Endovascular Sheath With Braided Wire Reinforcement
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Solution Overview
Problem
Current endovascular sheaths for treating venous reflux disease face challenges in visualization under ultrasonic and fluoroscopic imaging, shaft durability, and precise positioning near the sapheno-femoral junction, leading to potential complications like incomplete occlusion, non-targeted thermal energy delivery, and vessel perforation.
Innovation Solution
An endovascular sheath with a longitudinally reinforced tube featuring a braided wire for enhanced visibility and durability, a radiopaque tip for fluoroscopic visibility, a translucent shaft to maintain aiming beam clarity, and adjustable depth markers for precise insertion and withdrawal, along with an adjustable depth stop for secure positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Illumination intensity
If a conventional sheath is used, then the procedure can be performed, but the sheath material blocks the red aiming beam from being clearly visible on the skin surface
Solution Approach 1:
The sheath is designed with different optical properties at different locations: the proximal portion uses opaque material for protection and structural integrity, while the distal tip portion uses translucent material to allow visibility of the red aiming beam. This local differentiation resolves the contradiction by making the sheath both protective and visually transparent where needed.
Solution Approach 2:
The sheath employs a composite structure combining opaque and translucent materials in a single device. This composite design allows the sheath to simultaneously provide protection and enable visualization of the aiming beam, resolving the contradiction between these two requirements.
2Reliability
If the sheath tip is made opaque for protection, then durability is improved, but visibility under ultrasonic and fluoroscopic imaging is reduced
Solution Approach 1:
The sheath tip is designed with translucent material specifically at the distal end to maintain visibility under imaging modalities, while the proximal portion remains opaque for protection. This localized quality change allows the tip to be both protective and visible.
Solution Approach 2:
The sheath utilizes optical property changes (from opaque to translucent) at different locations to achieve both protection and visibility. The translucent tip allows imaging modalities to detect the sheath position while the opaque body provides durability.
3Ease of operation
If the sheath shaft is made flexible for easy insertion, then ease of operation is improved, but shaft durability and resistance to needle puncture are reduced
Solution Approach 1:
The sheath shaft uses a composite construction combining a flexible outer material with an inner reinforcement element. This composite structure provides both the flexibility needed for easy insertion and the strength required to resist needle puncture during the procedure.
Solution Approach 2:
The sheath is divided into functional segments: a flexible outer shaft for ease of insertion and a reinforced inner core for durability and puncture resistance. This segmentation allows each part to optimize its specific function without compromising the other.
4Measurement precision
If the sheath is designed for precise positioning at the sapheno-femoral junction, then measurement precision is improved, but device complexity increases due to positioning markers and depth stops
Solution Approach 1:
Positioning markers and depth stop features are pre-configured into the sheath structure during manufacturing. This preliminary preparation allows for precise positioning at the sapheno-femoral junction without requiring complex intra-procedural measurement systems, thus improving precision while limiting the increase in complexity to only essential features.
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
The solution provides improved visibility and durability, ensuring accurate positioning and reduced risk of complications, facilitating precise thermal treatment with enhanced control and accuracy during the procedure.
Implementation Method 1
The sheath tip is made with a radiopaque material that provides contrast under fluoroscopic imaging
Implementation Method 2
The sheath includes an ultrasonically visible reinforcement element that enhances visibility under ultrasonic imaging
Implementation Method 3
thermal energy generated by laser, radio or microwave frequencies is delivered to the inner vein wall causing vessel ablation or occlusion
Data Source
AI summary
An endovascular sheath device for use with a thermal treatment apparatus is provided. The device includes a longitudinal tube which is designed to receive a thermal treatment device and is designed to be inserted into a blood vessel. An ultrasonically visible reinforcement element is disposed along the length of the longitudinal tube. The reinforcement element such as a braided wire provides several functions including increased visibility under ultrasound, clearer identification of sheath tip, and increased durability to protect the fiber from needle punctures during tumescent injections into the perivenous space. The wire reinforcement also increases shaft torquability and kink resistance during sheath insertion and withdrawal.


