Tri-Point Biopsy Needle for Intact Tissue Sampling
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Solution Overview
Problem
Current fine needle biopsy techniques often result in small sample sizes and damaged cells, leading to false negatives and limited diagnostic value, particularly in minimally invasive liver biopsies, due to the limitations of existing needle designs and sampling methods.
Innovation Solution
A notched biopsy needle with a flexible elongate tubular cannula, featuring a distal beveled end with a long and short side, and a notch near the beveled end, configured to collect larger tissue cores with intact cells, reducing puncture force and enhancing sample integrity through a tri-point distal tip and arcuate cutting edge.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a small-bore needle is used for minimally invasive procedures, then patient trauma and procedural invasiveness are reduced, but sample size and cell integrity deteriorate
Solution Approach 1:
The needle tip is segmented into three distinct points (central beveled tip and two lateral pointed tips) that work together to penetrate tissue and define a sampling corridor. This segmentation allows the small-bore needle to effectively engage tissue and retrieve adequate samples despite the limited overall needle diameter
Solution Approach 2:
The needle exhibits local quality variations with a beveled central tip for primary penetration and two lateral pointed tips for tissue engagement. The notch positioned proximal to the tips creates a specific sampling zone. These localized structural features enable effective tissue sampling while maintaining a small overall needle gauge for minimally invasive procedures
2Object-affected harmful factors
If a small-bore needle is used for minimally invasive procedures, then patient trauma and procedural invasiveness are reduced, but cell integrity and tissue core quality deteriorate
Solution Approach 1:
The tri-point tip structure segments the penetration function across three points, allowing the needle to create a controlled tissue corridor that minimizes cellular disruption. The lateral tips engage tissue edges while the central tip provides stable penetration, collectively preserving tissue architecture for high-quality sampling
Solution Approach 2:
The beveled geometry of the central tip and pointed geometry of lateral tips create localized tissue interaction zones that minimize shear forces on cells. The notch positioning creates a defined sampling corridor that protects tissue cores from damage during retrieval, maintaining cell integrity despite the small needle bore
3Device complexity
If conventional needle designs are used, then device simplicity is maintained, but sample adequacy and diagnostic value deteriorate
Solution Approach 1:
The needle incorporates a tri-point tip structure with a central beveled tip and two lateral pointed tips, creating three distinct penetration points that work in unison. This segmented approach improves tissue engagement and sample retrieval reliability, directly enhancing diagnostic accuracy while adding only moderate structural complexity
Solution Approach 2:
The needle features localized structural variations including a beveled central tip for stable penetration, pointed lateral tips for tissue engagement, and a proximal notch for defining the sampling zone. These local quality enhancements improve sample adequacy and diagnostic value without requiring major redesign of the overall needle system
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 needle design allows for the reliable acquisition of intact tissue samples with reduced insertion force and improved diagnostic value, providing a larger sample size and higher cell integrity, comparable to larger gauge needles in terms of puncture force perception, while maintaining a small-bore size for minimally invasive procedures.
Implementation Method 1
The notch may include a distal lip defined by a portion of the cannula wall, the distal lip being configured to extend distally from a proximal-most end of the notch such that a central distal lip portion is disposed distal of lip end portions that are continuous with generally longitudinal lateral sides of the notch, and to include a distal-facing cutting edge.
Implementation Method 2
A fine needle (e.g., 18-gauge to 25-gauge) is directed to a target site, and suction is applied to the proximal end of a lumen of the needle to aspirate cells through its distal end.
Data Source
AI summary
A tri-point tissue-collection needle configured similarly to a fine-needle-aspiration needle is configured to excise intact tissue cores for collection. The distal tip is configured with three beveled points separated by cutting edges, where a single longer/more distal point is trailed by and circumferentially separated from a symmetrical pair of points, providing a bilaterally symmetrical needle cannula distal end. A stylet may be provided through a lumen of the needle during introduction into a patient body, where the distal end surface of the stylet may be configured to complement the tri-point needle end configuration.