WO2003082390A1 - Method for continuous measurement of flux of gases in the lungs during breathing - Google Patents

Abstract

A method of calculating the flux of any gas(x) in a CBC circuit for a ventilated or a spontaneous breathing subject, for example said gas(x) being; a) an anesthetic such as but limited to ; i)N2O ; ii) sevoflurane ; iii) isoflurane ; iv) halothane ; v) desflurame ; or the like b) Oxygen ; c) Carbon dioxide ; or the like utilizing the following relationships ; Flux of gas(x) = SGF (FSX - FEX) wherein SGF = Source of gas flow into the breathing circuit (CBC circuit) in liters/minute as read from the gas flow meter as set by the anesthesiologist ; FSX = Fractional concentration of gas X in the source gas (which is set by the anesthesiologist) ; FEX = Fractional concentration of gas X in the end expired gas as determined by a portable gas analyzer, or the like.

Description

TITLE OF INVENTION

METHOD FOR CONTINUOUS MEASUREMENT OF FLUX OF GASES IN THE LUNGS DURING BREATHING

FIELD OF INVENTION

This invention relates to a method of measuring uptake and elimination via the

lung of all gases for example including, but not limited to, anesthetics, oxygen

and carbon dioxide.

BACKGROUND OF THE INVENTION

The following represents a glossary of terms used within the specification. The

reader is referred to these definitions when interpreting the meaning of any

description herein.

1) NE : minute ventilation (the total volume of gas breathed in and out of the

lung per minute). PETC0₂: end tidal PCO2 (the partial pressure of CO2 at end

exhalation);

2) SGF: source gas flow (the flow of gas into a breathing circuit, in liters /min);

3) VA : alveolar ventilation (that ventilation that results in gas exchange between

the pulmonary capillaries and the air spaces (alveoli) of the lung), expressed in

liters /min. It is also defined as the total ventilation minus the ventilation of the

anatomic dead space ( VE - NDan );

4) NO₂ : The 0₂ consumed in liters per minute; 5) NC0₂ : The CO2 produced in liters per minute;

6) Fsx : fractional concentration of a gas x in source gas (gas entering a breathing

circuit);

7) Fix : fractional concentration of gas x in inspired gas (gas entering the patient's

lungs);

8) FEX : the fractional concentration of gas x in end expired gas;

9) CBC (conditional breathing circuit): a breathing circuit in which only exhaled

gas, and no source gas, exits from the circuit, as would be the case with a circle

circuit with a low flow of gas entering the circuit, or a Magill circuit in which a)

SGF is < 0.7 x VE ; b) the common breathing tube volume (see figure 1) is

greater than or equal to the sum of [(SGF x expiratory time) + the anatomical

dead space]; c) the volume of the breathing bag is greater than [the largest

expected tidal volume - (SGF x inspiratory time)].

Introduction

The measurement of uptake and elimination of gases via the lungs plays an

important role in medicine. Oxygen consumption (NO₂ ) and CO2 production

(NCθ₂) are two important parameters indicating cardio-respiratory fitness of

athletes. NO₂ and NC0₂ are also used as important indicators of the efficacy of

therapeutic intervention in critically ill patients. The ability to impose a transient

change in NO ₂ and NC0₂ allows one to calculate such important physiological

parameters as cardiac output and functional residual capacity. For the most part, anesthesia is induced and maintained by gases taken up by and eliminated from

the body via the lungs. Accurate measurement and control of uptake and

elimination of anesthetic gases would improve the control of anesthetic depth and

thereby the effectiveness and efficiency of the use of anesthetic gases. Accurate

control of uptake and elimination of therapeutic gases would allow more

controlled dosing when these gases are used as therapies for illness. Accurate

control of uptake and elimination of inert gases via the lung can be used for

various diagnostic and research purposes.

Present Art

Measuring gas flux

Measuring total gas flux requires the measurement of gas volumes for discrete

periods of time and multiplying these volumes by the concentration of the gas in

the volume.

Volume measurements

Measurement of exhaled gas volumes is very cumbersome in clinical or research

settings. One method requires timed collections of exhaled gas in bags and then

measuring the volume of the bags. Inhaled volumes are even more awkward to

measure continuously as the volumes enter the lung and one must measure the

volume of lung expansion or the volume depleted from a previously known

volume. This cannot be done breath-by-breath. These measurements are usually

simplified by measuring flow continuously at the mouth and integrating the flow electronically with respect to time to obtain "continuous" measures of volume.

Each type of flow measuring device has inherent problems leading to inaccuracy

of calculation of volume (see below).

Flux measurements

To measure the flux of a particular constituent (gas x) of the total gas that enters or

exits the lung is more complex. The concentration of x sampled at the mouth

during breathing changes between inhalation and exhalation as well as

continuously during each ventilatory phase. Therefore, to measure the flux of gas

x, the concentration of gas x must be measured continuously with a rapidly

responding gas analyzer, and the average concentrations over short intervals must

be multiplied by the volume changes over those same intervals. This requires

synchronization of flow-volume signals and gas concentration signals, then

multiplying the values and continuously summing them. A number of devices on

the market such as the Nmax (Sensormedics, Yorba Linda CA), Medical Graphics

CPOX/D, (Medical Graphics Corporation, St. Paul, Minnesota) and ΝICO

(Νovametrix, Wallingford, CT) measure the fluxes of C0₂ and /or O2 at the mouth

using this method. The same principles apply to measuring the flux of other gases

if appropriate gas sensors are used. Measuring gas fluxes during anesthesia

a) Understanding the anesthetic circuits

One circuit used for anesthesia is the Magill circuit with the Mapleson A

configuration illustrated in figure 1 ("Magill circuit"). The patient breathes

through the patient port (30). During inhalation, gas is drawn from the

source gas port (33) and the gas reservoir bag (34) along the common

breathing tube (32). Expiration is divided into two phases. The first phase

lasts from the beginning of exhalation until the filling of the gas reservoir bag

(34). During this first phase of exhalation, expired gas proceeds down the

common breathing tube (32) with gas from the anatomical dead space

preceding gas from the alveoli. Expired gas displaces gas in the breathing

tube (32) into the gas reservoir bag. During this phase of exhalation the

source gas is also directed into the gas reservoir bag. The second phase of

exhalation is from the time of filling of the gas reservoir bag (34) until the

beginning of inhalation. During this second phase of exhalation, the expired

gas exits through the one way pressure relief valve (31) that has an opening

pressure of about 2 cm H2O and the source gas proceeds along the common

breathing tube (32) displacing gas before it and forcing it out of the pressure

relief valve such that the last exhaled (alveolar gas) exits the valve first.

Kain and Nunn (Kain M.L., Nunn J.F. Anesthesiologji . 29: 964-974, 1968)

determined the minimum source gas flow required to prevent rebreathing in

anesthetized patients breathing through the circuit by sequentially decreasing the source gas flow until minute ventilation and end tidal PCO2 increased. It

is generally accepted that the source gas flow needed to prevent rebreathing

of alveolar gas is 70% of the minute ventilation ( VE ) (Understanding

Anesthesia Equipment by Dorsch J.A., and Dorsch S.E., Williams & Wilkins

Co. 1975, pg.169). The 30% savings in source gas is due to the rebreathing of

the anatomical dead space gas which does not undergo gas exchange in the

alveoli and therefore retains the same composition as source gas.

