CA2726604C - Ventilator apparatus and system for ventilation - Google Patents

Abstract

A ventilator (10) for use by a clinician in supporting a patient presenting pulmonary distress. A controller module (20) with a touch-screen display (26) operates a positive or negative pressure gas source (40) that communicates with the intubated or negative pressure configured patient through valved (46) supply and exhaust ports (42, 44). A
variety of peripheral, central, and or supply/exhaust port positioned sensors (54) may be included to measure pressure, volumetric flow rate, gas concentration, transducer, and chest wall breathing work. Innovative modules and routines (30) are incorporated into the controller module enabling hybrid, self-adjusting ventilation protocols and models that are compatible with nearly every conceivable known, contemplated, and prospective technique, and which establish rigorous controls configured to rapidly adapt to even small patient responses with great precision so as to maximize ventilation and recruitment while minimizing risks of injury, atelectasis, and prolonged ventilator days.

Description

VENTILATOR APPARATUS AND SYSTEM FOR VENTILATION
BACKGROUND OF THE INVENTION
Field of the Invention The invention relates to the field of ventilating human patients. More particularly, the present invention relates to an improved ventilator and method of operation for ventilation intervention and initiation, oxygenation, recruitment, ventilation, initial weaning, airway pressure release ventilation weaning, continuous positive airway pressure weaning, and continuous and periodic management and control of the ventilator.
Description of Related Art The inventor herein has previously invented, among other inventions, ventilator systems and methods of operation disclosed and claimed in U.S.
Patent No. 7,246,618, and in U.S. Patent Application Publication Nos. 2008/0072901, 2006/0174884, 2003/0111078.
Airway pressure release ventilation (APRV) is a mode of ventilation believed to offer advantages as a lung protective ventilator strategy. APRV is a form of continuous positive airway pressure (CPAP) with an intermittent release phase from a preset CPAP level. Similarly, APRV allows maintenance of substantially constant airway pressure to optimize end inspiratory pressure and lung recruitment. The CPAP level optimizes lung recruitment to prevent or limit low volume lung injury. In addition, the CPAP level provides a preset pressure limit to prevent or limit over distension and high volume lung injury.
The intermittent release from the CPAP level augments alveolar ventilation.
Intermittent CPAP release accomplishes ventilation by lowering airway pressure. In contrast, conventional ventilation elevates airway pressure for tidal ventilation.
Elevating airway pressure for ventilation increases lung volume towards total lung capacity (TLC), approaching or exceeding an upper inflection point of an airway 4203540 v2 pressure ¨ volume curve (P-V curve). The P-V curve includes two limbs joined by upper and lower inflection points: an inspiratory or inspiration limb that is opposite an expiratory or expiration limb. Limiting ventilation below the upper inflection of the P-V
curve is one the goals of lung protective strategies.
Subsequently, tidal volume reduction is necessary to limit the potential for over distension. Tidal volume reduction produces alveolar hypoventilation and elevated carbon dioxide levels. Reduced alveolar ventilation from tidal volume reduction has led to a strategy to increase respiratory frequency to avoid the adverse effects of hypercapnia. However, increased respiratory frequency is associated with increase lung injury. In addition, increase in respiratory frequency decreases inspiratory time and lessens the potential for recruitment. Furthermore, increasing respiratory frequency increases frequency dependency and decreases potential to perform ventilation on the expiratory limb of the P-V curve.
During APRV, ventilation occurs on the expiratory limb of a pressure ¨ volume curve. The resultant expiratory tidal volume decreases lung volume, eliminating the need to elevate end inspiratory pressure above the upper inflection point.
Therefore, tidal volume reduction is unnecessary. CPAP levels can be set with the goal of optimizing recruitment without increasing the potential for over distension.
Consequently, end inspiratory pressure can be limited despite more complete recruitment, while ventilation can be maintained.
APRV was developed to provide ventilator support to patients with respiratory failure. Clinical use of APRV is associated with decreased airway pressures, decreased dead space ventilation and lower intra-pulmonary shunting as compared to conventional volume and pressure cycled ventilation. APRV limits excessive distension of lung units, thereby decreasing the potential for ventilator induced lung injury (VILI), a form of lung stress. In addition, APRV reduces minute ventilation requirements, allows spontaneous breathing efforts and improves cardiac output.
APRV is a form of positive pressure ventilation that augments alveolar ventilation and lowers peak airway pressure. Published data on APRV has documented airway pressure reduction on the order of 30 to 40 percent over

2 4203540 v2 conventional volume and pressure cycled ventilation during experimental and clinical studies. Such reduction of airway pressure may reduce the risk of VILI. APRV
improves ventilation to perfusion ratio (V/Q) matching and reduces shunt fraction compared to conventional ventilation. Studies performed utilizing multiple inert gas .. dilution and excretion technique (MIGET) have demonstrated less shunt fraction, and dead space ventilation. Such studies suggest that APRV is associated with more uniform distribution of inspired gas and less dead space ventilation than conventional positive pressure ventilation.
APRV is associated with reduction or elimination of sedative, inotropic and neuromuscular blocking agents. APRV has also been associated with improved hemodynamics. In a ten year review of APRV, Calzia reported no adverse hemodynamic effects. Several studies have documented improved cardiac output, blood pressure and oxygen delivery. Consideration of APRV as an alternative to pharmacological or fluid therapy in the hemodynamically-compromised, mechanically-ventilated patient has been recommended in several case reports.
APRV is a spontaneous breathing mode of ventilation that allows unrestricted breathing effort at any time during the ventilator cycle. Spontaneous breathing in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) has been associated with improved ventilation and perfusion, decreased dead space ventilation and improved cardiac output and oxygen delivery. ALI/ARDS is a pathological condition characterized by marked increase in respiratory elastance and resistance.
However, most patients with ALI/ARDS exhibit expiratory flow limitations.
Expiratory flow limitations results in dynamic hyperinflation and intrinsic positive end expiratory pressure (PEEP) development. In addition, ARDS patients experience increased flow resistance from external ventilator valving and gas flow path circuitry including the endotracheal tube and the external application of PEEP.
Several mechanisms can induce expiratory flow limitations in ALI/ARDS. In ALI/ARDS both functional reserve capacity (FRC) and expiratory flow reserve are reduced. Pulmonary edema development and superimposed pressure result in

3 4203540 v2 increased airway closing volume and trapped volume. In addition, the reduced number of functional lung units (derecruited lung units or alveolar and enhanced airway closure) decrease expiratory flow reserve further. Low volume ventilation promotes small airway closure and gas trapping. In addition elevated levels of PEEP
increase expiratory flow resistance. In addition to downstream resistance, maximal expiratory flow depends on lung volume. The elastic recoil pressure stored in the preceding lung inflation determines the rate of passive lung deflation.
APRV expiratory flow is enhanced by utilization of an open breathing system and use of low (0-5 cm H20) end expiratory pressure. Ventilation on the expiratory limb of the P-V curve allows lower PEEP levels to prevent airway closure.
Lower PEEP levels result when PEEP is utilized to prevent derecruitment rather than attempting partial recruitment. Increasing PEEP levels increases expiratory resistance, and conversely lower PEEP levels reduce expiratory resistance, thereby accelerating expiratory flow rates. Sustained inflation results in increased lung recruitment (increased functional lung units and increased recoil pressure) and ventilation along the expiratory limb (reduced PEEP and expiratory flow resistance), improving expiratory flow reserve.
In addition, release from a sustained high lung volume increases stored energy and recoil potential, further accelerating expiratory flow rates.
Unlike low volume ventilation, release from a high lung volume increases airway caliber and reduces downstream resistance. Maintenance of end expiratory lung volume (EELV) to eliminate the inflection point of the flow volume curve and the use of an open system allows reduction in circuitry flow resistance. EELV is maintained by limiting the release time and titrated to the inflection point of the flow time curve.
Reduced levels of end expiratory pressure are required when ventilation occurs on the expiratory limb of the P-V curve. In ALI/ARDS, increased capillary permeability results in lung edema. Exudation from the intravascular space accumulates, and superimposed pressure on dependent lung regions increases and compresses airspaces. Dependent airspaces collapse and compressive atelectasis results in severe V/Q mismatching and shunting. Regional transpulmonary pressure gradients that exist in the normal lung are exaggerated during the edematous phase

4 4203540 v2 of ALI/ARDS. Patients typically being in the supine position, such that forces directed dorsally and cephalad progressively increase pleural pressures in dependent lung regions. Ventilation decreases as pleural pressure surrounding the dependent regions lowers transalveolar pressure differentials. Full ventilatory support during controlled ventilation promotes formation of dependent atelectasis, increase V/Q
mismatching and intrapulmonary shunting. Increasing airway pressure can re-establish dependent transpulmonary pressure differential but at the risk of over distension of nondependent lung units.
Alternatively, spontaneous breathing, as with APRV, can increase dependent transpulmonary pressure differentials without increasing airway pressure. APRV

allows unrestricted spontaneous breathing during any phase of the mechanical ventilator cycle. As noted, spontaneous breathing can lower pleural pressure, thereby increasing dependent transpulmonary pressure gradients without additional airway pressure. Increasing dependent transpulmonary pressure gradients improves recruitment and decreases V/Q mismatching and shunt.
As compared to pressure support ventilation (PSV) multiple inert gas dilution technique, APRV provides spontaneous breathing and improved V/Q matching, intrapulmonary shunting and dead space. In addition, APRV with spontaneous breathing increased cardiac output. However, spontaneous breathing during pressure support ventilation was not associated with improved V/Q matching in the dependent lung units. PSV required significant increases in pressure support levels (airway pressure) to match the same minute ventilation.
Conventional lung protective strategies are associated with increased use of sedative agents and neuromuscular blocking agents (NMBA). The increased use of sedative and NMBA may increase the time the patient must remain on mechanical ventilation ("vent days") and increase complications. NMBA are associated with prolonged paralysis and potential for nosocomial pneumonia. APRV is a form of CPAP that allows unrestricted spontaneous breathing.
Decreased usage of sedation and neuromuscular blocking agents (NMBA) has been reported with APRV. In some institutions, APRV has nearly eliminated the

5 4203540 v2 use of NMBA, resulting in a significant reduction in drug costs. In addition to drug cost reduction, elimination of NMBA is thought to reduce the likelihood of associated complications such as prolonged paralysis and may facilitate weaning from mechanical ventilation.
Mechanical ventilation remains the mainstay management for acute respiratory failure. However, recent studies suggest that mechanical ventilation may produce, sustain or increase the risk of acute lung injury (ALI). Ventilator induced lung injury (VILI) is a form of lung stress failure associated with mechanical ventilation and acute lung injury. Animal data suggest that lung stress failure from VIL1 may result from high or low volume ventilation. High volume stress failure is a type of stretch injury, resulting from over distension of airspaces. In contrast, shear force stress from repetitive airway closure during the tidal cycle from mechanical ventilation results in low volume lung injury.
Initially, lung protective strategy focused on low tidal volume ventilation to limit excessive distension and VILI. Amato in 1995 and in 1998 utilized lung protective strategy based on the pressure-volume (P-V) curve of the respiratory system.
Low tidal volumes (6 ml/kg) confined ventilation between the upper and lower inflection points of the P-V curve. End expiratory lung volume was maintained by setting PEEP
levels to 2 cm H20 above the lower inflection point. Amato demonstrated improved survival and increased ventilator free days.
However, subsequent studies by Stewart and Brower were unable to demonstrate improved survival or ventilator free days utilizing low tidal volume ventilation strategy. Unlike Stewart and Brower, Amato utilized elevated end expiratory pressure in addition to tidal volume reduction. Such important differences between these studies limited conclusions as to the effectiveness of low tidal ventilation limiting ventilator associated lung injury (VALI).
Recent completion of the large controlled randomized ARDSNet trial documented improved survival and ventilator free days utilizing low tidal volume ventilation (6 ml/kg) vs. traditional tidal volume ventilation (12 ml/kg).
Although the low tidal volume group (6 ml/kg) and traditional tidal volume group (12 ml/kg) utilized

6 4203540 v2 identical PEEP/ Fi02 scales, PEEP levels were significantly higher in the low tidal volume group. Higher PEEP levels were required in the low tidal volume group in order to meet oxygenation goals of the study. Despite improved survival in the low tidal volume group (6 ml/kg) over traditional tidal volume group (12 ml/kg), survival was higher in the Amato study. The ARDSNet trial also failed to demonstrate any difference in the incidence of barotrauma. The higher PEEP requirements and the potential for significant intrinsic PEEP from higher respiratory frequency in the lower tidal volume group, may have obscured potential contribution of elevated end expiratory pressure on survival. Further studies are contemplated to address the issue of elevated end expiratory pressure.
In the prior art, utilization of the quasi-static inspiratory pressure versus volume (P-V) curve has been advocated as the basis or controlling a ventilator to carry out mechanical ventilation. The shape of the inspiratory P-V curve is sigmoidal and is described as having three segments. The curve forms an upward concavity at low inflation pressure and a downward concavity at higher inflation pressures.

