Dialysis system with disinfection unit

Abstract

A peritoneal dialysis ("PD") system includes a PD machine including a housing, a PD fluid pump housed by the housing, a plurality of PD fluid lines, and a plurality of PD fluid line connectors positioned and disposed at the housing to accept distal ends of the PD fluid lines to perform a disinfection sequence. The PD system further comprises a disinfection unit, the disinfection unit comprising: a disinfection unit housing; a PD fluid line connector positioned and arranged at the disinfection unit housing for receiving one of the PD fluid lines of the PD machine for a disinfection sequence; a line extending from the sterilization unit housing for connection to one of the PD fluid line connectors of the PD machine for sterilization of the sequence; and a sanitizing fluid pump contained by the sanitizing unit for pumping a sanitizing fluid during the sanitizing sequence.

Description

Technical Field

[0001] The present disclosure relates generally to medical fluid therapy, and particularly to dialysis fluid therapy requiring fluid heating. Background Art

[0002] Due to various reasons, a person's renal system may fail. Renal failure produces several physiological disturbances. For example, it is no longer possible to balance water and minerals or to secrete the daily metabolic load. In addition, toxic end products of metabolism, such as urea, creatinine, uric acid, etc., may accumulate in the patient's blood and tissues.

[0003] Dialysis is used to treat reduced kidney function, especially kidney failure. Dialysis removes waste products, toxins, and excess water from the body that would otherwise be removed by a normally functioning kidney. Dialysis treatment to replace kidney function is vital to many people because the treatment is life-saving.

[0004] One type of renal failure therapy is hemodialysis ("HD"), which typically uses diffusion to remove waste products from a patient's blood. A diffusion gradient occurs between the blood and an electrolyte solution (called dialysate or dialysis fluid) across a semi-permeable dialyzer to induce diffusion.

[0005] Hemofiltration ("HF") is an alternative renal replacement therapy that relies on the convective transport of toxins from the patient's blood. HF is achieved by adding replacement or substitution fluid to the extracorporeal circuit during treatment. The replacement fluid and the patient's accumulated fluid between treatments are ultrafiltered during HF treatment, providing a convective transport mechanism that is particularly beneficial in removing intermediate molecules and large molecules.

[0006] Hemodiafiltration ("HDF") is a treatment modality that combines convective and diffusive clearance. HDF uses a dialysis fluid flowing through a dialyzer, similar to standard hemodialysis, to provide diffusive clearance. In addition, a replacement solution is provided directly to the extracorporeal circuit to provide convective clearance.

[0007] Most HD, HF and HDF treatments are performed in centers. Today there is a trend toward home hemodialysis ("HHD"), in part because HHD can be performed every day, providing treatment benefits that are superior to center hemodialysis treatments, which are usually performed every 2 or 3 weeks. Studies have shown that more frequent treatments remove more toxins and wastes and cause less fluid overload between dialysis sessions than patients who receive less frequent but potentially longer treatments. Patients who receive more frequent treatments do not experience as many down cycles (fluid and toxin swings) as center patients who have accumulated toxins for two or three days before treatment. In some areas, the nearest dialysis center may be miles away from the patient's home, resulting in door-to-door treatment time consuming most of the day. Treatment at a center near the patient's home may also consume most of the patient's day. HHD can be performed during the evening or daytime when the patient is relaxing, working or otherwise productive.

[0008] Another type of renal failure therapy is peritoneal dialysis ("PD"), which infuses a dialysis solution (also called dialysis fluid) into the patient's peritoneal compartment via a catheter. The dialysis fluid contacts the peritoneum within the patient's peritoneal compartment. Waste products, toxins, and excess water flow from the patient's blood through capillaries in the peritoneum and enter the dialysis fluid due to diffusion and osmosis, i.e., an osmotic gradient occurs across the membrane. The osmotic agent in the PD dialysis fluid provides the osmotic gradient. Used or spent dialysis fluid is drained from the patient, thereby removing waste products, toxins, and excess water from the patient. This cycle is repeated, for example, multiple times.

[0009] There are various types of peritoneal dialysis therapies, including continuous flow peritoneal dialysis ("CAPD"), automated peritoneal dialysis ("APD"), tidal flow dialysis, and continuous flow peritoneal dialysis ("CFPD"). CAPD is a manual dialysis treatment. Here, the patient manually connects an implanted catheter to a drain to allow used or spent dialysis fluid to drain from the peritoneal chamber. The patient then switches the fluid connection so that the patient's catheter is connected to a bag of fresh dialysis fluid to infuse fresh dialysis fluid into the patient through the catheter. The patient disconnects the catheter from the bag of fresh dialysis fluid and allows the dialysis fluid to reside in the peritoneal chamber, where the transfer of waste, toxins, and excess water occurs. After the residence time, the patient repeats the manual dialysis procedure, for example four times a day. Manual peritoneal dialysis requires a significant amount of time and effort from the patient, leaving ample room for improvement.

[0010] Automated peritoneal dialysis ("APD") is similar to CAPD in that dialysis treatment includes a drain cycle, a fill cycle, and a dwell cycle. However, an automated PD machine typically performs the cycles automatically while the patient sleeps. A PD machine relieves the patient from having to manually perform treatment cycles and from having to transport supplies during the day. The PD machine is fluidly connected to an implanted catheter, a source or bag of fresh dialysis fluid, and a fluid drain. The PD machine pumps fresh dialysis fluid from a dialysis fluid source through the catheter and into the patient's peritoneal chamber. The PD machine also allows the dialysis fluid to dwell within the chamber and allows for the transfer of waste, toxins, and excess water. The source may include multiple liters of dialysis fluid, which includes several solution bags.

[0011] The PD machine pumps the used or spent dialysate from the patient's peritoneal cavity through the catheter to drain. As with the manual process, several drain cycles, fill cycles, and dwell cycles occur during dialysis. The "final fill" may occur at the end of APD treatment. The final fill fluid may remain in the patient's peritoneal compartment until the next treatment begins, or may be manually emptied at some point during the day.

