Unit dose assembly

A cap and tube assembly device including a tube with a nozzle mounted on one end of the tube and having a thin wall section puncturable to provide a discharge on the other end of the nozzle. Also provided is a cap having a first end with an inside cross section sized to engage the nozzle and having an axially centered puncture spike positioned in a first position spaced from the thin wall and movable to a second position to puncture the thin wall. The puncture spike has a chisel shaped edge for forming a hole in the wall and a central bore for providing access to the contents of the tube. The cap has a second enclosing an applicator for dispensing the contents of the tube, whereby the contents of the tube is transferred to the applicator through the bore of the puncture means.

FIELD OF THE INVENTION 
This invention relates to a unit dose assembly and more particularly to a 
cap for use with a tube in which a unit dose is provided in the tube. The 
tube may contain a single dose of medicine, eyewash, disinfectant or other 
pharmaceutically related product. The device is particularly suitable for 
use with medicaments which need to be topically applied, and is ideal for 
use with iodine solutions which are used to sterilize and clean skin prior 
to injections or I-V insertions. 
BACKGROUND OF THE INVENTION 
Cape and tube assemblies which carry medicines and the like have obtained 
significant interest in the pharmaceutical industry. Not only is there a 
concern for resistance to undesirable tampering, such as by a child, there 
is increased interest in application of sterile fluids to the body for 
various treatment purposes. 
In my recent patent, U.S. Pat. No. 4,867,326, I have provided an excellent 
design for a child resistant cap. The design described in my patent is of 
great value in providing a product wherein there is easy and convenient 
inspection of unit dose sterile medicaments in a cap and tube assembly. 
The unit is child resistant and suitable for a high reliability pass/fail 
inspection by the user. 
In my patented design, the cap is used to activate or pierce a thin wall in 
the tube which provides access to the contents of the tube. The cap then 
must be removed and the contents may be deployed. While this system is 
excellent for delivering unit doses of medicines, such as, for example, 
eyedrops, the prior art designs have not been entirely satisfactory when 
the contents of the tube are to be applied topically. Accordingly, one 
object of the present invention is to provide a unit dose assembly for 
topical applications of the contents. 
Often times, it is particularly desirable to be able to apply disinfectant 
and other sterilizing solutions to the skin directly, such as when 
injections or incisions are being made. Iodine solutions are often rubbed 
on the skin prior to administration of an injection. 
Even in surgery, there are times when it is desirable to apply 
disinfectants or other medicaments topically. In operating room 
conditions, it is absolutely essential that the equipment be sterile and 
be protected from contamination from exterior sources. Thus, while the 
contents of a container might be sterile and suitable for use in surgery 
or other operating room procedures, the outside of the container itself is 
not sterile. 
Additionally, even when a particular solution is used repetitively in a 
surgical procedure, it is less than desirable to have large quantities of 
these solutions. If all of the solution is not used, it is either wasted 
by being discarded or it represents a potential source of contamination 
when it is used during a succeeding procedure. For that reason, sterile 
unit dose applications of these solutions would be of great advantage to 
the art. It is another object of this invention to provide unit dose 
assemblies for topical applications under sterile conditions such as 
operating room environments. 
One particular concern in surgical facilities is the need to account for 
objects before and after surgery. Accordingly, if a unit dose system were 
to be provided which would be sterile and otherwise suitable for 
accomplishing the objects of the present invention, concern would always 
remain that the cap might be lost. Once it has been used to puncture the 
thin wall end of the tube and has been removed to permit access to the 
contents of the tube, it must be accounted for separately. Accordingly, it 
is an object of this invention to provide a unit dose assembly for topical 
applications which remains in one piece after access to the tube has been 
obtained. 
Other objects will appear hereinafter. 
SUMMARY OF THE INVENTION 
It has now been discovered that the above and other objects of the present 
invention may be accomplished in the following manner. Specifically, a cap 
for a unit dose assembly for topical application has been discovered which 
includes the following components. 