Between the lower concavity and the upper concavity is the "linear" portion of the curve. The pressure point resulting in rapid transition to the linear portion of the curve has been termed the "lower inflection point".
The lower inflection point is thought to represent recruitment of atelectatic alveolar units. The increasing slope of the P-V curve above lower inflection point reflects alveolar compliance. Above the inflection point, the majority of air spaces are opened or "recruited". Utilizing the lower inflection point of the inspiratory P-V curve plus 2 cm H20 has been proposed to optimize alveolar recruitment. Optimizing lung recruitment prevents tidal recruitment/derecruitment and cyclic airway closure at end expiration. Ultimately, optimizing lung recruitment could potentially reduce shear force generation and low volume lung injury.
Despite an increase in the knowledge of those skilled in the relevant arts as to how to improve and maintain recruitment which minimizes the possibility of VILI and other anomalies, the systems, devices, and methods of the prior remain difficult to operate and employ for use with the best practice protocols. While due to many constraints, the often-cited challenges complained of by those skilled and practicing

7 4203540 v2 in the intensive care respiratory technical field is that a more automated and more accurate means is needed for applying the best practice APRV techniques.
More specifically, what has long been needed are improved devices and modes of operation that enable a clinician to more readily configure and reconfigure the desired APRV approach to respond to the individual presentation of each patient.
Preferably, such improved APRV devices and methods for use would establish the capability to give the clinical practitioner a comprehensive starting point of suitable APRV parameters that could be quickly fine-tuned to meet the needs of a particular patient.
More preferably, such an improved method and ventilator device would also be able to capture the real-time patient condition information used by a clinician in monitoring patient response to the initial APRV parameters, and to generate a more automated feedback loop that would enable the improved method or device to be automatically reconfigured within clinically preferred operational and protocol constraints. Even more preferably, a new method and apparatus is needed that would also enable more accurate and smaller adjustments to the various APRV
parameters that is presently possible with the present day equipment and methods, which must be manually adjusted. Such manual adjustments often result in unfavorable patient response that results from inaccurate adjustments or adjustments that cannot be made with enough precision due to the constraints or limited capabilities of the presently available equipment.
Most preferably, what is needed is a new and improved ventilator that incorporates new features and a mode of operation enabling greater flexibility, higher accuracy, and faster clinical response times in making adjustments to the various P-V curve and related parameters to accommodate unexpectedly changing patient conditions.
SUMMARY OF THE INVENTION
Many heretofore unmet needs are met and problems of the prior art are solved with the innovative ventilator embodiments according to the principles of the invention. Such features and capabilities may preferably or optionally include, among

8 4203540 v2 other elements and for purposes of illustration and example but not for purposes of limitation, improved and more accurate ventilation capabilities than has been possible with the many prior attempts.
In one preferred configuration of the invention, a ventilator or ventilator system for assisting the respiratory function of a patient under the direction of a clinician contemplates the ventilator having a computerized, operation controller or control module or computing device that is in electronic communication with an intra-ventilator and/or extra-ventilator electrical or data circuit or data network.
The controller also preferably includes a display, which can be a touch-screen display or any other suitable display, including an application-specific, customized display that incorporates data input or receiving devices into the display, with or without a touch-screen capability.
The controller or computing device also preferably includes a memory or storage capability that can include hard disk drives, removable drives and any desired form of storage device. Input devices are also desirable and can include keyboards, mouse pointers, data entry tablets, voice-activated input devices, and electronic media reading devices, among many others.
Additionally contemplated input devices include wired and wireless communications components for networking, data transfer, data capture, and data monitoring such as monitoring communications from electro-impedance tomography devices, ultrasound equipment, computed and computer-aided tomography devices, digital output fluoroscopes, x-ray equipment, magnetic resonance imaging and spectroscopy equipment, minimally invasive surgical and bronchoscopic visualization devices, and similarly capable equipment.
The inventive ventilators of the invention also preferably include a gas supply pump and/or pressurized gas source. The 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 and more preferably a plurality of valves and supply and exhaust ports. More preferably,

9 4203540 v2 a number of valves may be incorporated that can be electronically in communication with the controller or computing device for actuation.
Such valves can typically be included in line with the supply and exhaust ports and can be operable in cooperation with the various types of sensors discussed elsewhere herein. What are often referred to as back-check valves, which enable fluid flow in one direction but which prevent fluid flow in an opposite direction. Such check valves may be included in the gas circuit or network to protect various components and the patient from unexpected and/or undesirable pressures or pressure shock. In this way, protection can be afforded to the patient, pump or pressurized gas source, sensors, and other equipment.
Other preferably optional embodiments of the invention are directed to ventilation and control in negative pressure applications and the contemplated gas supply pump or pressurized gas source also may preferably incorporate, either alone or in combination with any of the other features described elsewhere herein, a negative pressure or vacuum capability that is contemplated to be compatible for use with negative pressure thoracic or full-body cylinders, which are also sometimes referred to by those skilled in the ventilation and respiratory technical fields as single, biphasic, or multiphasic iron-lung or cuirass ventilators.
More preferably, the ventilators practiced according to the invention also preferably include any number of optional detectors, sensors, or detection devices, that can be used alone or in any combination to sample and determine pressures of the supplied gas, inspired gas, expired gas, at rest, inflection point, and many different types of dynamic patient airway pressures. Other useful sensors can include peripheral, central, and airway gas concentration sensors that can be positioned extracorporeally in the case of well-known capnometers (for detecting carbon-dioxide concentrations) or infrared oximeters (for detecting oxygen concentrations).
These types of devices can be attached to extremities such as fingers, toes, or ear lobes, which make it very convenient to sample, monitor, and detect peripheral concentrations or saturations of carbon dioxide (SpCO2) and oxygen (Sp02). For 4203540 v2 other contemplated ventilation applications, central line catheters or other techniques can enable monitoring of arterial 02 and CO2 gas concentrations (Pa02,PaCO2), which can have clinical value in certain ventilation modes of operation or protocols discussed elsewhere herein. For purposes of the instant invention, such pressure and gas concentration sensors are more preferably configured to electronically communicate with the contemplated controller or computing device of the ventilator so that the real-time and/or near-real-time data can be monitored as described in more detail below.
The inventive ventilator also contemplates incorporation of any number of equally suitable fluid flow rate sensors that also may be adapted to communicate with the data network, the data circuits, and/or directly with the controller or control module or computing device, and either wirelessly or over wired connections.
Such flow rate monitoring devices can be employed in multiple places in the gas network or circuit to monitor the total amount of gas supplied, inspired, expired, as well as the speed at which such activity is occurring or has occurred. With this information, pressure can be compared to total volume or rate of volumetric or mass flow of gas so that the novel ventilators can better control and ensure proper ventilation of the target respiratory system of the patient.
Additionally, such controls can improve the accuracy with which pressurized gas is supplied to the patient, and can lessen the risk of lung injury by monitoring and keeping gas flow rates within acceptable protocol limits. In any number of possible preferred configurations, the sensors can be arranged as a sensor array to simultaneously monitor any one or any number of ventilation-related parameters so as to maximize control over the ventilation procedure to ensure the best possible protocol implementation under the circumstances. In many preferably optional configurations of the invention, any of the noted sensors may be positioned proximate to and/or about the gas supply and/or exhaust ports, among other places in the gas network or circuit.
A command module, command routine, algorithm, commander, firmware, or program may preferably be resident in the memory or storage components of the controller or computing device. The command module is preferably operative to 4203540 v2 control the sensors, to control the supply pump, to receive communications or images or information from other devices, to receive input from the clinician or another via any of the contemplated input devices, and to operate the display to present prompts and/or display important information pertaining to the ventilation process. The command module may also be optionally configured to preferably communicate various ventilator information to other devices, to other wireless or wired networks, to the display for contemporaneous viewing, and to other remote devices and locations as may be desired.
Preferably, the control module may adjustably and/or variably actuate the pump or pressure source to vary the volume and/or pressure supplied thereby.
Further, the control module or command routine may more preferably be modified to also automatically, manually, or otherwise operate any of the plurality of valves, either alone or in combination with the control of the pump, for even more rigorous control over the pressure, volume, flow rate, and gas supply cycle times available for use in ventilating the patient. More preferably, the control module or command routine may preferably be adapted to coordinate such control of the valves with sampling of or receipt of information from any of the contemplated sensors to establish increased accuracy in sampling one or more pressure readings, gas concentrations, and/or volume or mass flow rates anywhere in the gas circuit or network, or the patient undergoing ventilation.
The present invention also contemplates operational compatibility with any number of conventionally accepted, investigational, and experimental ventilation modes. More preferably, the operational capability of the invention enables many heretofore unavailable hybrid modes wherein the innovative ventilator automatically changes its mode of operation in response to patient progress or difficulties.
For example, the ventilator can be configured to commence ventilation in a mandatory breath mode, and to monitor various patient pressure, volumetric, and gas concentration responses, among other responses, that may indicate a patient who was formerly heavily sedated and unable to breathe, has suddenly started to attempt to breathe spontaneously.

4203540 v2 Upon such detection, the inventive ventilation will automatically switch among many modes of operation including from full-support mandatory breath modes, to various modes having lesser degrees of breathing support, so as to cooperate with the patient's attempts to breathe independently. Additionally, if the patient relapses and discontinues spontaneous breathing attempts, the ventilator will revert to full, mandatory breath mode. To enable such capabilities, the new ventilator of the invention is preferably preconfigured with various automated and reconfigurable modes of operation. For purposes of assisting clinicians with selecting fully automated modes of operation, or to enable partial or fully customizable modes of operation, the optionally preferred configurations of the invention enable the clinician to select any particularly desired automated mode of operation.
Additionally, the clinician may also select an automated mode of operation and then modify only the desired parameters. Even further, the clinician may ignore the fully automated modes, and may enter preferred settings to select a fully customized mode of operation suitable for purposes of any conceivable ventilation protocol or mode of operation. In one particularly useful configuration, the ventilator incorporates the controller or control module or computing device to have three primary operational modules, including, for purposes of example but not for purposes of limitation, an initial setup module, an adjustment and maintenance module, and a weaning module.
In turn, the initial setup module includes among other elements, an optimal end expiratory lung volume (OEELV) sub-module that monitors a number of key patient parameters to ascertain and periodically compute the OEELV. The adjustment and maintenance module includes oxygenation, recruitment, and ventilation sub-modules of operation and protocols that are tightly constrained to rigorously and aggressively monitor and protect the key aspects of these ventilation operational modes. This is accomplished using precisely bounded monitoring paradigms that enable very gradual and extremely accurate changes to manage ventilation, to ensure optimal oxygen saturation, and, when needed, to exercise and maximize alveolar recruitment and prevent derecruitment. If any parameters experience unexpected or uncontrolled hysteresis, alarm events are triggered to enable intervention.

