Nested Vascular Access Device with Visual Blood Confirmation
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Solution Overview
Problem
Current vascular access devices lack ease of use and safety, particularly in indicating blood vessel puncture and reducing accidental needle sticks, with existing methods requiring complex procedures and high risk of complications.
Innovation Solution
The development of an access device comprising a needle, dilator, and medical article with side fenestrations and locking mechanisms, allowing for visual confirmation of body fluid presence and reducing needle stick risks through improved alignment and locking systems.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the Seldinger technique is used with needle, dilator, and sheath insertion, then vascular access can be achieved, but the risk of accidental needle sticks and over-wire complications increases
Solution Approach 1:
The patent implements a nested structure where the dilator is disposed within the sheath, and the needle is disposed within the dilator. This nested arrangement allows all components to be inserted together as a single unit, eliminating the need for separate needle and dilator insertions that increase needle stick risk. The guidewire is similarly nested within the needle, creating a compact, integrated system that reduces exposure to sharp components.
Solution Approach 2:
The patent pre-assembles the needle, dilator, and sheath in a nested configuration before patient insertion. The dilator is pre-positioned within the sheath, and the needle is pre-positioned within the dilator, with all components aligned and ready for single-step insertion. This preliminary preparation eliminates the need for multiple separate insertion steps, reducing the opportunity for accidental needle sticks during the procedure.
2Measurement precision
If traditional vascular access devices are used, then catheter insertion can be performed, but clear indication of blood vessel puncture is difficult to obtain
Solution Approach 1:
The patent incorporates visual indicators that change color or become visible upon blood vessel puncture. The sheath or dilator includes markings or windows that allow direct visualization of blood return when the needle successfully enters the vessel. This color or visual change provides immediate, unambiguous confirmation of proper puncture without requiring additional aspiration maneuvers or complex detection methods.
Solution Approach 2:
The patent introduces an intermediary visual indicator system between the needle tip and the operator. This intermediary mechanism (such as a window in the sheath or dilator, or a color-changing element) translates the internal event of blood vessel puncture into an externally visible signal, making the puncture event directly observable without requiring the operator to interpret subtle or indirect signs.
3Productivity
If separate insertion of needle and dilator is performed, then vascular access can be established, but the procedure complexity and time increase
Solution Approach 1:
The patent merges the needle, dilator, and sheath into a single integrated assembly that can be inserted together in one motion. The needle, dilator, and sheath are mechanically coupled in a nested configuration, allowing simultaneous insertion through the skin and into the blood vessel. This combining of multiple components into one insertable unit eliminates the need for separate insertion steps, reducing procedural complexity and increasing efficiency.
Solution Approach 2:
The patent creates a multi-functional integrated device where the needle serves both as a puncture instrument and as a guide for the dilator, while the dilator simultaneously dilates the tract and guides the sheath. This universal design allows a single assembly to perform multiple functions (puncture, dilation, and sheath delivery) that traditionally required separate devices and steps, thereby simplifying the overall procedure.
Data Source
AI summary
An access device for placing a medical article within a body space includes a needle, a dilator, and a medical article. The needle can include an elongated needle body with a distal end and a hub from which the needle body extends. The elongated needle body can include at least one side fenestration and an outer diameter. The dilator can be slideably disposed on the needle body and include a dilator hub and an elongated dilator shaft that extends from the dilator hub. The dilator shaft can include at least one side fenestration in communication with the needle side fenestration. The dilator shaft can also include an inner diameter that is less than the outer diameter of the needle. The medical article can include a tubular section and a hub. The tubular section can be disposed on the dilator and define a space between the medical article and the dilator in communication with the needle side fenestration through the dilator side fenestration. At a least portion of the medical article can be configured to allow visual determination of the presence of a body fluid within the space.