Blood collection needle disposal system

A closure is provided comprised of a thin flexible material for use on a needle disposal container so that a contaminated blood collection needle may be removed from its holder and deposited in the container without the user touching the needle or the needle hub. The device includes an elongated tapered opening to accommodate varying diameters of needle hubs. A feature of the invention includes a plurality of spaced apart elongated slots extending from each side of the opening which enhances the flexibility of the edges of the opening, which, in turn increases the wedging or wrench-grip action for unscrewing a needle from a collection assembly and at the same time allows ready transfer to a disposal container. The cap of the invention is configured to be utilized with a large variety of collection containers of varying sizes and shapes.

BACKGROUND AND STATEMENT OF THE INVENTION 
This invention relates, generally, to receptacles or containers with 
one-way openings for receiving blood collection needles contaminated with 
the blood of patients. More particularly, this invention relates to a cap 
which may be used with a variety of such receptacles which accommodate the 
user of blood collection needles by allowing for a wrenching action for 
gripping the hub of the needle so that the needle may be unscrewed from 
the rest of the collection device and subsequently thrust through the 
opening of the cap to be disposed of in the associated container. With 
such an arrangement, users of blood collection needles do not come in 
contact with any of the needle surface, they are not accidentally 
punctured by the needles and they do not need to, for any reason, touch 
the needles or their hubs. 
In the last several years, medical practitioners and paramedical 
technicians have become increasingly aware of the danger of contamination 
to themselves in the handling of blood collection needles, once a blood 
specimen has been taken from a patient who may be suffering from some 
contagious disease. Recently, such dangers have been intensified by the 
publicity engenered by the rapid increase in the spread of the Acquired 
Immune Deficiency Syndrome (AIDS) Virus. For that one disease alone, it is 
extremely important that no blood contact be made between the medical 
technician or practitioner's blood, and the blood of a diseased patient. 
A further problem arises later, of course, after the technician or 
practitioner has disposed successfully of the contaminated needle without 
being contaminated by the needle. That is, if such needles are simply 
discarded in the trash of a hospital or clinic, for example, anyone 
handling the garbage in the long succession of the passage of the garbage 
from the institution to a garbage dump may be exposed to contamination by 
those needles simply by someone grasping a bag containing such needles and 
puncturing their finger, for example. Moreover, such needles may be laid 
aside by a physician or technician during a difficult procedure, without 
thinking, and someone might lean against a table or shelf where the 
contaminated needle is lying and contaminate their own blood with a blood 
sample from the needle. 
While awareness of the contamination problem has increased considerably in 
the last two or three years, the danger of contamination has been around 
for a long time and a wide assortment of devices have been provided 
through the years to make disposal techniques safe and fast. Some devices, 
for example, have been developed to receive contaminated needles through 
an opening in the top of a container which cannot be opened. That is, the 
opening is surrounded by a plurality of integral flaps which are flexible 
and allow receipt of a sharp object through the opening. However, no one 
can remove the sharp objects passing through the opening in the opposite 
direction. This arrangement is satisfactory, providing that the needle 
does not have to be removed from the rest of the collection device. 
However, such an arrangement does not allow removal of the contaminated 
needle from a holder so that the holder itself may be utilized for 
subsequent blood collections. It follows that manual separation is 
required which invites contamination. Representative of such devices are 
containers such as those described and claimed in U.S. Pat. Nos. 4,520,926 
and 4,454,944. Both of these patents include arrangements for receiving 
not only single and multiple sample blood collection needles, but also 
syringes including the entire body of the syringe. 
A further arrangement of blood collection needle receiving containers for 
contaminated needles is taught in U.S. Pat. No. 4,466,538. The arrangement 
in that patent not only provides a one-way opening for receiving 
contaminated needles, but also, the opening includes a tapered 
configuration. The point of the tapered walls of the opening is to allow a 
large opening at one end to receive the hub of a needle. Thus, the user 
may move the needle hub in the opening from the large end of the opening 
to a more narrow portion of the opening in order to provide a wedging 
action so that the user may unscrew the needle hub from the rest of the 
blood collection assembly. Subsequent to the unscrewing manipulation, the 
released needle and hub are moved back toward the larger portion of the 
opening so the needle and hub will pass through the opening into the 
container below. 