4203540 v2 The weaning module includes an initial weaning assessment sub-module that enables close monitoring and small, slow changes to assess patient response to reduced ventilator support with rapid fall back to full support as needed.
With positive patient response, the initial weaning assessment sub-module enables complete ventilator reconfiguration into subsequently less supportive ventilation protocols for further weaning. Also included in the weaning module is an airway pressure release ventilation or APRV sub-module wherein spontaneous patient breaths are closely monitored so that support can be weaned as the patient gains control and consistency. With continued improvement, control is passed to the CPAP sub-module, which cycles up to a maximum CPAP support mode that is then gradually reduced to a minimal support mode until an extubation pressure is reached, at which point the patient is completely weaned from the ventilator.
For purposes of achieving these various modes of use, any of preferred or optional variations of the inventive ventilator may be predefined with or may receive and capture a number of parameters that can control how the ventilator operates in its various modes of operation. The controller or computing device may access stored parameters, may obtain new parameters from remote devices via wired or wireless communications, and may accept user input via the noted touch-screen display or any of the other input devices. Whatever the source of the operational settings or parameter, the information is typically stored in a database or an array that is stored in the memory or storage of the controller or computing device.
In one optionally preferred embodiment, these parameters are accessibly stored in one or more initialization parameter database(s), which may be resident in the 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 subsets of parameters may be grouped together in arrays such as one or more model patient data arrays or elements, which can be predefined to represent optimum ventilator settings that are well suited for a particular type of presenting patient or disease.

4203540 v2 For purposes of illustration, but not for purposes of limitation, such data arrays or initialization parameter databases may include, among other parameters and information, a PEEP, a target peripheral 02 concentration or an Sp02 quantity, an end tidal CO2 or etCO2 quantity, a fraction of inspired 02 or Fi02 quantity, a high pressure or P(high) that defines the maximum inspired pressure during mandatory or positive pressure assisted breaths, a low pressure or P(low) that can define a minimum pressure to be used during expiration and which can be zero or non-zero.
Other parameters can include a high time or T(high) that represents a period of inspiration during P(high) and a low time or T(low) that can represent a small period of time during which expiratory gas is expelled.
It may also be optionally preferred to include predefined or predetermined pressure change increments or pressure increments, P(inc), and time increments, T(inc), which can be any amount, and for which there can be multiple different preset increments that can be used as needed and so that clinical intervention may not be needed in more automated modes of operation. It has also been found to be sometimes desirable to store one or more tidal volumes, respiratory frequencies for mandatory breaths, to establish and store one or more pressure-volume curve slopes, and to establish one or more trigger pressures that enable the ventilator to detect a pressure drop trigger, which may indicate the patient is trying to spontaneously breathe.
In yet further optionally preferred variations, the ventilator may also be configured so that the command module can receive such initialization settings from the user or the clinician via the input device. Such settings can include those described elsewhere herein or any other possibly desirable parameters 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 supply pump is actuated to begin ventilation within the constraints of the selected automated program or settings or the manually entered parameters and settings.
During operation, the command module or routine samples, polls, or otherwise communicates with, any or all of the sensors in the array and measures the patient's actual data. A series of such sensor readings may be sampled so that 4203540 v2 an entire array of such data elements can be used to monitor patient response and ventilator performance, and to adapt the ventilator performance in response to patient status and condition. For purposes of example without limitation, sensor data that can be gathered may optionally include a patient Sp02 partial pressure (PP) or quantity, a patient etCO2 PP or quantity, a peak expiratory flow rate (PEER), an end expiratory lung volume (EELV) and a spontaneous frequency or machine respiratory frequency.
Once measured or sampled, the actual patient data array elements can be compared by the command module to any of the stored data to ascertain ventilator performance and patient response. For further example, such actual data may be compared to the one model patient data array. In this way, it can be determined whether the patient is responding favorably to ventilation. In another example, if the patient is responding well to ventilation, then a comparison between the patient's Sp02 and etCO2 and a comparable model patient data set would be acceptable. If acceptable, then the control routine can compute or generate a flag or Boolean value such as an Sp02 goal value and an etCO2 goal value that can be set to true, meaning the actual patient measurements indicate all is well. If not, then a false flag can be generated to enable the control routine to modify its behavior or seek clinical intervention by generating an alarm condition. Additionally, the control routine can poll pressure sensors and flow sensors during certain points in the inspiration and expiration phases of ventilation to ascertain an OEELV, which can provide clinically relevant feedback identifying patient response and ventilator performance.
In yet other optionally preferred configurations, the ventilator may be configured to modify its behavior in response to unfavorable patient response.
For further example, assume the SpO2was unfavorable and the SpO2goal value is false, which indicates undesirable oxygenation. As discussed in more detail elsewhere herein, the command module can preferably determine that increased or modified adjustments in ventilation are warranted to achieve the desired Sp02 level. To that end, the command module will adjust the operation of the pump, and functioning of the valves, and perhaps the concentration of supplied oxygen in the pressurized gas supply, and may thereby increase the P(high) the pressure increment, it may increase the T(high) by the time increment. In the alternative, it may be instead 4203540 v2 preferable to only modify the various operational parameters of the ventilator to increase or decrease the F102 quantity.
More preferably, in circumstances where the patient is responding well and it is warranted to start gently weaning from the ventilator support, the command module can instead set a flag or Boolean constant, such as an initial weaning value to be true, which can serve to notify other modules of the ventilator that weaning may begin. Conversely, if the patient is experiencing difficulties that may include non-perfused pulmonary dead space, it may be advantageous to modify the ventilator behavior to encourage recruitment of alveolar tissues. In certain circumstances, it may be advisable to generate an alarm signal seeking intervention. In other less challenging circumstances, it may desirable to set a recruitment flag or Boolean value to notify other control routine modules that a recruitment process is advisable.
In this circumstance, the control routine can modify the pump and valve operation to establish operation suitable for recruitment, which can include increasing P(high) by one or more P(inc), increasing T(high) by one or more T(inc)s, and/or adjusting T(low) by one or more T(inc)s.
In other situations where recruitment may not be indicated, it may be desirable to increase lung oxygenation. If so, the controller or computing device may make adjustments to the ventilator operation whereby an oxygenation flag or Boolean value is set to be true, which can invoke an oxygenation module that can poll the sensors to measure the peak expiratory flow rate and then compute an angle of deceleration of gas flow so that an appropriate time adjustment may be made, or so that T(low) may be decreased by one or more T(inc).
In yet other equally useful modes of operation, the ventilator can invoke an alveolar ventilation approach wherein the command module compares the spontaneous frequency to the machine respiratory frequency, ascertains the P(high), T(high), computes a minute ventilation (MV) value, adjusts the supply pump and valves to increase T(high) and P(high) by respective T(inc) and P(inc).
Similarly, a minute ventilation and recruitment module may be invoked wherein the MV is computed as a function of the currently in use P(high) and T(high), and adjustments are made to the P(high) and T(high).

4203540 v2 In more favorable patient response scenarios, an initial weaning assessment sub-module may be utilized wherein the command module or command routine samples the machine respiratory frequency and spontaneous respiratory frequency to ascertain that spontaneous breathing is occurring at a certain rate.
Comparing this rate to a predefined rate gives a good indication of whether an initial weaning assessment sub-module can be employed. If so, then the command routine can test for apnea and tachypnea. If neither condition is indicated, then the ventilator can be switched to a more suitable mode, such as an APRV mode, which makes it much easier for the intubated patient to breathe spontaneously.
As the patient who is experiencing initial ventilator weaning continues to improve, another mode of the ventilator enables a weaning module wherein spontaneous breathing and blood gas levels continue to be monitored while the P(high) is decreased while the T(high) is increased. In this way, the patient is encouraged to continue spontaneous breaths.
As improvements mount, further weaning is warranted. In this instance, the ventilator operates in another mode wherein weaning criteria can be considered in comparison to the actual patient data that is being monitored. In one suitable set of predetermined weaning criteria, an Fi02 threshold, an Sp02 threshold, a spontaneous tidal volume, a minute ventilation quantity, and an airway occlusion pressure (P0.1) are compared to the patient's actual values. If the patient fails to meet these criteria, then weaning is discontinued temporarily and more breathing support is given to the patient. In weaning failure, the control routine increases the P(high) and decreases T(high). Conversely, if the weaning criteria are passed by the patient's actual values, then the command module repeatedly initiates the cyclic weaning protocol wherein P(high) is decreased and T(high) is increased. The airway occlusion pressure P0.1 is measured and trended over time by a P0.1 module and is used to assess the work of breathing during spontaneous breaths. In the preferred embodiments, this is used to assess the impact of weaning and the resultant work of breathing, as is explained in connection with other modules elsewhere herein.

