JPH0227936B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention provides a sterile connection between two tubes.
The present invention relates to methods, devices and systems for forming sterile docking connections.

At present, there are numerous medical and scientific procedures that require the sterile transfer of fluids from one container to another. The only sterile transfer systems in current commercial use involve pre-joining the container tubes and then sterilizing the entire assembly. This is not flexible;
Moreover, it is costly. This is because new containers cannot be added and the number of containers required to be joined is often not known at the time of initial filling.

An example that requires sterile docking is continuous ambulatory peritoneal dialysis.
This is the case for peritoneal dialysis (CAPD).
This method uses a membrane diffusion cell (membrane diffusion cell) that cleans the blood of waste products normally removed by the kidneys.
An alternative to dialyzing blood outside the body (cell diffusion) and then returning the blood to the patient. Dialysis of the body is a time consuming process and in some cases results in damage to the blood due to exposure to substances and conditions outside the body. In CAPD, the patient receives spent dialysate.
It is only necessary to spend time draining the solution and replacing it with fresh solution.

CAPD patients have a tube connected to the patient's abdominal cavity via an implanted catheter.
The tube from the new bag of dialysis solution is connected to the patient's tube. Fresh dialysis solution is drained from the bag into the patient's peritoneal cavity, where it
Remain in time. During this treatment period, the empty bag is folded and carried by the patient, and the patient can continue with normal activities. After this treatment period, the spent dialysate is drained back into the empty bag, and the empty bag is then disconnected from the patient's tube. A new bag of dialysis solution is then connected to the patient's tube and the process is repeated. Connection of dialysis solution to a new bag, even with precautionary measures, exposes the end of the tube to airborne bacteria or other contaminants. Prior to the invention disclosed in U.S. Pat. No. 4,369,779, elaborate and costly precautions were used to ensure sterility, including the use of masks, gloves, gauze strips, and antiseptic solutions. There was no satisfactory method. Currently commercially available methods typically
Contamination occurs to the extent that peritonitis occurs once a year or more and the scar tissue from it interferes with dialysis.

A truly sterile connection would be able to minimize the occurrence of peritonitis. Other processing bags, for example for antibiotics, bacteriostatic agents or other medicaments, can also be connected as desired.

Similar requirements for sterile connections exist for blood bags. Currently, blood from donors is drawn into a primary bag which may be joined to one or two satellite bags, all of which are connected and sterilized before use. These accompanying bags contain blood separated components,
For example, plasma, platelets, processing agents such as bases,
buffering agents, stabilizers for cellular metabolism, other preservatives,
or cell rejuvenants: or necessary to retain cleaning agents to remove processing agents or other contaminants. In practice, it is not feasible to pre-connect bags for all desired treatments. Prior to the invention disclosed in US Pat. No. 4,369,779, supplementary treatments, such as new preservatives, could not be added aseptically during bag storage by commercially acceptable methods. Furthermore, to avoid the expense of unused collateral bags, the number of such bags is limited and selected based on anticipated demand. The inability to predict demand greatly increases inventory requirements and complicates blood supply scheduling.

Currently, it has very limited use in quality control, such as time assays of the quantity and quality of components of separated blood fractions. The main reason for its current limited use is that traditionally, using commercially available methods, placing the blood in a sterile blood unit exposes the blood to bacteria, so that the blood cannot be used within 24 hours of its entry. In other words, it requires that something be done. Therefore, although the viability of stored blood components can be extended by supplementary treatments, such as the addition of preservatives during storage, such treatments are not commonly performed. Furthermore, the main blood bag contains an anticoagulant that can only be sterilized by heat (steam), and therefore all pre-attached bags can also be sterilized by wet sterilization, i.e. by steam or hot water in an autoclave. Sterilized. These bags are made from plasticized polyvinyl chloride (PVC), although other materials are known to be useful in constructing bags, which are preferred for other reasons such as greater oxygen permeability. . Many such materials, such as oxygen permeable polyethylene, are not steam sterilizable, so they are not currently used in pre-connected systems.

Sterile connection means can be used to pre-install all wet sterilizable multiple bags without compromising sterility or limiting shelf life or without knowing which, if any, will be used. It would be possible to perform whatever processing desired without the need for a connection.

U.S. Patent No. 3,013,925, issued to Larsen on December 19, 1961, describes a method for welding two joints of thermoplastic pipe, comprising:
Beveled the inside of each end of the pipe joint to be welded and cut the end of the pipe,
For example, by pressing the ends of sections of pipe against a heated plate, the ends of the pipe are heated, and then the ends of the pipe are heated so that the softened material flows to the outside of the pipe and the ends of the pipe are welded together. are pressed together such that welding is accomplished without substantially forming a bead on the inside of the material.

U.S. Pat. No. 3,035,631, issued to Knowles on May 22, 1962, discloses a chip for welding plastic parts. The chip has a knife edge at each of its two opposite ends. One end of the knife is thick, whereas the other end is thin. This patent states that as the thin end passes through the joint, it will induce a molten plastic surface to flow together.

U.S. Patent No. 3,117,903, issued to Hix on January 14, 1964, discloses a method of joining thermoplastic pipes without forming troublesome internal ridges at the points of welding. . The ends of the pipes to be welded are immersed in a hot bath of an inert, high-boiling organic liquid to expand the ends and eliminate any nuisance when the pipes are withdrawn from the bath and the ends are abutted against each other. Flare outward so that the polymer of the two sections of pipe fuse together without forming a ridge.

Waldrum on July 29, 1975
U.S. Pat. No. 3,897,296, issued in
liquefying the surface by heating it to a temperature close to Discloses how to do so. This patent makes no mention of cutting the tube and forming a sterile dock.

U.S. Pat. No. 3,968,195, issued to Bishop on July 6, 1976, describes a method for forming a sterile connection between two rigid tubes whose free ends have thermoplastic diaphragms sealing the free ends. is disclosed. If a sterile connection between the free ends of two tubes is desired, the free ends of each rigid tube are aligned with a slight spacing and each thermoplastic diaphragm is opened by heating. The free ends of the rigid tubes are then brought into contact and held in place under slight pressure while the thermoplastic material cools and solidifies;
thereby creating a permanent connection. This method is 1
It requires a tube with a low melting point thermoplastic diaphragm on the end that can only be used once, ie no other connections can be made to the same tube.

June 24, 1980 Alexander et al.
U.S. Pat. No. 4,209,013 issued to et al. describes an improved sterile connector system for continuous peritoneal dialysis in which a dialysis solution container with a transfer port is coupled to a tube extending from the patient's peritoneal cavity. Disclosed. This improvement includes a flexible housing having a first section thereof for attachment to a transfer port and a second spaced apart section for attachment to a patient tube. The attachment area defines an opening to allow the transfer port and patient tube to extend within the interior of the flexible housing when they are attached to the housing. The flexible housing has means for receiving sterilization fluid and is operable to also allow the transfer port and patient tube to be sterilized and interconnected within the housing. be.

Williams on September 23, 1980
U.S. Pat. No. 4,223,675, issued to U.S. Pat. an autoclavable dispenser of an autoclavable material, the dry sterilized package comprising a sterile connection with the interior of the package; a dispenser containing a sterile liquid, the dispenser including a sterile connector having an initially closed sterile aperture in sterile communication with an interior thereof, the package sterile connector and the dispenser sterile connector mating with each other; The above system is disclosed as having a mating engagement.

Greff et at December 30, 1980
US Pat. No. 4,242,310, issued to US Pat. This device is interfitting with each other.
The housing includes a base portion and a cover portion adapted to provide a substantially closed interior volume. The housing includes means for receiving a first tube and means for receiving a transfer tube from a pharmaceutical solution container. The housing supports means positioned within the housing and operable from outside the housing for enabling manipulation of one of the tubes relative to the other tube. Means are provided for sterilizing the tube portion within the substantially closed inner volume.

