Abstract:
A diagnostic reagent dispensing bottle which includes a flexible container having an elongated cap mounting neck which is closed by a pierceable or punctureable membrane. A membrane-piercing-and-droplet-dispensing spike is also provided. The spike includes a conically-shaped orifice and a sharp membrane piercing point. The spike is carried by an elongated cap which has a body portion for mounting on the neck of the container. The neck and cap cooperate to position the spike in either (1) a shipping or non-piercing position or (2) a dispensing position wherein the spike pierces the membrane so that the reagent within the container can flow through the spike for dispensing. The cap also includes a cover or closure for closing the bottle which is hingedly connected to the cap body so that the cover is selectively positionable in either an open or closed position. Both detent and thread systems are disclosed for cooperation with the cap and neck to position and guide the spike relative to the pierceable membrane.

Description:
BACKGROUND OF THE INVENTION 
     This invention relates to liquid dispensing devices, and more particularly, to a bottle for dispensing a diagnostic reagent in droplets. 
     In the typing and testing of blood, very small and controlled quantities of a diagnostic reagent are added to a known quantity of blood in a test tube, the reaction of the reagent and blood is noted, and a characteristic of the blood is thus determined. Using a series of such tests with different reagents permits complete typing of the blood. Standardized test procedures have been developed and require the reagent to be dispensed as droplets with there being 20-25 droplets per milliliter (ml) of reagent. 
     The reagents can be quite expensive and are provided in small bottles which are referred to as BBR bottles (blood bank reagent bottles). The BBR bottles are typically made of glass, have a large mouth, and include a glass eye-dropper-like device for dispensing the reagent on a droplet-by-droplet basis. 
     The glass bottle is fragile, is subject to breakage during shipment and use, and when open, may be tipped over and the contents spilled. Furthermore, the number of droplets of reagent dispensed by the eye-dropper can vary due to variations in the geometry of the eye-dropper (e.g. orifice diameter, etc.) resulting from manufacturing techniques. It is also believed that the surface tension between the reagent and the eye-dropper surface may vary from reagent to reagent, which variation can also result in variations in the number of droplets per ml of reagent. 
     It is therefore an object of this invention to minimize bottle breakage and spillage. 
     It is another object of this invention to uniformly control the number of droplets of reagent dispensed to between 20-25 droplets/ml. 
     In using the present bottles, a technician may open a series of different BBR bottles for dispensing different reagents into test tubes. During testing (1) the technician may rest the dropper on the countertop and then return the dropper to the bottle; (2) he may touch the interior of the test tube with the eye-dropper; or (3) he might inadvertently return the dropper into a different reagent bottle. Each of the foregoing acts could result in contamination of the reagent or cross-contamination of test specimens which, in turn, could result in erroneous test results. 
     It is thus another object of this invention to provide a reagent dispensing system which minimizes or eliminates problems of contamination or cross-contamination. 
     Also during testing, it is possible that reagent bottles may be left open for substantial periods of time. By leaving the bottle open, it is possible that airborne contaminants could enter the reagent or that the bottle could be spilled. Furthermore, if the bottle is left open for prolonged lengths of time, the reagent on the dropper may dry to form a crust on the dropper. This is sometimes referred to as encrustation. It appears that the bottle is left open as a matter of convenience, since the cover is a separate piece. 
     It is thus another object of this invention to provide a construction wherein the cover is a part of the bottle so that closing the bottle after use is convenient. 
     Numerous plastic dispensing bottles are known in the prior art. These bottles generally are for the dispensing of liquids, such as detergents, cleaners and the like. Furthermore, hinges for positioning the closures on a cap or container are also known in the art. U.S. Pat. Nos. 3,289,877; 3,720,979; and 3,933,271 disclose such hinged containers. Food coloring dispensers are available which includes an inverted and conically shaped nozzle that allows the coloring agent to be dispensed as droplet. However, none of the foregoing bottles provide for the accurate metered dispensing of liquid on a droplet-by-droplet basis and the freedom of contamination and the convenience sought in the medical field. In the medical field, containers have been developed for permitting withdrawal of liquid from a container and into a syringe. See for example, U.S. Pat. Nos. 2,642,064 and 3,940,003. However, such containers are intended for a single use with all of the liquid being withdrawn at one time, not for the dispensing of such liquid on a droplet-by-droplet basis and such devices do not provide for closure and reuse of the container. 
