Visual inspection systems and methods for evaluating medical fluid containers

Abstract

A visual inspection system for evaluating medical fluid containers, the system comprising: a conveyor for conveying medical fluid containers; a light source located below the conveyor and positioned to illuminate the medical fluid containers; a camera located above the conveyor and positioned to capture a digital image of a seal formed in the medical fluid container; and a processor and memory configured to evaluate the digital image of the seal and identify a defect if one of the following is detected: (i) a leak is detected in the seal, or (ii) misalignment of the seal relative to an edge of the medical fluid container is detected.

Description

Technical Field

[0001] The present application relates to a medical fluid container inspection technology, and more particularly, to a medical fluid container visual inspection system and method. Background Art

[0002] Due to disease or other reasons, a person's renal system may fail. In renal failure of any cause, there are many physiological disturbances. The balance of the daily metabolic load of water, minerals and excreta is no longer possible in renal failure. During renal failure, toxic end products of nitrogen metabolism (urea, creatinine, uric acid, etc.) may accumulate in the blood and tissues.

[0003] Kidney failure and reduced kidney function are treated by dialysis. Dialysis removes waste products, toxins, and excess water from the body that should be removed by a functioning kidney. Because dialysis treatment to replace kidney function is life-saving, this treatment is vital to many people. People with failing kidneys cannot survive without replacing at least the filtering function of the kidneys.

[0004] Peritoneal dialysis is a dialysis therapy commonly used to treat renal function loss. Peritoneal dialysis uses a dialysis solution, which 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 located in the peritoneal cavity. Waste, toxins and excess water pass from the patient's bloodstream through the peritoneum and into the dialysate. The transfer of waste, toxins and water from the bloodstream to the dialysate is due to diffusion and osmosis, i.e., an osmotic gradient is generated across the peritoneum. The osmotic fluid after use is discharged from the patient's peritoneal cavity to remove waste, toxins and excess water from the patient's body. The above cycle is then repeated.

[0005] There are multiple peritoneal dialysis (PD) therapies, including continuous ambulatory peritoneal dialysis (CAPD), automated peritoneal dialysis (APD) and continuous flow peritoneal dialysis (CFPD). CAPD is a manual dialysis treatment, in which the patient connects the implanted catheter to a drainage device and allows the dialysate after use to be discharged from the peritoneal cavity. Then, the patient manually allows fresh dialysate to flow through the patient's indwelling catheter from the solution bag and enter the patient's peritoneal cavity. Then, the patient can disconnect the connection between the catheter and the solution bag to allow the dialysate to reside in the peritoneal cavity, thereby transferring waste, toxins and excessive water from the patient's bloodstream to the dialysis solution. After the residency cycle, the patient repeats the above-mentioned manual process. In CAPD, the patient performs multiple drainage, filling and residency cycles in one day, for example, about four times a day.

[0006] Automated peritoneal dialysis (APD) is similar to CAPD in that its dialysis treatment also includes drain, fill, and dwell cycles. However, an APD machine automatically performs three to four cycles of peritoneal dialysis treatment, usually overnight while the patient sleeps. An APD machine is typically fluidly connected to an implanted catheter, one or more solution bags, and a drain bag.

[0007] 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 transfer of waste products, toxins, and excess water from the patient's bloodstream to the dialysis solution can occur. The APD instrument then pumps spent dialysate from the peritoneal cavity through a catheter to a drainage device. The APD instrument is typically computer controlled so that dialysis treatment occurs automatically when the patient is connected to the dialysis instrument (e.g., 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.

[0008] As with manual treatment, multiple drain, fill, and dwell cycles will occur during APD. The "last fill" is typically used at the end of APD, when the patient is disconnected from the dialysis machine during the day, and it remains in the patient's peritoneal cavity. APD eliminates the need for the patient to manually perform the drain, dwell, and fill steps.

[0009] As mentioned above, both CAPD and APD involve the use of solution bags and drainage bags. Preparing such bags requires a great deal of care and skill. The bags must not leak and must be within certain specifications. The solution bags must also be sterilized to a certain level so that the solution can be safely delivered to the patient. The bags must also be properly labeled so that the user or caregiver can be sure that the patient is receiving the correct PD solution.

