Positive end expiratory pressure exhalation valve

Abstract

The invention belongs to the technical field of exhalation valves, and discloses an end-expiratory positive pressure exhalation valve which comprises a patch, an adjustable micro valve, a hole, a flow velocity sensor, a pressure sensor and a controller. An adjustable micro valve is arranged in the patch; a hole is formed in the adjustable micro valve; a controller is fixed at the left end of the adjustable micro valve; and a flow velocity sensor and a pressure sensor are fixed below the controller. The invention provides an airflow sensor and a controller, and when the airflow of a patient drops due to sleep apnea, the airflow sensor and the controller can automatically adjust, reduce the valve, increase the provided pressure and open the airway. When airflow is detected to be stable for a period of time, the valve is expanded, and the pressure is reduced to ensure comfort. The positive end-expiratory pressure device can provide adjustable and large positive end-expiratory pressure, and a treatment mode with high comfort and good compliance is provided for a patient.

Description

Technical Field

[0001] The present invention belongs to the technical field of expiratory valves, and particularly relates to an end-expiratory positive pressure expiratory valve. Background Art

[0002] Obstructive sleep apnea (OSA) is a disease characterized by repeated collapse of the upper airway at night. There are 170 million patients in China. Providing a positive pressure to the airway to maintain the patency of the upper airway is one of the treatment methods. Currently, there are patches attached to the nostrils, which can provide a certain positive pressure, but the positive pressure provided by the patches is too small and only suitable for mild OSA patients. Therefore, the current scope of use is relatively narrow.

[0003] The prior art is a single nostril patch with an opening slightly smaller than that of ordinary people's nostrils, providing a certain resistance during exhalation of the patient, thereby providing a certain positive pressure to the airway. However, with this method, the positive pressure provided varies among different people, the pressure is not adjustable and the pressure is small. Currently, it is only suitable for mild sleep apnea patients.

[0004] Through the above analysis, the problems and defects of the prior art are as follows:

[0005] (1) The positive pressure that can be provided to the airway is small. The pressure is not adjustable. Due to the non-adjustability of the pressure, the treatment effects vary among different people.

[0006] (2) The existing first-line treatment method for OSA, the ventilator, has the characteristic of poor compliance. The second-line treatment method, surgery, is an invasive operation and the effect is not ideal.

[0007] (3) The existing nasal patch type expiratory positive pressure patch on the market provides a small and non-adjustable expiratory positive pressure, and is only suitable for mild OSA patients. Summary of the Invention

[0008] Aiming at the problems existing in the prior art, the present invention provides an end-expiratory positive pressure expiratory valve.

[0009] The present invention is implemented as follows. An end-expiratory positive pressure expiratory valve includes:

[0010] A patch, an adjustable micro-valve, a hole, a flow rate sensor, a pressure sensor, and a controller;

[0011] An adjustable micro-valve is arranged inside the patch; a hole is opened inside the adjustable micro-valve; a controller is fixed at the left end of the adjustable micro-valve; a flow rate sensor and a pressure sensor are fixed below the controller.

[0012] Another object of the present invention is to provide a control method for an end-expiratory positive pressure expiratory valve:

[0013] Step 1, before going to bed, attach the present invention to the nostril opening through the patch;

[0014] Step 2: The patient falls asleep, and the flow rate sensor monitors the flow rate. If the flow rate drops by more than 30% compared to the flow rate in the previous three respiratory cycles and remains for 10 s, the valve is adjusted through the sensor, and the generated positive end-expiratory pressure increases.

[0015] Step 3: If the airflow does not drop for 2 minutes, the valve is adjusted through the sensor, and the generated positive end-expiratory pressure decreases.

[0016] Combined with the above technical solutions and the technical problems solved, the advantages and positive effects of the technical solution to be protected by the present invention are analyzed from the following aspects:

[0017] First, a patch is attached to the nostril. There is a resistance valve in the patch, which can generate a positive pressure and conduct it to the upper airway to maintain the airway patency, thereby preventing the occurrence of OSA.

