# Patent

## Title
Gas delivery, evacuation and respiratory monitoring system and method

## Abstract

A gas delivery, evacuation and respiratory monitoring system comprises a face mask having an inflow flapper valve and a fresh-gas inflow tube and an exhaust-gas outflow tube and a gas sampling tube, a fresh gas source and an exhaust-gas scavenging system, a fresh gas supply tube operative coupling the fresh gas source and the face mask, an exhaust-gas hose operatively coupling the scavenging system and exhaust-gas outflow tube, a carbon-dioxide monitoring device, also known as a capnograph and a carbon-dioxide sampling tube operative coupling the capnograph and the mask.

## Background
RELATED APPLICATION
The present application is a continuation-in-part of U.S. patent application Ser. No. 10,747,638 filed Dec. 29, 2003, issued July 7, 2005 as U.S. Pat. No. 7,004,163.


BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a gas delivery, evacuation and respiratory monitoring system and method and more particularly pertains to allowing a user to deliver at least one gas and scavenge the exhausted gasses as well as monitor the exhausted gasses in a safe and efficient manner.
2. Description of the Prior Art
The use of gas handling systems is known in the prior art. More specifically, gas handling systems previously devised and utilized for the purpose of delivering and/or evacuating and/or monitoring a gas flow are known to consist basically of familiar, expected, and obvious structural configurations, notwithstanding the myriad of designs encompassed by the crowded prior art which has been developed for the fulfillment of countless objectives and requirements.
By way of example, U.S. Pat. No. 4,328,797 issued on May 11, 1982 and is related to a naso-gastric oxygen mask. In addition, U.S. Pat. No. 2,023,267 issued on Dec. 3, 1935 and is related to a feeding means for gas masks.
While these devices fulfill their respective, particular objectives and requirements, the aforementioned patents do not describe a gas delivery, evacuation and respiratory monitoring system and method that allows allowing a user to deliver at least one gas and scavenge the exhausted gasses as well as monitor the exhausted gasses in a safe and efficient manner.
In this respect, a gas delivery, evacuation and respiratory monitoring system and method according to the present invention substantially departs from the conventional concepts and designs of the prior art, and in doing so provides an apparatus primarily designed and developed for the purpose of allowing a user to deliver at least one gas and scavenge the exhausted gasses as well as monitor the exhausted gasses in a safe and efficient manner.
Therefore, it can be appreciated that there exists a continuing need for a new and improved a gas delivery, evacuation and respiratory monitoring system and associated method which can be used for allowing a user to deliver at least one gas and scavenge the exhausted gasses as well as to concurrently monitor the exhausted gasses in a both a safe and efficient manner. In this regard, the present invention substantially fulfills this need.
SUMMARY OF THE INVENTION
In view of the foregoing disadvantages inherent in the known types of gas handling systems now present in the prior art, the present invention provides an improved a gas delivery, evacuation and respiratory monitoring system and method. As such, the general purpose of the present invention, which will be described subsequently in greater detail, is to provide a new and improved a gas delivery, evacuation and respiratory monitoring system and method which has all the advantages of the prior art and none of the disadvantages.
To attain this, the present invention essentially comprises a gas delivery, evacuation and respiratory monitoring system is disclosed. The system allows a user to deliver at least one gas and scavenge the exhausted gasses. The system also allows a user to monitor the exhausted gases. The delivery, scavenging and monitoring can be done in a safe and efficient manner. The system comprises several components in combination.
First provided is a face mask. The face mask is fabricated of a flexible material. The face mask has a face recipient area and a continuous side wall area and a dome area. The areas are continuous and form a surface. The mask has an upper portion and a lower portion. The dome area is located in the upper portion of the mask. the dome forms a closed, recessed portion of the mask. The dome forms a closed, recessed portion of the mask. The face mask has a nasal portion of a first width and a mouth portion of a second width. the nasal and mouth portions are continuous, with the second width being larger than the first width. The mask has a continuous side-wall portion with the side-wall portion having at least one intake hole there through. The intake hole has an associated flapper valve, to permit the passage of a gas into the mask from the surrounding atmosphere and to prevent the gas from within the mask moving into the surrounding atmosphere.