[0010] Historically, PD solution bags are made of polyvinyl chloride (PVC). However, in some jurisdictions, PVC is prohibited from being used to manufacture solution bags or infusion tubes for transporting fluids to or from patients. For this reason, non-PVC films and infusion tubes have been developed. However, applying these films and infusion tubes in practice has proven to be difficult. PVC is generally easier to process than non-PVC materials. There are many processing variations for non-PVC materials, which must be implemented, optimized and verified for regulatory purposes.

[0011] PVC and non-PVC fluid containers and the resulting fluid sets can be placed in an outer bag that holds the set together and protects the fluid container from being punctured. The outer bag needs to be sealed so as to fully protect the fluid set from all sides and maintain a sterile environment around the fluid set. For the reasons mentioned above, it is important to correctly form the outer bag seal so that the product has a standardized appearance. Manual inspection of such seals is cumbersome and in some cases, defects cannot be found. Therefore, there is a need for an improved PD outer bag assembly process. Summary of the invention

[0012] The present disclosure provides an improved medical fluid container, system and method for manufacturing the same. In one embodiment, the medical fluid container includes a medical fluid solution bag (e.g., a peritoneal dialysis solution bag) and a medical fluid drainage bag, which are connected by a pipeline. In one embodiment, the drainage bag is made of polyvinyl chloride (PVC), and the solution bag can be made of PVC or a material other than PVC (non-PVC). An outer bag is provided to hold the medical fluid or PD fluid set together, including a PVC solution bag and a non-PVC solution bag, a PVC drainage bag and a pipeline connecting the two bags.

[0013] However, it should be understood that the present disclosure is applicable to any type of medical fluid bag or set, such as saline bags, medical delivery or intravenous fluid bags, nutritional fluid bags, hemodialysis solution bags, citrate bags, and continuous renal replacement fluid bags, etc., which can be disposed in an outer bag.

[0014] In one embodiment, a visual system and method are provided to evaluate the outer bag seal. The outer bag seal is disposed near the opening edge of the outer bag, near a pair of incisions for assisting in opening the outer bag. The evaluation is performed in a very short time, e.g., about 0.9 seconds. The outer bag holding the PD fluid set is conveyed along a conveyor. In one embodiment, a digital camera is located above the conveyor and the outer bag. In one embodiment, a light source such as a series of light emitting diodes (LEDs) is located below the conveyor to emit light through the holes in the conveyor belt and illuminate the outer bag, which can be translucent or transparent. The light from the light source can be colored, e.g., blue or red. The illuminated outer bag seal is photographed as it passes under the digital camera.

[0015] A digital image of the outer bag seal is transmitted from the camera to the processing and control unit. An area to be evaluated is defined in the processing and control unit. That is, the processing and control unit does not evaluate the entire digital image, but rather evaluates a defined area around the outer bag seal. In one embodiment, the processing and control unit performs multiple evaluations on the outer bag seal within the defined area, including any two or more of the following: (i) seal wrinkle evaluation, (ii) seal leakage evaluation, (iii) seal angle evaluation, (iv) first seal misalignment evaluation (e.g., left or right), (v) second seal misalignment evaluation (e.g., top or bottom), (vi) seal burn evaluation, (vii) outer bag tear evaluation, (viii) first incision evaluation (e.g., distance from the outer bag edge), and (ix) second incision evaluation (e.g., length of the incision). In one embodiment, each of the at least two evaluations must be passed to enable the outer bag and PD fluid set to enter the next manufacturing step. If any of the at least two evaluations fail, the processing and control unit causes the outer bag and PD fluid set to be (e.g., automatically) transferred to a rejection station, and then the PD fluid set can receive a new outer bag.

[0016] In one embodiment, the orientation of the bag residing on the conveyor is not important because the defined area is adjustable to account for any misalignment. Additionally, the vertical position of the camera above the outer bag is not important because, in one embodiment, the lens of the camera is adjustable to focus the image at different distances from the outer bag. The visual inspection system and method are also highly optimizable because any nonconformities determined by the system and method can be compared to the actual bag. In one embodiment, each assessment is formed by analyzing the grayscale output of the digital image of the bag. The defects determined by the camera are compared to the actual bag defects or deficiencies, allowing the grayscale analysis to be honed and sharpened.

[0017] In view of the disclosure herein and without limiting the present disclosure in any way, unless otherwise stated, any aspect of any one of claims 1 to 20 may be combined with any other aspect of any other one or more of claims 1 to 20.