[0018] A micro-valve is placed on the nasal patch of the present invention to control the size of the opening of the nasal patch, and different pressures can be provided according to the nostril size of different people and the airflow conditions at night.

[0019] The present invention provides an airflow sensor and a controller. When the airflow of the patient drops due to sleep apnea, it is automatically adjusted. The valve shrinks, the provided pressure rises, and the airway opens. When the airflow is detected to be stable for a period of time, the valve expands and the pressure drops to ensure comfort.

[0020] The present invention can provide adjustable positive end-expiratory pressure with a relatively large pressure, providing a treatment method with high comfort and good compliance for patients.

[0021] A valve is placed on the nasal patch to increase the provided pressure intensity.

[0022] An airflow sensor and a controller are placed on the nasal patch, and the size of the valve is automatically adjusted according to the size of the airflow to control the intensity of the positive airway pressure provided.

[0023] Second, by integrating a micro flow rate sensor and a responsive pressure regulating unit in the respiratory channel structure, the present invention realizes dynamic detection of airflow changes and positive pressure support response regulation during the patient's spontaneous breathing process. Compared with the existing treatment methods that require continuous supply of forced airflow, this device does not rely on the continuous delivery of exogenous gas, but based on the change of the patient's own end-expiratory airflow intensity, accurately outputs the minimum interference pressure support, effectively avoiding the flow discomfort and mucosal irritation reaction caused by traditional positive pressure ventilation, significantly improving the long-term wearing compliance and tolerance of patients, and thus bringing a more stable therapeutic effect expectation.

[0024] In terms of health economic benefits, the present invention proposes a treatment structure solution with low power consumption and no external gas supply for the huge population of sleep disordered breathing in China. It can not only reduce the manufacturing and maintenance costs of positive pressure treatment equipment, but also significantly improve the initial treatment acceptance rate of patients with moderate to severe obstructive sleep apnea (OSA). By reducing the treatment termination rate, this device is expected to indirectly reduce the medical burden in the prevention of chronic diseases (such as hypertension, coronary heart disease, type 2 diabetes), and has measurable social health benefits and the effect of alleviating medical insurance expenditures.

[0025] From the retrieval of existing international technical literature and product systems, there is currently no commercial or publicly disclosed medical device that can "implement positive pressure support based on physiological flow characteristics feedback under the condition of no external gas supply". Existing nasal strips and mechanical ventilation devices mostly work based on static structures or constant pressure modes, and cannot take into account the two core indicators of "low invasiveness" and "dynamic pressure regulation", especially it is difficult to match the natural breathing rhythm of patients during the dynamic sleep cycle. The present invention constructs an integrated structure of "adjustable flexible positive pressure - airflow sensing feedback" in the field of sleep treatment for the first time, with obvious structural novelty and technological breakthrough.

[0026] At the same time, the present invention significantly breaks through the inherent understanding in the industry that positive pressure treatment must rely on a mechanical pump gas source. By adopting a miniaturized flow rate sensing structure and an adaptive feedback control logic, the traditional air flow drive scheme is evolved into a "pressure difference response system" based on the trend of air flow changes, breaking the technical path limitation that "positive end-expiratory pressure can only rely on a constant pressure output device". The establishment of this technical path conforms to the principle of "minimal intervention support ventilation" in engineering, has high engineering rationality and physiological compatibility, constitutes a substantial improvement to the existing design ideas, and has anti-rejection, creativity and significant practical value. Description of the Drawings

[0027] Figure 1 It is a structural diagram of the positive end-expiratory pressure expiratory valve provided by an embodiment of the present invention.

[0028] Figure 2 It is a flowchart of the control method of the positive end-expiratory pressure expiratory valve provided by an embodiment of the present invention.

[0029] Figure 3 It is a schematic diagram of related products provided by an embodiment of the present invention.

