Abstract:
A supplemental air diffusion device is shaped and configured to be attached to the body or clothing of a patient below the head and deliver supplemental air toward the mouth and nose of the patient. The supplemental air diffusion device includes a frustroconicoidal air diffusion body that has a smaller inlet opening at an inlet end and an enlarged diffusion opening at a diffusion end. An air inlet stem is integrally attached to the air diffusion body and includes a plurality of ribs and/or recesses for releasably locking a female connector of an air supply hose over the inlet stem. A pair of spaced-apart slits are provided through a flange extending laterally from an outer surface of the air diffusion device. Initially separate accessory patient attachment clamps are looped through the slits and provide for releasable attachment of the air diffusion device to a patient&#39;s clothing. A kit may include an air diffusion device, one or more accessory patient attachment clamps, and an air supply hose for establishing fluid communication between the air diffusion device and an air supply.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    1. The Field of the Invention 
         [0002]    The present invention relates to diffusion devices, kits and methods for delivering supplemental air to a patient. 
         [0003]    2. The Relevant Technology 
         [0004]    Maintaining a sufficient oxygen supply is critical to sustaining human life. While most people can easily obtain sufficient oxygen through normal breathing of ambient air, there are circumstances where ordinary breathing cannot provide adequate oxygen. Patients are often given supplemental air enriched with oxygen. The need for supplement air can be caused by many different conditions, including lung disease, trauma, hazards such as smoke inhalation, and premature birth. Supplemental air can also be used to deliver a medicament to a patient. 
         [0005]    Supplemental air is typically administered by delivering oxygenated air from a tank to the mouth and/or nose of the person. There are two principle ways supplemental air is administered to a person. One technique uses an oxygen mask that covers the person&#39;s nose and mouth. The oxygen mask typically allows the person to breathe surrounding air while delivering supplemental air to the space between the mask and the patient&#39;s face. The supplemental air mixes with the air being inhaled to ensure adequate oxygenation of the patient. Oxygen masks are commonly made of a translucent plastic. They typically have a connector on the outside that allows a hose to be attached and an outlet on the inside of the mask for delivering the supplemental air. They may have an elastic cord that wraps around the back of the head to secure the mask to the patient. 
         [0006]    While oxygen masks are very effective at delivering supplemental air to a patient, they can be uncomfortable, awkward, unsightly, and pose health risks for some patients. Some patient&#39;s can feel claustrophobic or anxious when hoses and/or devices are attached to their face or head. Infants and young children tend to pull them off as they are typically averse to objects covering their faces. Adults might use them while in a hospital, bedridden or otherwise out of sight of others, but may be averse to wearing them in public, particularly in social settings where they may draw negative attention and cause embarrassment. Masks muffle speech and inhibit normal conversation. From a safety standpoint, masks that cover the patient&#39;s face can make it difficult for caretakers to discover foreign objects or debris, such as food, vomit or mucous, that might be accidentally inhaled by the patient or that might obstruct the diffusion of supplement air 
         [0007]    To avoid some of the problems associated with masks, patients can be given supplemental air through a nasal device, i.e., tubes inserted into the nostrils and taped to the patient&#39;s face. Rather than covering the entire mouth and nose, the nasal device delivers supplemental air to only the nose. Nasal air delivery devices permit viewing of the mouth and allow the patient to talk more easily. However, such devices require nasal breathing by the patient to obtain supplemental air. Nasal delivery devices also suffer from negative social stigma, as they are both unsightly and emit audible bursts of air. Infants and young children tend to rip the tubes out of their noses, thereby destroying their effectiveness. 
         [0008]    One attempt to avoid the disadvantages of masks and nasal devices utilizes a food grade funnel jerry-rigged with a universal connector stuffed into the smaller end, often with the aid of tape to hold it in place, to which is attached a hose that supplies oxygen enriched supplemental air. This improvised funnel device is laid on the chest of an infant and supplemental air is blown out the enlarged funnel opening toward the face of the infant. 
         [0009]    Because the improvised funnel device does not cover the infant&#39;s face, infants do not notice it and tend to leave it in place, at least while sleeping on their backs. However, even small movements can cause the improvised funnel device to fall off the infant&#39;s chest, creating a dangerous situation for infants who require supplemental air to live. Consequently, the improvised funnel device generally cannot be used while the infant is awake or otherwise prone to move. It requires careful attention and/or frequent monitoring by a health care provider. Unless taped to a patient&#39;s body (e.g., by winding surgical tape around the funnel and patient&#39;s chest), the device cannot be used by a patient in a sitting, standing or other upright position, but only while supine on the patient&#39;s back. Tape may not always stick well to a patient&#39;s shirt, or it may stick too well and leave adhesive residue. 