The mask has a head strap that is coupled to the side wall of the mask to hold the mask in place. The dome area has a fresh-gas inflow tube of a first internal diameter coupled there to. The inflow tube has an inner portion and an outer portion. The inner portion is coupled to the dome area of the face mask. The outer portion of the fresh-gas inflow tube has a tapered external second diameter to allow the slip-fit there onto. The dome area also has an exhaust-gas outflow tube of a third internal diameter and a fourth external diameter. The fourth diameter is larger than the first and second and third diameters. The exhaust-gas outflow tube has an inner portion and an outer portion. The inner portion is coupled to the dome area of the face mask. The outer portion of the gas outflow tube is configured to allow the slip fit there onto. The gas outflow tube also has an exhaust-gas sampling tube of a fifth internal diameter coupled to the inner portion of the exhaust-gas outflow tube. The fifth diameter is smaller than the first, second, third and fourth diameters. The exhaust-gas sampling tube has an inward end coupled to the exhaust-gas outflow tube and an outward end. The outward end has a male coupling thread.
The component next provided is a fresh gas source having a outflow tube.
Next provided is a fresh gas supply tube fabricated of a flexible material. The gas supply tube has an inflow end and an outflow end having a second internal diameter. The inflow end is coupled to the outflow tube of the fresh gas source. The outflow end is coupled to the outer portion of the fresh-gas inflow tube of the face mask. Next provided is an exhaust-gas scavenging system having an inflow tube.
An exhaust-gas hose is next provided. The exhaust-gas hose is fabricated of flexible material and has an inflow end and an outflow end. The outflow end is coupled to the inflow tube of the exhaust-gas scavenging system. The inflow end has a fourth internal diameter so as to allow the exhaust-gas hose to be slipped onto and coupled with the outer portion of the exhaust-gas outflow tube.
Next provided is a carbon-dioxide monitoring device, also known as a capnograph. The device has a sample inflow tube for receiving gas samples.
Lastly provided is a carbon-dioxide sampling tube fabricated of a flexible material and having a fifth diameter. The carbon-dioxide sampling tube has an inflow end and an outflow end. The outflow end is operatively coupled to the capnograph sample inflow tube. The inflow end of the carbon-dioxide sampling tube has a female treaded coupler for receiving and coupling with the mask.
There has thus been outlined, rather broadly, the more important features of the invention in order that the detailed description thereof that follows may be better understood and in order that the present contribution to the art may be better appreciated. There are, of course, additional features of the invention that will be described hereinafter and which will form the subject matter of the claims attached.
In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of descriptions and should not be regarded as limiting.
As such, those skilled in the art will appreciate that the conception, upon which this disclosure is based, may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention.
It is therefore an object of the present invention to provide a new and improved a gas delivery, evacuation and respiratory monitoring system and method which has all of the advantages of the prior art gas handling systems and none of the disadvantages.
It is another object of the present invention to provide a new and improved a gas delivery, evacuation and respiratory monitoring system and method which may be easily and efficiently manufactured and marketed.
It is further object of the present invention to provide a new and improved a gas delivery, evacuation and respiratory monitoring system and method which is of durable and reliable constructions.
An even further object of the present invention is to provide a new and improved a gas delivery, evacuation and respiratory monitoring system and method which is susceptible of a low cost of manufacture with regard to both materials and labor, and which accordingly is then susceptible of low prices of sale, thereby making such a gas delivery, evacuation and respiratory monitoring system and method economically available to the medical community.
Even still another object of the present invention is to provide a gas delivery, evacuation and respiratory monitoring system and method for allowing a user to deliver at least one gas and scavenge the exhausted gasses as well as monitor the exhausted gasses in a safe and efficient manner.
Lastly, it is an object of the present invention to provide a new and improved gas delivery, evacuation and respiratory monitoring system comprised of a face mask having an inflow flapper valve and a fresh-gas inflow tube and an exhaust-gas outflow tube and a gas sampling tube, a fresh gas source and an exhaust-gas scavenging system, a fresh gas supply tube operative coupling the fresh gas source and the face mask, an exhaust-gas hose operatively coupling the scavenging system and exhaust-gas outflow tube, a carbon-dioxide monitoring device, also known as a capnograph, and a carbon-dioxide sampling tube operative coupling the capnograph and the mask.
These together with other objects of the invention, along with the various features of novelty which characterize the invention, are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and the specific objects attained by its uses, reference should be had to the accompanying drawings and descriptive matter in which there is illustrated preferred embodiments of the invention.



BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be better understood and objects other than those set forth above will become apparent when consideration is given to the following detailed description thereof. Such description makes reference to the annexed drawings wherein:
FIG. 1 is a side elevational view of a gas delivery, evacuation and respiratory monitoring system constructed in accordance with the principles of the present invention.
FIG. 2 is a cross sectional view taken along line 2—2 of FIG. 1.
FIG. 2A is an exploded perspective view of the nasal portion, flapper valve and associated holes of the prior Figures.
FIG. 3 is a front elevational view taken along line 3—3 of FIG. 1.
FIG. 3A is a bottom view taken along line 3A—3A of FIG. 3.
FIG. 4 is a side elevational view similar to FIG. 1 but illustrating an alternate embodiment of the invention.
FIG. 5 is a front elevational view taken along line 5—5 of FIG. 4.
FIG. 6 is front elevation view of the face mask of the invention showing the partial cuff.
FIG. 7 is a side elevational view of a gas delivery, evacuation and respiratory monitoring system constructed in accordance with another alternate embodiment of the present invention.
FIG. 8 is a bottom view of the other alternate embodiment of the invention shown in FIG. 7.



The same reference numerals refer to the same parts throughout the various Figures.
DESCRIPTION OF THE PREFERRED EMBODIMENT
With reference now to the drawings, and in particular to FIG. 1 thereof, the preferred embodiment of the new and improved a gas delivery, evacuation and respiratory monitoring system and method embodying the principles and concepts of the present invention and generally designated by the reference numeral 10 will be described.
The present invention, a gas delivery, evacuation and respiratory monitoring system 10 and method is comprised of a plurality of components. Such components in their broadest context include a face mask, a fresh air source, an exhaust-gas scavenging system, an exhaust-gas hose, a carbon dioxide monitoring system and a carbon dioxide sampling tube. Such components are individually configured and correlated with respect to each other so as to attain the desired objective.
More specifically, a gas delivery, evacuation and respiratory monitoring system 10 is disclosed. The system allows a user to deliver at least one gas and scavenge the exhausted gasses. The system also allows a user to monitor the exhausted gases. The delivery, scavenging and monitoring can be done in a safe and efficient manner. The system comprises several components in combination. First provided is a face mask 12. The face mask is fabricated of a flexible material. The face mask has a face recipient area 14 and a continuous side wall area 16 and a dome area 18. The areas are continuous and form a surface.
In an alternate embodiment, as shown in FIG. 3, the mask may have a soft cuff 23. The cuff may be made of a compressible material, or it may have an air space therein, the air being injected through a valve 25 that communicates with the space within the cuff.
In an alternate embodiment a partial cuff 27 of the mask may only partially cover the edge. The cuff may be air inflated of the cuff may be fabricated of a soft compressible material, such as sponge rubber, as described above. While FIG. 6 depicts the partial cuff being located within the lower portion of the mask, it is understood that the partial cuff may be located on any portion of the mask, such as on the upper portion.
The mask has an upper portion 20 and a lower portion 22. The dome area is located in the upper portion of the mask. The dome forms a closed, recessed portion of the mask 24.
The face mask has a nasal portion 30 of a first width and a mouth portion 32 of a second width. The nasal and mouth portions are continuous, with the second width being larger than the first width.
The mask has a continuous side-wall with the side-wall having at least one intake hole 40 there through. The intake hole has an associated flapper valve 42, to permit the passage of a gas into the mask from the surrounding atmosphere and to prevent the gas from within the mask moving into the surrounding atmosphere.
In an alternate embodiment, as shown in FIG. 2A, the valve may be configured to have a plurality of radially located holes 46 located around a central hole 48. The valve is coupled with the central hole, and the radial holes allow the passage of gasses there through.
The mask has a head strap 50 that is coupled to the side wall of the mask to hold the mask in place. The head strap may be coupled to the mask by a slip fit means or by a snap means or a clip means.
The dome area has a fresh-gas inflow tube 60 of a first internal diameter coupled there to. The inflow tube has an inner portion 62 and an outer portion 64. The inner portion is coupled to the dome area of the face mask. The outer portion of the fresh-gas inflow tube has a tapered external second diameter to allow the slip-fit there onto.
