CN111497344A - Medical fluid container molding system and method - Google Patents

Abstract

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

Description

Medical fluid container molding system and method

Technical Field

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

The renal system of a human may fail due to disease or other causes. In renal failure of any cause, there are many physiological disorders. The balance of water, minerals and excreta of the daily metabolic load is no longer possible in renal failure. During kidney failure, toxic end products of nitrogen metabolism (urea, creatinine, uric acid, etc.) may accumulate in blood and tissues.

Renal failure and reduced kidney function are treated by dialysis. Dialysis removes waste, toxins and excess water from the body that should be removed by a properly functioning kidney. Because this treatment is life-saving, dialysis treatment to replace kidney function is of vital importance to many people. A person with a failing kidney is unlikely to survive without replacing at least the filtering function of the kidney.

Peritoneal dialysis is one type of dialysis therapy commonly used to treat loss of renal function. Peritoneal dialysis uses a dialysis solution that is infused into the peritoneal cavity of a patient through a catheter that is implanted in the cavity. The dialysate contacts the patient's peritoneum, which is located in the peritoneal cavity. Waste, toxins and excess water pass from the patient's bloodstream through the peritoneum and into the dialysate. Due to diffusion and osmosis, transport of waste, toxins and water from the blood stream to the dialysis fluid takes place, i.e. an osmotic gradient takes place across the peritoneum. The used permeate is drained from the peritoneal cavity of the patient to remove waste, toxins and excess water from the patient. The above cycle is repeated.

There are a variety of 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 (drain) and allows the spent dialysate to drain from the peritoneal cavity. The patient then manually allows fresh dialysate to flow from the solution bag, through the patient's indwelling catheter and into the patient's peritoneal cavity. The patient may then disconnect the catheter from the solution bag and allow the dialysate to reside within the peritoneal cavity to transport waste, toxins and excess water from the patient's bloodstream to the dialysis solution. After the dwell period, the patient repeats the manual process described above. In CAPD, the patient performs multiple drainage, filling and dwell cycles within a day, for example, about four times per day.

Automated Peritoneal Dialysis (APD) is similar to CAPD in that dialysis treatment includes drain, fill, and dwell cycles. However, APD instruments automatically perform three to four cycles of peritoneal dialysis treatment, typically at night while the patient sleeps. The APD instrument is fluidly connected to an implanted catheter, to one or more solution bags, and to a drain bag.

APD instruments pump fresh dialysate from a dialysate source through a catheter into the peritoneal cavity of a patient and allow the dialysate to reside in the cavity so that transport of waste, toxins, and excess water from the patient's bloodstream to the dialysate solution can occur. The APD instrument then pumps the spent dialysate from the peritoneal cavity through the catheter to a drain. APD instruments are typically computer controlled so that dialysis treatment occurs automatically when a patient is connected to a dialysis instrument, for example, when the patient sleeps. That is, the APD system automatically and sequentially pumps fluid into the peritoneal cavity, allows for residence, pumps fluid out of the peritoneal cavity, and repeats the process.

As with manual handling, multiple cycles of liquid discharge, filling and dwell will occur during APD. "Final fill" is typically used at the end of APD, when the patient is separated from the dialysis machine during the day, it remains in the peritoneal cavity of the patient. APD eliminates the need for the patient to manually perform the drain, dwell and fill steps.

As described above, both CAPD and APD involve the use of solution and drain bags. The preparation of such bags requires a great deal of caution and skill. The bag must not leak and must be within a certain specification. The solution bag must also be sterilized to a level such that the solution can be safely delivered to the patient. The bag must also be correctly labeled so that the user or caregiver can determine that the patient is receiving the correct PD solution.

Historically, PD solution bags were made of polyvinyl chloride (PVC). However, in certain jurisdictions, PVC is prohibited for use in manufacturing solution bags or tubing for transporting fluids to and from patients. For this reason, non-PVC films and pipes have been developed. However, the application of these films and tubes in practice has proven difficult. PVC is generally easier to use than non-PVC materials. There are many processing variations of non-PVC materials that must be implemented, optimized, and validated for regulatory purposes.

In the forming, filling and sealing of PVC and non-PVC solution bags, bag forming is probably one of the most critical processes. Complicating the problem is the fact that PVC and non-PVC materials may vary from manufacturer to manufacturer, even from batch to batch from the same manufacturer. Therefore, a method of ensuring proper formation of solution bags when raw materials are changed is needed.

Disclosure of Invention

The present disclosure provides an improved medical fluid container, system, and method of making the same. In one embodiment, the medical fluid container comprises a medical fluid solution bag, such as a peritoneal dialysis solution bag and a medical fluid discharge bag, which are connected by tubing. 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 outer bag (over pouch) is provided to hold the medical fluid or PD fluid set together, including a non-PVC solution bag, a PVC drain bag, and tubing connecting the two bags.

In particular, in one general embodiment of the present disclosure, a solution bag forming system and method is disclosed. The bag forming system includes a bag forming machine having an upper die and a lower die. Each of the upper and lower molds includes a plurality of (e.g., three) mating dies (mating die) for simultaneously forming a plurality of solution bags. If the solution bag is made of PVC, the bag former performs high frequency or ultrasonic welding to seal the two PVC sheets together using a mating die. If the solution bag is made of a non-PVC material, the bag former 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 locator on each of the upper and lower dies that holds each die in a desired position and enables each die to be separated from one another.

It is desirable to place the dies separately from each other. The dies are provided separately so that if any die is damaged it is not necessary to handle or remove the remaining dies separately and replace or repair them. If the molds are formed together, they must be removed together and if any one mold is permanently damaged, the entire unitary mold must be discarded. It is also desirable to maintain an additional replacement die for replacing any individual die removed for repair or replacement, thereby minimizing downtime.

Providing the dies separately also allows each die to be leveled separately. Rather than having to level multiple dies together to achieve the best overall result for multiple integrated dies, the dies 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 a plurality of directions. In an alternative embodiment, shims are used instead of leveling screws. The upper die is adjustably fixed to the upper plate and the lower die is adjustably fixed to the lower plate.

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 the seal, the dies do not normally contact each other, but rather some space is left for the material thickness. Also, rather than 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 dies to the solution bag sheet.

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 so that the bags abut one another. In this way, (i) there is no wasted material between the pouches after they have been separated, and (ii) a single cut (slit) or cut (cut) forms the edges of two pouches, one on each of the two pouches, so that there is no need to further cut or slit those edges. In order for the pockets to abut each other, two adjacent dies also need to abut each other along a common seam between the two pockets.

In order to bring (i) the individual dies for the individual solution bags and (ii) the bags into abutment with each other, it is conceivable to provide (e.g., fasten) locators on each plate of the upper and lower dies, wherein the locators hold the corners of the dies so that each die is easily removed from its proper position and replaced. The locator also allows the mounting hole to be easily found and ensures that adjacent dies abut each other when the dies are inserted for operation.

As described above, the PVC solution bag is high frequency or ultrasonic welded, and the non-PVC solution bag is thermoformed. In either case, the energy supplied must be optimized for a particular 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, merely varying the amount of energy may not produce optimal 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.

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

The operator may slow down the cycle time if it is found that one or more of the dies cannot consistently reach the desired temperature and/or the energy level must be increased to a very high level to bring the dies to the desired temperature. The operator can also speed up the cycle time if it is found that the desired temperature can be reached even with lower die settings at lower energy levels. The adjustable medical fluid container cycle times of the present disclosure allow an operator to adjust the cycle time based on material differences between different manufacturers and between material lots from the same manufacturer.