     Thus the prior art does not disclose systems which provide the desired features and meet the foregoing objects. Those objects will become apparent from the following description and appended claims. 
     SUMMARY OF THE INVENTION 
     There is provided by this invention a reagent dispensing bottle which meets the foregoing objects. 
     The bottle includes a transparent and flexible, plastic container having an elongated cap-mounting neck which is closed by a pierceable or punctureable membrane. 
     A combination membrane-piercing and droplet-dispensing spike is also provided. The spike includes a nozzle, a membrane piercing point, an intermediate peripheral mounting shoulder and a longitudinal fluid passageway extending from the piercing point to the nozzle. The nozzle includes an inverted and conically shaped orifice which accurately controls droplet formation and dispensing and is self-draining. 
     The spike is carried by an elongated cap which has a body portion that is constructed for mounting on the neck of the container. The cap and neck cooperate to position the spike in a shipping or non-piercing position or in a dispensing position where the spike has pierced the membrane so that the reagent within the container can flow through the spike for dispensing. The cap also includes a cover or closure for closing the bottle. The cover is hingedly connected to the cap body and is selectively positionable in either an open or a closed position. 
     The bottle may be formed with either threads or guides-and-detents on the bottle neck with mating members being provided on the cap body for positioning the spike in the shipping or dispensing positions and for cooperation in driving the spike through the membrane. In the threaded embodiment, the cap is turned in order to drive the spike through the membrane, while in the guide-and-detent embodiment, the cap is thrust downwardly to drive the spike through the membrane. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a perspective view showing a droplet of reagent being dispensed from a BBR bottle into a test tube; 
     FIG. 2 is an exploded view showing the cap, the spike, and the elongated neck of the container of a BBR bottle of the thrust-opening type; 
     FIG. 3 is a view, mostly in section, showing a thrust-opening type of bottle with the cap and the spike in the shipping or non-pierced position, and with the cover closed; 
     FIG. 4 is a view partially in section, with the spike and the cap in the dispensing or pierced position with the cover open; 
     FIG. 5 is a front elevational view showing the cover portion of the cap; 
     FIG. 6 is a plan view showing the interior of the cover portion of the cap in the open position; 
     FIG. 7 is a greatly enlarged elevational view of the spike showing the piercing end and nozzle portions of the spike; 
     FIG. 8 is another view of the piercing end of the spike; 
     FIG. 9 is a sectional view taken along line 9--9 of FIG. 4 showing the manner in which the cap cooperates with the neck; 
     FIG. 10 is a sectional view showing an alternative embodiment for the cover; and 
     FIG. 11 is an exploded perspective view showing another BBR bottle which has a threaded neck and cap. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring now to the drawings, and more particularly, FIGS. 1 and 2, there is shown a BBR bottle 10 generally, dispensing a droplet of reagent 12 into a test tube 14. 
     THE REAGENT CONTAINER 
     The bottle 10 includes a reagent container 16 which is molded from a transparent and flexible plastic material. The container may be filled with the reagent during the molding process. The container 16 includes a bottom or base portion 18 which has a flat bottom and which is generally cylindrically shaped. A narrow, elongated neck portion 20 extends from the base and terminates in a top wall 22 which includes a punctureable or pierceable membrane. In the embodiment shown, the membrane is integral with the neck, although separate membranes, such as of foil, could be provided. The neck portion 20 includes a pair of substantially circumferential detents 24 and 26. The upper detent 24 is positioned near the top wall, and the lower detent 26 is positioned near the base of the neck whereby the neck joins with the base 18. Each of the detents is in the form of an undercut or notch and includes an inwardly and upwardly inclined surface which terminates in a flat transverse surface. 
     A pair of longitudinally extending and diametrically opposed guide slots, such as 28, are molded in the neck and extend from the top wall 22 downwardly past the lower detent 26. A flared surface or apron portion 30 is provided at the junction of the elongated neck 22 and the base portion 18. 
     In manufacturing the container 16, the container is blow-molded, and prior to the final sealing, the container may be filled with reagent and thereafter the container is finished sealed. Thus, the container itself is liquid-tight. 
     THE SPIKE 
     The spike 32 is best seen in FIGS. 2, 7 and 8. The spike 32 includes a lower piercing section 34 which terminates in a sharp and pointed tip 36. The lower section is tapered for sealing cooperation with the membrane wall 22 and the tip 36 includes the beveled faces 38, 40 and 42 which permits the spike to puncture the membrane 22. 
