WO1989011888A1

WO1989011888A1 - Mask for performing resuscitation

Info

Publication number: WO1989011888A1
Application number: PCT/US1989/002391
Authority: WO
Inventors: T. Anthony Donmichael
Original assignee: Donmichael T Anthony
Priority date: 1988-06-01
Filing date: 1989-05-31
Publication date: 1989-12-14

Abstract

A flexible, stretchable mask (30) that may be worn by a person assisting a victim of stopped breathing by administering mouth-to-mouth resuscitation. The mask (30) helps protect the rescuer from communicable diseases that the rescuer might otherwise contract and also makes the procedure more palatable to those concerned with mouth-to-mouth contact. The mask covers the lip and mouth area (16) of the rescuer and includes a one-way valve (18) that allows the rescuer to exhale air into the victim while preventing the rescuer from inhaling saliva from the victim. The mask is disposable, for maximum protection, is inexpensive, and does not require extensive training in its use.

Description

-I- HAS FOR PERFORMING RESUSCITATION

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to the field of medical devices and, more particularly, to devices for performing resuscitation.

2. Description of Related Art

As used herein, resuscitation refers to methods in which air is forced into the lungs of a victim of stopped breathing at regular intervals to provide the interchange of air necessary for respiration. If a victim of stopped breathing is to be saved from death, resuscitation must be quickly performed after the cessation of breathing. At times, the heart may also be stopped and then simultaneous cardiac resuscitation will also be necessary.

For providing resuscitation, the mouth-to-mouth technique has been in long use and a great portion of the population is familiar with its practice. The technique is not particularly difficult to learn and does not require special equipment. Therefore, the technique can be performed almost as quickly as a person acquainted with the technique can reach a victim. This is critical because, once breathing has stopped, permanent brain damage and death can occur in a matter of minutes. Unfortunately, the mouth-to-mouth technique requires mouth-to-mouth contact between rescuer and victim. This is unpalatable to many persons. Indeed, some feel the procedure is too unsanitary to perform. Many devices have been developed for performing resuscitation in which no mouth-to-mouth contact is required between rescuer and victim. These devices usually involve inserting some type of tube into the airway of a victim. Among these are intubation techniques, esophageal obturator airways, and the "bag valve mask" device. Intubating the trachea is superior in many respects. In this technique, an elongated tube is inserted from outside the body, through the neck,, and directly into the trachea, which is the air passage between the larynx and the bronchii of the lungs. This technique precludes air from being blown down the esophagus and into the stomach, is effective regardless of the victim's physical size, is not affected by aspiration of stomach contents, and quite effectively delivers air into the lungs. Unfortunately, successful performance of this technique requires a highly trained individual and typically is performed in a hospital setting where proper back-up systems and control over the environment can be maintained. Therefore, this technique has significant drawbacks in other settings, such as where a paramedic arriving at the scene of an accident is confronted with a non-breathing victim of cardiac arrest, drowning, or asphyxiation.

Another device for resuscitation is the eεophogeal obturator airway (EOA) . An EOA includes a long tube or conduit that is inserted into a victim's mouth and then down into the throat. The upper end^' of the conduit extending from the patient's mouth includes a face cup or flange that extends over the victim's mouth and nose area. The section of the conduit in the victim's esophagus has air openings, with the internal length of conduit below the openings being plugged. In this way, air may be forced down the conduit, out the air openings, and into the victim's lungs. Unfortunately, it is possible to mistakenly insert the EOA conduit into a victim's trachea, blocking the windpipe and preventing air from entering the lungs. With some EOA designs, gastric contractions against the conduit may cause rupture of the esphogaus. Finally, it may be difficult to obtain an effective, air-tight seal between the victim and the face cup or flange of the EOA. Without an air-tight seal, air can escape from between the victim's face and the mask, thus reducing the volume of air reaching the victim's lungs and hindering efforts to provide artificial respiration.

Another device for resuscitation is known as the bag valve mask, which comprises an air bag attached to an airway conduit that passes through a cup or a mask into a victim's esophagus. The cup is generally triangular in shape and is placed over the victim's mouth and nose area, one point of the triangle being placed over the bridge of the nose. The air bag may be squeezed so as to force air from the bag into the airway and into the victim's lungs. The cup has a one-way valve that prevents the victim's exhaled air from filling the bag and being forced back into the victim's lungs, but allows for the escape of exhaled air through the victim's nose and out of the cup. The volume of air delivered from the air bag is typically only one half liter of air, due to the typical person's grip size and arm strength for compressing the air bag. In contrast, a person using the mouth-to-mouth technique can typically exhale a full liter of air into the victim. Thus, the mouth-to-mouth technique is superior in this respect.

