Medical fluid container forming system and method

Abstract

The present application discloses a plurality of medical fluid container embodiments comprising: a container forming machine comprising an upper mold and a lower mold, each mold having a separately mounted mold; a control scheme for a container forming machine having a cycle time settable by a user; a container forming apparatus and a method of simultaneously sealing a container and a port tube within the container; and a fragile forming machine including a rotating carousel having a plurality of stations to perform different fragile forming steps.

Description

[0001] This application is a divisional application of the Chinese invention patent application filed on January 30, 2019, with application number 201910093412.7 and invention name “Medical Fluid Container Molding System and Method”. Technical Field

[0002] The present application relates generally to the field of medical fluid containers, and more particularly to a medical fluid container molding system and method. Background Art

[0003] Due to disease or other reasons, a person's renal system may fail. In renal failure of any cause, many physiological disturbances are present. The balance of the daily metabolic load of water, minerals and excreta is no longer possible in renal failure. During renal failure, toxic end products of nitrogen metabolism (urea, creatinine, uric acid, etc.) may accumulate in the blood and tissues.

[0004] Kidney failure and reduced kidney function are treated with dialysis. Dialysis removes waste products, toxins, and excess water from the body that should be removed by properly functioning kidneys. Dialysis treatment to replace kidney function is vital to many people because the treatment is life-saving. People with failing kidneys cannot survive without replacing at least the filtering function of the kidneys.

[0005] Peritoneal dialysis is a type of dialysis therapy that is commonly used to treat loss of renal function. Peritoneal dialysis uses a dialysis solution that is injected into the patient's peritoneal cavity through a catheter implanted in the cavity. The dialysate contacts the patient's peritoneum in the peritoneal cavity. Waste, toxins, and excess water pass through the peritoneum from the patient's bloodstream and enter the dialysate. Due to diffusion and osmosis, waste, toxins, and water are transported from the bloodstream to the dialysate, that is, an osmotic gradient occurs across the peritoneum. The used osmotic fluid is discharged from the patient's peritoneal cavity to remove waste, toxins, and excess water in the patient's body. The above cycle is repeated.

[0006] There are multiple peritoneal dialysis (PD) therapies, including continuous ambulatory peritoneal dialysis (CAPD), automated peritoneal dialysis (APD) and continuous flow peritoneal dialysis (CFPD). CAPD is a manual dialysis treatment, in which the patient connects the implanted catheter to a drain and allows the dialysate after use to be discharged from the peritoneal cavity. Then, the patient manually allows fresh dialysate to flow through the patient's indwelling catheter from the solution bag and enter the patient's peritoneal cavity. Then, the patient can disconnect the catheter from the solution bag and allow the dialysate to reside in the peritoneal cavity to deliver waste, toxins and excessive water from the patient's bloodstream to the dialysis solution. After the residency cycle, the patient repeats the above manual process. In CAPD, the patient performs multiple drainage, filling and residency cycles in one day, for example, about four times a day.

[0007] Automated peritoneal dialysis (APD) is similar to CAPD in that dialysis treatment includes drain, fill, and dwell cycles. However, an APD machine automatically performs three to four cycles of peritoneal dialysis treatment, usually at night while the patient sleeps. The APD machine is fluidly connected to an implanted catheter, to one or more solution bags, and to a drain bag.

[0008] The APD instrument pumps fresh dialysate from a dialysate source into the patient's peritoneal cavity through a catheter, and allows the dialysate to reside in the cavity so that the transfer of waste, toxins, and excess water from the patient's bloodstream to the dialysis solution can occur. The APD instrument then pumps spent dialysate from the peritoneal cavity to a drainage device through a catheter. The APD instrument is typically computer controlled so that dialysis treatment occurs automatically when the patient is connected to the dialysis instrument, for example, while the patient is sleeping. That is, the APD system automatically and sequentially pumps fluid into the peritoneal cavity, allows it to reside, pumps fluid out of the peritoneal cavity, and repeats the process.

[0009] As with manual treatment, multiple drain, fill, and dwell cycles will occur during APD. The "last fill" is typically used at the end of APD, when the patient is separated from the dialysis machine during the day, and it remains in the patient's peritoneal cavity. APD relieves the patient from having to manually perform the drain, dwell, and fill steps.

[0010] As mentioned above, both CAPD and APD involve the use of solution bags and drain bags. Preparing such bags requires a great deal of care and skill. The bags must not leak and must be within certain specifications. The solution bags must also be sterilized to a certain level so that the solution can be safely delivered to the patient. The bags must also be properly labeled so that the user or caregiver can be sure that the patient is receiving the correct PD solution.

[0011] Historically, PD solution bags are made of polyvinyl chloride (PVC). However, in some jurisdictions, PVC is prohibited from being used to manufacture solution bags or tubing for delivering fluids to or from patients. For this reason, non-PVC films and tubing have been developed. However, applying these films and tubing in practice has proven to be difficult. PVC is generally easier to use than non-PVC materials. There are many processing variations for non-PVC materials that must be implemented, optimized, and validated for regulatory purposes.

[0012] In the form, fill and seal of PVC and non-PVC solution bags, bag forming is probably one of the most critical processes. Complicating the issue is the fact that PVC and non-PVC materials can vary from manufacturer to manufacturer and even from batch to batch from the same manufacturer. Therefore, a method is needed to ensure the correct forming of solution bags when the raw materials vary. Summary of the invention

[0013] The present disclosure provides an improved medical fluid container, system and method of manufacturing the same. In one embodiment, the medical fluid container includes a medical fluid solution bag, such as a peritoneal dialysis solution bag, and a medical fluid drain bag, which are connected by a tube. In one embodiment, the drain bag is made of polyvinyl chloride ("PVC"), and the solution bag is made of PVC or a material other than PVC ("non-PVC"). An overpouch is provided to hold the medical fluid or PD fluid group together, including a non-PVC solution bag, a PVC drain bag, and a tube connecting the two bags.

[0014] In particular, in a main embodiment of the present disclosure, a solution bag forming system and method are disclosed. The bag forming system includes a bag forming machine having an upper mold and a lower mold. Each of the upper mold and the lower mold includes a plurality of (e.g., three) mating dies for simultaneously forming a plurality of solution bags. If the solution bag is made of PVC, the bag forming machine performs high frequency or ultrasonic welding to seal two PVC sheets together using the mating die. If the solution bag is made of a non-PVC material, the bag forming machine supplies heat to the mating die and thermoforms the two non-PVC sheets together. In either case, it is contemplated that the bag forming machine provides a positioner on each of the upper mold and the lower mold, which holds each mold in a desired position and enables each mold to be separated from each other.

[0015] It is desirable to provide the dies separately from one another. Providing the dies separately allows any die to be removed individually and replaced or repaired if damaged without handling or removing the remaining dies. If the dies were molded together, they would have to be removed together, and if any die were permanently damaged, the entire integral die would have to be discarded. It is also desirable to keep additional replacement dies available to replace any individual die removed for repair or replacement, thereby minimizing downtime.

[0016] Providing the dies separately also allows each die to be leveled individually. Unlike having to level multiple dies together to achieve the best overall result for multiple integrated dies, each die of the present disclosure can be optimized individually. In one embodiment, each die of the present disclosure is secured in place by a plurality of leveling screws (e.g., four leveling screws). Each of the plurality of leveling screws is adjusted so that each die can be leveled in multiple directions. In an alternative embodiment, shims are used instead of leveling screws. The upper die is adjustably secured to the upper plate, and the lower die is adjustably secured to the lower plate.

[0017] Providing the dies separately also allows each pair of upper and lower dies to be spaced apart from each other by a minimum gap. When the upper and lower dies are brought together to form a seal, the dies generally do not touch each other, but leave some space for the thickness of the material. Also unlike achieving the best overall result for multiple integrated dies, each die of the present disclosure can be optimized in position to generate an optimized or minimized gap. The smaller the gap between the upper and lower mating dies, the more efficient the energy transfer from the die to the solution bag sheet.

[0018] While the dies of the present disclosure are ideally separate, the present disclosure also contemplates forming multiple bags from a single pair of large PVC or non-PVC sheets such that the bags abut one another. In this manner, (i) no material is wasted between the bags after they are separated, and (ii) a single slit or cut forms the edges of the two bags, one on each of the two bags, so that no further cutting or slitting of those edges is required. In order for the bags to abut one another, the two adjacent dies also need to abut one another along the common seam between the two bags.

