Dialysis system with improved features including drip prevention

Abstract

A peritoneal dialysis (「PD」) system includes a housing, a PD fluid pump housed in the housing, and a reusable patient line extending from the housing. The reusable patient line includes a distal end configured to be connected to a patient line connector provided by the housing. The PD system also includes at least one reusable PD fluid line extending from the housing, and the at least one reusable PD fluid line includes a distal end configured to be connected to a PD fluid line connector provided by the housing. The PD system further includes a control unit configured to apply a negative pressure to at least one of the reusable patient line or the at least one reusable PD fluid line when each is connected to the patient line connector or the PD fluid line connector, respectively, of the PD fluid pump.

Description

Technical Field

[0001] Technical Field The present disclosure generally relates to medical fluid treatment, and more particularly to dialysis fluid treatment that requires fluid heating.

Background Art

[0002] Background Due to various causes, a person's renal system may cease to function. Renal insufficiency results in several physiological impairments. For example, it becomes impossible to balance water and minerals or to excrete the daily metabolic load. Furthermore, toxic end products of metabolism such as urea, creatinine, and uric acid can accumulate in the patient's blood and tissues.

[0003] Reduced kidney function, especially renal insufficiency, is treated by dialysis. Dialysis removes waste products, toxins, and excess water from the body that a normally functioning kidney would normally remove. Dialysis treatment for kidney replacement is a life-saving treatment and is therefore very important for many people.

[0004] One type of renal insufficiency therapy is hemodialysis ("HD"), which generally uses diffusion to remove waste products from the patient's blood. A diffusion gradient is created across a semipermeable dialyzer between the blood and an electrolyte solution called the dialysate or dialysis fluid, causing diffusion.

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

[0006] Hemodiafiltration (HDF) is a treatment method that combines convective clearance and diffusive clearance. Similar to standard hemodialysis, HDF provides diffusive clearance using dialysate flowing through a dialyzer. Additionally, a substitution solution is directly supplied to the extracorporeal circuit, thereby providing convective clearance.

[0007] Most HD, HF, and HDF treatments are performed in treatment centers. Currently, there is a trend towards home hemodialysis ("HHD"), partly because HHD can be performed daily and generally offers therapeutic benefits superior to in-facility hemodialysis treatments that are usually performed two or three times a week. Studies have shown that more frequent treatments remove more toxins and waste products than patients receiving less frequent but perhaps longer treatments, and there is less fluid overload between dialysis sessions. Patients receiving more frequent treatments do not experience the same downcycles (fluctuations in body fluid and toxins) as in-facility patients who accumulate two or three days' worth of toxins before treatment. In certain regions, the nearest dialysis facility may be miles away from the patient's home, consuming most of a day in door-to-door treatment time. Treatments at a facility close to the patient's home can also consume most of the patient's day. HHD is performed at night or during the day while the patient is relaxed, at work, or engaged in other productive activities.

[0008] Another type of kidney failure therapy is peritoneal dialysis ("PD"), where a dialysis solution, also called dialysate, is injected into the patient's peritoneal cavity through a catheter. The dialysate comes into contact with the peritoneum within the patient's peritoneal cavity. Waste products, toxins, and excess water enter the dialysate from the patient's bloodstream through the peritoneal capillaries by diffusion and osmosis, i.e., an osmotic pressure gradient across the membrane is created. Osmotic substances in the PD dialysate provide the osmotic pressure gradient. The used or spent dialysate is drained from the patient, removing waste products, toxins, and excess water from the patient. This cycle is repeated multiple times, for example.

[0009] There are various types of peritoneal dialysis therapy, including continuous ambulatory peritoneal dialysis ("CAPD"), automated peritoneal dialysis ("APD"), tidal flow dialysis, and continuous flow peritoneal dialysis ("CFPD"). CAPD is a manual dialysis procedure. Here, the patient manually connects an implanted catheter to the drain to enable the drained or spent dialysis fluid to be removed from the peritoneal cavity. Next, the patient switches the fluid communication so that the patient catheter communicates with a bag of unused dialysis fluid and injects the unused dialysis fluid into the patient through the catheter. The patient disconnects the catheter from the bag of unused dialysis fluid, allowing the dialysis fluid to remain in the peritoneal cavity, and the transfer of excreta, toxins, and excess water takes place. After the dwell period, 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, and there is still plenty of room for improvement.

[0010] Automated peritoneal dialysis ("APD") is similar to CAPD in that the dialysis procedure involves drain, fill, and dwell cycles. However, an automated PD device typically performs these cycles automatically while the patient is asleep. The PD device liberates the patient from the need to perform the treatment cycles manually and the need to transport supplies during the day. The PD device makes fluid connections to an implanted catheter, a source or bag of unused dialysis fluid, and a fluid drain. The PD device pumps unused dialysis fluid from the dialysis fluid source through the catheter into the patient's peritoneal cavity. The PD device also enables the dialysis fluid to dwell in the cavity and the transfer of waste products, toxins, and excess water to occur. The source may contain several liters of dialysis fluid in multiple solution bags.

[0011] The PD device pumps the used or spent dialysate from the patient's peritoneal cavity and discharges it through the catheter. Similar to the manual process, several drain, fill, and dwell cycles are performed during dialysis. A "last fill" may be performed at the end of an APD treatment. The last fill fluid may remain in the patient's peritoneal cavity until the start of the next treatment, or it may be emptied manually at some point during the day.

[0012] Any of the above modalities that use pre-sterilized (e.g., bagged) dialysate carry a risk of dripping when connecting the bag in fluid communication for treatment. Another problem with pre-sterilized bagged dialysate is that the bag may have residual or remaining PD fluid after treatment, and the patient or caregiver must either transport and discard it or wait for the residual or remaining PD fluid to be delivered to the drain. A further problem with PD treatment is that the patient may disconnect the transfer set from the patient line so that, for example, during patient stay, the patient can move to another room and do work. If the patient does not notify the PD device in some form that the patient has been disconnected from the patient line and the patient stay ends, the PD device will attempt to drain from the absent patient, thereby causing problems such as drawing air into the fluid circuit or causing inaccuracies in the drainage volume.

[0013] Accordingly, there is a need for an improved dialysis system, such as a PD system, that addresses any one or more or all of the above problems. Summary of the Invention Means for Solving the Problems

[0014] Summary The present disclosure describes an automated peritoneal dialysis (“PD”) system that provides one or more PD treatment improvements. The system includes a PD device or cycler. The PD device can deliver unused heated PD fluid to a patient, for example, at 14 kPa (2.0 psig) or more. The PD device can remove used PD fluid or drainage from the patient, for example, at -5 kPa (-0.73 psig) to -15 kPa (-2.2 psig), for example, at -9 kPa (-1.3 psig) or more. The unused PD fluid can be delivered to the patient through a double-lumen patient line and is first heated to body fluid temperature, for example, 37°C. The heated PD fluid is then pumped through the unused PD fluid lumen of the double-lumen patient line to a disposable filter set, which is connected to the patient transfer set and then to an indwelling catheter that communicates with the patient's peritoneal cavity. The disposable filter set is in fluid communication with the unused PD fluid lumen and the used PD fluid lumen of the double-lumen patient line. The disposable filter set, in one embodiment, is provided as a final opportunity filter for the PD device and may be heat sterilized between treatments.

[0015] The system may include one or more PD fluid containers or bags that supply unused PD fluid to the PD device or cycler. The PD device or cycler may include an internal line having a two-way or three-way valve and at least one PD fluid pump for pumping unused PD fluid from one or more PD fluid containers or bags to the patient and removing used PD fluid from the patient to a house drain or drain container. One or more flexible PD fluid lines communicate from the internal line of the PD device or cycler to one or more PD fluid containers or bags. The flexible double-lumen patient line described above communicates from the internal line of the PD device or cycler to the patient. The flexible drain line communicates from the internal line of the PD device or cycler to a house drain or drain container. The system in one embodiment disinfects all internal lines, PD fluid lines, and double-lumen patient lines after treatment for reuse in the next treatment. The disinfection may include heat disinfection using the remaining unused PD fluid.

[0016] In one embodiment, it may be considered to leave the disinfectant solution in the PD device or the cycler until the following procedure. Therefore, the flexible PD fluid line and the double-lumen patient line are wet when disconnected from the PD device or the cycler. When a new procedure starts and the patient or caregiver removes the PD fluid line and the patient line from their docking connectors on the PD device, there is a risk of fluid leakage from the distal end of the line before (i) reconnecting the PD fluid line to a new PD fluid container or bag, and (ii) reconnecting the patient line to a new disposable filter set.

[0017] To prevent dripping or leakage, in one embodiment, the control unit of the PD device or the cycler opens an appropriate valve and is configured to apply a negative pressure to the PD fluid pump, the PD fluid line, and the double-lumen patient line before the patient or caregiver removes any of those lines during the treatment setting. Due to the negative pressure, the flexible line under negative pressure collapses slightly. In this way, when the patient or caregiver removes these lines for treatment setting, the flexible fluid line expands and a small amount of air is sucked into the end of the line, preventing leakage or dripping.

[0018] For a double lumen patient line, it is conceivable to program the control unit to place one or both of the unused lumen and the used lumen under negative pressure by opening at least one valve and operating the PD fluid pump. When the negative pressure reaches a desired or set negative pressure, for example, between -5 kPa (-0.73 psig) and -15 kPa (-2.2 psig), for example -9 kPa (-1.3 psig), the control unit closes at least one valve and stops the PD fluid pump. Closing at least one unused PD fluid valve locks the applied negative pressure in the unused PD fluid and / or the used PD fluid in the double lumen patient line (assuming no leakage). The locked negative pressure waits for the patient or caregiver to remove the patient line from the PD device or cycler during the treatment setting. For each of the PD fluid lines, the same procedure is carried out, for example, by using the same PD fluid pump but opening and closing different valves specific to the PD fluid line.

[0019] During the treatment setting, it is conceivable for the control unit to prompt the patient, either auditorily, visually, or audiovisually, via the user interface, to (i) wait to remove either the patient line or the PD fluid line until the system is ready (until the flexible line is placed under negative pressure), and / or (ii) make the patient aware that the system is ready for the treatment setting with either the patient line or the PD fluid line removed (e.g., the flexible line is placed under negative pressure). In this way, the patient or caregiver is guided to have the setting executed in a state where leakage and dripping are likely to be prevented.

[0020] The negative pressure described above enables the flexible line to be horizontally connected to the PD device or cycler. Next, the patient or caregiver may first pull the flexible line horizontally from each connector and then tilt the distal end of the flexible line vertically upward so that the disinfectant solution fits within the distal end. Removal of the flexible line under negative pressure inflates the line, draws air into the distal end, and prevents leakage while the patient or caregiver removes the distal end and tilts it upward. The distal end may then be connected and sealed to a new PD solution container or bag (PD solution line) and a new disposable filter set (patient line) without leakage or dripping of the disinfectant solution, such as the PD solution.