Both PVC and non-PVC solution bags have a fill port tube and a sample port tube. In the past, these port tubes were welded into place at different stations throughout the bag forming operation. In a third principal embodiment, it is contemplated that in the bag-making system and method of the present disclosure, the port tube seal is formed at the same time that the primary bag seal is formed. In one embodiment, the fill port tube and the sample port tube are first preheated. The preheated fill port tube and preheated sample port tube are then positioned sealed onto (i) one of the PVC or non-PVC solution bag sheets, or (ii) between two PVC or non-PVC solution bag sheets. The solution bag primary seal is then applied using, for example, the mold and die previously mentioned. As described above, in one embodiment, the PVC solution bag and port tube sealing is performed using high frequency or ultrasonic welding, while the non-PVC solution bag and port tube sealing is performed using thermal energy. The complete solution bag with the fill port tube and the sample port tube is then cooled (e.g., by water cooling). The port tube seal of the present disclosure avoids the secondary energy impact to the solution bag sheet when the port tube is sealed separately, thus reducing the risk of leakage.

The frangible material on the fill port tube is in place, as described below. Then, after cooling, the solution bag need only receive the injection site in the sample port before stacking and transporting to the filling machine or before transporting along the conveyor to the filling station in the 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.

As described above, both PVC and non-PVC solution bags have fill port openings that contain a frangible material. The frangible is a variety of types of valves that the patient or caregiver opens to allow medical fluid (e.g., peritoneal dialysis ("PD") fluid) to flow from the solution bag to the patient. The frangible for PVC and non-PVC solution bags includes a hard plastic breakable portion and a fill port tube that is at least partially inserted over the hard plastic breakable portion. The frangible may then be connected to one or both of the fill port opening of the solution bag and a fill line of the disposable, which in the PD example leads to the patient's indwelling catheter for filling or draining the peritoneal cavity of the patient.

In a fourth principal embodiment, a multi-station carousel fragile assembly system 210 is provided to prepare the fragile for subsequent insertion into a solution bag or medical fluid container. In one embodiment, the carousel of the fragile assembly system has eight stations, seven of which include assembly steps, one being empty (free). The guide plate is provided with eight fragile material holders. Each of the fragile supports holds a plurality of fragile objects (for example, twelve fragile objects). The machine rotates or guides the guide plates so that each fragile support stops at eight different positions around the turntable.

At a first station of the carousel, the fragile support receives a plurality of hard plastic breakable portions of the fragile. In one embodiment, the bracket holds the hard plastic breakable portion by a portion of the hard plastic breakable portion that is not inserted into the frangible tube. A portion of the hard plastic breakable portion that is inserted into the frangible tube extends outwardly from the bracket. The frangible portion is held in one embodiment in an auger that feeds the frangible portion to a frangible portion insertion station that grasps the frangible portion in the proper orientation and inserts the portions (e.g., twelve portions) simultaneously into the stent.

In one embodiment, the second station of the carousel is an open position. At the third station of the carousel, in one embodiment, the frangible portions are adjusted or straightened so that they can properly receive the adhesive and frangible tube at a subsequent station. The adjuster or straightener may comprise a thickened rod, for example of aluminium, which comprises a series of holes or bores (one for each frangible portion). The rod translates over the frangible portion, straightening and aligning the portions in an orderly and evenly spaced manner.

At a fourth station of the carousel, adhesive is applied to the breakable portions of the frangible objects. In various embodiments, the binder for the PVC friable is cyclohexanone, and the binder for the non-PVC friable is cumene or isopropyl alcohol. In one embodiment, the adhesive applicator is (i) lowered to collect the adhesive and move the next rack into position, and then (ii) raised so that the plurality of adhesive application pads each receive the lower half of each frangible portion to apply adhesive thereto. In one embodiment, the bracket includes an internal structure for rotating each frangible portion within the adhesive application pad to evenly distribute the adhesive 360 degree sections around each frangible portion.

At the fifth station of the carousel, the breakable sections each receive a frangible tube. The frangible tubes, like the frangible portion, are in one embodiment held in an auger, which conveys the frangible tubes to a frangible tube insertion station that grasps the frangible tubes in the proper orientation and simultaneously inserts the frangible tubes (e.g., twelve tubes) onto the corresponding frangible portion breakable adhesive, which is then held in place by the adhesive that has just been applied to shape the frangible.

At the sixth station of the carousel, a visual inspection is performed on the fragile object. Digital cameras take images of all (e.g., twelve) fragile objects. The processing and memory operate with the camera to analyze the digital image for errors in any assembled fragile objects. For example, the processing and memory may analyze the depth of the frangible portion within the frangible port tube, the alignment of the frangible portion relative to the frangible tube, and/or the presence or absence of the frangible tube, etc. Visual inspection ensures consistent appearance and quality of the fragile objects.

At the seventh station of the carousel, a fragile object is rejected if a visual inspection detects a defect in any of a plurality (e.g., twelve) of the fragile objects. In one embodiment, the fragile support is tilted and all fragile, even fragile passing inspection, is discharged into the reject bin. The reject bin may be checked later to retrieve good fragile objects. In one embodiment, the stent includes structure for marking defective fragile objects, making it easier to retrieve good fragile objects. In another alternative embodiment, the stent includes a structure that removes only defective fragile objects from the stent. In any event, at the eighth station of the carousel, good fragile objects are collected. In one embodiment, the fragile support is tilted and all of the fragile is released into the good product bin.

In view of the disclosure of the present disclosure and the disclosure is not to be in any way limited, any aspect described in 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 stated otherwise.

In other aspects of the disclosure, any of the structures and functions shown in fig. 1-15 may be combined with any of the other structures and functions disclosed in fig. 1-15.

In accordance with the present disclosure and the above-described aspects, it is an advantage of the present disclosure to provide improved medical fluid container or bag forming systems and methods.

Another advantage of the present disclosure is to provide an improved medical fluid container or bag forming system, and associated method of increasing throughput.

Another advantage of the present disclosure is to provide an improved medical fluid container or bag forming system and associated method and methodology that improves maintenance and reduces downtime.

Yet another advantage of the present disclosure is to provide an improved medical fluid container or bag forming system and associated method that provides variable cycle times.

It is yet another advantage of the present disclosure to provide an improved medical fluid container or bag forming system and associated method of operational flexibility.

Another advantage of the present disclosure is to provide an improved medical fluid container or bag forming system and associated method of joining a port tube and a container or bag seal.

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

Yet another advantage of the present disclosure is to provide an improved fragile object forming system and associated method.

It is yet another advantage of the present application to provide an improved fragile object forming system and related method that aim to ensure the consistency and quality of fragile objects.

The advantages discussed herein may be found in one or some (and possibly not all) of the embodiments disclosed herein. Additional features and advantages are described herein, and will be apparent from, the following detailed description and the figures.

Drawings

FIGS. 1A and 1B are cross-sectional views of the top of a polyvinyl chloride ("PVC") solution container and a non-PVC container, respectively, showing different frangible embodiments.

Fig. 2 is a top view of one embodiment of a medical fluid container or bag forming system and associated method of the present disclosure.

Fig. 3 is a side view of one embodiment of a medical fluid container or bag former for use with the medical fluid container or bag former system of fig. 1 and associated methods.

Fig. 4A is an isometric view of one embodiment of an upper mold for the medical fluid container or bag-forming machine of fig. 2.

Fig. 4B is an isometric view of one embodiment of a lower mold for the medical fluid container or bag-forming machine of fig. 2.

