Tamperproof breakaway port

An easy tear-open or breakaway port for a container wherein the breakaway line is provided by a preweakened portion having a reduced wall section with the width varying in a uniform and progressive manner from a minimum width to a maximum one. The breakaway feature is readily adaptable to plastic containers and can be utilized in conjunction with a handle or gripping member to facilitate the tearing along the preweakened portion.

BACKGROUND OF THE INVENTION 
This invention relates to a tamperproof breakaway port for a container. 
More particularly, this invention relates to an easy access opening in a 
container which will afford a sterile access entry point and is 
particularly suitable for utilization in plastic containers. 
Tear-open seals of the type concerned with in this invention are described 
in U.S. Pats. Nos. 1,327,190; 2,073,941; 2,893,611; 2,894,510 and 
3,509,879. In all of these patents with the exception of U.S. Pat. No. 
2,894,510 a preweakened wall section forming in effect a groove to 
preweaken the area along the desired tear is described. In these patents 
the preweakened line has the same cross section of wall thickness. In U.S. 
Pat. No. 2,894,510, flap members are provided which are torn apart to 
expose an entry port. The problem with preweakened sections of uniform 
cross section, or of the utilization of flaps, to provide a tamperproof 
entry port is in that they do not afford a uniform tear with consistent 
results. In the instance where handles are provided in conjunction with 
the tear open port as in U.S. Pat. No. 3,509,879, additional molding 
techniques must be utilized in applying the tamperproof feature to a bag. 
In addition, extra sealing steps must also be utilized in order to place 
the tamperproof port on a flexible container. 
It is an advantage of the present invention to afford a readily opened 
tamperproof port for access to a container. Other advantages are a 
tamperproof port which affords a sterile injection site into a blood bag 
or an I.V. solution container; an injection port which will provide for a 
positive tear open seal and be readily adaptable to being fabricated on a 
flexible plastic container. 
SUMMARY OF THE INVENTION 
The foregoing advantages are accomplished and the shortcomings of the prior 
art are overcome by the present tamperproof breakaway port wherein a 
weakened portion is provided in a tubular walled port which is in 
communication with the container. The weakened portion separates a cover 
section and that section secured to the container. The weakened portion is 
formed by a reduced wall section extending in a substantially transverse 
plane with respect to the longitudinal axis of the tubular port. The 
reduced wall section extends peripherally into the wall of the tubular 
port from the exterior surface thereof and varies in width in a uniform 
and progressive manner from a minimum to a maximum width. One embodiment 
has the reduced wall section formed with two minimum and maximum widths 
with the thinnest wall sections disposed diametrically opposite from each 
other with the widest wall sections in between.

DESCRIPTION OF ONE EMBODIMENT 
Proceeding to a detailed description of the present invention, the 
tamperproof breakaway tubular port units 10 are shown in FIG. 1 in 
conjunction with a resinous plastic, flexible blood bag 11 having the 
usual central outlet tube 12 with an overflap 14 from which extend outlet 
tube 12 and the tamperproof units 10. As best seen in FIG. 2, the 
tamperproof units 10 are positioned on bag 11 with each unit 10 having a 
port 20 with a central core 17, loosely positioned in tubular port 20. An 
outer skirt portion 27 extends around port 20 and an annular tapering 
groove 18 in unit 10 accommodates the straight wall 30 of tubular port 20, 
with breakaway port 10 thus forming a cover section 22 for port 20. Unit 
10 is provided with a tab or cap portion 16 having flanges 13 and 15 to 
secure it to external wall 19. It will be seen that wall 19 in addition to 
providing skirt 27 has an annular sealing flange 21 for sealing to flap 14 
and ultimately to bag 11. Reinforcing ribs 31 and 32 connect flange 21 
with skirt 27. Disposed in wall 19 is a weakened portion 23 extending in a 
substantially transverse plane with respect to the longitudinal axis of 
port unit 10 and extending peripherally into the wall 19. As best seen in 
FIG. 3, weakened portion 23 is of a generally V-shaped configuration with 
a flat inner reduced base wall section 24. It is preferably formed at a 
compound angle of 30.degree.. 
