Bronchial Isolation Valve with Pressure-Actuated Lips
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Solution Overview
Problem
Pulmonary diseases like COPD reduce lung elasticity, leading to inefficient air expulsion and oxygen exchange due to hyper-expanded, less elastic tissue, which existing flow control devices have not adequately addressed in terms of design and functionality.
Innovation Solution
A flow control device with a valve element comprising lips and inclined flaps that transitions between closed and open configurations based on airflow direction, specifically opening during exhalation to regulate airflow and potentially induce lung region collapse, designed for implantation in bronchial passageways to isolate diseased lung regions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing flow control devices are implanted in airways to regulate fluid flow to diseased lung regions, then the volume of diseased lung tissue can be reduced, but the devices are still in development stages and lack adequate design and functionality
Solution Approach 1:
The valve element is designed to dynamically transition between closed and open configurations in response to respiratory flow conditions. During inspiration, the valve remains closed to prevent air entry into the isolated lung region. During expiration, when flow reaches a threshold (e.g., 12-24 inches H2O), the valve opens to allow air expulsion. This dynamic behavior enables the device to automatically adapt to breathing patterns without complex control systems.
Solution Approach 2:
The device utilizes changes in flow parameters (pressure differential, flow rate) to trigger valve opening and closing. The lips are configured to remain closed at normal breathing pressures but open when exposed to expiratory flow in the range of 12-24 inches H2O. This parameter-based control simplifies the device design while ensuring reliable operation across different respiratory conditions.
2Ease of operation
If the valve element remains closed at normal breathing pressures, then air flow is blocked in the inspiratory direction, but the valve must open during exhalation to permit air flow in the expiratory direction
Solution Approach 1:
The valve element operates autonomously based on the physical conditions of respiratory flow. The lips are configured to automatically close at normal breathing pressures and automatically open when expiratory flow reaches the threshold range of 12-24 inches H2O. No external control mechanism is needed; the device uses the respiratory flow itself to actuate the valve, ensuring both ease of operation and reliable flow regulation.
Solution Approach 2:
The valve utilizes pneumatic pressure differentials created during respiratory cycles to control its state. During inspiration, negative pressure keeps the lips closed. During forced expiration, when positive pressure reaches the threshold (12-24 inches H2O), the pressure differential forces the lips open. This pneumatic actuation ensures automatic operation while maintaining accurate flow regulation based on physiological conditions.
3Reliability
If lips are configured to be parallel and contacted, then the valve remains closed during no air flow and inspiratory flow, but may require specific pressure to open during exhalation
Solution Approach 1:
The lips are configured with asymmetric geometry where they are parallel and contacted in the closed position, creating a tight seal during no flow and inspiration. The asymmetric shape allows the lips to maintain contact under low pressure differential but enables them to separate when sufficient expiratory pressure (12-24 inches H2O) is applied. This asymmetric design achieves both reliable sealing and controlled opening based on flow direction and pressure.
Solution Approach 2:
The lips feature curved surfaces that enhance sealing when parallel and contacted during the closed state. The curvature allows the lips to conform to each other and maintain intimate contact under low pressure, ensuring reliable sealing. During expiration, when pressure differential increases to the threshold range, the curved surfaces allow the lips to separate smoothly, enabling the valve to open without requiring excessive force.
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 regulates airflow to improve exhalation efficiency and reduce the volume of hyper-expanded lung tissue, enhancing breathing mechanics and oxygen exchange by isolating the diseased region, thus alleviating symptoms of pulmonary diseases.
Implementation Method 1
The first and second lips are configured to be in the closed configuration when exposed to no air flow, air flow in the inspiratory direction, and air flow in the expiratory direction at normal breathing pressures. The first and second lips may be additionally configured to be in the open configuration when exposed to air flow in the expiratory direction in the range of 12-24 inches H2O.
Data Source
AI summary
Disclosed are methods and devices for regulating fluid flow to and from a region of a patient's lung, such as to achieve a desired fluid flow dynamic to a lung region during respiration and/or to induce collapse in one or more lung regions. Pursuant to an exemplary procedure, an identified region of the lung is targeted for treatment. The targeted lung region is then bronchially isolated to regulate airflow into and/or out of the targeted lung region through one or more bronchial passageways that feed air to the targeted lung region. An exemplary flow control device is configured to block fluid flow in the inspiratory direction and the expiratory direction at normal breathing pressures and allow fluid flow in the expiratory direction at higher than normal breathing pressures.