CN111497343A

CN111497343A - System and method for ensuring accuracy of fragile object insertion

Info

Publication number: CN111497343A
Application number: CN201910092321.1A
Authority: CN
Inventors: 郑君阔; 周颖君
Original assignee: Baxter Medical Supplies Co ltd; Baxter International Inc
Current assignee: Baxter Medical Supplies Co ltd; Baxter International Inc
Priority date: 2019-01-30
Filing date: 2019-01-30
Publication date: 2020-08-07

Abstract

A medical fluid container frangible system, comprising: a retainer configured to releasably grasp a frangible object that selectively allows fluid to flow through the medical fluid container; a translational motion actuator configured to translate the holder; a rotational motion actuator configured to rotate the holder, the rotational motion actuator carried by the translational motion actuator; and a control unit programmed to cause (i) the translational motion actuator to be moved and to carry the rotational motion actuator to a first position in which the translational motion actuator and the rotational motion actuator move the holder and the frangible object to apply the adhesive to the frangible object, and (ii) the translational motion actuator to be moved and to carry the rotational motion actuator to a second position in which the translational motion actuator and the rotational motion actuator move the holder and the frangible object to insert the frangible object and the adhesive into a fill port tube of a medical fluid container.

Description

System and method for ensuring accuracy of fragile object insertion

Technical Field

The present disclosure relates to medical fluid container systems, and more particularly, to a frangible assembly of a medical fluid container system.

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 dialysis treatment to replace kidney function is life-saving, the treatment is vital to many people. A person with a failing kidney is unlikely to survive without at least the filtering function that replaces the kidney.

Peritoneal dialysis is a dialysis therapy commonly used to treat loss of renal function. Peritoneal dialysis uses a dialysis solution that is infused into the patient's peritoneal cavity through a catheter implanted in the patient's peritoneal 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. The transport of waste, toxins and water from the blood stream to the dialysate is due to diffusion and osmosis, i.e. an osmotic gradient is created 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 cycle described above is then repeated.

There are a variety of Peritoneal Dialysis (PD) therapies including Continuous Ambulatory Peritoneal Dialysis (CAPD), Automated Peritoneal Dialysis (APD), and continuous ambulatory peritoneal dialysis (CFPD). CAPD is a manual dialysis treatment in which the patient connects the implanted catheter to a 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 connection between the catheter and the solution bag to allow the dialysate to reside within the peritoneal cavity, thereby transferring waste, toxins and excess water from the patient's bloodstream into 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 its dialysis treatment also includes drain, fill and dwell cycles. However, APD instruments automatically perform three to four cycles of peritoneal dialysis treatment, typically overnight while the patient sleeps. APD instruments are typically fluidly connected to an implanted catheter, one or more solution and drain bags.

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 blood stream to the dialysate 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 (e.g., when the patient sleeps). 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.

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, which remains in the peritoneal cavity of the patient when the patient is disconnected from the dialysis machine during the day. 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 that carries fluids to or from a patient. For this reason, non-PVC films and infusion tubes have been developed. However, the use of these films and infusion tubes in practice has proven difficult. PVC is generally easier to process than non-PVC materials. There are many process variations of non-PVC materials that must be implemented, optimized and validated for regulatory purposes.

During the filling of current PD solution bags for PVC and non-PVC materials, since the PD solution comprises glucose, solutions that overflow due to incorrect insertion of fragile objects are prone to microbial growth, resulting in microbial risks. Spilled liquids must also be carefully cleaned, which can reduce production efficiency. Incorrectly inserted fragile also results in a high rejection rate of solution bags that may already contain solution when the fragile is inserted.

There is therefore a need for an improved system and method of fragile insertion.

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), while the solution bag may be made of PVC or a material other than PVC (non-PVC). Either way, an outer bag is provided to hold the medical fluid or PD fluid set together, including a PVC or non-PVC solution bag, a PVC drain bag, and tubing connecting the two bags.

In the production of PVC or non-PVC solution bags, the bag forming, filling and sealing (FFS) step is among the most critical steps and requires specialized equipment. The filling machine (filingmachine) of the present invention has a system and a method that involve three main aspects, in particular in the case of insertion of fragile objects. The first main aspect relates to the application of adhesive to fragile objects. The second main aspect relates to the application of a frangible substance to the solution bag. A third main aspect relates to the visual inspection of the placement of the fragile contents of the solution bag. It should be understood that the frangible includes a rigid plastic piece that can be broken or ruptured by the patient, which allows fluid communication between the solution bag and the patient filling line. The breakable rigid plastic piece can be inserted directly into the fill port tube of the solution bag (e.g., for a non-PVC solution bag) or connected to a frangible tube or housing that is inserted into the fill port tube of the solution bag (e.g., for a PVC solution bag). The term "fragile" as used herein is meant to encompass both versions as well as other versions that may exist now or later developed.

