Nested Biopsy Needle with Tapered Adaptor
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Solution Overview
Problem
Current biopsy methods, such as fine needle aspiration, often result in inadequate tissue samples due to the difficulty in obtaining sufficient specimen size without causing trauma or bleeding, especially when targeting small or hard-to-reach tissues like thyroid glands, leading to repeated procedures and increased risk of adverse events.
Innovation Solution
A biopsy needle system comprising an outer needle and an inner needle, guided by an adaptor with a tapered longitudinal passage, allowing for efficient tissue sampling with reduced trauma and improved specimen quality by enabling the safe insertion and positioning of the inner needle within the outer needle, facilitating better tissue aspiration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If fine needle aspiration is used to obtain tissue samples, then the procedure is less invasive and causes less trauma, but the sample size is often inadequate requiring repeated procedures
Solution Approach 1:
The patent employs a nested needle configuration where an inner needle is inserted through an outer needle. The outer needle (typically 19- or 20-gauge) serves as a guide and protective sheath, while the inner needle (typically 25-gauge) performs the actual tissue sampling. This nested arrangement allows the finer inner needle to benefit from the structural support and positioning accuracy of the outer needle, enabling adequate tissue sample collection with reduced trauma compared to using a single fine needle.
Solution Approach 2:
The adaptor serves as an intermediary component that facilitates the insertion of the inner needle through the outer needle. The adaptor includes a tapered passage that guides the inner needle tip through the hub of the outer needle, ensuring proper alignment and preventing the inner needle from becoming lodged. This intermediary mechanism enables the complex nested needle configuration to function reliably during the biopsy procedure.
2Device complexity
If a single needle is used for biopsy, then the device structure is simple, but it is difficult to position the needle accurately and safely in small or hard-to-reach tissues
Solution Approach 1:
The nested needle configuration allows the outer needle to serve as a positioning guide and protective sheath for the inner needle. The outer needle's larger diameter provides structural stability and easier maneuverability for reaching small or hard-to-access tissue sites, while the inner needle performs the precise sampling function. This nested arrangement combines the positioning advantages of a larger needle with the sampling capabilities of a finer needle.
Solution Approach 2:
The adaptor acts as an intermediary that enables safe and accurate needle positioning. Its tapered passage design guides the inner needle tip through the outer needle hub, ensuring proper alignment and preventing lodging. This intermediary mechanism is particularly valuable when accessing small or difficult-to-reach tissues, as it maintains precise needle positioning throughout the insertion process.
3Manufacturing precision
If repeated biopsy procedures are performed to obtain adequate samples, then the sample quality improves, but the risk of adverse events and infection increases
Solution Approach 1:
The nested needle system enables adequate tissue sample collection in a single procedure. The inner needle, supported by the outer needle, can obtain sufficient tissue material through one insertion, eliminating the need for repeated procedures. This reduces the cumulative risk of infection and adverse events associated with multiple needle insertions while maintaining high sample quality for pathological analysis.
4Ease of manufacture
If standard hypodermic needles are used, then the cost is low and availability is high, but they cannot safely guide inner needles through their hubs
Solution Approach 1:
The adaptor serves as a specialized intermediary component that enables the safe use of standard hypodermic needles in the nested configuration. While standard needles remain inexpensive and widely available, the adaptor provides the necessary tapered passage to guide the inner needle through the outer needle hub without lodging. This intermediary solution maintains the cost-effectiveness of standard needles while adding the safety and functionality needed for successful nested needle biopsies.
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 system enables quicker, less painful, and less traumatic biopsies with improved sample quality, reducing the need for multiple passes and minimizing tissue damage, while maintaining a low cost due to the use of standard needles and an inexpensive adaptor.
Implementation Method 1
The adaptor includes a tapered longitudinal passage that guides a distal end of the inner needle through the adaptor and into the longitudinal passage of the outer needle
Implementation Method 2
The tissue is drawn into the needle either by aspiration or by the capillary action of the needle
Implementation Method 3
Aspiration occurs with the use of a vacuum source such as a syringe
Data Source
AI summary
Disclosed herein is a biopsy needle system, an adaptor for the system, and a method of using the system. The system includes an outer needle, an inner needle, and an adaptor. The outer needle has a longitudinal passage, a length, and a hub on the proximal end of the outer needle. The inner needle has a longitudinal passage and a length that is greater than the length of the outer needle. The inner needle is configured to fit within the longitudinal passage of the outer needle. The adaptor is configured to fit within the hub of the outer needle and includes a tapered longitudinal passage that guides a distal end of the inner needle through the adaptor and into the longitudinal passage of the outer needle.