Intake resistance valve system with exhalation port

Abstract

An inspiratory resistance valve (IRV) system for controlling intrathoracic pressure during positive pressure ventilation, spontaneous inspiration, and CPR may include an inspiratory port. The IRV system may include a patient port. The IRV system may include a separate expiratory port. The IRV may include multiple atmospheric pressure sensing valves. Multiple atmospheric pressure sensing valves may isolate the expiratory port and the inspiratory port from each other.

Description

Technology Field

[0001] This application claims priority to U.S. Provisional Patent Application No. 62 / 992,706 filed on March 20, 2020, the entire disclosure of which is incorporated herein by reference.

[0002] Embodiments of the present invention relate to a device for increasing blood flow to a patient's chest during the recoil phase of cardiopulmonary resuscitation (CPR) and during spontaneous breathing. In particular, embodiments relate to an inspiratory resistance valve system having an inspiratory port and an expiratory port (IRV) having a separate expiratory port to prevent the expiratory gas from mixing with the inspiratory gas. Background Technology

[0003] Devices are often used to regulate a patient's chest pressure during cardiopulmonary resuscitation (CPR) and / or other medical treatments. Some techniques utilize a valve structure called an impedance threshold device (ITD) to help create negative pressure within the patient's chest by periodically blocking or obstructing the entry of breathing gases into the lungs. When a specific negative intrathoracic pressure is reached, the valve opens, allowing breathing oxygen to enter the patient's lungs. During CPR, positive pressure breathing is periodically delivered through the ITD to periodically inflate the lungs and deliver oxygen. While conventional devices effectively provide increased negative pressure levels, problems can arise where patient fluids, such as those caused by pulmonary edema, are transferred from the patient's airway to the valve or other devices, reducing or rendering them ineffective. Additionally, exhaled gas is mixed with inhaled gas in conventional ITDs. Therefore, improvement in intrathoracic pressure regulation is required. As prior art, there is U.S. Patent Publication US4856548 (published August 15, 1989) and U.S. Patent Application Publication US2003 / 0062040 (published April 3, 2003). The problem to be solved

[0004] Embodiments of the present invention relate to a device for increasing blood flow to a patient's chest during the rebound phase of CPR and during spontaneous breathing. In particular, the embodiment relates to an inspiratory resistance valve system having an exhalation port (IRV) having a separate exhalation port to prevent the exhaled gas from mixing with the inspiratory gas, thereby separating the inflow flow from the outflow flow and enabling the delivery of a higher O2 concentration to the patient during CPR. Additionally, the embodiment provides an outlet flow path for fluids, such as fluid from pulmonary edema, which directs these fluids out of the IRV and away from the inspiratory flow path of the IRV. In this regard, backflow protection may be desirable to help maintain the integrity of the fluid-sensitive valve mechanism. In some embodiments, the exhaled gas passes through a filter adjacent to the exhalation port to protect rescue personnel from potential pathogens, including viral particles. In some embodiments, one or more sensors are located within the IRV and between the inspiratory and exhalation flow ports. means of solving the problem

[0005] In one embodiment, an inspiratory resistance valve system (IRV) is provided for controlling intrathoracic pressure during positive pressure breathing, spontaneous inspiration, and CPR. The IRV may include an inspiratory port, a patient port, a separate expiratory port, and a plurality of atmospheric pressure sensing valves. The plurality of atmospheric pressure sensing valves may isolate the expiratory port and the inspiratory port from each other.

[0006] In some embodiments, a plurality of atmospheric pressure sensing valves may be arranged concentrically. The plurality of atmospheric pressure sensing valves may close the expiratory port and close the inspiratory port during positive pressure breathing delivery, and open the expiratory port to allow the patient's breath gas to be expelled during exhalation or chest compressions. All of the plurality of atmospheric pressure sensing valves in the area of ​​the inspiratory port and the expiratory port may be maintained in a closed position until the pressure within the patient port is -5 to -20 cm of water. One or both of the filters interfacing with the expiratory port and one of the plurality of atmospheric pressure sensing valves may provide an expiratory resistance of 2 to 10 cm of water. Each of the plurality of atmospheric pressure sensing valves is a one-way valve selected from the group comprising a duck-bill valve, a ball valve, annular valve, a round valve, a butterfly valve, a check valve, a balloon valve, a mushroom valve, a fish mouth valve, and a disc valve. The patient port may include a non-rebreather valve that enables virtually resistance-free positive pressure ventilation from the inspiratory port to the patient port.

[0007] In another embodiment, the inspiratory resistance valve system (IRV) may include a housing having an upper region, a lower region, and an exhalation region. The IRV may include a first pressure-responsive unidirectional valve positioned between the upper region and the lower region to allow positive pressure ventilation with an H2O resistance of less than 5 cm and to prevent all breathing gas from flowing from the upper region to the lower region when the pressure in the lower region is lower than atmospheric pressure. The IRV may include a second pressure-responsive valve positioned between the upper region and the lower region, which remains closed until the pressure in the lower region drops below a threshold level, at which point the second pressure-responsive valve opens, allowing breathing gas to flow into the patient's lungs due to the pressure difference between atmospheric pressure and the lower region. The IRV may include a third pressure-responsive valve positioned between the upper region and the exhalation region to prevent all exhalation fluid from flowing to the upper region when the pressure in the chest is higher than atmospheric pressure. The IRV may include a fourth pressure-response valve in the exhalation zone that closes when the pressure in the lower zone in contact with the patient is below atmospheric pressure and opens when the pressure in the lower zone in contact with the patient is above atmospheric pressure.

[0008] In some embodiments, the critical level may be water of about -5 to -20 cm. The IRV may include a physiological sensor positioned within one or both of the upper and lower regions. The IRV may include a communication interface that transmits a signal from the physiological sensor to one or both of the ventilator and the compression device. The IRV may include a filter that interfaces with the exhalation region. The second pressure response valve may include a duck-bill valve having an outer surface that optionally engages with a valve seat. The duck-bill valve may be opened so that inspiratory flow can be delivered to the patient while the outer surface engages with the valve seat to occlude the exhalation region from the upper region. The duck-bill valve may be closed, and the outer surface may be moved away from the valve seat to discharge exhaled fluid from the IRV and prevent exhaled fluid from flowing into the upper region.

[0009] In another embodiment, the inspiratory resistance valve system (IRV) may include a housing, a ventilation port configured to interface with a ventilation device, and a patient port configured to interface with a patient interface device. The IRV may include a separate exhalation port and a positive pressure ventilation path fluidly communicating with the ventilation port and the patient port. The positive pressure ventilation path may be configured to guide breathing air from the ventilation port to the patient port. The IRV may include a patient inspiration flow path fluidly communicating with the patient port. The patient inspiration flow path may be configured to deliver air to the patient port during the patient's spontaneous inspiration. The IRV may include an exhalation path fluidly communicating with the patient port. The exhalation path may be configured to guide exhaled fluid from the patient out of the IRV through the exhalation port. The exhalation path is separated from at least a portion of the positive pressure ventilation path and the patient inspiration path via a series of pressure-responsive valves to separate the inflow flow from the outflow flow so that the exhaled fluid does not mix with the inspiratory gas, resulting in the delivery of a higher concentration of O2 to the patient during CPR.

[0010] In some embodiments, a series of pressure-responsive valves includes a first atmospheric pressure valve interfacing with a positive pressure ventilation path, a first pressure sensing valve interfacing with a patient inspiratory path, a second pressure sensing valve interfacing between the inspiratory path and the expiratory path, and a second atmospheric pressure valve disposed inside the expiratory port. The closing pressure of the first atmospheric pressure valve may be less than -1 cm H2O. The opening pressure of the first pressure sensing valve may be about -5 to -20 cm H2O. The second pressure sensing valve may open when the pressure in the ventilation path is greater than 0 cm H2O and close when the pressure in the expiratory path is greater than 0 cm H2O. The opening pressure of the second atmospheric pressure valve may be about 0 to 10 cm H2O. The closing pressure of the second atmospheric pressure valve may be less than -1 cm H2O. The second pressure sensing valve and the second atmospheric pressure valve may form a single non-rebreather valve. A second atmospheric pressure valve allows respiratory fluid to enter the patient but prevents respiratory fluid from the lungs from coming into contact with the first atmospheric pressure valve. The IRV may include a first diaphragm coupled to the upper surface of the positive pressure ventilation path. The IRV may include a second diaphragm coupled to the lower surface of the expiratory path. The first diaphragm and the second diaphragm may each have a cracking pressure substantially at atmospheric pressure.

