Gravity feed dialysis system

Abstract

This invention relates to a gravity-fed dialysis system. A gravity-fed peritoneal dialysis (“PD”) machine includes: a frame configured to be positioned on a support surface; at least one force-measuring unit; a scale supported by the frame via the at least one force-measuring unit positioned between the frame and the scale; and a drainage container support mechanically connected to and extending downward from the scale. The machine is configured such that, when the frame is positioned on the support surface, at least one fresh PD fluid supply container can be supported above the at least one force-measuring unit by the scale, and at least one used PD fluid drainage container can be supported below the at least one force-measuring unit by the drainage container support, such that the combined weight of the fresh and used PD fluid can be sensed by the at least one force-measuring unit.

Description

[0001] This application is a divisional application of Chinese application No. 201980024415.3, filed on April 4, 2019, entitled "Gravity-fed dialysis system".

[0002] Cross-references to related applications

[0003] This application claims priority to U.S. Application No. 15 / 946,395, filed April 5, 2018, entitled “Gravity-fed dialysis system and method,” the entire contents of which are incorporated herein by reference. Background Technology

[0004] This disclosure relates generally to peritoneal dialysis, and more specifically to gravity-fed peritoneal dialysis.

[0005] For various reasons, a person's kidney system may fail. Kidney failure produces several physiological abnormalities. It becomes impossible to maintain the balance of water and minerals and excrete the daily metabolic load, and toxic metabolic end products (such as urea, creatinine, uric acid, etc.) may accumulate in the blood and tissues.

[0006] Kidney failure and decreased kidney function have been treated with dialysis. Dialysis removes waste, toxins, and excess water from the body that would otherwise be removed by functioning kidneys. Dialysis, an alternative to kidney function, is crucial for many people because this treatment can save lives.

[0007] Hemodialysis (“HD”) and peritoneal dialysis (“PD”) are two common dialysis therapies used to treat kidney failure. HD removes waste products, toxins, and excess water from a patient’s blood. The patient is connected to a hemodialysis machine via a catheter inserted into the patient’s vascular system. Blood is pumped from the patient, through the interior of a hollow porous tube connected to the machine, and back to the patient. The HD machine produces HD dialysis fluid, which is pumped out of the hollow porous tube to clean the blood via osmosis. Excess blood water, called ultrafiltration, is drawn from the blood through the pores of the membrane into the dialysis fluid, where it is carried to a drainage port. The cleaned blood is returned to the patient. A large amount of dialysis fluid (e.g., about 120 liters) may be consumed during a single hemodialysis session to dialyze the blood. HD treatments may last for several hours and may be performed approximately three or four times a week at a treatment center.

[0008] PD uses PD dialysis fluid, which is injected into the patient's peritoneal cavity via a catheter. The PD dialysis fluid comes into contact with the peritoneum of the peritoneal cavity. Waste, toxins, and excess water flow from the patient's blood through the peritoneum and enter the dialysis fluid via osmosis, i.e., an osmotic gradient appears across the entire membrane. Used dialysis fluid is drained from the patient to remove waste, toxins, and excess water from the patient. This cycle can be repeated.

[0009] There are several types of PD therapy, including Continuous Ambulatory Peritoneal Dialysis (“CAPD”) and Automated Peritoneal Dialysis (“APD”). CAPD is a manual dialysis treatment. The patient manually connects the implanted catheter to the drainage port to allow used dialysis fluid, previously injected into the patient at an earlier change, to drain from the patient's peritoneal cavity. The patient then connects the catheter to a bag of fresh dialysis fluid to inject fresh dialysis fluid into the patient through the catheter. The patient disconnects the catheter from the fresh dialysis bag, allowing the dialysis fluid to remain in the patient's peritoneal cavity, where the transfer of waste, toxins, and excess fluid occurs as described herein. After the residence period, the patient repeats the manual dialysis procedure (e.g., four times daily), with each procedure lasting approximately one hour.

[0010] CAPD is relatively inexpensive and gravity-driven, which typically does not subject patients to excessive pressure. Patient data published in the literature by Brandes et al. showed that the flow rate during filling cycles was relatively constant and correlated with the patient's posture (e.g., supine or sitting) and the head height of the supply bag. However, the duration of drainage cycles was typically about twice as long as filling cycles and showed an inverse relationship with time. Within a gravity-fed drainage cycle, approximately 80% of the intraperitoneal volume was drained within the first 40% of the total drainage time. Similar results were found in patient data published in the literature by Amici et al. The flow rates of gravity filling and drainage can also be affected by several additional parameters, such as catheter type and tube kit type. CAPD also requires a significant amount of time and effort from the patient.

[0011] A known CAPD system provided by the assignee of this disclosure comprises two 2.5-liter solution bags, one empty and one filled with fresh fluid. Tubing and clamps for treatment are provided for both bags. The fresh bag is positioned above the patient, while the empty drainage bag is positioned below the patient. The tubing of the bag containing fresh fluid is loosened to allow fresh fluid to flow to the patient under gravity, and the fresh bag is emptied. After the residence period, the tubing of the empty drainage bag is loosened to allow used dialysis fluid to flow from the patient to the drainage bag under gravity to fill it. The system is then discarded. To determine the amount of UF removed, the freshly filled bag is weighed before patient infusion and this weight is subtracted from the weight of the full drainage bag obtained after drainage. The patient must then manually record the UF weight difference. If the patient is prescribed to perform multiple filling, residence, and drainage cycles as is customary, the above process is repeated using a new CAPD dual-bag kit. To determine the total UF, for example, over a 24-hour period, the UF weight from each individual CAPD kit is added.

[0012] Similar to CAPD, APD involves drainage, filling, and retention cycles in dialysis treatment. However, APD machines typically perform cycles automatically while the patient is asleep. APD machines eliminate the need for patients to manually perform treatment cycles or transport supplies during the day. The APD machine is fluidly connected to an implanted catheter, a source or bag of fresh dialysis solution, and a fluid drainage port. The APD machine pumps fresh dialysis solution from the source or bag through the catheter into the patient's peritoneal cavity and allows the dialysis fluid to remain within the peritoneal cavity, resulting in the removal of waste, toxins, and excess fluid. The APD machine then pumps used dialysis fluid from the patient's peritoneal cavity to the drainage port. Several drainage, filling, and retention cycles occur during APD, similar to the manual procedure. A "last filling" may also occur at the end of both CAPD and APD, remaining in the patient's peritoneal cavity until the next treatment or intermediate dialysis fluid change.

[0013] One drawback of APD is cost. In some parts of the world, APD machines are expensive for the vast majority of patients. Therefore, there is a need for a low-cost method of peritoneal dialysis that can be performed while the patient is asleep, eliminating or reducing the time and effort required for patients undergoing CAPD, while still offering a low cost per treatment. Summary of the Invention

[0014] The examples described herein disclose a peritoneal dialysis (“PD”) system employing a gravity-feed PD machine operating with a disposable kit configured to reuse certain components to reduce single-use waste and costs. The gravity-feed PD machine includes a frame seated on casters and including handles, allowing the machine to be easily moved from one room to another within a patient’s home or residence. The frame extends upwards from the casters to a top plate mounted at the top of the frame. One or more force units are mounted on the top plate. For example, force units may be mounted at each corner of the top plate. Each force unit may include a force unit cup mounted to the top plate, a force unit located within the force unit cup, a compressible overload bushing seated above a force unit sensor located within the force unit cup, and a load applicator located between the force unit sensor and the compressible overload bushing.

[0015] A platform scale is placed on top of the force-measuring unit (e.g., on top of a compressible overload bushing) so that it is supported by the force-measuring unit but not connected to it. In this way, the one or more force-measuring units see and sense the total weight placed on and suspended from the platform scale. In one embodiment, the weight placed on the platform scale includes a supply container receiving tray sized to receive one or more fresh PD fluid supply containers. In one implementation, the receiving tray is sized to receive two five-liter fresh PD fluid bags.

[0016] In one embodiment, the weight suspended from the platform scale includes a drainage container support having a plurality of (e.g., first and second) members that are mounted to and extend downward from the platform scale. A drainage container receiving portion of the drainage container support is disposed (e.g., attached) at the bottom of the first and second members extending downward from the platform scale. A drainage container receiving platform can be hingedly attached to the drainage container receiving portion. A drainage container receiving tray can then be removably positioned on the drainage container receiving platform. One or more used PD fluid drainage containers can then be removably placed into the drainage container receiving tray. The one or more used PD fluid drainage containers can be tilted as desired via the hinged relationship between the drainage container receiving platform and the drainage container receiving portion.

[0017] Therefore, the arrangement of the gravity-feed machine positions the fresh PD fluid supply container at the top of the machine and the used PD fluid drainage container at or near the bottom of the machine, with the patient, seated or asleep for treatment, positioned approximately in the middle of the machine, between the supply and drainage containers. In this way, fresh PD fluid can flow from the fresh PD fluid supply container to the patient under gravity, while used PD fluid can flow from the patient to the used PD fluid drainage container under gravity. In one embodiment, before connecting the disposable kit to the patient, the machine first primes the disposable kit with fresh PD fluid from the fresh PD fluid supply container up to the drainage valve, such that if the patient is below the drainage valve during treatment, used PD fluid can be siphoned from the patient, flowing upwards through the drainage valve and downwards through the drainage line to the used PD fluid drainage container.

[0018] As described above, in one embodiment, the scale supports both fresh PD fluid and used PD fluid, such that the one or more force-measuring units sense the weight of both. Signals from the one or more force-measuring units are sent to a control unit having one or more processors, one or more memories, a user interface (display and input devices, such as touchscreens and / or membrane switches), one or more data ports (e.g., for accepting data cards), electronics (e.g., for dual-input voltage control), and in one embodiment, a network connection (e.g., Ethernet). The control unit controls valves that operate with the disposable kit (e.g., a fresh PD fluid (to the patient) valve and a used PD fluid (from the patient) valve). The control unit may also use feedback from one or more temperature sensors to control a heater (e.g., one or more resistance heating coils), wherein the heater and temperature sensors are located below the supply container receiving tray, to heat the tray and the fresh PD fluid container placed on the tray, such that the fresh PD fluid is heated to a desired temperature, such as body temperature or 37°C.