Fig. 5 is a front view of one embodiment for providing variable cycle times to the container or bag forming system and associated method of fig. 1.

Fig. 6A-6D are schematic diagrams illustrating one embodiment for providing a single handling port tube and a medical fluid container or bag primary seal.

Fig. 7 is a top view of one embodiment of a medical fluid container or bag frangible assembly system and associated method of the present disclosure.

Fig. 8 is a perspective view illustrating one embodiment of how the bracket of the medical fluid container or bag frangible assembly system of fig. 7 retains a frangible object.

Fig. 9 is a perspective view illustrating one embodiment of a lever of the medical fluid container or bag frangible assembly system of fig. 7 for adjusting and aligning the frangible.

Fig. 10 is a perspective view illustrating one embodiment of an adhesive applicator of the medical fluid container or bag frangible assembly system of fig. 7 for applying an adhesive or solvent to the frangible portion of the frangible.

Fig. 11 is a side view illustrating one embodiment of a frangible tube insertion station of the medical fluid container or bag frangible assembly system of fig. 7, applying a frangible tube to a frangible object.

Fig. 12 is a side view of one embodiment of a visual inspection station illustrating the medical fluid container or bag frangible assembly system of fig. 7, the visual inspection station evaluating each of the assembled frangible objects and frangible tubes.

Fig. 13 is a front cross-sectional view of one embodiment of a display device of the medical fluid container or bag frangible assembly system of fig. 7, illustrating a first frangible visual inspection failure mode.

Fig. 14 is a front cross-sectional view of one embodiment of a display device of the medical fluid container or bag frangible assembly system of fig. 7, illustrating a second frangible visual inspection failure mode.

Fig. 15 is a front cross-sectional view of one embodiment of a display device of the medical fluid container or bag frangible assembly system of fig. 7, showing a third frangible visual inspection failure mode.

Detailed Description

Solution container and frangible article

Referring now to the drawings, and in particular to FIGS. 1A and 1B, various embodiments of the fragile object of the present application are illustrated. Fig. 1A shows a portion of a polyvinyl chloride ("PVC") solution container or bag 110a, while fig. 1B shows a portion of a non-PVC solution container or bag 110B. Each container or solution bag 110a and 110b includes a fill port tube 112 and an injection site port tube 114.

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

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 breakable rigid plastic portion 118 b. The non-PVC breakable rigid plastic portion 118b as shown is not sealed within the down tube, but is sealed directly within the fill port tube 112. The non-PVC frangible 116b includes an upper PVC pipe 122, which may be made of a non-PVC material and connected to a fill line that continues to a Y-site (not shown).

The PVC solution container or bag 110a and the non-PVC solution container or bag 110b are collectively referred to herein as solution containers or bags 110. The systems and methods discussed herein are equally applicable to PVC frangible 116a, non-PVC frangible 116b, and other frangible configurations, collectively and generally referred to herein as frangible 116. Likewise, the PVC breakable rigid plastic portion 118a and the non-PVC breakable rigid plastic portion 118b are collectively and generally referred to herein as breakable rigid plastic portions 118.

Medical fluid container forming system including individualized mold

Referring now to fig. 2, one embodiment of a medical fluid container molding system 10 and associated method is illustrated. The system 10, including all of the controllable structures described herein, is controlled by a control unit 20, the control unit 20 including one or more processors 22, one or more memories 24 operable with the processors 22, electronics 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 processors and memories. In fig. 2, the control unit 20 controls, in operational sequence, a port tube preheating station 30, a positioning (tack) sealing station 40, a container or bag forming machine 48, and a water cooling station 100. Each of these major portions of the system 10 is discussed in detail below.

Fig. 3, 4A and 4B show the bag former 48 in more detail. Fig. 3 shows that the bag forming machine 48 includes an upper die 50, the upper die 50 cooperating with a lower die 70 to form a plurality of containers or bags 110 simultaneously. The upper die 50 includes a first upper die 52, a second upper die 54, and a third upper die 56, each of which is separate from each other and individually attached to an upper plate 60 by fasteners 58 (e.g., bolts or screws). Each of the first upper die 52, the second upper die 54, the third upper die 56, the upper plate 60, and the fasteners 58 may be made of a medical grade metal, such as stainless steel or titanium.

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 separated from each other and separately attached to a lower plate 80 via fasteners 58 (e.g., bolts or bolts). Each of the first lower die 72, the second lower die 54, the third lower die 76, the lower plate 80, and the fasteners 58 may be made of a medical grade metal, such as stainless steel or titanium.

The upper die 50 and the lower die 70 form a mating pair as shown and are formed such that the upper dies 52 and 56 directly abut the upper intermediate die 54 and the lower dies 72 and 76 directly abut the lower intermediate die 74. In this manner, when the dies 50 and 70 are brought together to form the container or bag 110, the formed bags abut one another such that one slit (slit) forms the edges of two containers or bags 110 without waste therebetween and without the need for further processing of the two edges.

In the illustrated embodiment, shims 78 are provided to help level each die 52, 54, 56, 72, 74, 76 individually. Shims 78 are placed between the dies 52, 54, 56, 72, 74, and 76 and the respective plates 50 and 70. The dies 52, 54, 56, 72, 74 and 76 are then individually secured to the respective plates 50 and 70 by fasteners 58. Shims 78 enable dies 52, 54, 56, 72, 74, and 76 to be leveled in two directions (e.g., in a first direction of the horizontal arrow shown in fig. 3 and in a second horizontal direction perpendicular to the arrow). Providing separate dies as shown allows each die to be leveled individually rather than having to employ optimal global leveling results for all three dies as would be the case if three dies were formed together, e.g., as a single unitary piece with the upper and lower plates 60, 80.

The gasket 78 also allows the respective pairs of upper and lower dies 52 and 72, 54 and 74, and 56 and 76 to be spaced apart from each other with minimal clearance when the dies 50 and 70 are closed together for sealing. When the upper dies 52, 54 and 56 and lower dies 72, 74 and 76, respectively, are brought together to form the seal, the dies do not normally contact each other, but rather leave some room for the material thickness. Again, rather than having to employ the best overall results for multiple integrated dies, each individual die pair 52 and 72, 54 and 74, and 56 and 76 of the present disclosure can produce an individually optimized or minimized gap by optimizing position. When the upper and lower mating dies are brought together to form a seal, the smaller the gap between them, the more efficient the energy transfer from the dies to the solution bag sheet.

In an alternative embodiment, leveling screws (not shown) are used in place of shims 78 to adjust 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 dies 52, 54, 56, 72, 74, and 76 to plates 60 and 80, respectively. Leveling screws may be threaded 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, auxiliary fasteners (not shown), particularly for the upper dies 52, 54, 56, may be used to secure the dies to the plates 60 and 80.

The upper die 50 in fig. 3 is driven by first and second upper linear actuators 62a and 62b, the first and second upper linear actuators 62a and 62b being supported by the upper mounting member 14 connected to the frame 12. As indicated by the arrows, the linear actuators 62a and 62b translate the pistons 64a and 64b up and down under the control of the control unit 20. Pistons 64a and 64b are connected to upper plate 60 to move upper dies 52, 54, and 56 up and down together as indicated by the arrows. The linear actuators 62a and 62b are pneumatically driven cylinders or alternatively comprise electro-mechanically driven steppers or servomotors connected to a rotary to translation conversion device, such as a ball or lead screw.