The dome area also has an exhaust-gas outflow tube 68 of a third internal diameter and a fourth external diameter. The fourth diameter is larger than the first and second and third diameters. The exhaust-gas outflow tube has an inner portion 70 and an outer portion 72. The inner portion is coupled to the dome area of the face mask. The outer portion of the gas outflow tube is configured to allow the slip fit there onto.
The gas outflow tube also has an exhaust-gas sampling tube 80 of a fifth internal diameter coupled to the inner portion of the exhaust-gas outflow tube. The fifth diameter is smaller than the first, second, third and fourth diameters. The exhaust-gas sampling tube has an inward end 82 coupled to the exhaust-gas outflow tube and an outward end 84. The outward end has a male coupling thread 86.
Next provided is a fresh gas source 88 having a outflow tube 90.
Next provided is a fresh gas supply tube 92 fabricated of a flexible material. The gas supply tube has an inflow end 94 and an outflow end 96 having a second internal diameter. The inflow end is coupled to the outflow tube of the fresh gas source. The outflow end is coupled to the outer portion of the fresh-gas inflow tube of the face mask.
Next provided is an exhaust-gas scavenging system 98 having an inflow tube 100.
Next provided is an exhaust-gas hose 102. The exhaust-gas hose is fabricated of flexible material and has an inflow end 104 and an outflow end 106. The outflow end is coupled to the inflow tube of the exhaust-gas scavenging system. The inflow end has a fourth internal diameter so as to allow the exhaust-gas hose to be slipped onto and coupled with the outer portion of the exhaust-gas outflow tube.
Next provided is a carbon-dioxide monitoring device 108, also known as a capnograph. The device has a sample inflow tube 110 for receiving gas samples.
Lastly provided is a carbon-dioxide sampling tube 112 fabricated of a flexible material and having a fifth diameter. The carbon-dioxide sampling tube has an inflow end 114 and an outflow end 116. The outflow end is operatively coupled to the capnograph sample inflow tube. The inflow end of the carbon-dioxide sampling tube has a female treaded coupler 118 for receiving and coupling with the outward end of the exhaust-gas sampling tube of the mask.
In an alternate embodiment, as shown in FIGS. 4 and 5, the dome of the mask may be a rotatable dome 120 and coupled to the mask nose portion so as to allow rotation of the dome in an azimuthal plane.
FIGS. 7 and 8 illustrate another alternate embodiment of the invention. In such alternate embodiment, there is provided a carbon-dioxide sampling tube 112 fabricated of a flexible material and having a fifth diameter. The carbon-dioxide sampling tube has an inflow end 114 and an outflow end 116. The outflow end is operatively coupled to the mask in proximity to the patient's nose during operation and use. The inflow end of the carbon-dioxide sampling tube has a coupler 119 for receiving and coupling with the mask rather than to the outward end of the exhaust-gas sampling tube as in the prior embodiments. It has been found that attaching the female thread coupler and inflow end 114 of the carbon dioxide sampling tube 112 to the mask and closer to the nose of the patient, more accurate monitoring of the patient may be attained. Except for the repositioning of the outward end of the exhaust-gas sampling tube, the other components of the system are as in the primary embodiment described above.
In addition to the system as described above, the present invention may also be considered as including a method for constructing a gas delivery, evacuation and respiratory monitoring system. Such method includes the steps of providing the components of the system as described above as well as the step of placing a system on a patient for allowing the system to deliver at least one gas and scavenge the exhausted gasses as well as monitor the exhausted gases in a safe and efficient manner. This allows a breath by breath analysis of carbon dioxide contents in the exhaled gasses, the system being configured to allow the safe administration of a gas to the face mask.
As to the manner of usage and operation of the present invention, the same should be apparent from the above description. Accordingly, no further discussion relating to the manner of usage and operation will be provided.
With respect to the above description then, it is to be realized that the optimum dimensional relationships for the parts of the invention, to include variations in size, materials, shape, form, function and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present invention.
Therefore, the foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

