Sterile, cold cut connection process, apparatus and system

Claim 3

A process for forming a sterile connection between a first and a second closed-end tube, both formed of thermoplastic resin, comprising (a) mounting said tubes in a pair of mounting means which holds said tubes in a flattened, closely adjacent, substantially parallel position, (b) cutting through the flattened part of each of said tubes, (c) separating and aligning said tubes with each other, (d) heating the cut tube ends to effect sterilization and melt the tube ends, (e) urging the desired molten tube ends together to form a joint between said tubes, and (f) cooling said joint and then applying stress to the joint to open the temporary seal in each tube, thereby providing fluid communication between the joined tubes.

Claim 4

A process according to claim 2 wherein the tube ends are heated at a temperature and for a time sufficient to effect sterilization.

Claim 5

A process according to claim 3 wherein the tube end are heated at a temperature below the temperature where the thermoplastic resin from which the tubes are made begins to degrade in the time used.

Claim 6

A process according to claim 4 wherein the mounting means holding the tubes is a pair of blocks having partial grooves therein which hold said tubes, said blocks providing the flattening of said tubes.

Claim 7

A process according to claim 4 wherein the tubes to be joined are flattened in step (a) to an extent that fully-closed temporary seals are formed by the heating means.

Claim 8

A process according to claim 4 wherein the tubes to be joined are flattened in step (a) to an extent the fluid-tight temporary seals are formed in step (e).

Claim 9

A process according to claim 7 wherein, prior to being flattened by the mounting means, the tubes are flattened with a clamp at the point where the heating means passes, said process thereby providing sealed stub-ends.

Claim 10

A process according to claim 7 wherein the mounting means are spaced apart a distance such that the tubes to be joined are flattened to an extent that fluid-tight temporary seals are formed in step (e).

Claim 13

An apparatus according to claim 11 wherein the means for urging the mounting blocks together is a spring.

Claim 14

An apparatus according to claim 11 wherein the means to provide movement between the cutting means, heating means, and the mounting blocks, the means for realigning and the means for urging the blocks together are cam means which provide movement generating five orthogonal motions.

Claim 15

An apparatus according to claim 13 wherein the cam means is a driven cam cylinder containing one groove in each face and one groove around its periphery, one of said mounting blocks being coupled to the groove in one face of said cam and to the groove around the periphery of the cam, said cutting and heating means being coupled to the groove in the other face of the cam cylinder, said apparatus having a controller coupled to the cam cylinder to control timing of operation of the apparatus.

Claim 16

An apparatus according to claim 11 wherein the mounting blocks comprise upper and lower portions hinged together, the inside surface of each upper portion being flat; partial grooves in said lower portions, said grooves serving to hold the tubes and beginning at a point removed from the proximal edge of each block and increasing in depth as the distal edge of each block is approached.

Claim 17

An apparatus according to claim 11 wherein the blocks are adapted to receive two tubes.

Claim 18

An apparatus according to claim 16 wherein the blocks are urged together as the heating means is withdrawn.

Claim 19

An apparatus according to claim 16 wherein the blocks are urged together after the heating means is withdrawn.

Claim 20

An apparatus according to claim 11 wherein the blocks are adapted to receive three tubes.

Claim 21

A sterile connection system for continuous ambulatory peritoneal dialysis in which a dialysis solution container with a transfer port that includes a segment of tubing is coupled to a tube extending from a patient's peritoneal cavity, wherein the improvement comprises a pair of mounting blocks adapted to receive, hold and flatten the transfer port tube and the patient's tube, cold-cutting means, means to provide movement between said blocks and said cutting means to a position such that the cutting means is between said blocks and traversing where the blocks are adapted to receive said tubes, means to realign said blocks to a position where the resulting different tube ends to be joined are aligned with and facing each other, means to separate the cutting means from the tubes that have been cut, means for heating the cut ends of the tubes, and means for urging together the tubes to be joined.

Claim 22

A sterile connection system according to claim 20 wherein the blocks are urged together as the heating means is withdrawn.

Claim 23

The sterile connection system according to claim 21 wherein the patient's tube is connectorfree and has a sealed distal end.

Claim 24

The sterile connection system according to claim 22 wherein the transfer port tube is connector-free, has a sealed distal end, and is the same diameter as that of the patient's tube.

Claim 25

A sterile connection system for joining two blood bags, each bag having a tube which can be used for connection and sterile connection being made by joining said tubes, wherein the improvement comprises a pair of mounting blocks adapted to receive, hold and flatten the tubes to be joined; cold-cutting means; means to provide movement between said blocks and said cutting means to a position such that the cutting means is between said blocks and traversing where the blocks are adapted to receive said tubes; means to realign said blocks to a position where the resulting two different tube ends to be joined are aligned with and facing each other; means to separate the cutting means from the tubes that have been cut, means for heating the cut ends of the tubes, and means for urging together the tubes to be joined.

Claim 26

A sterile connection system according to claim 24 wherein the blocks are urged together after the heating means has been withdrawn.

Claim 27

The sterile connection system according to claim 25 wherein one of the bags is a donor bag and its blood collection tube is one of the tubes to be joined.

Claim 28

The sterile connection system according to claim 26 wherein the two tubes to be joined are of the same diameter.

Claim 29

The sterile connection system according to claim 27 wherein the blood collection tube has a sealed distal end.

Claim 30

The sterile connection system according to claim 28 wherein the second bag is a transfer bag having a transfer port with a transfer tube and the transfer tube is the other tube to be joined.

Claim 31

The sterile connection system according to claim 29 wherein the transfer tube has a sealed distal end.

Claim 32

The sterile connection system for urinary drainage in which a first drainage container is connected to a drainage tube extended from a catheter implanted in a patient's urethra, wherein the improvement comprises (a) a second drainage container having a connector-free tube specifically for sterile connection and with a sealed distal end, both containers being disposable; and (b) a pair of mounting blocks adapted to receive, hold and flatten the drainage tube and the connector-free tube, cold-cutting means, means to provide movement between said blocks and said cutting means to a position such that the cutting means is between said blocks and traversing where the blocks are adapted to receive said tubes, means to realign said blocks to a position where the resulting different tube ends to be joined are separated and aligned with and facing each other, means to separate the cutting means from the tubes that have been cut, means for heating the cut ends of the tubes, and means for urging together the tubes to be joined.