Variable Orifice Shunt for Pulmonary Congestion Control
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Solution Overview
Problem
Pulmonary hypertension leads to increased blood pressure in the lungs, causing the heart to work harder and recruit blood from the splanchnic system, resulting in pulmonary congestion and hospital admissions, with existing treatments failing to effectively manage right ventricular afterload and pulmonary congestion.
Innovation Solution
The use of adjustable orifice devices, such as covered stents and shunt devices, that regulate blood flow through variable orifices using shape memory alloys and physiological feedback, allowing for dynamic adjustment of cross-sectional area to manage blood flow and reduce recruitment from the splanchnic system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If blood flow is increased to meet cardiac demand during pulmonary hypertension, then oxygen delivery is improved, but pulmonary congestion worsens
Solution Approach 1:
The patent employs a variable orifice constrictor that can dynamically adjust the cross-sectional area of the inferior vena cava lumen in response to physiological conditions. The device transitions from a fixed structure to a dynamic one that can constrict or expand based on real-time blood volume and pressure feedback, allowing the system to adapt blood flow levels to prevent pulmonary congestion while meeting cardiac demand.
Solution Approach 2:
The system incorporates physiological feedback mechanisms where sensors monitor blood volume, pressure, and flow rates, and this information feeds back to the control system that adjusts the variable orifice constrictor accordingly. This closed-loop feedback enables the device to respond to changing physiological conditions and automatically regulate blood flow to prevent pulmonary congestion.
2Object-affected harmful factors
If the cross-sectional area of the inferior vena cava is reduced to decrease blood flow, then pulmonary congestion is reduced, but cardiac output may be compromised
Solution Approach 1:
The variable orifice constrictor provides dynamic control of the inferior vena cava lumen area, allowing the system to adjust blood flow levels in real-time. Rather than a fixed reduction, the device can modulate the cross-sectional area based on physiological needs, ensuring pulmonary congestion is prevented while maintaining adequate cardiac output during periods of increased demand.
Solution Approach 2:
The device changes the physical parameter of the lumen cross-sectional area in a controlled and variable manner. By adjusting this geometric parameter dynamically rather than fixedly, the system can optimize blood flow conditions to reduce pulmonary congestion while preserving cardiac output function.
3Ease of manufacture
If a fixed orifice device is used to regulate blood flow, then manufacturing is simplified, but adaptability to varying physiological conditions is reduced
Solution Approach 1:
The patent transforms a static fixed-orifice design into a dynamic variable-orifice system. The variable orifice constrictor incorporates actuation mechanisms and control systems that enable the device to change its geometry and flow characteristics in response to physiological conditions, significantly enhancing adaptability while maintaining manufacturing feasibility through modular design approaches.
Solution Approach 2:
The variable orifice constrictor is designed to perform multiple functions: it can regulate blood flow, respond to physiological feedback, adapt to varying cardiac demands, and prevent pulmonary congestion. This multi-functionality makes the device universally applicable to different physiological states and conditions, overcoming the limitation of fixed-orifice devices.
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 effectively reduce pulmonary congestion and right ventricular afterload by controlling blood flow, minimizing heart workload, and reducing hospital readmissions by dynamically responding to physiological conditions.
Implementation Method 1
Shape memory alloys, such as Nitinol, exhibit martensitic transformation when cooled below the martensitic transformation start (Ms) temperature
Implementation Method 2
An implantable medical device of shape memory alloy exhibits superelastic, self-expanding property when the austenitic reverse transformation finish (Af) temperature is at or below the body temperature
Implementation Method 3
the control system is configured to heat the actuating element to constrict the actuating element
Data Source
AI summary
Described herein are shunt devices configured to achieve a targeted reduction in peak systolic pressure by percutaneously shunting from the superior vena cava to the right pulmonary artery. The shunt devices include a check valve with a cracking pressure to preserve a minimal transpulmonary pressure. Also described herein are flow diversion devices placed between pulmonary circulation vessels and venous vessels. The disclosed flow diversion devices are physiologically responsive through an adjustable orifice that can be adjusted after initial implantation through a non-invasive or minimally invasive procedure. Disclosed herein are flow control systems that are configured to reduce recruitment of blood from the splanchnic system. The flow control systems include a variable orifice constrictor (e.g., a covered stent) and a controller that delivers energy to the constrictor to reduce the cross-sectional area of the lumen through the variable orifice constrictor.