## Claims

1. A method for constructing a gas delivery, evacuation and respiratory monitoring system for allowing a user to deliver at least one gas and scavenge the exhausted gasses as well as monitor the exhausted gases in a safe and efficient manner comprising, in combination:
providing a face mask fabricated of a flexible material and having a face recipient area and a continuous side wall area and a dome area forming a continuous surface, with the mask having an upper portion and a lower portion, the dome area being located in the upper portion of the mask with the dome forming a closed portion of the mask and forming a recess therein, the face mask having a nasal portion of a first width and a mouth portion of a second width, the nasal and mouth portions being continuous, with the second width being larger than the first width, the mask having a continuous side-wall portion with the side-wall portion having at least one intake hole there through with the intake hole having an associated flapper valve to permit the passage of a gas into the mask from the surrounding atmosphere and to prevent the gas from within the mask moving into the surrounding atmosphere, the mask having a head strap being coupled to the side wall of the mask to hold the mask in place, the dome area having a fresh-gas inflow tube of a first internal diameter coupled there to with the inflow tube having an inner portion and an outer portion, the inner portion being coupled to the dome area of the face mask, the outer portion of the fresh-gas inflow tube having a tapered external second diameter to allow the slip-fit there onto, the dome area also having an exhaust-gas outflow tube of a third internal diameter and a fourth external diameter with the fourth diameter being larger than the first and second and third diameters, the exhaust-gas outflow tube having an inner portion and an outer portion with the inner portion being coupled to the dome area of the face mask and the outer portion of the gas outflow tube configured to allow the slip fit there onto, the gas outflow tube also having an exhaust-gas sampling tube of a fifth internal diameter coupled to the inner portion of the exhaust-gas outflow tube, with the fifth diameter being smaller than the first, second, third and fourth diameters, the exhaust-gas sampling tube having an inward end coupled to the exhaust-gas outflow tube and an outward end, the outward end having a male coupling thread whereby the face mask can fit snugly against the face so as to minimize gas leakage;
providing a fresh gas source having a outflow tube whereby a gas may be provided to the system;
providing a fresh gas supply tube fabricated of a flexible material with the gas supply tube having an inflow end and an outflow end having a second internal diameter, the inflow end being coupled to the outflow tube of the fresh gas source and the outflow end being coupled to the outer portion of the fresh-gas inflow tube of the face mask whereby the fresh gas may be conducted to the face mask, thereby providing a source of fresh gas to the face area;
providing an exhaust-gas scavenging system having an inflow tube whereby a gas may be provided to the system thereby providing a means for the removal of exhausted gas;
providing an exhaust-gas hose, fabricated of flexible material and having an inflow end and an outflow end with the outflow end being coupled to the inflow tube of the exhaust-gas scavenging system, the inflow end having a fourth internal diameter so as to allow the exhaust-gas hose to be slipped onto and coupled with the outer portion of the exhaust-gas outflow tube whereby exhausted gasses are conducted away from the face mask, thereby allowing for the entry of fresh gas into the face mask;
providing a carbon-dioxide monitoring device, also known as a capnograph, the device having a sample inflow tube for receiving gas samples whereby a gas sample may be analyzed, thereby enabling a user to monitor and analyze a gas sample:
providing a carbon-dioxide sampling tube fabricated of a flexible material having a fifth diameter, the carbon-dioxide sampling tube having an inflow end and an outflow end, the outflow end being operatively coupled to the capnograph sample inflow tube and the inflow end of the carbon-dioxide sampling tube having a female treaded coupler for receiving and coupling with the mask whereby a gas sample is conducted from the exhaust-gas tube to the capnograph for analysis, thereby allowing a breath by breath analysis of carbon dioxide contents in the exhaled gasses, the system being configured to allow the safe administration of a gas to the face mask, and
placing a system on a patient for allowing the system to deliver at least one gas and scavenge the exhausted gasses as well as monitor the exhausted gases in a safe and efficient manner.