Disposable Face Mask

Abstract

A disposable conductive anesthetic circuit is disclosed for eliminating respiratory infections caused by cross contamination from reuseable circuits. The disposable circuit is supplied in an hermetically sealed sterilized bag and includes an improved face mask having an elastomeric base covered with a conductive film, an improved two-piece fitting having a Y-shaped portion and an elbow portion, a pair of hoses bonded to the Y-shaped portion of the fitting, and a breathing bag.

Description

BACKGROUND

In a hospital operating room, respiratory infections caused by cross contamination from reuseable anesthetic circuits are a constant and serious hazard. Despite advances in cleaning and sterilizing procedures, there is no assurance that the problem has been effectively eliminated in reuseable equipment.

Additionally, reuseable circuits absorb gases such as the anesthetic during use. This not only increases induction time, but also results in the leaching into the circuit of the gases from a previous procedure. This may cause patient discomfort and/or materially interfere with the effectiveness of the anesthetic. In addition, over a period of time reuseable circuits tend to lose their conductivity as a result of repeated stretching, etc. This in turn increases the hazards of sparks, etc., from static electricity.

SUMMARY

The present invention provides means for overcoming the foregoing limitations and difficulties. More particularly, the present invention provides a disposable conductive anesthetic circuit which is economical to manufacture and is highly efficient in use. In the embodiment of the invention disclosed herein, a disposable conductive anesthetic circuit includes an improved face mask having an elastomeric base member with an encompassing sidewall, a closed top wall and an open bottom. The open bottom resiliently conforms to the contours of a wearer's face whereby it is highly effective to prevent the passage of air between the base member and the wearer's face. An aperture is provided in the top wall for receiving one end of the elbow bottom of a two-piece fitting having a Y-shaped portion and an elbow portion. The other end of the elbow portion is engaged on one leg of the Y-shaped portion and a pair of hoses are bonded to the other legs of the Y-shaped portion. This reduces handling time in the operating room and provides ease of induction from any plane or direction.

The mask is provided with a conductive film which covers at least a major portion of the outer surface area of the base member and which has an electrical resistance within a range of approximately 0-1 megohm. A retaining ring encompasses the aperture in the top wall and is held in place by a grommet which receives the elbow portion of the two-piece fitting. The retaining ring is provided with hooks for receiving a headstrap used to secure the mask in position on a wearer's face.

The circuit also includes a breathing bag and may be packaged in a sterilized bag.

DRAWINGS

FIG. 1 is a view of a disposable conductive anesthetic circuit embodying one form of the present invention with the face mask portion thereof in position on a wearer's face;

FIG. 2 is a plan view of an hermetically sealed package having the circuit of FIG. 1 contained therein;

FIG. 3 is a plan view, on a somewhat enlarged scale, of the face mask shown in FIG. 1;

FIG. 4 is a cross-sectional view, taken substantially along line 4--4 of FIG. 3, of the face mask shown in FIG. 1;

FIG. 5 is a bottom view of the face mask shown in FIG. 1;

FIG. 6 is an end view of the face mask shown in FIG. 1;

FIG. 7 is a cross-sectional view, taken substantially along line 7--7 of FIGS. 5, of the face mask in FIG. 1; and

FIG. 8 is an elevational view of a two-piece fitting used on the face mask of FIG. 3.

DESCRIPTION

Referring to the drawings in more detail and particularly to FIG. 1, the present invention is particularly adapted to be embodied in a disposable, conductive, anesthetic circuit 10. The embodiment of the circuit 10 disclosed herein includes a face mask 12 which may be positioned on the face F of a patient. The mask 12 is connected to a pair of flexible hoses 14 and 16 by a special fitting 18.

The circuit 10 also includes a breathing bag 19 which may be made by conventional methods. The breathing bag 19 is normally a suitable latex having a slightly tacky surface for ease of manipulation of the bag in an operating room. The bag 19 which may have a 3 liter capacity includes a hollow neck portion 20 that is adapted to frictionally engage a conventional down-leg 22 on a conventional anesthetic machine 24 having an outlet fitting 26. The fitting 26 also includes an inlet fitting 28 to which first the ends 30 and 32 of hoses 14 and 16, respectively, may be connected.

