CN209718781U - Medical fluid container breakable object system - Google Patents

Abstract

A kind of medical fluid container breakable object system, it includes: retainer is configured to releasedly catch breakable object, which selectively allows for fluid to flow through medical fluid container；Translational motion actuator is configured to the translatable retainer；Rotary motion actuator, is configured to the rotatable retainer, and the rotary motion actuator is carried by the translational motion actuator；And control unit, it is programmed so that (i) described translational motion actuator is moved, and rotary motion actuator is transported to first position, translational motion actuator and the mobile retainer of rotary motion actuator and breakable object in the position, to apply adhesive on breakable object, and (ii) described translational motion actuator is moved, and rotary motion actuator is transported to the second position, translational motion actuator and the mobile retainer of rotary motion actuator and breakable object in the position, with will breakable object and adhesive insertion medical fluid container filling exit pipe in.

Description

Medical Fluid Container Fragile System

technical field

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

Background technique

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

Kidney failure and reduced kidney function are treated with dialysis. Dialysis removes waste products, toxins, and excess water from the body that should be removed by properly functioning kidneys. Because dialysis treatment, used to replace kidney function, is life-saving, it is vital for 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 a type of dialysis therapy commonly used to treat loss of kidney function. Peritoneal dialysis uses a dialysis solution that is injected 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 products, toxins and water from the blood stream to the dialysate occurs due to diffusion and osmosis, ie the creation of an osmotic gradient across the peritoneum. The used permeate is drained from the patient's peritoneal cavity to remove waste, toxins and excess water from the patient. The above cycle is then repeated.

Various peritoneal dialysis (PD) therapies exist, 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 an implanted catheter to a drainage device and allows used 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 to allow the dialysate to reside within the peritoneal cavity, thereby transferring waste, toxins, and excess water from the patient's bloodstream into the dialysate solution. After the dwell period, the patient repeats the manual process described above. In CAPD, the patient performs multiple drain, fill and dwell cycles throughout the day, eg, about four times per day.

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

The APD instrument pumps fresh dialysate from a dialysate source through a catheter into the patient's peritoneal cavity and allows the dialysate to reside in the cavity so that waste, toxins, and excess water from the patient's bloodstream can occur to the patient's peritoneal cavity. Delivery of dialysis solution. The APD machine then pumps the spent dialysate from the peritoneal cavity through the catheter to the drain. APD machines are usually computer-controlled so that dialysis treatment occurs automatically while the patient is connected to the dialysis machine (eg, while the patient is sleeping). That is, the APD system automatically and sequentially pumps fluid into the peritoneal cavity, allows it to reside, pumps fluid out of the peritoneal cavity, and repeats the process.

As with manual processing, multiple drain, fill and dwell cycles will occur during APD. A "last fill" is usually used at the end of the APD and remains in the patient's peritoneal cavity while the patient is disconnected from the dialysis machine during the day. The APD frees the patient from manually performing the drain, dwell, and fill steps.

As mentioned above, both CAPD and APD involve the use of solution bags and drainage bags. Preparing such a bag requires a great deal of care and skill. Bags must not leak and must be within certain specifications. 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 properly labeled so that the user or caregiver can be sure that the patient is receiving the correct PD solution.

Historically, PD solution bags were made of polyvinyl chloride (PVC). However, in some jurisdictions, PVC is banned for use in the manufacture of solution bags or tubing for transporting fluids to and from patients. To this end, non-PVC films and infusion tubing have been developed. However, applying these films and infusion tubing in practice has proven difficult. PVC is generally easier to process than non-PVC materials. There are many processing variations for non-PVC materials that must be implemented, optimized and validated for regulatory purposes.

During the filling of PD solution bags currently used for PVC and non-PVC materials, since the PD solution includes glucose, spilled solution due to incorrect insertion of fragile objects is prone to microbial growth, resulting in a microbial risk. Spilled liquids must also be carefully cleaned, which reduces productivity. Incorrectly inserted frangibles also lead to a high reject rate of solution bags that may already contain solution when the frangible was inserted.

