WO2010107614A1

WO2010107614A1 - Leak-compensated pressure regulated volume control ventilation

Info

Publication number: WO2010107614A1
Application number: PCT/US2010/026618
Authority: WO
Inventors: Mehdi Jafari; Rhomere Jimenez; Gail Upham; Jeffrey Aviano
Original assignee: Nellcor Puritan Bennett Llc
Priority date: 2009-03-20
Filing date: 2010-03-09
Publication date: 2010-09-23
Also published as: US8973577B2; US8418691B2; US20100236555A1; US20130186401A1

Abstract

This disclosure describes systems and methods for compensating for leakage when during delivery of gas to a patient from a medical ventilator (20) in a pressure regulated volume control (PRVC) ventilation mode. The technology described herein includes systems and methods that compensate the delivery of PRVC ventilation for leakage in the patient circuit (30) by using leak-compensated lung flows as well as respiratory mechanics (lung compliance and lung resistance) estimated in a manner that compensates for elastic and inelastic leaks from the ventilation system (26).

Description

LEAK-COMPENSATED PRESSURE REGULATED VOLUME CONTROL VENTILATION

Introduction

In mechanical ventilation, pressure regulated volume control (PRVC) ventilation is a type of pressure regulated treatment that provides the capability to control the volume of gas delivered to the patient's lungs by adjusting the inspiratory target pressure. In PRVC, a selected volume is delivered to a patient by changing the pressure of the respiratory gas. During PRVC ventilation, the ventilator will evaluate the volume delivered to the patient and compare it against the desired volume set by the therapist. If delivered volume is less than the desired, therapist-selected volume, then the target pressure for the next breath will be increased proportionally. On the other hand, if the delivered volume exceeded the desired volume, the target pressure will be lowered. hi one implementation of PRVC, the ventilator estimates the compliance of the patient's lungs and uses the estimated lung compliance to calculate the target pressure that will result in the delivery of the pre-selected volume of gas. The magnitude and shape of the inspiratory flow delivered by the ventilator will be a function of the patient lung characteristics, breathing pattern, and other ventilator settings.

The lung compliance and lung resistance of a patient may be collectively referred to as the respiratory mechanics of the lung or, simply, the patient's respiratory mechanics, Because PRVC relies on the patient' s respiratory mechanics when determining what pressure to provide for each breath, more accurate determination of respiratory mechanics is essential to performance of the ventilator when providing PRVC ventilation.

Leak-Compensated Pressure Regulated Volume Control Ventilation

This disclosure describes systems and methods for compensating for leakage when during delivery of gas to a patient from a medical ventilator in a pressure regulated volume control (PRVC) ventilation mode. The technology described herein includes systems and methods that compensate the delivery of PRVC ventilation for leakage in the patient circuit by using leak-compensated lung flows as well as respiratory mechanics (lung compliance and lung resistance) estimated in a manner that compensates for elastic and inelastic leaks from the ventilation system. In part, this disclosure describes a method of compensating for leakage in a ventilation system during delivery of pressure regulated volume control ventilation to a patient. The method starts with monitoring an instantaneous flow of respiratory gas in the ventilation system based on one or more measurements of pressure and flow in ventilation system. Leakage of gas from the system is modeled as a first leakage component through a first orifice of a fixed size and a second leakage component through a second orifice of a vaiying size, in which the first and second leakage components are different functions of instantaneous pressure in the ventilation system. A leak-compensated delivered lung volume is then estimated for at least one breath based on the one or more measurements, the first leakage component and the second leakage component. The leak-compensated delivered lung volume and a predetermined respiratory mechanics model are then used to estimate a leak-compensated lung compliance. A target pressure to be delivered to the patient for a subsequent pressure-based breath is then calculated based on a desired lung volume, the leak- compensated delivered lung volume and the leak-compensated lung compliance. The target pressure is then delivered to the patient during the inspiratory phase of the next breath. The leak-compensated lung compliance may be estimated based on the leak- compensated delivered lung volume and a pressure difference, such as the difference between an end inspiratory pressure of a first breath and an end expiratory pressure of the first breath. The disclosure also describes a method of compensating for leakage in a ventilation tubing system during delivery of gas from a medical ventilator to a patient. The method includes measuring leakage from the ventilation tubing system during a first breath and calculating a leak-compensated delivered lung volume for the first breath based on the leakage. The method then estimates a lung compliance of the patient based on the leak- compensated delivered lung volume and pressure measurements taken during the first breath. Ventilation is then delivered to the patient in a second breath at a pressure determined based on a desired delivered lung volume, the leak-compensated delivered lung volume and the leak-compensated lung compliance. As part of measuring the leakage, the method may include identifying an inelastic leakage from the ventilation tubing system as a first function of at least one of a pressure measurement and a flow measurement in the ventilation system and identifying an elastic leakage from the ventilation tubing system as a second function of at least one of the pressure measurement and the flow measurement in the ventilation system.

The disclosure further describes a pressure support system, such as a respiratory ventilator. The system includes: a pressure generating system adapted to generate a flow of breathing gas; a ventilation tubing system including a patient interface device for connecting the pressure generating system to a patient; one or more sensors operatively coupled to the pressure generating system or the ventilation tubing system, in which each sensor is capable of generating an output indicative of a pressure or flow of the breathing gas in the ventilation tubing system; a leak estimation module that identifies leakage in the ventilation tubing system; a delivered lung volume module that calculates a leak- compensated delivered lung volume for a first breath based on the leakage during the first breath and the flow of the breathing gas in the ventilation tubing system; a respiratory mechanics calculation module that generates a leak-compensated lung compliance based on the leak-compensated delivered lung volume and at least one output indicative of a pressure of the breathing gas during the first breath; and a pressure control module that causes the pressure generating system to deliver a second breath to the patient at a target pressure calculated based on the leak-compensated lung compliance and the leak- compensated delivered lung volume.