[0019] In order to allow (i) individual moulds for individual solution bags and (ii) bags to abut against each other, it is conceivable to provide (e.g., fasten) retainers on the respective plates of the upper and lower moulds, wherein the retainers hold the corners of the moulds so that the respective moulds can be easily removed and replaced from their proper positions. The retainers also allow the mounting holes to be easily found and ensure that adjacent moulds abut against each other when the moulds are inserted for operation.

[0020] As mentioned above, PVC solution bags are high frequency or ultrasonic welded, while non-PVC solution bags are thermoformed. In either case, the energy supplied must be optimized for a specific brand or manufacturer of PVC or non-PVC material, and in some cases for different batches of PVC or non-PVC material from the same manufacturer. Typically, the variable to be optimized is the amount of ultrasonic energy or the amount of thermal energy. However, in some cases, simply varying the amount of energy will not produce the best results. For example, increasing the energy above a certain level to provide a proper seal may become too expensive and inefficient to achieve the desired results.

[0021] In a second major embodiment, it is desirable to provide a medical fluid container or solution bag forming system and method that alternatively or additionally allows the cycle time to be changed at the control unit of the medical fluid container or solution bag forming machine. The cycle time can be the time between two identical actions or processes. For the forming of the bag, the cycle time is considered to be the time between (i) when the PVC or non-PVC material begins to move toward the upper mold and the lower mold and when the same material area leaves the mold with the formed bag, or (ii) when the upper mold and the lower mold are brought together. In either case, it may occur, for example, that the cycle time is not enough for the mold to reach the desired temperature. The system and method of the present disclosure allow the operator to adjust the cycle time to optimize the bag forming process.

[0022] If it is found that one or more molds cannot consistently reach the desired temperature and / or the energy level must be increased to a very high level to get the mold to the desired temperature, the operator can slow down the cycle time. If it is found that the molds can reach the desired temperature even at a low energy level setting, the operator can speed up the cycle time. The adjustable medical fluid container cycle time of the present disclosure allows the operator to adjust the cycle time based on material differences between different manufacturers and between batches of material from the same manufacturer.

[0023] PVC and non-PVC solution bags all have filling port tubes and sample port tubes. In the past, these port tubes were welded in place at different workstations of the whole bag forming operation. In the third main embodiment, it is expected that in the bag making system and method of the present disclosure, the port tube seal is formed while the main bag is sealed. In one embodiment, the filling port tube and the sample port tube are preheated. Then the preheated filling port tube and the preheated sample port tube are positioned and sealed to one of (i) PVC or non-PVC solution bag sheets, or (ii) between two PVC or non-PVC solution bag sheets. Then the solution bag main seal is applied using, for example, the mold and mold mentioned before. As mentioned above, high frequency or ultrasonic welding is used to perform PVC solution bag and port tube sealing in one embodiment, and heat is used to perform non-PVC solution bag and port tube sealing. Then the complete solution bag with filling port tube and sample port tube is cooled (for example, by water cooling). The port tube sealing of the present disclosure avoids producing secondary energy impact to the solution bag sheet when the port tube is sealed separately, thus reducing the risk of leakage.

[0024] As described below, the frangible on the fill port tube is already in place. Then, after cooling, the solution bag only needs to receive an injection site in the sample port before being stacked and transported to a filling machine or before being transported along a conveyor to a filling station in a form, fill and seal machine. In either case, the bag making process of the present disclosure eliminates multiple manual steps associated with current bag making processes while also improving the effectiveness of quality process control.

[0025] As described above, both PVC and non-PVC solution bags have a fill port opening that accommodates a frangible. A frangible is a valve of various types that is opened by a patient or caregiver to allow a medical fluid (e.g., peritoneal dialysis ("PD") fluid) to flow from the solution bag to the patient. Frangibles for PVC and non-PVC solution bags include a hard plastic destructible portion and a fill port tube that is at least partially inserted into the hard plastic destructible portion. The frangible can then be connected to one or both of the fill port opening of the solution bag and the fill line of the disposable device, which in the PD example leads to the patient's indwelling catheter for filling or draining the patient's peritoneal cavity.

[0026] In a fourth main embodiment, a turntable frangible assembly system 210 is provided with multiple stations to prepare frangibles for subsequent insertion into solution bags or medical fluid containers. In one embodiment, the turntable of the frangible assembly system has eight stations, seven of which include assembly steps and one is free. The guide plate carries eight frangible holders. Each frangible holder holds a plurality of frangibles (e.g., twelve frangibles). The machine rotates or guides the guide plate so that each frangible holder stops at eight different locations around the turntable.

[0027] At the first station of the turntable, a breakable object holder receives a plurality of hard plastic breakable portions of a breakable object. In one embodiment, the holder holds the hard plastic breakable portion by a portion of the hard plastic breakable portion that is not inserted into the breakable tube. The portion of the hard plastic breakable portion that is inserted into the breakable tube extends outwardly from the holder. The breakable object breakable portions are held in an auger in one embodiment that feeds the breakable portions to a breakable portion insertion station that grabs the breakable portions in the proper orientation and inserts the portions (e.g., twelve portions) simultaneously into the holder.

[0028] In one embodiment, the second station of the turntable is an open position. At the third station of the turntable, in one embodiment, the breakable portions are adjusted or straightened so that they can properly receive adhesive and breakable tubes at subsequent stations. The adjuster or straightener may include a thickened rod, such as aluminum, that includes a series of holes or bores (one hole or bore for each breakable portion). The rod translates over the breakable portions, straightening and aligning the portions in an orderly and evenly spaced manner.

[0029] At the fourth station of the turntable, adhesive is applied to the breakable portion of the breakable object. In various embodiments, the adhesive for the PVC breakable object is cyclohexanone, while the adhesive for the non-PVC breakable object is cumene or isopropyl alcohol. In one embodiment, the adhesive applicator (i) is lowered to collect the adhesive and move the next bracket into position, and then (ii) is raised so that the multiple adhesive application pads each receive the lower half of each breakable portion of the breakable object to apply adhesive thereto. In one embodiment, the bracket includes an internal structure for rotating each breakable portion of the breakable object within the adhesive application pad so that the adhesive is evenly distributed around the 360 ​​degree portion of each breakable portion of the breakable object.

[0030] At the fifth station of the turntable, the frangible breakable parts each receive a frangible tube. The frangible tubes, like the frangible breakable parts, are held in an auger in one embodiment, which delivers the frangible tubes to a frangible tube insertion station, which grabs the frangible tubes in the proper orientation and simultaneously inserts the frangible tubes (e.g., twelve tubes) onto the adhesive loaded on the corresponding frangible breakable part, which is then secured in place by the adhesive just applied to form the frangible.

[0031] At the sixth station of the turntable, the breakables are visually inspected. A digital camera takes images of all (e.g., twelve) breakables. Processing and memory operate with the camera to analyze the digital images to find errors in any assembled breakables. For example, the processing and memory can analyze the depth of the breakable portion of the breakable within the breakable end tube, the alignment of the breakable portion of the breakable relative to the breakable tube, and / or the presence of a breakable tube, etc. The visual inspection ensures that the appearance and quality of the breakables are consistent.

[0032] At the seventh station of the turntable, if the visual inspection detects a defect in any of a plurality of (e.g., twelve) breakables, the breakable is rejected. In one embodiment, the breakable rack is tilted and all breakables, even those that pass the inspection, are discharged into a reject bin. The reject bin can be inspected later to retrieve good breakables. In one embodiment, the rack includes a structure for marking defective breakables, making it easier to retrieve good breakables. In another alternative embodiment, the rack includes a structure for removing only defective breakables from the rack. In any event, at the eighth station of the turntable, the good breakables are collected. In one embodiment, the breakable rack is tilted and all breakables are released into a good product bin.

[0033] In view of the disclosure of the present disclosure and the present disclosure is not limited in any way, any aspect of any one of claims 1 to 39 may be combined with any other aspect of any one or more of claims 1 to 39, unless otherwise stated.

[0034] In other aspects of the present disclosure, any structure and functionality shown in FIGS. 1 to 15 may be combined with any other structure and functionality disclosed in FIGS. 1 to 15 .

[0035]

[0013] In accordance with the present disclosure and the above aspects, an advantage of the present disclosure is to provide an improved medical fluid container or bag forming system and method.

[0036] Another advantage of the present disclosure is to provide improved medical fluid container or bag forming systems, and related methods to increase production output.

[0037] Another advantage of the present disclosure is to provide an improved medical fluid container or bag forming system and related methods and methodology that improve maintenance and reduce downtime.

[0038] Yet another advantage of the present disclosure is to provide improved medical fluid container or bag forming systems and related methods that provide variable cycle times.

