# Patent

## Title
Multi-port, intubation-permitting, oxygen mask

## Abstract

A versatile, multi-port, intubation-permitting oxygen mask is provided including two diaphragms (nasal and oral) each configured with a continuous, flexible, modifiable membrane from which an instrument-access port may be manually constructed, when and if needed. The novel oxygen mask preferably includes a multiple-inlet port having a standard oxygen tube connector and an interchangeable breathing-therapy device connector, a carbon dioxide sampling port, an exhaust port, and a nose clip. The mask can be worn as a standard oxygen mask during traditional oxygen therapy, yet quickly converted into an intubation mask. The clinician manually perforates the nasal and/or oral diaphragm to create a point and size of entry perfectly matched to the requirements for a variety of procedures that may be performed involving nasally or orally introduced scopes or probes—without disturbing the ongoing benefits of increased oxygen saturation and continuous monitoring of expired gases.

## Background
CROSS-REFERENCE TO RELATED APPLICATION
This application claims the benefit of co-pending U.S. Provisional Patent Application Ser. No. 61/173,816, filed Apr. 29, 2009, which is incorporated herein in its entirety.


BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to a medical device, and more particularly, to an oxygen mask configured with two perforatable, modifiable membranes, which are beneficially positioned to allow nasal or oral procedures after manual configuration by an attending clinician at the time of the procedure.
2. Description of the Prior Art
Providing sufficient oxygen to a patient is vital. A nasal cannula can be used to provide supplemental oxygen, but at times it is necessary to use a standard oxygen mask (a face mask contoured to fit over a patient's nose and mouth) to deliver a higher concentration of breathable oxygen gas. For example, if a procedure is begun with nasal cannula, but then the patient begins to need more oxygen, switching to an oxygen mask at that time is difficult and does not provide optimum oxygen to the patient. Thus an oxygen mask that can be worn before and during procedures, plus is designed to allow any of a wide variety of anticipated or unanticipated scope, probe, and tube orotracheal or nasotracheal procedures, is highly advantageous.
Although, conventional intubation masks are available, they are not versatile. They are generally particularly designed for either oral entry or nasal entry and a specific type of scope, probe, or tube; therefore, if the situation changes, the chosen mask may not allow access to the necessary point of entry with the necessary medical device. The multi-port, intubation-permitting oxygen mask of the present invention provides complete choice to the attending clinician.
Further, other treatments and monitoring may be required, such as breathing-therapy treatments and monitoring of expired gases to determine the condition of the patient. While conventional intubation masks do not provide for these, the present invention advantageously is extremely versatile, allowing quick and easy connection of carbon dioxide monitors and of a variety of breathing-therapy devices such as might be required, for example, a non-rebreather bag, bubble humidifier, humidifier nebulizer, drug nebulizer, etc.
Accordingly, there is an established need for a highly versatile multi-port, intubation-permitting oxygen mask that allows the attending medical personnel to choose the correct point of entry, allows monitoring of expired gases, allows treatment by any of a variety of breathing-therapy devices, increases patient safety and comfort, and greatly increases inspired and expired oxygen percentages—thus insuring that the medical personnel can offer the widest range of options available for the safest treatment possible.
SUMMARY OF THE INVENTION
The present invention is directed to a versatile, multi-port, intubation-permitting oxygen mask that can be worn during standard oxygen therapy, with the option, if need arises, to be quickly converted into an intubation mask, without disturbing the ongoing benefit to the patient of the increased oxygen saturation achieved by wearing the oxygen mask. Plus, the novel oxygen mask of the present invention optionally enables the continuous monitoring of the expired gases through the carbon dioxide sampling port and the use of breathing-therapy devices.
The multi-port, intubation-permitting oxygen mask includes at least two novel modifiable diaphragms (a nasal diaphragm and an oral diaphragm) and a standard oxygen tube connector. Preferably the intubation-permitting oxygen mask also includes a multiple-inlet port (comprising an interchangeable breathing-therapy device connector and preferably the standard oxygen tube connector), a carbon dioxide sampling port, an exhaust port, and a nose clip. Each of the two diaphragms is configured with a thin, continuous, flexible, perforatable, modifiable membrane from which an instrument-access port may be manually constructed, when and if needed. The interchangeable breathing-therapy device connector allows attachment of any breathing-therapy device, such as, for example, a non-rebreather bag or nebulizer.
As the continuous membrane of either the nasal or oral diaphragm is manually perforated and modified by the clinician at the time of use, the point of entry and size of entry is completely under the control of the clinician, so can be perfectly matched to the requirements for any of the variety of procedures that may be performed involving any nasally or orally introduced scope or probe, such as, for example, esophagogastroduodenoscope (EGD), bronchoscope, fiber-optic endoscopy, transesophageal echocardiography (TEE), and awake intubation. The material of the diaphragm provides a partial but significant seal around the scope or probe, retaining the oxygen therapy advantages (after the clinician perforates the appropriate diaphragm for the procedure to be performed and the tube is inserted).
An object of the present invention is to provide a multi-port, intubation-permitting oxygen mask that can be adapted for use with a wide variety of medical scopes, probes, and tubes.
A further object of the present invention is to provide a multi-port, intubation-permitting oxygen mask that is inexpensive and disposable.
Another object of the present invention is to provide a multi-port, intubation-permitting oxygen mask that is configured to allow a clinician to quickly convert the multi-port, intubation-permitting oxygen mask from a standard oxygen mask to an endoscopic or intubation mask.
An additional object of the present invention is to provide for increased oxygen saturation.
A further object of the present invention is to provide a multi-port, intubation-permitting oxygen mask that may be configured to allow continuous monitoring of carbon dioxide of expired gases.
Another object of the present invention is to provide convenient nasal or oral access, allowing the attending clinical to choose the correct point of entry and size of entry as needed to perform any of a variety of procedures.
An additional object of the present invention is to provide a multi-port, intubation-permitting oxygen mask that may be configured to conveniently allow attachment of a non-rebreather bag to greatly increase inspired and expired oxygen percentages.
A further object of the present invention is to provide a high oxygen flow mask that does not need to be inflated, or to use positive pressure, function efficiently.
These and other objects, features, and advantages of the present invention will become more readily apparent from the attached drawings and from the detailed description of the preferred embodiments, which follow.