[0021] A second PD treatment improvement feature of the present disclosure may be provided instead of or in addition to the drip prevention feature and includes a feature of emptying the PD solution container or bag, which helps reduce the weight and mess associated with the removal and disposal of disposable items after treatment. Residual or remaining PD solution may remain in one or more or all of the PD solution containers or bags at the end of the treatment, and the likelihood is often high. The volume of the patient fill for the PD treatment is typically determined via the patient's prescription, and the prescription sheet sets the volume of unused PD solution to be delivered to the patient for each patient fill. The volume of the patient fill, e.g., 1.5 to 2 liters, is typically smaller than the volume of the PD solution container or bag, e.g., 2 liters. Based on these volumes, some unused PD solution tends to remain in the container or bag. Usually, the patient or caregiver must wait while the residual PD solution is drained after the treatment, or stop the drainage and transport the bag with the residual solution for disposal. The residual solution adds weight, potential leakage, and mess to the disposal of the bag.

[0022] To help reduce problems associated with the remaining fluid after treatment, the control unit of the PD device or cycler of the present disclosure is configured, in one embodiment, to remove residual PD fluid from the PD fluid container or bag during one or more patient dwells. During patient dwell, the PD cycler is typically inactive. On the other hand, the PD device or cycler of the present disclosure utilizes the sufficient time provided during one or more patient dwells to drain (to the house drain or drain container) from the PD fluid container or bag such that at the end of the treatment, the PD fluid container or bag is empty or as empty as possible. In this way, the patient or caregiver can more easily dispose of a lighter and cleaner PD fluid container than if the bag had contained residual PD fluid. However, here, the patient does not need to wait after treatment and can dispose of the PD fluid container or bag immediately after the end of the treatment.

[0023] In one embodiment, the control unit waits for the final patient dwell to remove any residual PD fluid from either the PD fluid container or bag. During the final patient dwell, the control unit opens or switches appropriate valves at different times to draw residual PD fluid from the desired PD fluid container or bag via the PD fluid pump. During each period of a different bag drainage sequence, the control unit also opens one or more drain valves such that the PD fluid pump can pump residual PD fluid from one of the PD fluid containers or bags. In an alternative embodiment, the control unit uses each patient dwell of the treatment, or at least one intermediate patient dwell, to remove any residual PD fluid from the most recently used PD fluid container or bag.

[0024] One or more of the PD fluid containers or bags can also hold unused PD fluid for two or more patient fill volumes. The control unit in one embodiment knows the volume of each PD fluid container or bag and is configured to wait until the PD fluid container or bag is almost completely empty and patient dwell occurs before attempting to completely drain any remaining PD fluid to the drain. For this purpose, the control unit in one embodiment also knows how much unused PD fluid has been drained from each of the PD fluid containers or bags during the course of the treatment.

[0025] In various embodiments, one of the PD fluid containers or bags may hold icodextrin formulated to be delivered to the patient at the end of the treatment as the last fill. The icodextrin remains in the patient's body until the next night treatment or until an intermediate exchange such as a daytime exchange. Since the last fill of icodextrin is the last step performed by the PD device or cycler for the treatment, there is no subsequent patient dwell. Here, the control unit may be configured to attempt to pump as much icodextrin as possible into the patient during the last fill. The control unit may then pump any remaining residual icodextrin remaining at the end of the last fill to the drain. Alternatively, the patient or caregiver may stop the PD device or cycler at the end of the treatment and transport the PD fluid container or bag with any residual icodextrin (however, all other containers or bags are empty or substantially empty) for disposal.

[0026] The third PD treatment improvement feature of the present disclosure may be provided instead of, or in addition to, one or both of the drip prevention feature and the feature of emptying the bag, and includes confirming that the patient is connected to the patient line before starting a new patient drain. A patient during patient dwell may be disconnected from the double-lumen patient line, for example, by disconnecting the patient transfer set from the disposable filter set described herein. The user interface may provide a button or input device that enables the patient to notify the PD device or the control unit of the cycler that the patient is disconnected from the machine. However, even if such an input device is provided, the patient may forget to press or activate the input device. In an alternative embodiment, such an input device is not provided and the patient is to reconnect to the double-lumen patient line before the start of the next patient drain.

[0027] In any of the scenarios described above, when the next patient drain is started, the patient may not be present and not connected to the double-lumen patient line. In that case, and if a patient disconnected from the PD device or cycler connects the distal end of the double-lumen patient line to the patient line connector in the device, the negative pressure applied by the PD fluid pump during the subsequent patient drain will result in a negative pressure spike or increase because the negative pressure extends to the closed unused PD fluid side of the fluid line within the PD device or cycler. Instead, if a patient disconnected from the PD device or cycler leaves (hangs) the double-lumen patient line, air will be drawn into the used PD fluid lumen of the double-lumen patient line by the negative pressure applied by the PD fluid pump during the subsequent patient drain.

[0028] To prevent any of the above situations from occurring, the control unit of the PD device or cycler of the present disclosure may cause a small amount of unused PD fluid (which may be heated) to be pumped towards the patient along the double-lumen patient line by the PD fluid pump. The small amount of unused PD fluid to be pumped may be on the order of 1 to 10, for example, 5 milliliters ("ml"), and may be pumped into the unused PD fluid lumen if a double-lumen patient line is used. Alternatively or additionally, the next treatment procedure is patient drainage, and since only a small amount of PD fluid is pumped, the control unit may cause a small amount of used PD fluid to be pumped into the used PD fluid lumen of the double-lumen patient line.

[0029] When a small amount of unused / used PD fluid is pushed towards the patient, if the patient is properly connected to the disposable filter set and the double-lumen patient line, the output from one or more pressure sensors to the control unit indicates the characteristic that the patient is properly connected. The output may be the same as or similar to the output sensed during patient filling, for example. When it is determined that the output from one or more pressure sensors indicates the characteristic that the patient is properly connected for treatment, the control unit 100 initiates the next patient drainage.

[0030] When a small amount of unused / used PD fluid is being pushed out towards the patient, if the patient is not properly connected to the disposable filter set and the double-lumen patient line, and when the distal end of the double-lumen patient line is placed and connected to the patient line connector in the device, the output from one or more pressure sensors to the control unit shows a positive pressure increase characteristic of the distal end of the double-lumen patient line being connected to the patient line connector. Here, the small amount of unused / used PD fluid added to the double-lumen patient line and the internal PD fluid line of the PD device or cycler causes a characteristic positive pressure increase because additional fluid is being pushed into the closed internal lines of the PD device or cycler. When it is determined that the output from one or more pressure sensors indicates that the double-lumen patient line is improperly connected to the patient line connector, the control unit causes the user interface to issue an alarm or warning, either audibly, visually, or audiovisually, and notifies the patient that the patient line needs to be removed from the PD device or cycler and connected to the disposable filter set (which is connected to the patient's transfer set).

[0031] When a small amount of unused / used PD fluid is being pushed out towards the patient and the patient is not properly connected to the disposable filter set and the double-lumen patient line, and the distal end of the double-lumen patient line is left unconnected by the patient, the output from one or more pressure sensors to the control unit shows a pressure different from when the patient line is connected to the patient. When it is determined that the output from one or more pressure sensors indicates that the double-lumen patient line is left unconnected by the patient, the control unit causes the user interface to issue an alarm or warning, either audibly, visually, or audiovisually, and notifies the patient that the patient line needs to be connected to the disposable filter set (which is connected to the patient's transfer set).

[0032] In a first aspect of the present disclosure, which can be combined with any other aspect or part thereof without limiting the present disclosure in any way, a peritoneal dialysis ("PD") system includes a housing, a PD fluid pump housed by the housing, a reusable patient line extending from the housing, the reusable patient line including a distal end configured to be connected to a patient line connector provided by the housing, at least one reusable PD fluid line extending from the housing, the at least one reusable PD fluid line including a distal end configured to be connected to a PD fluid line connector provided by the housing, and a control unit configured to apply a negative pressure to at least one of the reusable patient line or the at least one reusable PD fluid line when connected to the patient line connector and the PD fluid line connector, respectively, before any line is connected for treatment to the PD fluid pump.

[0033] In a second aspect of the present disclosure, which can be combined with any other aspect or part thereof, the reusable patient line is a dual-lumen patient line including an unused PD fluid lumen and a used PD fluid lumen, and the negative pressure is applied to at least one of the unused PD fluid lumen and the used PD fluid lumen.

[0034] In a third aspect of the present disclosure, which can be combined with any other aspect or part thereof, the negative pressure is applied to the unused PD fluid lumen by operating the PD fluid pump in a direction opposite to the treatment direction, and the negative pressure is applied to the used PD fluid lumen by operating the PD fluid pump in the treatment direction.

[0035] In a fourth aspect of the present disclosure, which can be combined with any other aspect or part thereof, the PD system includes a plurality of PD fluid line valves, and the negative pressure is applied to the plurality of PD fluid lines through the PD fluid pump and by sequentially opening the plurality of PD fluid line valves.

[0036] In a fifth aspect of the present disclosure that can be combined with any other aspect or a part thereof, the negative pressure is from -5 kPa (-0.73 psig) to -15 kPa (-2.2 psig).

[0037] In a sixth aspect of the present disclosure that can be combined with any other aspect or a part thereof, during the disinfection sequence, the reusable patient line is connected to the patient line connector, at least one reusable PD fluid line is connected to at least one PD fluid line connector, and negative pressure is automatically applied after the disinfection sequence.

[0038] In a seventh aspect of the present disclosure that can be combined with any other aspect or a part thereof, the housing houses an internal PD fluid line, and the reusable patient line and at least one reusable PD fluid line form a closed PD fluid loop with the internal PD fluid line for the disinfection sequence.

[0039] In an eighth aspect of the present disclosure that can be combined with any other aspect or a part thereof, the PD system includes a user interface, and the control unit is further configured to cause the user interface to provide a message to wait until the line disconnection preparation sequence for removing the reusable patient line and at least one reusable PD fluid line from the housing is completed.

[0040] In a ninth aspect of the present disclosure that can be combined with any other aspect or a part thereof, the PD system includes a user interface, and the control unit is further configured to cause the user interface to provide a message indicating that the reusable patient line and at least one reusable PD fluid line are ready to be removed from the housing.

[0041] In a tenth aspect of the present disclosure that may be combined with any other aspect or a part thereof, the user interface is further configured to provide a moving graphic indicating an appropriate method for removing the distal end of the reusable patient line or the reusable PD fluid line from the housing.

[0042] In an eleventh aspect of the present disclosure that may be combined with any other aspect or a part thereof, negative pressure collapses at least one of the reusable patient line or at least one reusable PD fluid line before removal from the housing and expands it after removal from the housing, thereby tending to hold the PD fluid within at least one of the reusable patient line or at least one reusable PD fluid line.

[0043] In a twelfth aspect of the present disclosure that may be combined with any other aspect or a part thereof, the PD system includes a disposable filter set for connection to the distal end of the reusable patient line when removed from the housing.

