1. Field of the Invention
This invention generally pertains to methods and devices useful for the administration and delivery of liquid oral medications and more particularly concerns a self resealing closure for medication bottles containing liquid medication drawn and administered by oral syringes.
2. State of the Prior Art
The administration of liquid medications such as cough and cold medicines, whether over the counter or prescription medication, to young children and infants requires careful control over dosage. In the case of adults the dosage of such medications is often measured by tea or table—spoonfuls. The spoons may vary in size to a considerable degree, and they may be filled to different levels, resulting in substantial variations in the administered dose. Adults, because of their larger body mass, are unlikely to suffer adverse effects from such variations. However, small children, having much smaller body mass, have often suffered adverse consequences and in fact result in thousands of children being hospitalized each year. Similar problems occur when unsupervised children gain access to and take such medicines, which are often colored and flavored to appeal to children's tastes, and thus may receive an overdose of the medicine. The aforementioned difficulties are compounded when the liquid medications are concentrated and intended for administration with a dropper. A parent may think little of giving a child an extra drop or two, thinking it is a harmless amount, but in fact this too may have undesirable and harmful outcomes in the case of small children.
More recently this problem has been addressed through the use of oral syringes which more accurately measure and dispense small volumes of liquid medication in a consistent manner. Oral syringes differ from conventional hypodermic type syringes in that the neck extending from the end of the syringe barrel is sized such that standard hypodermic needles cannot be mated to it. Instead, the oral syringe is used to deliver a stream of liquid medication to the oral cavity of young patients, who are often uncooperative.
The liquid medication is drawn by immersing the open end of the neck of the syringe in the contents of the medication bottle and pulling the syringe plunger from the barrel in the conventional manner. The neck of the medication bottle typically does not admit the syringe barrel into the bottle, so that the liquid contents must be brought within reach of the syringe end by tilting the bottle. However, as the contents of the bottle are consumed and depleted, the liquid level drops and it becomes necessary to incline the bottle to an increasing degree so as to bring the liquid within reach of the short neck of the oral syringe. This can be difficult to accomplish without spilling some of the contents. This process has been somewhat facilitated through the use of a plug fitted into the neck of the medication bottle and having a plug opening of reduced diameter relative to the diameter of the bottle neck. The plug opening admits the syringe neck into the bottle neck but also provides an interior rim which helps contain the liquid contents while the dose is drawn into the syringe. Also, the barrel end may be pressed against the plug to further help contain the liquid during this operation.
Nonetheless, the use of oral syringes with liquid medications remains inconvenient and dependent to an undesirable degree upon the manual dexterity of the user.
According to the present invention, a liquid oral medication bottle is provided with a self resealing elastomeric closure normally sealing the bottle and adapted to admit the syringe neck into the bottle while maintaining a substantially liquid tight seal between the elastomeric closure and the syringe neck. The neck of the oral syringe has an orificed blunt end which is inserted through the elastomeric closure into the bottle. The bottle is tilted or inverted such that the orificed blunt end is immersed in the liquid medication contained in the bottle, and a dose of the medication is drawn into the syringe barrel. The syringe neck is withdrawn from the bottle to allow self resealing of the elastomeric closure.
In one embodiment of the invention the elastomeric closure is initially unbroken and the method further comprises the step of urging the orificed blunt end of the syringe neck against the elastomeric closure with sufficient force for rupturing the closure and passing the neck's orificed end therethrough and into the bottle.
The elastomeric closure preferably has a septum of elastomeric material, the septum having a generally depressed dished portion including an area of minimum thickness. The dished portion increases in thickness radially from the minimum thickness to a much thicker elastomeric material encompassing the area of minimum thickness, the depressed portion and the area of minimum thickness being shaped and configured to elastically distend for passing the blunt orificed end of the syringe neck through a tear in the area of minimum thickness. The septum self recloses by returning opposite edges of the tear to a substantially contiguous closed condition after withdrawal of the syringe neck from the septum.
These and other improvements, features and advantages of the present invention will be more clearly understood by reference to the following detailed description of the preferred embodiment taken in conjunction with the accompanying drawings.
a is an enlarged cross section as in
With reference to the accompanying drawings in which like numerals reference like elements,
The prior art plug generally indicated by numeral 10 has a plug top 12 in which is defined a circular depression 14 bounded at a lower end by an interior annular flange 16 which encompasses a center hole 18 through the plug top. Plug 10 also has a cylindrical side wall 22 open at a lower end 22a and from which extend four axially spaced radial ribs 24. The center hole 18 provides a reduced aperture when plug 10 is pressed into the neck of a medication bottle and interior flange 16 provides an annular containment dam which helps reduce the likelihood of spillage when the medication bottle is tilted or inverted onto the oral syringe. Nonetheless, substantial dexterity of the user on the part of the user is needed to avoid spillage of the liquid medication.
