Endoscopic Biopsy Device With Pivoting End Effectors for Tortuous Paths

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Solution Overview

Problem

Conventional biopsy devices face challenges in accessing tortuous paths due to the size of their distal assembly, leading to unsatisfactory tissue acquisition and increased trauma, requiring multiple samples and longer procedure times.

Innovation Solution

A medical device with opposing first and second end effectors that pivot about a common axis, allowing for independent movement and a wide range of configurations, including a closed configuration for navigation through tortuous paths and an open configuration for tissue grasping and cutting, facilitated by a wire actuated through a catheter lumen.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If conventional biopsy devices are used with a standard distal assembly size, then the device structure is simple and easy to manufacture, but the device cannot access tortuous paths and causes excessive tissue trauma

Engineering Contradiction:
Improveability to access tortuous pathsVSAvoidtissue trauma
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The distal assembly is divided into separate articulation joints that allow independent movement of end effectors relative to the catheter axis. This segmentation enables the device to navigate tortuous paths by bending at multiple joints while keeping the overall profile small enough to pass through narrow body passages.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device incorporates articulation mechanisms that allow dynamic adjustment of the end effector orientation and position. The end effectors can pivot and rotate independently to adapt to the specific geometry of the target site, enabling access to hard-to-reach areas without forcing the device through tissue.

Inventive Principle:
Principle #15Dynamics

2Object-affected harmful factors

If the distal assembly size is reduced to access tortuous paths, then the device can navigate narrow passages, but the tissue acquisition capability becomes insufficient

Engineering Contradiction:
Improvetissue traumaVSAvoidtissue sample quality
Core Design Contradiction:
Object-affected harmful factorsVSQuantity of substance

Solution Approach 1:

The end effectors are designed with articulation capabilities that allow them to open to a sufficient gape for tissue grasping and cutting after navigating through the catheter. The dynamic opening mechanism ensures that despite the small profile during navigation, the end effectors can achieve adequate size for effective tissue acquisition at the target site.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The end effectors are configured to nest within the catheter lumen during insertion and navigation, presenting a minimal profile. Once positioned at the target site, the end effectors deploy outward from the nested configuration to achieve the necessary opening for tissue manipulation, effectively transitioning from a compact storage state to a functional working state.

Inventive Principle:
Principle #7Nested doll (Nesting)

3Quantity of substance

If multiple tissue samples are acquired to ensure sufficient quality, then the sample quality for analysis is improved, but the procedure time increases and costs increase

Engineering Contradiction:
Improvesample qualityVSAvoidprocedure time
Core Design Contradiction:
Quantity of substanceVSLoss of time

Solution Approach 1:

The device incorporates a cutting mechanism that works in conjunction with the grasping end effector to obtain adequate tissue samples in a single acquisition. This mechanical cutting capability replaces the need for multiple blind sampling attempts, ensuring sufficient tissue quality is achieved in one controlled action.

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

4Adaptability or versatility

If conventional biopsy devices are used, then the device structure is simple, but the device cannot independently pivot end effectors to contact tissue at different locations

Engineering Contradiction:
Improveindependent effector movementVSAvoiddevice structure
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The articulation system is divided into separate joints and linkages that control the movement of each end effector independently. This segmented mechanical structure allows the first and second end effectors to pivot and rotate relative to each other and to the catheter axis, providing independent positioning capability while maintaining a manageable overall device complexity.

Inventive Principle:
Principle #1Segmentation

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 ability to access hard-to-reach areas with minimal tissue trauma and reduces the number of samples needed, improving procedure efficiency and safety.

Implementation Method 1

A medical device with opposing first and second end effectors that pivot about a common axis, allowing for independent movement and a wide range of configurations, including a closed configuration for navigation through tortuous paths and an open configuration for tissue grasping and cutting, facilitated by a wire actuated through a catheter lumen.

Methodology Applied
Scientific EffectMechanical Force: Mechanical Force

Data Source

PatentEP3972497B1Endoscopic medical device
Publication Date: 2025.09.24 BOSTON SCI LTD
  • EP3972497B1 patent drawingFigure 1~2
  • EP3972497B1 patent drawingFigure 3A~4
  • EP3972497B1 patent drawingFigure 5A~6

AI summary

A medical device includes opposing first and second end effectors coupled together to move from an open configuration to a closed configuration, a first link with a distal end pivotally connected to a proximal end of the first end effector, the first link including a first slot at a proximal end of the first link, a second link with a distal end pivotally connected to a proximal end of the second end effector, and a first actuator pin slidable within the first slot.