[0044] In a thirteenth aspect of the present disclosure that may be combined with any other aspect or a part thereof, the PD system includes at least one PD fluid container for connection to the distal end of at least one reusable PD fluid line when removed from the housing.

[0045] In a fourteenth aspect of the present disclosure that may be combined with any other aspect or a part thereof, at least one of the patient line connector or at least one PD fluid line connector is installed horizontally with respect to the housing.

[0046] In a fifteenth aspect of the present disclosure that may be combined with any other aspect or a part thereof, the control unit is further configured to lock negative pressure at the distal end of the reusable patient line to at least one valve before any line is connected for treatment.

[0047] In a 16th aspect of the disclosure that can be combined with any other aspect or a part thereof, the control unit is further configured to lock the negative pressure at the distal end of at least one PD fluid line to at least one valve before any of the lines are connected for treatment.

[0048] In a 17th aspect of the disclosure that can be combined with any other aspect or a part thereof, a peritoneal dialysis (「PD」) apparatus includes a housing, a PD fluid pump housed by the housing, a reusable patient line extending from the housing, the reusable patient line including a distal end configured to be connected such that the reusable patient line is in fluid communication with at least one internal PD fluid line located within the housing, at least one reusable PD fluid line extending from the housing, the at least one reusable PD fluid line including a distal end configured to be connected such that at least one PD fluid line is in fluid communication with at least one internal PD fluid line, and a control unit configured to apply a negative pressure to at least one of the reusable patient line or the at least one reusable PD fluid line when connected to communicate with at least one internal PD fluid line to the PD fluid pump before any of the lines are connected for treatment.

[0049] In an 18th aspect of the disclosure that can be combined with any other aspect or a part thereof, during a disinfection sequence, the reusable patient line is arranged in fluid communication with at least one internal PD fluid line, the at least one reusable PD fluid line is arranged in fluid communication with at least one internal PD fluid line, and the negative pressure is automatically applied after the disinfection sequence.

[0050] In a 19th aspect of the disclosure that can be combined with any other aspect or a part thereof, the control unit is further configured to lock the negative pressure at the distal end of the reusable patient line to at least one valve before any of the lines are connected for treatment.

[0051]

[0051] In a 20th aspect of the present disclosure that can be combined with any other aspect or a part thereof, the control unit is further configured to lock the negative pressure at the distal end of at least one PD fluid line to at least one valve before any line is connected for treatment.

[0052]

[0051] In a 21st aspect of the present disclosure that can be combined with any other aspect or a part thereof, a peritoneal dialysis (「PD」) system includes a plurality of PD fluid containers, and further includes a PD device including a housing, a PD fluid pump housed by the housing, and a control unit configured to cause the PD fluid pump to extract residual PD fluid from at least one of the plurality of PD fluid containers during patient stay.

[0053]

[0051] In a 22nd aspect of the present disclosure that can be combined with any other aspect or a part thereof, the PD system includes separate PD fluid lines extending from the housing to each of the PD fluid containers, and the residual PD fluid is pumped through at least one respective PD fluid line.

[0054]

[0051] In a 23rd aspect of the present disclosure that can be combined with any other aspect or a part thereof, the PD fluid line is reusable.

[0055]

[0051] In a 24th aspect of the present disclosure that can be combined with any other aspect or a part thereof, the plurality of PD fluid containers are in fluid communication with a disposable pumping section operable with the PD fluid pump.

[0056]

[0051] In a 25th aspect of the present disclosure that can be combined with any other aspect or a part thereof, the control unit is configured to cause the PD fluid pump to extract residual PD fluid from the plurality of PD fluid containers during the final patient stay.

[0057] In a 26th aspect of the present disclosure that can be combined with any other aspect or part thereof, the PD device includes a PD fluid valve for each PD fluid container, and the control unit is configured to sequentially open the PD valves for the respective PD fluid containers while residual PD fluid is pumped from the respective PD fluid containers during the final patient dwell.

[0058] In a 27th aspect of the present disclosure that can be combined with any other aspect or part thereof, when one of the PD fluid containers is the last filling container, the control unit is further configured to cause the PD fluid pump to perform a final patient fill using the last filled PD fluid from the last filling container after the final patient discharge following the final patient dwell.

[0059] In a 28th aspect of the present disclosure that can be combined with any other aspect or part thereof, the control unit is further configured to pre-determine that each PD fluid container from which residual PD fluid is pumped has residual PD fluid that is less than the filling volume.

[0060] In a 29th aspect of the present disclosure that can be combined with any other aspect or part thereof, the control unit is configured to pump residual PD fluid from at least one of the plurality of PD fluid containers to the drain.

[0061] In a 30th aspect of the present disclosure that can be combined with any other aspect or part thereof, the drain is a drain container or a house drain.

[0062] In a 31st aspect of the present disclosure that can be combined with any other aspect or part thereof, the control unit is configured to pump residual PD fluid from at least one of the plurality of PD fluid containers to a different PD fluid container.

[0063] In a 32nd aspect of the present disclosure that can be combined with any other aspect or part thereof, during a plurality of patient dwells, the control unit is configured to cause the PD fluid pump to withdraw residual PD fluid from at least one of the plurality of PD fluid containers.

[0064] In a 33rd aspect of the disclosure that can be combined with any other aspect or a part thereof, the PD device includes a PD fluid valve for each PD fluid container, and the control unit is configured to sequentially open the PD valves for the respective PD fluid containers while residual PD fluid is being pumped from the respective PD fluid containers during one period of patient dwell.

[0065] In a 34th aspect of the disclosure that can be combined with any other aspect or a part thereof, the control unit is further configured to cause the PD fluid pump to perform a final patient fill using the last filled PD fluid from the last filled container after the final patient drain when one of the PD fluid containers is the last filled container.

[0066] In a 35th aspect of the disclosure that can be combined with any other aspect or a part thereof, the control unit is further configured to pre-determine for each PD fluid container from which residual PD fluid is pumped that the PD fluid container has residual PD fluid that is less than the fill volume.

[0067] In a 36th aspect of the disclosure that can be combined with any other aspect or a part thereof, a method for assisting in the transport of peritoneal dialysis ( "PD") disposable articles after treatment, the method comprising causing a PD fluid pump to pump PD fluid from a PD fluid container to a patient for patient fill, and during a subsequent patient dwell, causing the PD fluid pump to remove residual PD fluid from the PD fluid container such that the residual PD fluid need not be transported after treatment.

[0068] In a 37th aspect of the disclosure that can be combined with any other aspect or a part thereof, the method includes determining that the amount of residual PD fluid is less than a predetermined fill volume amount before pumping the residual PD fluid from the PD fluid container.

[0069] In a 38th aspect of the disclosure that can be combined with any other aspect or a part thereof, the method includes pumping the residual PD fluid from the PD fluid container to a drain or another PD fluid container.

[0070] In a 39th aspect of the disclosure that can be combined with any other aspect or part thereof, the subsequent patient dwell is the final patient dwell and includes causing a PD fluid pump to remove residual PD fluid from a plurality of PD fluid containers during the final patient dwell.

[0071] In a 40th aspect of the disclosure that can be combined with any other aspect or part thereof, the subsequent patient dwell is the first patient dwell and includes causing a PD fluid pump to remove residual PD fluid from a second PD fluid container during a second patient dwell.

[0072] In a 41st aspect of the disclosure that can be combined with any other aspect or part thereof, the method includes causing a PD fluid pump to pump the last filled PD fluid to a patient after removing residual PD fluid from each of the other PD fluid containers.

[0073] In a 42nd aspect of the disclosure that can be combined with any other aspect or part thereof, a peritoneal dialysis ("PD") system includes a housing, a PD fluid pump housed by the housing, a pressure sensor positioned and arranged to sense the pressure of PD fluid pumped by the PD fluid pump, a patient line in fluid communication with the PD fluid pump, the patient line being configured to be arranged to be in fluid communication with a patient transfer set for performing a PD treatment, and a control unit configured to (i) cause a PD fluid pump to pump a quantity of PD fluid into the patient line before patient drainage, (ii) record an output from the pressure sensor due to the pumped quantity of PD fluid, and (iii) determine whether the patient line is in fluid communication with the patient transfer set based on the output from the pressure sensor.

[0074] In a 43rd aspect of the disclosure that can be combined with any other aspect or part thereof, the control unit is further configured to initiate patient drainage when it is determined that the patient line is in fluid communication with the patient transfer set based on the output from the pressure sensor.

[0075] In a 44th aspect of the disclosure that can be combined with any other aspect or a part thereof, the control unit is further configured to provide a visual, auditory, or audiovisual message when it is determined based on the output from the pressure sensor that the patient line is not in fluid communication with the patient transfer set.

[0076] In a 45th aspect of the disclosure that can be combined with any other aspect or a part thereof, after the message, or in combination with the message, the control unit is further configured to request confirmation that the patient line is disposed in fluid communication with the patient transfer set.

[0077] In a 46th aspect of the disclosure that can be combined with any other aspect or a part thereof, when the control unit receives confirmation that the patient line is disposed in fluid communication with the patient transfer set, (i) before patient drainage, it causes the PD fluid pump to pump a second amount of PD fluid into the patient line, (ii) records a second output from the pressure sensor resulting from the second pumped amount of PD fluid, and (iii) is further configured to determine whether the patient line is in fluid communication with the patient transfer set based on the second output from the pressure sensor.

[0078] In a 47th aspect of the disclosure that can be combined with any other aspect or a part thereof, the control unit is further configured to determine the position of the distal end of the patient line based on the output from the pressure sensor when it is determined that the patient line is not in fluid communication with the patient transfer set.

[0079] In a 48th aspect of the disclosure that can be combined with any other aspect or a part thereof, one determined position of the distal end of the patient line is connected to the patient line connector in the housing, and the control unit is further configured to provide a visual, auditory, or audiovisual prompt that prompts disconnection from the patient line connector in the housing and reconnection to the connector at the patient.

[0080] In a 49th aspect of the disclosure that can be combined with any other aspect or a part thereof, one determined position at the distal end of the patient line remains unconnected, and the control unit is further configured to provide a visual, auditory, or audiovisual prompt to prompt the connection of the distal end to the connector in the patient.

[0081] In a 50th aspect of the disclosure that can be combined with any other aspect or a part thereof, the amount of PD fluid is 1 to 10, for example, 5 milliliters ("ml").

[0082] In a 51st aspect of the disclosure that can be combined with any other aspect or a part thereof, the pressure sensor includes a plurality of pressure sensors, and the control unit is configured to determine whether the patient line is in fluid communication with the patient transfer set based on a plurality of outputs from the plurality of pressure sensors.

[0083] In a 52nd aspect of the disclosure that can be combined with any other aspect or a part thereof, the patient line is reusable and extends from the housing.

[0084] In a 53rd aspect of the disclosure that can be combined with any other aspect or a part thereof, the patient line is disposable and is in fluid communication with a disposable pumping section operable with a PD fluid pump.

[0085] In a 54th aspect of the disclosure that can be combined with any other aspect or a part thereof, the patient line is configured to be disposed in fluid communication with the patient transfer set via a disposable filter located between the patient line and the patient transfer set.

