DD237634A5 - STERILE CONNECTION PROCESSING DEVICE AND SYSTEM - Google Patents

Abstract

A method and apparatus for making a sterile connection between thermoplastic resin tubes is described. A portion of each tube is compressed and a hot cutter is passed through the compressed sections such that each tube is temporarily sealed and molten ends are created on the tubes. The tubes are aligned and then the desired molten ends of the tubes are pressed against each other to form a connection between the tubes for each pair of tube ends to be connected. Each joint is cooled and then subjected to a light load to release the temporary seals in each tube, creating a connection for the fluid between the connected tubes.

Description

For this 11 pages drawings

Field of application of the invention

The present invention relates to a method and apparatus for making a sterile connection (sterile seal) between two tubes.

At the present time, there are a number of medical and scientific procedures that require the sterile transfer of fluids from one container to another. The only truly sterile transmission system currently in commercial use involves prior connection of the containers to tubes and then sterilization of the entire assembly. This is immovable and costly because no new containers can be added and the number of containers needed is often unknown at the time of the initial filling.

An example of where sterile compounds are needed is continuous ambulatory peritoneal dialysis (CAPD). This method relates to the replacement dialysis of blood outside the body in diffusion cells with membranes in which metabolic waste products, which are normally removed by the kidneys, are washed out of the blood, which then flows back into the patient. Diajysis outside the body is a time-consuming process and sometimes results in damage to the blood by ingesting materials and conditions outside the body. The CAPD procedure requires that the patient only spend time draining the dialysate delivered and replacing it with a fresh solution.

The CAPD patient receives a tube connected to his or her peritoneal cavity through an implanted catheter. A tube from a container of fresh dialysis solution is connected to the patient's tube. The fresh dialysis solution is passed from the container into the peritoneal cavity, where it remains for about 3 to 4 hours. During this treatment period, the empty container is collapsed and carried by the patient, who may continue with their normal activities. After this treatment section, the dialysis solution introduced is returned to the empty container, which is then separated from the patient's tube. Then a container of fresh dialysis solution is connected to the patient's tube and the treatment is repeated. The combination with a new container of dialysis solution exposes the end of the tube to the bacteria or other contaminants present in the environment which are being obtained by the precautions taken. Prior to the invention described in US Pat. No. 4,369,779, there was no way to ensure sterility, despite the careful and costly precautions that were taken which included the use of masks, gloves, gauze strips, and sanitizing solutions.

Normally, the processes now commercially available impurities to the extent that a case of peritonitis occurs on average perhaps once a year or several times a year, and the scar of the same in the tissue prohibits dialysis.

A truly sterile connection could minimize the incidence of peritonitis. Other treatment containers, such as those for antibiotics, bacterial inhibitors, or other drugs, could also be combined, if desired.

A similar need for sterile compounds exists for blood conserves. At the present time, the blood is withdrawn from a dispenser and directed into a first container which may be connected to one or two satellite containers, all of which have been sterilized prior to use. These satellite containers may be required to store components separate from the blood, such as plasma or platelets; Treatment agents such as alkalis, bases, buffer solutions, cell metabolism stabilizers, other preservatives or builders; or wash solutions for removing treatment or other contaminants. In fact, it is not feasible for all treatments that may be desired to have pre-connected containers. Prior to the invention described in U.S. Patent No. 4,369,779, post-treatments such as fresh preservations during container storage could not be performed by a commercially acceptable method. In addition, the number of satellite containers is chosen on the basis of a limited, predetermined requirement in order to avoid the expense of unnecessary satellite containers. The inability to predict the need well adds to the expense of collecting and complicates the collection of blood donors. In general, very limited use is made of a quality control such as a time sample of the quantity and quality of components in separate blood fractions. The main reason for the generalized use is that here, using the conventional methods available, each time a sterile blood unit is engaged, the blood is exposed to bacteria, requiring the blood to be put to use within 24 hours of the procedure becomes. That is, such treatments generally are not performed, although the viability of the stored blood components may be prolonged by subsequent treatments such as the addition of a preservative during storage.

In addition, the primary blood vessel contains anti-clotting agents which can also be sterilized by heat (steam), d. H. all previously connected containers are also sterilized by wet-sterilization techniques, for example by steam or hot water in an autoclave. These containers are made of a plasticized polyvinyl chloride (PVC), although other materials are known which may find use in the manufacture of containers which are advantageously useful for other purposes, such as high oxygen permeability. Since many such materials, for example, oxygen-permeable polyethylenes, can not be sterilized by steam, they have not hitherto been used in pre-bonded systems.

A sterile connector would allow any desired treatment to be performed without compromising sterility, limiting storage life, or requiring a prior connection of a plurality of containers, all of which would need to be wet sterilized without it is known in advance whether they will all be used.

Characteristic of the known technical solutions

US Pat. No. 3,013,925 issued to Larsen on December 19, 1961, describes a method in which two joints of thermoplastic pipes are welded, the inside of each end of the joints of the pipes to be welded being chamfered and the ends the tubes are pressed, for example, by pressing the ends of the sections of the tubes against a heating plate, after which the ends of the sections are pressed against each other such that a flow of the plasticized material to the outside of the tubes occurs and a weld is caused essential without the formation of an annular bead on the inside of the welded tubes.

US Pat. No. 3,035,631, issued to Knowlesam on May 22, 1962, describes an apparatus for welding parts made of plastic. The device has a cutting edge at each of two opposite ends. One end of the cutting edge is thick while the other is thin. The patent describes that the thin end produces molten plastic surfaces which flow into one another as it passes through the joint.

U.S. Patent 3,117,903, issued to Hixam January 14, 1964, describes a method of joining thermoplastic pipes without creating a burr on the inside at the point of welding which can cause inconvenience.

The ends of the tubes to be welded are immersed in a hot bath of high boiling point inert organic liquid to cause the ends to expand and bulge outwardly such that the polymer in the two parts of the tubes flows into each other without forming a burr, which can cause inconvenience when the tubes are pulled out of the bath and the ends are compressed.

US Pat. No. 3,897,296, issued to Waldrum on June 29, 1975, describes a method for welding together two surfaces of plastic by juxtaposing the surfaces, heating the surfaces to a temperature close to the flash point of the plastic surfaces around these surfaces liquefying, removing a portion of the liquefied surfaces to produce the non-oxidized surfaces adjacent thereto and immediately contacting the non-oxidized surfaces with each other.

The patent is latent, both in terms of cutting a tube and forming a sterile seal. US Pat. No. 3,968,195, issued to Bishop on June 6, 1976, discloses a method for making a sterile connection between two solid tubes, the free ends of which have a thermoplastic diaphragm closing the free ends. When a sterile connection is to be made between these two tubes, the free ends of the respective tubes are aligned in alignment with each other a slight distance apart, and each of the thermoplastic diaphragms is opened by heating. The free ends of the solid tubes are then brought into contact with each other and held in that position using a slight pressure, during which time the thermoplastic material cools and solidifies, creating a permanent bond.

This method requires tubes which have diaphragms of a material with a low melting point at their ends and which can only be used once, i. another connection with the same pipe can not be made.

US Pat. No. 4,209,013, issued to Alexander et al. On June 24, 1980, provides an improvement in the manufacture of sterile peritoneal dialysis continuous connection systems in which a container for the dialysis solution has a transfer port connected to the tube from the peritoneal cavity of the patient. The improved embodiment includes a flexible housing having a first portion thereof for attachment to the transfer passage and a second portion for attachment to the patient's tube remote from the first portion. The attachment areas define openings that allow the transfer passageway and the patient's tubing to extend into the interior of the flexible housing when attached thereto. The flexible housing has means for accommodating a sterilizing fluid in the housing and can be operated to permit sterilization of the patient's transmission passage and tube within the housing, and also both within the housing can be connected to each other.

