Continuous ambulatory peritoneal dialysis device flow control valve and method of use

Abstract

The application provides a continuous ambulatory peritoneal dialysis device flow control valve and a use method, the continuous ambulatory perodialysis device flow control valve comprises a control valve assembly, the control valve assembly comprises a shell and a controller, the shell is provided with three liquid medicine ports, the controller comprises a connecting pipe, the controller is installed on the shell, the controller is connected with the shell in a liquid sealing mode, the shell has a first surface, the controller has a second surface, the first surface and the second surface are attached, steam can penetrate between the first surface and the second surface, and the controller can control the connecting pipe to be connected or disconnected with any at least two liquid medicine ports.The application has the advantages that: the connectivity of the valve device is improved; operation is relatively simple; and the valve device has sound and / or physical feedback functions.

Description

TECHNICAL FIELD

[0001] The present invention relates to the field of dialysis medical devices, and more particularly, to a continuous ambulatory peritoneal dialysis device flow control valve and method of use. BACKGROUND

[0002] When a patient's kidney function fails, waste and excess body fluids normally filtered by the kidney accumulate in the patient's blood. Therefore, patients with kidney function failure need to be dialyzed to prevent the accumulation of waste toxicity. CAPD is a method of using the membrane in the peritoneal cavity of an end-stage renal disease patient to separate and remove waste and excess body fluids from the patient's body fluid system.

[0003] It is known that peritoneal dialysis is a dialysis method that uses the abdominal lining (peritoneum) as a natural blood filter. When using this method, a catheter is surgically implanted into the peritoneal cavity to infuse dialysate. The surgically implanted catheter end along the abdominal wall can be connected to the patient's pipette. The pipette can be connected / disconnected to the patient's connector on the flow control valve. The dialysate comes into contact with the capillaries throughout the peritoneum, and the accumulated waste is diffused from the patient's blood into the dialysate, which is then discharged from the peritoneum with the dialysate; this process is repeated 4 times a day to keep the patient's blood free of waste and other excess body fluids.

[0004] The present invention relates to continuous ambulatory peritoneal dialysis (CAPD), a method of peritoneal dialysis, as the name implies, is a method of dialysis that is continuously replaced many times a day while the patient is not in bed. When using the CAPD method, the patient does not affect normal activities such as work or study during the dialysis process.

[0005] During a single CAPD treatment (or exchange), the patient connects the dialysate bag and a separate drain bag to the implanted CAPD catheter. The dialysate bag is placed at shoulder height or higher, and the drug solution flows into the peritoneal cavity by gravity. The drain bag is placed on the floor and also drains the outflow by gravity. The flow control valve used between the pipette and the drain bag can be used to regulate the dialysate inlet and the outflow outlet.

[0006] It is worth noting that although the CAPD device appears to operate from top to bottom, i.e. first infusion, then drainage, in fact it does not. The patient can complete the CAPD exchange operation by first draining, then re-infusing. The dialysate from the previous CAPD exchange is drained before the new liquid is infused. The patient's daily activities for 4-6 hours after the exchange will not be affected, and the accumulation of blood toxins and excess body fluids can be drained again.

[0007] The CAPD devices currently in use do not accommodate all patient populations well, due to differences in manual dexterity, visual acuity, and other disease states. For example, a high rate of inflow of dialysate into the peritoneal cavity can cause discomfort to the patient. This is particularly true when the dialysate is not at body temperature. This can be due to emotional instability, lack of exercise, or lack of a source of warming the dialysate. It can also be due to the fact that taller patients can accommodate a higher flow rate than shorter patients.

[0008] More importantly, some patient populations are unable to accommodate the CAPD device and / or perform the CAPD exchange procedure under conditions that are conducive to handling and maintaining a sterile connection. The patient is required to perform the CAPD exchange procedure in a clean environment, and should also wear a mask, wash his or her hands, use sterile equipment, and check the dialysate bags for possible breakage. Failure to take these precautions can result in peritoneal infection (peritonitis).

[0009] Furthermore, the CAPD devices currently in use do not accommodate the needs of the patient population well, because some patients can not be able to use the external clamps or to be familiar with the sequence of operation required in conventional valve devices, due to disability or age. SUMMARY

[0010] The present invention provides a continuous ambulatory peritoneal dialysis device flow control valve and method of use that addresses the problems of the prior art. The objects of the present invention are achieved by the following technical solutions.

[0011] The present invention relates to improved CAPD devices and components, and in particular to improved control valves for CAPD devices.

[0012] In order to minimize the risk of mis-treatment or infection, the present invention also relates to an improved CAPD procedure.