The disclosure also describes a controller for a medical ventilator that includes a microprocessor, a module (which may be a software program executed by the microprocessor, or a component comprising software, hardware and/or firmware that is separate from the microprocessor) that calculates leak- compensated delivered lung volume and leak-compensated lung compliance based on instantaneous elastic leakage and instantaneous inelastic leakage of breathing gas from a ventilation system, and a pressure control module that provides pressure regulated volume control ventilation at a pressure determined based on the leak-compensated delivered lung volume and the leak- compensated lung compliance.

These and various other features as well as advantages which characterize the systems and methods described herein will be apparent from a reading of the following detailed description and a review of the associated drawings. Additional features are set forth in the description which follows, and in part will be apparent from the description, or may be learned by practice of the technology. The benefits and features of the technology will be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the invention as claimed.

Brief Description of the Drawings

The following drawing figures, which form a part of this application, are illustrative of described technology and are not meant to limit the scope of the invention as claimed in any manner, which scope shall be based on the claims appended hereto, FIG. 1 illustrates an embodiment of a ventilator connected to a human patient.

FIG. 2 schematically depicts example systems and methods of ventilator control. FIG. 3 illustrates an embodiment of a method of compensating for leakage in a ventilator providing pressure-regulated volume control ventilation to a patient.

FIG. 4 illustrates an embodiment of a method for calculated leak-compensated lung flow and delivered lung volume while providing pressure-regulated volume control ventilation to a patient.

FIG. 5 illustrates a functional block diagram of modules and other components that may be used in an embodiment of ventilator that compensates for elastic and rigid orifice sources of leaks when determining the target pressure during pressure-regulated volume control ventilation.

Detailed Description

Although the techniques introduced above and discussed in detail below may be implemented for a variety of medical devices, the present disclosure will discuss the implementation of these techniques in the context of a medical ventilator providing pressure regulated volume control (PRVC) ventilation to a human patient. The reader will understand that the technology described in the context of a medical ventilator for human patients could be adapted for use with other systems such as ventilators for non-human patients and general gas transport systems in which leaks may cause a degradation of performance. In PRVC ventilation, a ventilator may evaluate the volume delivered to the patient over a breath or a specified time period and compare it against the volume set by the therapist. If the delivered volume is less than the setting, then the pressure target is increased proportionally.

FIG. 1 illustrates an embodiment of a ventilator 20 connected to a human patient 24 that is adapted to provide PRVC ventilation. Ventilator 20 includes a pneumatic system 22 (also referred to as a pressure generating system 22) for circulating breathing gases to and from patient 24 via the ventilation tubing system 26, which couples the patient to the pneumatic system via physical patient interface 28 and ventilator circuit 30. Ventilator circuit 30 could be a dual-limb or single-limb circuit for carrying gas to and from the patient. In a dual-limb embodiment as shown, a wye fitting 36 may be provided as shown to couple the patient interface 28 to the inspiratory limb 32 and the expiratory limb 34 of the circuit 30.

The present systems and methods have proved particularly advantageous in noninvasive settings, such as with facial breathing masks, as those settings typically are more susceptible to leaks. However, leaks do occur in a variety of settings, and the present description contemplates that the patient interface may be invasive or non-invasive, and of any configuration suitable for communicating a flow of breathing gas from the patient circuit to an airway of the patient. Examples of suitable patient interface devices include a nasal mask, nasal/oral mask (which is shown in FIG. 1), nasal prong, full-face mask, tracheal tube, endotracheal tube, nasal pillow, etc. Pneumatic system 22 may be configured in a variety of ways. In the present example, system 22 includes an expiratory module 40 coupled with an expiratory limb 34 and an inspiratoiy module 42 coupled with an inspiratory limb 32. Compressor 44 or another source(s) of pressurized gas (e.g., air and oxygen) is coupled with inspiratory module 42 to provide a gas source for ventilatory support via inspiratory limb 32. The pneumatic system may include a variety of other components, including sources for pressurized air and/or oxygen, mixing modules, valves, sensors, tubing, accumulators, filters, etc. Controller SO is operatively coupled with pneumatic system 22, signal measurement and acquisition systems, and an operator interface 52 may be provided to enable an operator to interact with the ventilator (e.g., change ventilator settings, select operational modes, view monitored parameters, etc.). Controller 50 may include memory 54, one or more processors 56, storage 58, and/or other components of the type commonly found in command and control computing devices. The memoiy 54 is computer-readable storage media that stores software that is executed by the processor 56 and which controls the operation of the ventilator 20. In an embodiment, the memoiy 54 comprises one or more solid-state storage devices such as flash memory chips, hi an alternative embodiment, the memory 54 may be mass storage connected to the processor 56 through a mass storage controller (not shown) and a communications bus (not shown). Although the description of computer-readable media contained herein refers to a solid-state storage, it should be appreciated by those skilled in the art that computer-readable storage media can be any available media that can be accessed by the processor 56. Computer-readable storage media includes volatile and non- volatile, removable and non-removable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, program modules or other data. Computer-readable storage media includes, but is not limited to, RAM, ROM, EPROM, EEPROM, flash memory or other solid state memory technology, CD-ROM, DVD, or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and which can be accessed by the computer.

As described in more detail below, controller 50 issues commands to pneumatic system 22 in order to control the breathing assistance provided to the patient by the ventilator. The specific commands may be based on inputs received from an operator, the patient 24, the pneumatic system 22 and sensors, the operator interface 52 and/or other components of the ventilator, hi the depicted example, operator interface includes a display 59 that is touch-sensitive, enabling the display to serve both as an input and output device.