     The upper end of the spike includes a nozzle section 44 which terminates in an inverted and conically-shaped orifice 46. The angle and depth of the cone are very important as those factors primarily control and determine droplet formation and size. In this embodiment an included angle of between about 70°-85° is preferred and 82° has been found to be optimum. The cone intersects the outer wall portions of the nozzle 44 so as to form a sharp ring-like edge 48. It has been found that with this nozzle shape, each droplet is formed entirely within the cone and the reagent is not drawn upwardly over the sides of the nozzle section 44. 
     A fluid path 50 extends longitudinally through the spike and terminates at its upper end in the cone 46 and terminates at its lower end in the pointed tip 36. It is desirable that the fluid path taper slightly inwardly so that it is wider at the lower end than it is at the upper end. A draft angle of 1/2° as per side is desirable. 
     It has been found that the inverted cone shape of nozzle is desirable in that it provides a self-draining feature. When the bottle is placed upright, liquid which may be left in the cone tends to drain downwardly back through the fluid passageway 50 and into the container 16. Furthermore, it is believed that there may be some fluid mechanical effects due to the narrow constriction at the upper end of the passageway which causes air being drawn into the container to have a higher velocity at the constriction, thus helping clear the cone and fluid passageway, thereby preventing encrustation. 
     Positioned between the upper nozzle section 44 and the lower piercing portion 34 is a circular disc-like cap-engaging-and-retaining shoulder 52. The shoulder 52 includes upper and lower tapered surfaces 52a and 52b and positioned immediately above the shoulder 52 is a short cylindrical cap-engaging section 54. 
     THE CAP 
     Referring to FIGS. 2, 5 and 6, the cap 56 generally is shown. The cap 56 includes: (1) a hollow, elongated, body portion or neck-engaging section 58; (2) a two-position or &#34;living&#34; hinge 60; and (3) a cover or closure 62. 
     The body portion 58 of the cap is hollow and cylindrical and includes an internal, circumferential, detent-engaging shoulder 64 which cooperates with detents 24 and 26 on the neck. The shoulder 64 includes an upwardly and inwardly inclined surface and an outwardly-extending transverse surface. Thus the shoulder will matingly engage detents 24 and 26. It is intended that the cap be movable only downwardly from the first detent 24 to the second detent 26, and that the cap be held securely in each of those positions. 
     A pair of elongated, longitudinally-extending and diametrically opposed guide ribs, such as 66, are provided on the interior of the cap for slidably engaging the guides 28 so as to longitudinally align the cap 56 on the neck 20 and prevent rotation of the cap. The upper end of the cap includes a transverse wall 68 having a spike-engaging aperture 70 which includes a pair of oppositely tapering surfaces 72 and 74. A straight, cylindrical aperture 76 is provided above the shoulder-engaging aperture. When assembled, the nozzle section of the spike extends upwardly through the cap wall with the section 54 sealingly engaging the section 76 and the shoulder 52 snappingly and securely engaging the shoulder-retaining aperture 70. 
     The integrally formed hinge 60 includes a pair of pivot members 78 and 80. An active L-shaped hinge member 82 is provided which is integrally joined to the neck-engaging section 56 at a flexible pivot point 84 and to the cover at a flexible pivot point 86. Hinges of this type cause the cover to be biased either in an open or closed position. Thus as shown in FIG. 2, the cap is held and biased into the open position until the user pushes the cover toward the closed position. In the closed position, the hinge holds the cover closed. 
     The cover section 62 includes a nozzle-engaging tip or plug 88 which extends from the top wall of the cover toward the nozzle and is intended to engage the nozzle so as to close the fluid passageway and thus cooperate in minimizing drying of reagent and encrustation. The cover includes a pair of offset finger engageable ears 91 and 93, which permits the cap to be flicked open from a side position. This is done so as to minimize the possibility of the user touching the nozzle as he opens the cover. 
     A latching ridge 90 and shoulder 94 are provided on the neck-engaging body and a mating recess 92 is provided in the cover. This permits the cap to be not only closed but sealingly secured so as to prevent contamination, minimize encrustation, and require a positive act to fully open the bottle. 
     In an alternative cover construction, as shown in FIG. 10, the cover 95 includes a depending pin 96 which enters and sealingly engages the fluid passageway 50 and a depending sleeve or skirt 97 which sealingly engages the outer surface of the nozzle 44. 