[0019] Regarding PD fluid control, the control unit learns from the force measurement unit how much fresh PD fluid was initially loaded onto the supply container receiving tray, for example, the weight of two 5-liter bags of fresh PD fluid. After the first patient filling, the control unit learns from the force measurement unit how much fresh PD fluid has been delivered to the patient, for example, how much the weight has decreased. After the first patient stay and drainage, where used dialysis fluid is removed into the used PD fluid drainage container, the control unit learns from the force measurement unit, for example, by how much weight has increased, how much used PD fluid and additional ultrafiltration (“UF”) has been removed from the patient, and fluid now remains in the fresh PD fluid container (located above the scale) and the used PD fluid container (located below the scale). After the first patient filling, stay, and drainage, and assuming drainage is complete, the control unit is expected to see a weight greater than the initial weight of fresh PD fluid due to the removal of UF from the patient. The second, third, and fourth cycles of filling, retention, and drainage are performed in the same manner as described above. In these cycles, the filling volume is determined by the weight loss due to the flow of fresh PD fluid from the machine to the patient under gravity, while the drainage volume is determined by the weight increase due to the flow of used PD fluid and UF from the patient to the machine under gravity.

[0020] Once all fresh PD fluid has been drained from the fresh PD fluid supply container and all used PD fluid and UF have been drained from the patient into the used PD fluid drainage container, the control unit can calculate the total amount of UF removed from the patient for treatment by subtracting the initial total amount of fresh fluid from the final total amount of used fluid. In this manner, the amount of UF for each cycle and the total amount can be determined by the control unit and force measurement unit arrangement of this disclosure. This amount can be displayed to the user in the dialysis device's user interface and recorded for download to an external storage device, such as a Universal Serial Bus (“USB”) flash drive, or, in one embodiment, for uploading to a network and / or via a network connection to a remote server.

[0021] In one embodiment, the disposable kit of this disclosure reuses a supply line from a previous treatment and a connected fresh PD fluid supply container in the current treatment. The disposable kit includes a multi-port connector, such as a tee connector, or a Y-connector or T-connector. The patient line is attached at one end to a first port of the multi-port connector and at the other end to the patient. The supply line is attached at one end to a second port of the multi-port connector and at the other end to one or more fresh PD fluid supply containers (e.g., branched or split into two or more branch lines leading to multiple supply containers). The drainage line is attached at one end to a third port of the multi-port connector and at the other end to one or more used PD fluid drainage containers (e.g., branched or split into two or more branch lines leading to multiple drainage containers). In one embodiment, the drainage line and drainage container are used as the supply line and supply container in a previous treatment, which is possible because (i) the supply container is empty at the end of the treatment, (ii) the supply line has at least no significant contact with outflow fluid from the patient, and (iii) the reusable line and base are used in subsequent treatments for the same patient.

[0022] In various embodiments, the connector for the supply line connected to the second port of the multiport connector includes a breakable portion that the user causes to break, leaving a portion of the connector remaining and discarded along with the multiport connector, patient tubing, and drainage tubing. The remaining portion of the connector is reused and includes an auxiliary connection portion that removably seals to a third port of a new multiport connector. The removable seal is configured to provide a suitable liquid-tight connection while still requiring a connection force that may not be excessive for supplying older patients. In the same manner, the breakable portion is configured such that its breaking force is not excessive.

[0023] In one embodiment, the gravity flow PD system of this disclosure is configured to provide different types of automated PD treatment. Treatments can be programmed into a control unit at the machine and can be downloaded to the control unit via a network and / or uploaded to the control unit from a remote data storage device (e.g., a USB drive). The control unit can, for example, offer the patient the option of performing automated peritoneal dialysis (“APD”) treatment or device-assisted continuous ambulatory peritoneal dialysis (“DA-CAPD”) treatment. The main differences between APD treatment and DA-CAPD treatment are: (i) more automated cycles are present in APD treatment compared to DA-CAPD, and (ii) the filling volume used for APD treatment is generally different (e.g., less) than that used for DA-CAPD treatment, and (iii) the residence time used for APD treatment is generally different (e.g., less) than that used for DA-CAPD treatment. DA-CAPD treatment may also have more manual changeover steps than APD treatment.

[0024] The control unit allows patients to run APD therapy one day and DA-CAPD therapy the next, and vice versa. The control unit can also store multiple APD and DA-CAPD treatments and allow patients to select the desired treatment to run for one day or multiple consecutive days.

[0025] In view of and without limiting the disclosure herein, in a first aspect of the disclosure (which may be combined with any other aspect listed herein unless otherwise specified), a gravity-fed peritoneal dialysis (“PD”) machine includes: a frame configured to be positioned on a support surface; at least one force unit; a scale supported by the frame via the at least one force unit positioned between the frame and the scale; and a drainage container support that, when the frame is positioned on the support surface, is in mechanical communication with and extends downward from the scale, wherein the machine is configured such that, when the frame is positioned on the support surface, at least one fresh PD fluid supply container can be supported above the at least one force unit by the scale, and at least one used PD fluid drainage container can be supported below the at least one force unit by the drainage container support, such that the combined weight of the fresh PD fluid and the used PD fluid can be sensed by the at least one force unit.

[0026] In a second aspect of this disclosure (which may be combined with any other aspect listed herein unless otherwise specified), the drainage container support includes: a plurality of components and a drainage container receiving portion, the plurality of components being in mechanical communication with and extending downward from the platform scale, the drainage container receiving portion being located between the plurality of components.

[0027] In a third aspect of this disclosure (unless otherwise specified, it may be combined with the second aspect in conjunction with any other aspects listed herein), the dialysis machine includes a drainage container receiving tray that can be removably positioned above a drainage container receiving portion of a drainage container support, the drainage container receiving tray being sized to accept the at least one used PD fluid drainage container.

[0028] In the fourth aspect of this disclosure (unless otherwise specified, it may be combined with the second aspect in conjunction with any other aspects listed herein), the frame includes a plurality of legs, each of the plurality of legs defining a profile, and wherein each of the plurality of members of the drainage container support defines a profile that matches the profile of at least one of the legs.

[0029] In the fifth aspect of this disclosure (which may be combined with any other aspect listed herein unless otherwise specified), the drainage container support is directly connected to the platform scale.

[0030] In the sixth aspect of this disclosure (unless otherwise specified, it may be combined with any other aspects listed herein), the platform scale includes a plurality of corner sections, and between the platform scale and the frame, the dialysis machine includes a plurality of force measuring units, the plurality of force measuring units including one force measuring unit supporting each corner section of the platform scale.

[0031] In the seventh aspect of this disclosure (unless otherwise specified, it may be combined with any other aspects listed herein), the dialysis machine includes a supply container receiving tray in mechanical communication with a scale, the supply container receiving tray being sized to receive the at least one fresh PD fluid supply container.

[0032] In the eighth aspect of this disclosure (unless otherwise specified, it may be combined with the seventh aspect in conjunction with any other aspects listed herein), at least one of the scales or supply container receiving trays is configured to support the at least one fresh PD fluid supply container at an angle that directs the fresh PD fluid toward a lowered outlet portion of the supply container.

[0033] In the ninth aspect of this disclosure (unless otherwise specified, it may be combined with the seventh aspect in conjunction with any other aspects listed herein), the dialysis machine includes a heater positioned and arranged to heat the supply container receiving tray, thereby heating the at least one fresh PD fluid supply container.

[0034] In the tenth aspect of this disclosure (unless otherwise specified, it may be combined with any other aspect listed herein), the dialysis machine includes: a control unit; a first valve, under the control of the control unit, to selectively allow fresh PD fluid to flow by gravity from the at least one fresh PD fluid supply container to the patient; and a second valve, under the control of the control unit, to selectively allow used PD fluid to flow by gravity from the patient to the at least one used PD fluid drainage container.

[0035] In the eleventh aspect of this disclosure (unless otherwise specified, it may be combined with the tenth aspect in conjunction with any other aspects listed herein), the at least one force measuring unit is signal-connected to the control unit.

[0036] In the twelfth aspect of this disclosure (unless otherwise specified, it may be combined with the tenth aspect in conjunction with any other aspects listed herein), the control unit includes a user interface comprising a display and at least one input device, the control unit being programmed to display a variety of different PD treatment types and enabling a user to select one of the treatment types for an upcoming treatment using the at least one input device.

[0037] In the thirteenth aspect of this disclosure (unless otherwise specified, it may be combined with the twelfth aspect in conjunction with any other aspects listed herein), the first type of PD treatment includes automated peritoneal dialysis, while the second type of PD treatment includes device-assisted continuous ambulatory peritoneal dialysis.

[0038] In the fourteenth aspect of this disclosure (unless otherwise specified, it may be combined with any other aspect listed herein), the at least one force measuring unit includes a force measuring unit mounting cup supporting a force measuring unit sensor, the force measuring unit mounting cup being mounted to a frame and housing a load applicator positioned and arranged to deliver a load to the force measuring unit sensor, the load applicator being in mechanical communication with the platform scale.

