BACKGROUND OF THE INVENTION1. 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.
SUMMARY OF THE INVENTIONAccording 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.
BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1 shows a prior art plug of the type fitted in liquid medication bottles for use in conjunction with an oral syringe;
FIG. 2 is a cross sectional view of the plug ofFIG. 1 taken along line2-2 inFIG. 1;
FIG. 3 is a top side perspective view of the improved plug with the self resealing elastomeric closure according to the present invention;
FIG. 4 is a cross sectional view taken along line4-4 inFIG. 3;
FIG. 4ais an enlarged cross section as inFIG. 4;
FIG. 5 is a top side perspective view of a typical medication bottle fitted with the plug ofFIGS. 3 and 4;
FIG. 6 is a cross section taken along line6-6 inFIG. 5;
FIG. 7 illustrates how the neck of the oral syringe is inserted through the elastomeric closure of the inverted medication bottle ofFIGS. 5 and 6;
FIG. 8 shows how a dose of liquid medication is drawn into the oral syringe from the inverted medication bottle;
FIG. 9 is a cross section taken along line9-9 showing the sealing engagement of the elastomeric seal about the exterior surface of the syringe neck;
FIG. 10 is a view taken as inFIG. 9 showing the self resealing of the elastomeric closure to a substantially liquid tight condition upon withdrawal of the oral syringe; and
FIG. 11 illustrates typical delivery of the medication dose by the oral syringe to the oral cavity of a child.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTSWith reference to the accompanying drawings in which like numerals reference like elements,FIGS. 1 and 2 show a prior art plug of the type fitted in the neck of liquid oral medication bottles in order to facilitate the drawing of the liquid medication into an oral syringe.
The prior art plug generally indicated bynumeral10 has aplug top12 in which is defined acircular depression14 bounded at a lower end by an interiorannular flange16 which encompasses acenter hole18 through the plug top.Plug10 also has acylindrical side wall22 open at alower end22aand from which extend four axially spacedradial ribs24. Thecenter hole18 provides a reduced aperture whenplug10 is pressed into the neck of a medication bottle andinterior flange16 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.
FIGS. 3 and 4 show an improvedplug30 according to the present invention. In plug30 a self resealingelastomeric closure32 closes thecenter hole18 of theprior art plug10. The prior art plug structure (hereafter referred to as shell10) is used in theplug30 of this invention as a supporting shell for theself resealing closure32. The self resealingelastomeric closure32 includes a onepiece closure body34 supported in an interference fit above and below theinner flange16 ofshell10, such that theclosure body34 is permanently locked to theshell10.
In a presently preferred method ofmanufacture plug30 is manufactured in a two step process, in which theshell10 is molded first andclosure32 is then molded onto theshell10. 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. Theplug shell10 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.
Theclosure body34 is generally disk shaped with acentral depression36 including a dishedseptum40 in thetop surface38 of theclosure body34. As best seen inFIG. 4a, theseptum40 has a generally depressed dished portion42 including an area ofminimum thickness44 as measured between the septum bottom and the underside orinterior surface46 of theclosure body34. The dished portion42 ofseptum40 increases in thickness radially from theminimum thickness44 to a much thickerelastomeric material48 encompassing the area of minimum thickness.
It has been found advantageous to provide a greater minimum thickness of elastomer in theself resealing closure32 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 aplug30 of nominal 20 mm diameter the overall thickness ofclosure body34 may be approximately 3 mm, the diameter ofcentral depression36 at thetop surface38 may be 4.80 mm, the depth of thecentral depression36 may be 1.5 mm deep and the minimum thickness at the center of theclosure body34 may be 1.6 mm thick. For a 24mm diameter plug30 the thickness ofclosure body34 may be approximately 4.25 mm, the diameter ofcentral depression36 at thetop surface38 may be 5.5 mm, the depth of thecentral depression36 may be 2.00 mm deep and the minimum thickness at the center of theclosure body34 may be 2.25 mm thick. In general, theminimum thickness44 at the bottom of the dished portion42 inplug30 may be approximately equal to the depth of thecentral depression36.