4203540 v2 Assuming for further purposes of illustration that the patient continues improving, then the command module changes ventilator operation again, and monitors P(high) until a CPAP threshold is reached, which enables another conversion of the ventilator operation into a CPAP sub-module. This sub-module is much more comfortable for patients, and reduces the dependence of the ventilator.
As the further improvements are manifested, the command module begins to gradually reduce the CPAP pressure until an extubation threshold pressure is reached. Also, it may be optionally preferable during the CPAP and other modes of operation to enable the controller to incorporate an automatic tube compensation pressure or ATC pressure which boosts the ventilator support just enough to overcome the frictional losses encountered when breathing through the gas network or circuit of tubing involved in use of the ventilator.
In operation, various methods of use of the ventilator are possible using any of the embodiments of the invention and modifications, variations, and alternative arrangements thereof. Using any of the physical configurations of the inventive ventilators described elsewhere herein, one method of use involves entering settings via the input device including at least one of (i) an automated initialization setting and (ii) a parameter to be stored in the memory that includes at least one of (a) a PEEP
quantity, (b) an Sp02 quantity, (c) an etCO2 quantity, (d) an Fi02 quantity, (e) a high pressure, (f) a low pressure, (g) a high time, (h) a low time, (i) a pressure increment, (j) a time increment, (k) a tidal volume, (I) a respiratory frequency, (m) a pressure-volume slope, (n) a trigger pressure, and (o) a predetermined weaning criteria including at least one of an F102 threshold, an Sp02 threshold, a spontaneous tidal volume, a minute ventilation quantity, and an airway occlusion pressure (P0.1).
Next, the command routine receives the settings from the clinician via the input device and commands the controller to actuate the supply pump. This commences respiratory assistance to the patient whereby the gas circuit communicates with the patient using one each of the Fi02 quantity, the high and low pressure, and the high and low time. Patient actual data array elements are measured by using the command routine to communicate with the plurality of sensors. Measurement of at least one of (i) a patient Sp02 quantity, (ii) a patient 4203540 v2 etCO2 quantity, (iii) a peak expiratory flow rate, (iv) an end expiratory lung volume and (v) a spontaneous frequency, is taken.
The command routine compares the patient actual data array to at least one of the settings and computes at least one of an Sp02 goal value, an etCO2 goal value, and an optimal end expiratory lung volume, which values are used to determine whether the patient should be initially weaned, undergo recruitment and increased oxygenation, or be maintained in an unaltered state of ventilation.
If the patient is improving, then measuring and comparing at least one of the patient actual data array elements to the predetermined weaning criteria to set a flag or Boolean weaning value to true is warranted (meaning the patient did not fail the weaning test). If passed, the cyclic weaning is initiated by adjusting at least one of the supply pump and the plurality of valves to decrease the P(high) by one or more pressure increments.
Also, to decrease the ventilator support even further, the T(high) is gradually increased and the P(high) is gradually decreased until the CPAP threshold is reached, where after the ventilator is switched into CPAP mode where it remains until the CPAP pressure may be decreased until the extubation threshold pressure is reached, after which the patient may be removed from the ventilator.
In other optionally preferred novel embodiments, any of the monitoring devices, sensors, computers, or computing devices may be connected with any of the other components wirelessly or with a wire. Any of the contemplated components may also be in communication with any of the other components across a network, through a phone line, a power line, conductor, or cable, and/or over the internet. In other alternatively preferred configurations of the invention, the resident software program may have numerous features that, for purposes of example without limitation, enable different functionalities.
More preferably, such resident software program and/or programs may enable any of the contemplated information to be communicated by text, voice, fax, and/or email messages either periodically, when certain predefined or predetermined 4203540 v2 conditions occur, such as predefined alarm events or conditions, and/or when anomalous, unexpected, or expected power readings occur and/or are detected.
These variations, modifications, and alterations of the various preferred and optional embodiments may be used either alone or in combination with one another and with the features and elements already known in the prior art and also herein contemplated and described, which can be better understood by those with relevant skills in the art by reference to the following detailed description of the preferred embodiments and the accompanying figures and drawings.
BRIEF DESCRIPTION OF THE DRAWING(S) Without limiting the scope of the present invention as claimed below, and referring now to the drawings and figures, wherein like reference numerals across the drawings, figures, and views refer to identical, corresponding, or equivalent elements, methods, components, features, and systems:
FIG. 1 shows a ventilator and system in accordance with the present invention;
FIG. 2 shows a schematic diagram of the operation of the ventilator and system of FIG. 1;
FIGs. 3a and 3b are schematic diagrams of an OEELV sub-module of operation of the ventilator and system of FIG. 1;
FIG. 4 shows a schematic diagram of the interrelationships between the modules of operation of the ventilator and system of FIG. 1;
FIG. 5 shows a schematic diagram of an oxygenation sub-module of operation of the ventilator and system of FIG. 1;
FIG. 6 is a schematic diagram of a recruitment sub-module of operation of the ventilator and system of FIG. 1;

4203540 v2 FIG. 7 is a schematic diagram of a ventilation sub-module of operation of the ventilator and system of FIG. 1;
FIG. 8 is schematic diagram of an initial weaning assessment sub-module of operation of the ventilator and system of FIG. 1;
FIG. 9 is schematic diagram of an ARPV sub-module of operation of the ventilator and system of FIG. 1;
FIG. 10 is a schematic diagram of a CPAP sub-module of operation of the ventilator and system of FIG. 1;
FIG. 11 is an area diagram of an OEELV sub-module and assessment of operation of the ventilator and system of FIG. 1;
FIG. 12 is an area diagram of an OEILV sub-module and assessment of operation of the ventilator and system of FIG. 1;
FIG. 13 is an area diagram of a spontaneous breathing sub-module and assessment of operation of the ventilator and system of FIG. 1;
FIG. 14 is a schematic airway pressure versus time tracing for airway pressure release ventilation;
FIG. 15 is an airway pressure versus time tracing during the inspiratory P(high) phase of ventilation;
FIG. 16 is an airway volume versus pressure curve illustrating a shift from the inspiratory limb to the expiratory limb thereof;
FIG. 17 is an inspiratory and expiratory gas flow versus time tracing for airway pressure release ventilation;

4203540 v2 FIG. 18 is an expiratory gas flow versus time tracing;
FIG. 19 is a set of expiratory gas flow versus time tracing illustrating determination of whether flow pattern is normal, restrictive or obstructive based on the shape of the tracing; and FIG. 20 is a set of airway pressure versus time tracings illustrating ventilation weaning by successive reductions in pressure P(high) and substantially contemporaneous increases in time T(high).
DETAILED DESCRIPTION OF THE INVENTION
Referring now to the various figures and illustrations, those skilled in the relevant arts should appreciate that each of the preferred, optional, modified, and alternative embodiments of the inventive ventilator and ventilator system 10 and method of operation contemplate interchangeability with all of the various features, components, modifications, and variations within the scope of knowledge of those skilled in the relevant fields of technology and illustrated throughout the written description, claims, and pictorial illustrations herein.
With this guiding concept in mind, and with reference now to FIG. 1, one possible embodiment of a ventilator and ventilator system 10 is illustrated, which is in communication with the patient P undergoing ventilation therapy. The ventilator and ventilator system 10 also preferably includes a gas supply pump and/or pressurized gas source 12 having a positive pressure port 14, and optionally a negative pressure port 16. The gas pump or source 12 supplies positive pressure gas 14 and can also supply negative pressure or a vacuum 16 for non-invasive negative pressure applications such as iron-lung or similar therapies. A wide variety of commercially available ventilators may be modified according to the principles of the invention and one such device includes what is referred as the model EvitaXL, which is available from Draeger Medical, Inc. of Telford, Pennsylvania, USA, and Lubeck, Germany.
The ventilator 10 also preferably includes a controller or control module or computing device 20 that is in electronic communication with an intra-ventilator 4203540 v2 and/or extra-ventilator electrical or data circuit or data network 22. The controller 20 also preferably includes a display 26. The display 26 may be a conventional device that receives unidirectional signals from the controller 20, but may also be any of a number of possibly preferred bidirectional devices such as a touch-screen display that can be used as an input device 28, and which may also have a data entry capability such as a built-in keyboard or keypad similar to the keyboard input device 28 shown in FIG. 1.
The controller or computing device 20 also preferably includes a memory or storage capability 24 that can include flash drives, optical media, hard disk drives, solid state disk drives, random access memory, non-volatile memory, removable storage devices, remote internet-based storage devices, network appliance-type devices, and the like.
Typically, the gas supply pump or pressurized gas source 12 communicates positive or negative pressure to the patient P through a gas circuit or network of tubes 40. The gas network or circuit 40 may also include an inspiration or supply port 42 and an expiratory or exhaust port 44. A number of valves are usually also included to control and meter fluid flow and would preferably include a supply valve 46, a sensor valve (not shown), and an exhaust valve 52, all of which would likely be in communication with the controller 20 via the data network 22 so that the command module 30 may control and operate the valves automatically to start and stop ventilation and to control pressure and flows rates to the patient P during operation.
The supply and exhaust valves 46 and 52 may be also operable to periodically close for short periods of time to enable pressure sensors to obtain various static pressure readings. Additionally, the sensor valve may be operable to close such as to protect various sensors from pressure circuit transients and to prevent spurious readings such as when the ventilator 10 may be automatically responding to patient P improvements or relapses by changing modes of operation from mandatory breathing support to augmentative support modes.
In addition to the contemplated input devices described elsewhere herein, there may be certain diagnostic imaging devices that can be incorporated into the 4203540 v2 operation of the ventilator 10 of the invention to communicate quantitative pulmonary function information such lung volume, dead space ratios, and the like.
Additional and possible useful devices may also include, for purposes of example without limitation, electro-impedance tomography devices 70, ultrasound equipment 80, computed and computer-aided tomography devices 90, and other types of Doppler imaging sensors 95 that may enable various quantitative or subjective pulmonary function imagery.
Various types of optionally preferred detectors, sensors, or detection devices, also have utility for purposes of the invention to enable precise control and analysis of volumetric and mass flow rates as well as pressures of the supplied gas, inspired gas, and expired gas, which in turn enables calculation of various other static and dynamic pulmonary function parameters, as is discussed in more detail elsewhere herein.
With continued reference to FIG. 1, a group of sensors 54 can be arrayed proximate to the ventilator 10 and patient P. An oximeter or 02 saturation sensor 56 may be used peripherally to ascertain peripheral or venous 02 content Sp02 and a capnography sensor or capnometer or CO2 sensor 58 may be used to determine end tidal or peripheral CO2 saturation levels (etCO2, SpCO2). For certain applications involving long term supine ventilation, it may be desired to also monitor arterial blood gas concentrations, among other parameters. In these instances, invasive methods can be used such as central line catheters to assess pulmonary arterial 02 and levels using a Pa02sensor 60 and/or a PaCO2sensor 62.
It is also optionally preferred to monitor various airway pressures, volumetric, and mass flow rates so that patient P response can be continuously assessed.
For purposes of monitoring airway pressures, an airway pressure sensor or pressure gauge 64 can be placed in a number of places along the gas network or circuit, and is more preferably positioned proximate to the supply and exhaust ports 42, 44 at the intubation site of the patient P. An airway flow sensor 66 can be similarly positioned to enable monitoring of volumetric flow rates of inspiratory and expiratory gases. In certain applications, it has been found desirable to employ strain gauges mounted on the thorax to enable monitoring of chest movement during pulmonary breathing 4203540 v2 cycles, which can be an additional source of volumetric pulmonary patient P
function as well as a source of patient P work expended for spontaneous breaths.
With reference now also to FIG. 2, the ventilator 10 also incorporates the control module 20 and/or the command module 30 to include three primary operational modules, including, for purposes of example but not for purposes of limitation, an initial setup module or protocol 100, an adjustment and maintenance module 200, and a weaning module 250. During initial ventilator 10 startup, a number of initial parameters are set based upon input from the clinician or by accessing a predefined set of parameters. With reference now also to FIGS. 2, 3, and 4, the preliminary initialization routines will be described. In FIG. 4, it can be seen that the clinician may enter their preferred settings 110 into the display 26 or input device 28. In the alternative, any number of possible predefined automated settings 120 may be accessed and used as defined or customized in whole or in part to prepare the ventilator 10 for operation. Once the clinician or automated settings 110, 120 are selected, the settings 110, 120 are populated with various other initialization parameters 130 during the operation of the initial setup module 100. As the operation of the ventilator 10 commences, the command module 30 invokes an OEELV sub-module or assessment routine 150.
With specific reference now to FIGS. 3a and 3b, it can be seen that the initial setup module 100 includes the OEELV sub-module or assessment routine 150. The OEELV sub-module 150 periodically and on demand will determine a ventilation range as a function of obstructiveness of the lung and the hypocarbic, normal, and/or hypercarbic condition of the patient P. As part of the evaluation, the OEELV
sub-module 150 determines whether the computationally ascertained OEELV is in the range appropriate for the conditional status of the patient P. For example without limitation, if the patient P has obstructive lungs, and is experiencing high range hypoventilation, i.e., hypercarbia, then an appropriate or desired OEELV
should be in the range of about 30% to 40%.
If the computationally ascertained OEELV is higher than this range, then the T(low) parameter is increased by 0.05 seconds. Conversely, if the computationally ascertained OEELV is lower than the desirable range of 30% to 40%, then the T(low) 4203540 v2 parameter is lowered with the intent to achieve the appropriate OEELV range.
In this way, the novel OEELV sub-module 150 can execute very fine adjustments of actual OEELV to stimulate optimum conditioning of the ventilated patient's P
pulmonary response. To wit, adjustments of 0.05 seconds in T(low) will enable slow and gradual optimization of the OEELV best suited to the disease modality. Although for purposes of illustration and explication of various aspects of the invention, increments of 0.05 seconds or other amounts of time have been described. However, the principles of the invention in this aspect are also suitable for even more gradual changes in time, and can include milliseconds and smaller and larger orders of magnitude.
Once T(low) is set, the OEELV sub-module 150 relinquishes control for a period of time and the command module 30 again resumes control to then invoke the adjustment and maintenance module 200, which includes an oxygenation sub-module 300, a recruitment sub-module 400, and a ventilation sub-module 500.
The module 200 and its component sub-modules 300, 400, and 500 include protocols configured to rigorously monitor and protect the key aspects of the patient's P
physiological ventilation and pulmonary response profile to enable maximized recovery and weaning with minimum pulmonary injury risk. During the ensuing ventilation process, the patient's P Sp02 and etCO2 are continuously monitored via the respective Sp02 and etCO2 sensors 56, 58 to ensure a target or goal of Sp02 of at least about 95% and etCO2 of no more than between about 34 to 45 mm Hg are maintained (FIG. 4).
The command module 30 next passes control to oxygenation sub-module 300, which is described in more detail specifically in FIGS. 4 and 5. As the oxygenation sub-module 300 assumes control for a short period of time, the Sp02 is again assessed so that adjustments may be made as required in the fractionally inspired 02, which is otherwise referred to as the Fi02 parameter 360. Once adjustments are made to Fi02 320, 340, 350, the command module 30 cooperates with the oxygenation sub-module 300 to assess whether a P(high) pressure adjustment must be made or whether the initial weaning assessment sub-module 600 is invoked. If the patient P is responding well, and if the Fi02 330 and Sp02 310 quantities are suitable, then control will be transferred to the initial weaning assessment sub-module 600, which is discussed in more detail elsewhere herein.