[0018] In other aspects of the present disclosure, Figures 1 to 5G Any structure and functionality disclosed may be used with Figures 1 to 5G any other structural and functional combinations disclosed.

[0019] In view of the present disclosure and the above aspects, one advantage of the present disclosure is to provide a visual inspection system and method for evaluating medical fluid containers, particularly evaluating outer bags placed around medical fluid sets.

[0020] Another advantage of the present disclosure is to provide a visual inspection system and method that evaluates multiple potential bag sealing issues.

[0021] Another advantage of the present disclosure is to provide a visual inspection system and method that automatically rejects products that fail inspection.

[0022] Yet another advantage of the present disclosure is to provide a visual inspection system and method that can be easily inspected and improved.

[0023] The advantages discussed herein may be found in one or some, but not all, of the embodiments disclosed herein.Additional features and advantages are described herein and will be apparent from the following detailed description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 is a perspective view of a medical fluid container transfer assembly having one embodiment of the visual inspection system and method of the present disclosure.

[0025] Figure 2 is shown in more detail Figure 1 A camera stand perspective view of the system and method.

[0026] Figure 3A and 3B An example screen is shown showing a medical fluid product analyzed under the present systems and methods that was determined to be unacceptable.

[0027] Figure 4A and 4B An example screen is shown showing an approved medical fluid product analyzed under the present systems and methods.

[0028] Figures 5A to 5G Different example failure modes analyzed under the present systems and methods are shown. DETAILED DESCRIPTION

[0029] System and Operation

[0030] Referring now to the drawings, in particular Figure 1 , embodiments of a visual inspection system 10 and related methods are provided. Figure 1In the figure, three medical fluid product lines 12, 14 and 16 are shown. System 10 can optionally operate with any number of medical fluid product lines, including only one product line. In one embodiment, the medical fluid container includes a medical fluid solution bag (e.g., a peritoneal dialysis solution bag) and a medical fluid drainage bag, which are connected by a pipeline. In one embodiment, the drainage bag is made of polyvinyl chloride (PVC), and the solution bag is made of a material (non-PVC) other than PVC or PVC. An outer bag 18 is provided to keep the medical fluid or PD fluid set together, including a PVC or non-PVC solution bag, a PVC drainage bag and a pipeline connecting the two bags. The outer bag 18 and the fluid set contained therein form a fluid set 20 with an outer bag. The fluid set 20 with an outer bag is transmitted along lines 12, 14 and 16.

[0031] It should be understood that the present disclosure is applicable to any type of medical fluid bag or set, such as saline bags, medical delivery or intravenous fluid bags, nutritional fluid bags, hemodialysis solution bags, citrate bags, and continuous renal replacement fluid bags, etc., which can form part of a fluid set 20 with an outer bag.

[0032] exist Figure 1 In each of the lines 12, 14 and 16, a motorized conveyor is provided which conveys the fluid package 20 with the outer bag toward the camera station 30a, 30b or 30c. Figure 1 , line 12 conveys the fluid package 20 with the outer bag toward camera station 30a, line 14 conveys the fluid package 20 with the outer bag toward camera station 30b, and line 16 conveys the fluid package 20 with the outer bag toward camera station 30c. Along each line 12, 14 and 16, the fluid package 20 with the outer bag is placed so that the sealed end 18a of the outer bag 18 is positioned parallel to the direction of the conveyor to move under its corresponding camera station 30a, 30b or 30c.

[0033] Each camera station 30a, 30b, and 30c includes a housing 32, which may be made of metal, plastic, or a combination thereof. Figure 2 As shown, housing 32 houses a digital camera. Figure 1A separate reject unit 50 operable with a reject conveyor 52 is shown at the end of each line 12, 14, and 16. Any fluid set 20 with an outer bag (and any sealed end 18a of the outer bag 18 of the fluid set 20 in one embodiment) that is judged as unqualified under the visual inspection system 10 is rejected by the reject unit 50 and sent to the reject conveyor 52. The reject conveyor 52 can be a single conveyor or multiple conveyors. In the illustrated embodiment, the reject conveyor 52 discharges the fluid set 20 with an outer bag in two directions into wheeled boxes 54 and 56, so that the reject conveyor 52 can be two conveyors, a first conveyor extending in a first direction to the wheeled box 54, and a second conveyor extending in a second direction to the wheeled box 56. Here, (i) one of the conveyors is configured to receive rejected fluid sets 20 with outer bags from lines 12 and 14, while the other conveyor is configured to receive rejected fluid sets 20 with outer bags from line 16; or (ii) one of the conveyors is configured to receive rejected fluid sets 20 with outer bags from lines 14 and 16, while the other conveyor is configured to receive rejected fluid sets 20 with outer bags from line 12.