BRIEF DESCRIPTION OF THE DRAWINGS
The preferred embodiments of the invention will hereinafter be described in conjunction with the appended drawings, provided to illustrate and not to limit the invention, where like designations denote like elements, and in which:
FIG. 1 is a front view showing a preferred embodiment of the multi-port, intubation-permitting oxygen mask of the present invention;
FIG. 2 is a right side view showing the preferred embodiment of the multi-port, intubation-permitting oxygen mask of the present invention;
FIG. 3 is a left side view showing the preferred embodiment of the multi-port, intubation-permitting oxygen mask of the present invention;
FIG. 4 is a perspective view showing the preferred embodiment of the multi-port, intubation-permitting oxygen mask of the present invention in use; and
FIG. 5 is a perspective view showing the preferred embodiment of the multi-port, intubation-permitting oxygen mask of the present invention in a second use.



Like reference numerals refer to like parts throughout the several views of the drawings.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Shown throughout the figures, the present invention is directed toward a versatile, multi-port, intubation-permitting oxygen mask having two membrane-covered diaphragms that is usable as a standard oxygen mask, but, if the need arises, it is quickly and easily convertible to an intubation mask by manual creation of an instrument-access port by perforating and adapting the continuous modifiable membrane of the nasal or the oral diaphragm to fit the instrument to be used in the particular medical procedure. For example, scopes, probes, and tubes such as used for the following procedures are conveniently accommodated: esophagogastroduodenoscopy (EGD), awake intubation, fiber-optic endoscopy, transesophageal echocardiography (TEE), bronchoscopy, and other orotracheal or nasotracheal intubations. The novel multi-port, intubation-permitting oxygen mask is designed to provide an increase in a patient's oxygen saturation before and during intubation. Further, the available optional multiple ports offer convenient optional connections for other medical devices that may be needed.
Referring now to FIG. 1, the multi-port, intubation-permitting oxygen mask, shown generally as reference number 10, is illustrated in accordance with a preferred embodiment of the present invention. As shown, the multi-port, intubation-permitting oxygen mask comprises the following elements: a mask body 19, a nasal diaphragm (with nasal modifiable membrane 25); and an oral diaphragm 20 (with oral modifiable membrane 30); a multiple-inlet port 21 configured with two connectors (a standard oxygen tube connector 11 and an interchangeable breathing-therapy device connector 12); a carbon dioxide sampling port 31; an exhaust port 17; a nose clip 16; and two strap attachments 13, 14. The novel mask is preferably lightweight, comfortable to wear, ergonomically shaped, and disposable.
The generally concave mask body 19 is preferably molded of a generally gas-impermeable material, such as non-toxic medical grade plastic polymer material (i.e., silicone or polyvinyl chloride [PVC]). The mask material is preferably transparent to allow clinicians to observe the patient's condition. The mask body 19 and connections and attachments are preferably disposable. The two strap attachments 13, 14 are configured to receive a conventional adjustable elastic retaining strap to secure the mask body to the patient's head. The two strap attachments 13, 14 are disposed on opposing sides of the mask body 19 and are preferably integrally molded with mask body 19.
The mask body 19 has a peripheral edge 23, a nasal aperture (nasal diaphragm 15 occluded or sealed by nasal modifiable membrane 25), an oral aperture (oral diaphragm 20 occluded or sealed by oral modifiable membrane 30), an outer surface 27, and an inner surface (the inwardly facing surface generally opposing outer surface 27, which defines a cavity adapted to fit over the mouth and at least the lower region of the nose of a patient). The surrounding peripheral edge 23 is preferably contoured so as to substantially seal against the surrounding facial tissue of the patient, to thereby establish an interior chamber portion. The mask body 19 has a nasal zone and an oral zone, in the general areas of the nose and mouth of the patient when the mask is placed in position on the patient's face. The peripheral edge 23 may, optionally, have an enhanced seal, such as, for example, an air cushion or foam.
The mask body 19 preferably has an adjustable nose clip 16 disposed in the upper nasal zone, which can be adjusted to conform to the nose to stabilize the multi-port, intubation-permitting oxygen mask in position on the patient's face.
A carbon dioxide sampling port 31 is optionally, but preferably disposed in a generally central area of the mask body 19. This positioning near the nostrils of the patient allows accurate sampling of the expired gases breathed into the cavity formed by the mask body 19.
The multi-port, intubation-permitting oxygen mask 10 also preferably includes a multiple-inlet port 21. The multiple-inlet port preferably comprises both a standard oxygen tube connector 11 and an interchangeable breathing-therapy device connector 12.