[0011] During the delivery of positive pressure ventilation, the first atmospheric pressure valve and the second atmospheric pressure valve are open, while the first pressure sensing valve and the second pressure sensing valve are closed. During spontaneous inspiration, the first pressure sensing valve and the second atmospheric pressure valve are open, while the first atmospheric pressure valve and the second pressure sensing valve are closed. During one or both of the chest compression phase of CPR and patient exhalation, the second pressure sensing valve may be opened and the first atmospheric pressure valve, the first pressure sensing valve, and the second atmospheric pressure valve may be closed, thereby allowing the breathing fluid to exit the IRV without mixing with the inspiratory gas. During the decompression phase of CPR, the first atmospheric pressure valve, the first pressure sensing valve, and the second pressure sensing valve are closed to lower the intrathoracic pressure, prevent breathing gas from entering the patient, provide space for the increased blood volume returning to the patient's heart during the decompression phase, increase circulation to the patient's coronary arteries, and lower the intracranial pressure. Brief explanation of the drawing

[0012] Further understanding of the characteristics and benefits of various IRV embodiments can be achieved by referring to the following drawings. In the attached drawings, similar components or functions may have the same reference label. Additionally, various components of the same type may be distinguished by using a dash after the reference number and a second reference number to distinguish similar components. Where only the first reference number is used in the specification, the description applies to one of the similar components having the same first reference number, regardless of the second reference number. FIG. 1a is a schematic diagram of an intake resistance valve system having an exhalation port (IRV) according to an embodiment. Figure 1b is a diagram illustrating the airflow through the IRV of Figure 1a during positive pressure ventilation delivery. Figure 1c illustrates the airflow through the IRV of Figure 1a during spontaneous inspiration. Figure 1d illustrates the airflow through the IRV of Figure 1a during the chest compression phase of CPR or during patient exhalation. Figure 1e is a diagram showing the state of the IRV in Figure 1a during the decompression phase of CPR. FIG. 2a is a perspective view of an IRV according to embodiments. Figure 2b shows a disassembled view of the IRV of Figure 2a. Fig. 2c is a front cross-sectional view of the IRV of Fig. 2a. Figure 2d is a diagram illustrating the airflow through the IRV of Figure 2a during positive pressure ventilation delivery. Figure 2e is a diagram illustrating the airflow through the IRV of Figure 2a during spontaneous inhalation. Figure 2f is a diagram illustrating the airflow through the IRV of Figure 2a during the chest compression phase of CPR or patient exhalation. Figure 2g is a diagram showing the state of the IRV in Figure 2a during the decompression phase of CPR. FIG. 3a is an exploded view of an IRV according to an embodiment of the present invention. FIG. 3b illustrates a front cross-sectional view of the IRV of FIG. 3a. Figure 3c is a diagram illustrating the airflow through the IRV of Figure 3a during positive pressure ventilation delivery. Figure 3d is a diagram illustrating the airflow through the IRV of Figure 3a during spontaneous inhalation. Figure 3e is a diagram illustrating the airflow through the IRV of Figure 3a during the chest compression phase of CPR or patient exhalation. Figure 3f is a diagram showing the state of the IRV in Figure 3a during the decompression phase of CPR. Figure 4 is a diagram illustrating sensors arranged within the IRV of Figure 3a. Figure 5 is a drawing showing a sampling tube integrated into the IRV of Figure 3a. Figure 6 is a graph showing airway pressure and chest pressure during CPR with and without IRV. Specific details for implementing the invention

[0013] The subject matter of the embodiments of the present invention is described specifically to satisfy legal requirements, but such description is not necessarily intended to limit the scope of the claims. The claimed subject matter may be implemented in other ways, may include other elements or steps, and may be used in conjunction with other existing or future technologies. This description should not be construed as implying a specific order or arrangement among various steps or elements, except where the order of individual steps or the arrangement of elements is explicitly described.

[0014] The performance of CPR on a cardiac arrest patient involves chest compressions (performed using manual and / or automated devices) to aid blood circulation to vital organs, including the heart, lungs, and brain. In some embodiments, active compression decompression (ACD) CPR may be performed, which involves actively decompressing between each compression rather than allowing the chest to rebound on its own. During the compression phase of CPR, blood is pushed from the heart into the aorta, and air is pushed from the chest into the atmosphere through the trachea and airways. During the decompression phase (both manual and active), blood from areas far from the chest flows into the chest, and air flows into the chest through the patient's airways.

[0015] The application of the method and device described in this application in conjunction with any of the aforementioned CPR methods results in an intrathoracic vacuum during the chest wall rebound phase. This increases circulation to the coronary arteries and lowers intracranial pressure during the chest wall decompression phase. Often, positive pressure ventilation must be periodically delivered to the patient to inflate the lungs and supply oxygen. For example, the lungs may be inflated through periodic negative pressure ventilation using an iron lung or a chest cuirass device.

[0016] During the chest decompression or recoil phase of CPR, or during spontaneous inspiration, the pressure within the chest decreases to a level between -1 and -15 cm H2O. This draws breathable gases into the lungs unless an IRV is present in the circuit. IRVs obstruct the entry of respiratory gases into the lungs due to their valve system. When an IRV is present in the circuit, the negative chest pressure generated during chest recoil (passive or active) or patient inspiration—whether during the chest recoil phase of CPR or spontaneous inspiration—enhances the backflow of venous blood into the lungs and creates a vacuum that lowers intracranial pressure. Collectively, this increases cardiac preload and amplifies cardiac outcomes during CPR and spontaneous breathing. During CPR, this process occurs more rapidly with active chest decompression during the chest recoil or recoil phase. In addition, it occurs more efficiently when lifting the head and chest during CPR or in situations involving traumatic brain injury, as the height of the head and chest utilizes gravity to drain venous blood from the brain and improve blood distribution within the lungs.

[0017] During chest compressions, blood is propelled from the heart to the brain and the rest of the body, and air is expelled from the lungs. Air can be expelled through an IRV capable of providing a low level of fixed or variable resistance, typically in the range of about 0 cm H2O to about 15 cm H2O, more commonly in the range of about 2 cm H2O to about 10 cm H2O. This resistance can be provided by one or more valves of the IRV system (e.g., the exhalation valve described herein), filter materials, and / or other means having a low flow of a positive pressure gas such as oxygen.

[0018] Each chest compression of air is expelled out of the lungs and cannot re-enter them due to the valve system. As a result, the amount of breathing gas within the lungs gradually decreases. The amount of breathing gas expelled from the lungs during each chest compression creates space for more blood to return to the heart and lungs and fill during the decompression phase, whenever positive pressure is not applied to the chest by the chest compression. This process occurs more rapidly with active chest decompression during the chest recoil or decompression phase of CPR. To help generate much greater negative pressure within the patient's chest between chest compressions (during the decompression phase), the valve structure according to the present invention may be connected to the patient's airway. Such a valve structure can periodically prevent or obstruct the inflow of breathing gas into the lungs while allowing breathing gas to escape from the lungs during chest compressions, thereby allowing periodic ventilation.

[0019] FIG. 1a illustrates a schematic diagram of a valve structure in the form of an inspiratory resistance valve having an exhalation port (IRV) (100). The IRV (100) may include a plurality of valves that operate to regulate the pressure within the patient's thoracic cavity. The IRV (100) may include a plurality of branches, tubes, and / or other lumens (102) that allow breathing gas to flow to and from the patient. As illustrated (although other configurations are possible), the IRV (100) includes a patient inspiratory lumen (102a), a positive pressure ventilation lumen (102b), and a patient exhalation lumen (102c). Here, the lumens (102) are coupled together in parallel with a ventilation port (104) located at the top of the lumen (102) and a patient port (106) located at the bottom of the lumen (102), but the lumens (102) and / or ports are possible. Various one-way valves may be provided within one or more lumens (102) to control the flow of breathing gas to and from the patient. The one-way valves may be in the form of check valves, mouth valves, spring valves, duck valves, ball valves, and / or other mechanically or electronically controlled valves and switches.

[0020] As illustrated, the patient inspiratory lumen (102a) includes a one-way valve (108) that acts as a safety valve to allow breathing gas to be inhaled into the patient's airway through the ventilation port (104) in the event of spontaneous inhalation by the patient, while preventing the gas from flowing out of the IRV (100). Often, the one-way valve (108) has a cracking pressure of about -5 to -20 cm H2O.