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

Utility model content

The present disclosure provides an improved medical fluid container, system and method of manufacture. In one embodiment, the medical fluid container includes a medical fluid solution bag, such as a peritoneal dialysis solution bag, and a medical fluid drainage bag, connected by tubing. In one embodiment, the drainage bag is made of polyvinyl chloride (PVC), while the solution bag can be made of PVC or a material other than PVC (non-PVC). Either way, an outer bag is provided to keep 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 form, fill and seal (FFS) step is among the most critical steps and requires specialized equipment. The filling machine of the present invention has a system and method involving three main aspects, particularly in the case of having a frangible insertion. The first major aspect involves applying adhesives to breakables. The second major aspect involves applying frangibles to solution bags. The third major aspect involves visual inspection of the placement of fragile objects within the solution bag. It should be understood that frangibles include rigid plastic pieces that can be broken or ruptured by the patient, allowing fluid communication between the solution bag and the patient filling line. The destructible rigid plastic piece can be inserted directly into the solution bag's fill port tube (e.g., for non-PVC solution bags), or connected to a frangible tube or housing that is inserted into the solution bag's fill port Orifice tubes (for example, for PVC solution bags). The term "fragile" as used here is meant to cover both versions above as well as others that may exist now or be developed later.

The first and second main aspects involve the use of pneumatic actuators or cylinders and electric motors, such as servo motors or stepper motors, for translational (pneumatic cylinder) and rotational movement (servo motors or stepper motors) of fragile objects. In one embodiment, a servo motor or stepper motor (breakables motor) is mounted on the pneumatic cylinder so that the breakables motor and pneumatic cylinder can be conveyed together as needed. The pneumatic cylinder translates a shaft with claws or retainers that releasably clasp and hold (eg, pneumatically) the frangible. The output of the frangible motor is configured to rotate the shaft or rotatable portion of the shaft, which in turn rotates the frangible claw or holder and the frangible grip. In one embodiment, the shaft or rotatable portion of the shaft is fitted with a gear cooperating with a mating gear mounted to a member connected to and driven by the frangible motor. In another embodiment, the shaft or rotatable portion of the shaft and the member connected to and driven by the frangible motor are mechanically and operatively connected by belts and pulleys.

In a first main aspect, a separate adhesive dipper is dipped into the adhesive source. In various embodiments, the adhesive used for the PVC solution bag is cyclohexanone and the adhesive used for the non-PVC solution bag is cumene or isopropanol. The binder source may comprise any of these binders. In one embodiment, the adhesive dipper is generally hook-shaped, but it is widened so that it can hold a volume of adhesive. Hooks are usually rounded at the base with an open top. The interior surface of the generally circular bottom of the adhesive dipper is formed with one or more grooves to store or hold adhesive. After dipping into the adhesive source, the adhesive dipper translates upward to receive the frangible insertion area, which has been translated into position by the linear actuator or cylinder. The frangibles motor then controls the shaft to rotate the claws or holders so that the frangibles held by the claws rotate within the grooved, generally circular bottom of the macerator such that the frangibles are within 360 degrees of their diameter Receive adhesive inside.

If the bottom of the hook shape is fully rounded and has no open top if desired, then after dipping the adhesive source, the adhesive dipper translates up to a position to receive the frangible insertion area. The cylinder then moves the shaft, jaws and frangibles within the fully circular insertion area of the macerator. Control of the frangible motor then causes the shaft to rotate the jaws or holders, causing the frangible to rotate within the recessed circular bottom of the macerator such that the frangible receives adhesive within 360 degrees of its diameter.

In one embodiment, an adhesive dipper is dipped into the adhesive for each frangible. Alternatively, the generally circular bottom of the adhesive dipper holds enough adhesive to properly coat multiple frangibles. 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 major aspect, a linear actuator or cylinder and frangible motor inserts the adhesive coated frangible into the filling spout tube of the solution bag. In one embodiment, the cylinder and the frangible motor cooperate such that at a first portion of the cylinder's translational insertion (eg, halfway inserted), the frangible motor causes the frangible to rotate; position and remaining part (eg half), the breakable motor will not cause the breakable to rotate. Here, on the first part, the frangible translates and rotates, which causes the adhesive to be spread on the tip of the inner diameter of the filling spout tube. Once good adhesive coverage has been ensured, the rest of the insertion of the frangible only translates and does not rotate through the tip of the inner diameter of the filling spout tube. Once the frangible insertion is complete, the claw or retainer releases the frangible and the frangible 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 breakables motor are transferred between the first and second main aspects by separate transfer means, which transfer means may be controlled by the same or different control units. In a second embodiment, the cylinder and the frangible motor remain stationary while the first and second primary sides of the adhesive dipper and solution bag respectively are fed sequentially to the frangible held by the jaws, which can also be determined by Same or different control unit control.