[0030] Figure 1 In it: 1. Patch; 2. Adjustable micro-valve; 3. Hole; 4. Flow rate sensor and pressure sensor; 5. Controller. Detailed Embodiments

[0031] To make the objectives, technical solutions and advantages of the present invention more clearly understood, the present invention will be further described in detail below in conjunction with embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0032] As Figure 1 shown, an end-expiratory positive pressure expiratory valve provided by an embodiment of the present invention includes:

[0033] Patch 1, adjustable micro-valve 2, hole 3, flow rate sensor and pressure sensor 4, controller 5.

[0034] An adjustable micro-valve 2 is provided inside the patch 1; a hole 3 is opened inside the adjustable micro-valve 2; a controller 5 is fixed to the left end of the adjustable micro-valve 2; a flow rate sensor and a pressure sensor 4 are fixed below the controller 5.

[0035] As Figure 2 shown, a control method for an end-expiratory positive pressure expiratory valve provided by an embodiment of the present invention:

[0036] S101, before going to bed, attach the present invention to the nostril opening through the patch.

[0037] S102, when the patient falls asleep, the flow rate sensor monitors the flow rate. If the flow rate drops by more than 30% of the flow rate in the previous 3 respiratory cycles and lasts for 10 s, the valve is adjusted through the sensor, and the generated end-expiratory positive pressure rises.

[0038] S103, if the airflow does not drop for 2 minutes, the valve is adjusted through the sensor, and the generated end-expiratory positive pressure drops.

[0039] Applied to patients with sleep apnea or patients with simple snoring; related products are as Figure 3 shown.

[0040] When the patient starts to exhale, the gas first enters the adjustable micro-valve 2 located inside it through the patch 1. This valve is a variable aperture control component designed based on the MEMS (Micro-Electro-Mechanical Systems) structure. Its built-in hole 3 serves as an airway flow-limiting structure for applying an initial expiratory resistance. This process can form a certain degree of airway positive pressure in the early stage of exhalation, which helps to maintain the patency of the upper airway.

[0041] The aperture of the orifice 3 of the adjustable micro-valve 2 can be dynamically adjusted according to the expiratory flow rate and pressure. The adjustment is performed by the controller 5 executing a closed-loop feedback control logic: by analyzing the real-time data collected by the underlying sensing module (i.e., the flow rate sensor and the pressure sensor 4), the controller 5 calculates the current optimal passage diameter based on a preset threshold curve, thereby controlling the internal actuating structure of the valve (such as a piezoelectric actuator or an electromagnetic micro-driver) to adjust the aperture and achieve personalized positive expiratory pressure management.

[0042] The flow rate sensor and the pressure sensor 4 are integrated below the controller 5 and are perpendicularly arranged with respect to the expiratory airflow path. They respectively adopt hot film flow rate detection and micro-pressure capacitance induction technologies to perform high-frequency sampling (≥100 Hz) of the respiratory flow rate (unit: L / min) and the upper airway pressure (unit: cmH2O). This dual-parameter sensing mechanism ensures that the controller can obtain high-precision data in real time and guarantees the system's fast response ability to sudden changes in respiratory resistance.

[0043] The controller 5 is embedded with a multi-module control algorithm, including a fuzzy controller, a PID control unit, and a fast-response differential filtering module. The fuzzy controller determines the required range of positive end-expiratory pressure adjustment according to the patient's breathing pattern; the PID module then makes dynamic adjustments based on the real-time error to precisely control the rate and amplitude of the aperture change. This control strategy can achieve dynamic and stable control of the positive end-expiratory pressure value maintained within ±0.5 cmH2O.

[0044] The adjustable micro-valve 2 adopts a multi-layer stacked structure design, which consists of a flexible silicone rubber diaphragm and a rigid support structure. After the controller issues an adjustment instruction, the driving component causes a slight deformation of the diaphragm, thereby controlling the effective flow area of the orifice 3. This structure enables the valve to achieve controllable variable resistance under a micro-pressure difference and ensures the stability of the positive pressure formed at the end of expiration.

[0045] This positive end-expiratory pressure expiratory valve constitutes an adaptive closed-loop system: the sensor senses data → the controller analyzes and processes it → the valve structure is adjusted → the respiratory resistance changes → the feedback sensing data, forming a dynamic self-stabilizing loop.