[0086] In a 55th aspect of the disclosure that can be combined with any other aspect or a part thereof, the patient line is a double-lumen patient line, and pumping a certain amount of PD fluid into the patient line includes pumping that amount into one or both of the unused or used PD fluid lumens of the double-lumen patient line.

[0087] In a 56th aspect of the present disclosure that can be combined with any other aspect or a part thereof, a method for preventing the initiation of patient drainage with a disconnected or improperly connected patient line, the method comprising, prior to patient drainage, pumping a quantity of PD fluid into the patient line, measuring the pressure resulting from the quantity of PD fluid pumped into the patient line, determining from the resulting pressure whether the patient line is in fluid communication with the patient transfer set, and initiating patient drainage if it is determined that the patient line is in fluid communication with the patient transfer set.

[0088] In a 57th aspect of the present disclosure that can be combined with any other aspect or a part thereof, the method comprises determining the position of the distal end of the patient line from the resulting pressure if it is determined that the patient line is not in fluid communication with the patient transfer set.

[0089] In a 58th aspect of the present disclosure that can be combined with any other aspect or a part thereof, the method comprises facilitating connection of the patient line based on the determined position of the distal end.

[0090] In a 59th aspect of the present disclosure that can be combined with any other aspect or a part thereof, the method comprises repeating the pumping, measuring, determining, and initiating drainage after receiving confirmation that the patient line is disposed in fluid communication with the patient transfer set.

[0091] In a 60th aspect of the present disclosure that can be combined with any other aspect or a part thereof, any of the features, functionalities, and alternatives described in connection with one or more of FIGS. 1 - 5 can be combined with any of the features, functionalities, and alternatives described in connection with any of the others of FIGS. 1 - 5.

[0092] In light of the above aspects described herein and the present disclosure, an advantage of the present disclosure is to provide an improved dialysis system and method that operate to prevent leakage when accessing a pre-sterilized dialysis fluid, for example, in a bag.

[0093] Another advantage of the present disclosure is to provide a dialysis system configured to detect and perform appropriate operations when a currently used container or bag runs out of dialysis fluid during a procedure, for example, during PD patient filling.

[0094] A further advantage of the present disclosure is to provide a PD system configured to automatically remove residual PD fluid during one or more patient dwells and reduce the burden of disposable removal and transportation after the procedure.

[0095] Additional features and advantages are described in the following detailed description and figures and will become apparent therefrom. The features and advantages described herein are not all-inclusive, and in particular, many additional features and advantages will be apparent to those skilled in the art upon consideration of the drawings and description. Also, it should be noted that no particular embodiment need have all of the improvements or advantages described herein, and it is clearly contemplated that individual advantageous embodiments may be claimed separately. In particular, the systems of the present disclosure may have any one or more or all of the drip prevention structures and techniques, structures and techniques for emptying a PD fluid container, and structures and techniques for patient connection confirmation before drainage described herein. Further, it should be noted that the language used herein is selected primarily for readability and description purposes and does not limit the scope of the subject matter of the present invention.

Brief Description of the Drawings

[0096]

Figure 1

[0097]

Figure 2

[0098]

Figure 3

[0099]

Figure 4

[0100]

Figure 5

DETAILED DESCRIPTION OF THE INVENTION

[0101] DETAILED DESCRIPTION SYSTEM OVERVIEW Referring now to the drawings, and in particular to FIG. 1, a medical system showing the improved features of the present disclosure is shown via a peritoneal dialysis ("PD") system 10. The system 10 includes a PD device 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 via, for example, a tablet or smartphone. The control unit 100 also includes a transceiver and a network (not shown), for example, a wired or wireless connection to the Internet, to send treatment data to and receive prescription instructions / changes from a server of a physician or clinician that interfaces with a computer of the physician or clinician. The control unit 100 in one embodiment controls all electrical fluid flow and heating components of the system 10 and receives outputs from all sensors of the system 10. The system 10 in the illustrated embodiment includes durable reusable components that contact unused and used PD fluid, which requires that the PD device or cycler 20 be disinfected, for example, by heat sterilization, between treatments.

[0102] The system 10 of FIG. 1 includes an in-line resistance heater 56, reusable supply lines or tubes 52a1-52a4 and 52b, an air trap 60 operating with respective upper and lower level sensors 62a and 62b, an air trap valve 54d, a vent valve 54e located along a vent line 52e, a reusable line or tube 52c, a PD fluid pump 70, temperature sensors 58a and 58b, pressure sensors 78a, 78b1, 78b2 and 78c, reusable patient-side tubes or lines 52f and 52g having respective valves 54f and 54g, a double-lumen patient line 28, a hose reel 80 for retracting the patient line 28, a reusable drain tube or line 52i extending to a drain line connector 34 and having a drain line valve 54i, and reusable recirculation disinfection tubes or lines 52r1 and 52r2 operating with respective disinfection valves 54r1 and 54r2. A third recirculation or disinfection tube or line 52r3 extends between disinfection or PD fluid line connectors 30a and 30b for use during disinfection. A fourth recirculation or disinfection tube or line 52r4 extends between disinfection connectors 30c and 30d for use during disinfection.

[0103] The system 10 further includes PD fluid containers or bags 38a-38c (e.g., holding the same or different formulations of PD fluid) respectively connected to the distal ends 24e of reusable PD fluid lines 24a-24c. The system 10d further includes a fourth PD fluid container or bag 38d connected to the distal end 24e of a reusable PD fluid line 24d. The fourth PD fluid container or bag 38d may hold the same or different type of PD fluid (e.g., icodextrin) as provided within the PD fluid containers or bags 38a-38c. The reusable PD fluid lines 24a-24d, in one embodiment, extend through an opening (not shown) defined or provided by the housing 22 of the cycler 20.

[0104] In the illustrated embodiment, system 10 includes four disinfection or PD fluid line connectors 30a-30d for connection to the distal ends 24e of reusable PD fluid lines 24a-24d, respectively, during disinfection. System 10 also provides a patient line connector 32 including an internal lumen, e.g., a U-shaped lumen, that directs fresh or used dialysate from one PD fluid lumen to the other PD fluid lumen of the connected distal end 28e of dual-lumen patient line 28 for disinfection. Reusable supply tubes or lines 52a1-52a4 communicate with reusable supply lines 24a-24d, respectively. Reusable supply tubes or lines 52a1-52a3 operate with valves 54a-54c, respectively, to allow PD fluid to be drawn into cycler 20 from desired PD fluid containers or bags 38a-38c. Three-way valve 94a in the illustrated example allows control unit 100 to select between (i) 2.27% (or other) glucose dialysate from container or bag 38b or 38c and (ii) icodextrin from container or bag 38d. In the illustrated embodiment, icodextrin from container or bag 38d is connected to a normally closed port of three-way valve 94a.

[0105] System 10, in one embodiment, is configured such that drain line 52i during patient fill is fluidly connected downstream of PD fluid pump 70. In this way, if drain valve 54i fails or somehow leaks during patient fill of patient P, unused PD fluid is forced into disposable drain line 36 instead of potentially drawing used PD fluid into pump 70. Disposable drain line 36, in one embodiment, is removed for sanitization, and drain line connector 34 is capped via cap 34c, forming a closed sanitization loop. PD fluid pump 70 may be an inherently precise pump, such as a piston pump, or a less precise pump, such as a gear pump, that operates in conjunction with a flow meter (not shown) to control the flow rate and volume of unused and used PD fluid.

[0106] System 10 may further include a leak detection pan 82 disposed 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 illustrated example, system 10 is provided with an additional pressure sensor 78c located upstream of the PD fluid pump 70, which enables measurement of the suction pressure of the pump 70 and helps the control unit 100 to more accurately determine the pump volume. The additional pressure sensor 78c in the illustrated embodiment may be filled with air or a mixture of air and PD fluid, but should nevertheless be located along a vent line 52e that is at the same negative pressure as the PD fluid located within the PD fluid line 52c.

[0107] System 10 in the example of FIG. 1 includes redundant pressure sensors 78b1 and 78b2, the output of one of which is used for pump control as described herein, and the output of the other pressure sensor is a safety or watchdog output to confirm that the control pressure sensor is reading accurately. The pressure sensors 78b1 and 78b2 are located along a line that includes a third recirculation valve 54r3. System 10 may use one or more crosses marked with an X in FIG. 1, which may be capable of (i) reducing the overall amount and volume of reusable internal tubing, (ii) reducing the number of valves required, and (iii) minimizing the portion of the fluid circuit shared by both unused and used PD fluid.

[0108] System 10 in the example of FIG. 1 further includes an acid source such as a citric acid container or bag 66. The citric acid container or bag 66 is selectively in fluid communication with a second three-way valve 94b via a citric acid valve 54m disposed along a citric acid line 52m. The citric acid line 52m is connected to the normally closed port of the second three-way valve 94b in one embodiment 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 citric (or other) acid does not reach the treatment fluid line during treatment. Instead, citric (or other) acid is used during disinfection.

[0109] In one embodiment, the control unit 100 uses the feedback from any one or more of the pressure sensors 78a - 78c to enable the PD device 20 to deliver unused heated PD fluid to the patient at, for example, 14 kPa (2.0 psig) or more. The pressure feedback is used to enable the PD device 20 to remove used PD fluid or drainage from the patient at, for example, -5 kPa (-0.73 psig) to -15 kPa (-2.2 psig), for example -9 kPa (-1.3 psig) or more (more negative). The pressure feedback can be used in a proportional, integral, derivative ("PID") pressure routine to pump the unused and used PD fluids at a desired positive or negative pressure.

[0110] The in-line resistance heater 56 under the control of the control unit 100 can heat the unused PD fluid to body temperature, for example 37°C, for delivery to the patient P at a desired flow rate. The control unit 100 in one embodiment uses the feedback from the temperature sensor 58a in a PID temperature routine to pump the unused PD fluid to the patient P at a desired temperature.

[0111] FIG. 1 also shows that the system 10 includes a disposable filter set 40 in fluid communication with the unused PD fluid lumen and the used PD fluid lumen of the double-lumen patient line 28 and is used. The disposable filter set 40 includes a disposable connector 42 that connects to the distal end 28e of the reusable patient line 28. The disposable filter set 40 also includes a connector 44 that connects to the patient transfer set. The disposable filter set 40 further includes a sterilizing grade filter membrane 46 that further filters the unused PD fluid. The disposable filter set 40 is provided as a final opportunity filter for the PD device 20 and is heat sterilized between treatments in one embodiment. Pathogens that, although unlikely, may remain after sterilization are filtered from the PD fluid through the sterilizing grade filter membrane 46 of the disposable filter set 40.

[0112] Figure 1 shows the configuration of system 10 for treatment with PD fluid containers or bags 38a - 38d connected via reusable flexible PD fluid lines 24a - 24d respectively. The double - lumen patient line 28 is connected to patient P via a disposable filter set 40. The disposable drain line 36 is connected to a drain line connector 34. In Figure 1, the PD device or cycler 20 of 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 a treatment.

