JP5628669B2 - Artificial respiratory apparatus and system for ventilation - Google Patents

Description

(Claim priority on related applications)
This application claims the benefit of the priority date of a co-pending and co-pending US Provisional Patent Application No. 60 / 924,835 (filed Jun. 2, 2007), which is the sole and common inventor Nader Maher. In the name of HABASHHI, it is filed under the name “VENTILATOR APPARATUS AND SYSTEM FOR VENTILATION”, the entirety of which is incorporated by reference as fully described herein.

(Field of Invention)
The present invention relates to pulmonary ventilation in human patients. More specifically, the present invention relates to improved ventilators, and interventions and initiation of pulmonary ventilation, oxygen supply, supplementation, ventilation, initial withdrawal, airway pressure release ventilation withdrawal, continuous positive airway pressure withdrawal and continuous And it relates to an improved operating method of periodic ventilator management and control.

(Description of related technology)
The inventor of the present invention invented the ventilator system and method of operation previously disclosed and claimed in Patent Document 1 and Patent Document 2, Patent Document 3, and Patent Document 4 among other inventions, All of which are incorporated by reference as if fully set forth herein.

  Airway pressure release ventilation (APRV) is a mode of ventilation that is believed to provide an advantage as a ventilator strategy to protect the lungs. APRV is a form of continuous positive airway pressure (CPAP) with an intermittent release phase from preset CPAP levels. Similar to APRV, maintaining a substantially constant airway pressure allows optimizing end inspiration / pressure and lung replenishment. CPAP levels optimize lung recruitment to prevent or limit low volume lung injury. In addition, CPAP levels provide preset pressure limits to prevent or limit excessive inflation and high volume lung injury.

  Intermittent release from CPAP levels increases alveolar ventilation. Intermittent CPAP release achieves ventilation by reducing airway pressure. In contrast, conventional ventilation increases the airway pressure for tidal volume. Increasing the airway pressure for ventilation increases lung volume towards total lung volume (TLC) and approaches the upper inflection point of the airway pressure-volume curve (PV curve), or Beyond that. The PV curve includes two parts joined by upper and lower inflection points, such as inspiration or inspiration, opposite to exhalation or exhalation. Limiting ventilation below the upper inflection of the PV curve is one of the goals of the lung protection strategy.

  Subsequently, a reduction in tidal volume is necessary to limit the possibility of excessive inflation. The reduction in tidal volume results in alveolar hypoventilation and elevated carbon dioxide levels. Reduced alveolar ventilation by reducing tidal volume has led to a strategy to increase respiratory frequency and avoid the adverse effects of hypercapnia. However, increased respiratory frequency is associated with increased lung injury. In addition, increased breathing frequency decreases inspiratory time and reduces the likelihood of replacement. Furthermore, increasing the breathing frequency increases the frequency dependence and reduces the possibility of ventilation on the exhalation part of the PV curve.

  During APRV, ventilation occurs on the expiratory part of the pressure-volume curve. The resulting exhaled tidal volume reduces lung volume and eliminates the need to increase inspiratory end pressure above the upper inflection point. Therefore, it is not necessary to reduce the tidal volume. The CPA level can be set for the purpose of optimizing replenishment without increasing the possibility of excessive swelling. As a result, the end-inspiratory pressure can be limited while maintaining ventilation despite more complete replenishment.

  APRV was developed to provide ventilator support for patients with respiratory failure. The clinical use of APRV is associated with reduced airway pressure, reduced dead space ventilation, and lower intrapulmonary short circuit compared to conventional metered and pressured ventilation. APRV limits excessive swelling of the lung units, thereby reducing the possibility of ventilator-induced lung injury (VILI), a form of lung burden. In addition, APRV reduces minute ventilation requirements, enables spontaneous breathing efforts, and improves cardiac output.

  APRV is a form of positive pressure ventilation that increases alveolar ventilation and reduces maximum airway pressure. Previously reported data for APRV has demonstrated an approximately 30-40 percent reduction in airway pressure during demonstration and clinical studies compared to conventional metered and pressured ventilation. Such a reduction in airway pressure may reduce the risk of VILI. APRV improves the matching of ventilation to perfusion ratio (VA / Q) and reduces the short circuit rate compared to conventional ventilation. Studies conducted utilizing multiple inert gas dilution and evacuation techniques (MIGET) have demonstrated less short-circuit rate and dead space ventilation. Such studies suggest that APRV is associated with more uniform inspiratory gas distribution and less dead space ventilation than traditional positive pressure ventilation.

  APRV is associated with the reduction and elimination of sedatives, inotropics, and neuromuscular blockers. APRV has also been associated with improved hemodynamics. A 10-year review of APRV reported that Calzia had no harmful hemodynamic effects. Several studies have demonstrated improved cardiac output, blood pressure, and oxygen delivery. The study of APRV as an alternative to pharmacological or infusion therapy in patients with impaired hemodynamics and mechanical ventilation is recommended in several case reports.

  APRV is a spontaneous mode of ventilation that allows unlimited breathing effort at any time during the ventilator cycle. Spontaneous breathing in acute lung injury / acute respiratory distress syndrome (ALI / ARDS) is associated with improved ventilation and perfusion, reduced dead space ventilation, and improved cardiac output and oxygen delivery. ALI / ARDS is a pathological condition characterized by a marked increase in respiratory modulus and resistance.

However, most ALI / ARDS patients exhibit expiratory restriction. Expiratory flow limitation results in the generation of dynamic hyperinflation and endogenous breath positive end expiratory pressure (PEEP). In addition, ARDS patients experience increased flow resistance from external ventilator valve regulation and gas flow circuits, including external application of endotracheal tubes and PEEP.

  Several mechanisms can induce expiratory flow restriction in ALI / ARDS. In ALI / ARDS, both functional reserve (FRC) and expiratory flow reserve are reduced. The occurrence of pulmonary edema and superimposed pressure results in increased airway closure capacity and collection capacity. In addition, a reduced number of functional lung units (unsupplemented lung units or alveoli and increased airway closure) further reduces expiratory flow reserve. Low volume ventilation facilitates slight airway closure and gas collection. In addition, increased levels of PEEP increase expiratory flow resistance. In addition to downstream resistance, the maximum expiratory flow depends on lung volume. The elastic recoil pressure that is preserved with lung inflation determines the passive lung contraction rate.

  APRV expiratory flow is enhanced by the use of an open breathing system and the use of low (0-5 cm H2O) end expiratory pressure. Ventilation over the expiratory portion of the PV curve allows for lower PEEP levels and prevents airway closure. Lower PEEP levels occur when PEEP is used to prevent depletion rather than attempting partial replenishment. Increasing the PEEP level increases exhalation resistance, conversely, a lower PEEP reduces exhalation resistance, thereby accelerating the exhalation flow rate. Continuous inflation results in increased pulmonary recruitment (increased functional lung units and increased recoil pressure) and ventilation along the expiratory part (reduced PEEP and expiratory flow resistance), improving expiratory reserve.

  In addition, release from sustained high lung volume increases stored energy and recoil potential and further accelerates expiratory flow rate. Unlike low volume ventilation, release from high lung volume increases airway inner diameter and reduces downstream resistance. Maintaining end-expiratory lung volume (EELV) at the inflection point of the flow capacity curve and the use of an open system allows a reduction in circuit flow resistance. The EELV is maintained by limiting the release time and gradually increases to the inflection point of the time flow curve.

  A reduced end expiratory pressure level is required when ventilation occurs on the expiratory portion of the PV curve. In ALI / ARDS, increased capillary permeability results in pulmonary edema. Leaching from the vessel lumen accumulates, increasing the superimposed pressure on the ventilated lung region and compressing the void. The ventilation gap collapses and the compressed atelectasis leads to severe VA / Q mismatch and short circuit. The local pulmonary pressure gradient, present in normal lungs, is accentuated during the ALI / ARDS edema phase. The patient is typically in a supine position, and the force gradually directed to the dorsal and cranial sides increases the intrathoracic pressure in the ventilated lung region. Ventilation decreases as the intrathoracic pressure surrounding the ventilation area reduces the transalveolar pressure differential. Complete ventilatory support during controlled ventilation promotes the formation of ventilated atelectasis and increases VA / Q mismatch and intrapulmonary short circuit. Increasing airway pressure can re-establish a ventilated transpulmonary pressure difference, but there is a risk of excessive inflation of non-ventilated lung units.

  Alternatively, spontaneous breathing, like APRV, can increase the ventilation transpulmonary pressure differential without increasing airway pressure. APRV allows unlimited spontaneous breathing during any phase of the mechanical artificial respiratory cycle. As already mentioned, spontaneous breathing can reduce intrathoracic pressure and thereby increase the ventilatory transpulmonary pressure gradient without additional airway pressure. Increasing the ventilated transpulmonary pressure gradient improves replenishment and reduces VA / Q mismatches and shorts.

  Compared to pressure assisted ventilation (PSV) multiple inert gas dilution technique, APRV provides spontaneous breathing as well as improved VA / Q matching, intrapulmonary short circuit, and dead space. In addition, APRV with spontaneous breathing increased cardiac output. However, spontaneous breathing during pressure assisted ventilation was associated with improved V / Q agreement in ventilated lung units. PSV required a significant increase in pressure assist level (airway pressure) to match the same minute ventilation.

  Traditional pulmonary protection strategies are associated with increased use of sedatives and neuromuscular blockers (NMBA). Increased use of sedatives and NMBA may increase the time that a patient must remain on mechanical ventilation (“ventilation days”) and increase complications. NMBA is associated with the possibility of prolonged paralysis and nosocomial pneumonia. APRV is a form of CPAP that allows unlimited spontaneous breathing.

  Sedation and reduced use of neuromuscular blockade (NMBA) have been reported with APRV. In some facilities, APRV has almost eliminated the use of NMBA, resulting in a significant reduction in drug costs. In addition to reducing drug costs, the elimination of NMBA is believed to reduce the likelihood of related complications such as prolonged paralysis and may facilitate withdrawal from mechanical ventilation.

  Mechanical ventilation remains the mainstay management of acute respiratory failure. However, recent studies suggest that mechanical ventilation may create, persist, or increase the risk of acute lung injury (ALI). Ventilator-induced lung injury (VILI) is a form of lung burden failure associated with mechanical ventilation and acute lung injury. Animal data suggests that lung burden failure due to VILI may result in high or low volume ventilation. High capacity failure is a type of stretch injury that results from excessive expansion of the voids. In contrast, shear loading due to repeated airway closure during a single ventilation cycle with mechanical ventilation results in low volume lung injury.

  Initially, lung protection strategies focused on low tidal volume ventilation to limit excessive inflation and VILI. Amato utilized a lung protection strategy in 1995 and 1998 based on the pressure-volume (PV) curve of the respiratory system. A low tidal volume (6 ml / kg) limited ventilation between the upper and lower inflection points of the PV curve. End expiratory lung volume was maintained by setting the PEEP level to 2 cm H2O above the lower inflection point. Amato has demonstrated improved survival and increased number of days without artificial respirator.

  However, subsequent studies by Stewart and Bower were unable to demonstrate improved survival and increased number of days without artificial respirator using low tidal ventilation strategies. Unlike Stewart and Bower, Amato utilized elevated end expiratory pressure in addition to reducing tidal volume. Such significant differences between these studies limited the conclusion regarding the effectiveness of low tidal volume ventilation, which limits ventilator-related lung injury (VALI).

  The recent completion of the large-scale random ARDSNet trial improved survival by using lower tidal volume ventilation (6 ml / kg) compared to conventional tidal volume ventilation (12 ml / kg) And demonstrated days without artificial respirator. The low tidal volume group (6 ml / kg) and the traditional tidal volume group (12 ml / kg) utilized the same PEEP / FiO2 scale, but the PEEP level was significantly higher in the low tidal volume group it was high. Higher PEEP levels were required in the lower tidal volume group to meet the study oxygenation goals. Despite improved survival in the lower tidal volume group (6 ml / kg) compared to the traditional tidal volume group (12 ml / kg), survival was even higher in the Amato study. The ARDSNet test also failed to demonstrate a difference in the incidence of barotrauma. The possibility of significant endogenous PEEP with higher PEEP requirements and higher breathing frequency in the low tidal volume group may have obscured the potential contribution of increased end-expiratory pressure to survival. Further studies are considered to address the problem of elevated end expiratory pressure.

  In the prior art, the use of a quasi-static inspiration pressure versus volume (P-V) curve has been proposed as a reference for controlling a ventilator to perform mechanical ventilation. The shape of the intake PV curve is S-shaped and is represented as having three segments. The curve forms an upward concavity at low inflation pressures and a downward concavity at higher inflation pressures. There is a “straight” portion of the curve between the lower and upper concave portions. The pressure point that results in a rapid transition to the straight part of the curve is called the “lower inflection point”.

  The lower inflection point is thought to represent the replacement of atelectasis alveolar units. The increasing slope of the PV curve above the lower inflection point reflects alveolar flexibility. Above the inflection point, the majority of the voids are opened or “refilled”. Utilizing the lower inflection point of the inspiratory PV curve plus 2 cm H2O has been proposed to optimize alveolar recruitment. Optimizing lung replenishment prevents tidal volume replenishment / depletion and periodic airway closure at the end of expiration. Ultimately, optimizing lung recruitment can potentially reduce shear generation and low volume lung injury.

US Pat. No. 7,246,618 US Patent Application Publication No. 2008/0072901 US Patent Application Publication No. 2006/174848 US Patent Application Publication No. 2003/0111078

  Despite the increased knowledge of those skilled in the art regarding how to improve and maintain supplementation that minimizes the possibility of VILI and other abnormalities, prior art systems, devices, and methods remain the best practice protocol. It remains difficult to operate and adopt for use with. Due to a number of limitations, the challenges often addressed by those skilled in the intensive care breathing technology field require more automatic and more accurate means to apply the best practice APRV technique It is said that.