[0039] Yet another advantage of the present disclosure is to provide a method for providing an improved medical fluid container or bag forming system and associated operational flexibility.

[0040] Another advantage of the present disclosure is to provide an improved medical fluid container or bag forming system and related method of incorporating a port tube and container or bag seal.

[0041] Another advantage of the present disclosure is to provide an improved medical fluid container or bag forming system and related method that avoids secondary energy impacts to the formed medical fluid container or solution bag when the port tube is individually sealed, thereby reducing the risk of leakage.

[0042] Yet another advantage of the present disclosure is to provide improved breakable forming systems and related methods.

[0043] Yet another advantage of the present application is to provide an improved breakable object forming system and related methods designed to ensure the consistency and quality of the breakable objects.

[0044] The advantages discussed herein may be found in one or some (perhaps not all) of the embodiments disclosed herein.Additional features and advantages are described herein and will be apparent from the following detailed description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1A and 1B Cross-sectional views of the tops of a polyvinyl chloride ("PVC") solution container and a non-PVC container, respectively, illustrating different breakable embodiments.

[0046] Figure 2is a top view of one embodiment of the disclosed medical fluid container or bag forming system and related methods.

[0047] Figure 3 is a side view of one embodiment of a medical fluid container or bag forming machine for use with the medical fluid container or bag forming system and associated method of FIG. 1 .

[0048] Figure 4A is used for Figure 2 An isometric view of one embodiment of an upper mold of a medical fluid container or bag forming machine.

[0049] Figure 4B is used for Figure 2 An isometric view of one embodiment of a lower mold of a medical fluid container or bag forming machine.

[0050] Figure 5 is an elevation view of one embodiment for providing variable cycle time to the container or bag forming system and related method of FIG. 1 .

[0051] Figures 6A to 6D is a schematic diagram showing one embodiment for providing a single access port tube and primary seal for a medical fluid container or bag.

[0052] Figure 7 is a top view of one embodiment of the disclosed medical fluid container or bag frangible assembly system and associated methods.

[0053] Figure 8 It is shown Figure 7 A perspective view of one embodiment of how a bracket of a medical fluid container or bag frangible assembly system holds a frangible.

[0054] Fig. 9 It is shown Figure 7 A perspective view of one embodiment of a rod of a medical fluid container or bag frangible assembly system for adjusting and aligning a frangible.

[0055] Fig.10 It is shown Figure 7 A perspective view of one embodiment of an adhesive applicator of a medical fluid container or bag frangible assembly system for applying an adhesive or solvent to a frangible destructible portion of the frangible.

[0056] Fig.11 It shows Figure 7 A side view of one embodiment of a frangible tube insertion station of a medical fluid container or bag frangible assembly system that applies a frangible tube to a frangible.

[0057] Fig.12 It shows Figure 7A side view of one embodiment of a visual inspection station of a medical fluid container or bag frangible assembly system that evaluates each assembled frangible and frangible tube.

[0058] Fig.13 yes Figure 7 A front cross-sectional view of one embodiment of a display device for a medical fluid container or bag frangible assembly system illustrating a first frangible visual inspection failure mode.

[0059] Fig.14 yes Figure 7 A front cross-sectional view of one embodiment of a display device for a medical fluid container or bag frangible assembly system illustrating a second frangible visual inspection failure mode.

[0060] Fig.15 yes Figure 7 A front cross-sectional view of one embodiment of a display device for a medical fluid container or bag frangible assembly system illustrating a third frangible visual inspection failure mode. DETAILED DESCRIPTION

[0061] Solution containers and breakables

[0062] Referring now to the drawings, in particular Figure 1A and 1B , various embodiments of the frangible object of the present application are shown. Figure 1A A portion of a polyvinyl chloride ("PVC") solution container or bag 110a is shown, and Figure 1B A portion of a non-PVC solution container or bag 110b is shown. Each container or solution bag 110a and 110b includes a fill port tube 112 and an injection site port tube 114.

[0063] The fill port tube 112 of the PVC solution container or bag 110a receives a PVC frangible 116a, which includes a PVC destructible rigid plastic portion 118a. The PVC destructible rigid plastic portion 118a is sealed within a lower tube 120 of the PVC frangible 116a. The lower tube 120 may also be made of PVC and is sealed within the interior of the fill port tube 112. The PVC frangible 116a also includes an upper tube 122, which may be made of PVC and connected to a fill line that continues to the Y-region (not shown).

[0064] The fill port tube 112 of the non-PVC solution container or bag 110b receives a non-PVC frangible 116b, which includes a non-PVC destructible rigid plastic portion 118b. The non-PVC destructible rigid plastic portion 118b as shown is not sealed within a lower tube, but is instead sealed directly within the fill port tube 112. The non-PVC frangible 116b includes an upper PVC tube 122, which may be made of a non-PVC material and connected to a fill line that continues to a Y-section (not shown).

[0065] PVC solution container or bag 110a and non-PVC solution container or bag 110b are collectively referred to herein as solution container or bag 110. The systems and methods discussed herein are equally applicable to PVC breakables 116a, non-PVC breakables 116b, and other breakable configurations, collectively and generally referred to herein as breakables 116. Likewise, PVC destructible rigid plastic portions 118a and non-PVC destructible rigid plastic portions 118b are collectively and generally referred to herein as destructible rigid plastic portions 118.

[0066] Medical fluid container molding system including separate mold

[0067] Reference now Figure 2 , shows an embodiment of a medical fluid container molding system 10 and related methods. The system 10, including all controllable structures described herein, is controlled by a control unit 20, which includes one or more processors 22, one or more memories 24 operating with the processors 22, electronic devices 26 operable with the one or more processors 22 and the one or more memories 24, and a user interface / display device 28 for inputting commands to the one or more processors 22 and the one or more memories 24 and for displaying data from the processing and memories. Figure 2 In the system 10, the control unit 20 controls the port tube preheating station 30, the tack sealing station 40, the container or bag forming machine 48 and the water cooling station 100 in an operational sequence. Each of these major parts of the system 10 is discussed in detail below.

[0068] Figure 3 , Figure 4A and Figure 4B The bag forming machine 48 is shown in greater detail. Figure 3 The bag forming machine 48 is shown to include an upper mold 50 that cooperates with a lower mold 70 to simultaneously form a plurality of containers or bags 110. The upper mold 50 includes a first upper mold 52, a second upper mold 54, and a third upper mold 56, each of which is separate from one another and individually attached to an upper plate 60 by fasteners 58 (e.g., bolts or screws). Each of the first upper mold 52, the second upper mold 54, the third upper mold 56, the upper plate 60, and the fasteners 58 can be made of a medical grade metal, such as stainless steel or titanium.

[0069] Likewise, the lower mold 70 includes a first lower mold 72, a second lower mold 74, and a third lower mold 76, each of which is separate from one another and individually attached to a lower plate 80 via fasteners 58 (e.g., bolts or bolts). Each of the first lower mold 72, the second lower mold 54, the third lower mold 76, the lower plate 80, and the fasteners 58 may be made of a medical grade metal, such as stainless steel or titanium.

[0070] The upper mold 50 and the lower mold 70 form a mating pair as shown, and are formed so that the upper molds 52 and 56 abut directly against the upper intermediate mold 54, and so that the lower molds 72 and 76 abut directly against the lower intermediate mold 74. In this way, when the molds 50 and 70 are brought together to form the container or bag 110, the formed bags abut each other so that one slit forms the edges of the two containers or bags 110 without waste material in between and without the need for further processing of the two edges.

[0071] In the illustrated embodiment, shims 78 are provided to assist in individually leveling each mold 52, 54, 56, 72, 74, 76. The shims 78 are placed between the molds 52, 54, 56, 72, 74, and 76 and the corresponding plates 50 and 70. The molds 52, 54, 56, 72, 74, and 76 are then individually secured to the corresponding plates 50 and 70 by fasteners 58. The shims 78 allow the molds 52, 54, 56, 72, 74, and 76 to be leveled in two directions (e.g., in Figure 3 Providing separate dies as shown allows each die to be leveled individually, rather than having to adopt the best overall leveling result for all three dies, as would be the case if the three dies were formed together, for example, as an integral piece with the upper plate 60 and the lower plate 80.

