CN116077820A

CN116077820A - Flow control valve of continuous ambulatory peritoneal dialysis device and use method

Info

Publication number: CN116077820A
Application number: CN202211522561.9A
Authority: CN
Inventors: 孙兴才; 沈士诚
Original assignee: Qingdao Ruinai Medical Technology Co ltd
Current assignee: Qingdao Ruinai Medical Technology Co ltd
Priority date: 2022-11-30
Filing date: 2022-11-30
Publication date: 2023-05-09
Also published as: WO2024113858A1

Abstract

The invention provides a flow control valve of a continuous ambulatory peritoneal dialysis device and a use method thereof, wherein the flow control valve of the continuous ambulatory peritoneal dialysis device comprises a control valve assembly, the control valve assembly comprises a shell and a controller, three liquid medicine ports are arranged on the shell, the controller comprises a connecting pipe, the controller is arranged on the shell and is connected with the shell in a liquid-tight mode, the shell is provided with a first surface, the controller is provided with a second surface, the first surface is attached to the second surface, steam can permeate 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 invention has the advantages that: the connectivity of the valve device is improved; the operation is relatively simple; with acoustic and/or physical feedback functions.

Description

Flow control valve of continuous ambulatory peritoneal dialysis device and use method

Technical Field

The invention relates to the field of dialysis medical equipment, in particular to a flow control valve of a continuous ambulatory peritoneal dialysis device and a use method.

Background

In patients with renal failure, waste and excess body fluids that the kidneys typically filter out accumulate in the patient's blood. Therefore, patients suffering from renal failure need to prevent accumulation of waste toxicity by dialysis. CAPD is the use of membranes in the peritoneal cavity of end stage renal patients to separate and remove waste and excess body fluids from the patient's body fluid system.

Peritoneal dialysis is well known as a dialysis method using an abdominal lining (peritoneal membrane) as a natural blood filter. Using this method, the catheter can be surgically implanted into the peritoneal cavity to be filled with dialysate (dialysate). The surgically implanted catheter end along the abdominal wall may be connected to a patient pipette. The pipettor may connect/disconnect the patient connector on the flow control valve. The dialysate contacts capillaries throughout the peritoneum, and accumulated waste diffuses from the patient's blood into the dialysate and then out of 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.

The present invention relates to Continuous Ambulatory Peritoneal Dialysis (CAPD), a method of peritoneal dialysis, as the name implies, that is, a dialysis method that is continuously changed multiple times throughout the day while the patient is ambulatory. When CAPD method is adopted, the normal activities such as work or study are not affected in the dialysis process of the patient.

For a single CAPD treatment (or replacement), the patient would need to connect a dialysate bag and a separate drain bag to the implanted CAPD catheter. The dialysate bag is placed at a shoulder height or higher and gravity flows the fluid into the peritoneal cavity. The liquid draining bag is placed on the floor and also drains the effluent liquid in the body by gravity. The use of a flow control valve between the pipettor and drain bag can be used to regulate the dialysate inlet and effluent outlet.

It is noted that while CAPD devices appear to operate from top to bottom, i.e., first pouring and then draining, this is not true in practice. The patient can complete CAPD replacement by draining and then re-infusing. The dialysate from the previous CAPD change will be drained before new fluid is infused. The daily activities of the patient after the replacement for 4-6 hours are not affected, and the blood toxins and excessive body fluid can be discharged again after accumulation.

In view of the variety of manual skill, visual acuity, and other disease states, the CAPD devices currently in use are not well suited for use by all types of individuals suffering from such disease. For example, too fast a flow of dialysate into the peritoneal cavity may cause patient discomfort. This is especially true when the dialysate does not reach body temperature completely. This may be due to emotional instability, lack of exercise, or lack of a warming source for the medical fluid. It is also possible that a relatively tall patient may accommodate a high flow rate, while a short patient is less accommodated.

More importantly, some patient populations are unable to adapt to CAPD devices and/or perform CAPD replacement procedures under conditions conducive to handling and maintaining a sterile connection. When the patient finishes CAPD replacement operation, the patient needs to carry out in a clean and sanitary environment, and also wears a mask, and the patient is cleaned with both hands, and the patient is checked whether the medicine liquid bag is possibly damaged by using sterile equipment. Without such precautions, peritoneal infection (peritonitis) is likely to be caused.

In addition, the CAPD devices currently in use are far from meeting the needs of the patient population because some patients are likely to be unable to use the external clamps or familiarity with the sequence of operations necessary in conventional valve devices, given disabilities or age issues.

Disclosure of Invention

The invention provides a flow control valve of a continuous ambulatory peritoneal dialysis device and a use method thereof, which can solve the problems existing in the prior art. The aim of the invention is achieved by the following technical scheme.

