Surgery – Respiratory method or device
Reexamination Certificate
1997-09-29
2002-10-29
Weiss, John G. (Department: 3761)
Surgery
Respiratory method or device
C128S203120, C128S203290
Reexamination Certificate
active
06470882
ABSTRACT:
BACKGROUND OF THE INVENTION
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'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.
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.
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.
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).
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, which ensures that the aerosol that has been sprayed into the holding chamber will be drawn into the baby'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'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 medication when the baby inhales during approximately five or six breaths.
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'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.
By way of background, inhaled therapy is the main,stay 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 limited to their 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 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'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
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.
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).
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
Amirav Israel
Newhouse Michael T.
Hoekendijk & Lynch, LLP
Weiss John G.
Weiss Joseph F.
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