In the third major aspect, solution bags and inserted frangibles are inspected by the vision inspection subsystem. In one embodiment, the visual inspection subsystem is integrated with the frangible insertion operation just described. In another embodiment, the solution bag with the frangible inserted is delivered to the visual inspection subsystem. In one embodiment, the visual inspection subsystem includes a camera, which may be a digital camera that forms one or more digital images of each frangible insertion. Lights can be provided behind the breakable insert for illumination, which can help improve digital image quality. The light may be, for example, one or more arrays of light emitting diodes (LEDs), such as red or blue LEDs. The light can remain on throughout the work shift, or only turn on when a solution bag is present.

A digital camera is electrically and/or data communicatively coupled to a processor and memory (eg, the same control unit discussed above) for receiving and analyzing digital images. The digital images are temporarily stored in memory. The memory also stores programs executed by the processor and the memory to evaluate various aspects of the frangible insert. Aspects to be evaluated may include any of the following: (i) depth of insertion, (ii) absence of frangibles, or (iii) friables at misaligned angles. In one embodiment, if any aspect of the evaluation shows a failure, the solution bag with defective frangibles is automatically conveyed to a reject station.

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

In view of the foregoing, it is an advantage of the present invention to provide a parenteral, eg, peritoneal dialysis (PD) solution frangible insertion procedure that avoids solution spillage or splashing due to improper assembly of the frangible.

Another advantage of the present disclosure is to provide a parenteral (eg, PD) solution frangible insertion procedure that greatly reduces or eliminates microbial risk.

Another advantage of the present disclosure is to provide a parenteral (eg, PD) solution frangible insertion procedure that greatly reduces or eliminates clean-up time associated with frangible insertion, thereby increasing production efficiency.

Another advantage of the present disclosure is to provide a parenteral (eg, PD) solution frangible insertion procedure that greatly reduces the reject rate of solution bags due to improperly inserted frangibles.

Yet another advantage of the present disclosure is to provide a parenteral (eg, PD) solution frangible insertion procedure that checks to ensure that the required precision of insertion has been achieved.

The advantages discussed herein can be found in one or some, but 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 accompanying drawings.

Description of drawings

Figures 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.

Figure 2 is a front view of one embodiment for applying adhesive to an adhesive infiltrator.

Figure 3 is a perspective view showing one embodiment of the dipping portion of the adhesive dipper in greater detail.

Figure 4 is a side view of one embodiment of the following components: a retainer configured to releasably grasp a breakable object; a translational motion actuator configured to translate the retainer; and a rotational motion actuator , which is configured to rotate said holder; said part applying adhesive to the frangible object by means of an adhesive dipper in a first position.

Figure 5 is a side view of one embodiment of the following components: a retainer configured to releasably grasp a breakable object; a translational motion actuator configured to translate the retainer; and a rotational motion actuator , which is configured to rotate said retainer; said means places a frangible in a second position into a filling spout tube of a solution container, and the insertion is assessed by a visual inspection subsystem.

6 is an elevational cross-sectional view of one embodiment of a display device of the present disclosure showing a first frangible insertion visual inspection fail mode.

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

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

Detailed ways

Solution Containers and Fragiles

Referring now to the drawings, and in particular FIGS. 1 and 2 , there are shown various embodiments of frangibles of the present disclosure. Figure 1A shows a portion of a polyvinyl chloride (PVC) solution container or bag 110a, while Figure 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 filling spout 112 of the PVC solution container or bag 110a receives a PVC frangible 116a, which comprises a PVC breakable rigid plastic piece 118a. A PVC breakable rigid plastic piece 118a is sealed within the down tube 120 of the PVC frangible 116a. Down tube 120 may also be made of PVC and is sealed inside filler spout tube 112 . The PVC frangible 116a also includes an upper tube 122, which may be made of PVC and is connected to a filling line (not shown) extending to the Y site.