The lower die 70 in fig. 3 is driven by first and second lower linear actuators 82a, 82b, the first and second lower linear actuators 82a, 82b being supported by the lower mounting member 16 connected to the frame 12. As indicated by the arrows, linear actuators 82a and 82b translate pistons 84a and 84b up and down under the control of control unit 20. Pistons 84a and 84b are connected to lower plate 80 to move lower dies 72, 74, and 76 up and down together as indicated by the arrows. The linear actuators 82a and 82b are pneumatically driven cylinders or alternatively comprise electro-mechanically driven steppers or servomotors connected to a rotation to translation conversion device, such as a ball or lead screw.

In one embodiment, the linear actuators 62a, 62b, 82a, and 82b may be precisely positioned to maintain a gap of less than 1 millimeter between the dies 52 and 72, 54 and 74, and 56 and 76 when the dies are brought together to form the container or bag 110. In the case where the linear actuators 62a, 62b, 82a and 82b are pneumatically driven, a finely adjustable hard stop (hardstop) may be used to set the end of travel of the weld location. In any event, when the dies 52 and 72, 54 and 74, and 56 and 76 are brought together to each form the desired weld gap, the control unit 20 causes energy to be applied to the dies 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 weld that seals the two PVC sheets 66 and 86 together. If the container or bag 100 is made of a non-PVC material, the energy applied is thermal energy that seals the two non-PVC sheets 66 and 86 together.

Fig. 3 generally illustrates that the container or bag sheets 66 and 86 may be fed from or through the upper feed roller 68, the lower feed roller 88a, the upper exit roller 68b, and the lower exit roller 88 b. In one embodiment, container or bag sheets 66 and 86 are fed by upper feed rollers 68a and lower feed rollers 88a, while upper exit rollers 68b and lower exit rollers 88b are motorized and under the control of control unit 20 pull and guide (index) the sheet through the exit rollers and between upper die 50 and lower die 70 at set intervals to simultaneously produce multiple (e.g., three) containers or bags 100 at each guide.

Fig. 4A and 4B show the upper die 50 and the lower die 70 in more detail. Fig. 4A shows an upper die 50 including upper dies 52, 54, and 56, each of which is secured to an upper plate 60 by fasteners 58. Fig. 4A also shows die 52 abutting die 54, and die 54 in turn abutting die 56. Each of the dies 52, 54 and 56 is provided with rounded corners, however it allows the inner locators 90 a-90 d to be located between the dies while the outer locators 92a and 92b are located outside of the dies 52, 54 and 56. The locators 90 a-90 d, 92a and 92b are each secured to the upper plate 60 by fasteners 98. Locators 90 a-90 d, 92a and 92b are shaped to correspond to the corners of the dies 52, 54 and 56 to facilitate removal and replacement of the individual dies from their correct positions. The locator also results in easy access to the mounting holes for the fasteners 58 and ensures that adjacent dies 52 and 54, 54 and 56 abut one another when the dies are inserted for operation.

Fig. 4B shows a lower die 70 including lower dies 72, 74, and 76, each of which is fastened to a lower plate 80 by fasteners 58. Fig. 4B also shows die 72 abutting die 74, and die 74 in turn abutting die 76. Each of the dies 72, 74 and 76 is provided with rounded corners, however, it allows the inner locators 94 a-94 d to be located between the dies while the outer locators 96a and 96b are located outside of the dies 72, 74 and 76. The locators 94 a-94 d, 96a and 96b are respectively fixed to the lower plate 80 by fasteners 98. Locators 94a to 94d, 96a and 96b are shaped to correspond to the corners of the dies 72, 74 and 76 to facilitate removal and replacement of the individual dies from their correct positions. The locators also make it easy to find mounting holes for fasteners 58 and ensure that adjacent dies 72 and 74, 74 and 76 abut each other when the dies are inserted for operation.

Variable cycle time for container forming machines

Fig. 5 shows one embodiment of a setup screen of the user interface/display device 28 of the control unit 20 of the system 10. The control unit 20 is programmed via the setup screen of fig. 5 to allow the operator to vary the cycle time. The cycle time may be the time between two identical actions or processes associated with the container or bag former 48, for example, in connection with the guidance of the machine 48. For machine 48, a logical cycle time is (i) the time between when the PVC or non-PVC sheets 66 and 86 begin to move up the mold 50 and down the mold 70 and when the same area of material leaves the mold with the formed bag, i.e., the lead 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 are brought together. In either case, for example, the cycle time may not be sufficient to bring the molds 52, 54, 56, 72, 74, 76 to the desired temperature. The setup screen of fig. 5 allows the operator to adjust the cycle time to optimize the bag forming process.

As shown in fig. 5, an operator using a touch screen keyboard may, for example, type in 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. The setting screen of fig. 5 notifies the user that in the Cycle Time Mode (Cycle Time Mode), the speeds of the 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 drum speed. On the settings screen of fig. 5, the user also sets the energy level, e.g., switches between low, medium, and high energy levels, until the desired setting is found. The energy level may also be set quantitatively, for example, by setting a desired mold temperature for contacting sheets 66 and 86. As discussed herein, if the container or bag 100 is made of PVC, the bag former 48 performs high frequency or ultrasonic welding through the use of mating dies 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 mating 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 dies 52, 54, 56, only to the lower dies 72, 74, 76, or to both the upper and lower die sets.

Using the setup screen of fig. 5, the operator may slow (increase) the cycle time if it is found that one or more of the dies 52, 54, 56, 72, 74, or 76 (each of which may have a thermocouple temperature reading at the display device 28 in one embodiment) cannot consistently reach the desired temperature and/or the energy level must be increased to an extremely high level to bring the die to the desired temperature. If it is found that the dies 52, 54, 56, 72, 74 or 76 consistently reach the desired temperature even at low level settings, the operator can speed up (reduce) the cycle time. The adjustable medical fluid container cycle time of the present application advantageously allows an operator to adjust for material differences between manufacturers and between different material lots from the same manufacturer.

Integrated container and port tube seal

Referring now to fig. 2 and 6A-6D, a container or bag forming method for use with the handling system 10 of the present application is shown. The fill port tube 112 and injection site port tube 114 are typically sealed to one of the sheets 66 and 86 of the solution bag or container 110 prior to sealing the sheets 66 and 86 together. Doing so requires a separate operation and also subjects the sheets 66 and 86 to a secondary energy impact, creating a risk of leakage. In this application, the port tube seal and the container or bag seal are integrated.

In fig. 6A, the fill port tube 112 and the injection site port tube 114 are preheated at the heated portion of the tubes labeled H. The fill port tube 112 may or may not have a frangible mass 116 as shown. Fig. 2 shows that the system 10 includes 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 a conveyor 32 that conveys the heated portions H (fig. 6A) of the port tubes 112 and 114 below or inside a heater 34, which heater 34 may be a radiant heater, a convection heater (e.g., hot air), a resistance heater, or a combination thereof. The heater 34 heats the heated portions 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. The adhesive welds may be performed at, for example, 200 ℃ to 500 ℃, depending on the material used for the port tubes 112 and 114 and the sheets 66 and 86. The preheat temperature of the heating section H is thus a percentage of the tack welding temperature, for example, 100 ℃ to 300 ℃.

In fig. 6B, the preheated fill port tube 112 and injection site port tube 114 are next tack welded at the heated portion H of the tube labeled in fig. 6A, now labeled E, which represents the energy applied to tack weld one or both sheets 66 and 86 of the molded container or bag 110. Fig. 2 shows that the system 10 comprises a positioning and sealing station 40 under the control of the control unit 20. The positional sealing 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 positional sealer 42. If the port tubes 112, 114 and the sheets 66 and/or 86 are made of PVC, the positional sealer 42 performs high frequency or ultrasonic welding to positionally seal the port tubes 112 and 114 to one or both of the sheets 66 and/or 86 at energy region E in FIG. 6B. If the port tubes 112, 114 and sheets 66 and/or 86 are made of a non-PVC material, the positional sealer 42 provides heat to positionally seal the port tubes 112 and 114 to one or both of the sheets 66 and/or 86 at energy region E in FIG. 6B.

