Peritoneal dialysis system and method for managing patient excretion pain

Abstract

A peritoneal dialysis ("PD") system includes: a PD fluid pump; a patient line for receiving used PD fluid pumped by the PD fluid pump during patient discharge; a control unit configured to cause the PD fluid pump to pump used PD fluid through the patient line according to a first command pressure during patient discharge; and a personal digital assistant ("PDA") in wireless communication with the control unit, the PDA configured to enable the patient to send a command to the control unit while experiencing patient discharge, the command instructing the control unit to cause PD fluid to be pumped according to a second command pressure during patient discharge.

Description

Technical Field

[0001] The present disclosure relates generally to medical fluid therapy, and in particular to dialysis fluid therapy. Background Art

[0002] Due to various reasons, a person's kidney system can fail. Kidney failure produces several physiological disturbances. It is no longer possible to balance water and minerals or excrete the daily metabolic load. Toxic end products of metabolism (such as urea, creatinine, uric acid and other substances) may accumulate in the patient's blood and tissues.

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

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

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

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

[0007] Most HD, HF and HDF treatments are performed in centers. Today there is a trend toward home hemodialysis ("HHD"), in part because HHD can be performed every day, which provides therapeutic benefits compared to hemodialysis treatments in centers that are usually performed every two or three weeks. Studies have shown that more frequent treatments remove more toxins and wastes and provide less interdialytic fluid overload than patients who receive less frequent but potentially longer treatments. Patients who receive more frequent treatments do not experience as many down cycles (fluctuations of fluids and toxins) as patients in centers, where patients have accumulated two or three days' worth of toxins before treatment. In some areas, the nearest dialysis center may be many miles away from the patient's home, which results in home treatment time taking up most of the day. Treatment at a center near the patient's home may also take up most of the patient's day. HHD can be performed at night or during the day while the patient is relaxing, working or otherwise producing.

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

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

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

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

[0012] APD patients may experience what is known as drain pain. The negative pressure applied to the patient's peritoneal cavity during draining may cause pain, especially for new patients whose peritoneal cavity may be extra sensitive. The pain level may be to a level where the patient no longer wishes to continue APD therapy. Certain APD machines are configured to supply the negative pumping pressure using pneumatic pressure or air pressure applied to the air side of one or more flexible membranes or diaphragms. The negative pressure draws the flexible membrane or diaphragm inward, causing the spent PD fluid or effluent to be drawn away from the patient along the fluid side of the flexible membrane or diaphragm. The applied negative pneumatic pressure is constant, meaning that the applied pressure is the same regardless of the non-constant conditions present at the patient.

[0013] Conditions that exist at the patient change. For example, assuming a nighttime treatment where the patient is sleeping, the patient's sleeping position changes. Also, during the patient's discharge, the volume of effluent that resides within the patient's peritoneal cavity changes. Each of these changing conditions affects the flow rate of spent PD fluid or effluent that flows along the patient line back to the APD machine. The flow rate affects the amount of pressure drop along the patient line, wherein the higher the flow rate, the higher the pressure drop.

[0014] In low flow patient conditions, for example, the patient's sleeping position has limited the discharge flow rate to some extent, or the patient's peritoneal cavity is almost empty, resulting in a lack of effluent supply, the corresponding pressure drop will be lower. The constant negative pressure applied for both high and low discharge flow rates will create an environment in which the patient is painful to discharge during low discharge flow rates.

[0015] Therefore, a need exists for an improved APD system that reduces or eliminates expulsion pain in patients. Summary of the invention

[0016] The present disclosure describes an automated peritoneal dialysis ("PD") system that reduces or eliminates drain pain. The PD system includes a PD machine or cycler. PD treatment using a PD machine occurs in cycles, each cycle having a fill phase, a dwell phase, and a drain phase. During the fill phase, fresh PD fluid is delivered to the patient under positive pressure. During the dwell phase, the just-filled fluid stays or remains in the patient and treats the patient. During the drain phase, the spent PD fluid is removed from the patient under negative pressure.

