Transvalvular Conduit Support Stent for Blood Pump Fixation

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Solution Overview

Problem

Existing small, less invasive blood pumps face challenges in maintaining a blood flow conduit securely centered within the aortic valve orifice, leading to potential thrombus formation and regurgitation due to non-central positioning, which can result in dangerous thromboembolism and valve wear.

Innovation Solution

A fixation device comprising a valve stent and conduit support ring, affixed to the aortic annulus with suturing, and optionally a threaded support ring, to maintain the conduit centrally within the valve, preventing thrombus formation and ensuring proper valve closure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Volume of moving object

If a small diameter conduit is used to pass through the aortic valve, then the pump size can be reduced for less invasive implantation, but the conduit cannot be securely centered in the valve orifice and may touch the valve annulus creating thrombus risk

Engineering Contradiction:
Improvepump sizeVSAvoidconduit positioning stability
Core Design Contradiction:
Volume of moving objectVSReliability

Solution Approach 1:

A support ring is introduced as an intermediary device between the conduit and the aortic valve annulus. The support ring receives the conduit and provides a stable platform that prevents the conduit from touching the valve annulus, thereby eliminating the crevice where thrombus could form while allowing the use of small diameter conduits

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The support ring extends radially outward from the conduit in a direction perpendicular to the conduit's longitudinal axis. This radial extension creates a larger footprint that engages with the valve annulus to provide stabilization, effectively adding a dimensional element that prevents conduit displacement without increasing the conduit's longitudinal dimensions

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Ease of manufacture

If the conduit is positioned off-center in the valve orifice, then implantation may be simpler, but thrombus forms in the crevice between the conduit and valve annulus which can break free as thromboembolism

Engineering Contradiction:
Improveimplantation simplicityVSAvoidthrombus formation
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The support ring acts as a mediator between the conduit and the valve annulus, preventing direct contact between the conduit and the annular tissue. This eliminates the crevice space where blood could stagnate and form thrombus, while the support ring itself maintains a smooth surface that does not promote thrombus formation

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The support ring is pre-formed with a configuration that automatically centers the conduit within the valve orifice upon implantation. The radial extensions of the support ring engage with the valve annulus in advance to establish proper conduit positioning before blood flow begins, preventing thrombus formation from the outset

Inventive Principle:
Principle #10Preliminary action

3Adaptability or versatility

If the conduit moves within the valve orifice, then the device may adapt to valve motion, but existing conduit positioning allows valve wear and thrombus development

Engineering Contradiction:
Improveconduit movement flexibilityVSAvoidvalve lifespan
Core Design Contradiction:
Adaptability or versatilityVSDuration of action of stationary object

Solution Approach 1:

The support ring serves as a stable intermediary structure that is anchored to the valve annulus and supports the conduit. This separation allows the conduit to be held in a fixed, optimized position relative to the valve orifice, preventing friction between the conduit and valve tissue that would cause wear and extend valve lifespan

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The support ring's radial extensions provide a stable platform that constrains the conduit in the radial dimension while allowing minimal movement in other dimensions. This dimensional control ensures the conduit remains centered in the valve orifice during valve cycling, preventing wear and thrombus formation over millions of cycles

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

Data Source

PatentUS11383075B2Support stent for transvalvular conduit
Publication Date: 2022.07.12 JARVIK ROBERT
  • US11383075B2 patent drawing
  • US11383075B2 patent drawing
  • US11383075B2 patent drawing

AI summary

Miniature axial flow pumps are implanted inside the heart or major arteries to provide hemodynamic support. These pumps commonly utilize tubular blood conduit tubes to transport blood across the aortic valve. The valve leaflets themselves are very thin and flexible, and will seal against the conduit if it is centered within the valve orifice. The present invention provides a conduit support device that retains the conduit centered within the annulus of the natural heart valve. A leaflet valve stent may be combined with a conduit support device comprised of a ring supported by posts attached to the valve stent ring. A blood pump may be attached to the center of a transvalvular support stent, for optimal fixation of the pump with relation to a trileaflet or bi-leaflet tissue or polymer valve.