An aseptic/sterile fluid connection between two containers is formed by radio frequency sealing together portions of transfer regions of two containers. Each transfer region has a layer of a relatively high melt temperature material such as a rubber or elastomer positioned between two outer container walls made of a flexible thermoplastic, for example polyvinyl chloride. The transfer regions are placed in registry, and the radio frequency welding fuses together portions of adjacent container outer walls and forms a fluid opening therethrough.

BACKGROUND OF THE INVENTION 
The present invention relates generally to a method and means for providing 
sterile/aseptic transfer of fluids between two containers. More 
particularly, the present invention relates to the formation of a 
sterile/aseptic connection between two containers. 
As described in U.S. Pat. No. 4,022,256, the problem of the sterile 
transfer of fluid arises in a number of different areas. One area in 
particular includes the area of blood handling. Since blood contains 
several major different components, each serving a unique function, the 
use of whole blood for transfusion has become unnecessary in many cases. 
Instead, required components can be removed, allowing the balance of the 
blood to be employed elsewhere. Thus, blood component therapy has helped 
to ease the blood storage shortage somewhat, at a time of rapidly 
increasing demand. 
In U.S. Pat. No. 4,022,256, the disclosure of which is incorporated herein 
by reference, there is described an arrangement wherein two sterile 
containers, one of which has a fluid which is desired to transfer to the 
other, are each formed of a plastic tube, or have a tube coupled thereto 
as an extension from the interior of the respective containers. Each tube 
has near a closed end or somewhere along its length, a "sterile transfer 
region" comprising a plastic material ("Material One") which can be made 
to melt and flow at a sterilizing temperature. These sterile transfer 
regions which can have any desired closed cross-sectional area, also 
contain a liner or window of a second material ("Material Two") on an 
inside thereof. Material Two will not melt at the temperature at which 
Material One melts and flows. 
The containers are positioned so that their sterile transfer regions, 
overlap and are pressed against one another in a manner so that where they 
are in contact, there is an interface region of the meltable material, 
Material One, while the inside liners, constructed from Material Two, 
internally cover the walls opposite the location where the walls of the 
two sterile transfer regions touch. The region where the two sterile 
transfer regions touch is clamped together between two opposing jaws of a 
conduction heating device wherein one jaw may be a flat surface. 
The disclosed connection system requires the use of exotic and relatively 
costly materials such as fluorinated ethylene propylene copolymer as the 
liner material. Moreover, the particular means used for melting the layers 
constructed from Material One can be cumbersome and ill-suited for some 
materials. 
Another connection system is disclosed in U.S. Pat. No. 4,157,723. In this 
patent, there is disclosed a connection which may be formed between two 
sealed conduits in which each conduit carries an opaque, thermoplastic 
wall portion preferably having a melting range above essentially 
200.degree. C. Preferably, the opaque thermoplastic wall portions are 
carried on the conduit about their periphery by transparent wall portions 
of the conduit. The opaque wall portions of the conduits are brought 
together into facing contact, and then exposed to sufficient radiant 
energy to cause the opaque wall portions to fuse together, and to open an 
aperture through the fused wall portions. This provides a sealed 
communication between the interiors of the conduits. The patent states 
that alternatively RF energy can be utilized. 
In U.S. Pat. No. 4,325,417, there is disclosed another connector member for 
sealed conduits utilizing a crystalline plastic barrier membrane. In this 
patent, there is disclosed a connector member for a fluid flow path which 
comprises a transparent housing enclosing an opaque barrier membrane or 
wall portion blocking flow through the flow path. The barrier membrane is 
adapted to be openable by exposure to radiant energy from the interior 
through the transparent housing. In accordance with the disclosure, the 
barrier membrane is made of a predominantly crystalline plastic material, 
and accordingly, exhibits a relatively sharp melting point for improved 
opening characteristics upon exposure to the radiant energy. 
In U.S. Pat. No. 4,434,822, there is disclosed a system for the sterile 
mixing of materials. In this patent, there is disclosed a fluid transfer 
assembly including first and second connector members, each associated 
with a fluid conduit and having a meltable wall which normally seals the 
connector member, and thus the associated conduit. The connector members 
can be coupled together with the meltable walls positioned in facing 
contact. One of the meltable walls includes a radiant energy absorbing 
material. The other meltable wall is relatively non-absorbent radiant 
energy, but does conduct heat energy. By exposing the coupled assembly to 
a source of radiant energy, the one wall melts in response to thermal 
radiation, while the other wall conducts heat energy from the melting wall 
to also melt. By melting, the walls open a fluid path between the fluid 
conduits. 