“An Aseptic Fluid Transfer System for
Blood and Blood Components”, BAMyhre
et al., Transfusion, Vot.18, No.5, pp.546−
552, Sept-Oct. 1978, discloses a method for heat sealing two sterile fluid transfer system (AFTS) units together. The AFTS unit includes a layer of Katon film, an aromatic polyimide resin that is stable at relatively high temperatures. A pair of dies, one of which is flat and one of which has a raised "H" shaped area, is
are placed between the dies and brought together under a pressure of 100 psi (6.9 x 10 ⁶ dynes per square centimeter). The temperature of the die is increased to 200°C (392°C) over a period of 45 seconds. Upon withdrawal of the die and removal of the AFTS units from the die, the AFTS units are heat sealed together by a seal surrounding the opening between the AFTS units. A configured blood bag fitted with an AFTS unit can thereby be joined. This system is time consuming and requires specifically configured units that can only be used once.

DE 2250130 A1 discloses a method and a device for bonding plastic parts by welding. This method involves two
characterized in that two plastic parts are pressed against a heating element introduced between the two parts. The area of the plastic part adjacent to the heating element is surface melted by a very short and very high temperature action, and while maintaining the pressure exerted on the thermoplastic part, the heating element is withdrawn from the plastic part and 2
Immediately press the two parts together. This West German patent application does not mention plastic tubes or how to make a sterile connection between two closed end tubes.

U.S. Pat. No. 4,369,779 issued to Spencer on January 25, 1983 discloses a method, apparatus and system for aseptically connecting two sterile closed end tubes. . This method involves passing a hot cutting means through each tube and simultaneously forming a continuous fused seal between the heated cutting surface and the cross section of each tube, thereby maintaining a seal between the tubes, aligning the tubes with each other, and joining each fused end of the tubes together to form a joint between the tubes while maintaining the seal.

This patent describes a cutting means, means adapted to heat the cutting means, and a pair of mounting blocks adapted to receive and hold two tubes to be joined;
means for imparting movement between said blocks and said cutting means to a position such that said cutting means is between said blocks and traverses where said block is adapted to receive a tube; and two different tube ends; and means for separating the blocks and the cutting means while pressing the blocks together. Disclose. The patent states that during the connection there should be no significant visible deformation of the tubes and that in order to obtain a reliable docking, the tubes to be joined should be It is taught that there should be no more than a thin film of liquid on the wall near that location.

When using this patented method, express the liquid from the tube before making the sterile connection.
In particular, it is necessary to achieve a sterile connection at least in the portion of the tube that has a 13-25 mm (0.5-1 inch) air gap. There is a need for a sterile docking method that provides a sterile connection of liquid-filled tubes, thereby achieving a strong bond without introducing contaminants or disintegrating the liquid. This is especially true if a suitable air gap is not present or is not desired. There is also a need for such a method that provides total containment of fluid within the tube.

The present invention provides methods, devices, and systems for aseptically connecting sterile closed-end tubes.
The method includes flattening a section of each tube to bring the inner walls of each tube into contact, passing a hot-cutting means through the flattened section of each tube, thereby temporarily bringing the inner walls of each tube together. sealing and providing fused tube ends; aligning the tubes to be connected with each other; and joining the desired fused ends of the tubes together to form a joint between the tubes. , cooling the joint and subjecting it to stress to open temporary seals in each tube, thereby providing fluid communication between the joined tubes. Although the method is broadly applicable, it provides an improvement over the method of US Pat. No. 4,369,779 ('779 patent) when used with liquid-filled tubes.

The apparatus of the invention comprises cutting means, means adapted to heat the cutting means, a pair of mounting blocks adapted to receive, hold and flatten the tubes to be joined; means for imparting movement between said blocks and said cutting means to a position such that said means are between said blocks and traverse where said blocks are adapted to hold the tube; and two different tube ends; Means are provided for realigning the blocks to a mutually aligned and mutually facing position, means for separating the blocks and the cutting means, and means for pressing the mounting blocks together.

In the present invention, the tubes to be joined are flattened in appropriate areas so that the inner walls meet. The tubes are then sequentially or simultaneously melted (melt-through) by hot cutting means.
is melted through, with the molten polymer temporarily sealing the resulting molten tube end. The tubes are temporarily sealed so that viable airborne or surface bacteria cannot find passage into either of the tubes. The tubes are moved into alignment after the heated cutting means slide away and the fused tube ends are then pressed together to form a joint. The joints are briefly cooled and then subjected to slight stress to open temporary seals in each tube. The joint is sturdy and strong and multiple additional joints can be made on the same tube in subsequent sterile connections. Furthermore, each subsequent connection can be made at exactly the same point on the tube. This method can be used to create more than one joint by using multiple tubes (more than two) and multiple tube slots.

The step of flattening the tube and then providing a temporarily sealed tube end is not taught by the '779 patent. The method of the present invention does not require maintenance of a connective fused seal between the heated cutting surface and the cross section of each tube. The tubes to be connected in the method of the invention have closed ends, i.e.
The tube has a sealed end, or is connected to a container such as a blood bag or dialysis bag, or is connected to a catheter implanted in the patient, or in some other manner, the tube end is connected to an external Closed to the environment. Although the method of the present invention can also be practiced with open-ended tubes, there are no advantages.

Referring to FIG. 1, sealed end 12 of thermoplastic tube 20 is connected to blocks 17 and 18.
Partial slots 13 and 1 machined in
4 is inserted. The sealed end 19 of tube 21 is inserted into machined partial slots 15 and 16 in blocks 17 and 18. Partial slots 13-14 and 15-16 are shown in FIG. 1 as blocks 17 and 18, respectively, with the exception of about 1/16 inch on the inside facing edges.
length has been extended. The partial slots decrease in depth as they approach the inner edge of each block. The upper portions of blocks 17 and 18 are not shown for clarity. The tube is shown in the flattened state that occurs when the two parts of each mounting block are closed. 1-4, tubes 20 and 21 are connected to blood bags 10 and 11. In FIGS. Or one of the tubes
One may be connected to the dialysis bag and the other may be connected to the patient's peritoneal cavity. The tube connected to the patient's abdominal cavity may be connected to the bag instead of having a sealed end at the other end.

Referring now to Figure 2, two blocks 1
7 and 18 are slid in the direction shown by the arrows against the hot cutting means 34, which in the figure is a steel blade, so that the cutting means melts through the tubes 20 and 21, respectively. There are fused temporary seals 37-38 and 39-40 that close and seal the separated portions of 21. Seals 37-38 and 39-40 result from mutual fusion of the inner walls of tubes 20 and 21 in the vicinity of hot-cutting means 34. These fused temporary seals 37, 38, 39 and 40 provide for the exchange of air between the inside of the tubes 20 and 21 and the environment immediately outside the tubes and to prevent particles suspended in the air or on the surfaces of the tubes or equipment. prevent contamination from

Referring to FIG. 3, block 17 includes tubes 20 and 21 as well as partial slots 13 and 16.
have been moved relative to block 18 so that they are aligned on both sides of the hot cutting means.

Referring to FIG. 4, blocks 17 and 18 and hot-cutting means 34 have been moved relative to each other, with slots 13 and 16 and tubes 20 and 21 still in alignment. The tube ends to be joined were urged together and the fused tube ends were fused, thereby joining tubes 20 and 21 together. Blocks 17 and 18 holding tubes 20 and 21 were pressed together by springs 52 (shown in FIG. 5) during the period in which they and cutting means 34 were moved relative to each other. FIG. 4 shows the upper part of the mounting blocks 17 and 18 or the lid 22.
and 23 are also shown. Lids 22 and 23 have flat inner surfaces that flatten the tube when the lids are closed. The lids 22 and 23 are securely attached to the handles 41 and 42 by suitable means (not shown) such as soldering or screws.
It is equipped with The handles 41 and 42 consist of brackets 24 and 25.
Attached to 5 are latches 26 and 27 by hinges 28 and 29. When the lid is closed, latches 26 and 27 are inserted into latch slots 35 and 36 on blocks 17 and 18 to apply sufficient pressure to flatten tubes 20 and 21 in the area of the blocks. Lid 22 and 2
3 connects to block 17 via hinges 30 and 31.
and 18 at the bottom parts 8 and 9.

