III. United States Patent (19) Howard et al. 5,690,097. Nov. 25, ) Assignee: Board of Regents, The University of

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United States Patent (19) Howard et al. III USOO5690097A 11 Patent Number: 45 Date of Patent: Nov. 25, 1997 54 COMBINATION ANESTHETIC MASK AND OXYGENTRANSPORTSYSTEM 75) Inventors: Gregory L. Howard; Michelle Bowman-Howard, both of Houston, Tex. 73) Assignee: Board of Regents, The University of Texas System, Austin, Tex. 21 22 51 (52) (58 56) Appl. No.: 656,387 Filed: May 31, 1996 Int. Cl.... A62B 7/00) U.S. Cl.... 128/205.11; 128/204.25: 128/204.29 Field of Search... 128/203.12, 203.22, 128/203.23, 203.24, 203.25, 203.28, 204.18, 20422, 204.23, 202.27, 205.11, 204.29, 911, 912; 137/3, 896 2,473,518 2,843,121 2,897,833 References Cited U.S. PATENT DOCUMENTS 6/1949 Garrard et al.. 7/1958 Hudson. 8/1959 Seeler. 3,316,907 3,794,072 3,850,171 3,906,996 3,913,607 3,977.432 4,036,253 4,266,540 4.595,002 4,848,333 5,144.945 5,301,662 5,372,129 5/1967 Goupil. 2/1974 Diedrich et al.. 11/1974 Ball et al.. 9/1975 DePass et al.. 10/1975 Price. 8/1976 Vidal. 7/1977 Fegan et al.. 5/1981 Panzik et al.. 6/1986 Michaels et al.. 7/1989 Waite. 9/1992 Nishino et al.. 4/1994 Bagwell et al.. 12/1994 Ryder. Primary Examiner Vincent Millin Assistant Examiner-Robert N. Wieland Attorney; Agent, or Firm-Akin, Gump, Strauss, Hauer & Feld, L.L.P. 57 ABSTRACT A system to provide supplemental oxygen to a patient via an oronasal mask and an oxygenation adaptor, the adaptor providing for countercurrent flow of fresh (oxygen enriched) gas and exhaled gas with minimal mixing to reduce oxygenrequirements. The Coanda effect is employed to establish and maintain wall attachment of the exhaled gas stream to minimize mixing with incoming fresh gas. 11 Claims, 2 Drawing Sheets 99 44, 1B

U.S. Patent Nov. 25, 1997 Sheet 1 of 2 777-77727777.7272/7 17.12a2a2a27/272 Fig. A Y 5 O

U.S. Patent Nov. 25, 1997 Sheet 2 of 2

1. COMBINATION ANESTHETIC MASK AND OXYGEN TRANSPORTSYSTEM BACKGROUND FIELD OF THE INVENTION The invention relates to methods and apparatus for sup porting oxygenation in a patient, and in particular for patients being transported. Oxygenation of patients in transport Providing supplemental oxygen for spontaneously breath ing patients during transport between and within health care facilities is a common safety precaution. Such patients may have impaired pulmonary gas exchange due to lung disease and/or a blunted ventilatory response to carbon dioxide associated with recently administered anesthetics or seda tives. Supplemental oxygen is often administered via a relatively loose-fitting face shield or mask which can raise the avenge fraction of inspired oxygen (FiO2) from about 0.21 (for room air) to about 0.250-0.35. The actual FiO, attained depends on the patient's minute ventilation and maximum inspiratory flow rate as well as on the flow rate of oxygen used and the adjustment of any air-entrainment dilutor that may be present. Because maximum inspiratory flow rates usually far exceed the flow rate of oxygen or oxygen-enriched air and there is little or no provision for rebreathing, patients often inhale variable (and poorly controlled) quantities of room air with each breath. Room air leaks into relatively loosely fitting face shields and masks during part of each inspiration, and excess fresh gas (that is, oxygen or oxygen-enriched air) together with exhaled gas leaks out in a similar manner during exhalation. Thus, conventional oxygen supplementation systems are relatively wasteful of oxygen (much of which is lost to the ambient atmosphere instead of benefiting the patient). An additional disadvantage of face shields and loose-fitting masks is that they are of little use for assisting or controlling ventilation if the patient experiences respiratory arrest requiring resuscitation. Relatively loose-fitting face shields and masks also rep resent an added expense when they replace an anesthesia mask on patients being transported from an operating room to a recovery room or intensive care unit. The added expense may be justified in current practice, however, because the T-piece and rebreathing tube (or analogous apparatus) needed to conventionally adapt anesthesia masks for trans port of spontaneously breathing patients are relatively bulky and include respiratory dead space which may be detrimen tal to some patients. Thus, a relatively compact and inex pensive adaptor for use with an anesthesia maskin a patient transport system would be a desirable alternative to the currently available supplemental oxygen transport equip Inent described above. SUMMARY OF THE INVENTION The invention comprises a system to provide supplemen tal oxygen to a