[0113] Figure 2 shows system 10 in the disinfection mode. The PD fluid containers or bags 38a - 38d are removed, and instead, the flexible PD fluid lines 24a - 24d are inserted, each in a sealed state with a disinfection or PD fluid line connector 30a - 30d. The reusable double - lumen patient line 28 is disconnected from the disposable filter set 40 (which is discarded), and the distal end 28e of the double - lumen patient line 28 is inserted in a sealed state into a 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 a cap 34c to form a closed disinfection loop 90. The PD device or cycler 20 of system 10 in Figure 2 is configured to perform a disinfection sequence, for example, a heat disinfection sequence in which unused PD fluid is heated to a disinfection temperature, for example, 70°C - 90°C, via an in - line heater 56. The PD fluid pump 70 circulates the heated PD fluid through the closed disinfection loop 90 for a time required to properly disinfect the fluid components and lines of the disinfection loop.

[0114] Drip prevention Referring further to FIG. 2, in one embodiment, it may be considered to leave the disinfectant solution within the PD device or cycler 20 until the following procedure. Accordingly, the flexible PD fluid lines 24a-24d, the disinfection or PD fluid line connectors 30a-30d, the double-lumen patient line 28, and the patient line connector 32 are wet when disconnected from the PD device or cycler 20. At the start of a new procedure, there is a risk of fluid leakage from the distal ends 24e, 28e before the patient or caregiver can reconnect to (i) unused PD fluid containers or bags 38a-38d (for the PD fluid lines) and (ii) unused disposable filter sets 40 (for the patient line) when (i) the distal ends 24e of the reusable PD fluid lines 24a-24d are removed from the connectors 30a-30d respectively and (ii) the distal end 28e of the double-lumen patient line 28 is removed from the patient line connector 32.

[0115] To prevent dripping or leakage, in one embodiment, the control unit 100 of the PD device or cycler 20 opens an appropriate valve and applies a negative pressure to the reusable PD fluid lines 24a-24d and the double-lumen patient line 28 to the PD fluid pump 70 to slightly collapse the flexible lines under negative pressure before the patient or caregiver removes any of those lines during the procedure setup. In this way, when the patient or caregiver (i) removes the distal ends 24e of the reusable PD fluid lines 24a-24d from the PD fluid line connectors 30a-30d respectively and (ii) removes the distal end 28e of the double-lumen patient line 28 from the patient line connector 32, the flexible PD fluid lines 24a-24c and the double-lumen patient line 28 expand and draw a small amount of air into the ends of the lines to prevent leakage or dripping.

[0116] Regarding the double-lumen patient line 28, it is conceivable to program the control unit 100 to place one or both of the unused lumen and the used lumen of the double-lumen patient line 28 under negative pressure. Looking at FIG. 2, it is conceivable that the control unit 100 opens the unused PD fluid valve 54f and the vent valve 54e and leaves the three-way valve 94b in its normally closed state (all other valves may be closed), thereby placing the unused PD fluid lumen of the double-lumen patient line 28 under negative pressure. Then, the control unit 100 operates the PD fluid pump 70 in the reverse direction to apply a negative pressure to the disinfection fluid, such as PD fluid, located in the unused PD fluid line 52f and the unused PD fluid lumen of the double-lumen patient line 28. When the negative pressure reaches the desired or set negative pressure, that is, for example, between -5 kPa (-0.73 psig) and -15 kPa (-2.2 psig), for example, -9 kPa (-1.3 psig), as measured by the pressure sensor 78a output to the control unit 100, the control unit closes at least the unused PD fluid valve 54f and stops the PD fluid pump 70. Closing the unused PD fluid valve 54f locks the negative pressure applied to the portion of the unused PD fluid line 52f located downstream of the unused PD fluid valve 54f and the unused PD fluid of the double-lumen patient line 28 (assuming no leakage). The locked negative pressure waits for the patient or caregiver to remove the patient line distal end 28e from the patient line connector 32 during the treatment setting.

[0117] Referring to FIG. 2, it is contemplated that the control unit 100 places the used PD fluid lumen of the double-lumen patient line 28 under negative pressure by opening the used PD fluid valve 54g and the drain valve 54i (all other valves may be closed). Next, the control unit 100 operates the PD fluid pump 70 in the forward direction to apply a negative pressure to the disinfectant fluid, e.g., PD fluid, located within the used PD fluid line 52g and the used PD fluid lumen of the double-lumen patient line 28. When the negative pressure reaches the desired or set negative pressure, i.e., measured by the pressure sensors 78b1, 78b2, and / or 78c output to the control unit 100, e.g., between -5 kPa (-0.73 psig) and -15 kPa (-2.2 psig), e.g., -9 kPa (-1.3 psig), the control unit closes at least the used PD fluid valve 54g and stops the PD fluid pump 70. Closing the used PD fluid valve 54g locks the negative pressure applied to the portion of the used PD fluid line 52g located upstream of the used PD fluid valve 54g and the used PD fluid of the double-lumen patient line 28 (assuming no leaks). The locked negative pressure waits for the patient or caregiver to remove the patient line distal end 28e from the patient line connector 32 during the treatment setting.

[0118] Referring to FIG. 2, it is conceivable that the control unit 100 places the reusable PD fluid line 24a under negative pressure by opening the valves 54a, 54d and the drain valve 54i (all other valves may be closed). Then, the control unit 100 operates the PD fluid pump 70 in the forward direction to apply a negative pressure to the disinfectant fluid, e.g., the PD fluid, located within the reusable PD fluid line 24a. When the negative pressure reaches the desired or set negative pressure, i.e., measured by the pressure sensor 78c output to the control unit 100, e.g., between -5 kPa (-0.73 psig) and -15 kPa (-2.2 psig), e.g., -9 kPa (-1.3 psig), the control unit closes at least the PD fluid valve 54a and stops the PD fluid pump 70. Closing the PD fluid valve 54a locks the negative pressure applied to the portion of the PD fluid line 52a1 located upstream of the PD fluid valve 54a and the reusable PD fluid line 24a (assuming no leakage). The locked negative pressure awaits the patient or caregiver to remove the PD fluid line distal end 24e from the disinfection or PD fluid line connector 30a.

[0119] Referring to FIG. 2, for any one or more or all of the reusable PD fluid lines 24b, 24c and 24d, the same procedure as described above for the reusable PD fluid line 24a is performed by the control unit 100, except that (i) in the case of the reusable PD fluid line 24b, the valve 54b replaces the valve 54a, (ii) in the case of the reusable PD fluid line 24c, the valve 54c replaces the valve 54a, and (iii) in the case of the reusable PD fluid line 24d, the toggle three-way valve 94a replaces the valve 54a. The locked negative pressure awaits the patient or caregiver to remove any one or more or all of the PD fluid line distal ends 24e from the disinfection connectors 30b - 30d, respectively.

[0120] While the control unit 100 is in the treatment setting, it is conceivable that the user interface 108 prompts the patient, either auditorily, visually, or audiovisually, to (i) wait for the removal of either the patient line or the PD fluid line until the system 10 is ready (e.g., until the flexible lines 24a - 24d and 28 are placed under negative pressure), and / or (ii) notify the patient that the system 10 is ready for the treatment setting with either the patient line or the PD fluid line removed (e.g., the flexible lines 24a - 24d and 28 are placed under negative pressure). In this way, the patient or caregiver is guided so that the setting is executed in a state where leakage and dripping are likely to be prevented.

[0121] The negative pressure described above enables the patient line connector 32 and the disinfection connectors 30b - 30d to be attached or installed horizontally or substantially horizontally along the housing 22 of the cycler 20, and it may be desirable to do so. Then, the patient or caregiver may first pull out the distal ends 24e, 28e horizontally from their respective connectors, and then tilt the distal ends 24e, 28e vertically upward so that the disinfection solution fits inside the distal ends 24e, 28e. The expansion of the flexible lines 24a - 24d and 28 and the drawing in of air into the distal ends 24e, 28e prevent leakage during the removal of the distal ends 24e, 28e horizontally and their tilting upward. Then, the distal ends 24e, 28e may be respectively connected and sealed to new PD fluid containers or bags 38a - 38d and disposable filter sets 40 without leakage or dripping of the disinfection solution such as PD fluid.

[0122] Method 110 of FIG. 3 summarizes an embodiment of the drip prevention structure and methodology of the system 10 of the present disclosure. At ellipse 112, method 110 begins. At block 114, the control unit 100 causes the user interface 108 to display (visually, auditorily, or audiovisually) a message prompting the user to wait until the PD device or cycler 20 completes the disconnection preparation sequence and until the sequence is complete, the patient removes the flexible PD fluid lines 24a-24d and the double-lumen patient line 28 from the PD device or cycler 20. At block 116, when the disconnection preparation sequence is complete, the control unit 100 automatically draws a vacuum in each of the flexible PD fluid lines 24a-24d and the double-lumen patient line 28 (one or both lumens), for example as described above. At block 118, the control unit 100 causes the user interface 108 to display (visually, auditorily, or audiovisually) a message that the PD device or cycler 20 is ready for the flexible PD fluid lines 24a-24d and the double-lumen patient line 28 to be removed and connected to the PD fluid containers or bags 38a-38d or the disposable filter set 40, respectively. The user interface 108 may optionally display a video or moving graphic of the distal ends 24e, 28e of the flexible lines being horizontally removed from the PD device or cycler 20, after which the user tilts the distal ends 24e, 28e to a vertical position with the disinfectant contained within the distal ends 24e, 28e. At ellipse 120, method 110 ends.

[0123] Feature of emptying the PD fluid container Residual or remaining PD fluid may remain in one or more or all of the PD fluid containers or bags 38a - 38d at the end of the procedure, and the likelihood is often high. The volume of the patient fill for PD treatment is typically determined via the patient's prescription, and the prescription sets the volume of unused PD fluid to be delivered to the patient for each patient fill. The volume of the patient fill, for example 1.5 - 2 liters, is typically smaller than the volume of the PD fluid container or bag, for example 2 liters. Based on these volumes, some unused PD fluid tends to remain in the container or bag.

[0124] Typically, the patient or caregiver must wait while the residual PD fluid is drained after the procedure, or stop the drainage and transport the bag with the residual fluid for disposal. The residual fluid adds weight, potential leakage, and mess to the bag disposal. Referring to FIG. 1, the control unit 100 of the PD device or cycler 20 of the system 10 is programmed or configured in one embodiment to remove residual PD fluid from the PD fluid containers or bags 38a - 38d using one or more patient dwells. During the patient dwell, the PD cycler is generally inactive. On the other hand, the control unit 100 of the PD device or cycler 20 of the present disclosure utilizes the sufficient time provided during one or more patient dwells to empty or nearly empty the PD fluid containers or bags 38a - 38d at the end of the procedure. In this way, the patient or caregiver can dispose of the PD fluid containers or bags 38a - 38d that are lighter and cleaner than if the bags had contained residual PD fluid. However, the patient does not have to wait and can dispose of the PD fluid containers or bags 38a - 38d immediately after the end of the procedure.