FIG. 5 shows blocks 17 and 18 with slots 13 and 16 aligned and in the position they will occupy after the weld has been made and the welded tube removed. The device of the present invention operates similarly to the sterile docking device disclosed in U.S. Pat. No. 4,369,779, except as specifically noted herein. Because of this,
The relevant portions of that patent are incorporated herein by reference. Blocks are guided by 45, 46 and 47
Shown slidably mounted above. The bottom part 9 of the block 18 consists of two parts 50 and 51 which are interconnected by a bolt 53 to allow rotational movement of part 51. Thereby, the portions 51 are individually attached to the block 17 by the spring 52 as the block and the tube (not shown) retained by the block are retracted from the cutting means (not shown for clarity). can be pushed towards.

FIG. 5 also shows the operation of handle 49 and stop block 48 against which mounting blocks 17 and 18 are pressed. Operation of this aspect is best explained by reference to FIGS. 1-3 discussed above and by use of FIGS. 5-7. The operator inserts the tube ends into slots 13-14 and 15-16 as shown in FIG. The lids 22 and 23 are closed and latched, thereby causing the tube to flatten in the vicinity of the mounting block. Cutting means 34 shown in FIG.
and the block heater 55 is connected to the cutting means 3.
4 is lowered between stop block 48 and mounting blocks 17 and 18 so that it is aligned with the space between the blocks. This positioning causes the block heater 55 and cutting means 34 to be fixedly arranged within the upper portion 57 of the housing 56 shown in FIG. Place the stop block 48 and the attached slide into the housing 56.
by being fixedly arranged within the base portion 58 of the. The two sections of the housing are attached by hinges 59.

The blade block heater 55 (FIG. 6) for heating the cutting means is activated. Blocks 17 and 18 fit together and cooperate with each other as described in U.S. Pat. No. 4,369,779. The operator pushes the handle 49 which moves the blocks 17 and 18 on the slide 45, thereby moving the flattened tubes across the hot cutting means 34 as shown in FIG. Seal the molten ends. Block 17 first hits stop block 48, thereby disengaging the two blocks sufficiently to allow block 18 to move until it hits stop block 48 and stops. Block 1
This further movement by 8 aligns slots 13 and 16 as shown in FIG. The operator immediately pulls back the handle 49 and
The friction between the blocks moves block 18 connected to block 9 and also block 17. The block and the tube ends to be joined are retracted away from the hot cutting means 34. As the corner of block 18 leaves the edge of block 48, spring 52 forces portion 51 of block 18 to rotate slightly around bolt 53 toward block 17, thereby removing the temporarily sealed tubes being joined. A slight force is applied to the ends as they slide away from the edge of the hot-cutting means (see Figure 5).
A stop 54 on slide 46 terminates movement of the block and handle. The operator removes the spliced tube after an approximately 5 second delay to allow the splice to cool.

FIG. 8 shows tubes 20 and 21 joined at temporary seals 37' and 40' which have now been fused to form a joint. In FIG. 9, the joint is compressed to break the temporary seal and provide fluid communication between the tubes.

Suitable cutting means for use in the present invention include any of the forms described in US Pat. No. 4,369,779. The cutting means can also be a hot wire or a hot fluid stream as described in co-pending US patent application Ser. No. 395,794. The relevant disclosures of the above applications are incorporated herein by reference. If a hot wire is used, it can be heated by electrical resistance. The wire should have sufficient strength, stiffness and chemical inertness.

Preferably, the cutting means has, as an outer layer, at least about 173 watts at a thickness of 0.1 mm.
a folded sheet of metal having a thermal conductivity of 〓 and a tensile yield strength of at least about 34 x 10 ⁴ kPa at a thickness of 0.1 mm, a resistor disposed inside the fold of the folded sheet of metal, and A heating element comprising a layer of dielectric adhesive that is stable to about 260° between the inner surface of the folded sheet of metal and the surface of the resistor, thereby interconnecting the resulting structure. Glue to. This heating element is a commonly assigned Benin
et al., co-pending U.S. patent application Ser. No. 408,417.
In this embodiment the metal is preferably copper;
The heating element is preferably an etched foil resistor manufactured from stainless steel.
foil resistor) and the adhesive is preferably an acrylic adhesive. When the heating element or cutting means is in any of the forms described in the '779 patent, it can have a thickness within the range described in that patent, but preferably has a thickness of about 0.25 mm to about It is 0.36mm.

Blood and dialysis bags and tubes in modern use are made from plasticized polyvinyl chloride for flexibility, strength and steam sterilization. Generally, the cutting means for these plasticized polyvinyl chloride tubes is about 500〓
(260°C) to 750°C (399°C), which is also suitable for most other thermoplastic tubes. The preferred cutting means, copper-laminated elements, are generally about 600㎓ (316
°C). The cutting means is (1) sufficiently high to rapidly (less than 1 second) kill bacteria or bacterial spores on the outer surface of the tube and (2) sufficiently high to rapidly melt the thermoplastic resin forming the tube. Preferably at temperature. The tubes are heat sealed closed or connected to the bag at their ends.
Both tubes and the bags to which they are connected will be sterile. Approximately 425〓 (218℃)
Below, the bacteria and bacterial spores are not quickly killed by the heat from the cutting means. This temperature for rapid killing depends on the rate of heat transfer from the cutting means. For example, for solid metals a minimum temperature of 500㎓ (260°C) should be observed. Above about 750°C (390°C), most polymers such as plasticized polyvinyl chloride or polyolefins, such as polypropylene or polyethylene, begin to become too liquid to maintain a seal. When using the preferred cutting means, about 520°C (271°C) is the preferred temperature for use with conventional plasticized polyvinyl chloride blood bag tubes.
Another upper limit is the temperature at which the resin forming the tube begins to deteriorate during the time it is exposed to the heated cutting means (approximately 2 seconds). For plasticized polyvinyl chloride and polyolefins, the upper limit is approximately above the melting point of the thermoplastic resin forming the tube.
300〓(149℃).

Tubes are produced by melting the polymer from which the tube is made against the cutting means.
The polymer should be advanced to the cutting means at such a speed that no mechanical cutting of the unmolten polymer or visible deformation of the tube should occur. Excessive heating times should be avoided to minimize excessive melting or degradation of the polymer. Conventional 165 mil (4.2
mm) outer diameter, 10 millimeters (0.25 mm) wall thickness, plasticized PVC blood bag tubes, a time of 0.5 to 1.5 seconds to cut the two tubes is most satisfactory. I understand. The time to reposition the tubes and align them should not be so slow as to cause the presence of degraded polymer in the welded joint. The rate of withdrawal of the cutting means is important to minimize deterioration and excessive melting, and is from 0.1 to
I found it to be a satisfying 1 second. The total hot cutting means contact time is preferably about 1-3 seconds, most preferably 1.5 seconds.
After removal of the hot cutting means, cooling of the tube takes place for about 3-5 seconds and the tube is then removed from the block. The new joint is temporarily sealed. The joint is then subjected to a slight stress, e.g.
Squeezing with pounds of force breaks the temporary seal, thereby achieving fluid communication between the two tubes. Low stress can also be achieved by squeezing the joined tubes from a distance of the joint, if the tubes are substantially filled with liquid, or by other suitable means.