Yet another sterile connector is disclosed in U.S. Pat. No. 4,253,500. In 
this patent, there is disclosed a sterile connector adapted for multiple 
junctions wherein a sealed, sterile connection may be provided between a 
pair or more of containers having transparent, flexible, thermoplastic 
sealed walls, each of which contains an opaque, relatively rigid, hollow 
sealing member in the general shape of a truncated cone, open at both 
ends. The containers are brought together in facing contact, and the 
hollow sealing members are nested together with portions of the 
transparent walls of the containers positioned therebetween. The nested, 
sealing member cones are irradiated with infrared energy through the 
transparent container walls to heat the nested sealing members. As a 
result of this, heat is conducted to the portions of the transparent walls 
between the nested sealing members to seal the portions of the transparent 
walls together in an annular area between the sealing members. A portion 
of the transparent walls retained in the nested sealing members may be 
torn away to make a sterile connection between the two containers. 
SUMMARY OF THE INVENTION 
The present invention provides an improved method and means for providing 
sterile/aseptic transfer of fluids between two containers. To this end, 
the present invention provides a sterile/aseptic connector utilizing radio 
frequency to permanently seal or join together two containers each having 
a transfer region with flexible thermoplastic outer walls, e.g. polyvinyl 
chloride (PVC), including an inner liner area of a high melt temperature, 
bio-compatible low dielectric material such as, a rubber or elastomer, for 
example silicone rubber. 
In an embodiment, the invention provides a flexible container with 
polyvinyl chloride outer walls and a high melt temperature, low dielectric 
deformable elastomer or rubber inner liner. 
In an embodiment, the invention provides a sterile fluid connection between 
two sterile containers comprising two adjacent layers of a thermoplastic 
fused together in part and including an opening formed in the fused 
portion. 
In an embodiment, the invention provides a sterile/aseptic connection 
system including a radio frequency energy source and sealing dies capable 
of applying pressure while delivering sealing energy to effectively seal 
two such flexible containers together. 
In an embodiment, the invention provides a method for forming a 
sterile/aseptic connection between two containers where each container is 
provided with a transfer region, each transfer region is provided with a 
high melt temperature rubber or elastomer layer sandwiched between two 
layers of PVC, the two transfer regions are placed in registry, and then 
radio frequency welding energy is applied to melt together two adjacent 
PVC layers and to create a fluid opening therethrough. 
An advantage of the invention is the use of a low dielectric, high melt 
temperature inner liner layer in the form of a common rubber or elastomer 
as opposed to an exotic costly laminated matrix of fluorinated ethylene 
propylene copolymer. 
An additional advantage provided by the invention is that the fabrication 
of a disposable component is made less costly because the inner liner 
material can simply be placed within an existing container design during 
manufacture. 
Yet a further advantage provided by the invention is that polyvinyl 
chloride materials are more responsive to radio frequency energy than 
induction heat sealing such that energy can be focused at the interface 
between the two containers to be joined to create a more effective and 
reliable weld or seal. 
And yet a further advantage of the invention is that having a flexible, 
deformable high melt temperature material as the inner layer allows the 
welded junction to more readily and reproducibly conform to the shape of 
the sealing die. 
Additional features and advantages of the present invention are described 
in, and will be apparent from, the detailed description of the presently 
preferred embodiments and from the drawings.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS 
As described above, the invention provides a method and means for creating 
an aseptic or sterile connection between two containers. Thus, the 
invention includes not only the structure of the connection but also the 
method by means of which it is formed. 
Unless otherwise qualified, "container" and "enclosure" as used herein and 
in the claims refers both to enclosures and containers such as bags and 
the like as well as tubes and the like. Additionally, unless otherwise 
qualified, "liner" or "patch" as used in the Detailed Description or the 
claims, refers to a film or layer of material of any surface area, i.e., 
"patch" is not meant to limit the size of a layer or region to a 
relatively small area and likewise, "liner" does not necessarily mean a 
large area. 
As illustrated in FIG. 1, two containers 10 and 12 can be joined together 
by means of an aseptic or sterile connection by fusing together portions 
thereof referred to herein as "transfer regions." In this regard, the 
containers 10 and 12 illustrated in FIG. 1 include outer walls 14 and 16, 
respectively, made of a thermoplastic material capable of being radio 
frequency sealed at, preferably, sterilizing temperatures. Such a material 
is, for example, polyvinyl chloride (PVC). 