[0012] In any of the above modes involving automated machines, component wear may become an issue. Component wear increases as components are used more frequently with higher flow or power inputs and over longer periods of time. Because automated machines provide critical treatment to their patients, it is important that the machines are as reliable as possible. When an automated machine fails in the clinic, the stress on the remaining machines increases. When an automated machine fails in a patient's home, a replacement machine needs to be quickly swapped out for the defective machine so that the patient's treatment plan is interrupted as little as possible.

[0013] For each of the above reasons, it would be desirable to provide an APD machine that reduces component wear. Summary of the invention

[0014] The present disclosure describes an automated peritoneal dialysis ("PD") system that provides one or more PD therapy improvements. The system includes a PD machine or circulation machine. The PD machine is capable of delivering fresh, heated PD fluid to a patient at a pressure of, for example, 14 kPa (2.0 psig) or higher. The PD machine is capable of removing used PD fluid or effluent from a patient at, for example, between -5 kPa (-0.73 psig) and -15 kPa (-2.2 psig), such as -9 kPa (-1.3 psig) or higher. Fresh PD fluid can be delivered to the patient via a dual-lumen patient line and first heated to body fluid temperature, such as 37°C. The heated PD fluid is then pumped through the fresh PD fluid cavity of the dual-lumen patient line to a disposable filter kit, which is connected to the patient's transfer kit, which in turn is connected to an indwelling catheter that leads to the patient's peritoneal cavity. The disposable filter kit is in fluid communication with the fresh and used PD fluid cavities of the dual-lumen patient line. In one embodiment, a disposable filter kit is provided as a last chance filter for a PD machine that can be heat sterilized between treatments.

[0015] The system may include one or more PD fluid containers or bags that supply fresh PD fluid to the PD machine or circulator. The PD machine or circulator may include internal lines with two-way or three-way valves and at least one PD fluid pump for pumping fresh PD fluid from one or more PD fluid containers or bags to the patient and for removing used PD fluid from the patient to a house drain or drain container. One or more flexible PD fluid lines lead from the PD machine or circulator internal lines to the one or more PD fluid containers or bags. The above-mentioned flexible double-lumen patient line leads from the PD machine or circulator internal lines to the patient. The flexible drain line leads from the PD machine or circulator internal lines to a house drain or drain container. In one embodiment, the system sterilizes all internal lines, PD fluid lines, and double-lumen patient lines after treatment for reuse in the next treatment.

[0016] Sterilization may involve thermal sterilization using remaining fresh PD fluid, which may be heated to a sterilization temperature of about 70°C to 90°C or higher, as described herein. In order to provide good sterilization and heat transfer to each line being sterilized, the PD fluid pump (if used) would need to be run at a relatively high pumping volume, resulting in the risk of cavitation and associated wear of pump seals. Therefore, it is contemplated that the PD fluid pump is not used at all or is not used as the primary sterilization fluid drive pump during the sterilization sequence.

[0017] The system of the present disclosure alternatively provides a disinfection unit that can be separated from the PD machine or cycler. The disinfection unit includes an additional pump that can be used in addition to or in place of the PD fluid pump during disinfection. To this end, the disinfection unit pump can be a long-lasting pump that is less accurate than the PD fluid pump, but which can operate at a higher flow rate than the PD fluid pump without causing significant wear. The disinfection unit pump can be a centrifugal pump, for example. The higher flow rate can be, for example, 200 milliliters ("ml") / min to 500 milliliters / minute (ml / min). Optionally, the disinfection unit includes a second disinfection unit inline heater that is specifically selected to heat the fluid moving at the elevated disinfection flow rate and heat the disinfection fluid to the temperature specified herein or to a potentially higher disinfection temperature, such as 90°C to 110°C.

[0018] In one embodiment, the disinfection unit includes a PD fluid line connector that accepts the distal end of any desired one of the reusable flexible PD fluid lines of a PD fluid machine or cycler. The disinfection unit also includes a flexible line that extends to an open PD fluid line connector located at the PD fluid machine or cycler. The two fluid connections to the disinfection unit enable the internal lines and fluid components of the disinfection unit to form part of the disinfection circuit of the PD machine or cycler during a disinfection sequence. The sealed connection with the PD fluid line connector and the flexible line can be made by the patient or caregiver at the time of disinfection after treatment.

[0019] Electrical controls can be implemented in the disinfection unit in a variety of different ways. When only a disinfection unit pump is provided, an on / off button or switch can be used, which the patient or caregiver can switch to "on" to start the disinfection sequence, for example after confirming that the PD machine or circulation machine has been correctly configured for disinfection. The disinfection unit may include an alternating current ("AC") plug and any electronic devices required to convert the AC voltage to the disinfection unit pump voltage when necessary. When a disinfection unit heater is also provided, an on / off switch can still be used for the patient or caregiver to actuate. However, at least one temperature sensor and a controller are also provided, which is used to use the output from the one or more temperature sensors as feedback for controlling the power to the heater so that the disinfection fluid, which can be a PD fluid, leaves the disinfection unit to the PD machine or circulation machine at the desired disinfection temperature.

[0020] When necessary, the disinfection unit may also provide one or more pressure sensors and a controller, the controller being used to use the output from the one or more pressure sensors as feedback for controlling the disinfection unit pump so that the disinfection fluid leaves the disinfection unit to the PD machine or circulation machine at the desired disinfection pressure. The temperature sensor controller and the pressure sensor controller may be part of the entire disinfection unit control unit, which may include one or more processors and one or more memories. The disinfection unit may also include a user interface, such as a single-line or multi-line light emitting diode ("LED") or a liquid crystal display ("LCD"), wherein the disinfection unit control unit may also include a video controller.

[0021] As discussed herein, the control unit of the PD machine or cycler may also include a transceiver and a wired or wireless connection to a network (not shown) (e.g., the Internet, etc.). The control unit of the disinfection unit may also include a transceiver for wirelessly communicating with the control unit of the PD machine or cycler, such as via Bluetooth or Wifi wireless technology. In one embodiment, instead of the patient or caregiver powering the disinfection unit during disinfection, the control unit of the PD machine or cycler tells the control unit of the disinfection unit when to power the disinfection unit pump and the disinfection unit heater (if provided), for example, after the control unit of the PD machine or cycler has confirmed that the patient or caregiver has made all necessary connections for the disinfection sequence. Therefore, here, the patient or caregiver can connect the disinfection unit to a PD machine or cycler as described herein, set up the PD machine or cycler for disinfection, and then be free to leave and perform other tasks.