         [0010]    Another problem with the improvised funnel device is that the universal connector is merely provisionally attached and can easily become detached or leak. Leakage can cause waste and/or result in insufficient supplemental air reaching the patient. Detachment can result in total cessation of supplemental air to the patient, which can result in harm or death. 
         [0011]    In view of the foregoing, there is a tremendous need, long felt in the art, to provide improved devices and methods for delivering supplemental oxygen to a patient. 
       BRIEF SUMMARY OF THE INVENTION 
       [0012]    The present invention relates to supplemental air diffusion devices that overcome some or all of the aforementioned problems. The supplemental air diffusion devices include an inlet stem to which a supplemental air hose can be attached, a frustroconicoidal diffusion body integrally attached to the inlet stem, and attachment means on the diffusion body for attaching accessory patient attachment devices to the diffusion body. The invention provides for ready and secure attachment of the diffusion device to a patient while in many different positions, reliable diffusion of supplemental air to the patient without the risk of leaking or detachment of the inlet stem, and easy removal of the device from the patient. The diffusion device can be attached so as to not block or cover any part of the patient&#39;s face (e.g., on the chest below the neck). 
         [0013]    The inlet stem of the diffusion device advantageously includes coupling means for releasably locking a female coupler of an air supply hose thereto. In one embodiment, the coupling means comprise a plurality of ribs and/or recesses formed on an outer surface of the inlet stem. In use, the ribs and/or recesses on the inlet stem form a male connector which interlocks with one or more corresponding ribs and/or recesses associated with an inner surface of a female connector on an end of the air supply hose. The inlet stem can be tapered to permit progressively tighter fit between the inlet stem and the female air supply hose connector as the female connector is inserted over the inlet stem. The inlet stem may include a stop, such as an annular ridge, that limits the distance the inlet stem can be inserted into the female connector. 
         [0014]    The inlet stem is advantageously formed integrally with the frustroconicoidal diffusion body to prevent the inlet stem from becoming detached during use. The diffusion device may include stiffening means for preventing bending or collapse of the inlet stem relative to the diffusion body while inserting the inlet stem into the female connector of the air supply hose. An example of stiffening means are one or more raised stiffening ribs molded into the surface of, and bridging the interface between, the diffusion body and inlet stem. The stiffening means can also prevent bending or detachment of the inlet stem from the diffusion body while attached to and/or being removed from the female connector of the air supply hose. 
         [0015]    The diffusion body is generally frustroconicoidal and has a smaller inlet opening at one end into which supplemental air is introduced from the inlet stem and an intermediate body portion that expands to an enlarged diffusion opening through which the supplemental air can be diffused toward a patient&#39;s face. The increase in size of the frustroconicoidal diffusion body from the smaller inlet opening to the enlarged diffusion opening causes a decrease in velocity of the supplement air stream as it diffuses to fill the volume of the diffusion body. An enlarged column of supplement air exits the diffusion opening and moves toward the vicinity of the patient&#39;s mouth and nose at a controlled velocity. 
         [0016]    The attachment means provide for attachment of one or more accessory patient attachment devices to the diffusion device. Examples of means for attaching an accessory patient attachment device to the diffusion device include one or more slits, holes, snaps, Velcro®, adhesive, permanent weld, or combinations thereof formed on the air diffusion body and/or on a flange extending laterally from the air diffusion body. 
         [0017]    The accessory patient attachment devices are configured and provide means for removably attaching the diffusion device to a patient. Examples of accessory patient attachment devices and means for removably attaching the diffusion device to a patient&#39;s include one or more snaps, buttons, clips, clamps, Velcro®, or combinations thereof. The one or more accessory patient attachment devices may be integrally or removably connected to the diffusion device. One example of an accessory patient attachment device comprises a spring-loaded clamp that clips onto a patient&#39;s clothing and a flexible strap that can be attached to the diffusion device (e.g., by being looped through a recess in the air diffusion body or a recess in a flange extending laterally from a side of the diffusion body). The flexible strap includes a snap, Velcro® or other interlocking feature for securing the strap to the diffusion device. The accessory patient attachment device may also include an elongate strap that can wrap around and provide direct attachment of the diffusion device to the patient&#39;s body. 