  More specifically, what has been needed for many years is an improved device that allows clinicians to easily configure and reconfigure the desired APRV approach to accommodate each patient's individual presentation. It is an operation mode. Preferably, such improved APRV devices and methods of use establish the ability to give clinicians a comprehensive starting point for suitable APRV parameters that can be quickly fine-tuned to meet the needs of a particular patient. To do.

  More preferably, such improved methods and ventilator devices also collect real-time patient status information used by clinicians in monitoring patient response to initial APRV parameters, and improved A more automatic feedback loop can be generated that allows the method or device to be automatically reconfigured within clinically favorable operations and protocol constraints. More preferably, new methods and approaches are needed that also allow for more precise and fine tuning of the various APRV parameters that are currently possible with modern equipment and methods that must be manually adjusted. Such manual adjustments often result in adverse patient response due to inaccurate adjustments or adjustments that cannot be made with sufficient accuracy due to the limitations or limited capabilities of currently available equipment.

  Most preferably, what is needed is greater flexibility, higher accuracy in adjusting various PV curves and related parameters to accommodate unexpectedly changing patient conditions, And a new and improved ventilator that incorporates new features and modes of operation that allow for faster clinical reaction times.

  A novel ventilator embodiment in accordance with the principles of the present invention satisfies many previously unmet needs and solves the problems of the prior art. Such features and capabilities are preferably, or optionally, for purposes of illustration and example, among other elements, but are not intended to be limiting and have been improved and in many conventional trials. It may include more accurate ventilation capacity than was possible.

  In one preferred configuration of the present invention, a ventilator or ventilator system for assisting a patient's respiratory function under the guidance of a clinician is provided with electrical or data inside and / or outside the ventilator. Consider a ventilator having a computerized operational controller or control module or computing device in electrical communication with a circuit or data network. The controller also preferably includes a display, which includes an application specific customized display that incorporates a data input or receiving device into the display with or without touch screen capability, or any other It can be a suitable display.

  The controller or computing device also preferably includes memory or storage capability, which may include a hard disk drive, a removable drive, and any desired form of storage device. Input devices are also desirable and can include, among others, a keyboard, mouse pointer, data input tablet, voice activated input device, and electronic media reading device.

  Additional studied input devices include network formation, data transfer, data collection, and electronic impedance tomography devices, ultrasound equipment, computerized and computer-aided tomography devices, digital output fluoroscopes, Wired and wireless communication components for data monitoring such as X-ray equipment, magnetic resonance imaging and spectroscopy equipment, minimally invasive surgical and bronchoscopy visualization devices, and monitoring communications from similarly capable equipment including.

  The ventilator of the present invention also preferably includes a gas supply pump and / or a pressurized gas source. A gas pump or source supplies positive pressure gas to the patient through a gas circuit or network of pipes, tubes, hoses, or other types of conduits. The gas network or circuit may also include at least one valve, more preferably a plurality of valves, and supply and exhaust ports. More preferably, multiple valves may be incorporated for actuation that may be in electronic communication with a controller or computing device.

  Such valves can typically be included in line with the supply and exhaust ports and can be operable in conjunction with various types of sensors discussed elsewhere herein. What is often called a check valve, which allows fluid flow in one direction but prevents fluid flow in the opposite direction. Such check valves may be included in the gas circuit or network to protect various components and patients from unexpected and / or undesirable pressures or pressure shocks. In this way, protection can be provided to the patient, pump or pressurized gas source, sensors, and other equipment.

  Other preferably optional embodiments of the present invention are directed to controlling ventilation and application of negative pressure, and the gas supply pumps or pressurized gas sources discussed are also preferably alone or as used herein. In combination with any of the other features described elsewhere, may incorporate negative pressure or vacuum capabilities that are considered to be compatible with use with negative pressure chest or whole body cylinders, which may also include ventilation and breathing techniques. It may also be referred to by those skilled in the art as a monophasic, biphasic, or polyphasic artificial lung or thorax ventilator.

  More preferably, the ventilator practiced in accordance with the present invention also preferably provides supply gas, inspiratory gas, expiratory gas pressure, and many different types of dynamic patient airway pressure at the inflection point at rest. It includes any number of optional detectors, sensors, or detection devices that can be used alone or in combination to sample and determine. Other useful sensors can be located outside the body in the case of the well-known capnometer (for detecting carbon dioxide concentration) or infrared pulse oximeter (for detecting oxygen concentration), Perimeter, center, and airway gas concentration sensors can be included.

  These types of devices can be attached to the tip of a finger, toe, or earlobe, which is highly capable of sampling, monitoring, and detecting ambient concentrations or saturation of carbon dioxide (SpO2) and oxygen (SpO2). Make it convenient. For other contemplated ventilation applications, centerline catheters or other techniques can allow monitoring of arterial O2 and CO2 gas concentrations (PaO2, PaCO2), which is the other part of this document. Certain ventilation modes or protocols described in can have clinical values. For the purposes of the present invention, such pressure and gas concentration sensors are more preferably ventilators so that real-time and / or near real-time data can be monitored, as will be described in more detail below. Configured to communicate electronically with the considered controller or computing device.

  The ventilator of the present invention may also be adapted to communicate with a data network, data circuitry, and / or directly with a controller or control module or computing device over a wireless or wired connection. Consider incorporating any number of equally suitable fluid flow rate sensors. Such flow rate monitoring devices may be used at multiple locations in a gas network or circuit to monitor supply, inspiration, total amount of exhaled gas, and the rate at which such occurs or has occurred. Can be adopted. With this information, the pressure is compared to the total volume or volume of gas or mass flow so that the new artificial respirator can better control and ensure proper ventilation of the patient's target respiratory system. be able to.

  In addition, such control can improve the accuracy with which pressurized gas is delivered to the patient, reducing the risk of lung injury by monitoring and maintaining gas flow rates within acceptable protocol limits. Can do. In any number of possible preferred configurations, any one or any number of ventilation-related parameters can be simultaneously used to maximize control of the ventilation procedure and ensure the best possible protocol execution under that circumstance. Sensors can be arranged as sensor arrays to be monitored. In many preferably optional configurations of the present invention, any of the described sensors may be located in the gas network or circuit, in proximity to the gas supply and / or exhaust ports, and / or It may be positioned around.

  The command module, command routine, algorithm, commander, firmware, or program may preferably reside in a memory or storage component of the controller or computing device. The command module is preferably via any of the input devices considered to control the sensor, to control the feed pump, to receive communications or images or information from other devices It is operable to receive input from a clinician or the like and to operate a display to provide prompts and / or to display important information regarding the ventilation process. The command module optionally communicates various ventilator information, preferably to other devices, other wireless or wired networks, displays for simultaneous viewing, and other remote devices and locations as desired. It may be configured to.

  Preferably, the control module may adjustably and / or variably activate the pump or pressure source to vary the volume and / or pressure supplied thereby. In addition, the control module or command routine more preferably, alone or with the control of the pump, for more precise control of the pressure, volume flow and gas supply cycle time available when ventilating the patient. In combination, any of the plurality of valves may be modified to operate automatically, manually, or otherwise. More preferably, the control module or command routine preferably coordinates such control of the valve with the sampling or reception of information from any of the considered sensors, anywhere in the gas circuit or network. Or for a patient undergoing ventilation, it may be adapted to establish increased accuracy in sampling one or more pressure measurements, gas concentrations, and / or volume or mass flow rate.

  The present invention also contemplates operational compatibility with any number of conventionally accepted, testing and experimental ventilation modes. More preferably, the operating capability of the present invention allows for many previously unavailable hybrid modes, and the new ventilator automatically changes its operating mode as the patient progresses or is difficult. Change to For example, if the ventilator begins to ventilate in forced breathing mode and indicates that a patient who was previously severely sedated and could not breathe suddenly began to spontaneously breathe Among other reactions, there can be configured to monitor various patient pressure, volume, and gas concentration responses.

  In order to cooperate with the patient's attempt to breathe independently upon such detection, the ventilation of the present invention includes from fully assisted mandatory breathing modes to various modes with a lesser degree of breathing assistance. Automatically switch between many operating modes. In addition, if the patient relapses and interrupts the spontaneous breathing trial, the ventilator returns to full forced breathing mode. To enable such capabilities, the new ventilator of the present invention is preferably preconfigured with various automatic and reconfigurable modes. For the purpose of assisting the clinician in selecting a fully automated mode of operation, or enabling a partially or fully customizable mode of operation, an optional preferred configuration of the present invention is optional for the clinician. Makes it possible to select a particularly desired automatic operating mode.

  In addition, the clinician may also select an automatic mode of operation and then modify only the desired parameters. In addition, the clinician may ignore the fully automatic mode and enter preferred settings to select a fully customized operating mode suitable for the purpose of any possible ventilation protocol or mode of operation. Also good. In one particular useful configuration, the ventilator incorporates a controller or control module or computing device and includes an initialization module, an adjustment and maintenance module, and a withdrawal module, for purposes of example and not limitation, You may have three main operating modules.

  In turn, the initialization module includes an optimal OEELV evaluation mode that, among other factors, monitors several key patient parameters to determine end-expiratory lung volume (OEELV) and calculates it periodically. The regulation and maintenance module includes operating modes and protocols for oxygen supply, replenishment, and ventilation, which are tightly constrained to strictly and actively monitor and protect the major aspects of these ventilation modes of operation. Very gradual and highly accurate changes to manage CO2 ventilation, to ensure optimal oxygen saturation, and to perform and maximize alveolar replenishment and prevent depletion when needed This is achieved using an accurate bounded monitoring paradigm that enables. If any parameter experiences unexpected or uncontrolled hysteresis, an alarm event is triggered to allow intervention.

  The withdrawal module includes an initial withdrawal protocol that allows close monitoring and slight and slow changes to assess patient response to reduced ventilator assistance that is quickly returned to full assistance as needed . With a positive patient response, the initial withdrawal protocol allows a complete ventilator reconfiguration to a subsequent low assist ventilation protocol for further withdrawal. The withdrawal module also includes an airway pressure release ventilation or APRV protocol mode, in which spontaneous patient breathing is closely monitored so that assistance can be withdrawn as the patient gains control and consistency. . With continuous improvement, control is passed to continuous positive airway pressure or CPAP protocol mode, which circulates to maximum CPAP support mode and then gradually decreases to minimum support mode until extubation pressure is reached, then The patient is completely withdrawn from the ventilator.

  In order to achieve these various modes of use, any of the preferred or optional variations of the ventilator of the present invention is how the artificial respirator operates in its various modes of operation. May be predefined with several parameters that may be controlled, or they may be received and collected. The controller or computing device may access the stored parameters, obtain new parameters from the remote device via wired or wireless communication, and any of the touch screen displays or other input devices described above. User input may be accepted via Whatever the operating setting or parameter source, the information is typically stored in a database or array that is stored in the memory or storage of the controller or computing device. In one optionally preferred embodiment, these parameters are stored accessible to one or more initialization parameter databases, which may reside in controller memory or storage.

  These initialization parameters can be accessed and displayed or communicated to any other device. Alone, or in combination with this database, additional parts of the parameters can be predefined to represent optimal ventilator settings that are well suited for a particular type of symptomatic patient or disease. One or more model patient data arrays or arrays such as elements may be grouped together.

For purposes illustration and not by way of limitation, such data sequence or initialization parameter database, among other parameters and information, expiratory positive end expiratory pressure or PEEP, target peripheral O2 concentration or SpO2 amount, expiration End CO2 or etCO2 amount, fraction of inspiratory O2 or FiO2 amount, high or P (high) defining maximum inspiratory pressure during forced or positive pressure assisted breathing, minimum pressure used during exhalation can be defined , May be zero or non-zero, including low pressure or P (low). Other parameters can include a high time or T (high) that represents the period of inspiration, and a low time or T (low) that can represent a brief period during which exhaled gas is exhaled.

  Also, optionally, it may be preferable to include a predetermined or predetermined pressure change increment or pressure increment P (inc), time increment T (inc), which may be any amount, for which, as required, And there can be multiple different preset increments that can be used so that clinical intervention may be unnecessary in a more automatic mode of operation. It also remembers one or more tidal volumes and breathing frequencies of forced breathing, establishes and stores one or more pressure-volume curve gradients, and the patient is trying to breathe spontaneously It has also been found that it is sometimes desirable to establish one or more induced pressures that allow artificial respiration to detect pressure drops.

  In a further optionally preferred variation, the ventilator may also be configured such that the command module can receive such initialization settings from a user or clinician via an input device. Such settings can include settings described elsewhere herein, or any other possibly desirable parameter that can improve the use of the ventilator. Once any preferred settings and / or parameters are entered into the controller and / or command routine, the feed pump is activated and within the selected automatic program or settings or manually entered parameters and settings constraints, Ventilation can be started.

  In operation, the command module or routine samples, polls, or communicates with any or all of the sensors in the array to measure the patient's actual data. A series of such sensor measurements use the entire array of such data elements to monitor patient response and ventilator performance, and to adapt ventilator performance according to patient status and condition It may be sampled so that it can. For unlimited example purposes, sensor data that can be collected are optionally patient SpO2 partial pressure (PP) or volume, patient etCO2P or volume, peak expiratory flow (PREF), end expiratory lung volume (EELV), and Spontaneous frequency or mechanical breathing frequency may be included.

  Once measured or sampled, the actual patient data array elements can be compared with any of the stored data by the command module to confirm ventilator performance and patient response. As a further example, such actual data may be compared to one model patient data sequence. In this way, it can be determined whether the patient is responding favorably to ventilation. In another example, if the patient is well responsive to ventilation, a comparison of the patient's SpO2 and etCO2 to an equivalent model patient data set is acceptable. If acceptable, the control routine can calculate or generate a flag or Boolean value, such as an SpO2 target value and etCO2 target value that can be set to true, and if all is well, the actual patient measurement value Means that If not acceptable, generating a warning condition can generate a false flag to allow the control routine to modify its behavior or to seek clinical intervention. In addition, the control routine can poll the pressure and flow sensors at some point during the inspiration and expiration phase of ventilation to determine optimal end expiratory lung volume (OEELV), which is a measure of patient response and ventilation. Clinically relevant feedback identifying instrument performance can be provided.