[0021] The positive pressure lumen (102b) is configured to allow positive pressure ventilation to be delivered to the patient's airway. The positive pressure lumen (102b) includes a movable and / or deformable diaphragm (110) that seals the upper portion of the positive pressure lumen (102b). The positive pressure lumen (102b) includes a one-way valve (112) that allows air to pass into the patient port (106) and then be delivered to the patient's airway. The one-way valve (112) prevents breathing gases and / or other fluids (e.g., pulmonary edema fluid and / or blood) from the lungs from flowing back into the positive pressure lumen (102b). In some embodiments, the diaphragm (110) may have a cracking pressure substantially equal to atmospheric pressure so that positive pressure ventilation can move and / or deform the diaphragm (110) to allow positive pressure air to be delivered into the positive pressure lumen (102b). In some embodiments, to provide a diaphragm (110) having a cracking pressure substantially equal to atmospheric pressure, the diaphragm (110) includes one or more ventilation ports (118) that minimize air resistance associated with the diaphragm (110) through which an airflow caused by the movement of the diaphragm (110) passes. Once the incoming positive pressure airflow passes through the diaphragm (110), it forcibly opens a one-way valve (112) and passes into the patient's airway. The one-way valve (112) may have a cracking pressure of 1 cm H2O and possibly 0 cm H2O so that any amount of pressure breathing can open the one-way valve (112). By designing the diaphragm (110) and the one-way valve (112) to have a low cracking or opening pressure, the breathing gas is delivered through the IRV (100) to the patient's airway with minimal or no resistance from the IRV (100).

[0022] The exhalation lumen (102c) is configured to allow exhalation gas and / or other fluids from the patient to be discharged outside the IRV (100). To do so, the exhalation lumen (102) includes a one-way valve (114) leading to an exhalation port (116). The upper part of the exhalation lumen (102c) may be sealed from the ventilation port (104) to prevent exhalation gas or other fluids from passing through the ventilation port (104). The one-way valve (114) has a cracking pressure of about 0 to 12 mmHg. This causes the one-way valve (114) to open when fluid (gas and / or liquid) is discharged from the patient's airway, allowing the fluid to exit the IRV (100) through the exhalation port (116). The one-way valve (114) may have a fixed or variable resistance adjustable over an exhalation pressure range between 2 and 12 mmHg. When chest compressions are performed during CPR, air is expelled from the patient's lungs. This air can pass through the one-way valve (114) and exit the exhalation port (116). Similarly, patient exhalation can flow out of the exhalation port (116) through the one-way valve (114). In some embodiments, pulmonary edema may occur, which may cause fluid that can be exhaled by the patient and delivered into the IRV (100) through the patient port (106). This fluid can also pass through the one-way valve (114) and exit the exhalation port. In some embodiments, a filter, such as a HEPA filter, may be attached to or integrated into the interface between the exhalation port and the atmosphere. This may serve to protect the rescuer from potential infection by preventing harmful germ particles (bacteria and viruses) from contaminating the air around the patient. The filter may also be used as an intentional means to provide a level of exhalation resistance.

[0023] FIGS. 1b through 1e illustrate the operation of the IRV (100) under different breathing conditions. In particular, these figures show in detail the various valve positions of the IRV 100 throughout breathing and CPR. The arrow in FIG. 1b illustrates the airflow through the IRV (100) during the delivery of positive pressure ventilation. Positive pressure ventilation can be delivered using a manual and / or automatic respirator coupled with the ventilation port (104). For example, ventilation can be delivered using mouth-to-mouth ventilation, an oral mask, a respirator bag, an automatic or semi-automatic ventilator, a chest plate, or a steel lung-like device, etc. During ventilation, air is generally forced into the IRV (100) through the ventilation port (104) at a pressure lower than the cracking pressure of the one-way valve (108) (e.g., less than 5-12 cm H2O). If the air pressure of the positive pressure ventilation is below the cracking pressure of the one-way valve (108), the positive pressure ventilation cannot pass through the one-way valve (108) and instead flows against the underside of the diaphragm (110). This pressure causes the diaphragm (110) to move and / or deform, allowing the airflow to enter the positive pressure lumen (102b). The air then forces the one-way valve (112) open and is delivered to the patient's airway through the patient port (106). During positive pressure ventilation, the one-way valve (108, 114) remains closed so that all air delivered by the ventilation is delivered to the patient. In some embodiments, the one-way valve (112), which may be a duckbill valve or an exhalation valve, blocks the expiratory lumen (102c) to prevent the positive pressure ventilation from opening the one-way valve (114). In this configuration, the one-way valve (112) provides two functions in the IRV (100) having a separate exhalation port (116): 1) prevent backflow of gas and fluid from the lungs and 2) block the exhalation port structure during positive pressure ventilation.

[0024] In some cases, the patient may voluntarily inhale to create a negative pressure within the chest that causes air to be drawn into the patient port (106) as illustrated by the arrow in FIG. 1c. As air is pushed in, the diaphragm (110) is drawn against the upper surface of the positive pressure lumen (102b), sealing the positive pressure lumen (102b) and preventing air from passing through. At the same time, the one-way valve (114) is closed, so that both the diaphragm (110) and the one-way valve are closed when the pressure within the patient port (106) is less than 1 atmosphere. When the force of the patient's inhalation exceeds the cracking pressure of the one-way valve (108), the one-way valve (108) opens, and breathing gas is introduced into the patient's airway through the patient inhalation lumen (102a) and the patient port (106) as illustrated herein. The one-way valve (108) opens at a predetermined cracking or opening pressure, but the diaphragm (110) and the one-way valve (114) remain closed as long as the pressure in the patient port (106) is maintained at less than 1 atmosphere. For example, during spontaneous inspiration or chest wall recoil after compression during CPR, negative pressure within the chest keeps the diaphragm (110) and the one-way valve (114) in the closed position. During spontaneous inspiration, the negative pressure generated within the chest before the valve (108) opens draws venous blood back into the chest from the brain and other structures outside the chest. This increases cardiac output, blood circulation throughout the body, and blood pressure. The cracking pressure of the valve (108) can vary between 5-20 cm H2O depending on clinical needs. Generally, the cracking pressure that provides optimal clinical benefit during CPR is about 10-16 cm H2O. Within this range, circulation is improved.

[0025] When the chest is compressed (manually and / or automatically) or when the patient breathes, breathing gas flows from the patient through the IRV (100) as illustrated by the arrow in FIG. 1d. For example, exhaled gas passes through the patient port (106) and forces the one-way valve (114) open. Then, exhaled gas flows out of the exhaled port (116) through the one-way valve (114). Due to the operating direction of the one-way valves (108, 112), these valves (108, 112) are all closed while the patient exhales. This arrangement is particularly useful for patients suffering from pulmonary edema, where fluid may accumulate in the lungs that can be exhaled through the IRV (100). Due to the one-way valve arrangement of the IRV (100), any fluid (exhaled gas and / or pulmonary edema fluid) is directed out of the exhalation port (116) through the one-way valve (114), preventing any pulmonary edema fluid from passing through the one-way valve (108, 112) and / or preventing interference with the proper operation of the one-way valve (108, 112). In some embodiments, a collection bag or other container may be combined with the exhalation port (116) and / or lumen (102) to collect any fluid released from the IRV (100). Additionally, the valve arrangement of the IRV (100) effectively separates the inhalation flow from the exhalation flow so that exhaled carbon dioxide-rich gas is not mixed with the inhaled gas. This allows for the delivery of a higher concentration of oxygen to the patient during CPR, thereby allowing for higher oxygen levels in the patient's bloodstream and consequently achieving improved resuscitation results.

[0026] During the decompression phase of CPR, the chest wall recoils as the rescuer's hands (or chest compression device) are lifted. In the case of A-CD-CPR, the chest is actively decompressed, such as by pulling the chest upward using a suction cup and / or adhesive. During this phase of CPR, negative pressure is created inside the chest (below the cracking pressure of the one-way valve (108)). FIG. 1e illustrates the state of the IRV (100) during the decompression phase of CPR. Here, the one-way valve (108, 114) and the diaphragm (110) are closed to prevent breathing gas from entering the patient. By preventing breathing gas from entering the patient through multiple cycles of chest compression and chest recoil, increasingly less air is present within the chest wall, providing space for increasingly more blood to return to the heart during the chest wall recoil phase. This increases circulation to the coronary arteries and lowers intracranial pressure during the chest wall decompression phase, leading to a higher rate of successful resuscitation outcomes. Additionally, during the decompression phase of CPR, the pressure inside the chest is maintained below atmospheric pressure at a level determined by the upper chest wall recoil (which can be passive or active) when the anterior chest wall is actively pulled upward while the patient is in a supine position.