[0022] It is also contemplated that the outputs from one or more temperature sensors and / or one or more pressure sensors of the PD machine or cycler are wirelessly transmitted to corresponding controllers of the control unit of the disinfection unit for use as feedback to control the power applied to the disinfection unit heater and / or the flow rate (or other pressure regulation parameters) of the disinfection unit pump. In this way, a disinfection fluid (e.g., PD fluid) can be delivered from the disinfection unit at a desired disinfection temperature and / or pressure without having to provide corresponding temperature and / or pressure sensors within the unit.

[0023] During sterilization, in one embodiment, the control unit of the PD machine or cycler is programmed to set the PD fluid pump, which may be a piston pump, so that the PD fluid pump is in a free flow position in which sterilizing fluid may flow through the PD fluid pump without operating the pump. In an alternative embodiment, the control unit operates the PD fluid pump at a slow or reduced speed, for example, during sterilization. Likewise, in one embodiment, the control unit of the PD machine or cycler is programmed not to supply power to the inline heater of the PD machine or cycler during sterilization if the sterilization unit is provided with its own heater. In an alternative embodiment, the control unit supplies a small amount of power to the inline heater of the PD machine or cycler during sterilization even if the sterilization unit is provided with its own heater. The control unit supplies full power to the inline heater of the PD machine or cycler during sterilization even if the sterilization unit is not provided with its own heater. Here, the inline heater of the PD machine or cycler is relied upon to heat the sterilizing fluid to the desired sterilization temperature.

[0024] After disinfection, the disinfection unit can remain connected to the PD machine or cycler until the time of the next treatment. At this time, the patient or caregiver can (i) disconnect the flexible line of the disinfection unit from the PD fluid line connector located at the PD fluid machine or cycler, (ii) disconnect the distal end of the reusable flexible PD fluid line of the PD fluid machine or cycler from the PD fluid line connector of the disinfection unit, and (iii) connect the flexible line of the disinfection unit to the PD fluid line connector of the disinfection unit. This disconnection and reconnection fluidly closes the disinfection unit and maintains it in a relatively clean and disinfected state. The disinfection unit is then ready for its next use.

[0025] Advantages of using a disinfection unit include, but are not limited to, increased flow during the disinfection sequence. It is also contemplated that the reusable valves of a PD machine or cycler will not have to be opened and closed as much because the increased flow increases surface contact efficiency. The speed of the PD fluid pump can be reduced or even stopped. The risk of cavitation within the PD fluid pump is also reduced and possibly eliminated, thereby increasing disinfection efficiency and reducing wear on the PD fluid pump. The disinfection fluid temperature can also be increased, which can reduce disinfection time.

[0026] In accordance with the disclosure set forth herein, and without limiting the present disclosure in any way, in a first aspect of the present disclosure, which may be combined with any other aspect or portion thereof, a peritoneal dialysis ("PD") system comprises: a PD machine comprising a housing, a PD fluid pump housed by the housing, a plurality of PD fluid lines, and a plurality of PD fluid line connectors positioned and arranged at the housing to receive distal ends of the PD fluid lines to perform a disinfection sequence; and a disinfection unit comprising a disinfection unit housing, a PD fluid line connector positioned and arranged at the disinfection unit housing for receiving one of the PD fluid lines of the PD machine for the disinfection sequence, a line extending from the disinfection unit housing for connection to one of the PD fluid line connectors of the PD machine for the disinfection sequence, and a disinfection fluid pump housed by the disinfection unit for pumping disinfection fluid during the disinfection sequence.

[0027] In a second aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the PD fluid pump is set to a free flow position during the disinfection sequence.

[0028] In a third aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the PD fluid pump is operated at a low speed during sterilization.

[0029] In a fourth aspect of the disclosure which may be combined with any other aspect or a portion thereof, the disinfection unit comprises a control unit configured to cause the disinfection fluid pump to pump disinfection fluid at 200 to 500 ml / min during a disinfection sequence.

[0030] In a fifth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the disinfection unit comprises at least one pressure sensor positioned and arranged to sense the pressure of the disinfection fluid during the disinfection sequence, the at least one pressure sensor having a pressure sensor output to a disinfection unit control unit, and wherein the disinfection unit control unit is configured to use the at least one pressure sensor output as feedback for operating the disinfection fluid pump so that the disinfection fluid is at a desired pressure or within a desired pressure range during the disinfection sequence.

[0031] In a sixth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the PD machine includes a PD machine control unit in data communication with a disinfection unit control unit, the PD machine also including at least one pressure sensor, the at least one pressure sensor being positioned and arranged to sense the pressure of the disinfection fluid in the PD machine during the disinfection sequence, the at least one pressure sensor having a pressure sensor output transmitted to the disinfection unit control unit via data communication, and wherein the disinfection unit control unit is configured to use the at least one pressure sensor output as feedback for operating the disinfection fluid pump so that the disinfection fluid is at a desired pressure or within a desired pressure range during the disinfection sequence.

[0032] In a seventh aspect of the present disclosure which may be combined with any other aspect or part thereof, the disinfection unit comprises a control unit and a heater under control of the disinfection unit control unit such that the disinfection fluid heater heats the disinfection fluid to 70°C to 110°C during the disinfection sequence.

[0033] In an eighth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the disinfection unit comprises at least one temperature sensor positioned and arranged to sense the temperature of the disinfection fluid during the disinfection sequence, the at least one temperature sensor having a temperature sensor output to a disinfection unit control unit, and wherein the disinfection unit control unit is configured to use the at least one temperature sensor output as feedback for operating the disinfection fluid pump so that the disinfection fluid is at a desired temperature or within a desired temperature range during the disinfection sequence.