The first and second main aspects relate to the use of pneumatic actuators or cylinders and electric motors, such as servo motors or stepper motors, to move the fragile objects in translation (pneumatic cylinders) and in rotation (servo motors or stepper motors). In one embodiment, the servo motor or stepper motor (the fragile object motor) is mounted on the pneumatic cylinder so that the fragile object motor and the pneumatic cylinder can be transported together as needed. The pneumatic cylinder translates a shaft having a jaw or retainer that releasably clasps and retains (e.g., pneumatically) the fragile object. The output of the fragile object motor is configured to rotate the shaft or rotatable portion of the shaft, which in turn rotates the fragile object controlling jaw (claw) or holder and the fragile object. In one embodiment, the shaft or rotatable portion of the shaft is fitted with a gear that mates with a mating gear that is mounted to a member that is connected to and driven by the fragile object motor. In another embodiment, the shaft or rotatable portion of the shaft and the member connected to and driven by the fragile motor are mechanically and operatively connected by a belt and pulley.

In a first main aspect, a separate adhesive impregnator is immersed in the adhesive source. In various embodiments, the adhesive used for PVC solution bags is cyclohexanone, while the adhesive used for non-PVC solution bags is cumene or isopropyl alcohol. The binder source may comprise any of these binders. In one embodiment, the adhesive impregnator is generally hook-shaped, but it is widened so that it can accommodate a quantity of adhesive. The hook-shaped bottom is generally circular with an open top. The inner surface of the generally circular bottom of the adhesive impregnator is formed with one or more grooves to store or hold adhesive. After dipping into the adhesive source, the adhesive impregnator translates upward to receive an insertion region of the frangible object, which has been translated into position by a linear actuator or cylinder. The fragile motor then controls the shaft to rotate the jaws or holder so that the fragile held by the jaws rotates within the slotted generally circular bottom of the infuser so that the fragile receives adhesive over 360 degrees of its diameter.

If the bottom of the hook shape is perfectly round and there is no open top as desired, the adhesive impregnator translates upward to a position to receive a frangible insert zone after being dipped into the adhesive source. The cylinder then moves the shaft, jaws and fragile object within the perfectly circular insertion area of the infuser. The fragile motor is then controlled to cause the shaft to rotate the pawl or holder, thereby causing the fragile to rotate within the grooved circular base of the infuser so that the fragile receives adhesive over 360 degrees of its diameter.

In one embodiment, an adhesive impregnator is immersed into the adhesive for each friable material. Alternatively, the generally circular bottom of the adhesive impregnator holds enough adhesive to properly coat (coat) the plurality of fragile objects. The steps just described for the first main aspect of the present disclosure are automated and controlled by one or more control units.

In a second principal aspect, a linear actuator or cylinder and a frangible object motor insert an adhesive-coated frangible object into the fill port tube of the solution bag. In one embodiment, the cylinder and the fragile object motor cooperate such that during a first portion of translational insertion (e.g., half insertion) of the cylinder, the fragile object motor rotates the fragile object; while in the second position of translational insertion of the cylinder and the remainder (e.g., one half), the fragile object motor does not cause the fragile object to rotate. Here, on the first part, the frangible object is translated and rotated, which results in the adhesive being spread over the tip of the inner diameter of the filler neck. Once good adhesive coverage is ensured, the remainder of the insertion of the frangible object, passing through the tip of the inner diameter of the filler neck, is merely translated without rotation. Once the frangible insertion is complete, the pawl or retainer releases the frangible, which becomes part of the solution bag.

The steps just described for the second main aspect of the present disclosure are also automated and controlled by one or more control units. In one embodiment, the cylinder and the fragile object motor are transferred between the first and second main aspects by separate transfer means, which may be controlled by the same or different control units. In a second embodiment, the cylinder and the fragile object motor are kept stationary, while the first and second main aspects of the adhesive infuser and the solution bag, respectively, are successively fed to the fragile object held by the jaws, which may also be controlled by the same or different control units.