The 30% savings in source gas flow with the Magill breathing circuit

represents the maximum efficiency available for source gas without the use of

a CO2 absorber. As the cost of anesthesia varies directly with the flow of

source gas, circuits with CO2 absorbers, the most popular being the "circle

circuit" depicted in figure 2, allows a marked reduction in source gas flow

(SGF) without causing a rise in end tidal PCO2. The balance of VE is

provided by rebreathing of previously exhaled gases and the C0₂ absorber

(6) prevents the build-up of CO2 in the circuit and the patient. As not all of

the delivered anesthetic is extracted during a breath, exhaled gas has a

considerable concentration of anesthetic that can be re-supplied to the patient

when rebreathed. The circle circuit contains a patient port (1), and an

expiratory limb (2) leading to a one way expiratory valve (3). Distal to the

valve there is a flexible gas reservoir (4), a pressure relief valve (5) where

excess expired gas is vented, and a container for C0₂-absorbing crystals (6).

When the patient inhales, he draws fresh gas entering the fresh gas inlet (7) and makes up the balance of inspired gas by drawing gas from the gas

reservoir through the Cθ2-absorber. The source gas and the previously

exhaled gas join to flow through the one-way inspiratory valve (8) to the

patient through the inspiratory limb (9). When the patient exhales, gas

passes down the expiratory limb of the circuit (2), past the expiratory valve

(3), and enters the flexible gas reservoir (4). When the gas reservoir fills to

capacity, pressure in the circuit increases and the pressure relief valve (5)

opens, releasing gas to atmosphere during the remainder of exhalation.

During exhalation, fresh gas entering the circuit (7) is displaced back into the

CO2 absorber (6). This fresh gas enters the inspiratory limb (9) and is made

available to the patient on subsequent breath(s).

The depletion of O2 and anesthetic from the circuit is prevented by re-

supplying both gases through the fresh gas inlet (7). The anesthesiologist can

control the total flow of gas as well as the concentrations of all its constituent

components such as oxygen, nitrous oxide and anesthetic agent. The

minimum gas flow into the circuit is that needed to replace the oxygen

consumed and anesthetic absorbed by the body. The CO2 absorbers extract

only CO2, allowing other gases to pass through unchanged. Calculation of uptake or elimination of gases with rebreathing circuits (-present art):

When a subject breathes via a Magill, circle, or Fisher isocapnia (rebreathing

and non-rebreathing) circuit, and the SGF entering the circuit is equal to or

greater than VE , the circuit acts like a nonrebreathing circuit, i.e., inspired

concentration of gas x is that of the SGF, i.e., Fsx. When SGF is less thanVE,

inspired gas is composed of both SGF and previously exhaled gas in the

Magill, circle and Fisher rebreathing isocapnia circuit; and composed of SGF

and reserve gas in the Fisher non-rebreathing isocapnia circuit. As a result,

the concentration of x varies throughout inspiration in a complex way

depending on VE , pattern of breathing, and SGF. To measure the inspired

volume of x, inspiration must be broken up into small intervals during which

the total volume must be multiplied by the average concentration of x; the

resulting discrete volumes of x must be summed for the duration of

inspiration. Similarly, to calculate the expired volume of x, continuous

measurements of expired flows and expired concentrations of x are required.

The net uptake or elimination of x over a given time is the algebraic sum of

the inhaled and exhaled volumes of x during that time.

Reference List

1. Kain ML, Nunn JF. Fresh gas economics of the Magill Circuit. Anesthesiology

1968;29(5):964-74.

2. Wissing H, Kuhn I, Rietbrock S, Fuhr U. Pharmacokinetics of inhaled

anaesthetics in a clinical setting: comparison of desflurane, isoflurane and

sevoflurane [see comments]. Br.J Anaesth. 2000;84(4):443-9.

3. Rietbrock S, Wissing H, Kuhn I, Fuhr U. Pharmacokinetics of inhaled

anaesthetics in a clinical setting: description of a novel method based on

routine monitoring data [see comments]. Br.J Anaesth. 2000;84(4):437-42.

4. Bouillon T, Shafer SL. Hot air or full steam ahead? An empirical

pharmacokinetic model of potent inhalational agents [editorial; comment]

[published erratum appears in Br J Anaesth 2000 Jun;84(6):833]. Br.J Anaesth.

2000;84(4):429-31.

It is an object of this invention is to provide a simpler and more accurate method

of measuring uptake and elimination via the lung of all gases for example

including, but not limited to, anesthetics, oxygen and carbon dioxide. _ _

It is a further object of this invention is to provide a method of controlling gas flux

(defined as uptake or elimination from the lung) independent of minute

ventilation.

Further and other objects of the invention will become apparent to those skilled in

the art when considering the following summary of the invention and the more

detailed description of the preferred embodiments illustrated herein.

SUMMARY OF THE INVENTION

According to a primary aspect of the invention we provide a method of

measuring the flux of any gas by utilizing SGF times expired concentration of that

gas. This is especially applicable in the operating room where all of the equipment

required to provide the necessary information is already in use: the circuit, the

SGF flowmeters, the gas sensors.

The ability to make a step change in VA via a change in SGF or Fsx can be used to

obtain a control measurement of VA as well as cardiac output by two different

methods, the Gideon method and the Fisher method. This proffers marked

advantages on these methods with respect to versatility, cost, and accuracy.

The method relates to the novel application of known circuits for measurements of

gas flux. Further three new circuits that allow the use of the method outside the

operating room in ventilated patients/subjects are also provided, a) the Magill configured for controlled ventilation; b) the rebreathing isocapnia circuit

configured for controlled ventilation; and c) the balloon valve circuit.

With reference to the gas input the following conditions apply/result:

• Breathing via a circuit in which the total flow of gas entering the circuit

is less than or equal to the subject's alveolar ventilation,

• The balance of gas inhaled is composed of gas that has substantially the

same concentration of gas x as is in the alveoli of the lung

• This gas may actually be previously exhaled gas that has been stored

and made available to be rebreathed, or it may come from an external

gas source in which the concentration of x is substantially the same as

that in the alveoli of the lung

• The input gas flow and concentration of x in input gas are known and

determined by the user

The continuous measurement of expired gas concentrations is possible by utilizing

a convenient gas analyzer. Based on the known values therefore that will be

further described herein after;

• The rate of elimination of gas x = SGF x (FEX - Fsx) for any CBC circuit

as described herein.

• The rate of elimination of gas x = the input total gas flow x (FEX - Fix),

where Fix is the concentration of x in inspired gas

• Gas input parameters • Breathing via a circuit in which the total flow of gas entering the circuit

is less than or equal to the subject's alveolar ventilation,

• The balance of gas inhaled is composed of gas that has substantially the

same concentration of gas x as is in the alveoli of the lung

• This gas may actually be previously exhaled gas that has been stored

and made available to be rebreathed, or it may come from an external

gas source in which the concentration of x is substantially the same as

that in the alveoli of the lung

• The input gas flow and concentration of x in input gas are known and

determined by the user

According to one aspect of the invention there is provided a method of calculating

the flux of any gas(x) in a CBC circuit for a ventilated or a spontaneous breathing

subject,

for example said gas(x) being;

a) an anesthetic such as but limited to;

i) N₂0;

ii) sevoflurane;

iii) isoflurane;

iv) halothane;

v) desflurame; or the like

b) Oxygen;

c) Carbon dioxide;

or the like

utilizing the following relationships;

Flux of gas(x) = SGF (Fsx - FEX)

wherein

SGF = Source of gas flow into the breathing circuit (CBC circuit) in

liters/minute as read from the gas flow meter as set by the anesthesiologist;

Fsx = Fractional concentration of gas X in the source gas (which is set by the

anesthesiologist);

FEX = Fractional concentration of gas X in the end expired gas as determined

by a portable gas analyzer, or the like.

