Barbed Biopsy Stylet for Intact Tissue Core Extraction
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Solution Overview
Problem
Current fine needle aspiration (FNA) techniques for biopsy procedures often require multiple passes of the needle, leading to inefficiencies, discomfort for patients, and a risk of false negatives due to small, disaggregated cell samples that are inadequate for diagnostic purposes, especially for histological analysis.
Innovation Solution
A medical biopsy stylet system with an elongate stylet body that includes longitudinal splits forming opposed legs with inward-facing barbs, which occupies the needle lumen and engages tissue without moving relative to the needle, allowing for the collection of intact tissue cores for on-site evaluation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If fine needle aspiration (FNA) is used to obtain tissue samples, then the procedure is less invasive and causes less patient discomfort, but the sample size is small and cells are disaggregated, leading to insufficient diagnostic material
Solution Approach 1:
The stylet is divided into multiple segments including a proximal solid portion and a distal split portion with barbs, allowing it to function both as a support structure during needle insertion and as an active tissue engagement mechanism for core sample collection, thus resolving the contradiction between minimally invasive approach and adequate sample acquisition
Solution Approach 2:
Instead of using a hollow needle to aspirate cells (FNA approach), this invention uses a solid stylet with barbs that actively engages and extracts tissue cores (FNB approach), inverting the traditional aspiration mechanism to achieve both minimal invasiveness and adequate sample size through a single pass
2Quantity of substance
If multiple needle passes are performed to obtain sufficient tissue sample, then adequate diagnostic material can be collected, but the procedure time increases and patient discomfort increases
Solution Approach 1:
The barbed stylet is pre-configured within the needle lumen before the procedure, with the distal split portion and barbs ready to engage tissue immediately upon needle insertion, eliminating the need for multiple passes by ensuring adequate sample collection in a single targeted action
Solution Approach 2:
The barbed stylet automatically engages and secures tissue cores through its intrinsic barb structure upon needle insertion, without requiring additional manual manipulation or multiple insertion attempts, thus reducing procedure time while maintaining sample adequacy
3Quantity of substance
If multiple needle passes are performed to obtain sufficient tissue sample, then adequate diagnostic material can be collected, but the risk of false negatives increases due to insufficient or damaged cells
Solution Approach 1:
The barbed stylet structure with its distal split portion creates multiple barb elements that can simultaneously engage and secure adequate tissue cores, ensuring sufficient diagnostic material is obtained in a single pass, thereby reducing the need for repeated procedures and minimizing false negative results
Solution Approach 2:
By inverting from passive aspiration (FNA) to active core extraction (FNB) using the barbed stylet, the system obtains intact tissue cores that maintain cellular architecture and viability, significantly improving diagnostic reliability and reducing false negatives compared to disaggregated cell samples from multiple FNA passes
Data Source
AI summary
A tissue-collection stylet is configured with inward-facing barbs, for use in a needle, and particularly configured to capture intact tissue cores suitable for histological analysis. The stylet may be provided together with a needle as part of a biopsy system in which the stylet remains at least partially or fully within a lumen of the needle during collection of tissue samples and/or other samples.