FIG. 2 schematically depicts exemplary systems and methods of ventilator control. As shown, controller 50 issues control commands 60 to drive pneumatic system 22 and thereby circulate breathing gas to and from patient 24. The depicted schematic interaction between pneumatic system 22 and patient 24 may be viewed in terms of pressure and/or flow "signals." For example, signal 62 may be an increased pressure which is applied to the patient via inspiratory limb 32. Control commands 60 are based upon inputs received at controller 50 which may include, among other things, inputs from operator interface 52, and feedback from pneumatic system 22 (e.g., from pressure/flow sensors) and/or sensed from patient 24. In an embodiment, before the respiratory mechanics of a patient can be determined, the mechanics of the ventilation tubing system may be determined, For example, when modeling the delivery of gas to and from a patient 24 via a closed-circuit ventilator, one simple assumption is that compliance of the ventilator circuit 30 (the "circuit compliance") is fixed and that all gas injected into the ventilator circuit 30 that does not exit the circuit 30 via the expiratory limb 34 (in a dual-limb embodiment) fills the circuit as well as the patient's lungs and causes an increase in pressure. As gas is injected (Li), the lung responds to the increased gas pressure in the circuit 30 by expanding. The amount the lung expands is proportional to the lung compliance and is defined as a function of gas pressure differential (e.g., lung compliance = volume delivered/pressure difference). As discussed in greater detail below, this assumption is not valid when leaks are present.

The term circuit compliance is used to refer to the relationship between the pressure in the ventilator circuit 30 (or ventilator circuit 30 and attached patient interface 28, depending on how the compliance is determined) changes based on changes in volume delivered into the circuit. In an embodiment, the circuit compliance may be estimated by pressurizing the ventilator circuit 30 (or circuit 30 and interface 28 combination) when flow to the patient is blocked and measuring the volume of additional gas introduced to cause the pressure change (compliance = volume delivered/pressure difference).

The term circuit resistance is used to refer to the amount the pressure changes between two sites upstream and downstream the ventilator circuit as a function of volumetric flow rate through that circuit. Circuit resistance may be modeled as a two- parameter function of flow and several methods for modeling and calculating circuit resistance are known in the art. For example, in an embodiment, the circuit resistance may be estimated by passing several fixed flow rates through the circuit and measuring the pressure difference between certain upstream and downstream sites and finding the best curve fit to the collected data.

Methods of determining circuit compliance and circuit resistance (such as those described above) may be executed by the operator prior to attaching the patient to the ventilator as part of the set up of the ventilator 20 to provide therapy. Other methods of determining circuit compliance and/or resistance during therapy are also known and could be adapted for use with the disclosed leak-compensation systems and methods described herein. In many cases, it may be desirable to establish a baseline pressure and/or flow trajectoiy for a given respiratory therapy session. The volume of breathing gas delivered to the patient's lung (Lj) and the volume of the gas exhaled by the patient (L₂) are measured or determined , and the measured or predicted/estimated leaks are accounted for to ensure accurate delivery and data reporting and monitoring. Accordingly, the more accurate the leak estimation, the better the baseline calculation of delivered and exhaled flow rates and volumes.

Errors may be introduced due to leaks in the ventilation tubing system 26. The term ventilation tubing system 26 is used herein to describe the ventilator circuit 30, any equipment attached to or used in the ventilator circuit 30 such as water traps, monitors, drag delivery devices, etc. (not shown), and the patient interface 28. Depending on the embodiment, this may include some equipment contained in the inspiration module 42 and/or the expiration module 40. When referring to leaks in or from the ventilation tubing system 26, such leaks include leaks within the tubing system 26 and leaks where the tubing system 26 connects to the pressure generator 22 or the patient 24. Thus, leaks from the ventilation tubing system 26 include leaks from the ventilator circuit 30, leaks from the patient interface 28 (e.g., masks are often provided with holes or other pressure relief devices through which some leakage may occur), leaks from the point of connection of the patient interface 28 to the patient 24 (e.g., leaks around the edges of a mask due to a poor fit or patient movement), and leaks from the point of connection of the patient interface 28 to the circuit 30 (e.g., due to a poor connection between the patient interface 28 and the circuit 30).

For the purpose of estimating how a leak flow rate changes based on changes in pressure in the ventilation tubing system 26, the instantaneous leak may be modeled as a leak through a single rigid orifice or opening of a fixed size in which that size is determined based on comparing the total flow into the inspiratory limb 32 and out of the expiratory limb 34. However, this leak model does not take into account any elastic component of leak source(s) in the system 26, that is how much of the area of any of the holes or openings in the ventilation tubing system 26 through which leakage occurs may change due to an increase or decrease in pressure.

It has been determined that not accounting for elastic leakage from the ventilation tubing system 26 can cause many problems. First, if only the inelastic/fixed orifice model is used to estimate leak, the subsequent errors caused by ignoring the elastic effects of any actual leaks end up generating inaccurate estimates of flow rates into the lung. This can cause the ventilator 20 to estimate gas volume delivered into the lung inaccurately when, in fact, the elastic leaks in the system 26 have let more gas escape than estimated. Second, if the elasticity of the leak source is ignored, any other calculation, estimate, or action that the ventilator 20 may perform which is affected by the leak estimate will be less accurate. In the systems and methods described herein, the provision of PRVC ventilation is made more accurate by compensating for leakage from the ventilation tubing system. In the embodiments described herein fixed (rigid) and elastic components of the system leakage are used when determining the lung flow, net lung volume, lung compliance and lung resistance of the patient. This results in a more accurate determination of lung compliance and lung resistance and, therefore, ventilation of patients based on respiratory mechanics. While the systems and methods are presented in the context of specific leakage models, the technology described herein could be used to compensate the respiratory mechanics determined by any model for leakage using any type of mechanical ventilator or other device that provides gas.