[0013] The improved control valve and device of the present invention relates to a closed valve device that has improved space compared to the prior art components.

[0014] The valve device of the present invention consists of an outer valve body and a multi-position central screw flow controller that are coaxially connected to each other. The present invention is designed in such a way that it can fully satisfy the requirements of steam permeation moist heat sterilization.

[0015] The present invention also provides a CAPD device and components that allow the user to further control the flow rate through the device, thereby further improving the comfort of the patient using the device. The components of the present invention also improve the ergonomic features, including the shape and size, to facilitate the user's operation, improve the feedback of the control valve engagement, and improve the communication of the valve device opening and closing (e.g., to the drain bag or the dialysate bag) during the steps of the CAPD exchange procedure.

[0016] The present application also provides a valve and device that resists potential contamination from both hands, water or the surrounding environment by being enclosed. Such a valve and device is critical for patients in areas where sanitary conditions are poor (e.g., lack of clean water or other conditions that prevent infection).

[0017] The present application provides a simple one-way controller that is provided with treatment steps and is relatively simple to operate. The controller of the present application has audible and / or physical feedback that determines if the controller is in the correct position to perform the next step during use. The controller also takes into account other ergonomic features that are suitable for different patient populations in its design.

[0018] The present application remedies these and other deficiencies in the prior art CAPD valves by providing a single controller that is suitable for a wide range of patient populations and environments.

[0019] The present application also relates to improved methods of operating and using a CPAD device. The present application provides a control valve that allows steam permeation control valve sterilization.

[0020] The methods and components of the present application also provide a controlled operating system that can be used to determine previous and upcoming steps in a dialysis procedure.

[0021] The present application also includes components and designs for direct sampling of effluent within a CPAD device. BRIEF DESCRIPTION OF DRAWINGS

[0022] Other features, objects, and advantages of the present application will become more apparent from the following detailed description of non-limiting embodiments thereof.

[0023] Figure 1 A CAPD device in use is shown;

[0024] Figure 2 A first embodiment of the present application is shown in isometric view;

[0025] Figure 3 A top view of the embodiment is shown; Figure 2

[0026] Figure 4 A side view of the embodiment is shown; Figure 2

[0027] An exploded view of the embodiment is shown; Figure 5 Figure 2 A perspective view of the embodiment is shown;

[0028] Figure 6 Figure 2 ​​​Top view of the embodiment;

[0029] Figure 7 Shown is Figure 6 Close-up view of the section;

[0030] Figure 8 Shown is Figure 2 Top view of the embodiment along Figure 3 Sectional view of the middle 8-8 tube;

[0031] Figure 9 Shown is Figure 2 Top view of the embodiment along Figure 3 Sectional view of the middle 9-9 tube;

[0032] Figure 10A Shown is Figure 2 Top view of the embodiment in four different directions;

[0033] Figure 10G Shown is Figure 2 Top view of the embodiment, showing controlled liquid flow;

[0034] Figure 10G-1 Different liquid flow rates are shown in -10G-4;

[0035] Figure 11 Shown is Figure 10A Table of steps described in -F;

[0036] Figure 12 Shown is Figure 2 Side sectional view of the embodiment, first embodiment of the plug / slot;

[0037] Figure 13 Shown is Figure 2 Side sectional view of the embodiment, second embodiment of the plug / slot;

[0038] Figure 14 Close-up sectional view of the plug / slot based on the present invention, facilitating the method described in the present invention;

[0039] Figure 15 Shown is Figure 12 Close-up sectional view of the design;

[0040] Figure 16 Shown is Figure 15 Close-up sectional view of the design;

[0041] Figures 17-19 Side sectional view of different embodiments of the present invention;

[0042] Figures 20-29 Steps for use by the patient of the embodiment of the present invention are shown in -F;

[0043] Figures 30-35 The steps of the application are shown, and the patient can control the flow of fluid during the procedure. DETAILED DESCRIPTION

[0044] The specific embodiments of the present application will be described below in conjunction with the drawings and examples, and those skilled in the art can clearly and completely understand the technical solutions of the present application, the technical problems solved by the present application and the technical effects produced by the present application through the content described in the specification. It can be understood that the specific embodiments described herein are only used to explain the present application, but not to limit the present application. In addition, only the parts related to the present application are shown in the drawings for the convenience of description.