The anesthetic circuit 10 is preferably supplied in an hermetically sealed package 34. The present package 34 includes a transparent, plastic bag having an open top 36. The top 36 may be sealed with a conventional tear strip 38. As explained in more detail subsequently, the contents of the package 34, i.e., the anesthetic circuit 10, is completely sterilized while it is in the package 34. As a result when it is removed from the package 34, it is all ready for use without any further treatment.

The face mask 12 (FIGS. 3 to 7) which is a one-piece molding includes an elastomeric base member 40 having an encompassing side wall 42, a closed top wall 44 and an open bottom 46. The open bottom 46 is formed by the lower edge 48 of the side wall 42. The lower edge 48 is contoured to conform to the contour of the face F of the patient. The edge 48 has a fairly large radius and is very resilient. As a consequence, one size of mask is generally adequate to accommodate practically any human face with a sufficient degree of sealing to prevent the passage of air between the base member 40 and the face F.

The top wall 44 has an aperture 50 provided therein for receiving a suitable conduit means which includes grommet 52, two-piece fitting 18 and hoses 14 and 16. In the embodiment this includes a grommet 52 (FIGS. 3 and 4) made from any suitable material. For example, the grommet 52 may be of an electrically conductive polyethylene material having a durometer rating of approximately 72 or neoprene polymeric material having a durometer rating of 55. Either material must have an electrical resistance within a range of approxiamtely 0-1 megohm.

The grommet 52 includes a hollow, cylindrical core 54. The inner or lower end of the grommet 52 includes a rounded or toroidal surface 56. The outer or upper end includes a rounded or toroidal surface 58. The space between these two enlargements is approximately equal to the thickness of base member 40 adjacent aperture 50. Accordingly, the grommet 52 may be snapped into position in aperture 50 with a friction fit whereby the lower torus 56 is disposed on the inside of face member 40. The upper torus 58 is then disposed on the outside of the base member 40.

A shoulder 60 on the grommet 52 is effective to trap a strap support or headstrap-retaining ring 62 between upper torus 58 and top wall 44. The retaining ring 62 may be made from a suitable material, such as 20-gauge, cold-rolled, sheet steel which is zinc plated and provided with a chromate finish. Four hooks 64, 66, 68 and 70 (FIG. 3) are uniformly spaced around the plate member 72. An aperture 74 (FIG. 4) is provided in the center of the plate 72.

The face mask 12 also includes a conductive film 76 which covers at least a major portion of the outer surface area of base member 40. This film 76 has an electrical resistance within a range of approximately 0-1 megohm. The base member 40 may be made from a wide variety of materials. However, at the present time one of the preferred materials is a polyurethane foam material having a density of approximately 12-14 lbs. per cubic foot alternatively, the foam material may have a density of approximately 3 - 5 pounds per cubic foot.

It has been found desirable for the face mask 12 to be made from a water blown foam provided with a sprayed coating on the outside surface. Since a water blown foam is activated by moisture at room temperature, it may be formulated to produce a more flexible face mask than is produced with heat-activated foams.

The base member 40 is normally a cast or molded foam part. Accordingly, it may be coated with film 76 by spraying the molds before introducing foam into the cavities. Alternatively, the conductive film 76 may be sprayed onto base member 40 after it is removed from the mold. The conductive film 76 preferably has a 0.001 to 0.002 inch thickness and comprises a material having an electrical resistance in a range of approximately 0-1 megohm. The film must also have a minimum elongation of 80 percent to prevent cracking during elongation.

The two-piece fitting 18 (best seen in FIG. 8) includes an elbow-type fitting 78 having a first end 80 and a second end 82. The first end 80 is adapted to fit into the grommet 52 on the face mask 12. The elbow 78 is preferably slidably mounted in the fitting 84, and as a result the elbow 78 may be rotated relative to the fitting 84. The second end 82 is coupled to neck 86 of a Y-shaped fitting 84.

The fitting 84 has a pair of legs 88 and 90 on the side opposite from the neck 86. The two legs 88 and 90 are adapted to receive the ends 92 and 94 of the hoses 14 and 16. The surfaces of the legs 88 and 90 are preferably corrugated or serrated to insure the hoses 14 and 16 being retained in position. The neck 86 of fitting 84 in addition to accepting end 82 of elbow 78 has been designed to fit into and rotate in grommet 52 as an alternate assembly. The ID of neck 86 of fitting 84 and ID of end 80 of elbow 78 has been designed to accept intertracheal tubing connectors.