The filling spout 112 of the non-PVC solution container or bag 110b receives a non-PVC frangible 116b comprising a non-PVC breakable rigid plastic piece 118b. The non-PVC breakable rigid plastic piece 118b as shown is not sealed within the down tube, but is sealed directly inside the filling spout tube 112. The non-PVC frangible 116b includes an upper PVC pipe 122, which may be made of a non-PVC material and connects to a filling line (not shown) that continues to the Y site.

PVC solution container or bag 110a and non-PVC solution container or bag 110b are collectively referred to herein as solution container or bag 110 . The systems and methods discussed herein are equally applicable to PVC frangibles 116a, non-PVC frangibles 116b, and other frangible configurations. These are collectively and generally referred to herein as frangibles 116 . Likewise, PVC destructible rigid plastic piece 118 a and non-PVC destructible rigid plastic piece 118 b are collectively referred to herein as destructible rigid plastic piece 118 .

systems and operations

Referring now to FIG. 2 , adhesive infuser 30 of system 10 is shown. The adhesive impregnator 30 comprises a linear actuator 32 which is under the control of the control unit 20 . Control unit 20 includes one or more processors 22, one or more memories 24 operable with processors 22, electronics 26 operable with one or more processors 22 and one or more memories 24, and A user interface/display device 28 for entering commands to and displaying data from the one or more processors 22 and one or more memories 24 . Line W extending from linear actuator 32 shows that the linear actuator (and all components shown here with line W) are connected to electronics 26 and are controlled by one or more processors 22 and Control of one or more memory stores 24 .

In one embodiment, the linear actuator 32 is a pneumatically controlled cylinder, wherein a circuit 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 to which the pneumatic conduit extends or together with the electronics 26 of the control unit 20 .

A linear actuator 32 drives an arm 34 connected to or formed with a macerator 36 for collecting adhesive. Boom 34 and macerator 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 adhesive or solvent in adhesive source 38 . As shown in dashed lines in FIG. 2 , control unit 20 commands linear actuator 32 to actuate boom 34 and macerator 36 such that the macerator extends into adhesive source 38 to collect a quantity of adhesive or solvent. In various embodiments, the adhesive or solvent contained in the adhesive source 28 of the PVC solution bag is cyclohexanone, while the adhesive or solvent contained in the adhesive source 28 of the non-PVC solution bag is isophthalic acid. Propylbenzene or isopropanol.

Figure 3 shows one embodiment of macerator 36 in more detail. In the embodiment shown, the macerator 36 is generally U-shaped or J-shaped. The incubator 36 includes a connection portion 36a that is connected to or extends from the boom 34 of the adhesive incubator 30 . The extension portion 36b extends from the connection portion 36a to the U-shaped portion 36c of the infuser 36 . One or more grooves 36d are formed inside the U-shaped portion 36c. As the macerator 36 dips into the binder source 38, the one or more grooves 36d catch and collect additional binder or solvent.

The U-shaped or J-shaped opening 36e of the incubator 36 allows the frangible 116 to be moved into position to receive the adhesive, and the linear actuator 32 then bonds the boom 34 and incubator 36 from the adhesive source 38. Pull up on the solvent or solvent to catch the fragile. In alternative embodiments, the U-shaped portion 36c may be circular. In this case, the groove 36d may extend a full 360 degrees in the circle, and wherein the linear actuator 32 moves the boom 34 and the macerator 36 from the stick before the frangibles move into the circular portion 36c of the macerator 36. The adhesive or solvent of the mixture source 38 is pulled upwards.

Referring now to FIG. 4 , adhesive infuser 30 is again shown having linear actuator 32 , boom 34 , infuser 36 having U-shaped portion 36c and adhesive or solvent source 38 . The system 10 is further shown having a motion actuation assembly 40 under the control of the control unit 20 . Motion actuation assembly 40 includes a second linear actuator 42 which, similar to linear actuator 32, may be a pneumatically controlled cylinder with wiring W allowing for electrically opening and closing at least one pneumatic valve to allow positive pressure and / or negative pressure to actuate the piston. One or more pneumatic valves may also be located at the linear actuator or cylinder 42 , or together with the electronics 26 of the control unit 20 , with the pneumatic lines extending to the linear actuator 42 . In alternative embodiments, one or both of linear actuators 32 and 42 are electromechanically driven. For example, by stepper motors or servo motors and a rotation-to-translation converter (such as a ball or lead screw).