4203540 v2 In the alternative, the oxygenation sub-module 300 and command module 30 assess the P(high) condition 380. If P(high) is adjusted 390, then another iteration of the OEELV sub-module 150 is also conducted to support the optimum OEELV sub-module 150 discussed earlier. As control returns to the oxygenation sub-module 300, P(high) is again assessed 370 to determine whether recruitment sub-module 400 is warranted or whether P(high) must again be adjusted. Assuming for purposes of further illustration that recruitment sub-module 400 is indicated, the oxygenation sub-module 300 relinquishes control to command module 30, which invokes the recruitment sub-module 400.
Referring now also to FIG. 6, recruitment sub-module 400 reevaluates the P(high) condition in a different context 420, 430, 450, as depicted in more detail in FIG. 6. In the circumstance where P(high) becomes greater than 40 cm H20 450, an alarm signal 410 is sounded to affect immediate intervention. Otherwise, P(high) is adjusted 460, 390, 480 to improve the pulmonary condition of patient P and the Sp02 is again iteratively re-examined 310 while recruitment sub-module 400 continues attempts to increase lung surface, reduce dead space, and re-inflate alveolar units as much as possible until Sp02 values 310 indicate the need for oxygenation sub-module 300. Feedback of information from other concurrently running modes may be sampled periodically via feedback loop 180 by command module 30, which can interrupt recruitment as needed and transfer control or invoke a more important mode when required by patient P physiology. For example, if command module 30 detects inbound information from feedback loop 180 describing increased etCO2 values approaching or exceeding desired limits, control can revoked by command module 30 so that ventilation sub-module 500 can be invoked.
With continued reference to the previously discussed figures and now also to FIG. 7, command module 30 invokes ventilation sub-module 500 to redress an actual or approaching out of limit etCO2 condition. The ventilation sub-module re-evaluates end tidal CO2 levels 510, reassesses OEELV conditions, and then assesses patient P breath spontaneity 570 against the set rate or respiratory frequency values obtained from the clinician 110 or automated settings 120. If breathing spontaneity remains at or below the set rate 570, then an alveolar 4203540 v2 ventilation sub-module 504 is affected to adjust T(high) 530, 540 and P(high) 370, 390 as may be needed to further optimize pulmonary response.
However, as patient P recovers pulmonary responsiveness and breath spontaneity improves beyond the set rate of, for purposes example without limitation, to a rate of 15 spontaneous breaths over the set rate, then an alveolar ventilation sub-module 504 is effected whereby T(high) 530, P(high) 370 are adjusted separately, and then in combination 520 for lower values of P(high). For higher values of P(high), the minute ventilation sub-module 506 evaluates Vt 560 to determine whether recruitment sub-module 400 is warranted. If not, then Sp02 is again verified 310, T(high) is adjusted 550, and the patient P is examined against a tachypnea assessment worksheet 590 that is a function of the set rate or respiratory frequency and the actual patient P rate defined in the assessment worksheet 590. As with other modules, the command module 30 continues to poll for information inbound on the feedback loop 180 so that control can be instantly seized to maintain optimal pulmonary response parameters across the spectrum of continuously monitored variables.
Attention is now invited also to FIG. 8 with the hypothetical suggestion that command module 30 recalled control from the ventilation sub-module 500 for another pass through the oxygenation sub-module 300, and the parameters were evaluated favorably for the command module 30 to invoke the initial weaning assessment sub-module 600. As with other modules, the Fi02 330, Sp02 310, etCO2 510, breathing spontaneity 570, and possible tachypnea (spontaneous breathing above the set rate) 580 are re-evaluated. Assuming patient P responds well, then P(high) is assessed 610 and if warranted, the spontaneity of breathing is compared against apnea parameters 620. The markedly improving patient P will then experience one of the very novel aspects of the inventive ventilator 10 as the command module 30 reconfigures the ventilator 10 away from the mandatory breath control mode and invokes an assisted breathing mode. If the patient P does not respond well, P(high) and T(high) are adjusted 630 and the command module 30 again invokes the initial weaning assessment sub-module 600 to reassess Fi02 330, Sp02 310, etCO2 510 and breathing spontaneity 570, 580.

4203540 v2 With reference now also to FIG. 9, those knowledgeable in the pertinent fields of expertise will appreciate that the command module 30 invokes an airway positive release ventilation or APRV sub-module 700, which can be much more comfortable for the recovering pulmonary patient P. Here too, the APRV sub-module 700 re-verifies the pulmonary conditioning of the patient P and examines P(high) 610.

However, unlike other modules, the APRV sub-module 700 institutes a new parameter evaluation set referred to herein as the weaning criteria 710. These criteria evaluate the patient P against a more rigorous series of critical pulmonary physiological conditions to ensure the patient can withstand the added stresses of substantially less gradual changes in the ventilation sub-module of operation.
Before the command module 30 discontinues the mandatory breathing modes of operation, the patient P must pass these weaning criteria 710. If the patient P fails the weaning criteria 710, then the command module 30 re-invokes the initial weaning assessment sub-module 600, or another module if feedback loop 180 alerts the command module 30 to a more urgent requirement.
Assuming the weaning criteria 710 are met, however, then the patient P is deemed able to withstand greater changes in the pressure-volume slope profile being induced by the ventilator and ventilator system 10. Accordingly, the APRV sub-module 700 effects additional adjustments 720 to wean or reduce the patient's P
reliance on the mandatory breathing modality of the ventilator 10. This weaning process and re-evaluation 720, 730, 710 continues to iterate if well tolerated by the patient P until P(high) is less than or equal to a pressure of only 20 cm H20.
At this point, the patient P is recovering well and absent an important indication to the contrary over the feedback loop 180, the command module 30 again completely reconfigures the operational profiles of the ventilator 10.
As illustrated in detail in FIG. 10, the commander or command module 30 invokes the CPAP sub-module 800 in a maximum CPAP assistance mode, which speeds up the process of removing the patient P from reliance on the ventilator 10.
P(high) is assessed 810 and the patient P continues to be evaluated against the weaning criteria 710, and for gross and undesirable deviations from acceptable pulmonary response limits, in which case CPAP is increased 830. As the patient's P
recovery accelerates, the CPAP sub-module 800 decreases assistance 820, 840, 4203540 v2 850, until an extubation pressure 860 is reached. Hereafter, the clinician intervenes and extubates the weaned patient P.
Among many possible modifications to any of the embodiments of the inventive ventilator 10, one particularly useful variant includes a modified OEELV
sub-module (not shown), that can be incorporated as an improvement to the OEELV
sub-module 150, or which may be included as an independent mode capable of operating and cooperating with OEELV sub-module 150. With continued reference to the various figures and especially to FIGS. 3a and 3b, and with reference now also now to FIG. 11, those having an understanding of the relevant areas of technology may recall that OEELV is derived by using the elements and reference points information acquired during the P(low)IT(low) cycle as is described elsewhere herein. The proposed and optionally preferred OEELV sub-module 150 is ideally functioning for the duration of the ventilation therapy and is operative to continuously optimize EELV, or end expiratory lung volume, of the therapeutic patient P.
The derived OEELV is a function of disease state (see, e.g., FIGS. 3a and 3b), and the patient's P pulmonary responsiveness to the oxygenation sub-module 300, recruitment sub-module 400, and ventilation sub-module 500. In a compliant patient P, the OEELV sub-module 150 optimizes EELV by adjusting the T(low) time period. Preferably, the OEELV sub-module 150 also validates the acquired information by using multiple sampling, averaging, and various statistical methods over time for validation and error detection.
Adjustments of the OEELV are based upon the elements and flow and time reference points acquired during the P(low)/T(low) cycle. Flow and time reference points within the flow/time area, which is established by the P(low)/f(low) cycle, may be used to measure and calculate changes occurring in lung volume during the P(low)/T(low) cycle. For purposes of example and further illustration, but not for purposes of limitation, and looking again to FIG. 11, the preferred OEELV sub-module 150 measures the peak expiratory flow rate (PEER) 1100, the decay phase 1110, and the truncation phase 1120 to calculate the angle of deceleration (ADEC) of gas flow and the termination of the flow of gas to determine optimal T(low) adjustment. The OEELV sub-module 150 thereby enables a heretofore unavailable 4203540 v2 dynamic adjustment, which more accurately and more responsively establishes and maintains the most optimal actual OEELV of the patient P.
An analysis of FIG. 11 ought to reveal to those skilled in the arts that an extrapolation phase 1130 may be used to calculate a residual volume and pressure as a function of time. The PEFR 1100 of FIG. 11 represents the rapid depressurization evidenced by the relaxation and recoil of the thorax after the machine breath. The decay phase 1110 represents the decaying energy drive and the downstream resistance to gas flow. The flow termination phase or truncation phase 1120 establishes the point in the time course of flow where the flow can be determined either as a function of the disease process, or the parameter setting that was input by the user or clinician. The 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, we recall that the OEELV sub-module 150 as well as the OEELV sub-module 150 both measure the peak expiratory flow and the truncation of gas flow, and then uses this information to calculate the ADEC or angle of deceleration, which is in turn used to establish the ideal OEELV value. With this approach, it should be observed that changes in the truncation point will change the angle of deceleration. When the resulting angle becomes less acute, the resultant observation is that recruitment has occurred. Conversely, when the angle becomes more acute, derecruitment is indicated.
Therefore, the OEELV sub-module 150 suggest adjustments to at least one of P(high), P(low), T(high), or T(low). In the instance where derecruitment is detected, P(high) or T(high) should be increased, or T(low) should be decreased, or some combination thereof should be effected. On the other hand, if recruitment is detected in this way, P(high) should be decreased, T(high) or T(low) should be increased, or some combination thereof should be effected.
The present invention also contemplates in any of the embodiments of the invention an optimal end inspiratory lung volume (OEILV) sub-module 1200 than can 4203540 v2 further augment aspects of the recruitment sub-module 400 of FIG. 6. In this alternative variation to any of the embodiments of the innovative ventilator and ventilator system 10, the OEILV sub-module 1200 is optionally or preferably invoked by the command module 30 as needed. More preferably, the OEILV sub-module 1200 is invoked by the recruitment sub-module 400. Even more preferably, the OEILV sub-module 1200 is invoked by the recruitment sub-module 400 at any moment outside the actual recruitment phases or inspiratory pressurization because the OEILV sub-module 1200 ideally assesses for derecruitment and is active or engaged only during the machine or ventilator 10 breath. Most preferably, the OEILV
sub-module 1200 monitors the existing sensor data to identify changes in flow and time during the P(high)/T(high) cycle of ventilation.
When invoked, the OEILV sub-module 1200 is active over time during the machine breath and acquires recorded reference points of the flow/time course to P(high)/T(high) cycle. The OEILV sub-module 1200 uses this acquired data to identify changes in flow and time coordinate grid during the P(high)/T(high) cycle. If such changes are in fact identified, the OEILV sub-module 1200 may preferably communicate a message to the command module 30, the recruitment sub-module 400, and/or over the feedback loop 180, to initiate recruitment. Even more preferably, the OEILV sub-module 1200 may also suggest and/or effect manual or automated adjustments to P(high) and/or T(high) to further minimize actual or prospective derecruitment and/or to improve the pulmonary conditions of the ventilation therapy and/or the response or conditioning of the patient P.
In the non-recruitment phase of the recruitment sub-module 400, the OEILV
sub-module 1200, when active, preferably may also intermittently adjust P(high), T(high), or both, and/or may notify the command module 30, the feedback loop 180, and/or other modules of the recommended adjustments, and/or may communicate to the clinician manually or automatically so as to seek clinical intervention if warranted.
These adjustments in P(high), T(high), or both, may be applied in an occasional, intermittent, and/or cyclic manner, and may be effected either manually, through informative messages, or through automation.

