Splittable Needle Assembly for Stable Guidewire Catheter Placement
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Solution Overview
Problem
The Seldinger technique for central venous catheter placement is time-consuming and increases the risk of patient trauma and infection due to the handling of multiple medical devices, with challenges in safely removing the needle without dislodging the guidewire or catheter.
Innovation Solution
A catheter placement system featuring a splittable needle with a splitter system and needle safety system, allowing safe withdrawal of the needle while maintaining guidewire position, and encapsulating needle halves to prevent trauma and fluid exposure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the Seldinger technique is used for catheter placement, then the catheter can be placed in the vasculature, but the procedure becomes time-consuming and increases the risk of patient trauma and infection due to multiple device interchanges
Solution Approach 1:
The patent combines multiple separate devices (needle, guidewire, catheter) into a single integrated catheter placement system. The needle assembly includes an integrated guidewire and preloaded catheter, eliminating the need for multiple device interchanges and reducing the number of steps in the procedure.
Solution Approach 2:
The needle assembly serves multiple functions simultaneously: it provides vascular access, guides the guidewire through the vasculature, and delivers the preloaded catheter to the target site. This multi-functional design reduces the need for separate devices for each step.
2Ease of operation
If the needle is withdrawn after guidewire insertion, then the needle can be removed from the access site, but the guidewire may be dislodged or the catheter may be removed from the guidewire
Solution Approach 1:
The catheter is preloaded onto the guidewire within the needle assembly before the procedure begins. This preliminary positioning ensures that when the needle is withdrawn, the catheter remains securely attached to the guidewire, preventing dislodgement.
Solution Approach 2:
The system employs a nested structure where the catheter is positioned within the needle assembly and attached to the guidewire. The guidewire passes through the needle lumen, and the catheter is preloaded over the guidewire, creating a nested configuration that maintains stability during needle removal.
3Reliability
If multiple medical devices are used in the catheter placement procedure, then the catheter can be placed with proper guidewire support, but the number of touch contaminations and infection risks increases
Solution Approach 1:
By merging the needle, guidewire, and catheter into a single integrated system, the patent reduces the number of times devices need to be touched, handled, and interchanged during the procedure. This directly reduces touch contamination opportunities and improves infection control.
Data Source
AI summary
Advanced catheter placement systems require disengaging a needle from the guidewire without disturbing a position of the guidewire within the vasculature. Embodiments include withdrawing the needle proximally and drawing the needle over a splitter system that includes a splitter wedge. The splitter system separates the needle along a longitudinal axis. A portion of the guidewire can then pass between a first portion and a second portion of the needle, allowing the needle to disengage the guidewire. A catheter disposed on a proximal portion of the guidewire can then be advanced thereover into the vasculature. A needle safety system can adhere a puncture-resistant adhesive tape to the split portions of the needle. The tape can encapsulate the portions of the needle mitigating any damage or trauma caused by sharpened edges of the needle portions.