In a third main aspect, the solution bag and inserted fragile are inspected by a visual inspection subsystem in one embodiment, the visual inspection subsystem is combined with the fragile insertion operation just described.

The digital camera is electrically and/or data communicatively coupled to a processor and memory (e.g., the same control unit discussed above) for receiving and analyzing the digital images. The digital image is temporarily stored in a memory. The memory also stores a program for execution by the processor and the memory to evaluate various aspects of the fragile insert. Aspects to be evaluated may include any of: (i) insert depth, (ii) frangible objects are missing, or (iii) frangible objects are at a misaligned angle. In one embodiment, if either aspect of the evaluation shows a failure, the solution bag with the defective fragile is automatically transported to the rejected station.

In light of the disclosure herein, and not in any way limiting the disclosure, any aspect of any one of claims 1 to 25 may be combined with any other aspect of any one or more of claims 1 to 25. Unless otherwise indicated.

In other aspects of the disclosure, any of the structures and functions disclosed in fig. 1-8 may be combined with any of the other structures and functions disclosed in fig. 1-8.

In view of the foregoing, it is an advantage of the present invention to provide a parenteral, e.g., Peritoneal Dialysis (PD) solution fragile insertion procedure that avoids spillage or splashing of the solution due to improperly assembled fragile objects.

Another advantage of the present disclosure is to provide a parenteral (e.g., PD) solution fragile insertion procedure that greatly reduces or eliminates microbial risks.

Another advantage of the present disclosure is to provide a parenteral (e.g., PD) solution fragrancer insertion procedure that greatly reduces or eliminates cleaning time associated with the insertion of fragrancers, thereby improving production efficiency.

Another advantage of the present disclosure is to provide a parenteral (e.g., PD) solution friable insertion procedure that greatly reduces the rate of rejection of solution bags due to improperly inserted friable material.

Yet another advantage of the present disclosure is to provide a parenteral (e.g., PD) solution fragile insertion procedure that checks to ensure that the desired insertion accuracy has been achieved.

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

Drawings

Fig. 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 front view of one embodiment for applying adhesive to an adhesive impregnator.

FIG. 3 is a perspective view showing one embodiment of the impregnation section of the adhesive impregnator in greater detail.

FIG. 4 is a side view of one embodiment of the following components: a holder configured to releasably grasp a fragile object; a translational motion actuator configured to translate the holder; and a rotary motion actuator configured to rotate the holder; the components are applied to the fragile object at a first location by an adhesive impregnator.

FIG. 5 is a side view of one embodiment of the following components: a holder configured to releasably grasp a fragile object; a translational motion actuator configured to translate the holder; and a rotary motion actuator configured to rotate the holder; the above-described components place the fragile object in the fill port tube of the solution container in the second position and assess insertion by the visual inspection subsystem.

Fig. 6 is an elevational, cross-sectional view of one embodiment of a display device of the present disclosure, illustrating a first fragile insertion visual inspection failure mode.

Fig. 7 is an elevational, cross-sectional view of one embodiment of a display device of the present disclosure, illustrating a second fragile insertion visual inspection failure mode.

Fig. 8 is an elevational, cross-sectional view of one embodiment of a display device of the present disclosure, illustrating a third fragile insertion visual inspection failure mode.

Detailed Description

Solution container and frangible article

Referring now to the drawings, and in particular to fig. 1 and 2, various embodiments of the frangible objects of the present disclosure are shown. 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 contains 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 material 116a comprising a rigid plastic breakable member 118 a. A rigid plastic rupturable PVC member 118a is sealed within a lower tube 120 of PVC frangible material 116 a. The lower tube 120 may also be made of PVC and sealed inside the filler neck 112. The PVC fragile 116a further includes an upper tube 122, which upper tube 122 may be made of PVC and connected to a filling line (not shown) extending to the Y-site.

The fill port tube 112 of the non-PVC solution container or bag 110b receives a non-PVC frangible 116b comprising a non-PVC breakable rigid plastic member 118 b. The non-PVC breakable rigid plastic member 118b as shown is not sealed within the down tube, but rather 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 filling line (not shown) that continues to the Y-site.

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 fragile 116a, non-PVC fragile 116b, and other fragile configurations. These are referred to collectively and generally herein as the frangible objects 116. Likewise, the PVC breakable rigid plastic member 118a and the non-PVC breakable rigid plastic member 118b are collectively referred to herein as breakable rigid plastic members 118.