[0027] An embodiment of the IRV (200) is illustrated in FIG. 2a. The IRV (200) may function in a manner similar to the IRV (100) and may include any of the features described above. The IRV (200) comprises an upper cap (226) having a ventilation port (204) for actively providing breathing gas to a patient, a lower cap (228) having a patient port (206) to be paired with a patient interface such as a face mask, and a housing (220) comprising an endotracheal tube, a supraglottic airway device, other airway devices and / or other interfaces (not shown). The housing (220) defines an interior in which a valve structure similar to the valve arrangement of the IRV (100) is placed. In some embodiments, the housing (220) defines a number of inhalation / exhalation ports (216) that allow exhalation gas and / or other fluids to enter the IRV (200) and / or inhalation gas in the case of spontaneous inhalation. In some embodiments, the intake / exhalation ports (216) may be separated so that individual ports (216) can be used only for intake or exhalation. As illustrated, the intake / exhalation ports (216) are arranged in a radial pattern through the surface of the upper cap (226), but other arrangements and / or numbers of intake / exhalation ports (216) are possible.

[0028] FIGS. 2b and 2c illustrate the internal components of the IRV (200). In contrast to the parallel arrangement of lumens (102) in the IRV (100), the IRV (200) includes three concentric flow paths, but other arrangements are possible. As illustrated, the central support (222) provides a central lumen (202b) that serves as a positive pressure flow path similar to the positive pressure lumen (102b). A diaphragm (210) is positioned against the upper surface of the central lumen (202b) to seal the upper end of the central lumen (202b), while a flow backflow valve (212) is positioned at the inner and / or bottom end of the central lumen (202b) to allow air to pass into the patient port (206) and then into the patient airway, thereby blocking the entry of exhaled fluid into the central lumen (202b) and / or ventilation port (204). The above flow reverse valve (212) may be similar to the one-way valve (112) described above.

[0029] Although a mouthpiece valve is exemplified, the flow backflow valve (212) may be any type of unidirectional valve, such as a check valve, a duck-bill valve, a spring valve, a non-rebreather valve, etc. In some embodiments, the diaphragm (210) may have a cracking pressure substantially equal to atmospheric pressure so that positive pressure breathing moves and / or deforms the diaphragm (210) to deliver positive pressure air into the interior of the central lumen (202b). In some embodiments, to provide a diaphragm (210) having a cracking pressure substantially equal to atmospheric pressure, the diaphragm (210) and / or diaphragm holder (224) includes one or more ventilation ports (218) that enable airflow resulting from the movement of the diaphragm (210), passing through to minimize air resistance associated with the movement of the diaphragm (210). When passing through the diaphragm (210), the incoming positive pressure airflow forcibly opens the flow backflow valve (212) and passes through the patient port (206) into the patient's airway. The one-way valve (212) may have a cracking pressure of less than 1 mmHg and possibly 0 mmHg so that the one-way valve (212) can be opened by any positive pressure breathing. By designing the diaphragm (210) and the one-way valve (212) to have a low cracking pressure, the breathing gas is delivered through the IRV (200) to the patient's airway with minimal or no resistance from the IRV (200). In some embodiments, the one-way valve (212) opens with each positive pressure breath and simultaneously blocks the breathing gas from exiting through the exhalation port (216). In this configuration, the one-way valve (212) is preferably designed as a mouthpiece valve or duck-bill valve that provides three functions: 1) to prevent gas and fluid from flowing back from the lungs so that these fluids do not disable the diaphragm (210) and the pressure response valve (208); 2) to prevent mixing of inhaled and exhaled gases so that the reduction of oxygen delivered to the patient is prevented; and 3) to block the exhalation port structure during positive pressure breathing.In addition, using this approach, when a flow sensor is used in the IRV, minute volumes can be measured during ventilation.

[0030] The IRV (200) defines an exhalation path (202c) that operates in a manner similar to the exhalation lumen (102c) described above. As illustrated, the exhalation path (202c) is generally annular in shape and extends around the central lumen (202b). The exhalation path (202c) is configured to allow exhalation gas and / or other fluids from the patient to be discharged out of the IRV (200). The exhalation path (202c) includes an exhalation valve (214) which may be similar to a one-way valve (114). The exhalation valve (214) leads to an inhalation / exhalation port (216). The exhalation path (202c) may be sealed from the ventilation port (204) and the central lumen (202b) to prevent exhalation fluid from passing through the ventilation port (204) and the central lumen (202b). For example, the solid walls of the flow backflow valve (212) and the housing (220) prevent the exhalation path (202c) from fluidly communicating with the ventilation port (204) and the central lumen (202b) during the operation of the IRV (200). The exhalation valve (214) may have a cracking pressure between approximately 0 and 10 mmHg or may be variable and adjustable. This causes the exhalation valve (214) to open when fluid (gas and / or liquid) is expelled from the patient's airway, allowing the fluid to exit the IRV (200) through the inhalation / exhalation port (216). For example, when chest compressions are applied during CPR, air is expelled from the patient's lungs. This air can pass through the exhalation valve (214) and exit the inhalation / exhalation port (216). Similarly, patient exhalation can flow out of the inhalation / exhalation port (216) through the exhalation valve (214). In some embodiments, pulmonary edema may occur, which may cause fluid that can be exhaled by the patient and delivered into the IRV (200) through the patient port (206). This fluid may also pass through the exhalation valve (214) and exit the exhalation port.

[0031] The IRV (200) defines a patient inspiratory passage (202a) that operates in a manner similar to the patient inspiratory lumen (102a) described above. As illustrated, the patient inspiratory passage (202a) is generally annular in shape and extends around the central lumen (202b). The patient inspiratory passage (202a) partially overlaps the lower part of the exhalatory passage (202c) and extends annularly outward from the upper part of the exhalatory passage (202c) connected to the inspiratory / exhalatory port (216). As illustrated, the patient inspiratory passage (202a) includes a vacuum valve (208) that operates in a manner similar to the aforementioned one-way valve (108). For example, the vacuum valve (208) acts as a safety valve that allows breathing gas to be inhaled into the patient's airway through the ventilation port (204) in the event of spontaneous inhalation by the patient. Often, the vacuum valve (208) has a cracking pressure of about -5 to -20 mmHg.

[0032] Although the exhalation valve (214) and vacuum valve (208) are generally depicted as being annular, other types of valves are possible in some embodiments. For example, one of the two valves may be in the form of a separate valve at one or more locations of the IRV (200). As just one example, the exhalation valve (214) and vacuum valve (208) may be in the form of a mouth valve or a duck-bill valve. The IRV (200) may include one or more of each valve located at separate locations.

[0033] FIG. 1 and FIG. 2d through 2g illustrate the operation of the IRV (200) under different breathing conditions. Arrow in FIG. 1. FIG. 2d illustrates the airflow through the IRV (200) during positive pressure ventilation delivery. Positive pressure ventilation can be delivered using a manual and / or automatic respirator coupled with the ventilation port (204). For example, ventilation can be delivered using mouth-to-mouth ventilation, an oral mask, a ventilator bag, an automatic or semi-automatic ventilator, a chest armor, or a steel lung-like device. During ventilation, air is typically forced into the IRV (200) through the ventilation port (204) and flows around the diaphragm (210) until it comes into contact with the underside of the diaphragm (210). This airflow causes the diaphragm (210) to move and / or deform, allowing the airflow to enter the central lumen (202b). Next, air is forced open through the flow reversal valve (212) and delivered to the patient's airway through the patient port (206). The reversal valve (212), preferably a duck-bill valve or a gas valve, also blocks the expiratory passage (202c) in the process of ensuring that positive pressure ventilation is delivered to the patient. During positive pressure ventilation, the vacuum valve (208) and the expiratory valve (214) remain closed so that all air delivered by the respirator is delivered to the patient.

[0034] In some cases, the patient may spontaneously inhale, which creates a negative pressure within the chest that causes air to be drawn into the inhalation / exhalation port (216) as illustrated by the arrow in FIG. 2e. As air is drawn in through the inhalation / exhalation port (216) instead of through the ventilation port (206), the diaphragm (210) remains in position relative to the upper surface of the central lumen (202b), and the floating backflow valve (212) remains closed to seal the central lumen (202b) and prevent air from passing through. When the force of the patient's inhalation exceeds the cracking pressure of the vacuum valve (208), the vacuum valve (208) opens, and the breathing gas is drawn into the patient's airway through the patient inhalation path (202a) and patient port (206) as illustrated herein. The vacuum valve (208) may be a spring-loaded valve, a mushroom valve, a strain gauge valve, and / or other types of pressure-sensing valve. The vacuum valve (208) may have a preset crack or opening pressure between approximately -5 and -20 cm H2O. During spontaneous inhalation, the negative pressure within the chest maintains the exhalation valve (214) in the closed position.

