Rotating Biopsy Needle Stylet Mechanism

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Solution Overview

Problem

Existing biopsy needle devices often cause axial translation impact during tissue sample collection, leading to potential trauma and inaccuracy in sample extraction, as they require longitudinal movement to sever the sample, which can result in damage to surrounding tissues and organs.

Innovation Solution

The biopsy needle assembly features a needle with a distal end having a window and a stylet with a notch, allowing for rotational cutting and sample capture without axial displacement, minimizing translational movement and reducing trauma by using a mechanism where the stylet rotates to open and close the window, facilitating precise tissue sampling.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If axial translation is used to sever tissue sample, then cutting action is achieved, but tissue trauma and sampling inaccuracy increase

Engineering Contradiction:
Improvesampling accuracyVSAvoidtissue trauma
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

Instead of moving the needle axially to cut tissue, the patent inverts the approach by rotating the stylet within the needle to open and close the window, thereby capturing and severing the tissue sample through rotational motion rather than longitudinal translation.

Inventive Principle:
Principle #13The other way round (Inversion)

Solution Approach 2:

The patent transitions from one-dimensional axial motion to two-dimensional rotational motion. The stylet rotates within the needle, using angular displacement in the circumferential dimension to achieve tissue capture and severing, thereby eliminating the need for harmful axial translation at the tissue site.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Productivity

If longitudinal movement is used to capture tissue sample, then sample extraction is achieved, but surrounding tissues and organs are damaged

Engineering Contradiction:
Improvesample extraction efficiencyVSAvoiddamage to surrounding tissues
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent inverts the conventional approach by using rotational motion of the stylet to close the window and capture tissue, rather than advancing the needle longitudinally to push tissue into the lumen. This eliminates axial displacement at the tissue site while maintaining effective sample capture.

Inventive Principle:
Principle #13The other way round (Inversion)

Solution Approach 2:

The window in the needle and the stylet act as intermediaries that enable tissue capture through rotation. The window provides a controlled opening/closing mechanism, and the rotating stylet serves as the mediating element that opens and closes this window, allowing tissue to be captured and severed without direct axial impact.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Manufacturing precision

If axial displacement is used during biopsy, then tissue severing is achieved, but precision of sample collection decreases

Engineering Contradiction:
Improvesample collection precisionVSAvoidmechanism complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent employs dynamic rotational motion of the stylet within the needle to achieve precise tissue capture. The stylet can rotate to open the window for tissue entry, then rotate to close the window for capture, and finally rotate to sever the sample, providing dynamic control over the sampling process without axial displacement.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The rotating stylet mechanism is self-contained within the needle assembly, with the stylet's rotation itself performing the functions of opening/closing the window and severing tissue. The system uses its own internal rotational motion to achieve precise sample collection without requiring external axial displacement mechanisms.

Inventive Principle:
Principle #25Self-service

Data Source

PatentEP3624699B1Rotating biopsy needle
Publication Date: 2023.10.04 MERIT MEDICAL SYSTEMS INC
  • EP3624699B1 patent drawingFigure 1
  • EP3624699B1 patent drawingFigure 2~2B
  • EP3624699B1 patent drawingFigure 3~4

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 to minimize or eliminate the axial translation of the biopsy needle beyond a targeted location.