The fitting 18 may be made from any suitable material. However, it is preferably made from a plastic having an electrical resistance within a range of approximately 0-1 megohm. Although the hoses 14 and 16 may be made from any desirable material, it has been found advantageous to use an electrically conductive polyethylene material having an electrical resistance with a range of approximately 0-1 megohm.

In order to use the present invention the various parts of the anesthetic circuit 10 are sealed in the package 34. Because of the unique design and low cost, all of the parts are brand new. Normally, the mask 12, Y-fitting 84 and the two hoses 14 and 16 are preassembled before packaging. Although the breathing bag 18 is contained in the package 34, it is normally included as a separate item. The contents of the bag, i.e., the mask 12, the hoses 14 and 16, the Y-fitting 84 and the breathing bag 18 are all sterilized when they are in the package 34.

In order to use the anesthetic circuit 10 at the time of an operation, the package 34 is placed in the operating room preparatorily to the operation. When the operation is about to commence, the package 34 is opened by removing tear strip 38. As soon as this tear strip 38 is removed, all of the parts of the breathing circuit 10 are exposed and readily available. Since all of these have been previously sterilized, they are ready for use without any further preparation. The breathing bag 19 is removed and connected to the anesthetic machine 24 by frictionally sliding the bag fitting 20 of the bag 19 over the down-leg 22.

The assembly comprising mask 12, fitting 18, hoses 14 and 16 are then removed from package 34. The ends 30 and 32 of the hoses 14 and 16 are then frictionally slipped onto the fittings 28, 26, respectively, of the machine 24. The mask 12 may then be positioned on the patient's face F. Since the mask is made of a resilient foam, it is very easy to handle and use. It can be easily manipulated into position on the patient's face whereby it will be comfortable and always operate effectively.

The circulation of the anesthetic may then commence. If desired a suitable headstrap (not shown) may be engaged on hooks 64, 66, 68 and 70 and positioned behind the patient's head H.

At the completion of the operation, the face mask 12 is removed from the patient's face F and the circuit 10 is removed from the machine. Since all of the parts of this circuit 10 are very low cost, they are discarded upon the completion of the operation. As a consequence, the various parts of the circuit 10 are only used once. Therefore, the circuit cannot be contaminated by any prior usage, etc.

Claims

What is claimed is:

1. In a disposable conductive anesthetic circuit, the improvement which includes a face mask having

an elastomeric cup-shaped base member having an encompassing side wall, a closed top wall and an open bottom, said open bottom being conformable to the contours of a wearer's face for preventing the passage of air between said base member and said wearer's face, said base member being relatively soft, light in weight and having substantially all of its entire body formed of a one-piece deformable molding of polyurethane foam material and being sufficiently rigid to maintain its formation,

said closed top wall having an aperture provided therein for fluid communication with said base member, and

a conductive film covering at least a major portion of the outer surface area of said base member, said conductive film having an electrical resistance within a range of approximately 0-1 megohm.

2. The improvement of claim 1 wherein said polyurethane foam material is water-blown.

3. The improvement of claim 1 including

a retaining ring encompassing said aperture, said retaining ring having headstrap-receiving hook means provided thereon.

4. The improvement of claim 1 including

a grommet having a hollow, cylindrical core encompassed by a lower torus and an upper torus spaced from said lower torus a distance approximately equal to the thickness of said base member adjacent said aperture,

said grommet including means associated therewith for snap-fitting into position in said aperture with said lower torus disposed inside of said base member and said upper torus disposed on the outside of said base member, said grommet having an electrical resistance within a range of approximately 0-1 megohm.

5. The improvement of claim 4 including

a headstrap-retaining ring encompassing said grommet between said upper torus and said conductive film,

said retaining ring including headstrap-receiving hook means and having an electrical resistance within a range of approximately 0-1 megohm.

6. The improvement of claim 4 including

a two-piece fitting having an elbow portion and a Y-shaped portion, and

said elbow portion including a first end removably engaged in close-fitting relationship in the core in said grommet and a second end engaged in one end of said Y-shaped portion in slidable rotation thereto.