A tube containing a unit dose, such as a quantity of iodine for sterilizing 
or cleaning the skin, is provided with a nozzle having one end mounted on 
or part of one end of the tube and a thin end wall section on the other 
end of the nozzle. The thin wall section is puncturable to provide a 
discharge of the contents. A major part of the assembly is a cap having a 
first end with an inside cross section sized to engage the nozzle, the cap 
has an axially centered puncture means positioned to puncture the thin 
wall when it is moved from a first position spaced therefrom, during 
storage, to a second position during use. The puncture means includes a 
central bore for providing access to the contents of the tube. The cap 
includes a second end in communication with the first end through that 
central bore. The second end encloses an applicator for dispensing the 
contents of the tube, which may be accomplished when the thin wall or 
membrane is pierced by the puncture means. 
In a preferred embodiment, the nozzle and first end of the cap have a ring 
and groove assembly or other arrangement by which a surface of resistance 
and an interference surface mutually combine to locate the cap with 
respect to the tube in the first position. 
In another embodiment, the applicator means includes a material capable of 
expanding when fluid is transferred from the tube to the applicator. A 
preferred material is polyurethane since it can be sterilized, is soft, 
contains no threads and is Federal Drug Administration approved. Cotton, 
paper, other wicking materials, felt, sponges and other synthetic foams 
which have most of these same properties are also useful as applicator 
materials. In a preferred embodiment, the applicator and the second end 
include a means for preventing removal of the applicator during use. 
The entire device is intended to be sterilized. The sterile package may be 
included in a blister pack which can be opened without contacting the 
sterile inside, for example, and dropped onto a sterile cloth in an 
operating room. Alternatively, a removable cover means may be placed on 
the second end, such as a peel off cover, to protect the applicator from 
contamination.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
As shown in the figures, a unit dose assembly for topical applications 
shown generally by the reference numeral 10 includes a tube portion 11 
which is sealed at one end 13 after a quantity of medicament has been 
placed inside the tube 11. The tube 11 has a nozzle 15 at the other end, 
and the nozzle 15 is fitted with a cap 17. 
As shown in FIG. 2, the cap 17 has an upper compartment 19 and lower 
compartment 21. The lower compartment 21 includes a piercing means 23 
which is supported by the divider disc 25. Divider disc 25 separates the 
upper compartment 19 and the lower compartment 21. The piercer 23 includes 
an orifice 27 through the piercer 23, which permits transfer of the 
contents of the tube 11 from the lower compartment 21 to the upper 
compartment 19. 
The nozzle 15 is joined at one end to the tube 11 and at the other end is 
provided with a nozzle tip 29. Nozzle tip 29 includes a thin wall portion 
31, which is of sufficient thickness to prevent the contents of the tube 
11 from being removed until the membrane 31 is penetrated. 
The cap 17 is located in a first position on the nozzle 15 by a groove 33 
and ring 35. This combination of ring and groove provides a surface of 
resistance in the groove and an interference surface in the ring. Of 
course, the ring 35 can be placed on the cap 17 and the groove on the 
nozzle 15 if desired. 
The upper portion 19 of the cap 17 is preferably filled with a material 
which is suitable for use as an applicator. Polyurethane foam and other 
synthetic foam materials, felt, sponges, paper and other wicking 
materials, cotton, and other soft materials can be used, depending upon 
the material contained in the tube and the use for which it is intended. 
It is preferred to use a polyurethane foam, or something similar, which 
can be sterilized, such as by gamma radiation, and which is soft, has no 
threads, and is FDA approved. 
In order to activate the device of the present invention, all that is 
necessary is to press on the upper compartment 19 of the cap 17 so that 
the piercing member 23 penetrates the thin membrane 31. The force needs to 
be sufficient to overcome the resistance due to the groove 33 and ring 35. 