  In yet another optionally preferred configuration, the ventilator may be configured to modify its behavior in response to adverse patient response. As a further example, assume that SpO2 is disadvantageous and the SpO2 target value is false, which indicates an undesirable oxygen supply. As discussed in further detail elsewhere herein, the command module can preferably determine that increased or modified ventilation is guaranteed to achieve the desired SpO2 level. . To that end, the command module may adjust the pump operation, valve function, and possibly the concentration of the supplied oxygen in the pressurized gas supply, thereby increasing P (high) by a pressure increment, T (high) may be increased by a time increment. In the alternative, it may instead be preferable only to modify various operating parameters of the ventilator to increase or decrease the amount of FiO2.

  More preferably, in situations where the patient is responding smoothly and guaranteed to begin gently withdrawing from ventilator assistance, the command module will instead flag it as a true initial withdrawal value, etc. Or a Boolean constant can be set, which can serve to notify other modules of the ventilator that may initiate withdrawal. Conversely, if the patient is experiencing difficulties that may include a non-perfused lung dead space, it may be advantageous to modify the ventilator's behavior to facilitate alveolar tissue replacement Good. In certain situations, it may be wise to generate an alarm signal for intervention. In other less difficult situations, it may be desirable to set a refill flag or Boolean value to notify the control routine module that the refill process is sensible. In this situation, the control routine increases P (high) by one or more P (inc), increases T (high) by one or more T (inc), and / or one or more. The pump and valve operation can be modified to establish an operation suitable for replenishment, which can include increasing T (low) by T (inc) of

  In other situations where supplementation may not be indicated, it may be desirable to increase pulmonary oxygen supply. In that case, the controller or computing device may make adjustments to the ventilator operation so that the oxygen supply flag or Boolean value is set to true, which polls the sensor to assume the maximum expiratory flow. And then the gas flow deceleration angle can be calculated so that an appropriate time adjustment may be made or T (low) may be reduced by T (inc) The oxygen supply module can be activated.

  In yet another equally useful mode of operation, the ventilator can activate the alveolar ventilation approach, and the command module compares the spontaneous frequency with the mechanical respiratory frequency and calculates P (high) or T (high). Confirm, calculate minute ventilation (MV) values, adjust feed pumps and valves to increase T (high) and P (high) by each T (inc) and P (inc). Similarly, the minute ventilation and replenishment module may be activated, and MV is calculated as a function of P (high) and T (high) currently in use, and adjustments are made to P (high) and T (high). Done.

  In more favorable patient response scenarios, an initial withdrawal module may be utilized, where the command module or command routine samples the mechanical and spontaneous breathing frequencies to indicate that spontaneous breathing is occurring at a certain rate. Check. Comparing this speed with a predetermined speed gives a clear indication of whether the initial departure protocol can be employed. If so, the command routine can test for apnea and polypnea. If neither state is indicated, the ventilator can be switched to a more suitable mode, such as an APRV mode, that makes it easier for the intubated patient to breathe more spontaneously.

  As patients experiencing initial ventilator withdrawal continue to improve, another mode of ventilator enables the withdrawal protocol and P (high) is decreased while T (high) is increased. While breathing, spontaneous breathing and blood gas levels continue to be monitored. In this way, the patient is encouraged to continue spontaneous breathing.

  As the improvement increases, further withdrawal is guaranteed. In this case, the ventilator can operate in another mode and review withdrawal failure criteria compared to the actual patient data being monitored. In a set of preferred default withdrawal failure criteria, the FiO2 threshold, SpO2 threshold, spontaneous tidal volume, minute ventilation, and airway obstruction pressure (P0.1) are compared to the patient's actual values. If the patient fails to meet these criteria, withdrawal is temporarily interrupted and further breathing assistance is provided to the patient. In a failure to leave, the control routine increases P (high) and decreases T (high). Conversely, if the withdrawal failure criteria are met by the patient's actual value, the command module will repeatedly start the periodic withdrawal protocol and P (high) will be decreased. The airway obstruction pressure P0.1 is measured at P0.1 and is trended over time. The module is used to evaluate breathing work during spontaneous breathing. In a preferred embodiment, this is used to assess the impact of withdrawal and the resulting breathing work, as described in relation to other modules elsewhere in this specification.

  For further illustrative purposes, assuming that the patient continues to improve, the command module changes the ventilator behavior again and monitors P (high) until the continuous positive airway pressure (CPAP) threshold is reached, which Allows another conversion of ventilator operation to CPAP mode. This mode is even more comfortable for the patient and reduces reliance on the ventilator. As further improvements are developed, the command module begins to gradually reduce the CPAP pressure until the extubation threshold pressure is reached. Also, optionally, during CPAP and other modes of operation, ventilator support is enhanced to overcome the friction loss encountered when breathing through the tubing gas network or circuit involved in ventilator use. It may be preferable to allow the controller to incorporate an automatic tube correction pressure or ATC pressure amount.

  In operation, various uses of the ventilator are possible using any of the embodiments of the present invention, as well as modifications, variations, and alternative arrangements thereof. Using any of the physical configurations of the ventilator of the present invention described elsewhere herein, one method of use is via an input device: (i) automatic initialization Settings, and (ii) (a) positive end-tidal pressure, (b) SpO2, (c) etCO2, (d) FiO2, (e) high pressure, (f) low pressure, (g) high time, ( h) Low time, (i) Pressure increment, (j) Time increment, (k) Tidal volume, (l) Respiration frequency, (m) Pressure-volume gradient, (n) Induced pressure, and (o) FiO2 A setting comprising at least one of a predetermined withdrawal failure criterion including at least one of a threshold, SpO2 threshold, spontaneous tidal volume, minute ventilation, and airway obstruction pressure (P0.1) With the step of entering

  The command routine then receives settings from the clinician via the input device and instructs the controller to activate the delivery pump. This initiates breathing assistance to the patient, whereby the gas circuit communicates with the patient using one of FiO 2 quantity, high pressure and low pressure, and high time and low time each. The actual patient data array element is measured by using a command routine to communicate with multiple sensors. Measurements of at least one of (i) patient SpO2 amount, (ii) patient etCO2 amount, (iii) maximum expiratory flow rate, (iv) end expiratory lung volume, and (v) spontaneous breathing frequency are obtained.

  The command routine compares the patient's actual data array with at least one of the settings to calculate at least one of the SpO2 target value, etCO2 target value, and optimal end-tidal lung volume, which values are Used to determine whether the patient should be withdrawn first, receive supplementation and increased oxygen supply, or be maintained with unchanged ventilation.

  If the patient is improving, the step of measuring at least one of the patient's actual data array elements and setting the flag or Boolean exit failure value to false compared to the default exit failure criteria is guaranteed (Meaning that the patient did not fail the withdrawal test). If successful, periodic disengagement is initiated by adjusting at least one of the feed pump and the plurality of valves to reduce P (high) by one or more pressure increments.

  Also, to further reduce ventilator support, T (high) is gradually increased and P (high) is gradually decreased until the CPAP threshold is reached, after which the ventilator Switch to CPAP mode, in which case the CPAP pressure may be reduced until the extubation threshold pressure is reached, after which the patient may be removed from the artificial respirator.

  In other optionally preferred novel embodiments, any of the monitoring device, sensor, computer, or computing device may be connected to any of the other components wirelessly or by wire. . Any of the considered components may also be in communication with any of the other components over the network, through telephone lines, power lines, conductors, or cables, and / or over the Internet. . In another alternatively preferred configuration of the invention, the resident software program may have a number of features for the purposes of an unlimited example.

  More preferably, such resident software programs and / or programs periodically, when certain predetermined or predetermined conditions occur, such as predetermined alarm events or conditions, and / or abnormal, unexpected Or any of the considered information can be communicated by text, voice, fax, and / or email message when an expected power measurement occurs and / or is detected It may be.

