a medical device sensor with biological matter in a bile duct, electrically analyzing biological matter with the sensor to identify an electrical parameter, identifying biological matter from a liver, pancreas or gall bladder from the electrical parameter, and outputting indicia of the biological matter to a user of the medical device.