Abstract:
Methods for delivering medication to an infant using a nasal mask and infant soother device, e.g., a pacifier. The nasal mask is drawn into sealing contact with the infant&#39;s face as the baby sucks on the soother device. The medication is delivered to a small dead space created by the mask for inhalation by the infant.

Description:
BACKGROUND OF THE INVENTION  
         [0001]    Aerosol medications of all kinds are used to treat lung diseases or use the lung as a portal of entry to treat systemic disease. One of the most important conditions for which aerosols are used commonly is asthma, a condition for which first line therapy is inhaled beta 2- agonist bronchodilators and inhaled steroids. Asthma is a very common condition in babies and infants, more common than in older children or adults. However, most devices for administering aerosol medication to babies are derived from those developed initially for delivery of asthma medication to adults and older children. Most, if not all, such devices, whether liquid nebulizers or designed for use with metered dose inhalers (MDIs) include the use of masks covering the mouth and the nose for the delivery of the medication. However, recent studies have shown by means of radiolabelled medication of aerosol delivery to the lungs, that the use of current masks is inefficient with newborns and other very young infants, most of the medication being deposited on the infant&#39;s face. Furthermore, babies tend to object to having a face mask firmly applied to their face and often begin to cry. These factors greatly decrease the efficiency of aerosol medication delivery to their lungs.  
           [0002]    If a nebulizer and face mask are used to provide inhaled aerosols to a spontaneously breathing infant, it is vital that the mask be snugly attached to the face to insure adequate delivery. Studies have shown that with liquid nebulization even a 1 centimeter distance from the face decreases the dose delivered by 50 percent or more. Furthermore, nebulizers in infants tend to have the same disadvantages as in older children, namely, high cost, need for a power supply, lack of portability, complexities of assembly, loading and duration of administration. Infants are not very patient and do not like to sit still for prolonged periods of 10 to 20 minutes usually required for nebulization of liquid solutions. This makes the MDI with a valved holding chamber and mask the delivery system of choice in this age group.  
           [0003]    The addition of a face mask to conventional valved holding chambers has gained considerable acceptance from practitioners for the treatment of infants. However, it is recognized that the presently available devices are less than ideal because infants do not readily accept the face mask (at least initially). For infants up to the age of about two years the mask must remain on the face tightly for at least three to six breaths, approximately 20 to 30 seconds, which may be difficult to achieve with a squirming and often crying infant at least until he gets used to it.  
           [0004]    Infants prefer to breathe through the nose until at least 18 months of age and are easily capable of sucking from the breast or bottle while breathing normally. Sucking is a very soothing activity for most babies. Sucking is performed during feeding or as a pacifier. We have designed devices that will allow a combination of sucking activity of the baby while at the same time ensuring that medication is delivered to the respiratory tract of the infant while the infant is relatively content. The devices are comprised of a 145 milliliter widely used valved holding chamber attached to a nasal mask (aerochamber).  
           [0005]    Alternatively the holding chamber may not have an integral valve, but both its inhalation and exhalation valves could be contained within the masks. When the baby sucks on the bottle or soother, the mask is pulled tightly onto the nose, and surrounds the nostrils of the baby, ensures that the aerosol that has been sprayed into the holding chamber will be drawn into the baby&#39;s lungs with each breath through the nose during approximately 20 seconds (five to six breaths). A mask and holding chamber would have an attachment that would extend downwards around the baby bottle or come onto the nipple so that any feeding bottle or nipple could be used. A set screw would allow the bottle to be adjusted in such a manner that the nasal mask would fit snugly, but without undo pressure around the infant&#39;s nostrils when the nipple of the bottle or soother is being sucked on vigorously. The resulting self-administered (but caregiver facilitated) seal between the mask and the face around the nostrils would provide an excellent opportunity for actuation of the metered dose inhaler into the aerosol holding chamber, and delivery of the mediation when the baby inhales during approximately five or six breaths.  