FIG. 3 illustrates an embodiment of a method of compensating PRVC ventilation for leakage during delivery of gas from a medical ventilator to a patient. In the method 300 shown, a medical ventilator such as that described above with reference to FIGS. 1 and 2 is used to provide PRVC ventilation to a patient.

The method 300 illustrated starts with a setup operation 301 in which the operator directs the ventilator to provide PRVC ventilation. In the setup operation 301, the operator selects a volume of gas to be delivered to the patient, that is to be delivered into the lung, over a specified time period such as a minute, a number of breaths, etc. This desired delivered volume is received by the ventilator and stored in memory for use during PRVC ventilation.

In the embodiment shown, the method 300 includes a circuit compliance and resistance operation 302. In that operation 302, the ventilator circuit compliance and resistance are estimated. In an embodiment, this may be performed prior to connecting the ventilator to the patient (as previously described). Alternatively, it may be dynamically determined periodically throughout the delivery of ventilatory support to the patient. The circuit compliance and resistance may be used in the remaining operations to correct for any losses in volume or effects on the volume delivered to the patient introduced due to the patient circuit.

After the circuit compliance and resistance have been determined, the ventilator is connected to the patient and an initialization operation 304 is performed. In the initialization operation 304 the ventilator operates for an initialization period in order to generate an initial estimate of lung compliance. If the ventilator already has some knowledge of the respiratory mechanics of the patient (e.g., the respiratory mechanics have been recently determined during provision of a different type of ventilation or an operator has provided initial settings for lung compliance and resistance), this operation 304 may be automatically or manually omitted in favor of the previously determined values.

A description of an embodiment of the initialization operation 304 is as follows. Because the ventilator does not know the patient's mechanics when the PRVC breath type is selected, it performs a startup routine to obtain initial data, hi an embodiment, upon startup the ventilator delivers some number (e.g., two, four, etc.) of consecutive pressure- based breaths. One or more of these initial breaths given in the startup period may also include an end-inspiratory or other maneuver that yields estimates of the patient's lung compliance. Using four training breaths for the initialization operation 304 as an example, the first breath is delivered using a predicted resistance for the artificial airway and conservative estimates for patient lung compliance. The predicted values may be determined based on known characteristics of the patient, such as based on the patient's ideal body weight (IBW), height, gender, age, physical condition, etc. Each of the following three pressure-based breaths averages stepwise decreased physiologic values with the estimated lung compliance values from the previous breaths, weighting earlier estimates less with each successive breath, and yielding more reliable estimates for lung compliance. Other methods may be used to find a first estimate of the lung compliance and update it on an ongoing basis as ventilation continues.

In an embodiment of the method 300, a leakage estimate may also be done prior to the initialization operation 304. Prior determination of leak parameters allows for estimates of respiratory mechanics to be made. This may include delivering pressure- regulated breaths with specific settings or performing specific "leak maneuvers", that is a specified set of controlled actions on the part of the ventilator that allow leakage parameters to be identified and quantified, such as interrupting the therapeutic delivery of respiratory gas and holding or changing the pressure and flow, so that data concerning the leakage of the system during the controlled actions may be obtained. For example, a leak maneuver may include periodically holding the pressure and flow in the circuit constant while determining (based on a comparison of the measured flow into the inspiratory limb and the measured flow out of the expiratory limb via the exhalation valve) the net leakage from the system. In an embodiment, such a leak maneuver may be performed during specific parts of the respiratory phase, e.g., at the end of the expiratory phase. In yet another embodiment, a sequence of pressure-based test breaths is delivered with specific settings to determine leak parameters prior to execution of test breaths for respiratory mechanics determinations.

After the initialization operation 304, the ventilator provides ongoing PRVC ventilation to the patient in a PRVC ventilation operation 306. As discussed above, during PRVC ventilation the ventilator calculates a target pressure to be delivered to the patient during inspiration based on the desired lung volume to be delivered and the leak- compensated lung compliance of the patient. When in an inspiratory phase, the ventilator raises the pressure in the ventilator tubing system so that the target inspiratory pressure is applied. During exhalation, the pressure may be dropped to some pre-selected positive end expiratory pressure (PEEP) level or to atmospheric level depending on the desires of the operator. The duration of the inspiratory and expiratory phases may be determined based on patient effort or based on a preselected inspiratory time.

As described above, the target pressure delivered during each inspiratory phase is determined based on the desired lung volume to be delivered and leak-compensated lung compliance of the patient. In order to compensate for leakage in the circuit, in the method 300 shown the PRVC ventilation operation 306 includes the ongoing calculation of leakage while providing ventilation, as illustrated by the leakage calculation/compensation operation 307. As discussed in greater detail below with reference to FIG. 4, the leakage is calculated and the leak-compensated values for lung flow and current lung volume (i.e., the volume of gas in the lung at that moment) are determined taking into account the calculated leakage. The method 300 also includes determining the leak-compensated delivered lung volume in a delivered volume calculation operation 308. The delivered volume calculation operation 308 uses the leak-compensated lung flow and net lung volume to determine how much gas was delivered to the lungs of the patient during the breath. In an embodiment, this operation 308 is an ongoing operation in which the volume of gas delivered to the patient is accumulated over the course of the inspiratory phase, so that upon completion of the inspiratory phase the accumulated volume is the total delivered volume for the breath. Alternatively, this operation 308 may be performed as soon as the inspiratory phase ends, any time during the expiratory phase or at the beginning of the next inspiratory phase using leak-compensated lung flow or volume data collected during the breath.