Preferably, the mounting block is fabricated from a thermally conductive metal to act as a heat sink to facilitate rapid cooling of the joint.
The tubes are preferably pressed toward each other within about 1-2 seconds after the hot-cutting means is removed, but are urged toward each other as the hot-cutting means is removed.
together) can be done. Since the newly obtained tube end is temporarily sealed, it is not necessary in the present invention to maintain a molten seal of polymer between the tube and the hot cutting means, and in practice such It should be understood that this is not possible when the cutting means is a hot wire or a hot fluid stream. For a cutting means approximately 0.30 mm (12 mil) thick and centered in the space between the mounting blocks and for a tube of approximately 5.5 mm (215 mil) outside diameter, the spacing between the blocks is approximately 0.38 mm. mm
(15 mils) to about 4.1 mm (160 mils). Preferably the space between blocks is about 0.76mm
(30 mils) to 2.0 mm (80 mils).

The tube used should be formed from a thermoplastic resin that melts at a temperature at least 50° lower than the temperature at which the thermoplastic resin begins to deteriorate during the time it is exposed to heat in the process of the invention. The tubes to be joined can be made from the same material or from compatible resins. As used herein, "compatible resins" means that the melting points of the two materials may cause polymer degradation or otherwise weaken or otherwise form a single melt phase and subsequent strong bonding. Both thick viscous melts flow together to form a single melt phase without the formation of thermal or other chemical reaction products that interfere with cooling and solidification. This means that the materials are in close enough proximity to form at co-operating temperatures. For example, polyethylene is compatible with polyethylene copolymers and polypropylene.

In a preferred embodiment of the invention, the means for imparting motion between the blocks and the cutting means, the means for realigning the blocks, and the means for pressing the blocks against each other provide a motion that produces three orthogonal motions. It is a cam means for giving. The cam means is preferably a driven cam cylinder comprising one groove in each face and one groove around its periphery. One of the mounting blocks is coupled to a groove in one face of the cam and a groove around the periphery of the cam. The cutting means is coupled to the groove on the other side of the cam.

In this embodiment, the device preferably has a control device coupled to the cam cylinder to control the timing of operation of the device. In this aspect of the invention, the device is similar to the automatic sterile connection device disclosed in commonly assigned U.S. Patent Application No. 408,418, filed Aug. 16, 1982. It should be understood that the apparatus of the present invention differs from the apparatus of the said application in those respects which are necessary to achieve the spirit of the invention.

Referring to FIG. 10, the sterile connection device selected for purposes of illustrating this embodiment is shown generally as 60 and includes a housing 62 as its main components, a cutting mechanism 64 pivotally connected to the housing; A pair of mounting blocks 66, 68 spaced from each other on the same plane, motor 7
Exhaust pump 70a and motor 7 driven by
a cam cylinder 72 driven by 4 and an electronic control unit 7
Contains 6. The cutting means is a heating element of the preferred type described hereinabove. The specific embodiments disclosed include push buttons 71a, 7 for checking the battery used in the cutting means and for indicating when the system is ready and for initiating the sterile connection operation, respectively.
Also includes 1b and 71c. A magazine 79 for holding a new heating element and a load-ejector lever for feeding the heating element to the cutting mechanism.
-eject lever) 81 is also shown.

The mechanism for generating the three orthogonal movements required for bonding can be seen in Figure 11, which shows a typical arrangement of the mechanism. More specifically, it includes three cams to achieve three movements. In the preferred embodiment shown, the cam is connected to cylinder 7
Grooves 78, 80, 82 on two different faces.
This device ensures that the three cams are never out of phase. A heating element holder 87 for heating element 85 is pivotally mounted to housing 62 at one end and engaged in cam groove 78 at the other end. The heating element 85 is between the mounting blocks 66, 68 and the tubes 66a, 68a are held side by side in the blocks for joining.
It is positioned below. A pivoting block 86 is journaled to the housing 62 at one end and attached to the mounting block 6 at the other end.
It is journaled to 6. Intermediately to its end, the mounting block 66 is engaged in the cam groove 82. Mounting block 66 is a follower
Also engaged with the surrounding cam groove 80 via 67,
Mounting block 68, on the other hand, is secured to housing 62. Motor 74 rotates cam cylinder 72.

Heating element 85 is an etched stainless steel foil resistor laminated between sheets of copper connected to the battery. In use, it is subjected to a short heating cycle (approximately 6 seconds) and one-shot use (a new heating element is used for each joint).

The aseptic connection operation with the disclosed device utilizes three orthogonal movements involving mounting block 66 and heating element 85. These include lifting the heating element 85 upwardly through the tubes 66a and 68a, shifting the tubes to align the tubes to be joined with each other, and finally, during or after retracting the heating element. This involves pressing the rear tubes against each other. In the particular embodiment shown, the tubes are pressed together while the heating element is retracted. The cam cylinder 72 rotates in the direction of the arrow (Fig. 12).
and this circuit causes cam groove 78 to lift heating element 85 upwardly through tubes 66a, 68a. With heating element 85 present between the tubes, continued rotation of the cam cylinder causes cam groove 82 to move mounting block 66 to align tubes 66a, 68a. The continuous rotation of the cam cylinder is caused by the surrounding cam groove 80.
causes the heating element 85 to force the mounting block 66 towards the fixed mounting block 68 as it is lowered. The tubes 66a, 68a, each temporarily sealed, are thus pressed together to form a sterile connection therebetween. The tube is removed from the block and squeezed to break the temporary seal;
Fluid communication between the two tubes is thereby achieved.

As best shown in FIG. 13, tube mounting blocks 66, 68 include covers 90, 92 that are pivotally mounted to tube holder bases 96, 98 at hinge points 93, 94. Complete channels 66b, 66c are provided in mounting block 66 to hold the tubes to be joined and mounting block 68 is likewise provided with complete channels 68.
b, 68c. The channels are flared out at their facing ends and raise the lips 66d, 66e and 68d, 68e to flatten the tube. The interior surfaces of covers 90, 92 are similarly shaped. When the covers 90, 92 are closed,
Latches 90a, 92a are placed over lips 96a and 98a of respective bases 96 and 98 to create a force sufficient to flatten the tube.

The heating element loading and ejection system and control device are not essential to the invention. Suitable systems and their operation are described in U.S. Patent Application No.
No. 408,418, the relevant portions of which are incorporated herein by reference.

Figures 14a and 14b show another embodiment of the device of the invention. In this embodiment the device has a band shape and is held in the hand, thereby allowing it to be used in places where access is difficult. The device chosen for illustrative purposes is shown generally as 101 and includes a housing 10 as an outer component.
2. Tube slots 114a and 114, respectively
a pair of mounting blocks 114 and 115, providing cover 104 and switch 103;

Referring to FIG. 15, mounting block 114
and 115 is a U-shaped tube slot 114a,
External wall 1 having 114b and 115a, 115b
14c and 115c. The front walls 111 and 112 of the mounting block are connected to the rear walls 116 and 117.
Similarly, it is movable linearly. Rear wall 116 and 11
Connected to 7 are linkages 118 and 119, respectively, which provide flattening of the tube as will be explained later. The front and rear walls of each mounting block are integral with the front and rear portions of the inner wall. Central part 113 of the inner wall
a and 113b are base portions 138 and 139, respectively.
permanently attached to the The base and outer walls of each mounting block are an integral part of blocks 133, 134 extending into a sleeve 135, which is shown with its top portion cut away to further illustrate additional elements. in fact,
This sleeve extends over linkage 118 and 119. The cutting means 141 is aligned under the space in the mounting block and rests firmly but removably on a holder 140 which is fixedly attached to the arm 126.