Difficulties have taken place in the use of such arrangements, however, in 
that the needle hubs have a tendency to become "hung-up" in the narrow 
portion of the opening so that the user must manually unwedge and move the 
needle hub from the narrow portion of the opening to the wider portion so 
that the needle and hub will drop in. This, of course, creates the danger 
that the technician may become contaminated with blood on the contaminated 
needle during this maneuver to attempt to remove the needle hub from its 
wedged position in the opening. 
This patent also includes the provision of the top surface of the cap 
having a slanted top surface so as to encourage the movement of the needle 
hub, once it has been unscrewed from the blood collection assembly to move 
downwardly toward the enlarged portion of the opening in the slanted 
surface of the cap of the container. Nevertheless, even with the downward 
slant of the opening, needle hubs become wedged readily in the narrow 
portion during the unscrewing or wrenching action necessary or required to 
unscrew the needle hub from the opening. 
In U.S. Pat. No. 4,375,849 a collection cup of the kind discussed herein is 
designed to include a cap having a specially shaped opening for bearing 
engagement by the cartridge structure of a double ended needle unit to 
permit unthreading of the needle unit from a syringe barrel as a 
one-handed operation, whereupon the thus-separated needle unit is intended 
to fall into the collection cup without direct handling by the technician. 
However, such cap constructions have not prevented occasional jamming of 
the needle unit, as discussed above with respect to U.S. Pat. No. 
4,466,538 such that it becomes necessary to dislodge the needle unit 
manually resulting in possible contamination or injury. Other collection 
cup designs have included a movable cap which can be closed when the cup 
is full to permit cup handling for disposal purposes without contacting 
the used needles. However, cap constructions of this type have been 
susceptible to relatively easy reopening, sometimes inadvertently, 
resulting in potential contamination, injury, or unauthorized reuse. 
With this invention, by contrast, a cap or closure is provided for 
incorporation into a contaminated blood collection needle assembly with 
the surface thereof comprised of a thin flexible material which gives upon 
contact or receipt of a needle assembly through the opening disposed in 
the cap or closure. The arrangement of the invention here includes a 
specific configuration of opening having tapered walls in the manner 
discussed above with respect to the prior art. However, incorporated with 
the opening are a plurality of elongated slots extending from each side of 
the opening which provide a flexible wrenching action for the hub of a 
needle assembly thrust into the opening. That is, the flexible material of 
the cap "gives" with such a thrusting movement and then grips the hub and 
provides a wrenching action allowing the technician to unscrew the hub 
from the rest of the blood collection assembly. 
Once this unscrewing action has taken place, the wrenching action is 
overcome simply by a further thrusting forward of the hub through the 
opening because of the built-in flexibility of the edges of the opening, 
in accordance with this invention. The tapered opening of the invention is 
such, that, alternatively, the unscrewed hub of the needle assembly may 
simply be moved toward the enlarged end of the opening for it to fall 
through the opening. At any rate, the flexibility of the engaging surfaces 
of the opening in combination with the elongated slots placed in strategic 
locations along each side edge thereof provides the appropriate gripping 
action for the hub for obtaining the unscrewing action required to release 
the hub from the rest of the collection assembly while still not causing 
the hub to be "hung-up" and wedged into the opening as was the case with 
the previous arrangements with rigid edges for the opening. 
As a further feature of the invention herein, the specific combination of 
opening in the cap of the invention may be placed in a cap surface which 
is horizontal, or perpendicular to the axis of the cap. However, the top 
surface of the invention here may be inclined in the same manner as taught 
in the prior art patents discussed above but in the reverse direction, the 
incline downwardly being toward the small end of the opening. Such a 
slanted surface enhances the movement of the holder toward the wedging 
position for increasing the wrenching action to unscrew the hub from the 
rest of the assembly. 
As purely illustrative of materials which may be used to form the flexible 
closure of the invention, one may select, for example, polypropylene. 
