Valve Loading Device for Air Bubble Removal in Transcatheter Heart Valve Systems

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Solution Overview

Problem

Conventional transcatheter heart valve systems face challenges in removing air bubbles from the delivery device lumen, especially with small lumens, which can lead to air embolisms during implantation procedures.

Innovation Solution

A valve loading device with a housing, sealing apparatuses, and a port is used to create a negative pressure environment within the chamber, allowing for the removal of air bubbles from the liquid before loading the stented prosthetic heart valve into the delivery device, ensuring an air bubble-free system for implantation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional flushing methods are used to remove air bubbles, then liquid is pushed through the lumen to move bubbles out, but this is difficult with exceedingly small lumens and new bubbles can be introduced that are difficult to remove

Engineering Contradiction:
Improveair bubble removal effectivenessVSAvoiddifficulty of bubble removal
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

Instead of pushing liquid through the lumen to move bubbles out (conventional flushing), the patent applies negative pressure to the chamber to actively draw bubbles out through the port. This inversion of the flushing approach allows effective bubble removal from small lumens without introducing new bubbles, as the negative pressure creates a suction effect that pulls bubbles toward the port for removal.

Inventive Principle:
Principle #13The other way round (Inversion)

2Object-affected harmful factors

If the delivery device catheter has exceedingly small lumens for minimally-invasive delivery, then patient trauma is reduced, but air bubble removal becomes difficult and risk of air embolisms increases

Engineering Contradiction:
Improvepatient traumaVSAvoidrisk of air embolisms
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent applies negative pressure to the chamber before the stented prosthetic heart valve is loaded into the delivery device catheter. This preliminary action removes air bubbles from the liquid in advance, ensuring that when the valve is loaded and the system is ready for implantation, the small-lumen delivery device is already free of air bubbles, eliminating the risk of air embolisms while maintaining the minimally-invasive small catheter design.

Inventive Principle:
Principle #10Preliminary action

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 solution effectively removes air bubbles from the transcatheter heart valve system, reducing the risk of air embolisms and ensuring a bubble-free environment for the stented prosthetic heart valve during implantation, thereby enhancing the safety and efficacy of the procedure.

Implementation Method 1

A negative pressure can be generated in the chamber, and air bubbles removed from the delivered liquid, via the port

Methodology Applied
Scientific EffectNegative pressure: Pressure Gradient

Data Source

PatentUS10010411B2Devices and methods for preparing a transcatheter heart valve system
Publication Date: 2018.07.03 MEDTRONIC VSACULAR GALWAY
  • US10010411B2 patent drawing
  • US10010411B2 patent drawing
  • US10010411B2 patent drawing

AI summary

Devices and methods for preparing a transcatheter heart valve system. The device includes a housing, sealing apparatuses and a port. The housing forms a chamber sized to receive a prosthetic valve and a portion of a delivery device. During use, the prosthesis is seated in the chamber, and the sealing apparatuses operated to seal the chamber about the delivery device. Air bubbles in a liquid delivered through the delivery device and to the chamber are removed from the system via the port, thereby flushing the system. Further, the device is manipulated to permit loading of the prosthesis into the delivery device in an air bubble-free environment.