[0017] In one embodiment, the PD machine can deliver fresh, heated PD fluid to the patient at, for example, 14 kPa (2.0 psig) or higher. The PD machine can remove spent PD fluid or effluent from the patient at, for example, -9 kPa (-1.3 psig) or even greater negative pressure. The resulting flow rate to or from the patient may depend on several factors, including: where the patient is located in height compared to the pumping portion of the APD machine; the patient's sleeping position (assuming nighttime treatment); and the amount of effluent remaining in the patient's peritoneal cavity for the patient to drain.

[0018] If the PD machine pulls too hard during the drain phase, the patient may experience pain at the patient's sensitive peritoneal cavity. Drain pain often occurs at the end of the drain tube when there is less used PD fluid to be pulled by the machine's suction. Drain pain may also occur at or due to a misplaced PD catheter that resides in the patient. Only the patient who is experiencing drain pain knows the level of pain. The pain may be significant enough that the patient eventually seeks alternative renal failure treatments.

[0019] To alleviate discharge pain, a mobile application is provided that is accessed via a patient's smartphone or laptop / wireless keypad in accordance with the present disclosure. The smartphone or laptop / wireless keypad (which may be referred to as a personal digital assistant ("PDA")) is synchronized to the PD machine, for example, via WIFI, Bluetooth or other wireless technology. Wireless communication allows the patient during discharge to control the amount of negative pressure or suction provided by the machine, for example, if the patient is experiencing discharge pain, the negative pressure or suction is reduced. To this end, the control unit of the PD machine receives the wireless communication and causes the PD fluid pump to modify its negative output pressure accordingly. A smartphone or laptop / wireless keypad with a mobile application of the present disclosure in one embodiment provides and displays "up" and "down" buttons or selectors that enable the patient to increase and decrease the negative pressure or suction level of the PD machine between the minimum allowable negative pressure and the maximum allowable negative pressure. The display screen of the smartphone or laptop / wireless keypad displays a negative pressure level number, such as 1 to 10, which is a relative scale, where 1 indicates the minimum allowable negative pressure, 10 indicates the maximum allowable negative pressure, and 2 to 9 range from minimum pressure to maximum pressure.

[0020] The "up" and "down" buttons or selectors count up, one after the other, in the selected direction. For example, if the patient begins to experience a lot of discharge pain while the PD machine is pumping at a high negative pressure level, the patient can press the "min" or minimum button, which causes the pump to modify its output so that the negative pressure is reduced from whatever level it is at to the minimum negative pressure level of 1. If the patient instead feels well and wants to speed up the discharge phase by raising the negative pressure level, the patient can press the "max" or maximum button, which causes the pump to modify its output so that the negative pressure is increased from whatever level it is at to the maximum negative pressure level of 10. In one embodiment, negative pressure levels 1 through 10 are each within established safe patient pressure limits such that in no case can the PD machine supply too much negative pressure (potentially over-pressurizing the patient) or too little negative pressure (resulting in ineffective patient discharge).

[0021] The smartphone or laptop / wireless keypad also provides a Send button. When the negative pressure value that the patient wishes to send to the PD machine has been selected, the patient selects or presses the Send button, which causes the smartphone or laptop / wireless keypad to wirelessly deliver the new commanded negative pressure value to the control unit of the PD machine. Thus, the patient can increment the negative pressure values ​​at the smartphone or laptop / wireless keypad without sending those values ​​to the PD machine. Pressing the Send button causes the negative pressure value currently displayed at the smartphone or laptop / wireless keypad to be delivered to the PD machine, which accordingly changes the used PD fluid pumped from the patient. After the patient presses the Send button, the smartphone or laptop / wireless keypad may optionally display a pop-up confirmation button to confirm that the patient wants to deliver the new negative pressure value to the PD machine.

[0022] The PD machine may employ, for example, pneumatic PD fluid pumping or electromechanical PD fluid pumping. In the case of pneumatic PD fluid pumping, the negative pressure level may be adjusted by adjusting the variable orifice of a pressure regulator. In the case of pneumatic pumping, the negative pressure of the PD fluid may be known by measuring the pneumatic drive pressure, which is the same as the PD fluid pressure. If the PD fluid pumping is instead electromechanical, such as via a piston pump, the negative pressure level may be adjusted by adjusting the speed of a motor (such as a stepper motor driving the electromechanical pump). In the case of electromechanical pumping, the negative pressure of the PD fluid may be known by placing a pressure sensor along the negative pressure PD fluid line leading to the electromechanical pump (or in fluid communication therewith).