The leak- compensated delivered lung volume for the breath is then used in a lung compliance calculation operation 310 to calculate a leak-compensated lung compliance for the patient. In an embodiment, the lung compliance calculation operation 310 includes using the following equation to determine lung compliance:

Leak- Compensated Lung Compliance = W(EIP-EEP) in which V is the leak-compensated delivered lung volume for the breath, EIP is the pressure at the end of the inspiratory phase of the breath, and EEP is the pressure at the end of the expiratory phase of the breath. As mentioned above, these pressure values are determined from the monitoring of pressure and/or flow during the PRVC ventilation operation 306.

The above equation is but one example of a method of determined lung compliance from parameters monitored by a ventilator such as pressure, flow and volume. Any suitable method may be used as long as the monitored parameters are compensated for the leakage identified in the leakage calculation/compensation operation 307 so that a leak- compensated lung compliance is obtained.

In an embodiment, the delivered volume calculation operation 308 and lung compliance calculation operation 310 may be performed as a single operation at the same time instead of separately as shown.

Based on the leak-compensated lung compliance, the system then calculates a target pressure for the next breath in a calculate target pressure operation 312. This calculation takes into account the leak-compensated volume of gas delivered to the patient's lungs during the last breath to determine if sufficient volume is being delivered relative to the desired volume identified by the operator. This calculation also may take into account the leak-compensated volume of gas delivered during earlier breaths depending on the time period over which the desired volume is to be delivered. Depending on the comparison of the leak-compensated delivered lung volume and the desired delivered lung volume, the target pressure to be used for the next breath may be raised or lowered relative to the current pressure. The amount the target pressure is raised or lowered is a function of the leak-compensated lung compliance, the predicted or known inspiratory phase duration and ventilator settings as well as patient safety precautions.

The newly determined values of lung compliance and lung resistance may be averaged, low-pass filtered or otherwise combined with the previously determined values. These revised values are then stored for use in later delivery of PRVC ventilation. In an embodiment, the delivered volume calculation operation 308, lung compliance calculation operation 310 and calculate target pressure operation 312 may be performed as a single operation at the same time instead of separately as shown. After calculating the revised target pressure, upon the next inspiration the ventilator then provides the revised target pressure to the patient, illustrated in FIG. 3 by the flow returning to the PRVC ventilation operation 306. The method 300 is then repeated from that point until the delivery of PRVC ventilation is terminated by some outside action, such as, change of mode setting or failure to converge on an acceptable lung compliance value.

FIG. 4 illustrates an embodiment of a method for calculating leak-compensated parameters while providing PRVC ventilation to a patient. In an embodiment, the method 400 corresponds to the operations performed during the leakage determination operation 306 discussed with reference to FIG. 3. In the embodiment of the method 400 illustrated, the operations occur repeatedly while the ventilator is providing PRVC ventilation, such as once a sample period or computation cycle, while the ventilator is providing either the target pressure (during the inspiratory phase) or an expiratory pressure such as PEEP (during the expiratory phase).

During PRVC ventilation, the pressure and flow and other parameters of the system are monitored, illustrated by the monitoring operation 402. In an embodiment, the monitoring operation 402 collects data including the instantaneous pressure and/or flow at or indicative of one or more locations in the ventilation tubing system. Depending upon how a particular leak model is defined, the operation 402 may also include making one or more calculations using data from pressure and flow measurements taken by the sensors. For example, a model may require a flow measurement as observed at the patient interface even though the ventilation system may not have a flow sensor at that location in the ventilation tubing system. Thus, a measurement from a sensor or sensors located elsewhere in the system (or data from a different type of sensor at the location) may be mathematically manipulated in order to obtain an estimate of the flow observed at the patient interface in order to calculate the leak using the model.

The data obtained in the monitoring operation 402 is then used to calculate leakage from the ventilator tubing system in a leakage calculation operation 404. In an embodiment, the leakage calculation operation 404 uses the data obtained in the monitoring operation 402, e.g., some or all of the instantaneous pressure and flow data collected during the monitoring operation 402 as well as information about the current respiratory phase (inhalation or exhalation).

The leakage calculation operation 404 calculates an instantaneous leakage flow or volume for the sample period. The instantaneous leakage is calculated using a mathematical formula that has been previously determined. In an embodiment, the mathematical formula is a leakage model that separates the leak into the sum of two leak components, inelastic leak and elastic leak, in which each component represents a different relationship between the quantity of leakage from the ventilation system and the measured current/instantaneous pressure and/or flow of gas in the ventilation system. As discussed above, the inelastic leak may be modeled as the flow through a rigid orifice of a fixed size while the elastic leak may be modeled as the flow through a different orifice of a size that changes based on the pressure (or flow) of the gas in the ventilation system.

An example of a method and system for modeling leak in a ventilation system as a combination of an elastic leak component and an inelastic leak component can be found in commonly-assigned U.S. Provisional Patent Application Serial Number 61/041,070, filed March 31, 2008, titled VENTILATOR LEAK COMPENSATION, which application is hereby incorporated by reference herein. The VENTILATOR LEAK COMPENSATION represents one way of characterizing the leak from a ventilation system as a combination of elastic and inelastic components. Other methods and models are also possible and may be adapted for use with this technology.

The mathematical formula used to calculate leakage may contain several parameters that are empirically determined and that may be periodically or occasionally revised in order to maintain the accuracy of the leakage estimate. For example, in an embodiment the parameters of a leakage formula include a first constant associated with the rigid orifice and a second constant associated with the variable-sized orifice. At various times during ventilation, the calculated leakage may be checked against a measured leakage and, if the estimate is significantly different from the measured leakage, the constants may be revised. This revision of the parameters in a leakage formula may be done as part of the leakage calculation operation 404 or may be done as a separate operation (not shown) that may, or may not, be performed every sample period.

