US 3357426 A
Description (OCR text may contain errors)
Q. 5 m 5 N w 2 m A, H\\\\\\\\\\\\\\\ Q mm n. ap 3H J 9% w W 4 fl D. D. COHEN AND DISPOSABLE COMPONENTS Filed Jan.
Dec. 12, 1967 ADHERENT FACE MASK HAVING A QUICK DISCONNECT F United States Patent Office 3,357,426 Patented Dec. 12, see? ADHERENT FACE MASK HAVING A QUICK DISCONNECT FITTING AND DISPOSA- BLE COMPONENTS David 1). Cohen, Northridge, Calif., assignor to The Regents of the University of California Filed Jan. 14, 1965, Ser. No. 425,527 8 Claims. (Cl. 128205) ABSTRACT OF THE DISCLOSURE A low-cost face mask having a ring-like coupling adapted to be secured in place on the wearers face during use and a cooperating quick disconnect fitting for connection to respiration apparatus. The coupling is shallow and of large diameter so as to afford convenient access to the nose and mouth of the wearer during use. The coupling is secured in place on the face by means of a thin, pliable sealing flap detachably secured to the coupling and having a pressure-sensitive adhesive on its face-engaging side. The sealing flap conforms to the contours of the wearers face and adheres to the face to provide an effective seal in positive-pressure operation even when auxiliary equipment such as tubes leading to the nose or mouth are used. The quick disconnect fitting is friction fit onto the coupling portion and is configurated so as to cooperate with the coupling to provide a relatively small breathing chamber.
This invention relates to an improved face mask for respiratory use, and more particularly to an inherent mask of this type having a quick disconnect fitting and disposable components.
Face masks of the subject type find widespread use in a variety of different applications. In the medical field, by way of example, they are used to administer certain anesthetics, and in ventilating a patient where the lungthorax system which enables the patent to breathe spontaneously is paralyzed by use of anesthetics. Also, they are widely used in administering intermittent positive pressure breathing therapy to patients having a variety of respiratory disorders. Both in ventilating a patient where paralysis is present, and in administering positive pressure therapy, the lungs are inflated under a regulated pressure on the order of ten to sixty centimeters of water. This is normally followed by a passive or negative expiration phase during which the patient is permitted or caused to expire to the atmosphere.
Because of the pressures involved, it will be appreciated that sealing between the mask and the face of the patient is a prime requisite. This is especially true where the lung-thorax system is paralyzed-In such a case, the patients life depends upon receiving positive pressure ventilation. Also, scaling is important when administering anesthetic gases at ambient pressure in order to prevent dilution with air.
Serious sealing problems are encountered in practice, stemming from the fact that facial contours vary greatly from patient to patient. While masks are normally furnished in a few different sizes, it is obviously not feasible to construct them to conform exactly to the contours of a given patient.
To obtain sealing, the usual practice is to press the mask very tightly against the face, particularly in the relatively raised facial areas in order to insure engagement and sealing in the relatively depressed areas. This practice, together with the fact that most masks and their associated fittings are heavy, frequently causes damage to the facial tissue. At the very least, a patient receiving positive pressure therapy is subjected to severe discomfort and tends to become apprehensive.
Such sealing problems are often compounded in the medical field. During surgery, it is often necessary to have tubes and the like, such as a nasogastric tube, leading from the patient to auxiliary equipment. Commonly, such tubes pass between the perimeter of the mask and the face at a fleshy part of the latter, but, at best, it is extremely difficult to obtain sealing around the tubes with masks heretofore available. Moreover, during most surgical procedures, it is necessary to obtain access fre quently to the patients nose and mouth. To gain access, the mask is temporarily removed. Thus, even if the seal is once established, it may be necessary to repeat the time-consuming process.
