Core Biopsy Needle Camming Assembly for Intact Tissue Sampling

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Solution Overview

Problem

Conventional fine needle aspiration (FNA) techniques require numerous needle passes, often resulting in morselization and inadequate tissue samples, especially for solid masses, and existing rotating needle designs suffer from manufacturing complexities and reliability issues, failing to provide optimal core biopsies for diagnostic purposes.

Innovation Solution

A medical instrument with a camming subassembly that allows for a combination of axial and rotary motion of the needle, ensuring a consistent and sizable core biopsy specimen, featuring a flexible needle assembly with stainless steel and Nitinol components, and a redesigned camming mechanism for smooth operation through flexible endoscopes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If conventional FNA technique with multiple needle passes is used, then cell aspiration is achieved, but tissue morselization and inadequate sample quality occur

Engineering Contradiction:

Improvetissue sample quantityVSAvoidtissue sample integrity

Core Design Contradiction:

Quantity of substanceVSManufacturing precision

Solution Approach 1:

The needle assembly incorporates a camming mechanism that converts linear actuation motion into combined axial advancement and rotational motion during tissue engagement. This dynamic motion pattern allows the needle to garnish intact core biopsies in a single pass, eliminating the need for multiple repetitive needle passes that cause tissue morselization while maintaining adequate sample quantity and integrity.

Inventive Principle:

Principle #15Dynamics

2Manufacturing precision

If rotating needle design is implemented, then core biopsy capability is improved, but manufacturing complexity and reliability issues increase

Engineering Contradiction:

Improvebiopsy specimen qualityVSAvoidcamming assembly complexity

Core Design Contradiction:

Manufacturing precisionVSDevice complexity

Solution Approach 1:

The camming mechanism serves as an intermediary component that mediates between the simple linear actuation motion applied by the operator and the complex combined axial-rotational motion required for optimal core biopsy. By introducing this mechanical intermediary, the system achieves reliable rotating needle functionality without requiring complex direct drive mechanisms, thereby improving biopsy specimen quality while controlling manufacturing complexity.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Ease of operation

If camming assembly is located in distal aspect of needle, then rotation is achieved, but operator control and manufacturing difficulty worsen

Engineering Contradiction:

Improveoperator controlVSAvoidassembly manufacturing

Core Design Contradiction:

Ease of operationVSEase of manufacture

Solution Approach 1:

Instead of locating the camming assembly in the distal aspect of the needle as in conventional designs, this invention inverts the arrangement by positioning the camming mechanism in the proximal handle assembly. This inversion allows the operator to directly control the camming action through handle manipulation, significantly improving ease of operation. Simultaneously, it simplifies manufacturing by allowing assembly of the camming mechanism in the accessible proximal region rather than requiring complex distal needle assembly.

Inventive Principle:

Principle #13The other way round (Inversion)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The instrument achieves substantial and intact core biopsies with minimal passes, reducing trauma and ensuring adequate tissue quality for multiple diagnostic examinations, while maintaining compatibility with existing endoscope handles and flexibility through extreme bends.

Implementation Method 1

a second elongate flexible tubular segment... made of Nitinol and has a length less than one-fourth of the length of the first elongate tubular segment

Methodology Applied

Scientific EffectElasticity: Elasticity

Implementation Method 2

made of Nitinol

Methodology Applied

Scientific EffectShape Memory Alloy: Shape Memory Alloy

Implementation Method 3

The first elongate flexible tubular segment is made at least predominantly of braided filaments of stainless steel and is effectively rigid in torsion so as to exhibit a 1:1 rotation from one end to an opposite end

Methodology Applied

Scientific EffectTorsion: Torsion Spring

Data Source

PatentUS12478358B1Rotating fine needle core biopsy device with improved camming subassembly

Publication Date: 2025.11.25 NAKAO NAOMI L

AI summary

An endoscope biopsy instrument includes a scamming sub assembly located at a proximal end of a handle and adapted to rotate an elongate needle shaft member during an axial motion of an outer handle member and the elongate needle shaft member relative to an inner handle member. Two key elements extend outwardly from a stylist member into corresponding helical guide grooves with interleaved windings in an inner surface of the inner handle member. The helical guide grooves are located within a proximal end portion of the inner handle member and extend from a proximal end of the inner handle member to a point located intermediately along the inner handle member. The helical guide grooves, of the inner handle member, are parallel and accordingly have the same screw pitch. The stylist is rotatably connected at a proximal end to a proximal end of the outer handle member and is affixed at a distal end to the needle shaft member.