Vented spike connection component

A connection component suitable for use with an enteral fluid delivery set is arranged in the form of a replacement for the cap of a pre-filled, foil sealed fluid container. The connection component includes a fluid outlet passage which is arranged in the form of a projecting spike which penetrates and opens the foil seal as the connection component is attached to the pre-filled container.

BACKGROUND AND SUMMARY OF THE INVENTION 
The present invention relates to a connection component arranged for 
mounting on a tubing assembly for connection to a prefilled, foil-sealed 
container, and in particular to a connection component which includes a 
spike for penetrating a foil seal and an air vent. 
In an enteral fluid delivery system for a patient, there is a need to 
provide a component that will effect a quick connection of a fluid 
delivery set to a prefilled, foil-sealed container containing enteral 
nutritional fluid. In such systems the connecting component is preferrably 
in the form of a cap, which replaces the shipping cap on the prefilled 
container, and includes means for perforating the foil seal on the 
container during attachment. Such automatic perforation is desirable to 
simplify the set-up procedure. It is further desirable that the connecting 
component provide a means to allow air to vent into the container as fluid 
flows from the container. Such venting should be achieved without 
permitting venting air bubbles from entering the outlet flow channel. 
Accordingly, it is an object of the present invention to provide a 
connection component for effecting a quick coupling between a fluid 
delivery set and a prefilled, sealed container that minimizes the time of 
exposure of the container contents between seal puncture and attachment to 
the fluid delivery set. 
Another object of this invention is to provide such a connection component 
for use with prefilled, foil-sealed containers that inhibits entry of air 
into the fluid flow path. 
A still further object of this invention is to provide such a connection 
component that can puncture and deform the seal of a prefilled bottle in a 
manner that permits the venting of air into the container and the pumping 
of fluid therefrom. 
These and other objects of the invention are obtained by means of a 
connection component adapted to be attached to a prefilled, fluid 
container, said component including a circular wall portion, a pointed 
projecting member extending from the wall portion and spaced from the 
center of the wall portion, said projecting member having a fluid 
receiving passage passing through the wall portion, said projecting member 
being spaced from the center of the wall portion, and an air vent on the 
wall portion, spaced from the center of the wall portion at a position 
opposite from said projecting member. 
For a better understanding of the invention, as well as other objects and 
further features thereof, reference is had to the following detailed 
description of the preferred embodiments which makes reference to the 
following set of drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
Referring to FIGS. 1 and 2 the vented spike connection component of the 
present invention is generally comprised of a housing body 1 including a 
circular wall having a top surface 2, a bottom innerside surface 3, and a 
rim 4 adapted to be detachably mounted to the neck 41 of a prefilled 
container 40. The connection component is preferably formed from molded 
plastic and has a one piece construction. 
The housing body 1 is provided with two cylindrically shaped members 5 and 
6 extending outward from surface 2. Member 5 has an internal passage of 
which forms an air vent and includes a one way valve 9 arranged within 
recess 8 formed as an enlargement of the inner end of passage 7. A cover 
20 may be provided to close passage 7 prior to use. 
Cylindrical member 6 includes a top portion 10 extending outward from 
surface 2 and is adapted to be attached to a plastic tubing 30 which along 
with the connection component forms an enteral fluid delivery set. 
Cylindrical member 6 also includes a bottom portion 11 having a spike 
formed by truncating the cylindrical member portion 11 with an 
intersecting angled plane starting at a location 12 just below the bottom 
surface 3 of the housing body 1 to a point 13 extending below the edge 14 
of the rim 4. Member 6 includes a central passage through which enteral 
fluid can pass from container 40 into tubing 30. 
In the FIG. 1 embodiment, the circular wall formed between surfaces 2 and 3 
has a central axis designated C1 about which the connection component is 
rotated for attachment to fluid container bottle 40. In the illustrated 
embodiment cylindrical member 5 and 6 are each offset from axis C1 on 
opposite sides of C1. In addition the shape of the spike 13 formed on 
portion 11 of cylindrical member 6 is oriented so that the opening of the 
central passage is facing away from the vent passage 7 formed through 
member 5. The center C3 of member 6 is offset by approximately 0.1 inch 
from the center C1 of the connection component. This offset provides for 
effective action of the spike end 13 in opening a passage through a foil 
seal on a fluid container 40. 
The center C3 of member 6 is offset by approximately 0.5 inch from the 
center C2 of member 5. This separation, along with the orientation of the 
opening of the passage in member 6 prevents air bubbles which enter fluid 
via vent passage 7 from being drawn into the outlet passage in member 6. 
Additionally, a rib 15 is provided on the bottom innerside surface 3 of 
the connection component. The rib 15 acts to deflect the seal after it has 
been punctured, thereby prohibiting the seal from obstructing the air 
passage in member 5. 
With the aforedescribed vented spike connection component of the present 
invention, possible interference caused by collection of the seal of the 
container around the base of the projecting member, after it has pierced 
the seal of the container, is eliminated by the deformation of the seal in 
a manner as shown in FIG. 3. This irregularly shaped aperture 43 in the 
seal 42 is caused by the offset of its centerline C3 of cylindrical member 
6 from the axis C1 of the housing. With reference to FIG. 4, the aperture 
43 is sufficiently extended to permit air to be vented into the container 
without being obstructed by the foil seal 42. Also the aperture is 
sufficiently deformed at the center as to allow clear passage of the fluid 
to the fluid carrying projecting member 6. 
When in use the connection component according to the present invention 
disposes the long side 601 of the fluid carrying projecting member 6 
adjacent the vented air stream 602 as illustrated in FIG. 5. This 
placement provides a physical barrier between the vented air stream 602 
and the area adjacent the point of fluid exit 603. Coupled with a 
sufficient distance displacement between the air stream 602 and the fluid 
exit point 603 they form a system that provides reliable delivery of the 
fluid from the container to the fluid flow circuit without inducement of 
air into the circuit in the form of a bubble. Further, the flow of fluid 
or vent air is not obstructed by the foil seal. 
The detailed description of the preferred embodiment of the invention 
having been set forth herein for the purpose of explaining the principles 
thereof, it is known that there may be modification, variation or change 
in the invention without departing from the proper scope of the invention 
and the claims thereto.