[0034] In one embodiment, the reject unit 50 includes an electromechanical and / or pneumatic actuator configured to grab the rejected fluid package with outer bag 20 from the conveyor of the line 12, 14 or 16 and lift the diverter plate in an angled manner to slide the rejected fluid package with outer bag 20 onto the reject conveyor 52 for transfer to the reject box 54 or 56. The fluid package with outer bag 20 that passes the visual inspection of the system 10 is collected from each line 12, 14 and 16 and delivered to the next operation through the outlet conveyor 58.

[0035] Figure 1 Also shown is a display device 34 disposed at each camera station 30a, 30b, and 30c. In one embodiment, the display device 34 is a color monitor that may or may not have a touch screen cover that allows user input. The display device 34 cooperates with the camera stations 30a, 30b, and 30c, either wired or wirelessly, to display images captured by the digital cameras of the camera stations 30a, 30b, and 30c and related evaluation information, including evaluation criteria and evaluation results, information about the fluid set 20 with an outer bag, time and date stamps, etc. The display device 34 can also be configured to display why or which evaluation has caused the fluid set 20 with an outer bag to fail the visual inspection of the system 10.

[0036] Reference now Figure 2, the camera station 30 is shown in more detail (reference is made to each camera station 30a, 30b, and 30c). The cover 32 is shown in phantom so that the interior of the camera station 30 can be seen. In particular, a camera 36 is shown, which can be a digital camera. For camera 36, ​​a suitable camera is provided by Cognex Corporation, Natick, MA, USA 01760-2059. Camera 36 can have its own processor and memory to store and execute vision software. Camera 36 outputs to a computer in a wired or wireless alternative manner. Figure 2 The control unit 24 and the camera 36 may each include a transceiver or transmitter / receiver for wireless communication. Each line 12, 14 and 16 ( Figure 1 ) provides a unified control unit 24; alternatively, a separate control unit 24 may be provided for each line 12, 14 and 16. In any case, suitable vision software may be provided by the camera manufacturer, such as VisionPro provided by the above-mentioned manufacturers. TM or VisionPro ViDi TM software.

[0037] In one embodiment, the vision software converts the digital color image captured by the camera 36 into a digital grayscale image and evaluates the grayscale image according to the program and algorithm of the system 10. The vision software can perform individual evaluations in grayscale, for example, the nine evaluations discussed below. Using grayscale for evaluation helps speed up the analysis so that all evaluations can be performed before the next fluid set 20 with an outer bag arrives at the camera 36. In one embodiment, all nine evaluations are performed within 0.9 seconds.

[0038] exist Figure 2 In the embodiment shown, the camera 36 is slidably mounted on a rod 38, which is fixed above the conveyor of the line 12, 14 or 16. In this way, the camera 36 can be slid along the rod 38 to place the camera in an optimal position relative to the direction of movement of the fluid set 20 with the outer bag. The optimal position cooperates with the position of the trigger sensor 40, which is triggered when the camera 36 will capture an image of the sealed end 18a of the outer bag 18. The trigger sensor 40 can be optical, such as a laser sensor, a transmitter / receiver, an infrared sensor, a magnetic sensor, an inductive sensor, a capacitive sensor, a proximity sensor or other sensor suitable for detecting the leading edge of the fluid set 20 with the outer bag. The trigger sensor 40 can be mounted below the fluid set 20 with the outer bag or above the set, for example, along the rod 38.

[0039] In one embodiment, there is a time delay between when the fluid set 20 with the outer bag is sensed by the trigger sensor 40 and when the trigger is sent to the camera 36 to capture an image of the sealed end 18a of the outer bag 18 of the set 20. The time delay may be programmed into the trigger sensor 40 or the control unit 24, which is in wired or wireless communication with the trigger sensor 40. In one embodiment, the trigger sensor 40 sends a wired or wireless signal to the control unit 24 once the leading edge of the fluid set 20 with the outer bag is detected, and wherein the control unit 24 is programmed to add a time delay (e.g., less than one second) to allow the sealed end 18a of the outer bag 18 to be positioned just below the camera 36, ​​over which the camera is aimed to capture an image of the sealed end 18a.