[0023] In accordance with the disclosure set forth herein, and without limiting the present disclosure in any way, in a first aspect of the present disclosure, which may be combined with any other aspect or portion thereof, a peritoneal dialysis ("PD") system includes: a PD fluid pump; a patient line for receiving spent PD fluid pumped by the PD fluid pump during a patient drain; a control unit configured to cause the PD fluid pump to pump the spent PD fluid through the patient line according to a first command pressure during the patient drain; and a personal digital assistant ("PDA") in wireless communication with the control unit, the PDA being configured to enable a patient, while undergoing the patient drain, to send a command to the control unit, the command instructing the control unit to cause the PD fluid pump to pump the spent PD fluid according to a second command pressure during the patient drain.

[0024] In a second aspect of the disclosure which may be combined with any other aspect or a portion thereof, the second command pressure is less than the first command pressure, the second command pressure facilitating reduction of pain experienced by a patient during expulsion of the patient.

[0025] In a third aspect of the disclosure which may be combined with any other aspect or a portion thereof, the second command pressure is greater than the first command pressure, the second command pressure facilitating a reduction in duration of the patient expulsion.

[0026] In a fourth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the PDA provides a set of relative pressure values ​​from which the patient can select for sending the command, and wherein the control unit is configured to convert the selected relative pressure value into the second command pressure.

[0027] In a fifth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the PDA provides a set of relative pressure values ​​from which the patient can select for sending the command, and wherein the control unit is configured to convert the selected relative pressure value into a pump actuation value corresponding to the second command pressure.

[0028] In a sixth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the PDA provides a set of relative pressure values ​​from which the patient can select for sending the command, and wherein the PDA is configured to convert the selected relative pressure value into the second command pressure.

[0029] In a seventh aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the PDA provides a set of relative pressure values ​​from which the patient can select for sending the command, and wherein the PDA is configured to convert the selected relative pressure value into a pump actuation value corresponding to the second command pressure.

[0030] In an eighth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the PDA provides a set of relative pressure values ​​from which the patient can select for sending the command, and wherein the PDA provides at least one of an upper increment selector or a lower increment selector for incrementing through the set of relative pressure values.

[0031] In a ninth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the PDA further provides a display for displaying increasing relative pressure values.

[0032] In a tenth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the PDA further provides a selector for causing the incremental relative pressure value desired by the patient or a converted value of the incremental relative pressure value to be delivered to the control unit.

[0033] In an eleventh aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the PDA further provides a selector for moving through the set of relative pressure values ​​to a minimum relative pressure value.

[0034] In a twelfth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the PDA further provides a selector for moving through the set of relative pressure values ​​to a maximum relative pressure value.

[0035] In a thirteenth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the PD fluid pump is pneumatically operated or electromechanically operated.

[0036] In a fourteenth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the PDA is configured to register with the control unit such that after registration, the PDA and the control unit automatically communicate wirelessly when powered.

[0037] In a fifteenth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the PDA is configured to register with the control unit via a serial number or a QR code from the PDA, the serial number or QR code being input into the control unit.

[0038] In a sixteenth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the PDA runs a mobile application configured to enable the patient, while experiencing the patient discharge, to send the command to the control unit.

[0039] In a seventeenth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, the command is a first command, wherein the control unit is further configured to communicate with a patient clinic via a network, and wherein the PDA further provides a selector, the selector being configured such that a second command is generated when the selector is selected, the second command requesting the control unit to contact the patient clinic.

[0040] In an eighteenth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the PD fluid pump and the control unit are part of a PD machine, and wherein the PDA is remote from the PD machine.

[0041] In a nineteenth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, a peritoneal dialysis ("PD") system comprises: a PD fluid pump; a patient line for receiving PD fluid pumped by the PD fluid pump during a PD treatment process; a control unit configured to cause the PD fluid pump to pump the PD fluid through the patient line according to a first command pressure during the PD treatment process; and a personal digital assistant ("PDA") that wirelessly communicates with the control unit, the PDA being configured to enable a patient while undergoing the PD treatment process to send commands to the control unit, the commands instructing the control unit to cause the PD fluid pump to pump PD fluid according to a second command pressure during the PD treatment process.