In fig. 6C, the preheated and tack welded fill port tube 112, injection site port tube 114, and sheets 66 and 86 are next formed together to seal the primary container or bag at energy zone E in fig. 6C, which extends along the entire boundary of container or bag 110. One suitable structure and method for forming the primary seal E of fig. 6C for a container or bag forming machine 48 is shown and described in fig. 2, 3, 4A and 4B. It should be understood, however, that the method illustrated in fig. 6A-6D is not limited to the use of a bag former 48. Alternatively, for example, the sheet for the container or bag 110 may be first separated before beginning the preheating in fig. 6A.

In fig. 6D, the fill port tube 112 and the injection site port tube 114 are now fully sealed to the sheets 66 and 86 that have been subjected to the primary sealing energy E in fig. 6C to at least form the shape of the container or bag, and then cooled at the water cooling station 100. The water cooling station 100 may be configured to spray water W as shown. The water cooling station 100 may optionally include a water bath for cooling. In either case, the water cooling station 100 may be configured to cool (i) only the portion of the container or bag 110 that includes the port tubes 112, 114, or (ii) the entire container or bag 110 that includes the port tubes 112, 114. In one embodiment, water cooling occurs as the containers or bags 110 are conveyed through or past the water cooling station 100.

Fragile object assembling system

Referring now to fig. 7-12, in a fourth principal embodiment of the present disclosure, a multiple station frangible object assembly system 210 is provided to prepare the frangible objects 116 for insertion into the fill port tube 112. The turntable or guide plate 212 of the fragile assembly system 210 has eight stations in one embodiment, seven of which include assembly steps, one being empty or open. Guide plate 212 carries eight frangible supports 232 (fig. 8-12) and has an octagonal shape in the illustrated embodiment (but could have more or fewer supports and different corresponding shapes). The handling equipment of the different stations of the fragile object assembly system 210 discussed below is generally oriented perpendicular to the sides of octagonal guide plate 212. Each frangible support 232 holds a plurality of frangible objects 116, for example twelve frangible objects. The fragile object 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 guide (indexer) 214. In either case, guide 214 rotates or guides guide plate 212 such that each fragile support 232 stops at eight different positions around the carousel.

The fragile assembly system 210 shown in fig. 7 includes a first auger (auger)216 for supplying the fragile breakable portion 118 and a second auger 218 for supplying the tube 122 of the fragile. The system 210 includes all of the 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, the control unit 220 including one or more processors 222, one or more memories 224 operating with the processors 222, electronics 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 processes and memories.

Fig. 7 and 8 illustrate a first station or frangible portion insertion station 230 of the turntable or guide plate 212, wherein a frangible support 232 receives the plurality of hard plastic breakable portions 118 of the frangible objects 116. As shown in fig. 7, the auger 216 feeds the frangible portion to the frangible portion insertion station 230. The auger 216 of the frangible portion in the illustrated embodiment is a circular auger in which the frangible portion 118 becomes increasingly separated as the portions move radially outward along the circular path of the auger. A separate frangible portion 118 is then inserted (e.g., from top to bottom) into the mating hole of the frangible portion inserter 238 of fig. 8. A frangible portion inserter 238 is connected to the rotating rod 236. Rotating rod 236 and frangible element breakable portion inserter 238 can each be made of metal (e.g., stainless steel or aluminum) or strong plastic (e.g., teflon or nylon).

As indicated by the double-headed rotation arrows in fig. 8, the rotating rod 236 is electromechanically or pneumatically rotated in clockwise and counterclockwise directions. Specifically, the rotating lever 236, and thus the frangible portion inserter 238, is rotated clockwise 90 degrees downward to the position shown in fig. 8 for receiving the frangible portion 118 (e.g., twelve portions). Rotating rod 236, and thus frangible element breakable portion inserter 238, rotates 90 degrees counterclockwise and upward and then delivers frangible element breakable portion 118 to rack 232.

The bracket 232 as shown in fig. 8 includes a bushing 234 (e.g., a bushing 234 for each frangible portion 118). The bracket 232 and bushing 234 may each be made of metal (e.g., stainless steel or aluminum) or strong plastic (e.g., teflon or nylon). A bushing 234, as described below, is rotatably coupled within the bracket 232. Once the rotary lever 236, and thus the frangible portion inserter 238, is rotated clockwise and upward 90 degrees, the rotary lever 236 and the frangible portion inserter 238 are translated electromechanically or pneumatically such that the frangible portion 118 is transferred from the frangible portion inserter 238 together into the bushing 234 of the carriage 232, as indicated by the double-headed straight arrow in fig. 8. As shown in fig. 8, each bracket 232 is mounted flush with one of the octagonal edges of guide plate 212 so that rotating rod 236 and frangible element breakable portion inserter 238 do not have to translate on guide plate 212. After delivering the frangible portion 118 to the bushing 234 of the carriage 232, the rotating rod 236 and frangible portion inserter 238 are rotated back to the position of FIG. 8 and rotated 90 degrees clockwise to receive a new set of frangible portions 118.

In one embodiment, the second or open station 240 of the carousel or leader 212 is an open or empty station. Fig. 7 shows a rack 232 holding the frangible portion 118 at a second or opening station 240.

Fig. 7 and 9 illustrate a third or frangible breakable portion adjustment and alignment station 250 of the turntable or guide plate 212, wherein the frangible breakable portion 118 is aligned to ultimately receive the frangible tube 122. As shown in fig. 9, the shelf 232 holds the frangible portion 118 such that the portion of the frangible portion 118 inserted into the frangible tube 122 extends outwardly from the shelf 232. The alignment station 250 includes a thickened alignment rod 252 having a cylindrical alignment bore 254 (e.g., apertures 254 for each portion of each frangible breakable portion 118 extending from the bracket 232, the alignment rods 252 may be made of metal (e.g., stainless steel or aluminum) or strong plastic (e.g., teflon or nylon), as shown by the double-headed straight arrows in figure 9, the alignment rod 252 is electromechanically or pneumatically translated toward the carriage 232 such that the aperture 254 extends over the portion of the frangible portion 118 extending from the carriage 232, this action adjusts and aligns each frangible portion 118 within the carriage 232 into an orderly and evenly spaced state, so that the frangible portion 118 is in the correct position to receive the frangible tube 122 at a later station, after adjustment, the alignment rod 252 translates back to the position shown in fig. 9 to wait for the next carriage 232.

It should be appreciated that while carriage 232 is undergoing the alignment operation associated with fig. 9, a second carriage connected to guide plate 212 at station 230 is undergoing insertion of frangible portion 118 as just described in connection with fig. 8.

Fig. 7 and 10 show a fourth or frangible adhesive application station 260 of the turntable or guide plate 212, wherein an adhesive or solvent is applied to a portion of the exposed portion of the frangible portion 118. The adhesive application station 260 in the embodiment shown in fig. 10 has an adhesive applicator 262 that is electromechanically or pneumatically translated downward, as indicated by the single vertical arrow in fig. 10, into and out of a trough 270 filled with adhesive or solvent 272. Both the adhesive applicator 262 and the groove 270 may be made of metal (e.g., stainless steel or aluminum) or strong plastic (e.g., teflon or nylon). In various embodiments, the binder or solvent 272 for the PVC frangible 116 is cyclohexanone, and the binder or solvent 272 for the non-PVC frangible 116 is cumene or isopropyl alcohol.

