Superior Vena Cava Flow-Restricting Implant for Congestion Control

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Solution Overview

Problem

Congestive heart failure (CHF) occurs when the heart is unable to maintain required blood flow, leading to blood accumulation and associated complications such as leg edema, deep vein thrombosis, renal and hepatic congestion, and subsequent kidney and liver failure.

Innovation Solution

A method and device for controlling blood flow rate by implanting a blood flow affecting implant in the superior vena cava (SVC) with a constricted orifice to reduce blood flow to the right atrium, using adjustable or fixed orifices to manage pressure gradients and induce tissue ingrowth for stenosis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If blood flow to the right atrium is increased to improve cardiac output, then cardiac function is improved, but blood accumulation in the heart increases causing congestion and complications

Engineering Contradiction:

Improvecardiac outputVSAvoidblood accumulation and congestion

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces an intermediary device (flow restriction implant) placed in the superior vena cava to mediate blood flow control. This implant constricts the SVC lumen to restrict blood flow into the right atrium, preventing blood accumulation while maintaining adequate cardiac output through controlled flow regulation rather than complete blockage.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent applies parameter changes by adjusting the degree of flow restriction through varying orifice sizes and positions in the implant. By controlling the cross-sectional area of the orifice (e.g., 50% or less of SVC cross-sectional area), the system regulates blood flow rate to achieve the optimal balance between preventing congestion and maintaining cardiac output.

Inventive Principle:

Principle #35Parameter changes

2Object-affected harmful factors

If flow in the superior vena cava is restricted to reduce blood accumulation, then congestion and complications are reduced, but pressure gradient increases

Engineering Contradiction:

Improvecongestion and complicationsVSAvoidpressure gradient

Core Design Contradiction:

Object-affected harmful factorsVSStress or pressure

Solution Approach 1:

The patent incorporates feedback mechanisms through pressure sensing capabilities that monitor the pressure gradient across the implant. This feedback allows for real-time adjustment of flow restriction intensity, ensuring the pressure gradient remains within safe limits while still achieving adequate blood flow reduction to prevent congestion.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The patent employs dynamic flow control through adjustable orifices that can change their opening size based on operational requirements. The orifice can be configured to provide variable flow restriction, allowing the system to adapt to changing hemodynamic conditions and maintain appropriate pressure gradients while preventing blood accumulation.

Inventive Principle:

Principle #15Dynamics

3Productivity

If an implant is implanted in the superior vena cava to control blood flow, then blood flow rate is regulated, but device complexity is introduced

Engineering Contradiction:

Improveblood flow rate controlVSAvoidimplant structure

Core Design Contradiction:

ProductivityVSDevice complexity

Solution Approach 1:

The patent divides the flow control function into segmented components: an outer support structure, an inner constraining element with the orifice, and positioning mechanisms. This segmentation allows each component to perform its specific function independently, simplifying the overall implant design while achieving effective blood flow rate control through the coordinated action of these modular elements.

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

Reduces blood accumulation in the heart, minimizing leg edema and preventing complications like deep vein thrombosis and liver failure by regulating blood flow effectively.

Implementation Method 1

the implant comprises an orifice enclosing a constricted lumen having an orifice cross-sectional area, so as to reduce flow rate of blood from the superior vena to the right atrium flowable through the orifice

Methodology Applied

Scientific EffectFluid flow restriction through constricted orifice: Pressure Gradient

Implementation Method 2

measuring a pressure difference between a first measurement location in the superior vena cava, provided proximally adjacent to the target location, and a second measurement location in the right atrium

Methodology Applied

Scientific EffectPressure gradient: Pressure Gradient

Data Source

PatentUS20250331861A1Controlling rate of blood flow

Publication Date: 2025.10.30 TOTAL MEDICAL INC

AI summary

Blood flow affecting implant and implantation thereof in superior vena cava, optionally including disintegration of endothelium layer and inducing tissue ingrowth within implant. Implant includes elongated body with optional tubular inner layer forming orifice, shapeable to final orifice diameter for restricting blood flowing therethrough to chosen average flow rate; and/or tubular outer layer provided coaxially around inner layer. Outer layer is formed of second material provided in elastically deformable state for facilitating elastic radial self-expanding from collapsed diameter up to relaxed maximal expanded diameter greater than diameter of inner wall portion of superior vena cava. Inner layer is formed of first material, in plastically or elastically deformable state.