[0042] In a twentieth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the PD fluid is spent PD fluid and the PD treatment procedure is patient drain.

[0043] In a twenty-first aspect of the present disclosure, which may be combined with any other aspect or portion thereof, a peritoneal dialysis ("PD") machine comprises: a PD fluid pump; a patient line for receiving spent PD fluid pumped by the PD fluid pump during a patient drain; a control unit configured to cause the PD fluid pump to pump the spent PD fluid through the patient line according to a first command pressure during the patient drain; and a user interface in communication with the control unit, the user interface configured to enable a patient while undergoing the patient drain to send commands to the control unit, the user interface commands instructing the control unit to cause the PD fluid pump to pump the spent PD fluid according to a second command pressure during the patient drain.

[0044] In a twenty-second aspect of the present disclosure, which may be combined with any other aspect or portion thereof, a PD system includes a personal digital assistant ("PDA") that wirelessly communicates with the control unit, the PDA also being configured to enable the patient to send commands to the control unit while experiencing the patient discharge, the PDA commands instructing the control unit to cause the PD fluid pump to pump the used PD fluid according to a second command pressure during the patient discharge.

[0045] In a twenty-third aspect of the present disclosure that may be combined with any other aspect or a part thereof, Figures 1 to 5 Any features, functions and alternatives described in any one or more of the figures may be combined with Figures 1 to 5 any features, functions and alternatives described in any other figures in the drawings.

[0046]

[0013] According to the above aspects and the present disclosure set forth herein, an advantage of the present disclosure is to provide systems and methods for automated peritoneal dialysis ("PD") machines or cyclers that allow for minimization of patient discharge pain.

[0047] Another advantage of the present disclosure is to provide systems and methods for a PD machine or cycler that provide patient control over discharge pressure management.

[0048] Another advantage of the present disclosure is to provide systems and methods for a PD machine or cycler that allow for minimal patient expulsion pain without requiring additional PD machine equipment.

[0049] Furthermore, it is an advantage of the present disclosure to provide systems and methods for discharge pressure control that are easy for the patient to use.

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

[0051] Figure 1 is a cross-sectional schematic diagram of one embodiment of a peritoneal dialysis ("PD") system of the present disclosure that is configured to allow a patient to have discharge pressure control.

[0052] Figure 2 is a schematic diagram showing an alternative electromechanical pump and its closed loop pressure control.

[0053] Figure 3 is a schematic diagram of one embodiment of a patient drain pressure control PD system of the present disclosure, which includes a PD machine, associated PD fluid containers and patient connections, and a remote personal digital assistant ("PDA") for implementing drain pressure control.

[0054] Figure 4 is a schematic diagram illustrating a remote PDA embodiment in more detail.

[0055] Figure 5 is a process flow diagram illustrating one method for implementing patient exhaust pressure control into the PD therapy of the present disclosure. DETAILED DESCRIPTION

[0056] Referring now to the drawings and in particular to Figure 1 , shows an example system 10 including the patient discharge pain reduction method of the present disclosure. The system 10 includes a dialysis machine 20 (such as an APD machine) operating a medical fluid handling device 70 (such as a dialysis fluid cassette). Figure 1 The PD machine 20 in the example of FIG. 7 includes a housing 22 defining a pump interface 24 having a pump actuator or pump actuation region 26 for actuating a medical fluid processing device 70 . Figure 1The pump actuation region 26 in the example of the embodiment of the present invention is pneumatically actuated via a positive pneumatic line 28 extending from a positive pneumatic source 30 to perform a pumping or discharge stroke, for example, to (i) push fresh heated dialysis fluid to the peritoneal cavity of the patient 12 via the patient line 16 and the patient transfer kit 18; (ii) push fresh dialysis fluid to a heating container (not shown) to be heated to body temperature, such as 37° C., by a dialysis fluid heater (not shown); or (iii) push spent dialysis fluid to a drain. The patient line 16 may be three to seven meters long, such as approximately 4.5 meters or 6.7 meters, and have an inner diameter of, for example, three to four millimeters. The pump actuation region 26 in the illustrated embodiment is pneumatically actuated via a negative pneumatic line 32 extending from a negative pneumatic source 34 to perform a pumping or extraction stroke, for example, to (i) draw fresh dialysis fluid from a PD fluid source 40 via a supply line 42; (ii) draw fresh heated dialysis fluid from a heating container (not shown); or (iii) draw used dialysis fluid from the peritoneal cavity of the patient 12 via the patient line 16 and transfer kit 18.