An important aspect of the weakened portion 23 is the fact that wall 
portion 24, although forming a continuous single groove, is not of a 
uniform dimension but as best seen in FIG. 4, has a varying width in a 
uniformly progressive manner from a minimum width at points 25 and 26 to a 
maximum width at points 28 and 29. It will be noted that these minimum and 
maximum widths are located diametrically opposite to each other with the 
minimum widths located adjacent ribs 31 and 32. In a preferred manner, 
these wall thicknesses as represented by 25 and 26 will be approximately 
0.005 inch to 0.008 inch and at points 28 and 29 will be 0.014 to 0.017 
inch. 
In FIG. 5 another embodiment is described as breakaway unit 110. Similar 
numbers are employed to indicate similar parts as in the previous 
embodiment except that they are in the 100 series. The I.V. bag 111 is of 
the type described in U.S. Pat. No. 3,915,212 entitled "Flexible Medical 
Fluid Container Having a Combined Fill and Administration Port and 
Reinforced Hanger" and is commonly assigned. It will be noted in this 
particular embodiment that weakened portion 123 is disposed adjacent to 
extended wall portions 130 and 131 formed from external wall 119 and tab 
portion 116, respectively, with tab portion 116 and wall portion 131 
forming in effect a cover section 122 for port 120. It will also be noted 
from FIG. 6 that the weakened portion 123 is of a generally V-shaped 
configuration throughout its entire circumferential or circualar length. 
As this particular tamperproof port is used in conjunction with an I.V. 
flexible bag, it will have a reseal unit 135 contained in unit 110 and 
will be accommodated therein by means of a shoulder portion 133 in wall 
119. One difference between embodiments 10 and 110 is that in unit 110, 
there are no reinforcing ribs adjacent the smallest widths 125 and 126. 
The same dimensions will apply as in the wall thickness 24 in unit 10: the 
dimension for wall 124 at its smallest widths at 125 and 126 will be in 
the range of 0.005 to 0.008 inch and its widest dimension at 128 and 129 
will be in the range of 0.014 to 0.017 inch. 
Operation 
A better understanding of the advantages of the tamperproof units 10 and 
110 will be had by a description of their fabrication and operation. 
Referring to unit 10 first, cap 22 will be molded separately from port 20. 
At time of fabrication, flap 14 will be placed on bag 11 and flange 21 
extending from wall 19 placed on flap 14 which seats skirt 27 over port 
wall 30. Flange 21 is then sealed to flap 14 which in turn is sealed to 
bag 11. When it is desired to gain access to tubular port 20, indicia will 
be indicated on wall 19 as to the weakest points, namely 25 and 26 in 
preweakened portion 23. Tab 16 will be grasped by the operator and will be 
bent or flexed in a direction toward and away from points 25 and 26 to 
cause an initial break at either of these points. Bending of tab 16 in the 
indicated direction will cause a complete tear around wall 24 with the 
tear originating at the minimum wall thickneses 25 or 26 and proceeding in 
both a clockwise and counterclockwise manner through the widest widths 28 
and 29 to the opposing minimum thicknesses. Removal of cover section 22 of 
unit 10 which extends above the preweakened portion 23 will be effected, 
which will include the central core 17 whereas flanges 21 and that portion 
of wall 19 extending between flange 21 and preweakened portion 23 will 
remain secured to bag 11. It should be noted that central core 17 will aid 
in a tearing along preweakened section 23 and wall 24 in that it will 
provide an internal flexing on tube 20 so as to induce the shearing effect 
in wall 19. This is the purpose as to the core 17 terminating immediately 
adjacent the preweakened portion 23 although to the inside of tubular port 
20. Tearing will also be aided by placement of stabilizing ribs 31 and 32 
adjacent weakest points 25 and 26. One sharp movement will effect complete 
removal and access to bag 11 by means of a piercing cannula through 
remaining tube 20. 