[0035] When the chest is compressed (manually and / or automatically) or when the patient breathes, breathing gas flows from the patient through the IRV (200) as illustrated by the arrow in FIG. 2f. For example, exhaled gas passes through the patient port (206) and forcibly opens the exhalation valve (214). Exhaled gas flows out of the inhalation / exhalation port (216) through the exhalation valve (214). Due to the operating direction of the vacuum valve (208) and the flow counterflow valve (212), these valves (208, 212) are both closed during patient exhalation. This arrangement is particularly useful for patients suffering from pulmonary edema, where fluid may accumulate in the lungs that can be exhaled through the IRV (200). Due to the unidirectional valve arrangement of the IRV (200), all fluid (exhaled gas and / or pulmonary edema fluid) is directed out of the inhaled / exhaled port (216) through the exhaled valve (214), thereby preventing the passage of pulmonary edema fluid and / or preventing interference with the proper operation of the vacuum valve (208) and the flow backflow valve (212). Additionally, the valve arrangement of the IRV (200) effectively separates the exhaled flow and the inhaled flow so that the exhaled gas does not mix with the inhaled gas. This allows for the delivery of a higher concentration of oxygen to the patient during CPR, thereby allowing for higher oxygen levels in the patient's bloodstream and consequently achieving improved resuscitation results.

[0036] During the decompression phase of CPR, the chest wall recoils as the rescuer's hands are lifted. In the case of ACD-CPR, the chest is actively decompressed, such as by pulling the chest upward using a suction cup and / or adhesive. During this phase of CPR, negative pressure is created inside the chest (below the cracking pressure of the vacuum valve (208)). FIG. 2g illustrates the state of the IRV (200) during the decompression phase of CPR. The vacuum valve (208), exhalation valve (214), and diaphragm (210) are closed to prevent breathing gas from entering the patient. By preventing breathing gas from entering the patient through multiple cycles of chest compression and chest recoil, increasingly less air is present within the chest wall, providing space for increasingly more blood to return to the heart during the chest wall recoil phase. The pressure inside the chest becomes a more negative value. This draws more venous blood into the chest, increases circulation to the coronary arteries, and lowers intracranial pressure during the chest wall decompression phase, thereby increasing the rate of successful resuscitation.

[0037] The drawings shown in this specification represent potential paths for gas exchange in and out of the patient, but the dimensions of the IRV (200) are representative but not exact, and represent one of a number of potential valve mechanisms (e.g., duck-bill valve, ball valve, annular valve, circular valve, butterfly valve, check valve, balloon valve, grooved valve, mushroom valve, disc valve, etc.) of FIGS. 2a through 2g.

[0038] In addition to the described IRV, additional features are equipped within the IRV system, including a battery-operated timing light to help guide ventilation at a given rate, a sensor to measure pressure inside the IRV, electronic components that provide physiological sensing and receive signals and / or transmit them to a separate receiver, and / or a microphone and electronic system capable of providing auditory signals and instructions (e.g., instructing a rescuer to breathe faster or slower).

[0039] An embodiment of the IRV (300) is illustrated in FIGS. 3a and 3b. The IRV (300) may function in a manner similar to the IRV (100, 200) and may include any of the features described above. The IRV (300) includes a housing (320) that defines a central aperture (328) capable of accommodating a ventilation port (304) for connecting the IRV (300) to a ventilation device. The ventilation port (304) may be fitted inside the housing (320) and may include a flange (330) capable of holding the ventilation port (304) in place within the central aperture (328). The flange (330) may define a plurality of apertures (332) extending through the thickness of the flange (330) at a location radially outside the central aperture (328). The apertures (332) may be in fluid communication with an atmospheric pressure source. The IRV (300) may include a patient port (306) configured to be paired with a patient interface such as a face mask, an endotracheal tube, other airway devices and / or other interfaces (not shown). The patient port (306) may have a structure similar to a ventilation port (304) and may include a flange (334) defining a plurality of exhalation ports (316) in the form of an aperture. The housing (320) defines an interior in which a valve structure similar to the valve arrangement of the IRV (100, 200) is placed. The exhalation ports (316) may expose the rear surface of one or more valves of the IRV (300) to atmospheric pressure.

[0040] Similar to IRV (200), IRV (300) may include three concentric channels, but other arrangements are also possible. As illustrated, the central support (322) defines a central lumen (302) which may be annular in shape. The annular lumen (302) may serve as a positive pressure channel similar to the positive pressure lumen (102b and / or 202b). The bottom of the central support (322) may define a plurality of apertures (338) that fluidly engage with the annular lumen (302). A diaphragm (310) may seal the top of the annular lumen (302). The diaphragm (310) may have a cracking pressure substantially equal to atmospheric pressure. A one-way valve (312), such as a duck-bill valve, is positioned inside and / or at the bottom of the annular lumen (302) to prevent fluid from entering the annular lumen (302) and / or ventilation port (304), while air passes through the patient port (306) and is subsequently delivered to the patient's airway while preventing exhalation. The one-way valve (312) may be similar to the one-way valve (112) and / or flow backflow valve (212) described above. When operated, a positive pressure airflow can be opened to flow through the diaphragm (310) and the one-way valve (312) can be forcibly opened before passing through the patient port (306) into the patient's airway. The one-way valve (312) may have a cracking pressure of less than 1 mmHg, possibly 0 mmHg, so that the one-way valve (312) can be opened by any positive pressure breathing. By designing the diaphragm (310) and the one-way valve (312) to have a low cracking pressure, the breathing gas is delivered to the patient's airway through the IRV (300) with minimal or no resistance from the IRV (300).

[0041] The central plate (340) may be seated on the central support (322) below the flange (330) of the ventilation port (304). The central plate (340) may define a plurality of apertures (342) arranged in an annular pattern. The central plate (340) may also define a central aperture (344), which may serve as an intake port that allows intake gas to enter the IRV (300) in the case of spontaneous intake. The apertures (342) of the central plate (340) may be aligned with the apertures (332) of the flange (330). An atmospheric diaphragm (310) may be positioned between the apertures (342) and the apertures (332). The atmospheric diaphragm (310) can enable airflow to enter the IRV (300) through the aperture (332) and aperture (342) when a specific cracking pressure is met, which will be explained in more detail below.

[0042] The safety check valve assembly may be positioned within the central support (322) to allow voluntary breathing with a low level of resistance. For example, the safety check valve (308) may be positioned around the central aperture (344) of the central plate (340). The safety check valve (308) may be configured to seal the central aperture (344) of the central plate (340) when in the closed position and to allow airflow into the annular lumen (302) when in the open position. The safety check valve (308) may be biased toward the closed position by a spring (362). For example, the base of the spring (362) may be positioned against the base of the central support (322), and the upper part of the spring (362) may be pressed against a piston (364). The piston (364) may be positioned against the lower part of the safety check valve (308). The spring force of the spring (362) can be selected to provide a cracking pressure of the safety check valve (308) in the range of -5 to -20 cm of water, and often less than about -12 cm of water. This can enable the safety check valve (308) to open and deliver air to the patient port (306) when the patient is receiving CPR and / or the patient is breathing spontaneously, and when a sufficiently strong vacuum is created when the chest recoils.

[0043] The exhalation port plate (370) may interface with the lower central support (322). The exhalation port plate (370) may form a plurality of apertures (372) that fluidly communicate with the annular lumen (302). The apertures (372) may be aligned with the exhalation port (316) of the flange (334) of the patient port (306). The exhalation port plate (370) may also define a central aperture (374) that is aligned with the patient port (306) and can accommodate the end of the one-way valve (312). A valve seat (376) may be positioned around the central aperture (374). The valve seat (376) allows the outer surface (318) of the one-way valve (312) to seal the exhalation path of the IRV (300) when the outer surface (318) is pressed against the valve seat (376). The exhalation valve (314) may be positioned between the aperture (372) and the exhalation port (316). The exhalation port (316) may provide atmospheric pressure to the rear of the exhalation valve (314) to keep the exhalation valve (314) in a closed position in the absence of pressure from the exhalation fluid. The exhalation valve (314) may be annular in shape, and the exhalation valve (314) may be a one-way valve oriented to allow the exhalation flow to exit the IRV through the aperture (372) while preventing the airflow from entering the IRV (300) through the aperture (372).

[0044] In some embodiments, a filter (390) may be provided below the aperture (372). The filter (390) may be a HEPA filter capable of preventing harmful bacterial particles (bacteria and viruses) from contaminating the air around the patient, thereby protecting the rescuer from possible infection. A filter plate (392) may be positioned below the filter (390) and may be coupled to the bottom end of the housing (320) to secure the internal components of the IRV (300) within the housing (320). The filter plate (392) may define a plurality of external exhalation ports (394) that allow exhaled air to be filtered and subsequently vented from the interior of the IRV (300) or otherwise discharged.