         [0018]    According to one particularly useful embodiment, the attachment means provides for attachment of multiple spaced-apart accessory patient attachment devices to the air diffusion body. This allows the diffusion device to be attached to a patient&#39;s body or clothing at spaced-apart points or regions of connection (e.g., 2), which greatly increases positional stability of the device compared to a single point of attachment. Providing multiple points or regions of connection greatly reduces the degree of freedom of movement of the diffusion device compared to a single point of connection, which may allow a diffusion device to flop back and forth in response to patient movements. Reducing the degree of freedom of movement increases comfort to the patient and more reliably directs the supplement air flow toward the person&#39;s mouth and nose. 
         [0019]    The diffusion device may be advantageously formed from a transparent polymer, which provides greatly improved ability to see if emesis or other foreign debris might have fallen into the diffusion body and/or inlet stem, which could potentially block the flow of supplemental air and compromise the ability of the patient to receive supplemental air. 
         [0020]    In an alternative embodiment, the diffusion device may have a pre-attached air supply hose. The supply hose may be removably or integrally attached to the inlet stem of the diffusion device. In one embodiment, the outer wall of the inlet is stepped to provide a smaller outer diameter at the tip and a larger diameter up the wall to increase tightness of fit between the inlet stem and air supply hose. An end of the air supply hose can be attached over and glued or otherwise integrally connect onto the outer wall of the inlet stem. An elongate main portion extends from the inlet end for attachment to an air supply. 
         [0021]    The invention also includes a method for delivering supplemental air to a person. The method includes providing a supplemental air diffusion device as described herein, attaching one end of an air supply hose to the inlet stem and another end of the air supply hose to a supplement air supply, and attaching the diffusion device to the clothing or body of a person with the diffusion opening directing supplemental air toward the mouth and nose of the person. In the case where initially separate accessory patient attachment devices are used, they are first attached to the diffusion device and then used to removably attach the device to the patient&#39;s clothing or body. 
         [0022]    Because the supplemental air diffusion device is securely attached below the person&#39;s face, the person can move about and assume different positions without compromising the ability to obtain supplemental air. The ability of the inventive diffusion device to remain in place near a patient&#39;s face is particularly beneficial in the case of infants who require supplemental air to stay alive. Compared to conventional masks and nasal tubes, a person can talk and socialize with minimal intrusiveness and does not appear like an obvious invalid, which can greatly improve confidence in social settings. 
         [0023]    The invention further includes kits for use in delivering supplemental air to a patient. An exemplary kit includes a supplemental air diffusion device as discussed herein, an air supply hose having a connector at one end for coupling the air supply hose to the inlet stem of the diffusion device, and one or more accessory patient attachment devices as described herein, or which are generally known in the art for use in attaching badges or other devices to a person&#39;s clothing, for use in removably and securely attaching the diffusion device to a person&#39;s clothing or body. 
         [0024]    The inventive devices, kits and methods advantageously allow persons to non-intrusively receive supplemental oxygen without having to wearing a mask over their face or having tubes stuffed into their nose. Such devices, kits and methods can provide supplemental air whether the person is standing or sitting, conscious or unconscious. The inventive devices, kits and methods are particularly advantageous for use with infants and small children because the diffusion device is less likely to be removed by the infant or child as they are not connected to the head or face of the infant or child. The diffusion devices are far more aesthetically pleasing compared to masks or tubes. The devices of the invention also provide improved safety for patients since health care provides can more easily examine the airway of a patient using the device and/or can observe objects that may be blocking the optimal flow of air through the diffusion device. This is particularly true in the case where the device is made from a transparent material. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0025]    To further clarify the above and other advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which: 
           [0026]      FIG. 1  illustrates a perspective view of a supplemental air diffusion device according to one embodiment of the invention; 
           [0027]      FIG. 2  illustrates a bottom perspective view of the air diffusion device of  FIG. 1 ; 
           [0028]      FIG. 3  illustrates a top view of the supplemental air diffusion device of  FIG. 1 ; 
           [0029]      FIG. 4  illustrates a side elevational view of the air diffusion device of  FIG. 1 ; 
           [0030]      FIG. 5A  is a cross-sectional view of the air diffusion device of  FIG. 1 ; 
           [0031]      FIG. 5B  is a cross-sectional view of an alternative embodiment of a supplemental air diffusion device according to the invention; 
           [0032]      FIG. 5C  is a cross-sectional view of another alternative supplemental air diffusion device according to the invention; 
           [0033]      FIG. 5D  is a cross-sectional view of another alternative supplemental air diffusion device according to the invention having an air guiding extension; 
           [0034]      FIGS. 6A and 6B  illustrate exemplary accessory patient attachment devices that may be used to attach a supplemental air diffusion device to a patient&#39;s clothing; 
           [0035]      FIG. 7  illustrates a kit that includes a supplemental air diffusion device, accessory patient attachment devices, and an air supply hose tubing configured for coupling the supplement air diffusion device to a supplemental air supply; 
           [0036]      FIG. 8A  illustrates a diffusion device attached to an infant&#39;s clothing providing supplemental air to the infant; and 
           [0037]      FIG. 8B  illustrates a diffusion device attached around an infant&#39;s body providing supplemental air to an infant. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0038]    The present invention is directed to devices for delivering supplemental air to a patient, methods for using the device, and kits including the device. The supplemental air diffusion device is shaped and configured for attachment to the body or clothing of a patient and to direct supplemental air toward the mouth and nose of a person without being connected over the head or face of the patient. 
