Laser Cut Needle Cannula with Apertured Distal Segment
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Solution Overview
Problem
Current fine needle aspiration techniques often result in small sample sizes and low cell integrity, leading to false negatives and limited diagnostic value, especially when trying to access difficult anatomical areas, due to the lack of flexibility in existing biopsy needles which can buckle or kink during endoscopic procedures.
Innovation Solution
The development of biopsy needles with a distal portion featuring a plurality of apertures in an interrupted helical pattern or notch design, enhancing flexibility and allowing for larger sample sizes to be obtained without increasing the needle gauge, and incorporating a sealing member to maintain suction and prevent contamination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If a larger gauge needle is used to obtain larger tissue samples, then sample size increases, but needle flexibility decreases causing buckling and kinking during endoscopic procedures
Solution Approach 1:
The needle wall is segmented by forming a plurality of apertures through it, creating multiple discrete openings that allow the needle to flex and bend without buckling while maintaining structural integrity and sample collection capability
Solution Approach 2:
The apertures are concentrated in the distal portion of the needle where flexibility is most needed for navigation through curved endoscopes, while the proximal portion maintains full wall integrity for structural support and sample retrieval
2Ease of operation
If a smaller gauge needle is used to maintain flexibility, then needle flexibility improves, but sample size decreases resulting in insufficient diagnostic material
Solution Approach 1:
The apertured wall structure provides flexibility comparable to smaller needles while the overall larger needle gauge maintains the capacity to retrieve sufficient tissue samples for diagnostic analysis
3Ease of operation
If the needle wall is made thinner to increase flexibility, then needle flexibility increases, but needle strength decreases causing deformation during insertion and sample retrieval
Solution Approach 1:
The apertures are distributed through the wall in a pattern that maintains structural strength while allowing controlled flexing, preventing both buckling during insertion and deformation during sample retrieval
Solution Approach 2:
The needle combines regions of full wall thickness for strength with regions containing apertures for flexibility, creating a composite structural design that optimizes both mechanical properties
4Quantity of substance
If multiple passes of the needle are performed to obtain sufficient sample size, then sample quantity increases, but procedure time increases and patient exposure to procedural risks increases
Solution Approach 1:
The apertured needle design enables a single pass to produce a sample equivalent to or exceeding multiple passes with traditional needles, eliminating repeated insertions and reducing procedural time and patient exposure
Data Source
Figure 1
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AI summary
Needles are provided including elongate tubular cannulas having proximal portions, distal portions, and cannula walls defining cannula lumens. A distal portion of an elongate tubular cannula may include a distal end, one or more apertures disposed through, and along a first length of, the cannula wall in a pattern enhancing flexibility relative to a second length of the cannula wall lacking the apertures, and a sealing member disposed on the apertures. The apertures impart enhanced flexibility to the needle for navigating through tortuous pathways.