[0039] In the fifteenth aspect of this disclosure (unless otherwise specified, it may be combined with any other aspect listed herein), a gravity-fed peritoneal dialysis (“PD”) machine includes: a frame configured to be positioned on a support surface; at least one force measuring unit; a scale supported by the frame via the at least one force measuring unit positioned between the frame and the scale; and a drainage container support that, when the frame is positioned on the support surface, is in mechanical communication with and extends downward from the scale, wherein the machine is configured such that, when the frame is positioned on the support surface, at least one fresh PD fluid supply container is capable of... The at least one force measuring unit is supported above by a platform scale, and at least one used PD fluid drainage container is supported below the at least one force measuring unit by a drainage container support; and a control unit configured to monitor the instantaneous combined weight of fresh PD fluid and used PD fluid via feedback from the at least one force measuring unit, wherein the control unit is configured to determine the amount of fresh PD fluid filled by recording a decrease in the instantaneous combined weight, and the control unit is configured to determine the amount of used PD fluid drained by recoding an increase in the instantaneous combined weight.

[0040] In the sixteenth aspect of this disclosure (unless otherwise specified, it may be combined with the fifteenth aspect in conjunction with any other aspects listed herein), the control unit is also configured to determine the amount of ultrafiltration removed from the patient by distinguishing between the amount of patient filling and the amount of patient drainage.

[0041] In the seventeenth aspect of this disclosure (unless otherwise specified, it may be combined with the sixteenth aspect in conjunction with any other aspect listed herein), the distinction occurs in the following situations: (i) after multiple patient drainages and summing the resulting amount of ultrafiltration removed, or (ii) once after summing multiple patient filling volumes and patient drainage volumes.

[0042] In the eighteenth aspect of this disclosure (unless otherwise specified, it may be combined with any other aspect listed herein), a peritoneal dialysis (“PD”) system comprises: a disposable kit including at least one fresh PD fluid supply container, at least one used PD fluid drainage container, and tubing located between the at least one fresh PD fluid supply container and the at least one used PD fluid drainage container; and a gravity-feed PD machine capable of operating with the disposable kit, the gravity-feed PD machine comprising: a frame configured to be positioned on a support surface; at least one force measuring unit; and a scale. The scale is supported by the frame via at least one force-measuring unit positioned between the frame and the platform scale; and a drainage container support, which is mechanically connected to and extends downward from the platform scale when the frame is set on the support surface, wherein the machine is configured such that when the frame is set on the support surface, at least one fresh PD fluid supply container can be supported by the platform scale above the at least one force-measuring unit, and at least one used PD fluid drainage container can be supported by the drainage container support below the at least one force-measuring unit, such that the combined weight of the fresh PD fluid and the used PD fluid can be sensed by the at least one force-measuring unit.

[0043] In the nineteenth aspect of this disclosure (unless otherwise specified, it may be combined with the eighteenth aspect in conjunction with any other aspects listed herein), the gravity-feed PD machine includes at least one valve configured to operate with a tube located between at least one fresh PD fluid supply container and the patient, and at least one valve configured to operate between the patient and at least one used PD fluid drainage container.

[0044] In the twentieth aspect of this disclosure (which may be combined with any other aspect listed herein unless otherwise specified), a peritoneal dialysis (“PD”) system comprises: a disposable kit including at least one fresh PD fluid supply container, at least one used PD fluid drainage container, and tubing located between the at least one fresh PD fluid supply container and the at least one used PD fluid drainage container; and a gravity-feed PD machine capable of operating with the disposable kit, the gravity-feed PD machine including a control unit having a user interface and at least one input device, wherein the control unit is configured to provide a user with the option to perform any of the following functions: (i) automated peritoneal dialysis (“APD”) treatment, wherein three or more patient fills are performed using one or more APD residence durations, or (ii) device-assisted continuous ambulatory peritoneal dialysis (DA-CAPD) treatment, wherein two patient fills are performed using one or more DA-CAPD residence durations, wherein the average DA-CAPD residence duration is longer than the average APD residence duration.

[0045] In the twenty-first aspect of this disclosure (unless otherwise specified, it may be combined with the twentieth aspect in conjunction with any other aspects listed herein), the DA-CAPD treatment patient filling uses a variable (e.g., more) amount of fresh PD fluid compared to the APD patient filling.

[0046] In the twenty-second aspect of this disclosure (which may be combined with the twentieth aspect in conjunction with any other aspects listed herein unless otherwise specified), DA-CAPD treatment includes more manual steps than APD treatment.

[0047] In the twenty-third aspect of this disclosure (unless otherwise specified, it may be combined with any other aspects listed herein), a disposable kit for dialysis treatment includes: a patient tubing including a first connector configured for connection to a patient connector and a second connector configured for connection to a first port of a multiport connector; and a supply tubing including a first connector configured for connection to a PD fluid supply container and a second connector configured for connection to a second port of the multiport connector, wherein the second connector of the supply tubing includes a breakable portion that allows: after dialysis treatment, in the event of breakage of the breakable portion, an auxiliary connection portion of the supply tubing and the second connector to be retained for use as a drainage tubing for subsequent dialysis treatment, wherein a third port of the multiport connector is configured to allow the supply tubing and the auxiliary connection portion from previous dialysis treatment to be used as a drainage tubing for dialysis treatment, and wherein the auxiliary connection portion from previous dialysis treatment is configured to be removably sealed to the third port for dialysis treatment.

[0048] In the twenty-fourth aspect of this disclosure (unless otherwise specified, it may be combined with the twenty-third aspect in conjunction with any other aspects listed herein), the multi-port connector includes a Y-connector or a T-connector.

[0049] In the twenty-fifth aspect of this disclosure (unless otherwise specified, it may be combined with the twenty-third aspect in conjunction with any other aspects listed herein), the disposable kit also includes a PD fluid supply container connected to the first connector, which serves as a PD fluid drainage container for subsequent treatment.

[0050] In the twenty-sixth aspect of this disclosure (which may be combined with the twenty-fifth aspect in conjunction with any other aspects listed herein), the size of the PD fluid supply container is excessive relative to the amount of fresh PD fluid stored in the PD fluid supply container, such that when operating as a PD fluid drainage container, it is able to store the amount of ultrafiltration removed from the patient.

[0051] In the twenty-seventh aspect of this disclosure (unless otherwise specified, it may be combined with the twenty-third aspect in conjunction with any other aspects listed herein), the first connector of the supply line is a first first connector, and wherein the supply line is divided into a first branch and a second branch, the first branch leading to the first first connector capable of being connected to a first PD fluid supply container, and the second branch leading to a second first connector capable of being connected to a second PD fluid supply container.

[0052] In the twenty-eighth aspect of this disclosure (unless otherwise specified, it may be combined with the twenty-seventh aspect in conjunction with any other aspects listed herein), the first PD fluid supply container is used as a first PD fluid drainage container for subsequent treatment, and the second PD fluid supply container is used as a second PD fluid drainage container for subsequent treatment.

[0053] In the twenty-ninth aspect of this disclosure (unless otherwise specified, it may be combined with the twenty-seventh aspect in conjunction with any other aspects listed herein), the supply line includes a common portion between the second connector of the supply line and the first and second branches, and the disposable kit includes a line clamp fitted to the common portion, which is closed before causing the fragile portion of the second connector of the supply line to break.

[0054] In the thirtieth aspect of this disclosure (unless otherwise specified, it may be combined with the twenty-third aspect in conjunction with any other aspects listed herein), the third port of the multiport connector includes a flange, and wherein the auxiliary connection portion includes at least one hook sized and arranged to removably (e.g., snap-fit) engage with the flange of the third port when the auxiliary connection portion is removably sealed to the third port.

[0055] In the thirty-first aspect of this disclosure (unless otherwise specified, it may be combined with the twenty-third aspect in conjunction with any other aspects listed herein), the outer diameter of the auxiliary connection portion is larger than the inner diameter of the third port of the multi-port connector, for removably sealing the auxiliary connection portion to the third port (e.g., by press-fit).

[0056] In the thirty-second aspect of this disclosure (which may be combined with any other aspect listed herein unless otherwise specified), a disposable kit for dialysis treatment includes: a patient tubing including a first connector configured for connection to a patient connector and a second connector configured for connection to a first port of a multiport connector; and a supply tubing including a first connector configured for connection to a PD fluid supply container and a second connector configured for connection to a second port of the multiport connector, wherein the supply tubing is configured to allow at least a portion of the second connector and a tube of the supply tubing to be used as a drainage tubing for subsequent dialysis treatment, wherein a third port of the multiport connector is configured to allow a tube from a previous dialysis treatment and at least a portion of the second connector to be used as a drainage tubing for dialysis treatment, and wherein said at least a portion of the second connector from the previous dialysis treatment is configured to be removably sealed to the third port.

[0057] In the thirty-third aspect of this disclosure (unless otherwise specified, it may be combined with the thirty-second aspect in conjunction with any other aspects listed herein), the second connector includes a breakable portion that allows at least a portion of the second connector and the tube of the supply line to break at the breakable portion and to serve as a drainage line for subsequent dialysis treatment.

[0058] In the thirty-fourth aspect of this disclosure, in conjunction with Figures 1 to 19 Any publicly disclosed structure and function can be combined with Figures 1 to 19 Combine any other publicly available structures and functions.

[0059] In view of this disclosure and the above aspects, the advantage of this disclosure is that it provides an improved gravity-fed PD machine.

[0060] Another advantage of this disclosure is that it provides an improved PD disposable kit.

[0061] Another advantage of this disclosure is the reduction of single-use waste and costs.

[0062] Another advantage of this disclosure is that it reduces the amount of manual continuous non-reliable bed PD actions and steps.

[0063] Another advantage of this disclosure is that it provides a gravity-fed PD that is efficient and cost-effective to construct.

[0064] Another advantage of this disclosure is that it provides a gravity-fed PD machine that precisely controls the flow rate of fresh and used fluids as well as the amount of UF removed.

[0065] The advantages discussed herein can be found in one or more (and possibly not all) of the embodiments disclosed herein. Additional features and advantages are described herein and will be apparent from the following detailed description and accompanying drawings. Attached Figure Description

[0066] Figure 1 This is a top-view perspective view of one embodiment of the peritoneal dialysis system disclosed herein.