[0034] In a ninth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the PD machine includes a PD machine control unit in data communication with a disinfection unit control unit, the PD machine also includes at least one temperature sensor, the at least one temperature sensor is positioned and arranged to sense the temperature of the disinfection fluid in the PD machine during the disinfection sequence, the at least one temperature sensor has a temperature sensor output transmitted to the disinfection unit control unit via data communication, and wherein the disinfection unit control unit is configured to use the at least one temperature sensor output as feedback for operating the disinfection fluid pump so that the disinfection fluid is at a desired temperature or in a desired temperature range during the disinfection sequence.

[0035] In a tenth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the PD machine comprises a heater, and wherein the PD machine heater is not powered during the disinfection sequence.

[0036] In an eleventh aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the PD machine includes a heater, and wherein the PD machine heater is provided with a small amount of power during the sterilization sequence.

[0037] In a twelfth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the disinfection unit comprises a switch configured such that manual actuation of the switch causes the disinfection fluid pump to start pumping the disinfection fluid.

[0038] In the thirteenth aspect of the present disclosure, which may be combined with any other aspect or part thereof, the PD machine includes a PD machine control unit, and the disinfection unit includes a disinfection unit control unit that communicates data with the PD machine control unit, and wherein the PD machine control unit is configured to automatically command the disinfection unit control unit to cause the disinfection fluid pump to start pumping the disinfection fluid.

[0039] In a fourteenth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the PD machine control unit is configured to automatically command the disinfection unit control unit to cause the disinfection fluid pump to start pumping disinfection fluid after receiving confirmation that multiple disinfection sequence steps have been completed.

[0040] In a fifteenth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, a peritoneal dialysis ("PD") system comprises: a PD machine comprising a housing, a PD fluid pump housed by the housing, a patient line in fluid communication with the PD fluid pump, a patient line connector positioned and arranged at the housing to receive a distal end of the patient line to perform a disinfection sequence, a plurality of PD fluid lines, and a plurality of PD fluid line connectors positioned and arranged at the housing to receive a distal end of the PD fluid line to perform a disinfection sequence; and a disinfection unit comprising a disinfection unit housing, a PD fluid line connector positioned and arranged at the disinfection unit housing for receiving one of the PD fluid lines of the PD machine for the disinfection sequence, a line extending from the disinfection unit housing for connection to one of the PD fluid line connectors of the PD machine for the disinfection sequence, and a disinfection fluid pump housed by the disinfection unit for pumping disinfection fluid during the disinfection sequence.

[0041] In a sixteenth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, the patient line is a dual lumen patient line comprising a fresh PD fluid lumen and a spent PD fluid lumen.

[0042] In a seventeenth aspect of the present disclosure which may be combined with any other aspect or portion thereof, at least one of the patient line, the plurality of PD fluid lines, or the line extending from the sterilization unit housing is a flexible line.

[0043] In an eighteenth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, a peritoneal dialysis ("PD") system comprises: a PD machine, the PD machine comprising a PD machine control unit, a PD fluid pump under the control of the PD machine control unit; and a disinfection unit, the disinfection unit being configured to be placed in communication with the PD machine disinfection fluid, the disinfection unit comprising a disinfection unit control unit and a disinfection fluid pump, the disinfection unit control unit being configured to be placed in data communication with the PD machine control unit, the disinfection fluid pump being under the control of the disinfection unit control unit, wherein the PD machine control unit is configured to automatically command the disinfection unit control unit to cause the disinfection fluid pump to start pumping disinfection fluid in a disinfection sequence.

[0044] In a nineteenth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the PD machine control unit is configured to automatically command the disinfection unit control unit to cause the disinfection fluid pump to start pumping disinfection fluid after receiving confirmation that multiple disinfection sequence steps have been completed.

[0045] In the twentieth aspect of the present disclosure, which may be combined with any other aspect or part thereof, in combination with the attached Figure 1 and 2 Any one or more of the features, functions and alternatives described herein may be combined with the attached Figure 1 and 2 Any features, functions and alternative combinations described in any other figures in the.

[0046]

[0013] According to the above aspects and the present disclosure set forth herein, an advantage of the present disclosure is to provide a durable peritoneal dialysis ("PD") system using sterilization wherein sterilization fluid flow and / or temperature is increased.

[0047] Another advantage of the present disclosure is to provide a durable peritoneal dialysis ("PD") system using disinfection wherein disinfection sequence efficiency is improved.

[0048] Another advantage of the present disclosure is to provide a durable peritoneal dialysis ("PD") system using sterilization wherein component wear is reduced.

[0049] Yet another advantage of the present disclosure is to provide a durable peritoneal dialysis ("PD") system using sterilization that is relatively easy to implement.

[0050] Additional features and advantages are described in and will be apparent from the following detailed description and accompanying drawings. The features and advantages described herein are not all-inclusive, and in particular, many additional features and advantages will be apparent to one of ordinary skill in the art in view of the accompanying drawings and description. Moreover, it is not necessary for any particular embodiment to have all of the improvements or advantages listed herein, and it is expressly contemplated that each advantageous embodiment is separately claimed. Furthermore, it should be noted that the language used in this specification is selected primarily for readability and instructional purposes, and does not limit the scope of the subject matter of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] Figure 1 is a fluid flow diagram of one embodiment of a medical fluid (eg, PD fluid) system in a treatment state.

[0052] Figure 2 is a fluid flow diagram of one embodiment of a medical fluid (eg, PD fluid) system in a sterilization state using the sterilization unit of the present disclosure. DETAILED DESCRIPTION

[0053] Referring now to the drawings, and in particular to Figure 1 , a medical system with enhanced disinfection of the present disclosure is illustrated via a peritoneal dialysis ("PD") system 10. The system 10 includes a PD machine or cycler 20 and a control unit 100 having one or more processors 102, one or more memories 104, a video controller 106, and a user interface 108. The user interface 108 may alternatively or additionally be a remote user interface, for example, via a tablet or smartphone. The control unit 100 may also include a transceiver and a wired or wireless connection to a network (not shown) (e.g., the Internet) for sending treatment data to a doctor's or clinician's server connected to a doctor's or clinician's computer and receiving prescription instructions / changes therefrom. The transceiver is also used to communicate with a disinfection unit 110 as discussed herein. In one embodiment, the control unit 100 controls all power fluid flow and heating components of the PD machine or cycler 20 and receives outputs from all sensors of the PD machine. The system 10 in the illustrated embodiment includes durable and reusable components that contact fresh and used PD fluids, which require that the PD machine or cycler 20 be sterilized between treatments, such as via thermal sterilization.