7. The improvement of claim 6 wherein

said base member is molded from a polyurethane foam activated by moisture at room temperature.

8. A disposable conductive anesthetic circuit, said circuit being connectable to an anesthetic machine and including the combination of

a face mask including an elastomeric cup-shaped base member having an encompassing side wall, a closed top wall and an open bottom, said base member being relatively soft, light in weight and having substantially all of its entire body formed of a one-piece deformable molding of polyurethane foam material and being sufficiently rigid to maintain its formation,

said open bottom being conformable to the contours of a wearer's face for preventing the passage of air between said base member and said wearer's face,

said closed top wall having an aperture provided therein,

a conductive film covering at least a major portion of the outer surface area of said base member, said conductive film having an electrical resistance within a range of approximately 0-1 megohm, and

conduit means having first ends connectable to said anesthetic machine and second ends connectable to said aperture.

9. The disposable conductive anesthetic circuit of claim 8 wherein said polyurethane foam material is water-blown.

10. The disposable conductive anesthetic circuit of claim 8 wherein said conduit means includes:

a grommet having a hollow, cylindrical core encompassed by a lower torus and an upper torus spaced from said lower torus a distance approximately equal to the thickness of said base member adjacent said aperture,

said grommet including means associated therewith for snap-fitting into position in said aperture with said lower torus disposed inside of said base member and said upper torus disposed on the outside of said base member,

said grommet having an electrical resistance within a range of approximately 0-1 megohm.

11. The disposable conductive anesthetic circuit of claim 10 wherein said conduit means further includes,

a two-piece fitting having an elbow portion and a Y-shaped portion,

said elbow portion having a first end removably engaged in close-fitting relationship in the core in said grommet and a second end engaged in one leg of said Y-shaped portion in slidable rotation thereto, and hose means connected to second and third legs on said Y-shaped portion.

12. The disposable conductive anesthetic circuit of claim 11 including

a headstrap-retaining ring encompassing said grommet between said upper torus and said base member.

13. The disposable conductive anesthetic circuit of claim 12 including

a breathing bag having an open neck portion communicating with said anesthetic machine.

14. A face mask for a conductive anesthetic circuit including conduit means for connecting said mask to an anesthetic machine, said mask including:

an elastomeric cup-shaped base member having an encompassing side wall, a closed top wall and an open bottom, said open bottom being conformable to the contours of wearer'face for preventing the passage of air between said base member and said wearer'face, said closed top wall having an aperture provided therein for receiving said conduit means, said base member being relatively soft, light-in-weight and having substantially all of its entire body formed of a one-piece deformable molding of polyurethane foam material and being sufficiently rigid to maintain its formation; and

a conductive film covering at least a major portion of the outer surface area of said base member, said conductive film having an electrical resistance within a range of approximately 0-1 megohm.

15. The face mask of claim 14 wherein

said base member is made from a polyurethane foam having a density of approximately 13 lbs. per cubic foot.

16. The face mask defined in claim 14 wherein said polyurethane foam material is water-blown.

17. The face mask of claim 14 including

a headstrap-retaining ring encompassing said aperture, said ring including headstrap-receiving hook means.

18. The face mask defined in claim 14 wherein said conduit means includes:

a grommet having a hollow, cylindrical core encompassed by a lower torus and an upper torus spaced from said lower torus a distance approximately equal to the thickness of said base member adjacent said aperture,

said grommet including means associated therewith for snap-fitting into position in said aperture with said lower torus being disposed inside of said base member and said upper torus being disposed on the upper side of said base member, said grommet having an electrical resistance within a range of approximately 0-1 megohm.

19. The face mask of claim 18 including

a headstrap-retaining ring encompassing said grommet between said upper torus and said conductive film,

said retaining ring including headstrap-receiving hook means and having an electrical resistance within a range of approximately 0-1 megohm.

20. The face mask of claim 15 wherein said conduit means further includes:

a two-piece fitting having an elbow portion and a Y-shaped portion, said elbow portion including a first end removably engaged in close-fitting relationship in the core in said grommet and a second end engaging one leg of said Y-shaped portion in slidable rotation thereto, and hose means engaging the other two legs of said Y-shaped portion.