US Pat. No. 4,223,675, issued to Williams on September 23, 1980, describes a system for producing sterile, non-autoclave containers for holding a fluid containing an autoclave-sterilized fluid and a dry-sterilized package comprising a cartridge Material which is not capable of being exposed to the conditions in an autoclave, said dry sterilized packaging including a sterile connection with the interior of said packaging, a dispenser suitable for autoclaving, made of a substance, which may be sterilized in an autoclave containing a liquid sterilized inside the dispenser, said dispenser including a sterile connector having an initially closed sterile port in sterile communication with the interior of the dispenser and said sterile connection element of the package and said sterile connection element of the dispenser are in a connection with each other.

US Pat. No. 4,292,310, issued to Greff et al. On December 30, 1980, describes a device for making sterile connections by means of which it is possible to provide the connection of a first tube to a transfer tube for a medical solution container , The apparatus comprises a housing including a base portion and a cover portion adapted to be interconnected to provide a substantially closed internal volume. The housing has means for receiving a first tube and means for receiving the transfer tube from the medical fluid container. The housing is provided with means located inside the housing and operable from the outside of the housing to allow manipulation of one tube relative to the other tube. There are also means to sterilize the tube parts in the interior of the substantially closed volume. An article by Myhre, BA and others, "An Aseptic Fluid Transfer System for Blood and Blood Components", Transfusion, Vol. 18, No. 5, pp. 546-552, September / October 1978, describes a method of heat sealing two units of aseptic fluid transfer systems (AFTS) together The aseptic fluid transfer system units include a layer of a Kapton® film (an aromatic polyimide resin that is stable at relatively high temperatures) A pair of mold elements, one of which is flat and the other has an area in the form of a raised "H", are compressed together under a pressure of 100 psi (6.9 x 10 ⁶ dyne / cm ² ) with the units of aseptic fluid Transfer systems that are located between the mold elements, brought into contact. The temperature of the mold elements is increased over a period of 45 seconds up to a value of 200 ⁰ C. The mold elements are withdrawn, and after removing the units of the aseptic fluid transfer systems from the mold members, the units of the aseptic fluid transfer systems are heat sealed together by a seal surrounding the opening between the units of the aseptic fluid transfer systems. Hereby, blood vessels provided with units of the aseptic fluid transmission systems can be connected. This system is slow and requires specially designed units that can only be used once.

DE-OS 2250130 describes a method and an apparatus for sealing plastic parts by welding. The method is characterized in that two pieces of plastic, which are to be joined together, are pressed onto a heating element, which is inserted between the two parts. The portions of the plastic parts which come into contact with the heating element are melted at their surfaces in a very short time by applying a very high temperature, and then the heating element is drawn out between the two plastic parts, while the pressure on the plastic parts is exercised, is maintained, and the two plastic parts are pressed together immediately. The German patent specification does not consider plaster tubes, nor does it deal with them like a sterile one

Connection between two pipes with closed ends can be made.

U.S. Patent No. 4,369,779, issued to Spencer on January 25, 1983, describes a method, apparatus, and system for the sterile connection of two closed-ended sterile tubes. The method involves driving a hot cutting element through each tube and simultaneously forming a continuously molten seal between a heated cut surface and a cross-sectional area of each of said tubes, thereby obtaining a seal between the inside and outside of the tubes, and aligning the tubes Tubing together and connecting the respective molten ends of the tubes together to provide a connection between the tubes, both while maintaining said seal.

This patent includes a device having a cutting device, means for subjecting said cutting device to heating, a pair of mounting blocks intended to receive two tubes to be connected, means for movement between said mounting blocks and said cutting device to a position in which the cutting device between said mounting blocks and this crosses at the point at which the blocks are intended to align said mounting blocks in a position in which two different pipe ends aligned with each other are aligned and facing each other with their surfaces and means to separate said mounting blocks and the cutting device from each other while the mounting blocks are driven against each other. The patent teaches that no appreciable visible deformation of the tubes occurs during the manufacture of the connection and that, with the aim of obtaining a perfect seal, the tubes to be connected need not contain more liquid than a thin film the walls at or near the places where they are to be cut and connected. When the method according to this patent is to be used, it is necessary to push the liquid away from the tubes before the connection can be sterilized or at least to effect a sterile connection to a part of the tube having an air gap of 13 to 25 mm. There is a need for a sterile sealing method which allows a sterile connection of tubes filled with liquid, whereby a firm connection must be effected without the ingress of contaminants or without decomposition of the liquid. This is particularly important if a suitable air gap is not present or not desirable. There is also a need for such a method that allows for complete retention of the fluid in pipes.

Object of the invention

The aim of the invention is to overcome the shortcomings of the aforementioned solutions.

Explanation of the essence of the invention

The object of the invention is to provide a device for making a connection, with which any treatment can be carried out without problems of sterilization, without having to compromise on the limitation of the lifetime in storage or the requirement of the prior connection of a plurality of containers all of which would have to be wet sterilized without knowing if they are all used and a method of making such a compound.

The method according to the invention for achieving the stated object involves the following cuts for producing a stable connection of thermoplastic tubes with closed ends:

a) arrangement of said tubes in a pair of mounting blocks;

b) compressing the tubes in a region such that the inner walls of each tube are brought together under pressure;

c) holding the pipes in this condition;

d) introducing a hot cutter into the compressed portions of each tube at a rate such that the thermoplastic resin from which said tubes are made and which contacts the hot cutter is melted, with the inside of the walls of each Pipe temporarily sealed together and sealed ends of the pipes are obtained.

e) taking out the hot cutting device;

f) aligning the pipes to be connected with each other in alignment;

g) pressing together the desired molten ends of the tubes such that a welded connection is formed between the tube ends;

h) cooling the welded joints;

i) applying a load to the flattened welded joint such that the temporary seal in the

Inside the tubes breaks up and creates a connection for the fluid between the connected pipes. The inventive device for producing a sterile connection of thermoplastic tubes with closed ends comprises two mutually spaced mounting blocks, which are preferably provided with a first and a second slot, which emanate from the non-adjacent sides of the mounting blocks and in front of the edge of the adjacent Pages end, decreasing to this end in depth. At the provided with the slots upper side covers are mounted, which are fixed by means of hinges pivotally mounted on the mounting blocks and having a smooth inner surface, by means of which in the closed state, the inserted tubes are flattened. These covers are locked by means of handles designed as closure elements in the closed state. The mounting blocks are slidably mounted transversely to the direction of the slots, both together relative to a cutter and against each other, such that either the first and second slots of each mounting block face each other, or the first slot of one mounting block is the second slot of the other mounting block while the other two slots are not facing each other. A mounting block is expediently made in two parts, such that the upper part with the slots with the aid of a pivot bearing can perform a rotating movement against the lower part. It is provided a spring, which is the upper

Press part in the direction of the other mounting block, if the cutting device is not between the Montagebiöcken.

Furthermore, a cutting device is provided which is fixed to a heating block. It is expediently designed as a folded sheet of metal, wherein on the inside of the folded sheet an electrical resistance element and a dielectric adhesive are provided, the latter between the sheet surface and the electrical resistance of Heizungsbiock and the cutting device are arranged displaceable against the mounting blocks perpendicular to the direction of displacement of the mounting blocks ,

The thickness of the cutting device is advantageously 0.25 to 0.36 mm. It is suitably made of copper sheet and the electrical resistance is advantageous as etched foil resistance, suitably made of stainless steel. As an adhesive, an acrylic adhesive can be used. The cutting device can also be designed as a steel blade, as a hot wire or as a hot fluid jet.

embodiment

The invention will be explained in more detail with reference to an embodiment. In the accompanying drawing show:

4: FIG. 5: FIG. 6:

Fig. 7: Fig. 8: Fig. 9: Fig. 10:

Fig. 12: Fig. 13: Fig. 14a and 14b:

Fig. 15: Fig. 16: Fig. 17:

Fig. 18: Fig. 19: Fig. 20 and 21: Fig. 22: Fig. 23 and 24:

a plan view of the mounting blocks, which are used to hold two tubes to be connected to each other, with the mounting blocks are in their initial position; a plan view of the two tubes, which are separated by a hot cutting device; a plan view of the two tubes, which are brought back into a position in which they are aligned and facing each other; a perspective view of the mounting blocks of the cutting device and the welded tubes; a perspective view of the mounting blocks, which are slidably disposed on their guide rails; a perspective view of the mounting blocks, which are slidably disposed on their guide rails, and the cutting device with its heating device; a perspective view of the mounting blocks, which are arranged fixed in a housing; a perspective view of the welded tubes, which still have the temporary seal; a perspective view of the welded tubes, in which the second seal is applied; an isometric view of an automatic device for making a connection according to the present invention; an isometric view, partially broken away, of the powered cam device used to move the mounting blocks and cutter of the sterile connection device; a view of the device according to FIG 11 along the line 12-12. an isometric view of the mounting blocks, as used in the apparatus according to FIG. 10;

a plan view and a side view of another embodiment of the device according to the present invention; a perspective view of the device according to Fig. 14; a perspective view illustrating details of the arms 126 and 129; a top view of the arm 126 with the two tubes to be cut by means of the hot cutting device; a plan view of a portion of the block 137; a plan view of the mounting blocks, wherein the left block was rotated by 90 °;

Plan views of mounting blocks each having 4 Sch; a perspective view of another embodiment of the mounting blocks;

Sectional views of a re-weldable connector for a silastic catheter.