[0067] Figure 2 Is with Figure 1 A front view of an embodiment of a gravity-fed dialysis machine used in conjunction with the system.

[0068] Figure 3 yes Figure 2 Side view of an embodiment of a gravity-fed dialysis machine.

[0069] Figure 4 yes Figure 2 Top and rear perspective views of an embodiment of a gravity-fed dialysis machine.

[0070] Figure 5 yes Figure 2 Rear view of an embodiment of a gravity-fed dialysis machine.

[0071] Figure 6 This is a schematic diagram illustrating one embodiment of the fresh and used dialysis solution weight suspension system and method of this disclosure.

[0072] Figure 7A It is able to Figures 2 to 5 A top-view perspective view of an embodiment of a force-measuring unit arrangement structure used in a gravity-fed dialysis machine.

[0073] Figure 7B It is able to Figures 2 to 5 A side cross-sectional view of an embodiment of a force measuring unit arrangement structure used in a gravity-fed dialysis machine.

[0074] Figure 8 It is able to Figures 2 to 5 A side view of an embodiment of a force measuring unit used in a gravity-fed dialysis machine.

[0075] Figure 9 This is a top view illustrating one embodiment of a disposable kit of the present disclosure, which combines a freshly opened disposable kit with a reusable portion of a previously used disposable kit for treatment.

[0076] Figure 10 This is a top view of one embodiment when the disposable kit of this disclosure is removed from its aseptic packaging.

[0077] Figure 11 yes Figure 10 A top view of one embodiment of the disposable kit shows the portion of the drainage tubing used for subsequent treatment and the portion discarded after treatment.

[0078] Figure 12 This is a front cross-sectional view of one embodiment of a multiport connector used with the disposable kit of this disclosure.

[0079] Figure 13A Is with Figure 12 A front cross-sectional view of an embodiment of a breakable connector used with multi-port connectors.

[0080] Figure 13B Is with Figure 12 Multi-port connectors used together Figure 13A Top view, front view, and perspective view of the fragile connector.

[0081] Figure 14A This is a front cross-sectional view of another embodiment of a multiport connector used with the disposable kit of this disclosure.

[0082] Figure 14B It is used in conjunction with the disposable kit disclosed herein. Figure 14A Top-view perspective of a multi-port connector.

[0083] Figure 15A Is with Figure 14A and Figure 14B A front cross-sectional view of an embodiment of a breakable connector used with multi-port connectors.

[0084] Figure 15B It is related to 14A and Figure 14B Multi-port connectors used together Figure 15A Top-view perspective of the fragile connector.

[0085] Figure 16 An example automated peritoneal dialysis (“APD”) treatment is shown on a display device of the PD system disclosed herein and can be performed by the PD system.

[0086] Figure 17 A first example device-assisted continuous ambulatory peritoneal dialysis (“DA-CAPD”) treatment is shown on a display device of the PD system disclosed herein and is operable by the PD system.

[0087] Figure 18 A second example of device-assisted continuous ambulatory peritoneal dialysis (“DA-CAPD”) treatment is shown on a display device of the PD system disclosed herein and is capable of being performed by the PD system.

[0088] Figure 19 A third example device-assisted continuous ambulatory peritoneal dialysis (“DA-CAPD”) treatment is shown on a display device of the PD system disclosed herein and can be performed by the PD system. Detailed Implementation

[0089] Gravity feeder and system

[0090] Now refer to the accompanying drawings, and especially to... Figure 1 The image illustrates a peritoneal dialysis (“PD”) system 10. The PD system 10 includes a PD machine 15 and a disposable kit 110. In one embodiment, the PD machine 15 is a gravity-feed PD machine. In one embodiment, the gravity-feed machine 15 does not use a pump and relies on gravity for all fluid movement. In an alternative embodiment, the gravity-feed machine 15 may employ one or more pumps, such as pumps for removing used PD fluid from the patient to a drainage port. The disposable kit 110 is shown and discussed in detail below. Figures 2 to 5 Different views of machine 15 are provided.

[0091] The PD machine 15 in the illustrated embodiment includes a frame 20 made of a material of suitable strength, such as stainless steel, steel, aluminum, fiberglass, or plastic, such as polyethylene or polypropylene. The frame 20 in the illustrated embodiment includes a base made of three components 22, 24, and 26, which are screwed, welded, adhered, or integrally formed together. In the illustrated embodiment, the base of the frame 20 does not include a front component, allowing easy lifting into or removal from at least one used PD fluid drainage container of the disposable kit 110. It should be understood that the base of the frame 20 in the illustrated embodiment does not directly support the weight of the at least one used PD fluid drainage container. However, the base of the frame 20 is large enough to extend around the at least one used PD fluid drainage container.

[0092] Multiple casters 30 are connected to the bottom of the side members 22 and 24 of the base of the frame 20, allowing the PD system 10 to be easily moved using handles 32 and 34 connected to the frame 20. Support legs 36 and 38 extend upward from the members 22 and 24 of the base of the frame 20, respectively. Support legs 36 and 38 may be screwed, welded, glued to members 22 and 24, or integrally formed with said members 22 and 24, respectively. In one embodiment, Figure 5 and Figure 6 The legs 36 and 38 are shown terminating at their upper ends in the top plate 40. The legs 36 and 38 may be screwed, welded, adhered to the top plate 40, or integrally formed with the top plate 40.

[0093] The top plate 40 can be considered as the top of the frame 20, wherein all structures above the top plate 40 are supported by force-measuring units 50. For example, in Figure 7A In the illustrated embodiment, four force-measuring units 50 are provided, one at each corner of the top plate 40. If desired, fewer or more force-measuring units 50 can be provided on the top plate 40, including a single central force-measuring unit. In one embodiment, the force-measuring units 50 are spaced apart to evenly support the platform scale 60 resting on top of the force-measuring units 50. In the illustrated embodiment, four force-measuring units 50 are provided, one at each corner of the platform scale 60.

[0094] Figures 1 to 5The machine 15 also includes a drainage container support 70. In the illustrated embodiment, the drainage container support 70 includes a plurality of members 72 and 74 that are mechanically in communication with (e.g., connected to or integrally formed with) a platform scale 60 and extend downward from it. Additionally, members 72 and 74 are mechanically in communication with, for example, a drainage container receiving portion 76 located between members 72 and 74, such as being connected to or integrally formed with the drainage container receiving portion. In the illustrated embodiment, a drainage container receiving platform 78 is fixed to and seated above the drainage container receiving portion 76. Figure 2 and Figure 3 As shown, the drainage container receiving platform 78 can be hingedly fixed to the drainage container receiving portion 76, such that one or more used PD fluid drainage containers located in the drainage container receiving tray 79 can be tilted as desired to prepare for placement into or removal from the machine 15.

[0095] It should be understood that the legs 36 and 38 of the frame 20 connected to the top plate 40 provide rigidity to the three members 22, 24, and 26 of the base of the frame 20, tending to prevent members 22 and 24 from bending outward or inward relative to each other. Furthermore, the dimensions and shapes of members 72 and 74 of the drainage container support 70 are set to align with and follow the contours of the legs 36 and 38 of the frame 20. In this way, the platform scale 60, which floats along the force measuring unit 50 (not attached to the force measuring unit 50), and the drainage container support 70 are laterally constrained between the legs 36 and 38 of the frame 20. This, combined with the arrangement of the weight, pins, and receiving holes placed on the force measuring unit (discussed below), the construction of the force measuring unit 50 (discussed below), and the side panels attached to the platform scale 60 (discussed below), prevents the platform scale 60 from sliding off the top plate 40.

[0096] Figures 1 to 5 In one embodiment, the gravity-fed PD machine 15 also includes a control unit 100. The control unit 100 includes one or more microprocessors that operate in conjunction with one or more memories programmed to store one or more peritoneal dialysis treatments, as discussed in detail below. The control unit 100 may also include a video controller capable of operating in conjunction with the one or more microprocessors and the one or more memories to control a user interface 102, which includes a display 104a and at least one input device 104b. The input device 104b may be one or more electromechanical buttons, such as membrane switches, and / or a touchscreen overlay operating in conjunction with the display 104a. The display 104a may be a liquid crystal display (“LCD”) or a light-emitting diode (“LED”) display.

[0097] Figure 2 and Figure 3 In one embodiment, the control unit 100 is provided with multiple valves, such as a fresh PD fluid (to the patient) valve 106a and a used PD fluid (from the patient) valve 106b. Valves 106a and 106b may be electrically actuated solenoid valves under the control of the control unit 160. In one embodiment, valves 106a and 106b are spring-closed and energized to provide fail-safe operation in the event of power loss. Typically, during patient filling, the control unit 100 will energize and open the upper fresh PD fluid valve 106a, while the lower used PD fluid valve 106b will be de-energized and closed. During patient drainage, the control unit 100 will cause the lower used PD fluid valve 106b to energize and open, while the upper fresh PD fluid valve 106a will be de-energized and closed. During patient stay, the control unit 100 will cause both valves 106a and 106b to be de-energized and closed.

[0098] Figure 6 An embodiment illustrating the suspension of a fresh PD fluid supply container 144 and a used PD fluid drainage container 140 using the system 10 and related methods of this disclosure is shown schematically. System 10 includes a frame 20 having components 22, 24, and 26 (in...) Figure 6 (Only component 26 is visible) The legs 36 and 38 are mechanically linked, as already described herein. As shown, the frame 20 sits on a supporting surface or the ground. The frame 20 also includes a top plate 40, which... Figure 6 The support or flange is shown as a separate support located at the upper end of the legs 36 and 38. In the illustrated embodiment, the drainage container support 70 is located inside the frame 20. The drainage container support 70 includes side members 72 and 74, which are joined together via the drainage container receiving portion 76 of the support 70. The side members 72 and 74 of the drainage container support 70 are mechanically linked or attached to the scale 60 at their upper ends.