These variations, modifications, and alterations of the various preferred and optional embodiments, alone or in combination with each other, and the features known and discussed and described herein in the art. Together with the elements, they may be better understood by those skilled in the art by reference to the following detailed description and accompanying drawings and drawings.
For example, the present invention provides the following.
(Item 1)
A ventilator system for assisting a patient's respiratory function under the guidance of a clinician,
A supply pump and control module in communication with the data circuit and a gas circuit having a plurality of valves, a supply port and an exhaust port, and for communicating pressurized gas to the patient, the control module comprising the data A feed pump and control module including a display, an input device and a memory in communication with the circuit;
A sensor arrangement in communication with the data circuit, wherein the sensor is in communication with at least one of the exhaust port and the supply port, at least one pulse oximeter, at least one capnometer, and at least one pressure. A sensor array comprising a sensor and at least one flow meter;
A command module resident in the memory that instructs the control module to adjustably actuate the supply pump and the plurality of valves to establish at least one pressure , volume , and flow rate in a gas circuit A command module that is operable as
And at least one initialization parameter database resident in the memory, said a display communicable with, and, (a) expiratory positive end expiratory pressure, (b) SpO2 weight, (c) etCO2 weight, (d) FiO2 amount, (e) high pressure, (f) low pressure, (g) high time, (h) low time, (i) pressure increment, (j) time increment, (k) tidal volume, (l) mechanical breathing An initialization parameter database storing at least one model patient data array element including frequency, (m) pressure-volume gradient, (n) induced pressure, and (o) occlusion pressure;
With
The command module communicates with the sensor array element to: (i) patient SpO2 quantity, (ii) patient etCO2 quantity, (iii) maximum expiratory flow, (iv) end expiratory lung volume, and (v) spontaneous breathing frequency. Measuring actual data array elements of at least one of the patients,
The command module compares the patient's actual data array to the at least one model patient data array and adjusts the delivery pump to provide the at least one model patient data array, SpO2 target value, etCO2 target value, And a ventilator system to achieve at least one of optimal end-tidal lung volumes.
(Item 2)
When the patient SpO2 amount is less than the SpO2 target value, the command module communicates with the sensor array, checks the patient's actual data array, checks the high pressure,
The command module determines a FiO2 value when the high pressure is greater than or equal to a high pressure threshold, and (a) when the FiO2 value is greater than or equal to the FiO2 threshold, the control module causes the high pressure to increase by a pressure increment. And adjusting at least one of the supply pump and the plurality of valves to increase the high time by a time increment, and (b) when the FiO2 value is less than the FiO2 threshold; The ventilator system of item 1, wherein the control module adjusts at least one of the supply pump and the plurality of valves to increase the amount of FiO2.
(Item 3)
If the patient SpO2 amount is greater than or equal to the SpO2 target value, the command module communicates with the sensor array, checks the patient's actual data array, and checks the FiO2 value;
(A) when the FiO2 value is equal to or greater than a FiO2 threshold, the command module adjusts at least one of the supply pump and the plurality of valves to reduce the FiO2 amount. And (b) when the FiO2 value is less than the FiO2 threshold, the command module sets an initial withdrawal value to indicate a true value.
(Item 4)
If the patient SpO2 amount is less than the SpO2 target value, the command module communicates with the sensor array and checks the patient's actual data array to indicate whether the supplement value is a true value or a false value. Determine whether
When the replenishment value indicates (i) a true value, the control module generates a clinician alarm signal; and (ii) when the false value indicates a control module, (a) the control module increases the high pressure by a pressure increment. At least one of the supply pump and the plurality of valves to increase (b) increase the high time by a time increment, and (c) adjust the low time by another time increment. The ventilator system of item 1, wherein the ventilator system is adjusted.
(Item 5)
If the patient SpO2 amount is less than the SpO2 target value, the command module communicates with the sensor array, checks the patient's actual data array, and calculates an optimal end expiratory lung volume value;
If the optimal end expiratory lung volume value is greater than or equal to (a) the optimal end expiratory lung volume threshold, the command module sets the oxygen supply value to indicate a true value, and (b) optimal end expiratory lung volume If less than the threshold, the command module (i) polls the sensor array to measure the maximum expiratory flow, measure gas flow truncation, and calculate a gas flow deceleration angle to Selecting one of the time increments; (ii) setting a refill value to indicate a true value; and (iii) adjusting at least one of the supply pump and the plurality of valves; The ventilator system of claim 1, wherein the control module is instructed to reduce the low time by applying a selected time increment.
(Item 6)
If the patient etCO2 amount is less than the etCO2 target value, the spontaneous breathing frequency is less than a mechanical breathing frequency, and the high time is less than a high time threshold, the high pressure is determined,
If the high pressure is determined to be less than (a) a high pressure threshold, the command module increases at least one of the high time and the high pressure by at least one respective time increment and pressure increment. Commanding the control module to adjust at least one of the supply pump and the plurality of valves, and (b) if determined to be greater than or equal to the high pressure threshold, the command module Instructing the control module to adjust at least one of the supply pump and the plurality of valves by increasing at least one of the high times by at least one respective time increment The ventilator system according to Item 1.
(Item 7)
When the patient etCO2 amount is less than the etCO2 target value, the spontaneous breathing frequency is greater than or equal to a mechanical breathing frequency, and the high time value is greater than or equal to a high time threshold, the high pressure is determined;
If it is determined that the high pressure is greater than or equal to (a) a high pressure threshold, the command module sets the replenishment value to indicate a true value and the high time by at least one respective time increment. By commanding the control module to adjust at least one of the supply pump and the plurality of valves, and (b) the command module when determined to be below a high pressure threshold The control to regulate at least one of the supply pump and the plurality of valves by decreasing the high time and increasing the high pressure by at least one respective time increment and pressure increment. A ventilator system according to item 1, wherein the ventilator system commands the module.
(Item 8)
The control module detects that the patient etCO2 amount is greater than or equal to the etCO2 target value, the command module samples to confirm spontaneous breathing frequency;
(A) the free-onset respiratory frequency is, when it is less than the spontaneous breathing frequency threshold, the command module checks the tachypnea value, when the multi breathing target value indicates a true value, the command module, ventilation The value can be set to indicate a true value,
(B) the free-onset respiratory frequency is, when it is spontaneous respiration frequency threshold or more, the command module checks the apnea value, (i) the wireless respiration value, when indicating the true value, the command module Can set the ventilation value to indicate a true value, and (ii) when the apnea value indicates a false value, the command module causes the airway pressure release ventilation withdrawal value to indicate a true value. The ventilator system according to item 1, wherein the ventilator system can be set as follows.
(Item 9)
The control module detects that the patient etCO2 amount is greater than or equal to the etCO2 target value, the command module samples the high pressure, sets the high pressure value, samples the spontaneous breathing frequency,
When the command module detects that the spontaneous frequency is greater than or equal to the spontaneous frequency threshold and the high pressure value is greater than or equal to the high pressure threshold, the command module includes at least one of the supply pump and the plurality of valves. A ventilator according to item 1, wherein one is adjusted to start the withdrawal by instructing the control module to decrease the high pressure by a pressure increment and to increase the high time by a time increment. system.
(Item 10)
Further comprising the at least one model patient data array further comprising a predetermined withdrawal failure criterion establishing a FiO2 threshold, SpO2 threshold, spontaneous tidal volume, minute ventilation, and airway obstruction pressure;
The command module communicates with the data circuit to sample the sensor array, measure at least one of the patient's actual data array elements, and compare the elements to the predetermined leave failure criteria. Determine whether the exit failure value is true or false,
The command module (a) adjusts at least one of the supply pump and the plurality of valves to increase the high pressure by a pressure increment when the withdrawal failure value indicates the true value. And command the control module to increase the high time by a time increment, and (b) when the leave failure value indicates the false value, the command module Item 2. The cyclic disengagement is started repeatedly by instructing the control module to adjust at least one of the plurality of valves to decrease the high pressure and high time by pressure and time increments. Ventilator system.
(Item 11)
Each time the command module initiates another periodic withdrawal, the command module verifies the high pressure until a continuous positive airway pressure threshold is reached, and the command module sets the continuous positive airway pressure value to a true value. A ventilator system according to item 10, which can be set to indicate:
(Item 12)
The at least one model patient further comprising: a predetermined continuous positive airway pressure; and a FiO2 threshold, SpO2 threshold, spontaneous tidal volume, minute ventilation, and a default withdrawal failure criteria that establish airway obstruction pressure Further comprising a data array;
The command module communicates with the data circuit to sample the sensor array, measure at least one of the patient's actual data array elements, and compare the element to the predetermined leave failure criteria. Determine whether the withdrawal failure value indicates true or false,
When the command module determines that (a) the withdrawal failure value indicates the true value, the command module adjusts at least one of the supply pump and the plurality of valves to maintain the continuous Instructing the control module to increase the positive airway pressure and (b) determining that the withdrawal failure value indicates the false value, the command module determines that the continuous airway until the extubation threshold pressure is reached. Item 2. The ventilator system of item 1, wherein the positive pressure is periodically decreased.
(Item 13)
When the high pressure is (a) less than a high pressure threshold, the command module adjusts at least one of the supply pump and the plurality of valves to determine the continuous positive airway pressure based on the high pressure. And (b) when above the high pressure threshold, the command module adjusts at least one of the supply pump and the plurality of valves to adjust the airway pressure. 13. A ventilator system according to item 12, wherein the control module is instructed to adjust open ventilation withdrawal.
(Item 14)
A ventilator for use by a clinician in assisting a patient presenting with pulmonary distress,
A controller including a display, an input device, and a memory in electrical communication with the data network, the gas network including at least two valves and a supply port and an exhaust port in communication with the patient; A controller incorporating a source of pressurized gas in fluid communication;
A plurality of sensors in communication with the data network, the at least one oxygen saturation sensor in communication with at least one of the exhaust port and the supply port; at least one capnometer and at least one pressure gauge; A plurality of sensors, and at least one gas flow meter;
A command routine resident in the memory for operably actuating at least one of the source of pressurized gas and the valve to establish at least one pressure , volume and flow rate in the gas network; , that runs to drive the controller, and a command routine,
The command routines, the clinical physician (i) automatic initialization setting, and (ii) (a) breath endings positive pressure amount, (b) SpO2 weight, (c) etCO2 weight, (d) FiO2 amount, ( e) high pressure, (f) low pressure, (g) high time, (h) low time, (i) pressure increment, (j) time increment, (k) tidal volume, (l) machine breathing frequency, (m ) pressure - volume gradient, (n) induced pressure, and (o) at least one of the parameters stored in the memory including occlusion pressure, i.e. (i) and (ii), the input device at least one of Prompt on the display to enter settings via
The command routine communicates with the plurality of sensors to (i) a patient SpO2 amount, (ii) a patient etCO2 amount, (iii) a maximum expiratory flow rate, (iv) an end expiratory lung volume, and (v) a spontaneous breathing frequency. Measuring actual data array elements of at least one of the patients,
The command routine compares the patient's actual data array to at least one of the settings and includes at least one of the settings of SpO2 target value, etCO2 target value, and optimal end-tidal lung volume. A ventilator that calculates at least one.
(Item 15)
If the patient SpO2 amount is less than the SpO2 target value, the command routine communicates with the plurality of sensors, checks the patient's actual data array, and calculates an optimal end expiratory lung volume value;
When the optimal end expiratory lung volume value is equal to or greater than (a) the optimal end expiratory lung volume threshold, the command routine sets the oxygen supply value to indicate a true value, and (b) the optimal end expiratory lung volume If less than the threshold, the command routine (i) polls the plurality of sensors to measure the maximum expiratory flow, measure gas flow truncation, and calculate a gas flow deceleration angle. Selecting one of the time increments, (ii) setting a refill value to indicate a true value, and (iii) adjusting at least one of the pressurized gas source and the plurality of valves. The ventilator of claim 14, wherein the controller is instructed to reduce the low time by applying the selected time increment.
(Item 16)
If the patient etCO2 amount is less than the etCO2 target value, the spontaneous breathing frequency is less than a mechanical breathing frequency, and the high time is less than a high time threshold, the high pressure is determined,
If the high pressure is determined to be (a) less than a high pressure threshold, the command module increases at least one of the high time and the high pressure by at least one respective time increment and pressure increment. Commanding the control module to adjust at least one of the supply pump and the plurality of valves, and (b) if determined to be greater than or equal to the high pressure threshold, the command module Instructing the control module to adjust at least one of the supply pump and the plurality of valves by increasing at least one of the high times by at least one respective time increment Item 15. The ventilator according to item 14.
(Item 17)
When the patient etCO2 amount is less than the etCO2 target value, the spontaneous breathing frequency is greater than or equal to mechanical breathing frequency, and the high time is greater than or equal to a high time threshold, the high pressure is determined,
If it is determined that the high pressure is greater than or equal to (a) a high pressure threshold, the command module sets the replenishment value to indicate a true value and sets the high time by at least one respective time increment. Commanding the control module to adjust at least one of the supply pump and the plurality of valves by changing, and (b) the command module if determined to be less than the high pressure threshold Adjusting the at least one of the supply pump and the plurality of valves by decreasing the high time and increasing the high pressure by at least one respective time increment and pressure increment 15. A ventilator according to item 14, which commands a module.
(Item 18)
Means for ventilating a patient presenting with respiratory distress to a clinician,
Means for communicating pressurized gas to the patient and for discharging gas from the patient;
Means for controlling the supply means, including means for displaying information, means for receiving input from the clinician, and means for storing information;
A plurality of means for detecting a physical state of the gas communicated to the patient by the supply means, comprising: (a) at least one means for detecting pressure; and (b) detecting volumetric flow rate. A plurality of means, including at least one means for detecting, (c) at least one means for detecting the concentration of oxygen, and (d) at least one means for detecting the concentration of carbon dioxide;
Means for instructing said means for controlling to adjustably communicate said pressurized gas with a variable pressurized volume flow rate and to detect said physical state of said gas, said instructions The means comprises means for residing in the means for storing the information;
The means for the display, against the clinical physician, (i) automatic initialization setting, and (ii) (a) breath endings positive pressure amount, (b) SpO2 weight, (c) etCO2 amount, ( d) FiO2 amount, (e) high pressure, (f) low pressure, (g) high time, (h) low time, (i) pressure increment, (j) time increment, (k) tidal volume, (l) At least one of the parameters held in the means for storing including mechanical breathing frequency, (m) pressure-volume gradient, (n) induced pressure, and (o) occlusion pressure, ie (i) and (ii) includes means for setting and inputting at least one of)
The means for directing receives the settings from the clinician and activates the means for supplying to physically characterized by the amount of FiO2, the high pressure and low pressure, the high time and low time. Instructing the means for controlling to communicate the pressurized gas supply to a patient having a condition;
The means for indicating is in communication with one of the plurality of means for detecting, (i) a patient SpO2 amount, (ii) a patient etCO2 amount, (iii) a maximum exhalation flow, (iv) an end of expiration Measuring at least one patient actual data array element of lung volume and (v) spontaneous breathing frequency;
The means for controlling compares the patient's actual data array to at least one of the settings , and at least one of the settings is an SpO2 target value, an etCO2 target value, and an optimal end expiratory lung volume. Means for performing ventilation, calculating at least one of
(Item 19)
If the patient etCO2 amount is less than the etCO2 target value, the spontaneous breathing frequency is less than a mechanical breathing frequency, and the high time is less than a high time threshold, the high pressure is determined,
If the high pressure is determined to be less than (a) a high pressure threshold, the command module increases at least one of the high time and the high pressure by at least one respective time increment and pressure increment. Commanding the control module to adjust at least one of the supply pump and the plurality of valves, and (b) if determined to be greater than or equal to the high pressure threshold, the command module Instructing the control module to adjust at least one of the supply pump and the plurality of valves by increasing at least one of the high times by at least one respective time increment Means for performing ventilation according to item 18.
(Item 20)
If the patient etCO2 amount is less than the etCO2 target value, the spontaneous breathing frequency is greater than or equal to the received mechanical breathing frequency, and the high time is greater than or equal to a high time threshold, the high pressure is determined;
If it is determined that the high pressure is greater than or equal to (a) a high pressure threshold, the command module sets the replenishment value to indicate a true value and sets the high time by at least one respective time increment. Commanding the control module to adjust at least one of the supply pump and the plurality of valves by changing, and (b) the command module when determined to be less than the high pressure threshold Adjusting the at least one of the supply pump and the plurality of valves by decreasing the high time and increasing the high pressure by at least one respective time increment and pressure increment 19. Means for providing ventilation according to item 18, commanding a module.
(Item 21)
At least one parameter further comprising: (i) auto-initialization settings; and (ii) FiO2 threshold, SpO2 threshold, voluntary tidal volume, minute ventilation, and airway obstruction pressure At least one of them,
The means for commanding communicates with the means for detecting to measure an actual value and to determine whether the leave failure value is a true or false value compared to at least one of the predetermined leave failure criteria. Determine which of the
When the means for commanding determines that (a) the detachment failure value indicates a true value, the means for commanding adjusts the means for supplying to increase the high pressure by a pressure increment. Instructing the means for controlling to increase the time and to decrease the high time by a time increment, and (b) to command when determining that the leave failure value represents a false value The ventilation of item 18, wherein the means for repetitively initiating periodic disengagement by instructing the means for controlling to adjust the means for supplying to reduce the high pressure by a pressure increment. Means for doing.
(Item 22)
Each time the means for commanding initiates another periodic departure, the means for commanding confirms the high pressure and continues the cycle until a continuous positive airway pressure threshold is detected, Item 22. The means for performing ventilation according to item 21, wherein the means for commanding allows a continuous positive airway pressure value to be set to indicate a true value.
(Item 23)
At least one parameter further comprising: (i) auto-initialization settings; and (ii) FiO2 threshold, SpO2 threshold, voluntary tidal volume, minute ventilation, and airway obstruction pressure At least one of them,
The means for commanding communicates with the means for detecting to measure an actual value and to determine whether the leave failure value is a true or false value compared to at least one of the predetermined leave failure criteria. Determine which of the
If the means for commanding determines that (a) the withdrawal failure value indicates a true value, the means for commanding adjusts the means for supplying to provide the continuous positive airway pressure. Instructing the means for controlling to increase, and (b) determining that the fail-to-leave value indicates a false value, the means for instructing the duration until the extubation threshold pressure is reached. The means for providing ventilation according to item 18, wherein the positive positive airway pressure is periodically reduced.

Without limiting the scope of the invention as claimed below, reference is now made to the figures and drawings, wherein like numerals in the drawings, figures and drawings are identical, corresponding or equivalent elements, methods, Refers to components, features, and systems.
FIG. 1 shows a ventilator and system according to the present invention. FIG. 2 shows a schematic diagram of the operation of the ventilator and system of FIG. 3a and 3b are schematic views of the OEELV mode of operation of the ventilator and system of FIG. FIG. 4 shows a schematic diagram of the interrelationship between modules of operation of the ventilator and system of FIG. FIG. 5 shows a schematic diagram of the oxygen delivery mode of operation of the ventilator and system of FIG. FIG. 6 is a schematic diagram of a refill mode of operation of the ventilator and system of FIG. FIG. 7 is a schematic diagram of the ventilation mode of operation of the ventilator and system of FIG. FIG. 8 is a schematic diagram of an initial withdrawal mode of operation of the ventilator and system of FIG. FIG. 9 is a schematic diagram of an ARPV withdrawal mode of operation of the ventilator and system of FIG. FIG. 10 is a schematic diagram of the CPAP withdrawal mode of operation of the ventilator and system of FIG. FIG. 11 is an OEELV mode of operation of the ventilator and system of FIG. 1 and an area diagram of the evaluation. 12 is an area diagram of the OEILV mode and evaluation of the operation of the ventilator and system of FIG. FIG. 13 is an area diagram of the spontaneous mode of operation and evaluation of the ventilator and system of FIG. FIG. 14 is a schematic airway pressure versus time trace for airway pressure release ventilation. FIG. 15 is a trace diagram of airway pressure versus time during the inspiratory P (high) phase of ventilation. FIG. 16 is an airway volume versus pressure curve illustrating the transition from the inspiratory part to the expiratory part. FIG. 17 is a trace diagram of inspiratory and expiratory gas flow versus time for airway pressure release ventilation. FIG. 18 is a trace diagram of exhaled gas flow versus time. FIG. 19 is a set of expiratory gas flow versus time trace diagrams illustrating the determination of whether the flow pattern is normal, restrictive, or obstructive based on the shape of the trace diagram. is there. FIG. 20 is a set of airway pressure versus time traces illustrating ventilatory withdrawal with a continuous decrease in pressure P (high) and an approximately simultaneous increase in T (high).

