Sterile connection apparatus

A sterile connection apparatus is provided for enabling the connection of a first tube to a transfer tube of a medical solution container. The apparatus includes a housing having a cover portion which is adapted for interfitting with a base portion to provide a substantially closed interior volume. The first tube and the transfer tube of the medical solution container are introduced within the interior volume and the housing carries means located therewithin and operable from the outside of the housing for enabling manipulation of one of the tubes. In this manner, the first tube may be disconnected from and/or connected to the transfer tube. Means are provided for sterilizing the tubes within the substantially closed interior volume.

BACKGROUND OF THE INVENTION 
The present invention concerns an apparatus for enabling the sterile 
connection of a first tube to a transfer tube of a medical solution 
container. Although the illustrative embodiment of the invention is 
described in connection with tube transfer during ambulatory peritoneal 
dialysis, it is to be understood that other sterile tube transfers can be 
achieved in accordance with the present invention, such as the transfer of 
a tube from one blood bag to another. Thus, as used herein, the term 
"medical solution container" is intended to encompass containers of all 
shapes and materials and including any type of solution which may be 
introduced to a patient for medical purposes. 
In many medical applications, it is necessary to remove a connector tube 
from a first medical solution container and to then introduce it to a 
second medical solution container. It is, of course, desirable and, on 
occasion, required that the transfer of the tube from one medical solution 
container to the other medical solution container be achieved in a sterile 
manner. 
For example, in one type of ambulatory peritoneal dialysis, a tube which is 
coupled to the patient's peritoneal cavity is first connected to the 
transfer port (i.e., transfer tube) of a fresh dialysate solution 
container. For ambulatory purposes, the container is preferably in the 
form of a flexible plastic bag. 
The dialysate solution is then introduced into the patient's peritoneal 
cavity via the transfer tube and the patient's tube and the dialysate 
solution is allowed to remain in the patient's peritoneal cavity for 
several hours, for example three to four hours. During this period of 
time, the patient's tube is not disconnected from the transfer tube, but 
the patient's tube may be clamped and the dialysate solution bag may be 
folded and carried by the patient. 
Thereafter, the patient's tube is unclamped and the dialysate solution is 
drained back into the solution bag. Once the dialysate solution has been 
drained into the solution bag, the patient's tube is disconnected from the 
transfer tube of the used solution container and is inserted into the 
transfer tube of a fresh solution container. Thereupon the procedure is 
repeated. It is desirable, however, that during the disconnection of the 
patient's tube from the used dialysate solution container and connection 
of the patient's tube to a fresh dialysate solution container, that such 
connection be accomplished in a sterile manner. In addition, other medical 
procedures utilize similar connections which may desirably be accomplished 
in a sterile manner. 
For example, in blood administration a tube coupled to a patient's vein is 
first inserted into the transfer port of a fresh blood bag. After the 
blood has been introduced from the fresh blood bag to the patient, it may 
be necessary to introduce blood from another blood bag to the patient. 
Under such conditions, the patient's tube is removed from the transfer 
port of the first blood bag and is inserted into the transfer port of 
another blood bag. The desirability of accomplishing such transfer in a 
sterile manner is apparent. 
It is, therefore, an object of the present invention to provide a system 
for enabling the sterile transfer of a first tube from the transfer tube 
of a first medical container and to the transfer tube of another medical 
container. 
Another object of the present invention is to provide sterile connection 
apparatus that is simple in construction and easy to manufacture. 
A further object of the present invention is to provide a method for 
enabling a patient to connect, in a sterile manner, (a) a tube coupled to 
the patient to (b) a transfer tube of a medical solution container. 
Other objects and advantages of the present invention will become apparent 
as the description proceeds. 
SUMMARY OF THE INVENTION 
In accordance with the invention, sterile connection apparatus is provided 
for enabling the connection of a first tube to a transfer tube of a 
medical solution container. The apparatus comprises a housing including a 
base portion and a cover portion. The portions are adapted for 
interfitting with each other to provide a substantially closed interior 
volume. 
The housing includes means for receiving the first tube and means for 
receiving the transfer tube from a medical solution container. The housing 
carries means which are located within the housing and operable from 
outside the housing for enabling manipulation of one of the tubes with 
respect to the other tube. Means are provided for sterilizing the tubes 
within the substantially closed interior volume. 
In the illustrative embodiment, the housing includes hinge means connecting 
the base portion to the cover portion. Locking means are provided for 
maintaining the base portion and the cover portion in their closed 
position during manipulation of the tube. 
In the illustrative embodiment, the receiving means comprises grooves 
defined by one of the base portion and cover portion. The manipulation 
means comprises a glove extending into the interior of the housing and the 
sterilization means comprises a container of sterilizing solution located 
within the housing and adapted for manipulation by the glove. 
In the illustrative embodiment, the housing is substantially 
light-transmissive to enable viewing of the interior volume from the 
exterior thereof when the base portion and cover portion are in their 
closed position. A rack is provided for holding a pair of medical solution 
containers adjacent each other for enabling easy insertion of the transfer 
tubes into the housing's receiving means. The rack comprises a base having 
three generally parallel members extending therefrom whereby a medical 
solution container may be positioned between two of the three members. 
A more detailed explanation of the invention is provided in the following 
description and claims, and is illustrated in the accompanying drawings.

DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENT 
Referring to the drawings, a housing 10 which is preferably rectilinear in 
form, includes a lower base portion 12 and a cover 14 connected thereto by 
means of a pair of hinges 16. Cover 14 is pivotable from an open position 
(FIG. 1) about the axes of hinges 16 to a closed position (FIG. 3). A 
locking device 18 is provided to maintain the housing in its closed 
position as desired. The housing is preferably formed of a transparent 
plastic material so as to enable viewing of the interior thereof from the 
exterior thereof while the cover 14 is in its closed position. 
One vertical side 20 of cover 14 defines an opening for receiving a glove 
22 which extends into the cover in a generally horizontal direction. A 
band 24 is fastened to side 20 and to glove 22 for maintaining glove 22 in 
place with respect to cover 14. Glove 22 is preferably formed of extremely 
flexible rubber or plastic material, as is well-known in the medical glove 
art, and the opening defined by side 20 is such that a seal is provided 
when the cover 14 is closed. Side 20 of cover 14 has an extended portion 
26 which interfits with recessed portion 28 of base 12. Extended portion 
26 enables the positioning of ring 24 on the cover 14 without requiring a 
larger size housing. 
A first groove 30 is defined by the top edge 32 of base 12, for receiving 
tube 34 from a patient. In ambulatory peritoneal dialysis applications, 
tube 34 could be connected to a catheter which is coupled to the patient's 
peritoneal cavity. In blood administration, tube 34 could be connected to 
a fitting which is coupled to the vein of the patient. 
Two other grooves 36 and 38 are also defined along top edge 32 of base 12, 
on side 40 of base 12. Grooves 36 and 38 are adapted for receiving the 
transfer ports 42 and 44 of medical solution containers. It has been found 
that by providing grooves 30, 36 and 38 along top edge 32 of base 12, and 
by utilizing a generally planar bottom edge 46 of cover 14, when the tubes 
34, 42 and 44 are inserted into the grooves and the cover 14 is closed, 
the tubes will be held in place yet not clamped closed so long as the 
grooves 30, 36 and 38 are sufficiently dimensioned. Of course, if desired, 
the grooves 30, 36 and 38 could be defined by bottom edge 46 of cover 14 
and top edge 32 of base 12 could be generally planar. Further, using 
appropriate dimensions both top edge 32 and bottom edge 46 could be 
grooved for receiving the tubes 30, 42 and 44. 
A sterilization device is located within housing 10. As illustrated in FIG. 
2, a spray can of a sterilizing agent, such as Betadine or hydrogen 
peroxide is provided. In the embodiment of FIG. 1, a steam generator 50 is 
located within housing 10 for generating steam to sterilize the items 
within the housing. Other sterilizing agents may be used, such as ozone, 
ethylene oxide or ultraviolet light. Further, a sterilizing solution could 
be placed within the housing and the solution could be applied by cloth or 
cotton to the parts within the housing. 
A rack 52 is provided for holding the medical solution containers in place 
during sterilization. Rack 52 comprises a horizontal base 54 with three 
members 55, 56 and 57 extending vertically upwardly therefrom. A first 
medical solution container 60 is placed between members 55 and 56 and a 
second medical solution container 62 is placed between members 56 and 57, 
as illustrated in the drawings. Medical solution containers 60 and 62 are 
preferably of the flexible bag type. The operation of the system will now 
be described with respect to ambulatory peritoneal dialysis. Assume that 
the patient has drained the solution from his peritoneal cavity back into 
solution bag 62. Solution bag 62 is placed between members 56 and 57 and 
transfer port 44 is inserted into groove 38 while cover 14 is open. Tube 
34, which is coupled to the patient's peritoneal cavity, is inserted into 
groove 30. A fresh dialysate solution bag 60 is placed between members 55 
and 56 and its transfer port 42 is placed into groove 36. 
Once tubes 34, 44 and 42 have been placed into grooves 30, 38 and 36, 
respectively, cover 14 is closed and locked by means of lock 18. 
Thereafter, the sterilizing agent may be utilized. For example, the steam 
generator 50 may be activated so that the contents of the housing are 
sterilized. The patient can then insert his hand into glove 22, remove 
spike 64 (which is connected to the end of tube 34) from transfer port 44 
and insert spike 64 into transfer port 42 of fresh dialysate solution 
container 60. As illustrated in the FIG. 2 embodiment, the patient may 
spray a sterilization agent on the transfer ports while the cover 14 is 
closed, to sterilize the transfer ports. It may be desirable to utilize 
the sterilization agent while spike 64 is connected to transfer port 44, 
also while spike 64 is removed from both transfer ports and also after 
spike 64 has been inserted into transfer port 44. On the other hand, it 
may be found desirable to utilize the sterilization agent only during one 
or two of these transfer positions of spike 64. 
Instead of utilizing a glove which extends into the housing, it may be 
desirable to utilize a mechanical linkage which can be operated from the 
outside of the housing. Such remotely controlled mechanical linkages are 
well-known in the art of handling radioactive materials, for example. 
The patient may wish to use the sterile connection apparatus of the present 
invention for removing the patient's tube from a medical solution 
container and then capping the patient's tube instead of transferring it 
to another medical solution container. In this manner, only the patient's 
tube and the transfer port of the medical solution container to which the 
patient's tube is connected will be introduced into the housing. It can be 
seen that although certain illustrative embodiments of the invention have 
been shown and described, various modifications and substitutions may be 
made without departing from the novel spirit and scope of the present 
invention.