Micropuncture Kit Depth Indicators for Carotid Access
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Solution Overview
Problem
Current technologies face challenges in accessing the carotid artery for interventional procedures due to the limitations of existing access devices, which are often designed for femoral access, leading to increased complexity and risk, especially when dealing with tortuous or diseased arteries.
Innovation Solution
A system of devices and methods optimized for direct access into the common carotid artery, including a micropuncture kit with direct visual guidance, transcarotid access devices, guide catheters, and guide wires, specifically designed to facilitate safe and easy access for peripheral and neurovascular interventions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If femoral access is used for arterial access, then the access site is easily entered and devices can be introduced, but the procedure becomes more complex and risky when the target site is distant or the arteries are tortuous/diseased
Solution Approach 1:
The access system is divided into separate modular components: a puncture needle for initial access, a guidewire for navigation, and a catheter for device delivery. This segmentation allows each component to be optimized for its specific function and enables flexible assembly based on procedural needs, reducing overall system complexity while maintaining ease of access.
Solution Approach 2:
The access system is designed to be universally applicable to multiple arterial access sites (femoral, carotid, radial) and various interventional procedures. The catheter and guidewire components can be exchanged while keeping the access needle and basic delivery system, allowing one system to handle diverse clinical scenarios without increasing procedural complexity.
2Reliability
If femoral access is used, then arterial access is achieved, but radiation exposure to operators increases and precision for nearby targets decreases
Solution Approach 1:
The system introduces a carotid artery access needle as an intermediary approach when femoral access is unsuitable. This alternative access route serves as a mediator that reduces radiation exposure for nearby targets (brain, neck vessels) while maintaining reliable arterial access. The needle includes depth indicators and anatomical landmarks as intermediaries to guide precise placement without excessive radiation.
Solution Approach 2:
The system replaces reliance on fluoroscopic imaging (radiation-based mechanical guidance) with anatomical landmark-based visual guidance for needle placement. Depth indicators on the needle and knowledge of anatomical landmarks allow operators to accurately position the needle without continuous radiation exposure, substituting mechanical/radiological guidance with anatomical/visual methods.
3Adaptability or versatility
If standard access devices are used for carotid access, then access is achieved, but the risk increases due to device limitations
Solution Approach 1:
The access needle incorporates local quality features specifically tailored for carotid artery access: depth indicators positioned at critical intervals, anatomical landmark references, and a needle design optimized for the specific geometry and depth of carotid puncture. These localized adaptations enhance safety for carotid procedures while maintaining overall device versatility for other access sites.
Solution Approach 2:
The system performs preliminary actions to ensure safety before the main procedure: the needle includes pre-marked depth indicators and anatomical landmark guides that allow the operator to verify correct positioning before advancing the guidewire and catheter. This preliminary verification step prevents malpositioning and reduces procedural risk while maintaining device adaptability.
Data Source
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AI summary
A micropuncture kit for direct access of a surgically exposed vessel using direct visual guidance includes a micropuncture access needle (120) having a proximal hub coupled to an elongate shaft defining an inner lumen and a visible depth indicator (124) positioned on the elongate shaft a distance away from a distal tip of the elongate shaft. The kit includes an access guidewire (140) sized to be received through the inner lumen of the micropuncture access needle (120) and a microaccess cannula (160) having an elongate body defining an inner lumen and a plurality of visible depth indicators (165) formed on the elongate body. The guidewire (140) includes a distal tip and at least one visible depth indicator (143) positioned on the access guidewire (140) a distance away from the distal tip of the guidewire. Each of the plurality of visible depth indicators (165) identifies a distance from a distal tip of the cannula (160). Related systems, devices and methods are provided.