Butterfly Needle Assembly with Flexible Wing Closure
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Solution Overview
Problem
Current subcutaneous infusion systems face challenges such as increased cost due to complex needle assembly fabrication, lack of sterility maintenance before use, and discomfort from hard elements that do not conform to the skin, along with the need for separate adhesive strips and potential for accidental needle sticks.
Innovation Solution
A butterfly needle assembly featuring a flexible member with a central region and adhesive protected by a removable cover, a needle hub for tubing, and a closing system that encloses the needle using flexible wings, allowing for easy assembly across various needle gauges and maintaining sterility until use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a 90° bent needle is used to minimize needle disturbance, then needle stability is improved, but manufacturing complexity and cost increase
Solution Approach 1:
The needle assembly is divided into separate components: a straight needle, a hub, and a flexible member with wings. The 90° angle is achieved through the configuration of these assembled parts rather than by bending the needle itself, simplifying manufacturing while maintaining the perpendicular orientation needed for stability.
2Ease of operation
If the needle is exposed for use, then ease of insertion is improved, but risk of accidental needle stick increases
Solution Approach 1:
The wings are pre-positioned in an open state during packaging and sterilization, allowing the needle to remain protected until use. Upon activation, the wings automatically fold back to expose the needle for insertion, then return to a closed protective position afterward, eliminating the need for manual manipulation that could cause accidental sticks.
3Reliability
If the needle is hermetically sealed for sterility, then sterility maintenance is improved, but ease of access and assembly worsens
Solution Approach 1:
The assembly is segmented into sterilizable components (needle, hub, flexible member) that can be separately packaged and sterilized. The wings are designed to remain in an open configuration during sterilization, allowing autoclave penetration and steam circulation, then automatically close upon activation to protect the needle.
Solution Approach 2:
The flexible member acts as an intermediary mechanism between the sterilization process and the needle protection function. It allows the needle to be protected during handling while maintaining sterility through separate component packaging, and automatically transitions to expose the needle when activated without requiring complex opening mechanisms.
4Strength
If hard elements are used in the needle assembly, then structural strength is improved, but patient comfort deteriorates due to lack of skin conformance
Solution Approach 1:
The wings and adhesive member are constructed from flexible materials that can conform to the contours of the patient's skin and body surfaces. This flexible outer structure maintains the structural integrity needed for needle support while providing comfort and adaptability to irregular skin surfaces, eliminating the discomfort associated with rigid elements.
Data Source
AI summary
Provided is a butterfly needle assembly, including: a flexible member having a central region with a first side member and a second side member collectively providing a generally flat bottom, the central region having a middle area; an adhesive dressing disposed upon the generally flat bottom, the adhesive dressing protected by a removable cover; a needle hub disposed within the central region, the needle hub receiving a flexible tubing line generally parallel to the generally flat bottom and providing a needle extending generally normal to the generally flat bottom from the middle area of the central region, the needle extending for a first length; a removable needle cover initially disposed about the needle, the removable needle cover structured and arranged to removably engage with the needle hub; and a closing system structured and arranged to close the first side member and the second side member of the flexible member about the needle. A method of making a butterfly needle assembly is also provided.