Cardiac Chamber Prosthesis with Elastic Membrane for Physiological Flow

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Solution Overview

Problem

Current cardiac assistance systems, such as axial flow ventricular assist devices, fail to produce a physiological flow that conforms to the sinus rhythm, leading to issues like backflow, excessive suction, and damage to heart tissue, and are invasive and non-selective, affecting the natural heart morphology and function.

Innovation Solution

A cardiac chamber prosthesis with an inner and outer elastic membrane, featuring adjustable apertures and connection elements, that mimics the physiological behavior of cardiac chambers by varying volume in response to fluid pressure, allowing for pulsatile and adaptable flow, and can be implanted in various cardiac chambers with reduced size and weight, requiring less energy and being easier to manufacture.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If axial flow ventricular assist devices are used, then continuous blood flow is provided, but physiological flow conforming to sinus rhythm is not achieved, causing backflow and excessive suction

Engineering Contradiction:
Improvephysiological flow conformityVSAvoidbackflow and excessive suction
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent employs periodic action by utilizing the natural sinus rhythm of the heart to periodically inflate and deflate the elastic membrane within the cardiac chamber prosthesis. This periodic volume variation creates pulsatile flow that conforms to physiological cardiac cycles, eliminating the continuous non-pulsatile flow of axial flow devices that causes backflow and excessive suction. The elastic membrane inflates during diastole to fill the chamber and deflates during systole to eject blood, matching natural heart rhythm.

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The patent applies parameter changes by varying the volume of the elastic membrane in response to fluid pressure changes throughout the cardiac cycle. The membrane transitions between inflated and deflated states based on pressure differential between atrium and ventricle, dynamically adjusting flow parameters to match physiological conditions. This pressure-responsive volume change eliminates the fixed continuous flow of axial flow devices.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If current cardiac assistance systems are implemented, then heart failure is treated, but invasive procedures and tissue damage occur

Engineering Contradiction:
Improvetherapeutic effectivenessVSAvoidinvasive procedures and tissue damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The cardiac chamber prosthesis applies self-service by utilizing the heart's own sinus rhythm and natural pressure differentials to drive the inflation and deflation of the elastic membrane. No external power source or complex control system is needed - the device automatically responds to physiological pressure changes, eliminating the need for invasive external connections and reducing tissue damage associated with current assist devices.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The elastic membrane acts as an intermediary between the natural heart function and the prosthetic chamber. It translates natural pressure differentials into volumetric changes that restore physiological flow patterns, serving as a bridge that eliminates the need for direct mechanical intervention in the heart tissue required by current assist devices.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Weight of moving object

If reduced size and weight prosthesis are designed, then ease of implantation and energy consumption are improved, but manufacturing complexity may increase

Engineering Contradiction:
Improveprosthesis weightVSAvoidmanufacturing simplicity
Core Design Contradiction:
Weight of moving objectVSEase of manufacture

Solution Approach 1:

The patent employs flexible shells and thin films by using an elastic membrane as the core component of the prosthesis. This thin-film approach dramatically reduces the weight and size of the device compared to rigid mechanical pumps, while the membrane can be manufactured using established techniques for elastic materials. The flexible nature of the membrane allows it to be folded or compressed for minimal invasive implantation.

Inventive Principle:
Principle #30Flexible shells and thin films

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 cardiac chamber prosthesis and associated system provide a physiological flow that adapts to the cardiac cycle, reducing invasive procedures, minimizing tissue damage, and improving therapeutic options for severe heart failure patients with better hemodynamic characteristics and reduced energy consumption.

Implementation Method 1

an inner elastic membrane, having an inner surface delimiting an elastically variable volume... the inner elastic membrane and the reference support elastic membrane structure delimit a primary interspace between them that is configured to receive a fluid with varying amount and/or pressure so as to dynamically modify a volume of the primary interspace

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentEP4010043B1Cardiac chamber prosthesis and related cardiac assistance system
Publication Date: 2023.08.30 ROMANO SRL
  • EP4010043B1 patent drawingFigure 1(a)~1(b)
  • EP4010043B1 patent drawingFigure 2~5(b)
  • EP4010043B1 patent drawingFigure 3(a)~3(b)

AI summary

Cardiac chamber prosthesis configured to be implanted in a cardiac chamber (10; 20; 30; 40) comprising a native outlet valve (50; 60; 70; 80) and at least one inlet aperture (50; 70) selected from the group comprising a native inlet valve (50; 70) and one or more outlet mouths of venae cavae or pulmonary veins (120; 125; 130), wherein the cardiac chamber prosthesis comprises: an inner elastic membrane (250; 255; 260; 650; 750; 850), a reference support elastic membrane structure (200; 205, 225, 290A; 600; 700; 800) comprising or consisting of an outer elastic membrane (200; 205; 600; 700; 800) provided with a plurality of clips (210) configured to grip an inner wall (45) of the cardiac chamber (10; 20; 30; 40), wherein the elastic inner and outer membranes (250, 200; 255, 205; 260, 200; 650, 600; 750, 700; 850, 800) form an outlet border (285; 675; 785; 885) configured to surround and be sutured on the native outlet valve (50; 60; 70; 80) and at least one inlet border (275; 685; 775; 875A, 875B) configured to surround and be sutured on said at least one inlet aperture (50; 70), wherein the inner elastic membrane (250; 255; 260; 650; 750; 850) and the reference support elastic membrane structure (200; 205, 225, 290A; 600; 700; 800) are connected to each other by means of a plurality of primary variable connection elements (290; 290B), whereby the inner elastic membrane (250; 255; 260; 650; 750; 850) and the reference support elastic membrane structure (200; 205, 225, 290A; 600; 700; 800) delimit a primary interspace (230; 230B; 630; 730; 830) between them that is configured to receive a fluid with varying amount and/or pressure so as to dynamically modify a volume of the primary interspace (230; 230B; 630; 730; 830) and said elastically variable volume delimited by the inner surface (254; 654; 754; 854) of the inner elastic membrane (250; 255; 260; 650; 750; 850).