With most formed cups or flanges placed on the victim, maintaining an effective seal over the victim's mouth and nose area is difficult. In the case of the bag valve mask, it is especially difficult to maintain an effective airtight seal while simultaneously squeezing the air bag. Using straps or the like to fasten the cup or mask of the bag valve mask to the PCI7US89/02391 1888

-4-

victim still may not provide an effective seal because the victim's lips are typically flaccid or collapsed. The cup being pressed against flaccid lips does not seal effectively. Furthermore, it is dangerous to fasten the mask to the victim rather than actively hold the mask in place. If the mask is not actively held in place and monitored by a rescuer, the mask may slip or come.out of position during resuscitation without being noticed. Rescue efforts may continue without the realization that little air is reaching the victim's lungs. Therefore, persons trained in the use of the bag valve mask do not use the device without actively holding the mask in place, rather than fastening it to the victim. For this reason, the bag valve mask technique typically requires at least two persons to provide effective respiration. Thus, the mouth-to-mouth resuscitation technique is perhaps the best known and most effective technique, in terms of efficacy, training, and timeliness. As noted above, because the victim's lips and associated facial muscles are flaccid, virtually no flange or cup placed on a victim's face will produce a perfect seal. A nearly perfect seal, however, can be created by forming the lips of a rescuer into a pursed condition and covering the victim's mouth. The perfect seal is due in no small part to the rescuer's ability to close his lips over the mouth area of the victim and perfectly conform to the mouth.

The mouth-to-mouth technique is superior to tracheal intubation because it does not require a special hospital setting, provides an effective seal, and can be quickly and easily used with little training. The mouth-to-mouth technique is superior to the EOA device because it cannot result in damage to the esophogaus, cannot force air into the stomach, does not include any device that might mistakenly be inserted into the victim's stomach, and can be quickly and easily PCI7US89/02391 11888

-5-

υsed with comparatively little training. The mouth-to-mouth technique is also superior to the bag valve mask because mouth-to-mouth allows the rescuer to deliver a full liter of air into the victim's lungs, provides an effective seal, and can easily be performed by one person.

Although the mouth-to-mouth method has been billed as the "kiss of life" and its lifesaving capabilities are undisputed, some persons are still hesitant to perform the procedure on aesthetic grounds. In addition, recent concerns over Acquired Immune Deficiency Syndrome (AIDS) , and the concomitant heightened awareness of communicable diseases that may be spread by exchange of saliva, have brought the practice of mouth-to-mouth resuscitation virtually to a halt. Among the public at large, this means that no alternative procedures are typically used to assist non-breathing victims of cardiac arrest, asphyxiation, or drowning. Among paramedics and other medical personnel, this means less preferable methods such as the bag valve mask are being used. This means that the most effective technique available, and the most capable of saving lives, will not be performed. Thus, there is a need for a device that can be used with the mouth-to-mouth resuscitation technique that protects both victim and rescuer from exposure to communicable diseases and AIDS and makes the technique more palatable.

SUMMARY OF THE INVENTION

The present invention allows the mouth-to-mouth resuscitation technique to be used, with its superior seal and air volume, while significantly reducing the danger of coming into contact with the saliva of a victim. The present invention comprises a disposable, stretchable mask that fits over the rescuer's mouth and nose, and helps prevent the victim's saliva or other gastric secretions from penetrating through the mask and coming into contact with the rescuer. The mask allows a rescuer to exhale air into a victim via a one-way valve located in the mouth area of the mask. The mask and one-way valve provide a seal against exchange of the victim's saliva and that of the rescuer. The mask is flexible enough to allow the rescuer to use his lips to provide an effective airtight seal over the victim's mouth area. The rescuer can still provide the full volume of air possible into the victim. Other than placing the mask over the rescuer's face, no other change is necessary from the standard mouth-to-mouth resuscitation technique. Therefore, the mask can be quickly placed into widespread use with medical personnel and even the public at large without additional training. The mask itself is lightweight, inexpensive, and disposable. Thus, a rescuer need not worry about possible secretions from a previously unknown victim on whom the device was used.

The mask is made of a stretchable, pliable material, such as latex. This provides a close fit over the rescuer's face regardless of variations in size from rescuer to rescuer. The mask is held in proper position on the rescuer by holding means extending from the mask. The mask covers the rescuer's lip area and nose area, includes air holes for breathing by the rescuer, and stretches to extend over the rescuer's chin. Because the mask is stretchable, the mask fits tightly but comfortably over the rescuer's face. This allows the rescuer to perform other activities, such as heart massage for cardiopulmonary resuscitation and basic life support. The mask can be quickly and easily removed from the rescuer by pulling up on the chin area of the mask if the rescuer, for example, should feel faint or ill. If desired, the inner surface of the mask may be covered or lined with a material that prevents contact between a rescuer's skin and the mask material, in order to acco odate persons who are sensitive to the material from which the mask is constructed. The outer surface of the mask may be similarly covered inβtead of or in addition to the inner surface, and the coating may be selected so as to be hypoallergenic.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a perspective view of a first, embodiment of the present invention;

Figure 2 is a cross-sectional view of the Figure 1 mask in a fastened position.

