Modular Biopsy Handle With Interchangeable Needle And Protection
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Solution Overview
Problem
Current fine needle aspiration devices for endoscopic ultrasound and endobronchial ultrasound procedures lack needle safety features, are not designed to accommodate various needle diameters, and result in inefficiencies due to needle durability issues and procedural complexities, leading to increased risk of needle stick injuries and prolonged procedures.
Innovation Solution
A modular delivery handle system that allows interchangeable needles of different sizes, featuring a protective mechanism to prevent needle exposure and a locking mechanism to secure the needle during use, enhancing safety and procedural efficiency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If traditional FNA devices with integrated needles are used, then the device structure is simple, but the needle cannot be exchanged and durability issues arise
Solution Approach 1:
The device is divided into separate components: a reusable hub assembly and exchangeable needle assemblies. The needle assembly can be detached and replaced independently from the hub, allowing needle exchange without discarding the entire device. This segmentation enables versatility while maintaining reasonable device complexity.
Solution Approach 2:
The hub assembly serves as a universal component that can accommodate multiple different needle assemblies through a standardized interface. The hub's internally cylindrical shape configured to interchangeably receive needle subassemblies allows one hub to work with various needles of different sizes and types, providing multi-functionality.
2Object-affected harmful factors
If needle protection features are added, then safety improves, but device complexity increases
Solution Approach 1:
The needle protector is pre-positioned in a retracted state during normal operation, allowing free needle movement. When needle exchange or disposal is needed, the protector is activated to advance and cover the needle tip. This preliminary positioning maintains operational simplicity while enabling safety protection when needed.
Solution Approach 2:
The needle protector acts as an intermediary component between the needle and the external environment. It provides a mechanical barrier that prevents direct contact with the sharp needle tip during safe handling and disposal, reducing needle stick injuries without requiring complex safety systems.
3Adaptability or versatility
If multiple needle sizes are accommodated, then versatility improves, but manufacturing complexity increases
Solution Approach 1:
The hub assembly is designed with a universal internally cylindrical receptacle that can accommodate needles of various diameters. This universal interface allows the same hub to work with multiple needle sizes (e.g., 19G, 22G, 25G) without requiring different hub designs, maintaining ease of manufacture while achieving versatility.
Solution Approach 2:
The system accommodates different needle parameters (diameters, lengths) by allowing exchange of the needle subassembly as a complete unit. The hub maintains fixed geometric parameters for manufacturing simplicity, while the interchangeable needles provide the necessary parameter variations for different clinical requirements.
4Reliability
If needle locking mechanism is implemented, then needle security improves, but device complexity increases
Solution Approach 1:
The needle assembly incorporates self-retaining features such as friction fits, snap engagements, or simple latch mechanisms that automatically secure the needle to the hub during insertion. These self-service locking features provide reliable needle retention without requiring complex external locking systems or multiple components.
Solution Approach 2:
The needle assembly is designed as a disposable component that is attached to the reusable hub. The simple locking mechanism provides sufficient reliability for the needle's intended use duration, after which the entire needle assembly is discarded. This approach maintains reliability while minimizing the complexity and cost of the locking mechanism.
Data Source
AI summary
The invention provides device for needle biopsy having a novel delivery handle system for interchangeably delivering needles of various sizes to a biopsy site. The delivery handle system is adjustable in length and includes a proximal slideably disposed over a middle handle member, the middle handle member is slideably disposed over a distal handle member. The proximal handle member includes an inner hub housing component configured to interchangeably receive a needle subassembly that can be inserting into and withdrawn from the proximal handle member. The needle subassembly includes a needle of a plurality of different sizes, a needle luer, a needle hub coupled to a proximal end portion of the needle, and a needle protector subassembly. The needle protector subassembly includes a needle protection hub configured to receive the distal end of a needle.