spontaneously breathing patient via a close fitting oronasal mask such as the masks used to support and/or assist ventilation during anesthesia. Such a system can be easily implemented for patients being transported from an operating room to a recovery room or intensive care unit. By quickly and inexpensively adapting conventional anesthesia masks for a new role in providing supplemental oxygen, often but not exclusively in a transport environment, the invention offers a way to enhance patient O 15 25 30 35 45 50 55 65 2 safety and shorten recovery time while conserving oxygen (relative to the demands of conventional oxygen supplemen tation systems). Oxygen conservation is achieved by ensur ing substantially complete delivery of fresh gas flows into the mask (with relatively small mounts being carried out by an exiting gas stream), and by substantial reduction of leaks around mask edges due to the anatomically conforming nature of masks such as those used for administering anes thesia. During use of the invention, oxygen-enriched fresh gas (typically substantially pure oxygen or ambient air to which oxygen has been added) is carried to the oronasal mask through an oxygenation adaptor, the mask connector portion of which preferably fits slidingly and sealingly into the mask connector orifice (usually a circular orifice 22 mm in diam eter and substantially formed within the thickness of the mask body). The adaptor allows simultaneous flow of fresh gas into the mask and exhaled gas out of the mask through the mask connector orifice. Because a fresh gas outlet is located substantially within (including slightly distal to or slightly proximal to) the mask connector portion of the adaptor, a fresh gas flow is substantially delivered into the mask while a relatively small component of the fresh gas flow is available in the region of the mask connector to facilitate relatively smooth gas flow out of the mask during exhalation as explained below. Countercurrent flow of fresh (oxygen-enriched) gas and exhaled gas thus takes place through the same orifice, but with minimal mixing of the two gas streams. Consequently, most fresh gas passing through the fresh gas outlet actually enters the mask (that is, moves into the mask significantly beyond the mask connector orifice) where it can mix with and displace other gas already there. This action has the effect of raising the oxygen content of gas within the mask even during exhalation, the gas remaining after exhalation being substantially that which enters the patient's airway first on the next inhalation. Since relatively small amounts of fresh gas are carried away with the exhaled gas before entering the mask, the fresh gas oxygen content is substantially preserved for use in raising the oxygen content of gas within the mask. Thus, supple mental oxygen flow rates needed to obtain a predetermined increase in FiO for a patient can be set relatively lower than would be necessary in systems wherein significant mixing of fresh and exhaled gases occurs outside of the mask connec tor orifice (that is, significantly before entry into the mask, as in a Bain circuit or a Mapleson B or C circuit). Mixing of fresh gas and exhaled gas streams in the oxygenation adaptor of the present invention is minimized by substantial physical separation of the gas streams as they pass through the mask connector region of the adaptor. In preferred embodiments, this separation is facilitated by locating a fresh gas outlet substantially centrally (that is, substantially coaxially) within the mask connector portion. The slightly higher-than-ambient pressure ahead of the (preferably substantially axially moving) fresh gas stream within the mask connectorportion tends to divert any exiting gas stream toward the substantially cylindrical wall of the mask connector portion where the Coanda effect then tends to cause wall attachment of the exhaled gas stream in a substantially cylindrical flow pattern. Relatively small amounts of fresh gas available from a substantially centrally moving fresh gas stream in the mask connector portion can move laterally (that is, toward the connector portion wall) to be entrained by the exiting gas stream. This relatively small lateral gas flow allows the Coanda effect to persist substan tially throughout the mask connector portion, forming the exiting gas stream into a substantially cylindrical shell of