[0045] It should be noted that the structures, proportions, sizes, etc. shown in the drawings of the specification are only used to cooperate with the content described in the specification for understanding and reading by those skilled in the art, and do not have technical significance to limit the conditions that can be implemented by the present application, so any modification of the structure, change of the proportion relationship or adjustment of the size, which does not affect the effects that can be produced by the present application and the purposes that can be achieved, should fall within the scope of the technical content disclosed by the present application.

[0046] The terms such as "first", "second", "the", etc. cited herein do not represent quantity limitation, but can represent singular or plural. The terms "include", "contain", "have" and any variations thereof involved in the present application are intended to cover non-exclusive inclusion; for example, a process, method, system, product or device including a series of steps or modules is not limited to the listed steps or units, but can also include steps or units that are not listed, or can also include other steps or units inherent to the process, method, product or device. The terms "connect", "connected", "coupled" and the like involved in the present application are not limited to physical or mechanical connection, but can also include direct or indirect electrical connection.

[0047] Figure 1 The CAPD device diagram in use is shown. As Figure 1As shown, CAPD set 10 includes a solution bag 12 and a drain bag 14 connected to a patient via a solution line 16, a drain line 18, and a patient line 20 that can be connected to a transfer set 120. The solution line 16 is a first line, the patient line 20 is a second line, and the drain line 18 is a third line. CAPD set 10 uses a control valve assembly 22. Control valve assembly 22, which is interposed between solution line 16, drain line 18, and patient line 20, allows solution to flow from solution bag 12 to drain bag 14 during a set priming step, from solution bag 12 to the patient during a dialysate fill step, and from the patient to drain bag 14 during a drain step. Control valve assembly 22 of the present application includes a control knob 26 that can be twisted to ensure that the steps are performed in the proper order (see Figure 2 As will be apparent from the description of CAPD set 10 and control valve assembly 22, CAPD set 10 does not require the use of external clamps that are currently provided with CAPD sets, thereby minimizing the risk of operator error. Also, CAPD set 10 is in the "all valves closed" position when the patient line / transfer set connection and disconnection steps are performed.

[0048] As will be apparent from the description of CAPD set 10 and control valve assembly 22, CAPD set 10 does not require the use of external clamps that are currently provided with CAPD sets, thereby minimizing the risk of operator error. Also, CAPD set 10 is in the "all valves closed" position when the patient line / transfer set connection and disconnection steps are performed.

[0049] Figure 2 One embodiment of control valve assembly 22 of the present application is described. Control valve assembly 22 generally includes a housing 24 and a control knob 26. Control knob 26 is a twist flow control knob that is ergonomically designed to allow the user to sequentially adjust the valves to perform a fill, drain, prime, or stop operation. For example, Figure 3 Control valve assembly 22 is shown in the fill position.

[0050] As shown in Figure 2 Housing 24 includes a tubular body 25 (also shown in Figure 5As shown, the tubular body has three extended fluid ports 28, 30, 32. Fluid ports 28, 30, 32 are used to connect fluid line 16, drain line 18 or patient line 20 / pipette 120, respectively, and are therefore referred to as fluid port 30, drain fluid port 32 and patient fluid port 28. Of these, fluid port 30 is a first fluid port, patient fluid port 28 is a second fluid port, and drain fluid port 32 is a third fluid port. Controller 26 is capable of connecting or disconnecting any two or more of the fluid ports. For example, controller 26 is capable of connecting fluid ports 28 and 30, fluid ports 28 and 32, and fluid ports 30 and 32, respectively, and controller 26 is capable of simultaneously disconnecting fluid ports 28, 30, 32. Preferably, controller 26 is also capable of simultaneously connecting fluid ports 28, 30, 32.

[0051] Housing 24 is provided with a top flange 34 and a bottom flange 36, which are ergonomically designed for easy gripping. The top flange 34 is provided with sequential step names and / or icons.

[0052] As shown above and below, Figure 3 Top flange 34 is provided with indicia 38 that indicate the ports dedicated to filling, rinsing, draining, etc., and the CAPD process being performed. The indicia can be any number, word, symbol, plug or socket, etc., that is tactile and helps the user to correctly perform the procedure. As described below, this is designed to facilitate the user's smooth and efficient performance of all the important steps.

[0053] Figure 4 Shown is Figure 3 A plan view of control valve assembly 22. As shown, Figure 3 Fluid port 30 is perpendicular to drain fluid port 32 and rinse or patient fluid port 28. As described below, this perpendicular design is used to facilitate the user's smooth transition from one treatment step to another. Figure 4 Also shown is that fluid ports 28, 30, 32 are in the same plane, i.e., they are in the same horizontal plane in control valve assembly 22, which allows the fluid to flow efficiently through control valve assembly 22.