In the illustrated embodiment, a linear actuator or cylinder 42 translates a shaft having a purely translational portion 44 and a translational and rotational portion 46 . If the linear actuator 42 is capable of translating an axis that also rotates, no purely translational portion 44 of the axis is required. In either case, the distal end of the shaft driven by linear actuator 42 is capable of translation and rotation. A gear 48 is connected to the rotating portion 46 of the linear actuator shaft. Gear 48 may be plastic, such as a rigid plastic (eg, Teflon or nylon), or metal (eg, stainless steel or aluminum), while shafts 44/46 are metal (eg, in one embodiment, stainless steel).

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, eg, mounted below the linear actuator as shown. The electronics 26 precisely controls the output shaft 52 of the stepper motor or servo motor 50 , eg, precisely controls the acceleration, velocity and positioning of the output shaft 52 . A gear 54 is connected to the output shaft 52 of the electric motor 50 . Gear 54 may be plastic (e.g., in one embodiment, a rigid plastic such as Teflon or Nylon), or metal (such as stainless steel or aluminum), while shaft 52 is metal (e.g., in one embodiment, a Stainless steel).

The linear actuator gear 48 is shown meshing with the motor gear 54, both of which may be 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 actuator assembly 40 causes the motor 50 to turn the shaft 52, which causes the motor gear 54 to turn the linear actuator gear 48, which turns the linear actuator shaft. 44/46 of the rotating part 46, which is also translated by the linear actuator 42.

A retainer or pawl 60 is located at the distal end of the linear actuator shaft 44/46. The retainer or jaws 60 are opened and closed pneumatically by positive and/or negative pressure air delivered to the jaws 60 via pneumatic tubes 62. Positive and/or negative air pressure opens and closes the first finger 64 and second finger 66 around the frangible 116, the fingers gripping the frangible for movement. Considering the motion capabilities just described for the motion actuation assembly 40 and the operation of the holder or jaw 60, it should be understood that the frangible object 116 can be controllably grasped, translated, rotated and released by the control unit 20 of the system 10.

Looking at Figure 4, in one embodiment, linear actuator 42 translates frangible 116 to the desired position to receive adhesive. Adhesive infuser 30 lifts the U-shaped infuser out of adhesive or solvent source 38 such that U-shaped portion 36c (including groove 36d with adhesive or solvent) contacts the frangible in place. Motor 50 moving actuation assembly 40 rotates retainer or jaw 60 in a clockwise and/or counterclockwise direction, as indicated by the circular arrows in FIG. 4 . In one embodiment, the frangible 116 is rotated more than 360 degrees, such as 900 degrees, within the U-shaped portion 36c to ensure complete application of the adhesive or solvent around the entire 360 degrees of the outer diameter of the frangible 116 . After the frangible 116 has received the appropriate amount of adhesive or solvent, the linear actuator 42 removes the frangible 116 from within the U-shaped portion 36c of the infuser 36 and returns the infuser 36 to the source of adhesive or solvent. Solvent source 38 for additional binder or solvent. Alternatively, dipper 36 may have sufficient adhesive to coat multiple frangibles 116 .

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

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

In FIG. 5 , the gripper 70 with the pliers 72 gripping the solution container or bag 110 has been moved into position to receive the frangible 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 retainer or jaw 60 so that in the first position (eg, halfway inserted) of the linear actuator or cylinder 42 for total translational insertion, the easy The frangible motor 50 rotates the frangible 116 ; while in the second position and remainder (eg, second half) of total translational insertion of the linear actuator or cylinder 42 , the frangible motor does not cause the frangible to rotate. Here, on the first portion, the frangible 116 is translated and rotated (e.g., less than 360 degrees total rotation), which causes the adhesive or solvent to be smeared on the tip of the entire or nearly the entire inner diameter of the filling spout tube 112 . Once good adhesive coverage is ensured, the rest of the insertion of the frangible 116 passes through the tip of the inner diameter of the filling spout tube 112 in translation rather than rotation. Once the frangible insertion is complete, the claw or retainer 60 releases the frangible 116 and the frangible becomes part of the solution bag 110 .