In the present invention, the pipes to be connected are compressed in an appropriate portion such that the inner walls collide. Then, the tubes are melted sequentially or simultaneously by means of a hot cutter, the molten polymer giving a temporary seal resulting in fused ends of the tubes.

Because the tubes are temporarily sealed, viable bacteria can not find access to the inside of the tubes from the ambient air or from the surface. The tubes are moved to an aligned position before or after the hot cutter has slid out, and then the molten ends of the tubes are forced against each other to form a joint.

The compound is briefly cooled and then subjected to a light load to open the temporary seal in each tube. The connection is sound and strong, and subsequently a number of additional compounds having a sterile condition can be made with the same tube. In addition, any subsequently produced connection can be made at exactly the same location of the pipe. The method can be used to make more than one connection at a time by using multiple tubes (more than two) and multiple slots to accommodate the tubes.

The process steps of flattening the tubes and providing the temporary sealing of the ends of the tubes are not taught in US Patent 4,469,779, the method of the present invention does not require that there be continuous between the heated surface of the cutter and a portion of the tube at right angles thereto a molten seal is maintained. The pipes to be joined in the process according to the present invention have closed ends, i. H. the pipes have sealed ends, the pipe is with a container,

connected to a catheter implanted in a patient, for example, or in some other ways the ends of the tubes are sealed against external environmental conditions. The present method can also work with pipes that have open ends, but this does not give any advantages. '

Reference is now made to FIG. 1. The sealed end 12 of the thermoplastic tube 20 is inserted into non-continuous slots 13 and 14, which in mounting blocks 17; 18 are incorporated. The sealed end 19 of the tube 21 is in the slots 15; 16 introduced, which is also in the mounting blocks 17; 18 are incorporated. The slits 13; 14 and 15; 16 extend in the figure in the longitudinal direction of the respective mounting blocks 17; 18 with the exception of approximately 1.58 mm at the inner surface edge and are aligned so that they can accommodate straight ends of pipes. The slits 13; 14 and 15; 16 decrease in depth near the point where they reach the inner edge of each mounting block. The upper parts of the mounting blocks have not been shown to improve the clarity. The tubes are shown in a flattened condition that results when the two parts of each assembly block are closed. In Fig. 1 to 4, the tubes 20 and 21 are connected to blood containers 10 and 11. Alternatively, one of said tubes may also be connected to a dialysis container and the other to the peritoneal cavity of a patient. The tube connected to the peritoneal cavity of the patient may also be connected to a container on the other side instead of having a sealed end.

Reference is now made to FIG. 2. The two mounting blocks 17 and 18 are slidably moved in the direction indicated by the arrows relative to the hot cutter 34, which is shown in the figure as a steel blade. As a result, the hot cutting device has melted through the tubes 20 and 21, and there are now melted temporary seals 37 and 38 and 39 and 40, which provide the separate parts of the tubes 20 and 21, respectively, with a sealed closure. The seals 37 and 38 and 39 and 40 are produced by welding the inner wall surface of the tubes 20 and 21 in the vicinity of the hot cutting device 34 together. These molten temporary seals 37; 38; 39 and 40 prevent both an exchange of air between the interior of the tubes 20 and 21 and the immediately adjacent external environment of the tubes, as well as contamination by particles contained in the air or on the surfaces of the tubes or the device.

Reference is now made to FIG. 3. The mounting block 17 has been moved relative to the mounting block 18 so that the slots 13 and 16 are aligned with the inner tubes 20 and 21 on the opposite sides of the hot cutting device 34 in alignment.

Reference is now made to FIG. 4. The mounting blocks 17 and 18 with the slots 13 and 16 and the tubes 20 and 21 are still aligned with each other and the hot cutter has been moved in relation to them. The ends of the tubes to be connected were pressed against each other, and the molten ends of the tubes were fused together, and thereby the tubes 20 and 21 were joined together. The mounting blocks 17 and 18, which hold the tubes 20 and 21, are compressed by means of a spring 52 (shown in Fig. 5) over time while moving them and the cutter 34 in relation to each other. 4, the upper parts or covers 22 and 23 of the mounting blocks are shown. The covers 22 and 23 have a flat inner surface that flattenes the tubes when the covers are closed. The covers 22 and 23 are provided with handles 41 and 42 which are securely fastened by suitable means (not shown) such as by soldering or screwing. The handles 41 and 42 are formed from brackets 24 and 25, to which by means of hinges 28 and 29 pressure locks or pawls 26 and 27 are attached. When the covers 22 and 23 are closed, the pressure locks 26 and 27 are inserted into pressure-lock slots 35 and 36 in the mounting blocks 17 and 18 to produce a pressure sufficient to cause the tubes 20 and 21 in the area of the mounting blocks 17 and 18 flatten. The covers 22 and 23 are fixed to the lower parts 8 and 9 of the mounting blocks 17 and 18 by means of hinges 30 and 31.

In Fig. 5, the mounting blocks 17 and 18 are shown in a position in which the slots 13 and 16 are aligned with each other and mounting blocks 17 and 18 are in a position that they occupy after the welding has been performed and removed the welded tubes were.

The device according to the present invention operates in the same way as the device for producing sterile seals described in US Pat. No. 4,369,779, with the exception of what has been described elsewhere herein. For this reason, relevant passages from this patent have been incorporated into the present invention description with corresponding reference. The mounting blocks 17 and 18 are shown slidably and on rails 45; 46 and 47 mounted. The lower part 9 of the mounting block 18 is composed of two parts 50 and 51, which are connected to each other by means of a bolt such that a rotational movement of the part 51 is made possible. This allows the member 51 to be individually urged by the spring 52 in the direction of the mounting block 17 when the mounting blocks 17 and 18 and the tubes (not shown) are retracted by the cutting device (not shown for clarity). In Fig. 5, the operation of the handle 49 and the stop block 48 is also shown, against which the mounting blocks 17 and 18 are pressed. Operation may best be described with reference to Figures 5 to 7, further referring to Figures 1 to 3, which have already been described. The working with the device introduces the ends of the tubes 20 and 21 in the slots 13 and 14 and 15 and 16, as shown in Fig. 1. Then, the covers 22 and 23 are closed and locked, thereby causing the tubes 20 and 21 in the vicinity of the mounting blocks 17 and 18 to be compressed. Now, the cutting device 34 and the heating block 55 shown in Fig. 6 are lowered, such that the cutting device 34 is brought to a position between the stop block 48 and the mounting blocks 17 and 18, with the gap between the two said mounting blocks 17 and 18 is aligned. This positioning is accomplished by locating the heater block 55 and cutter 34 firmly in the upper portion 57 of the housing 56 shown in Fig. 7 and the mounting blocks 17 and 18, stop block 48 and associated sliders in the lower portion 58 of the housing 56 are fixed, such that when closing the housing 56, the cutting device 34 is properly brought into the desired position. The two components of the housing 56 are connected to each other by means of a hinge 59.