While the groove 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 individually applying the adhesive or solvent 272 to each of the multiple application regions 264 of the adhesive applicator 262 with a brush or syringe. However, in any application embodiment, as adhesive applicator 262 translates beneath guide plate 212, application area 264 of adhesive applicator 262 is provided with adhesive or solvent 272 or covered by adhesive or solvent 272. In the illustrated embodiment, the application region 264 is a U-shaped cut formed along the top edge of the adhesive applicator 262.

Once the application region 264 of the adhesive applicator 262 is covered by the adhesive or solvent 272, the adhesive applicator 262 is electromechanically or pneumatically translated upward, as indicated by the single vertical arrow in fig. 10, which aligns the application region 264 with the exposed portion of the frangible intraregistry 118, as indicated by the series of smaller upward arrows in fig. 10. Once in alignment, the control unit 220 causes the shaft 266 extending to the rear of the carriage 232 to engage a rotary actuator 268 (fig. 7), such as a stepper motor or servo motor, located at the adhesive application station 260. In various embodiments, the shaft 266 is connected to each bushing 234 within the interior of the bracket 232 by a belt and gear, belt and pulley, mating gears, etc., such that when the rotary actuator 268 rotates the shaft 266, each bushing 234 and the frangible portion 118 retained therein likewise rotate. The rotary actuator 268 may rotate the shaft 266, the bushing 234, and the frangible portion 118 in a single direction or in multiple directions (as indicated by the two rotational arrow directions around the bushing 234 in fig. 10), and may rotate as many times in one or more rotational directions as desired, which allows the exposed portion of the circular frangible portion 118 to pick up adhesive or solvent evenly around a 360 degree portion of each exposed portion.

The above-described adhesive application process is repeated for each bracket 232. It should be understood that while the frangible portion 118 receives adhesive or solvent at station 260 in fig. 10, the adjacent leg 232 connected to the guide plate 232 is undergoing the alignment operation associated with fig. 9, while the second leg connected to the guide plate 212 at station 230 is undergoing the insertion of the frangible portion 118 described in fig. 8.

Fig. 7 and 11 illustrate a fifth or frangible tube assembly station 280 of the turntable or guide plate 212, wherein the frangible tube 122 is simultaneously assembled over the exposed adhesive-laden portion of the frangible article breakable portion 118. In one embodiment, similar to the frangible portion 118, the frangible tube 122 is supplied by an auger 218, and the auger 218 conveys the frangible tube 122 to a frangible tube inserter 290 (fig. 7). Frangible tube auger 218 in the illustrated embodiment is a circular auger in that frangible tube 218 becomes increasingly separated as it moves radially outward along the circular path of the auger.

The frangible inserter 290 shown in fig. 11 includes a lower frangible tube holding tray 282 that holds separate frangible tubes 122 (e.g., twelve tubes 122 total) for each frangible portion 118. The frangible inserter 290 also includes a tube slider 284 that is electro-mechanically or pneumatically driven downward by a piston 286 as indicated by the vertical arrow in FIG. 11, which causes the tube slider 284 to engage the top of each frangible tube 122. The tubing 122 is clamped between a tubing retention tray 282 and a tubing slider 284, the tubing retention tray 282 and the tubing slider 284 being translated together, either electromechanically or pneumatically, as indicated by the horizontal arrows in fig. 11, such that the frangible tubing 122 simultaneously slides onto the frangible portion 118, and the frangible tubing 122 is then sealed in place by the adhesive or solvent 272 applied to the exposed portion of the frangible portion 118 at the previous station. The frangible portion 118 is held in place at the bracket 232 as shown in FIG. 11.

The above-described frangible tube 122 insertion process is repeated for each stent 232. It should be understood that while the frangible portion 118 receives the frangible tube 122 at station 280 of FIG. 11, the frangible portion 118 of the adjacent leg 232 is receiving adhesive or solvent at station 260 in FIG. 10, the next adjacent leg 232 connected to the guide plate 232 is undergoing the alignment operation associated with FIG. 9, and the third leg connected to the guide plate at station 230 is undergoing the insertion of the frangible portion 118 described in FIG. 8.

Fig. 7 and 12 show a sixth or visual inspection station 300 of the turntable or guide plate 212 in which the frangible objects 116 (including the breakable sections 118 and frangible tubes 122) are inspected to confirm that they are properly connected. Visual inspection ensures consistent appearance and quality of the fragile objects 116. Fig. 7 and 12 show that the vision inspection station 300 is provided with a camera 302, such as a digital camera, located within a housing 304, which takes images of the insertion of the fragile object. One suitable camera for camera 302 is provided by connaissance Corporation of Natick county, massachusetts (Cognex Corporation, Natick, MA, USA 01760-. The camera 302 may have its own processing and memory to store and execute vision software. The camera 302 may alternatively be output, wired or wirelessly, to vision software stored and executed at the one or more processors 222 and memory 224 of the control unit 220. The control unit 220 and the camera 302 may each comprise a transceiver or a transmitter/receiver for wireless communication. Suitable vision software may be provided by the camera manufacturers listed above, such as VisionPro^TMOr VisionPro ViDi^TMAnd (3) software.

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 programs and algorithms of the system 210. The vision software may perform a separate grayscale evaluation, such as the three evaluations discussed below for each fragile insertion. Using grayscale for evaluation helps to speed up the analysis so that all evaluations can be performed before the guiding board 212 is guided.

In the embodiment shown in fig. 12, camera 302 is mounted on housing 304. In alternative embodiments, the camera 302 may be mounted at other locations within the housing 304. In any case, the focal point (dashed line) of the camera 302 is at the connection between the frangible portion 118 of the frangible object and the frangible tube 122. In one embodiment, control unit 220 is programmed such that upon completion of the guidance of guidance panel 212 automatically triggers camera 302 for image capture.

FIG. 12 also illustrates that, in one embodiment, the visual inspection station 300 includes a light source 306, the light source 306 being located on an opposite side of the frangible portion 118 and frangible tube 122 from the camera 302. in one embodiment, the light source 306 includes a light array, such as a light emitting diode ("L ED"), which may be white or colored (e.g., blue or red), L ED. the control unit 220 may control the light source 306 to illuminate when needed, such as when the guide station 212 completes the guide, to improve the quality of the image captured by the camera 302.

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 either evaluation fails, the vision software outputs "fail" to the control unit 220. In another embodiment, the vision software outputs a gray count for each evaluation (e.g., three evaluations) and the control unit 220 is programmed to determine the pass or fail of each evaluation. Here, too, if the result of each evaluation is passed, the control unit 220 determines that "pass" as a whole. If the result of either evaluation fails, the control unit 220 determines that "fails" as a whole.

At the seventh or rejected fragile collection station 320 (fig. 7) of the turntable or guide plate 212, the fragile is rejected if the vision inspection station 280 detects a flaw in any one of a plurality (e.g., twelve) of fragile items. In one embodiment, the fragile support 232 is tilted (using a structure similar to the rotating bar 236) and all fragile objects, even those passing inspection, are rejected into a reject bin located below, for example, the rejected fragile object collection station 320. The reject bin may be inspected later to retrieve good fragile objects. In one embodiment, rejected fragile collection stations 320 passing through the bushings 234 can mark defective fragile, thereby facilitating retrieval of good fragile. In another alternative embodiment, the rejected fragile collection station 320 passing through the sleeve 234 can remove only defective fragile from the rack 232.

