Helical Coil Tissue Collection System for ERCP Sampling

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Solution Overview

Problem

Current tissue sampling methods, such as cytology brushes, often result in inadequate tissue collection due to soft bristles and sample loss, leading to low sensitivity in detecting biliary cancer, particularly in procedures like ERCP, where insufficient sample quantities hinder accurate diagnosis.

Innovation Solution

A tissue collection system comprising a tubular member with a helically wound coil or scraping members designed to collect tissue samples, featuring a pull wire to adjust the pitch of the coil and cavities with proximally or distally facing openings to enhance tissue collection and retention.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If traditional cytology brushes with soft bristles are used for tissue sampling, then the procedure is simple and easy to perform, but the tissue collection amount is insufficient leading to low sensitivity in detecting biliary cancer

Engineering Contradiction:
Improvetissue collection amountVSAvoiddevice structure
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

The tissue collection member is divided into multiple scraping members arranged in a circular array, each with cavities for tissue retention. This segmentation allows the device to collect and hold larger tissue samples compared to traditional single-brush designs, directly addressing the insufficient tissue collection amount while maintaining operational simplicity

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The scraping members with cavities are designed to nest tissue samples within enclosed spaces during the sampling process. This nesting structure prevents sample loss and enables retention of adequate tissue quantities for accurate cancer detection, resolving the contradiction between sample amount and device complexity

Inventive Principle:
Principle #7Nested doll (Nesting)

2Quantity of substance

If traditional cytology brushes are used for tissue sampling, then the device structure is simple, but sample loss occurs during the procedure leading to inadequate tissue for diagnosis

Engineering Contradiction:
Improvesample retentionVSAvoiddevice structure
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

Each scraping member includes cavities that nest and hold tissue samples securely during withdrawal and transport. This nested structure prevents sample loss throughout the procedure, ensuring adequate tissue reaches the laboratory for diagnosis while adding minimal complexity to the overall device

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The scraping members are designed with flexible structures that conform to the tissue surface while maintaining sample integrity. This flexibility allows effective tissue collection without compromising device simplicity, resolving the contradiction between sample retention and device complexity

Inventive Principle:
Principle #30Flexible shells and thin films

3Quantity of substance

If the helically wound coil with adjustable pitch is used, then tissue collection effectiveness is improved, but the device complexity increases due to the pull wire mechanism

Engineering Contradiction:
Improvetissue yieldVSAvoidadjustable mechanism
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

The helically wound coil's pitch is made adjustable through the pull wire mechanism, allowing the tissue collection member to adapt its configuration during the procedure. This dynamic adjustment optimizes tissue yield by enabling the coil to expand or contract as needed, while the pull wire provides a simple actuation method that minimizes overall device complexity

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The pitch of the helical coil is changed as a controllable parameter to optimize tissue collection effectiveness. By allowing this single geometric parameter to vary, the device achieves improved tissue yield without requiring complex multi-parameter control systems, resolving the contradiction between tissue yield and device complexity

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS20240225623A1Tissue sample device and methods
Publication Date: 2024.07.11 BOSTON SCIENTIFIC SCIMED INC
  • US20240225623A1 patent drawing
  • US20240225623A1 patent drawing
  • US20240225623A1 patent drawing

AI summary

A tissue collection system for collecting a sample from the body. The tissue collection system may comprise a tubular member having a proximal end region and a distal end region and defining a lumen extending from the proximal end region to the distal end region, an elongate shaft slidably disposed within the lumen of the tubular member, the elongate shaft extending from a proximal end region to a distal end region, and a tissue collection member disposed adjacent to the distal end region. The tissue collection member may comprise a helically wound coil including a plurality of windings.