The blade heater block (Fig. 6) for heating the cutter is put into operation. The mounting blocks 17 and 18 are connected together and cooperate together, as described in US-PS 4369779. The working with the device pushes the handle 49, whereby the mounting blocks 17 and 18 together on the slide rails 45; 46 and 47 are moved. In this case, the compressed ends of the tubes are moved over the hot cutter 34, as has already been shown in Fig. 2, and the freshly molten ends of each tube become temporary

sealed. The mounting block 17 abuts the stop block 48 first, causing the two mounting blocks 17 and 18 to be brought sufficiently out of operative relationship such that the mounting block 18 continues to move until it abuts against the stop block 48. This further movement of the mounting block 18 causes the alignment of the slots 13 and 16, as shown in Fig. 3. The operator with the device pulls the handle 49 mm immediately thereafter to move the mounting block, which is connected to the handle 49, and by a frictional engagement between the two mounting blocks 17 and 18, the mounting block 17 also. The mounting blocks 17 and 18 and the ends of the tubes 20 and 21 to be connected are moved back and removed from the hot cutter 34. When the corner of the mounting block 18 leaves the edge of the stop block 48, the spring 52 presses on the part 51 of the mounting block 18, so that it easily rotates about the Bolaen 53 in the direction of the mounting block 17; so that a small force is exerted on the temporarily sealed ends of the tubes 20 and 21 to be joined as they slide off the edge of the cutter 34 (see Fig. 5). The stop 54 on the slide rail 46 stops the movement of M'ontageblöcke 17 and 18 and the handle 49th

The device operator removes the connected pipe after approximately 5 seconds have elapsed to allow the connection to cool.

In Fig. 8, tubes 20 and 21 are shown connected to the assembled temporary seals 37 'and 40' to form a joint. In Fig. 9, the joint has been compressed to break the temporary seals 37 'and 40' and provide a connection for the fluid between the two tubes 20 and 21.

Suitable cutting devices for use in the present invention are included in any form described in U.S. Patent No. 4,396,779. The cutting device may also be in the form of a hot wire or a jet of hot fluid, as described in co-pending U.S. Patent Application Serial No. 395,794, the pertinent contents of which are incorporated herein by reference. If a hot wire is used, it can be heated by the electrical resistance. The wire should have sufficient strength, stiffness and chemical resistance.

Preferably, the cutting device is implemented as a heating element containing as an outer layer a folded metal sheet having a thermal conductivity of at least about 173 watts / m ° K at a thickness of 0.10 mm and an elastic tensile strength of at least about 34 χ 10 ⁴ KPa at a thickness of 0.10mm. Furthermore, the cutting device includes a resistor disposed on the inside of the fold of the folded sheet of metal and a layer of a dielectric adhesive material which is stable up to about 260 ⁰ C, between the inner surfaces of said folded metal sheet and the Surfaces of said resistance, whereby the resulting construction is glued together. This heater element is described in co-pending U.S. Patent Application Serial No. 408417 to Benir et al. In this embodiment, the metal used is preferably copper, the heater element is preferably an etched foil resistor made of stainless steel and the adhesive material is preferably an acrylic adhesive. When the heating element or cutter is in one of the forms described in US Pat. No. 4,369,779, it may have a thickness which is within the range set forth in this patent, but preferably its thickness is in a range of about 0.25 mm to about 0.36 mm.

Blood and dialysis containers and tubes, as commonly used, are made of a plasticized polyvinyl chloride because of flexibility, strength and steam sterilizability. In general, the cutting devices for such plasticized polyvinyl chloride pipes are heated to a temperature of about 26O ⁰ C to 399 ⁰ C, which is sufficient for most other thermoplastic pipes. The preferably used cutting devices, copper coated elements, are generally not heated higher than to about 316 ° C. The cutting device is preferably brought to a high enough temperature to

1. Quickly kill any bacteria or bacterial spores on the outer surface of the tube (in less than a second)

2. quickly melt the thermoplastic resin from which the tubes are made.

The tubes are sealed at their ends by heat sealing or connected to containers. The pipes, and whatever they may have for a container or for several containers, were sterilized. Below a temperature of about 218 ° C, bacteria or bacterial spores are not killed fast enough by the heat of the cutter. This temperature required for rapid killing depends on the rapid transfer of heat from the cutter. For example, consider a massive metal blade with a temperature of 260 ^° C. Above about 399 ° C, most polymers such as plasticized polyvinyl chloride or polyolefins such as polypropylene or polyethylenes begin to liquefy to obtain a seal. The preferred temperature for use with conventional plasticized polyvinyl chloride blood vessels and pipes is 271 ⁰ C, if the preferred cutting devices are used. Another upper limit is the temperature at which the resin from which the tube is made begins to decompose during the time it is exposed to the heated cutter (approximately 2 seconds). For plasticized polyvinyl chloride and polyolefins, the upper limit is about 149 ° C above the melting point of the thermoplastic resin from which the tube was made.

The tube should be advanced in the cutter to such an extent that the polymer from which the tube is made melts upon contact with the cutting means and there should be no mechanical cutting of unmelted polymer or significant visible deformation of the tube. An excessively long heating time should be avoided, due to the fact that the expansion of the melting is to be kept to a minimum or even a decomposition of the polymer is avoided. For tubing with a conventional outside diameter of 4.2 mm and a wall thickness of 0.25 mm for plasticized polyvinyl chloride tubing for blood vessels, a time of 0.5 to 1.5 seconds was used to cut the two tubes back into their respective orientation Position should not be chosen so slowly that decomposed polymer can form in the molten compound. The speed of extraction of the cutter is significant in that decomposition phenomena and extended melting can be minimized, and it has been found that a time of 0.1 to 1 second is most suitable for this purpose. A total time for contact with the hot cutter of about 1 to 30 seconds has been found to be useful and, most preferably, a time of 1.5 seconds has been found. After removing the hot cutting device, the tubes are cooled in a period of

about 3 to 5 seconds, and then the pipes are taken out of the assembly blocks. The new compound is then subjected to a light load, such as in the form that it is slightly compressed, i. H. with a force of 0.5 to 1 kp to break the temporary seal and thereby effect communication for the fluid between the two tubes. Slight stress may also be caused by the fact that the connected pipes are pushed apart further from the joint when the pipes are practically filled with liquid, or by other suitable means.

The mounting blocks are preferably made of a high thermal conductivity material to ensure that the heat sink serves to rapidly cool the connection. The tubes are preferably pressed together for a period of 1 to 2 seconds after the hot cutter has been withdrawn, but may continue to be forced against each other after the hot cutter has been removed. It is to be understood that in the method according to the present invention it is not necessary to maintain molten polymer seals between the tubes and the hot cutter because the newly obtained ends of the tubes are temporarily sealed. In fact, this would not be possible if a hot wire or a stream of hot fluid is used as the cutting device. For a cutter having a thickness of about 0.3 mm and an arrangement in the middle of the gap between the mounting blocks and for pipes having an outer diameter of about 5.5 mm, the gap between the mounting blocks should be about 0.38 mm to about 4, 1 mm. Advantageously, a gap between the mounting blocks of about 0.76 mm to about 2mm.

The tube used should be made of a thermoplastic resin which is at a temperature at which it begins to decompose during the time it is subjected to heating in the process according to the present invention.

The pipes to be connected may be made of the same material or may be made of compatible resins. "Compact resins" of the type used in the present process means that the melting points of the two materials are close enough to each other such that they both form viscous melts at the operating temperature which flow into one another to form a single melt phase. without decomposition or formation of thermal or other chemical reaction products which could weaken or otherwise interfere with the formation of a single melt phase and its subsequent cooling and solidification into a solid compound.

For example, polyethylene is compatible with polyethylene copolymers and polypropylene.

In a preferred embodiment of the invention, the means for generating movement between the mounting blocks and the cutting device, the means for aligning the mounting blocks and the means for compressing the mounting blocks against each other are designed as cam devices capable of generating movement in three orthogonal directions of movement , The cam device is preferably a driven cam cylinder which includes a groove in each side surface and a groove around its circumference. One of the mounting blocks is connected to the groove in a side surface of the cam cylinder and the groove extending around its circumference. The cutter is connected to the groove in the other side surface.