The term instantaneous is used herein to describe a determination made for any particular instant or sampling period based on the measured data for that instant. For example, if a pressure measurement is taken every 5 milliseconds (sample period), the pressure measurement and the leak model can be used to determine an instantaneous leak flow based on the instantaneous pressure measurement. With knowledge of the length of the sample period, the instantaneous flow may then be used to determine an instantaneous volume of gas leaking out of the circuit during that sample period. For longer periods covering multiple sample periods the instantaneous values for each sample period may be summed to obtain a total leakage volume. If a measurement is also the most recent measurement taken, then the instantaneous value may also be referred to as the current value. After the current leak has been calculated, the method 400 further estimates the leak-compensated instantaneous lung flow to or from the patient in a lung flow estimation operation 406. The estimated lung flow is compensated for the leak flow calculated in the instantaneous leak calculation operation 404 so that it represents a more accurate estimate of the actual flow into (or out of depending on the point of view and period selected) the lungs of the patient.

Ln the embodiment illustrated, the leak- compensated net and delivered lung volumes are also calculated as part of the lung flow estimation operation 406. In an embodiment, this may be performed by maintaining a running summation of net flow into/out of the lung over the period of a breath and a running summation of the flow delivered to the patient during the inspiratory phase. For example, upon triggering inhalation, the ventilator may set a variable corresponding to net lung volume to zero and, each sample period, update this net lung volume to include the detected leak- compensated instantaneous lung flow delivered to the patient during that sample period, Likewise, the ventilator may also set a variable corresponding to delivered lung volume to zero and, each sample period during the inspiratoiy phase, update this net lung volume to include the detected leak-compensated instantaneous lung flow into the patent, if any, during that sample period.

In the PRVC ventilation method 40Θ illustrated, the leak-compensated lung flow or delivered lung volume will ultimately be used to calculate a leak- compensated lung compliance as described in FIG. 3. Ultimately, this leak-compensated lung compliance along with other leak-compensated data will be used to determine the target pressure for the next inspiratoiy phase.

The method 400 is then repeated every computational cycle or sample period, as illustrated by the feedback loop, so that the leak-compensated instantaneous lung flow and leak-compensated delivered lung flow are continuously determined during PRVC ventilation. The following is a discussion of two embodiments of methods for compensating the estimation of respiratory mechanics for leaks. The first embodiment is that of applying leak compensation to a static compliance and resistance determination. The second embodiment is that of applying leak compensation to a dynamic compliance determination. FIG. 5 illustrates a functional block diagram of modules and other components that may be used in an embodiment of ventilator that compensates for elastic and rigid orifice sources of leaks when determining the target pressure during PRVC ventilation, hi the embodiment shown, the ventilator 500 includes pressure sensors 506 (two are shown placed at different locations in the system), flow sensors (one is shown), and a ventilator control system 502. The ventilator control system 502 controls the operation of the ventilator and includes a plurality of modules described by their function. In the embodiment shown, the ventilator control system 502 includes a processor 508, memoiy 514 which may include mass storage as described above, a leak estimation module 512 incorporating a parametric leak model accounting for both elastic and rigid orifice leak sources such as that described in U.S. Provisional Application 61/041 ,070 previously incorporated herein, a target pressure calculation module 516, a pressure and flow control module 518, a monitoring module 522, a leak-compensated lung compliance module 524, and a leak-compensated lung flow and volume estimation module 526. The processor 508 and memory 514 have been discussed above. Each of the other modules will be discussed in turn below.

The main functions of the ventilator such as receiving and inteipreting operator inputs and providing therapy via changing pressure and flow of gas in the ventilator circuit are performed by the control module 518. In the context of the methods and systems described herein, the module 518 will perform one or more actions upon the determination that a patient receiving therapy is inhaling or exhaling. hi the embodiment described herein, the control module 518 determines and provides the appropriate pressure to the patient when in PRVC ventilation mode, This may include performing one or more calculations based on leak-compensated lung flow, leak-compensated lung volume, leak-compensated lung compliance and leak-compensated lung resistance.

The calculation of the target pressure to provide during the inspiratory phase of a breath is performed by the target pressure calculation module 516. The target pressure is calculated based on the therapist-selected desired lung volume and the leak- compensated delivered lung volume. The module 516 utilizes one or more respiratory models suitable for determination of target pressure based on monitored parameters and/or leak- compensated respiratory mechanics such as lung compliance. The module 516 uses leak- compensated values for one or both of lung flow and delivered lung volume when calculating the target pressure, depending on the method used by the module. Leak- compensated values may be retrieved if they have already been calculated or may be calculated as needed from leakage information received from the leak-compensated lung flow and net lung volume estimation module 526. The dynamic calculation of lung compliance is performed by the leak-compensated lung compliance calculation module 524. The module 524 utilizes one or more dynamic respiratoiy models, such as that described above with reference to lung compliance calculation operation 310 of FIG. 3, to calculate leak-compensated lung compliance. The module 524 uses leak-compensated values for one or both of lung flows and delivered lung volume when calculating lung compliance. Leak-compensated values may be retrieved if they have already been calculated or may be calculated from leakage information received from the leak- compensated lung flow and delivered lung volume estimation module 526. The current conditions in the ventilation system are monitored by the monitoring module 522. This module 522 collects the data generated by the sensors 504, 506 and may also perform certain calculations on the data to make the data more readily usable by other modules or may process the current data and or previously acquired data or operator input to derive auxiliary parameters or attributes of interest. In an embodiment, the monitoring module 522 receives data and provides it to each of the other modules in the ventilator control system 502 that need the current pressure or flow data for trie system.