Pursuant to the present invention, containers 10 and 12 also include inner 
liner patches or portions 18 and 20, respectively, comprising a high melt 
temperature, low dielectric material, for example silicone rubber. This 
high melt temperature dielectric material melts at a temperature that is 
greater than the melting temperature of the outer wall material. 
The shape of container 10 is such that the walls 14a and 14b define a 
cavity 22 within which a fluid can be contained. Similarly, the walls 16a 
and 16b define a cavity 24 within which a fluid can be contained. The 
liners 18 and 20 can be appropriately secured to the inner surfaces of the 
walls 14a and 16a, respectively, for example, by melt bonding of the outer 
walls to the liners. It can be appreciated that by virtue of such 
positioning, the liners are disposed between two layers of the 
thermoplastic material. 
However, the liners 18 and 20 need not be attached to the outer walls. It 
is only important to have such a liner present during formation of the 
aseptic/sterile connection, and thus the liner can be unattached and 
loosely fitted between two outer walls of a container. 
Moreover, to the extent the liner is attached to the outer wall, such 
attachment can occur at any time prior to the time when the containers are 
positioned for sterile connection. Indeed, if desired, the liner can be 
attached to the wall at the time of compression between the two sealing 
dies 30 and 32. 
As further illustrated in FIG. 1, the transfer regions of the two 
containers 10 and 12 are positioned such that they are sufficiently in 
registry, and the container walls 14b and 16b, not including the inner 
liner patches 20, lie against each other, i.e., the liner patches 18 and 
20 face each other. Then, as illustrated in FIG. 2, the transfer regions 
are pressed together or clamped together between two opposing die members 
30 and 32 of a radio frequency heating device. 
As illustrated in FIG. 3, pressure and energy is applied such that the 
meltable outer walls 14b and 16b become fluid at the material interface 34 
between the two containers 10 and 12 and are displaced by being squeezed 
between the pressurized die members, while the high melt temperature liner 
material patches 18 and 20 do not flow. As discussed above, because the 
outer walls are constructed from an RF responsive material such as 
polyvinyl chloride, energy will be focused at the interface 34 between the 
two containers 10 and 12 to be joined, and, therefore, the interface walls 
14b and 16b will melt before the outer walls 14a and 16a will melt. 
Moreover, due to the use of radio frequency welding, it is possible to 
easily melt together the adjacent outer walls 14b and 16b even when a 
liquid is located in the containers 10 and 12. This is due to the fact 
that the energy is transmitted and focused on the interface area. 
It can be appreciated that the inner liner layers 18 and 20 help maintain 
the sterility of the connection by preventing the formation of openings in 
the outer walls 14a and 16a opposite the interfacing walls 14b and 16b. 
Because these outer walls 14a and 16a do not form part of the interface 
and are maintained separate therefrom by the liners 18 and 20, these outer 
walls 14a and 16a are not subject to the concentration of radio frequency 
energy presented at the interface, and thus do not melt as readily. 
As illustrated in FIG. 4, eventually, the interfacing walls 14b and 16b of 
the two containers 10 and 12 will melt. After a sufficient heating and 
squeezing time, an opening or aperture is formed in the fused area due to 
the squeezing action of the dies 30 and 32. Upon retraction of the die 
members 30 and 32 or termination of the RF energy, the materials will cool 
and fuse together and an aseptic/sterile pathway 34 is created between the 
two containers 10 and 12. The integrity of the lined walls 14a and 16a of 
the containers 10 and 12 is maintained by means of the inner liners 18 and 
20, even though some thinning of the walls 14a and 16a can occur. 
Although one liner material suitable for constructing the liners 18 and 20 
is silicone rubber, other materials such as rubbers or elastomers which do 
not melt at sterilizing temperatures can be used as well. Silicone rubber 
presents a low cost acceptable material. 
Additionally, materials other than PVC can be used as the outer walls 14 
and 16. An important feature, however, is RF responsiveness and preferably 
meltability at sterilizing temperatures. By utilizing materials that melt 
at sterilizing temperatures, a connection can be made using temperatures 
that sterilize the connection site, ensuring the sterility of the process. 
One means for providing the radio frequency sealing is through the use of a 
modified Model 1100 laboratory hand-held tube sealer provided by 
Engineering and Research Associates, Inc., which is illustrated in FIG. 5. 