Another important factor with respect to face masks for medical uses is sanitation. Many of the masks heretofore available have been difficult and, in some cases, impossible to clean satisfactorily. In this connection, it will be appreciated that the optimum situation, insofar as sanitation is concerned, is to provide a mask in which at least the face-engaging portion is disposed after a single use. Various attempts have been made in the past to afford such a mask, but they have been unsuccessful. Problems of inadequate sealing and of prohibitive costs have hampered the development and marketing of such a mask.
In view of the foregoing, it is a primary object of this invention to provide an improved face mask for respiratory use that obviates the problems of the prior art.
Another object is to provide an improved face mask embodying means for affording a highly effective pressure seal between the mask and the face of the wearer.
A related object is to provide a mask of the type described which is light in weight and may be worn comfortably in sealing relationship with the face, notwithstanding substantial irregularities in the facial contour.
A further object is to provide a mask of the type described, having a detachable front portion or cap that may be conveniently removed to afford access through a large central opening to the patients nose and mouth without removing the face-engaging sealing assembly of the mask from the face.
It is a further object of the invention to provide an improved face mask having a face piece of narrow profile, so as to afford a relatively small breathing chamber and thereby minimize re-breathing of expired gas.
It is still another object to provide an improved face mask of the type described capable of effective high pressure applications and of being worn comfortably, and which is further characterized in that it is highly sanitary from the standpoint that its face-engaging assembly is disposed after a single use.
A still further object is to provide an improved mask capable of accomplishing all of the foregoing objects, yet which is relatively simple in construction and capable of being mass-produced at a low cost.
These and other objects, features and advantages of the invention will be better understood by referring to the following detailed description taken in conjunction with the accompanying drawing in which:
FIGURE 1 is a perspective View of the mask of the invention positioned for use on the face of the wearer;
FIGURE 2 is a vertical sectional view through the 4 center of the mask and illustrating it in place on the face;
the mask of the invention with certain parts being cut 3 away and removed to show underlying parts more clearly.
Referring to the drawing and, in particular, to FIG- URES 1 and 2 the mask of the invention is designated by the reference numeral It). It includes generally a disposable assembly including a coupling 12 and a sealing flap '14. Detachably connected to the coupling 12 is a closure cap or quick disconnect fitting 16 which, in turn, is adapted for connection by a hose 18 to suitable respiration apparatus (not shown).
Effective sealing is achieved with the mask of the invention by making the sealing flap 14 of a thin, pliable material coated on its face-engaging side with a pressuresensitive adhesive 20. Such material must, of course, be relatively impervious to gas, and both the material and the adhesive must be non-contaminating and non-irritating to the patients skin. Various plastic fi ms coated with adhesive have been found to give especially advantageous results. Not only do plastics have the aforementioned desired physical properties, but they are easily pressed into conformity with the facial contours and have a soft, comfortable feel. It will be understood, however, that satisfactory results may be achieved with other materials such as certain papers.
The flap 14 may be cut from a flat sheet of film of substantially uniform thickness. It is shaped so that when it is pressed against the face its upper edge is below the eyes and its side and bottom portions extend well out onto the cheeks and, preferably, at least a short distance down under the chin.
The coupling 12 embodies a ring-like connecting flange 22 that defines an enlarged central opening in the mask. At the lower end of the flange 22, an annular base flange 24 projects radially outwardly a short distance for connection to the flap 14. At least the connecting flange is formed of a resilient and relatively stiff material in order that it will tend to retain its shape when subjected to external forces. For convenience of manufacture, the base flange 24 may, as in the illustrative case, be integral with the connecting flange 22. Forming of the coupling 12 may then be easily accomplished at low cost by molding it from a suitable plastic.
Referring to FIGURES 2 and 4, it may be seen that the coupling 12 is sized so that when it is positioned centrally on the face it encompasses the nose and mouth and presents an enlarged central opening. The base flange 24 on its perimeter extends across the bridge of the nose below the eyes, then downwardly across the cheeks outwardiy of the edges of the mouth and finally down across the chin. Preferably, the connecting flange 22 is relatively shallow in height in relation to the width of the opening, so that its outer end is disposed about flush with the end of the patients nose when the mask is positioned for use. By virtue of the large opening afforded by the coupling 12 and its shallow height, convenient access may be had i with the assembly 12, 14 in place to both the nose and mouth.
