Biopsy Wiper Mechanism for Tissue Sample Collection
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Solution Overview
Problem
Core needle biopsy devices face challenges in managing tissue samples due to the unique needle and cutter configuration, particularly in collecting severed tissue samples from the notch, which can be challenging due to size and shape issues and the characteristics of the samples, such as being sticky or clingy.
Innovation Solution
A core needle biopsy device with a tissue sample holder featuring a wiper mechanism that bends and propels tissue samples from the notch into a sample chamber, facilitating efficient collection and storage of multiple samples with a single insertion, combining features of core needle and vacuum-assisted biopsy devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a core needle biopsy device uses a sharp solid piercer with a lateral tissue receiving notch to collect tissue samples, then the device can be operated with a single hand and single insertion, but only one tissue sample can be collected per insertion and the severed tissue sample is difficult to remove from the notch due to size and shape constraints
Solution Approach 1:
The tissue receiving notch is divided into multiple separate receiving chambers instead of a single continuous notch. Each chamber can independently receive and hold a tissue sample, allowing multiple samples to be collected during a single insertion while maintaining the simple single-handed operation characteristic of core needle biopsy devices.
Solution Approach 2:
The linear one-dimensional notch structure is transformed into a multi-chamber three-dimensional receiving space. This dimensional expansion allows the single insertion to accommodate multiple tissue samples by utilizing vertical and lateral space within the notch structure, thereby increasing productivity without complicating the operation.
2Device complexity
If a core needle biopsy device uses a sharp solid piercer with a lateral tissue receiving notch, then the device structure remains simple, but the severed tissue sample adheres to the notch walls making removal difficult
Solution Approach 1:
Different regions of the tissue receiving chambers are designed with different surface properties. The chamber walls are made with a low-adhesion coating or textured surface in specific areas to prevent tissue sample adhesion, while other areas maintain the necessary structural support. This localized differentiation allows easy sample removal without compromising the overall simplicity of the device structure.
Solution Approach 2:
A movable partition or separator is introduced within the notch structure that acts as an intermediary between the tissue sample and the notch walls. This partition can be easily moved to release adherent samples from the chamber walls, providing a simple mechanism for sample removal without requiring complex device structures.
3Productivity
If a core needle biopsy device collects multiple samples per insertion, then productivity increases, but the device complexity increases due to additional components
Solution Approach 1:
Multiple tissue receiving chambers are merged into a single integrated notch structure rather than using separate, independent collection mechanisms. This merging allows multiple samples to be collected simultaneously in one insertion while maintaining a unified, relatively simple overall device structure. The chambers share common walls and space, avoiding the need for multiple separate components.
Solution Approach 2:
The tissue receiving chambers are designed as multi-functional elements that can receive, hold, and facilitate removal of multiple tissue samples of varying sizes and types. The universal chamber design accommodates different sample characteristics without requiring specialized structures for each sample type, thereby increasing productivity without proportionally increasing device complexity.
Data Source
AI summary
A core needle biopsy device includes a body, a needle assembly, a drive assembly, and a tissue sample holder. The body includes a housing defining a recess. 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 tissue sample holder is formed in the recess. The tissue sample holder has a removable cover, a driver, and a wiper. The cover is disposed over the recess. The housing and the cover together define a sample chamber. The driver is configured to move the wiper relative to a portion of the biopsy device to manipulate a severed tissue sample into the sample chamber.