[0099] In the illustrated embodiment, Figure 6 The control unit 100 is supported by the frame 20. The control unit 100 includes control valves 106a and 106b as described herein. The disposable kit 110 includes a fresh PD fluid supply container 144, a used PD fluid drainage container 140, and tubing between them, which will be described in detail below. Figure 6Component numbers for the tubing and other components of the disposable kit are provided to illustrate one embodiment used for positioning during use with machine 15. Fresh fluid tubing 120a, 120b, 120c travels from fresh PD fluid supply container 144 through fresh PD fluid (to patient) valve 106a to patient P. Used fluid tubing 120a, 120b, 120c travels from patient P through used PD fluid (from patient) valve 106b to used PD fluid drainage container 140. Fresh PD fluid flows from fresh PD fluid supply container 144 to patient P under gravity, and from patient P (e.g., via siphon action) to used PD fluid drainage container 140.

[0100] like Figure 6 As shown, the scale 60, drainage container support 70, fresh PD fluid supply container 144, used PD fluid drainage container 140, and associated tubing of the disposable kit 110 are all supported by one or more force measurement units 50 located between the scale 60 / drainage container support 70 and the top plate 40 / frame 20. These one or more force measurement units 50 are powered by the control unit 100 and send force measurement unit weight signals to the control unit 100. Therefore, the combined weight of any remaining fresh PD fluid, any collected used PD fluid, and any collected UF from the patient is monitored by the one or more force measurement units 50. The fluid weight not visible to the one or more force measurement units 50 is the weight of the fluid currently remaining in the patient's body. Therefore, to calculate and measure patient filling, the control unit 100 fills via valve 106a until a specified weight reduction is recorded via the one or more force measurement units 50. Once the desired filling weight is recorded, the control unit 100 closes valve 106a. To calculate and measure patient drainage (including consumed PD fluid and UF), control unit 100 drains through valve 106b and records the increase in weight via one or more force measurement units 50 until patient drainage is complete, at least in part due to possible changes in the amount of UF, which may or may not be a specific weight increase. Once patient drainage is complete, for example, by automatically determining via force measurement unit 50 or by manual observation of a slowing increase in the weight of the outflow, control unit 100 closes valve 106b.

[0101] The above-described configuration of the fresh PD fluid supply container 144 and the used PD fluid drainage container 140 for the suspension system 10 is advantageous for several reasons. First, as discussed, all non-patient fluid weights are sensed by the same one or more force units 50, which simplifies force unit placement and fluid weight calculation. Second, the force unit and plate-to-plate or platform configuration via the top plate 40, force units 50, and scale 60 makes it possible to evaluate the output of the force units 50. In one embodiment, each force unit 50 is equidistant or approximately equidistant from the intended center of mass of the scale 60 and the total weight supported by the scale, such that, theoretically, each force unit senses the same weight. The control unit 100 sums the weights from each force unit 50 to arrive at the sensed total weight. For example, if the sensed total weight is 60 kilograms (“kg”), the reading for each force unit should be approximately 15 kg. The control unit 100 can be programmed such that if the reading of one of the force measuring units is inconsistent with the readings of the other force measuring units (e.g., by ±10%), the control unit sends an alarm to the user interface 102, and may additionally or alternatively send it via a network to a service center, server, and / or portal to arrange for the misaligned force measuring unit to be repaired or replaced. Therefore, providing multiple force measuring units 50 results in a self-adjusting type of system.

[0102] Multiple force measuring units 50 also allow the scale 60 to read accurately even when it tilts from its intended position, and also allow it to self-diagnose when tilting occurs. Once tilted, readings from multiple (e.g., four) force measuring units should still be accurately added to the total weight, but here two force measuring units 50 may read the same value but differ overall from the other two force measuring units 50. For example, assuming the total weight is again 60 kg, two of the force measuring units will read 16 kg, while the other two will read 14 kg. In this tilting example, the control unit 100 can be programmed to recognize that the scale 60 has tilted from its intended position and send an alert to the user interface 102 once all bags have been removed from the system 10, so that the user can correct the tilting problem.

[0103] Regarding patient filling and drainage, during treatment, the patient typically sits or lies between one or more fresh PD fluid supply containers at the top and one or more used PD fluid drainage containers at the bottom, allowing fresh PD fluid to flow from the one or more fresh containers to the patient and from the patient to the one or more used PD fluid drainage containers under gravity. However, if the patient sits or lies below the drainage container valve 106b during treatment, the system 10 uses a siphon technique to allow used PD fluid to flow upwards through the drainage valve 106b and then downwards along the drainage line to the one or more used PD fluid drainage containers. To this end, the control unit 100 performs a pre-flush procedure before treatment, which allows fresh PD fluid to flow out of the one or more fresh PD fluid containers to expel air from the supply line and patient line, which may be equipped with vent caps, and at least a portion of the drainage line extends to and / or passes through the drainage valve 106b. The pre-flushed disposable kit 110 enables the siphon effect.

[0104] Figure 5 and Figure 6 The control unit 100 also includes electronics 108. Electronics 108 may include an on / off switch, an AC power plug and / or power cord, one or more converters (e.g., including one or more transformers) that can provide electrical insulation, and any one or more data input / output ports. The electronics may also include an Ethernet card or other devices that allow the control unit 100 to access a remote server, for example, via the Internet or another wide area network. The control unit 100 can be programmed to receive device programs from a remote server. The device programs can run automated peritoneal dialysis (“APD”) and device-assisted continuous ambulatory peritoneal dialysis (“DA-CAPD”) treatments described below.

[0105] Figure 4 and Figure 5 The machine 15 is shown to include a cable / signal cable 42 extending from a printed circuit board 44 to a control unit 100. The printed circuit board 44 and cable 42 supply power to a force-measuring unit 50 and include conductors configured to carry one or more different types of signals to and from the control unit 100. These conductors may be, for example, a first conductor carrying a weight signal from the force-measuring unit 50, a second conductor carrying a temperature signal from a thermocouple or thermistor (e.g., positioned along the underside of the top wall 64b), and / or other conductors carrying signals from other types of sensors, such as one or more humidity or conductivity sensors positioned in the supply container receiving tray 80 to locate leaking supply bags 140.

[0106] Figure 7Aand Figure 7B The top plate 40, force measuring unit 50, and platform scale 60 are shown in more detail. In the illustrated embodiment, the legs 36 and 38 of the frame 20 are screwed to the top plate 40, while in the illustrated embodiment, components 72 and 74 are screwed to the platform scale 60. Figure 7A Four force measuring units 50 are shown, for example, located between the top plate 40 and the platform scale 60. Figure 7A The printed circuit board 44, which operates together with the force measuring unit 50, is also shown in more detail. Figure 7A Additionally, it is shown that the top plate 40 may be fitted with a pin or bolt 46 that extends through a matching orifice 68 formed in the platform scale 60 to center the platform scale relative to the top plate 40, thereby further restricting lateral movement of the platform scale 60 relative to the top plate 40 while allowing vertical movement of the platform scale relative to the top plate.

[0107] Figure 7B In one embodiment, the force measuring unit 50 is screwed to the top plate 40, while the platform scale 60 floats on the top force measuring unit 50. Figure 7B The weighing platform 60 is further shown to be connected to or formed with a sidewall 62, wherein the sidewall supports a cover 64. The cover 64 includes a front wall 64a, a top wall 64b, a rear wall 64c, and a sidewall 64d. The sidewall 62 and the cover 64 float together with the platform scale 60. The cover 64 prevents the platform scale 60 from being removed from any of the force-measuring units 50.

[0108] A supply container receiving tray 80 is provided, and this supply container receiving tray 80 rests on or is screwed to the top wall 64b of the cover 64. The supply container receiving tray 80 is sized to receive one or more fresh PD fluid supply containers of the disposable kit 110. In the illustrated embodiment, the sidewall 62 is angled such that the top wall 64b of the cover 64 and the supply container receiving tray 80 are inclined, such that the front end of at least one fresh PD fluid supply container placed in the tray 80 is located below the rear end of the container. The front end of the at least one container includes a port for connecting to a tube of the disposable kit. The inclined arrangement of the at least one fresh PD fluid supply container allows air in the container to move toward the rear end of the one or more containers, which has a higher elevation.

[0109] In the illustrated embodiment, the resistance heating coil 66 is placed inside the cover 64, for example, attached to the underside of the top wall 64b of the cover 64. Figure 7BThe heating coil 66, shown in cross-section, may meander back and forth along the bottom of the top wall 64b of the cover 64. Electrically, the heating coil 66 may be a single coil or may be divided into two or more coils. In one embodiment, the heater 66 operates in conjunction with a temperature sensor (not shown) positioned along the underside of the top wall 64b to provide temperature sensor feedback to the control unit 100, thereby helping to control the output of the heater 66 to achieve the desired fresh PD fluid temperature. In one embodiment, the electronics 44 includes an analog-to-digital converter to facilitate temperature feedback. In one embodiment, the control unit electronics 108 includes: circuitry, such as a sensor sensing an incoming alternating current (“AC”) voltage; and a switch, such as a metal-oxide-semiconductor field-effect transistor (“MOSFET”), which the control unit 100 switches based on the sensed AC voltage such that the heating coil 66 receives the same heating power regardless of the input AC voltage. The switches and / or sensors described above for heater power may alternatively be located at the top panel electronics 44. Electronic device 108 may also include a converter that accepts a range of AC inputs, such as from 90VAC to 240VAC, so that machine 15 can operate regardless of the input AC voltage. The converter may also output a desired voltage in a desired form, for example, converting 120VAC to 12VDC depending on the power requirements of the instruments, sensors, and control unit 100 of machine 15.