           [0006]    Most babies and infants are obligatory nose breathers most of the time (with the exception of infants with nasal obstruction due to the common cold, etc., or while crying) and it is therefore more logical to emphasize the nasal route for inhalation when devising an MDI accessory aerosol delivery system. Indeed, even when a face mask is used, the aerosol is actually inhaled most of the time through the nose. The face mask thus has a much larger dead space than necessary which in situations of low tidal volume, such as in neonates or infants can considerably reduce the efficiency of delivery of aerosol medication. A small mask that preferentially directs the aerosol towards the infant&#39;s nose is thus superior to a face mask. Furthermore, aerosol delivered by means of a face mask must pass across the lower half of the face to get to the nostrils. Much of the steroid is thus actually delivered to the skin of the face, and there have been case reports of steroid side effects such as acne under these conditions. By using a nasal mask or a system that directs the aerosol towards the nose, this problem would be minimized or eliminated since the aerosol would pass directly into the nares and from there into the lungs.  
           [0007]    By way of background, inhaled therapy is the mainstay of asthma management. Traditionally, most inhaled medication has been delivered by small volume wet nebulizers which are relatively bulky, expensive and not always available when needed because of their limited portability. Metered dose inhalers are much more efficient, convenient and less expensive. The main problem with “press and inhale” metered dose inhalers is a need to coordinate aerosol discharge and inhalation. This problem has been solved in recent years by valved holding chambers that can be filled with aerosol from which the patient inhales, and thus receives a medication. These devices disassociate aerosol delivery into the aerosol holding chamber from inhalation, and so improve the reliability of aerosol administration. The use of a one-way valve system provides for inhalation from the aerosol holding chamber during normal breathing followed by exhalation via another valve in the mask. This permits aerosol to be delivered to infants and children during tidal breathing provided that an appropriate mask is used to seal the innerface between the aerosol delivery system and the infant&#39;s face around the mouth and nose. This system works very well with older children and adults who can be taught to inhale by mouth. However, it is less effective with neonatals and newborns who preferentially breathe through the nose.  
         SUMMARY OF THE PRESENT INVENTION  
         [0008]    It is the principal object of the present invention to utilize a nasal mask with an existing aerochamber. The nasal mask directs the aerosol of medication droplets or dry particles to the nose and thus does not deposit medication on parts of the face remote from the nose. It also has the smallest total mask volume and thus smallest dead space of any inhaler system used for delivering medication to infants.  
           [0009]    Furthermore, it is an object of the present invention to provide an adapter for holding a nasal applicator, and for also holding a bottle of milk or water or infant soother (rubber or plastic nipple) to ensure that the nasal mask is applied by the sucking activity of the infant (a soothing activity for a young child).  
           [0010]    The nasal mask which we use is attached to an aerosol holding chamber having a volume of 25 milliliters to 250 milliliters. There is an inspiratory and expiratory valve integral to the mask or to the device, or there may be an inspiratory valve on the holding chamber and an expiratory valve as an integral part of the nasal mask to insure that the aerosol is delivered to the infant on inspiration only. The nasal mask would have an important advantage of greatly reducing the volume of the mask dead space, compared to the usual face mask (from about 15 to 50 milliliters, to about 5 to 10 milliliters) and so would improve aerosol delivery efficiency. This is very important for improving aerosol therapy in infant patients. An additional advantage that would be extremely important to the patient is the combination of the nasal mask for aerosol delivery with an infant bottle and rubber nipple, or soother, so that when the infant sucks the nasal mask is applied firmly to the face around the nose. Infants up to the age of about 18 months are virtually obligatory nose breathers, so the aerosol would be delivered efficiently to a relatively contented child. It has been shown that if the infant is presented with aerosolized medication while it is crying, virtually none of the drug gets to the lungs. By contrast, if the child is breathing quietly and is comfortable the aerosol delivery to the lungs is relatively efficient.  
           [0011]    To these ends, the principle of exclusively nasal administration of aerosolized medication is combined with a technique for the child to suck while breathing the medication. All of the possible permutations and combinations such as the use of a bottle with liquid in it and a rubber nipple, or even the possibility of breast feeding while the nasal mask is applied to the nose, are to be considered. Alternatively, a soother could be clamped to the nasal mask.  