[0054] Figure 1The system 10 includes an inline resistive heater 56, reusable supply lines or tubes 52a1 to 52a4 and 52b, an air trap 60 working in conjunction with corresponding upper and lower sensors 62a, 62b, an air trap valve 54d, an exhaust valve 54e positioned along an exhaust line 52e, a reusable line or tubing 52c, a PD fluid pump 70, temperature sensors 58a and 58b, pressure sensors 78a, 78b1, 78b2 and 78c, reusable patient tubing or lines 52f and 52g with corresponding valves 54f and 54g, a dual lumen patient line 28, a hose reel 80 for retrieving the patient line 28, a reusable drain tubing or line 52i extending to a drain line connector 34 and having a drain line valve 54i, and reusable recirculating sterile tubing or lines 52r1 and 52r2 operating in conjunction with corresponding sterile valves 54r1 and 54r2. A third recirculation or sterilization conduit or line 52r3 extends between sterilization or PD fluid line connectors 30a and 30b for use during sterilization. A fourth recirculation or sterilization conduit or line 52r4 extends between sterilization connectors 30c and 30d for use during sterilization.

[0055] The system 10 also includes PD fluid containers or bags 38a-38c (e.g., holding the same or different formulations of PD fluid) connected to the distal ends 24e of the reusable PD fluid lines 24a-24c, respectively. The system 10d also includes a fourth PD fluid container or bag 38d connected to the distal end 24e of the reusable PD fluid line 24d. The fourth PD fluid container or bag 38d can hold the same or a different type of PD fluid (e.g., icodextrin) as the PD fluid provided in the PD fluid containers or bags 38a-38c. In one embodiment, the reusable PD fluid lines 24a-24d extend through an aperture (not shown) defined or provided by the housing 22 of the PD machine or cycler 20.

[0056] The system 10 in the illustrated embodiment includes four sterile or PD fluid line connectors 30a-30d for connecting to the distal ends 24e of the reusable PD fluid lines 24a-24d, respectively, during sterilization. The system 10 also provides a patient line connector 32 that includes an inner lumen, such as a U-shaped inner lumen, that directs fresh PD fluid from one PD fluid lumen to the other PD fluid lumen of the connected distal ends 28e of the dual lumen patient line 28 for sterilization. Reusable supply tubing or lines 52a1-52a4 are in communication with the reusable supply lines 24a-24d, respectively. The reusable supply tubing or lines 52a1-52a3 operate with valves 54a-54c, respectively, to allow PD fluid from the desired PD fluid container or bag 38a-38c to be drawn into the cycler 20. The three-way valve 94a in the example shown allows the control unit 100 to select between (i) 2.27% (or other) glucose dialysis fluid from the container or bag 38b or 38c and (ii) icodextrin from the container or bag 38d. In the embodiment shown, the icodextrin from the container or bag 38d is connected to the normally closed port of the three-way valve 94a.

[0057] In one embodiment, system 10 is configured so that drain line 52i is fluidly connected downstream of PD fluid pump 70 during a patient fill. In this way, if drain valve 54i fails or somehow leaks during a patient fill of patient P, fresh PD fluid is pushed down disposable drain line 36 rather than potentially pulling used PD fluid into pump 70. In one embodiment, disposable drain line 36 is removed for sterilization, wherein drain line connector 34 is capped via cap 34c to form a closed sterilization circuit. PD fluid pump 70 can be an inherently precise pump such as a piston pump, or a less precise pump such as a gear pump that operates in cooperation with a flow meter (not shown) to control the flow and volume of fresh and used PD fluid.

[0058] The system 10 may also include a leak detection disc 82 located at the bottom of the housing 22 of the cycler 20 and a corresponding leak detection sensor 84 that outputs to the control unit 100. In the example shown, the system 10 is provided with an additional pressure sensor 78c located upstream of the PD fluid pump 70 that allows the suction pressure of the pump 70 to be measured to help the control unit 100 determine the pump volume more accurately. The additional pressure sensor 78c in the embodiment shown is located along the exhaust line 52e, which can be filled with air or a mixture of air and PD fluid, but the exhaust line 52e should still be at the same negative pressure as the PD fluid located in the PD fluid line 52c.

[0059] Figure 1The system 10 in the example includes redundant pressure sensors 78b1 and 78b2, the output of one of the redundant pressure sensors 78b1 and 78b2 is used for pump control, while the output of the other pressure sensor is a safety or watchdog output to ensure that the control pressure sensor is accurately reading. The pressure sensors 78b1 and 78b2 are located along the pipeline including the third recirculation valve 54r3. The system 10 can also be used via Figure 1 The X marks one or more cross-pieces, which can (i) reduce the total amount and volume of internal reusable tubing, (ii) reduce the number of valves required, and (iii) allow the portion of the fluid circuit to be shared by fresh and used PD fluids to be minimized.

[0060] Figure 1 The system 10 in the example of also includes an acid source, such as a citric acid container or bag 66. The citric acid container or bag 66 is selectively fluidly connected to the second three-way valve 94b via a citric acid valve 54m located along the citric acid line 52m. In one embodiment, the citric acid line 52m is connected to the normally closed port of the second three-way valve 94b to provide a redundant valve between the citric acid container or bag 66 and the PD fluid circuit during treatment. The redundant valve ensures that no citric acid (or other) reaches the treatment fluid line during treatment. Citric acid (or other acid) is used instead during disinfection.

