Dispensing – With cutter and/or punch – To form dispensing opening in container
Reexamination Certificate
1999-10-21
2001-05-01
Shaver, Kevin (Department: 3754)
Dispensing
With cutter and/or punch
To form dispensing opening in container
C222S089000, C222S090000
Reexamination Certificate
active
06223940
ABSTRACT:
BACKGROUND OF THE INVENTION
Bags made of flexible material have been used since antiquity for the storage and dispensing of fluids. Wine and water storage bags made from animal skins are still in use, just as they were in antiquity. Latex rubber bags with attached hoses and probes found early use administering enemas in the medical field. All such bags have openings formed in them during manufacture for manually filling the bag with liquid, as well as for dispensing it.
In 1969 Baxter Laboratories introduced the first intravenous formula storage and dispensing bag. This bag differed from conventional bags in that the fluid was introduced in the manufacturing process and the bag was then sealed and sterilized for shipment to the customer. The bag offered a number of advantages over glass bottles previously used for this purpose. It was lighter, stronger and more compact, making it easier to ship and store. Because it was collapsible, it did not require a separate venting mechanism to allow air to enter as it was emptied. Elimination of the vent simplified the emptying process. No vent was needed in the administration set bag connector, either, and inadvertent administration of air to the patient was prevented.
The liquid formula in these prior art intravenous formula bags was normally dispensed with a dispensing spike which was forced through a dispensing port structure on the bag. The port structure was sealed into the bag during manufacture by laminating it between the two sheets of plastic film from which the bag was constructed. The port structure normally comprised a rigid plastic tube having an internal lumen obstructed by a thin, molded plastic septum. The spike, which was molded of rigid plastic, was used to puncture the septum. Fluid could then flow out of the bag through the spike. The spike was held in place by a friction fit in the lumen.
Generally, such a spike would be a component of an administration set designed to deliver the fluid to a patient or to some other container, or location, for use. In its most common form, the spike is connected to a length of plastic tubing. The tubing normally terminates with a connector designed to facilitate final delivery. In the case of an intravenous solution, the administration set connector is usually designed to be connected to a needle.
Incorporating a port in a bag in the aforedescribed manner remains the most common method of fabrication today. The method is effective, but relatively costly because of the need for a separate port structure and a secondary fabrication operation to seal the port structure between the two film layers of the bag. In addition, the seal area around the port structure has a tendency to leak.
Attempts have been made to improve dispensing systems for sealed bags by gluing a port structure to the outer surface of a bag. Such a system is illustrated in the Kuhn et al. U.S. Pat. Nos. Des. 361,838 and 338,726. In this system, the port structure has no internal septum, i.e., the bag wall is punctured by a dispensing spike. This greatly simplifies the fabrication of the bag because no port structure need be incorporated during fabrication. The elimination of a port structure which must be assembled with the bag is especially important with modern bag manufacturing technology where bags are formed, filled and sealed in a continuous, high speed process. By gluing the port structure onto the bag surface after forming, filling and sealing, manufacturing problems are greatly reduced. However, this system still requires a separate port structure, and an additional operation is needed to attach it to the bag by gluing, for example.
In the aforedescribed prior art systems the dispensing spikes are similar. They each have a sharp, piercing tip on one end of an elongated spike body containing a fluid passage. There is a very slight taper from the tip to a flange surrounding the body, and spaced from the tip, which serves as a stop. Retention, and a tight, non-leaking fit, are obtained by the friction fit of the spike body in the port structure. In one case, the spike pierces the bag wall itself. In the other case, the spike pierces a septum in the port structure.
SUMMARY OF THE INVENTION
An object of the present invention is to provide a new and improved plastic film storage bag and dispenser for dispensing fluid from the bag.
Another object is to provide a new and improved plastic film storage bag and dispenser for dispensing fluid from the bag wherein the bag does not require a separate port structure which is integral with, or fastened to, the bag.
Still another object is to provide a new and improved plastic film storage bag and dispenser for dispensing fluid from the bag wherein the plastic film forms a fluid tight seal with the dispenser when the film is punctured by the dispenser.
A further object is to provide a new and improved plastic film storage bag and dispenser for dispensing fluid from the bag wherein the dispenser is a plastic dispensing spike which cooperates with the plastic film to form a fluid tight seal when the spike pierces the film and is seated.
Yet a further object is to provide a new and improved dispensing spike for plastic film storage bags.
Another object is to provide a new and improved method of dispensing fluid from plastic film storage bags.
The foregoing and other objects are realized in accord with the present invention by providing a plastic film storage bag and dispenser for dispensing fluid from the bag. The dispenser comprises a dispensing spike which penetrates the wall of the bag but does not require a separate port structure.
In a first embodiment of the invention, the spike includes a tear drop shaped body which terminates in a sharp point. The body pierces the film wall of the bag, point first. The body progressively stretches the film to form a hole of increasing diameter. After the largest diameter portion of the body passes through the film, the film around the hole progressively contracts elastically, following a bulbous face of the body until it reaches a reduced diameter end of the body, opposite the point. A skirt extends radially outwardly adjacent this reduced diameter end. The plastic film of the bag contracted around the hole grips the reduced diameter end of the spike between the bulbous face of the body and the skirt adjacent it.
With the spike inserted into the bag in this manner, the contracted film around the hole in the film forms a fluid tight seal with the reduced diameter circumference of the body between the bulbous face of the body and the skirt. The pressure exerted by the fluid in the bag is normally effective to press the film tightly against the skirt and increase the effectiveness of the seal while retaining the puncture spike even more securely in the bag. At the same time, the fluid pressure in the bag acting on the bulbous face of the body, where it faces the skirt, is normally effective to balance pressure acting on inwardly facing surfaces of the body and, accordingly, oppose the forces which would otherwise tend to expel the spike from the bag.
In one variation of the first embodiment, a fluid outlet passage extends longitudinally through the entire spike, opening through a flattened side of a conical tip on the body. In this variation of the invention, the conical tip is inclined to the longitudinal axis of the spike.
In another variation of the first embodiment, the fluid outlet passage is tee-shaped. The cross-passage of the tee opens through both sides of a conical tip which is concentric with the longitudinal axis.
In a modification of the spike embodying features of either of the aforedescribed variations of the invention, a circular strip of adhesive is placed on the flange, adjacent the reduced diameter end of the bulbous body. The inner diameter of the circular strip corresponds to the outer diameter of the bulbous body at its maximum diameter. The outer diameter of the strip is slightly less than the outside diameter of the flange. When the dispensing spike pierces the bag in the aforedescribed manner, the adhesive adheres
Brinks Hofer Gilson & Lione
Bui Thach H
Lione Richard G.
Radius International Limited Partnership
Shaver Kevin
LandOfFree
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