In this embodiment of the present invention, the apparatus preferably comprises control means connected to the cam cylinder for controlling the timing of the operation of the apparatus. In this embodiment, the device according to the present invention is similar to the device for automated production of sterile compounds disclosed in US Pat. 408418, filed on 16.8.82. It will be understood that the apparatus of the present invention differs from the said patent application to such an extent as it is necessary to effect the technical progress of the present invention. Reference is now made to FIG.

The device for making a sterile connection chosen for purposes of explanation of this embodiment of the present invention has been generally designated by reference numeral 60 and includes as main components a housing 62, a cutting mechanism 64 pivotally connected to the housing, a pair of mounting blocks 66 and 68 spaced apart in the same plane, a vacuum pump 70a driven by a motor 70, a cam cylinder 72 driven by a motor 74, and an electronic control unit 76.

The cutting device is formed by a heating element, preferably of the type described in the previous part. The specific embodiment described also includes pushbutton switches 71a, 71b and 71c for testing a battery used for the cutting device, for indicating when the system is in order and for indicating the operation of establishing the sterile connection. Furthermore, magazines 79 for storing fresh heating elements and operating levers 81 for feeding the heating elements into the cutting mechanism are shown. The mechanism used to produce the three orthogonal movements required to make the connection is shown in Figure 11, which shows a typical implementation of such a mechanism. In more detail, it includes three cams for generating the three movements.

In the preferred embodiment of the present invention, it is shown that the cams are in the form of flutes 78; 80 and 82 are arranged, which are arranged on different surfaces of the cam cylinder 72. This arrangement ensures that the three cams never go out of phase. A holder 87 for the heating elements 85 is pivotally mounted at its one end to the housing 62 and is at its other end with the cam groove 78 in operative relationship. The heating element 85 is mounted between the mounting blocks 66 and 68 and below the tubes 66a and 68a, which are held side by side by the mounting blocks to be connected. In the housing 62, a pivotable block 86 is secured by means of a journal bearing with its one side to the housing 62 and a second journal bearing on the mounting block 66. The mounting block 66 is indirectly with its ends with the cam groove 82 in operative relationship. The mounting block 66 also engages the circumferentially extending cam groove 80 via a follower 67, while the mounting block 68 is secured to the housing 62. The motor 74 rotates the cam cylinder 72 in turns. The heating element 85 is an etched resistance of a stainless steel foil disposed between two copper plates connected to a battery. During operation, it is exposed to a short heating cycle (approximately 6 seconds) and is designed for a single use (a new heating element is used for each connection).

Movements for the mounting block 66 and the heating element 85 required. These movements are the upward movement of the heating element 85 through the tubes 66a and 68a, shifting the tubes to align with each other and ultimately compressing the tubes 66a and 68a against each other during or after the heating element 85 is retracted. In the particular embodiment shown, the tubes 66a and 68a are pressed against each other while the heating element 85 is retracted. The cam cylinder 72 begins to rotate in the direction of the arrows (Figure 12) and, by this rotation, the cam groove 78 lifts the heating element upwardly through the tubes 66a and 68a. While the heating element 85 remains between the tubes 66a and 68a, the rotation of the cam cylinder 72 continues. As a result, the cam groove 82 moves the mounting block 66 so that the tubes 66a and 68a are aligned with each other. The continued rotation of the cam cylinder 72 causes the circumferential cam groove 80 to move the mounting block 66 toward the fixed mounting block 68 when the heating element 85 is lowered back down. As a result, the tubes 66a and 68a, which are each temporarily heat sealed, form a sterile connection with each other. The tubes are removed from the mounting blocks and compressed to break the temporary seal, thereby effecting communication for the fluid between the two tubes.

As best seen in Figure 13, the mounting blocks 66 and 68 for the tubes 66a and 68a have covers 90 and 92 which are pivotally secured by hinges 93 and 94 to the base portion of the tube holders 96 and 98 , Completely machined channels 66b and 66c are made in the mounting block 66 to hold the pipes to be interconnected. The mounting block is similarly provided with fully machined channels 68b and 68c. The channels expand at their forward ends and have protruding lips 66d and 66e and 68d and 68e which serve to compress the tubes. The surfaces of the insides of the covers are made similar in shape. When the covers 90 and 92 are closed, pawls 90a and 92a are locked by lips 96a and 98a disposed on the respective bases 96 and 98 to provide sufficient force to compress the tubes.

When operating the heating element 85, the loading and ejection system and the control are not essential to the invention elements for the present invention. Suitable systems and their application are described in U.S. Patent Application Serial No. 408418, the relevant passages of which are incorporated herein by reference.

Figs. 14a and 14b show another embodiment of the device according to the present invention. In this embodiment, the device has a bar shape and is held in the hand, making it possible to use it in places where accessibility is difficult. The device which has been selected for illustration is generally designated by the reference numeral 101 and includes, as external components, the housing 102 and a pair of mounting blocks 114 and 115 in which slots 114a and 114b and 115a and 115b, respectively, are provided for receiving the tubes. the cover 104 and the switch 103.

Referring now to FIG. The mounting blocks 114 and 115 have outer walls 114c and 115c, in which U-shaped slots 114a and 114b and 115a and 115b are provided, which would be used to measure the tubes. The front walls 111 and 112 of the mounting blocks are linearly movable as are the rear walls 116 and 117. To the rear walls 116 and 117 are connected levers 118 and 119, respectively, which serve to compress the tubes, as will be explained below. The front and rear walls of each mounting block are integrated with the front and rear parts of the inner walls. The middle parts 113a and 113b of the inner walls are fixedly mounted on the base parts 138 and 139, respectively. The base part and the outer wall of each mounting block are an integral part of the respective block 133 and 134 which extends into the sleeve 135. The sleeve 135 is shown with cutaway top to better represent the other components. In the practical embodiment, the sleeve 135 extends to cover the levers 118 and 119. The cutting device 141 is disposed below the mounting blocks 114 and 115, aligned with the slot between the two mounting blocks 114 and 115, and is fixed but replaceable in the holder 140, which in turn is fixed to the arm 126.

The arm 126 extends rearwardly and has an upwardly extending portion (see FIG. 16) extending into the sleeve 135. The arm 126 has a cam surface 125 which is mounted on a bolt 127 to cause the upward movements for the holder 140 of the cutting device 141. The bolt 127 is fixedly attached to the moving member 128, which in turn is fixed to the block 123. The block 123 is fixedly secured to a reversing ball screw 107, which is guided on a reversing ball screw shaft 124. A DC motor 122 causes the rotation of the ball screw 124 for reverse operation when it is put into operation. The arm 126 is pivotally supported by the bolt 145, which is fixedly arranged on the arm 129. Another bolt (not shown) mounted on the other side of the moving member 128 extends through the slot 147 in the arm 129. When this bolt has been moved to its extreme right position, it ensures that the arm 1 ". 29 is moved under the tubes after they have been connected to each other When the rod 105 (Figure 14b) is pushed, it raises the arm 129 up against the freshly connected tubes to exert a suitable force on them to make the connections The motor 122 and sleeve 135 are fixedly secured to the housing 102.

Operation of this embodiment of the device may best be understood by reference to Figures 14a and 14b and Figure 18. The worker works by arranging two pipes to be connected to each other in the slots, in the mounting blocks 114 and 115.

He then pushes the switch 103 forward, thereby causing the bottom of the switch to move over the tops of the levers 118 and 119, forcing them down. Depressing the levers 118 and 119 causes the front walls 111 and 112 and the rear walls 116 and 117 of the mounting blocks 114 and 115 to move together to stationary positions 113a and 113b, respectively, compressing the tubes. The forward movement of the switch 103 also causes the cover 104 to be closed and a current to flow to the motor 122 and to the cutter 141, through a conventional system of wires and contacts (not shown). The block 123 moves forward with its moving member 128 taken along. As the moving member 128 advances, the arm 126 is raised so that the hot cutter 141 penetrates the tubes 153 and 154 and melts therethrough (see Fig. 17). The extension 155 extends into the slot 156 in the block 137 and acts on the wedge 157, just at the time after the cutting device 141 has melted through the tubes, wherein the mounting block 114 is moved forward to the opening 114 b with to align the opening 115a and thus the pipe parts, the

The forward movement of the mounting block 114 is terminated by a stop (not shown) fixedly secured to the housing 102. The forward movement of the cutter is terminated when the extension 130 reaches the end of the slot 131.

