Method of forming a connection between two sealed conduits using radiant energy

Method of forming a connection between two sealed conduits using radiant energy

BAXTER TRAVENOL LABORATORIES? INC.,

C. 51914

BACKGROUND OF THE INVENTION

The need to form a sterile, sealed connection between a pair of conduits arises particularly in the field of blood and blood component handling., as well as in other areas where a sterile connection between containers is desired.

In the blood handling field, it may be desired to make use of only one half of a unit of blood in a bag or the like. When this happens, it is customary to discard the nonused portion of the blood unit within a day after the access to the bag was made, even when efforts are made to maintain sterility by using conventionally accepted aseptic methods of access to the blood bag. This is so because only one or two air-borne bacteria could multiply in the stored blood to create the danger of septicemia, if the bacteria were allowed to multiply over a period of more than a very few hours, and the blood was then administered to a patient.

Accordingly, to eliminate the need for disposing of the remainder of a unit of blood when only a partial unit is needed, or for the many other reasons why sealed, sterile access between various containers would be desired, a considerable amount of research has taken place in developing aseptic fluid transfer systems.

For example, Berkman, et al. U.S. Patent No. 4,022,256, discloses a sterile connection means in which a heat-fusable tube carries an inner layer of plastic material which is nonmeltable at the temperature used. An allegedly-sterile connection is made by the use of a heating die pressing the nonmeltable layer through the melting outer layers of the tube, to provide a sterile connection between the two tubes with the melted layers of the tube forming a single, perforated layer.

The invention of the Berkman patent requires a special heating die to press the nonmelting layer of material through the meltable layers of the conduits. Also, in the embodiment shown in the Berkman patent, the meltable material presses against the heating die. Any adhesion of the meltable material to the heating die when the die is pulled apart after the pressing step could cause the connection to rip open, or at least be seriously weakened.

In accordance with this invention, the use of a heating and pressing die for obtaining a sterile connection between two conduits is eliminated. Instead, radiant energy is used to selectively melt a portion of the conduit wall without providing any physical contact of a die or the like to the melting portion. Also, in this invention, mechanical connection means may be provided between the two conduits to protect the fused, sterile connection area from being mechanically ripped apart.

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There is thus provided the method of opening a fluid communication between sealed conduits mechanically connected together by relatively transparent housing means, said conduits separated by opaque wall means positioned within said housing means, comprising: exposing said relatively opaque wall means to a source of radiant energy β 'י positioned outside said relatively transparent housing means of an intensity and duration sufficient to cause said relatively opaque wall means to fuse and to open an aperture therethrough, providing camtunication between the interiors of said sealed conduits.

DESCRIPTION OF THE INVENTION

In accordance with this invention, a connection, and particularly a sterile connection, may be formed between sealed conduits. Each conduit carries a thermoplastic wall portion preferably having a melting temperature of at least essentially 200° C., and which is opaque to the particular radiant energy intended for use herein. Such melting temperature, which may be a range of temperatures, may be determined, for example, by differential thermal analysis.

To make the sterile connection, the opaque wall portions of the conduits are brought together into facing contact. The opaque wall portions are exposed to sufficient radiant energy to cause them to fuse together, and to open an aperture through the fused wall portions. This provides sealed communication between the interiors of the conduits.

Preferably, the opaque thermoplastic wall portions are carried about their peripheries by a transparent, rigid housing which typically defines the end of a conduit. The remainder of the conduit may be flexible, if desired. The rigid housing is transparent, and is made of a material which is not materially softened under the specific radiant energy conditions used in the process. Instead, the radiant energy can pass through the transparent housing, which preferably surrounds and protects the opaque wall portions as they are placed together in facing contact, so that primarily it is the opaque facing wall portions that are heated to their melting point rather than the transparent housing, which supports and protects the opaque wall portions.

As the opaque wall portions melt, they preferably fuse together into a single sealed mass, and, due to the melting, a central aperture is formed in the melted, opaque, thermoplastic wall portion. Any bacteria residing upon the exterior surfaces of the opaque wall portions are entrapped in the melted mass and preferably killed by exposure to the melting temperature of the opaque wall portions, which melting temperature is preferably on the order of 220° to 250° C.

The radiant energy can be provided to the system by means of visible, infrared, ultraviolet, or radio frequency energy as may be desired. The term opaque implies that the opaque wall portions are adapted to absorb a high percentage of the particular radiant energy to which it is exposed. The term transparent implies that a lower percentage of the radiant energy applied is absorbed. Focused, infrared radiant energy is particularly desirable for use.

Lasers may also be used as desired to provide the radiant energy.

The opaque wall portions may be prestressed by uniaxial or biaxial orientation, or with radial stress patterns, to facilitate the formation of the central aperture as the opaque wall portions seal together. Also, unstressed wall portions may be used, with the central aperture formation taking place by cohesion during the wetting.

Referring to the drawings, Figure 1 is an elevational view of a pair of conduit ends, the other ends of which may be connected to a pair of blood bags or the like, each terminating in a pair of housings which carry an opaque, thermoplastic wall portion in accordance with this invention.

Figure 2 is an enlarged view, taken partly in longitudinal section, of one of the conduit ends as shown in Figure 1.