[0061] In one embodiment, control unit 100 uses feedback from any one or more of pressure sensors 78a-78c to enable PD machine 20 to deliver fresh, heated PD fluid to the patient at a pressure of, for example, 14 kPa (2.0 psig) or higher. Pressure feedback is used to enable PD machine 20 to remove spent PD fluid or effluent from the patient at, for example, between -5 kPa (-0.73 psig) and -15 kPa (-2.2 psig), such as -9 kPa (-1.3 psig) or higher (more negative). Pressure feedback can be used in a proportional, integral, derivative ("PID") pressure routine for pumping fresh and spent PD fluid at a desired positive or negative pressure.

[0062] The inline resistive heater 56 under the control of the control unit 100 is capable of heating the fresh PD fluid to body temperature, e.g., 37° C., for delivery to the patient P at a desired flow rate. In one embodiment, the control unit 100 uses feedback from the temperature sensor 58 a in a PID temperature routine for pumping fresh PD fluid to the patient P at a desired temperature.

[0063] Figure 1The system 10 is also shown to include and use a disposable filter kit 40, which is in fluid communication with the fresh PD fluid lumen and the used PD fluid lumen of the dual lumen patient line 28. The disposable filter kit 40 includes a disposable connector 42, which is connected to the distal end 28e of the reusable patient line 28. The disposable filter kit 40 also includes a connector 44 that is connected to the patient's transfer kit. The disposable filter kit 40 also includes a hydrophilic filter membrane 46, which can be a sterilizing grade filter that further filters the fresh PD fluid. In one embodiment, the disposable filter kit 40 is provided as a last chance filter for the PD machine 20, which has been heat sterilized between treatments. Any pathogens that may remain after sterilization (although unlikely) are filtered from the PD fluid via the hydrophilic filter membrane 46 of the disposable filter kit 40.

[0064] Figure 1 The arrangement of the system 10 for treatment via PD fluid containers or bags 38a to 38d connected by reusable flexible PD fluid lines 24a to 24d, respectively, is shown. The dual lumen patient line 28 is connected to the patient P via a disposable filter kit 40. The disposable drain line 36 is connected to the drain line connector 34. Figure 1 In the embodiment of the present invention, the PD machine or cycler 20 of the system 10 is configured to perform a plurality of patient drain, patient fill, patient dwell and priming procedures as part of a treatment or in preparation for performing a treatment.

[0065] Figure 2 The system 10 is shown in a sterilization mode. Three of the four PD fluid containers or bags 38a-38d are removed and the corresponding flexible PD fluid lines 24a-24d are instead inserted in a sealing manner into the corresponding sterilization or PD fluid line connectors 30a-30d, respectively. The reusable dual lumen patient line 28 is disconnected from the disposable filter kit 40 (which is discarded) and the distal end 28e of the dual lumen patient line 28 is sealingly inserted into the patient line connector 32. The disposable drain line 36 is removed from the drain line connector 34 and discarded. The drain line connector 34 is capped via the cap 34c to form a closed sterilization circuit 90. Figure 2 The PD machine or cycler 20 of the system 10 in is configured to perform a sterilization sequence, such as a thermal sterilization sequence, in which fresh PD fluid is heated to a sterilization temperature, such as 70° C. to 90° C. or higher, as discussed herein. The heated PD fluid is circulated within a closed sterilization loop 90, and the circulation continues for the amount of time required to properly sterilize the fluid components and lines of the sterilization loop.

[0066] In order to provide good sterilization and heat transfer to each of the sterilized lines, the PD fluid pump 70 (if used as the primary sterilization sequence pump) would need to be operated at a relatively high pumping rate, resulting in the risk of cavitation and associated wear of the pump seals. Therefore, it is contemplated that the PD fluid pump 70 is not used at all or is not used as the primary sterilization fluid drive pump during the sterilization sequence.

[0067] Figure 2 The system 10 of the present disclosure is shown to alternatively provide a disinfection unit 110 that can be separate from the PD machine or cycler 20. The disinfection unit 110 includes a disinfection unit housing 112 that holds an additional pump 114 that can be used in addition to or in place of the PD fluid pump 70 during disinfection. To this end, the disinfection unit pump 114 can be a long-lasting pump that is less accurate than the PD fluid pump 70, but which can operate at a higher flow rate than the PD fluid pump 70 without causing significant wear. The disinfection unit pump 114 can be, for example, a centrifugal pump. The higher flow rate can be, for example, 200 milliliters ("ml") / min to 500 ml / min. Figure 2 Also shown, the disinfection unit 110 optionally includes a second disinfection unit inline heater 116 located within the disinfection unit housing 112, which is specifically selected to heat the fluid moving at an elevated disinfection flow rate and heat the disinfection fluid to the temperatures specified herein or possibly higher disinfection temperatures, such as 90°C to 110°C.

[0068] In one embodiment, the disinfection unit 110 includes a PD fluid line connector 118 at the disinfection unit housing 112, which receives the distal end 24e of any desired one of the reusable flexible PD fluid lines 24a to 24d of the PD fluid machine or circulation machine 20. In the illustrated embodiment, the PD fluid line connector 118 receives the distal end 24e of the reusable flexible PD fluid line 24a. The disinfection unit 110 also includes a flexible line 120 extending from the disinfection unit housing 112 to an open PD fluid line connector 30a to 30d located at the PD fluid machine or circulation machine 20. In the illustrated embodiment, the flexible line 120 is connected to the PD fluid line connector 30a. The two fluid connections to the disinfection unit 110 enable the internal lines and fluid components of the disinfection unit to form part of the disinfection circuit 90 of the PD machine or circulation machine during the disinfection sequence. The sealed connection to the PD fluid line connector 118 and the flexible line 120 can be made by the patient or caregiver at the time of disinfection after treatment.

[0069] Power control can be implemented in the disinfection unit 110 in a variety of different ways. If only a disinfection unit pump 114 is provided, an on / off button or switch 122 can be provided at the disinfection unit housing 112, which the patient or caregiver can switch to "on" to initiate the disinfection sequence. The disinfection unit 110 includes an alternating current ("AC") plug 124 at the disinfection unit housing 112 and any electronics (within the housing 112) required to convert the AC voltage to the disinfection unit pump voltage, as necessary. If a disinfection unit heater 116 is also provided, an on / off switch 122 can still be provided for the patient or caregiver, however, at least one temperature sensor 126 and a disinfection unit control unit 130 for using the output from the one or more temperature sensors 126 as feedback for controlling power to the inline heater 116 are provided so that the disinfection fluid, which may be a PD fluid, leaves the disinfection unit 110 to the PD machine or cycler 20 at a desired disinfection temperature or within a desired temperature range.