Arm 126 extends rearwardly and has an upwardly raised portion (FIG. 16) extending into sleeve 135. Arm 1
26 includes a camming surface 125 that rides on a pin 127 that provides a lifting action on the cutting means holder 140. Pin 127 is fixedly attached to actuator tab 128, which is fixedly attached to block 123.
Block 123 is a ball reverse shaft (ball
124 (reverser shaft) 124. DG motor 122 imparts rotational motion to ball reverser shaft 124 when activated. Arm 126 pivots about pin 145 which is fixedly attached to arm 129. Other pins (not shown) attached to the other side of actuator tab 128 are attached to arm 12.
9 through slot 147. When this pin is moved to the right end, it acts to move arm 129 under the tube after the tube is connected. When rod 105 (Fig. 14b) is pushed, it applies sufficient force to lift arm 129 against the newly joined tube and open the joint. Motor 122 and sleeve 135
is fixedly attached to housing 102.

The operation of the mode rod is shown in Figures 14a and 14b, and Figure 1.
This is best understood by referring to FIG. The operator places the two tubes to be joined into the slots of mounting blocks 114 and 115. The operator then pushes the switch 103 forward to lock the bottom of the switch into the linkages 118, 11.
9 across the top, thereby flattening the tube. Flattening the linkage moves the front walls 111 and 112 and the rear walls 116 and 117 of the mounting block relative to each other towards the stationary portions 113a and 113b, thereby flattening the tube. Forward movement of this switch acts to close the lid 104 and the wiring and contacts (not shown).
It also acts to activate the current to the motor 122 and cutting means 141 through a conventional system. Block 123 is actuator tab 12
Move forward while supporting 8 with it. As actuator tab 128 moves forward, arm 1
26 is raised such that the hot cutting means 141 traverses and melts through the tubes 153, 154 (see FIG. 17). Protrusion 155 is block 1
37 into the slot 156 and the cutting means engages the wedge 157 just after it has melted through the tube, and the mounting block 114 is moved forward to open the opening 114b 115a and hence the tube contained therein. Align with the parts. Forward movement of mounting block 114 is terminated by a stop (not shown) fixedly attached to housing 102. The forward movement of the cutting means causes the protrusion 130 to pass through the slot 13.
It ends when the end of 1 is reached.

Arm 126 continues its forward movement to move cutting means 141 past the tube. When or after the blade has passed the two tubes to be connected, the portion 136 of the mounting block 115 is moved around the pin 149, which is fitted into the bracket 151, by the action of a spring (not shown). The portion of block 115 in front of area 152 is pivoted to block 114.
causing the tubes to be pressed toward each other, thereby joining the two tubes. The operator allows the joint to cool and then removes the rod 105 (Figure 14b).
to raise arm 129 and press the joint open to provide fluid communication between the tubes.

The operational elements constituting this embodiment can be used in the illustrated band model or can be used in the device of the invention similar to a hand-held calculator or gun. Each of these configurations is
Provides characteristics that are more palatable to certain environments.
For example, a gun model could be better suited for one-handed operation.

Tubes that are flattened in the mounting blocks can have a small portion occupying the space between the mounting blocks that can trap liquid. In the present invention, the tube is either (1) only sufficiently so that the inner wall is not in intimate sealing contact at the edges of the tube, or (2) completely such that the inner wall is in intimate sealing contact. It can be flattened to In the first mode, residual liquid in the tube occupying the space between the mounting blocks flows through the flattened area into the rounded portion of the tube during the passage of the hot-cutting means. Because of this, the liquid in the tube is retained within it and strong,
An occlusion-free joint occurs; however, the stub end of the tube
ends) may not have a fluid-tight seal.

The second mode can be carried out in various ways,
As a result, the stump end of the tube is sealed fluid-tight, thereby providing complete containment. In one embodiment, the two tubes are flattened with a clamp in the space between the mounting blocks before being flattened with the mounting blocks. In this embodiment, all fluid is displaced from the portion of the tube involved in the sterile connection operation. The use of clamps is also useful in situations where the tube is very rigid. Alternatively, the mounting blocks can be spaced a distance apart to hold the tube flat in this area, thereby preventing liquid trapping. For example, for a tube with an outside diameter of approximately 5.5 mm (215 mils), the gap between the blocks is approximately 0.38 mm (15 mils).
from about 1.0 mm (40 mils), preferably about 0.76 mm (30 mils)
mill). In either type of operation, the hot-cutting means can be retracted before alignment of the tubes. The tubes can then be aligned and provide a sterile joint under conditions that do not allow them to cool significantly before joining.

In this complete containment mode as described above, the newly fused tube ends that are not connected to form a joint are provided with a temporary seal that can be made permanent by the use of a Hematron device. appear. Referring to FIGS. 2 and 3, tubes 20 and 21
The sealed end 12 of the tube 20 and the sealed end 19 of the tube 21 are adjacent to the cutting element 34 when the tubes are melted through and brought into alignment by the hot cutting element 34. It can be seen that it has a temporary seal on the closed end. By either of two other features of the invention the use of a hematron device can be avoided and a permanent seal can be achieved. FIG. 19 illustrates an alternative alignment to the alignment shown in FIG. In this embodiment, one of the mounting blocks is rotated 180 degrees about a central horizontal axis parallel to the axis running through the center of each flattened tube. This rotation aligns tubes 20 and 21 and stump ends 12a and 19a, respectively. After the hot cutting means 34 has been withdrawn, the tubes 20 and 21 are pressed together and the stump ends 12a and 19a are simultaneously pressed together to form a joint. Each cooled joint can be slightly compressed to provide fluid communication between the joined sections of the tube.

A second alternative to the use of a hematron device to obtain a permanent seal in a fully contained manner is illustrated by FIGS. 20 and 21. Second
Figure 0 shows mounting blocks 160 and 161;
The mounting blocks each have partial slots 162, 164, 166 and 16 machined therein.
8 and 163, 165, 167 and 169. The slots are similar to those shown in FIGS. 1-4, except that there are four slots in each block. Sealed end 175 of tube 170 is inserted into slots 164 and 165. Sealed end 174 of tube 171 is inserted into slots 166 and 167. Each has both sealed ends (1
62, 163 and 176, 177) are inserted into the slots 162, 163 and 168, 169. A hot cutting means is passed through the tube piece; the tubes are aligned with the desired areas facing each other (FIG. 21), the cutting means is removed, and the fused ends are pushed tightly together. Being forced. As a result of this operation, tube end 174 of tube 171 and tube end 175 of tube 170 are joined to sealed tube end 177 and sealed tube end 162, respectively, to provide a permanent seal of ends 174 and 175. When using either of these alternative modes, preferably a cam operated unit is utilized.

“Seal” is the closure of a tube end; “connection” means a welded joint that holds two tubes together; and “temporary” means a closure if the operator so desires. , meaning that the seal can be opened with light force, i.e. 1-2 pounds, but otherwise the seal will remain closed. “Temporary seals” may have pinholes. “Fluidtight Temporary Seal”
Temporary seal means that it has no pinholes and does not allow fluid to enter or exit. A "stump end" is a tube end that is not intended to be joined. Approximately 1.0mm (40mil) and approximately 2.0mm
(80 mils), preferably between gaps of about 1.5 mm (60 mils). That is, a pinhole-free temporary seal can be obtained after the cutting means have been withdrawn. However, some of the fluid may exit before it is withdrawn.

In the device of the invention, a dialysis solution container having a transfer port containing a segment of the tube is coupled to a tube extending from an implanted catheter opening into the patient's peritoneal cavity. It can form part of a sterile connection system for continuous ambulatory patient subject peritoneal dialysis. In this aspect of the invention, the patient tube and/or transfer tube can have an entry port with a protective cover or a sealed distal end, but preferably both are sealed. It has a far end. This system minimizes the possibility of peritonitis and allows other treatment bags, such as antibiotic, bacteriostat, or other pharmaceutical bags, to be connected as desired. Furthermore, this embodiment has the added advantage of eliminating the need for the patient to carry an empty dialysis solution bag. This is because the bag can be sterilely disconnected using the device of the present invention by melting the tube and heat sealing both the patient tube and the bag tube. In this manner, the second tube is not placed within the tube slot.
The freshly separated tube is allowed to cool and then permanently sealed, if desired, by the use of a hematron device. This embodiment also eliminates the need for current labor-intensive processes used to achieve sterility.