[0125] In one embodiment, the control unit 100 waits for the final patient dwell to remove residual PD fluid from one of the PD fluid containers or bags 38a - 38d. During the final patient dwell, the control unit 100 opens or switches appropriate valves, such as valves 54a, 54b, 54c, and 94a, at different times to draw residual PD fluid from the desired PD fluid container or bag 38a - 38d via the PD fluid pump 70. During each period of a different bag drainage sequence, the control unit 100 also opens valves 54d and drain valve 54i so that the PD fluid pump 70 can pump residual PD fluid to the drain via the drain line 36 from one of the PD fluid containers or bags 38a - 38d.

[0126] In an alternative embodiment, the control unit 100 uses each patient dwell of the treatment, or at least one intermediate patient dwell, to remove residual PD fluid from the most recently used PD fluid container or bag 38a - 38d. Assume that the first patient fill is from PD fluid container or bag 38a. In one example, during subsequent patient dwells, the control unit 100 opens valves 54a, 54d, and 54i to pump residual PD fluid from the PD fluid container or bag 38a to the drain via the PD fluid pump 70. Assume that the next patient fill is from PD fluid container or bag 38b. In one example, during subsequent patient dwells, the control unit 100 opens valves 54b, 54d, and 54i to pump residual PD fluid from the PD fluid container or bag 38b to the drain via the PD fluid pump 70. Assume that the third patient fill is from PD fluid container or bag 38c. In one example, during subsequent patient dwells, the control unit 100 opens valves 54c, 54d, and 54i to pump residual PD fluid from the PD fluid container or bag 38c to the drain via the PD fluid pump 70.

[0127] Any one or more of the PD fluid containers or bags 38a to 38d can also store unused PD fluid for two or more patient fill volumes. The control unit 100 knows the volume of each PD fluid container or bag 38a to 38d in one embodiment, and after waiting for patient dwell time that occurs after the PD fluid container or bag 38a to 38d has become almost completely empty, it is configured to attempt to completely drain any remaining PD fluid by the method described herein. For this purpose, the control unit 100 also knows how much unused PD fluid has been drained from each of the PD fluid containers or bags 38a to 38d. In one embodiment, the PD fluid pump 70 is an essentially accurate pump such as a piston pump, where each stroke volume is known and pumped accurately. Here, the control unit 100 counts the number of pump strokes performed by the PD fluid pump 70 for each PD fluid container or bag 38a to 38d, and multiplies the number of strokes by the known stroke volume to arrive at the total volume of unused PD fluid removed from the PD fluid container or bag 38a to 38d. In another embodiment, the PD fluid pump 70 operates with a flow meter (not shown) that outputs to the control unit 100. The output of the flow meter is integrated over the time that the PD fluid pump 70 pumps unused PD fluid from a given PD fluid container or bag 38a to 38d, from which it can be known how much PD fluid has been removed.

[0128] FIG. 1 shows, in one embodiment, that the PD fluid container or bag 38d holds icodextrin. Icodextrin is formulated to be delivered to the patient as the last fill at the end of the treatment. Icodextrin remains in the patient's body until the next nightly treatment or until an intermediate PD fluid exchange such as a daytime exchange. Since the last fill of icodextrin is the last step performed by the PD device or cycler 20 for the treatment, there is no subsequent patient stay. Here, the control unit 100 may be configured to attempt to pump as much icodextrin as possible into the patient during the last fill. Then, the control unit 100 may pump the residual icodextrin remaining in the PD fluid container or bag 38d into the drain at the end of the last fill (e.g., using the PD fluid pump 70 with the three-way valve 94a switched and the valves 54d and 54i open). Alternatively, the patient or caregiver may stop the PD device or cycler 20 at the end of the treatment and transport the PD fluid container or bag 38d with the residual icodextrin for disposal (however, all other containers or bags 38a - 38c are empty or substantially empty).

[0129] Method 130 of FIG. 4 summarizes an embodiment of the structure and methodology for emptying the PD fluid container of the system 10 of the present disclosure. At ellipse 132, method 130 begins. At diamond 134, the control unit 100 determines whether the previously used PD fluid container or bags 38a-38d are too close to empty to be used for another patient fill. At block 136, if the previously used PD fluid container or bags 38a-38d still have sufficient PD fluid to perform a patient fill, the control unit 100 causes the same PD fluid container or bag to be used for the next patient fill and then returns to diamond 134. At block 138, if the previously used PD fluid container or bags 38a-38d are nearly empty and do not have sufficient PD fluid to perform a patient fill, during the subsequent patient dwell, the control unit 100 causes any residual PD fluid remaining in the PD fluid container or bags 38a-38d to be pumped to a drain (house drain or drain container), for example, by the method described herein.

[0130] Next, method 130 is divided. In an embodiment where all eligible PD fluid containers or bags 38a - 38d are emptied during the last patient stay, in diamond 140 the control unit determines whether there is another PD fluid container or bag with residual PD fluid to be emptied. If so, the control unit 100 returns to block 138 during the same last patient stay and pumps any residual PD fluid remaining in different eligible PD fluid containers or bags 38a - 38d to the drain, for example, by the method described herein. When the residual PD fluid from all eligible PD fluid containers or bags 38a - 38d has been pumped to the drain, in diamond 142 the control unit 100 then determines, for example, whether there is a last fill container or bag 38d that holds icodextrin. If there is a last fill container or bag 38d, in block 144 the control unit 100 pumps the last fill PD fluid from the last fill container or bag 38d to the patient after the final patient drain. In block 146, the control unit 100 provides the patient or caregiver with the option of either immediately pumping any remaining last fill PD fluid to the drain or discarding the disposable set that includes the last fill container or bag 38d having the remaining last fill PD fluid to be drained, where the patient or caregiver has completed the procedure and is ready to discard it.

[0131] Instead, in an embodiment where the PD fluid containers or bags 38a - 38d are emptied during the next patient stay, in diamond 148 the control unit 100 determines whether there is another PD fluid container or bag (other than the last patient fill) for another patient fill. If so, in block 150 the control unit 100 causes a patient drain and subsequently a patient fill from a different PD fluid container or bag 38a - 38d at an appropriate time. Then, method 130 returns to diamond 134 and repeats the procedure for the different PD fluid container or bag. In diamond 148, if the control unit 100 determines that there is no other PD fluid container for another patient fill (other than the last patient fill), in diamond 152 the control unit 100 then determines whether there is a last fill container or bag 38d, for example, holding icodextrin. If there is a last fill container or bag 38d, in block 154 the control unit 100 pumps the last fill PD fluid to the patient from the last fill container or bag 38d after the final patient drain. In block 156, the control unit 100 provides the patient or caregiver with the option of either immediately pumping any remaining last fill PD fluid to the drain or discarding a disposable set including the last fill container or bag 38d having the remaining last fill PD fluid to be drained that the patient or caregiver has completed the procedure on.

[0132] In ellipse 158, the two branches of method 130 converge and method 130 ends.

[0133] Patient connection confirmation before drainage Referring to FIG. 1 in which patient P is connected to the double-lumen patient line via filter set 40, during patient stay, the patient may be disconnected from the double-lumen patient line 28, for example, by removing the patient transfer set from the disposable filter set 40. The user interface 108 may provide a button or input device that enables the patient to notify the control unit 100 of the PD device or cycler 20 that the patient is disconnected from the device. However, even if such an input device is provided, the patient may forget to press or activate the input device. In an alternative embodiment, such an input device is not provided, and the patient is to reconnect to the double-lumen patient line 28 before the start of the next patient drainage.

[0134] In any of the scenarios described above, when the next patient drainage is started, there may be no patient present and not connected to the double-lumen patient line 28. In that case, and if a patient disconnected from the PD device or cycler 20 connects the distal end 28e of the double-lumen patient line 28 to the patient line connector 32 of the device, the negative pressure applied by the PD fluid pump 70 during the subsequent patient drainage will result in a negative pressure spike or increase because the negative pressure extends to the closed unused PD fluid side of the fluid line within the PD device or cycler 20. Instead, if a patient disconnected from the PD device or cycler 20 leaves the double-lumen patient line 28, air will be drawn into the used PD fluid lumen of the double-lumen patient line 28 by the negative pressure applied by the PD fluid pump 70 during the subsequent patient drainage.

[0135] To prevent any of the above situations from occurring, the PD device of the system 10 or the control unit 100 of the cycler 20 may cause the PD fluid pump 70 to pump a small amount of unused PD fluid (which may be heated) towards the patient along the double-lumen patient line 28. The small amount of unused PD fluid to be pumped may be on the order of 1 to 10, for example 5 milliliters ("ml"), and may be pumped into the unused PD fluid lumen if the double-lumen patient line 28 is used. In an embodiment for pumping a small amount of unused PD fluid into the unused PD fluid lumen of the double-lumen patient line 28, the control unit 100 opens the appropriate supply valves 54a - 54c or 94a, valve 54d and valve 54f (or switches in the case of the three-way valve 94a), and causes the PD fluid pump 70 to pump in the forward direction of the treatment for the number of strokes set to supply the set small amount of unused PD fluid. Alternatively or additionally, the next treatment procedure is patient drainage and only a small amount of PD fluid is pumped, so the control unit 100 may cause a small amount of used PD fluid to be pumped into the used PD fluid lumen of the double-lumen patient line 28. Here, the control unit 100 opens the drain valve 54i and the used PD fluid valve 54g, and causes the PD fluid pump 70 to pump in the direction opposite to the treatment direction for the number of strokes set to supply the set small amount of used PD fluid.

[0136] When a small amount of unused / used PD fluid is pushed out towards the patient, if the patient is properly connected to the disposable filter set 40 and the double-lumen patient line 28, the output from one or more pressure sensors, such as any one or more of the pressure sensors 78a, 78b1, 78b2, and 78c, to the control unit 100 indicates the characteristic that the patient is properly connected. The output may be the same as or similar to the output sensed during patient filling, for example. When it is determined that the output from one or more pressure sensors indicates the characteristic that the patient is properly connected for treatment, the control unit 100 initiates the next patient drainage.

[0137] When a small amount of unused / used PD fluid is pushed towards the patient and the patient is not properly connected to the disposable filter set 40 and the double-lumen patient line 28, and when the distal end 28e of the double-lumen patient line 28 is placed and connected to the patient line connector 32, the output from one or more pressure sensors, such as any one or more of the pressure sensors 78a, 78b1, 78b2, and 78c, to the control unit 100 indicates a positive pressure increase characteristic of the distal end 28e of the double-lumen patient line 28 being connected to the patient line connector 32. Here, the small amount of unused / used PD fluid added to the double-lumen patient line 28 and the internal PD fluid line of the PD device or cycler shows the characteristic of positive pressure increase because the additional fluid is pushed into the closed internal lines of the PD device or cycler 20. When it is determined that the output from one or more pressure sensors indicates the characteristic that the double-lumen patient line 28 is improperly connected to the patient line connector 32, the control unit 100 causes the user interface 108 to issue an alarm or warning audibly, visually, or audiovisually, and notifies the patient that it is necessary to remove the patient line from the patient line connector 32 and connect it to the disposable filter set 40 (connected to the patient transfer set).