21. The face mask of claim 20 wherein

said base member is molded from a polyurethane foam which may be activated at room temperature and which has a density within the range of approximately 3-5 lbs. per cubic foot.

22. In a disposable conductive anesthetic circuit, the improvement which includes a face mask having:

an elastomeric cup-shaped base member having an encompassing side wall, a closed top wall and an open bottom, said open bottom being conformable to the contours of a wearer's face for preventing the passage of air between said base member and said wearer's face, said base members being relatively soft, light-in-weight and having substantially all of its entire body formed of a one-piece deformable molding of polyurethane foam material, and being sufficiently rigid to maintain its formation,

said closed top wall having an aperture provided therein for fluid communication with said base member,

a conductive film covering at least a major portion of the outer surface area of said base member, said conductive film having an electrical resistance within a range of approximately 0-1 megohm,

a grommet having a hollow, cylindrical core encompassed by a lower torus and an upper torus spaced from said lower torus a distance approximately equal to the thickness of said base member adjacent said aperture,

said grommet including means associated therewith for snap-fitting into position in said aperture with said lower torus disposed inside of said base member and said upper torus disposed on the outside of said base member, said grommet having an electrical resistance within a range of approximately 0-1 megohm,

a two-piece fitting having an elbow portion and a Y-shaped portion, and

said elbow portion including a first end removably engaged in close-fitting relationship in the core in said grommet and a second end engaged in one end of said Y-shaped portion in slidable rotation thereto.

23. A disposable conductive anesthetic circuit, said circuit being connectable to an anesthetic machine and including the combination of:

a face mask including an elastomeric cup-chaped base member having an encompassing side wall, a closed top wall and an open bottom, said base member being relatively soft, light-in-weight and having substantially all of its entire body formed of a one-piece deformable molding of polyurethane foam material, and being sufficiently rigid to maintain its formation,

said open bottom being conformable to the contours of a wearer's face for preventing the passage of air between said base member and said wearer's face,

said closed top wall having an aperture provided therein,

a conductive film covering at least a major portion of the outer surface area of said base member, said conductive film having an electrical resistance within a range of approximately 0-1 megohm,

conduit means having first ends connectable to said anesthetic machine and second ends connectable to said aperture,

said conduit means including a grommet having a hollow, cylindrical core encompassed by a lower torus and an upper torus spaced from said lower torus a distance approximately equal to the thickness of said base member adjacent said aperture,

said grommet including means associated therewith for snap-fitting into position in said aperture with said lower torus disposed inside of said base member and said upper torus disposed on the outside of said base member,

said grommet having an electrical resistance within a range of approximately 0-1 megohm,

a two-piece fitting having an elbow portion and a Y-shaped portion, and

said elbow portion having a first end removably engaged in close fitting relationship in the core in said grommet and a second end engaged in one leg of said Y-shaped portion, in slidable rotation thereto, and hose means being removably connectable to second and third legs on said Y-shaped portion.

24. A face mask for a conductive anesthetic circuit including conduit means for connecting said mask to an anesthetic machine, said mask including:

an elastomeric cup-shaped base member having an encompassing side wall, a closed top wall and an open bottom, said open bottom being conformable to the contours of wearer's face for preventing the passage of air between said base member and said wearer's face, said base member being relatively soft, light-in-weight and having substantially all of its entire body formed of a one-piece deformable molding of polyurethane foam material and being sufficiently rigid to maintain its formation, said closed top wall having an aperture provided therein for receiving said conduit means,

a conductive film covering at least a major portion of the outer surface area of said base member, said conductive film having an electrical resistance within a range of approximately 0-1 megohm,

said conduit means including a grommet having a hollow, cylindrical core encompassed by a lower torus and an upper torus spaced from said lower torus a distance approximately equal to the thickness of said base member adjacent said aperture,

said grommet including means associated therewith for snap-fitting into position in said aperture with said lower torus being disposed inside of said base member and said upper torus being disposed on the upper side of said base member, said grommet having an electrical resistance within a range of approximately 0-1 megohm, and

a two-piece fitting having an elbow portion and a Y-shaped portion, said elbow portion including a first end removably engaged in close-fitting relationship in the core in said grommet and a second end engaging one leg of said Y-shaped portion, in slidable rotation thereto, and hose means removably engaging the other two legs of said Y-shaped portion.