Biopsy Needle Locking Mechanism for Precision Sampling

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Solution Overview

Problem

Prior art biopsy needle arrangements collect excessive tissue and risk bacterial contamination during insertion, leading to potential infection, with increasing antibiotic resistance rendering chemical solutions less effective.

Innovation Solution

A biopsy needle arrangement with a locking mechanism between the needle tip and sheath, ensuring no gap between them, combined with a 'plough' or conical tip configuration for precise tissue sampling and reduced bacterial collection, minimizing tissue displacement and infection risk.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If a biopsy needle arrangement is used to collect tissue samples, then biopsy sampling capability is improved, but bacterial contamination risk increases due to large amount of tissue collected during insertion

Engineering Contradiction:
Improvebiopsy sampling capabilityVSAvoidbacterial contamination risk
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The needle arrangement is divided into distinct functional segments: a sheath that remains stationary during insertion, and a needle assembly that can be advanced independently. The needle includes a shaft portion and a tip portion with a cutting edge, allowing tissue sampling to occur only at the target location rather than along the entire insertion path.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The cutting edge is extracted as a separate functional element at the tip of the needle, distinct from the insertion path. This allows the needle to penetrate tissue without collecting excessive material along the trajectory, and only at the specific target point where the cutting edge engages the tissue to obtain the biopsy sample.

Inventive Principle:
Principle #2Taking out (Extraction)

2Object-affected harmful factors

If antibiotics are used to address bacterial contamination, then infection risk is reduced, but effectiveness decreases due to increasing antibiotic resistance

Engineering Contradiction:
Improveinfection riskVSAvoidantibiotic effectiveness
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The design converts the potential harm of needle insertion into a benefit by ensuring that the needle tip is sharp and precise, allowing for minimal tissue disruption and reduced bacterial release. The cutting edge is designed to cleanly excise tissue rather than tear or crush it, which reduces the risk of bacterial contamination while maintaining effective biopsy sampling.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

3Ease of operation

If the needle tip is allowed to move freely relative to the sheath, then ease of operation is improved, but biopsy precision decreases due to gap formation and tissue displacement

Engineering Contradiction:
Improveneedle operation flexibilityVSAvoidbiopsy precision
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The needle assembly is designed with dynamic characteristics that allow it to be advanced relative to the sheath during insertion, then locked in position once the target depth is reached. This dynamic design provides ease of operation during insertion while ensuring precision during the biopsy sampling phase.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

A locking mechanism acts as an intermediary between the needle assembly and the sheath, maintaining a precise fixed relationship during the biopsy sampling phase while allowing relative movement during insertion. This intermediary mechanism ensures that the cutting edge remains properly positioned relative to the sheath opening for accurate tissue sampling.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Ease of operation

If the second sheath opening edge is positioned high relative to the cavity bottom, then ease of operation is improved, but biopsy quality deteriorates due to upward lifting forces on tissue

Engineering Contradiction:
Improvesheath operationVSAvoidbiopsy quality
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The sheath opening is designed with differentiated local qualities: the first sheath opening edge is positioned to engage the tissue for cutting, while the second sheath opening edge is positioned lower to prevent upward lifting forces. This local differentiation ensures that each part of the sheath opening performs its specific function optimally, with the second edge acting as a support surface rather than a lifting force.

Inventive Principle:
Principle #3Local quality

Data Source

PatentEP4216826B1Improved biopsy arrangement
Publication Date: 2024.06.26 SAGA SURGICAL AB
  • EP4216826B1 patent drawingFigure 1a~1d
  • EP4216826B1 patent drawingFigure 2a~2e
  • EP4216826B1 patent drawingFigure 3a~3c

AI summary

A biopsy needle arrangement (20) comprises a needle sheath (22) and a needle (21) configured to lock a tip portion (23) of the needle in relation to the sheath when the needle arrangement has obtained a closed state. The locking, which is obtained by configurations of sheath opening edges and proximal tip edges, between the tip portion of the needle and the sheath is in a third direction Z as well as in a rotational sense in that the tip cannot rotate around a longitudinal axis defined by a first direction X.