[0070] When necessary, the disinfection unit 110 may also include one or more pressure sensors 128. The disinfection unit control unit 130 uses the output from the one or more pressure sensors 128 as feedback for controlling the disinfection unit pump 114 so that the disinfection fluid leaves the disinfection unit at a desired disinfection pressure or within a desired pressure range to reach the PD machine or circulation machine. The disinfection unit control unit 130 in the illustrated embodiment may be housed within the disinfection unit housing 112 and include one or more processors 132 and one or more memories 134. The disinfection unit control unit 130 may also include a user interface 136, such as a single-line or multi-line light emitting diode ("LED") or a liquid crystal display ("LCD"), wherein the control unit may also include a video controller.

[0071] As discussed herein, the control unit 100 of the PD machine or cycler 20 may also include a transceiver and a wired or wireless connection to a network (not shown) (e.g., the Internet, etc.), etc. The control unit 130 of the disinfection unit 110 may also include a transceiver for wirelessly communicating with the control unit 100 of the PD machine or cycler 20, such as via Bluetooth or Wifi wireless technology. Alternatively or additionally, the control unit 130 may be arranged to communicate with the control unit 100 by wire, such as via an Ethernet cable. In one embodiment, instead of the patient or caregiver powering the disinfection unit 110 during disinfection, the control unit 100 of the PD machine or cycler 20 informs the control unit 130 of the disinfection unit 110 when to power the disinfection unit pump 114 and the disinfection unit heater 116 (if provided), for example, after the control unit 100 of the PD machine or cycler 20 has confirmed that the patient or caregiver has made all necessary connections for the disinfection sequence. Here the patient or caregiver can accordingly connect the disinfection unit 110 to a PD machine or cycler 20 as described herein, make all other necessary disinfection connections, and then be free to walk away and perform other tasks.

[0072] It is also contemplated that the outputs from one or more temperature sensors 58a, 58b and / or one or more pressure sensors 78a, 78b1, 78b2, 78c of the PD machine or cycler 20 are wirelessly transmitted to the control unit 130 of the disinfection unit 110 for use as feedback to control the power applied to the disinfection unit heater 116 and / or the flow rate (or other pressure regulation parameters) of the disinfection unit pump 114, respectively. In this way, a disinfection fluid (e.g., PD fluid) can be delivered from the disinfection unit 110 at a desired disinfection temperature and / or pressure without having to provide corresponding temperature and / or pressure sensors within the disinfection unit.

[0073] During sterilization, in one embodiment, the control unit 100 of the PD machine or cycler 20 is programmed to set the PD fluid pump 70, which may be a piston pump, so that the PD fluid pump 70 is in a free-flow position where sterilization fluid can flow through the PD fluid pump without operating the pump. In an alternative embodiment, the control unit 100 operates the PD fluid pump 70 at a slow or reduced speed during sterilization. Likewise, in one embodiment, if the sterilization unit 110 is provided with its own heater 58, the control unit 100 of the PD machine or cycler 20 is programmed not to provide power to the inline heater 58 of the PD machine or cycler 20 during sterilization. In an alternative embodiment, even if the sterilization unit 110 is provided with its own heater 116, the control unit 100 provides a small amount of power to the inline heater 58 of the PD machine or cycler 20 during sterilization. If the sterilization unit 110 is not provided with its own heater, the control unit 100 may provide full power to the inline heater 58 of the PD machine or cycler 20 during sterilization. Here, the inline heater 58 of the PD machine or cycler 20 is relied upon to heat the sterilization fluid to the desired sterilization temperature.

[0074] After disinfection, the disinfection unit 110 can remain connected to the PD machine or cycler 20 until the next treatment. At this time, the patient or caregiver can (i) disconnect the flexible line 120 of the disinfection unit from the PD fluid line connector (e.g., connector 30a) located at the PD fluid machine or cycler 20, (ii) disconnect the distal end 28e of the reusable flexible PD fluid line (e.g., line 24a) of the PD fluid machine or cycler 20 from the PD fluid line connector 118 of the disinfection unit 110, and (iii) connect the flexible line 120 of the disinfection unit to the PD fluid line connector 118 of the disinfection unit. This disconnection and reconnection fluidly closes the disinfection unit 110 and maintains it in a relatively clean and disinfected state. The disinfection unit 110 is then ready for its next use.

[0075] It is contemplated that the disinfection unit 110 is relatively small, lightweight, and easily transported to and from the PD machine or cycler 20 as desired (or may be kept close to the PD machine or cycler 20) if desired. Therefore, the housing 112 may be provided with a handle for carrying the disinfection unit 110. The housing 112 may also be provided with feet for placing the disinfection unit 110 next to the PD machine or cycler 20. The housing 112 may also be provided with wheels or casters if desired.

[0076] It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Therefore, such changes and modifications are intended to be covered by the appended claims. For example, although the disinfection unit 110 has been described herein as a unit separate from the PD machine or cycler 20, some or all of the components of the disinfection unit 110 may be integrated into the PD machine or cycler 20 or encapsulated in a housing that is merged with the housing 22 of the PD machine or cycler 20.

Claims

1. A peritoneal dialysis ("PD") system comprising: A PD machine, the PD machine comprising: case, a PD fluid pump housed by the housing, Multiple PD fluid lines, and a plurality of PD fluid line connectors positioned and arranged at the housing to receive distal ends of the PD fluid lines to perform a sterilization sequence; and A disinfection unit, comprising: Disinfection unit housing, a PD fluid line connector positioned and arranged at the disinfection unit housing for receiving one of the PD fluid lines of the PD machine for use in the disinfection sequence, a line extending from the disinfection unit housing for connection to one of the PD fluid line connectors of the PD machine for use in the disinfection sequence, and A sterilization fluid pump is housed by the sterilization unit for pumping sterilization fluid during the sterilization sequence.