The arm 126 continues its forward movement, with the result that the cutting device is moved down under the tubes. When or after the blade having passed two tubes to be connected, the part 136 of the mounting block 115 is pivoted about the bolt 149 fixed to the bracket 151 by the action of a spring (not shown) cause the portion of the mounting block 115 on the front side 152 to be printed in the direction of the mounting block 114, thereby connecting the two tubes. The device operator cools the connections and then presses on the bar 105 (Figure 14b) to cause the arm 129 to be raised and press against the connection such that the temporary seal is opened and a connection for the fluid between the two tubes is formed.

The functional elements included in this embodiment of the present invention may find use in the rod-shaped element described herein or used in devices according to the present invention having a shape similar to a calculator or a pistol. Each of these configurations provides aspects that are more subject to different environmental conditions. For example, the gun-shaped model would be more suitable for one-handed operation.

The tubes which are compressed in the mounting blocks may contain a small portion which occupies the space between the mounting blocks, in which liquid can be retained. In the device according to the present invention, the tubes can either be compressed so that 1) they are compressed only so far that at the edges of the tubes the insides of the walls are not in tightly sealed contact, or 2) that the insides the walls are in a tight sealed contact. In the first case, an existing residual liquid, which occupies the space between the two mounting blocks in the tubes, after compressing the portion in the round part of the tube, while the cutting device is passed through the tubes. This means that any liquid contained in the tubes will be retained and a solid, inclusion-free compound will result. The end stubs of the pipes can not be sealed liquid-tight.

The second possibility can be achieved in various ways, which have the result that the end stubs of the pipes are sealed liquid-tight and thus a perfect adherence is achieved. In one embodiment, prior to compressing the tubes with the mounting blocks, the two tubes are compressed in the space between the mounting blocks with a clamp. In this embodiment, any fluid is removed from the part of the tubes that is in the area where the sterile connection is made. The use of a clip would also be useful in those situations where the tube is very stiff. Alternatively, for this purpose, the mounting blocks may be spaced apart from each other by a distance which keeps the tubes compressed so as to avoid the retention of fluid.

For example, with tubes having an outer diameter of about 5.5 mm, the distance between the mounting blocks could be about 0.38 mm to about 1 mm, preferably about 0.76 mm. In either case of operation of the apparatus, the hot cutters may be withdrawn prior to aligning the tubes. The tubes may then be aligned and connected to give a sterile connection, provided that they are not allowed to cool significantly before being connected.

In this method of complete retention, as previously described, the freshly molten tube ends, which are not joined together to make a connection, are provided with temporary seals which can be made durable using a known device.

Referring to Figs. 2 and 3, it can be seen that the sealed end 12 of the tube 20 and the sealed end 19 of the tube 21 have temporary seals at the ends located on the cutter 34 as the tubes 20 and 21 pass through the hot cutting device has been melted and slid into the aligned position. The use of a known device can be avoided and permanent seals can be achieved when one or two other features of the present invention are used. FIG. 19 illustrates one of the alternatives to alignment shown in FIG. In this embodiment of the present invention, one of the mounting blocks has been rotated through 180 ° about the central horizontal axis, which is parallel to the axis passing through the center of each compressed tube. This rotation brings the tubes 20 and 21 and the tube ends 12 and 19a into an aligned position. After the hot cutter 34 has been retracted, the tubes 20 and 21 are compressed and the tube stubs 12a and 19a are compressed at the same time to form joints. Each cooled joint may then be subjected to a slight pressure to provide a connection for the fluid between the connected parts of the tubes.

A second alternative to the use of a known device for producing permanent seals in the case of a method for complete retention is shown in FIGS. 20 and 21. Fig. 20 shows mounting blocks 160 and 161, the corresponding partial slots 162; 164; 166 and 168 and 163, respectively; 165; 167 and 169 machined. Apart from the fact that here four partial slots are provided in each mounting block, the partial slots are similar to those shown in Fig. 1 to 4. The sealed end 175 of the tube 171 is inserted in the partial slots 164 and 165. The sealed end 174 of the tube 171 is inserted in the partial slots 166 and 167. Short tube ends 178 and 179, each having sealed ends (172 and 173 and 176 and 177, respectively), are inserted in the sub-slots 162 and 163 and 168 and 169, respectively. The hot cutter is forced through the four tube pieces, the tubes are aligned so that the desired parts face each other with their surfaces (Fig. 21), the cutter is retracted and the molten ends are pressed against each other. The result of this procedure is that the pipe end 174 of the pipe 171 and the pipe end 175 of the pipe 170 are connected to the sealed pipe end 177 and to the sealed pipe end 172, respectively, to obtain a permanent seal of the ends 174 and 175. If one of these alternative methods is to be used, it is preferable to use a device controlled by cams.

A "seal" is the seal of a pipe end, "joint" is understood to mean the welded joint connecting two pipes together, and "temporarily" means that a seal is applied by means of a small force application, for example 0.5 to 1 kp, can be opened, if desired by those working with the device, otherwise the seal remains closed A "temporary seal" may have pinholes. A "liquid-tight temporary seal" is understood to mean a seal that has no pinholes and that does not allow entry or exit of a fluid. "Pipe stubs" are ends of pipes that are not connected. In the area of a gap of about 1 mm to about 2 mm, preferably about 1.5 mm, temporary seals that are completely closed can be achieved after the cutting device has been withdrawn. However, a small amount of the fluid may escape before the cutter is retracted. The device according to the present invention may be part of a sterile connection system used for continuous ambulatory peritoneal dialysis, in which a container having a dialysis solution having a passage opening containing a piece of tubing connected to a tube protrudes from an opening of a catheter implanted in the cavity of the patient's abdominal fall. In this embodiment of the present invention, the patient's tubing and / or the transfer tubes may have an entry port provided with a protective cover or a sealed distal end, but preferably with a sealed distal end. This system minimizes the potential for peritonitis and makes it possible to connect any other treatment container, such as a container for antibiotics, a bacteriostat or container for other medicines, as desired. Moreover, this embodiment of the present invention offers the additional advantage of avoiding the need for the patient to carry the empty dialysis solution container with them because the container can be removed by sterile means of the apparatus of the present invention by using the apparatus of the present invention Pipe is melted through and both ends, so both the patient's tube and the tube can be heat sealed to the container. In this case, no second pipe is inserted in the partial slots for the pipes. The freshly separated tubes are left to cool and then, if deemed appropriate, a permanent seal is made by means of a known device. The present embodiment also avoids the need for a current laboratory method that is used to achieve sterility.

In another embodiment of the present invention, the device according to the invention forms part of a sterile connection system for connecting two blood vessels. One of the containers may be a dispensing container and the other a transfer container. The dispenser container has a blood collection tube and may conveniently be provided with a transfer port having a transfer tube. The transfer container has a transfer pipe (collecting pipe). The two containers can be connected to one another in a sterile manner by connecting the connecting tube of the transfer container to the transfer opening of the dispensing container. The transfer opening of the dispensing container may be a conventional filling opening, i. H. it may have a protective cover and a septum on the inside of the opening. The containers may also be interconnected by connecting the blood collecting tube of the dispensing container to the collection tube of the transfer container.