[0110] Wiring (not shown) from heating coil 66 travels via cable / signal cable 42 to control unit 100. Control unit 100 controls heating coil 66 to heat fresh PD fluid in its containers placed on container receiving tray 80 to body temperature (e.g., 37°C). Control unit 100 can use and switch the power supply duty cycle of coil 66 to heat the fresh PD fluid. The top wall 64b of lid 64 and any one or more other walls (lid 64 may be a single piece of metal bent and welded together) may be made of a thermally conductive material (such as aluminum, steel, or stainless steel). Container receiving tray 80 may also be made of a thermally conductive material (such as aluminum, steel, or stainless steel) so that heat from heating coil 66 can be easily conducted to one or more PD fluid containers placed on container receiving tray 80. In the illustrated embodiment, the front and side walls of container receiving tray 80 may be coated with an insulating material 82 (e.g., a high-melting-point polymer, fabric, fiberglass, or possibly an insulating coating) so that a user can touch those surfaces without feeling overheated.

[0111] Now for reference Figure 8An embodiment of the force measuring unit 50 is shown. In the illustrated embodiment, the force measuring unit 50 includes a cup 52 made of metal (e.g., stainless steel, steel, or aluminum), fiberglass, or plastic (e.g., polyethylene or polypropylene), which, as shown, aligns and secures the force measuring unit 50 to the top plate 40. The cup 52 holds the force measuring unit sensor 54 such that the wiring (power and signal, not shown) of the force measuring unit sensor 54 can extend from the cup 52 into the cable / signal cable 42 traveling to the control unit 100.

[0112] As shown, a compressible overload bushing 56 (e.g., a polyurethane compound or compressible silicone or silicone foam) is held within a cup 52 and abuts against a scale 60. A helical spring can be used instead of a flexible material, but may be subjected to excessive periodic motion, which may require software filtering / suppression for correction. It should be understood that software filtering can be implemented regardless of the material (polymer or metal) used for the bushing 56 or the type of compressible structure (compound, foam, or spring). In any case, software filtering can mitigate the effects of mechanical noise (vibration and other disturbances) present in system 10.

[0113] The compressible overload bushing 56 and cup 52 protect the force sensor 54 from abrupt changes in load (e.g., an increase due to bag placement) and weight overload. The overload bushing 56 is sized and arranged to maintain a gap G between the top of the cup 52 and the bottom of the scale 60. In this way, the compressible overload bushing 56, the load applicator 58, and the force sensor 54 see the full weight placed on the scale 60 (the weight of the fresh PD fluid) and the full weight suspended from the scale (the weight of the used PD fluid). The bushing material is selected to compress in a known proportion to the applied load, thereby incrementally closing the gap G as the load increases within the target measurement range. When the load has increased beyond the target range and approaches the overload limit of the force sensor 54, the gap G becomes fully closed. The fully closed gap transfers all excess load to the cup 52, thereby protecting the force sensor 54 before an overload can occur.

[0114] A metal (e.g., stainless steel, steel, or aluminum) or plastic (e.g., polyethylene or polypropylene) load applicator 58 is located below a compressible overload bushing 56 to transfer weight from the flexible overload bushing 56 to a force-measuring unit sensor 54, which then sends a corresponding weight signal to the control unit 100. Also as Figure 8 As shown, screws, studs or other types of components extend downward from the platform scale 60 into the compressible overload bushing 56 to position the platform scale 60 in the desired position on the force measuring unit 50 and to prevent the platform scale from slipping off the force measuring unit 50.

[0115] Disposable kit

[0116] Now for reference Figure 9 An embodiment of a fully connected, ready-to-use disposable kit 110 is shown. A new patient tubing 112 is connected to the first port (described below) of a new multiport connector 130a or 130b. A new supply tubing 120 is connected via branches 120b and 120c to two (or more, or only a single container) filled with fresh PD fluid supply containers 144 (e.g., bags), and via their common portion 120a to the second port of the new multiport connector 130a or 130b. In one embodiment, the fresh PD fluid supply container 144 is oversized (e.g., 10 percent or more oversized) relative to the amount of fresh PD fluid held within it, such that the supply container 144 has additional volume when later used as a drainage container 140 to retain the patient's removed ultrafiltration (“UF”) volume. Alternatively, standard-sized supply containers 144 are typically provided with a certain amount of empty space filled with air, allowing standard containers to be tested to see if they can repeatedly retain the aforementioned additional UF volume when later used as drainage containers. The reused supply line 120' (now the drainage line) is connected via branches 120b' and 120c' to two (or more or only a single container) empty used PD fluid drainage containers 140 (e.g., bags) and via their common portion 120a' to the third port of a new multiport connector 130a or 130b (described below).

[0117] Following treatment or after a 24-hour cycle of treatment, control unit 100 can cause any remaining fresh supply fluid to be delivered to drainage container 140 to empty PD fluid supply containers 144, making them ready for reuse with supply line 120. Used PD fluid drainage containers 140 are filled with patient outflow (and unused fresh fluid) and discarded with patient line 112. Figures 9 to 11 It should be understood that the disposable kit 110 significantly reduces disposable costs and waste.

[0118] Now for reference Figure 10An embodiment of a disposable kit 110, packaged or removed from its packaging, is shown. The disposable kit 110 is housed in a package sterilized by gamma rays, steam, and / or ethylene oxide. In the illustrated embodiment, the disposable kit 110 does not contain a fresh PD fluid supply container 144 or a used PD fluid drainage container 140. Instead, in one embodiment, the fresh PD fluid supply container 144 is sterilized and housed separately, while the used PD fluid drainage container 140 is housed with the drainage line 120' from a previous treatment. The supply line 120 from the current treatment and the fresh PD fluid supply container 144 are reused in subsequent treatments as the drainage line 120' and the used PD fluid drainage container 140, respectively. Reusing the supply line 120 from a previous treatment and the fresh PD fluid supply container 144 for use in the current treatment reduces disposable waste and costs.

[0119] The tubing of the disposable kit 110 can be made of suitable medical-grade materials, such as polyvinyl chloride (“PVC”), silicone, polypropylene (“PP”), polyethylene (“PE”), and mixtures thereof. The connector of the disposable kit 110 can be made of suitable medical-grade materials, such as PVC, silicone, PP, PE, and mixtures thereof. The PD fluid supply container and PD fluid drainage container of the disposable kit 110 can be made of suitable medical-grade materials (such as those listed above).

[0120] Figure 10 The packaged disposable kit 110 is shown to include a patient tubing 112, which includes or is attached at a first end to a first connector or patient connector 114 configured for connection to a patient's indwelling catheter (not shown). For example, the patient may have a patient transfer kit to access a PD catheter implanted within the patient's peritoneal cavity. The patient connector 114 is protected by a patient connector cap 116 until treatment is performed using system 10, at which point the patient removes the cap 116 and connects the patient connector 114 to the patient's transfer kit. The cap 116 may be fitted with a hydrophobic filter or vent to allow air to be diverted from the patient tubing to the atmosphere during the pre-flush discussed above. The patient tubing 112 is connected at a second end to one port of a multi-port connector 130a or 130b (such as a Y-connector or a T-connector). The connections from patient tubing 112 to patient connector 114 and multiport connectors 130a or 130b can be the same or different, and can be any of the following: compression (e.g., press-fit) connection, hose barb connection, or Luer connection. Example embodiments of multiport connectors 130a and 130b are discussed in detail below.

[0121] Figure 10 The packaged disposable kit 110 is shown to include a supply line 120 having a common portion 120a branching from a Y-connector or T-connector 122 into a first branch 120b and a second branch 120c. Branches 120b and 120c terminate at a first connector or supply container connector 124, which may be, for example, a spike. The spike 124 is configured to pierce mating connectors of a first PD fluid supply container and a second PD fluid supply container (not shown). In the illustrated embodiment, the spike 124 is covered by an end protector 126. The end protector 126 protects the spike 124 until it is time to pierce the PD fluid supply container, at which point the end protector is removed. The connector 124 may alternatively be a compression (e.g., press-fit) connection, a hose barb, or a Luer connector. In the illustrated embodiment, a line clamp 128 is placed at the common portion 120a to open or close the supply line 120 as desired.

[0122] The common portion 120a of the supply line 120 terminates at the second connector or breakable connector 150a or 150b via any suitable type of connection (e.g., compression (e.g., press-fit) connection, hose barb connection, or Luer connection) and / or via adhesive (e.g., thermal adhesive, solvent adhesive, ultrasonic adhesive, adhesive bonding, etc.). The breakable connector 150a or 150b is then connected to the second port of the multi-port connector 130a or 130b via any suitable type of connection (e.g., compression (e.g., press-fit) connection, hose barb connection, or Luer connection) and / or via adhesive (e.g., thermal adhesive, solvent adhesive, ultrasonic adhesive, adhesive bonding, etc.). The breakable connector 150a or 150b includes a breakable portion that allows the retained auxiliary connection portion to disconnect from the portion of the breakable connector 150a or 150b connected to the second port of the multi-port connector 130a or 130b. The remaining auxiliary connection portion of the breakable connector 150a or 150b is configured to be sealed to the third port of the multiport connector 130a or 130b via any suitable type of connection (e.g., compression (e.g., press fit) connection, hose barb connection, or Luer connection), thereby allowing the supply line 120 and the one or more fresh PD fluid supply containers 144 to be used as drainage lines 120' and one or more used PD fluid drainage containers 140 in subsequent treatments.

[0123] like Figure 10As shown, the third port of the multiport connector 130a or 130b may initially be provided with a cap 118, wherein the cap is removable to allow the auxiliary connection portion of the supply line 120 from a previous dialysis treatment and the breakable connector 150a or 150b to be used as the drainage line 120' for the current dialysis treatment. Again, the auxiliary connection portion from the previous dialysis treatment is configured to be removably sealed to the third port of the multiport connector 130a or 130b for use in dialysis treatment.

