Sterile docking process, apparatus and system

• US 4,369,779 A
• Filed: 06/04/1981
• Issued: 01/25/1983
• Est. Priority Date: 02/23/1981
• Status: Expired due to Term

• Current Assignee: E. I. du Pont de Nemours and Company (Corteva, Inc.)
• Original Assignee: E. I. du Pont de Nemours and Company (Corteva, Inc.)
• Inventors: Spencer, Dudley W. C.
• Primary Examiner(s): Ball, Michael W.
• Application Number:
  US06/267,291
• Time in Patent Office: 600 Days
• Field of Search: 156/158, 156/159, 156/296, 156/502, 156/503, 156/251 M, 156/304.2, 156/304.5, 156/304.3, 156/358, 156/433, 128/214 D, 128/214.2, 128/213 R, 128/213 A, 264/248
• US Class Current: 604/29
• CPC Class Codes: A61M 39/146 by cutting and welding
• CPC Class Codes: B29C 65/00 Joining or sealing of preformed parts , e.g. welding of plastics materials; Apparatus therefor general aspects of processes or apparatus for joining preformed parts B29C66/00; using porous material formed by internal pressure generated therein for joining preformed parts B29C44/1228, B29C44/326
• CPC Class Codes: B29C 65/2046 using a welding mirror which also cuts the parts to be joined, e.g. for sterile welding
• CPC Class Codes: B29C 65/2061 by sliding
• CPC Class Codes: B29C 65/2076 perpendicularly to the plane comprising the parts to be joined
• CPC Class Codes: B29C 65/7802 Positioning the parts to be joined, e.g. aligning, indexing or centring
• CPC Class Codes: B29C 65/7841 Holding or clamping means for handling purposes clamping means for the purpose of applying pressure on the parts to be joined, in the area to be joined B29C66/81; work holders in general B25B; devices for holding or positioning work for welding metal B23K37/04
• CPC Class Codes: B29C 66/0018 being sterile
• CPC Class Codes: B29C 66/1142 Single butt to butt joints
• CPC Class Codes: B29C 66/5221 for forming coaxial connections, i.e. the tubular articles to be joined forming a zero angle relative to each other
• CPC Class Codes: B29C 66/71 characterised by the composition of the plastics material of the parts to be joined welding bar compositions B29C65/125
• CPC Class Codes: B29C 66/723 being multi-layered B29C66/7292, B29C66/72941 take precedence
• CPC Class Codes: B29C 66/7373 Joining soiled or oxidised materials
• CPC Class Codes: B29C 66/73921 characterised by the materials of both parts being thermoplastics
• CPC Class Codes: B29C 66/8226 Cam mechanisms; Wedges; Eccentric mechanisms
• CPC Class Codes: B29C 66/857 Medical tube welding machines
• CPC Class Codes: B29C 66/949 characterised by specific time values or ranges
• CPC Class Codes: B29K 2023/06 PE, i.e. polyethylene
• CPC Class Codes: B29K 2023/12 PP, i.e. polypropylene
• CPC Class Codes: B29K 2027/06 PVC, i.e. polyvinylchloride
• CPC Class Codes: B29L 2023/22 : Tubes or pipes, i.e. rigid bent tubes not for use as pipe couplings B29L2023/004
• CPC Class Codes: Y10S 604/905 : Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

A process, apparatus and system for making a sterile connection between two thermoplastic resin tubes is disclosed. The tubes are cut by a hot cutting means so as to form a molten interface between the tubes and the cutting means. The tubes are aligned with each other and slid off an edge of the cutting means while being urged together. As the thermoplastic resin cools a sterile weld is formed. The cutting means should either be thin or have a sharp edge where the aligned tubes are slid off and joined.

Claims

1. A process of joining first and second thermoplastic tubes together transversely of the axis of each tube comprising urging a hot cutting means through each tube and simultaneously forming a continuous molten seal between a heated cutting surface and a transverse section of each said tube thereby maintaining a seal between the interior and exterior of said tubes aligning said tubes with each other and, joining the respective molten ends of said tubes together to form a joint between said tubes, both while maintaining said seal.