In a preferred embodiment of the present invention, which is suitable both for the blood vessel connection system and the CAPA system, the dispensing container and the dialysis container, in particular for a sterile connection, have an additional tube (pork tail) which is unconnected and remote End has a seal. The term "no compound" as used herein means that the tube does not have any conventional bonding means, such as a plastic compound with a diaphragm, a low melting point thermoplastic insert, an insert which is fusible by external energy application The tube has a sealed opposite end, which is closed only by sealing the tube end together with the application of heat, a solvent or the like, In the system according to the invention for the sterile connection of blood vessels the need for a preceding connection It is understood that the term "blood vessel" as used herein refers collectively to both the donor container (primary container) and the secondary container (satellite). In the practice of the present invention, satellite container sterile can be connected to a dispensing container as demand increases. The dispensing container may be made of a material that can be sterilized by wet sterilization; such as polyvinyl chloride, while the satellite containers need not be suitable for wet sterilization but may be made of a material which can only be sterilized by dry sterilizing means such as by radiation treatment or treatment with ethylene oxide. The satellite container may be made of, for example, an O ₂ -permeable polyethylene which increases the viability of the platelets. Alternatively, the satellite container may be made of a polyethylene copolymer, a polyethylene laminate, polypropylene or any other material that is compatible with the material of which the blood container is made. The satellite container may also be made of a material that is incompatible with the material of which the dispenser container is made, as long as the tubes to be interconnected are made of compatible materials. For example, the dispensing container and its tube may be made of polyvinyl chloride, while the satellite container is made of polypropylene, but its tube is made of polyvinylchloride and is sealed to the satellite container by means of a solvent. Solvent welding technologies are well known in the art. Additional treatments may be performed sterile and also washing to eliminate treatment agents may be effected in a sterile manner. Some users believe that a risk for hepatitis can be reduced by washing the red blood cells without first cooling.

A device for producing a sterile compound according to the present invention can also be used to provide a system for producing sterile connections for containers which can not be autoclaved but which contain a wet-sterilized (autoclave) liquid. The system is constructed similar to that described in US Pat. No. 4,223,675, however, the device according to the present invention eliminates the need to provide special connectors which are mounted on the tubes.

With the aid of the device according to the present invention, a dry-sterilized package can be made of a synthetic heating material which is not suitable for being subjected to conditions of wet sterilization, but which is particularly suitable for prolonged storage of body fluids. The autoclavable liquid is filled in a container which can be autoclaved and provided with a filling tube, which can then be closed by heat sealing. The storage container and the liquid are then wet sterilized in an autoclave. The storage container is then connected to a dry sterilized container with the aid of a device according to the present invention and the corresponding method. Dehydrated sterilized containers may be provided with a tube with no connection having a heat sealed opposite end, which tube is specifically for making a sterile connection. After the sterile compound has been prepared, the autoclave sterilized liquid is transferred to the dry sterilized container, which is not autoclavable. If desired, the two containers can be separated using the apparatus of the present invention by melting and heat-sealing the connecting tube so that each container remains provided with a tube which is unconnected and has a heat-sealed opposite end. Other containers can be connected to each container by subsequently making a sterile connection. The liquid which can be autoclaved may be a non-clotting liquid and the storage package may be made of polyvinyl chloride. The container which can not be autoclaved may be a blood container which may be made of any of the materials described above.

The method according to the present invention for connecting two thermoplastic tubes together, transverse to the axis of each tube, may be carried out by means of the specific embodiment of the device according to the present invention described herein, but is not limited thereto. By the use of the term "transverse" is meant transverse to the axis of each tube, but not necessarily at right angles to said axes.The tube may be compressed in a horizontal, vertical or diagonal plane, but the diagonal plane is preferably used when using a cam-controlled device with a copper-covered cutting element, as described above.

Fig. 22 illustrates mounting blocks 180 and 182 for pipes, which are designed to compress the pipes in a diagonal plane. The mounting blocks 180 and 182 for the tubes include covers 185 and 186 which are pivotally mounted to the base parts 183 and 184 of the tube holders by means of hinges 190 and 192. In the mounting block 180, partial slots 183a and 183b are arranged, and in the mounting block 182, partial slots 184a and 184b which receive the tubes to be connected. On the surfaces of the inner ends of the sub-slots 183a and 183b and 184a and 184b jaws 193 and 194 are provided. The jaw 193 has flat surfaces 193a and 193b, and the jaw 194 has flat surfaces 194a and 194b for not compressing the tubes when the upper and lower halves of each mounting block are closed. The cover 186 of the mounting block 182 has a corresponding jaw 196 with flat surfaces 196a and 196b which cooperate with the flat surfaces 194a and 194b. The cover 185 is similarly equipped. The flat surfaces of the jaws are at an angle of approximately 35 ° to the horizontal plane. The inner surfaces of the covers 186 and 185 have hinged cam portions 185c and 186c, respectively, which are latched to the base portions 183 and 184 via rollers 183d and 184d when the covers are closed to develop sufficient force to compress the tubes. The hinged cam member 186c is held in an upright position above its hinging by friction created by a spring washer (not shown) installed in the hinge 188.

The hinged cam portion 185 c is executed in the same way. When the closing of the mounting blocks 180 and 182 is started and the jaws of the covers for compressing the tubes contact the tubes, the covers 185 and 186 no longer pivot freely so that the cam parts 185c and 186c begin to pivot and engage with the rollers 183d and 184d of the base parts 183 and 184 enter into operative relationship. As the pivoting cam surfaces 185d and 186d engage the rollers, they pull the jaws of the covers down against the tubes, causing the tubes to compress against the lower jaws 193 and 194. When the cam members 185c and 186c are fully pivoted, the tubes are fully compressed and the rollers are fully engaged to keep the mounting blocks 180 and 182 closed. The cutter can be moved in any transverse direction through the compressed tubes, regardless of the direction in which the tubes were compressed. In the method according to the present invention, the ends of the tubes resulting from the "melt-through" step, which are not joined, are preferably temporarily sealed in a liquid-tight manner, thereby avoiding the need to clamp them or connect pipe stoppers closed to them. Permanent seals may subsequently be made by using a known device or by rotating about 180 ° of one of the mounting blocks, rather than a displacement for alignment In the method according to the present invention, inclusions of the contents of the connected tubes have been eliminated. and consequently, subsequent connections can be made at the same site of the tubes The latter aspect provides another aspect of the present invention The CAPD patient has a surgically implanted silastic catheter that has an outer titanium compound it has, to which a polyvinyl chloride tube having a tip (delivery member) is attached. It is necessary to replace the polyvinyl chloride tube about once a year. This replacement involves the patented infection of the peritoneum. In accordance with the present invention, the titanium connector may be replaced with a tube, a refastenable connector 200 (see Fig. 24) made of a thermoplastic tube, such as polyester, polymethane, or polypropylene, attached to the silastic catheter 205 and the polyvinyl chloride tube 207 is connected by suitable plastic connecting elements 202 and 203. Exchanging the delivery member may then be effected by the application of the method of the present invention by employing a new delivery member. Reference is now made to FIG. 23. The new delivery member has an end 209 prior to connection which has a fastener which is connected to a sealed tube of a selected thermoplastic tube and then connected in a sterile manner to the portion 211 of the reflowable connector which secures into the silastic catheter

is. With the method according to the present invention, when the catheter has been implanted, it can be heat-sealed at the end of its refractile catheter, and the delivery member can be bonded thereto using the method of the present invention.

The device and method of the present invention are also applicable to other peritoneal dialysis therapies, such as intermittent peritoneal dialysis (IPD), continuous cyclic peritoneal dialysis (CCPD) and other therapies using the peritoneal membrane. It may be conveniently used in urine drainage and may find use in the preparation of sterile medical dosages and in other sterile packaging procedures. IPD is a machine automated peritoneal dialysis wherein the dialysate is prepared from a concentrate and then administered to the patient in a controlled manner by controlling inflow and residence time for a predetermined period of time. CCPD is a machine-automated peritoneal dialysis in which the changes of the peritoneal fluids are performed automatically at night and the abdominal cavity is filled during the day.

Conventional urinary drainage introduces an internal urinary catheter into the urethra and urinary bladder to correct for temporary anatomical or physiological urinary obstruction, to facilitate urological surgery, or to allow accurate measurement of urine output in very sick patients. The catheter is connected to a drainage tube which, in turn, is connected to a urine drainage container, which is normally used for drainage three times a day.

