Stylet Guide-Assisted Biopsy Needle System

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Solution Overview

Problem

Current biopsy techniques face challenges in accurately approaching small and deep lesions, leading to complications such as bleeding and pneumothorax due to the difficulty in repositioning larger-diameter needles, which cause injury to vessels and the pleura.

Innovation Solution

A system utilizing a thin-diameter, flexible guide stylet that can be bent to modify its path, combined with a modified penetration needle and a torquer for precise guidance, allowing multiple attempts without causing significant trauma or complications.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If a larger-diameter needle is used for biopsy, then the tissue sampling capability is improved, but the risk of bleeding and pneumothorax increases

Engineering Contradiction:
Improvetissue sampling capabilityVSAvoidbleeding and pneumothorax risk
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The biopsy procedure is segmented into two distinct phases: first inserting a thin guide stylet to establish the path and minimize trauma, then introducing the larger biopsy needle through the established tract. This segmentation allows each component to perform its optimal function without compromising the other.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The thin guide stylet acts as an intermediary element that facilitates the safe introduction of the larger biopsy needle. It creates a pilot channel through vulnerable tissues, serving as a mediator that protects against direct trauma from the larger needle while enabling subsequent tissue sampling.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Quantity of substance

If a larger-diameter needle is used for biopsy, then the tissue sampling capability is improved, but the difficulty of repositioning increases

Engineering Contradiction:
Improvetissue sampling capabilityVSAvoidrepositioning difficulty
Core Design Contradiction:
Quantity of substanceVSEase of operation

Solution Approach 1:

The procedure separates the positioning function (performed by the flexible, easy-to-reposition guide stylet) from the tissue sampling function (performed by the larger biopsy needle). The guide stylet can be freely adjusted and repositioned without causing significant trauma, while the biopsy needle remains stationary once positioned.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The guide stylet is inserted and positioned first, establishing the correct path before the biopsy needle is introduced. This preliminary action allows for easy adjustments and corrections before committing the larger, harder-to-reposition needle to its final position.

Inventive Principle:
Principle #10Preliminary action

3Object-affected harmful factors

If a thin-diameter needle is used for biopsy, then the risk of bleeding and pneumothorax is reduced, but the tissue sampling capability deteriorates

Engineering Contradiction:
Improvebleeding and pneumothorax riskVSAvoidtissue sampling capability
Core Design Contradiction:
Object-affected harmful factorsVSQuantity of substance

Solution Approach 1:

The system divides the function between two components: the thin guide stylet minimizes trauma during insertion, while the separate larger biopsy needle provides adequate tissue sampling capability. Each component is optimized for its specific function without compromise.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The guide stylet serves as an intermediary that enables the use of a larger biopsy needle by creating a safe passage. Without this intermediary, direct insertion of the larger needle would cause excessive trauma; with it, the larger needle can be used safely through the pre-established channel.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP4378395A1Stylet guide-assisted transcutaneous needle biopsy system
Publication Date: 2024.06.05 PETABAS THEODOROS
  • EP4378395A1 patent drawingFigure 1
  • EP4378395A1 patent drawingFigure 2
  • EP4378395A1 patent drawingFigure 3

AI summary

An innovative biopsy needle system used in biopsies to obtain abnormal tissue from various organs for pathological examination is described. The difference with the needles currently used is that in the approach of the lesion a thin metal guide stylet is used, which approaches the lesion more easily with lower or even without complications. The puncture needle, of our proposal, consists of an outer cannula and an inner stylet. In our proposal the piercing needle shows a modification, its inner collar in its central position has a lumen along its entire length compatible in diameter with the diameter of the guide stylet. Thus, after the easy approach to the lesion by the guide stylet, the outer puncture needle, which carries the lumen inside with the stylet of the penetration needle may be forced forward and guided into the lesion. Then, by simultaneously removing the guide stylet with the stylet of the penetration needle, the sting of the piercing needle is released, forming a tunnel between the lesion and the outer space, through which a suitable pistol-type biopsy needle (GUN) passes to obtain the tissue biopsy.