In another embodiment, the device of the invention forms part of a sterile connection system for connecting two blood bags. One of the bags can be a donor bag and the other can be a transfer bag. The donor bag will have a blood collection tube and
A transfer port may optionally have a transfer tube. The transfer bag has a transfer tube (connection tube). The two bags may be sterilely connected by mating the transfer bag's connection tube to the donor bag's transfer port. The donor bag transfer port can be a conventional inlet port, such as an inlet port having a protective cover and a septum inside the port.
The bags may also be connected by joining the blood collection tube of the donor bag to the connection tube of the transfer bag.

In a preferred embodiment for both the blood bag system and the CAPO system, the donor bag and the dialysis bag include an additional tube (pigtail) with a distal end that is unconnected and sealed, especially for sterile connections. have The term "unconnected" as used herein indicates that the tube does not have any conventional fittings such as plastic fittings with diaphragms, low melting point thermoplastic inserts, inserts that can be fused by radiant energy, etc. means. The tube has a sealed distal end made only by sealing the tube ends together by the use of a hot solvent or the like.

In the system of the present invention for aseptic connection of blood bags, the need to pre-install the bags in the system is eliminated. As used herein, the expression "blood bag" collectively refers to either a donor bag or a satellite bag. The invention allows accessory bags to be sterilely connected to supplier bags as required. Donor bags can be manufactured from wet sterilizable materials such as polyvinyl chloride, whereas accessory bags do not have to be wet sterilizable, but rather can be made by dry sterilization means such as irradiation or ethylene oxide treatment. It can be manufactured from materials that can only be sterilized by hand. For example, the accessory bag can be constructed from O ₂ permeable polyethylene to increase platelet viability. Alternatively, the accessory bag can be made from polyethylene copolymer, polyethylene laminate, polypropylene, or other materials that are compatible with the materials of which the donor bag is constructed. The accessory bag can be made of a material that is incompatible with the material that makes up the donor bag, so long as the tube to which it is connected is made of a compatible material. For example, the donor bag and its tube can be manufactured from polyvinyl chloride, whereas the accessory bag can be manufactured from polyethylene, the tube can be manufactured from polyvinyl chloride, and the accessory bag can be manufactured from polyethylene. Can be solvent welded to the bag. Techniques for solvent welding are well known in the art. Ancillary treatments can be added aseptically and cleaning to remove treatment agents can be performed aseptically. Some practitioners
We believe that by washing red blood cells without prior freezing, we can reduce the risk of hepatitis.

The sterile connection device of the present invention can also be used to provide a system for manufacturing sterile, non-autoclavable body fluid containers having wet-sterilized (autoclaved) liquids therein. The present system is similar to the system described in US Pat. No. 4,223,675; however, the device of the present invention eliminates the need to have a specific connector attached to the tube.

The present invention can be used to produce dry sterilized packages from synthetic resin materials that are unsuitable for being subjected to wet sterilization conditions, but are particularly suitable for long-term storage of body fluids. The autoclavable liquid is placed into an autoclavable dispenser with an access tube that can then be closed by heat sealing. The dispenser package and liquid can then be wet sterilized in an autoclave. The dispenser package is then aseptically connected to a dry sterilized container by using the apparatus and method of the present invention. The dry sterilized container may include a connector-free tube with a sealed distal end, which tube is specifically for aseptic connection. After the sterile connections are made, the autoclaved liquid is transferred to a non-autoclavable dry sterilized container. 2 as desired
The two containers are melted through and heat sealed using the apparatus of the invention so that each container is left with a tube without a connector with a sealed distal end. can be separated into Other packages can be connected to either container by a subsequent sterile docking operation. The autoclavable liquid can be an anticoagulant and the autoclavable dispenser package can be constructed from polyvinyl chloride. The non-autoclavable container can be a blood bag constructed from materials such as those described above in this specification.

The method of the invention for joining two thermoplastic tubes transversely to the axis of each tube can be carried out using, but is not limited to, the particular embodiments of the apparatus of the invention described above. . As used herein, transverse;
means that the axis of each tube is crossed (crosswise).
, but not necessarily at right angles to the axis. The tube can be flattened in horizontal, vertical or diagonal planes; however, diagonal planes are conveniently preferred when using controller operated cam cylinder units and copper Laminated cutting elements are described herein.

FIG. 22 shows a tube mounting block 180 designed to flatten the tube in an oblique plane.
and 182 will be explained. The tube mounting blocks 180, 182 are attached to the tube holder base 183,
184 includes covers 185, 186 pivotally mounted at hinge points 190, 192.
Slots 183a and 183b are for mounting block 1.
80 and slots 184a, 184
b is provided on a mounting block 182 for holding the tubes to be joined. The ends of the inner facing slots 183a, 183b and 184a, 184b are respectively connected to the jaws 19.
3 and 194. The jaws 193 have flat surfaces 193a, 193b, and the jaws 194 have flat surfaces 19 for flattening the tube when the upper and lower halves of each mounting block are closed.
4a and 194b. Mounting block 182
The cover 186 has flat surfaces 194a, 194b.
flat surfaces 196a, 19 for cooperating with
6b has a corresponding jaw 196. Cover 185 is similarly equipped. Jiyo's flat surface is at an angle of approximately 35° with the horizontal plane.

The inner surfaces of covers 185, 186 are flat. The covers 185, 186 act against the rollers 183d, 18 of the bases 183, 184 when the covers are closed creating a force sufficient to flatten the tube.
cam portions 185c and 186, each pivoting on a pivot, fit over 4d;
It has c. Pivoting cam portion 186c is held in an up-position about its pivot by friction created by a spring washer (not shown) inserted into pivot hinge 188. Pivot cam portion 185c is similarly shaped. When the mounting block begins to close and the cover flattening jaw contacts the tube, the covers 185, 186 no longer pivot freely, so that the cam portions 185c, 186c begin to pivot and the base 183 , 184 rollers 183d, 184d
begin to engage. Pivot cam surface 185d, 1
As 86d engage the rollers, they pull the cover jaws down against the tube, flattening the tube against the lower jaws 193,194. When the cam portions 185c, 186c are pivoted sufficiently, the tube is fully flattened and the rollers are fully engaged to hold the mounting blocks 180, 182 closed.

The cutting means can be forced through the flattened tube in a transverse direction, regardless of the surface flattening the tube. Using the method of the invention, tube ends resulting from the "melting through" step and not intended to be connected are preferably temporarily sealed fluid-tightly, thereby closing them. Eliminates the need to shut clamp or connect closed stump tube ends to them. A permanent seal is then obtained by the use of a hematron device or by a 180° rotation of one of the mounting blocks instead of a transition for alignment.

In the method of the invention, occlusion inside the joined tubes is eliminated and subsequent connections can be made at the same location on the tubes. The latter feature provides another aspect of the invention.
CAPD patients have surgically implanted silastic catheters with external titanium connectors to which are attached polyvinyl chloride tubes with spikes (administration sets). PVC tubes need to be replaced approximately once a month. This replacement presents a potential source of infection of the peritoneum.

In the present invention, titanium connectors are made from a thermoplastic resin such as polyester, polyurethane or polypropylene which are connected to the silicone catheter 205 and polyvinyl chloride tube 207 by suitable plastic fittings 202, 203. Weldable connector 2
00 (see FIG. 24). Replacement of a dosing set can be accomplished by using the method of the present invention to connect a new dosing set. Referring to FIG. 23, the new set, prior to connection, has an end 209 with a fitting that connects a sealed tube of selected thermoplastic and is then reweldable to the silastic catheter. 211 of the connector in a sterile manner. Using the method of the present invention, a catheter can have its reweldable connector end thermally sealed when implanted, and the administration set can have its reweldable connector end thermally sealed by utilizing the present invention. Can be connected.