2. The PD system according to claim 1, wherein: The PD fluid pump is set to a free flow position during the disinfection sequence.

3. The PD system according to claim 1, wherein: The PD fluid pump is operated at a low speed during sterilization.

4. The PD system according to claim 1, wherein: The disinfection unit comprises a control unit configured to cause the disinfection fluid pump to pump the disinfection fluid at 200 ml / min to 500 ml / min during the disinfection sequence.

5. The PD system according to claim 4, wherein: The disinfection unit comprises at least one pressure sensor positioned and arranged to sense the pressure of the disinfection fluid during the disinfection sequence, the at least one pressure sensor having a pressure sensor output to the disinfection unit control unit, and wherein the disinfection unit control unit is configured to use the at least one pressure sensor output as feedback for operating the disinfection fluid pump so that the disinfection fluid is at a desired pressure or within a desired pressure range during the disinfection sequence.

6. The PD system according to claim 4, wherein: The PD machine includes a PD machine control unit that communicates data with the disinfection unit control unit, and the PD machine also includes at least one pressure sensor, which is positioned and arranged to sense the pressure of the disinfection fluid in the PD machine during the disinfection sequence, and the at least one pressure sensor has a pressure sensor output transmitted to the disinfection unit control unit via data communication, and wherein the disinfection unit control unit is configured to use the at least one pressure sensor output as feedback for operating the disinfection fluid pump so that the disinfection fluid is at a desired pressure or within a desired pressure range during the disinfection sequence.

7. The PD system according to claim 1, wherein: The disinfection unit comprises a control unit and a heater, the heater being controlled by the disinfection unit control unit such that the disinfection fluid heater heats the disinfection fluid to 70° C. to 110° C. during the disinfection sequence.

8. The PD system according to claim 7, wherein: The disinfection unit comprises at least one temperature sensor positioned and arranged to sense the temperature of the disinfection fluid during the disinfection sequence, the at least one temperature sensor having a temperature sensor output to the disinfection unit control unit, and wherein the disinfection unit control unit is configured to use the at least one temperature sensor output as feedback for operating the disinfection fluid pump so that the disinfection fluid is at a desired temperature or within a desired temperature range during the disinfection sequence.

9. The PD system according to claim 7, wherein: The PD machine includes a PD machine control unit that communicates data with the disinfection unit control unit, and the PD machine also includes at least one temperature sensor, which is positioned and arranged to sense the temperature of the disinfection fluid in the PD machine during the disinfection sequence. The at least one temperature sensor has a temperature sensor output transmitted to the disinfection unit control unit via data communication, and wherein the disinfection unit control unit is configured to use the at least one temperature sensor output as feedback for operating the disinfection fluid pump so that the disinfection fluid is at a desired temperature or in a desired temperature range during the disinfection sequence.

10. The PD system according to claim 7, wherein: The PD machine includes a heater, and wherein the heater of the PD machine is not powered during the disinfection sequence.

11. The PD system according to claim 7, wherein: The PD machine includes a heater, and wherein the heater of the PD machine is provided with a small amount of power during the disinfection sequence.

12. The PD system according to claim 1, wherein: The disinfection unit includes a switch configured such that manual actuation of the switch causes the disinfection fluid pump to begin pumping the disinfection fluid.

13. The PD system according to claim 1, wherein: The PD machine includes a PD machine control unit, and the disinfection unit includes a disinfection unit control unit in data communication with the PD machine control unit, and wherein the PD machine control unit is configured to automatically command the disinfection unit control unit to cause the disinfection fluid pump to start pumping the disinfection fluid.

14. The PD system according to claim 13, wherein: The PD machine control unit is configured to automatically command the disinfection unit control unit to cause the disinfection fluid pump to start pumping the disinfection fluid after receiving confirmation that a plurality of disinfection sequence steps have been completed.

15. A peritoneal dialysis ("PD") system comprising: A PD machine, the PD machine comprising: case, a PD fluid pump housed by the housing, a patient line in fluid communication with the PD fluid pump, a patient line connector positioned and arranged at the housing to receive a distal end of the patient line to perform a disinfection sequence, Multiple PD fluid lines, and a plurality of PD fluid line connectors positioned and arranged at the housing to receive distal ends of the PD fluid lines to perform the disinfection sequence; and A disinfection unit, comprising: Disinfection unit housing, a PD fluid line connector positioned and arranged at the disinfection unit housing for receiving one of the PD fluid lines of the PD machine for use in the disinfection sequence, a line extending from the disinfection unit housing for connection to one of the PD fluid line connectors of the PD machine for use in the disinfection sequence, and A sterilization fluid pump is housed by the sterilization unit for pumping sterilization fluid during the sterilization sequence.

16. The PD system according to claim 15, wherein: The patient line is a dual lumen patient line including a fresh PD fluid lumen and a spent PD fluid lumen.

17. The PD system according to claim 15, wherein: At least one of the patient line, the plurality of PD fluid lines, or the line extending from the sterilization unit housing is a flexible line.

18. A peritoneal dialysis ("PD") system comprising: A PD machine, the PD machine comprising: PD machine control unit, a PD fluid pump controlled by the PD machine control unit; and A disinfection unit, the disinfection unit being configured to be placed in communication with the PD machine disinfection fluid, the disinfection unit comprising: a disinfection unit control unit configured to be placed in data communication with the PD machine control unit, and a sterilizing fluid pump controlled by the sterilizing unit control unit, Wherein, the PD machine control unit is configured to automatically command the disinfection unit control unit to enable the disinfection fluid pump to start pumping disinfection fluid during the disinfection sequence.

19. The PD system according to claim 18, wherein: The PD machine control unit is configured to automatically command the disinfection unit control unit to cause the disinfection fluid pump to start pumping the disinfection fluid after receiving confirmation that a plurality of disinfection sequence steps have been completed.

20. The PD system according to claim 18, wherein: The disinfection unit includes a switch configured such that actuation of the switch causes the disinfection fluid pump to begin pumping the disinfection fluid.

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