According to another aspect of the invention there is also provided a method of

calculating the flux of oxygen in a CBC circuit for a ventilated and /or spontaneous

breathing subject utilizing the following relationship; _ _

Flux of oxygen = SGF (Fso2 - FE02)

wherein

SGF = Source of gas flow into the breathing circuit (CBC circuit) in

liters/minute as read from the gas flow meter as set by the anesthesiologist;

Fsx = Fractional concentration of gas O2 in the source gas (which is set by

the anesthesiologist);

FEX = Fractional concentration of gas O2 in the end expired gas as

determined by a portable gas analyzer, or the like.

In one embodiment for the abovementioned methods the CBC circuit is selected

from the group consisting of i) a circle circuit; ii) a Magill breathing circuit; iii) an

isocapnia circuit, whether breathing or non-breathing (as taught by co-pending

Fisher et al), or the like.

In another embodiment for the abovementioned methods the CBC circuit is an

improved Magill circuit as described herein. In yet another embodiment for the abovementioned methods the CBC circuit is an

improved rebreathing circuit as described herein.

In yet another embodiment for the abovementioned methods the CBC circuit is an

improved non-rebreathing circuit as described herein.

Preferably in yet another embodiment the abovementioned methods are used to

determine oxygen consumption in order to measure cardiac out put by any known

method, such as the Fick method.

Preferably in yet another embodiment the abovementioned methods are used to

determine oxygen consumption in, for example, an operating room setting or the

like. Preferably in yet another embodiment the abovementioned methods are used

to optimize oxygen consumption. Preferably the abovementioned methods are

utilized as an early indication of malignant hyperthermia.

According to yet another aspect of the invention there is provided a method of

calculating the flux of any gas other than carbon dioxide, in a CBC circuit with low

gas flow of source gas and with a carbon dioxide absorber in place utilizing the

following relationship;

Flux of gas X = SGF (FEX - FRBX) wherein

SGF = Source of gas flow into the breathing circuit (CBC circuit) in

liters/minute as read from the gas flow meter as set by the anesthesiologist;

FEX = Fractional concentration of gas X in the end expired gas as determined

by a portable gas analyzer, or the like;

FRBX = Concentration of gas X in the expired limb of circuit before the gas

passes through the carbon dioxide absorber and mixes with gas coming from the

flow meter.

Preferably in yet another embodiment the abovementioned methods are used to

determine the flux of an anesthetic for example:

i) N₂0;

ii) sevoflurane;

iii) isoflurane;

iv) halothane;

v) desflurame,

or the like _ _

Preferably said methods are used to determine how much anesthetic is being

absorbed by the patient. Preferably said anesthetic is N2O.

According to yet another aspect of the invention there is provided an improved

Magill circuit the improvement comprising an inspiratory and expiratory limbs, a

pressure relief valve at the end of the expiratory limb, a port for entry of SGF, and

a gas reservoir bag, the components of the Magill system utilized for spontaneous

ventilation; or alternatively for controlled ventilation, the gas reservoir bag is

enclosed in a container with a port for connection to a ventilator breathing circuit,

the pressure relief valve being enclosed in a container with a port for connection to

a ventilator breathing circuit;

wherein on exhalation, the patient breathes out through the patient port and

during the initial part of exhalation, the gas reservoir is partially empty and the

resistance to flow along the inspiratory limb is less than that of the expiratory limb

because the higher opening pressure of the pressure relief valve must be overcome

before flow can proceed through the expiratory limb,

wherein during the initial part of expiration, the expired gas enters the inspiratory

limb, displacing gas in the inspiratory limb and from the SGF into the gas

reservoir, as the gas reservoir fills, the pressure in the circuit increases above the

opening pressure of the pressure relief valve and the remainder of the expired gas

is directed down the expired limb displacing the gas out of the expired limb through the pressure relief valve to the ventilator breathing circuit from where it is

eventually vented to atmosphere through the expiratory port and the SGF

continues to flow towards the patient down the inspiratory limb, displacing

previously exhaled gas into the expiratory limb;

wherein during inhalation, the balloon valve occludes the ventilator circuit

expiratory port and a volume of gas equal to a tidal volume is delivered by the

ventilator into the ventilator circuit and hence into the SGF gas reservoir box,

thereby displacing a volume equal to the tidal volume from the SGF gas reservoir

into the inspiratory limb of the Magill circuit, the SGF continues to flow towards

the patient down the inspiratory limb;

wherein the net tidal volume of the patient is equal to the volume displaced from

the gas reservoir plus the SGF multiplied by the duration of inspiration, because

the pressures on both sides of the Magill pressure relief valve are equal during

inspiration, the differential pressure provided by the "opening pressure" of the

valve keeps it closed during inspiration;

assuming that:

(1) the volume of the inspiratory limb is greater than or equal to [(SGF x

expiratory time) + the anatomical dead space]; and the breathing bag volume is greater than [the largest expected tidal volume - (SGF x

inspiratory time)],

(2) SGF is < 0.7 x VE

According to yet another aspect of the invention there is provided an improved

rebreathing isocapnia circuit comprising a Y piece with a patient port, and

inspiratory limb of the Y piece with a one way inspiratory valve and an expiratory

limb of the Y piece with a one way expiratory valve; the inspiratory limb being

connected to a SGF and a gas reservoir, the expiratory limb leading to an

expiratory gas reservoir, the expiratory gas reservoir having a one way valve at

the port where expired gases are vented from the expired gas reservoir which

allows gas to exit the expiratory gas reservoir but not enter, having disposed

between the expiratory limb and the inspiratory limb distal to the inspiratory and

expiratory valves a bypass limb that contains a one-way valve with an opening

pressure of the valve, being for example approximately 1.5 cm H2O, greater than

the valves in the inspiratory limb of the Y piece and the expiratory limb of the Y

piece; the direction of opening of the one-way valve in the bypass limb being from

the expiratory limb to the inspiratory limb, the inspiratory and expiratory limbs

being extended by tubing of variable lengths, the inspiratory and expiratory

reservoirs being enclosed in a box with 3 ports; one port communicates with the

box, one port communicates with the interior of the SGF reservoir only, one port

communicates with the expiratory gas reservoir, the SGF reservoir is continuous

with the inspiratory limb of the circuit, the expiratory gas reservoir is continuous _ -

with the expiratory limb of the circuit and has a port through which expired gas

exits the expired gas reservoir and enters the box, a ventilator, a mushroom valve

synchronized to occlude the ventilator circuit expiratory port during the

inspiratory phase attached to the box ventilator port such that during the

inspiratory phase, the tidal volume of the ventilator is discharged into the box ,

which will displace an equal volume from the gas reservoirs in the box; as the

valve in the bypass limb has a greater opening pressure than the inspiratory valve,

the inspiratory reservoir will be compressed in preference to the expiratory

reservoir, when the inspiratory reservoir is collapsed, the remainder of the tidal

volume will result from compression of the expiratory reservoir and displacement

of gas through the bypass limb and valve and inspiratory valve to the patient, the

total tidal volume will be equal to the volume displaced from the inspiratory

reservoir plus the volume displaced from the expiratory reservoir plus the SGF

multiplied by the time during inspiration; during exhalation, the balloon valve is

deflated, opening the expiratory port of the ventilator circuit to atmosphere and

the expiratory reservoir bag to atmosphere via the port, thus allowing exhaled gas

to flow past the expiratory one-way valve down the expiratory limb into the

expiratory reservoir, SGF flowing into the port being directed down the

inspiratory limb to the SGF reservoir, wherein gas is displaced in the box by

expansion of the SGF reservoir and the expiratory gas reservoir is displaced from

the box via the ventilator expiratory port; wherein SGF is less than or equal to VE

- NDan . According to yet another aspect of the invention there is provided an improved

non-rebreathing circuit, the improvement comprising a balloon valve circuit for

spontaneous ventilation of a patient breathing spontaneously, said circuit having a

Y piece with a patient port, an inspiratory limb including a balloon valve,

connected to SGF and a gas reservoir, an expiratory limb consisting of a balloon

valve leading to an expiratory gas reservoir, which has a port opening to the

atmosphere, a tank of compressed air flows through solenoid valves to open or

close the balloon valves, the solenoid valves being controlled electronically by a

computer, a pressure transducer connected to a mouthpiece for measuring when

the fresh gas reservoir has been fully collapsed, the computer for receiving the

signal and sending a signal to the solenoid valve to close the inspiratory valve and

open the expiratory valve, the fresh gas flow continuously filling the fresh gas

reservoir.

