Multi-Directional Bendable Sheath Tube for Precise Catheter Alignment

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Solution Overview

Problem

Existing transcatheter intervention systems face challenges in efficiently navigating complex anatomical structures due to limited flexibility and stability, particularly when treating mitral or tricuspid regurgitation, which requires precise alignment and adjustment of delivery devices.

Innovation Solution

A sheath with a multi-layer composite tube body featuring a woven mesh with varying density and elastomer hardness along its length, combined with traction mechanisms, allows for multi-directional bending and stable support, enabling precise adjustment of the distal end for optimal delivery path alignment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If the sheath uses a uniform structure throughout its length, then manufacturing is simple, but it cannot provide both flexibility for navigation and stability for support simultaneously

Engineering Contradiction:
ImproveflexibilityVSAvoidstructure
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The sheath is divided into multiple sections along its length, with each section having different structural characteristics. The distal section has a looser braid structure for flexibility, while proximal sections have tighter structures for stability, allowing the sheath to navigate complex anatomy while maintaining control

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different sections of the sheath have locally optimized properties: the distal section features a looser braid density and softer durometer for enhanced flexibility and conformability, while proximal sections maintain tighter braiding and higher durometer for structural support and pushability

Inventive Principle:
Principle #3Local quality

2Adaptability or versatility

If the sheath has high flexibility to navigate complex structures, then navigation capability improves, but stability and support decrease

Engineering Contradiction:
Improvenavigation capabilityVSAvoidstability
Core Design Contradiction:
Adaptability or versatilityVSStability of the object's composition

Solution Approach 1:

The sheath is segmented into functional zones with distinct mechanical properties, allowing the distal portion to be highly flexible for navigation while proximal portions remain stiff for stability and operator control

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The braid density and material durometer vary locally along the sheath length, creating a gradient from flexible distal sections to stable proximal sections, enabling simultaneous navigation capability and structural support

Inventive Principle:
Principle #3Local quality

3Strength

If the woven mesh has high density throughout, then structural strength is maintained, but bending flexibility is reduced

Engineering Contradiction:
Improvestructural strengthVSAvoidbending flexibility
Core Design Contradiction:
StrengthVSAdaptability or versatility

Solution Approach 1:

The braid density is optimized locally: distal sections have lower braid density (e.g., 40-60 braids per inch) to allow bending and conformability, while proximal sections have higher braid density (e.g., 80-100 braids per inch) to maintain structural strength and resistance to compression

Inventive Principle:
Principle #3Local quality

4Ease of manufacture

If the elastomer hardness is uniform throughout the sheath, then manufacturing is simple, but performance in different sections is compromised

Engineering Contradiction:
Improvemanufacturing simplicityVSAvoidperformance optimization
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The elastomer material has varying durometer values along the sheath length: softer material (e.g., 60-80 durometer) in distal sections for flexibility and comfort, and harder material (e.g., 80-100 durometer) in proximal sections for structural integrity and pushability

Inventive Principle:
Principle #3Local quality

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 enhances the flexibility and stability of the sheath, allowing for quick and precise alignment with treatment sites, reducing operation time and complexity by facilitating seamless navigation through complex anatomical structures.

Implementation Method 1

the traction mechanism comprises an anchoring ring and a traction wire, wherein the anchoring ring is sleeved on the distal end of the woven mesh, the distal end of the traction wire is connected with the anchoring ring

Methodology Applied
Scientific EffectTension: Tension

Implementation Method 2

a reinforcing wire is wound around the outside of the traction wire, and the outer surface of the reinforcing wire is fixedly connected with the elastomer

Methodology Applied
Scientific EffectCompression resistance:

Implementation Method 3

the bending section is a multi-layer composite tube body and comprises a plurality of segments, a middle layer of the multi-layer composite tube body is a woven mesh

Methodology Applied
Scientific EffectForce distribution:

Data Source

PatentEP4272703B1Multi-directional bendable sheath tube and transcatheter intervention system
Publication Date: 2025.09.17 HANGZHOU VALGEN MEDTECH CO LTD
  • EP4272703B1 patent drawingFigure 1~2
  • EP4272703B1 patent drawingFigure 3~4
  • EP4272703B1 patent drawingFigure 5~6

AI summary

Disclosed are a sheath adjustable in multiple directions and a transcatheter interventional system. The sheath that can be adjusted in multiple directions includes: a body section, a bending section, connected with the distal end of the body section, the bending section is a multi-layer composite tube body and includes a plurality of segments, the middle layer of the multi-layer composite tube body is a woven mesh, and the density of the woven mesh of the plurality of segments is gradually reduced in the direction from the proximal end to the distal end; and at least a pair of traction mechanisms, each pair of the traction mechanism respectively passes through the bending section and the body section, to adjust the bending angle of the bending section to different directions.