Inverting Temporary Valve Sheath for Minimally Invasive Blood Flow Control

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Solution Overview

Problem

Current percutaneous cardiovascular procedures require a temporary valve to maintain unidirectional blood flow during valve repair or replacement, but existing solutions are invasive and lack efficient deployment and removal methods, potentially causing trauma to the vessel and prolonging procedure time.

Innovation Solution

A percutaneous temporary valve system with an inverting sheath and dilator mechanism that allows reversible deployment and removal, featuring a radially expanded canopy shape for unidirectional blood flow and a method for reducing the valve's outer profile for easy withdrawal, utilizing braided members and optional ribs for structural support.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a temporary valve is used to maintain unidirectional blood flow during percutaneous procedures, then blood flow control is improved, but the risk of vessel trauma and prolonged procedure time increases

Engineering Contradiction:
Improveblood flow controlVSAvoidvessel trauma
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The sheath is designed to be inverted during delivery, with the temporary valve contained within the inverted configuration. Upon deployment, the sheath is everted to its normal configuration, deploying the valve in the process. This inversion technique allows the valve to be delivered in a compact state while minimizing trauma during insertion and removal

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

2Duration of action of moving object

If a temporary valve is deployed to maintain blood flow during procedures, then hemodynamic support is improved, but the time and effort required for deployment and removal increases

Engineering Contradiction:
Improvehemodynamic support durationVSAvoidprocedure time
Core Design Contradiction:
Duration of action of moving objectVSLoss of time

Solution Approach 1:

The temporary valve is pre-assembled and integrated with the sheath in a ready-to-deploy configuration before insertion. The inversion mechanism is pre-configured so that simple manipulation during deployment automatically transitions the valve from its contained state to its functional deployed state, reducing the time and complexity of the deployment process

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The sheath and valve system is designed with dynamic inversion capability, allowing smooth transition between compressed delivery configuration and expanded functional configuration. This dynamic design enables rapid deployment and removal without requiring complex manual manipulation or additional devices

Inventive Principle:
Principle #15Dynamics

3Reliability

If the valve is delivered in an expanded configuration, then immediate functionality is improved, but the difficulty of insertion through narrow access increases

Engineering Contradiction:
Improveimmediate functionalityVSAvoidinsertion difficulty
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The sheath is inverted during delivery, containing the temporary valve within its inverted configuration. This inversion allows the valve to be delivered in a compact, low-profile state that can easily navigate narrow access pathways. Upon deployment, the sheath is everted to its normal configuration, automatically deploying the valve to its functional expanded state

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

Data Source

PatentEP3495012B1Inverting temporary valve sheath
Publication Date: 2024.07.17 VALVE MEDICAL
  • EP3495012B1 patent drawingFigure 1
  • EP3495012B1 patent drawingFigure 2
  • EP3495012B1 patent drawingFigure 3

AI summary

A percutaneous device including a temporary valve (104) attached to a sheath, the sheath having an inverting section for delivery and removal thereof from a blood vessel. The sheath is inverted for delivery, housing the valve between inverted layers thereof. To deploy said valve, the sheath is everted to position the temporary valve on an outer surface thereof. The temporary valve and sheath are reversibly movable between inverted and deployed configurations. Upon eversion, the temporary valve assumes a radially expanded canopy shape (106) having an outer diameter selected to contact the vessel wall and allow blood flow in only one direction. The temporary valve may be removed by releasing one end of the valve from the sheath, flattening the temporary valve along the longitudinal axis of the sheath. Also provided is a temporary valve system comprising a dilator (160) for inverting and everting the sheath, said dilator being removably connected to the sheath and comprising a nosecone (166) at its distal end.