Franseen Biopsy Needle with Countersink Retention

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Solution Overview

Problem

Current biopsy devices struggle to obtain full, intact, and clean core samples of soft tissues efficiently, often resulting in crushed or incomplete samples due to the lack of tissue retention and the need for multiple attempts, which increases patient discomfort and procedural time.

Innovation Solution

A biopsy device featuring a coaxially disposed outer and inner needle with a Franseen tip and a countersink, along with a vacuum generating component, allows for precise tissue cutting and retention, enabling the capture of a full core sample with minimal tissue compression and efficient extraction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If an automated biopsy device advances the outer needle into soft tissue at high speed (200 cm/min), then the biopsy procedure is simplified and shortened, but the coring needle pushes the tissue aside rather than drawing it into the needle, resulting in incomplete samples

Engineering Contradiction:
Improvebiopsy procedure speedVSAvoidtissue sample completeness
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

The biopsy device is divided into two functional components: an outer needle for rapid tissue penetration and an inner needle for precise sample capture. This segmentation allows each component to perform its specialized function - the outer needle advances quickly to reach the target while the inner needle with its hooked tip precisely engages and retrieves the tissue core, resolving the contradiction between speed and sample completeness

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The inner needle acts as an intermediary between the outer needle and the tissue sample. It is positioned within the outer needle lumen and extends beyond the outer needle tip, serving as the active element that engages the tissue while the outer needle provides structural support and rapid advancement capability

Inventive Principle:
Principle #24Intermediary (Mediator)

2Manufacturing precision

If an FNA device is used to obtain soft tissue samples, then full core samples can be obtained, but the procedure requires manual manipulation and multiple attempts, increasing patient discomfort and procedural time

Engineering Contradiction:
Improvetissue sample integrityVSAvoidprocedural time
Core Design Contradiction:
Manufacturing precisionVSLoss of time

Solution Approach 1:

The inner needle is pre-positioned within the outer needle lumen before the biopsy procedure begins, with its tip extending beyond the outer needle tip. This preliminary positioning ensures that as soon as the outer needle penetrates the tissue, the inner needle is already in place to engage and capture the tissue core, eliminating the need for manual manipulation and multiple attempts

Inventive Principle:
Principle #10Preliminary action

3Ease of operation

If the inner needle tip is positioned proud of the outer needle tip before firing, then tissue can be engaged, but the inner needle may crush or damage the soft tissue sample during extraction

Engineering Contradiction:
Improvetissue engagement capabilityVSAvoidtissue damage
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The inner needle tip is designed with a localized hooked configuration that provides targeted engagement capability only at the tip region, while the rest of the inner needle maintains a smooth surface to prevent tissue damage during extraction. This local quality differentiation allows effective tissue engagement without compromising sample integrity during retrieval

Inventive Principle:
Principle #3Local quality

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 device effectively obtains a full, clean core biopsy sample with reduced tissue damage and penetration depth, enhancing sample integrity and reducing procedural time and patient discomfort.

Implementation Method 1

a vacuum generating component. In one feature, the biopsy device includes a piston disposed within a chamber and coupled to the inner needle for manually drawing a vacuum within the chamber

Methodology Applied
Scientific EffectVacuum: Vacuum

Data Source

PatentEP2598040B1Full core biopsy device
Publication Date: 2020.09.02 PAVE LLC
  • EP2598040B1 patent drawingFigure 1
  • EP2598040B1 patent drawingFigure 2~3
  • EP2598040B1 patent drawingFigure 4~5

AI summary

A biopsy device includes coaxially disposed inner and outer needles in which the outer needle tip is configured for obtaining a tissue sample. The inner surface of the outer needle includes a tissue retention feature which may include a countersink and/or a feature formed in the inner surface. The device may be configured such that the inner needle does not extend past a certain point within the outer needle.