The operation and fabrication of port unit 110 is substantially the same as 
that indicated for tamperproof port unit 10 except that unit 110 with wall 
119 having extended portion 130 and tab portion 116 with extension 131 
will be sealed integrally to bag 111 by means of flange 121. Cover section 
122 will thus be sealed over reseal 135 with the sealing of flange 121 to 
bag 111. Indicia will be indicated on tab portion 116 to indicate the 
minimum wall thicknesses 125 and 126. At either point, tab portion 131 
would be grasped and pulled to initially effect a tearing action. The 
tearing would then proceed in a simultaneous clockwise and 
counterclockwise motion until the tears meet in an area of minimum wall 
thickness at which time the tab or cover section 122 would be removed 
while flange 121 and that portion of wall 119 extending between 
preweakened portion 123 and flange 121 will remain secured to and in 
communication with bag 111. At this stage, an injection needle or cannula 
with tubing can be inserted in through reseal device 135 and into the 
inside of solution container 111 for the purpose of either adding material 
thereto or withdrawing it. 
By providing walls 24 and 124 with varying widths in a uniformly 
progressive manner from a minimum width to a maximum one, returning to a 
minimum one with the minimum and maximum widths oppositely disposed, the 
tamperproof units can be removed with a minimum amount of effort and in a 
positive manner. If desired, although of no apparent advantage the walls 
24 and 124 could be constructed with a minimum width uniformly progressing 
in a clockwise and counterclockwise manner to a unitary maximum width or 
with a multiplicity of minimum and maximum wall thicknesses which are 
interconnected with a constantly increasing or decreasing wall portion to 
provide an undulating effect. Regarding unit 10, by having a central core 
17 and wall 19 with skirt 27 extending down over outlet tube 20 a 
substantial distance, sterility of the port is assured on the outside as 
well as on the inside. Another important aspect in making the breakaway 
sections 23 and 123 is that the uniform thickness of 0.005 to 0.008 inch 
is not practical from a molding standpoint. It has been determined that a 
minimum average thickness of 0.011 is required to properly mold the part. 
By varying the thickness over the breakaway section, one is able to obtain 
the required cross sectional area for properly filling the mold cavity 
without increasing the thickness of the breakaway at the point where the 
break is initially generated. 
As seen from the drawing and particularly FIGS. 4 and 7, weakened portions 
23 and 123 have wall thicknesses which vary in width in a uniformly 
progressive manner from a minimum thickness to a maximum one. While no 
degree of taper is critical, it is important that the taper be such that 
the wall thicknesses progressively increase in two directions toward a 
maximum width. Further, it will be apparent that units 10 and 110 would be 
interchangeable on bags 11 and 111. 
It should also be pointed out, although it is not of a critical matter, 
that tab flanges 13 and 15 have a 0.650 inch diameter and are 0.045 inch 
thick whereas ribs 31 and 32 are 0.062 inch in width. 
Units 10 and 110 are molded from flexible polyvinylchloride. However, other 
resinous flexible plastic materials could be utilized such as any 
injection or compression moldable plastic. Further, glass could be used if 
desired. 
While units 10 and 110 have been shown in conjunction with ports for blood 
bags and additive ports, respectively, it should be understood that the 
tamperproof units could be utilized with any container port where 
sterility is a factor. In such instance the container port could be 
employed to add or withdraw materials or administer the contents of the 
container. 
It will thus be seen that through the present invention there is now 
provided a tamperproof tear open unit which is easily constructed yet can 
be opened with a minimum amount of effort and in a positive manner. The 
tear open units can be easily fabricated from existing molding equipment 
and result in units which are easily assembled with plastic fluid 
containers. The tear open units afford a sterile entry port without 
excessive parts being utilized in conjunction with the tear open units. 
The foregoing invention can now be practiced by those skilled in the art. 
Such skilled persons will know that the invention is not necessarily 
restricted to the particular embodiments presented herein. The scope of 
the invention is to be defined by the terms of the following claims as 
given meaning by the preceding description. I claim: