Hemostatic Valve Guide for Vascular Introducer Leakage

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Solution Overview

Problem

Existing introducer sheaths used for vascular access in cardiac treatments often experience excessive blood leakage due to damage or perforation of the hemostatic valve during insertion of medical devices, requiring skilled user interaction and specific experience.

Innovation Solution

An introducer sheath with a hemostatic valve featuring a guide, such as a funnel, that directs objects towards the center of the valve, reducing the risk of perforation and improving ease of use by minimizing human factor considerations and accommodating a wider range of use conditions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a hemostatic valve is used to prevent blood leakage, then blood leakage is reduced, but the valve is susceptible to damage or perforation during insertion

Engineering Contradiction:

Improveblood leakage preventionVSAvoidvalve damage or perforation

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A guide structure is introduced as an intermediary element between the insertion path and the hemostatic valve. The guide directs medical devices toward the center of the valve, preventing direct contact with vulnerable valve regions and eliminating the harmful effect of perforation while preserving the blood leakage prevention function.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The guide structure is pre-configured in the hub to establish a protected insertion path before the medical device contacts the hemostatic valve. This preliminary arrangement ensures that devices are properly directed toward the center of the valve, preventing damage before it can occur.

Inventive Principle:

Principle #10Preliminary action

2Reliability

If user skill and experience are required to prevent valve damage, then valve reliability improves, but ease of operation deteriorates

Engineering Contradiction:

Improvevalve integrityVSAvoiduser skill requirement

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The guide structure enables the system to protect itself by automatically directing medical devices toward the center of the hemostatic valve. This self-guiding mechanism eliminates the need for user skill or experience to prevent valve damage, as the structure itself ensures proper device placement and prevents perforation.

Inventive Principle:

Principle #25Self-service

3Ease of operation

If the insertion path is not guided, then device insertion is simpler, but valve perforation risk increases

Engineering Contradiction:

Improveinsertion simplicityVSAvoidperforation risk

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The guide acts as an intermediary that simplifies the insertion process by providing a predetermined safe path. Rather than requiring complex user maneuvers to avoid perforation, the guide structure itself ensures devices follow a safe trajectory toward the center of the valve, reducing perforation risk while maintaining insertion simplicity.

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentUS20230414916A1Hemostatic valve for medical device introducer

Publication Date: 2023.12.28 ABIOMED INC

AI summary

An introducer for insertion of a medical device into a patient's vasculature includes an elongate introducer body, a hub, and a hemostatic valve. The elongate introducer body includes a longitudinal axis, a proximal region, a distal region, and an inner lumen. The hub is coupled to the proximal region of the introducer body. The hemostatic valve is disposed within the hub and forms a liquid-tight seal across the inner lumen. The introducer includes a guide configured to guide an object towards the center of the valve during insertion of the object.