[0054] Figure 5 Shown is an exploded view of control valve assembly 22. Controller 26 is provided with a knob that is attached to a generally tubular rotator 27 that is designed to be inserted into and rotated within tubular body 25 of housing 24. The user changes the operating position by rotating controller 26, which, as described below, is used to adjust the fluid flow rate to a particular position, e.g., the fill position. Rotator 27 has fluid openings 40, 42, 44 that correspond to fluid ports 30, 32, 28 of housing 24, so that controller 26 and housing 24 are coaxially aligned with each other.

[0055] according to Figure 5 As shown, to prevent contamination of the control valve assembly 22, the O-ring 48 is first installed on the controller 26, specifically between the knob and the tubular rotating body 27. This creates a sealed, closed condition, ensuring the sterility of the drug solution channel during use and throughout the device's service life. Figure 8 and Figure 9 The detailed design of the outer casing is shown. To prevent contamination of connecting pipes 50 and 52, two O-rings 48 can also be used in the device (see...). Figure 19 ), to seal the drug passage in the control valve in another way, such as Figure 6 As shown. Both designs described above meet the design requirements of this invention. During installation, an O-ring 48 made of a self-lubricating material or a synthetic material should be selected to ensure smooth screwing of the controller 26.

[0056] Figure 6 This is a top cross-sectional view of the control valve assembly 22, showing the tubular rotating body 27 of the controller 26 nested within the outer tubular body 25. The rotating body 27 has liquid openings 40, 42, and 46, which can be aligned with the liquid ports 30, 32, and 28 of the tubular body 25. The rotating body 27 includes a connecting pipe 50 extending from the first liquid opening 40 to the liquid opening 46 (spanning the diameter of the tubular rotating body 27) and a connecting pipe 52 extending to the liquid opening 42 (spanning the radius of the tubular rotating body 27), with the diameter and radius pipes intersecting (approximately 90°). The controller 26 can control the connecting pipes 50 and 52 to connect or disconnect any at least two liquid ports. Preferably, the controller 26 can also control the connecting pipes 50 and 52 to simultaneously connect liquid ports 28, 30, and 32.

[0057] The rotating body 27 of the controller 26 and the tubular body 25 of the housing 24 are coaxially mounted to each other, and the joint surface is textured on one or both sides to create gaps.

[0058] The O-ring creates a seal around the liquid channel. The textured surface forms a controllable joint gap, allowing steam to successfully penetrate and sterilize, thus enabling the control valve assembly 22 to achieve 10... -6 The sterility assurance level (SAL) is achieved.

[0059] Figure 7 What is shown is Figure 6 A partial enlarged view of the design shows the interaction between the controller 26 and the tubular body 25 of the housing 24. This design also facilitates the control of the control valve assembly 22; the resistance generated by their interaction helps to properly regulate the flow rate of the medicine through the control valve assembly 22. In other words, the frictional engagement is sufficient to avoid unintended crosstalk between certain channels because the flow setting is retained during operation until the user has completed the adjustment.

[0060] As mentioned above, Figure 8 and Figure 9 are cross-sectional views of the control valve assembly 22 along the Figure 3 8-8 and 9-9 tubes, respectively, further illustrating the interaction between the rotating body 27 of the control 26 and the tubular body 25 of the housing 24, and the sealing condition created by the O-ring installed at the interface. The rotating body 27 is fitted within the tubular body 25, and the rotating body 27 is in close contact with the tubular body 25, and is normally fitted at the bottom of the housing 24, so that the solution ports 28, 30, 32 of the tubular body 25 can be aligned with the solution openings 40, 42, 46 of the rotating body at the same level. As shown in Figure 5 , the sealing is accomplished by using the O-ring 48 above the solution level.

[0061] The present application improves the comfort of the user. By twisting the control 26 and the tubular body 25, the solution flow through the control valve assembly 22 can be adjusted by the user, and the solution flow rate is determined by the patient (i.e., the user). As will be described below, the flow rate can be adjusted to low, high, and no flow, and the specific flow rate is determined by the patient's experience.

[0062] Figure 10A -F are top views of the control valve assembly 22 in different operating positions. The figures show that the direction of the solution tubes and the solution ports can be determined by twisting the rotating body, so that the solution flows according to the steps of each CAPD exchange, and the CAPD exchange operation is completed. As mentioned above, the housing 24 has three solution channels or solution ports 28, 30, 32, which are 90° apart (as shown in the figure). However, those skilled in the art can understand that the three solution channels or solution ports 28, 30, 32 can be distributed at any angle that can ensure smooth flow of the solution between any two solution ports, including but not limited to uniform distribution at intervals of 90° or 120°.