FIGS. 5 and 6 illustrate a typical medication bottle B fitted with the self resealingelastomeric plug30 ofFIGS. 3 and 4. As shown inFIG. 6, when theplug30 is press-fitted into the bottle neck N, theradial ribs18 are flexed upwardly from their normal radial condition and the inherent resilience of the elastomeric rib material presses theribs18 against interior of the cylindrical bottle neck in a friction fit which both retains theplug30 in the bottle neck N and also provides a liquid tight seal for containing the liquid contents L from leaking between the plug and the bottle neck. The bottle neck N also has an exterior thread T onto which is screwed a removable twist-on bottle cap C. In an initial condition ofelastomeric closure32 theseptum40 is unbroken, i.e., forms a continuous closed partition across the bottle neck N, as seen in the cross section ofFIG. 6.
FIGS. 7 and 8 illustrate how a dose of liquid medication is drawn with a typical oral syringe S from medication bottle B provided with theplug30 of this invention. Oral syringe S may be a commercially available syringe having asyringe barrel100 with asyringe neck102 at a proximal end of thebarrel100 and asyringe plunger106 slidable withinbarrel100.Syringe neck102 extends from anend wall104 of the syringe barrel. Thesyringe neck102 is a cylindrical or tapering stub terminating in a generallyblunt end108. Abore110 throughsyringe neck102 opens in anorifice112 in theblunt end108 and communicates with the interior of thesyringe barrel100, as best seen inFIGS. 9 and 10.
The depressed dished portion42 and the area ofminimum thickness44 are shaped and configured to rupture and elastically distend for under the urging of the bluntorificed end108 of thesyringe neck102 and passing theorificed end108 and a portion ofneck102 through atear120 created in the area ofminimum thickness44 of theseptum40, a condition depicted inFIG. 9. The dished portion42 and the area ofminimum thickness44 are self reclosing by returningopposite edges120′ of the tear to a substantially contiguous closed condition after withdrawal of thesyringe neck102 from the torn septum, as shown inFIG. 10.
Preferably, the shape and diameter of theupper portion50 of thecentral depression36 is sized to closely receive thesyringe neck102, Theupper portion50 helps guide the neck of the syringe and to hold it in general alignment with the center of the area ofminimum thickness44 of dishedseptum40 as thesyringe neck102 is advanced into thedepression36 and urged against the depressed portion42 to rupture or tear the area of minimum thickness and throughseptum40, thereby to place theorifice112 on theblunt end108 at the end of the syringe neck into fluidic communication with the interior of the medicine bottle N, a condition seen inFIGS. 8 and 9.
As shown inFIG. 8, the medication bottle with the fluidically coupled oral syringe may be held inverted or upside down so that the liquid contents L in the bottle N overlie theorifice112 of the syringe neck. In this position, theplunger106 of the oral syringe S may be pulled from thesyringe barrel100, thereby to draw a dose D of liquid medication L into the syringe barrel. The prescribed dosage is measured by aligning the plunger bottom with acorresponding marker114 on the syringe barrel.
In the fluidically coupled condition ofFIG. 8, the perforatedelastomeric closure32 is distended to admit passage of thesyringe neck102 and because of its inherent elasticity forms a tight seal about the exterior surface of the syringe neck, as inFIG. 9. A close fit betweensyringe neck102 andupper portion50 ofdepression36 further assists in preventing leakage. Consequently, the liquid L is contained in the bottle B and does not leak onto the underlying syringe S.
Once the desired dosage D has been drawn, the oral syringe S is withdrawn from the bottle B, whereupon theelastomeric closure32 is free to self reseal to a substantially liquid tight condition, as indicated inFIG. 10.
Theimproved plug30 with theself resealing closure32 of this invention provides a number of advantages over the prior art plug ofFIGS. 1 and 2.
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 tightelastomeric closure32.
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.
Theplug30 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 thecentral cavity36 in each case is guided by the neck diameter of the oral syringe S to be used with that combination ofplug30 and container B. For example, oral syringes in 5 ml, 10 ml and 20 ml capacities are in general use and havesyringe necks102 of varying sizes, typically 3 to 4 mm in diameter. In each case, the diameter ofupper portion50 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 thecentral cavity36 may be inverted on theclosure body34 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.