Preferably any previous method described herein may be used to calculate the rate

of elimination of a gas X for any input total gas flow utilizing the following further

relationships;

wherein the rate of elimination of gas X = the input total gas flow (multiplied by)

F_EX - Fix;

wherein FEX is defined above and Fis is the concentration of X in inspired

gas. Preferably said method is incorporated in an algorithm spreadsheet, formula or

the like contained within software which is capable of running on a computing

device, or is installed therein.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following examples, there are described several preferred embodiments to

illustrate the invention. However, it should be understood that the invetin is not

intended to be limited to the specific embodiments.

Figure 1 is schematic diagram of a typical Magill circuit having a Mapleson

A configuration.

Figure 2 is schematic diagram of a typical circle anaesthetic circuit.

Figure 3 is schematic diagram of an improved Magill circuit having a

Mapleson A configuration for controlled ventilation illustrated in one embodiment

of the invention.

Figure 4 is schematic diagram of an improved rebreathing isocapnia circuit

for spontaneous ventilation illustrated in one embodiment of the invention.

Figure 5 is schematic diagram of an improved rebreathing isocapnia circuit

for controlled ventilation illustrated in one embodiment of the invention.

Figure 6 is schematic diagram of an an actively controlled rebreathing

circuit for controlled ventilation illustrated in one embodiment of the invention. Figure 7 is schematic diagram of a non-rebreathing isocapnia circuit for

spontaneous ventilation illustrated in one embodiment of the invention.

Figure 8 is schematic diagram of a non-rebreathing isocapnia circuit for

controlled ventilation illustrated in one embodiment of the invention.

Figure 9A and 9B illustrate diagrams of flow and integrated concentration

curves for carbon dioxide.

Figure 10 illustrates with 95% confidence intervals the comparison of

measurements of NC0₂fσr the method of the present invention and the Douglas

Bag collection method and differences between those measurements.

Figure 11 illustrates a comparison of NCθ₂ for the standard bag collection

method, a metabolic cart and the method of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

The reader is referred generally to the figures with regard to the following

description of various embodiments of the invention.

Our improved method:

Circuit:

a) A rebreathing circuit in which only exhaled gas and no source gas exits

from the circuit, as would be the case with

i) a circle circuit,

(1) patient breathing spontaneously or mechanically ventilated,

(2) SGF much less than VE , for example SGF is less than half of VE , Magill circuit

(1) Patient breathing spontaneously

(2) Nentilated patients: The Magill circuit (figure 1) was designed for

spontaneously breathing patients only as it was felt that the

efficiencies of the circuit vis a vis conservation of SGF could not be

obtained with manual-assisted or mechanical ventilation (1). We

describe a modification of the Magill breathing circuit that will

provide all of the benefits with respect to calculation of gas flux

during mechanical ventilation. The circuit (figure 3) consists of a Y-

piece (47) with an opening to the patient (35) and inspiratory (38)

and expiratory (36) limbs, a pressure relief valve at the end of the

expiratory limb (37), a port for entry of SGF (39), and a gas reservoir

bag (40) — components of the Magill system used for spontaneous

ventilation. For controlled ventilation, the gas reservoir bag (40) is

enclosed in a container with a port (44) for connection to a ventilator

breathing circuit. The pressure relief valve (37) is enclosed in a

container (48) with a port for connection to a ventilator breathing

circuit.

On exhalation, the patient breathes out through the patient port (35).

During the initial part of exhalation, the gas reservoir (40) is partially

empty and the resistance to flow along the inspiratory limb (38) is

less than that of the expiratory limb (36) because the higher opening pressure of the pressure relief valve (37) must be overcome before

flow can proceed through the expiratory limb (36). Therefore,

during the initial part of expiration, the expired gas enters the

inspiratory limb (38), displacing gas in the inspiratory limb (38) and

from the SGF (39) into the gas reservoir (40). When the gas reservoir

(40) fills, the pressure in the circuit increases above the opening

pressure of the pressure relief valve (37) and the remainder of the

expired gas is directed down the expired limb (36) displacing the gas

out of the expired limb through the pressure relief valve (37) to the

ventilator breathing circuit from where it is eventually vented to

atmosphere through the expiratory port (49). The SGF continues to

flow towards the patient down the inspiratory limb (38), displacing

previously exhaled gas into the expiratory limb (36).

During inhalation, the balloon valve (43) occludes the ventilator

circuit expiratory port (49) and a volume of gas equal to a tidal

volume is delivered by the ventilator (42) into the ventilator circuit

(46) and hence into the SGF gas reservoir box (41), thereby displacing

a volume equal to the tidal volume from the SGF gas reservoir (40)

into the inspiratory limb of the Magill circuit (38). The SGF continues

to flow towards the patient down the inspiratory limb (38). The net

tidal volume of the patient is equal to the volume displaced from the

gas reservoir (40) plus the SGF multiplied by the duration of inspiration. Because the pressures on both sides of the Magill

pressure relief valve (37) are equal during inspiration, the differential

pressure provided by the "opening pressure" of the valve (37) keeps

it closed during inspiration.

(3) the volume of the inspiratory limb is greater than or equal to [(SGF x

expiratory time) + the anatomical dead space]; the breathing bag

volume is greater than [the largest expected tidal volume - (SGF x

inspiratory time)],

(4) SGF is < 0.7 x VE

iii) The rebreathing isocapnia circuit:

(1) Patient breathing spontaneously (Fisher rebreathing isocapnia

circuit, Figure 4). Circuit consists of a Y piece with patient port (58),

and inspiratory limb of Y piece (60) with a one way inspiratory valve

(59) and an expiratory limb of Y piece (61) with a one way expiratory

valve (53). The inspiratory limb is connected to SGF (51) and a gas

reservoir (52). The expiratory limb leads to an expiratory gas

reservoir (56). The expiratory gas reservoir (56) has a port opening to

atmosphere (57). Between the expiratory limb and the inspiratory

limb, distal to the inspiratory (59) and expiratory (53) valves, is a

bypass limb (62) that contains a one-way valve (54) with an opening

pressure approximately 1.5 cm H2O greater than the inspiratory (53) and expiratory (59)valves; the direction of opening of the one-way

valve in the bypass limb (62) is from expiratory limb to the

inspiratory limb.