System and operation

Referring now to fig. 2, an adhesive impregnator 30 of the system 10 is shown. The adhesive impregnator 30 includes a linear actuator 32, the linear actuator 32 being under the control of the control unit 20. The control unit 20 includes one or more processors 22, one or more memories 24 operative with the processors 22, electronics 26 operative with the one or more processors 22 and the one or more memories 24, and a user interface/display 28 for inputting commands to the one or more processors 22 and the one or more memories 24 and displaying data from the processors and memories. Lines W extending from the linear actuator 32 show that the linear actuator (and all components shown here with lines W) is connected to the electronics 26 and is controlled by the one or more processors 22 and the one or more memories 24 of the control unit 20.

In one embodiment, the linear actuator 32 is a pneumatically controlled cylinder, wherein the line W electrically opens and closes at least one pneumatic valve to allow positive and/or negative pressure to actuate the cylinder. The one or more pneumatic valves may be located at the linear actuator 32 or with the electronics 26 of the control unit 20 with pneumatic tubing extending to the linear actuator 32.

The linear actuator 32 drives a boom (arm)34, the boom 34 being connected to or formed with an impregnator 36 for collecting adhesive. Boom 34 and impregnator 36 may be made of metal, such as stainless steel or aluminum, or may be made of plastic that is strong and able to withstand contact with the adhesive or solvent in adhesive source 38. As shown in phantom in fig. 2, the control unit 20 commands the linear actuator 32 to actuate the boom 34 and the macerator 36 so that the macerator extends into the adhesive source 38 to collect a quantity of adhesive or solvent. In various embodiments, the binder or solvent contained in the binder source 28 of the PVC solution bag is cyclohexanone, and the binder or solvent contained in the binder source 28 of the non-PVC solution bag is cumene or isopropyl alcohol.

Fig. 3 shows one embodiment of the macerator 36 in more detail. In the illustrated embodiment, the macerator 36 is generally U-shaped or J-shaped. The impregnator 36 includes a connecting portion 36a that is connected to or extends from the boom 34 of the adhesive impregnator 30. The extension portion 36b extends from the connection portion 36a to a U-shaped portion 36c of the impregnator 36. One or more grooves 36d are formed on the inside of the U-shaped portion 36 c. One or more grooves 36d capture and collect additional adhesive or solvent as the impregnator 36 is immersed in the adhesive source 38.

The U-shaped or J-shaped opening 36e of the macerator 36 allows the frangible object 116 to move into position to receive the adhesive, and then the linear actuator 32 pulls the boom 34 and macerator 36 upward from the adhesive or solvent of the adhesive source 38 to receive the frangible object. In an alternative embodiment, the U-shaped portion 36c may be circular. In this case, the groove 36d may extend a full 360 degrees within the circle, and wherein the linear actuator 32 pulls the boom 34 and the macerator 36 upward from the adhesive or solvent of the adhesive source 38 before the fragile object moves into the rounded portion 36c of the macerator 36.

Referring now to FIG. 4, the adhesive impregnator 30 is again shown having a linear actuator 32, a boom 34, an impregnator 36 having a U-shaped portion 36c, and an adhesive or solvent source 38. System 10 is further shown having a motion actuation assembly 40 under the control of control unit 20. The motion actuation assembly 40 includes a second linear actuator 42, which, like the linear actuator 32, may be a pneumatically controlled cylinder, with a line W allowing electrically opening and closing at least one pneumatic valve to allow positive and/or negative pressure to actuate the piston. One or more pneumatic valves may likewise be located at the linear actuator or cylinder 42, or together with the electronics 26 of the control unit 20, with pneumatic lines extending to the linear actuator 42. In alternative embodiments, one or both of the

linear actuators

32 and 42 are electromechanically driven. For example, by a stepper motor or servo motor and a rotary to translational transducer (e.g., a ball or lead screw).

In the illustrated embodiment, a linear actuator or cylinder 42 translates a shaft having a purely translating portion 44 and a translating and rotating portion 46. If the linear actuator 42 is capable of translating a shaft that also rotates, a purely translating portion 44 of the shaft is not required. In either case, the distal end of the shaft driven by the linear actuator 42 is capable of translation and rotation. The gear 48 is connected to the rotating portion 46 of the linear actuator shaft. The gear 48 may be plastic, such as a rigid plastic (e.g., polytetrafluoroethylene or nylon), or metal (e.g., stainless steel or aluminum), while the shaft 44/46 is metal (e.g., stainless steel in one embodiment).