3 finite thickness wherein most of the exiting gas stream is effectively separated from the countercurrent stream of incoming fresh gas. This effective separation of countercur rent gas streams minimizes mixing of the two streams and thus facilitates the efficient delivery of fresh gas through the mask connector portion of the oxygenation adaptor and into the mask even during exhalation. To accomplish the above actions during use with an oronasal mask, the oxygenation adaptor of the present invention comprises a substantially hollow rebreathing chamber having an internal volume and a room air port sealingly coupled (as by molding, gluing or welding) to the rebreathing chamber and communicating with the rebreath ing chamber internal volume. The rebreathing chamber may be substantially cylindrical, having a first end, a second end, and an axis Substantially centered and extending between said first and second ends. A substantially hollow and substantially cylindrical mask connectorportion of the adaptor (preferably having a 22 mm outside diameter) has a first end, a second end, and an axis substantially centered and extending between the first and second connector portion ends. The mask connector portion first end is sealingly coupled to the rebreathing chamber and communicates with the rebreathing chamber internal vol ume for coupling the rebreathing chamber to an oronasal mask. Where the rebreathing chamber is substantially cylindrical, the rebreathing chamber axis may preferably be substantially collinear with the connector portion axis. Additionally, the oxygenation adaptor comprises an elon gated tubular fresh gas injection means comprising a longi tudinal fresh gas channel. The longitudinal fresh gas channel has a proximal fresh gas inlet and at least one distal fresh gas outer, at least one distal fresh gas outlet being within or proximate to the mask connector portion. The longitudinal fresh gas channel may be of any size and length compatible with the fresh gas supply to be used, but it preferably comprises a distal portion substantially coaxial with the mask connector portion axis. Note that the preferred position of at least one distal fresh gas outlet may be proximate the mask connector portion first end or (more preferably) the second end (or at a predeter mined position between the first and second ends). For any given application, the most preferred position may be empirically determined as a function of, for example, the fresh gas flow rate, the patient's minute ventilation, and the maximum exiting gas flow rate through the mask connector portion. Note also that while the design of the oxygenation adaptor minimizes turbulence in an exiting gas stream to minimize mixing of fresh gas and exiting gas streams, turbulence may be preferred in an entering gas stream comprising room air which passes through the room airport to encourage sub stantially uniform oxygen enrichment of the gas subse quently breathed by a patient. Thus the room air port may comprise flow directing means (such as a plurality of vanes) to facilitate substantially spiral or otherwise turbulent gas flow in the rebreathing chamber. The present invention also comprises an oronasal mask oxygen transport system comprising a compatible embodi ment of the above oxygenation adaptor and an oronasal mask having a connector orifice with an inside diameter of approximately 22 mm, the mask connector portion being slidingly fitted within the mask connector orifice. A further embodiment of the invention comprises a method of providing oxygen-emiched gas to an oronasal mask. The method comprises sealingly connecting the above 10 15 25 30 35 45 50 55 65 4 oxygenation adaptor to an oronasal mask using the mask connector portion and then directing pressurized oxygen enriched gas into the fresh gas inlet. This method comple ments a method of providing oxygen-enriched gas to a spontaneously breathing patient, the latter method compris ingfitting an oronasal mask to the patient and connecting the above oxygenation adaptor to the oronasal mask using the mask connector portion, followed by direction of pressur ized oxygen-enriched gas into the fresh gas inlet. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 schematically illustrates an oxygenation adaptor for use with an anesthesia mask in a transport system. FIG. 1A schematically illustrates a longitudinal cross section of the oxygenation adaptor of FIG. 1. FIG. 1B schematically illustrates a transverse cross section of the oxygenation adaptor of FIG. 1. FIG. 2 schematically illustrates an exploded view of an oronasal mask oxygen transport system comprising the oxygenation adaptor of FIG. 1 an anesthesia mask (cross section view). DETALED DESCRIPTION FIGS. 1, 1A, 1B schematically illustrate an oxygenation adaptor 99 for an oronasal mask. The adaptor comprises a substantially hollow rebreathing chamber 20 having an internal volume 22 and a room airport 30 sealingly coupled (typically molded into) rebreathing chamber 20 and com municating with rebreathing chamber internal volume 22. A substantially