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

The present invention also relates to improved CAPD procedures in order to maximize the avoidance of false treatments or the initiation of infections.

The improved control valve and apparatus of the present invention relates to a shut-off valve apparatus having room for improvement over prior art components.

The valve device consists of an outer valve body and a multi-position central screw flow controller which are coaxially connected with each other. The invention adopts special design, and can completely meet the sterilization requirement of a steam permeation damp-heat method.

The invention also provides a CAPD device and a component, which can help a user to further control the flow rate passing through the device, thereby further improving the comfort level of the patient on the basis of the existing component. The components of the present invention also provide improved ergonomic features, including changing the shape and size, facilitating user operation, improving feedback of control valve engagement during CAPD replacement procedures, and improving connectivity of the valve assembly to and from a drain bag or fluid bag, for example.

The invention also provides a valve and device that resists potential contamination by hands, water or the surrounding environment by means of a closed anti-contamination device. Such valves and devices are critical to patients living in areas of poor hygienic condition (e.g., lack of clean water, or no other conditions to prevent infection).

The present invention provides a simple unidirectional controller provided with treatment steps that is relatively simple to operate. The controller of the present invention has an acoustic and/or physical feedback function that can determine if the controller can perform the next step in the correct position during use. The controller also allows for other ergonomic features to be designed to fit different patient populations.

The present invention overcomes these and other drawbacks of the prior art CAPD valves by a single controller that is suitable for a wide range of patient populations and environments.

The invention also relates to improved methods of operating and using the CPAD device. The present invention provides a control valve that allows sterilization of a vapor permeation control valve.

The method and components of the present invention also provide a controlled operating system that can be used to determine the steps that were previously and upcoming of a dialysis procedure.

The invention also includes components and designs for direct sampling of effluent within a CPAD device.

Drawings

Other features, objects and advantages of the present invention will become more apparent from the detailed description of non-limiting embodiments of the invention given below with reference to the accompanying drawings.

FIG. 1 shows a CAPD device diagram in use;

FIG. 2 shows an isometric view of a first embodiment of the invention;

FIG. 3 shows a top view of the embodiment of FIG. 2;

FIG. 4 is a side view of the embodiment of FIG. 2;

FIG. 5 is an exploded view of the embodiment of FIG. 2;

FIG. 6 shows a top cross-sectional view of the embodiment of FIG. 2;

FIG. 7 is a close-up view of the cross-section of FIG. 6;

FIG. 8 is a cross-sectional view of the embodiment of FIG. 2 taken along line 8-8 of FIG. 3;

FIG. 9 is a cross-sectional view of the embodiment of FIG. 2 taken along line 9-9 of FIG. 3;

FIGS. 10A-F show top cross-sectional views of the embodiment of FIG. 2 in four different directions;

FIG. 10G is a top cross-sectional view of the embodiment of FIG. 2 illustrating controlled flow;

FIGS. 10G-1-10G-4 illustrate various fluid flow rates;

FIG. 11 is a table of steps depicted in FIGS. 10A-F;

FIG. 12 shows a side cross-sectional view of the embodiment of FIG. 2, i.e., a first embodiment of a plug/socket;

FIG. 13 shows a side cross-sectional view of the embodiment of FIG. 2, a second embodiment of a plug/socket;

FIG. 14 is a close-up cross-sectional view of a plug/socket according to the present invention, which may be used to facilitate the practice of the method of the present invention;

FIG. 15 is a close-up cross-sectional view of the design of FIG. 12;

FIG. 16 is a close-up cross-sectional view of FIG. 15;

FIGS. 17-19 are side cross-sectional views of various embodiments of the present invention;

FIGS. 20-29 illustrate patient use steps of an embodiment of the present invention;

figs. 30-35 illustrate steps of the present invention whereby a patient may control the flow of medical fluid during operation.

Detailed Description

The following description of the embodiments of the present invention is given by way of illustration and example only, and the technical solution, problems and effects achieved by the present invention will be apparent to those skilled in the art from the description of the present invention. It is to be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention. In addition, for convenience of description, only a portion related to the present invention is shown in the drawings.

It should be noted that, the structures, proportions, sizes, etc. shown in the drawings are only used for being matched with those described in the specification for understanding and reading, and are not intended to limit the conditions under which the present invention can be implemented, so that the present invention has no technical significance, and any modification of structures, changes in proportions or adjustment of sizes, without affecting the efficacy and achievement of the present invention, should fall within the scope covered by the technical content disclosed in the present invention.