The motion actuation assembly 40 also includes a stepper motor or servo motor 50, which in the illustrated embodiment is mounted to the linear actuator 42, e.g., below the linear actuator as shown. The electronics 26 precisely control the output shaft 52 of the stepper motor or servo motor 50, for example, precisely control the acceleration, velocity, and positioning (positioning) of the output shaft 52. The gear 54 is connected to the output shaft 52 of the motor 50. The gear 54 may be plastic (e.g., a hard plastic such as polytetrafluoroethylene or nylon in one embodiment), or metal (such as stainless steel or aluminum) while the shaft 52 is metal (e.g., stainless steel in one embodiment).

The linear actuator gear 48 is shown as meshing with the motor gear 54, and both the linear actuator gear 48 and the motor gear 54 may be spur gears (spur gears) having radially extending teeth. The ratio between gears 48 and 54 can be one to one or the ratio between the two gears can be reduced. As shown in fig. 4, under the control of the control unit 20, the motion actuation assembly 40 causes the motor 50 to rotate the shaft 52, causes the motor gear 54 to rotate the linear actuator gear 48, and causes the linear actuator gear 48 to rotate the rotating portion 46 of the linear actuator shaft 44/46, which is also translated by the linear actuator 42.

The retainer or pawl 60 is located at the distal end of the linear actuator shaft 44/46. The retainer or jaw 60 is pneumatically opened and closed by positive and/or negative pressure air delivered to the jaw 60 via a pneumatic tube 62. The positive and/or negative pressure air opens and closes the first and

second fingers

64, 66 around the frangible objects 116, which the fingers grab to move. In view of the motion capabilities and operation of the holder or jaw 60 just described with respect to the motion actuation assembly 40, it should be understood that the frangible object 116 may be controllably grasped, translated, rotated, and released by the control unit 20 of the system 10.

Looking at fig. 4, in one embodiment, the linear actuator 42 translates the frangible object 116 to a desired location to receive the adhesive. The adhesive impregnator 30 raises the U-shaped impregnator from an adhesive or solvent source 38 so that the U-shaped portion 36c (including the trough 36d with adhesive or solvent) contacts the fragile object in place. The motor 50 of the motion actuation assembly 40 rotates the keeper or pawl 60 in a clockwise and/or counterclockwise direction, as indicated by the circular arrow in fig. 4. In one embodiment, the frangible object 116 rotates more than 360 degrees, such as 900 degrees, within the U-shaped portion 36c to ensure that the adhesive or solvent is fully applied around the entire 360 degrees of the outer diameter of the frangible object 116. After the frangible object 116 has received the appropriate amount of adhesive or solvent, the linear actuator 42 moves the frangible object 116 out of the U-shaped portion 36c of the macerator 36 and returns the macerator 36 to the adhesive or solvent source 38 for additional adhesive or solvent. Alternatively, the macerator 36 may have sufficient adhesive to coat the plurality of fragile objects 116.

As noted above, it is contemplated that macerator 36 may alternatively be moved to a position for transferring adhesive or solvent prior to moving fragile 116 to a position within U-shaped portion 36c of macerator 36. This alternative movement would allow the U-shaped portion 36c to be rounded if desired.

FIG. 4 shows that in one embodiment, motion-actuating assembly 40 is pivotally mounted about an axis A, which may comprise a shaft connected to a motor (not shown) under the control of control unit 20, which rotates motion-actuating assembly 40 about axis A ninety degrees in a counterclockwise direction in FIG. 4 to the frangible object insertion position of FIG. 5. Fig. 5 shows motion actuation assembly 40 having linear actuator 42, shaft 44/46, gear 48, motor 50, shaft 52 and gear 54 for mating with gear 48, and a retainer or pawl mounted on shaft 44/46, as described in fig. 4. For fragile insertion, the system 10 of FIG. 5 also includes a clamp 70 for holding the fill port tube 112 and thus the solution container 110. The gripper 70 may be part of a larger pneumatically or electromechanically driven robot or gantry system that allows the gripper 70 to move in and out of the position shown in FIG. 5. The clamp 70 in the illustrated embodiment includes a clamp (clamp)72 for holding a fill port tube 112 of a solution container or bag 110. The forceps 72 may include fingers or other gripping structures similar to the retainer or jaws 60 that are pneumatically actuated via positive and/or negative pressure air via a pneumatic conduit 74.