Following insertion of the frangible 116 just described, the gripper 70 may be configured to move the solution bag 110 to the next operation such that the holder or jaw 60 under operation of the motion actuation assembly 40 retrieves a new frangible. Object 116 on which the motion actuation assembly 40 is rotated 90 degrees about axis A, clockwise in FIG. 5 , to the adhesive or solvent application position of FIG. 4 . The process described in connection with FIGS. 4 and 5 is then repeated.

Figure 5 also shows that the jig 70 may be provided with a camera 76, such as a digital camera, which takes images of the insertion of the breakable. A suitable camera for camera 76 is available from Cognex Corporation of Natick, MA 01760-2059. Camera 76 may have its own processor and memory to store and execute vision software. Camera 76 may alternatively output wired or wirelessly to vision software stored and executed at one or more processors 22 and memory 24 of 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 ^™ or VisionPro ViDi ^™ software from the manufacturers mentioned above.

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

In the embodiment shown in FIG. 5 , camera 76 is mounted on jig 70 . In alternative embodiments, the camera 76 may be mounted elsewhere. In any event, the focus of the camera 76 is on the upper portion of the filling spout tube 112 , where the breakable 116 is located. In one embodiment, the control unit 20 is programmed such that completion of the insertion of the breakable object 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 side of the container or bag 110 opposite the camera 76 . In one embodiment, the light source 78 comprises an array of lights, such as light emitting diodes (LEDs), which may be white or colored, such as blue or red LEDs. The control unit 20 may control the light source 78 to emit light when needed (eg, when a fragile insertion is complete) to improve the quality of the image captured by the camera 76 .

Once the camera 76 captures an image of the fragile insertion, vision software (stored in the camera 76 or the control unit 20) evaluates the image. As noted above, multiple evaluations (discussed below), eg, three evaluations, may be performed. In one embodiment, the vision software outputs a "pass" to the control unit 20 if the result of each assessment is a pass. If the result of any one evaluation is fail, the vision software outputs "fail" to the control unit 20 . In another embodiment, the vision software outputs grayscale counts for each of the three assessments, for example, and the control unit 20 is programmed to determine pass or fail for each assessment. Here too, if the result of each evaluation is pass, the control unit 20 determines "pass" as a whole. If the result of any one evaluation is a failure, the control unit 20 determines the overall "failure".

If the frangible insertion is determined to be overall "passed," the control unit 20 causes the gripper 70 to convey the fluid container or bag 110 to the next operation. A suitable "qualified" message may also be displayed on the user interface/display device 28 along with other relevant information. If either evaluation is negative, in one embodiment, control unit 20 causes gripper 70 to convey fluid container or bag 110 to a reject bin. A suitable "failure" message can also be displayed on the display device 28 along with other relevant information.

Visual inspection assessment

Reference is now made to FIGS. 6 through 8 , which illustrate example screens from the user interface/display device 28 for different rejected or rejected frangible insertion reject modes. Failure patterns may include any one or more of the following: (i) the frangible is inserted to the wrong depth, (ii) the frangible is missing, or (iii) the frangible is at a misaligned angle. In one embodiment, the fluid container or bag 110 is rejected if any image of the frangible insertion fails in any of the analysis modes.

Figure 6 shows an example of a failed insertion depth assessment. Here, the frangible 116 is not inserted far enough into the filling spout tube 112 . The result of the in-depth evaluation is therefore disqualified.

Figure 7 shows an example of the assessment of the presence of unacceptable frangibles. Here, the frangible 116 is completely absent. The result of the assessment of the presence of fragile objects was therefore unsatisfactory.

Figure 8 shows an example of a failed fragile alignment evaluation. Here, the angle of the frangible 116 relative to the fill spout tube 112 is too large (eg, greater than X degrees) to be considered a well-sealed engagement. The result of the alignment evaluation is therefore disqualified.

