Tri-leaflet Haemostatic Valve with Hydrophilic Coating

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Solution Overview

Problem

Haemostatic valves used in medical devices face challenges such as high resistance to movement, potential damage to flexible or small-diameter inserts due to friction, and leakage issues with existing seal designs, which can lead to adverse outcomes during medical procedures.

Innovation Solution

A tri-leaflet valve design with elongate flexible leaflets that form a polygonal passage when open and seal along adjacent longitudinal sides, potentially made from compliant or non-compliant materials, and featuring a hydrophilic coating to enhance sealing and reduce friction, along with configuring means like pressurizable chambers or twisting elements to achieve a secure closure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional seals or disk-shaped valves are used to achieve good sealing characteristics, then sealing efficiency is improved, but resistance to movement of the insert increases substantially

Engineering Contradiction:
Improvesealing efficiencyVSAvoidresistance to movement
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The valve is divided into multiple discrete seals arranged in series along the longitudinal axis, each seal being independently positioned at different locations. This segmentation allows each seal to contribute to the overall sealing function while distributing the frictional resistance across multiple points rather than concentrating it at a single location, thereby reducing the total resistance to insert movement.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A lubricant is introduced as an intermediary substance between the seals and the insert to reduce friction. The lubricant is delivered through a lumen in the insert or through the sheath wall, creating a lubricating film that minimizes direct contact and friction between the seal surfaces and the insert, thereby reducing resistance to movement while maintaining sealing effectiveness.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If closure pressure is increased to reduce leakage paths, then sealing efficiency is improved, but friction between the valve and insert increases, making it harder to slide the insert through

Engineering Contradiction:
Improvesealing efficiencyVSAvoidfriction during insertion
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The sealing function is distributed across multiple discrete seals rather than relying on a single high-pressure seal. Each seal operates at lower individual closure pressures to achieve the same overall sealing effect, thereby reducing the friction and resistance to insert movement while maintaining leakage prevention.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A lubricant is used as an intermediary to reduce the friction between the seals and the insert. The lubricant allows the seals to maintain effective closure pressure for sealing while minimizing the resistive force against insert movement, effectively decoupling the sealing pressure from the frictional resistance.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If multiple valves in series are used to improve sealing characteristics, then sealing efficiency is improved, but the complexity of the device increases

Engineering Contradiction:
Improvesealing efficiencyVSAvoidnumber of valve elements
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

Multiple sealing functions are combined into a single integrated valve assembly rather than using separate valve elements. The multiple discrete seals are arranged in series within one valve structure, achieving improved sealing characteristics while avoiding the complexity of multiple independent valve mechanisms.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The valve assembly is designed to perform multiple functions simultaneously: providing series-arranged sealing surfaces for improved leakage prevention, accommodating lubricant delivery through integrated lumens, and maintaining low friction for insert movement. This multi-functionality reduces the need for additional separate components, thereby reducing overall device complexity while maintaining sealing efficiency.

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

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 tri-leaflet valve provides improved sealing efficiency with reduced friction, minimizing the risk of insert damage and leakage, while allowing easy insertion and withdrawal, thus enhancing the reliability of medical procedures.

Implementation Method 1

featuring a hydrophilic coating to enhance sealing and reduce friction

Methodology Applied
Scientific EffectHydrophilic coating: Hydrophile

Implementation Method 2

configuring means like pressurizable chambers or twisting elements to achieve a secure closure

Methodology Applied
Scientific EffectPressurisation: Pressurisation

Data Source

PatentUS8235946B2Haemostatic valve
Publication Date: 2012.08.07 COOK MEDICAL TECHNOLOGIES LLC
  • US8235946B2 patent drawing
  • US8235946B2 patent drawing
  • US8235946B2 patent drawing

AI summary

There is disclosed a tri-leaflet valve (100) in which the leaflets (102) extend for substantially the entire length of the valve (100). The valve (100) is provide with a waist (106). An element (16) inserted in the tri-leaflet valve (100) can be sealed by closure of the valve (100), for example by pressurization or twisting. The seat is more effective then prior art seals.