The main risk associated with currently practiced urinary drainage is infection of the urinary tract and there is a great need for sterile design. The apparatus and method according to the present invention meet these requirements, the apparatus according to the present invention, when used with appropriate means available, can be used for sterile access, for container removal or replacement, and for irrigation , The drainage system used for these purposes consists of a Foley catheter connected to a drain tube connected to a low-cost drainage reservoir; from additional available drainage containers having a tube without connection, in particular for a sterile connection, and having a sealed opposite end; irrigation tanks and spikes, which equally have a tube without connection to a sealed opposite end and a device for sterile connection. Instead of draining the container three times a day, the used drainage container can be removed in a sterile manner and a new container can be reconditioned three times a day. In this embodiment of the present invention, the device would operate in the full retention mode.

An example of another sterile packaging method to which the device according to the present invention can be applied is the packaging of sterile milk and fruit juices. In current conventional production, the contents and packages are sterilized separately and then combined in a sterile packaging system. The packaging includes a drinking tube. Consumers have experienced difficulties in opening the packages and using the drinking tubes contained therein. When using the device according to the present invention, the container may be a polyethylene container with an outlet opening (tube) serving as a drinking tube. During the packaging process, the drinking tube may be temporarily sealed sterile with the device according to the present invention. The package may be opened for drinking by applying pressure to the fingers causing the sterile temporary seal to open.

The present invention will be further illustrated by the following embodiment by all temperatures are in ⁰ C are indicated and all percentages are by volume .-%, provided that this is not brought otherwise expressed.

The apparatus used was a cam cylinder device as described above with reference to Figs. 10-12 and had a pair of stainless steel mounting blocks (Fig. 22) for the tubes, each about 2.86 cmχ3 , 81 χ 1,9cm tall and each divided by means of hinges in halves, so that they could be opened. In the bottom

One half of each assembly block had two slits spaced 0.79 cm apart from center line to centerline, 0.53 cm wide and 0.21 cm deep to accommodate the tubes that were to be welded. At the adjacent ends of each mounting block and at a distance of 0.13 cm from the slots were arranged 0.15 cm wide jaws which served to compress the tubes symmetrically with respect to the axes of the round tubes. The opposing surfaces of these jaws on the adjacent mounting blocks are about 0.13 cm apart. The top half of each mounting block had a matching 0.15 cm wide jaw for compression near the compressed surface which, when pivoted so as to hit the bottom half, formed a cover over the open slots for the tubes.

One mounting block was fixed while the other was pivotally movable in two orthogonal directions. A laminated welding blade (cutting device) 1.27 cm high and 3.43 cm long and 0.03 cm thick was pivotally mounted below the slots for the pipes, so that it was 0.03 cm in the 0.13 cm wide space between the pipes Assembly blocks was centered. The blade was fixed on three edges. The resistor was supplied with electrical energy via contact pads disposed on a surface of the blade. The blade was powered by a constant DC power source of 1.35 amps.

To make a connection, two parts of a plasticized tube of polyvinylchloride having an outer diameter of 5.5mm and 0.81mm thick walls were pressed into the slots. The assembly blocks were closed; Each tube was compressed in the area of the jaws. The blade was activated. When its temperature reached about 271 ⁰ C (after about 5 to 8 seconds), the blade was pivoted upwardly by about 1.02 cm to simultaneously melt through the two compressed tubes while the flow continued to feed the blade to heat. The moveable mounting block was then pivotally slid by 0.79 cm to align the tubes that were to be connected. The blade was swung down at the same time as the movable mounting block was slid by 0.89 cm toward the fixed mounting block to press against each other the molten ends of the pipes that were to be connected. The power supply for the blade has been switched off,

after she reached her bottom position. The time required to lift the blade, to move the movable mounting block until the ends of the tubes to be connected were aligned, and the blade was returned to its lower position while the ends were pressed against each other about 3 seconds. The joined ends of the tubes were then cooled for at least about 5 seconds before being removed from their brackets, and the compressed tube joints were then manually subjected to a force to force the passages between a person's fingers.

The blade was changed for each connection. The bonded pipes had about 70% of their original strength when stressed for tensile strength and had no leaks. Using the device described above and the method described above, twenty connections were made. The tubes used in the front slots had a length of 30.5 cm and were approximately 60% filled with a nutrient solution for bacterial growth. The pipes were sealed at both ends by means of a known device and sterile at their inner side. The outside of each tube was covered with spores of the "Bazillus Circulans." Seventeen of the tubes used in the rear slots had a length of 15.2 cm, half filled with the nutrient solution, heat sealed at both ends, and at their ends The other three tubes were 3.05 cm long, 60% filled with the nutrient solution and otherwise run the same as the other tubes, none of the tubes used in the rear slots was covered with bacteria.

For each connection to be made, the tubes were placed in the mounting blocks in the same way. Each of the two tubes for each connection was oriented so that the end of the tube containing air was on the right side. (The mounting blocks were arranged in the same manner as shown in Fig. 22.) The pipes were arranged such that the position of separation is approximately 8.9 cm from the right end of the rear pipe and 11.4 cm from the right end of the front pipe. There was a column of fluid in the path of the blade, present in every tube. The left mounting block was first closed, then the right one was closed. This resulted in an initial pressure inside the tube which was about 0.15kp / cm ² at the site of the weld.

After the joints were made, they were pressed to break the temporary seals that held the pipes in place at the weld in their compressed form. Breaking the temporary seals opened the connection for the fluid between the two tubes of each connection. The bonded tubes were then subjected to a heat treatment of 35 ^° C. for four days. All these interconnected tubes so "hatched" showed no evidence that their interior was contaminated by bacteria, the presence of which would have been indicated by an indicator present in the growth medium which would have caused discoloration when bacteria would have been present.

Claims (9)

Invention claim: 1. A method for producing a sterile connection of thermoplastic tubes with closed ends characterized by the following steps: a) arranging said tubes in a pair of mounting blocks; b) compressing the tubes in a region such that the inner walls of each tube are pressure bonded together; c) holding the pipes in this condition; d) inserting a hot cutter into the compressed portions of each tube at a rate such that the thermoplastic resin of the tubes that contact the hot cutter is melted, with the insides of the walls of each tube being temporarily sealed and fused together Ends of the tubes are obtained; e) taking out the hot cutting device; f) aligning the pipes to be connected with each other in alignment; g) pressing together desired molten ends of the tubes such that a welded connection is formed between the tube ends; h) cooling the welded joints; i) applying a load to the flattened welded joint such that the temporary interlock inside the pipes breaks and a connection for the fluid between the connected pipes occurs. 2. A device for producing a sterile connection of thermoplastic tubes with closed ends together, for carrying out the method according to item 1, characterized in that it comprises two mutually spaced with one another mounting blocks, which are each provided with a first and a second slot, the starting from the non-adjacent sides of the mounting blocks and ending before the edge of the adjacent sides, decreasing in depth towards these ends; having at the provided with said slots upper side covers which are hingedly attached by hinges to the mounting blocks and having a smooth inner surface and can be locked by means of handles designed as closure elements in the closed state; in that the mounting blocks are slidable transversely to the direction of the slots, both together relative to a cutting device and against each other such that either the first and second slots of a mounting block face each other or the first slot of one mounting block faces the second slot of the other mounting block while the two other slots do not oppose each other, that a mounting block is made in two parts, such that the upper part by means of a pivot bearing can perform a rotational movement against the lower part and that a spring is provided, which the upper part in the direction of another mounting block presses when the cutting device is no longer between the mounting blocks, that further includes a cutting device which is attached from a heating block, that the cutting device is designed as a folded metal sheet, wherein on the inside the folded sheet is provided with an electrical resistance element and a dielectric adhesive, the latter between the sheet surface and the resistance element and that the heating block and the cutting device against the mounting blocks perpendicular to the displacement direction thereof is slidably disposed. 3. Device according to item 2, characterized in that the thickness of the cutting device is 0.25 to 0.36 mm. 4. The device according to item 2, characterized in that the metal of the cutting device is copper. 5. Device according to item 2, characterized in that the electrical resistance element is an etched foil resistor. 6. Device according to item 5, characterized in that the foil resistance consists of stainless steel. 7. The device according to item 2, characterized in that the cutting device is a steel blade. 8. The device according to item 2, characterized in that the cutting device is a hot wire. 9. Device according to item 2, characterized in that the cutting device is a hot fluid jet.