[0138] In one embodiment, the user interface 108 provides a patient line connection confirmation button that the patient presses after reconnecting the double-lumen patient line 28 to the disposable filter set 40. When one or more processors 102 of the control unit 100 receive a confirmation input from the user interface 108, the control unit starts the next patient drainage. If the patient does not press the confirmation button on the user interface 108 after a certain period of time, the control unit 100 makes a timeout decision, stops the treatment, causes the user interface 108 to issue an alarm or warning audibly, visually, or audiovisually, and notifies the patient that the current treatment has been stopped.

[0139] In an alternative embodiment, the patient line connection confirmation button is not provided. Instead, after an auditory, visual, or audiovisual patient line reconnection alert or warning, the control unit 100 waits for a predetermined time, e.g., one minute. The control unit 100 then causes the PD fluid pump 70 to pump a separate small amount of unused / used PD fluid (which may be heated) towards the patient along the double-lumen patient line 28 and monitors the output from one or more of the pressure sensors 78a, 78b1, 78b2, or 78c. The above process is repeated until the readings from one or more of the pressure sensors 78a, 78b1, 78b2, or 78c indicate that the patient has reconnected the double-lumen patient line 28 to the disposable filter set 40. The control unit then initiates the next patient drainage. After a certain number of attempts, if the readings from one or more of the pressure sensors 78a, 78b1, 78b2, or 78c still indicate that the patient has not reconnected the double-lumen patient line 28 to the disposable filter set 40, the control unit 100 stops the treatment and causes the user interface 108 to issue an auditory, visual, or audiovisual alert or warning to notify the patient that the current treatment has been stopped.

[0140] When a small amount of unused / used PD fluid is being pushed towards the patient, if the patient is not properly connected to the disposable filter set 40 and the double-lumen patient line 28, and if the distal end 28e of the double-lumen patient line 28 is left unconnected by the patient, the output to the control unit 100 from one or more pressure sensors, such as one or more of the pressure sensors 78a, 78b1, 78b2, and 78c, indicates a different pressure than when the patient line is connected to the patient.

[0141] When it is determined that the outputs from one or more pressure sensors 78a, 78b1, 78b2, and 78c indicate that the double-lumen patient line 28 has been left unconnected by the patient, the control unit 100 causes the user interface 108 to issue an audible, visual, or audiovisual alarm or warning, and to notify the patient that the patient line needs to be connected to the disposable filter set 40 (which is connected to the patient transfer set). The user interface 108 may again provide a confirmation button for the patient to confirm when the double-lumen patient line 28 has been reconnected to the disposable filter set 40. Alternatively, the control unit 100 described above may wait for a certain period of time before delivering another small amount of unused / used PD fluid into one or both lumens of the double-lumen patient line 28. If the confirmation button is pressed, or if a pressure reading from one of the additional PD fluid expulsions indicates that the patient line has been reconnected, the control unit 100 initiates the next patient drainage. Instead, if the confirmation button is not pressed after a timeout period, or if the pressure readings after a predetermined number of PD fluid expulsion attempts do not indicate that the patient line has been reconnected, the control unit 100 stops the procedure and issues an alarm or warning notifying the patient to the same effect as described herein.

[0142] Method 170 of FIG. 5 summarizes an embodiment of the pre-discharge patient connection confirmation structure and methodology of the system 10 of the present disclosure. At ellipse 172, method 170 begins. At block 174, at the end of patient dwell and prior to the start of patient discharge, the control unit 100 causes a small amount of unused PD fluid to be pumped into the unused fluid lumen of the dual-lumen patient line 28 and / or a small amount of used PD fluid to be pumped into the unused fluid lumen of the dual-lumen patient line 28, for example, by the methods described herein. At block 176, the control unit 100 causes one or more readings from one or more associated pressure sensors to determine the response to a small amount of fluid delivery. At diamond 178, the control unit 100 determines whether the pressure response to a small amount of fluid delivery indicates that the patient is properly connected to the dual-lumen patient line 28. At block 180, if the determined pressure response to a small amount of fluid delivery indicates that the patient is properly connected to the dual-lumen patient line 28, the control unit 100 initiates the next patient discharge.

[0143] At diamond 182, if the determined pressure response to a small amount of fluid delivery indicates that the patient is not properly connected to the dual-lumen patient line 28, the control unit 100 determines whether the pressure response indicates that the dual-lumen patient line 28 is (i) connected to the PD device or cycler 20 or (ii) not connected and hanging. At block 184, if the pressure response indicates that the dual-lumen patient line 28 is connected to the PD device or cycler 20, the control unit 100 audibly, visually, or audiovisually prompts the patient via the user interface 108 to remove the dual-lumen patient line 28 from the PD device or cycler 20 and connect it to the filter set 40 prior to the next patient discharge. At block 186, if the pressure response indicates that the dual-lumen patient line 28 is not connected and hanging, the control unit 100 audibly, visually, or audiovisually prompts the patient via the user interface 108 to retrieve the dual-lumen patient line 28 and connect it to the filter set 40 prior to the next patient discharge.

[0144] In block 188, method 170 may prompt the patient auditorily, visually, or audiovisually, if necessary (shown by the dashed line), to confirm when the double-lumen patient line 28 is properly connected for the next patient drainage. In diamond 190, control unit 100 may wait, if necessary (shown by the dashed line), to be confirmed by user interface 108 from the patient that the double-lumen patient line 28 is properly connected for the next patient drainage. Upon receiving the confirmation in diamond 190, or alternatively after a certain period after the prompt in block 184 or block 186, the method returns to block 174 and pumps another small volume of PD fluid to confirm by pressure readings that the double-lumen patient line 28 is properly connected for the next patient drainage.

[0145] Method 170 ends at ellipse 192 after the next patient drainage is initiated at block 180.

[0146] In a further alternative embodiment, method 170 does not provide a prompt at block 184 or block 186. Instead, after a certain time, it returns to block 174, pumps another small volume of PD fluid, and determines again via pressure readings that the double-lumen patient line 28 is properly connected for the next patient drainage.

[0147] In yet another alternative embodiment, after receiving the confirmation in diamond 190, method 170 relies on that confirmation, does not return to block 174, and instead initiates the next patient drainage. <000047>

[0148] 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. Accordingly, such changes and modifications are intended to be within the scope of the appended claims. For example, the system 10 for the features of the improved procedure described herein need not use redundant or durable components, and instead, a disposable set having a disposable pump section that contacts the corresponding medical fluid may be used. Such a disposable cassette may or may not use the disposable filter set 40. For example, the disposable filter set 40 is not required as a final opportunity filter in the case of a system that does not perform heat disinfection, while the unused PD fluid is brought online and the disposable filter set 40 may still be provided if used as a final opportunity filter for the online PD fluid. The PD fluid pumping with the disposable set may instead be performed via pneumatic pump operation of the sheet of the disposable cassette of the disposable set, via electromechanical pump operation of the sheet of the disposable cassette of the disposable set, or via peristaltic pump operation of a pumping tube segment provided with the disposable set. Also, although it is taught to apply a negative pressure to the reusable double-lumen patient line 28 for leakage prevention, it is conceivable to apply a negative pressure to a reusable single-lumen patient line instead for leakage prevention.

[0149] Furthermore, although the structure and function for emptying the container or bag of the present disclosure have been described in connection with pumping residual unused PD fluid into the drain, alternatively, it is conceivable to provide additional fluid lines and valves that enable the control unit 100 to pump the residual PD fluid into another PD fluid container or bag. It may be necessary during the procedure to discard the unused PD fluid and pump it into the drain. Examples include overheating or underheating of the unused PD fluid in the in-line resistive heater 56, and instead of pumping the overheated or underheated PD fluid to the patient P, the fluid is pumped into the drain until an appropriately heated PD fluid is detected. Another example is the detection of air in the unused PD fluid. In either case, pumping the unused PD fluid into the drain can result in a shortage of unused PD fluid. Therefore, here, by pumping the residual PD fluid from the previously used PD fluid container or bag into the later used PD fluid container or bag, the previously used PD fluid container or bag is emptied while storing the unused PD fluid for later use as needed. The residual pumping into the later used container or bag may be performed only during the last patient stay as described above, or may be performed over two or more patient stays. During the last patient stay, the control unit 100 causes any residual PD fluid in the later used PD fluid container or bag to be pumped into the drain in the manner described above.

[0150] Furthermore, although the pre-discharge patient connection confirmation structure and function of the present disclosure have been described in connection with the disposable filter set 40 shown in FIG. 1, the disposable filter set 40 is not required. Instead, a patient line 28, which may be a double-lumen or single-lumen patient line, may be directly connected to the patient transfer set. Furthermore, although it has been described that a small amount of used PD fluid is pumped into the used PD fluid lumen of the double-lumen patient line 28 for connection confirmation, alternatively, the tube or line configuration of the PD device or cycler 20 may be modified so that a small amount of unused PD fluid can be pumped into the used PD fluid lumen of the patient for connection confirmation.

Claims

1. A peritoneal dialysis (“PD”) system comprising: a housing; a PD fluid pump housed by the housing; a reusable patient line extending from the housing, the reusable patient line including a distal end configured to be connected to a patient line connector provided by the housing; at least one reusable PD fluid line extending from the housing, the at least one reusable PD fluid line including a distal end configured to be connected to a PD fluid line connector provided by the housing; a control unit configured to apply a negative pressure to the PD fluid pump and to at least one of the reusable patient line or the at least one reusable PD fluid line when each is connected to the patient line connector and the PD fluid line connector, respectively, prior to any of the lines being connected for treatment. A PD system comprising the above.

2. The PD system according to claim 1, wherein the reusable patient line is a double lumen patient line including an unused PD fluid lumen and a used PD fluid lumen, and the negative pressure is applied to at least one of the unused PD fluid lumen and the used PD fluid lumen.

3. The PD system according to claim 2, wherein the negative pressure is applied to the unused PD fluid lumen by operating the PD fluid pump in a direction opposite to the treatment direction, and the negative pressure is applied to the used PD fluid lumen by operating the PD fluid pump in the treatment direction.

4. The PD system according to claim 1, further comprising a plurality of PD fluid line valves, wherein the negative pressure is applied to the plurality of PD fluid lines through the PD fluid pump and by sequentially opening the plurality of PD fluid line valves.

5. The PD system according to claim 1, wherein the negative pressure is between -5 kPa (-0.73 psig) and -15 kPa (-2.2 psig).

6. During the disinfection sequence, the reusable patient line is connected to the patient line connector, the at least one reusable PD fluid line is connected to at least one PD fluid line connector, and the negative pressure is automatically applied after the disinfection sequence. The PD system according to claim 1.

7. The housing houses an internal PD fluid line, and the reusable patient line and the at least one reusable PD fluid line form a closed PD fluid loop with the internal PD fluid line for the disinfection sequence. The PD system according to claim 6.