In fig. 5, the gripper 70 with the gripper 72 holding the solution container or bag 110 has been moved into position to receive the fragile object 116 under the control of the control unit 20. In one embodiment, the control unit 20 is programmed to cause the motion actuation assembly 40 to move the holder or jaw 60 such that, in a first position (e.g., half inserted) of total translational insertion of the linear actuator or cylinder 42, the fragile object motor 50 rotates the fragile object 116; while in the second position and the remainder (e.g., the second half) of the total translational insertion of the linear actuator or cylinder 42, the fragile object motor does not cause the fragile object to rotate. Here, on the first portion, the frangible object 116 is translated and rotated (e.g., a total rotation of less than 360 degrees), which results in the adhesive or solvent being spread over the entire or nearly the entire inner diameter of the tip of the filler neck 112. Once good adhesive coverage is ensured, the remainder of the insertion of the frangible object 116 is translated, rather than rotated, through the tip of the inner diameter of the fill port tube 112. Once the frangible insertion is complete, the pawl or retainer 60 releases the frangible object 116, which becomes part of the solution bag 110.

After insertion of the frangible object 116 just described, the clamp 70 can be configured to move the solution bag 110 to the next operation such that the retainer or claw 60 under operation of the motion actuation assembly 40 retrieves a new frangible object 116 on which to rotate the motion actuation assembly 40 about axis a, 90 degrees clockwise in fig. 5, to the adhesive or solvent application position of fig. 4. The process described in connection with fig. 4 and 5 is then repeated.

Fig. 5 also shows that the holder 70 may be provided with a camera 76, for example a digital camera, which takes an image of the insertion of the fragile object. One suitable camera for the camera 76 is provided by Connaissance corporation of Ticke, Mass. (zip code 01760-. The camera 76 may have its own processor and memory to store and execute vision software. The camera 76 may alternatively be output, wired or wirelessly, to vision software stored and executed at the one or more processors 22 and memory 24 of the control unit 20. The control unit 20 and the camera 76 may each include a transceiver or transmitter/receiver for wireless communication. Suitable vision software may be provided by the camera manufacturer, such as VisionPro, supplied by the manufacturer mentioned above^TMOr VisionPro ViDi^TMAnd (3) software.

In one embodiment, the vision software converts the digital color image captured by the camera 76 into a digital grayscale image and evaluates the grayscale image according to the programs and algorithms of the system 10. The vision software may perform individual evaluations in grayscale, for example, three evaluations per fragile insertion discussed below. The use of grayscale for evaluation helps to speed up the analysis so that all evaluations can be performed before the gripper 70 moves the container or bag 110 to the next operation.

In the embodiment shown in fig. 5, the camera 76 is mounted on the fixture 70. In alternative embodiments, the camera 76 may be mounted elsewhere. In any case, the focal point of the camera 76 is located at the upper portion of the filler neck 112, i.e., at the location of the frangible objects 116. In one embodiment, the control unit 20 is programmed such that completion of the fragile insertion automatically triggers image capture by the camera 76.

FIG. 5 also shows that in one embodiment, the system 10 includes a light source 78 located on the opposite side of the container or bag 110 from the camera 76. in one embodiment, the light source 78 includes an array of lights, such as light emitting diodes (L ED), which may be white or colored, such as blue or red, L ED. the control unit 20 may control the light source 78 to emit light when needed (e.g., upon completion of the insertion of a fragile object) to improve the quality of the image captured by the camera 76.

Once the camera 76 captures an image of the fragile insertion, the vision software (stored in the camera 76 or control unit 20) evaluates the image. As described above, multiple evaluations (discussed below), e.g., three evaluations, may be performed. In one embodiment, if the result of each evaluation is pass (pass), the vision software outputs "pass" to the control unit 20. If the result of either evaluation is a fail (fail), the vision software outputs a "fail" to control unit 20. In another embodiment, the vision software outputs, for example, a gray count for each of the three assessments, and the control unit 20 is programmed to determine the pass or fail for each assessment. Here, too, if the result of each evaluation is qualified, the control unit 20 determines that it is "qualified" as a whole. If the result of any one of the evaluations is a fail, the control unit 20 determines that it is "failed" as a whole.