4203540 v2 In further aspects of the optionally preferred OEILV sub-module 1200, and with reference also to FIG. 12, the OEILV sub-module 1200 may preferably incorporate a resistive element 1210 that occurs during the onset of the machine breath, an inflection point 1250 that correlates with an inflection or a half-way point of the machine breath cycle (the resistive-elastic transition point), and an elastic element 1220 that corresponds with the relaxing subsequent to the machine breath.
It is important to note that the OEILV sub-module 1200 measures the inflection point 1250 to determine if the slope of the elastic element 1220 changes.
In other words, the inquiry seeks to learn whether the elastic element 1220 becomes more acute in derecruitment and less acute in recruitment. Those skilled in the arts may come to understand that the combination of information available from FIGS. 11 and 12 and the accompanying discussion herein enables a heretofore unavailable means of more accurately discerning whether recruitment has been accomplished or whether derecruitment has occurred. The various modes now available and according to the principles of the invention enable more accurate and more automated systems for better managing and mitigating recruitment and derecruitment during many possible ventilation therapy protocols.
In any of the embodiments of the inventive ventilator 10 and modes and methods of operation, the breathing spontaneity can be further assessed using an optionally preferred spontaneous breathing sub-module 1340 that is graphically depicted in FIG. 13. This spontaneous breathing sub-module 1340 may be further invoked by any of the other modes, modules, and routines of the inventive ventilator

10. Even so, this spontaneous breathing sub-module 1340 may find special utility in being optionally invoked through the command module 30 alone and/or by either the ventilation sub-module 500 or by the initial weaning assessment sub-module 600.
In addition to comparing the actual spontaneous breaths per unit time of the patient P, this sub-module 1340 may preferably assess and analyze the nature of spontaneous breathing to identify and quantify breathing effort, otherwise referred to as the "work of breathing." More preferably, the spontaneous breathing sub-module 1340 assesses the effect of weaning on the work of breathing. Any of the sensors described elsewhere herein, such as one or more of the strain gauges 68, can be 4203540 v2 elastically or tightly affixed to the thorax of the patient P to sense and record movement, and solid-state or similarly capable accelerometers can also be used to gain additional data points that can be used to compute actual work expended to breathe.
Referring to FIG. 13 again, such data points can be correlated against a spontaneous breath initiation phase 1360, a spontaneous peak phase 1370, and a spontaneous termination phase 1380. Even more preferably, such data can be adduced during any of the spontaneous breath evaluations 570, 580 (FIGS. 7 and 8) occurring during the ventilation and initial weaning assessment sub-modules 500, 600, as well as any other suitable time. These additional indicia of the pulmonary conditioning and response of the patient P can further illuminate the patient's P true cardiopulmonary physiology, which can lessen the risk that the patient P is prematurely removed from ventilation therapy due to patient P resistance or other issues.
With continued reference to the various figures and preceding discussion, those knowledgeable in the relevant arts may appreciate that for certain preferred circumstances, the invention also contemplates initiating ventilation of the patient P
in an APRV sub-module 700 based on initial oxygenation and ventilation settings.
The patient P can then have the safety of the mandatory breath capability of the ventilator 10 while commencing ventilation therapy with a less intrusive profile. The ARPV airway pressure during expiration (P(low)) is substantially zero throughout ventilation to allow for the rapid acceleration of expiratory gas flow rates.
Typically, the fraction of oxygen in the inspired gas (F102) is initially set at about 0.5 to 1.0 (i.e., about 50% to 100%). The highest airway pressure achieved during inspiration (P(high)) must be sufficiently high to overcome airspace-closing forces and initiate recruitment of lung volume. P(high) may suitably be initialized at a default value of about 35 cm H20.
Alternatively, P(high) may be established based on either the severity and type of lung injury or the recruitment pressure requirements. The latter method is preferred in cases where the ratio of the partial pressure of oxygen in the blood of the patient P to the fraction of oxygen present in the inspired gas (i.e., Pa02/Fi02, 4203540 v2 which is commonly abbreviated as P/F) is less than or equal to about two hundred millimeters of mercury (200 mm Hg). The P/F ratio is preferably monitored continuously.
Where the type and severity of lung injury are characterized by a P/F of greater than about 350 mm Hg, an initial value of P(high) within the range of about 20 cm H20 to 28 cm H20 is preferably established. On the other hand, if the P/F ratio is less than about 350 mm Hg, P(high) is preferably initialized within the range of about 28 cm H20 to 35 cm H20.
In situations where the P/F ratio is less than or equal to about 200 mm Hg, which may occur where the patient's P initial injury is non-pulmonary and/or the lung injury is of an indirect nature, the invention contemplates establishment of P(high) at a value of between about 35 mm Hg and 40 mm Hg but preferably not appreciably above 40 mm Hg. In cases where P(high) is initially established at a default value of about 35 cm H20, P(high) is reduced from such a value once P/F exceeds about mm Hg. Initiation of ventilation also requires the establishment of time (duration) settings for inspiration and expiration.
Initially, the duration of the positive pressure phase (T(high)) is established at a value within the range of about 5.0 to about 6.0 seconds unless the measured PaCO2 is greater than about 60 mm Hg. In that case, T(high) is more preferably set to a lower initial value of within the range of about 4.0 to 5.0 seconds. The duration of the ventilator 10 release phase (T(low)) may suitably be initialized at a value within the range of 0.5 to 0.8 seconds with about 0.7 seconds being a preferred default value.
Once initial values of P(high), P(low), T(high) and T(low) have been established, ventilation continues in a repetitive APRV mode cycle generally as illustrated in FIG. 14. During management of ventilation in accordance with the invention, the initial values of one or more of these parameters are re-assessed and modified in accordance with measured parameters as has been described in connection with earlier descriptions.