[0124] Figure 11 Showing the results after use Figure 10 The disposable kit 110. The structure to the left of the plus sign is reused for subsequent treatments, while the structure to the right of the plus sign is discarded. In particular, Figure 10 The supply line 120 is now replaced by a drainage line 120' for reuse. This drainage line includes a common portion 120a' connected to the retained auxiliary connectors 150a and 150b, and branches 120b' and 120c' leading to a connector 124 connected to the now empty supply bag 140. The patient line 112 leading to the patient connector 114 and to the multi-port connector 130a or 130b is discarded. The multi-port connector 130a or 130b is connected at its second port to a small portion disconnected from the auxiliary connectors 150a and 150b. Before closing the current drainage line 120', the line clamp 128 can be pushed as far as possible towards the auxiliary connectors 150a and 150b to prevent as much air as possible from entering the drainage line 120' before the next treatment. Closing the line clamp 128 before connecting a new drainage line 120' for subsequent dialysis treatment also prevents residual solution from overflowing from the fresh PD fluid container.

[0125] Now for reference Figure 12 An embodiment for a multi-port connector 130a is shown. The multi-port connector 130a can be made of any medical-grade connector material described above. The multi-port connector 130a includes a first port 132 for connection to a patient line 112 via adhesive (e.g., thermal bonding, solvent bonding, ultrasonic bonding, adhesive bonding, etc.), compression (e.g., press-fit), tubing barb connection, or Luer connection. The multi-port connector 130a includes a second port 134 for connection to a supply line 120 via compression (e.g., press-fit), tubing barb connection, or Luer connection. The multi-port connector 130a includes a third port 136 for connection to a reusable supply line 120' via compression (e.g., press-fit), tubing barb connection, or Luer connection, wherein the reusable supply line 120' is now used as a drainage line as described above.

[0126] As shown in the figure, the third port 136 of the multiport connector 130a includes a flange 138, which can be integrally molded with the rest of the multiport connector. As shown in the figure, the flange 138 includes or defines a plurality of apertures 138a and 138b for capturing hooks from the breakable connector, as described below.

[0127] Figure 13A and Figure 13B An embodiment of the breakable connector 150a is shown in more detail. The breakable connector 150a is configured to be hermetically connected to a third port 136 of the multiport connector 130a. The breakable connector 150a can be made of any medical-grade connector material described above. The breakable connector 150a includes a discard portion 152 having a port 154, which is connected to a second port 134 of the multiport connector 130a via a compression (e.g., press-fit) connection, a tubing barb connection, or a Luer connection and / or via adhesive (such as thermal bonding, solvent bonding, ultrasonic bonding, adhesive bonding, etc.). The breakable connector 150a also includes a retaining portion 156 having a port 158, which is connected to the supply line 120 via a compression (e.g., press-fit) connection, a tubing barb connection, or a Luer connection and / or via adhesive (such as thermal bonding, solvent bonding, ultrasonic bonding, adhesive bonding, etc.).

[0128] The discard portion 152 and the retainable portion 156 are separated from each other by a breakable portion or breakable line 160. The user disconnects the retainable portion 156 and the attached supply line 120 (which is reused) from the discardable portion 152 and the attached multi-port connector 130a, as well as the connected patient line 114 and drainage line (from the supply line 120 of a previous treatment), thus discarding the discardable portion, the attached multi-port connector, and the connected patient line and drainage line. The breakable portion or breakable line 160 is configured such that its breaking force is not excessive for potentially older patients. This force can range from approximately ten Newtons to approximately sixty Newtons. The retainable portion 156 includes an auxiliary connection portion 162 terminating at the breakable line 160. The auxiliary connection portion 162 is sized and arranged to removably seal to the third port 136 of the multi-port connector 130a. For example, the maximum outer diameter of the auxiliary connection portion 162 may be 5.60 mm, while the minimum inner diameter of the third port may be 5.0 mm, resulting in a compression or press fit between the auxiliary connection portion 162 and the third port 136 of the multiport connector 130a.

[0129] The retaining portion 156 also includes or defines arms 164 and 166 (which may be integrally molded with the breakable connector 150a), the arms being configured to be curved such that hooks 168 located at the distal ends of arms 164 and 166 can snap into holes 138a and 138b of the third port 136 of the multiport connector 130a. The combined magnitude of the force required to connect the auxiliary connecting portion 162 and hooks 168 to and from the third port 136 of the multiport connector 130a is selected to provide a good seal without placing an undue burden on potentially older patients. For example, the connecting force may be from about forty Newtons to about ninety Newtons (e.g., fifty Newtons), while the resulting sealing force may be from about one hundred Newtons to about two hundred and twenty Newtons.

[0130] Now for reference Figure 14A and Figure 14B An embodiment of a multi-port connector 130b is illustrated. The multi-port connector 130b can be made of any of the medical-grade connector materials described above. The multi-port connector 130b includes a first port 142 for connection to a patient line 112 via a compression (e.g., press-fit) connection, a tubing barb connection, or a Luer connection and / or via adhesive (such as thermal bonding, solvent bonding, ultrasonic bonding, adhesive bonding, etc.). The multi-port connector 130b includes a second port 146 for connection to a supply line 120 via a compression (e.g., press-fit) connection, a tubing barb connection, or a Luer connection and / or via adhesive (such as thermal bonding, solvent bonding, ultrasonic bonding, adhesive bonding, etc.). The multi-port connector 130b includes a third port 148 for connection to a reusable supply line 120' via a compression (e.g., press-fit) connection, a tubing barb connection, or a Luer connection, wherein the reusable supply line 120' is now used as a drainage line as described above. As shown in the figure, the third port 148 of the multiport connector 130b includes a flange that can be integrally molded with the rest of the multiport connector. The flange is used for manual operation of the multiport connector 130b, rather than for attachment to the fragile connector 150b as in the cases of multiport connector 130a and fragile connector 150a.

[0131] Figure 15A and Figure 15BAn embodiment of the breakable connector 150b is shown in more detail. The breakable connector 150b is configured to be hermetically connected to a third port 148 of the multiport connector 130b. The breakable connector 150b can be made of any medical-grade connector material described above. The breakable connector 150b includes a discard portion 172 having a port 174, which is connected to a second port 146 of the multiport connector 130b via a compression (e.g., press-fit) connection, a tubing barb connection, or a Luer connection and / or via adhesive (such as thermal bonding, solvent bonding, ultrasonic bonding, adhesive bonding, etc.). The breakable connector 150b also includes a retaining portion 176 having a port 178, which is connected to the supply line 120 via a compression (e.g., press-fit) connection, a tubing barb connection, or a Luer connection and / or via adhesive (such as thermal bonding, solvent bonding, ultrasonic bonding, adhesive bonding, etc.).

[0132] The discard portion 172 and the retainable portion 176 are separated from each other by a breakable portion or breakable line 180. The user disconnects the retainable portion 176 and the attached supply line 120 (which is reused) from the discardable portion 172 and the attached multi-port connector 130b, as well as the connected patient line 114 and drainage line (from the supply line 120 of a previous treatment), and discards the discardable portion, the attached multi-port connector, and the connected patient line and drainage line. The breakable portion or breakable line 180 is configured such that its breaking force is not excessive for potentially older patients. This force can range from about ten Newtons to about sixty Newtons. The retainable portion 176 includes an auxiliary connection portion 182 terminating at the breakable line 180. The auxiliary connection portion 182 is sized and arranged to removably seal to the third port 148 of the multi-port connector 130b. For example, the maximum outer diameter of the auxiliary connection portion 182 can be 6.00 mm, while the minimum inner diameter of the third port 148 can again be 5.0 mm, resulting in a compression or press fit between the auxiliary connection portion 162 and the third port 148 of the multiport connector 130b.

[0133] Unlike the fragile connector 150a, the fragile connector 150b does not include an arm to provide additional connection. Instead, the maximum outer diameter of the auxiliary connection portion 182 is made larger than that of the auxiliary connection portion 182 of the fragile connector 150a. However, the force required to connect the auxiliary connection portion 182 to the third port 148 of the multi-port connector 130b can be the same as or similar to the force required to connect the auxiliary connection portion 162 to the third port 136 of the multi-port connector 130a, for example, from about forty Newtons to about ninety Newtons (e.g., fifty Newtons).

[0134] PD treatment

[0135] System 10 performs automated patient filling, residence, and drainage for the patient. It is conceivable that the control unit 100 of the gravity-fed dialysis machine 15 stores treatments that the patient can recall and / or stores templates that allow the patient to establish or form treatments on a given day. In either case, it is conceivable to offer the patient the option of performing automated peritoneal dialysis (“APD”) treatment or device-assisted continuous ambulatory peritoneal dialysis (“DA-CAPD”) treatment. The main differences between APD treatment and DA-CAPD treatment are: (i) there are more automated cycles in APD treatment compared to DA-CAPD, and because (ii) the filling volume of APD treatment differs from that of DA-CAPD treatment (generally less), and (iii) the residence time of APD treatment differs from that of DA-CAPD treatment (generally less). DA-CAPD treatment may also have more manual change steps than APD treatment; however, APD therapy is capable of including one or more manual mid-day fluid changes.

[0136] Figure 16 An APD treatment 200 is shown displayed on a display device 102 of machine 15. Assuming the supply container receiving tray 80 holds two containers of five liters each containing fresh dialysis fluid, each of the six automatic refills of the APD treatment 200 can comprise a refill volume of approximately 1.6 liters. Assuming a total treatment time of nine hours, each of the five short cycles lasts approximately 108 minutes, resulting in a residence time of approximately 80 to 100 minutes per cycle. Machine 15 provides the final refill volume remaining in the patient's body during the day until the next nightly treatment using machine 15. The APD treatment 200 in the illustrated embodiment does not require manual replacement.