(2) Patient ventilated: The rebreathing isocapnia circuit was described

for spontaneously breathing subjects, and its use with ventilated

subjects was not contemplated. Accordingly, to use the circuit for

controlling VA and measuring gas flux during controlled

ventilation, we describe a new rebreathing isocapnia circuit suitable

for use with mechanically ventilated subjects. Referring to figure 5:

The circuit consists of a Y piece with patient port (58), and

inspiratory limb of Y piece with a one way inspiratory valve (78) and

an expiratory limb of Y piece with a one way expiratory valve (77).

The inspiratory limb is connected to a SGF (66) and a gas reservoir

(67). The expiratory limb leads to an expiratory gas reservoir (69).

The expiratory gas reservoir (69) has a one way valve (81) at the port

where expired gases are vented from the expired gas reservoir (71)

which allows gas to exit the expiratory gas reservoir but not enter it.

Between the expiratory limb and the inspiratory limb, distal to the

inspiratory (78) and expiratory (77) valves is a bypass limb that

contains a one-way valve (65) with an opening pressure of the valve

approximately 1.5 cm H2O greater than valves in the inspiratory limb

of the Y piece (78) and the expiratory limb of the Y piece (77); the direction of opening of the one-way valve in the bypass limb (65) is

from the expiratory limb to the inspiratory limb. The inspiratory and

expiratory limbs are extended by tubing of variable lengths, (64) and

(72) respectively. The inspiratory (67) and expiratory (69) reservoirs

are enclosed in a box with 3 ports: one port (79) communicates with

the box; one port (80) communicates with the interior of the SGF

reservoir only; one port (70) communicates with the expiratory gas

reservoir. The SGF reservoir (67) is continuous with the inspiratory

limb (64) of the circuit. The expiratory gas reservoir (69) is

continuous with the expiratory limb of the circuit (72) and has a port

(71) through which expired gas exits the expired gas reservoir and

enters the box. A ventilator (73) a mushroom valve (74)synchronized

to occlude the ventilator circuit expiratory port (75) during the

inspiratory phase, is attached to the box ventilator port (79) such that

,during the inspiratory phase, the tidal volume of the ventilator is

discharged into the box (68). This will displace an equal volume

from the gas reservoirs in the box. As the valve in the bypass limb

(65) has a greater opening pressure than the inspiratory valve (78),

the inspiratory reservoir (67) will be compressed in preference to the

expiratory reservoir (69). When the inspiratory reservoir is

collapsed, the remainder of the tidal volume will result from

compression of the expiratory reservoir (69) and displacement of gas

through the bypass limb and valve (65) and inspiratory valve (78) to the patient. The total tidal volume will be equal to the volume

displaced from the inspiratory reservoir (67) plus the volume

displaced from the expiratory reservoir (69) plus the SGF multiplied

by the time during inspiration.

During exhalation, balloon valve (74) is deflated, opening the

expiratory port of the ventilator circuit (75) to atmosphere and the

expiratory reservoir bag to atmosphere via port (71), thus allowing

exhaled gas to flow past the expiratory one-way valve (77) down the

expiratory limb (72) into the expiratory reservoir (69). SGF flowing

into port (66) is directed down the inspiratory limb (64) to the SGF

reservoir (67). Gas displaced in the box (68) by expansion of the SGF

reservoir (67) and the expiratory gas reservoir (69) is displaced from

the box via the ventilator expiratory port (75).

(4) SGF is less than or equal to VE - NDan .

iv) Νon-rebreathing isocapnia circuit:

(1) Spontaneous ventilation (as per Fisher patent, see figure 7)

The subject breathes in and out through port (1). Upon expiration

one way valve (2) opens and allows expired gas to leave the circuit.

Simultaneously, one way valve (4) is forced shut and allows fresh

gas reservoir (3) to fill up with pressurized gas from gas source (5).

Upon inhalation, one way valve (2) is forced closed and one way valve (4) is opened, drawing in fresh gas stored in the reservoir (3). If

the volume in the reservoir is insufficient for a single tidal volume,

the residual volume of the breath is drawn from demand valve (6),

connected to a pressurized gas source of CO2. The preferred

concentration of this gas source is arterial PCO2 to maintain

isocapnia.

(2) Controlled ventilation (as in dog paper with Laerdal bag, see figure

8)

During controlled ventilation the subject breathes through port (1).

Non-rebreathing valve (3) forces expired gas through port (2).

During inspiration gas is inspired from the self inflating bag (4)

using a mechanical force to drive the gas through non-rebreathing

valve (3). One way valve (5) ensures that all the gas within the bag is

forced through valve (3) only. Simultaneously, fresh gas from

pressurized source (7) fills up the fresh gas reservoir (6).

During expiration the bag is allowed to self-inflate with gas stored in

fresh gas reservoir. If the volume stored in the reservoir is

insufficient for a single tidal volume, the residual volume of the bag

is made up of gas drawn through low pressure valve (8) from a

pressurized source (9), ideally containing arterial concentrations of

CO2 to maintain isocapnia. iii) Balloon valve circuit

(1) Spontaneous ventilation (see figure 6)

Patient breathing spontaneously (balloon isocapnia circuit, Figure 6).

Circuit consists of a Y piece with patient port (100). Inspiratory limb

consists of a balloon valve (108), connected to SGF (109) and a gas

reservoir (110). Expiratory limb consists of a balloon valve (107),

leads to an expiratory gas reservoir (119), which has a port opening

to the atmosphere. A tank of compressed air (106) flows through

solenoid valves (104) to open or close balloon valves (108 and 107).

The solenoid valves are controlled electronically by a computer (103).

A pressure transducer (102) connected to the mouthpiece (101)

measures when the fresh gas reservoir has been fully collapsed. A

computer receiving the signal (103) sends a signal to solenoid valve

(104) to close inspiratory valve (108) and open expiratory valve (107).

The fresh gas flow (109) continuously fills fresh gas reservoir (110).

Henceforth, all of the above circuits, under conditions suitable for measuring flux

of gas using SGF, Fsx, and FEX will be referred to collectively as "conditional

breathing circuits, or CBC". For all CBC, we calculate the flux of gas x by multiplying SGF (as read from the

gas flow meter as set by the anesthesiologist) by the difference between the

expired gas concentration of x (FEX) and the gas concentration of x being delivered

into the circuit (Fsx) (which is also set by the anesthesiologist). Thus, for any gas x

(other than CO2 if a circle anesthetic circuit contains a CO2 absorber in the circuit,

see below):

Flux of gas x = SGF (Fsx - FEX) (1)

The advantage of using equation (1) to calculate flux, is that a) SGF is set by the

anesthesiologist, is precisely known, and is constant; b) Fsx is set by the

anesthesiologist and is precisely known and is constant. This contrasts with the

inspired concentration measured at the mouth, Fix, which may vary throughout

inspiration.

Rationale for new approach:

The principle will be illustrated with a circle circuit (see figure 2), but similar

considerations can be made for all of the circuits and conditions outlined below.

With a patient breathing via a circle circuit, and SGF set substantially lower than

VE , for example one half VE , only exhaled gas leaves the circuit. Therefore, at

low SGF, all of the SGF can be considered "fresh gas" and will contribute to

alveolar ventilation. Therefore we consider SGF = VA . The rest of the gas entering the alveoli is rebreathed gas. Another way of looking at this is to consider

the patient to be an additional gas compartment of the circuit; we can then

consider the mass balance as it applies to the circuit alone. From the perspective of

the circuit, we no longer need to deal with the complex gas concentrations and

flows that occur at the circuit-patient interface as in the previous art. We deal only

with the gas concentrations and flows that occur with respect to gases entering

and leaving the circuit. The volume of a gas entering the circuit (SGF x Fsx) is equal

to that of the gas eliminated from the circuit (SGF x FEX) plus that of the gas

absorbed or eliminated by the patient (SGF [Fsx - FEX]) .