[0072] When the molds 50 and 70 are closed together for sealing, the gasket 78 also allows each pair of upper and lower molds 52 and 72, 54 and 74, and 56 and 76 to be spaced apart from each other with a minimum gap. When the upper molds 52, 54 and 56 and lower molds 72, 74 and 76 are gathered together to form a seal, these molds are usually not in contact with each other, but leave some space for material thickness. Again, different from having to adopt the best overall result for multiple integrated molds, each individual mold pair 52 and 72, 54 and 74, and 56 and 76 of the present disclosure can produce a gap that is individually optimized or minimized by optimizing the position. When the upper and lower mating molds are gathered together to form a seal, the smaller the gap between them, the more effective the energy transfer from the mold to the solution bag sheet.

[0073] In an alternative embodiment, leveling screws (not shown) are used in place of shims 78 to adjust the dies 52, 54, 56, 72, 74, and 76 to level the dies and set the gap width therebetween. Leveling screws may be used in place of fasteners 58 to secure the dies 52, 54, 56, 72, 74, and 76 to plates 60 and 80, respectively. The leveling screws may be passed through fine threads in the dies 52, 54, 56, 72, 74, and 76 and then turned toward the plates 60 and 80 to set the desired height. Once the desired height for each leveling screw is set, additional fasteners (not shown) may be used (particularly for the upper dies 52, 54, 56) to secure the dies to plates 60 and 80.

[0074] Figure 3 The upper mold 50 in the embodiment of the present invention is driven by a first upper linear actuator 62a and a second upper linear actuator 62b, which are supported by an upper mounting member 14 connected to the frame 12. As shown by the arrows, the linear actuators 62a and 62b translate pistons 64a and 64b up and down under the control of the control unit 20. The pistons 64a and 64b are connected to the upper plate 60, thereby moving the upper molds 52, 54 and 56 up and down together as shown by the arrows. The linear actuators 62a and 62b are pneumatically driven cylinders, or alternatively include electromechanically driven steppers or servomotors, which are connected to a rotation-to-translation conversion device, such as a ball or lead screw.

[0075] Figure 3 The lower mold 70 in the embodiment of the present invention is driven by a first lower linear actuator 82a and a second lower linear actuator 82b, which are supported by a lower mounting member 16 connected to the frame 12. As shown by the arrows, the linear actuators 82a and 82b translate pistons 84a and 84b up and down under the control of the control unit 20. The pistons 84a and 84b are connected to the lower plate 80, thereby moving the lower molds 72, 74 and 76 up and down together as shown by the arrows. The linear actuators 82a and 82b are pneumatically driven cylinders, or alternatively include electromechanically driven steppers or servomotors, which are connected to a rotation-to-translation conversion device, such as a ball or lead screw.

[0076] In one embodiment, the linear actuators 62a, 62b, 82a and 82b can be precisely positioned so that when the molds are brought together to form the container or bag 110, the gap between the molds 52 and 72, 54 and 74, and 56 and 76 is maintained to be less than 1 mm. In the case where the linear actuators 62a, 62b, 82a and 82b are pneumatically driven, a finely adjustable hard stop can be used to set the end of the travel of the welding position. In any case, when the molds 52 and 72, 54 and 74, and 56 and 76 are brought together to form the required welding gaps, the control unit 20 causes energy to be applied to the mold to simultaneously form three containers or bags 100. If the container or bag is made of PVC, the energy applied is a high frequency or ultrasonic welding that seals the two PVC sheets 66 and 86 together. If the container or bag 100 is made of non-PVC material, the energy applied is thermal energy that seals the two non-PVC sheets 66 and 86 together.

[0077] Figure 3 It is generally shown that the container or bag sheet 66 and 86 can come from or be fed by the upper feed roller 68, the lower feed roller 88a, the upper exit roller 68b and the lower exit roller 88b. In one embodiment, the container or bag sheet 66 and 86 is fed by the upper feed roller 68a and the lower feed roller 88a, while the upper exit roller 68b and the lower exit roller 88b are motorized and pull and guide (index) the sheet through the exit roller and between the upper mold 50 and the lower mold 70 at set intervals under the control of the control unit 20, thereby manufacturing multiple (for example, three) containers or bags 100 at the same time at each guide.

[0078] Figure 4A and 4B The upper mold 50 and the lower mold 70 are shown in more detail. Figure 4A An upper die 50 is shown including upper dies 52 , 54 , and 56 , each secured to an upper plate 60 by fasteners 58 . Figure 4A Also shown is die 52 abutting die 54, which in turn abuts die 56. Each of the dies 52, 54, and 56 is provided with rounded corners, which however allow internal locators 90a to 90d to be located between the dies, while external locators 92a and 92b are located outside the dies 52, 54, and 56. Each of the locators 90a to 90d, 92a and 92b is secured to the upper plate 60 by fasteners 98. The locators 90a to 90d, 92a and 92b are shaped according to the corners of the dies 52, 54, and 56, making it easy to remove and replace each die from the correct position of the die. The locators also make it easy to find the mounting holes for the fasteners 58 and ensure that the adjacent dies 52 and 54, 54 and 56 abut against each other when the dies are inserted for operation.

[0079] Figure 4BA lower die 70 is shown including lower dies 72 , 74 , and 76 , each of which is fastened to a lower plate 80 by fasteners 58 . Figure 4B Also shown is die 72 abutting die 74, which in turn abuts die 76. Each of the dies 72, 74, and 76 is provided with rounded corners, which however allow internal locators 94a to 94d to be located between the dies, while external locators 96a and 96b are located outside the dies 72, 74, and 76. The locators 94a to 94d, 96a, and 96b are fixed to the lower plate 80 by fasteners 98, respectively. The locators 94a to 94d, 96a, and 96b are formed according to the corners of the dies 72, 74, and 76, so that it is easy to remove and replace each die from the correct position of the die. The locators also make it easy to find the mounting holes for the fasteners 58 and ensure that when the dies are inserted for operation, the adjacent dies 72 and 74, 74 and 76 abut against each other.

[0080] Variable cycle times for container forming machines

[0081] Figure 5 One embodiment of a settings screen of the user interface / display device 28 of the control unit 20 of the system 10 is shown. The control unit 20 is configured to Figure 5 The setup screen of the machine 48 is programmed to allow the operator to change the cycle time. The cycle time can be the time between two identical actions or processes associated with the container or bag forming machine 48, for example, related to the piloting of the machine 48. For the machine 48, a logical cycle time is (i) the time between when the PVC or non-PVC sheet 66 and 86 begins to move toward the upper mold 50 and the lower mold 70 and when the same area of ​​material leaves the mold with the formed bag, that is, the pilot time between the rollers 68a, 88a, 68b and 88b being actuated, or (ii) the time between when the upper mold 50 and the lower mold 70 come together. In either case, for example, the cycle time may not be sufficient to allow the molds 52, 54, 56, 72, 74, 76 to reach the desired temperature. Figure 5 The setup screen allows the operator to adjust the cycle time to optimize the bag forming process.

[0082] like Figure 5 As shown in , an operator using a touch screen keyboard can, for example, enter a desired cycle time. In the illustrated embodiment, the control unit 20 allows the operator to set the cycle time anywhere between four and eight seconds (inclusive). Figure 5 The setup screen of informs the user that in Cycle Time Mode, the speeds of rollers 68a, 88a, 68b, and 88b are automatically set by setting the cycle time. That is, in a different mode where the cycle time is not set, the user may have to set the roller speeds. Figure 5On the settings screen of , the user also sets the energy level, for example, switching between low, medium and high energy levels until the desired setting is found. The energy level can also be set quantitatively, for example, by setting the desired mold temperature for contacting the sheets 66 and 86. As discussed herein, if the container or bag 100 is made of PVC, the bag forming machine 48 performs high frequency or ultrasonic welding by using a matching mold to seal the two PVC sheets 66 and 68 together. If the container or bag 100 is made of a non-PVC material, the bag forming machine 48 supplies heat to the matching mold and thermoforms the two non-PVC sheets 66 and 68 together. In either case, the ultrasonic or thermal energy may be applied only to the upper mold 52, 54, 56, only to the lower mold 72, 74, 76, or to both the upper mold set and the lower mold set.

[0083] use Figure 5 The operator can slow down (increase) the cycle time if it is found that one or more of the molds 52, 54, 56, 72, 74, or 76 (in one embodiment, each mold can have a thermocouple temperature reading at the display device 28) cannot consistently reach the desired temperature and / or the energy level must be increased to an extremely high level to bring the mold to the desired temperature. If it is found that the mold 52, 54, 56, 72, 74, or 76 consistently reaches the desired temperature even at a low energy level setting, the operator can speed up (decrease) the cycle time. The adjustable medical fluid container cycle time of the present application advantageously allows the operator to adjust for material differences between manufacturers and between different material batches from the same manufacturer.