2. A process of forming a sterile connection between a first tube formed of a thermoplastic resin and a second tube formed of a thermoplastic resin comprising mounting said tubes in a pair of mounting means which hold said tubes in a closely adjacent substantially parallel position, urging an edge of a hot cutting means having substantially flat surfaces through both said tubes at a rate such that the thermoplastic resin from which said tubes are formed which is in contact with said cutting means is molten, whereby a molten interface is formed between the substantially flat surfaces of said cutting means and each of said tubes, maintaining said molten interfaces while aligning said tubes with each other and then passing said tubes over an edge of said cutting means while urging said tubes together, and permitting the thusly joined molten interfaces to cool whereby a sterile connection is formed between said tubes.

3. The process of claim 2 wherein the hot cutting means is maintained at above about 500°

F.

4. The process of claim 3 wherein the hot cutting means is maintained at a temperature below the temperature where the thermoplastic resin from which the tubes are made begins to degrade in the time used.

5. The process of claim 4 wherein the mounting means holding the tubes are a pair of blocks having slots therein which hold said tubes.

6. The process of claim 5 wherein the blocks are spaced from about 5 to about 50 mils from said cutting means while the molten interfaces are being formed.

7. The process of claim 6 wherein the blocks are spaced from about 10 to about 20 mils from said cutting means while the molten interfaces are being formed.

8. An apparatus for forming a sterile connection comprising a cutting means, means adapted to heat said cutting means, a pair of mounting blocks adapted to receive and hold two tubes to be joined, 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 tubes, means adapted to realign said blocks to a position where two different tube ends are aligned with and facing each other and means to separate said blocks and said cutting means while urging said blocks together.

9. An apparatus for forming a sterile connection comprising a cutting means;

means adapted to heat said cutting means;

a pair of mounting blocks adapted to receive and hold two tubes to be joined;

means for movement of the mounting blocks to first, second and third positions, the cutting means being between the mounting blocks in the first position, said mounting blocks being relatively displaced in said second position to align two different tube ends facing each other, said mounting blocks being separated from said cutting means in said third position, and spring means urging said mounting blocks together when in the third position.

10. The apparatus of claim 9 wherein the blocks are spaced from about 5 to about 50 mils from said cutting means when said cutting means is positioned between said blocks.

11. The apparatus of claim 10 wherein the blocks are spaced from about 10 to about 20 mils from said cutting means when said cutting means is positioned between said blocks.

12. 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 and hold the transfer port tube and the patient'"'"'s tube, cutting means, means adapted to heat said 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 different tube ends are aligned with and facing each other, and means to separate said blocks and said cutting means while urging said blocks together.

13. The sterile connection system of claim 12 wherein the patient'"'"'s tube is connector-free and has a sealed distal end.

14. The sterile connection system of claim 12 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.

15. 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 and hold the tubes to be joined, cutting means, means adapted to heat said 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 different tube ends are aligned with and facing each other, and means to separate said blocks and said cutting means while urging said blocks together.

16. The sterile connection system of claim 15 wherein one of the bags is a donor bag and its blood collection tube is one of the tubes to be joined.

17. The sterile connection system of claim 16 wherein the two tubes to be joined are of the same diameter.

18. The sterile connection system of claim 17 wherein the blood collection tube has a sealed distal end.

19. The sterile connection system of claim 18 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.

20. The sterile connection system of claim 19 wherein the transfer tube has a sealed distal end.

21. The sterile connection system of claim 15 wherein one of the bags is a donor bag having, in addition to its blood collection tube, a connector-free tube to be used specifically for sterile connection, said tube having a sealed distal end.

22. The sterile connection system of claim 21 wherein the donor bag is steam sterilizable and the other bag is a transfer bag made from material which is dry sterilizable only.

23. The sterile connection system of claim 22 wherein the transfer bag has a connector-free tube having a sealed distal end.

24. The sterile connection system of claim 23 wherein the two tubes to be connected are of the same diameter.