[0063] Figure 10A The first step of the operation before the patient uses the CAPD device 10 and the control valve assembly 22 is shown. The control 26 is set in a position, and during the steam sterilization process, both connection tubes 50, 52 can be used for the solution ports 28, 30, 32. During the sterilization process, the three solution ports are connected simultaneously or sequentially in pairs to ensure that the 10 -6 sterile assurance level (SAL) can be maintained. After sterilization, the CAPD device 10 is assembled and connected to the solution bag 12 and the drain bag 14. The three solution ports are connected sequentially in pairs, i.e., the solution ports 28 and 30 are connected first, then the solution ports 28 and 32 are connected, and finally the solution ports 30 and 32 are connected. The above connection sequence can be adjusted according to needs or usage habits.

[0064] After the assembly and connection are completed, the patient can use the CAPD device 10 with the control valve assembly 22, asFigures 10B-10F The control valve assembly 22 for the rinse step is shown. Figure 10B The connection tubes 50, 52 communicate the fluid port 28 and the fluid port 32, allowing the patient to initiate the flow of fluid from the fluid bag to complete the rinse step.

[0065] As Figure 10C the patient turns the control 26 clockwise, all of the fluid ports 28, 30, 32 are in the closed position, i.e., no fluid will flow through the control valve assembly 22. In this position, the patient can attach the connector to the pipette.

[0066] After connecting the set 10, the patient can proceed to complete the drain step, as Figure 10D The connection tube 50 communicates the fluid port 28 and the fluid port 32, allowing the patient's abdominal effluent or spent dialysate to flow to the drain bag.

[0067] After the drain step is complete, the patient can then complete the fill step, with the connection tube 50 communicating the fluid port 30 and the fluid port 28, allowing fluid from the fluid bag to enter the patient's abdominal cavity, as Figure 10E is shown.

[0068] After the drain step is complete, the patient can turn the control 26 to the closed valve position, as Figure 10F is shown, no fluid will continue to flow through the control valve assembly 22. At this point, the patient can disconnect the pipette. After the exchange procedure is complete, the patient can perform the dwell step, allowing the dialysate to remain in the peritoneal cavity for 4 to 6 hours. The patient can then check the effluent for cloudiness, weigh and record the weight of the fluid-containing drain bag. After the procedure is complete, the effluent or spent dialysate and the used disposable bag can be discarded. The patient can ambulate without any impairment of normal activities.

[0069] Figure 11 The above procedure is also described in the table of

[0070] Figure 10A -FAlthough various flow settings have been given, Figure 10G the ability of the user to control the amount of fluid going to the patient is described. The control 26 controls the flow of fluid through the control valve assembly 22 by adjusting the area of the connection between the connection tubes 50, 52 and the fluid ports 28, 30, 32. As Figure 10G is shown, when the connection tube 50 and the fluid port 30 are not fully open and aligned, the flow rate of the fluid will be lower than when the fluid path is fully aligned. The patient can then decide on a flow rate that is appropriate for the patient during the fill step, see Figure 10G-2 and 10G-3. Figure 10G-1 is shown in the closed position (no flow), Figure 10G-4 is shown in the open position (full flow).

[0071] The controller 26 can also assist the patient in controlling by means of a plug 56 and a slot 58, see Figures 12-16 The different operations shown on the top flange surface and below the knob are manually and / or audibly prompted when the rotating body is in the correct position.

[0072] The plug 56 and slot 58 can prevent the patient from returning to a previous step, depending on the configuration. For example, Figure 15 and Figure 16 The plug 56 and slot 58 can prevent the user from pulling back during the operation. Figure 16 The blocking / interfering action is more pronounced than shown in Figure 15 ( and Figure 13 ). It is possible for the patient to return to a previous step, in which case the plug 56 and / or slot 58 can be configured as a one-way structure.

[0073] These designs can also allow the patient to pull back one step. For example, the patient can occasionally forget to flush the device before use, in which case the patient can pull back one step. As shown in Figure 14 The sloped or rounded plug and / or slot can assist the patient in pulling the controller 26, which is rotated to the drain position, back to the valve flush position. The patient can return to the flush position as long as the patient port cap 54 is not removed, thus preventing the patient from having to deal with and replace the entire device.

[0074] The above scenarios are still factors that need to be considered in the present invention and can be incorporated into the present invention.