[0084] Integrated container and port tube seals

[0085] Reference now Figure 2 and Figures 6A to 6D , shows a container or bag forming method for the operating system 10 of the present application. Before the sheets 66 and 86 are sealed together, the filling port tube 112 and the injection site port tube 114 are usually sealed to one of the sheets 66 and 86 of the solution bag or container 110. Doing so requires a separate operation and also exposes the sheets 66 and 86 to secondary energy impact, thereby creating a risk of leakage. In the present application, the port tube seal and the container or bag seal are integrated.

[0086] exist Fig. 6A , the fill port tube 112 and the injection site port tube 114 are preheated at the heated portion of the tubes marked H. The fill port tube 112 may or may not have a frangible 116 as shown. Figure 2 The system 10 is shown to include a port tube preheating station 30, which is under the control of the control unit 20. The port tube preheating station 30 in the illustrated embodiment includes heating portions H ( Fig. 6A ) is transported to a conveyor 32 under or inside a heater 34, which may be a radiant heater, a convection heater (e.g., hot air), a resistive heater, or a combination thereof. The heater 34 heats the heated portion H of the port tubes 112 and 114 to a suitable temperature so that the port tubes 112 and 114 can withstand tack welding in the next step. Tack welding can be performed at, for example, 200° C. to 500° C., depending on the materials used for the port tubes 112 and 114 and the sheets 66 and 86. The preheat temperature of the heated portion H is therefore a percentage of the tack welding temperature, for example, 100° C. to 300° C.

[0087] exist Figure 6B The preheated fill port tube 112 and injection site port tube 114 are then Fig. 6A The heated portion H of the tube marked in FIG. 1 is tack welded, now marked with E, which represents the energy applied to tack weld one or both sheets 66 and 86 of the molded container or bag 110. Figure 2 The system 10 is shown to include a position seal station 40 under the control of the control unit 20. The position seal station 40 includes one or more motorized arms that retrieve the preheated port tubes 112 and 114 and place the port tubes in position relative to the sheets 66 and 86 and the position sealer 42. If the port tubes 112, 114 and the sheets 66 and / or 86 are made of PVC, the position sealer 42 performs high frequency or ultrasonic welding to form a seal between the port tubes 112 and 114 and the sheets 66 and / or 86. Figure 6B The port tubes 112 and 114 are positioned and sealed to one or both of the sheets 66 and / or 86 at the energy zone E in the PVC film. If the port tubes 112, 114 and the sheets 66 and / or 86 are made of non-PVC materials, the positioning sealer 42 provides heat to seal the port tubes 112 and 114 to one or both of the sheets 66 and / or 86. Figure 6B Energy region E in the seal positions port tubes 112 and 114 to one or both of sheets 66 and / or 86 .

[0088] exist Figure 6C In the process, the preheated and tack welded fill port tube 112, injection site port tube 114 and sheets 66 and 86 are then formed together to form a Figure 6C The main container or bag is sealed at the energy zone E in the container or bag 110, and the energy zone E extends along the entire perimeter of the container or bag 110. Figure 2 , 3 , 4A and 4B show and describe the method for forming Figure 6C A suitable structure and method for the primary seal E in the container or bag forming machine 48. However, it should be understood that Figures 6A to 6D The method shown is not limited to the use of bag forming machine 48. Alternatively, for example, at the beginning Fig. 6A Prior to preheating in the reactor, the sheets for the containers or bags 110 may first be separated.

[0089] exist Fig.6D , the filling port tube 112 and the injection site port tube 114 are now completely sealed to the Figure 6C The primary sealing energy E in the water is used to form the sheets 66 and 86 in the shape of at least a container or bag, and then cooled at the water cooling station 100. The water cooling station 100 can be configured to spray water W as shown. The water cooling station 100 optionally includes a water bath for cooling. In either case, the water cooling station 100 can be configured to (i) cool only the portion of the container or bag 110 including the port tubes 112, 114, or (ii) cool the entire container or bag 110 including the port tubes 112, 114. In one embodiment, water cooling occurs when the container or bag 110 is transported through or through the water cooling station 100.

[0090] Fragile assembly system

[0091] Reference now Figures 7 to 12 In a fourth main embodiment of the present disclosure, a plurality of stations of a frangible assembly system 210 are provided to prepare frangibles 116 for insertion into a fill port tube 112. A turntable or guide plate 212 of the frangible assembly system 210 has eight stations in one embodiment, seven of which include assembly steps and one of which is empty or open. The guide plate 212 carries eight frangible holders 232 ( Figure 8-12 ) and has an octagonal shape in the illustrated embodiment (although more or fewer supports and different corresponding shapes are possible). The operating equipment of the different stations of the frangible assembly system 210 discussed below are generally oriented perpendicular to the sides of the octagonal guide plate 212. Each frangible support 232 holds a plurality of frangibles 116, such as twelve frangibles. The frangible assembly system 210 includes a motor 214, such as a stepper motor or a servo motor (e.g., with a gear reduction to increase torque), or a pneumatically actuated indexer 214. In either case, the indexer 214 rotates or guides the guide plate 212 so that each frangible support 232 stops at eight different positions around the turntable.

[0092] like Figure 7The illustrated frangible assembly system 210 includes a first auger 216 for supplying a frangible breakable portion 118 and a second auger 218 for supplying a tube 122 of frangibles. The system 210 includes all controllable structures described herein, such as the guide 214 (electric motor or pneumatic actuator), the first auger 216, the second auger 218, and the various stations discussed below, and in one embodiment, the system 210 is under the control of a control unit 220, which includes one or more processors 222, one or more memories 224 operating with the processors 222, electronic devices 226 operable with the one or more processors 222 and the one or more memories 224, and a user interface / display device 228 for inputting commands to the one or more processors 222 and the one or more memories 224 and displaying data from the processing and memories.

[0093] Figure 7 and 8 A first station or breakable portion insertion station 230 of a turntable or guide plate 212 is shown, wherein a breakable holder 232 receives a plurality of hard plastic breakable portions 118 of a breakable object 116. Figure 7 As shown, the auger 216 feeds the breakable portions to the breakable portion insertion station 230. The breakable portion auger 216 in the illustrated embodiment is a circular auger in which the breakable portions 118 become increasingly separated as the portions move radially outward along the circular path of the auger. The individual breakable portions 118 are then inserted (e.g., from top to bottom) into the breakable portion insertion station 230. Figure 8 The frangible destructible part inserter 238 is inserted into the mating hole of the frangible destructible part inserter 238. The frangible destructible part inserter 238 is connected to the rotating rod 236. The rotating rod 236 and the frangible destructible part inserter 238 can each be made of metal (such as stainless steel or aluminum) or strong plastic (such as Teflon or nylon).

[0094] like Figure 8 As shown by the bidirectional rotation arrow in FIG. 2 , the rotating rod 236 is electromechanically or pneumatically rotated in a clockwise and counterclockwise direction. Specifically, the rotating rod 236, and then the frangible breakable portion inserter 238, is rotated 90 degrees clockwise downward to Figure 8 The position shown in FIG. 2 is for receiving the frangible portions 118 (eg, twelve portions). The rotating rod 236 and, in turn, the frangible portion inserter 238 are rotated 90 degrees counterclockwise upward and then the frangible portions 118 are delivered to the rack 232 .

[0095] like Figure 8The illustrated bracket 232 includes a bushing 234 (e.g., a bushing 234 for each breakable portion 118). The bracket 232 and bushing 234 may each be made of a metal (e.g., stainless steel or aluminum) or a strong plastic (e.g., Teflon or nylon). The bushing 234, as described below, is rotatably connected within the bracket 232. Once the rotating rod 236, and thus the breakable portion inserter 238, is rotated upward 90 degrees clockwise, the rotating rod 236 and the breakable portion inserter 238 are electromechanically or pneumatically translated so that the breakable portion 118 is transferred from the breakable portion inserter 238 to the bushing 234 of the bracket 232 together, as shown. Figure 8 As shown by the double-direction straight arrows in Figure 8 As shown, each bracket 232 is mounted flush with one of the octagonal edges of the guide plate 212 so that the rotating rod 236 and the frangible portion inserter 238 do not have to translate on the guide plate 212. After the frangible portion 118 is delivered to the bushing 234 of the bracket 232, the rotating rod 236 and the frangible portion inserter 238 are rotated back to the guide plate 212. Figure 8 position and rotated 90 degrees clockwise to receive a new set of frangible destructible portions 118.