  Referring now to the various charts and illustrations, those skilled in the art will appreciate preferred, optional, modified, and alternative embodiments of the ventilator and ventilator system 10 and method of operation of the present invention. Are within the knowledge of those skilled in the art and are exemplified throughout all the various features, components, modifications, and variations illustrated throughout the written description, claims, and graphical illustrations herein. It should be understood to consider compatibility.

  In view of this guidance concept, referring now to FIG. 1, one possible embodiment of a ventilator and ventilator system 10 in communication with a patient P undergoing ventilation therapy is illustrated. Yes. The ventilator or ventilator system 10 also preferably includes a gas supply pump and / or a pressurized gas source 12 having a positive pressure port 14 and optionally a negative pressure port 16. The gas pump or source 12 supplies a positive pressure gas 12 and can also supply a negative pressure or vacuum 14 for non-invasive negative pressure application such as oxygenator or similar therapy. In accordance with the principles of the present invention, a wide variety of commercially available ventilators may be modified, and one such device is described by Draeger Medical, Inc. (Referred to as Model EvitaXL, available from (Telford, Pennsylvania, USA and Lubeck, Germany)).

  The ventilator also preferably includes a controller or control module or computing device 20 in electrical communication with electrical or data circuitry or data network 22 within and / or outside the ventilator. The controller 20 also preferably includes a display 28. The display 28 may be a conventional device that receives a unidirectional signal from the controller 20, but may also be used as the input device 28 and is similar to the keyboard input device 28 shown in FIG. Any number of possibly preferred interactive devices, such as a touch screen display, that may also have data entry capabilities such as a built-in keyboard or keypad.

  The controller or computing device 20 is also preferably a flash drive, optical media, hard disk drive, solid state disk drive, random access memory, non-volatile memory, removable storage device, remote internet based storage device, network appliance type device, and Includes memory 24 or storage capability 24, which may include equivalents.

  Typically, supply pump or pressurized gas source 12 communicates positive or negative pressure to patient P through a tube gas circuit or network 40. The gas network or circuit 40 may also include an inspiratory or supply port 42 and an expiratory or exhaust port 44. Typically, several valves are also included to control and measure the flow rate, and preferably include a supply valve 46, a sensor valve 50, and an exhaust valve 52, all of which are used by the command module 30 for ventilation. The possibility to communicate with the controller 20 via the data network 22 so that the valves may be automatically controlled and operated to start and stop and control the pressure and flow rate to the patient during operation. Is expensive.

  Supply and exhaust valves 46 and 52 may also be operable to periodically close over a short period of time to allow the pressure sensor to take various static pressure measurements. In addition, the sensor valve closes to protect the various sensors from pressure circuit transients, and by changing the operating mode from forced breathing support to incremental support mode, the ventilator 10 can be It may be operable to prevent false measurements, such as when it may be automatically responding to improvement or recurrence.

  In addition to the discussed input devices described elsewhere herein, the artificial respiration of the present invention to convey quantitative lung function information, such as lung volume, dead space rate, and the like There may be certain diagnostic imaging devices that can be incorporated into the operation of the instrument. Additional and conceivable useful devices may also be used for unlimited example purposes, electronic impedance tomography device 70, ultrasound instrument 80, computerized and computer-aided tomography device 90, and various quantitative methods. Alternatively, other types of Doppler that may enable subjective lung function images may include the image sensor 95.

  Various types of optionally preferred detectors, sensors, or detection devices also provide accurate control and analysis of volume and mass flow rates and supply gas, inspiratory gas, and expiratory gas pressures for purposes of the present invention. May in turn enable the calculation of various other static and dynamic lung function parameters, as will be discussed in further detail elsewhere in this specification. .

  With continued reference to FIG. 1, a group of sensors 54 may be arranged in close proximity to the ventilator and the patient P. A pulse oximeter or O2 saturation sensor 56 may be used in the vicinity to determine the peripheral or venous O2 content SpO2, and a capnography sensor or capnometer or CO2 sensor 58 may be used to determine end-tidal or peripheral CO2 saturation. It may be used to determine the degree (etCO2, SpCO2). For certain applications involving long-term supine ventilation, it may also be desirable to monitor arterial blood gas concentrations, among other parameters. In these cases, invasive methods such as centerline catheters can be used to assess pulmonary artery O2 and CO2 levels using PaO2 sensor 60 and / or PaCO2 sensor 62.

  Also, optionally, various airway pressures, volume flow rates, and mass flow rates are preferably monitored so that patient response can be continuously evaluated. For the purpose of monitoring airway pressure, airway pressure sensors or pressure gauges 64 can be placed at several locations along the gas network or circuit, more preferably at the intubation site of patient P at the supply and exhaust ports. 42, 44 in the vicinity. The airway flow sensor 66 can be similarly positioned to allow monitoring of inspiratory and expiratory gas volume flow. In some applications, placed on the chest to allow monitoring of chest movements during the lung respiratory cycle, which can be an additional volume of lung patient function source as well as a source of patient work consumed for spontaneous breathing. It has been found desirable to employ strain gauges.

  Referring now also to FIG. 2, the ventilator also includes three main operating modules, including an initialization module or protocol 100, an adjustment and maintenance module 200, and a disengagement module 250, for purposes of illustration and not limitation. The control module 20 and / or the command module 30 are also incorporated to include During initial ventilator 10 activation, several initial parameters are set based on clinician input or by accessing a predetermined set of parameters. Here, the preliminary initialization routine will be described with reference to FIGS. In FIG. 4, it can be seen that the clinician may enter preferred settings on the display 26 or input device 28. Alternatively, any number of possible predetermined automatic settings 120 can be accessed and used as defined in whole or in part to customize the ventilator 10 for operation. May be. Once the clinician or automatic settings 110, 120 are selected, the settings 110, 120 are entered into various other initialization parameters 130 during operation of the initialization module 100. When the operation of the ventilator 10 starts, the command module 30 activates the OEELV mode or evaluation routine 150.

  Referring now specifically to FIGS. 3a and 3b, it can be seen that the initialization module 100 includes an optimal end-expiratory lung volume or OEELV mode or evaluation routine 150. OEELV mode 150 determines the ventilation range as a function of pulmonary obstruction and patient P's hypoventilation, nominal, or percarbonate status periodically and on demand. As part of the evaluation, the OEELV mode 150 determines whether the computationally confirmed OEELV is in an appropriate range for the condition state of the patient P. As an unlimited example, if patient P has an obstructive lung and is experiencing a high range of hypoventilation, the appropriate or desired OEELV should be in the range of about 30% to 40%.

  If the calculated OEELV is higher than this range, the T (low) parameter is increased by 0.5 seconds. Conversely, if the computationally confirmed OEELV is lower than the desired range of 30% to 40%, the T (low) parameter is lowered in order to achieve a suitable OEELV range. In this way, the new OEELV mode or evaluation protocol can achieve the fine tuning of the actual OEELV mode 150 to stimulate optimal conditioning of the pulmonary response of the ventilated patient P. That is, a 0.5 second adjustment of T (low) allows for a slow gradual optimization of OEELV that is most appropriate for the disease aspect. For purposes of illustration and detail of various aspects of the invention, an amount of 0.5 seconds or other amounts of time have been described. However, in this aspect, the principles of the present invention are also suitable for more gradual changes in time and can include milliseconds and smaller and larger digits.

  Once T (low) is set, OEELV mode 150 relinquishes control over a period of time, and again, command module 30 resumes control, then oxygen supply mode 300, replenishment mode 400, And activate the adjustment and maintenance module 200, including the ventilation mode 500. Module 200 and its component modes 300, 400, 500 closely monitor and protect key aspects of the patient's physiological ventilation and lung response profile, maximizing recovery with minimal risk of lung injury And a protocol configured to allow withdrawal. To ensure that the target or target of at least about 95% SpO2 and only about 34-45 mmHg etCO2 is maintained during the ventilation process (FIG. 4), the patient's SpO2 and etCO2 Monitored continuously via sensors 56,58.

  The command module 30 then passes control to the oxygen supply mode 300, which is specifically described in more detail in FIGS. When the oxygen supply mode 300 assumes control in a short period of time, SpO2 is referenced again so that adjustments may be achieved as needed in partial inhalation O2, also called FiO2 parameters. See 360 in FIG. Once adjustments to FiO 2 are made, the command module 30 cooperates with the oxygen supply mode 600 to evaluate whether a P (high) pressure adjustment should be made or whether the initial disengagement mode 600 should be activated. . If patient P is responding well, and if FiO2 and Spo2 quantities are preferred, control is transferred to initial withdrawal mode 600, which is described in further detail elsewhere herein. The

  Alternatively, the oxygen supply mode 300 and the command module 30 evaluate the P (high) state 380. If P (high) is adjusted 390, another iteration of the OEELV mode is performed to support the optimal OEELV mode 150 described above. Again, when control returns to the oxygen supply mode 300, P (high) is again evaluated to determine whether the replenishment mode 400 is guaranteed or P (high) must be adjusted again. The For further illustrative purposes, assuming that the refill mode 400 is shown, the oxygen supply mode 300 transfers control to the command module 30, which activates the refill mode 400.

  Referring now also to FIG. 6, the replenishment mode 400 reevaluates the P (high) state in different situations 420, 430, 450, as depicted in more detail in FIG. In situations where P (high) becomes unmanageable 450, an alarm signal is issued to achieve immediate intervention. Otherwise, P (high) is adjusted to improve pulmonary conditioning of patient P 460, 470, 480, again SpO2 is re-examined 310, while replenishment mode 400 is Continue trying to increase lung surface as much as possible, reduce dead space, and reinflate alveolar units until the SpO2 value 310 indicates the need for oxygen delivery mode 300. Information feedback from other concurrency modes may be periodically sampled by the command module 30 via the feedback loop 180, interrupting replenishment and transferring control as needed, or More important modes can be activated when required by the patient's physiology. For example, if the command module 30 approaches or exceeds a desired limit, represents an increased etCO2 value, or detects received information from the feedback loop 180, the ventilation mode 500 can be activated. The command module 30 can invalidate the control.

  With continued reference to the aforementioned chart, and now also referring to FIG. 7, the commander or command module 30 activates the ventilation mode 500 to correct the actual or out-of-limit etCO2 condition. Ventilation mode 500 re-evaluates end-tidal CO2 level 510, re-evaluates OEELV state 150, and then the patient's spontaneous breathing with respect to a set rate or respiratory frequency value obtained from clinician 110 or auto setting 120. Is evaluated 570. If breathing spontaneity remains below the set rate 570, the lungs can be adjusted to adjust T (high) 530, 540 and P (high) 370, 390 as needed to further optimize back reaction. Blast ventilation submode 504 is achieved.

  However, if patient P recovers pulmonary responsiveness and breathing spontaneousness improves beyond the set rate to the rate of 15 spontaneous breaths above the set rate for the purposes of an unlimited example, alveolar ventilation Sub-mode 506 is achieved, whereby T (high) 530, P (high) 370 are adjusted separately and then combined 520 for the lower value of P (high). For the higher value of P (high), the minute ventilation submode 506 evaluates Vt 560 to determine whether the replenishment mode 400 is guaranteed. Otherwise, SpO2 is again verified 310, T (high) is adjusted 550, polypnea assessment, which is a function of the set speed or respiration frequency, and the actual patient speed defined in the assessment worksheet 590 For 590, patient P is examined. As with the other modes, the commander or command module 30 can be associated with the feedback loop 180 so that control can be immediately acquired to maintain optimal lung response parameters over a series of continuously monitored variables. Keep polling for incoming information.

  Here, along with a hypothetical proposal that the commander 30 has called back control from the ventilation mode 500 to pass through the oxygen supply mode 300 once again, and the parameters have been advantageously evaluated in order for the commander to activate the initial withdrawal mode 600. FIG. 8 is also noted. As with the other modes, FiO2 330, SpO2 310, etCO2 510, spontaneous breathing 570, and possible polypnea 580 are reevaluated. Assuming that patient P responds well, P (high) is evaluated 610, 630, and if guaranteed, spontaneous breathing is compared 620 to the apnea parameters. Then, when the command module 30 reconfigures the ventilator 10 away from the forced breathing control mode and activates the assisted breathing mode, the patient P who is significantly improving is just new to the ventilator 10 of the present invention. Experience one of these aspects.

  Referring now also to FIG. 9, one of ordinary skill in the art will understand that commander 30 activates positive airway pressure release ventilation or APRV mode 700, which can be even more comfortable for patient P in the convalescent lung. I will. Again, APRV mode 700 re-validates pulmonary conditioning of patient P and examines 610 P (high). However, unlike other modes, the APRV mode 700 establishes a new parameter estimate, referred to herein as a leave failure criterion 710. These criteria evaluate patient P against a more stringent set of critical pulmonary physiology and allow the subject to withstand the additional burden of a substantially less gradual change in ventilation mode of operation. Make sure. Patient P must pass criteria 710 before command module 30 interrupts the mandatory breath mode of operation. If the patient fails the exit criteria 710, the command module 30 restarts the initial exit mode 600, or restarts to another mode if the feedback loop 180 warns the emergency requirement by the commander 30. To do.