[0075] Figure 14 The slot can also be used to control the speed of the fluid through the control valve assembly 22 (as shown in Figure 10G ). The slot 58 can be added around the ports or can be adjusted, especially for the fill ports, to provide low, medium, and high fill settings as needed for patient compliance. Since the control valve assembly 22 is a closed system, the user can switch between the above settings and the previous flow rate without concern for contamination. The user can set the flow rate to a first speed and then select a faster or slower speed based on that. The user can also rotate the controller 26 forward or backward without concern for contamination.

[0076] As mentioned above, the control valve assembly 22 is a closed system using a single O-ring 48 with a closed or solid bottom, see Figure 8 and Figure 9 . The O-ring 48 is used for sealing to prevent potential contamination from destroying the sterile condition. Figure 17 , 18 and 19 show other embodiments of the present invention in which the controller can be equipped with a single O-ring or two O-rings, as shown in Figure 19 . Also, the controller has a closed bottom (Figure 18 ) or open bottom ( Figure 19 Both are closed systems according to the present invention. Of course, other sealing design factors can also be considered within the scope of the present invention. The design allows... Figure 6 and Figure 7 When the textured surfaces interact as shown, and the device is also a closed system, it will also be included in the scope of this invention.

[0077] Manufacturing method

[0078] The following discussion is about Figure 6 , Figure 7 and Figure 10A The method for manufacturing the control valve assembly 22 and CAPD device 10 shown herein. The CAPD device 10 involved in this manufacturing method is a sterile device.

[0079] In a preferred method of manufacturing the control valve assembly 22, after complete assembly, the control valve assembly 22 is connected to the filling tube and the drain tube, which are in turn connected to the filling bag (containing dialysate) and the drain bag, respectively. A port cap 54 (a patient armor connector with a pull-ring cap) is connected to the patient port; the port cap 54 is typically filled with an antibacterial agent. The entire assembly is placed in a sealed bag and then steam-sterilized.

[0080] like Figure 6 and Figure 7 As shown. There is a gap of about 5-15 micrometers between the rotating body 27 and the interior of the outer shell 24 and the tubular body 25. The structure is textured on one or the other or both sides. During the sterilization process, while maintaining a tight fit between the components, steam can pass through the gaps and ports to complete the internal sterilization of the controller. Figure 7 The surface texture shown is a simple rough texture, but textures such as cross-hatching or bar lines can also be used instead.

[0081] How to use

[0082] The accompanying drawings illustrate the improved method of the present invention. Compared with the prior art, these methods generally have two main improvements: improvements in the limitation of steps and the user's ability to individually control the drug flow rate compared to the prior art required to complete the dialysis process. For example... Figures 20-29 As shown, the patient prepares to complete the CAPD device replacement procedure in a known manner, namely, creating a hygienic environment, checking the CAPD device for potential contamination, warming the dialysate bag on a warming pad, placing the drain bag on the floor, and then hanging the medication bag at shoulder height. Figures 20-29 The steps shown and described relate to the location of control valve assembly 22, see previous... Figure 10A -F is shown.

[0083] In the selected method, such as Figure 20As shown, disconnect the CAPD device 10, which contains the control valve assembly 22, from the sterile bag or container, and connect the medication bag 12 and the drain bag to the control valve assembly. The patient tube 28 remains covered.

[0084] like Figure 21 As shown, hang up the medicine bag, then adjust the controller to the rinsing position (e.g., Figure 10B and Figure 24 (As shown) and break off the easily breakable end on the medicine bag (such as...) Figure 22 (As shown). At this point, the dialysate will flow directly from the filling bag to the drain bag (as shown). Figure 23 (As shown), rinse the inside of the controller to further ensure a clean and hygienic connection with the patient.

[0085] After the rinsing process is complete, close all valves and remove the port cover 54 from connector 122 (e.g., Figure 25A (As shown), remove the cap of pipette 120 (not shown in the figure) and connect pipette 120 to the port, wherein the cap of pipette 120 is the first cap and the port cap 54 is the second cap, as shown. Figure 25 , 25A As shown in Figure 25B. Figure 25B The diagram shows connector 122 after removing port cap 54, with antibacterial agent 124 housed within it. Antibacterial agent 124 can be placed on a carrier, sprinkled on the connector, or applied to the surface. Using antibacterial agent 124 minimizes the risk of peritonitis infection. Connector 122 on control valve assembly 22 typically connects to the female Luer-lock connector of patient pipette 120 using a male Luer-lock connection. This secure, closed connection ensures sterility of the medication channels, thereby minimizing the risk of infection. At this point, all medication ports 28, 30, and 32 of control valve assembly 22 and controller 26 are in the closed position (see...). Figure 10C ).