[0096] In one embodiment, the second or open station 240 of the turntable or guide plate 212 is an open or empty station. Figure 7 A support 232 is shown which holds the frangible breakable portion 118 at the second or opening station 240 .

[0097] Figure 7 and 9 A third station or frangible portion adjustment and alignment station 250 is shown for the turntable or guide plate 212, wherein the frangible portion 118 is aligned to ultimately receive the frangible tube 122. Fig. 9 As shown, the bracket 232 holds the frangible portion 118 so that the portion of the frangible portion 118 inserted into the frangible tube 122 extends outward from the bracket 232. The alignment station 250 includes a thickened alignment rod 252 having a cylindrical alignment hole 254 (e.g., a hole 254 for each portion of the frangible portion 118 extending from the bracket 232). The alignment rod 252 can be made of metal (e.g., stainless steel or aluminum) or a strong plastic (e.g., Teflon or nylon). Fig. 9As shown by the double-direction straight arrows in FIG. 1 , the alignment rod 252 is electromechanically or pneumatically translated toward the bracket 232 so that the hole 254 extends over the portion of the frangible breakable portion 118 extending from the bracket 232. This action adjusts and aligns each frangible breakable portion 118 within the bracket 232 to an orderly and evenly spaced state so that the frangible breakable portion 118 is in the correct position to receive the frangible tube 122 at a later station. After adjustment, the alignment rod 252 is translated back to Fig. 9 to wait for the next bracket 232.

[0098] It should be understood that although the bracket 232 is being Fig. 9 associated alignment operation, but the second bracket connected to the guide plate 212 at station 230 is being just combined Figure 8 The frangible described may disrupt the insertion of portion 118 .

[0099] Figure 7 and 10 A fourth station or frangible adhesive application station 260 of the turntable or guide plate 212 is shown wherein adhesive or solvent is applied to a portion of the exposed portion of the frangible breakable portion 118 . Fig.10 The adhesive application station 260 in the embodiment shown in FIG. 1 has an adhesive applicator 262 that is translated downwardly by electromechanical or pneumatic motion, such as Fig.10 272, into and out of a tank 270 filled with an adhesive or solvent 272. Both the adhesive applicator 262 and the tank 270 can be made of metal (such as stainless steel or aluminum) or a strong plastic (such as Teflon or nylon). In various embodiments, the adhesive or solvent 272 for the PVC breakables 116 is cyclohexanone, while the adhesive or solvent 272 for the non-PVC breakables 116 is cumene or isopropyl alcohol.

[0100] While the slot 270 of the adhesive or solvent 272 provides one way to apply the adhesive or solvent to the adhesive applicator 262, other ways are possible, such as applying the adhesive or solvent 272 individually to each of the plurality of application areas 264 of the adhesive applicator 262 with a brush or syringe. However, in any applicable embodiment, the application area 264 of the adhesive applicator 262 is provided with or covered with the adhesive or solvent 272 as the adhesive applicator 262 translates under the guide plate 212. In the illustrated embodiment, the application area 264 is a U-shaped cutout formed along the top edge of the adhesive applicator 262.

[0101] Once the application area 264 of the adhesive applicator 262 is covered with the adhesive or solvent 272, the adhesive applicator 262 is electromechanically or pneumatically translated upward, such as Fig.10This causes the application area 264 to align with the exposed portion of the frangible destructible portion 118 (come into registry), as shown by the single vertical arrow in FIG. Fig.10 Once aligned, the control unit 220 causes the shaft 266 extending to the rear of the bracket 232 to align with the rotary actuator 268 ( Figure 7 ) is engaged, and a rotary actuator 268 (e.g., a stepper motor or servo motor) is located at the adhesive application station 260. In various embodiments, the shaft 266 is connected to each bushing 234 inside the bracket 232 by a belt and gear, a belt and pulley, a mating gear, etc., so that when the rotary actuator 268 rotates the shaft 266, each bushing 234 and the frangible breakable portion 118 held within the bushing also rotate. The rotary actuator 268 can rotate in a single direction or in multiple directions (such as Fig.10 The shaft 266, bushing 234 and frangible portion 118 are rotated (as shown by the two rotation arrow directions around the bushing 234) and can be rotated multiple times in one or more rotation directions as needed, so that the exposed portion of the circular frangible portion 118 is evenly provided with adhesive or solvent around the 360 ​​degree portion of each exposed portion.

[0102] The above adhesive application process is repeated for each bracket 232. It should be understood that although the frangible destructible portion 118 is Fig.10 station 260 in the receiving station 260, but the adjacent bracket 232 connected to the guide plate 232 is being connected to the adjacent bracket 232. Fig. 9 The related alignment operation is performed while the second bracket connected to the guide plate 212 at station 230 is being performed. Figure 8 The frangible described may disrupt the insertion of portion 118 .

[0103] Figure 7 and 11 A fifth station or frangible tube assembly station 280 of the turntable or guide plate 212 is shown, wherein the frangible tube 122 is simultaneously assembled onto the exposed adhesive-loaded portion of the frangible breakable portion 118. In one embodiment, similar to the frangible breakable portion 118, the frangible tube 122 is supplied by an auger 218, which delivers the frangible tube 122 to a frangible tube inserter 290 ( Figure 7 ). The frangible tube auger 218 in the illustrated embodiment is a circular auger in which the frangible tubes 218 become increasingly separated as they move radially outward along the circular path of the auger.

[0104] like Fig.11The illustrated frangible inserter 290 includes a lower frangible tube holding tray 282 that holds a separate frangible tube 122 (e.g., twelve tubes 122 total) for each frangible destructible portion 118. The frangible inserter 290 also includes a tube slider 284 that is actuated by a piston 286 such as Fig.11 The tubes 122 are clamped between the tube holding tray 282 and the tube slider 284, which are shown as the vertical arrows in FIG. Fig.11 The frangible tubes 122 are simultaneously slid onto the frangible destructible portion 118 by electromechanical or pneumatic means as shown by the horizontal arrows in the figure, and then the frangible tubes 122 are sealed in the correct position by the adhesive or solvent 272 applied to the exposed portion of the frangible destructible portion 118 at the previous station. Fig.11 The frangible breakable portion 118 is shown held in place at the bracket 232 .

[0105] Repeat the above frangible tube 122 insertion process for each bracket 232. It should be understood that although the frangible breakable portion 118 is Fig.11 The station 280 receives the frangible tube 122, but the frangible breakable portion 118 of the adjacent bracket 232 is being Fig.10 The station 260 receives the adhesive or solvent, and the next adjacent bracket 232 connected to the guide plate 232 is being connected to the Fig. 9 Related alignment operations, while the third bracket connected to the guide plate at station 230 is being performed Figure 8 The frangible described may disrupt the insertion of portion 118 .

[0106] Figure 7 and 12 A sixth station or visual inspection station 300 of the turntable or guide plate 212 is shown where the frangibles 116 (including the breakable portions 118 and frangible tubes 122) are inspected to confirm they are properly connected. The visual inspection ensures the appearance and quality of the frangibles 116. Figure 7 and 12The visual inspection station 300 is shown provided with a camera 302, such as a digital camera, located within a housing 304, which captures an image of the fragile object insertion. One suitable camera for the camera 302 is provided by Cognex Corporation, Natick, MA, USA 01760-2059. The camera 302 can have its own processing and memory to store and execute vision software. The camera 302 can alternatively output to the vision software stored and executed at one or more processors 222 and memory 224 of the control unit 220, either wired or wirelessly. The control unit 220 and the camera 302 can each include a transceiver or transmitter / receiver for wireless communication. Suitable vision software can be provided by the camera manufacturers listed above, such as VisionPro TM or VisionPro ViDi TM software.

[0107] In one embodiment, the vision software converts the digital color image captured by the camera 302 into a digital grayscale image and evaluates the grayscale image according to the program and algorithm of the system 210. The vision software can perform separate grayscale evaluations, such as the three evaluations discussed below for each fragile object insertion. Using grayscale for evaluation helps speed up the analysis so that all evaluations can be performed before the guide plate 212 is guided.

[0108] exist Fig.12 In the illustrated embodiment, the camera 302 is mounted on the housing 304. In alternative embodiments, the camera 302 may be mounted elsewhere within the housing 304. In any case, the focus (dashed line) of the camera 302 is on the connection between the frangible breakable portion 118 of the frangible and the frangible tube 122. In one embodiment, the control unit 220 is programmed so that the camera 302 is automatically triggered for image capture upon completion of the guiding of the guide plate 212.