  However, assuming that the withdrawal failure criteria 710 is met, the patient P is considered to be able to withstand greater changes in the pressure-volume gradient profile induced by the ventilator and the system 10. Thus, the APRV mode 700 achieves additional adjustment 720 to disengage or reduce the patient's dependence on the ventilator 10 forced breathing aspect. This withdrawal process and reevaluation 720, 730, 710 will continue to repeat if patient P is well tolerated until P (high) is less than or equal to 20 centimeters of water column pressure. At this point, patient P is recovering smoothly, and in contrast to feedback loop 180, there are no significant signs and again, command module 30 completely reconfigures the ventilator 10 operating profile.

  As illustrated in detail in the figure, the commander or command module 30 activates a continuous positive airway pressure or CPAP mode 800 in the maximum CPAP positive pressure assist mode, which causes the patient P from relying on the ventilator 10. Accelerate the removal process. However, patient P continues to be evaluated against withdrawal failure criteria 710 for severe and undesirable deviations from acceptable pulmonary response limits. As patient recovery accelerates, CPAP mode 800 reduces assistance 820, 830, 840, 850 until extubation pressure 860 is reached. Thereafter, the clinician intervenes and extubates from the patient P who has left.

  Among the many possible modifications to any of the embodiments of the ventilator 10 of the present invention, one particularly useful variation can be incorporated as an improvement to the OEELV mode 150 or with the OEELV mode 150 Includes a modified OEELV mode 1050 that may be included as an independent mode that can operate and cooperate. Continuing with reference to the various charts and in particular with reference to FIGS. 3a and 3b and now also with reference to FIG. 11, those skilled in the art will understand that P (low) / T ( It may be recalled that OEELV or optimal end expiratory lung volume is delivered by using element and reference point information obtained during the (low) cycle. The proposed and optionally preferred OEELV1050 mode is ideally functional for the duration of ventilation therapy and is operable to continually optimize therapeutic patient P's EELV or end-tidal lung volume .

  The derived OEELV is a function of the medical condition (see, eg, FIGS. 3a and 3b) and the patient's lung responsiveness to oxygen delivery mode 300, supplement mode 400, and ventilation mode 500. For patient P complaining of a medical condition, OEELV mode 1050 optimizes EELV by adjusting the T (low) period. Preferably, OEELV mode 1050 also validates the obtained information by using multiple sampling, averaging, and various statistical methods over time for validation and error detection.

  The adjustment of OEELV is based on factors obtained during the P (low) / T (low) cycle and flow and time reference points. Established by the P (low) / T (low) cycle, the flow and time reference points within the flow time zone measure and calculate the changes that occur in lung volume during the P (low) / T (low) cycle. May be used for For purposes of example and further illustration, and not by way of limitation, looking again at FIG. 11, the preferred OEELV mode 1050 measures the maximum expiratory flow (PEFR) 1100, the decay phase 1110, and the truncation phase 1120 to determine the gas flow. Calculate the deceleration angle (ADEC) of the gas and the end of the gas flow and determine the optimum T (low) adjustment. Thereby, OEELV mode 1050 allows dynamic adjustments that were previously unavailable to establish and maintain patient P's optimal actual OEELV more accurately and more responsively.

  The analysis of FIG. 11 should make it clear to those skilled in the art that extrapolation phase 1130 may be used to calculate residual volume and pressure as a function of time. The PEFR 1100 in FIG. 11 represents a rapid decompression as evidenced by chest relaxation and recoil after mechanical breathing. Damping phase 1110 represents the damping energy drive and downstream resistance to gas flow. The flow termination or truncation phase 1120 establishes a location or area where flow can be determined as a function of either the disease process or parameter settings entered by the user or clinician. Extrapolation phase 1130 can be used graphically and / or algebraically to determine and calculate pressure, volume, and time.

  As described elsewhere herein and with continued attention to FIG. 11, OEELV mode 1050 and OEELV mode 150 both measure maximum expiratory flow and gas flow truncation, and then ideal It is recalled that this information is used to calculate the ADEC or deceleration angle that is used in sequence to establish a typical OEELV value. With this approach, it should be observed that changing the truncation point changes the deceleration angle. If the resulting angle is not too steep, the resulting observation is that replenishment has occurred. Conversely, when the angle is steeper, depletion is indicated.

  Thus, OEELV mode 1050 or 150 suggests adjustment of at least one of P (high), P (low), T (high), or T (low). If depletion is detected, either P (high) or T (high) should be increased, or T (low) should be decreased, or some combination thereof is achieved Should. On the other hand, if replenishment is detected in this way, P (high) should be decreased, T (high) or T (low) should be increased, or some combination thereof is achieved It should be.

  The present invention also contemplates an optimal end-inspiratory end lung volume or OEILV mode 1200 that can further increase aspects of the supplemental mode 400 of FIG. 6 in any of the embodiments of the present invention. In this alternative variation to any of the embodiments of the innovative ventilator and ventilation system 10, the OEILV mode 1200 is optionally or preferably activated by the command module 30 as needed. . More preferably, the OEILV mode 1200 is activated by the refill mode 400. More preferably, since OEILB mode 1200 ideally evaluates for de-replenishment and is operating or in use during breathing of machine or ventilator 10, OEILV mode 1200 is used for actual replacement phase or inspiration. It is activated by the refill mode 400 at any moment outside the pressurization. Most preferably, the OEILV mode 1200 monitors existing sensor data to identify changes in flow and time during the P (high) / T (high) cycle of ventilation.

  When activated, the OEILV mode 1200 is active over time during mechanical breathing and obtains a recorded reference point for the flow time course up to the P (high) / T (high) cycle. The OELIV mode 1200 uses this acquired data to identify changes in the flow and time coordinate grids during the P (High) / T (High) cycle. If such a change is actually identified, OEILV mode 1200 may preferably communicate a message on commander 30, refill mode 400, and / or feedback loop 180 to initiate refill. . More preferably, the OEILV mode 1200 is also to further minimize actual or anticipated depletion and / or to improve lung status and / or patient P response and conditioning in ventilation therapy In addition, manual or automatic adjustment of P (high) and / or T (high) may be suggested and / or achieved.

  In the depletion phase of replenishment mode 400, OEILV mode 1200 may also preferably adjust P (high), T (high), or both intermittently when active, and / or Commander 30, feedback loop 180, and / or other modes of recommended adjustments may be notified and / or communicated to the clinician manually or automatically to seek clinical intervention if warranted. May be. These adjustments at P (high), T (high), or both may be applied from time to time, intermittently and / or periodically and are accomplished manually, through notification messages, or through automation. May be.

  In further aspects of the optionally preferred OEILV mode 1200, and also referring to FIG. 12, the OEILV mode 1200 preferably correlates with a resistance element 1210 that occurs during the onset of mechanical breathing, an inflection or midpoint of the mechanical breathing cycle. An inflection point 1250 and an elastic element 1220 corresponding to relaxation after mechanical breathing may be incorporated. It is important to note that the OEILV mode 1200 measures the resistance-elastic transition point 1250 to determine whether the slope of the elasticity 1220 changes.

  In other words, the query seeks to know if the elastic element 1220 becomes steeper in depletion and less sudden in refill. The combination of information available from FIGS. 11 and 12 and the accompanying discussion in this document will enable those skilled in the art to more accurately identify whether replenishment has been achieved or whether depletion has occurred. Will be able to understand that it enables the means that were not available. Available now and in accordance with the principles of the present invention, the various modes provide a more accurate and automatic system for better managing and mitigating replenishment and de-replenishment during many possible ventilation therapy protocols. to enable.

  In any of the embodiments of the ventilator 10 mode and method of operation of the present invention, an optionally preferred spontaneous mode 1340, schematically depicted in FIG. 13, is used to further assess spontaneous spontaneity. be able to. This spontaneous mode 1340 may be further activated by any of the other modes, modules, and routines of the ventilator of the present invention. Even so, this spontaneous mode 1340 is optionally specially activated via the command module 30 alone and / or by the ventilation mode 500 and / or by the initial withdrawal mode 600. Usefulness may be found.

  In addition to comparing the actual spontaneous breaths per unit time of the patient P, this mode 1340 also preferably evaluates and analyzes the nature of the spontaneous breaths, also known as “breathing work”, a breathing effort May be identified and quantified. More preferably, the spontaneous mode 1340 assesses the impact of withdrawal on breathing work. Any of the sensors described elsewhere herein, such as one or more of the strain gauges 68, are elastically applied to the patient's chest so as to sense and record movement and solid state. Accelerometers with similar capabilities to obtain additional data points that can be added to or firmly attached or used to calculate the actual work consumed in breathing Can also be used.

  Referring again to FIG. 13, such data points can be correlated to the spontaneous breath initiation phase 1360, the spontaneous peak phase maximum 1370, and the spontaneous termination phase 1380. More preferably, such data is obtained during any of the spontaneous breath assessments 570, 580 (FIGS. 7, 8) that occur during the ventilation and initial withdrawal modes 500, 600, as well as any other suitable time. Can be presented. Such additional signs of patient P's pulmonary conditioning and response can further reveal the patient's true cardiopulmonary physiology, which can cause patients to withdraw from ventilation therapy due to patient resistance or other issues. The risk of being removed prematurely can be reduced.

  Continuing with reference to the various charts and previous discussions, for those skilled in the art, for some desirable situations, the present invention also contemplates initiating patient ventilation in the APRV mode 700 based on initial oxygen supply and ventilation settings. You will be able to understand what to do. Patient P can then have the safety of the forced breathing capability of ventilator 20 while initiating ventilation therapy with a minimally invasive profile. The ARPV airway pressure during expiration (P (low)) is substantially zero throughout ventilation to allow for rapid acceleration of the expiration gas flow rate. Typically, the fraction of oxygen in the intake gas (FiO2) is initially set to about 0.5 to 1.0 (ie, about 50% to 100%). The maximum airway pressure achieved during inspiration (P (high)) must be high enough to overcome the void closure force and begin replenishment of lung volume. P (high) may be suitably initialized with an initial value of about 35 cm H2O.

  Alternatively, P (high) may be established based on either the severity and type of lung injury, or supplemental pressure requirements. The latter method is preferred when the ventilation / perfusion ratio is about 200 millimeters of mercury (200 mmHg) or less. The ventilation-perfusion ratio is preferably monitored continuously. It is the ratio of the fraction of oxygen present in the inspiratory gas to the partial pressure of oxygen in the patient's blood (ie PaO2 / FiO2, but generally abbreviated as P / F).

  When the severity and type of lung injury is characterized by a P / F greater than about 350 mmHg, an initial value of P (high) in the range of about 20 cmH2O to 28 cmH2O is preferably established. On the other hand, if the P / F ratio is less than about 350 mmHg, P (high) is preferably initialized within a range of about 28 cmH2O to 35 cmH2O.

  In situations where the P / F ratio is about 200 mmHg or less, such as can occur when the patient's initial injury is non-pulmonary disease and / or lung injury is an indirect property, Considering the establishment of P (high), which is a value up to 40 mmHg, but preferably not clearly exceeding 40 mmHg. If P (high) is initially established with an initial value of about 35 cm H2O, once P / F exceeds about 250 mmHg, P (high) is reduced from such value. The onset of ventilation also requires the establishment of inspiration and expiration time (duration) settings.

  Initially, the duration of the positive pressure phase (T (high)) is established at a value in the range of about 5.0 to about 6.0 seconds, as long as the measured PaCO2 does not exceed about 60 mmHg. In that case, T (high) is more preferably set to a lower initial value in the range of about 4.0 to 5.0 seconds. The duration of the ventilator release phase (T (low)) may be suitably initialized with a value in the range of 0.5 to 0.8 seconds, with about 0.7 seconds being a preferred initial value. is there.

  Once the initial values of P (high), P (low), T (high), and T (low) are established, ventilation generally continues in a repetitive APRV mode cycle as illustrated in FIG. During ventilation management according to the present invention, the initial value of one or more of these parameters is reevaluated and modified according to the measured parameters as described in connection with the preceding description.

  In the management of ventilation according to the present invention, the main goal is to maintain the carbon dioxide concentration (PaCO2) in the blood of the ventilated patient at a level below about 50 mmHg. For that purpose, the arterial PaCO2 is continuously monitored or measured as clinically indicated and the ventilator is controlled to adjust the ventilation as follows. At any time after ventilation has started, but preferably immediately, or as soon as there is an indication of hypercapnia (PaCO2 above about 50 mmHg), the T (low) setting is optionally Are preferably checked and readjusted if necessary.

  In accordance with the present invention, optimal end expiratory lung volume is maintained by gradual increase in the duration of the expiratory or release phase by terminating T (low) based on expiratory gas flow. To do so, the flow of exhaled gas is measured by the ventilator and checked with respect to the time at which the ventilator controller begins to terminate the release phase. The expiratory exhaust valve should be activated to terminate the release phase T (low) when the flow of expiratory gas decreases from about 25% to 50% of its absolute maximum expiratory flow (PEFR). An example is illustrated in FIG. In that example, T (low) is terminated by controlling the exhalation exhaust valve to terminate the release phase when the expiratory gas flow is reduced to 40% PEFR.

  If monitoring of PaCO2 indicates that there is hypocapnia (PaCO2 below about 50 mmHg), T (high) is increased by about 0.5 seconds while maintaining P (high) substantially unchanged. It is done. As indicated by subsequent measurements of PaCO2, if the patient remains hypocapnic, it will be explained unless oxygen supply is sufficient and withdrawal is not contraindicated based on criteria further described below A withdrawal in the manner may be initiated.

  However, patients with hypercapnia cannot be withdrawn. In the case of hypercapnia, the present invention considers evaluation of expiratory flow patterns before making further significant adjustments to the ventilation parameters. This evaluation can be easily performed by a software program stored in the ventilator control unit that performs automatic analysis of expiratory flow versus time trace diagrams. As illustrated in FIG. 19, normal expiratory flow is characterized by a flow that drops substantially monotonically from the beginning of the release phase to its end and does not decline prematurely or suddenly. In contrast, the restrictive flow drops rapidly from the beginning of the release phase to zero or a relatively small value. Occluded flow is characterized by an inflection point where the duration tends to be further extended beyond which the flow velocity decreases significantly from its initial velocity.

