Peelable Sheath Introducer for Endoluminal Prosthesis Delivery

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Solution Overview

Problem

Current endoluminal prosthesis delivery systems with longer preloaded components become cumbersome and difficult to control, especially as the length of the main body sheath increases, complicating the delivery of prosthetic devices to vascular sites like aneurysms, and may require additional catheters, wires, or stents.

Innovation Solution

An endoluminal prosthesis introducer featuring an elongate tubular sheath with a reinforced longitudinal segment and a peelable segment that splits proximally when a force is applied to the distal end, allowing the reinforced segment to move distally relative to the cannula, enabling the prosthesis to be deployed without the need for excessively long preloaded components.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Length of moving object

If the length of the main body sheath is increased to deliver prosthetic devices to distant vascular sites, then the delivery reach is improved, but the preloaded components become significantly longer and more difficult to control

Engineering Contradiction:
Improvemain body sheath lengthVSAvoidcontrol of preloaded components
Core Design Contradiction:
Length of moving objectVSEase of operation

Solution Approach 1:

The sheath is divided into two distinct segments: a reinforced proximal segment that provides structural support and stability, and a peelable distal segment that can be separated from the prosthesis. This segmentation allows the reinforced segment to remain relatively short and controllable while the peelable segment enables prosthesis deployment without requiring excessively long preloaded components throughout the entire sheath length.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The peelable segment is extracted as a separate, removable portion of the sheath that can be peeled away from the prosthesis during deployment. This extraction allows the main reinforced sheath to be kept short and controllable, while the peeled-away segment provides the necessary coverage for prosthesis delivery and deployment at the target site.

Inventive Principle:
Principle #2Taking out (Extraction)

2Length of moving object

If the length of the main body sheath is increased, then the delivery reach is improved, but the device complexity increases requiring additional catheters, wires, or stents

Engineering Contradiction:
Improvemain body sheath lengthVSAvoidnumber of additional components
Core Design Contradiction:
Length of moving objectVSDevice complexity

Solution Approach 1:

The peelable segment serves multiple functions: it provides coverage for the prosthesis during delivery, acts as a deployment mechanism when peeled away, and eliminates the need for separate deployment tools or additional components. This multi-functionality reduces device complexity while maintaining the ability to deliver prosthetics to distant sites.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The peelable segment is designed to be self-contained and self-operating. The operator simply applies force to peel the segment away from the prosthesis, and the segment itself performs the deployment function without requiring additional catheters, wires, or stents. This self-service mechanism simplifies the overall device architecture.

Inventive Principle:
Principle #25Self-service

3Adaptability or versatility

If longer preloaded components are used to traverse the delivery system, then the delivery capability is improved, but the components become significantly more difficult to control

Engineering Contradiction:
Improvedelivery capabilityVSAvoidcontrol of preloaded components
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

By segmenting the sheath into reinforced and peelable portions, the system allows the reinforced segment to remain short and easily controllable, while the peelable segment provides the necessary length for prosthesis coverage. This eliminates the need for extremely long preloaded components that would be difficult to control.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Instead of making the entire sheath long and controllable, the invention inverts the approach by making the sheath short and controllable with a reinforced segment, and using a peelable segment that is peeled away during deployment. This inversion allows delivery capability without the need for long, difficult-to-control preloaded components.

Inventive Principle:
Principle #13The other way round (Inversion)

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

This design allows for a shorter introducer system, improving control and reducing the complexity of delivery by enabling the prosthesis to be deployed with a shorter sheath and pusher catheter, while maintaining stability and kink-resistance, thus simplifying the delivery process and reducing the need for additional components.

Implementation Method 1

Upon application of a force applied to a distal end of the sheath, the peelable segment progressively splits in a proximal direction

Methodology Applied
Scientific EffectMechanical Force: Mechanical Force

Implementation Method 2

the reinforced segment longitudinally moves relative to the cannula in a distal direction

Methodology Applied
Scientific EffectMechanical Force: Mechanical Force

Data Source

PatentEP3078354B1Endoluminal prosthesis introducer
Publication Date: 2019.02.13 COOK MEDICAL TECHNOLOGIES LLC
  • EP3078354B1 patent drawingFigure 1
  • EP3078354B1 patent drawingFigure 2
  • EP3078354B1 patent drawingFigure 3

AI summary

An endoluminal prosthesis introducer may include an elongate tubular sheath (130, 330, 430) including a reinforced longitudinal segment (136, 336) and a peelable longitudinal segment (134, 334, 434) extending distally from the reinforced segment (136, 336). An elongate tubular cannula may be disposed within the sheath. Upon application of a force applied to a distal end of the sheath (130, 330, 430), the peelable segment (134, 334, 434) may progressively split in a proximal direction, and the reinforced segment (136, 336) may longitudinally move relative to the cannula in a distal direction.