[0040] Figure 2 Also shown is a visual inspection system 10 in one embodiment, which includes a light source 60 located below each camera station 30a, 30b, and 30c. In one embodiment, the light source 60 includes an array of light-emitting elements, such as light-emitting diodes (LEDs), which can be colored, such as blue or red LEDs. The light source 60 is positioned (i) below the conveyor of the lines 12, 14, and 16 to emit light through a hole in the conveyor (and / or the conveyor can be light-permeable, such as translucent); or (ii) adjacent to the conveyor of the lines 12, 14, and 16, on the side facing the sealed end 18a of the outer bag 18 of the set 20, wherein the light-emitting element is directed onto the conveyor, located between the conveyor and the sealed end 18a. The control unit 24 can control the light source 60 to illuminate when needed (e.g., when the sensor 40 detects a fluid set 20 with an outer bag), or to continuously illuminate during the operation of the visual inspection system 10. The light from the light source 60 illuminates at least the sealed end 18a of the outer bag 18, which helps to improve the quality of the image captured by the camera 36.

[0041] Once the camera 36 captures an image of the sealed end 18a of the outer bag 18, the visual software (stored in the camera 36 or the control unit 24) evaluates the image. As described above, multiple evaluations (discussed below) may be performed, for example, nine evaluations. In one embodiment, if the result of each evaluation is qualified, the visual software outputs "qualified" to the control unit 24. If the result of any one evaluation is unqualified, the visual software outputs "unqualified" to the control unit 24. In another embodiment, the visual software outputs, for example, a grayscale count of each of the nine evaluations, and the control unit is programmed to determine the qualification or failure of each evaluation. Here again, if the result of each evaluation is qualified, the control unit 24 determines that the overall "qualified". If the result of any one evaluation is unqualified, the control unit 24 determines that the overall "unqualified".

[0042] If the overall "good" is determined, the control unit 24 causes the corresponding fluid set 20 with an outer bag to be conveyed to the next operation through the outlet conveyor 58. A suitable "good" message can also be displayed on the display device 34 for the line 12, 14 or 16 together with the other information discussed above. If the overall "bad" is determined, the control unit 24 instead causes the rejection unit 50 of the line 12, 14 or 16 to send the bad fluid set 20 with an outer bag to the rejection conveyor 52 and the box 54 or 56. A suitable "bad" message can be displayed on the display device 34 for the line 12, 14 or 16 together with the other information discussed above.

[0043] Evaluate

[0044] Reference now Figure 3A and 3B , an exemplary screen from the display device 34 of a rejected or unacceptable product or fluid set 20 with an outer bag is shown. Figure 3A and 3B is the same image captured by camera 36, ​​where Figure 3A Only the image is shown, and Figure 3B An image with overlay analysis by the vision software is shown. The vision software is advantageous because it can account for different fluid packages 20 with outer bags listed below: fluid packages 20 with outer bags that are in different orientations, are not perfectly square, or are not aligned with the conveyors of lines 12, 14, and 16. The software automatically adjusts for any orientation the package presents and performs the analysis accordingly. However, in Figure 3A In the example, seal 18b at sealed end 18a of outer bag 18 is clearly not parallel to edge 18c of outer bag 18. Legend 42 at lower right of display 34 shows that seal 18b at wrong angle, possibly other failures, resulted in three of nine failures (showing 1 instead of 0) in nine evaluations. Figure 3B The overlay analysis (lines and matrices) involved in the nine assessments scored in Figure 42 is shown. Figure 3A and Figure 3B The overall assessment of the fluid set 20 with an outer bag in is therefore "failed".

[0045] Figure 4A and 4B An exemplary screen from the display device 34 of an approved product or fluid set 20 with an outer bag is shown. Figure 4A and 4B The same image is taken by camera 36, ​​where Figure 4A Only the image is shown, and Figure 4BAn image with overlay analysis by vision software is shown. The vision software is also advantageous because it allows for imperfections in other parts of the formation of the outer bag 18. For example, due to the inherently imperfect nature of the outer bag 18, the edge 18c of the outer bag 18 is obviously not completely consistent or parallel with the seal 18b. The system 10 configures the vision software with appropriate tolerances when necessary. If different types of disposables or bags are being evaluated, the system 10 can provide different, for example, more stringent tolerances, wherein the formation of alternative disposables or bags can be better controlled. Figure 4A and 4B A legend 42 is shown at the lower right of the display device 34 indicating that all nine evaluations of the current sealed end 18a of the outer bag 18 have passed (all displaying 0). Figure 4B The overlay analysis (lines and matrix) involved in the nine assessments scored in Figure 42 is shown again. Figure 4A and 4B The overall assessment of the fluid set 20 with an outer bag in is therefore "acceptable".