References to words such as "first," "second," "the," and the like are not intended to be limiting in number, but rather may be singular or plural. The terms "comprising," "including," "having," and any variations thereof, are intended to cover a non-exclusive inclusion; for example, a process, method, system, article, or apparatus that comprises a list of steps or modules is not limited to only those steps or units listed but may include additional steps or units not listed or inherent to such process, method, article, or apparatus. The terms "connected," "coupled," and the like in connection with the present invention are not limited to physical or mechanical connections, but may also include direct or indirect electrical connections.

Figure 1 shows a CAPD device diagram in use. As shown in fig. 1, the CAPD device 10 is equipped with a drug solution (dialysate) bag 12 and a drain bag 14, connected to a patient through a drug solution tube 16, a drain tube 18, and a patient tube 20 connected to a pipette 120, which can be connected to each other. Wherein the medical fluid tube 16 is a first line, the patient tube 20 is a second line, and the drain tube 18 is a third line. The present CAPD device 10 uses a control valve assembly 22. The control valve assembly 22 between the

fluid lines

16, 18, 20 allows fluid to flow from the fluid bag 12 to the fluid bag 14 when the device flushing step is completed, from the fluid bag 12 to the patient when the dialysate filling step is completed, and from the patient to the fluid bag 14 when the draining step is completed. The control valve assembly 22 of the present invention includes a control 26 (see fig. 2) that ensures simple and orderly threading of the operating steps. It will be readily apparent from the description of CAPD device 10 and control valve assembly 22 that CAPD device 10 does not require the use of external clamps currently provided with CAPD devices, thus minimizing the risk of operating errors. Also, the present CAPD device 10 will be in the "all valves closed" position when performing the patient tubing/pipettor connection and disconnection steps.

As described below, the CAPD device 10 of the present invention may assist a user in orderly completing a dialysis procedure, such as flushing, draining, filling, stopping, and stopping. This orderly operation allows "all valves to be opened" allowing steam to enter the flow controller to complete sterilization during the damp heat sterilization cycle.

FIG. 2 illustrates one embodiment of a control valve assembly 22 of the present invention. The control valve assembly 22 generally includes a housing 24 and a controller 26. The controller 26 is a screw-on flow controller, which is an ergonomically designed knob, and when in use, a user can sequentially adjust the valves to complete a fill, drain, flush, or stop operation. For example, FIG. 3 shows the control valve assembly in a charge position.

As shown in fig. 2, the housing 24 includes a tubular body 25 (also shown in fig. 5) having three elongated

medical fluid ports

28, 30, 32. The

medical fluid ports

28, 30, 32 are used to connect the medical fluid tube 16, the fluid discharge tube 18, or the patient tube 20/pipette 120, respectively, and are therefore referred to as a medical fluid port 30, a fluid discharge medical fluid port 32, and a patient medical fluid port 28. Wherein the medical fluid port 30 is a first medical fluid port, the patient medical fluid port 28 is a second medical fluid port, the fluid discharge medical fluid port 32 is a third medical fluid port, and the controller 26 can connect or disconnect any at least two medical fluid ports. For example, the controller 26 can communicate with the

medical fluid ports

28 and 30, the

medical fluid ports

28 and 32, and the

medical fluid ports

30 and 32, respectively, and the controller 26 can simultaneously disconnect the

medical fluid ports

28, 30, 32; preferably, the controller 26 is also capable of simultaneously communicating with the

medical fluid ports

28, 30, 32.

The housing 24 is provided with a top flange 34 and a bottom flange 36, which are ergonomically designed, easy to grasp, and are provided with sequential step names and/or icons.

As described above and shown in fig. 3, the top flange 34 carries indicia 38 indicating the ports dedicated to filling, flushing, draining, etc. and the CAPD process being performed. The indicia may be any number, word, symbol, tactile indicia such as a plug or socket that aids the user in properly performing the operating procedure. The purpose of this design is to facilitate the user in operating all important steps smoothly and efficiently, as described below.

Fig. 4 is a plan elevation view of the control valve assembly 22 of fig. 3. As shown in fig. 3, the fluid port 30 is perpendicular to the fluid discharge port 32 and the irrigation or patient fluid port 28. As described below, this perpendicular design is used because it is convenient for the user to smoothly transition from one treatment step to another. Fig. 4 also shows that the

fluid ports

28, 30, 32 are in the same plane as each other, i.e., they are in the same horizontal plane in the control valve assembly, allowing fluid to effectively flow through the control valve assembly 22.