           [0012]    Furthermore, the invention is applicable to the use of either wet medication, or dry, powdered medication. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWING FIGURES  
       [0013]    The present invention will best be understood with reference to the following drawings when taken in connection with the ensuing specification, wherein:  
         [0014]    [0014]FIG. 1 is a side elevation view, partially in section, showing the use of the mask with a holding chamber and also a bottle of milk or water;  
         [0015]    [0015]FIG. 2 is an end elevation view taken along the lines  2 - 2  in FIG. 1;  
         [0016]    [0016]FIG. 3 is a view in perspective of the holding device for the mask and a bottle;  
         [0017]    [0017]FIG. 4 is a side elevation view similar to FIG. 1 showing the nasal mask being used with breast feeding;  
         [0018]    [0018]FIG. 5 is an end elevation view taken from the left side of FIG. 4, showing how the device would be oriented with breast feeding;  
         [0019]    [0019]FIG. 6 is a side elevation view of an alternative embodiment of the invention;  
         [0020]    [0020]FIG. 7 is an end elevation view of the embodiment of FIG. 6 viewed along lines  7 - 7  in FIG. 6; and  
         [0021]    [0021]FIG. 8 is a side elevation view of a self-contained nipple. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0022]    Reference first should be had to FIG. 1- 3 , wherein there is shown a typical embodiment of the present invention. The device shown includes a holder  10  for two vessels. The holder  10  includes devices for securing a holding chamber  12  and a bottle  14 . The holding chamber  12  may be built along the lines taught by Nowacki, et al., in U.S. Pat. No. 4,470,412 and includes an inhalation valve at the exit end of the structure. The devices are all applied to a baby or infant  16  having a nose  18  and a mouth  20 .  
         [0023]    The bottle  14  may be uniform diameter and cylindrical, and has at the exit end a nipple  22  intended to be held in the mouth of the child. Aligned holes  24  and  26  are provided in the exit and entrance walls of the holder  10  which is shown as being of rectangular construction. O-rings  28  and  30  fit in these holes to receive the bottle  14 . These O-rings provide a loose fit for the bottle  14 , and a set screw  36  bears against the side of the bottle to clamp it in place, taking up the loose fit of the O-rings  28  and  30 .  
         [0024]    Above the openings for the bottle there are openings  38  and  40  in the end walls of the rectangular holder  10 . O-rings  42  and  44  are received in the holes  38  and  40  to provide a loose fit for the chamber  12 , which is adapted to receive the medication. The O-rings  42 ,  44  receive the body of the chamber  12 , which is cylindrical in shape, and a setscrew  46  bears against the side of the chamber  12  to hold it in the O-rings.  
         [0025]    At the inlet of the chamber  12  there is a universal back  48  made of rubber and adapted to receive an L-shaped fitting  50 , as shown in FIG. 1. The fitting  50  is configured to carry a replaceable MDI  52  (Metered Dose Inhaler). The Metered Dose Inhaler contains a certain amount of asthma medication, and when one pushes down on the MDI a metered dose of aerosolized medication is discharged into the interior of the chamber  12 . The MDI may be of the type that holds a liquid droplet aerosol, or it may be designed to contain a dry powder. The chamber  12  is large enough that the medication is thoroughly dispersed with the air within the chamber before it is inhaled.  
         [0026]    At the exit end of the chamber  12  there is a nasal mask in the form of a cup-shaped housing  54  which fits over the nose  18  of the infant, preferably leaving little room around the nose to minimize the dead space of the mask, as discussed above. This results in efficient aerosol delivery, yet there is very little exposed skin which can be contacted by the medication dispensed by the chamber  12 . Most of the medication thus enters the infant&#39;s nose directly and much more of it is deposited in the infant&#39;s or baby&#39;s lungs, thereby greatly improving the efficiency of the device. Also, there is much less chance of steroid effect on the skin as so little skin is exposed to the drug particles.  
         [0027]    Referring to FIGS. 4 and 5, the holder  10  may be used without change even while the baby is nursing at the mother&#39;s breast  98  with a nipple  58  inserted in the baby&#39;s mouth. It is only necessary to pivot the device a few degrees about the chamber  12  to retain a good fit of the mask  54  on the baby&#39;s nose, with the bottle  14  pivoted somewhat away from the mother&#39;s breast. The bottle  14  may either remain in place in its holder, as shown, or it may be removed from the holder  10  prior to use of the device with breastfeeding. Whether the baby is receiving milk from the mother&#39;s breast, or milk or water from a bottle, or even sucking on a rubber or plastic nipple, such as from a pacifier, she will be soothed. She will not be frightened or in an anxious state from the mask  54  (which receives medication from the chamber  12  placed over her nose. As such, in contrast to current devices, the invention will allow the baby to almost certainly tolerate the 20 seconds of drug administration (5-6 breaths) and, therefore, is more likely to improve asthma control or provide relief from an asthma attack.  