The base flange 24 serves as means for attaching theflap 14 to the coupling 12. In accomplishing this, an aperture 26 is cut in the flap which is just slightly larger in diameter than the maximum outside diameter of the connecting flange 22. The flap 14 is disposed over the flange 22 with its adhesively coated underside in engagement with the upper surface of the flange 24. The adhesive bonds the parts together in a sealed connection.
The closure cap 16 includes a central lid 28 and a skirt 30 that depends from the periphery of the lid. Detachable connection of the cap 16 and coupling 12 is accomplished by sizing the parts so that the cap is telescopically re-.
ceived in a close-sliding fit on the connecting flange 22. To facilitate installation and removal of the cap and to enhance the seal, the mating surfaces of the skirt 30 and flange 22 are tapered slightly inwardly from bottom to top. Thus, as the cap 16 is pressed firmly down on the coupling, the connection becomes progressively tighter. With such a detachable connection, installation and removal of the cap can be accomplished quickly and easily. Moreover, in most situations, the scaling is entirely adequate. However, in high pressure applications, it may be desir= able to provide additional sealing means.
When the. cap 16 is in place on the coupling and the mask is positioned for use, a sealed breathing chamber 32 is provided in the interior of the mask. As may be seen in FIGURE 2, the lid 28 is then disposed adjacent the upper end of the connecting flange 22. Because of this positioning and in view of the shallow height of the coupling, the volume or dead air space of the chamber 32 is relatively. small. This constitutes an important feature of the present invention since it tends to minimize rebreathing of expired gas. 7
The cap 16, like the coupling '12, is formed of a resilient and relatively stiff material. In this connection, it is to be noted, however, that some flexibility is desirable in order to insure the parts conform in shape to one another for good sealing. Yet, the parts still must have the desired stiffness in order to insure that they retain their shapes and may be conveniently connected and detached. It is further noted that in many applications, particularly in the medical field, it is desirable to be able to observe the nose and mouth when the mask is in place. Thus, it is advantageous to fornr'the cap 16 and, preferably, also the connecting flange 22 of a transparent material.
An outlet fitting 34 is provided in the skirt 30 to pro vide an inlet-outlet passage to the exterior from the breathing chamber 32. Connection of the breathing chamber 32 to the hose 18 is accomplished by pressing the hose onto the fitting. To insure that the opening in the skirt 30 to the fitting 34 is not blocked, the skirt preferably varies in height around its circumference from a maxi mum adjacent the fitting to a minimum at a diametrically opposite position. Such an arrangement enables the volume of the breathing chamber 32 to be kept at a minimum, yet the inlet-outlet passage to open at all times, as shown in FIGUREQ.
The mask 10 is supplied with the disposable assembly including the coupling 12 and the flap 14 bonded together in the manner previously described. In order to protect the adhesive 20' on the underside of the flap 14 prior to using the mask, a paper-like backing 36 is adhered to it. To ready the mask for use, it is simply necessary to remove the backing by peeling it off in the manner shown in FIGURE 5. Removal is facilitated by slitting the backing at a number of locations, as at 38, to divide it into corresponding sections.
In order to accommodate patients with different size faces, the mask 10 is furnished in different sizes. Since the flap 14 is adapted to readily conform to variations in facial contour, a mask of given size will function entirely satisfactorily on patients with faces of considerably different sizes. Accordingly, the mask of the invention is advantageous from the standpoint that a relatively few sizes will accommodate virtually all patients.
Installation of the mask 10 may be quickly and easily acomplished. In surgical use, it is desirable to have auxiliary equipment leading 'to the nose or mouth. Typically, a naso-gastric tube 40 is employed. Normally, such a tube would first be inserted and secured in place as by the adhesive tab 42.