In any case, good fragile is collected at an eighth or accepted fragile collection station 330 (fig. 7) of the turntable or guide plate 212. In one embodiment, the fragile support 232 is tilted (using a structure similar to the rotating bar 236) and all of the fragile is released into a good product bin, which is located, for example, below the accepted fragile collection station 330.

It should be understood that all of the previously described stations, except the open station 240, are performing their operations simultaneously when the described visual inspection is performed at station 300 and the rejected and accepted fragile collections are performed at stations 320 and 330.

Visual inspection assessment

Referring now to fig. 13-15, exemplary screens from the user interface/display 228 of the medical fluid container fragile assembly system 210 are shown for illustrating different failure modes involving rejected or failed fragile assemblies. Failure modes may include any one or more of the following: (i) improper depth of insertion of the frangible tube, (ii) absence of the frangible tube, or (iii) insertion of the frangible tube at a misaligned angle. In one embodiment, if any image of the fragile assembly fails any one of the analysis modes, the fluid container or bag 110 is rejected.

Fig. 13 shows an example of a failed insertion depth evaluation. Here, the frangible portion 118 is not inserted deep enough into the upper tube 122 of the frangible object 116. The result of the depth evaluation is thus "fail".

FIG. 14 shows a failed fragile missing evaluation example. Here, the frangible tube 122 is completely absent. The result of the fragile occurrence assessment is a "failure".

FIG. 15 shows an example of a failed fragile alignment assessment. Here, the frangible tube 122 is inclined relative to the frangible portion 118 beyond a predetermined angular value (e.g., greater than 10 degrees) and is not considered a well-sealed engagement. Therefore, the result of the alignment evaluation is "failure".

It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present application and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims. For example, although the present systems and methods are primarily described in connection with peritoneal dialysis bags, it should be understood that the present systems and methods are applicable to other types of parenteral bags, such as blood treatment bags, medical fluid delivery bags, saline bags, and the like. Additionally, although the present systems and methods are primarily described in connection with medical fluid bags, it should be understood that the present systems and methods are applicable to other types of medical fluid containers, such as more rigid medical fluid containers.

List of component numbers

10-medical fluid container forming system

12-System framework

14-Upper mounting Member connected to frame

16-lower mounting member connected to the frame

20-control unit for a container forming system

22-processor of control unit of container forming system

24-memory for a control unit of a container-forming system

26-electronics for a control unit of a container forming system

28-user interface/display device for control unit of bag forming system

30-port tube preheating station

Conveyor of 32-port pipe preheating station

34-preheating station heater

40-position sealing station

42-position sealer

48-Container or bag Forming machine

50-upper die

52-first Upper die of the Upper die

54-second upper die of upper die

56-third Upper die of Upper die

58-die fastener

60-upper plate

62 a-first upper linear actuator

62 b-second Upper Linear actuator

64 a-piston of first upper linear actuator

64 b-piston of second Upper Linear actuator

66-bag-on sheet

68 a-feed roller for bag-on sheet

68 b-exit roller for bag-on sheet

70-lower die

72-first lower die of lower die

74-second lower die of lower die

76-third lower die of lower die

78-shim

80-lower plate

82 a-first lower linear actuator

82 b-second lower linear actuator

84 a-piston of first lower linear actuator

84 b-piston of second lower linear actuator

86-lower bag sheet

88 a-feed roller for bagging sheet

88 b-exit roller for bagging sheet

90a to 90 d-upper moulds

92a and 92 b-locators on the outside of the upper moulds

94a to 94 d-positioner between lower moulds

96a and 96 b-locators on the outside of the lower mold

98-locator fastener

100-Water Cooling station

110 a-polyvinyl chloride ("PVC") solution container or bag, generally referred to herein as solution container or bag 110

110 b-non-PVC solution container or bag, generally referred to herein as solution container or bag 110

112-fill port tube

114-injection site port tube

116a-PVC friable material, generally referred to herein as friable material 116

116 b-non-PVC friable material, generally referred to herein as friable material 116

118a-PVC breakable rigid plastic portion, generally referred to herein as breakable portion 118

118 b-non-PVC breakable rigid plastic portion, generally referred to herein as breakable portion 118

Lower pipe of 120-PVC fragile object

122-upper tube for fragile articles

210-medical fluid container fragile assembly system

212-guide plate of medical fluid container fragile assembly system

214-actuator for guiding a plate

216-auger for supplying breakable portions of fragile objects

218-screw conveyor for pipes for supplying fragile objects

220-control unit of medical fluid container fragile object assembling system

222-processor for a control unit of a medical fluid container fragile assembly system

224-memory for a control unit of a system for frangible assembly of medical fluid containers

226-electronics for a control unit of a system for frangible assembly of medical fluid containers

228-user interface/display device for control unit of frangible assembly system for medical fluid containers

230-fragile part insertion station

232-bracket

234-bracket bushing

236-rotating rod

238-breakable part inserter

240-open station

250-fragile object breakable part adjusting and aligning station

252-alignment rod

254-cylindrical alignment hole in alignment rod

260-adhesive application station

262-adhesive applicator

264-application area of adhesive applicator

266-shaft extending into the rear of the bracket

268-Rotary actuator of adhesive application station

270-groove 270

272-Binders or solvents

280-Fragile tube Assembly station

282-tube holding tray

284-tube slider

286-piston connected to tube slider

290-fragile inserter

300-vision inspection station

302-digital camera

304-digital camera shell

306-light source of digital camera

320-rejected fragile Collection station

330-accepted Fragile Collection station

Claims (39)

1. A medical fluid container molding machine, comprising:

the upper die comprises a first upper die and a second upper die;

a lower die comprising a first lower die and a second lower die, the upper die and the lower die being aligned such that the first upper die is operably aligned with the first lower die and the second upper die is operably aligned with the second lower die;

an upper plate for adjustably and separately receiving the first and second upper dies such that the first and second upper dies can be individually leveled; and

a lower plate for adjustably and individually receiving the first and second lower dies such that the first and second lower dies can be individually leveled.

2. The medical fluid container molding machine of claim 1, wherein said upper mold further comprises a third upper mold that is adjustably and independently received by said upper plate such that said first, second and third upper molds are individually levelable.

3. The medical fluid container molding machine of claim 2 wherein said lower die further comprises a third lower die operably aligned with said third upper die, said third lower die being adjustably and independently receivable by said lower plate such that said first, second and third lower dies may be individually leveled.

4. The medical fluid container molding machine of claim 1 wherein said first upper die abuts said second upper die and said first lower die abuts said second lower die such that a first medical fluid container and a second medical fluid container are molded adjacent to each other and a single cutout forms a first side of said first medical fluid container and a first side of said second medical fluid container.

5. The medical fluid container molding machine of claim 4 further comprising a third upper die operably aligned with a third lower die, wherein said third upper die abuts said second upper die and said third lower die abuts said second lower die such that said second and third medical fluid containers are molded adjacent to each other and a single second cutout forms a second side of said second medical fluid container and a first side of said third medical fluid container.

6. The medical fluid container molding machine of claim 1, wherein said first upper die, second upper die, first lower die, and second lower die are each adjustably and independently connected to said upper and lower plates by a plurality of leveling fasteners.

7. The medical fluid container molding machine of claim 1, including a plurality of upper locators between said first upper die and said second upper die and a plurality of lower locators between said first lower die and said second lower die, said upper locators facilitating removal and replacement of said first upper die and said second upper die and said lower locators facilitating removal and replacement of said first lower die and said second lower die.