[0086] exist Figure 26 (and Figure 10D In this process, the patient completes the drainage step, connecting the patient tube to the drainage tube and introducing the used dialysis fluid into the drainage bag.

[0087] After the drainage process is completed, controller 26 will stay in place. Figure 27 (And 10E) indicates the filling location, at which point fresh dialysate will flow into the patient's peritoneal cavity. See below. Figures 30-35 As shown, if the controller has different flow rate settings, such as low, medium, and high speed, patients can choose according to their own experience. If the flow rate is too slow, a higher setting can be selected; if the flow rate is too high and feels uncomfortable, the knob can be turned back to a lower flow rate setting.

[0088] After the filling process is completed, close the valve and disconnect the device connection, as follows: Figure 28The control valve assembly 22 can be provided with an "end" position to lock the knob and prevent the control valve assembly 22 from being reused. The patient can perform a dwell step, during which the dialysate is ultrafiltered into the patient's peritoneal cavity for 4 to 6 hours. At the beginning of the dwell phase, the patient can check the quality and quantity of the spent dialysate. The patient can then disconnect completely and do something else until it is time to drain and fill again.

[0089] As mentioned above, a second improvement disclosed by the present application is the ability of the user to self-regulate the flow of the solution. Figures 30-35 As shown, the user has the ability to determine the flow of the solution through the device according to preference.

[0090] In Figure 30 , the user is seated in a chair and holds the control valve assembly 22 in his hand. The control valve assembly 22 can also be placed on a table or other flat surface.

[0091] The user turns the control 26 to the first flow setting, for example Figure 31 high flow or open flow, as indicated by the three arrows, means that the tubing and solution port are aligned, as shown by the alignment of the plug 56 and the slot 58. Figure 32

[0092] For some users, the full flow rate can be uncomfortable. In the present application, the user can adjust the flow rate, as shown in Figure 33 . The user can turn the control 26 clockwise to decrease the flow rate. For example, the user can turn the control 26 so that the flow rate is medium. The plug 56 and the slot 58 correspond to the state shown in Figure 29 , in which the plug is in a different slot 58 than Figure 27 . The decrease in flow rate is shown in Figure 30 .

[0093] As can be seen, the present application allows the user to decrease or increase the flow rate of the solution by the position of the control 26. The ability to adjust does not require an additional flow valve assembly and maintains the sterile conditions within the CAPD device 10 and the control valve assembly 22.

[0094] Comparative Example

[0095] The components of the present application were tested as follows and compared to the results of components currently available on the market.

[0096] Test Method:

[0097] ​Four (4) components were removed according to heat resistance (high heat resistance and low heat resistance) level and then Bacillus stearothermophilus was cultured. The spore level of each culture component was about 106. For the component manifold portion, culture was performed on the inner surface and inside of each port. Culture was also performed between the component gaskets and the channel inner surface. The cultured components were dried in a HEPA laminar flow hood for about 3 hours. After drying, the components were reassembled with the channel positioned in alignment with the three (3) ports in the "open" position. Three (3) components of each heat resistance level were placed in separate sterilization bags. Autoclave cycle was set for 20 minutes exposure, 122°C (251.6°F).

[0098] One (1) component in each heat resistance level was used as a positive control component that was not subjected to autoclave cycles.

[0099] Results:

[0100] Low heat resistance and high heat resistance positive control components showed: TNTC - too numerous to count.

[0101] Three (3) test components of high heat resistance and 3 test components of low heat resistance showed 0 CFU - zero colony forming units.

[0102] The above cultured samples were analyzed.

[0103] Explanation:

[0104] No growth was found on the test sample plates after the 20 minute autoclave sterilization cycle at 122°C (high heat resistance and low heat resistance). Therefore, it can be determined that steam penetration was successful and penetrated to the interior of the components assembled according to the present invention, even with the sealed tube connected.

[0105] Existing commercial three-way stopcock evaluation:

[0106] Two (2) existing commercial three-way stopcocks were subjected to autoclave cycles at 121°C. Both three-way stopcocks were damaged during the cycle, indicating that the material, dimensional stability, and durability were not ideal.

[0107] The foregoing is considered as illustrative only of the principles of the application. Further, since the application has been described with reference to particular structures and embodiments, it is not intended that the application be limited, to the details described. Rather, it is intended that the application include all modifications and alterations in the conception and construction of the application that will come within the scope of the application. Although the foregoing has been described in some detail for purposes of clarity, it will be apparent that certain changes and modifications can be made without departing from the principles thereof. It will be readily understood by those skilled in the art that numerous changes and modifications can be made to the preferred embodiments shown herein, without departing from the inventive concepts disclosed herein. It is intended that all such modifications and changes be included within the scope of the following claims.

