Zig-Zag Expandable Sheath for Kink-Resistant Vessel Navigation

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Solution Overview

Problem

Existing expandable introducer sheaths for prosthetic devices are prone to kinking when passing through curved vasculature, requiring increased insertion force and posing a risk of trauma to the patient.

Innovation Solution

The introduction of a kink-resistant expandable sheath with a cylindrical frame formed by a plurality of struts arranged in a zig-zag configuration, which allows the sheath to expand from a first diameter to a second diameter upon passage of a medical device, minimizing kinking and reducing insertion force.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional expandable sheaths are used, then the sheath can be expanded to accommodate prosthetic devices, but the sheath is prone to kinking when passing through curved vasculature

Engineering Contradiction:
Improvekink resistanceVSAvoidpassage through curved vasculature
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The sheath incorporates a zig-zag configuration that allows controlled curving and bending without kinking. The alternating pattern of compressed and uncompressed portions enables the sheath to navigate curved vasculature while maintaining structural integrity and preventing kink formation.

Inventive Principle:
Principle #14Spheroidality (Curvature)

Solution Approach 2:

The sheath transitions from a static rigid structure to a dynamic flexible structure that can adapt its shape. The expandable design with zig-zag configuration allows the sheath to dynamically adjust its curvature and flexibility to match the vasculature path, preventing kinks during navigation.

Inventive Principle:
Principle #15Dynamics

2Adaptability or versatility

If the sheath is expanded to accommodate larger prosthetic devices, then the device can be delivered, but increased insertion force is required

Engineering Contradiction:
Improvedevice accommodation capacityVSAvoidinsertion force
Core Design Contradiction:
Adaptability or versatilityVSForce

Solution Approach 1:

The sheath is divided into multiple segments or sections along its length, with alternating compressed and uncompressed portions in the zig-zag configuration. This segmentation allows progressive expansion and reduces the peak force required by distributing the expansion effort across multiple sections rather than requiring simultaneous expansion of the entire sheath.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The sheath utilizes changes in physical parameters including radial dimension (expansion from collapsed to expanded state) and structural configuration (zig-zag pattern). These parameter changes enable the sheath to accommodate larger devices while the alternating compressed/uncompressed portions facilitate gradual expansion that reduces insertion force requirements.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP4149603B1Kink-resistant expandable sheath
Publication Date: 2026.03.04 EDWARDS LIFESCIENCES CORP
  • EP4149603B1 patent drawingFigure 1~2
  • EP4149603B1 patent drawingFigure 3~4
  • EP4149603B1 patent drawingFigure 5~6

AI summary

Expandable sheaths are disclosed herein. In some aspects, the sheath comprises at least one plurality of struts arranged to form an expandable cylindrical frame such that the formed frame is kink resistant. The disclosed frames are configured to expand from a first diameter d1 in an unexpended position to a second diameter d2 an expanded position upon passage of a medical device, while maintaining the kink resistance. Also disclosed are methods of making the same.