Body Lumen Flow Modulator for Renal Pressure and Flow Control
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Solution Overview
Problem
Existing therapies for conditions such as heart failure, hypertension, and kidney disease fail to effectively improve blood flow and kidney functionality without causing complications, and there is a need for devices that can modulate fluid flow within body lumens to treat these conditions.
Innovation Solution
Devices and methods are provided to create pressure differences and fluid entrainment at lumens, using upstream and downstream components to accelerate and decelerate fluid flow, thereby improving blood flow and reducing pressure in renal arteries and veins to enhance kidney function and treat heart failure and hypertension.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stress or pressure
If conventional therapies (diuretics, vasoconstrictors) are used to treat heart failure and hypertension, then blood pressure and fluid volume are controlled, but blood flow to kidneys is reduced and kidney functionality deteriorates
Solution Approach 1:
The device segments the vascular system by placing a flow modulator at a specific location (e.g., renal artery or renal vein) to create localized flow modification. This allows independent control of blood flow to the kidney while maintaining systemic blood pressure control, thereby improving kidney function without compromising overall hypertension management.
Solution Approach 2:
The flow modulator creates localized changes in blood flow characteristics at its position within the vascular system. By adjusting the geometry and positioning of the modulator, the device can locally increase blood flow to the kidney while the rest of the vascular system maintains normal pressure-regulating function.
2Quantity of substance
If diuretics are used to reduce fluid volume in heart failure, then blood pressure is controlled, but blood flow to kidneys is reduced and kidney function deteriorates
Solution Approach 1:
The flow modulator acts as an intermediary device between the systemic circulation and the renal circulation. It can selectively direct blood flow to the kidney while allowing the rest of the body to lose fluid volume through diuretics, thus protecting kidney function during volume reduction therapy.
Solution Approach 2:
The device segments the circulatory system into systemic and renal components, allowing independent management of fluid volume in the systemic circulation while maintaining adequate blood flow to the kidney through the flow modulator.
3Stress or pressure
If vasoconstrictors are used to raise blood pressure in heart failure, then perfusion is maintained, but blood flow to kidneys is reduced and kidney function deteriorates
Solution Approach 1:
The flow modulator segments the vascular system to allow systemic vasoconstriction for blood pressure control while maintaining dedicated blood flow to the kidney. The device creates a protected pathway for renal perfusion that is independent of systemic vasoconstrictor effects.
Solution Approach 2:
The device creates localized vasodilation or flow enhancement at the renal artery or renal vein position, counteracting the systemic vasoconstrictor effect locally in the kidney bed while maintaining systemic blood pressure control.
4Productivity
If a flow modulator device is deployed to improve blood flow to kidneys, then kidney function is improved, but device complexity and potential complications increase
Solution Approach 1:
The invention extracts the essential function of flow modulation into a simple, focused device structure. By removing unnecessary complexity and focusing on a single functional element (the flow modulator geometry), the device achieves effective blood flow control with minimal structural complexity.
Solution Approach 2:
The flow modulator can be designed as a simple, potentially disposable device that is inserted and then removed, avoiding the need for complex long-term implanted devices. This approach reduces device complexity and eliminates the need for sophisticated retrieval mechanisms.
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 devices efficiently improve kidney function by increasing blood flow with minimal energy loss, reducing the need for diuretics and other therapies, and preventing complications like strokes by diverting emboli, thus treating heart failure and hypertension effectively.
Implementation Method 1
accelerate a fluid stream passing through the upstream component towards the downstream component to generate a low pressure region
Implementation Method 2
entrainment of fluid at lumens that branch off from other lumens for enhancing or modifying fluid flow
Implementation Method 3
downstream component having an entry, an exit, and a cross-sectional flow area that diverges from the entry towards the exit
Data Source
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. Delivery devices including a sheath and inner assembly also are provided for delivering the flow modulator to the body lumen. The delivery device may maintain the flow modulator in its collapsed, delivery state upon retraction of the sheath for ease of readjustment within the body lumen prior to full deployment of the flow modulator within the body lumen.