[0046] Figure 4A Also shown is a cutout 18d disposed in the outer bag 18. The cutout 18d helps the patient or caregiver to open the outer bag 18 to obtain the medical fluid set located within the outer bag. Fig. 5F and Figure 5G The cutout 18d is discussed further.

[0047] In one embodiment, the nine assessments scored in Legend 42 are as follows: (i) seal wrinkle assessment, (ii) seal leakage assessment, (iii) seal angle assessment, (iv) first seal misalignment assessment (e.g., left or right), (v) second seal misalignment assessment (e.g., top or bottom), (vi) seal burn assessment, (vii) outer bag tear assessment, (viii) first cut assessment (e.g., distance from outer bag edge), and (ix) second cut assessment (e.g., length of cut). The seal angle assessment (iii) is scored by its Figure 3A and Figure 3B The other eight failure modes of the seal 18b of the sealing end 18a are shown in Figures 5A to 5G The system 10 configures the vision software (at the camera 36 or the control unit 24) to individually and independently evaluate each of these failure modes as discussed herein.

[0048] Figure 5A A seal wrinkle failure is shown, where a wrinkle W in the seal 18b is analyzed according to the system 10 and found to be outside the allowable limit. Wrinkles can form when one layer of the outer bag 18 to be sealed is bent or offset relative to another layer. Figure 5AAs shown, the resulting seal 18b is bowed or bent. If the bow or bend W is greater than the allowed limit, this may indicate that the seal 18b is under pressure and is therefore prone to leakage, and the result of the seal wrinkle evaluation is a failure. Figure 5A It should be noted that a seal wrinkle failure may alternatively or additionally be determined by evaluating the distance between the edges 18c of the two layers of the outer bag 18 to be sealed.

[0049] Figure 5B A seal leak failure is shown, where a gap G is found in the seal 18b according to the analysis of the system 10. The gap G would allow non-sterile air to enter the outer bag 80, so the result of the seal leak assessment is a failure.

[0050] Figure 5C The first seal misalignment evaluation is shown, where a lateral displacement D of seal 18b (in the same direction as seal 18b) is found according to the analysis of system 10. The lateral displacement D leaves a gap that will allow non-sterile air to enter the outer bag 18, so the result of the first seal misalignment evaluation is failed. Although the gap created is similar to Figure 5B The results of the seal leakage failures in the same way are the same, but the causes are different, for example, a misaligned seal instead of an intermittent seal, so it is desirable to classify the gaps under different failure modes.

[0051] Figure 5D A second seal misalignment evaluation is shown, where an unacceptable upward or downward displacement D (perpendicular to the direction of seal 18b) of seal 18b is found according to the analysis of system 10. Figure 5D , the displacement D of seal 18b downwardly toward edge 18c so that cutout 18d ( Figure 5E and 5F ) will interfere with the seal and cause leakage. The result of the second seal misalignment evaluation is therefore a failure. If the displacement D of seal 18b is, on the contrary, unacceptably upward, seal 18b may be too close to the contents in outer bag 18, thereby exerting pressure on seal 18b, which may cause leakage.

[0052] Figure 5E A seal burn failure is shown, where a burn B is found in seal 18b according to the analysis of system 10. Burn B may be due to excessive sealing energy being applied to a particular point along seal 18b, for example, due to a stoppage of the sealing conveyor. Burn B is poor in appearance and is inconsistent with a proper seal 18b and may cause leakage. The result of the seal burn evaluation is therefore a failure.

