Patent Application
20110315146
Continuous positive airway pressure is a method of sustaining the breathing of fragile infants (typically prematurely born infants) by gently blowing air into the nostrils to maintain positive pressure in the airways, thereby keeping the airways open. Canula seals that gently adhere to the infants nose, cheek and upper part of the upper lip, and that provide a pair of apertures for supporting the canulas that are placed into the infant nostrils to deliver the air have been commercially available. Also, canula seals have been made by neo-natal nurses by cutting a pattern from wound dressing. Those using these canula seals have noticed some phenomena that have not been 100% desirable. Sometimes a portion of the canula seal would peel away from the infant's face. Also, health care personnel would sometimes place some of the portion intended to cover the philtrum over the vermillion of the infant's upper lip.
In a different environment, these issues might have escaped notice entirely, but when dealing with premature infants, even the smallest issue draws attention. Accordingly, careful study has identified the source of these problems and to recognition of the desirability of design improvements.
The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope. In various embodiments, one or more of the above-described problems have been reduced or eliminated, while other embodiments are directed to other improvements.
In a first separate aspect, the present invention may take the form of a nasal CPAP canula seal having directions of “above” and “below” by its anticipated placement on an infant face, above being higher up on the face and below being lower down. The seal has a canula supporting portion, defining holes for canula passage into the nostrils, and a nose-anchoring portion extending about the apertures and designed to help anchor the nasal CPAP canula seal by adhering to the infant nose. Also, the nose-anchoring portion defines a laterally central notch cut-out adapted to form a moisture vent when the nose-anchoring portion is folded about the nose.
In a second separate aspect, the present invention may take the form of a method of applying a nasal CPAP canula seal in such a manner that a vent is provided to permit moisture to escape from the nose skin. The method utilizes a nasal CPAP canula seal that has a canula supporting portion, defining apertures for canula passage into the nostrils and a nose-anchoring portion, attached to the canula supporting portion and defining a notch. The method includes placing the nasal CPAP canula seal about the infant nose so that the apertures are coincident with the infant's nostrils and the notch is substantially over the tip of the infant nose, thereby forming a vent that permits moisture to escape.
In a third separate aspect, the present invention may take the form of a nasal CPAP canula seal having directions of “above” and “below” by its anticipated placement on an infant face, above being higher up on the face and below being lower down and thereby defining latitude as a set of lines going horizontally across the canula seal. The seal includes a canula supporting portion, defining apertures, in turn defining aperture centers, for canula passage into the nostrils, and a nose-anchoring portion extending about the apertures and designed to help anchor the nasal CPAP canula seal by adhering to the infant nose, the nose anchoring portion having at least one latitude of greatest width. Also, the aperture centers are within two millimeters of the latitude of greatest width.
In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the drawings and by study of the following detailed descriptions.
Exemplary embodiments are illustrated in referenced drawings. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than restrictive.
Referring to
In alternative preferred embodiments, the layer of seal 10 that contacts the infant face is made of silicone or acrylic adhesive. For example, Silbione 4512 A/B, which may be obtained from a distributor named on the website www.bluestarsilicones.com may be used. One advantage of this type of material is that it can be washed and yet still maintain its adherent properties. Skilled persons will recognize that the sheet of polyurethane may be replaced with any one of a broad range of biocompatible films that are widely available and many of which are clear. If both materials used are transparent, the seal 10 has an additional advantage, that the infant skin tissue will be more clearly visible underneath seal 10. This will help medical personnel quickly spot potential problems.
Seal 10 includes a nose covering portion 12 and a lip and cheek adhering portion 14. Nose covering portion 12 defines a pair of nostril apertures 16 for supporting the CPAP tubes 60 (
The nose covering portion 12 includes two petals 20 and defines a notch 22. In the use of prior art canula seals, it was found that during application of the seal, petals would sometime approach the eye of the infant. After analysis and experimentation, it was found that shorter rounded petals still provided sufficient adhesion and yet avoided this problem.
Apertures 16 define a center-to-center spacing length 24. It has been found that, across the various sizes seals 10, that if the length of petals 20 is kept below two center-to-center spacing lengths 24, that the danger of approaching the eye is minimized.
The acute angles of prior art seals appear to have provided a point for seal 10 to begin to separate from the skin to which it was adhered. It has been found that one way to avoid this problem is to avoid acute angles at the tips 26 of petals 20, in favor, ideally of an arcuate upper edge at tips 26. The definition of nose covering portion 12 is completed by a pair of cuts 28, permitting portion 12 to separate from portion 14 during application.
The bottom portion of lip and cheek adhering portion 14 is covered with hook material tape 30, that is applied during manufacturing and has outwardly projecting hooks. Referring to
Lip and cheek portion 14 defines a cut-out 32, which helps medical personnel avoid placing a portion of the seal 10 on the vermillion 70 (FIGS. 2+3) of the upper lip. The vermillion is the red part of the lip, as opposed to the thicker-skinned portion that extends upwardly toward the nose and cheek. The vermillion 70 is very sensitive and ideally should not covered. Some have suggested that covering a portion of the vermillion 70 may interfere with an infants ability to begin nursing. Whether or not this is accurate, cutout 32 makes it easier to avoid placing a portion of seal 10 over the vermillion 70, to avoid any resulting problems, and to provide greater infant comfort.
As noted previously petals 20 define a notch 22. When applied about the infant nose, as shown in
Placement of the nostril apertures 16 is an exercise in delicate determination of a difficult to optimize location. To accommodate all nose shapes (representative of different racial groups and variations within racial groups) it has been found that optimally, even without the cut-out 32, it is important that apertures 16 be close to the bottom of lip and cheek adhering portion 14. Generally speaking, it is desirable that this distance be no greater than two center-to-center spacing lengths 24, and optimally less than one and one-half center-to-center spacing lengths 24.
While a number of exemplary aspects and embodiments have been discussed above, those possessed of skill in the art will recognize certain modifications, permutations, additions and sub-combinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced are interpreted to include all such modifications, permutations, additions and sub-combinations as are within their true spirit and scope.