With the protective backing 36 peeled off to expose the adhesive 20, the coupling 12 is positioned centrally on the frontal portion of the face, as illustrated in FIG- URES 2 and 4. Because of the contours of the face, the base flange normally will not make continuous engagement with the face. Rather, inmost cases, it will engage the bridge of the nose at its upper end and the chin at its lower end.
Once the coupling is so positioned, the flap 14 is pressed or wiped firmly against the face so that it adheres thereto. By virtue of being pliable, it readily conforms to variations in facial contour. Moreover, it may be molded or formed tightly around the tube 40 in the manner shown in FIGURE? to block leakage along it. I
Since the flap 14 is formed from a flat sheet, while the face curves back away from the oro-nasal area and has many changes in contour, the flap will wrinkle somewhat as it is wiped against the face. However, this in no way detracts from sealing as the material adheres to itself in the wrinkled areas to close off any leakage paths. I
To supply gas to the patient, it is simply necessary to slip the cap 16, which, in turn, is connected by the hose 18 to auxiliary respiration apparatus, over the connecting flange 22 of the coupling 12. In this condition, illustrated in FIGURES l and 2, the breathing chamber 32 in the interior" of the mask is sealed except for the inlet-outlet passage leading to the respiration apparatus. It is significant to note that scaling in this case is not dependent upon the force exerted by the mask againstthe face. Rather, it is a matter of the sealing flap 14 adhering to the skin. By virtue of the nature of the construction of the mask 10, it is extremely light in weight. Further, it is only the weight of the mask and of a portion of the delivery equipment connected thereto, i.e., the base 18, that is supported on the face. In addition, the base flange 24 is arranged to flex slightly, as in FIGURE 2, to distribute the weight over a relatively broad area of contact with the face so as to reduce the unit pressure. This light weight and limited flexibility of the flange 24, together with the fact that the flap 14 is formed of a soft, pliable material, enables the mask to be worn comfortably even for prolonged periods.
Should it be desirable to obtain access to the nose or month, which is usually the case during a surgical procedure, the cap 16 is simply detached. As may be seen in FIGURE 4, the relatively large opening in the coupling 12 then affords convenient access. When it is subsequently desired to administer additional gas, the cap is slipped back over the connecting flange. As is apparent, repeated removal and installation of the cap in no way disturbs sealing between the disposable assembly 12, 14 which remains in place.
Following surgery, a patient is often taken to a recovery room where oxygen is administered. Should this be the case, the cap 1c is removed and the disposable assembly 12, 14 is left in place as the patient is moved. In the recovery room another cap 16, connected to suitable delivery apparatus, is attached to the connecting flange.
Following use, the disposable assembly 12, 14 is quickly and easily removed from the patient by peeling the sealing flap 14 off of the face. This assembly, which is relatively inexpensive to make, is then disposed, whereas the cap may be kept for subsequent use. In this connection, it will be appreciated that optimum conditions of sanitation are achieved since a new, sterile face-engaging assembly is employed for each patient. On the other hand, the re-usable cap is configurated so as to be readily adapted to be cleaned and sterilized.
While one embodiment of the invention has been illustrated and described in considerable detail, it will be understood that this is only by way of illustration, and that numerous changes in the details or" construction and arrangement may be made without departing from the spirit and scope of the invention. it is further noted in this connection that while the mask has been described as especially adapted for use in a medical environment, it has useful applications in many others, including aviation, industrial and military environments, among others.
1. A face mask, comprising:
a shallow ring-like coupling arranged to be positioned on the frontal port-ion of the face, said coupling, when so positioned, presenting an enlarged front opening encompassing the nose and mouth for affording convenient access thereto, the width of said opening in the region of said nose and mouth being substantially greater than the maximum height of said coupling;
means on said coupling and adapted for continuous engagement With the face outwardly of the coupling for retaining said coupling so positioned and for establishing and maintaining a sealing relationship between said coupling and the face;
a quick disconnect fitting receivable by said coupling for closing said front opening and cooperating with said coupling to provide a shallow breathing chamher in the interior of said mask;
and means for establishing an inlet-outlet passage from said chamber.
