Vascular Access Device with Blood Flow Visualization and Guidewire Interlock
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Solution Overview
Problem
Conventional vascular access devices lack ease of use and safety, particularly in indicating successful vessel puncture and reducing accidental needle sticks and over-wire complications.
Innovation Solution
An access device featuring a needle with a dilator coaxially disposed about it, including a guidewire interlock and side openings that align to facilitate blood flow visualization, along with a releasable interlock mechanism to prevent accidental guidewire retraction and rotation, enhancing safety and usability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional vascular access devices are used, then the basic function of introducing medical articles is achieved, but the ease of use and safety are insufficient
Solution Approach 1:
The patent incorporates a viewing space with a red indicator that changes appearance based on blood flow detection. When the needle successfully punctures the blood vessel, blood flows through the viewing space causing the red indicator to change color or appearance, providing clear visual feedback to the operator about successful vessel entry and proper needle orientation.
Solution Approach 2:
The device provides real-time feedback to the operator through the viewing space that allows visualization of blood flow. This feedback mechanism enables the operator to confirm successful vessel puncture and adjust needle position or orientation as needed, improving both ease of operation and safety by preventing misplaced needle sticks.
2Loss of information
If side openings are added to facilitate blood flow visualization, then the indication of vessel puncture is improved, but the device complexity increases
Solution Approach 1:
The patent combines the viewing space function with the existing needle and dilator structure. The viewing space is integrated into the assembly, and the red indicator is incorporated into either the needle or dilator component, merging multiple functions (structural support, blood flow visualization, and operational feedback) into a single integrated device without requiring separate complex subsystems.
Solution Approach 2:
The viewing space serves multiple purposes: it provides a pathway for blood flow visualization, acts as a structural component of the needle-dilator assembly, and facilitates the red indicator's visual feedback function. This multi-functionality reduces the need for additional separate components, thereby limiting the increase in device complexity while improving vessel puncture indication.
3Reliability
If a releasable interlock mechanism is implemented to prevent accidental guidewire retraction, then the safety is improved, but the device complexity increases
Solution Approach 1:
The releasable interlock mechanism provides dynamic control over the guidewire's position. It allows the guidewire to be securely locked during insertion and manipulation phases, then easily released when the operator needs to advance or adjust the guidewire. This dynamic locking and unlocking capability enhances safety by preventing accidental retraction while maintaining operational flexibility when needed.
Solution Approach 2:
The interlock mechanism is designed to be self-regulating through operator-controlled release. The mechanism automatically engages to secure the guidewire during procedures, and the operator can easily disengage it when intentional adjustment is required. This self-service design eliminates the need for complex external control systems while maintaining high safety standards.
4Ease of manufacture
If the needle and dilator are made coaxially disposed, then the ease of manufacture is improved, but the ease of operation for indicating vessel puncture becomes more challenging
Solution Approach 1:
The patent resolves the coaxial arrangement limitation by introducing a viewing space that extends in a different dimensional orientation. This viewing space allows blood flow to be visualized from the side, perpendicular to the coaxial needle-dilator axis, enabling clear vessel puncture indication without compromising the manufacturing advantages of the coaxial configuration.
Solution Approach 2:
The viewing space acts as an intermediary element between the coaxial needle-dilator assembly and the operator's visual perception. It provides a dedicated pathway and surface (with the red indicator) that translates the internal blood flow state into an external visual signal, bridging the gap between the compact coaxial structure and the operational requirement for clear puncture indication.
Data Source
AI summary
An access device places a medical article within a body space of a patient. The device has a needle that includes a needle body and hub. The device further includes a dilator coaxially disposed and slideable over the needle body and a medical article. A viewing space is disposed between the dilator and the medical article with at least one passageway or conduit connecting the viewing space with the interior bore of the needle body. The passageway is defined at least in part by openings through the sides of the needle and dilator. At least a portion of the conduit or passageway can be defined by one or more grooves between the needle and dilator. The device can further include a guidewire and an interlock between the guidewire and the needle and/or dilator. The device can further include one or more stops disposed between the guidewire and the needle and/or dilator to limit the extent to which the guidewire can be moved (e.g., advanced) relative to the needle or inhibit such relative movement (e.g., backwards movement).