[0045] In some embodiments, the one-way valve (312) and the outer surface (118) of the one-way valve (312) may operate as a single "non-rebreather" valve adjacent to the patient port (306), which can prevent mixing of inspiratory and exhaled airflow. For example, when the central valve portion of the one-way valve (312) (e.g., a duck-bill valve, etc.) is opened, positive pressure ventilation from the ventilation port (304) to the patient port (306) is made possible with substantially no resistance, whereas the outer surface (118) is positioned against the valve seat (376) to seal the exhaled airway. When breathing gases leave the patient, the chest is compressed, or when the patient exhales, these gases are pushed away from the outer surface (118) of the valve seat (376) to block the non-rebreathing valve, thereby opening the exhalation path to discharge exhaled air from the IRV (300) through the outer exhalation port (304) and / or filter (390), while the central valve portion of the one-way valve (312) closes to seal the inhalation path. The use of such a non-rebreathing valve can provide several advantages. For example, such a valve can eliminate or reduce the possibility of rebreathing exhaled carbon dioxide-rich gas when the valve's dead space is small, allow the IRV (300) to be utilized in spontaneous and / or controlled breathing applications, and enable the airflow volume to be measured to be finely divided.

[0046] The IRV (300) defines an exhalation path that operates in a manner similar to the exhalation lumen (102c) and exhalation path (202c) described above. The exhalation flow path is generally annular in shape and extends around the central lumen (302). The exhalation flow path allows exhalation gas and / or other fluids of the patient to be discharged out of the IRV (300). The exhalation path extends from the patient port (306) through the gap between the valve seat (376) and the outer surface (318) of the one-way valve (312) and passes through the aperture (372), exhalation valve (314), and filter (390) before exiting through the outer exhalation port (394). For example, pressure from the exhalation flow can force the entire one-way valve (312) upward so that the outer surface (318) is separated from the valve seat (376) to form a gap that provides access to the exhalation flow path. The exhalation path may be sealed from the ventilation port (304) and the annular lumen (302) to prevent any exhalation fluid from passing through the ventilation port (304) and the annular lumen (302). For example, a one-way valve (312) and a rigid wall of the housing (320) prevent the exhalation path from fluidly communicating with the ventilation port (304) and the annular lumen (302) during the operation of the IRV (300). The exhalation valve (314) may have a cracking pressure of about 0 to 10 mmHg or may be variable and adjustable. This causes the exhalation valve (314) to open when fluid (gas and / or liquid) is expelled from the patient's airway, allowing the fluid to exit the IRV (300) through the external exhalation port (394). For example, when chest compressions are applied during CPR, air is expelled from the patient's lungs. This air can pass through the exhalation valve (314) and exit the external exhalation port (394). Similarly, patient exhalation can flow out of the external exhalation port (394) through the exhalation valve (314).In some embodiments, pulmonary edema may occur, which may cause fluid that can be exhaled by the patient and delivered into the IRV (300) through the patient port (306). This fluid may also pass through the exhalation valve (314) and exit through the external exhalation port (394).

[0047] The IRV (300) defines a patient inspiratory passage that operates in a manner similar to the patient inspiratory lumen (102a) and patient inspiratory passage (202a) described above. The patient inspiratory passage is generally annular in shape and extends around the annular lumen (302). The patient inspiratory passage partially overlaps the lower part of the exhalatory passage and extends annularly outward from the upper part of the exhalatory passage connected to the safety check valve (308). For example, the patient inspiratory passage may extend from the ventilation port (304) and through the central aperture (344) of the central plate (340), the safety check valve (308), the annular lumen (302), the aperture (338), the one-way valve (312), and the patient port (306). The safety check valve (308) may be opened so that in the event of spontaneous inspiration by the patient, breathing gas can be inhaled into the patient's airway through the central aperture (344). Often, the safety check valve (308) has a cracking pressure of about -5 to -20 mmHg.

[0048] Although the exhalation valve (314) and safety check valve (308) are generally depicted as being annular, other types of valves are possible in some embodiments. For example, one of the two valves may be in the form of an individual valve located at one or more positions of the IRV (300). As one example, the exhalation valve (314) and safety check valve (308) may be in the form of an exhalation valve or an ore-bill valve. The IRV (300) may include one or more of each valve located at separate positions.

[0049] FIG. 1 and FIG. 3c through 3f illustrate the operation of the IRV (300) under different breathing conditions, as indicated by the arrow in FIG. 2. As illustrated in FIG. 3c through 3e, the flow path of breathing air during positive pressure ventilation, spontaneous inhalation, and exhalation can be aligned concentrically around the axis of the IRV (300). The arrow in FIG. 3c illustrates the airflow through the IRV (300) during the delivery of positive pressure ventilation. Positive pressure ventilation can be delivered using a manual and / or automatic respirator coupled with a ventilation port (304). During ventilation, air is typically forced into the IRV (300) through the ventilation port (304), and the atmospheric diaphragm (310) is forced open. The air then enters the annular lumen (302) and aperture (338) before passing into the interior of the one-way valve (312). Then, air is forced open through the one-way valve (312) and delivered to the patient's airway through the patient port (306). During positive pressure ventilation, the safety check valve (308) and the exhalation valve (314) remain closed so that all air delivered by the respirator is delivered to the patient. In some embodiments, the one-way valve (312) opens with each positive pressure breath and simultaneously blocks the exhalation gas from exiting through the exhalation port (304). For example, the outer surface (318) of the one-way valve (312) may block the exhalation flow path by blocking the opening (372) from the exhalation gas by facing the valve seat (376) of the exhalation port plate (370). In this configuration, the one-way valve (312) may preferably be designed as a mouth valve or duck-bill valve that provides two functions: 1) to prevent backflow of gas and fluid from the lungs, and 2) to block the exhalation port structure during positive pressure ventilation.

[0050] In some cases, the patient may spontaneously inhale by creating a negative pressure within the chest that causes air to be drawn into the patient port (306), as indicated by the arrow in FIG. 3d. The negative pressure within the chest opens the one-way valve (312), and when the negative pressure is sufficiently low, the safety check valve (308) can be pulled downward against the spring force of the spring (362). Then, air can be drawn from the ventilation port (304) through the central aperture (344) into the annular lumen (302) and aperture (338). During spontaneous inhalation, the negative pressure within the chest keeps the exhalation valve (314) in the closed position and biases the outer surface (318) of the one-way valve against the valve seat (376). The atmospheric diaphragm (310) remains in the closed position during spontaneous inhalation. With the configuration described above, the patient can gasp for air on their own without the use of a pressure sensor, as the valve system opens properly. Rather, such spontaneous intake is possible due to a cracking pressure in the range of -5 to -20 cm H2O and an arrangement of various valves. In an alternative embodiment, this cracking pressure range can be adjusted, for example, by changing the spring tension within the safety check valve.

[0051] When the chest is compressed (manually and / or automatically) or when the patient breathes, the breathing gas flows out of the patient and through the IRV (300) as illustrated by the arrow in FIG. 3e. For example, the exhaled gas passes through the patient port (306) and causes the outer surface (318) of the one-way valve (312) to move away from the valve seat (376) to provide access to the aperture (372). The exhaled gas can be forced to pass through the exhaled valve (314), which opens the filter (390) and the external exhaled port (394). Due to the operating direction of the safety check valve (308) and the one-way valve (312), these valves (308, 312) remain closed during patient exhalation. This arrangement is particularly useful for patients suffering from pulmonary edema, where fluid may accumulate in the lungs that can be exhaled through the IRV (300). Due to the one-way valve arrangement of the IRV (300), all body fluids (exhaled gas and / or pulmonary edema fluid) are guided through the exhalation valve (314) and discharged through the external exhalation port (394), preventing the passage of pulmonary edema fluid and / or preventing interference with the proper operation of the safety check (308) and the one-way valve (312). Additionally, the valve arrangement of the IRV (300) effectively separates the inspiratory flow and the exhalation flow so that exhaled gas does not mix with inspiratory gas. This allows for the delivery of a higher concentration of oxygen to the patient during CPR, thereby allowing for higher oxygen levels in the patient's bloodstream and consequently achieving improved resuscitation results.

[0052] During the decompression phase of CPR, the chest wall recoils as the rescuer's hands are lifted. In the case of ACD-CPR, the chest is actively decompressed, such as by pulling the chest upward using a suction cup and / or adhesive. During this phase of CPR, negative pressure is created within the chest (below the cracking pressure of the safety check valve (308)). Fig. 3f illustrates the state of the IRV (300) during the decompression phase of CPR. The safety check valve (308), exhalation valve (314), and atmospheric diaphragm (310) are closed to prevent breathing gases from entering the patient. By preventing breathing gases from entering the patient through multiple cycles of chest compression and chest recoil, increasingly less air is present within the chest wall, providing space for increasingly more blood to return to the heart during the chest wall recoil phase. This increases circulation to the coronary arteries and lowers intracranial pressure during the chest wall decompression phase, thereby increasing the success rate of resuscitation.

