Biopsy Needle Sample Retention via Segmented Cutting

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Solution Overview

Problem

Existing biopsy needle systems face challenges in efficiently severing and retaining tissue samples during the biopsy process, often resulting in incomplete or damaged samples.

Innovation Solution

The biopsy needle assembly incorporates an outer tubular member with a distal end configured to core and sever a first portion of the tissue sample, and a cutting member that slides within the tubular member to sever a second portion of the sample, with a mechanism to retain the sample within the needle assembly during withdrawal.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If a single cutting edge is used to sever the tissue sample, then the device structure is simple, but the sample may be damaged or incomplete

Engineering Contradiction:
Improvesample integrityVSAvoidcutting mechanism complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The cutting function is divided into two separate cutting edges: a first cutting edge that cuts the proximal portion of the tissue sample and a second cutting edge that cuts the distal portion. This segmentation allows each cutting edge to be optimized for its specific function, ensuring complete sample separation without damage while maintaining a relatively simple overall structure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The proximal and distal cutting edges are positioned at different locations within the needle assembly, with the proximal cutting edge located closer to the needle hub and the distal cutting edge positioned further away. This local differentiation allows each cutting edge to address specific portions of the tissue sample, ensuring complete and intact sample retrieval.

Inventive Principle:
Principle #3Local quality

2Reliability

If the needle assembly is designed to retain the sample during withdrawal, then sample loss is reduced, but the device complexity increases

Engineering Contradiction:
Improvesample retention reliabilityVSAvoidretention mechanism complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The tissue sample is nested within the hollow needle assembly, with the needle hub providing an internal cavity that accommodates the sample. The proximal and distal cutting edges work together to seal the sample within this nested space, preventing loss during withdrawal without requiring additional complex retention mechanisms.

Inventive Principle:
Principle #7Nested doll (Nesting)

3Manufacturing precision

If a complex multi-component cutting mechanism is used, then sample completeness is improved, but the ease of operation decreases

Engineering Contradiction:
Improvesample completenessVSAvoidbiopsy procedure ease
Core Design Contradiction:
Manufacturing precisionVSEase of operation

Solution Approach 1:

The needle assembly merges multiple functions into a single integrated structure: the hollow needle shaft serves as both the insertion tool and the sample retention container, while the proximal and distal cutting edges are incorporated as integral parts of the needle assembly. This merging allows the device to achieve complete sample retrieval through a single straightforward insertion and cutting action, maintaining ease of operation.

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentEP3687417B1Biopsy needle sample retention system
Publication Date: 2025.04.30 MERIT MEDICAL SYSTEMS INC
  • EP3687417B1 patent drawingFigure 1
  • EP3687417B1 patent drawingFigure 2A~2B
  • EP3687417B1 patent drawingFigure 3A~3C

AI summary

A biopsy needle assembly configured for use with a tissue biopsy device is disclosed. The biopsy needle assembly may be configured to be advanced to a predetermined tissue sample, sever the tissue sample, and extract the tissue sample from a body tissue of a patient. The biopsy needle assembly may be further configured with two or more cooperating members configured to sever a sample.