Fig. 5 shows an exploded view of the control valve assembly 22. The control 26 is provided with a knob which is connectable to a generally tubular rotation body 27 which is required to be inserted into the tubular body 25 of the housing 24 and rotated in the tubular body 25. The user changes the operating position by screwing the controller 26, as described below, using the controller 26 to adjust the flow rate of the medical fluid to a particular location, for example, to adjust the flow rate of the medical fluid when in the fill position. The rotator 27 has

fluid openings

40, 42, 44 corresponding to the

fluid ports

30, 32, 28 on the housing 24 so that the controller 26 and the housing 24 can be seen coaxially aligned with one another.

According to fig. 5, in order to avoid contamination of the control valve assembly 22, an O-ring 48 is first mounted on the control 26, i.e. between the knob and the tubular rotation body 27. Thus, a sealed and closed condition can be formed, and the sterility of the liquid medicine channel is ensured during the use of the device and the whole service life range, as shown in the detailed design of the shell structure in fig. 8 and 9. To avoid contamination of the

connection pipes

50 and 52, two O-rings 48 (see fig. 19) may also be used in the device to seal the liquid medicine channel in the control valve in another way, as shown in fig. 6. Both designs meet the design requirements of the invention. The O-ring 48 of self-lubricating or synthetic material should be chosen for installation to ensure smooth threading of the controller 26.

Fig. 6 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 housing tubular body 25. The rotator 27 is provided with

fluid openings

40, 42, 46, the

fluid openings

40, 42, 46 being capable of alignment with the

fluid ports

30, 32, 28 of the tubular body 25. The rotation body 27 includes a connection tube 50 (across the diameter of the tubular rotation body 27) extending from the first medical fluid opening 40 to the medical fluid opening 46 and a connection tube 52 (across the radius of the tubular rotation body 27) extending to the medical fluid opening 42, the diametrical position tube intersecting the diametrical position tube (around 90 °). The controller 26 is capable of controlling the

connection pipes

50, 52 to connect or disconnect any at least two medical fluid ports, and preferably the controller 26 is also capable of controlling the

connection pipes

50, 52 to simultaneously connect the

medical fluid ports

28, 30, 32.

The rotator 27 of the controller 26 and the tubular body 25 of the housing 24 are mounted coaxially with each other, and the joint surface is textured on one or both sides to create a gap.

The O-ring creates a sealing condition around the fluid passage. The textured surface forms a controlled interface gap to allow vapor permeation sterilization to be successfully completed to achieve 10 for the control valve assembly 22 ^-6 Sterility Assurance Level (SAL).

Fig. 7 shows an enlarged view of a portion of the design of fig. 6, where the controller 26 and the tubular body 25 of the housing 24 would interact. This design also facilitates control of control valve assembly 22 and the resistance created by the interaction of the two helps to properly regulate the flow of fluid through control valve assembly 22. That is, frictional engagement is sufficient to avoid unintended crosstalk between certain channels, as the flow setting is preserved during operation until user adjustment is complete.

As mentioned above, fig. 8 and 9 are sectional views of the control valve assembly 22 taken along the lines 8-8 and 9-9, respectively, of fig. 3, further illustrating the sealing condition created by the interaction between the rotating body 27 of the controller 26 and the tubular body 25 of the housing 24 by the mounting of an O-ring at the interface. The rotator 27 is mounted within the tubular body 25, the rotator 27 being in close proximity to the tubular body 25 and typically being mounted at the bottom of the housing 24, so that the

fluid ports

28, 30, 32 of the tubular body 25 can be aligned on the same horizontal plane as the

fluid openings

40, 42, 46 of the rotator. As shown in fig. 5, sealing is accomplished by the use of an O-ring 48 above the level of the fluid.

The invention improves the comfort level of the user. By screwing the controller 26 and the tubular body 25, the flow of the medical fluid through the control valve assembly 22 is self-regulated by the user, and the flow rate of the medical fluid is also self-determined by the patient (i.e., user). As described below, the flow rate may be generally adjusted to be low, high, and no flow, with the particular flow rate being dependent on the patient experience.

Fig. 10A-F show top views of the control valve assembly 22 in various operating positions. The figure shows that the rotating body can be screwed to determine the direction of the liquid medicine pipe and the liquid medicine port, so that the liquid medicine flows according to the step of changing each CAPD, and the CAPD changing operation is completed. As previously described, the housing 24 has three fluid passages or

ports

28, 30, 32 that are 90 deg. (as shown). However, it will be appreciated by those skilled in the art that the three fluid passages or

ports

28, 30, 32 may be distributed at any angle that ensures smooth flow of fluid between any two fluid ports, including, but not limited to, evenly distributed at 90 ° or 120 ° intervals.