If it is determined that the fragile insertion is "acceptable" as a whole, the control unit 20 causes the gripper 70 to transfer the fluid container or bag 110 to the next operation. Suitable "qualifying" messages may also be displayed on the user interface/display 28 along with other relevant information. If either evaluation is not acceptable, in one embodiment, the control unit 20 causes the gripper 70 to transfer the fluid container or bag 110 to the rejected tank. Suitable "fail" messages may also be displayed on the display device 28 along with other relevant information.

Visual inspection assessment

Referring now to fig. 6-8, there are shown exemplary screens from the user interface/display 28 for different reject or unacceptable modes of fragile insertion. Failure mode may include any one or more of the following: (i) improper depth of insertion of the frangible object, (ii) missing of the frangible object, or (iii) the frangible object being at a misaligned angle. In one embodiment, if any image of the frangible insert is not acceptable in any of the analysis modes, the fluid container or bag 110 is rejected.

Fig. 6 shows an example of an unqualified insertion depth evaluation. Here, the frangible object 116 is not inserted far enough into the filler neck 112. The result of the depth evaluation is therefore not qualified.

FIG. 7 shows an example of an evaluation of the presence of unacceptable fragile objects. Here, the fragile object 116 is completely absent. The result of the evaluation of the presence of friable matter is therefore not qualified.

FIG. 8 shows an example of a failed fragile alignment assessment. Here, the angle of the frangible object 116 relative to the filler neck 112 is too large (e.g., greater than X degrees) to be considered a good sealing engagement. The result of the alignment evaluation is therefore not good.

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 subject matter 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 element numbers

10-system

20-control unit

22-one or more processors of the control unit

24-one or more memories of a control unit

26-an electronic device operable with one or more processors and one or more memories

28-user interface/display device

30-adhesive impregnator

Linear actuator or cylinder for 32-adhesive impregnator

34-boom of adhesive impregnator

36-impregnator of adhesive impregnator

36 a-connection to the boom

36 b-extension

36 c-U-shaped section of impregnator

36 d-one or more recesses for obtaining adhesive

36 e-opening for receiving a fragile item

38-adhesive Source

40-motion actuation assembly

42-linear actuator or cylinder

44-translational part of the linear actuator shaft

46-rotating part of the shaft of a linear actuator

48-gears connected to the rotating part of the linear actuator shaft

50-servomotors or stepper motors

52-output shaft of servomotor or stepping motor

54-gears connected to the output shaft of a servomotor or stepper motor

60-holders or claws for holding fragile articles

62-pneumatic conduit for actuating a holder or jaw

64-first finger of retainer or claw

66-second finger of retainer or claw

70-clamp for holding filling opening tube of solution container

72-pliers for holding the clamp of a filling spout of a solution container

74-pneumatic duct for actuating pliers of a gripper

76-digital camera for visual inspection of fragile object insertion

78-light source opposite to digital camera

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-filling opening 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

118 a-a rigid plastic breakable member of PVC, generally referred to herein as the rigid plastic breakable member 118

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

Lower pipe of 120-PVC fragile object

122-upper tube for fragile articles

Claims

1. A medical fluid container frangible system, comprising:

a holder configured to releasably grasp a frangible object that selectively allows fluid to flow through the medical fluid container;

a translational motion actuator configured to translate the holder;

a rotary motion actuator configured to rotate the holder;

a source of binder;

an adhesive impregnator; and

a control unit programmed such that: (i) the adhesive impregnator is dipped into an adhesive source, (ii) the translational motion actuator translates the holder and the frangible object such that the frangible object is in place to receive the adhesive impregnator or insert the frangible object into the adhesive impregnator, and (iii) the rotational motion actuator rotates the holder and the frangible object such that the frangible object rotates within the adhesive impregnator to obtain the adhesive.

2. The medical fluid container frangible system of claim 1, wherein the retainer comprises pneumatically actuated fingers that releasably grasp the frangible.

3. The medical fluid container fragile system of claim 1, wherein said translational motion actuator comprises a pneumatically driven linear actuator.

4. The medical fluid container fragile system of claim 1, wherein said rotary motion actuator comprises a servo motor or a stepper motor.

5. The medical fluid container fragile system of claim 1, wherein said rotary motion actuator is carried by said translational motion actuator.

6. The medical fluid container frangible system of claim 1, comprising a shaft located between the translational motion actuator and the retainer, wherein at least a portion of the shaft connected to the retainer is rotatable such that the retainer rotates with at least a portion of the shaft, and wherein the rotational motion actuator is operably connected to at least a portion of the shaft by a mating gear or belt and pulley.