8. The PD system according to claim 1, further comprising a user interface, wherein the control unit is further configured to cause the user interface to provide a message to wait until a line disconnection preparation sequence is completed before removing the reusable patient line and the at least one reusable PD fluid line from the housing.

9. The PD system according to claim 1, further comprising a user interface, wherein the control unit is further configured to cause the user interface to provide a message indicating that the reusable patient line and the at least one reusable PD fluid line are ready to be removed from the housing.

10. The PD system according to claim 9, wherein the user interface is further configured to provide a movement graphic indicating an appropriate method for removing the distal end of the reusable patient line or the reusable PD fluid line from the housing.

11. The negative pressure collapses at least one of the reusable patient line or the at least one reusable PD fluid line before removal from the housing and expands it after removal from the housing, thereby holding the PD fluid in at least one of the reusable patient line or the at least one reusable PD fluid line. The PD system according to claim 1.

12. The PD system according to claim 1, further comprising a disposable filter set for connecting to the distal end of the reusable patient line when removed from the housing.

13. The PD system according to claim 1, further comprising at least one PD fluid container for connection to the distal end of the at least one reusable PD fluid line when removed from the housing.

14. The PD system according to claim 1, wherein at least one of the patient line connector or the at least one PD fluid line connector is installed horizontally with respect to the housing.

15. The PD system according to claim 1, wherein the control unit is further configured to lock the negative pressure at the distal end of the reusable patient line to at least one valve before any of the lines are connected for treatment.

16. The PD system according to claim 1, wherein the control unit is further configured to lock the negative pressure at the distal end of the at least one PD fluid line to at least one valve before any of the lines are connected for treatment.

17. A peritoneal dialysis (“PD”) device, a housing, a PD fluid pump housed by the housing, a reusable patient line extending from the housing, the reusable patient line including a distal end configured to be connected such that the reusable patient line is in fluid communication with at least one internal PD fluid line located within the housing, at least one reusable PD fluid line extending from the housing, the at least one reusable PD fluid line including a distal end configured to be connected such that the at least one PD fluid line is in fluid communication with the at least one internal PD fluid line, a control unit configured to apply a negative pressure to at least one of the reusable patient line or the at least one reusable PD fluid line when connected in fluid communication with the at least one internal PD fluid line to the PD fluid pump before any of the lines are connected for treatment. A PD device comprising.

18. During the disinfection sequence, the reusable patient line is disposed in fluid communication with at least one internal PD fluid line, the at least one reusable PD fluid line is disposed in fluid communication with the at least one internal PD fluid line, and the negative pressure is automatically applied after the disinfection sequence. The PD device according to claim 17.

19. The control unit is further configured to lock the negative pressure at the distal end of the reusable patient line to at least one valve before any of the lines are connected for treatment. The PD device according to claim 17.

20. The control unit is further configured to lock the negative pressure at the distal end of the at least one PD fluid line to at least one valve before any of the lines are connected for treatment. The PD device according to claim 17.

21. A peritoneal dialysis (“PD”) system comprising a plurality of PD fluid containers, a PD device comprising a housing, a PD fluid pump housed by the housing, a control unit configured to cause the PD fluid pump to withdraw residual PD fluid from at least one of the plurality of PD fluid containers during patient dwell, and a PD device including A PD system comprising.

22. The PD system according to claim 21, further comprising a separate PD fluid line extending from the housing to each of the PD fluid containers, the residual PD fluid being pumped through at least one respective PD fluid line.

23. The PD fluid line is reusable. The PD system according to claim 22.

24. The plurality of PD fluid containers are in fluid communication with a disposable pumping section operable with the PD fluid pump. The PD system according to claim 21.

25. The control unit is configured to cause the PD fluid pump to withdraw residual PD fluid from the plurality of PD fluid containers during the final patient dwell. The PD system according to claim 21.

26. The PD device includes a PD fluid valve for each PD fluid container, and the control unit is configured to open the PD valves for the respective PD fluid containers in sequence while residual PD fluid is being pumped from the respective PD fluid containers during the final patient dwell. The PD system according to claim 25.

27. The control unit is further configured to cause the PD fluid pump to perform a final patient filling using the final filled PD fluid from the last filled container after the final patient drainage after the final patient stay, when one of the PD fluid containers is the last filled container, in the PD system according to claim 25.

28. The control unit is further configured to pre-determine for each PD fluid container from which residual PD fluid is pumped, that the PD fluid container has residual PD fluid less than the filling volume, in the PD system according to claim 25.

29. The control unit is configured to cause the residual PD fluid to be pumped to a drain from at least one of the plurality of PD fluid containers, in the PD system according to claim 21.

30. The drain is a drain container or a house drain, in the PD system according to claim 29.

31. The control unit is configured to cause the residual PD fluid to be pumped to a different PD fluid container from at least one of the plurality of PD fluid containers, in the PD system according to claim 21.

32. The control unit is configured to cause the PD fluid pump to extract residual PD fluid from at least one of the plurality of PD fluid containers during a plurality of patient stays, in the PD system according to claim 21.

33. The PD device includes a PD fluid valve for each PD fluid container, and the control unit is configured to sequentially open the PD valve for each of the PD fluid containers while residual PD fluid is being pumped from each of the PD fluid containers during one period of the patient stay, in the PD system according to claim 32.

34. The control unit is further configured to cause the PD fluid pump to perform a final patient filling using the final filled PD fluid from the last filled container after the final patient drainage, when one of the PD fluid containers is the last filled container, in the PD system according to claim 32.

35. The control unit is further configured to pre-determine for each PD fluid container from which residual PD fluid is pumped, that the PD fluid container has residual PD fluid less than the filling volume, in the PD system according to claim 32.

36. A method for assisting in the transportation of peritoneal dialysis ( "PD") disposable articles after treatment, the method comprising: causing a PD fluid pump to pump PD fluid from a PD fluid container to a patient during patient filling; and during subsequent patient dwell, causing the PD fluid pump to remove residual PD fluid from the PD fluid container so that the residual PD fluid need not be transported after treatment. A method comprising the above. **Claim 37** The method according to claim 36, further comprising determining that the amount of residual PD fluid is less than a predetermined filling volume before pumping the residual PD fluid from the PD fluid container. **Claim 38** The method according to claim 36, further comprising pumping the residual PD fluid from the PD fluid container to a drain or another PD fluid container. **Claim 39** The method according to claim 36, wherein the subsequent patient dwell is a final patient dwell, and the method includes causing the PD fluid pump to remove residual PD fluid from a plurality of PD fluid containers during the final patient dwell. **Claim 40** The method according to claim 36, wherein the subsequent patient dwell is an initial patient dwell, and the method includes causing the PD fluid pump to remove residual PD fluid from a second PD fluid container during a second patient dwell. **Claim 41** The method according to claim 36, further comprising causing the PD fluid pump to pump the last filled PD fluid to the patient after removing residual PD fluid from each of the other PD fluid containers. **Claim 42** A peritoneal dialysis ("PD") system comprising: a housing; a PD fluid pump housed by the housing; a pressure sensor positioned and arranged to sense the pressure of the PD fluid pumped by the PD fluid pump; a patient line in fluid communication with the PD fluid pump, the patient line being configured to be arranged to be in fluid communication with a patient transfer set for performing a PD treatment; and a control unit configured to: (i) cause the PD fluid pump to pump a quantity of PD fluid into the patient line before patient drainage; (ii) record the output from the pressure sensor resulting from the pumped quantity of PD fluid; and (iii) determine whether the patient line is in fluid communication with the patient transfer set based on the output from the pressure sensor. A PD system comprising the above components. **Claim 43** The control unit of claim 42 is further configured to initiate the patient drain when it is determined, based on the output from the pressure sensor, that the patient line is in fluid communication with the patient transfer set.

44. The control unit of claim 42 is further configured to provide a visual, audible, or visual-audible message when it is determined, based on the output from the pressure sensor, that the patient line is not in fluid communication with the patient transfer set.

45. After or in combination with the message, the control unit of claim 44 is further configured to request confirmation that the patient line is disposed in fluid communication with the patient transfer set.

46. After receiving confirmation that the patient line is disposed in fluid communication with the patient transfer set, the control unit: (i) causes a second amount of PD fluid to be pumped into the patient line by the PD fluid pump prior to the patient drain; (ii) records a second output from the pressure sensor resulting from the second pumped amount of PD fluid; and (iii) is further configured to determine, based on the second output from the pressure sensor, whether the patient line is in fluid communication with the patient transfer set. The PD system of claim 45.

47. The control unit of claim 42 is further configured to determine the position of the distal end of the patient line based on the output from the pressure sensor when it is determined that the patient line is not in fluid communication with the patient transfer set.

48. One determined position of the distal end of the patient line is connected to a patient line connector in the housing, and the control unit is further configured to provide a visual, audible, or visual-audible prompt that prompts disconnection from the patient line connector in the housing and reconnection to a connector on the patient. The PD system of claim 47.

49. One determined position of the distal end of the patient line remains unconnected, and the pre-control unit is further configured to provide a visual, auditory, or audiovisual prompt to prompt the connection of the distal end to the connector in the patient. The PD system according to claim 47.

50. The certain amount of PD fluid is from 1 to 10, for example 5 milliliters ("ml"). The PD system according to claim 42.

51. The pressure sensor includes a plurality of pressure sensors, and the control unit is configured to determine whether the patient line is in fluid communication with the patient transfer set based on a plurality of outputs from the plurality of pressure sensors. The PD system according to claim 42.

52. The patient line is reusable and extends from the housing. The PD system according to claim 42.

53. The patient line is disposable and is in fluid communication with a disposable pumping section operable with the PD fluid pump. The PD system according to claim 42.

54. The patient line is configured to be disposed in fluid communication with the patient transfer set via a disposable filter located between the patient line and the patient transfer set. The PD system according to claim 42.

55. The patient line is a double-lumen patient line, and pumping a certain amount of PD fluid into the patient line includes pumping the certain amount into one or both of the unused or used PD fluid lumens of the double-lumen patient line. The PD system according to claim 42.

56. A method for preventing the initiation of patient drainage with an unconnected or improperly connected patient line, the method comprising: Before patient drainage, pumping a certain amount of PD fluid into the patient line; Measuring the resulting pressure from the certain amount of PD fluid pumped into the patient line; Determining from the resulting pressure whether the patient line is in fluid communication with the patient transfer set; Initiating the patient drainage when it is determined that the patient line is in fluid communication with the patient transfer set. Including, method.

57. The method of claim 56, further comprising determining a position of a distal end of the patient line from the resulting pressure when it is determined that the patient line is not in fluid communication with the patient transfer set. **Claim 58** The method of claim 57, further comprising facilitating connection of the patient line based on the determined position of the distal end. **Claim 59** The method of claim 56, further comprising repeating the pumping, measuring, determining, and initiating the discharge after receiving confirmation that the patient line is disposed in fluid communication with the patient transfer set.

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