Covered Flow-Regulation Stent for Splanchnic Venous Flow Control
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Solution Overview
Problem
Patients with heart failure experience venous congestion and pulmonary capillary wedge pressure due to fluid redistribution from the splanchnic venous reservoir to the inferior vena cava, which is exacerbated during periods of elevated sympathetic tone, leading to pulmonary congestion and potential acute decompensation.
Innovation Solution
Deployment of a collapsible stent with a variable-diameter bladder or covering within the hepatic veins and/or inferior vena cava to regulate blood flow, using a transcatheter approach, which can be adjusted to modulate blood flow restriction based on the patient's condition.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a stent with covering is deployed to limit blood flow from splanchnic venous reservoir to inferior vena cava, then venous congestion is reduced and pressure gradients increase, but device complexity increases
Solution Approach 1:
The stent is divided into multiple segments or sections along its length, with each segment capable of independent adjustment. This segmentation allows the device to regulate blood flow at different levels of the inferior vena cava, providing more precise control over venous return while maintaining a manageable structural complexity through modular design
Solution Approach 2:
The stent incorporates adjustable components that allow dynamic modification of the blood flow restriction level. The covering can be adjusted to vary the degree of occlusion, enabling the device to adapt to changing patient conditions and optimize therapy effectiveness without requiring a completely different device design
2Adaptability or versatility
If a collapsible stent with variable-diameter bladder is used to regulate blood flow, then adaptability to patient condition improves, but manufacturing precision requirements increase
Solution Approach 1:
The bladder is designed with variable diameter along its length, allowing different sections to provide different degrees of compliance and flow restriction. This parameter variation enables the device to adapt to different anatomical configurations and patient conditions, while the manufacturing process is optimized to achieve the required precision through controlled forming techniques
Solution Approach 2:
The bladder is constructed as a flexible, thin-walled structure that can collapse and expand in response to pressure changes and adjustment mechanisms. This flexible shell design provides the necessary adaptability for flow modulation while being amenable to manufacturing through techniques such as extrusion, molding, or laminating pre-formed membranes
Data Source
AI summary
A cardiac implant includes a frame forming an inner lumen and sized for delivery into a blood vessel and a covering extending at least partially along the frame to at least partially restrict lateral blood flow from one or more branching blood vessels into the blood vessel. The covering forms one or more folds at or near a distal end of the frame.