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. These changes and modifications can be made without departing from the spirit and scope of the 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 fluid bags, such as blood treatment fluid 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 the control unit

26 - Electronic device operable with one or more processors and one or more memories

28 - User interface/display device

30 - adhesive dipper

32 - Linear actuator or cylinder for adhesive impregnator

34 - Boom for adhesive macerator

36 - Dipper for Adhesive Dipper

36a – connection to boom

36b - extension

36c - U-shaped part of macerator

36d - One or more grooves for obtaining adhesive

36e - Opening for receiving fragile objects

38 - Binder source

40 - Motion Actuation Assembly

42 - Linear Actuator or Cylinder

44 - Translating part of linear actuator shaft

46 - Rotating part of linear actuator shaft

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

50 - Servo motor or stepper motor

52 - Output shaft of servo motor or stepper motor

54 - The gear that connects to the output shaft of the servo motor or stepper motor

60 - Holders or claws for holding fragile objects

62 - Pneumatic conduit for actuating the retainer or jaws

64 - Retainer or first finger of claw

66 - Retainer or second finger of claw

70 - Clamp for holding the filling spout tube of the solution container

72 - Pliers for holding the clamp of the filling spout tube of the solution container

74 - Pneumatic conduit for pliers for actuating the gripper

76 - Digital Camera for Visual Inspection of Fragile Insertion

78 - Light source opposite digital camera

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

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

112-Filling mouth tube

114 - Injection site port tube

116a - PVC frangible, commonly referred to herein as frangible 116

116b - Non-PVC frangibles, commonly referred to herein as frangibles 116

118a - Destructible Rigid Plastic Part of PVC, generally referred to herein as Destructible Rigid Plastic Part 118

118b - Non-PVC destructible rigid plastic parts, generally referred to herein as destructible rigid plastic parts 118

120 - Down tube for PVC frangibles

122 - Upper tube for frangibles.

Claims (25)

1. a kind of medical fluid container breakable object system, which is characterized in that the medical fluid container breakable object system includes:

Retainer, the retainer are configured to releasedly catch breakable object, and the breakable object selectively allows for fluid to flow through Medical fluid container；

Translational motion actuator, the translational motion actuator are configured to the translatable retainer；

Rotary motion actuator, the rotary motion actuator are configured to the rotatable retainer；

Adhesive source；

Adhesive-dipping device；And

Control unit, described control unit are programmed so that: (i) described adhesive infuser immerses in adhesive source, (ii) Retainer and breakable object described in the translational motion actuator translation, so as to be in appropriate location described to receive for the breakable object Adhesive-dipping device, or make the breakable object insertion described adhesive infuser, and (iii) described rotary motion actuator rotation Turn the retainer and breakable object, so that the breakable object rotates in described adhesive infuser to obtain described adhesive.

2. medical fluid container breakable object system according to claim 1, which is characterized in that the retainer includes pneumatic The finger-shaped material of actuating, the finger-shaped material releasedly catch the breakable object.

3. medical fluid container breakable object system according to claim 1, which is characterized in that the translational motion actuator Linear actuators comprising pneumatic actuation.

4. medical fluid container breakable object system according to claim 1, which is characterized in that the rotary motion actuator Include servomotor or stepping motor.

5. medical fluid container breakable object system according to claim 1, which is characterized in that the rotary motion actuator It is carried by the translational motion actuator.

6. medical fluid container breakable object system according to claim 1, which is characterized in that the medical fluid container is easy The system that minces includes the axis between the translational motion actuator and the retainer, wherein being connected to for the axis is described At least part of retainer is rotatable, so that the retainer rotates together at least part of the axis, and Wherein the rotary motion actuator is operably connected at least the one of the axis by coupling gear or ribbon and pulley Part.

7. medical fluid container breakable object system according to claim 1, which is characterized in that described control unit is also matched Being set to makes the breakable object go to few 360 degree in described adhesive infuser inward turning to obtain adhesive.

8. medical fluid container breakable object system according to claim 1, which is characterized in that described control unit is also matched Being set to makes each breakable object of described adhesive infuser and immerses in described adhesive source.

9. medical fluid container breakable object system according to claim 1, which is characterized in that described control unit is also matched Being set to translates up described adhesive infuser to meet with the breakable object from described adhesive source.

10. medical fluid container breakable object system according to claim 9, which is characterized in that the medical fluid container Breakable object system is configured to: the breakable object is moved to position appropriate before described adhesive infuser is translated by (i) It sets, so that the breakable object receives described adhesive infuser, or (ii) described will glue before the breakable object is translated Mixture infuser is translated up from described adhesive source, so that in breakable object insertion adhesive-dipping device.

11. medical fluid container breakable object system according to claim 1, which is characterized in that described adhesive infuser Including at least semicircular bottom, the bottom has at least one groove formed therein, and the groove is viscous for collecting Mixture is to pass to the breakable object.