7. The medical fluid container frangible system of claim 1, wherein the control unit is further configured to rotate the frangible within the adhesive infuser at least 360 degrees to obtain an adhesive.

8. The medical fluid container frangible system of claim 1, wherein the control unit is further configured to cause the adhesive impregnator to dip into the adhesive source for each frangible.

9. The medical fluid container frangible system of claim 1, wherein the control unit is further configured to translate the adhesive impregnator upward from the adhesive source to meet the frangible.

10. The medical fluid container frangible system of claim 9, wherein (i) the frangible object is translated into position such that the frangible object receives the adhesive impregnator before the adhesive impregnator is translated, or (ii) the adhesive impregnator is translated upward from the adhesive source such that the frangible object is inserted into the adhesive impregnator before the frangible object is translated.

11. The medical fluid container frangible system of claim 1, wherein the adhesive impregnator includes an at least semi-circular base having at least one groove formed therein for collecting adhesive for transfer to the frangible.

12. A medical fluid container frangible system, comprising:

a holder configured to releasably grasp a frangible object that selectively allows fluid flow through the medical fluid container;

a translational motion actuator configured to translate the holder;

a rotary motion actuator configured to rotate the holder;

a clamp for holding a fill port tube of a medical fluid container; and

a control unit programmed such that: (i) the translational and rotational motion actuators simultaneously translate and rotate the holder and the refill to a first position within the fill port tube, and (ii) the translational and rotational motion actuator translates the holder and the refill to a second, more distal position within the fill port tube.

13. The medical fluid container frangible system of claim 12, wherein the first position is at least about a first half of the total distance traveled by the frangible object within the filling spout and the second, more distal position is at least about a second half of the total distance traveled by the frangible object within the filling spout.

14. The medical fluid container frangible system of claim 12, wherein in (i), the frangible body rotates less than 360 degrees.

15. The medical fluid container frangible system of claim 12, wherein the control unit is further programmed such that the translational motion actuator and the rotational motion actuator move the retainer and frangible object prior to (i) and (ii) to apply the adhesive to the frangible object.

16. The medical fluid container frangible system of claim 12, wherein the retainer comprises pneumatically actuated fingers that releasably grasp the frangible.

17. The medical fluid container fragile system of claim 12, wherein said translational motion actuator comprises a pneumatically driven linear actuator.

18. The medical fluid container fragile system of claim 12, wherein said rotary motion actuator comprises a servo motor or a stepper motor.

19. The medical fluid container fragile system of claim 12, wherein said rotary motion actuator is carried by said translational motion actuator.

20. The medical fluid container frangible system of claim 12, comprising a shaft located between the translational motion actuator and the retainer, wherein at least a portion of the shaft connected to the retainer is rotatable such that the retainer rotates with at least a portion of the shaft, and wherein the rotational motion actuator is operably connected to at least a portion of the shaft by a mating gear or belt and pulley.

21. The medical fluid container fragile system of claim 12, wherein said medical fluid container fragile system comprises a visual inspection subsystem having a camera positioned and arranged to capture a digital image of the fragile inserted into said filler neck.

22. The medical fluid container fragile system of claim 21, wherein said medical fluid container fragile system comprises a processor and a memory, said processor and memory configured to evaluate said image for at least one of the following criteria: (i) a depth of insertion of the frangible object, (ii) a missing frangible object, or (iii) a misaligned angle of the frangible object.

23. The medical fluid container fragile system of claim 22, wherein said processor and memory are provided with said control unit.

24. The medical fluid container frangible system of claim 22, wherein a container in which the frangible has been inserted into the fill port tube is rejected if the evaluation of any of (i) through (iii) fails.

25. A medical fluid container frangible system, comprising:

a translational motion actuator configured to translate the holder;

a rotational motion actuator configured to rotate the holder, the rotational motion actuator carried by the translational motion actuator; and

a control unit programmed such that: (i) the translational actuator moves and carries a rotational actuator to a first position in which the translational actuator and the rotational actuator move the holder and the frangible to apply the adhesive to the frangible, and (ii) the translational actuator is moved and carries a rotational actuator to a second position in which the translational actuator and the rotational actuator move the holder and the frangible to insert the frangible and the adhesive into a fill port tube of a medical fluid container.