Fig. 10A shows a first step of the patient's operation prior to use of the CAPD device 10 and control valve assembly 22. The controller 26 is provided in a single location and both

connection tubes

50, 52 may be used for the

medical fluid ports

28, 30, 32 during steam sterilization. Three liquid medicine ports are communicated simultaneously or in sequence in the sterilization process to ensure that 10 can be maintained ^-6 Sterility Assurance Level (SAL). After sterilization, CAPD device 10 is assembled and connected to a medical fluid bag 12 and a fluid discharge bag 14. The three liquid medicine ports are communicated with each other in sequence, namely, the

liquid medicine ports

28 and 30 are communicated with each other, the

liquid medicine ports

28 and 32 are communicated with each other, and the

liquid medicine ports

30 and 32 are communicated with each other, and the communication sequence can be adjusted according to the requirement or the use habit.

The patient may use CAPD device 10 with control valve assembly 22 after the assembly connection is complete, as shown in FIGS. 10B-10F. Fig. 10B shows a control valve assembly 22 for use in a medical fluid flushing procedure. The

connection tubes

50, 52 communicate the fluid port 28 with the fluid port 32, allowing the patient to begin the flow of fluid through the fluid bag to complete the flushing step.

As shown in fig. 10C, when the patient screws the controller 26 clockwise, all of the

fluid ports

28, 30, 32 are in the closed position, i.e., fluid does not flow through the control valve assembly 22. In this position, the patient may connect the connector to the pipette.

After connecting the device 10, the patient may continue to complete the drainage step, as shown in fig. 10D. The connection tube 50 communicates between the fluid port 28 and the fluid port 32, and the effluent or spent dialysate from the patient's abdominal cavity can flow to the drain bag.

After the draining step is completed, the patient then needs to complete the filling step, and the connection tube 50 communicates with the liquid medicine port 30 and the liquid medicine port 28, and the liquid medicine enters the abdominal cavity of the patient from the liquid medicine bag, as shown in fig. 10E.

After the draining step is completed, the patient will screw the controller 26 to the closed valve position, as shown in fig. 10F, and the medical fluid will not continue to flow through the control valve assembly 22. The patient can then disconnect the pipette. After the replacement procedure is completed, the patient may perform a dwell step in which the dialysate remains in the peritoneal cavity for 4 to 6 hours. The patient can then check whether the effluent is turbid and then weigh and record the weight of the bag. After the operation is completed, the effluent or spent dialysate needs to be discarded and the disposable bag used. The patient can walk without affecting normal activities.

The above procedure is also described in the table of fig. 11, and is also described in detail in the later drawings.

Fig. 10A-F, while various flow settings have been presented, fig. 10G illustrates the ability of the user to control the amount of drug flowing to the patient tube. The controller 26 controls the flow rate of the chemical flowing through the control valve assembly 22 by adjusting the area of the connection surface communicating between the

connection pipes

50, 52 and the

chemical ports

28, 30, 32. As shown in fig. 10G, when the connection tube 50 and the medical fluid port 30 are not fully opened and aligned, the flow rate of the medical fluid may be lower than that of the completely aligned medical fluid passage. The patient may then decide to adapt his own flow rate when filling the liquid, see fig. 10G-2 and 10G-3. Fig. 10G-1 shows the off state (no flow), and fig. 10G-4 shows the on state (full flow).

The controller 26 may also assist patient control via the plug 56 and socket 58, see the various operations shown in fig. 12-16 below the top flange surface and knob, manually and/or by audible prompts when the rotator is in the correct position.

The plug 56 and socket 58 may prevent the patient from returning to previous steps, depending on the configuration. As shown in fig. 15 and 16, the plug 56 and the socket 58 may prevent a user from pulling back during operation. Fig. 16 shows a more pronounced blocking/blocking effect than that shown in fig. 15 (and fig. 13). It is possible for the patient to return to the previous step, in which case the plug 56 and/or socket 58 may be made of unidirectional construction.

These designs may also allow the patient to pull one step backward. For example, the patient may pull one step backward when he or she occasionally forgets to flush the device before using it. As shown in fig. 14, an angled or rounded plug and/or socket may assist the patient in pulling the controller 26 threaded to the drain position back to the valve flushing position. The patient can return to the flush position as long as the patient port cover 54 is not removed, thereby preventing the patient from having to dispose of and replace the entire device.

The above is still a consideration of the present invention and may be incorporated into the present invention.

The slot shown in fig. 14 may also be used to control the rate of fluid flow through the control valve assembly 22 (as shown in fig. 10G). Additional slots 58 may be provided around the port or the slots 58 may be adjustable, particularly for fluid filled ports, to add low, medium and high fluid filling settings as needed for patient compliance. Since the control valve assembly 22 is a closed device, the user can switch between the above setting and the previous flow rate without fear of contamination. The user may adjust the streaming speed to a first speed and then select how fast to slow based on this. The user may also screw the controller 26 forward or backward without fear of contamination.