12. a kind of medical fluid container breakable object system, which is characterized in that the medical fluid container breakable object system includes:

Retainer, it is configured to releasedly catch breakable object the retainer, and the breakable object selectively allows for fluid stream Cross medical fluid container；

Translational motion actuator, the translational motion actuator are configured to the translatable retainer；

Rotary motion actuator, the rotary motion actuator are configured to the rotatable retainer；

Fixture, the fixture are used to keep the filling exit pipe of medical fluid container；And

Control unit, described control unit are programmed so that: (i) described translational motion actuator and rotary motion actuating Device translates simultaneously and rotates the retainer and breakable object to the first position of filling exit pipe, and (ii) described translational motion actuating Device translates the farther second position in the retainer and breakable object to filling exit pipe.

13. medical fluid container breakable object system according to claim 12, which is characterized in that the wherein first position It is at least about the first half for the total distance that the breakable object is advanced in the filling exit pipe, and the farther second position It is at least about the latter half for the total distance that the breakable object is advanced in the filling exit pipe.

14. medical fluid container breakable object system according to claim 12, which is characterized in that described frangible in (i) Object rotates less than 360 degree.

15. medical fluid container breakable object system according to claim 12, which is characterized in that described control unit also by It is programmed so that the translational motion actuator and the rotary motion the actuator mobile retainer before (i) and (ii) And breakable object, to apply adhesive on the breakable object.

16. medical fluid container breakable object system according to claim 12, which is characterized in that the retainer includes gas The finger-shaped material of dynamic actuating, the finger-shaped material releasedly catch the breakable object.

17. medical fluid container breakable object system according to claim 12, which is characterized in that the translational motion actuating Device includes the linear actuators of pneumatic actuation.

18. medical fluid container breakable object system according to claim 12, which is characterized in that the rotary motion actuating Device includes servomotor or stepping motor.

19. medical fluid container breakable object system according to claim 12, which is characterized in that the rotary motion actuating Device is carried by the translational motion actuator.

20. medical fluid container breakable object system according to claim 12, which is characterized in that the medical fluid container Breakable object system includes the axis between the translational motion actuator and the retainer, wherein the axis is connected to institute It is rotatable for stating at least part of retainer, so that the retainer rotates together at least part of the axis, and And wherein the rotary motion actuator is operably connected to the axis at least by coupling gear or ribbon and pulley A part.

21. medical fluid container breakable object system according to claim 12, which is characterized in that the medical fluid container Breakable object system includes visual inspection subsystem, and the visual inspection subsystem has camera, and the camera is positioned and arranged At the digital picture that will capture the breakable object being inserted into the filling exit pipe.

22. medical fluid container breakable object system according to claim 21, which is characterized in that the medical fluid container Breakable object system includes processor and memory, and the processor and memory are configured as at least one in following index Kind is in the angle of misalignment to assess described image: (i) breakable object insertion depth, (ii) breakable object missing, or (iii) breakable object Degree.

23. medical fluid container breakable object system according to claim 22, which is characterized in that the processor and storage Device is equipped with described control unit.

24. medical fluid container breakable object system according to claim 22, which is characterized in that the medical fluid is easy Breakable object system is configured to: if (i) being failure to the assessment result of any one of (iii), being refused described frangible Object has been inserted into the container of the filling exit pipe.

25. a kind of medical fluid container breakable object system, which is characterized in that the medical fluid container breakable object system includes:

Retainer, the retainer are configured to releasedly catch breakable object, and the breakable object selectively allows for fluid to flow through Medical fluid container；

Translational motion actuator, the translational motion actuator are configured to the translatable retainer；

Rotary motion actuator, the rotary motion actuator are configured to the rotatable retainer, the rotary motion actuating Device is carried by the translational motion actuator；And

Control unit, described control unit are programmed so that: (i) described translational motion actuator is mobile and causes rotary motion Dynamic device is transported to first position, and in the first position, the translational motion actuator and the rotary motion actuator are mobile The retainer and breakable object, to apply adhesive on the breakable object, and (ii) described translational motion actuator quilt It is mobile that rotary motion actuator is simultaneously transported to the second position, in the second position, the translational motion actuator and described The mobile retainer of rotary motion actuator and breakable object hold the breakable object and described adhesive insertion medical fluid In the filling exit pipe of device.