Exchangeable Hemostatic Valve Modules for Sheath Introducers

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Solution Overview

Problem

Existing sheath introducers with single hemostatic valves fail to ensure effective hemostasis during the simultaneous introduction and manipulation of multiple interventional devices, leading to poor blood containment and risk of air embolism in procedures requiring multiple device usage.

Innovation Solution

A sheath introducer system with exchangeable hemostatic valve modules, featuring a single entry port valve module for solo device introduction and a multiple entry port valve module for simultaneous device manipulation, secured by a locking collar and designed to provide fluid-tight seals through elastomeric materials and compressible segments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a single hemostatic valve is used in the sheath introducer, then the device complexity is reduced and ease of operation is improved, but the reliability of hemostasis deteriorates during simultaneous introduction of multiple interventional devices

Engineering Contradiction:

Improvehemostasis reliabilityVSAvoidvalve module configuration

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The hemostatic valve is divided into separate exchangeable valve modules, each designed for specific procedures (single device or multiple devices). This segmentation allows the system to provide reliable hemostasis for the specific procedure being performed without requiring a complex multi-functional valve for all scenarios.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The valve housing is designed with universal compatibility to accept different types of valve modules (single-port or multi-port). This universality allows a single sheath introducer system to adapt to various procedural requirements by simply changing the valve module, rather than designing different entire systems for different scenarios.

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Adaptability or versatility

If multiple puncturable hemostatic valves are used to accommodate multiple devices, then the adaptability for multiple device procedures is improved, but the device complexity increases and hemostasis reliability deteriorates

Engineering Contradiction:

Improvemulti-device procedure capabilityVSAvoidhemostasis effectiveness

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

Instead of using multiple separate puncturable valves that create multiple potential failure points, the invention segments the hemostatic function into dedicated valve modules with integrated sealing mechanisms. Each module is designed as a complete, reliable unit that maintains hemostasis through its engineered sealing interface with the sheath.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The valve modules are designed as disposable components that are exchanged between procedures. This allows for optimized design of each module for its specific function without needing to make the entire system disposable or reusable, balancing cost and performance.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Ease of operation

If the sheath introducer is designed for single device introduction, then the ease of operation is improved, but the adaptability for multiple device procedures deteriorates

Engineering Contradiction:

Improvedevice introduction simplicityVSAvoidprocedure type flexibility

Core Design Contradiction:

Ease of operationVSAdaptability or versatility

Solution Approach 1:

The system transitions from a static single-configuration valve to a dynamic system where the valve module can be exchanged based on procedural needs. The locking collar mechanism enables quick and simple exchange while maintaining a secure connection, allowing the system to adapt its configuration without complex adjustments.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The sheath introducer incorporates a universal valve housing that can accommodate both single-port and multi-port valve modules. This universal design maintains operational simplicity for single-device procedures while providing the flexibility to switch to multi-port modules when multiple devices are required.

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

Ensures reliable hemostasis during both single and multiple device procedures, reducing the risk of blood leakage and air embolism by providing a secure and efficient pathway for interventional devices through the use of exchangeable valve modules.

Implementation Method 1

designed to provide fluid-tight seals through elastomeric materials and compressible segments

Methodology Applied

Scientific EffectElasticity: Elasticity

Data Source

PatentUS8845588B2Sheath introducer system with exchangeable hemostatic valves

Publication Date: 2014.09.30 MEDTRONIC VASCULAR INC

AI summary

A sheath introducer system with exchangeable hemostatic valve modules is disclosed. A first valve module includes a single entry port to ensure hemostasis during the introduction of an interventional device, such as a main graft delivery system for treatment of an abdominal aortic aneurysm (AAA). A second valve module includes multiple entry ports to ensure hemostasis during the simultaneous introduction and manipulation of multiple interventional devices, such as multiple guiding catheters for use in delivering various intravascular graft components for completion of branch perfusion, for instance, during treatment of the AAA.