         [0039]    For purposes of this invention, the term “frustroconicoidal” is strictly not limited to shapes that are precisely defined by the term “frustroconical”. Rather, “frustroconicoidal” includes, but is not limited to, conical-like shapes that have a circular or semicircular cross-section, a v-shaped cross-section, a parabolic cross-section, a stepped cross-section, among others. 
         [0040]      FIGS. 1 and 2  show perspective views of a supplemental air delivery device  10  according to one embodiment of the invention. Supplemental air delivery device  10  includes a frustroconicoidal air diffusion body  12  having an air diffusion end  14  and an air inlet end  16 . Air diffusion end  14  defines an enlarged diffusion opening  18 , and air inlet end  16  defines a smaller inlet opening  20 . Air diffusion body  12  defines an outer wall that generally increases in size, and bounds an inner passageway, extending between inlet opening  20  and diffusion opening  18 . 
         [0041]    Integrally attached to diffusion body  12  is an inlet stem  22  proximal to inlet end  16 , which includes a stem opening  23  in fluid communication with inlet opening  20 . Inlet stem may be tapered on both the inner and outer walls. 
         [0042]    Diffusion opening  18  can be any size and shape so long as it is sufficiently large to direct a desired amount of supplemental air toward a patient&#39;s face (i.e., mouth and nose). Body  12  increases in size from inlet end  16  toward diffusion end  14 .  FIG. 3  is a top view of diffusion device  10 , illustrating exemplary diameters of the diffusion opening  18 , inlet opening  20 , and stem opening  23  according to one embodiment of the invention. As shown in  FIG. 3 , diameter  24  of diffusion opening  18  is substantially larger than diameter  26  of inlet opening  22 , which is larger than diameter  27  of stem opening  23 . The expansion of body  12  between inlet opening  20  and diffusion opening  18 , and to some extent the increasing inner diameter of inlet stem  22 , allow the diffusion device to reduce the flow speed of air traveling out of device  10  compared to air flowing into device  10 . 
         [0043]    The desired diameter of diffusion opening  18  can depend on the volume of air being delivered to the patient and the age of the patient. For example, diffusion openings with smaller diameters are typically used with infants and small children, while larger diameter diffusion openings can be used with older patients. In one embodiment, the diameter  24  of the diffusion opening  18  is greater than 5 cm, more preferably greater than 7.5 cm, and most preferably greater than 10 cm. 
         [0044]    The diffusion device  10  also includes one or more flanges (e.g., flanges  28   a  and  28   b ) extending from air diffusion body  12 . Flanges  28   a  and  28   b  include slits or openings  30   a  and  30   b  (collectively slits or openings  30 ). The slits  30  provide means for attaching accessory patient attachment devices to diffusion device  10 . Flanges  28  can have any shape or thickness and slits or openings  30  can have any size or shape so long as the openings  30  can be formed in flanges  28 . 
         [0045]    In a preferred embodiment, device  10  includes at least two flanges for use connecting diffusion device  10  to a patient via accessory patient attachment devices. Providing more than one attachment point for connecting device  10  to the body or clothing of the patient is advantageous as it prevents device  10  from swiveling from side to side when a person wearing the device leans from side to side. In one embodiment, the flanges are proximate to the center of gravity of the device. In another embodiment, the flanges  28  are positioned near the proximal end  14  of the device  10 . 