[0053] Fig. 5F and 5G The first and second cutouts are shown to be unqualified, for example, the distance to the side ( Fig. 5F ) and the length of the cut ( Figure 5G As described above, the cutout 18d helps the patient or caregiver to open the outer bag 18 to obtain the medical fluid set located therein. Fig. 5F In the analysis of the system 10, it is found that the spacing of the left cutout 18d is acceptable, but the distance between the right cutout 18d and the side of the outer bag 18 is unacceptable and therefore unqualified. Figure 5G In the example, the analysis by the system 10 found that the length of the left cutout 18d was acceptable, but the length of the right cutout 18d was unacceptable and therefore failed. Fig. 5F and 5G In the figure, neither the right incision 18d provides adequate external bag opening assistance to the patient and is cosmetically inferior and inconsistent with the proper incision 18d. The result of the incision evaluation is a failure.

[0054] It should be understood that various changes and modifications to the currently preferred embodiments described herein will be apparent to those skilled in the art. These changes and modifications may be made without departing from the spirit and scope of the present subject matter and without reducing its expected advantages. Therefore, it is expected that the appended claims cover these changes and modifications. For example, although the present system and method are described primarily in conjunction with peritoneal dialysis bags, it should be understood that the present system and method are applicable to other types of parenteral fluid bags, such as blood processing fluid bags, medical fluid delivery bags, saline bags, etc. In addition, although the present system and method are described primarily in conjunction with medical fluid bags, it should be understood that the present system and method are applicable to other types of medical fluid containers, such as more rigid medical fluid containers.

[0055] Part Number List

[0056] 10- Visual Inspection System

[0057] 12, 14, 16-Medical Fluid Product Line

[0058] 18-Outer bag

[0059] 18a-Sealed end of outer bag

[0060] 18b-Sealing of outer bag

[0061] 18c - Edge of outer pocket

[0062] 20-Fluid suit with outer bag

[0063] 24-Control Unit

[0064] 26-Processor

[0065] 28-Memory

[0066] 30a, 30b, 30c - Camera Station

[0067] 32-Camera stand shell

[0068] 34-Display device

[0069] 36-Camera

[0070] 38 – Camera Mounting Pole

[0071] 40-Trigger Sensor

[0072] 42- Legend on the display device

[0073] 50-Reject Unit

[0074] 52-Rejection Conveyor

[0075] 54, 56-wheeled box

[0076] 58-Export conveyor

[0077] 60-Light Source

Claims

1. A visual inspection system for evaluating medical fluid containers, characterized in that The system comprises: a conveyor for conveying medical fluid containers; a light source located below the conveyor and positioned to illuminate the medical fluid container; a camera located above the conveyor and positioned to capture a digital image of a seal formed in a medical fluid container; and a processor and memory configured to evaluate the digital image of the seal for: (i) the presence of a leak in the seal, and (ii) misalignment of the seal relative to a rim of the medical fluid container, and if (i) or (ii) is detected, identify a defect; a trigger sensor adapted to detect a leading edge of the medical fluid container, wherein the trigger sensor is configured to send a signal to the processor and memory upon detecting the leading edge of the medical fluid container; The processor and memory are configured to control the camera to capture a digital image of a seal formed in the medical fluid container a predetermined time after receiving the signal from the trigger sensor.

2. The visual inspection system according to claim 1, characterized in that The processor and memory are further configured to evaluate the digital image of the seal for seal misalignment, wherein the seal is shifted left or right along the direction of the seal, and to identify a defect if seal misalignment is detected.

3. The visual inspection system according to claim 1, characterized in that The processor and memory are also configured to evaluate the digital image of the seal for seal misalignment, wherein the seal is moved upward or downward in a direction perpendicular to the seal, and to identify a defect if seal misalignment is detected.

4. The visual inspection system according to claim 1, characterized in that The processor and memory are also configured to evaluate the digital image of the seal for the presence of seal burn and to identify a defect if seal burn is detected.

5. The visual inspection system according to claim 1, characterized in that The processor and memory are also configured to evaluate the digital image for a tear in the medical fluid container and, if a tear is detected, identify the defect.

6. The visual inspection system according to claim 1, characterized in that The medical fluid container includes at least one incision to assist in opening the medical fluid container, and the digital image also captures the at least one incision, wherein the processor and memory are further configured to evaluate the distance of the at least one incision in the digital image to an edge of the medical fluid container and identify a defect if the distance is outside of an allowable specification.

7. The visual inspection system according to claim 1, characterized in that: The medical fluid container includes at least one incision to assist in opening the medical fluid container, the digital image also captures the at least one incision, and wherein the processor and memory are further configured to evaluate a length of the at least one incision in the digital image and identify a defect if the length is outside of an allowed specification.