2. A face mask, comprising:
a shallow coupling formed of a relatively stiff material and arranged to be positioned on the frontal portion of the face, said coupling presenting a front opening encompassing the nose and mouth to afford conveninet access thereto, the width of said opening in the region of said nose and mouth being substantially greater than the maximum height of said coupling;
a sealing flap formed of a thin, pliable material secured to said coupling and extending outwardly therefrom about its entire perimeter, said flap being adapted to make substantially continuous engagement with the facial area surrounding the nose and mouth;
a pressure-sensitive adhesive on the face-engaging side of said flap for adhering said flap to the face in sealing relationship over the area of such continuous engagement;
closure means detacha'bly connected to said coupling and cooperating therewith to define a wall portion of a shallow breathing chamber in the interior of the mask;
and means on said closure means for establishing an inlet-outlet passage from said chamber.
3. The subject matter of claim 2 further characterized in that said flap is formed from a flat sheet of plastic of substantially uniform thickness.
4. The subject matter of claim 2 including a removable backing adhered to said adhesive on the face-engaging side of said flap for protecting the same prior to use.
5. A face mask, comprising:
a shallow ring-like coupling arranged to be positioned on the frontal portion of the face, said coupling, when so positioned, presenting an enlarged front opening of circular shape encompassing the nose and mouth for affording convenient access thereto, the diameter of said opening in the region of said nose and mouth being substantially greater than the maximum height of said coupling;
a sealing flap formed of a thin, pliable material secured to said coupling and extending outwardly therefrom about its entire perimeter, said flap being conformable to variations in surface contour so as to engage the facial area surrounding the nose and mouth;
means on the face-engaging side of said flap for removably adhering said flap to the face in the area of such engagement and thereby establishing a pressure seal between said coupling and the face;
and a quick disconnect means detachably connected to said coupling and cooperating with said coupling to provide a shallow breathing chamber within said mask, and means including an inlet-outlet passage to the interior of said mask.
6. A face mask, comprising:
a shallow coupling formed of a resilient and relatively stiff material and including an annular connecting flange of large inside diameter in the region of the nose and mouth in relation to its height and a base flange projecting radially outwardly a short distance from the lower end of said connecting flange, said coupling being adapted to be positioned on the frontal portion of the face with said base flange in engagement therewith and said front opening encompassing 7 8 the nose and mouth for affording convenient access 7. The subject matter of claim 6 wherein said quick thereto; disconnect means includes a closure cap telescopically rea sealing flap formed of a thin, pliable sheet material ceived in a close sliding fit by said connecting flange, and and secured to said base flange continuously around wherein the engaging wall surfaces of said cap and conthe entire perimeter thereof and extending outwardly 5 meeting flange are tapered inwardly from bottom to top. therefrom, said flap being conformable with varia- 8. The subject matter of claim 7 wherein at least said tions in surface contour so as to engage the facial area closure cap is formed of a transparent material. surrounding the nose and mouth; means on the face-engaging side of said flap for remov- References Cited ably adhering said flap to the face in the area of such 10 UNITED STATES PATENTS engagement and thereby establishing a pressure seal 1,465,316 8/1923 Rice 128 195 an h i zl z d i s oil h e t riez r d e ta e lf bl connect d to 4/1947 Lambertsen et a1 1282O5 y 6 3,049,121 8/1962 Brumfield et al 128146.2
said coupling and cooperating with said coupling to provide a shallow breathing chamber within said 15 RICHARD A. GAUDET Primary Examinermask, said means including an inlet-outlet passage to the interior of said mask. W. E. KAMM, Assistant Examiner.