The devices and methods of the invention are also useful in other peritoneal dialysis treatments, such as intermittent peritoneal dialysis (IPD), continuous cycle peritoneal dialysis (CCPD), and other treatments that use the peritoneum.
can be used advantageously in
and can be used in the manufacture of sterile medical supplies and other sterile packaging processes. IPD is a mechanically automated peritoneal dialysis in which the dialysate is prepared from a concentrate and then delivered to the patient over a predetermined period of time with mechanical control of flow and residence times. CCPD is a mechanically automated peritoneal dialysis in which peritoneal fluid exchange occurs automatically at night and the abdomen is full during the day.

Conventional urine drainage involves an in-dwelling urinary catheter introduced into the body.
A catheter is placed in the bladder/urethra to create a temporary anatomic or physiological urinary obstruction.
urological surgery
or enable accurate measurement of urine output in patients with severe medical conditions. The catheter is connected to a drainage tube, and the drainage tube is connected to a urine drainage bag, which is typically used for drainage three times a day.
accessed twice.

Urinary tract infections are a major risk associated with current urine excretion processes and there is a strong requirement for sterile access. The device of the present invention satisfies that need. The device of the present invention can be used for sterile access for bag removal or replacement and irrigation when used with suitable disposables. The drainage system for this use is a drain tube connected to a low cost disposable drain bag.
Foley catheter connected to a Foley catheter, especially a tube without a connector for sterile connection and an additional disposable drainage bag with a sealed distal end; cleaning bags and syringes having one end and a tube without a connector;
and a sterile connecting device. Instead of draining the bag three times a day, a used drainage bag can be aseptically disconnected and a new bag can be aseptically connected three times a day. For this embodiment, the device of the present invention can be used in a total containment mode.
containment mode).

One example of another sterile packaging in which the apparatus of the invention may be advantageously used is the packaging of sterile milk and fruit juices.
In modern commercial manufacturing, the contents and packaging are sterilized separately and then combined in a sterile packaging system. The package also includes a drinking straw. Consumers have encountered difficulties in opening the package and using the drinking straw incorporated therein.

Using the device of the invention, the container can be a polyethylene bag with a tube as a drinking straw. During the packaging operation, the straw can be temporarily sealed aseptically by the device of the invention. The package can be opened for drinking by applying finger pressure to force the sterile temporary seal to open.

The invention will be further illustrated by the following examples. All temperatures are in degrees Celsius and all percentages are by volume unless otherwise noted.

EXAMPLE The devices used were cam-operated devices such as those described herein with respect to FIGS. 10-12, and each were approximately 1-1/8 inches by 1.5
inch (3.81 cm) by 0.75 inch (1.9 cm) and each has a pair of stainless steel tube mounting blocks that are hinged in half so that they can be opened. In the bottom half of each mounting block there are two slots for holding the tubes to be welded, the two slots are 0.31 inch (0.79 cm) apart center to center and 0.21 inch (0.5 cm) wide. and 0.21 inch (0.53 cm) deep. At the adjacent end of each mounting block and located 0.05 inch (0.13 cm) from the slot is a 0.06 inch (0.15 cm) wide jaw for flattening each tube symmetrically about the round tube axis. It was hot. Opposing sides of these jaws on adjacent mounting blocks were approximately 0.05 inches (0.13 cm) apart. The top half of each mounting block has a mating 0.06 inch (0.15 cm) wide flattened jaw adjacent to a flat surface that pivots to form a cover over the open tube slot when meeting the bottom half. Was.

One mounting block was stationary, while the other could pivot in two orthogonal directions. Laminated welded wafer (cutting means), 0.50
inch (1.27cm) height and 1.35 inch (3.43cm)
length and 0.012 inch (0.03 cm) thickness was pivotably held below a tube slot having dimensions of 0.012 inch (0.03 cm) centered with a 0.05 inch (0.13 cm) gap between the mounting blocks. . The wafer was firmly supported by three edges. Electrical contacts engaged resistor contact pads exposed on one side of the wafer.
The wafer was heated by a constant 1.35 amp DC source.

215 mils (5.5mm) for each joint made
Two sections of plasticized polyvinyl chloride having an outside diameter and a wall thickness of 32 mils (0.81 mm) were pressed into the slot. The mounting block was closed, thereby flattening each tube in the area of the jaw.
Activated the wafer. The temperature is approximately 271° (520°
〓) (after about 5-8 seconds), the wafer is pivoted up about 0.4 inches (1.02 cm) while the current continues to power the wafer while flattening both sides. The tube was melted through. The movable block is then pivoted about 0.31 inches (0.79 cm) to align the tubes to be joined. The wafer is then pivoted while the movable block is pivoted approximately 0.35 inches (0.89 cm) toward the fixed holder to squeeze together the molten tube ends to be joined. I was forced to descend. The wafer current was stopped when it reached the lowered position. The time for raising the wafer and for the movable block to align the ends to be joined and for the wafer to return to its lowered position while squeezing the ends together was approximately 3.0 seconds. The joined tube ends were then allowed to cool for at least about 5 seconds before they were removed from the holder. The flat tube joint was then popped by manually squeezing the joint between the fingers.

The wafer was replaced for each joint. The bonded tubes had approximately 70% of their original strength when pulled under tension and did not leak.

Twenty joints were made using the apparatus and method described above. The tubes used in the forward slots were 12 inches (30.5 cm) long and were approximately 60% filled with nutrient solution for bacterial growth. The tube was closed at both ends by heat sealing with a hematron device and the inside was sterile. The outside of each tube was coated with Bacillus circulans spores. Seventeen of the tubes used in the rear slots were 6 inches (15.2 cm) long, half full of nutrient solution, heat sealed at both ends, and sterile on the inside. The other three tubes were 12 inches (30.5 cm) long, 60% filled, and otherwise the same. Any of the tubes used in the rear slots were coated with bacteria.

For each joint, the tube was placed into the mounting block in the same manner. Each of the two tubes for each joint was oriented with the end of the air-containing tube to the right (the mounting block was similarly positioned in the orientation shown in FIG. 22). Cut the tube at the site of amputation.
severance) is approximately 3.5 inches (8.9 cm) from the right edge of the rear tube and 4.5 inches (8.9 cm) from the right edge of the front tube.
inch (11.4cm). A column of liquid was placed in the path of the wafer in each tube. The left mounting block was closed first, then the right mounting block. This resulted in an internal initial pressure of approximately 2 psig at the weld site.

After the joints were formed, they were squeezed to break the temporary seal holding the tubes flat at the weld, thereby providing fluid communication between the two tubes for each joint. The joined tubes were then incubated at 35° for 4 days. All of the bonded tubes so incubated showed no evidence of contamination of their interior with bacteria. The presence of bacteria is
If present, it was present in the growth medium and indicated by an indicator showing a color change when bacteria were present.

