Sheath Assembly Multi-Layer Structure Axial Support Bending Compliance

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Solution Overview

Problem

The existing interventional instrument delivery systems face challenges in navigating the tortuous vascular system due to mechanical performance requirements such as axial support and bending compliance, which affect safety and control during operation.

Innovation Solution

A sheath assembly with a multi-layer structure, including an inner lining tube, a metal tube, and an outer wrapping membrane, featuring elastic expansion pieces and connectors for improved axial support and bending compliance, allowing for precise control and orientation of the distal end during delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a single-layer sheath structure is used, then the device complexity is reduced, but the axial support performance and bending compliance are insufficient

Engineering Contradiction:
Improveaxial support performanceVSAvoidsheath structure complexity
Core Design Contradiction:
StrengthVSDevice complexity

Solution Approach 1:

The sheath employs a multi-layer composite structure consisting of an inner lining tube, a metal tube with expansion pieces, and an outer wrapping membrane. This composite construction provides enhanced axial support performance while maintaining bending compliance, resolving the contradiction between strength and structural complexity.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The metal tube is segmented into a main tube and a head tube with elastic expansion pieces arranged circumferentially. This segmentation allows different sections to perform specialized functions: the main tube provides axial support while the head tube with expansion pieces enables bending compliance and directional control.

Inventive Principle:
Principle #1Segmentation

2Ease of manufacture

If the sheath structure is simplified, then the manufacturing process is easier, but the control precision during bending adjustment is reduced

Engineering Contradiction:
Improvesheath manufacturing easeVSAvoidbending control precision
Core Design Contradiction:
Ease of manufactureVSManufacturing precision

Solution Approach 1:

The sheath incorporates elastic expansion pieces that can dynamically adjust the bending characteristics of the head tube. These expansion pieces allow the sheath to transition between different stiffness states, enabling precise control during bending adjustment while maintaining a relatively simple manufacturing process.

Inventive Principle:
Principle #15Dynamics

3Reliability

If a multi-layer sheath structure is implemented, then the mechanical performance is improved, but the device complexity increases

Engineering Contradiction:
Improvemechanical performanceVSAvoidsheath assembly complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The multi-layer sheath structure applies different material properties and structural characteristics to different sections and layers. The inner lining tube provides smooth passage, the metal tube with expansion pieces provides axial support and bending control, and the outer wrapping membrane provides protection. This local optimization of quality enhances overall mechanical performance while keeping each component relatively simple.

Inventive Principle:
Principle #3Local quality

Data Source

PatentUS11864999B2Sheath for delivering interventional instrument and sheath assembly
Publication Date: 2024.01.09 VENUS MEDTECH (HANGZHOU) INC
  • US11864999B2 patent drawing
  • US11864999B2 patent drawing
  • US11864999B2 patent drawing

AI summary

The present invention discloses a core assembly, a sheath assembly, a sheath, a sheath processing method and an interventional instrument delivery system and method. A core assembly for delivering an interventional instrument according to the present invention comprises a core tube, a locking member fixed at a distal end of the core tube for connecting the interventional instrument, and a bendable adjustable tube mounted around an outer periphery of the core tube, wherein the distal ends of the bendable adjustable tube and the core tube are fixedly connected to each other, and the proximal ends can slide relative to each other.