[0109] Fig.12 Also shown, in one embodiment, the visual inspection station 300 includes a light source 306, which is located on the opposite side of the frangible breakable portion 118 and the frangible tube 122 from the camera 302. In one embodiment, the light source 306 includes a light array, such as a light emitting diode ("LED"), which can be a white or colored (e.g., blue or red) LED. The control unit 220 can control the light source 306 to illuminate when needed, such as when the guidance station 212 completes the guidance, to improve the quality of the image captured by the camera 302.

[0110] Once the camera 302 captures an image of the fragile component, the vision software (stored in the camera 302 or the control unit 220) evaluates the image. As described above, multiple (discussed below) evaluations (e.g., three evaluations) may be performed. In one embodiment, if the result of each evaluation passes, the vision software outputs a "pass" to the control unit 220. If the result of any evaluation fails, the vision software outputs a "fail" to the control unit 220. In another embodiment, the vision software outputs a grayscale count for each evaluation (e.g., three evaluations), and the control unit 220 is programmed to determine a pass or fail for each evaluation. Here again, if the result of each evaluation passes, the control unit 220 determines an overall "pass". If the result of any evaluation fails, the control unit 220 determines an overall "fail".

[0111] At the seventh station or rejected fragile collection station 320 ( Figure 7 ) at a location where visual inspection station 280 detects a defect in any one of a plurality of (e.g., twelve) breakables, the breakable is rejected. In one embodiment, breakable holder 232 is tilted (using a structure similar to rotating rod 236) and all breakables, even those that pass inspection, are rejected into a reject bin located, for example, below a rejected breakable collection station 320. The reject bin can then be inspected to retrieve good breakables. In one embodiment, the rejected breakable collection station 320 via bushing 234 is able to mark defective breakables, thereby making it easier to retrieve good breakables. In another alternative embodiment, the rejected breakable collection station 320 via bushing 234 is able to remove only defective breakables from holder 232.

[0112] In any case, at the eighth station or receiving fragile collection station 330 ( Figure 7 ) to collect the good breakables. In one embodiment, the breakables rack 232 tilts (using a structure similar to the rotating rod 236) and all breakables are released into a good product bin, which is located, for example, below the accepted breakables collection station 330.

[0113] It should be understood that while the described visual inspection is being performed at station 300 and the collection of rejected and accepted breakables is being performed at stations 320 and 330, all of the previously described stations except for the opening station 240 are performing their operations simultaneously.

[0114] Visual inspection assessment

[0115] Reference now Figures 13 to 15, shows an exemplary screen from the user interface / display device 228 of the medical fluid container frangible assembly system 210, which is used to illustrate different failure modes involving rejected or failed frangible assemblies. The failure modes may include any one or more of the following: (i) the frangible tube is not inserted to the proper depth, (ii) the frangible tube is missing, or (iii) the frangible tube is inserted at a misaligned angle. In one embodiment, if any image of the frangible assembly fails any of the analysis modes, the fluid container or bag 110 is rejected.

[0116] Fig.13 An example of a failed insertion depth assessment is shown. Here, the frangible breakable portion 118 is not inserted deep enough into the upper tube 122 of the frangible 116. The result of the depth assessment is therefore "failed".

[0117] Fig.14 An example of a failed frangible missing evaluation is shown. Here, the frangible tube 122 is completely missing. Therefore, the result of the frangible presence evaluation is "failed".

[0118] Fig.15 An example of a failed frangible alignment assessment is shown. Here, the frangible tube 122 is tilted relative to the frangible breakable portion 118 beyond a predetermined angle value (e.g., greater than 10 degrees) and is not considered a well-sealed joint. Therefore, the result of the alignment assessment is "failed."

[0119] It should be understood that various changes and modifications to the currently preferred embodiments described herein will be apparent to those skilled in the art. These changes and modifications may be made without departing from the spirit and scope of the present application, and will not reduce its expected advantages. Therefore, it is intended that these changes and modifications be covered by the appended claims. For example, although the present system and method are described primarily in conjunction with peritoneal dialysis bags, it should be understood that the present system and method are applicable to other types of parenteral fluid bags, such as blood treatment fluid bags, medical fluid delivery bags, saline bags, etc. In addition, although the present system and method are described primarily in conjunction with medical fluid bags, it should be understood that the present system and method are applicable to other types of medical fluid containers, such as more rigid medical fluid containers.

[0120] Part Number List

[0121] 10-Medical fluid container molding system

[0122] 12-System Framework

[0123] 14- Upper mounting member connected to the frame

[0124] 16-Lower mounting member connected to the frame

[0125] 20-Control unit for container forming system

[0126] 22-Processor of the container forming system control unit

[0127] 24-Memory for the control unit of the container forming system

[0128] 26- Electronics for control units of container forming systems

[0129] 28-User interface / display device for control unit of bag forming system

[0130] 30-Port Tube Preheating Station

[0131] 32-Port Tube Preheating Station Conveyor

[0132] 34-Preheating station heater

[0133] 40- Positioning sealing station

[0134] 42-Positioning sealer

[0135] 48-Container or bag forming machine

[0136] 50- Upper mold

[0137] 52-First upper mold of the upper mold

[0138] 54-Second upper mold of upper mold

[0139] 56- The third upper mold of the upper mold

[0140] 58-die fasteners

[0141] 60-on board

[0142] 62a-First upper linear actuator

[0143] 62b - Second upper linear actuator

[0144] 64a - Piston of first upper linear actuator

[0145] 64b - Piston of the second upper linear actuator

[0146] 66-Bag sheet

[0147] 68a - Feed roller for bagging sheet

[0148] 68b-Exit roller for bagging sheet

[0149] 70-lower mold

[0150] 72-first lower mold of the lower mold

[0151] 74- The second lower mold of the lower mold

[0152] 76- The third lower mold of the lower mold

[0153] 78-Gasket

[0154] 80-lower board

[0155] 82a-First lower linear actuator

[0156] 82b - Second lower linear actuator

[0157] 84a - Piston of the first lower linear actuator

[0158] 84b - Piston of the second lower linear actuator

[0159] 86-Bag sheet

[0160] 88a - Feed roller for lower bag sheet

[0161] 88b-Exit roller for bagging sheet

[0162] 90a to 90d - Locator between upper dies

[0163] 92a and 92b - Locators on the outside of the upper die

[0164] 94a to 94d - Locator between lower dies

[0165] 96a and 96b - Locator on the outside of the lower die

[0166] 98-Locator Fastener

[0167] 100-Water Cooling Station

[0168] 110a-Polyvinyl chloride ("PVC") solution container or bag, generally referred to herein as solution container or bag 110 110b-Non-PVC solution container or bag, generally referred to herein as solution container or bag 110

[0169] 112-Fill Port Tube

[0170] 114-Injection Site Port Tube

[0171] 116a-PVC fragile, generally referred to as fragile 116 in this article

[0172] 116b- Non-PVC fragile objects, generally referred to as fragile objects 116 in this article

[0173] 118a-PVC destructible rigid plastic part, generally referred to herein as the destructible part of the fragile object 118118b-Non-PVC destructible rigid plastic part, generally referred to herein as the destructible part of the fragile object 118120-PVC lower tube of the fragile object

[0174] 122-Fragile upper tube

[0175] 210-Medical Fluid Container Fragile Assembly System

[0176] 212-Guide plate for medical fluid container fragile assembly system

[0177] 214-Guide plate actuator

[0178] 216-Screw conveyor for supplying breakable parts of fragile objects

[0179] 218 - Screw conveyor for pipes supplying fragile items

[0180] 220-Control unit for medical fluid container fragile assembly system

[0181] 222-Processor for a control unit of a medical fluid container breakable assembly system

[0182] 224-Memory for a control unit of a medical fluid container frangible assembly system

[0183] 226-Electronics for control unit of medical fluid container frangible assembly system

[0184] 228-User Interface / Display Device for Control Unit of Fragile Assembly System for Medical Fluid Container

[0185] 230-Fragile objects can destroy some insertion stations

[0186] 232-Stand

[0187] 234-Bracket Bushing

[0188] 236-Rotating rod

[0189] 238-Fragile objects can destroy some inserters

[0190] 240-Open Station

[0191] 250 - Fragile objects can damage some adjustment and alignment stations

[0192] 252-Alignment Rod

[0193] 254-Cylindrical alignment holes in alignment rods

[0194] 260-Adhesive Application Station

[0195] 262-Adhesive Applicator

[0196] 264 - application area of ​​adhesive applicator 266 - shaft extending into rear of stent

[0197] 268 - Rotary actuator of adhesive application station 270 - Slot 270

[0198] 272-Adhesive or solvent

[0199] 280-Fragile Tube Assembly Station

[0200] 282-Tube Holding Tray

[0201] 284-Tube Sliders

[0202] 286-Piston connected to tube slider

[0203] 290-Fragile Inserter

[0204] 300-Vision Inspection Station

[0205] 302-Digital Camera

[0206] 304-Digital camera housing

[0207] 306-Light source for digital camera

[0208] 320 - Rejected fragile collection station 330 - Accepted fragile collection station.