Figure 3 is an elevational view showing the two conduit ends of Figure 1 after they have been joined together to bring the opaque wall portions into facing contact, further showing schematically the step of exposing the opaque wall portions to sufficient radiant energy to cause them to fuse together and open an aperture.

Figure 4 is an enlarged view, taken in longitudinal section, of the structure of Figure 3 prior to the step of exposure to radiant energy as described above.

Figure 5 is an enlarged, longitudinal sectional view of a portion of the structure of Figure 3, taken after the step of exposure to radiant energy.

» I ' Referring to the drawings, conduits 10, 12 are shown to include flexible sections 14, 16, one end of each which may be connected to a conventional blood bag 17, 19 or other container.

Housings 18, 20 are shown being made of a transparent, high melting plastic material such as Lexan, a polycarbonate material sold by General Electric. Each housing defines a hollow interior chamber 21 in conununication with the bore of tubes 14 or 16, plus a bayonet member 22 and a slot 24. Both bayonet 22 and slot 24 are positioned asymmetrically on the housing so that each bayonet 22 can fit into a corresponding slot 24 of an identical housing in a generally permanent, snap-fit relation. Each bayonet 22 may be retained in slot 24 by the hooking action , of barbs 26.

Accordingly, upon connection of a pair of housings 18, 20, they are only disconnected again with a great deal of effort. Preferably, enlarged portions 28 of each bayonet 22 are proportioned to bear against the inner wall of the slot 24 of the mating housing, to make the disconnection of the housings yet more difficult by reducing the capability of bayonets 22 to flex rearwardly.

Each housing 18, 20 carries an opaque wall portion , which may be made out of a thermoplastic material having a melting temperature of preferably at least 200° C.

For example, polycarbonate materials such as Lexan may be used, or polysulfone material such as Union Carbide's Udel or Radel. Also, polyethersulfone materials may be used.

The thermoplastic opaque wall portion 30 generally contains a filler such as carbon black to render it opaque, although other desired fillers which are absorbent of the type of radiant energy to be used may be provided as a substitute for carbon black, for example, iron oxide, manganese dioxide, or the like.

Opaque, thermoplastic wall portion 30 is shown to be a disc which is preferably thinner at its central portion 32 than at its peripheral portions. Disc 30 may be retained by ultrasonic sealing or the like about its periphery to its housing in a recess 34 thereof, and is shown to bulge slightly outwardly, to facilitate good, pressurized contact between facing pairs of opaque wall portions, as shown in Figure 4. Annular groove 33 provides room for the plastic of wall portion to flow as the opaque disc is assembled into the transparent housing.

Figure 4 also shows how bayonets 22 fit into the opposed slots 24 of the mating housings, to provide permanent connection between the respective housings, with the opaque wall portions 30 being pressed together, and surrounded in protective manner by the respective housings.

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After housings 18, 20 have been connected, they are irradiated with radiant energy of a type which is absorbed by the particular opaque wall portions used. Specifically, infrared radiation is one preferred form of radiant energy. It may be provided, for example, by the use of two 150 Watt Sylvania lamps with an elliptical reflector type (model DJL). This provides focused, infrared light which can be focused at the centers of abutting wall portions 30 to rapidly heat them over a period of preferably ten to twenty seconds to essentially the melting point, resulting in the fusing of the respective wall portions 30 together, and the formation of aperture 36, by relief of stress or by simple cohesive forces, through wall portions 30.

Bacteria trapped on the wall portion are killed by heating of wall pprtion 30 to its melting temperature, and are further entrapped upon rehardening of the melted material of wall portions 30. This results in the formation of a connection between the sterile flow channels 21, while the continued maintenance of sterility in the channels is assured.

The fused wall portions 30 fuse together to form a hermetic seal about aperture .36, to prevent a break in the sterility of the flow path. At the same time, the seal line 38 between the respective majabeaas. wall portions

Ύ is protected from mechanical rupture by the generally permanent connection between respective housings 18, 20.

Alternatively, if it is desired to utilize radio frequency energy or the like as the radiant energy, opaque wall portions 30 may be made out of a plasticized polyvinylchloride, while the remainder of housings 18, 20 may be made of a plastic material which is relatively inert to R. F. energy, for example polypropylene, polyethylene, poly(vinyl chloride-vinylidene chloride), or a similar material which does not heat significantly when it is exposed to radio frequency or other high energy, high frequency radiant electrical fields.

Accordingly, by this invention a sterile connection can be made, for example, between a full and an empty blood bag by simply connecting a conduit from each of the bags which carries a respective housing 18, 20 in accordance with this invention. The connected housings can be briefly exposed, for example for about fifteen seconds to focused infrared radiation, to melt the opaque wall sections, fusing them together and forming an aperture through the sections. The sterile connection is thus achieved, through which a portion of the blood of the full blood bag can be passed to the empty bag for use. Thereafter, the bags may be disconnected in conventional manner by heat sealing one or both of the flexible conduits 14, 16 leading from the blood bag to the housings 18, 20 in a HEMATRON^ heat sealer, sold by the Fenwal Division of Baxter Travenol Laboratories, Inc. Then the blood bags may be conveyed to their desired site of use, or back to long-term storage.

The above has been offered for illustrative purposes only, and is not intended to limit the scope of the invention of this application, which is as defined in the claims below.