[Brief explanation of drawings]

FIG. 1 is a plan view of the mounting block used to hold the two tubes to be joined in the starting position. FIG. 2 is a plan view of two tubes separated by hot cutting means. FIG. 3 is a plan view of the two tubes being repositioned and aligned opposite each other. FIG. 4 is a perspective view of the mounting block, cutting means and welded tube. FIG. 5 is a perspective view of the mounting block slidably attached to the guide. FIG. 6 is a perspective view of the cutting means with the mounting block and block heater slidably mounted on the guide. FIG. 7 is a perspective view of the mounting block fixedly arranged within the housing. FIG. 8 is a perspective view of the welded tube still with a temporary seal. FIG. 9 is a perspective view of the welded tube with the temporary seal broken. 5 to 7 belong to one embodiment of the present invention. FIG. 10 is an isometric view of the automatic sterile connection device of the present invention. 11 is a partially cut away isometric view of the driven cam used to move the mounting block and cutting means of the sterile connection device of FIG. 10; FIG. Figure 12 is the 11th
12 is a cross-sectional view taken along line 12-12 of the figure; FIG. 13th
The figure is an isometric view of a mounting block used in the apparatus of FIG. 10. Figures 14a and 14b are top and side views of another embodiment of the device of the invention. FIG. 15 is a perspective view of the apparatus of FIG. 14.
FIG. 16 is a perspective view showing details of arms 126 and 129. FIG. 17 is a plan view of the arm 126 with the two tubes cut by the hot cutting means. FIG. 18 is a plan view of the block 137. FIG. 19 is a plan view of the mounting block with the left block rotated 180 degrees. 20 and 21 are top views of mounting blocks each having four slots. FIG. 22 is a perspective view of another embodiment of the mounting block. FIGS. 23 and 24 are cross-sectional views of a reweldable connector for a Shilastayk catheter. In the figure, 10, 11... blood bag, 1
3, 14, 15, 16... Partial slot of mounting block, 17, 18... Mounting block, 2
0, 21... Thermoplastic tube, 34... Hot cutting means, 45, 46, 47... Guide, 48... Stopping block, 52... Spring, 55
...Block heater, 56 ...Housing, 60
... Sterile connection device, 62 ... Housing, 64 ...
... Cutting mechanism, 66, 68 ... Mounting block, 72 ... Cam cylinder, 85 ... Heating element, 102 ... Housing, 114, 115 ...
Mounting blocks, 114a, 114b, 115
a, 115b...tube slot, 103...
Switch, 104...Cover, 126...Arm, 129...Arm, 160, 161...Mounting block, 162, 163, 164, 165,
166, 167, 168, 169... Partial slot, 170, 171... Tube, 180, 18
2...Mounting block, 183a, 183b, 1
84a, 184b...Slot, 185, 186
...Cover, 185c, 186c...Cam part.

Claims (1)

[Scope of Claims] 1. A method of joining thermoplastic closed-ended tubes to each other across the axis of each tube, comprising: (a) flattening the area of each tube to form an inner wall of each tube; (b) passing said flattened area of each tube through hot cutting means and providing a fused tube end; (c) aligning the tubes to be connected with each other; (d) said joining the desired molten ends of the tubes together to form a joint between the tubes for each pair of tube ends to be connected; (e) cooling each joint; A method comprising applying stress to a portion of the tube to open a temporary seal in each tube, thereby providing fluid communication between the joined tubes. 2. A method for forming a sterile connection between a first closed-end tube and a second closed-end tube formed from a thermoplastic resin, comprising: (a) a flattened close-fitting tube; (b) an edge of the hot cutting means having a substantially flat surface is in contact with the cutting means; through the flattened portion of each tube at such a rate that the thermoplastic resin forming the tubes melts, thereby temporarily sealing the inner walls of each tube together and melting the tubes. (c) aligning the tubes with each other; (d) pressing the desired fused tube ends together to form a joint between the tubes; and (e) forming a joint between the tubes. A method comprising cooling and then stressing the joint to open a temporary seal in each tube, thereby providing fluid communication between the joined tubes. 3. A device for forming a sterile connection between thermoplastic tubes, comprising cutting means, means adapted to heat the cutting means, and receiving, holding and flattening the tubes to be joined. a pair of mounting blocks adapted to accommodate the tube, and movement between the blocks and the cutting means into a position such that the cutting means is between the blocks and traverses where the blocks are adapted to receive the tube. for each pair of tubes to be joined, means adapted to realign the blocks to a position in which the two different tube ends are mutually aligned and facing each other; Apparatus comprising means for separating the blocks and said cutting means and means for pressing said mounting blocks together. 4. A device for forming a sterile connection between thermoplastic tubes, comprising cutting means, means adapted to heat the cutting means, and receiving, holding and flattening the tubes to be joined. a pair of mounting blocks adapted to accommodate the mounting blocks; and means for moving the mounting blocks into first, second and third positions, the cutting means being between the mounting blocks in the first position; The block is relatively displaced in the second position to align two mutually opposite tube ends for each pair of tubes to be joined; Apparatus separated from said cutting means in a third position and comprising means for pressing said mounting blocks together when in said third position. 5 A sterile connection system for continuous ambulatory patient peritoneal dialysis in which a dialysis solution container having a transfer port including a segment of the tube is coupled to a tube extending from the patient's peritoneal cavity, the transfer tube and the patient's a pair of mounting blocks adapted to receive, retain and flatten the tube; cutting means; and means adapted to heat the cutting means;
means for imparting movement between said blocks and said cutting means to a position such that said cutting means is between said blocks and traverses where said blocks are adapted to receive said tubes; means for realigning the blocks to a position in which the different tube ends are mutually aligned and facing each other; means for separating the blocks and the cutting means; and means for pressing the blocks together. Improved sterile connection system. 6. A sterile connection system for joining two blood bags, each bag having a tube that can be used for connection, and a sterile connection being made by joining the tubes. a pair of mounting blocks adapted to receive, hold and flatten the tube to be cut, cutting means, means adapted to heat the cutting means, the cutting means being located between the blocks; and means for imparting movement between said block and said cutting means to a position such that said block intersects at a point adapted to receive said tube, and the resulting two different tube ends to be joined are mutually aligned. and means for re-aligning the blocks to a mutually facing position; means for separating the blocks and the cutting means; and means for pressing the blocks together. system. 7. A sterile connection system for urine drainage, wherein the first drainage container is connected to a drainage tube extending from a catheter implanted in the patient's urethra, the sterile connection system comprising: (a) (b) a second drainage container having a tube without a connector for a sterile connection and having a sealed distal end, both containers being disposable; and (b) a connection between the drainage tube and the connector. a pair of mounting blocks adapted to receive, hold and flatten the tube, cutting means, means adapted to heat the cutting means, the cutting means being between the blocks and the means for imparting movement between said block and said cutting means to a position such that the block crosses where it is adapted to receive said tube, and the resulting two different tube ends to be joined mutually. improved sterility by comprising means for realigning the blocks into a position aligned and facing each other; means for separating the blocks and the cutting means; and means for pressing the blocks together. connection system. 8. A reweldable connector system for continuous ambulatory peritoneal dialysis in which a Silastic catheter is surgically implanted in the peritoneal cavity of a patient, comprising: (a) the catheter; ) a polyvinyl chloride tube optionally with spikes, and (c)
a thermoplastic connector tube having a threaded end, the connector tube being sterilely connected to the catheter at one end and to the polyvinyl chloride tube at the other end; (d) having a spike at one end; and a polyvinyl chloride tube having a connector tube portion at the other end, the connector tube portion being sealed at its distal end by fusion of the materials; (e) the thermoplastic connector tube and the a pair of mounting blocks adapted to receive, retain and flatten the thermoplastic connector tube portion; (f) cutting means;
(g) means adapted to heat the cutting means; and (h) the cutting means is between the blocks and the blocks are adapted to receive the thermoplastic connector tube and the thermoplastic connector tube portion. means for imparting movement between said block and said cutting means to a transverse position where said connector tube ends are aligned and facing each other; , a reweldable connector system improved by including means for separating said block and said cutting means and means for pressing said blocks together. 9. A Silastek catheter for continuous ambulatory patient peritoneal dialysis, comprising a thermoplastic connector tube aseptically attached to the Silastek catheter at one end of the tube, the other end of the tube being connected to the material. Improved silastic catheter by being sealed by fusion of. 10. A dosing set for continuous ambulatory patient peritoneal dialysis, comprising a polyvinyl chloride tube optionally having a spike at one end and connected to a thermoplastic connector tube at the other end by a fit, An improved administration set wherein the thermoplastic connector tube is aseptically sealed at its distal end by fusion of the material.