4203540 v2 In management of ventilation in accordance with the invention, a principal goal is to maintain the level of carbon dioxide in the blood of the ventilated patient P
(PaCO2) at a level of less than or equal to about 50 mm Hg. Toward that end, arterial PaCO2 is monitored continuously or measured as clinically indicated and the ventilator 10 controlled to adjust ventilation as follows. Any time after ventilation has commenced, but preferably soon thereafter or promptly upon any indication of hypercarbia (PaCO2 above about 50 mm Hg), the setting of T((ow) is optionally but preferably checked and re-adjusted if necessary.
According to the invention, optimal end expiratory lung volume is maintained by titration of the duration of the expiration or release phase by terminating T(low) based on expiratory gas flow. To do so, the flow rate of the expiratory gas is measured by the ventilator 10 and checked in relation to the time at which the controller of the ventilator 10 initiates termination of the release phase.
The expiratory exhaust valve should be actuated to terminate the release phase T(low), at a time when the flow rate of the expiratory gas has decreased to about 25%
to 50% of its absolute peak expiratory flow rate (PEFR) based on gas flow tracing and pulmonary disease process. An example is illustrated in FIG. 17. In that example, T(low) terminates by controlling the expiratory exhaust valve to terminate the release phase when the expiratory gas flow rate diminishes to 40% PEFR.
If monitoring of PaCO2 indicates hypocarbia is present (i.e., PaCO2 less than about 50 mm Hg), T(high) is increased by about 0.5 seconds while maintaining P(high) substantially unchanged. Should the patient P remain hypocarbic as indicated by subsequent measure of PaCO2, weaning in the manner to be described may be initiated provided oxygenation is satisfactory and weaning is not otherwise contraindicated based on criteria to be described further below.
The hypercarbic patient P though is not to be weaned. In the event of hypercarbia, the invention contemplates assessment of the expiratory flow pattern before making significant further adjustments to ventilation parameters. This assessment can readily be carried out by a software program stored within the control unit of the ventilator 10, which carries out automated analysis of the expiration flow versus time tracing. As illustrated in FIG. 19, normal expiratory flow is 4203540 v2 characterized by flow that declines substantially monotonically from the onset of the release phase through its termination and does not fall off prematurely or abruptly.
Restrictive flow in contrast declines rapidly from the onset of the release phase to zero or a relatively small value. Obstructive flow tends to be more extended in duration and is characterized by an inflection point beyond which the rate of flow falls off markedly from its initial rate.
FIG. 18 illustrates a gas flow pattern with a noticeable inflection point based on analysis of flow data provided by expiratory flow sensors, the control unit of the ventilator 10 is programmed to determine reference points during the P(low)IT(low) cycle. Flow and time reference points within the flow/time area, which is created or established by the P(low)IT(low) cycle, may be used to measure and calculate changes occurring in lung volume during the P(low)IT(low) cycle. If it is determined that obstructive or restrictive flow is present, the invention contemplates adjusting T(low) before making any other significant adjustments to ventilation parameters.
This can be done according to either of two alternative methods.
One method is to adjust T(low) to a predetermined value according to whether flow is either obstructive or restrictive but allowing T(low) to remain at its previous value if flow is normal. In the case of restrictive flow, T(low) should be adjusted to less than about 0.7 seconds. On the other hand, obstructive flow calls for a T(low) of greater duration, preferably greater than about 0.7 seconds with 1.0 to 1.2 being typical.
It is optional but advisable to promptly assess the sedation level of the hypercarbic patient P. Sedation of the patient P can be evaluated by any suitable technique such as the conventional clinical technique of determining a sedation agitation scale (SAS) score for the patient P. If the patient P appears over-sedated based on the SAS score (SAS score greater than about 2) or otherwise, reduction of sedation should be considered and initiated if appropriate. Thereafter, T(high) should be increased by about 0.5 seconds and P(high) increased concomitantly by about cm H20. After allowing sufficient time for these adjustments to take effect on the patient P, PaCO2 should be re-evaluated. If the patient P remains hypercarbic, T(high) should be increased again by about 0.5 seconds and P(high) again 4203540 v2 increased concomitantly by about 2 cm H20. PaCO2 should then be reassessed and concomitant increases of about 0.5 seconds in T(high) and about 2 cm H20 in P(high) repeated until the patient P is no longer hypercarbic. However, the total duration of T(high) should not be increased beyond a maximum of about fifteen (15) seconds.
Management of oxygenation in accordance with the invention is carried out with the goal of maintaining the level of oxygen in the arterial blood of the ventilated patient P (Pa02) at a value of at least about 80 mm Hg and a maintaining saturation level (Sa02) of at least about 95%. Preferably, fluctuations of Pa02 are held within a target range of about 55 mm Hg and 80 mm Hg. (Expressed in terms of Sp02, the target range would be between about 0.88 and 0.95, although where Pa02 and Sp02 data are both available, Pa02 would take precedence.) Responsive to a determination that oxygenation and saturation both meet the goals just specified, the ventilator 10 would be controlled to progressively decrease the fraction of oxygen in the inspired gas (Fi02) by about 0.5 about every thirty (30) minutes to one (1) hour with the objective of maintaining a blood oxygen saturation level (Sa02) of about 95% at a P(high) of about 35 cm H20 and an Fi02 of about 0.5. Upon meeting the latter objective, weaning in the manner to be described may be initiated provided the ventilation goal described earlier (i.e. a PaCO2 of less than about 50 mm Hg) is met and weaning is not otherwise contraindicated.
However, if the goals of oxygenation of Pa02 of at least about 80 mm Hg and arterial blood oxygen saturation (Sa02) of at least about 95% cannot both be maintained at the then-current Fi02, Fi02 is not decreased. Instead, P(high) is increased to about 40 cm H20 and T(high) increased substantially contemporaneously by about 0.5 seconds.
If such action does not result in raising oxygenation and saturation to at least the goals of Pa02 of about 80 mm Hg and Sa02 of about 95%, P(high) is increased to a maximum of about 45 cm H20 and T(high) is progressively further increased by about 0.5 seconds to 1.0 seconds. Oxygenation and saturation are then re-evaluated and, if they remain below goal, Fi02, if initially less than 1.0, may optionally be increased to about 1Ø Oxygen and saturation continue to be re-evaluated, and 4203540 v2 T(high) successively raised in increments of about 0.5 to 1.0 seconds until the stated oxygen and saturation goals are met.
Once those oxygenation and saturation goals are met, ventilation is controlled to maintain those goals while progressively decreasing Fi02 and P(high) toward the levels at which initiation of weaning can be considered. More particularly, P(high) is decreased by about 1 cm H20 per hour while Fi02 is decreased by about 0.05 about every thirty (30) minutes while maintaining an oxygen saturation of at least about 95%.
Weaning according to the invention, unless otherwise contraindicated, may commence after the oxygenation and ventilation goals described above have been met. That is, when PaCO2 remains below about 50 mm Hg and Sa02 remains at least about 95% at a P(high) of about 35 cm H20 and Fi02, if previously higher, has been weaned to a level of not greater than about 0.5. During weaning in accordance with the invention, T(high) is controlled to sustain recruitment while P(high) is reduced to gradually reduce airway pressure. As FIG. 20 illustrates, this is achieved by carrying out a series of successive incremental reductions in P(high) while substantially contemporaneously carrying out a series of successive incremental increases in T(high) so as to induce gradual pulmonary stress relaxation as FIG. 15 illustrates.
As a result, the pulmonary pressure versus volume curve shifts progressively from its inspiratory limb to its expiratory limb as illustrated in FIG. 16. As can be understood with reference to the previously described figures, weaning may be carried out in two stages, the first of which is more gradual than the second.
During the first stage, P(high) is reduced by about 2 cm H20 about every hour.
Substantially contemporaneously with each reduction in P(high), T(high) is increased by about 0.5 to 1.0 seconds up to, but not in excess of a T(high) of about 15 seconds in total duration.
As P(high) is being reduced in the manner just described, the fraction of oxygen in the inspired gas (Fi02) is also gradually reduced in accordance with P(high). During the first stage of weaning, this gradual weaning of Fi02 is carried out 4203540 v2 gradually. When P(high) has been reduced to about 24 cm H20 and Fi02 weaned to about 0.4 with the patient P sustaining a blood oxygen saturation (Sa02) of at least about 95% weaning may proceed to the more aggressive second stage. The term "substantially contemporaneously" should not be construed to be limited to necessarily require that changes occur precisely at the same moment. Rather, the term is to be construed broadly to encompass not merely events that occur at the same time, but also any which are close enough in time to achieve the advantages or effects described.
During continued weaning, successive reductions in P(high) and substantially contemporaneous increases in T(high) contemporaneous reductions continue about once every hour. However, during the second stage, the reductions in P(high) take place in increments of about 4 cm H20 and the increases in T(high) are each about 2.0 seconds. As reductions in P(high) continue, further weaning of F102 is implemented. Once Fi02 is weaned to about 0.3, airway pressures are reduced such that the ventilation sub-module by then has been transitioned from APRV to a substantially Continuous Positive Airway Pressure/Automatic Tube Compensation Mode (CPAP/ATC).
Once the patient P is tolerating CPAP at about 5 cm H20 with Fi02 of not greater than about 0.5, the patient's P ability to maintain unassisted breathing is assessed, preferably for at least about two (2) hours or more. Criteria for such assessments include: a) Sp02 of at least about 0.90 and/or Pa02 of at least about 60 mm Hg; b) tidal volume of not less than about 4 ml/kg of ideal bodyweight; c) respiration rate not significantly above about 35 breaths per minute, and d) lack of respiratory distress, with such distress being indicated by the presence of any two or more of the following: i) Heart rate greater than 120% of the morning-hour rate (though less than about five (5) minutes above such rate may be considered acceptable) ii) marked use of accessory muscles to assist breathing; iii) thoroco-abdominal paradox; iv) diaphoresis and/or v) marked subjective dyspnea.
If there is an indication of respiratory distress, CPAP at an airway pressure of about 10 cm H20 should be resumed and monitoring and reassessment carried out as needed. However, if criteria a) through d) above are all satisfied, the patient P

4203540 v2 may be transitioned to substantially unassisted breathing such as by extubation with face mask, nasal prong oxygen or room air, T-tube breathing, tracheotomy mask breathing or use of high flow CPAP at about 5 cm H20.
During all phases of ventilation, including initiation, management and weaning, the patient P should be reassessed at least about every two (2) hours and more frequently if indicated. Blood gas measurements (Pa02, Sa02 and PaCO2) which govern control of ventilation according to the invention should be monitored not less frequently than every two (2) hours though substantially continuous .. monitoring of all parameters would be ideal.
Just prior to and during weaning at least one special assessment should be conducted daily, preferably in the morning hours. If not possible to do so, a delay of not more than about four (4) hours could be tolerated. Weaning should not be initiated or continued further unless: (a) at least about 12 hours have passed since initial ventilation settings were established or first changed, (b) the patient P is not receiving neuromuscular blocking agents and is without neuromuscular blockade, and (c) Systolic arterial pressure is at least about 90 mm Hg without vasopressors (other than "renal" dose dopamine).
If these criteria are all met, a trial should be conducted by ventilating the patient P in CPAP mode at about 5 cm H20 and an Fi02 of about 0.5 for about five (5) minutes. If the respiration rate of the patient P does not exceed about 35 breaths per minute (bpm) during the five (5) minute period weaning as described above may proceed. However, if during the five (5) minute period the respiration rate exceeds about 35 bpm, it should be determined whether such tachypnea is associated with anxiety. If so, administer appropriate treatment for the anxiety and repeat the trial within about four (4) hours. If tachypnea does not appear to be associated with anxiety, resume management of ventilation at the parameter settings in effect prior to the trial and resume management of ventilation as described above. Re-assess at least daily until weaning as described above can be initiated.

4203540 v2 INDUSTRIAL APPLICABILITY
The embodiments of the present invention are suitable for use in many respiratory assistance applications that involve the use of ventilators and ventilator systems and methods of operation thereof. The various configurations and capabilities of the inventive ventilator and system and method of operation can be modified to accommodate nearly any conceivable respiratory assistance application and/or requirement. The arrangement, capability, and compatibility of the features and components of the novel ventilators, systems, and methods of operation and use described herein can be readily modified according to the principles of the invention as may be required to suit any particular critical and/or routine care and/or hospital, assisted care, or home care application or situation. Additionally, such inventive ventilators, systems, and methods are suitable for use with nearly all types of ventilation equipment including but not limited to positive pressure or negative pressure respiratory assistance devices.
Such modifications and alternative arrangements may be further preferred and/or optionally desired to establish compatibility with the wide variety of possible applications that are susceptible for use with the inventive and improved ventilators, respiratory assistance systems, and operational methods that are described and contemplated herein.
The scope of the claims should not be limited by the preferred embodiments set forth in the examples, but should be given the broadest interpretation consistent with the Description as a whole.

4203540 v2

Claims (22)

WHAT IS CLAIMED IS:

1. A ventilator system for assisting in respiratory function of a patient under direction of a clinician, comprising:
a supply pump and a control module in communication with a data circuit and a gas circuit having a plurality of valves and supply and exhaust ports, the control module including a display, input device, and a memory in communication with the data circuit;
a sensor array in communication with the data circuit that includes at least one oximeter, at least one capnometer, at least one pressure sensor, and at least one flow meter in communication with at least one of the supply and exhaust ports for measuring a patient actual data array element including at least one of (i) a patient SpO2 quantity, (ii) a patient etCO2 quantity, (iii) a peak expiratory flow rate, (iv) an end inspiratory lung volume, (v) an end expiratory lung volume, or (vi) a spontaneous breathing frequency;
at least one initialization parameter database resident in the memory communicable with the display and configured to store at least one model patient data array element that includes at least an FiO2 quantity, a high pressure, a low pressure, a high time, and a low time; and a command module resident in the memory operative to command the control module to adjustably actuate the supply pump or the plurality of valves to establish a pressure, volume, or flow rate in the gas circuit;
wherein the command module comprises an initial setup module with an optimal end expiratory lung volume assessment mode configured to ascertain an optimal end expiratory lung volume from a patient actual data array, and an adjustment and maintenance module with an oxygenation mode, and a ventilation mode, and a weaning module having a weaning mode, wherein the command module is configured to automatically perform a feedback loop from the sensor array to automatically perform a programmed order that includes, in order, the optimal end expiratory lung volume assessment mode, the oxygenation mode, the ventilation mode, and the weaning mode, Date Recue/Date Received 2022-06-30 wherein the command module is configured to determine when one mode is completed and automatically proceed to a next mode in the programmed order, wherein the command module is configured to determine when one mode is to proceed to an earlier mode in the programmed order, and automatically proceed to the earlier mode, and wherein the command module is configured to compare the patient actual data array to at least one model patient data array, and to automatically adjust the supply pump or the plurality of valves to adjust the pressure, the volume or the flow rate to achieve an SpO2 goal value, an etCO2 goal value, the optimal end expiratory lung volume and an optimal end inspiratory lung volume.

2. The ventilator system according to claim 1, wherein the adjustment and maintenance is further configured to implement a recruitment mode.

3. The ventilator system according to claim 1, wherein the weaning mode of the weaning module includes an initial weaning mode, an airway pressure release ventilation mode, and a continuous airway pressure or CPAP mode.