Another representative thermoplastic material is 
acrylonitrile-butadiene-styrene terpolymer. Furthermore, a thin flexible 
metallic cap may be utilized. The cap or closure of the invention, if it 
is made of a thermoplastic material, may be stamped, vacuum formed or 
injection molded. Preferably, the material will be polypropylene formed to 
have the major surface of the cap of a thickness of 1.27 mm. The range of 
thickness of the surface of the cap of the invention may be within the 
range of between about 0.1 and 2.0 mm. The dimension of the opening will 
be discussed in more detail below in the description of the drawings 
herein. However, it should be noted that the dimension of the opening is 
sized to accommodate any of the conventional needles on the market, such 
as those of Terumo, Sherwood and Becton, Dickinson and Company.

DETAILED DESCRIPTION OF THE DRAWINGS 
Referring to the drawings in which like reference characters refer to like 
parts throughout the several views thereof, an embodiment of apparatus 
incorporating the invention herein is illustrated in the form of a cap for 
closing the opening in a blood collection needle disposal system including 
a container therefore. It will be understood by practitioners-in-the-art, 
that the cap illustrated in FIG. 1 and the alternative embodiment in FIG. 
5 may be utilized and incorporated into a collection container assembly 
wherein the container may be of a variety of configurations including 
rectangular, square or round in shape and of a variety of sizes depending 
upon the specific application of the collection assembly in a particular 
location in a hospital or clinic, for example. Thus, in FIG. 1, a cap 10 
is shown illustrating the invention having an outer flange 14 surrounding 
the top surface 12 of the cap 10. Disposed between the outer flange 14 and 
the top surface 12 of cap 10 is an annular vertical wall 16 and a groove 
18 to be described in more detail below. As discussed above, top 12 may be 
comprised of vacuum formed polypropylene, for example, having a thickness 
of about 1.27 mm. and vacuum formed into the configuration shown. In this 
connection, it should be understood that cap 10 may be square or 
rectangular, as well, depending upon the opening upon which it is to be 
used. 
In accordance with the invention herein, an opening 20 is disposed in the 
top surface 12 of cap 10. As shown, opening 20 has tapered side walls 24 
diverging from small end 30 toward large end 31 of opening 20. These 
diverging walls allow for differing dimensions of the width of opening 20 
to accommodate varying sizes of needle hubs on the market. While the 
material making up the top surface 12 of cap 10 is flexible, as discussed 
above because of the material utilized and the thickness thereof, it is 
important to note that in accordance with this invention, opening 20 has 
disposed adjacent each side thereof spaced apart slots 36 which extend to 
very small circular openings 34. These slots 36 have the property of 
enhancing the flexibility of the tapered side edges 24 of opening 20 so as 
to allow the user of the device to grip the needle holder to be removed 
from a blood collection device so that the holder may be unscrewed and 
released from the rest of the collection assembly. This very same flexible 
property allows for readily thrusting the released holder hub with 
attached contaminated needle or needles through the opening 20 and into 
the container itself. 
While it will be understood by practitioners-in-the-art that cap 10 will 
have varying dimensions depending upon the specific container into which 
it will be incorporated and the use for which the container will be made 
(i.e., heavy duty use or light duty use in various locations in a clinic 
or hospital) as purely illustrative of dimensions of the embodiment of cap 
illustrating the invention herein one may note that the angle 26 of taper 
of side walls 24 may be about three degrees from the longitudinal axis of 
opening 20. The radius 22 of end 30 of opening 20 may be, for example, 
1.46 mm. while the radius 32 of opening 31 may be 4.66 mm. The dimension 
38 may be, for example, 21.74 mm. while the dimension 40 may be, for 
example, 22.22 mm. The overall diameter of cap 10 may be, in this 
embodiment, 49.88 mm. although this dimension will vary depending on the 
opening to be closed, and has little relationship to the dimensions of 
opening 20. In order to provide the flexibility of surface 12 of cap 10 in 
accordance with this invention, the slots 36 end in circular openings 
having a dimension which may be, for example, 1.58 mm. Slots 36 will be, 
for example, 0.38 mm. wide. 
It should be understood, that all of these dimensions are representative 
only of a specific embodiment of the invention as discussed herein. The 
dimensions will vary, as will be understood by practitioners-in-the-art 
depending upon the specific application of the container device, as 
discussed above. 