In the embodiment shown, leak-compensated lung flow and delivered lung volume are calculated by the lung flow module 526. The lung flow module 526 uses a quantitative model for lung flow of the patient during both inhalation and exhalation and from this characterization and pressure and flow measurements generates an estimate for instantaneous lung flow. In an embodiment, lung flow may be simply determined based on subtracting the estimated leak flow and measured outflow via the expiratory limb from the flow into the inspiratory limb, thereby generating a leak-compensated net flow into (or out of) the lung. The lung flow module 526 may or may not also calculate a leak- compensated delivered lung volume for a patient's breath as described above. Compression in the circuits and accessories may also be accounted for to improve the accuracy of estimated lung flow.

The leak model parameters are generated by the leak estimation module 512 which creates one or more quantitative mathematical models, equations or correlations that uses pressure and flow observed in the ventilation system over regular periods of respiratory cycles (inhalation and exhalation) and apply physical and mathematical principles derived from mass balance and characteristic waveform settings of ventilation modalities (regulated pressure or flow trajectories) to derive the parameters of the leak model incorporating both rigid and elastic (variable pressure-dependent) orifices. In an embodiment, the mathematical model may be a model such as: ϋmelastw ⁼ ^l ' "i Qelastic ⁼ ^2 "ι wherein Qel_asti_c is the instantaneous leak flow due to elastic leaks in the ventilation system, Q_mci_asti_c is the instantaneous leak flow due to inelastic leaks in the ventilation system, Ri is the inelastic leak constant, R₂ is the elastic leak constant, Pj is the current or instantaneous pressure measurement, x is an exponent for use when determining the inelastic leak and y is an exponent different than x for use when determining the elastic leak. The group Ri * Pj^X represents flow through an orifice of fixed size as a function of instantaneous pressure Pj and the group R₂ * Pi^y represents flow through a different orifice that varies in size based on the instantaneous pressure. The equations above presuppose that there will always be an elastic component and an inelastic component of leakage from the ventilation system. In the absence of an elastic component or a leak source of varying size, R₂ would turn out be zero.

In the embodiment shown, the current or instantaneous elastic leak is calculated by the leak estimation module 512. The calculation is made using the elastic leak portion of the leak model developed by the leak estimation module 512 and the pressure data obtained by the monitoring module 522. The leak estimation module 512 may calculate a new instantaneous elastic leak flow or volume for each pressure sample taken (i.e., for each sampling period) by the monitoring module 522. The calculated elastic leak may then be provided to any other module as needed. In the embodiment shown, the current or instantaneous inelastic leak is also calculated by the leak estimation module 512. The calculation is made using the inelastic leak portion of the leak model and the pressure data obtained by the monitoring module 522. The leak estimation module 512 may calculate a new instantaneous inelastic leak flow or volume for each pressure sample taken (i.e., for each sampling period) by the monitoring module 522. The calculated inelastic leak may then be provided to any other module as needed.

The system 500 illustrated will compensate lung flow for leaks due to elastic and inelastic leaks in the ventilation system. Furthermore, the system may perform a dynamic compensation of lung flow based on the changing leak conditions of the ventilation system and the instantaneous pressure and flow measurements. The system then compensates the lung compliance and target pressure calculations based on the estimated leakage in the system. By compensating for the inelastic as well as the elastic components of dynamic leaks, the medical ventilator can more accurately and precisely a target pressure so that the desired lung volume selected by the therapist is achieved. Furthermore, embodiments of the systems and methods described above may also include checks and balances based on patient type and known characteristics (e.g., Ideal Body Weight, etc.). For example, a calculated pressure target (or change between the current and the newly calculated pressure target to be used in the next inspiration) may be compared against a safety criteria based on Ideal Body Weight, age, gender, patient parameters determined during ventilation or operator provided safety thresholds.

If the comparison indicates the newly calculated pressure is unsafe, the ventilator may perform one or more safety actions. In an embodiment, such safety actions may include limiting stepwise changes in desired pressure target and generating alarms or warnings. Delivery of PRVC may also be terminated in situations deemed unsafe for the patient or when acceptable data are not available (e.g, when the process of lung compliance estimation fails to converge to an acceptable value). In such a situation the ventilator may switch to some other mode, such as a pressure support mode or volume control mode, than PRVC. The mode switched may be determined by the operator when setting up the PRVC ventilation or may be a default mode selected by the manufacturer. It will be clear that the systems and methods described herein are well adapted to attain the ends and advantages mentioned as well as those inherent therein. Those skilled in the art will recognize that the methods and systems within this specification may be implemented in many manners and as such is not to be limited by the foregoing exemplified embodiments and examples. For example, the operations and steps of the embodiments of methods described herein may be combined or the sequence of the operations may be changed while still achieving the goals of the technology. In addition, specific functions and/or actions may also be allocated in such as a way as to be performed by a different module or method step without deviating from the overall disclosure. In other words, functional elements being performed by a single or multiple components, in various combinations of hardware and software, and individual functions can be distributed among software applications, hi this regard, any number of the features of the different embodiments described herein may be combined into one single embodiment and alternate embodiments having fewer than or more than all of the features herein described are possible.

While various embodiments have been described for purposes of this disclosure, various changes and modifications may be made which are well within the scope of the technology described herein. For example, the systems and methods described herein could be adapted to periodically perform a static respiratory mechanics maneuver to obtain a more accurate lung compliance estimate in order to check the dynamically determined leak-compensated lung compliance. Numerous other changes may be made which will readily suggest themselves to those skilled in the art and which are encompassed in the spirit of the disclosure and as defined in the appended claims.