4. The ventilator system according to claim 1, wherein the at least one model patient data array element further includes at least one of a positive end expiratory pressure, an SpO2 quantity, an etCO2 quantity, a pressure increment, a time increment, a tidal volume, a machine respiratory frequency, a pressure-volume slope, a trigger pressure, or occlusion pressure.

5. The ventilator system according to Claim 1, wherein if the SpO2 goal value is false, the command module is configured to communicate with the sensor array and ascertains the patient actual data array to ascertain a patient FiO2 quantity and determine an FiO2 goal value; and wherein if the FiO2 goal value (a) is true, the command module is configured to communicate with the sensor array and ascertains the patient actual data array to Date Recue/Date Received 2022-06-30 ascertain the high pressure, and if the high pressure (i) is false, the command module is configured to command the control module to adjust at least one of the supply pump or the plurality of valves to increase the high pressure by at least one pressure increment and to increase the high time by at least one time increment, and sets the optimal end expiratory lung volume to be true, and (ii) is true, the command module is configured to set a recruitment value to be true, and (b) is false, the command module is configured to command the control module to adjust at least one of the supply pump or the plurality of valves to increase the Fi02 quantity.

6. The ventilator system according to Claim 1, wherein if the SpO2 goal value is true, the command module is configured to communicate with the sensor array and ascertains the patient actual data array to ascertain a patient Fi02 quantity and ascertains the patient actual data array to ascertain a patient FiO2 quantity and determine an FiO2 goal value; and wherein if the FiO2 goal value (a) is true, the command module is configured to command the control module to adjust at least one of the supply pump or the plurality of valves to decrease the Fi02 quantity and (b) is false, the command module is configured to set a ventilation value to be true.

7. The ventilator system according to Claim 1, wherein the command module is configured to communicate with the sensor array and ascertains the patient actual data array to compute a recruitment value; and wherein if the recruitment value (a) is true, the command module is configured to generate a clinician alarm signal, and, (b) is false, the command module is configured to command the control module to adjust at least one of the supply pump or the plurality of valves to increase the high pressure by at least one pressure increment, increase the high time by at least one time increment, and adjust the low time by at least another time increment, and ascertains the SpO2 goal value, and if the SpO2 goal value (i) is true, the command module is configured to set an oxygenation value to be true, and (ii) is false, the command module is configured to set the recruitment value to be true.

Date Recue/Date Received 2022-06-30

8. The ventilator system according to Claim 1, wherein the command module communicates with the sensor array and ascertains the patient actual data array to measure a peak expiratory flow rate, measure a truncation of gas flow, compute an angle of deceleration of gas flow, determine the optimal end expiratory lung volume, and ascertain a lung condition; and wherein if the lung condition (a) is true, the command module polls the sensor array to measure a patient PaCO2 quantity, adjusts the low time to achieve an optimal end expiratory lung volume of 25-60%, and sets an oxygenation value to be true, and (b) is false, the command module polls the sensor array to measure the patient PaCO2 quantity, adjusts the low time to achieve an optimal end expiratory lung volume of 50-85%, and sets an oxygenation value to be true.

9. The ventilator system according to Claim 4, wherein if the etCO2 goal value, a comparison between the spontaneous breathing frequency and the machine respiratory frequency and the high time is false, the command module is configured to determine the high pressure; and wherein if the high pressure (a) is false, the command module is configured to command the control module to adjust at least one of the supply pump or the plurality of valves to increase the high time by at least one time increment and increase the high pressure by at least one pressure increment and (b) is true, the command module is configured to command the control module to adjust at least one of the supply pump or the plurality of valves to increase the high time by at least one time increment.

10. The ventilator system according to Claim 4, wherein if the etCO2 goal value is false, a comparison between the spontaneous breathing frequency and the machine respiratory frequency is true and the high time is true, the command module is configured to determine the high pressure; and wherein if the high pressure (a) is true, the command module is configured to determine a release volume, and if the release volume (i) is false, the command module Date Recue/Date Received 2022-06-30 is configured to set a recruitment value to be true, and (ii) is true, the command module is configured to determine the SpO2 goal value, and (b) is false, the command module is configured to command the control module to adjust at least one of the supply pump or the plurality of valves to decrease the high time by at least one time increment and increase the high pressure by at least one pressure increment.

11. The ventilator system according to Claim 4, wherein if the etCO2 goal value is true, the command module is configured to set an initial weaning value to be true, and samples the spontaneous breathing frequency; and wherein rf the spontaneous breathing frequency (a) is false, the command module is configured to ascertain a tachypnea value that if true enables the command module to set a ventilation value to be true, and (b) is true, the command module is configured to ascertain the high pressure, and if the high pressure is false, the command module is configured to ascertain an apnea value and if the apnea value (i) is true, the command module is configured to set the ventilation value to be true, and (ii) is false, the command module is configured to set an airway pressure release ventilation value to be true.

12. The ventilator system according to Claim 1, wherein the command module is configured such that if the high pressure is true, the command module commands the control module to adjust at least one of the supply pump or the plurality of valves to decrease the high pressure by at least one pressure increment and to increase the high time by at least one time increment.

13. The ventilator system according to Claim 4, further comprising: at least one model patient data array further including predetermined weaning criteria that establishes an FiO2 threshold, an SpO2 threshold, a spontaneous tidal volume, a minute ventilation quantity, and an airway occlusion pressure;
wherein the command module is configured to communicate with the data circuit to sample the sensor array and measure at least one of the patient actual data array Date Recue/Date Received 2022-06-30 elements and to compare at least one of the patient actual data array elements to the predetermined weaning criteria to generate a weaning value; and wherein the command module is configured such that if the command module determines that the weaning value (a) is false, the command module commands the control module to adjust at least one of the supply pump or the plurality of valves to increase the high pressure by at least one pressure increment and to decrease the high time by at least one time increment, and (b) is true, the command module repeatedly initiate cyclic weaning by commanding the control module to adjust at least one of the supply pump or the plurality of valves to decrease the high pressure by at least one pressure increment and increase the high time by at least one time increment.

14. The ventilator system according to Claim 13, wherein the command module is configured such that each time the command module initiates another cyclic weaning, the command module ascertains the high pressure until a continuous positive airway pressure threshold is reached to enable the command module to set a continuous positive airway pressure value to be true.

15. The ventilator system according to Claim 14, wherein if the continuous positive airway pressure value is true, the command module is configured to communicate with the data circuit to sample the sensor array and measure at least one of the patient actual data array elements and to compare the at least one of the patient actual data array elements to the predetermined weaning criteria to generate a weaning value; and wherein the command module is configured to determine the weaning value, and if the weaning value (a) is false, the command module is configured to command the control module to adjust at least one of the supply pump or the plurality of valves to increase the continuous positive airway pressure, and (b) is true, the command module is configured to periodically decrease the continuous positive airway pressure until an extubation threshold pressure is reached.

16. The ventilator system according to Claim 15, wherein the command module is configured such that if the high pressure (a) is false, the command module commands Date Recue/Date Received 2022-06-30 the control module to adjust at least one of the supply pump or the plurality of valves to adjust the continuous positive airway pressure based on the high pressure, and (b) is true, the command module sets an airway pressure release ventilation to be true.

17. The ventilator system according to Claim 10, wherein if the SpO2 goal value (a) is false, the command module is configured to set a recruitment value to be true, and (b) is true, the command module is configured to command the control module to adjust at least one of the supply pump or the plurality of valves to decrease the high time by at least one time increment.

18. A ventilator for use by a clinician in supporting a patient presenting pulmonary distress, comprising:
a controller including a display, input device, and a memory together in electrical communication with a data network, the controller incorporating a pressurized gas source in fluid communication with a gas network that includes at least two valves and supply and exhaust ports in communication with the patient and the display including a prompt for entry via the input device of at least one of (i) an automated initialization setting and (ii) at least one or more parameters to be stored in the memory that includes (a) a positive end expiratory pressure, (b) an SpO2 quantity, (c) an etCO2 quantity, (d) an FiO2 quantity, (e) a high pressure, (f) a low pressure, (g) a high time, (h) a low time; (i) a pressure increment, j) a time increment, (k) a tidal volume, (l) a machine respiratory frequency, (m) a flow-time slope, (n) a trigger pressure, or (o) an occlusion pressure;
a plurality of sensors in communication with the data network that includes at least one oxygen saturation sensor, at least one capnometer, at least one pressure gauge, and at least one gas flow rate meter in communication with at least one of the supply and exhaust ports for measuring a patient actual data array element including (i) a patient SpO2 quantity, (ii) a patient etCO2 quantity, (iii) a peak expiratory flow rate, (iv) an end inspiratory lung volume, (v) an end expiratory lung volume, or (vi) a spontaneous breathing frequency;
Date Recue/Date Received 2022-06-30 a command routine resident in the memory operative for driving the controller to adjustably actuate the pressurized gas source and at least one of the valves to establish a pressure, volume, or flow rate in the gas network for comparing a patient actual data array to the at least one or more parameters, and for computing an SpO2 goal value, an etCO2 goal value, and an optimal end inspiratory lung volume and an optimal end expiratory lung volume;
wherein the command routine is configured to automatically perform a feedback loop from the plurality of sensors to automatically perform a programmed order that includes, in order, an optimal end expiratory lung volume assessment mode, an oxygenation mode, a ventilation mode, and a weaning mode, wherein the command routine is configured to determine when one mode is completed and automatically proceed to a next mode in the programmed order, wherein the command routine is configured to determine when one mode is to proceed to an earlier mode in the programmed order, and automatically proceed to the earlier mode, and wherein the command routine is configured to compare the patient actual data array to the at least one of the parameters, and to automatically adjust at least one of the valves to adjust the pressure, the volume or the flow rate to achieve the SpO2 goal value, the etCO2 goal value, and the optimal end inspiratory and expiratory lung volume.

19. The ventilator according to Claim 18, wherein the command routine communicates with the plurality of sensors and ascertains the patient actual data array to compute the optimal end expiratory lung volume value and ascertains a lung condition; and wherein if the lung condition (a) is true, the command routine polls the plurality of sensors to measure the patient etCO2 quantity, adjusts the low time to achieve an optimal end expiratory lung volume of 25-60%, and sets an oxygenation value to be true, and (b) is false, the command routine polls the plurality of sensors to measure Date Recue/Date Received 2022-06-30 the patient etCO2 quantity, adjust the low time to achieve an optimal expiratory lung volume of 50-85%, and sets an oxygenation value to be true.

20. The ventilator according to Claim 18, wherein if the etCO2 goal value is false, a comparison between the spontaneous breathing frequency and the machine respiratory frequency is false and the high time is false, the high pressure is determined; and wherein if the high pressure (a) is false, the command routine is configured to adjust at least one of the supply pump or the valves to increase at least one of the high time and the high pressure by at least one respective time increment and pressure increment and (b) is true, the command routine is configured to adjust at least one of the supply pump or the valves to increase the high time by at least one time increment.

21. The ventilator according to Claim 18, wherein if the etCO2 goal value is false, a comparison between the spontaneous breathing frequency and the machine respiratory frequency is true and the high time is true, the high pressure is determined;
and wherein if the high pressure value (a) is true and a release volume is false, the command routine is configured to set a recruitment value to be true, and (b) is false, the command routine is configured to adjust at least one of the supply pump or the valves to decrease the high time and increase the high pressure by at least one respective time increment and pressure increment.

22. The ventilator according to Claim 19, wherein the weaning mode includes an initial weaning mode, an airway pressure release ventilation mode, and a continuous airway pressure or CPAP mode.

Date Recue/Date Received 2022-06-30