[0053] The drawings shown in this specification represent potential paths for gas exchange in and out of the patient, but the dimensions of the IRV (300) are representative but not accurate scale and are not accurate to only one of the many potential valve mechanisms (e.g., duck-bill valve, ball valve, annular valve, circular valve, balloon valve, grooved valve, mushroom-shaped valve, disc valve, etc.) shown in FIGS. 3a through 3f.

[0054] In some embodiments, the IRV (300) may be described by the number of regions. For example, the IRV (300) may include an upper region, a lower region, and an exhalation region. The diaphragm (310) and / or safety check valve (308) may separate the upper region from the lower region so that the upper region may include any portion of the IRV included in the inhalation path on the ventilation port side of the safety check valve (308) which includes the diaphragm (310) and / or ventilation port (304). The lower region of the IRV (300) may include all portions of the IRV (300) included in the inhalation path on the patient port side of the diaphragm (310) and / or safety check valve (308) which include an annular lumen (302), an aperture (338), and a patient port (306). The exhalation region may include all portions of the IRV (300) included in the exhalation path other than the ventilation port (304). For example, the exhalation area may include a gap between the outer surface (318), the valve seat (376), the aperture (372), the filter (390), and the outer exhalation port (304). The lower area and the upper area may be separated by two valves (which may be considered as a single non-rebreather valve in some embodiments). For example, a one-way valve (312) may be placed between the lower area and the upper area and may be closed to prevent all exhalation fluid from flowing into the upstream area when the pressure in the chest is greater than atmospheric pressure. The interface between the outer surface (118) and the valve seat (376) may be closed to occlude the exhalation area when the pressure in the patient port (304) is lower than atmospheric pressure, and may be opened to allow exhalation fluid to be discharged from the IRV (300) when the pressure in the patient port (304) is higher than atmospheric pressure.

[0055] In some embodiments, the IRV (300) is one or more sensors. For example, the IRV (300) may include a sensor (400) located within the ventilation port (304) and / or a sensor (402) located within the patient port (306), as illustrated in FIG. 4. For example, the sensors (400 and / or 402) may be physiological sensors, such as pressure sensors and / or flow sensors. Measurements from the sensors (400 and / or 402) may be used to determine a chest compression / decompression cycle. Data from the sensors (400, 402) may be transmitted to a ventilation device and / or chest compression device using a communication interface that includes one or more wired and / or wireless connections, including a Bluetooth connection. Compression / decompression cycle data may be used by the ventilation device and / or chest compression device to synchronize the delivery of positive pressure breathing with the compression / decompression cycle. One or more indicator mechanisms, such as lighting and / or a display screen, may be provided on or inside the IRV (300). For example, one or more lights (404) may be placed on or inside the housing (320). The lights (404) may indicate various parameters such as the phase of the ventilation cycle, the timing of the ventilation rate, and / or a specific pressure level within the IRV (300).

[0056] In some embodiments, the IRV (300) may be configured to detect pressure within the chest. For example, the IRV (300) may include a lumen (500) that is fluidly connected and directly extends between the patient port (306) and the ventilation port (304), as illustrated in FIG. 5. A one-way valve (502) may be included within the lumen (500). With each chest compression, a portion of the exhaled air flow may pass through the one-way valve (502) (most of the exhaled air flow passes through the exhalation valve (314)). In an alternative embodiment, the lumen (500) may be sealed at the patient port and the ventilation port with a pressure-sensing material, for example, a membrane, so that pressure can be easily transmitted but fluid and / or gas cannot be transmitted from the patient port to the ventilation port. In some such embodiments, the sealed portion may be filled with fluid or gas to facilitate pressure conversion. As described above, this allows pressure within the chest to be detected using a sensor within the ventilation port (304) for synchronization of positive pressure breathing delivery. In some embodiments, the IRV (300) may be connected to the ventilation circuit, and the lumen of the patient port may be connected to a sensor within the patient port area or the ventilation circuit. In such embodiments, the IRV (300) may be reversibly or irreversibly coupled to the ventilation source or the ventilation source circuit.

[0057] Examples

[0058] In anesthetized pigs, CPR was performed using an automated device that provided compression and active decompression. As described herein, a functional IRV including an inspiratory port and a separate expiratory port (similar to the IRV 300) was attached to the endotracheal tube, and pressure was measured at the patient port level using a pressure transducer. With each positive pressure, the respiratory airway pressure was increased to approximately 20 mmHg and decreased to approximately -5 mmHg during each decompression step, as shown in Fig. 6.

[0059] The IRV described herein may be used in conjunction with physiological sensors, airflow sensors, pressure transducers, timing and / or status indicators, impedance sensors for detecting the air / blood ratio in the chest, and / or other interfaces of a controller or CPR device, ventilator and / or AED, to provide feedback regarding the method of performing CPR, delivering positive pressure ventilation, and / or delivering a shock to the patient. Additionally, information and further control from these sensors, transducers, lights, detectors, and other controllers may be transmitted via direct connection between devices, Bluetooth, and other non-hardwired communication means. Furthermore, in some embodiments, a one-way valve (108), a vacuum valve (208), and / or a safety check valve (308) may be combined with a "gasping gauge" or sensor that detects when each valve is opened. The sensor may trigger the activation of light and / or sound to notify the rescuer that the patient is attempting to breathe.

[0060] The methods, systems, and devices discussed above are exemplary. Some embodiments have been described as processes illustrated as flowcharts or block diagrams. While each may be described as a sequential process, many tasks may also be performed in parallel or simultaneously. Additionally, the order of tasks may be rearranged. The process may include additional steps not included in the drawings. All test methods described herein may be based on test standards in use at the time of submission or test standards developed after submission.

[0061] The systems and devices discussed above are for illustrative purposes only. It should be emphasized that various embodiments may appropriately omit, substitute, or add various procedures or components. Furthermore, features described in relation to a specific embodiment may be combined in various other embodiments. Different aspects and elements of the embodiments may be combined in a similar manner. Additionally, as technology advances, many components are illustrative and should not be interpreted as limiting the scope of the invention.

[0062] Specific details are provided in the description to provide a complete understanding of the embodiments. However, it will be understood by those skilled in the art that the embodiments may be practiced without these specific details. For example, well-known structures and techniques are illustrated without unnecessary details to avoid obscuring the embodiments. This description provides only exemplary embodiments and is not intended to limit the scope, applicability, or configuration of the invention. Rather, the foregoing description of the embodiments will provide those skilled in the art with possible descriptions for implementing the embodiments of the invention. Various changes may be made to the function and arrangement of elements without departing from the spirit and scope of the invention.

[0063] Although various embodiments have been described, those skilled in the art will recognize that various modifications, alternative configurations, and equivalents may be used without departing from the spirit of the invention. For example, the above elements may simply be components of a larger system, and other rules may take precedence over the application of the invention or be otherwise modified. Additionally, various steps may be performed before, during, or after considering the aforementioned elements. Accordingly, the above description should not be construed as limiting the scope of the invention.

[0064] Additionally, the words “include,” “equip,” “have,” “contain,” and “comprising” as used in this specification and the following claims specify the presence of the specified function, integer, component, or step, but do not exclude the presence or addition of one or more other functions, integers, components, steps, membranes, or groups.

[0065] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as generally or commonly understood. As used herein, the article “one” refers to one or more than one (i.e., at least one) of the grammatical objects of the article. For example, “element” means one element or one or more elements. When referring to measurable values ​​such as quantities, durations of time, etc., as used herein, “about”; and / or “approximately” includes a variation of ±20% or ±10%, ±5% or +0.1% from a specific value, provided that such variation is appropriate in the context of the system, device, circuit, method, and other implementation described herein. When referring to measurable values ​​such as quantities, durations of time, physical properties (e.g., frequency), etc., as used herein, “substantially” includes a variation of ±20% or ±10%, ±5% or +0.1% from a specific value, provided that such variation is appropriate in the context of the system, device, circuit, method, and other implementation described herein.