In summary, our method can be stated as: volume of gas x entering or leaving a

patient = volume of gas x entering the circuit - volume of gas x leaving the

circuit = SGF x Fsx - SGF x FEX

Or Flux of gas x = SGF (Fsx- FEX)

The prior art does not indicate that this is sufficient to calculate the uptake and

elimination of gases during anesthesia and continues to require the flow-averaged

concentrations of gas during inspiration and expiration measured at the patient-

circuit interface, i.e., at the mouth of the patient, to calculate gas flux. This is

evidenced by recent articles, for example by Wissig (2) and Rietbrock (3) which are

accepted as reflecting the state of the art by an editorial in the British Journal of Anaesthesia by Bouillon and Shafer (4), the latter being recognized in the

anesthesia profession as a world authority in the field of pharmacokinetics

Advantages of our approach over previous methods:

The advantages of our method in calculating the flux of a gas x would apply with

the use of any circuit in which the concentration of gas x in SGF entering the

circuit is known, SGF is less than or equal to VE - NDan and the circuit is such that

the difference between VE and SGF is made up of reserve gas, the concentration

of x in the reserve gas being substantially that in the alveoli at end exhalation; an

example of reserve gas of suitable composition is previously exhaled gas.

Examples of such circuits are the Magill circuit (Mapleson A configuration,

referred to as the 'Magill circuit'), the circle anesthetic circuit, and the rebreathing

and non rebreathing isocapnia circuit (Fisher patents).

The circle anesthetic circuit is the most commonly used circuit during anesthesia.

All anesthetic machines allow precise setting of SGF and its composition.

Therefore, SGF and Fsx are precisely known. Machines to continuously read out

concentrations of such gases as CO2, O2, Ν₂0, and anesthetic vapors have been

widely available for over a quarter of a century and are routinely available with all

modern anesthetic systems. With our method, the flux of any gas x can be readily

determined by multiplying SGF by (Fsx - FEX). Oxygen and CO2 analyzers are

compact and readily available outside of the operating room. The Mapleson A circuit and the rebreathing isocapnia circuit (Fisher) are inexpensive, easy to

assemble, and can be applied outside of the operating room. The method of

measurement of gas flux can be applied to measuring O2 consumption, CO2

production, pharmacokinetics of inhaled anesthetics and other drugs, and cardiac

output (the latter the subject of a separate patent application).

1) Measuring alveolar ventilation:

VA ( VE - NDan ) is very difficult to measure for two reasons.

a) First, VE is difficult to measure. To do this, one requires a device to

measure flow such as a pneumo tachometer and machine intelligence to

integrate the flow signal with respect to time and calculate volume.

Whereas minute ventilation can be calculated in mechanically ventilated

subjects from ventilator settings, it must be measured directly in

spontaneously breathing subjects. All flow sensing devices have drawbacks:

i) Pneumotachometers based on pressure differentials are expensive and

cumbersome to use outside a laboratory setting. They are affected by

changes in gas temperature and composition; condensation from

expired gas changes their calibration and requires addition of external

heaters which introduces its own errors at high flow rates. They are also

subject to drift, in part for the reasons just given, and require, or would

benefit from, frequent recalibration.

ii) Electronic turbines use low resistance rotating vanes to measure

volumes. Their major drawbacks include friction and inertia of the vane, resulting in a lag before flow is detected and continued spin after

flow has ceased

iii) Pitot tubes measure the pressure flowing against a series of small tubes

mounted at 90 degrees to the direction of gas flow. They are notoriously

alinear and sensitive to changes in gas composition, as occurs during

breathing,

iv) Hot-wire (mass flow) anemometers rely on the cooling effect caused by

laminar gas flow. However, they require sophisticated electronics and

difficult calibrations to maintain accuracy.

b) Second, anatomical dead space, NDan , is difficult to measure and estimates

based on body weight are inaccurate. Measurement of anatomical dead

space requires particular equipment and monitors and is prohibitively

difficult to do outside of a specialized laboratory.

Our method: The alveolar ventilation can be known precisely by simply reading

the flow setting on the flowmeter, which is a precisely calibrated instrument.

Therefore, our method

• does not require the expense of pneumotachometers

• is not affected by the inaccuracies inherent in the use of

pneumotachometers • circumvents the complexity of measuring minute ventilation, integration of

flow, and the requirement for precise rapid measures of gas concentrations

(see below).

• circumvents the complexity of measuring anatomical dead space,

• is just as accurate for spontaneously breathing subjects as it is with

ventilated subjects.

2) The previous art requires that measurements of flow be synchronized with

measurements of gas concentrations in order to calculate the breath-by-breath

flux of gas. The inspired gas concentration while breathing on a rebreathing

circuit varies continuously throughout the breath. The net inspired volume of

gas x is a flow-weighted average of the inspired gas concentration. To be able

to calculate this accurately, a very rapidly responding gas analyzer and precise

synchronization to the flow signal are required. This is very difficult in a

laboratory setting, and even more difficult in a clinical setting. At higher flows,

small errors in synchronization will give large errors in gas flux. Each error is

then multiplied by the number of breaths.

With our method, only the average expired concentration of gas is required.

This allows the use of much less expensive and slower portable gas analyzers.

During any testing procedure, gas concentrations in the gas mixture delivered

to the circuit are set by the person doing the test. When breathing through a rebreathing circuit and when SGF limits VA , gas flux calculations are

simplified to SGF x (Fsx - FEX).

3) The calculation with our method is more robust and accurate that that with the

prior art (see data).

a) With our method, SGF, Fsx , and FEX are precisely known. With the prior

art, the errors in measuring flow, gas concentrations, and synchronization

of flow and concentration signals, are additive.

b) Our method is independent of VE and extent of rebreathing. With the prior

art, inaccuracy of measurement of gas flux increases as VE and the extent

of rebreathing increases.

Applications for gas flux measurement:

1) Oxygen flux:

At present, there is no practical means to follow oxygen consumption intra-

and post-opera tively in the recovery room or intensive care area. Metabolic

carts that perform this function require the additional means to measure gas

flow and complex machine intelligence. Such machines typically cost in excess

of US$25,000 each, making it prohibitively expensive for routine use.

Our method would allow continuous and intermittent measurements of

oxygen consumption in ventilated as well as spontaneously breathing patients

who are in the operating room. Outside of the operating room, any of the CBC described above can be used to calculate oxygen consumption by means of a

simple calculation and without the cost of additional hardware.

a) In the operating room

• Oxygen consumption is an important index of health. Optimization of

oxygen consumption has been shown to decrease post-operative mortality

and morbidity, and improve organ function and survival in patients

undergoing intensive care after trauma, shock, sepsis and major surgery.

• Increases in oxygen consumption would be a very sensitive early sign of

malignant hyperthermia (MH), a rare but devastating condition triggered

by anesthesia and consisting of sudden explosive hypermetabolism,

increased oxygen consumption, C0₂ production, and high body

temperature. Currently, all anesthetized patients are monitored with

temperature probes. Increases in oxygen consumption would be a much

earlier sign of MH than increases in body temperature. Early detection and

thus early intervention would allow MH to be aborted before the fulminant

stage, averting much morbidity and saving many lives. Furthermore,

monitoring oxygen consumption with our method would be a much less

expensive than with electronic temperature probes which are expensive

and, because they have to be sterilized between patients, have short life

spans. Closed circuit anesthesia provides maximum efficiency of use of an

anesthetic gas. At present, determining the O2 flow for closed circuit

anesthesia requires "trial and error" adjustments of the O2 flow as indicated

by the trend in the extent of expiratory recoil of the ventilator bellows. The

exact flow of oxygen is almost impossible to ascertain and, as a result, there

is constant oscillation in the oxygen flow. The required flows of such other

gases as N2O and anesthetic vapor are impossible to set without knowing

the total body absorption of the gas. Attempting to set the anesthetic flow

rates by trial and error results in oscillation of anesthetic depth due to the

long delays between changes in source gas concentrations and the

development of a steady state gas concentration.