As described above, the control valve assembly 22 is a closed system using a single O-ring 48 with a closed or solid bottom, see fig. 8 and 9. The O-ring 48 serves to seal against potential contamination that could lead to the destruction of aseptic conditions. Figures 17, 18 and 19 show other embodiments of the invention where the controller may be provided with a single O-ring or two O-rings as shown in figure 19. Also, the controller has a closed bottom (fig. 18) or an open bottom (fig. 19). Both are closed systems of the present invention. Of course, other seal design factors are also contemplated by the present invention. Designs that allow the textured surfaces of fig. 6 and 7 to interact while also being a closed-type device are also contemplated by the present invention.

Method of manufacture

The following discussion is directed to the method of manufacturing the present control valve assembly 22 and CAPD device 10 shown in FIGS. 6, 7, and 10A. CAPD device 10 of the present manufacturing method is a sterile device.

In a preferred method of manufacturing the control valve assembly 22, the control valve assembly 22 is fully assembled and then connected to a fill tube and drain tube, which in turn are connected to a fill bag (filled with dialysate) and drain bag, respectively. Port cover 54 (patient armor connector with pull ring cover) is attached to the patient port, and port cover 54 is typically filled with an antimicrobial agent. The whole set of the product is placed in a sealed bag and then steam sterilized.

As shown in fig. 6 and 7. There is a gap of about 5-15 microns between the rotator 27 and the interior of the tubular body 25 of the housing 24, with one or the other or both sides of the structure textured, and during sterilization steam can pass through the gap and port interior to complete controller interior sterilization, while maintaining intimate engagement between the components. The surface texture shown in fig. 7 is a simple rough texture, and instead of a texture, lines such as cross hatching or columns may be used.

Application method

The following figures illustrate the improved process of the present invention. These methods generally have two major improvements over the prior art, namely, limitations in steps and improvements in the ability of the user to control the flow rate of the fluid alone over the prior art required to complete the dialysis process. As shown in fig. 20-29, the patient is ready to complete the CAPD device replacement operation 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 fluid bag at a height above the shoulder level. The steps shown and described in fig. 20-29 relate to the position of the control valve assembly 22, see previously shown in fig. 10A-F.

In selected methods, as shown in fig. 20, the CAPD device 10 with the control valve assembly 22 attached thereto is disconnected from the sterile bag or container, and the fluid bag 12 and the fluid discharge bag are connected to the control valve assembly. The patient tube 28 remains covered.

As shown in fig. 21, the medical fluid bag is hung up, and then the controller is adjusted to the flushing position (as shown in fig. 10B and 24) and the frangible head on the medical fluid bag is broken (as shown in fig. 22). At this time, the dialysate flows directly from the filling bag to the draining bag (as shown in fig. 23), and the controller is flushed to further ensure clean and sanitary connection with the patient.

After the flush step is completed, all valves are closed, the port cover 54 on the connector 122 is removed (as shown in fig. 25A), the cover of the pipette 120 is removed (not shown), and the pipette 120 is connected to the port, wherein the cover of the pipette 120 is a first cover and the port cover 54 is a second cover, as shown in fig. 25, 25A and 25B. Fig. 25B shows the connector 122 with the port cover 54 removed, and an antimicrobial agent 124 is contained within the connector 122. The antimicrobial 124 may be placed on a carrier, sprayed onto the connector, or coated onto a surface. The use of the antimicrobial 124 can maximize the risk of peritonitis infection. The connector 122 on the control valve assembly 22 is typically connected to a female luer lock connector of the patient transfer 120 in a male luer lock connection. The safe closed device connection mode can ensure the sterility of the liquid medicine channel, thereby avoiding the risk of infection to the greatest extent. All of the

fluid ports

28, 30, 32 of the control valve assembly 22 and the controller 26 are now in the closed position (see fig. 10C).

In fig. 26 (and fig. 10D), the patient completes the drain step, connecting the patient tube to the drain tube, and introducing the used dialysate into the drain bag.

After the draining step is completed, the controller 26 will be set to the fill position shown in fig. 27 (and 10E) where fresh dialysate will flow into the patient's peritoneal cavity. 30-35, if the controller has different flow rate settings, such as low, medium, and high speed settings, the patient will choose based on his own experience. A higher setting may be selected when the flow rate is too slow; if the flow rate is too high, and is uncomfortable, the knob may be turned back to the lower flow rate setting.