         [0028]    It will be understood that the mask  54  may be supplied in different sizes and possibly shapes to accommodate the nose of any baby imaginable, and said nipples may also occur in different sizes for different size children.  
         [0029]    Another embodiment of the invention makes use of a nipple actually built into the mask. In an alternative construction of the invention, the mask is still applied to the face (as with current nose/mouth masks) but an inner mask configured to fit around the nose is located within the outer mask. The soother can be molded into the rim of the mask, becoming a permanent part of it. Alternatively, an opening in the mask rim would allow the nipple of the baby bottle to be inserted to provide milk (or water) while sucking. This would pull the mask towards the infant&#39;s face and form a seal against the skin (aided if necessary by the mother or other caregiver).  
         [0030]    With reference to FIGS. 6 and 7, one possible construction according to such alternative embodiments includes an aerochamber  82  in communication with a source of medication  84  and a face mask  60 . An outer molded part of the face mask  60  is provided with an integral socket  80  designed to hold the aerochamber  82 , the latter having an L-shaped fitting to receive an MDI (metered dose inhaler)  84 . The face mask  60  supports a nasal mask  78  which is adapted to be placed over a baby&#39;s nose without surrounding the baby&#39;s mouth. The face mask  60  is molded rubber or plastic and is shaped as an oval funnel (i.e., it is higher than it is wide) designed to fit over both the nose and mouth of a baby or infant.  
         [0031]    The nasal mask  78  will flex up and down to a limited degree to ensure that it is a proper fit on the nose due to the rubber or plastic nature of the material of the molding  68 , while the rim of the molding seals out the ambient air. The nasal mask  78  operates the same as the nasal masks  12 ,  54  described above.  
         [0032]    At a lower part of the face mask  60  is a portion  64  configured and shaped to hold a nipple  66  with the tip  68  of the nipple in the baby&#39;s mouth. The nipple  66  will act as a pacifier and has a flange  74  (FIG. 7) coupled to the mask portion  64 . The nipple  66  also has a bulbous part  72  disposed opposite the tip  68  and received in the mask. In an alternative arrangement (not shown), the nipple  66  may be attached to a baby bottle by the bulbous part  72  of the nipple (FIG. 7) and the flange  72 . A double (or split) wall  74  extends against the bottom of the nipple to insure resistance to sucking on the nipple.  
         [0033]    In use, the small mask  78  is designed to just fit over the baby&#39;s or infant&#39;s nose and will be pulled in to form a very close fit with the nose upon inhalation. The outer molded part of the face mask is provided with an integral socket  80  designed to hold an aerochamber  82 , having an L-shaped fitting to receive an MDI (metered dose inhaler)  84 . The nasal mask  78  will flex up and down to a limited degree to ensure that it is a proper fit on the nose due to the rubber or plastic nature of the material of the molding, while the rim of the molding seals out the ambient air. The face mask  78  operates the same as the face mask  54  to deliver medication to the baby&#39;s nose during inhalation.  
         [0034]    [0034]FIG. 8 illustrates a design for a self-contained nipple  86  which can serve either of two purposes in the invention. The nipple  86  can be used independently of the mask, or it can be positioned anywhere on the mask and used without a bottle attached to it.  
         [0035]    For example, in the embodiment of FIG. 6, the nipple and the bottle may be considered to be a bit crowded. The mask may be partly cut away to leave room for positioning the nipple, or the mask may be omitted by mothers who have skilled hands. The nipple  86  in FIG. 8, which is not attached to a bottle and is completely self-contained, has its base closed off by a flange or wall  88  having a hole  90  into which a cork  92  (either real or synthetic) is inserted to close off the milk-holding portion  92  of the nipple. A few ccs of milk can be stored in the portion  92  of the nipple, which is a sufficient amount to allow a baby to nurse while taking medication. Either mask  54  or  80  is applied to the infant&#39;s face or nose independently of the nipple  86  to allow such nursing, or the nipple  86  can be coupled to any area of the mask, as described above.  
         [0036]    It will be noted that, as used in the claims, the term aerosolized medication encompasses both wet and dry medications. The particular forms and embodiments of the invention shown herein are for illustrative purposes only. Various changes will doubtless occur to those skilled in the art and will be understood as forming a part of the present invention insofar as they fall within the spirit and scope of the appended claims.