  FIG. 18 illustrates a gas flow pattern with significant inflection points. Based on the analysis of the flow data provided by the expiratory flow sensor, the ventilator control unit is programmed to determine a reference point during the P (low) / T (low) cycle. Flow and time reference points within the flow time zone, generated or established by the P (low) / T (low) cycle, measure changes occurring in lung volume during the P (low) / T (low) cycle and It may be used to calculate. If it is determined that occlusion or restricted flow is present, the present invention contemplates adjusting T (low) before making any other significant adjustments to the ventilation parameters. This can be done according to one of two alternative methods.

  One method adjusts T (low) to a default value depending on whether the flow is occlusive or restrictive, but if the flow is normal, T (low) remains at its previous value. Is to make it possible. For limited flow, T (low) should be adjusted to less than about 0.7 seconds. On the other hand, occluded flow requires a longer duration, preferably T (low) above about 0.7 seconds, with 1.0-1.2 seconds being typical.

  It is optional, but sensible, to assess the sedation level of hypercapnic patients quickly. Patient sedation can be assessed by any suitable technique, such as conventional clinical techniques for determining a patient's SAS score. If the patient appears to be overly sedated based on a SAS score (SAS score above about 2) or another method, sedation reduction should be considered and started if appropriate . Thereafter, T (high) should be increased by about 0.5 seconds, while P (high) should be increased by about 2 cm H2O. PaCO2 should be reassessed after allowing sufficient time for these adjustments to take effect on the patient. If the patient remains hypercapnic, again T (high) should be increased by about 0.5 seconds and at the same time P (high) should be increased by about 2 cmH2O. The simultaneous increase of about 0.5 seconds of T (high) and about 2 cm H2O of P (high) should then be repeated until PaCO2 is reassessed and the patient is no longer hypercapnic. However, the total duration of T (high) should not be increased beyond a maximum of about 15 seconds.

  Management of oxygen supply according to the present invention is carried out with the aim of maintaining oxygen concentration (PaO2) in the arterial blood of a ventilated patient at a value of at least about 80 mmHg and maintaining saturation (SaO2) at least 95%. . Preferably, the variation in PaO2 is kept within a target range of about 55 mmHg to 80 mmHg. (The target range expressed in terms of SpO2 is about 0.88 to 0.95, but if both PaO2 and SpO2 data are available, PaO2 takes precedence.) Both oxygen supply and saturation are In response to a decision to meet a specified goal, the ventilator is intended to maintain a blood oxygen saturation (SaO2) of about 95% with about 35 P (high) and about 0.5 FiO2. Is controlled to gradually reduce the fraction of oxygen in the intake gas (FiO2) from about 30 minutes to about 0.5 every hour. Satisfying the latter objective may initiate the withdrawal in the manner described as long as the aforementioned ventilation target (ie, PaCO2 of less than about 50 mmHg) is met and withdrawal is not contraindicated.

  However, if the goals of oxygen supply of at least about 80 mmHg PaO2 and at least about 95% arterial oxygen saturation (SaO2) cannot both be maintained with the current FiO2, FiO2 is not reduced. Instead, P (high) is increased to about 40 cm H 2 O, and at the same time T (high) is increased by about 0.5 seconds.

  If such action does not increase the oxygen supply and saturation to a target of at least about 80 mmHg PaO2 and about 95% SaO2, P (high) is increased to a maximum of about 45 cmH2O and T (high) Is gradually further increased by about 0.5 to 1.0 seconds. The oxygen supply and saturation are then reassessed and if they are still below the target, FiO2 may optionally be increased to about 1.0 if initially less than 1.0. Oxygen and saturation continue to be reevaluated, and T (high) is increased sequentially in increments of about 0.5 to 1.0 seconds until the specified oxygen and saturation target is met.

  Once these oxygen supply and saturation goals are met, ventilate to maintain these goals while gradually reducing FiO2 and P (high) towards a level where onset of withdrawal can be considered. Is controlled. More specifically, while maintaining oxygen saturation at least about 95%, P (high) is reduced by about 1 cm H2O per hour, while FiO2 is only about 0.05 every about 30 minutes. Reduced.

  Withdrawal according to the present invention may be initiated after the oxygen supply and ventilation goals described above are met, unless otherwise contraindicated. That is, at about 35 cm H2O P (high), PaCO2 still remains below about 50 mmHg, SaO2 still remains below at least about 95%, and FiO2 was previously high, about 0.5 or less. When it is being lowered to the level of During withdrawal according to the present invention, T (high) is controlled to continue replenishment, while P (high) is reduced to gradually reduce the airway pressure. As shown in FIG. 20, T (high) is performed so as to induce a gradual lung stress relaxation as shown in FIG. This is accomplished by performing a series of successive incremental increases.

  As a result, the pressure-volume curve of the lungs gradually changes from its inspiratory part to its expiratory part, as illustrated in FIG. As can be understood with reference to the previous diagram, the departure may be performed in two stages, the first stage being more gradual than the second stage. During the first phase, P (high) is reduced by about 2 cm H2O every hour. At approximately the same time as each reduction in P (high), T (high) is increased by about 0.5 to 1.0 seconds up to, but not exceeding, T (high) for a total duration of about 15 seconds. It is done.

  As P (high) is thus reduced, the fraction of oxygen in the intake gas (FiO2) is also gradually reduced according to P (high). During the first phase of withdrawal, this progressive reduction of FiO2 is performed gradually. Withdrawal is more aggressive when P (high) is reduced to about 24 cm H2O, FiO2 is reduced to about 0.4, and the patient maintains at least about 95% blood oxygen saturation (SaO2). You may proceed to the second stage. The term “substantially simultaneously” should not be construed as limited to necessarily requiring that changes occur exactly simultaneously. Rather, the term is to be interpreted broadly to encompass not only events that occur simultaneously, but also any event that is sufficiently close in time to achieve the described advantage or effect.

  During continuous withdrawal, the continuous reduction of P (high) and the substantially simultaneous increase and simultaneous reduction of T (high) continue about once every hour. However, during the second phase, the P (high) reduction occurs in increments of about 4 cm H2O, and the T (high) increase is about 2.0 seconds in steps. As the reduction of P (high) continues, further reduction of FiO2 is performed. Once FiO2 is reduced to about 0.3, the airway pressure is reduced so that the ventilation mode up to that time is transitioned from APRV to a nearly continuous positive airway pressure / automatic tube correction mode (CPAP / ATC). The

  Once the patient has a Fi. Withstanding CPAP at about 5 cm H 2 O with 2 preferably assesses the patient's ability to maintain unassisted breathing for at least about 2 hours or more. The criteria for such evaluation are: a) at least about 0.90 SpO2 and / or at least about 60 mmHg PaO2, b) tidal volume of at least about 4 ml / kg per ideal body weight, c) about 35 times per minute Respiratory rate that does not significantly exceed the respiration rate of d), and d) the absence of respiratory distress, such as i) a heart rate that exceeds 120% of the 6 am heart rate (but such a heart rate Less than about 5 minutes above the number may be considered acceptable), ii) significant use of breathing-assisted accessory muscle, iii) chest-abdominal oddity, iv) sweating, and / or v) significant Indicated by the presence of any two or more of subjective dyspnea.

  If there are signs of respiratory distress, CPAP is resumed at an airway pressure of approximately 10 cm H2O and monitoring and reassessment should be performed as necessary. However, if all of the above criteria a) to d) are met, the patient may be extubated with a face mask, nasal cannula oxygen or room air, T-tube breathing, tracheostomy mask breathing, or high flow CPAP at about 5 cm H2O. Etc., and may be transitioned to substantially unassisted breathing.

  During all phases of ventilation, including initiation, management, and withdrawal, patients should be reassessed at least about every 2 hours and more often if necessary. Blood gas measurements (PaO 2 and SaO 2 and PaCO 2) managed by the ventilation control according to the present invention should be monitored frequently every 2 hours or more, but almost continuous monitoring of all parameters is ideal. Considered.

  Immediately before and during withdrawal, at least one special assessment should be performed daily, preferably between 6 and 10 hours. If it is not possible to do so, a delay of at most about 4 hours can be tolerated. a) at least about 12 hours have passed since the initial ventilation setting was established or first changed, b) the patient has not received a neuromuscular blocking agent, and there is no neuromuscular blocking agent in the body, and c) Withdrawal should not be initiated or further continued unless the systolic blood pressure is at least about 90 mmHg without a vasopressor (other than the “kidney” dose of dopamine).

  If all of these criteria are met, the test should be conducted by ventilating the patient in CPAP mode at about 5 cm H2O and about 0.5 FiO2 for about 5 minutes. If the patient's breathing rate does not exceed about 35 breaths per minute (bpm) during a 5 minute period, withdrawal as described above may proceed. However, if the respiratory rate exceeds about 35 bpm during the 5 minute period, it should be determined whether such polypnea is associated with anxiety. If so, administer the appropriate treatment for anxiety and repeat the study within about 4 hours. If polypnea does not appear to be associated with anxiety, resume ventilation management at the parameter settings performed prior to the study and resume ventilation management as described above. Reassess at least daily until withdrawal can be initiated as described above.

(Industrial applicability)
Embodiments of the present invention are suitable for use in many respiratory assistance applications involving the use of ventilators and ventilator systems and methods of operation thereof. Various configurations and capabilities of the ventilator and system and method of operation of the present invention can be modified to accommodate almost any conceivable respiratory assistance application and / or requirement. The arrangement, capabilities, and suitability of the features and components of the novel ventilators, systems, and methods of use and operations described herein are subject to any specific emergency and / or routine practice, and It can be easily modified according to the principles of the present invention as needed to suit a hospital, care, or home care use or situation. In addition, such ventilators, systems, and methods of the present invention are suitable for use with almost any type of ventilator, including but not limited to positive or negative pressure respiratory assistance devices.

  Such modifications and alternative arrangements are compatible with a wide variety of possible applications that are easy to use with the improved ventilator, respiratory assistance system, method of operation of the present invention as described and discussed herein. It may be further preferred and / or optionally desired to establish gender. Thus, even if only a few such embodiments, alternatives, variations, and modifications of the invention are described and illustrated, the practice of such additional modifications and variations, and their equivalents Should be understood to be within the spirit and scope of the invention as defined in the following claims.

Claims (23)

