Total-containment sterile process and system

Claim 2

A tube welding assembly for butt welding two plastic tubes together comprising a pair of holders, said holders being aligned with each other and being non-shiftable with respect to each other, each of said holders including clamping means for clamping a respective one of the tubes while the tube is transversely folded across a fold line, a slitting station having slitting means for being disposed between said holders, said holders and said slitting means being relatively movable with respect to each other to permit said slitting means to be positioned for slitting each of the folded tubes generally at their fold lines when the tubes are relatively moved into contact with said slitting means, a welding station having heating means, said holders and said heating means being relatively movable with respect to each other for heating the cut tubes to their welding temperature, and means for moving said holders toward each other to cause the heated cut tubes to contact each other and be butt welded together without any re-alignment of the tubes.

Claim 3

The assembly of claim 1 wherein said slitting means is unheated for cold slitting the tubes.

Claim 4

The assembly of claim 1 wherein said welding station is downstream from said slitting station.

Claim 5

The assembly of claim 3 wherein said holders are side by side holders spaced from each other.

Claim 6

The assembly of claim 1 wherein said holders are laterally movable toward and away from each other and are otherwise stationarily mounted, and said slitting station and said welding station being sequentially movable toward and away from said holders.

Claim 7

The assembly of claim 1 wherein said welding station further comprises a cauterizing station.

Claim 8

The assembly of claim 1 wherein said slitting means comprises a heated wafer, said wafer comprising said slitting means and said heating means, and said slitting station and said welding station being the same station.

Claim 9

The assembly of claim 1, in combination therewith, a first bag containing a first fluid, one of said tubes being connected to said first bag, a second bag containing a second fluid, and the other of said tubes being connected to said second bag.

Claim 10

The assembly of claim 8 wherein said first fluid is used dialysate, and said second fluid being fresh dialysate.

Claim 11

The assembly of claim 1, in combination with said plastic tubes, and each of said tubes being folded upon itself with the fold lines in line with each other.

Claim 12

A tube welding assembly for butt welding two plastic tubes together comprising a pair of holders, each of said holders including clamping means for clamping a respective one of the tubes while the tube is transversely folded across a fold line, a slitting station having slitting means for being disposed between said holders, said holders and said slitting means being relatively movable with respect to each other to permit said slitting means to be positioned for slitting each of the folded tubes generally at their fold lines when the tubes are relatively moved into contact with said slitting means, a welding station having heating means, said holders and said heating means being relatively movable with respect to each other for heating the cut tubes to their welding temperature, means for moving said holders toward each other to cause the heated cut tubes to contact each other and be butt welded together, an aligning station having an aligning member, said aligning member and said holders being relatively movable with respect to each other, and said aligning member being located in the spacing between said holders whereby the folded tubes may be aligned with each other against said aligning member.

Claim 13

A tube welding assembly for butt welding two plastic tubes together comprising a pair of holders, each of said holders including clamping means for clamping a respective one of the tubes while the tube is transversely folded across a fold line, a slitting station having slitting means for being disposed between said holders, said holders and said slitting means being relatively movable with respect to each other to permit said slitting means to be positioned for slitting each of the folded tubes generally at their fold lines when the tubes are relatively moved into contact with said slitting means, a welding station having heating means, said holders and said heating means being relatively movable with respect to each other for heating the cut tubes to their welding temperature, means for moving said holders toward each other to cause the heated cut tubes to contact each other and be butt welded together, an aligning station having an aligning member, said aligning member and said holders being relatively movable with respect to each other, and said aligning member being located in the spacing between said holders whereby the folded tubes may be aligned with each other against said aligning member.

Claim 14

The assembly of claim 11 including a cauterizing station upstream from said slitting station for heating the exposed outer surfaces of the folded tubes before the tubes are cut.

Claim 15

The assembly of claim 12 wherein each of said stations is stationary, and said holders being movable sequentially into each of said stations.

Claim 16

The assembly of claim 13 wherein said holders are jointly movable, and said means for moving said holders toward each other comprising pivot means on at least one of said holders.

Claim 17

The assembly of claim 14 wherein said clamping means comprises contoured clamps.

Claim 18

A tube welding assembly for butt welding two plastic tubes together comprising a pair of holders, each of said holders including clamping means for clamping a respective one of the tubes while the tube is transversely folded across a fold line, a slitting station having slitting means for being disposed between said holders, said holders and said slitting means being relatively movable with respect to each other to permit said slitting means to be positioned for slitting each of the folded tubes generally at their fold lines when the tubes are relatively moved into contact with said slitting means, a welding station having heating means, said holders and said heating means being relatively movable with respect to each other for heating the cut tubes to their welding temperature, means for moving said holders toward each other to cause the heated cut tubes to contact each other and be butt welded together, and a locator bar pivotally connected to each of said holders for being pivoted from a first inactive position to a second position whereby each tube may be folded over a respective locator bar.

Claim 19

A tube welding assembly for butt welding two plastic tubes together comprising a pair of holders, each of said holders including clamping means for clamping a respective one of the tubes while the tube is transversely folded across a fold line, a slitting station having slitting means for being disposed between said holders, said holders and said slitting means being relatively movable with respect to each other to permit said slitting means to be positioned for slitting each of the folded tubes generally at their fold lines when the tubes are relatively moved into contact with said slitting means, a welding station having heating means, said holders and said heating means being relatively movable with respect to each other for heating the cut tubes to their welding temperature, means for moving said holders toward each other to cause the heated cut tubes to contact each other and be butt welded together, and a locator bar pivotally connected to each of said holders for being pivoted from a first inactive position to a second position whereby each tube may be folded over a respective locator bar.

Claim 22

The method of claim 17 including permitting the tubes to cool after the tubes having been butt welded, and applying a mechanical force to the cooled butt welded tubes to cause the butt welded tubes to open and to be restored to their round shape.

Claim 23

The method of claim 17 wherein the slitting step is performed by an unheated slitting member.

Claim 24

The method of claim 19 including heating the exposed outer surfaces of the folded tubes in the area of the fold lines before the tubes are slit.

Claim 25

The method of claim 20 including moving the folded tubes toward an alignment bar until the fold lines contact the alignment bar before the tubes are heated and slit.

Claim 26

The method of claim 17 wherein the step of slitting the tubes is done with a heated wafer to simultaneously slit the tubes and heat the tubes to their welding temperature.

Claim 27

The method of claim 17 including moving the folded tubes toward an alignment bar until the fold lines contact the alignment bar before the tubes are slit.

Claim 28

The method of claim 17 wherein the folding step includes folding each tube over a locator bar, and permitting each locator bar to remain between its tube until after the butt welding step.

Claim 29

The method of claim 17 wherein the tool for slitting the tubes is heated to an elevated temperature and then permitted to cool before slitting.

Claim 30

The method of claim 25 wherein the cooling is to about room temperature.

Claim 31

The method of claim 25 wherein the cooling is to a temperature above room temperature.

Claim 32

The method of claim 17 wherein one of the tubes originally extends from a first bag and the other tube originally extends from a second bag, the butt welding resulting in the remote end of the one tube being mounted to the second bag and in the remote end of the other tube being mounted to the first bag.

Claim 33

The method of claim 28 wherein each bag contains a fluid, and stripping each set of butt welded tubes away from each other.

Claim 34

The method of claim 29 wherein each fluid is dialysate.

Claim 35

The method of claim 17 wherein after the tubes are slit the tube ends are pressed together without any realignment of the tube ends.