Claims

1. A medical fluid container forming machine, characterized in that: The medical fluid container forming machine comprises: An upper mold, the upper mold comprising an upper mold; a lower mold, the lower mold comprising a lower mold, the upper mold and the lower mold being aligned so that the upper mold is operably aligned with the lower mold; A control unit that controls actuation of the upper mold and the lower mold so that the upper mold and the lower mold are brought together and energy is applied to form a medical fluid container, the control unit being configured to control: (i) the amount of energy applied by the upper mold and the lower mold, and (ii) a cycle time, which is a time interval for bringing the upper mold and the lower mold together to obtain a continuous medical fluid container, or a time interval for medical fluid container material to start moving toward the upper mold and the lower mold to obtain a continuous medical fluid container; and A user interface is in operable communication with the control unit, wherein the cycle time is variable and wherein a user can input a desired cycle time through the control unit.

2. The medical fluid container forming machine according to claim 1, characterized in that: The upper mold is a first upper mold and includes a second upper mold, the lower mold is a first lower mold and includes a second lower mold, and the upper mold and the lower mold are placed so that the first upper mold is operably aligned with the first lower mold, and the second upper mold is operably aligned with the second lower mold.

3. The medical fluid container forming machine according to claim 1, characterized in that: The amount of energy is applied by both the upper mold and the lower mold, or by a single mold of the upper mold or the lower mold.

4. The medical fluid container forming machine according to claim 1, characterized in that: For each cycle, the medical fluid container material is directed between the upper die and the lower die.

5. The medical fluid container forming machine according to claim 1, characterized in that: The desired cycle time enables the upper mold and the lower mold to reach a desired temperature.

6. A medical fluid container molding system, characterized in that: The medical fluid container molding system comprises: a port tube preheating station configured to preheat at least one of a fill port tube or a sample port tube; a position sealing station configured to position seal at least one of the preheated fill port tube or the sample port tube to at least one of the first medical fluid container material or the second medical fluid container material; An upper mold, the upper mold comprising an upper mold; A lower mold, the lower mold comprising a lower mold, the upper mold and the lower mold: (i) aligned so that the upper mold is operably aligned with the lower mold, and (ii) configured to ultimately seal at least one of the positioned sealed filling port tube or sample port tube to the first medical fluid container material and the second medical fluid container material, and to seal the first medical fluid container material and the second medical fluid container material together to form the medical fluid container.

7. The medical fluid container molding system according to claim 6, characterized in that: The medical fluid container forming system also includes a cooling station constructed and arranged to cool the formed medical fluid container.

8. The medical fluid container molding system according to claim 6, characterized in that: The medical fluid container forming system also includes an injection site insertion station configured to insert an injection site into the sample port tube.

9. The medical fluid container molding system according to claim 6, characterized in that: The fill port tube includes an inserted frangible breakable portion.

10. The medical fluid container molding system according to claim 6, characterized in that: The positioning sealing station is configured to seal at least one of the first medical fluid container material or the second medical fluid container material around a portion of a diameter of at least one of the preheated fill port tube or the sample port tube.

11. The medical fluid container molding system according to claim 6, characterized in that: The upper and lower dies are configured such that the first and second medical fluid container materials collectively and definitively seal around an entire diameter of at least one of the preheated fill port tube or the sample port tube.

12. The medical fluid container molding system according to claim 6, characterized in that: The port tube preheating station is configured to preheat the filling port tube and the sample port tube, the positioning and sealing station is configured to position and seal the preheated filling port tube and the preheated sample port tube to at least one of the first medical fluid container material or the second medical fluid container material, and the upper mold and the lower mold are configured to finally seal the positioned and sealed filling port tube and sample port tube to the first medical fluid container material and the second medical fluid container material.

13. The medical fluid container molding system according to claim 6, characterized in that: The upper mold is a first upper mold, and the upper mold includes a second upper mold, the lower mold is a first lower mold, and the lower mold includes a second lower mold, the upper mold and the lower mold are aligned so that the first upper mold is operably aligned with the first lower mold and the second upper mold is operably aligned with the second lower mold, and the upper mold and the lower mold are configured to finally seal at least one of the following items to the first medical fluid container material and the second medical fluid container material: (i) a first positioned sealed filling port tube and a second positioned sealed filling port tube, or (ii) a first positioned sealed sample port tube and a second positioned sealed sample port tube.

14. The medical fluid container molding system according to claim 6, characterized in that: The first medical fluid container material and the second medical fluid container material include polyvinyl chloride (PVC) sheets or non-PVC sheets.

15. A fragile assembly system for a medical fluid container, characterized in that: The medical fluid container fragile assembly system comprises: a guide plate, the guide plate comprising a plurality of fragile object racks, the guide plate guiding so that each of the fragile object racks is brought to each of a plurality of stations; a first station of the plurality of stations, the first station configured to insert a plurality of breakable portions of a breakable object into one of the plurality of breakable object holders; a second station of the plurality of stations, the second station configured to adjust and align a plurality of frangible breakable portions held within the holder; a third station of the plurality of stations, the third station configured to apply adhesive to the adjusted and aligned plurality of breakable portions of the breakable object; a fourth station of the plurality of stations, the fourth station configured to insert a frangible tube onto at least a portion of the plurality of frangible breakable portions having the applied adhesive; a fifth station of the plurality of stations at which the frangible object including the frangible portion and the frangible tube are inspected; a sixth station of the plurality of stations at which rejected breakables are collected; and A seventh station of the plurality of stations at which accepted breakables are collected.

16. The medical fluid container fragile assembly system according to claim 15, characterized in that: The guide plate is guided by a motor or pneumatically.

17. The medical fluid container fragile assembly system according to claim 15, characterized in that: The medical fluid container frangible assembly system includes at least one opening station at which no action is performed on the bracket or the destructible portion of the frangible.

18. The medical fluid container fragile assembly system according to claim 15, characterized in that: The medical fluid container frangible assembly system includes an auger positioned to deliver a frangible destructible portion to the first station.

19. The medical fluid container fragile assembly system according to claim 15, characterized in that: The first station is configured to translate the plurality of frangible breakable portions such that a first portion of each frangible breakable portion is inserted into the support and a second portion of each frangible breakable portion extends outwardly from the support.

20. The medical fluid container fragile assembly system according to claim 15, characterized in that: The second station includes a rod defining a plurality of apertures, the rod being translated toward the support so that the apertures pass through the frangible breakable portion to adjust and align the frangible breakable portion.

21. The medical fluid container fragile assembly system according to claim 15, characterized in that: The third station includes an adhesive applicator that is vertically dipped to receive adhesive and vertically raised to apply the adhesive to the breakable portion of the breakable.

22. The medical fluid container fragile assembly system according to claim 15, characterized in that: The third station includes a rotating mechanism configured to apply adhesive to a portion of the breakable portion of each of the breakables.

23. The medical fluid container fragile assembly system according to claim 15, characterized in that: The medical fluid container frangible assembly system includes an auger positioned to deliver the frangible tube to the fourth station.

24. The medical fluid container frangible assembly system according to claim 15, characterized in that: The fourth station is configured to use (i) a motor and a rotation-to-translation conversion device, or (ii) a pneumatic cylinder to translate the plurality of frangible tubes over at least a portion of the plurality of frangible breakable portions having the applied adhesive.

25. The medical fluid container frangible assembly system according to claim 15, characterized in that: The fifth station includes a visual inspection camera to inspect the breakables.

26. The medical fluid container frangible assembly system according to claim 25, characterized in that: The inspection at the fifth station includes at least one of: (i) analysis of the depth of the breakable portion of the frangible within the frangible tube, (ii) alignment of the breakable portion relative to the frangible tube, or (iii) the presence of the frangible tube.

27. The medical fluid container frangible assembly system according to claim 25, characterized in that: At the sixth station, each of the breakables of the rack is collected if any of the breakables is rejected.

28. The medical fluid container frangible assembly system according to claim 25, characterized in that: Only rejected breakables are collected at the sixth station.

29. The medical fluid container frangible assembly system according to claim 25, characterized in that: The rack is tilted to collect fragile objects at the sixth station.

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