Knowing gas flux would allow for more accurate setting of source gas

flows, a shorter feed-back loop, and thus more stable alveolar gas

concentrations during anesthesia as well as less frequent adjustments of

source gas concentration and flow. Patients would benefit by receiving the

intended and appropriate doses of anesthesia.

With our method, the O2 flow is readily determined as the

O2 flow = 0₂ flux = O2 consumption (in steady state) = SGF x (FSO2 ^■

where FSO2 is the concentration of O2 in the source gas and FEO2 is the

concentration of O2 in expired gas.

Calculating flux of any gas x when breathing via a circle circuit with low SGF

and with CO2 absorber in place

i) When x is CO2, and rebreathing of CO2 is prevented by means of a CO2

absorber in the circuit, equation (1) cannot be used and one needs to

know the NDan to calculate VA (as VA = VE - NDan ). Then, CO2 flux

= VA x (FECO2 - F1CO2), but since F1CO2 = 0, CO2 flux = VA X FEC0₂.

Our method does not confer any benefits to the calculation of the flux of

CO2 when a rebreathing circuit includes a CO2 absorber.

ii) For a rebreathing circuit that includes a CO2 absorber, or for any CBC,

and when x is any other gas:

flux _ of _ gas _ x = SGF(FEX - FSx) + (NE - NDan - SGF)(FE_X - FRBx) (2)

where Fsx is the concentration of x in the SGF entering the circuit and

FRBx is the concentration of x in the expired limb of the circuit before the

gas passes through the CO2 absorber and mixes with gas coming out of

the flowmeter. Since FEX = FRBX,

Flux of x = SGF (FEX - FRBX) (3)

Note that the actual inhaled concentration of x is the flow-weighted

average concentration of x in the mixed SGF and rebreathed gas.

However, with our method, the complex measurement and calculation

of the inhaled volume of x are unnecessary. To measure the flux of an

anesthetic, the SGF is multiplied by the difference between the end tidal

and SGF concentrations of x. The continuous measure of flux of any gas

by this method allows one to easily calculate the changes in anesthetic

gas absorption, and hence vaporizer setting required to maintain the

same end tidal concentrations of anesthetic for any SGF, including that

equal to O2 consumption, which is defined as "closed circuit"

anesthesia.

Examples of benefits of applying these methods:

• N2O is an anesthetic gas used in over 95% of anesthetic procedures. It is

used in ratios of 1:1 to 2:1 with O2. It is relatively insoluble in blood and

body tissues so that when used as an anesthetic, the tissues saturate

quickly with small volumes of the gas and the tissue uptake of N2O

approaches 0. Nevertheless, it is impossible with present art to know when tissues become saturated. Therefore, N₂0 flow settings are not

commonly changed throughout the operation. N₂0 is an environmental

pollutant breaking down the ozone layer and costs 10 times as much as

O2. The continued flow of N2O at levels greater than the rate of

absorption is not only a waste of N2O, but also wastes the anesthetic

vapor that is washed out of the circuit with the excess N2O.

• Knowing the exact flux of N2O as with our method would allow the

anesthesiologist to turn down, or off, the N2O when the tissues become

saturated with it (i.e., when the flux = 0). One would expect that the

tissues will become saturated in about 5 minutes. For a 2 hour

anesthetic, this would represent a 95% saving; the longer the operation,

the greater the saving.

• Halothane, isoflurane, sevoflurane, and desflurane are inhalation

anesthetic vapors. They have various costs ranging from a few cents per

milliliter for halothane and isoflurane to about one dollar per milliliter

for sevoflurane and desflurane. They are also environmental pollutants

breaking down the ozone layer. These vapors enter the anesthetic

circuits as part of SGF at various concentrations set by the

anesthesiologist. Knowing the rate of absorption of these anesthetic

vapors would allow the most efficient use of the anesthetics and the

most precise control of the depth of anesthetic. b) Outside the operating room:

With our method, a subject breathes spontaneously or is ventilated, via a

CBC as described above, oxygen consumption is calculated as

where SGF and FSO2 are deliberately set and therefore known, and FEO2 is

measured from a rapid O2 analyzer.

• Oxygen consumption in response to exercise is an important measure of

physical fitness. This is a standard test performed routinely around the

world by cardio-respiratory assessment laboratories to test exercise

capacity, cardio-pulmonary fitness and nutritional status in patients as

well as in athletes.

• Oxygen consumption is one of the measures required to measure

cardiac output by the Fick method.

Figures 9A, 9B, 10, and 11 illustrate flow and concentration curves for comparison

to

the "gold standard' of measuring flux (timed collection) to our method. Particularly Figures 9A and 9B illustrate diagrams of flow and integrated

concentration curves for carbon dioxide.

Figure 10 illustrates with 95% confidence intervals the comparison of

measurements of NC0₂ for the method of the present invention and the Douglas

Bag collection method and differences between those measurements.

Figure 11 illustrates a comparison of NC0₂ for the standard bag collection method,

a metabolic cart and the method of the present invention.

As many changes can be made to the various embodiments of the invention

without departing from the scope thereof; it is intended that all matter contained

herein be interpreted as illustrative of the invention but not in a limiting sense.

Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSINE PROPERTY OR PRIVILEGE IS CLAIMED ARE AS FOLLOWS:

1. A method of calculating the flux of any gas(x) in a CBC circuit for a ventilated or a spontaneous breathing subject,

for example said gas(x) being;

a) an anesthetic such as but limited to; i) Ν₂0; ii) sevoflurane; iii) isoflurane; iv) halothane; v) desflurame; or the like b) Oxygen; c) Carbon dioxide; or the like

utilizing the following relationships;

Flux of gas(x) = SGF (Fsx - FE_X)

wherein

SGF = Source of gas flow into the breathing circuit (CBC circuit) in liters /minute as read from the gas flow meter as set by the anesthesiologist;

Fsx = Fractional concentration of gas X in the source gas (which is set by the anesthesiologist); FEX = Fractional concentration of gas X in the end expired gas as determined by a portable gas analyzer, or the like.

2. A method of calculating the flux of oxygen in a CBC circuit for a ventilated and/or spontaneous breathing subject utilizing the following relationship;

Flux of oxygen = SGF (Fso2 - FE02)

wherein

SGF = Source of gas flow into the breathing circuit (CBC circuit) in liters /minute as read from the gas flow meter as set by the anesthesiologist;

Fsx = Fractional concentration of gas 0₂ in the source gas (which is set by the anesthesiologist);

FEX = Fractional concentration of gas O2 in the end expired gas as determined by a portable gas analyzer, or the like.

3. The method of claim 1 or 2 wherein the CBC circuit is selected from the group consisting of i) a circle circuit; ii) a Magill breathing circuit; iii) an isocapnia circuit, whether breathing or non-breathing (as taught by co-pending Fisher et al), or the like.

