Core Biopsy Needle Retention Geometry for Intact Tissue Sampling

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Solution Overview

Problem

Existing biopsy devices struggle to efficiently obtain intact, full-core tissue samples, particularly from soft tissues, due to the lack of effective tissue retention and the tendency to crush or push away tissue during the sampling process, which compromises the accuracy of pathological analysis and requires multiple attempts.

Innovation Solution

A biopsy device with a coaxially disposed inner and outer needle configuration, featuring a Franseen tip with prongs and a countersink or forcing cone on the outer needle, along with precise positioning of the inner needle to prevent tissue displacement, combined with optional vacuum assistance to ensure complete tissue capture and retention.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If a conventional core biopsy needle is used, then a tissue sample can be obtained, but the sample volume is limited and may not provide sufficient tissue for accurate pathological assessment

Engineering Contradiction:

Improvetissue sample volumeVSAvoidpathological assessment accuracy

Core Design Contradiction:

Quantity of substanceVSMeasurement precision

Solution Approach 1:

The needle is divided into an outer needle for tissue cutting and an inner stylet for sample retention, with the stylet featuring a specimen recess that segments the tissue capture zone to maximize sample volume while maintaining structural integrity during extraction

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The invention transitions from traditional linear needle designs to a three-dimensional Franseen tip geometry with prongs arranged in a specific spatial configuration, creating a cup-shaped specimen recess that captures tissue in multiple dimensions simultaneously, thereby increasing sample volume without proportionally increasing needle diameter

Inventive Principle:

Principle #17Another dimension (Dimensionality change)

2Quantity of substance

If manual FNA technique is used to obtain soft tissue samples, then full core samples can be obtained, but the procedure is time-consuming and technique-dependent requiring multiple attempts

Engineering Contradiction:

Improvetissue sample completenessVSAvoidbiopsy procedure time

Core Design Contradiction:

Quantity of substanceVSLoss of time

Solution Approach 1:

The Franseen tip geometry with its self-sharpening prongs and cup-shaped specimen recess automatically captures and retains tissue samples during the biopsy procedure without requiring manual manipulation or technique-dependent actions by the operator

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The invention changes the geometric parameters of the needle tip to specific angles and dimensions (prong angles, specimen recess depth and diameter) that optimize tissue capture efficiency, allowing consistent full core sample acquisition in a single pass regardless of operator skill level

Inventive Principle:

Principle #35Parameter changes

3Productivity

If high-speed automated biopsy device is used, then the procedure is faster, but the needle pushes tissue aside rather than drawing it in, compromising sample quality

Engineering Contradiction:

Improvebiopsy procedure speedVSAvoidtissue sample integrity

Core Design Contradiction:

ProductivityVSQuantity of substance

Solution Approach 1:

Instead of relying on needle advancement speed to draw tissue in, the invention inverts the approach by using a cup-shaped specimen recess that passively captures tissue as the needle advances, allowing high-speed operation without tissue displacement or push-away effects

Inventive Principle:

Principle #13The other way round (Inversion)

Solution Approach 2:

The cup-shaped specimen recess acts as an intermediary structure between the advancing needle and the target tissue, facilitating smooth tissue capture and retention during high-speed automated biopsy by distributing mechanical forces evenly across the tissue-sample interface

Inventive Principle:

Principle #24Intermediary (Mediator)

4Quantity of substance

If the inner needle tip extends beyond the outer needle tip, then tissue can be drawn into the needle, but the tissue becomes crushed compromising sample quality

Engineering Contradiction:

Improvetissue capture efficiencyVSAvoidsample integrity

Core Design Contradiction:

Quantity of substanceVSManufacturing precision

Solution Approach 1:

The invention inverts the traditional arrangement by having the inner stylet tip retract slightly behind the outer needle tip, allowing the Franseen tip prongs to capture tissue first, then the stylet to follow and retain the sample without applying crushing forces from ahead

Inventive Principle:

Principle #13The other way round (Inversion)

Data Source

PatentUS12478356B2Full core biopsy device

Publication Date: 2025.11.25 PAVE LLC

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 introduced to a biopsy site through an introducer in which the introducer is vented and/or a certain ratio of introducer inner diameter and biopsy device outer diameter is maintained.