Curved Biopsy Needle Stylet for Single-Insertion Tissue Sampling

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Solution Overview

Problem

Current biopsy needles with straight and rigid stylets require multiple insertions to obtain sufficient tissue samples, leading to increased risk of complications, patient discomfort, and unsatisfactory cosmetic results, as they struggle to collect larger tissue samples effectively.

Innovation Solution

A biopsy needle design featuring a bent or curved distal portion of the inner stylet relative to the outer coaxial sheath, allowing for a larger tissue sample collection and reduced number of insertions, with the stylet capable of bending to facilitate easier navigation and increased sample size without compromising sample integrity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If a straight and rigid stylet is used in a biopsy needle, then the stylet maintains stability and reduces lateral drift during insertion, but the tissue sample size collected is insufficient requiring multiple insertions

Engineering Contradiction:
Improvestylet stabilityVSAvoidtissue sample size
Core Design Contradiction:
Stability of the object's compositionVSQuantity of substance

Solution Approach 1:

The stylet is designed with a curved configuration that allows it to flex and adapt to tissue contours during insertion, transitioning from a rigid straight form to a dynamic curved form that follows tissue geometry, thereby increasing sample collection capacity while maintaining directional control

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The stylet incorporates a curved or bent configuration instead of a straight rigid form, allowing the distal portion to follow tissue contours and expand the effective sampling area, thereby collecting larger tissue samples in a single insertion while maintaining stability through the curve's geometric properties

Inventive Principle:
Principle #14Spheroidality (Curvature)

2Quantity of substance

If multiple needle insertions are performed to obtain sufficient tissue samples, then adequate sample size is achieved for diagnosis, but patient discomfort and risk of complications increase

Engineering Contradiction:
Improvetissue sample sizeVSAvoidpatient discomfort and complications
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The curved stylet is pre-configured before insertion to match the expected tissue geometry, allowing the needle to navigate and collect adequate tissue sample in a single predetermined motion, thereby eliminating the need for multiple insertions and associated complications

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The flexible curved stylet adapts its configuration during the single insertion process to optimize tissue engagement and sample collection, ensuring adequate sample size is obtained in one procedure rather than requiring multiple traumatic insertions

Inventive Principle:
Principle #15Dynamics

3Ease of manufacture

If a straight rigid stylet is used, then the needle structure is simple and easy to manufacture, but larger tissue samples cannot be collected effectively

Engineering Contradiction:
Improveneedle manufacturing simplicityVSAvoidtissue sample size
Core Design Contradiction:
Ease of manufactureVSQuantity of substance

Solution Approach 1:

The stylet is manufactured with a curved configuration using standard bending or forming processes, maintaining relative manufacturing simplicity while dramatically improving tissue sample collection capacity by allowing the stylet to conform to tissue contours and engage larger sample volumes

Inventive Principle:
Principle #14Spheroidality (Curvature)

Data Source

PatentUS11172912B2Biopsy needle and medical device incorporating the same
Publication Date: 2021.11.16 INNOVASCI LLC
  • US11172912B2 patent drawing
  • US11172912B2 patent drawing
  • US11172912B2 patent drawing

AI summary

Disclosed is a biopsy needle, medical device incorporating the biopsy needle, and method of using the biopsy needle and medical device. The biopsy needle and medical device is used to obtain a sample of tissue for further analysis and testing. The biopsy needle includes an inner stylet that is slidably engaged with an outer coaxial sheath and at least part of the distal portion of the stylet is bent or curved relative to the longitudinal axis of the coaxial sheath.