The Model 1100 hand-held tube sealer is designed to seal blood bags and 
other heavier blood processing tubing by high frequency dielectric heating 
and includes the following features: 
1. Sealing can be accomplished in any location reachable by hand; 
2. Sealing can be achieved in approximately one second; 
3. The sealer's external power control allows the operator to optimize seal 
time and the quality to match various types of tubing; 
4. Repetitive sealing for tube segmentation can be accomplished rapidly; 
5. Sealed segments can be readily separated by pulling and twisting from 
both sides; 
6. Continuous sealing will not cause excessive heat build-up and therefore 
burn throughs generally will not occur; and 
7. Sealing jaws, dies and lever can be easily disassembled for cleaning. 
As illustrated in FIG. 5, the Model 1100 tube sealer includes a hand-held 
unit 36 having opposing sealing jaws 36a and 36b. Jaw 36a is movable 
toward and away from jaw 36b by means of a lever 36c. 
The jaws 36a, 36b include sealing dies 36d and 36e, respectively, which are 
coupled to a radio frequency source 38 so that the dies 36a, 36e can weld 
together two sheets of meltable material. In FIG. 5, a tube 39 is 
illustrated as having been sealed closed at 39a by means of the Model 1100 
tube sealer. 
As illustrated in FIG. 6, the present invention is particularly useful in 
one embodiment for sealing together two blood bags 40 and 42. In this 
regard, as illustrated, the two blood bags 40 and 42 include suitable, 
flexible outer walls 44 and 46, respectively, made of, for example, 
polyvinyl chloride. In one corner of each of the bags 40 and 42, there is 
included a circular window or patch 50 or 52, respectively, of an inner 
liner material secured to the inner surface of one of the walls of the 
bags. 
The bags 40 and 42 can then be positioned such that the patches overlap but 
face each other as described above in connection with FIG. 1. Then, by 
utilizing a modified device such as a modified hand-held tube sealer, a 
sterile/aseptic connection 54 can be made in the patch area thereby to 
provide a sterile connection between the two blood bags 40 and 42. Of 
course, the particular shape of any connection will depend on the shape of 
the radio frequency welding die employed. In the embodiment of FIG. 5, the 
connection is elongated, however, it could just as well be circular or 
rectangular or letter shaped, e.g., "H" shaped. 
In FIG. 7 there is illustrated a pair of sealing dies 60 and 62 that are 
highly effective at concentrating radio frequency energy to melt the 
meltable layers at the interface area and conducting away melted matter so 
as to form the fluid opening in the resulting connection. It can be seen 
that the dies 60 and 62 include convex crowns 64 and 66 respectively. As a 
result, melted matter, such as the melted interfacing outer walls of 
flexible containers is easily pushed radially away from an axial center 
point of the dies, at which point an opening is formed between the two 
fusing interfacing outer walls. Moreover, should the container be filled 
with liquid, the convex shapes will push aside the liquid so that the dies 
will more closely press together and more fully focus the sealing energy 
at the interface area. 
Die 60 is illustrated in greater detail in FIGS. 8 and 9. As illustrated, 
the die 60 includes a cylindrical base 68. It has been found that a die 60 
having a cylindrical base 68, whose diameter is 0.5 inches and whose axial 
length is 0.25 inches, functions satisfactorily. Concentrically disposed 
on an axial end of the base 68 is the crown 64 which is substantially 
cylindrical in shape. It has been found that a crown 64 having a diameter 
of 0.375 inches and an axial length of 0.187 inches functions 
satisfactorily. 
The sealing die 62 is illustrated in greater detail in FIGS. 10 and 11. As 
illustrated, the die 62 includes a cylindrical base 70 on an axial end of 
which is disposed the somewhat hemispherically shaped crown 66. 
It has been found that a die 62 having an overall axial length of 0.5 
inches and its own axial length of 0.313 inches and a diameter of 0.5 
inches functions satisfactorily. Likewise, it has been found that a base 
70 having a crown 66 of having a diameter 0.312 inches functions 
satisfactorily. 
While the foregoing description only describes the formation of a single 
connection between two containers, it should be understood that multiple 
connections can be made in accordance with the above method and means of 
the present invention. 
As described above, a method and device are provided for making a sterile 
connection and passageway, between two separate detached containers on 
tubes. With respect to tubes, the tubes can extend from separate 
containers, or can be separately manufactured and later attached to 
containers. Due to the manner in which the connection is made, the 
interiors of the containers, or tubes, are never exposed to any possible 
contamination. Thus, a means for making sterile connections is provided. 
It should be understood that various changes and modifications to the 
presently preferred embodiments described herein will be apparent to those 
skilled in the art. Such changes and modifications can be made without 
departing from the spirit and scope of the present invention and without 
diminishing its attendant advantages. It is, therefore, intended that such 
changes and modifications be covered by the appended claims.