Figure .3 is a perspective view of the reverse side of the Figure 1 embodiment of the present invention;

Figure 4 is a rear perspective view of a second embodiment of the present invention; and

Figure 5 is a perspective view of a third embodiment of the present invention.

DETAI ED DESCRIPTION OF THE DRAWINGS

Figure 1 shows a first embodiment of the present invention that covers a rescuer's face from just below the eyes to under the chin, and extends roughly from ear to ear. Figure 3 shows the reverse side of the mask, while a cross-sectional view is presented in Figure 2. The mask 10 includes a generally triangular shaped face portion 12 constructed from an inexpensive stretchable, generally water impermeable and flexible material, such as latex or "MYLAR". The mask is formed so as to conform to and fit closely over a rescuer's face. A front surface 12a of the mask faces outward, while a reverse or inner surface 12b of the mask is adjacent the rescuer's face. The mask 10 includes two straps 20, 22 to hold the mask securely in place. The straps extend from the edge of the mask near the rescuer's ears and are preferrably integrally formed with the mask. Figure 1 shows the straps positioned behind the rescuer's head with their free ends fastened together using a releasable fastening means, such as tabs of "VELCRO" material 24, 26 located on the ends of the straps. The mask includes nostril openings 14 to allow the rescuer to breathe through his nose and includes a lip area 16 formed in the shape of pursed lips. The pre-formed^" lip area helps ensure that the rescuer's lips can use the mask material to form an air-tight seal over the victim's lips.

The mask may be held in position by a single strap, as shown in Figure 4, rather than two straps joined together. The single strap 21 is positioned around the back of the rescuer's head and holds the mask in proper position on the rescuer. Since the mask itself is constructed of a stretchable material, the strap needn't stretch in order to be positioned behind the rescuer's head. If the strap itself does not stretch, the mask will momentarily stretch enough to pull the strap over the rescuer's head and thereafter the elastic pull of the mask will pull against the strap, keeping the mask in proper position.

The mask includes a one-way valve 18 located in the center of the lip area. The one-way valve comprises a short conduit with one end that extends from the reverse side of the mask, to be held in the rescuer's mouth, and the other end that extends from the front surface of the mask, to be inserted into the victim's mouth. The one-way valve is designed so that the rescuer can exhale air out through the valve but cannot inhale air or fluids back through the valve. In use, the one-way valve 18 is inserted into the victim's mouth, whereupon the rescuer can perform the mouth-to-mouth resuscitation technique.

The mask is formed so as to extend over and under the rescuer's chin. In this way, the rescuer's chin acts as a fastening or anchoring point over which the mask may be stretched and helps ensure a snug fit of the mask to the rescuer. This allows the rescuer to carry out most actions without the mask becoming an obstruction or hindrance. If the rescuer should feel faint or ill or for some other reason desires quick removal of the mask, the rescuer can simply grab the mask from under the chin area and pull forward and upward on the mask, thereby moving the mask away from the rescuer's mouth and nose area and allowing unencumbered breathing. The mask can then be lowered and rescue efforts resumed. The mask can also be completely removed in this way, by pulling the mask completely over the head of the rescuer. The mask can also be removed by pulling the strap 21 or the fastened straps 20, 22 completely over the head of the rescuer. Alternatively, the mask can be completely removed by unfastening the straps 20, 22. Either one of these embodiments may be easily removed from the rescuer and are preferred embodiments of the invention.

Figure 2 shows a cross-sectional view of the mask and more clearly illustrates the chin area of the mask. Figures 3 and 4 show a rear perspective view of the mask. From this view, the rear surface 12b of the mask is clearly visible. The rear surface is shown coated or flocked with a fibrous material 13 to accoroodate persons who are sensitive to the flexible material, for example latex, from which the mask is constructed. The coating, or lining, may be any material sufficient to prevent contact between the mask material and the rescuer's face and may also be selected so as to be hypoallergenic. For example, the lining may be cotton or wool fibers applied as a flocking. The lining also may be deleted, to save manufacturing costs.