[0066] As used herein, including in the claims, “and” used in the list of items indicates that any combination of the listed items may be used, beginning with “at least one of the following” or “one or more of the following.” For example, a list of “at least one of A, B, and C” includes any combination of combinations A or B or C or AB or AC or BC and / or ABC (i.e., A and B and C). Additionally, multiple uses of A, B and / or C may form part of the combinations considered, to the extent that one or more occurrences or uses of item A, B, or C are possible. For example, a list of “at least one of A, B, and C” may also include AA, AAB, AAA, BB, etc. Explanation of the symbols

[0067] 100: IRV 102: Lumen 102a: Patient inspiratory lumen 102b: Positive pressure ventilation lumen 102c: Patient exhalation lumen 104: Ventilation port 106: Patient Port 110: Diaphragm 112, 114: One-way valves 116: Hogi Port 118: Ventilation port

Claims

Claim 1 In an inspiratory resistor valve system for controlling intrathoracic pressure during positive pressure breathing, spontaneous inspirations, and CPR, the system comprises: an inspiratory port; a patient port; a separate expiratory port; a first atmospheric pressure sensing valve that allows inspiratory flow through the inspiratory port when open; and a second atmospheric pressure sensing valve that allows exhalatory flow through the exhalatory port, wherein at least one of the first atmospheric pressure sensing valve and the second atmospheric pressure sensing valve isolates the exhalatory port and the inspiratory port from each other. An intake resistance valve system characterized by comprising: a safety check valve having a cracking pressure of -5 to -20 mm Hg, wherein, while the first atmospheric pressure sensing valve is closed, the safety check valve is opened to allow intake flow, so that fluid flows from the intake port through the patient port while the patient is performing voluntary intake. Claim 2 An intake resistance valve system according to claim 1, characterized in that the first atmospheric pressure sensing valve, the second atmospheric pressure sensing valve, and the safety check valve are arranged in concentric circles. Claim 3 An inspiratory resistance valve system according to claim 1, wherein the first atmospheric pressure sensing valve and the second atmospheric pressure sensing valve close the exhalation port during positive pressure breathing delivery, and the first atmospheric pressure sensing valve and the second atmospheric pressure sensing valve close the inspiratory port and open the exhalation port to enable the patient's breathing gas expulsion during exhalation or chest compression. Claim 4 An inhalation resistance valve system according to claim 1, characterized in that the first atmospheric pressure sensing valve, the second atmospheric pressure sensing valve, and the safety check valve located in the area of ​​the inhalation port and the exhalation port are maintained in a closed position until the pressure in the patient port becomes water of -5 to -20 cm. Claim 5 An intake resistance valve system according to claim 1, characterized in that at least one of the filter interfaced with the exhalation port and the third atmospheric pressure sensing valve provides an exhalation resistance of water of 2 to 10 cm. Claim 6 An intake resistance valve system according to claim 1, wherein each of the first atmospheric pressure sensing valve, the second atmospheric pressure sensing valve, and the safety check valve comprises a one-way valve selected from the group consisting of a duckbill valve, a ball valve, an annular valve, a round valve, a butterfly valve, a check valve, a balloon valve, a mushroom-shaped valve, a fish mouth valve, and a disc valve. Claim 7 An intake resistance valve system according to claim 1, characterized in that the second atmospheric pressure sensing valve operates as a non-rebreather valve enabling resistance-free positive pressure ventilation from the intake port to the patient port. Claim 8 In an intake resistance valve (IRV) system, the intake resistance valve system comprises: a housing having an upper region, a lower region, and an expiratory region; a first pressure-responsive unidirectional valve disposed between the upper region and the lower region to enable positive pressure ventilation with an H2O resistance of 5 cm or less and to block the flow of all breathing gas from the upper region to the lower region when the pressure in the lower region is less than atmospheric pressure; a second pressure-responsive valve disposed between the upper region and the lower region that remains closed until the pressure in the lower region drops below a threshold level, wherein the threshold level is a pressure difference between atmospheric pressure and the pressure in the lower region, causing the second pressure-responsive valve to open and allow breathing gas to flow into the patient's lungs; and a third pressure-responsive valve disposed between the upper region and the expiratory region to prevent all expiratory fluid from flowing to the upper region when the pressure in the chest is greater than atmospheric pressure. An inspiratory resistance valve system characterized by including: a fourth pressure response valve in the exhalation zone that is closed when the pressure in the lower zone interfacing with the patient is below atmospheric pressure and opens when the pressure in the lower zone interfacing with the patient exceeds atmospheric pressure. Claim 9 An intake resistance valve system according to claim 8, characterized in that the threshold level is water of -5 to -20 cm. Claim 10 An intake resistance valve system according to claim 8, characterized by including a physiological sensor disposed within one or both of an upper region and a lower region. Claim 11 An intake resistance valve system according to claim 10, further comprising a communication interface that transmits a signal from a physiological sensor to one or both of a ventilation device and a compression device. Claim 12 An intake resistance valve system characterized by further including a filter interfacing with the exhalation area in claim 8. Claim 13 An inspiratory resistance valve system according to claim 8, wherein the second pressure response valve comprises a duck-bill valve having an outer surface that optionally engages with a valve seat; wherein the duck-bill valve is opened to allow inspiratory flow to be delivered to the patient, but the outer surface engages with the valve seat to block the expiratory region in the upper region; and wherein the duck-bill valve is closed so that the outer surface moves away from the valve seat to discharge expiratory fluid from the inspiratory resistance valve system and prevent expiratory fluid from flowing into the upper region. Claim 14 In an inspiratory resistance valve system, the inspiratory resistance valve system comprises: a housing; a ventilation port configured to interface with a ventilation device; a patient port configured to interface with a patient interface device; a separate expiratory port; a positive pressure ventilation path configured to guide breathing air from the ventilation port to the patient port as a positive pressure ventilation path fluidly communicating with the ventilation port and the patient port; and a patient inspiratory path configured to deliver air to the patient port in the event of the patient's spontaneous inspiration as a patient inspiratory path fluidly communicating with the patient port. An inspiratory resistance valve system comprising: an exhalation path fluidly communicating with a patient port, wherein the exhalation path guides exhaled fluid from the patient to outside the inspiratory resistance valve system through the exhalation port, and wherein the exhalation path is separated from at least a portion of a positive pressure ventilation path and a patient inspiratory path through a series of pressure response valves to separate inflow and outflow, so that the exhaled fluid is not mixed with inspiratory gas, thereby delivering a higher concentration of O2 to the patient during CPR; wherein the series of pressure response valves comprises: a first atmospheric pressure valve interfacing with the positive pressure ventilation path; a first pressure sensing valve interfacing with the patient inspiratory path; a second pressure sensing valve interfacing between the inspiratory path and the exhalation path; and a second atmospheric pressure valve disposed within the exhalation port. Claim 15 delete Claim 16 An intake resistance valve system according to claim 14, characterized in that the closing pressure of the first atmospheric pressure valve is less than -1 cm H2O; the opening pressure of the first pressure sensing valve is -5 to -20 cm H2O; the second pressure sensing valve is opened when the pressure of the ventilation path is greater than 0 cm H2O and closed when the pressure of the exhalation path is greater than 0 cm H2O; the opening pressure of the second atmospheric pressure valve is 0 to 10 cm H2O; and the closing pressure of the second atmospheric pressure valve is less than -1 cm H2O. Claim 17 An intake resistance valve system according to claim 16, characterized in that the second pressure sensing valve and the second atmospheric pressure valve form a single non-rebreather valve. Claim 18 An inspiratory resistance valve system according to claim 14, characterized in that the second atmospheric pressure valve allows breathing fluid to enter the patient but prevents breathing fluid from the lungs from coming into contact with the first atmospheric pressure valve. Claim 19 In paragraph 14, while positive pressure ventilation is being delivered, the first atmospheric pressure valve and the second atmospheric pressure valve are opened, and the first pressure sensing valve and the second pressure sensing valve are closed; during spontaneous inspiration, the first pressure sensing valve and the second atmospheric pressure valve are opened, and the first atmospheric pressure valve and the second pressure sensing valve are closed; during one or both of the chest compression phase of CPR and patient expiration, the second pressure sensing valve is opened and the first atmospheric pressure valve, the first pressure sensing valve, and the second atmospheric pressure valve are closed, so that the breathing fluid exits the inspiratory resistance valve system without mixing with the inspiratory gas; during the decompression phase of CPR, the first atmospheric pressure valve, the first pressure sensing valve, and the second pressure sensing valve are closed to lower the intrathoracic pressure, prevent breathing gas from entering the patient, and provide space for increased blood volume, thereby increasing circulation to the patient's coronary arteries and intracranial pressure Intake resistance valve system characterized by lowering resistance. Claim 20 An intake resistance valve system according to claim 14, comprising: a first diaphragm connected to the upper surface of a positive pressure ventilation path; and a second diaphragm connected to the lower surface of an exhalation path, wherein the first diaphragm and the second diaphragm each have a cracking pressure that is atmospheric pressure.

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