4. The method of claim 1 or 2 wherein the CBC circuit is an improved Magill circuit as described herein.

5. The method of claiml or 2 wherein the CBC circuit is an improved rebreathing circuit as described herein.

6. The method of claim 1 or 2 wherein the CBC circuit is an improved non- rebreathing circuit as described herein.

7. The method of claim 2 used to determine oxygen consumption in order to measure cardiac out put by any known method, such as the Fick method.

8. The method of claim 2 used to determine oxygen consumption in, for example, an operating room setting or the like.

9. The method of claim 2 or 8 used to optimize oxygen consumption.

10. The method of claim 2 or 8 utilized as an early indication of malignant hyperthermia.

11. A method of calculating the flux of any gas other than carbon dioxide, in a CBC circuit with low gas flow of source gas and with a carbon dioxide absorber in place utilizing the following relationship;

Flux of gas X = SGF (FEX - FRBX)

wherein

SGF = Source of gas flow into the breathing circuit (CBC circuit) in liters/minute as read from the gas flow meter as set by the anesthesiologist;

FEX = Fractional concentration of gas X in the end expired gas as determined by a portable gas analyzer, or the like;

FRBX = Concentration of gas X in the expired limb of circuit before the gas passes through the carbon dioxide absorber and mixes with gas coming from the flow meter.

12. The method of claim 11 used to determine the flux of an anesthetic for example:

i) N₂0; ii) sevoflurane; iii) isoflurane; iv) halothane; v) desflurame, or the like

13. The method of claim 12 used to determine how much anesthetic is being absorbed by the patient.

14. The method of claim 13 wherein said anesthetic is N₂0.

15. An improved Magill circuit the improvement comprising an inspiratory and expiratory limbs, a pressure relief valve at the end of the expiratory limb, a port for entry of SGF, and a gas reservoir bag, the components of the Magill system utilized for spontaneous ventilation; or alternatively for controlled ventilation, the gas reservoir bag is enclosed in a container with a port for connection to a ventilator breathing circuit, the pressure relief valve being enclosed in a container with a port for connection to a ventilator breathing circuit-

wherein on exhalation, the patient breathes out through the patient port and during the initial part of exhalation, the gas reservoir is partially empty and the resistance to flow along the inspiratory limb is less than that of the expiratory limb because the higher opening pressure of the pressure relief valve must be overcome before flow can proceed through the expiratory limb, wherein during the initial part of expiration, the expired gas enters the inspiratory limb, displacing gas in the inspiratory limb and from the SGF into the gas reservoir, as the gas reservoir fills, the pressure in the circuit increases above the opening pressure of the pressure relief valve and the remainder of the expired gas is directed down the expired limb displacing the gas out of the expired limb through the pressure relief valve to the ventilator breathing circuit from where it is eventually vented to atmosphere through the expiratory port and the SGF continues to flow towards the patient down the inspiratory limb, displacing previously exhaled gas into the expiratory limb;

wherein during inhalation, the balloon valve occludes the ventilator circuit expiratory port and a volume of gas equal to a tidal volume is delivered by the ventilator into the ventilator circuit and hence into the SGF gas reservoir box, thereby displacing a volume equal to the tidal volume from the SGF gas reservoir into the inspiratory limb of the Magill circuit, the SGF continues to flow towards the patient down the inspiratory limb;

wherein the net tidal volume of the patient is equal to the volume displaced from the gas reservoir plus the SGF multiplied by the duration of inspiration, because the pressures on both sides of the Magill pressure relief valve are equal during inspiration, the differential pressure provided by the "opening pressure" of the valve keeps it closed during inspiration;

assuming that:

(1) the volume of the inspiratory limb is greater than or equal to [(SGF x expiratory time) + the anatomical dead space]; and the breathing bag volume is greater than [the largest expected tidal volume - (SGF x inspiratory time)],

(2) SGF is < 0.7 x VE

16. An improved rebreathing isocapnia circuit comprising a Y piece with a patient port, and inspiratory limb of the Y piece with a one way inspiratory valve and an expiratory limb of the Y piece with a one way expiratory valve; the inspiratory limb being connected to a SGF and a gas reservoir, the expiratory limb leading to an expiratory gas reservoir, the expiratory gas reservoir having a one way valve at the port where expired gases are vented from the expired gas reservoir which allows gas to exit the expiratory gas reservoir but not enter, having disposed between the expiratory limb and the inspiratory limb distal to the inspiratory and expiratory valves a bypass limb that contains a one-way valve with an opening pressure of the valve, being for example approximately 1.5 cm H2O, greater than the valves in the inspiratory limb of the Y piece and the expiratory limb of the Y piece; the direction of opening of the one-way valve in the bypass limb being from the expiratory limb to the inspiratory limb, the inspiratory and expiratory limbs being extended by tubing of variable lengths, the inspiratory and expiratory reservoirs being enclosed in a box with 3 ports; one port communicates with the box, one port communicates with the interior of the SGF reservoir only, one port communicates with the expiratory gas reservoir, the SGF reservoir is continuous with the inspiratory limb of the circuit, the expiratory gas reservoir is continuous with the expiratory limb of the circuit and has a port through which expired gas exits the expired gas reservoir and enters the box, a ventilator, a mushroom valve synchronized to occlude the ventilator circuit expiratory port during the inspiratory phase attached to the box ventilator port such that during the inspiratory phase, the tidal volume of the ventilator is discharged into the box , which will displace an equal volume from the gas reservoirs in the box; as the valve in the bypass limb has a greater opening pressure than the inspiratory valve, the inspiratory reservoir will be compressed in preference to the expiratory reservoir, when the inspiratory reservoir is collapsed, the remainder of the tidal volume will result from compression of the expiratory reservoir and displacement of gas through the bypass limb and valve and inspiratory valve to the patient, the total tidal volume will be equal to the volume displaced from the inspiratory reservoir plus the volume displaced from the expiratory reservoir plus the SGF multiplied by the time during inspiration; during exhalation, the balloon valve is deflated, opening the expiratory port of the ventilator circuit to atmosphere and the expiratory reservoir bag to atmosphere via the port, thus allowing exhaled gas to flow past the expiratory one-way valve down the expiratory limb into the expiratory reservoir, SGF flowing into the port being directed down the inspiratory limb to the SGF reservoir, wherein gas is displaced in the box by expansion of the SGF reservoir and the expiratory gas reservoir is displaced from the box via the ventilator expiratory port; wherein SGF is less than or equal to VE - NDan .

17. An improved non-rebreathing circuit, the improvement comprising a balloon valve circuit for spontaneous ventilation of a patient breathing spontaneously, said circuit having a Y piece with a patient port, an inspiratory limb including a balloon valve, connected to SGF and a gas reservoir, an expiratory limb consisting of a balloon valve leading to an expiratory gas reservoir, which has a port opening to the atmosphere, a tank of compressed air flows through solenoid valves to open or close the balloon valves, the solenoid valves being controlled electronically by a computer, a pressure transducer connected to a mouthpiece for measuring when the fresh gas reservoir has been fully collapsed, the computer for receiving the signal and sending a signal to the solenoid valve to close the inspiratory valve and open the expiratory valve, the fresh gas flow continuously filling the fresh gas reservoir.

18. The method of claims 1, 2, or 11 used to calculate the rate of elimination of a gas X for any input total gas flow utilizing the following further relationships;

wherein the rate of elimination of gas X = the input total gas flow (multiplied by) FEX - Fix; wherein FEX is defined above and Fis is the concentration of X in inspired gas.

19. The method of any previous claim wherein said method is incorporated in an algorithm spreadsheet, formula or the like contained within software which is capable of running on a computing device, or is installed therein.