The standard oxygen tube connector 11 is configured to accept a standard oxygen tube 34 (FIG. 4), allowing the breathable oxygen gas from a storage tank to flow to the patient through the connector 11. Conventionally, the oxygen tubing 34 has a proximal end fitted with a funnel shape connector for easy connection to the standard oxygen tube connector 11. The standard oxygen tube connector 11 is, optionally, a fixed connector or a swivel connector. The multi-port, intubation-permitting oxygen mask 10 can be used with up to approximately 15 liters of oxygen per minute.
The interchangeable breathing-therapy device connector 12 is configured to allow attachment of one of a number of conventional breathing-therapy devices, as required in the particular medical situation. Also, a first breathing-therapy device 33 (FIG. 4) may be attached to connector 12 for a first period of time, then removed, and a second breathing-therapy device may then be attached. The breathing-therapy device 33 that can be connected to connector 12 include, for example, a non-rebreather bag 37, bubble humidifier, humidifier or drug nebulizer 39, etc. Use of the non-rebreather bag with the novel oxygen mask, increases inspired and expired oxygen percentages by 300% for the patient with respiratory issues.
A cap 29 is preferably initially installed on the interchangeable breathing-therapy device connector 12, which is removable for usage of the connector 12.
One or more exhaust ports 17 are disposed in a generally central area of the mask body 19, allowing expired gases to be discharged. The exhaust port(s) 17 may include a one-way valve or may include perforations allowing free flowing of the expired gases. The exhaust port(s) 17 may be formed integrally with the molded mask body 19 or may be non-removably inserted into the mask body 19.
The nasal diaphragm 15 and oral diaphragm 20 are both configured with a thin, continuous, flexible, perforatable, modifiable membrane 25, 30. Preferably the modifiable membrane is formed of a plastic polymer material having a degree of elasticity that allows the membrane 25, to enfold the tube, scope, or probe, after being manually perforated to fit the particular tube or probe to be used. The diaphragm material provides a partial but significant seal around the scope or probe, allowing increased oxygen saturation for the patient.
The nasal diaphragm 15, disposed in the nasal zone of mask body 19, is positioned to accommodate nasotracheal intubations; the oral diaphragm 20, disposed in the oral zone of mask body 19, is positioned to accommodate orotracheal intubations. As the membrane 25, 30 of either the nasal 15 or oral diaphragm 20 is manually perforated and modified by the clinician at the time of use, the point of entry and size of entry is completely under the control of the clinician, so can be perfectly matched to the requirements for any of the variety of procedures that may be performed.
To use the novel multi-port, intubation-permitting oxygen mask 10, the novel mask 10 is positioned on a patient's face covering the mouth and at least a portion of the nose with the inner surface 40 toward the patient's face. The nose clip 16 is modified to fit the patient's nose and the elastic retaining strap (connected to the mask 10 at strap attachments 13, 14) is used to secure the mask body 19 to the patient's head. The novel mask 10 can be used as a standard oxygen mask and worn routinely during oxygen therapy, and then, without interruption, used for an unanticipated intubation; or it can be placed on the patient in anticipation of an intubation.
First an oxygen tube is connected to the oxygen tube connector 11 of multiple-inlet port 21, delivering oxygen to the patient. If intubation is needed, the attending clinician determines the procedure to be performed and notes the tube, scope, or probe to be used. The clinician then perforates the modifiable membrane(s) 25, 30 of the appropriate diaphragm(s) (nasal diaphragm 15 and/or oral diaphragm 20) to create an instrument access point 35, 38. The instrument 36 is then advanced into the oral orifice or nasal orifice of the patient (in correspondence to the procedure to be performed.) If desired, a tube 32 from a carbon dioxide monitor (such as a capnograph) is attached to the carbon dioxide sampling port 31. Further, if needed, cap 29 is removed and a breathing-therapy device 33 is attached to the interchangeable breathing-therapy device connector 12.
The intubation procedure then proceeds, with the multi-port, intubation-permitting oxygen mask 10 providing oxygen to the patient, allowing continual monitoring of expired gases, and allowing use of a breathing-therapy device 33 (FIG. 4), such as a non-rebreather bag, thereby greatly increasing the inspired and expired oxygen percentages.
From the foregoing, it will be apparent that the multi-port, intubation-permitting oxygen mask 10 of the current invention provides an inexpensive, disposable novel mask 10 that provides a standard oxygen mask that also allows convenient nasal or oral access while providing high oxygen flow, without using positive pressure or inflation. The novel mask is well-suited for use with a wide variety of medical scopes, probes, and tubes. The unique modifiable membranes 25, 20 of the nasal diaphragm 15 and oral diaphragm 20 allow a clinician to quickly convert the multi-port, intubation-permitting oxygen mask from a standard oxygen mask to an endoscopic mask.
Since many modifications, variations, and changes in detail can be made to the described preferred embodiments of the invention, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the scope of the invention should be determined by the appended claims and their legal equivalents.