[0108] While the application has been described and illustrated with reference to specific embodiments thereof, those skilled in the art will appreciate that various adaptations, changes, modifications, substitutions, deletions, or the like can be made without departing from the spirit and scope of the application as defined in the following claims. It is intended that the application be construed as including all such adaptations, changes, modifications, substitutions, deletions, or the like within its spirit and scope. Due to manufacturing processes, variations in the technical reproduction of the application between actual devices can exist. There can be other embodiments of the application that are not specifically illustrated. The specification and drawings should be considered illustrative only and not restrictive of the application. Modifications can be made by those skilled in the art, which are within the scope and spirit of the application as outlined by the claims. Although the methods disclosed herein have been described with reference to particular sequences for performing certain operations, it should be understood that these operations can be rearranged, split, or combined and still be considered equivalent methods within the scope of the application. Therefore, unless otherwise specifically indicated herein, the order and grouping of operations are not a limitation of the application.

Claims

1. A flow control valve for a continuous ambulatory peritoneal dialysis device, used to deliver medication during dialysis, characterized in that, A continuous ambulatory peritoneal dialysis device flow control valve includes a control valve assembly including a housing having three ports for fluid, and a controller including a tube, the controller being mounted on the housing and connected to the housing in a liquid tight manner, the housing having a first surface and the controller having a second surface, the first surface and the second surface being in contact, steam being able to permeate between the first surface and the second surface, the controller being able to control the tube to connect or disconnect any at least two of the ports for fluid; The controller controls the flow of fluid through the control valve assembly by adjusting the area of the connection surface between the tube and the ports for fluid; The controller further includes a knob and a rotating body, the knob being mounted above the rotating body, the rotating body being cylindrical, the housing having a tubular body with one end closed and the other end open, the rotating body penetrating into the tubular body, the tube being mounted inside the rotating body, the tube penetrating through the rotating body and being able to communicate with the ports for fluid, the first surface being located inside the tubular body, and the second surface being located outside the rotating body; The first surface and the second surface each have a texture, and the textures on the first surface and the second surface form a gap to facilitate steam permeation.

2. The continuous ambulatory peritoneal dialysis device flow control valve of claim 1, wherein, The continuous ambulatory peritoneal dialysis device flow control valve further includes a first tube, a second tube, and a third tube, the three ports for fluid being a first port for fluid, a second port for fluid, and a third port for fluid, the first port for fluid being connected to a fluid bag through the first tube, the second port for fluid being connected to a patient through the second tube, and the third port for fluid being connected to a drainage bag through the third tube.

3. The continuous ambulatory peritoneal dialysis device flow control valve of claim 2, wherein, The flow controller further includes a pipette and a connector, one end of the second tube being in communication with the second port for fluid, the other end of the second tube being in communication with one end of the pipette through the connector, the other end of the pipette being in communication with the abdominal cavity of the patient, the pipette being used to introduce and remove dialysis fluid into and out of the abdominal cavity of the patient.

4. The continuous ambulatory peritoneal dialysis device flow control valve of claim 3, wherein, The pipette includes a removable first cap, the connector includes a removable second cap, when the pipette and the connector are disconnected, the first cap covers the port of the pipette in communication with the connector, and the second cap covers the port of the connector in communication with the pipette; when the pipette and the connector are in communication, the first cap is removed from the pipette, and the second cap is removed from the connector.

5. The continuous ambulatory peritoneal dialysis device flow control valve of claim 1, wherein, The controller further includes an O-ring, the O-ring being sleeved outside the rotating body and above the tube.

6. The continuous ambulatory peritoneal dialysis device flow control valve of claim 1, wherein, The housing includes a plug, the controller includes a slot, the plug and the slot cooperate to determine the position of the controller, and different positions of the controller correspond to different connection states between the tube and the ports for fluid.

7. The continuous ambulatory peritoneal dialysis device flow control valve of claim 1, wherein, The housing includes a plug, the controller includes a slot, the plug and the slot cooperate to determine the position of the controller, and different positions of the controller correspond to different flow rates of fluid through the control valve assembly.

8. The continuous ambulatory peritoneal dialysis device flow control valve of claim 1, wherein, The housing includes a plug, the controller includes a slot, the plug and the slot cooperate to determine the position of the controller, and the position of the controller corresponds to different connection states between the tube and the ports for fluid and different flow rates of fluid through the control valve assembly.

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