Vascular Access Device Fenestration Blood Flash Channel
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Solution Overview
Problem
Current medical access devices for confirming vascular access lack effective mechanisms to ensure accurate placement of medical articles, such as catheters and sheaths, within body spaces, leading to potential complications and inefficiencies in fluid delivery or withdrawal.
Innovation Solution
The access device includes a needle with a fenestration, a dilator coaxially disposed about the needle, and an inner member positioned between the needle and dilator, forming a blood flash channel to confirm vascular access, along with a sheath assembly featuring a flexible tubular structure and a valve system for sealing and fluid communication.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a needle and dilator are used for vascular access, then the medical article can be delivered into the body space, but the accuracy of placement confirmation is insufficient
Solution Approach 1:
The patent utilizes blood flash visualization through the fenestration to provide immediate visual confirmation of vascular access. The appearance of blood flow through the fenestration serves as a clear visual indicator that the needle has successfully punctured the vessel, thereby improving measurement precision of placement accuracy.
Solution Approach 2:
The fenestration acts as an intermediary structure that allows blood to flow from the vessel through the needle wall into the space between the needle and dilator. This intermediary mechanism provides reliable confirmation of vascular access without requiring additional devices or complex procedures.
2Measurement precision
If the dilator is positioned distal to the fenestration, then the blood flash channel is formed, but the device structure becomes more complex
Solution Approach 1:
The patent employs a nested configuration where the needle, dilator, and sheath are coaxially disposed one within another. The fenestration in the needle allows blood to flash into the annular space between the needle and dilator, creating a built-in detection mechanism that adds functional complexity without requiring separate external components.
Solution Approach 2:
The dilator serves multiple functions: it provides structural support during insertion, creates the blood flash channel when positioned distal to the fenestration, and acts as a guide for subsequent catheter placement. This multi-functionality reduces the need for separate specialized components.
3Manufacturing precision
If an inner member is added between the needle and dilator, then the blood flash channel is optimized, but the device complexity increases
Solution Approach 1:
The inner member is positioned specifically in the region where the blood flash occurs (between the fenestration and the dilator). This localized component optimizes the flash channel configuration to ensure reliable blood visualization while minimizing the overall complexity by not adding components throughout the entire device length.
Solution Approach 2:
The inner member is pre-positioned within the dilator before needle insertion, establishing the optimal flash channel geometry in advance. This preliminary configuration ensures that when the needle punctures the vessel and blood flows through the fenestration, the flash channel is already optimally formed for detection.
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
This configuration enhances the accuracy and efficiency of vascular access by allowing blood to flow through the channel, indicating successful vessel puncture and providing a reliable conduit for medical articles, thereby improving the placement and functionality of medical devices within body spaces.
Implementation Method 1
A space between an outer diameter of the needle and an inner diameter of the inner member defines a blood flash channel in fluid communication with the fenestration to allow blood to flow from an interior of the needle through the fenestration to the blood flash channel when the needle punctures a blood vessel.
Data Source
AI summary
An access device for placing a medical article within a body space includes a needle, a dilator, and a sheath. The dilator can be coaxially and slideably disposed about the needle, and the sheath can be coaxially and slideably disposed about the dilator. The access device can further include a inner member coaxially disposed between the needle and dilator. The needle can include a fenestration in fluid communication with a space between the needle and inner member. When the needle punctures a blood vessel, the fenestration allows blood to flow into the space between the needle and inner member to provide a visual indicator to a physician or healthcare professional that the needle is in a vessel.