Referring now to FIG. 2, a sectional view of cap 10 is shown. As can be 
seen in FIG. 2, an annular flange 14 extends around the top surface of cap 
10. Furthermore, as can be seen in FIG. 2, the top surface 12 of cap 10 is 
slanted downwardly from the right-hand edge thereof to the left-hand edge 
thereof. The annular flange 14 is connected to a substantially vertical 
wall 16 which extends downwardly to a groove 18 which is formed by the 
connection 41 between the annular wall 16 and the top surface 12 of the 
cap assembly of the invention. An annular abutment 42 is shown which 
serves to provide a wedging action for fitting cap 10 upon a collection 
container for providing a blood collection needle disposal system. It 
should be understood, however, that cap 10 may be incorporated into and be 
integral with such a container when it is formed. 
Referring now to FIG. 3, an enlarged sectional view is shown of that 
portion of FIG. 2 in the circle designated "A" in FIG. 2. The enlargement 
shows in the sectional view thereof the left-hand end of the cap shown in 
FIG. 2 and details the configuration of the connection 41 forming the 
groove 18 and the annular abutment 42. The same comments can be made with 
respect to FIG. 4 which shows the same details of cap assembly 10. 
Referring now to FIG. 5, a further embodiment of cap assembly 50 is shown. 
As can be seen in this embodiment, an opening 54 is positioned in the top 
surface 52 of cap 50. The opening 54 is arranged and configured in the 
same manner as opening 20 in the embodiment shown in FIG. 1. As can be 
seen in FIG. 6, however, the top surface 52 is flat in this assembly, with 
no incline. Thus, the cap 50 shown in this assembly includes a depending 
skirt 67 with an annular wedge 68 for press fitting cap 50 into an opening 
of a blood collection needle disposal container for receiving needles 
thrust through opening 54 of cap 50. As purely illustrative of dimensions 
of the embodiment of cap 50 shown in FIGS. 5 and 6, dimension 66 is 22.22 
mm. while dimension 61 is 19 mm. and the thickness 64 of slots 62 is 0.794 
mm. The diameter of small end 56 of opening 54 is 3.45 mm. while the 
diameter of large end 58 of opening 54 is 6.13 mm. The dimension 70 is 
49.91 mm. Again, it should be emphasized here that these dimensions are 
representative only to illustrate the relationship of dimensions among the 
various parts of the cap or closure of the invention in order to provide 
the proper working action of the cap. Simultaneously the gripping and 
wrenching action necessary for unscrewing a needle hub is provided while 
at the same time there is sufficient flexibility to allow the released hub 
to become unwedged so as to be discarded through the opening without any 
unnecessary catching or wedging action requiring a manual manipulation to 
remove the released hub from the opening to allow it to fall into the 
container. 
Referring to FIG. 7, an embodiment of the invention is shown with a 
permanent closure 72 integrally mounted on cap 10 at one end of a 
conventional integral strap 70. Thus, once a container incorporating the 
cap 10 structure of the invention is filled, closure 72 may be moved in 
place for permanently closing opening 20. Closure 72 includes a depending 
central part 78 which extends into and through opening 20. Also, an 
annular depending locking flange 74 is included with closure 72. The outer 
end of flange 74 includes locking abutment 76 which, in the closed 
position of closure 72 wedges into groove 18 for holding closure 72 
permanently closed. I will be understood that many forms of permanent 
closure assemblies may be used to close opening 20 permanently. 
Thus, and as will be apparent from the foregoing, there are provided in 
accordance herewith, methods and apparatus for the release of a 
contaminated needle hub from the rest of a blood collection assembly and 
the proper gripping action therefore. Simultaneously, the required 
resilient properties are provided which enhance the releasing of the 
wrenched hub of such a contaminated needle so that it will fall easily and 
safely into the container therefore. Thus, the contaminated needle is 
removed from any contact with the technician making a contaminated blood 
collection and from any contact with anyone handling the disposal of goods 
from a hospital or clinic in the sequence of handling necessary for such 
removal to a garbage disposal dump or other facility provided for this 
purpose. 
Obviously, it will be apparent that the arrangement of an invention here is 
of a simple configuration so that the cap of the invention may be vacuum 
formed or injection molded utilizing assembly line techniques so that many 
thousands of such caps can be produced on a mass production basis 
inexpensively. 
While the methods and apparatus herein disclosed form preferred embodiments 
of this invention, this invention is not limited to those specific methods 
and apparatus, and changes can be made therein without departing from the 
scope of the invention which is defined in the appended claims.