         [0046]    Turning now to  FIG. 4 , the air diffusion body is shown having a bell-shaped outer wall portion  36  and inlet stem  22  is shown to include coupling means integrally formed therein. In one embodiment, coupling means  32  include a plurality of ribs  34   a - 34   d.  The stem  22  can be tapered and/or the ribs  34  can have an increasing diameter such that the ribs  34  form a tighter fit from the distal toward the proximal rib (i.e., an increasingly tighter fit from rib  34   a  to  34   d ) as a connector of an air supply hose is inserted over the inlet stem  22 . Ribs  34  can be configured to couple with a female connector  56  of an air supply hose  56  ( FIG. 7 ). In a preferred embodiment, the coupling means  32  are integrally formed into the inlet stem  22  of diffusion device  10  to prevent leaking or inadvertent decoupling during use, as can occur if the coupling means are a separate device attached to inlet stem  22 . 
         [0047]      FIG. 4  also shows stiffening means, attached to the air diffusion body  12  and air inlet stem  22 , for preventing bending or collapse of the inlet stem  22  relative to the diffusion body  12  while inserting the inlet stem  22  into a female connector of an air supply hose. As illustrated, the stiffening means may comprise one or more raised stiffening ribs (e.g., stiffening ribs  38   a - 38   c ) molded into the surface of, and bridging the interface between, the diffusion body  12  and inlet stem  22 . 
         [0048]    Diffusion device  10  is not limited to a device having a conical shape diffusion body. Frustroconicoidal air diffusion body  12  can have any shape with an enlarged opening at the proximal end that tapers to a smaller inlet opening for introducing air.  FIGS. 5A-5D  provide example alternative embodiments of the invention.  FIG. 5A  illustrates a device  38  with a conical or substantially v-shaped cross-section. The cross-section of device  38  in  FIG. 5A  has a generally linear taper.  FIG. 5B  alternatively shows a device  40  having a substantially parabolic cross-section.  FIG. 5C  shows a device  42  having a stepped cross-section.  FIG. 5D  shows a device that also includes an air guiding wall extension built into the air diffusion body in order to help direct air flow toward the patient&#39;s mouth and nose. 
         [0049]    The invention also extends to frustroconicoidal devices that have shapes other than those illustrated in  FIGS. 5A-5D . For example, the diffusion device is not limited to symmetrical cross sections. The diffusion device can have a regular or irregularly shaped horizontal cross-section. In one embodiment, the horizontal cross-section is a circle. Alternatively the horizontal cross-section can be a semicircle. 
         [0050]    The diffusion device of the invention may be used in conjunction with one or more accessory patient attachment devices, which are used for attaching the diffusion device to the body or clothing of a patient.  FIGS. 6   a  and  6   b  illustrate exemplary accessory patient attachment devices  44  and  44 ′ for attaching diffusion device  10  to a patient. Accessory patient attachment devices  44  and  44 ′ include a strap  46 , a male snap  48 , female snap  50 , and a clamp  52 . Strap  46  can be secured to flanges  28  by inserting strap  46  into slit or opening  30 . Snaps  48  and  50  can then be connected to secure strap  46  to device  10 . Clamp  52  or  52 ′ is then available for attachment to clothing on a patient. Strap  46 , snaps  48  and  50 , and clamps  52  and  52 ′ can be made of any material including plastic, metal or ceramic. 
         [0051]    Alternative configurations of accessory patient attachment devices  44  can be used. Patient attachment device  44  can be any length. Patient attachment device  44  can have two clamps or two snaps instead of one of each type of fastener. In one embodiment, a clamp can be used that is spring loaded to provide a desired clamping force. Alternatively the clamp can be made of memory plastic where the memory of the plastic provides the clamping force. Any means for attaching the accessory patient attachment device to the diffusion device and patient, including those disclosed herein and others known to those of ordinary skill in the art. Other examples of suitable connectors include buttons, Velcro® (i.e., hook and look systems), adhesives, and polymeric welds. The patient attachment device my include a strap that wraps around the patient&#39;s body rather than attaching directly to clothing. 
         [0052]    The present invention also includes kits for delivering supplemental air to a patient using the air diffusion device of the invention. As illustrated in  FIG. 7 , the kit may include an air diffusion device  10 , one or more patient connectors  44   a,    44   b,  and an air supply hose  56 . Air supply hose  56  is shown having a female connector  58  that is configured to engage coupling means  32  on inlet stem  22  of device  10 . Patient connectors  44   a  and  44   b  are configured to attach to device  10  through slits or openings  30 . According to other embodiments of kits according to the invention, either the air supply hose  56  or connectors  44  are merely optional. 
         [0053]    Device  10  can be made of any material that is compatible with the air supply being used and suitable for use on a person. Examples of suitable materials for making device  10  include polymers and metals. Biocompatible polymers are preferred. An example of a suitable material for manufacturing the diffusion device  10  includes a highly clarified polypropylene random copolymer. According to one embodiment, the diffusion device is advantageously made from a transparent material. Manufacturing device  10  from a transparent material may be advantageous in the case where it is desirable for a health care provider to view the inside of the device (e.g., to check for sputum, emesis or other foreign materials that might block air flow through the diffusion device  22 . In one embodiment, the polymer is FDA food grade and does not contain latex. 
         [0054]    In a preferred embodiment, diffusion device  10  is manufactured as a single integrated piece including the frustroconicoidal air diffusion body and the inlet stem. A single integrated piece can be achieved by manufacturing the diffusion device using injection molding. Forming the diffusion device as an integral, one-piece unit is advantageous because it eliminates the need to seal the joint between a separately formed coupling device and the inlet stem. Furthermore, an integrally formed coupler eliminates the risk that the coupler will leak or separate from the device during use. 
         [0055]      FIG. 8A  shows the use of a supplemental air diffusion device  10 , accessory patient attachment devices  44 , and air supply hose  56  to provide supplemental air to an infant. Accessory patient attachment devices  44  are connected to respective openings in the flanges extending form an outer surface of device  10 . Accessory patient attachment devices  44  are also connected to the clothing of the infant. Device  10  is thereby connected to the infant at a point below the head of the infant, with the diffusion opening  18  positioned so as to direct supplemental air toward the face of the infant. Preferably the diffusion device is attached to the patient with the diffusion opening near the patient&#39;s chin such that air is efficiently delivered to the patient&#39;s mouth and nose, but not so close to the face so as to bother the infant and trigger a response that would compromise the efficacy of the device. 
         [0056]    Air supply hose  56  is connected to the inlet stem of supplemental air device  10 . The end of air supply hose opposite device  10  can be connected to any known air supply. In one embodiment, the air supply hose is connected to an air tank with an enriched supply of oxygen. The air tank can include a regulator to release oxygenated air at a desired flow rate and/or at prescribed intervals. The air supply system can also include a nebulizer or other device for introducing a medicament into the air being delivered to the patient. 
         [0057]    During use, air supplied by hose  56  enters diffusion device  10  through inlet stem  22  at a relatively high flow rate. The air is diffused as it passes through the frustroconicoidal-shaped body. Because the diffusion opening  18  is much larger than the inlet into stem  22 , the flow of air leaving device  10  through opening  18  is much slower than the flow in hose  56 . Diffusion opening  18  is sized, shaped, and positioned to deliver the diffused air toward the mouth and nose of the patient. The fasteners on patient connector  44  ensure that the position is maintained during use. 
         [0058]      FIG. 8B  illustrates an accessory patient attachment device that includes an elongate strap that can wrap around and provide direct attachment of the diffusion device to the patient&#39;s body. 
         [0059]    The diffusion device of the invention allows a health care provider to effectively deliver supplemental air to a patient. Although the diffusion device does not provide a seal around the mouth of the patient, the amount of air can be adjusted to account for supplemental air lost to the surrounding air. The amount of supplemental air delivered to the patient is calculated based on the predicted amount of air lost to the surrounding air. The flow rate can be determined by the health care practitioner. 
         [0060]    The present invention advantageously allows a health care provider to deliver a consistent amount of supplemental air to a patient. Because the supplemental air diffusion device connects to the body or clothing of a patient instead of the head, the patient is much less likely to remove the device without permission from the health care provider. The air delivery device of the invention can be safer for a patient to use since the patient is more likely to maintain a supplemental air supply over a longer period of time. In many cases the benefits of maintaining a substantial flow of supplemental air outweigh the disadvantage of not sealing the air diffusion device around the patient&#39;s mouth and nose. 
         [0061]    The air diffusion device can be positioned in places other than the chest where the patient&#39;s position requires a different placement. For example, in some situations, the patient&#39;s head may be turned to the side of the body for a lengthy period of time. In this case, the supplemental air diffusion device can be positioned near the shoulder area of the patient to better deliver supplemental air to the patient. 
         [0062]    The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.