Claims

ClaimsWhat is claimed is:

1. A method of compensating for leakage in a ventilation system during delivery of pressure regulated volume control ventilation to a patient comprising: monitoring an instantaneous flow in the ventilation system based on one or more measurements of pressure and flow in ventilation system; modeling leakage as a first leakage component through a first orifice of a fixed size and a second leakage component through a second orifice of a vaiying size, wherein the first and second leakage components are different functions of instantaneous pressure in the ventilation system; estimating a leak-compensated delivered lung volume for at least one breath based on the one or more measurements, the first leakage component and the second leakage component; using the leak-compensated delivered lung volume and a predetermined respiratory mechanics model to estimate a leak-compensated lung compliance; and calculating a target pressure to be delivered to the patient for a subsequent breath based on a desired lung volume, the leak-compensated delivered lung volume and the leak- compensated lung compliance.

2. The method of claim 1 further comprising: estimating the leak-compensated lung compliance based on the leak-compensated delivered lung volume and a pressure difference.

3. The method of claim 2 wherein the pressure difference is a difference between an end inspiratory pressure of a first breath and an end expiratory pressure of the first breath.

4. The method of claim 1 wherein the method further comprises: calculating the target pressure based on a difference between the desired lung volume and the leak-compensated delivered lung volume.

5. The method of claim 1 wherein the method further comprises: determining a circuit compliance of ventilation system; and estimating a leak-compensated delivered lung volume for at least one breath based on the one or more measurements, the circuit compliance, the first leakage component and the second leakage component.

6. The method of claim 1 wherein the method further comprises: upon initiation of pressure regulated volume control ventilation, calculating an initial lung compliance from data obtained during a startup period; and determining an initial target pressure to be delivered to the patient for at least one breath after the startup period.

7. A method of compensating for leakage in a ventilation tubing system during delivery of gas from a medical ventilator to a patient comprising: measuring leakage from the ventilation tubing system during a first breath; calculating a leak-compensated delivered lung volume for the first breath based on the leakage; estimating a lung compliance of the patient based on the leak-compensated delivered lung volume and pressure measurements taken during the first breath; and delivering ventilation to the patient in a second breath at a pressure determined based on a desired delivered lung volume, the leak-compensated delivered lung volume and the leak-compensated lung compliance.

8. The method of claim 7 wherein measuring leakage further comprises: identifying an inelastic leakage from the ventilation tubing system as a first function of at least one of a pressure measurement and a flow measurement in the ventilation system; and identifying an elastic leakage from the ventilation tubing system as a second function of at least one of the pressure measurement and the flow measurement in the ventilation system.

9. The method of claim 7 wherein calculating the leak-compensated delivered lung volume further comprises: generating a plurality leak-compensated lung flows each associated with a different period of time within the first breath; generating the leak-compensated delivered lung volume for the first breath based on the leak-compensated lung flows.

10. The method of claim 7 wherein estimating the lung compliance further comprises: receiving the desired lung volume from an operator.

11. A pressure support system comprising: a pressure generating system adapted to generate a flow of breathing gas; a ventilation tubing system including a patient interface device for connecting the pressure generating system to a patient; one or more sensors operatively coupled to the pressure generating system or the ventilation tubing system, each sensor capable of generating an output indicative of a pressure or flow of the breathing gas in the ventilation tubing system; a leak estimation module that identifies leakage in the ventilation tubing system; a delivered lung volume module that calculates a leak-compensated delivered lung volume for a first breath based on the leakage during the first breath and the flow of the breathing gas in the ventilation tubing system; a respiratory mechanics calculation module that generates a leak-compensated lung compliance based on the leak-compensated delivered lung volume and at least one output indicative of a pressure of the breathing gas during the first breath; and a pressure control module that causes the pressure generating system to deliver a second breath to the patient at a target pressure calculated based on the leak-compensated lung compliance and the leak- compensated delivered lung volume.

12. The system of claim 11 further comprising: a memoiy storing a desired delivered lung volume provided by a user.

13. The system of claim 12 wherein the pressure regulated volume control module calculates the target pressure based on the desired delivered lung volume, the leak- compensated lung compliance and the leak-compensated delivered lung volume.

14. The system of claim 11 wherein the respiratory mechanics calculation module generates the leak- compensated lung compliance based on the leak-compensated delivered lung volume and a pressure difference.

15. The method of claim 14 wherein the pressure difference is a difference between an end inspiratory pressure of the first breath and an end expiratoiy pressure of the first breath.

16. The system of claim 11 wherein the leak estimation module further identifies an elastic leakage and an inelastic leakage in the ventilation tubing system.

17. The system of claim 16 wherein the delivered lung volume module calculates the leak-compensated delivered lung volume for a first breath based on the elastic and inelastic leakage during the first breath and the flow of the breathing gas in the ventilation tubing system.

18. A controller for a medical ventilator comprising: a microprocessor; a module that calculates leak-compensated delivered lung volume and leak- compensated lung compliance based on instantaneous elastic leakage and instantaneous inelastic leakage of breathing gas from a ventilation system; and a pressure control module that provides pressure regulated volume control ventilation at a pressure determined based on the leak-compensated delivered lung volume and the leak-compensated lung compliance.

19. The controller of claim 18 further comprising: a leak estimation module that identifies the instantaneous inelastic leakage and the instantaneous elastic leakage in the ventilator.

20. The controller of claim 18 further comprising: a memory that stores an identification of a target volume of gas to be delivered during pressure regulated volume control ventilation; and wherein the pressure control module provides pressure regulated volume control ventilation at a pressure determined based on the leak-compensated delivered lung volume, the leak-compensated lung compliance, and the target volume of gas.