Indwelling Aortic Flow Restricting Device for Heart Failure Fluid Management

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Solution Overview

Problem

Patients with heart failure often experience excess fluid buildup, leading to increased pressure on the heart, which current treatments, such as pharmaceuticals, may not effectively address due to drug resistance or compliance issues, necessitating alternative methods to manage fluid accumulation and blood pressure.

Innovation Solution

An indwelling medical device is implanted in the aorta or vena cava, featuring a catheter with a vessel opposing member and a flow altering element, such as a balloon or stent, to restrict blood flow, thereby inducing a physiologically mediated therapeutic response and reducing fluid buildup by increasing kidney perfusion.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If diuretics are used to treat excess fluid buildup, then fluid removal is achieved, but drug resistance and compliance issues occur

Engineering Contradiction:
Improvefluid removalVSAvoidtreatment compliance
Core Design Contradiction:
Quantity of substanceVSReliability

Solution Approach 1:

The patent replaces the pharmaceutical chemical system with a mechanical device system. The indwelling device with flow altering elements mechanically restricts blood flow through the aorta or vena cava, inducing a physiological diuresis response without requiring patient compliance with medication. This substitutes chemical therapy with a mechanical-physiological approach.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces an intermediary mechanism - the indwelling device with flow altering elements - that mediates between the external treatment system and the internal physiological response. The device creates controlled flow restriction that triggers the body's natural diuresis mechanism, serving as an intermediary that bypasses the need for direct pharmaceutical intervention.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If implantable devices are used to influence renal function, then pharmaceutical compliance issues are avoided, but device complexity increases

Engineering Contradiction:
Improvetreatment complianceVSAvoiddevice structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The device is segmented into distinct functional components: a catheter for delivery, a vessel opposing member portion for anchoring and flow direction, and flow altering elements for creating controlled restriction. This segmentation allows each component to perform its specific function efficiently while simplifying the overall design and deployment process.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The indwelling device structure serves multiple functions simultaneously: it provides mechanical support to maintain vessel patency, creates controlled flow restriction through the flow altering elements, and induces physiological diuresis. This multi-functionality reduces the need for separate devices and simplifies the overall treatment system.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Quantity of substance

If blood flow is restricted to induce therapeutic response, then fluid removal is enhanced, but blood pressure may be affected

Engineering Contradiction:
Improvefluid removalVSAvoidblood pressure
Core Design Contradiction:
Quantity of substanceVSStress or pressure

Solution Approach 1:

The flow restriction is applied locally at specific segments of the aorta or vena cava rather than systemically throughout the entire circulatory system. The flow altering elements create controlled restriction zones that specifically target renal perfusion and diuresis while minimizing impact on overall blood pressure through precise spatial localization of the effect.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The device applies partial flow restriction rather than complete occlusion, creating a controlled degree of flow limitation that is sufficient to induce diuresis without causing excessive blood pressure changes. The flow altering elements are designed to create optimal restriction levels that balance fluid removal efficacy with hemodynamic stability.

Inventive Principle:
Principle #16Partial or excessive 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 device effectively reduces fluid accumulation and improves cardiac function by enhancing renal perfusion and urine production, while also lowering blood pressure and sympathetic nervous system activation, as demonstrated in animal studies.

Implementation Method 1

configured to alter the blood flow through the lumen to restrict blood flow in the vessel and induce a physiologically mediated therapeutic response in the patient

Methodology Applied
Scientific EffectHemodynamic response: Pressure Gradient

Implementation Method 2

alter blood flow into one or both kidneys of the patient... enhancing renal perfusion and urine production

Methodology Applied
Scientific EffectRenal perfusion: Pressure Gradient

Data Source

PatentUS20220202557A1Method and device for acute treatment of fluid overload in patients with heart failure
Publication Date: 2022.06.30 WL GORE & ASSOC INC
  • US20220202557A1 patent drawing
  • US20220202557A1 patent drawing
  • US20220202557A1 patent drawing

AI summary

Various aspects of the present disclosure are directed toward apparatuses, systems and methods that include arranging an acute alteration of blood flow in, for example, heart failure patients.