hollow and substantially cylindrical mask con nector portion 40 has a first end 42, a second end 44, and an axis substantially centered and extending between first and second connector portion ends 42.44 respectively. Mask connector portion first end 42 is sealingly coupled (typically by molding, gluing or welding) to rebreathing chamber 20 and communicates with rebreathing chamber internal vol ume 22 for coupling rebreathing chamber 20 to an oronasal mask. Elongated tubular fresh gas injection means 50 com prises alongitudinal fresh gas channel 51 having a proximal fresh gas inlet 52 and at least one distal fresh gas outlet 54. At least one distal fresh gas outlet 54 is substantially within mask connector portion 40, but may be proximate mask connector portion first end 42 or proximate mask connector portion second end 44 or between first end 42 and second end 44. Oxygenation adaptor 99 may comprise a room airport 30 which itself comprises flow directing means 32 (such as, for example, a plurality of vanes) to facilitate substantially spiral gas flow turbulence in rebreathing chamber 22 to facilitate mixing of the turbulent entering air with fresh gas as the turbulent air passes distal fresh gas outlet 54 while flowing into a mask 98 (see FIG. 2). An oronasal mask oxygen transport system 100 is sche matically illustrated in FIG. 2, the system comprising the oxygenation adaptor 99 and an oronasal mask 98 having a connector orifice 80 with an inside diameter of approxi mately 22 mm. Mask connector portion 40 fits slidingly and sealingly within said mask connector orifice 80. What is claimed is: 1. An oxygenation adaptor for an oronasal mask, the adaptor comprising a substantially hollow rebreathing chamber having an internal volume; a room air port sealingly coupled to said rebreathing chamber and communicating with said rebreathing chamber internal volume;

S a substantially hollow and substantially cylindrical mask connector portion having a first end, a second end, and an axis substantially centered and extending between said first and second connector portion ends, said mask connector portion first end being sealingly coupled to said rebreathing chamber and communicating with said rebreathing chamber internal volume for coupling said rebreathing chamber to an oronasal mask, said mask having a thickness; elongated tubular fresh gas injection means comprising a longitudinal fresh gas channel, said longitudinal fresh gas channel having a proximal fresh gas inlet and at least one distal fresh gas outlet, each said distal fresh gas outlet being substantially within said mask connec tor portion, and substantially within said thickness of said mask, for delivering a fresh gas flow substantially into the mask. 2. The oxygenation adaptor of claim 1 wherein at least one said distal fresh gas outlet is proximate said mask connector portion first end. 3.The oxygenation adaptor of claim 1 wherein at least one said distal fresh gas outlet is proximate said mask connector portion second end. 4. The oxygenation adaptor of claim 1 wherein said rebreathing chamber is substantially cylindrical, having a first end, a second end, and an axis substantially centered and extending between said first and second ends. 5. The oxygenation adaptor of claim 4 wherein said rebreathing chamber axis is substantially collinear with said connector portion axis. 10 15 20 25 6 6. The oxygenation adaptor of claim 1 wherein said longitudinal fresh gas channel comprises a distal portion substantially coaxial with said mask connector portion axis. 7. The oxygenation adaptor of claim 1 wherein said room air port comprises flow directing means to facilitate sub stantially spiral gas flow in said rebreathing chamber. 8. The oxygenation adaptor of claim 1 wherein said mask connector portion has an outside diameter of approximately 22 mm. 9. An oronasal mask oxygen transport system, the system comprising the oxygenation adaptor of claim 8; and an oronasal mask having a connector orifice with an inside diameter of approximately 22 mm, said mask connector portion being slidingly and sealingly fitted within said mask connector orifice. 10. A method of providing oxygen-enriched gas to an oronasal mask, the method comprising sealingly connecting the oxygenation adaptor of claim 1 to the oronasal mask using said mask connector portion; and directing pressurized oxygen-enriched gas into said fresh gas inlet. 11. A method of providing oxygen-enriched gas to a spontaneously breathing patient, the method comprising fitting an oronasal mask to the patient; connecting the oxygenation adaptor of claim 1 to said oronasal mask using said mask connector portion; and directing pressurized oxygen-enriched gas into said fresh gas inlet.