Degassing Vascular Access Device for Air Inhibition

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Solution Overview

Problem

During percutaneous procedures, air can inadvertently enter the patient's vasculature through hemostasis valves due to pressure differentials, instrument movement, valve deformation, or aspiration, posing a risk of stroke by depriving tissues of oxygenated blood.

Innovation Solution

A degassing section is integrated into the vascular access device or an adjunct device, creating a closed-loop fluid circulation system with a sterile fluid container, supply, and return lines to collect and remove air bubbles using a circulating sterile fluid, preventing air from entering the vasculature.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a hemostasis valve is used to prevent blood loss during percutaneous procedures, then hemostasis is improved, but air can still enter the vasculature through the valve due to pressure differentials and valve deformation

Engineering Contradiction:

ImprovehemostasisVSAvoidair introduction

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A sterile fluid is introduced as an intermediary substance that flows through the hemostasis valve and into the vascular access device. This sterile fluid acts as a mediator between the external environment and the vasculature, blocking air from entering the blood stream while still allowing the hemostasis valve to function. The sterile fluid creates a physical barrier that prevents air bubbles from reaching the patient's circulation.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention utilizes hydraulic principles by introducing a sterile fluid that flows through the hemostasis valve and into the vascular access device. This fluid flow creates pressure differentials that prevent air from entering the vasculature. The continuous flow of sterile fluid acts as a hydraulic barrier, using fluid dynamics to block air bubbles while maintaining hemostasis.

Inventive Principle:

Principle #29Pneumatics and hydraulics

2Ease of operation

If instruments are passed through the hemostasis valve to perform percutaneous procedures, then procedural access is improved, but air bubbles can be drawn into the vasculature through the valve

Engineering Contradiction:

Improveprocedural accessVSAvoidair bubble introduction

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The sterile fluid serves as an intermediary that allows instruments to pass through the hemostasis valve while blocking air bubbles. The fluid flow continues uninterrupted during instrument manipulation, creating a protective barrier that prevents air from entering the vasculature even when instruments are being advanced or repositioned.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The sterile fluid is introduced into the system before instruments are passed through the hemostasis valve. This preliminary action establishes a protective fluid barrier in advance, ensuring that air bubbles are prevented from entering the vasculature during subsequent instrument manipulation and procedural operations.

Inventive Principle:

Principle #10Preliminary action

3Ease of manufacture

If aspiration is performed through the flush port to remove debris, then cleaning is improved, but air bubbles are drawn into the vasculature through the hemostasis valve

Engineering Contradiction:

ImprovecleaningVSAvoidair bubble introduction

Core Design Contradiction:

Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The sterile fluid acts as an intermediary that allows aspiration to occur while preventing air bubble introduction. When aspiration is performed through the flush port, the continuous flow of sterile fluid through the hemostasis valve creates a barrier that blocks air bubbles from entering the vasculature, while still enabling effective cleaning of the procedural site.

Inventive Principle:

Principle #24Intermediary (Mediator)

4Adaptability or versatility

If the hemostasis valve is deformed or damaged during multiple expansion/contraction cycles, then instrument flexibility is improved, but air can pass through the valve more easily

Engineering Contradiction:

Improveinstrument flexibilityVSAvoidair passage through valve

Core Design Contradiction:

Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The sterile fluid serves as a protective intermediary that compensates for valve deformation or damage. Even when the hemostasis valve is deformed during instrument manipulation, the continuous flow of sterile fluid maintains a barrier that prevents air from passing through, ensuring that valve imperfections do not lead to air bubble introduction into the vasculature.

Inventive Principle:

Principle #24Intermediary (Mediator)

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

Effectively inhibits the introduction of air into the vasculature, ensuring hemostasis and preventing potential strokes by maintaining a sterile fluid flow that collects and removes air bubbles, thus ensuring the safety of percutaneous procedures.

Implementation Method 1

creating a sterile fluid flow (mixing with the patient's blood) in a proximal portion of the access device or of an adjunct device coupled to the proximal end of the vascular access device

Methodology Applied

Scientific EffectFluid flow:

Implementation Method 2

air bubbles B drawn into the interior of the hub H, as indicated by arrows 28, may cling to the instrument C due to surface tension, indicated by reference number 29

Methodology Applied

Scientific EffectSurface tension: Surface Tension

Data Source

PatentUS8277410B2Methods and apparatus for inhibiting introduction of air into the vasculature during a percutaneous procedure

Publication Date: 2012.10.02 BOSTON SCIENTIFIC SCIMED INC

AI summary

Apparatus and methods for inhibiting the introduction of air into the body during a percutaneous procedure. The apparatus may include an instrument passage lumen defining a degassing region with a degassing region distal end and a degassing region proximal end, a fluid inlet port at the degassing region distal end, and a fluid outlet port at the degassing region proximal end. So configured, fluid will flow only from the degassing region distal end to the degassing region proximal end.