     THE ASSEMBLED BOTTLE AND ITS USE 
     Referring now to FIGS. 3 and 4, the spike 32 is shown mounted on the cap 56 with the cover 62 in the closed position. It will be noted that the plug 88 is in engagement with the conical portion 46 of the nozzle 44. The cap is shown in its shipment position with the cap detent shoulder 64 engaging the upper detent 24, and the piercing tip 36 positioned above the punctureable membrane 22. The BBR bottle 10 is shipped in this condition, and the detent system maintains the spike above the punctureable wall, thereby maintaining the sterility of the reagent until the user decides that the product is ready for use. This positive locking minimizes accidental spillage and loss of the reagent. In this device in order for the user to begin using the reagent, he must thrust the cap 56 downwardly so as to disengage the detent shoulder 64 from the neck detent 24. When this is done, the piercing tip 36 can be pushed through the top wall or membrane 22, thereby puncturing the membrane. The cap is continued to be thrust downwardly until the detent shoulder 64 engages the lower detent 26. When the cap and spike assembly are in this position, the upper wall 22 has been pierced and the tapered section 34 of the spike sealingly engages the pierced portion of the wall. Furthermore, the detent shoulder 64 and detent 26 maintain the position of the spike and cap relative to the neck and container. During the thrusting operation, the cap was guided by the ribs 66 sliding in the guide slots 28. As can be seen in FIG. 4, the bottom edge of the neck-engaging portion 58 of the cap engages the apron 30 of the container. In this position the bottle is ready for use by the technician. 
     In order to use the bottle at this point all that the technician needs to do is to open the bottle using the ears 91 or 93 and then tip the bottle in order to cause liquid to flow from the container into the neck portion. By squeezing the bottle, droplets of reagent can be expressed. With this construction, the bottle can be held in an attitude anywhere from an approximately horizontal to a vertical position and accurate droplet dispensing is achieved. As previously indicated, this construction permits controlled droplet formation in the range of 20-25 droplets/ml of reagent. The latch-forming projection 90 is one portion of a shoulder 94 which can be used to rest the bottle on the test tube. Referring back to FIG. 1, it will be seen that in use a side of the nozzle portion 44 can be rested on the edge of the test tube and the shoulder 94 will help the technician position the orifice above the test tube without contamination. 
     THE THREADED BBR BOTTLE 
     Referring now to FIG. 11, another embodiment for a BBR bottle is shown. In this embodiment the bottle includes a container 100 which has a tilted and elongated neck 102. The neck is provided with a series of screw threads 104 and a set of widely-spaced ratchet-like teeth 106. A pierceable membrane 108 is provided within a recessed well 110 in the neck 102. 
     An integral cap and spike assembly 112 is also provided. The assembly includes a hollow, elongated cap body 114, which has a series of internal screw threads 116 and a set of closely-spaced ratchet teeth 118. The cap also includes a cover 120 which is secured by the flexible hinge assembly 122 to the cap body. A membrane-piercing spike and dispensing nozzle are molded integrally into the cap body. The spike includes a lower piercing section 124 and an upper droplet dispensing section 126. A T-shaped flow path is provided and includes a longitudinal path 127a that extends through the spike from the nozzle toward the piercing end and a transverse path or cross-hole 127b that intersects the path 127a and exits the spike at the piercing end. This flow path permits the reagent to flow through the spike and be dispensed from the nozzle 126. 
     In shipment, the cap is positioned on the neck so that the piercing section 124 is spaced from the membrane 108 in a non-dispensing position. In order to use the bottle, the cap is twisted so that the threads 104 on the bottle and 116 on the cap cooperate to drive the spike 124 through the membrane. The rotation of the cap is continued until the ratchet teeth 118 on the cap engage the ratchet teeth 106 on the neck. The shape and spacing of both sets of the ratchet teeth are selected to prevent the cap from backing off and loosening. In other words, once the cap has been turned so as to pierce the membrane and the ratchet teeth engage, the cap cannot loosen or be backed off. Thus the cap is permanently affixed to the neck and the bottle is available for use. The convenience and features of the cover 120 are similar to those described in connection with the thrust opening type of bottle. 
     It will be appreciated that numerous changes and modifications can be made to the embodiment shown herein without departing from the spirit and scope of this invention.