As seen in FIG. 3, the lower chamber 21 of the cap 17 now fully 
accommodates the nozzle 15. The piercing member 23 extends into the nozzle 
15 and beyond the nozzle tip 29. Contents contained in tube 11 may now 
pass through the orifice or hole 27 in the piercer 23 and contact the 
applicator material 37. 
Typically, when a liquid is contained in the tube 11, and the tube 11 is 
squeezed or otherwise caused to force liquid to flow through the hole 27, 
the applicator material 37 will expand slightly due to its being filled 
with the fluid. 
As shown in FIG. 4, a liquid has entered the urethane foam 37 and extends 
out beyond the end of the upper compartment 19. This expansion of the foam 
37 can also take place in the dry form, prior to puncturing the thin wall 
membrane 31. For example, an optional cover 39 shown in FIG. 2, can 
maintain the applicator material 37 under compression until it is removed 
and the system is activated. Then, the applicator material 37 will expand 
as shown in FIGS. 3 and 4. 
It is recognized that use of the device of this invention requires that the 
contents of the tube 11 be forced through the hole 27. This transfer of 
contents will put some pressure on the applicator material 37. 
Particularly if the tube is squeezed excessively, the applicator material 
37 may not accommodate the fluid as rapidly as is desired. In order to 
preserve the integrity of the device and prevent the applicator material 
37 from escaping from the upper compartment 19, a shoulder 41 is formed in 
the upper compartment 19 and this shoulder 41 prevents movement of the 
applicator material 37. 
In an alternative embodiment, the applicator material 37 can be bonded, by 
heat or adhesive for example, to the dividing wall 25 separating the upper 
compartment 19 from the rest of the cap 17. Care should obviously be 
exercised to prevent plugging the hole 27 and no adhesive materials which 
are not fully approved by the FDA and other agencies should be employed. 
Instead of employing a cover such as the tab 39 shown in FIG. 2, it is 
contemplated that a preferred embodiment of the present invention will 
incorporate the device in a package, such as a flexible, sterilizable 
envelope. As shown in FIG. 5, the tube 11, cap 17 and exposed applicator 
material 37 are positioned on a substrate 43 which forms an envelope 45 
using conventional technology. Instructions and advertisements can be 
printed on either the substrate or the blister pack as desired. The 
packaging can be a paper-mylar envelope or a blister pack or other packing 
which can be sterilized by steam, gamma radiation and the like. 
It is intended that the device of the present invention will be sterilized 
prior to use. While there are a variety of ways for sterilizing, such as 
might be employed in the assembly of the device in its marketable form, it 
is preferred that the device be assembled and thereafter be sterilized 
using gamma ray sterilization techniques. Unless the contents of the tube 
11 are sensitive to gamma ray sterilization, this is the most effective 
way to ensure that the entire device is sterile. 
Since one of the preferred uses for the present invention is to dispense 
iodine solutions which themselves are used to sterilize and clean skin 
prior to injection or other surgical procedures, it is contemplated that 
these devices will be used in an operating room facility. In the blister 
pack embodiment, the device has been sterilized and is maintained sterile 
until it is time for use. Although the exterior envelope 45 and the 
substrate 43 may be contaminated, however slightly, by the environment, it 
is contemplated that someone in the operating room will be directly 
responsible for opening the package and allowing the tube 11 and cap 17 
assembly to be removed and placed on a sterile tray without the tube 
assembly 11 being touched. This is often done by a perimeter nurse. The 
surgeons and assistants who have been sterilized and are wearing 
sterilized gloves will then pick up the tube 11 in a sterile condition and 
will not have had to have contacted the outside of a tube that could have 
been contaminated in any way. 
Because of the present design, the cap 17 is not removed from the tube 11. 
For this reason, operating room parts counting procedures are not confused 
when the present invention is used. 
While particular embodiments of the invention have been illustrated and 
described herein, it is not intended to limit the invention. Changes and 
modifications may be made herein within the scope of the following claims.