After the priming step is completed, the valve is closed and the device is disconnected as shown in FIG. 28. The control valve assembly 22 may be provided with a "distal" position for locking the knob to prevent reuse of the control valve assembly 22. The patient may perform a dwell step in which the dialysate is ultrafiltered in 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 used dialysis fluid. The connection can then be completely disconnected to do other things until it is needed to drain and fill again.

As described above, a second improvement of the present disclosure is the self-regulation of the flow of medical fluid by the user. Figures 30-35 illustrate the ability of a user to determine the flow of medical fluid through the device based on preferences.

In fig. 30, after the device is assembled and attached to the body, the user sits on a chair, holds the control valve assembly 22, and places the control valve assembly 22 on a table or other surface.

The user screws the controller 26 to a first flow setting, such as high flow or open flow indicated by the three arrows in fig. 31, meaning that the connector tube and medical fluid port are aligned to correspond to the plug 56 and socket 58 shown in fig. 32.

For some users, full flow rates may be uncomfortable. In the present invention, the user can adjust the flow rate as shown in fig. 33. A user screwing the controller 26 clockwise may reduce the flow rate. For example, the user may screw the controller 26 to bring the flow rate to a medium speed. The plug 56 and the socket 58 correspond to the state shown in fig. 29, with the plug being located in the socket 58 different from that shown in fig. 27. The decrease in flow rate is seen in fig. 30.

It can be seen that the present invention can be used to either turn down or turn up the flow rate of the medical fluid by the position of the controller 26. The ability to adjust does not require additional flow valve assemblies and can also maintain sterile conditions within CAPD device 10 and control valve assembly 22.

Comparative example

The present invention performs the following tests on the components and compares the results with those of the components currently used in the market.

The testing method comprises the following steps:

four (4) parts were removed at the level of thermostability (high thermostability and low thermostability), and then Geobacillus stearothermophilus was cultured. The spore level of each culture part was about 106. For the component manifold portion, incubation is performed on the inner surface and inside each port. Culture is also performed between the part washers and on the inner surface of the channel. The cultured parts were dried in a HEPA laminar flow hood for about 3 hours. After drying, the parts are reassembled and the channels are positioned to align with the three (3) ports in the "open" position. Three (3) parts of each heat resistance level were placed into separate sterilization bags, respectively. The autoclave cycle was set to 20 minutes exposure, 122 ℃ (251.6 °f).

One (1) part of each heat resistance level was used as a positive control part, which was not circulated through the autoclave.

Results:

the low heat resistance and high heat resistance positive control parts showed: TNTC-was too numerous to count.

Three (3) test parts with high heat resistance and 3 test parts with low heat resistance showed 0CFU-0 (zero) colony forming units.

The above cultured samples were analyzed.

Description:

no growth (high heat resistance and low heat resistance) was found on the test sample plates after a 20 minute autoclave sterilization cycle at 122 ℃. Thus, it can be determined that the vapor permeation was successful, and it was possible to permeate into the inside of the assembled parts according to the present invention even if the sealing tube was connected.

Existing commercial three-way tap evaluation:

two (2) existing commercial three-way stopcocks were autoclaved at 121 ℃. Both three-way taps are damaged during the cycle, indicating that the material, dimensional stability and durability are not ideal.

The foregoing is considered as illustrative only of the principles of the invention. Furthermore, as the art is subject to continued improvements and innovations in the technical field, future developments of the invention must not be limited to the constructions and operations shown and described. Although the foregoing describes embodiments, details may be changed without departing from the invention.

While the invention has been described and illustrated with reference to specific embodiments thereof, the description and illustration is not intended to be limiting. It will be apparent to those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention as defined in the claims. There may be a distinction between technical reproduction in the present invention and actual equipment due to variables in the manufacturing process, etc. Other embodiments of the invention not specifically illustrated may exist. The specification and figures are to be regarded in an illustrative rather than a restrictive sense, and all such modifications are intended to be included within the scope of the present invention as defined in the appended claims. Although the methods disclosed herein have been described with reference to particular operations being performed in a particular order, it should be understood that these operations may be rearranged, sub-divided, or arranged to form an equivalent method without departing from the teachings of the invention. Thus, the order and grouping of the operations is not a limitation of the present invention unless specifically indicated herein.

Claims

1. The utility model provides a continuous ambulatory peritoneal dialysis device flow control valve for carry the liquid medicine in the dialysis process, a serial communication port, continuous ambulatory peritoneal dialysis device flow control valve includes the control valve subassembly, the control valve subassembly includes the shell, a controller, be equipped with three liquid medicine ports on the shell, the controller includes the connecting pipe, the controller is installed on the shell, be connected with the mode of liquid seal between controller and the shell, the shell has first surface, the controller has the second surface, first surface and second surface laminating, steam can permeate between first surface and the second surface, the controller can control the connecting pipe and connect or disconnect arbitrary two at least liquid medicine ports.

