Cannula Apparatus for VADs with Segmented Flow and Priming

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Solution Overview

Problem

The insertion of Ventricular Assist Devices (VADs) is complicated by the need for muscle coring and the risk of stroke due to ventricular intracavity free air and air introduction during pump priming, which can lead to suction occlusion and micro air bubbles.

Innovation Solution

A cannula apparatus with an outer and inner cannula that can be configured between open and closed arrangements to prevent tissue occlusion and air entry, featuring multiple sidewall openings to ensure blood flow and a priming mechanism that maintains fluid within the cannula without offloading the ventricle, reducing the risk of air introduction during placement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If direct ventricular coring is performed to place the distal tip of the cannula, then the distal tip is free from adjacent trabeculated fibro-muscular attachments, but the procedure becomes more complex and carries higher risk of complications

Engineering Contradiction:
Improvecannula placement reliabilityVSAvoidsurgical procedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The cannula is divided into multiple segments with multiple drainage holes distributed along its length rather than a single distal tip hole. This segmentation allows blood to enter through multiple locations, eliminating the need to precisely position a single distal tip away from trabeculated structures, thereby simplifying the surgical procedure while maintaining reliable cannula function

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A retrieval snare is introduced as an intermediary tool to capture and remove the cannula if proper placement cannot be achieved or if complications arise. This intermediary device provides a safety mechanism that reduces surgical risk and simplifies the overall procedure by offering a non-invasive retrieval option rather than requiring complex removal maneuvers

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If surgical maneuvers such as hypodermic needles are used to evacuate air from the outflow graft, then air is removed from the system, but additional bleeding risks are introduced and procedure time is prolonged

Engineering Contradiction:
Improveintracavity free airVSAvoidprocedure time
Core Design Contradiction:
Object-affected harmful factorsVSLoss of time

Solution Approach 1:

The cannula and VAD are primed with blood or blood-compatible fluid before implantation, and air evacuation ports are pre-positioned in the outflow graft. This preliminary preparation allows air to be evacuated through the pre-designed ports during normal surgical flow rather than requiring additional time-consuming maneuvers with hypodermic needles after implantation

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

Designated air evacuation ports serve as intermediary structures that provide a controlled pathway for air removal. These ports allow air to escape without requiring direct needle puncture of the graft, thereby eliminating the need for additional bleeding control measures and reducing procedure time

Inventive Principle:
Principle #24Intermediary (Mediator)

3Object-affected harmful factors

If hypodermic needles are used to puncture outflow graft material for air evacuation, then air is removed from the system, but post-implant bleeding risks are introduced

Engineering Contradiction:
Improveintracavity free airVSAvoidpost-implant bleeding
Core Design Contradiction:
Object-affected harmful factorsVSObject-generated harmful factors

Solution Approach 1:

The outflow graft incorporates designated air evacuation ports as intermediary structures that provide a controlled pathway for air removal. These ports are integrated into the graft material itself, allowing air to escape without requiring external needle puncture that would create uncontrolled bleeding risks. The ports can be accessed and sealed in a controlled manner, eliminating the need for additional bleeding control measures

Inventive Principle:
Principle #24Intermediary (Mediator)

4Object-affected harmful factors

If suction lines are used to evacuate air from the device chamber, then air is removed from the system, but micro air bubbles are introduced into the outflow graft

Engineering Contradiction:
Improvedevice chamber airVSAvoidmicro air bubbles in outflow graft
Core Design Contradiction:
Object-affected harmful factorsVSObject-generated harmful factors

Solution Approach 1:

The cannula incorporates a distal air evacuation port as an intermediary structure that provides a dedicated pathway for air removal from the device chamber. This port is positioned and designed to allow air to escape directly from the chamber without creating negative pressure that would draw blood and micro air bubbles into the outflow graft. The port serves as a controlled air evacuation route that prevents the harmful side effect of bubble introduction

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentUS10226558B2Cannula apparatus and ventricular assist systems using the cannula apparatus
Publication Date: 2019.03.12 MAYO FOUNDATION FOR MEDICAL EDUCATION & RESEARCH
  • US10226558B2 patent drawing
  • US10226558B2 patent drawing
  • US10226558B2 patent drawing

AI summary

Cannula apparatus, ventricular assist systems including the cannula apparatus, and methods of priming and placing the cannula apparatus and ventricular assist systems are described herein.