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

VSEngineering 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

Engineering Contradiction:
Improvevisibility of aiming beamVSAvoidsheath material composition
Core Design Contradiction:
Illumination intensityVSDevice complexity

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.

Inventive Principle:
Principle #3Local quality

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.

Inventive Principle:
Principle #40Composite materials

2Reliability

If the sheath tip is made opaque for protection, then durability is improved, but visibility under ultrasonic and fluoroscopic imaging is reduced

Engineering Contradiction:
Improvesheath protectionVSAvoidvisibility of sheath tip
Core Design Contradiction:
ReliabilityVSDifficulty of detecting and measuring

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.

Inventive Principle:
Principle #3Local quality

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.

Inventive Principle:
Principle #32Color changes

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

Engineering Contradiction:
Improveinsertion flexibilityVSAvoidneedle puncture resistance
Core Design Contradiction:
Ease of operationVSStrength

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.

Inventive Principle:
Principle #40Composite materials

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.

Inventive Principle:
Principle #1Segmentation

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

Engineering Contradiction:
Improvepositioning accuracyVSAvoidpositioning system components
Core Design Contradiction:
Measurement precisionVSDevice complexity

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.

Inventive Principle:
Principle #10Preliminary action

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

Methodology Applied
Scientific EffectRadiopacity: X-Ray

Implementation Method 2

The sheath includes an ultrasonically visible reinforcement element that enhances visibility under ultrasonic imaging

Methodology Applied
Scientific EffectUltrasonic reflection: Ultrasound

Implementation Method 3

thermal energy generated by laser, radio or microwave frequencies is delivered to the inner vein wall causing vessel ablation or occlusion

Methodology Applied
Scientific EffectLaser ablation: Laser Ablation

Data Source

PatentUS8887733B2Endovascular treatment apparatus and method
Publication Date: 2014.11.18 ANGIODYNAMICS INC
  • US8887733B2 patent drawing
  • US8887733B2 patent drawing
  • US8887733B2 patent drawing

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.