A ventilator system for assisting a patient's respiratory function under the guidance of a clinician,
A supply pump and control module in communication with the data circuit and a gas circuit having a plurality of valves, a supply port and an exhaust port, and for communicating pressurized gas to the patient, the control module comprising the data A feed pump and control module including a display, an input device and a memory in communication with the circuit;
A sensor arrangement in communication with the data circuit, wherein the sensor is in communication with at least one of the exhaust port and the supply port, at least one pulse oximeter, at least one capnometer, and at least one pressure. A sensor array comprising a sensor and at least one flow meter;
A command module resident in the memory that instructs the control module to adjustably actuate the supply pump and the plurality of valves to establish at least one pressure , volume , and flow rate in a gas circuit A command module that is operable as
And at least one initialization parameter database resident in the memory, said a display communicable with, and, (a) expiratory positive end expiratory pressure, (b) SpO2 weight, (c) etCO2 weight, (d) FiO2 amount, (e) high pressure, (f) low pressure, (g) high time, (h) low time, (i) pressure increment, (j) time increment, (k) tidal volume, (l) mechanical breathing An initialization parameter database storing at least one model patient data array element including frequency, (m) pressure-volume gradient, (n) induced pressure, and (o) occlusion pressure;
With
The command module communicates with the sensor array element to: (i) patient SpO2 quantity, (ii) patient etCO2 quantity, (iii) maximum expiratory flow, (iv) end expiratory lung volume, and (v) spontaneous breathing frequency. Measuring actual data array elements of at least one of the patients,
The command module compares the patient's actual data array to the at least one model patient data array and adjusts the delivery pump to provide the at least one model patient data array, SpO2 target value, etCO2 target value, And a ventilator system to achieve at least one of optimal end-tidal lung volumes. When the patient SpO2 amount is less than the SpO2 target value, the command module communicates with the sensor array, checks the patient's actual data array, checks the high pressure,
The command module determines a FiO2 value when the high pressure is greater than or equal to a high pressure threshold, and (a) when the FiO2 value is greater than or equal to the FiO2 threshold, the control module causes the high pressure to increase by a pressure increment. And adjusting at least one of the supply pump and the plurality of valves to increase the high time by a time increment, and (b) when the FiO2 value is less than the FiO2 threshold; The ventilator system of claim 1, wherein the control module adjusts at least one of the supply pump and the plurality of valves to increase the amount of FiO2. If the patient SpO2 amount is greater than or equal to the SpO2 target value, the command module communicates with the sensor array, checks the patient's actual data array, and checks the FiO2 value;
(A) when the FiO2 value is equal to or greater than a FiO2 threshold, the command module adjusts at least one of the supply pump and the plurality of valves to reduce the FiO2 amount. And (b) when the FiO2 value is less than the FiO2 threshold, the command module sets an initial withdrawal value to indicate a true value. If the patient SpO2 amount is less than the SpO2 target value, the command module communicates with the sensor array and checks the patient's actual data array to indicate whether the supplement value is a true value or a false value. Determine whether
When the replenishment value indicates (i) a true value, the control module generates a clinician alarm signal; and (ii) when the false value indicates a control module, (a) the control module increases the high pressure by a pressure increment. At least one of the supply pump and the plurality of valves to increase (b) increase the high time by a time increment, and (c) adjust the low time by another time increment. The ventilator system of claim 1, wherein the ventilator system is adjusted. If the patient SpO2 amount is less than the SpO2 target value, the command module communicates with the sensor array, checks the patient's actual data array, and calculates an optimal end expiratory lung volume value;
If the optimal end expiratory lung volume value is greater than or equal to (a) the optimal end expiratory lung volume threshold, the command module sets the oxygen supply value to indicate a true value, and (b) optimal end expiratory lung volume If less than the threshold, the command module (i) polls the sensor array to measure the maximum expiratory flow, measure gas flow truncation, and calculate a gas flow deceleration angle to Selecting one of the time increments; (ii) setting a refill value to indicate a true value; and (iii) adjusting at least one of the supply pump and the plurality of valves; The ventilator system of claim 1, wherein the control module is instructed to reduce the low time by applying a selected time increment. If the patient etCO2 amount is less than the etCO2 target value, the spontaneous breathing frequency is less than a mechanical breathing frequency, and the high time is less than a high time threshold, the high pressure is determined,
If the high pressure is determined to be less than (a) a high pressure threshold, the command module increases at least one of the high time and the high pressure by at least one respective time increment and pressure increment. Commanding the control module to adjust at least one of the supply pump and the plurality of valves, and (b) if determined to be greater than or equal to the high pressure threshold, the command module Instructing the control module to adjust at least one of the supply pump and the plurality of valves by increasing at least one of the high times by at least one respective time increment The ventilator system of claim 1. When the patient etCO2 amount is less than the etCO2 target value, the spontaneous breathing frequency is greater than or equal to a mechanical breathing frequency, and the high time value is greater than or equal to a high time threshold, the high pressure is determined;
If it is determined that the high pressure is greater than or equal to (a) a high pressure threshold, the command module sets the replenishment value to indicate a true value and the high time by at least one respective time increment. By commanding the control module to adjust at least one of the supply pump and the plurality of valves, and (b) the command module when determined to be below a high pressure threshold The control to regulate at least one of the supply pump and the plurality of valves by decreasing the high time and increasing the high pressure by at least one respective time increment and pressure increment. The ventilator system of claim 1, wherein the ventilator system commands the module. The control module detects that the patient etCO2 amount is greater than or equal to the etCO2 target value, the command module samples to confirm spontaneous breathing frequency;
(A) the free-onset respiratory frequency is, when it is less than the spontaneous breathing frequency threshold, the command module checks the tachypnea value, when the multi breathing target value indicates a true value, the command module, ventilation The value can be set to indicate a true value,
(B) the free-onset respiratory frequency is, when it is spontaneous respiration frequency threshold or more, the command module checks the apnea value, (i) the wireless respiration value, when indicating the true value, the command module Can set the ventilation value to indicate a true value, and (ii) when the apnea value indicates a false value, the command module causes the airway pressure release ventilation withdrawal value to indicate a true value. The ventilator system of claim 1, which can be set to: The control module detects that the patient etCO2 amount is greater than or equal to the etCO2 target value, the command module samples the high pressure, sets the high pressure value, samples the spontaneous breathing frequency,
When the command module detects that the spontaneous frequency is greater than or equal to the spontaneous frequency threshold and the high pressure value is greater than or equal to the high pressure threshold, the command module includes at least one of the supply pump and the plurality of valves. 2. The artificial respiration according to claim 1, wherein one is adjusted to initiate withdrawal by commanding the control module to decrease the high pressure by a pressure increment and to increase the high time by a time increment. System. Further comprising the at least one model patient data array further comprising a predetermined withdrawal failure criterion establishing a FiO2 threshold, SpO2 threshold, spontaneous tidal volume, minute ventilation, and airway obstruction pressure;
The command module communicates with the data circuit to sample the sensor array, measure at least one of the patient's actual data array elements, and compare the elements to the predetermined leave failure criteria. Determine whether the exit failure value is true or false,
The command module (a) adjusts at least one of the supply pump and the plurality of valves to increase the high pressure by a pressure increment when the withdrawal failure value indicates the true value. And command the control module to increase the high time by a time increment, and (b) when the leave failure value indicates the false value, the command module The cyclic disengagement is initiated repeatedly by instructing the control module to adjust at least one of the plurality of valves to decrease the high pressure and high time by pressure and time increments. The described ventilator system.   Each time the command module initiates another periodic withdrawal, the command module verifies the high pressure until a continuous positive airway pressure threshold is reached, and the command module sets the continuous positive airway pressure value to a true value. The ventilator system of claim 10, wherein the ventilator system can be configured to indicate The at least one model patient further comprising: a predetermined continuous positive airway pressure; and a FiO2 threshold, SpO2 threshold, spontaneous tidal volume, minute ventilation, and a default withdrawal failure criteria that establish airway obstruction pressure Further comprising a data array;
The command module communicates with the data circuit to sample the sensor array, measure at least one of the patient's actual data array elements, and compare the element to the predetermined leave failure criteria. Determine whether the withdrawal failure value indicates true or false,
When the command module determines that (a) the withdrawal failure value indicates the true value, the command module adjusts at least one of the supply pump and the plurality of valves to maintain the continuous Instructing the control module to increase the positive airway pressure and (b) determining that the withdrawal failure value indicates the false value, the command module determines that the continuous airway until the extubation threshold pressure is reached. The ventilator system of claim 1, wherein the positive pressure is periodically reduced.   When the high pressure is (a) less than a high pressure threshold, the command module adjusts at least one of the supply pump and the plurality of valves to determine the continuous positive airway pressure based on the high pressure. And (b) when above the high pressure threshold, the command module adjusts at least one of the supply pump and the plurality of valves to adjust the airway pressure. 13. The ventilator system of claim 12, wherein the ventilator system commands the control module to adjust open ventilation withdrawal. A ventilator for use by a clinician in assisting a patient presenting with pulmonary distress,
A controller including a display, an input device, and a memory in electrical communication with the data network, the gas network including at least two valves and a supply port and an exhaust port in communication with the patient; A controller incorporating a source of pressurized gas in fluid communication;
A plurality of sensors in communication with the data network, the at least one oxygen saturation sensor in communication with at least one of the exhaust port and the supply port; at least one capnometer and at least one pressure gauge; A plurality of sensors, and at least one gas flow meter;
A command routine resident in the memory for operably actuating at least one of the source of pressurized gas and the valve to establish at least one pressure , volume and flow rate in the gas network; , that runs to drive the controller, and a command routine,
The command routines, the clinical physician (i) automatic initialization setting, and (ii) (a) breath endings positive pressure amount, (b) SpO2 weight, (c) etCO2 weight, (d) FiO2 amount, ( e) high pressure, (f) low pressure, (g) high time, (h) low time, (i) pressure increment, (j) time increment, (k) tidal volume, (l) machine breathing frequency, (m ) pressure - volume gradient, the input device at least one of (n) induced pressure, and (o) at least one of the parameters stored in the memory including occlusion pressure, i.e. (i) and (ii) Prompt on the display to enter settings via
The command routine communicates with the plurality of sensors to (i) a patient SpO2 amount, (ii) a patient etCO2 amount, (iii) a maximum expiratory flow rate, (iv) an end expiratory lung volume, and (v) a spontaneous breathing frequency. Measuring actual data array elements of at least one of the patients,
The command routine compares the patient's actual data array to at least one of the settings and includes at least one of the settings of SpO2 target value, etCO2 target value, and optimal end-tidal lung volume. A ventilator that calculates at least one. If the patient SpO2 amount is less than the SpO2 target value, the command routine communicates with the plurality of sensors, checks the patient's actual data array, and calculates an optimal end expiratory lung volume value;
When the optimal end expiratory lung volume value is equal to or greater than (a) the optimal end expiratory lung volume threshold, the command routine sets the oxygen supply value to indicate a true value, and (b) the optimal end expiratory lung volume If less than the threshold, the command routine (i) polls the plurality of sensors to measure the maximum expiratory flow, measure gas flow truncation, and calculate a gas flow deceleration angle. Selecting one of the time increments, (ii) setting a refill value to indicate a true value, and (iii) adjusting at least one of the pressurized gas source and the plurality of valves. 15. The ventilator of claim 14, wherein the ventilator instructs the controller to reduce the low time by applying the selected time increment. If the patient etCO2 amount is less than the etCO2 target value, the spontaneous breathing frequency is less than a mechanical breathing frequency, and the high time is less than a high time threshold, the high pressure is determined,
If the high pressure is determined to be (a) less than a high pressure threshold, the command module increases at least one of the high time and the high pressure by at least one respective time increment and pressure increment. Commanding the control module to adjust at least one of the supply pump and the plurality of valves, and (b) if determined to be greater than or equal to the high pressure threshold, the command module Instructing the control module to adjust at least one of the supply pump and the plurality of valves by increasing at least one of the high times by at least one respective time increment 15. A ventilator according to claim 14. When the patient etCO2 amount is less than the etCO2 target value, the spontaneous breathing frequency is greater than or equal to mechanical breathing frequency, and the high time is greater than or equal to a high time threshold, the high pressure is determined,
If it is determined that the high pressure is greater than or equal to (a) a high pressure threshold, the command module sets the replenishment value to indicate a true value and sets the high time by at least one respective time increment. Commanding the control module to adjust at least one of the supply pump and the plurality of valves by changing, and (b) the command module if determined to be less than the high pressure threshold Adjusting the at least one of the supply pump and the plurality of valves by decreasing the high time and increasing the high pressure by at least one respective time increment and pressure increment The ventilator of claim 14, wherein the ventilator commands the module. Means for ventilating a patient presenting with respiratory distress to a clinician,
Means for communicating pressurized gas to the patient and for discharging gas from the patient;
Means for controlling the supply means, including means for displaying information, means for receiving input from the clinician, and means for storing information;
A plurality of means for detecting a physical state of the gas communicated to the patient by the supply means, comprising: (a) at least one means for detecting pressure; and (b) detecting volumetric flow rate. A plurality of means, including at least one means for detecting, (c) at least one means for detecting the concentration of oxygen, and (d) at least one means for detecting the concentration of carbon dioxide;
Means for instructing said means for controlling to adjustably communicate said pressurized gas with a variable pressurized volume flow rate and to detect said physical state of said gas, said instructions Means comprises: means present in the means for storing the information;
The means for the display, against the clinical physician, (i) automatic initialization setting, and (ii) (a) breath endings positive pressure amount, (b) SpO2 weight, (c) etCO2 amount, ( d) FiO2 amount, (e) high pressure, (f) low pressure, (g) high time, (h) low time, (i) pressure increment, (j) time increment, (k) tidal volume, (l) At least one of the parameters held in the means for storing including mechanical breathing frequency, (m) pressure-volume gradient, (n) induced pressure, and (o) occlusion pressure, ie (i) and (ii) including means Ru is set enter at least one of)
The means for directing receives the settings from the clinician and activates the means for supplying to physically characterized by the amount of FiO2, the high pressure and low pressure, the high time and low time. Instructing the means for controlling to communicate the pressurized gas supply to a patient having a condition;
The means for indicating is in communication with one of the plurality of means for detecting, (i) a patient SpO2 amount, (ii) a patient etCO2 amount, (iii) a maximum exhalation flow, (iv) an end of expiration Measuring at least one patient actual data array element of lung volume and (v) spontaneous breathing frequency;
The means for controlling compares the patient's actual data array to at least one of the settings , and at least one of the settings is an SpO2 target value, an etCO2 target value, and an optimal end expiratory lung volume. Means for performing ventilation, calculating at least one of If the patient etCO2 amount is less than the etCO2 target value, the spontaneous breathing frequency is less than a mechanical breathing frequency, and the high time is less than a high time threshold, the high pressure is determined,
If the high pressure is determined to be less than (a) a high pressure threshold, the command module increases at least one of the high time and the high pressure by at least one respective time increment and pressure increment. Commanding the control module to adjust at least one of the supply pump and the plurality of valves, and (b) if determined to be greater than or equal to the high pressure threshold, the command module Instructing the control module to adjust at least one of the supply pump and the plurality of valves by increasing at least one of the high times by at least one respective time increment The means for performing ventilation according to claim 18. If the patient etCO2 amount is less than the etCO2 target value, the spontaneous breathing frequency is greater than or equal to the received mechanical breathing frequency, and the high time is greater than or equal to a high time threshold, the high pressure is determined;
If it is determined that the high pressure is greater than or equal to (a) a high pressure threshold, the command module sets the replenishment value to indicate a true value and sets the high time by at least one respective time increment. Commanding the control module to adjust at least one of the supply pump and the plurality of valves by changing, and (b) the command module when determined to be less than the high pressure threshold Adjusting the at least one of the supply pump and the plurality of valves by decreasing the high time and increasing the high pressure by at least one respective time increment and pressure increment 19. The means for providing ventilation according to claim 18, wherein the module instructs the module. At least one parameter further comprising: (i) auto-initialization settings; and (ii) FiO2 threshold, SpO2 threshold, voluntary tidal volume, minute ventilation, and airway obstruction pressure At least one of them,
The means for commanding communicates with the means for detecting to measure an actual value and to determine whether the leave failure value is a true or false value compared to at least one of the predetermined leave failure criteria. Determine which of the
When the means for commanding determines that (a) the detachment failure value indicates a true value, the means for commanding adjusts the means for supplying to increase the high pressure by a pressure increment. Instructing the means for controlling to increase the time and to decrease the high time by a time increment, and (b) to command when determining that the leave failure value represents a false value 19. The method of claim 18, wherein said means repeatedly initiates periodic detachment by commanding said means for controlling said means for controlling to reduce said high pressure by a pressure increment. Means for ventilation.   Each time the means for commanding initiates another periodic departure, the means for commanding confirms the high pressure and continues the cycle until a continuous positive airway pressure threshold is detected, The means for ventilating according to claim 21, wherein said means for commanding allows a continuous positive airway pressure value to be set to indicate a true value. At least one parameter further comprising: (i) auto-initialization settings; and (ii) FiO2 threshold, SpO2 threshold, voluntary tidal volume, minute ventilation, and airway obstruction pressure At least one of them,
The means for commanding communicates with the means for detecting to measure an actual value and to determine whether the leave failure value is a true or false value compared to at least one of the predetermined leave failure criteria. Determine which of the
If the means for commanding determines that (a) the withdrawal failure value indicates a true value, the means for commanding adjusts the means for supplying to provide the continuous positive airway pressure. Instructing the means for controlling to increase, and (b) determining that the fail-to-leave value indicates a false value, the means for instructing the duration until the extubation threshold pressure is reached. The means for performing ventilation according to claim 18, wherein the positive airway pressure is periodically reduced.