Figure 5 shows a front perspective view of a third embodiment 30 of the present invention. The Figure 5 embodiment is a full face mask that extends from ear to ear and from under the rescuer's chin to cover the top of the rescuer's forehead. Again, the mask is formed out of flexible material such as latex, generally conforms to the shape of a rescuer's face, and includes a pre-formed lip area 16. The mask is provided with a one-way valve 18 in the lip area, nostril openings 14, and cutouts 31 for the rescuer's eyes. The mask is shown with a coating 15 on the outer surface to prevent contact between the victim's face and the latex material of the mask. The coating 15 may be the same as that described previously with respect to the Figure 3 and 4 embodiments.

The full face mask is provided with three straps 32, 34, 36. Two of the straps 32, 34 extend from the mask near the rescuer's ears, while the third strap 36 extends from the top of the mask near the forehead area. 11888

-12-

Preferably, the straps are integrally formed with the mask. The straps are pulled to the back of the rescuer's head to a common point of intersection, where they are fastened to each other by a releasable fastening means such as tabs of "VELCRO" material on each of the straps, thereby holding the mask in proper position. Alternatively, the straps may be formed as a single one-piece structure similarly to the Figure 4 embodiment. The full-face coverage provides an extra measure of protection for the rescuer from any gastric fluids from the victim. As with the previous embodiment, the inner surface of the mask may be lined with a material that prevents contact between the mask material and the rescuer's face. In practice, the rescuer places the mask in proper position over his face, fastens the mask in position, and places the end of the one-way valve in his mouth. Mouth-to-mouth resuscitation may then proceed in the typical manner. The pre-formed lip area allows the rescuer's lips to use the mask material in forming a substantially air-tight seal over the victim's mouth. When breathing air into the victim, the rescuer covers the victim's mouth with his own, while pinching shut the victim's nostrils. The portion of the one-way valve extending from the mask extends into the victim's mouth. The rescuer then exhales into the victim so as to fill the victim's lungs with air. When allowing the victim to exhale, the rescuer simply relaxes his lips and moves away from the victim, removing the one-way valve from the victim's mouth.

Because the disclosed mask creates little or no obstruction with the rescuer's movements, the rescuer may carry out other actions that may not otherwise be simultaneously possible. For example, when using the bag valve mask, it is recommended that one rescuer check for inflation of the lungs during compression of the air bag without simultaneously performing heart massage. A second rescuer ensures an air-tight seal with the mask against the victim. A third may perform heart massage. In contrast, the present invention allows a single rescuer to carry out simultaneous heart massage with the proper synchronization between heart massage and artificial respiration. Therefore, the present invention benefits not only artificial respiration but also cardiopulmonary resuscitation and basic life support.

For sanitary reasons, the mask should be discarded .after each use. Construction of the present invention fro relatively inexpensive materials makes this economically feasible. Thus, the mask is only used once and further helps to prevent the spread of disease.

Claims

WHAT IS CLAIMED IS:

1. A disposable device to be used by a rescuer while performing resuscitation on a victim of arrested breathing, the device comprising! protection means for preventing the passage of fluids between the mouth and face of the victim and the mouth and face of the rescuer and for preventing contact between the mouth of the victim and the mouth of the rescuer; and valve means in contact with said protection means for allowing the passage of air from the rescuer's lungs and mouth through said protection means and into the mouth and lungs of the victim, while preventing the inhalation of air and other fluids from the victim in a reverse direction.

2. A disposable device to be used by a rescuer while performing the mouth-to-mouth resuscitation technique on a victim of arrested breathing, the device comprising: a flexible, stretchable material that is impermeable to water and that is formed into a thin, pliable mask that generally conforms to the shape of a rescuer's lower face and completely covers the rescuer's mouth and lip area; and one-way valve means for allowing the one-way passage of air such that the rescuer may exhale air out said one-way valve means and into the victim's airway, but may not inhale air or fluids through said one-way valve means, said means comprising a valve extending through the mouth area of the mask.

3. A device as claimed in claim 2 further comprising holding means for securely holding the mask in proper position on the rescuer.

4. A device as claimed in claim 2 wherein the mask conforms to the shape of a rescuer's face and completely covers the rescuer's face from the forehead to the chin and from ear to ear.

5. A device as claimed in claim 2 wherein the stretchable material is latex.

6. A device as claimed in claim 2 wherein the surface of the mask adjacent the rescuer's skin is covered with a hypoallergenic material.

7. A device as claimed in claim 2 wherein the surface of the mask exposed when the mask is worn by the rescuer is covered with a hypoallergenic material.

8. A device as claimed in claim 3 wherein said holding means comprises at least two straps extending from the edge of the mask, the straps having releasable fastening means so that the ends of the straps may be releaβably fastened together.

9. A device as claimed in claim 3 wherein said holding means comprises a single strap extending from one edge of the mask to another.