Flow Modulator Stent for Portal Hypertension Treatment

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Solution Overview

Problem

Current technologies fail to effectively address the challenges of improving blood flow to prevent diseases, treat conditions like heart failure and hypertension, and enhance kidney functionality, while also avoiding complications such as blood clots and liver bypass issues.

Innovation Solution

The development of acute and chronic devices and methods that create pressure differences and induce fluid entrainment in body lumens, specifically using a stent with an upstream nozzle and downstream diffuser to enhance blood flow and reduce pressure, thereby improving organ function and treating related disorders.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stress or pressure

If TIPS creates an artificial channel to bypass liver circulation, then portal hypertension is treated, but blood flow to the liver is reduced causing complications

Engineering Contradiction:

Improveportal pressureVSAvoidliver function

Core Design Contradiction:

Stress or pressureVSReliability

Solution Approach 1:

The patent introduces a flow modulator device as an intermediary component in the portal vein that redirects blood flow through the TIPS channel while maintaining some flow to the liver. This mediator device allows controlled diversion of blood flow to reduce portal pressure while preserving essential hepatic perfusion, thus treating portal hypertension without completely bypassing liver circulation

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The flow modulator device changes the flow distribution parameter by creating a pressure differential that directs a portion of blood flow through the TIPS channel while maintaining adequate flow to the liver. By adjusting the device geometry and positioning, the blood flow distribution can be optimized to balance portal pressure reduction with liver function preservation

Inventive Principle:

Principle #35Parameter changes

2Stress or pressure

If conventional TIPS diverts blood flow away from the liver, then portal hypertension is relieved, but liver functionality deteriorates

Engineering Contradiction:

Improveportal pressureVSAvoidliver function

Core Design Contradiction:

Stress or pressureVSProductivity

Solution Approach 1:

Instead of completely diverting blood flow through TIPS, the flow modulator device implements partial diversion by allowing a controlled portion of blood to bypass the liver while maintaining sufficient flow for liver function. This partial action approach relieves portal hypertension to an therapeutic extent without exceeding the threshold that would cause liver dysfunction

Inventive Principle:

Principle #16Partial or excessive action

3Reliability

If no flow modification device is used, then blood flow remains natural, but conditions like heart failure and hypertension cannot be effectively treated

Engineering Contradiction:

Improvetreatment efficacyVSAvoidflow modification device

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The flow modulator device utilizes the natural hemodynamic forces (pressure gradients and flow velocities) present in the body to automatically redirect blood flow without requiring external power sources or active control systems. The device self-regulates based on physiological conditions, simplifying the overall system while maintaining treatment efficacy for heart failure and hypertension

Inventive Principle:

Principle #25Self-service

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

These devices and methods effectively improve blood flow and reduce pressure, leading to enhanced organ functionality, improved treatment outcomes for conditions like heart failure and hypertension, and reduced risk of complications such as blood clots and liver issues.

Implementation Method 1

creating pressure differences and/or fluid entrainment

Methodology Applied

Scientific EffectPressure differential: Pressure Gradient

Implementation Method 2

accelerates a fluid stream passing through the upstream component towards the downstream component to generate a low pressure region in a vicinity of the entrainment region that entrains additional fluid into the fluid stream

Methodology Applied

Scientific EffectFluid entrainment: Entrainment

Implementation Method 3

reduce pressure upstream of the flow modulator device within the body lumen

Methodology Applied

Scientific EffectPressure reduction: Depressurisation

Data Source

PatentUS20250025284A1Devices for acute and chronic flow modification in body lumens and methods of use thereof

Publication Date: 2025.01.23 NEPHRONYX LTD

AI summary

The acute and chronic devices and methods described herein include a body lumen fluid flow modulator including an upstream flow accelerator and a downstream flow decelerator. The fluid flow modulator preferably includes one or more openings that define a gap/entrainment region that provides a pathway through which additional fluid from a branch lumen(s) is entrained into the fluid stream flowing from the upstream flow accelerator to the downstream flow decelerator. The upstream flow accelerator may include a radially expandable portion that expands responsive to upstream pressures within the body lumen to accommodate a wider range of fluid flow rates. Additionally, the flow modulator may include a plurality of collapsible fixation elements for securing the flow modulator within the body lumen.