VAD Conduit Device for Noninvasive Heart Pump Replacement

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Solution Overview

Problem

Current ventricular assist device (VAD) connectors and configurations cause complications during implantation, removal, and replacement, including risk of bleeding, infection, and air exposure, due to healing of heart tissue around the device and the need for cardioplegia or cardiopulmonary bypass to manage blood flow.

Innovation Solution

A conduit device with a hollow cylindrical body and valve is placed within the heart wall, providing a sleeve for the VAD inflow tube and promoting tissue growth on its exterior surface, allowing for secure attachment and minimizing interaction with heart tissue during device removal and replacement, using a one-way valve to prevent backflow and reduce the need for surgical bypass.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a VAD connector is attached to the heart through sutures and tissue heals around the device, then the VAD is securely fixed to the heart, but removal or replacement of the VAD causes bleeding and embolization risks due to separation from healed tissue

Engineering Contradiction:
Improvesecure fixation of VAD to heartVSAvoidbleeding and embolization during removal
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The invention divides the connection system into three separate components: (1) a conduit embedded in the heart wall that provides a permanent access pathway, (2) a connector that attaches to the conduit and secures the VAD, and (3) the VAD itself. This segmentation allows the conduit to remain embedded and healed in the heart wall while the connector and VAD can be removed or replaced without disrupting the embedded conduit, thereby eliminating bleeding and embolization risks during device removal or replacement.

Inventive Principle:
Principle #1Segmentation

2Ease of manufacture

If the heart wall opening is left open during VAD implantation or replacement, then the procedure is simpler, but blood exits from the opening causing massive blood loss requiring cardioplegia or cardiopulmonary bypass

Engineering Contradiction:
Improvesimplicity of implantation procedureVSAvoidblood loss during implantation
Core Design Contradiction:
Ease of manufactureVSLoss of substance

Solution Approach 1:

The conduit is pre-embedded in the heart wall before VAD implantation, creating a sealed access pathway in advance. This preliminary action allows the heart wall opening to be closed during implantation procedures, preventing blood loss without requiring cardioplegia or cardiopulmonary bypass, while still providing easy access for VAD insertion through the pre-formed conduit opening.

Inventive Principle:
Principle #10Preliminary action

3Ease of operation

If the heart wall opening is left open during VAD procedures, then access is easier, but outside air enters the heart causing complications

Engineering Contradiction:
Improveaccess to heart chamberVSAvoidair embolization from outside air entry
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The conduit acts as an intermediary barrier between the outside environment and the heart chamber. It provides a controlled access pathway that allows insertion of the VAD while preventing uncontrolled entry of outside air into the heart. The conduit's sealed construction around the VAD connector eliminates the risk of air embolization while maintaining ease of operation during implantation and replacement procedures.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Adaptability or versatility

If a new VAD is implanted after removal, then the heart can be assisted again, but the healing process must recur causing infection and prolonged bleeding risks

Engineering Contradiction:
Improveability to replace VADVSAvoidinfection and bleeding risk during re-implantation
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

By segmenting the connection system so that the conduit remains embedded in the heart wall while the connector and VAD are separate, the invention enables VAD replacement without disrupting the healed conduit-tissue interface. The conduit serves as a permanent, healed access pathway that can be reused for multiple VAD implantations, eliminating the need for recurrent healing processes and associated infection and bleeding risks.

Inventive Principle:
Principle #1Segmentation

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 conduit device facilitates simplified and noninvasive VAD removal and replacement, reducing the risk of bleeding and infection, minimizing blood loss, and eliminating the need for cardioplegia or cardiopulmonary bypass, while maintaining a secure connection to the heart tissue.

Implementation Method 1

having an exterior surface comprising a tissue-growth promoting material adapted to promote growth of tissue on the exterior surface

Methodology Applied
Scientific EffectTissue growth:

Implementation Method 2

having an interior bore including a valve therein

Methodology Applied
Scientific EffectOne-way valve mechanism: Valve

Data Source

PatentEP2600918B1Conduit device for use with a ventricular assist device
Publication Date: 2021.10.13 HEARTWARE INC
  • EP2600918B1 patent drawingFigure 1
  • EP2600918B1 patent drawingFigure 2A~2B
  • EP2600918B1 patent drawingFigure 3A~3B

AI summary

The present invention is a conduit device designed to be placed within a wall of a heart, such as through a prepared opening or hole in the heart wall. The conduit is hollow and extends to form a sleeve over a portion of the heart pump, such as a VAD, which traverses the heart wall and enters a chamber of the heart. The conduit provides for a simplified and noninvasive approach to removal and/or replacement of the heart pump.