8. The medical fluid container molding machine of claim 7, wherein said plurality of upper locators are connected to said upper plate and said plurality of lower locators are connected to said lower plate.

9. The medical fluid container molding machine of claim 7 wherein said upper locator is located between rounded corners of said first upper die and said second upper die and said lower locator is located between rounded corners of said first lower die and said second lower die.

10. The medical fluid container molding machine of claim 9, wherein said machine includes additional upper locators positioned around the bullnose of said first upper die and said second upper die and additional lower locators positioned around the bullnose of said first lower die and said second lower die.

11. A medical fluid container molding machine, comprising:

an upper die including an upper die;

a lower die comprising a lower die, the upper die and the lower die being aligned such that the upper die is operably aligned with the lower die;

a control unit that controls actuation of the upper and lower dies such that the upper and lower dies come together and apply energy to mold a medical fluid container, the control unit configured to control: (i) an amount of energy applied by the upper and lower dies, and (ii) a cycle time, which is an interval of time during which the upper and lower dies are brought together to obtain a continuous medical fluid container, or an interval of time during which movement of medical fluid container material toward the upper and lower dies is initiated to obtain a continuous medical fluid container; and

a user interface in operable communication with the control unit, wherein the cycle time is variable, and wherein a user is able to input a desired cycle time via the control unit.

12. The medical fluid container molding machine of claim 11 wherein said upper die is a first upper die and said upper die comprises a second upper die, said lower die is a first lower die and said lower die comprises a second lower die, said upper and lower dies positioned such that said first upper die is in operable alignment with said first lower die and said second upper die is in operable alignment with said second lower die.

13. The medical fluid container molding machine of claim 11, wherein said amount of energy is applied by both said upper mold and said lower mold, or by a single one of said upper mold or said lower mold.

14. The medical fluid container molding machine of claim 11 wherein for each cycle, medical fluid container material is directed between said upper and lower dies.

15. The medical fluid container molding machine of claim 11 wherein said desired cycle time enables said upper and lower dies to reach a desired temperature.

16. A medical fluid container molding system, comprising:

a port tube pre-heating station configured to pre-heat at least one of a fill port tube or a sample port tube;

a positional sealing station configured to positionally 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 die including an upper die;

a lower die comprising a lower die, an upper die and a lower die: (i) aligned such that the upper die is operably aligned with the lower die, and (ii) configured to ultimately seal at least one of the position sealed fill port tube or sample port tube to the first and second medical fluid container materials and seal the first and second medical fluid container materials together to form the medical fluid container.

17. The medical fluid container molding system of claim 16, further comprising a cooling station constructed and arranged to cool the molded medical fluid container.

18. The medical fluid container molding system of claim 16, further comprising an injection site insertion station configured to insert an injection site into the sample port tube.

19. The medical fluid container molding system of claim 16, wherein said fill port tube includes an inserted frangible breakable portion.

20. The medical fluid container molding system of claim 16, wherein said positioning and sealing station is configured to seal at least one of said first medical fluid container material or second medical fluid container material around a portion of a diameter of at least one of said preheated fill port tube or sample port tube.

21. The medical fluid container molding system of claim 16, wherein said upper and lower dies are configured such that said first and second medical fluid container materials are commonly and ultimately sealed around an entire diameter of at least one of said preheated fill port tube or said sample port tube.

22. The medical fluid container molding system of claim 16, wherein said port tube preheating station is configured to preheat said fill port tube and said sample port tube, said positional sealing station is configured to positionally seal said preheated fill port tube and said preheated sample port tube to at least one of said first medical fluid container material or second medical fluid container material, and said upper and lower dies are configured to ultimately seal said positionally sealed fill port tube and sample port tube to said first medical fluid container material and second medical fluid container material.

23. The medical fluid container molding system of claim 16, wherein said upper mold is a first upper mold and said upper mold comprises a second upper mold, said lower mold is a first lower mold and said lower mold comprises a second lower mold, said upper and lower molds being aligned such that said first upper mold is operably aligned with said first lower mold and said second upper mold is operably aligned with said second lower mold, and said upper and lower molds being configured to ultimately seal at least one of the following to said first and second medical fluid container materials: (i) a first and a second position-sealed fill port tube, or (ii) a first and a second position-sealed sample port tube.

24. The medical fluid container molding system of claim 16, wherein said first and second medical fluid container materials comprise polyvinyl chloride (PVC) sheets or non-PVC sheets.

25. A medical fluid container fragile assembly system, comprising:

a guide plate comprising a plurality of fragile object holders, the guide plate guiding each of the fragile object holders to be brought to each of a plurality of stations;

a first station of the plurality of stations configured to insert a plurality of breakable portions of a frangible object into one of the plurality of frangible object holders;

a second station of the plurality of stations configured to adjust and align a plurality of frangible portions held within the holder;

a third station of the plurality of stations configured to apply adhesive to the adjusted and aligned plurality of frangible portions;

a fourth station of the plurality of stations configured to insert a frangible tube over at least a portion of the plurality of frangible portions having the applied adhesive;

a fifth station of the plurality of stations at which to inspect a frangible object comprising the frangible portion and the frangible tube;

a sixth station of the plurality of stations at which rejected fragile objects are collected; and

a seventh station of the plurality of stations at which accepted fragile material is collected.

26. The medical fluid container fragile assembly system according to claim 25, wherein the guide plate is guided by motor or pneumatic means.

27. The medical fluid container frangible assembly system of claim 25, comprising at least one opening station where no action is performed on the scaffold or the frangible portion.

28. The medical fluid container fragile assembly system according to claim 25, wherein said medical fluid container fragile assembly system comprises an auger positioned to convey a fragile portion to said first station.

29. The medical fluid container frangible assembly system of claim 25, wherein the first station is configured to translate the plurality of frangible portions such that a first portion of each frangible portion is inserted into the scaffold and a second portion of each frangible portion extends outwardly from the scaffold.

30. The medical fluid container frangible assembly system of claim 25, wherein the second station includes a rod defining a plurality of apertures, the rod translating toward the bracket such that the apertures pass through the frangible breakable portion to adjust and align the frangible breakable portion.

31. The medical fluid container frangible assembly system of claim 25, wherein the third station includes an adhesive applicator that is vertically submerged to receive adhesive and vertically elevated to apply the adhesive to the frangible portion.

32. The medical fluid container frangible assembly system of claim 25, wherein the third station includes a rotation mechanism configured to apply an adhesive on a portion of each of the frangible portions.

33. The medical fluid container fragile assembly system according to claim 25, wherein said medical fluid container fragile assembly system comprises an auger positioned to convey a frangible tube to said fourth station.

34. The medical fluid container frangible assembly system of claim 25, wherein the fourth station is configured to use (i) a motor and 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 with the applied adhesive.

35. The medical fluid container fragile assembly system according to claim 25, wherein said fifth station comprises a visual inspection camera to inspect said fragile.

36. The medical fluid container fragile assembly system according to claim 35, wherein the inspection at the fifth station comprises 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 frangible portion relative to the frangible tube, or (iii) the presence or absence of the frangible tube.

37. The medical fluid container fragile assembly system according to claim 35, wherein at said sixth station, each of said fragile objects of said rack is collected if any of said fragile objects is rejected.

38. The medical fluid container fragile assembly system according to claim 35, wherein only rejected fragile is collected at the sixth station.

39. The medical fluid container fragile assembly system according to claim 35, wherein the rack is tilted to collect fragile at the sixth station.

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