## Claims

1. A face mask for delivering breathable gas to a patient, comprising:
a concave mask body having a peripheral edge, an outer surface, and an inner surface defining a cavity, adapted to fit over the mouth and at least the lower region of the nose of a patient;
a nasal diaphragm sealed by a continuous, perforatable, modifiable nasal membrane from which an instrument-access port can be manually constructed;
an oral diaphragm sealed by a continuous, perforatable, modifiable oral membrane from which an instrument-access port can be manually constructed; and
a standard oxygen tube connector configured to allow a tube delivering breathable gas to be attached.

2. The face mask for delivering breathable gas to a patient, as recited in claim 1, further comprising a carbon dioxide sampling port configured to allow monitoring of expired gasses.

3. The face mask for delivering breathable gas to a patient, as recited in claim 1, further comprising an exhaust port.

4. The face mask for delivering breathable gas to a patient, as recited in claim 1, further comprising a nose clip to assist in retaining said face mask on a face.

5. The face mask for delivering breathable gas to a patient, as recited in claim 1, wherein said face mask is disposable.

6. The face mask for delivering breathable gas to a patient, as recited in claim 1, further comprising a multiple-inlet port configured with an interchangeable breathing-therapy device connector adapted to allow fluid communication between a breathing-therapy device and said cavity formed by said inner surface.

7. The face mask for delivering breathable gas to a patient, as recited in claim 6, wherein said standard oxygen tube connector is disposed on said multiple-inlet port.

8. The face mask for delivering breathable gas to a patient, as recited in claim 6, wherein said breathing-therapy device comprises a non-rebreather bag.

9. The face mask for delivering breathable gas to a patient, as recited in claim 6, wherein said breathing-therapy device comprises a nebulizer.

10. A method for providing a breathable gas to a patient, comprising:
providing a face mask configured with an oral diaphragm sealed with a continuous, perforatable oral modifiable membrane, a nasal diaphragm sealed with a continuous, perforatable nasal modifiable membrane, and a standard oxygen tube connector;
placing said face mask over the face of said patient; and
attaching a tube delivering breathable gas to said standard oxygen tube connector; and
supplying breathable gas to said patient.

11. The method for providing a breathable gas to a patient, as recited in claim 10, further comprising:
perforating one of said oral modifiable membrane and said nasal modifiable membrane to create an instrument-access port, with the perforation selection based on an intubation procedure to be performed; and
inserting an instrument associated with said intubation procedure through said instrument-access port; and
advancing said instrument into either the oral orifice or nasal orifice of said patient while supplying said breathable gas to said patient.

12. The method for providing a breathable gas to a patient, as recited in claim 11, wherein said face mask is further configured with a carbon dioxide sampling port and further comprising attaching a tube from a carbon dioxide monitor to said carbon dioxide sampling port.

13. The method for providing a breathable gas to a patient, as recited in claim 12, wherein said face mask is further configured with an interchangeable breathing-therapy device connector and further comprising attaching a breathing-therapy device to said interchangeable breathing-therapy device connector.

14. The method for providing a breathable gas to a patient, as recited in claim 13, wherein said breathing-therapy device comprises a nebulizer.

15. The method for providing a breathable gas to a patient, as recited in claim 14, wherein said breathing-therapy device comprises a non-rebreather bag.