Biopsy Device User Interface Indicators for Real-Time Feedback
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Solution Overview
Problem
Core needle biopsy devices face challenges in operating with real-time feedback and simplified user interaction due to their unique piercer and cutter configurations, leading to operator confusion and limited means for feedback.
Innovation Solution
A core needle biopsy device with a user interface that includes a drive assembly and firing assembly to facilitate multiple sample collection in a single insertion, featuring a tissue sample holder with an extraction mechanism and a user interface with indicators to provide real-time feedback and simplified interaction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a spring actuated mechanism is used to drive the piercer and cutting sheath in core needle biopsy devices, then the device structure is simplified, but multiple buttons or user input features are required to engage different movements during tissue acquisition, leading to operator confusion and limited real-time feedback
Solution Approach 1:
The patent implements a user interface with visual indicators that provide real-time feedback to the operator during tissue acquisition. The indicators show the current state of the drive mechanism and guide the operator through the sequence of operations, reducing confusion while maintaining the simple spring actuated drive structure.
Solution Approach 2:
The patent introduces a user interface as an intermediary between the simple spring actuated mechanism and the operator. This interface includes visual indicators and control elements that mediate the interaction, making the simple mechanical system easier to operate without adding mechanical complexity.
2Device complexity
If a core needle biopsy device with a single tissue receiving notch is used, then the device structure is simple, but only one tissue sample can be collected per insertion of the piercer and cutting sheath
Solution Approach 1:
The patent divides the tissue collection function into multiple notches on the piercer, allowing multiple tissue samples to be collected during a single insertion. Each notch can receive and hold a separate tissue sample, increasing productivity without significantly complicating the overall device structure.
Solution Approach 2:
The piercer is designed with multiple notches that serve the same tissue reception function simultaneously, allowing the single piercer-cutter assembly to collect multiple samples in one insertion, thereby achieving multi-functionality in sample collection.
3Productivity
If vacuum-assisted biopsy devices are used to remove multiple samples without requiring probe removal, then sample collection efficiency is improved, but the device requires complex vacuum modules and tethered connections for fluid and power communication
Solution Approach 1:
The patent extracts the vacuum mechanism from the handheld probe and relocates it to a separate base unit. The probe itself is simplified to contain only the essential biopsy components (piercer, cutter, notches), while the vacuum function is provided by an external module through a fluid connection, reducing the complexity of the probe while maintaining multiple sample collection capability.
Data Source
AI summary
A core needle biopsy device includes a needle assembly, a drive assembly, and a user interface. The needle assembly includes a piercer and a hollow cutter. The piercer includes a sharp distal tip and a notch proximal to the distal tip. The piercer is slidably disposed within the cutter to sever a tissue sample into the notch of the piercer. The drive assembly is configured to selectively move the piercer and the cutter. The user interface has a plurality of indicators. Each indicator of the plurality of indicators is configured to independently transition between a plurality of predetermined states to collectively define a plurality of predetermined status sequences that indicate movement of the piercer and the cutter via the drive mechanism.