[0137] For the following Figures 17 to 19 In the three DA-CAPD examples below, when a new disposable kit 110 is introduced, both supply containers 144 of the current disposable kit 110 are empty, allowing the supply containers to be used as drainage containers along with the new disposable kit 110, as described above. Supply containers 144 can be used as drainage containers for the new disposable kit 110 used for both DA-CAPD and APD. The examples below each assume that any manual filling will also use fresh dialysis fluid from supply containers 144 located at machine 15; however, this is not necessary. For example, a patient's routine may include manual drainage and filling performed while working with their back to machine 15. In this case, the total volume of fresh dialysis fluid loaded onto machine 15 via the new disposable kit 110 can be reduced to the volume of mid-day replacements performed during work, thus preventing waste of fresh fluid.

[0138] Figure 17A first DA-CAPD treatment 210 is shown on the display device 102 of machine 15. Assuming the supply container receiving tray 80 again holds two 5-liter containers of fresh dialysis fluid, the four total cycles shown (machine 15 performs three patient fills) can each include a fill volume of approximately 2.5 liters. Assuming a new kit 110 is also loaded at 10:30 PM, the fills occurring at 10:30 PM, 3:00 AM, and 7:30 AM are each performed by gravity-fed PD machine 15. The automatic residence time between 10:30 PM and 7:30 AM (e.g., approximately four or more hours) is significantly longer than with APD. Drainage occurring at 3:00 AM, 7:30 AM, and 10:30 PM is also performed by gravity-fed PD machine 15. In the illustrated embodiment, drainage and fill occurring at 6:00 PM are performed manually, while drainage occurring at 10:30 PM can be performed manually or via machine 15. In either case, the amount of patient effort required is significantly reduced.

[0139] Figure 18 A second DA-CAPD treatment 220 is shown on the display device 102 of machine 15. Assuming the supply container receiving tray 80 again holds two 5-liter containers of fresh dialysis fluid, the four total cycles shown can again each include a filling volume of approximately 2.5 liters. Assuming a new kit 110 is also loaded at 9:00 PM, fillings occurring at 9:00 PM, 1:30 AM, and 6:00 AM are each performed by gravity-fed PD machine 15. The automatic residence between 9:00 PM and 6:00 AM (e.g., approximately four or more hours) is significantly longer than APD. Drainages occurring at 1:30 AM, 6:00 AM, and possibly also at 9:00 PM are also performed by gravity-fed PD machine 15. In the illustrated embodiment, drainage and filling at 10:30 AM are performed manually, while drainage at 9:00 PM can be performed manually or via machine 15. Nevertheless, the amount of patient effort required is again significantly reduced.

[0140] Figure 19A third DA-CAPD treatment 230 is shown on the display device 102 of machine 15. Assuming the supply container receiving tray 80 again holds two 5-liter containers of fresh dialysis fluid, the four total cycles shown can again each include a filling volume of approximately 2.5 liters. Assuming a new kit 110 is also loaded at 11:00 PM, fillings occurring at 11:00 PM, 3:00 AM, and 7:00 AM are each performed by gravity-fed PD machine 15. The automatic residence time between 7:00 PM and 7:00 AM (e.g., approximately 150 minutes or more, e.g., four or more hours) is longer than with APD. Drainages occurring at 3:00 AM, 7:00 AM, and possibly also at 11:00 PM are also performed by gravity-fed PD machine 15. In the illustrated embodiment, drainage and filling at 7:00 PM are performed manually, while drainage at 11:00 PM can be performed manually or via machine 15. Nevertheless, the amount of patient effort required is again significantly reduced.

[0141] It should be understood that a key difference between APD and DA-CAPD is residence time. APD residence time per cycle is typically less than 2.5 hours (usually 1.5 to 2 hours), while DA-CAPD residence time is typically longer than 3 hours (e.g., typically 4.5 hours). Another key difference is total fill volume. The total fill volume of DA-CAPD (e.g., 6 to 8 liters) is typically smaller than that of APD (e.g., 10 to 12 liters). Figures 17 to 19 The example in the text uses two five-liter supply containers for DA-CAPD. If the patient uses a separate supply container, for example, at work for manual changing, that supply container can alternatively hold three to four liters or less.

[0142] Regardless of whether the treatment is APD or DA-CAPD, the control unit 100 is configured to determine the amount of fluid filled in the patient by recording the instantaneous weight reduction caused by the flow of fresh PD fluid from one or more fresh PD fluid supply containers 144 to the patient. Regardless of the treatment type, the control unit 100 also determines the patient's drainage volume by recording the instantaneous weight increase caused by the flow of used PD fluid from the patient to one or more used PD fluid drainage containers 140. The control unit 100 can then determine the amount of ultrafiltration (“UF”) removed from the patient in one or both ways: i. (i) calculating the UF amount after each filling, retention, and drainage cycle (which can be displayed to the patient via display device 104a) and summing the UF amounts of each cycle after treatment to calculate the total UF removed for the treatment (which can also be displayed to the patient via display device 104a), or (ii) summing the filling and drainage amounts after each filling, retention, and drainage cycle and then subtracting the total filling amount from the total drainage amount at the end of treatment to determine the total UF removed for the treatment (which can also be displayed to the patient via display device 104a).

[0143] It should be understood that, due to the force-measuring unit configuration of machine 15 as described herein, it is irrelevant for control unit 100 whether all fluid remains in one or more fresh PD fluid supply containers 144, all fluid remains in one or more used PD fluid drainage containers 140, or the fluid is separated between the one or more supply containers 144 and the one or more drainage containers 140. Control unit 100 reads the instantaneous weight from force-measuring unit 50 regardless. The distinguishing weight factor is how much fluid is currently retained in the patient and how much UF has been removed from the patient.

[0144] It should be understood that various modifications and variations of the presently preferred embodiments described herein will be apparent to those skilled in the art. Such modifications and variations can be made without departing from the spirit and scope of the subject matter and without diminishing its intended advantages. Therefore, it is intended that such modifications and variations be covered by the appended claims.

Claims

1. A disposable kit for dialysis treatment, the disposable kit comprising: The patient tubing includes a first patient tubing connector and a second patient tubing connector, the first patient tubing connector being configured to connect to a patient's indwelling catheter, and the second patient tubing connector being configured to connect to a first port of a multi-port connector. as well as A supply line, comprising a first supply line connector and a second supply line connector, the first supply line connector being configured to connect to a PD fluid supply container, and the second supply line connector being configured to connect to a second port of the multi-port connector, wherein the second supply line connector includes a breakable portion that allows, after dialysis treatment, the supply line and the second supply line connector to remain as an auxiliary connection after the breakable portion has been disconnected, for use as a drainage line for subsequent dialysis treatments. The third port of the multi-port connector is configured to allow a supply line and auxiliary connection portion from a previous dialysis treatment to be used as a drainage line for the dialysis treatment, and wherein the auxiliary connection portion from the previous dialysis treatment is configured to be removably sealed to the third port for the dialysis treatment.

2. The disposable kit of claim 1, wherein, The multi-port connector includes a Y-connector or a T-connector.

3. The disposable kit according to claim 1 or 2, further comprising the PD fluid supply container connected to the first supply line connector, the PD fluid supply container serving as a PD fluid drainage container for the subsequent dialysis treatment.

4. The disposable kit of claim 3, wherein, The PD fluid supply container is sized relative to the amount of fresh PD fluid stored in it, so that when operating as the PD fluid drainage container, it can store the amount of ultrafiltration removed from the patient.

5. The disposable kit of any of claims 1-2, wherein, The first supply line connector of the supply line is a first first supply line connector, and wherein the supply line is divided into a first branch and a second branch, the first branch leading to the first first supply line connector that can be connected to a first PD fluid supply container, and the second branch leading to a second first supply line connector that can be connected to a second PD fluid supply container.

6. The disposable kit of claim 5, wherein, The first PD fluid supply container serves as a first PD fluid drainage container for the subsequent dialysis treatment, and the second PD fluid supply container serves as a second PD fluid drainage container for the subsequent dialysis treatment.

7. The disposable kit of claim 5, wherein, The supply line includes a common portion between the second supply line connector of the supply line and the first branch and the second branch, and the disposable kit includes a line clamp fitted to the common portion, which is closed before disconnecting the breakable portion of the second supply line connector of the supply line.

8. The disposable kit of any one of claims 1 to 2, wherein, The third port of the multiport connector includes a flange, and wherein the auxiliary connection portion includes at least one hook, the hook being sized and arranged to removably hook onto the flange of the third port when the auxiliary connection portion is removably sealed to the third port.

9. The disposable kit of any of claims 1-2, wherein, The outer diameter of the auxiliary connection portion is larger than the inner diameter of the third port of the multi-port connector, so as to removably seal the auxiliary connection portion to the third port.

10. A disposable kit for dialysis treatment, the disposable kit comprising: The patient tubing includes a first patient tubing connector and a second patient tubing connector, the first patient tubing connector being configured to connect to a patient's indwelling catheter, and the second patient tubing connector being configured to connect to a first port of a multi-port connector. as well as A supply line, comprising a first supply line connector and a second supply line connector, the first supply line connector being configured to connect to a PD fluid supply container, and the second supply line connector being configured to connect to a second port of the multi-port connector, wherein the supply line is configured to allow at least a portion of the second supply line connector and the tubing of the supply line to be used as a drainage line for subsequent dialysis treatments. The third port of the multi-port connector is configured to allow at least a portion of the tube from the supply line of the previous dialysis treatment and the second supply line connector to be used as a drainage line for the dialysis treatment, and wherein the at least a portion of the second supply line connector from the previous dialysis treatment is configured to be removably sealed to the third port.

11. The disposable kit of claim 10, wherein, The second supply line connector includes a breakable portion that allows at least a portion of the second supply line connector and the tube of the supply line to be disconnected at the breakable portion, and serves as the drainage line for the subsequent dialysis treatment.

Images