8. The visual inspection system according to claim 1, characterized in that The system includes a reject station, and wherein if (i) or (ii) is detected, the medical fluid container is automatically transferred to the reject station.

9. The visual inspection system according to claim 1, wherein: The light source located below the conveyor includes a plurality of light emitting diodes (LEDs).

10. The visual inspection system according to claim 9, characterized in that The LED emits red light or blue light.

11. The visual inspection system according to claim 1, wherein: The medical fluid container is an outer bag for holding a medical fluid set.

12. A visual inspection system for evaluating a medical fluid container, characterized in that: The system comprises: a conveyor for conveying the medical fluid container; a light source located below the conveyor and positioned to illuminate the medical fluid container; a camera located above the conveyor and positioned to capture a digital image of the seal formed in the medical fluid container; and a processor and memory configured to evaluate the digital image of the seal for: (i) a first seal misalignment, wherein the seal is shifted left or right along a direction of the seal, and (ii) a second seal misalignment, wherein the seal is shifted upward or downward in a direction perpendicular to the seal, and if (i) or (ii) is detected, identify a defect; a trigger sensor adapted to detect a leading edge of the medical fluid container, wherein the trigger sensor is configured to send a signal to the processor and memory upon detecting the leading edge of the medical fluid container; The processor and memory are configured to control the camera to capture a digital image of a seal formed in the medical fluid container a predetermined time after receiving the signal from the trigger sensor.

13. The visual inspection system according to claim 12, characterized in that The processor and memory configured to evaluate the digital image include being configured to analyze a grayscale output of the digital image.

14. A visual inspection system for evaluating a medical fluid container, characterized in that: The system comprises: a conveyor for conveying medical fluid containers; a light source located below the conveyor and positioned to illuminate the medical fluid container; a camera located above the conveyor and positioned to capture a digital image of the seal formed in the medical fluid container; and a processor and memory configured to evaluate the digital image of the seal for: (i) seal burns, and (ii) tears in the medical fluid container, and if (i) or (ii) is detected, identify the defect; a trigger sensor adapted to detect a leading edge of the medical fluid container, wherein the trigger sensor is configured to send a signal to the processor and memory upon detecting the leading edge of the medical fluid container; The processor and memory are configured to control the camera to capture a digital image of a seal formed in the medical fluid container a predetermined time after receiving the signal from the trigger sensor.

15. The visual inspection system of claim 14, wherein: The processor and memory configured to evaluate the digital image include being configured to analyze a grayscale output of the digital image.

16. A visual inspection system for evaluating an outer bag holding a medical fluid set, the outer bag including at least one cutout to facilitate opening the outer bag, characterized in that: The system comprises: a conveyor configured to convey the outer bag; a camera positioned to capture a digital image of the at least one incision; and a processor and memory configured to evaluate the at least one cutout for: (i) a distance of the at least one cutout from an edge of the medical fluid container, and (ii) a length of the at least one cutout, and to identify a defect if the distance in (i) or the length in (ii) is outside of an allowed specification; a trigger sensor adapted to detect a leading edge of the medical fluid container, wherein the trigger sensor is configured to send a signal to the processor and memory upon detecting the leading edge of the medical fluid container; The processor and memory are configured to control the camera to capture a digital image of a seal formed in the medical fluid container a predetermined time after receiving the signal from the trigger sensor.

17. The visual inspection system of claim 16, wherein: The term "outside the permitted specification" includes "outside the permitted range".

18. The visual inspection system of claim 16, wherein: The system includes a light source for illuminating the outer bag.

19. A method for preparing an outer bag, characterized in that: The method comprises: placing the medical fluid set into the outer bag through the open end of the outer bag; conveying the outer bag containing the medical fluid set by a conveyor; applying a seal to the open end of the outer bag; detecting a front edge of the outer bag by a trigger sensor; capturing, by a camera, a digital image of the seal a predetermined time after detecting a leading edge of the outer bag; evaluating, by a processor and a memory, the digital image for a plurality of defects; and If any defects exist, the outer bag is identified by the processor and memory.

20. The method for preparing an outer bag according to claim 19, characterized in that: The method also includes forming at least one cut in the outer bag to facilitate opening of the outer bag, and evaluating the digital image for defects associated with the at least one cut.

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