2. The continuous ambulatory peritoneal dialysis device flow control valve of claim 1, wherein the controller controls the flow of the medical fluid through the control valve assembly by adjusting the area of the connection surface communicating between the connection tube and the medical fluid port.

3. The continuous ambulatory peritoneal dialysis device flow control valve of claim 2, further comprising a first conduit, a second conduit, and a third conduit, wherein the three fluid ports are a first fluid port, a second fluid port, and a third fluid port, the first fluid port is connected to the fluid bag via the first conduit, the second fluid port is connected to the patient via the second conduit, and the third fluid port is connected to the fluid bag via the third conduit.

4. The continuous ambulatory peritoneal dialysis set flow control valve of claim 3, wherein the flow controller further comprises a pipette and a connector, one end of the second tubing is in communication with the second fluid port, the other end of the second tubing is in communication with one end of the pipette via the connector, the other end of the pipette is in communication with the patient's peritoneal cavity, and the pipette is for introducing and removing dialysate from the patient's peritoneal cavity.

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

6. The flow control valve of the continuous ambulatory peritoneal dialysis device as claimed in claim 1, wherein the controller further comprises a knob and a rotating body, the knob is installed above the rotating body, the rotating body is cylindrical, a tubular body with one end closed and the other end open is arranged at the center of the housing, the rotating body penetrates into the tubular body, the connecting pipe is installed inside the rotating body, the connecting pipe penetrates through the rotating body and can be communicated with the liquid medicine port, the first surface is located inside the tubular body, and the second surface is located outside the rotating body.

7. The continuous ambulatory peritoneal dialysis set flow control valve of claim 1, wherein the controller further comprises an O-ring, the O-ring being positioned over the connecting tube outside of the rotating body.

8. The continuous ambulatory peritoneal dialysis set flow control valve of claim 1, wherein the first surface and the second surface are each textured, the texturing of the first surface and the second surface forming gaps for facilitating vapor permeation.

9. The continuous ambulatory peritoneal dialysis set flow control valve of claim 1, wherein the housing includes a plug and the controller includes a slot, the plug and slot cooperating to define a position of the controller, different positions of the controller corresponding to different connection states between the connector tube and the fluid port.

10. The continuous ambulatory peritoneal dialysis set flow control valve of claim 1, wherein the housing includes a plug and the controller includes a slot, the plug and slot cooperating to define a position of the controller, the different positions of the controller corresponding to a flow rate of the fluid through the control valve assembly.

11. The continuous ambulatory peritoneal dialysis set flow control valve of claim 1, wherein the housing includes a plug and the controller includes a slot, the plug and slot cooperating to define a position of the controller, the position of the controller corresponding to different connection conditions between the connection tube and the fluid port and a flow rate of fluid through the control valve assembly.

12. A method of using a flow control valve of a continuous ambulatory peritoneal dialysis device, comprising the steps of:

step 1: three liquid medicine ports of the control valve assembly are communicated simultaneously or three liquid medicine ports of the control valve assembly are communicated in sequence, and steam is used for sterilizing the flow control valve of the continuous ambulatory peritoneal dialysis device;

step 2: the first pipeline is used for connecting the first liquid medicine port and the liquid medicine bag, the third pipeline is used for connecting the third liquid medicine port and the liquid medicine bag, the connecting pipe is communicated with the first liquid medicine port and the third liquid medicine port through the control valve assembly, and liquid medicine flows from the liquid medicine bag through the control valve assembly to enter the liquid medicine bag so as to wash the control valve assembly;

step 3: disconnecting three liquid medicine ports of the control valve assembly, opening a liquid transfer device communicated with the abdominal cavity of a patient, opening a connector, connecting a second liquid medicine port with the connector by using a second pipeline, and connecting the liquid transfer device with the connector;

step 4: the connecting pipe is communicated with the second liquid medicine port and the third liquid medicine port through the control valve assembly, and the dialysate in the abdominal cavity of the patient is led out to the liquid draining bag;

step 5: the connecting pipe is communicated with the first liquid medicine port and the second liquid medicine port through the control valve assembly, and the dialysate in the liquid medicine bag is led into the abdominal cavity of a patient;

step 6: the connecting pipe is disconnected with three liquid medicine ports through the control valve component, the second pipeline and the liquid transfer device are disconnected, and the liquid transfer device is closed; and

step 7: the dialysate in the drain bag is checked, and the first, second and third lines are removed from the three fluid ports.