In a presently preferred method of manufacture plug 30 is manufactured in a two step process, in which the shell 10 is molded first and closure 32 is then molded onto the shell 10. This two step process permits different materials to be used for the two components, each suited to its function. The closure body is preferably molded of a relatively soft thermoplastic elastomeric material, for example, GLS2711 sold by GLS Thermoplastic Elastomers based in McHenry, Ill., a business unit of PolyOne Corporation of Avon Lake, Ohio. The plug shell 10 is preferably made of a harder, stiffer thermoplastic material such as polypropylene, a presently preferred material being a 50-50% blend of polypropylene and Synprene thermoplastic elastomer available from PolyOne Corporation.
The closure body 34 is generally disk shaped with a central depression 36 including a dished septum 40 in the top surface 38 of the closure body 34. As best seen in
It has been found advantageous to provide a greater minimum thickness of elastomer in the self resealing closure 32 intended for perforation by the neck of an oral syringe than the smaller minimum thickness preferred in previous filings and earlier disclosed embodiments of the perforable self-resealing elastomeric closure of this invention. For example, in a plug 30 of nominal 20 mm diameter the overall thickness of closure body 34 may be approximately 3 mm, the diameter of central depression 36 at the top surface 38 may be 4.80 mm, the depth of the central depression 36 may be 1.5 mm deep and the minimum thickness at the center of the closure body 34 may be 1.6 mm thick. For a 24 mm diameter plug 30 the thickness of closure body 34 may be approximately 4.25 mm, the diameter of central depression 36 at the top surface 38 may be 5.5 mm, the depth of the central depression 36 may be 2.00 mm deep and the minimum thickness at the center of the closure body 34 may be 2.25 mm thick. In general, the minimum thickness 44 at the bottom of the dished portion 42 in plug 30 may be approximately equal to the depth of the central depression 36.
The depressed dished portion 42 and the area of minimum thickness 44 are shaped and configured to rupture and elastically distend for under the urging of the blunt orificed end 108 of the syringe neck 102 and passing the orificed end 108 and a portion of neck 102 through a tear 120 created in the area of minimum thickness 44 of the septum 40, a condition depicted in
Preferably, the shape and diameter of the upper portion 50 of the central depression 36 is sized to closely receive the syringe neck 102, The upper portion 50 helps guide the neck of the syringe and to hold it in general alignment with the center of the area of minimum thickness 44 of dished septum 40 as the syringe neck 102 is advanced into the depression 36 and urged against the depressed portion 42 to rupture or tear the area of minimum thickness and through septum 40, thereby to place the orifice 112 on the blunt end 108 at the end of the syringe neck into fluidic communication with the interior of the medicine bottle N, a condition seen in
As shown in
In the fluidically coupled condition of
Once the desired dosage D has been drawn, the oral syringe S is withdrawn from the bottle B, whereupon the elastomeric closure 32 is free to self reseal to a substantially liquid tight condition, as indicated in
The improved plug 30 with the self resealing closure 32 of this invention provides a number of advantages over the prior art plug of
Firstly, the normally closed condition of the elastomeric septum, both before and after perforation with a syringe S, prevents contamination of the contents L with dust or any pollutants present in the immediate environment even while the bottle cap C is removed.
Secondly, the normally closed condition of the elastomeric closure makes the medication bottle doubly childproof, i.e., even if the twist-on cap C is forgotten, or even if it is removed by the child, the child is unable to drink from the bottle contents, which remain secure even if the bottle is turned upside down or tilted into the child's mouth.
Thirdly, the bottle is leak proof with or without the twist-on cap C as a result of the normally closed, substantially liquid tight elastomeric closure 32.
Fourth, the bottle can be upended onto the oral syringe S with little risk of leakage or spillage of the liquid medication L. This is an improvement over the prior art where continuous care had to be observed while drawing the liquid medication into the oral syringe to prevent spillage through the open hole of the prior art plug.
The plug 30 can be made in various diameters and dimensions to fit medication bottles or other containers having container or bottle necks N of different dimensions. The upper diameter of the central cavity 36 in each case is guided by the neck diameter of the oral syringe S to be used with that combination of plug 30 and container B. For example, oral syringes in 5 ml, 10 ml and 20 ml capacities are in general use and have syringe necks 102 of varying sizes, typically 3 to 4 mm in diameter. In each case, the diameter of upper portion 50 of the center cavity of the plug is sized accordingly to closely receive the diameter of the syringe neck.
It should be understood that in alternate embodiments of the invention the central cavity 36 may be inverted on the closure body 34 so that the cavity opens into the interior of the medicine bottle B and the dished septum faces the bottle interior.
While particular embodiments of the invention have been described and illustrated for purposes of clarity and explanation it should be understood that still other changes, modifications and substitutions will be apparent to those having only ordinary skill in the art without departing from the scope of the present invention as defined in the following claims.