[0046] Example 1: A PEEP support device for patients with chronic obstructive pulmonary disease (COPD).

[0047] In this embodiment, the patch is made of low-sensitization medical silicone, which adapts to the physiological curvature of the face to ensure comfortable wearing and airtightness. The initial aperture of the adjustable micro-valve 2 is set to 0.8 mm, and it can be dynamically adjusted within the range of 0.5 mm - 1.2 mm according to the flow rate signal, aiming to maintain the end-expiratory pressure between 5 - 8 cmH2O. The controller 5 integrates a 32-bit low-power MCU, and a fuzzy control algorithm is built-in to determine the characteristics of the expiratory cycle of COPD patients. The flow rate sensor adopts a thermistor structure, with a response time of less than 20 ms, and it can provide real-time feedback on the air flow dynamics. This embodiment shows good lung recruitment stability and respiratory synchronization during outpatient follow-up.

[0048] Embodiment 2: A micro PEEP valve module for mechanical ventilation assistance of ARDS patients

[0049] This embodiment is applicable to patients undergoing intubation mechanical ventilation in the ICU scenario. The device is connected to the expiratory end of the ventilator through a dedicated interface module. The initial closing degree of the holes of the micro-valve is relatively high, and the default setting is a 0.4 mm diameter to provide an initial PEEP of 10 cmH2O. The controller is connected to the hospital central monitoring system, and it can receive data on the changes in SpO2 and lung compliance, and cooperate with the built-in PID controller to achieve multi-parameter closed-loop optimization regulation. The pressure sensor adopts a MEMS piezoelectric film component, with a detection accuracy of ±0.2 cmH2O, ensuring that an effective end-pressure support can still be maintained under the high-variation ventilation resistance in ARDS, reducing the risk of alveolar collapse and barotrauma.

[0050] The above is only the specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art within the technical scope disclosed by the present invention, any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention shall be covered by the protection scope of the present invention.

Claims

1. An end-expiratory positive pressure expiratory valve, comprising a patch, an adjustable micro-valve, a hole, a controller, a flow rate sensor and a pressure sensor, It is characterized in that The patch is used to set the adjustable micro-valve. A hole penetrating through its valve body is provided inside the adjustable micro-valve. The controller is fixed on one side of the micro-valve. The flow rate sensor and the pressure sensor are arranged below the controller. The aperture of the hole is adjustable. The controller is connected to the sensors and electrically connected to the aperture adjustment structure inside the micro-valve for controlling the aperture change. The patch, the micro-valve, the controller and the sensors form a closed assembly structure.

2. The positive end-expiratory pressure expiratory valve according to claim 1, characterized in that, The adjustable micro-valve is processed by MEMS technology. The hole inside it is a cylindrical hole or a variable-diameter conical hole symmetrically arranged in the radial direction, and the aperture is adjustable within the range of 0.3 mm to 1.5 mm.

3. The positive end-expiratory pressure expiratory valve according to claim 1, wherein, The controller is provided with a microprocessor, a signal acquisition module and a drive circuit module. The microprocessor is used to process the data collected by the flow rate sensor and the pressure sensor and generate control signals.

4. The positive end-expiratory pressure expiratory valve according to claim 1, characterized in that, The flow rate sensor is a hot film type flow rate sensor, and the pressure sensor is a piezoelectric or capacitive micro-sensor. The sampling frequency of both is not less than 100 Hz.

5. The positive end-expiratory pressure expiratory valve according to claim 1, characterized in that, The micro-valve includes a flexible silicone rubber diaphragm and a rigid support housing. The diaphragm is connected to the hole adjustment component, and the aperture adjustment is realized through the deformation of the diaphragm.

6. The positive end-expiratory pressure expiratory valve according to claim 1, wherein The patch is made of medical-grade silicone material, with a thickness of 0.3 mm to 0.7 mm. The outer shape of the patch is a curved surface structure, suitable for facial wearing or interface connection.

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