Reusable Biopsy Device Disposable Needle Assembly

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Solution Overview

Problem

Reusable core needle biopsy devices face contamination risks and inefficient cleaning protocols due to internal contamination during tissue sample extraction, leading to safety hazards and high costs associated with vacuum-assisted devices.

Innovation Solution

A reusable core biopsy device with a disposable needle assembly that includes a contamination collection member to trap contaminants, reducing the risk of internal contamination and simplifying the cleaning process, while also incorporating noise-dampening features.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional reusable core needle biopsy devices are used, then the device can be reused, but contaminants travel through the needle and into the internal mechanisms of the reusable portion, creating safety hazards

Engineering Contradiction:

Improvedevice reusabilityVSAvoidinternal contamination

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device is divided into two distinct segments: a reusable drive assembly and a disposable needle assembly. This segmentation allows the contamination-prone needle portion to be discarded after single use, while the reusable drive assembly remains protected from contamination. The disposable needle assembly includes a contamination collection member that captures contaminants during the biopsy procedure, preventing them from reaching the reusable portion.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The contamination collection member is designed to extract and trap contaminants from the biopsy pathway. The member includes a collection chamber that captures contaminants as they are dislodged during tissue extraction, effectively removing them from the system before they can contaminate the reusable drive assembly mechanisms.

Inventive Principle:

Principle #2Taking out (Extraction)

2Reliability

If conventional reusable devices are used, then the device can be reused, but a complicated and inefficient cleaning and sterilization protocol is required, taking up to twenty-four hours

Engineering Contradiction:

Improvedevice reusabilityVSAvoidcleaning and sterilization time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The disposable needle assembly is extracted from the reusable drive assembly after a single use, eliminating the need for cleaning and sterilization of the needle portion. Only the drive assembly requires cleaning, which is significantly faster and simpler since it lacks the complex needle mechanisms and contamination collection chamber.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The needle assembly is designed as a disposable component that is discarded after one use, replacing the need for time-consuming sterilization processes. This disposable approach is more efficient than attempting to sterilize the entire device, as it eliminates the twenty-four hour sterilization wait time while maintaining safety standards.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Object-affected harmful factors

If vacuum assisted needle biopsy devices with closed disposable components are used, then internal contamination is prevented, but the devices are expensive and cost prohibitive

Engineering Contradiction:

Improveinternal contamination preventionVSAvoiddevice cost

Core Design Contradiction:

Object-affected harmful factorsVSEase of manufacture

Solution Approach 1:

The device separates expensive reusable components from cheaper disposable components. The drive assembly can be manufactured with higher quality materials and more precise mechanisms for repeated use, while the needle assembly uses simpler, less expensive materials suitable for single use only. This segmentation reduces overall cost compared to making the entire device disposable.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different parts of the device have different quality requirements. The reusable drive assembly receives higher manufacturing investment for durability and precision, while the disposable needle assembly uses cost-effective manufacturing. This local differentiation of quality standards optimizes overall device cost while maintaining performance where it matters most.

Inventive Principle:

Principle #3Local quality

Data Source

PatentUS11364022B2Reusable core needle biopsy device and disposable needle system to eliminate internal contamination risk in reusable portion of device

Publication Date: 2022.06.21 ITHEMBA LLC

AI summary

A reusable core biopsy device having a disposable needle assembly to trap and a reusable drive assembly to selectively drive the disposable needle assembly. The disposable needle assembly includes a contamination collection member defining a fluidically-sealed contamination collection chamber to receive and collect contamination during the extraction of the organic tissue sample. The reusable drive assembly includes a locking mechanism to maintain reusable drive assembly in a locked state. An activation member is to place the reusable drive assembly in an unlocked state, to thereby drive, in sequence, the inner needle member and the outer cannula member forward to extract the organic tissue sample.