[0057] The PD machine 20 also provides: a pressure sensor 44 for measuring a positive pneumatic pressure (corresponding to a positive PD fluid pressure) in the positive pneumatic line 28; and a pressure sensor 46 for measuring a negative pneumatic pressure (corresponding to a positive PD fluid pressure) in the negative pneumatic line 32. The PD machine 20 further includes a plurality of electrically operated pneumatic valves, such as valves 48, 50, 52, and 56. The pneumatic valve 48 is positioned in the positive pneumatic line 28 to selectively allow a positive pressure from the source 30 to reach the pump actuation area 26. The pneumatic valve 50 is positioned in the negative pneumatic line 32 to selectively allow a negative pressure from the source 34 to reach the pump actuation area 26. An exhaust valve 52 is disposed in an exhaust line 54 in communication with the positive pneumatic line 28 to selectively exhaust the positive pressure in the line 28 and the pump actuation area 26 to the atmosphere. A second exhaust valve 56 is provided in an exhaust line 58 in communication with the negative pneumatic line 32 to selectively exhaust the negative pressure in the line 32 and the pump actuation area 26 to the atmosphere. In an alternative embodiment, a single exhaust valve and line may be provided to exhaust both positive and negative pressures from the pump actuation area 26 to the atmosphere.

[0058] Figure 1The PD machine 20 is also shown to include: a positive pneumatic pressure regulator 62 (e.g., a variable orifice valve) positioned along the positive pneumatic line 28; and a negative pressure regulator 64 (e.g., a variable orifice valve) positioned along the negative pneumatic line 32. The positive pneumatic pressure regulator 62 sets the positive pneumatic pressure delivered to the pump actuation area 26 to a desired and controlled level, which is also the pressure of the fresh or spent PD fluid pumped out of the dialysis fluid cassette 70. The negative pneumatic pressure regulator 64 sets the negative pneumatic pressure drawn at the pump actuation area 26 to a desired and controlled level, which is also the pressure of the fresh or spent PD fluid pumped into the dialysis fluid cassette 70. In an alternative embodiment, the PD machine 20 can be pneumatically configured so that a single pressure regulator (e.g., a variable orifice valve) operates as a positive pneumatic pressure regulator and a negative pneumatic pressure regulator at different times. In any case, the negative pressure regulator allows the patient to adjust the negative PD fluid discharge pressure as desired and as described herein.

[0059] The pressure sensors 44 and 46, the pneumatic valves 48, 50, 52 and 56, and the variable orifice valves or regulators 62 and 64 are either output to the control unit 100 of the PD machine 20 or are under the control of the control unit 100. The control unit 100 in the illustrated embodiment includes: one or more processors 102; one or more memories 104; and a video controller for displaying images on a user interface 108 (which may alternatively or additionally include a display screen 132 and a patient discharge control input device of the present disclosure). The control unit 100 may have any one or more of a main controller, a safety controller, and / or a sub or delegate controller. The control unit 100 receives pressure readings from the pressure sensors 44 and 46 and selectively opens and closes the pneumatic solenoid valves 48, 50, 52 and 56 at programmed times or stages. The control unit 100 uses the outputs of the pressure sensors 44 and 46, respectively, in a pressure control routine (e.g., a proportional integral derivative ("PID") routine) to control the variable orifice valves or regulators 62 and 64 to deliver positive and negative pneumatic pressures at desired or commanded levels. It should be understood that the control unit 100 may be used with the control unit 100 for simplicity. Figure 1 Additional pressure sensors, temperature sensors, PD fluid valves, and PD fluid heaters, not shown, operate together.

[0060] Figure 1The control unit 100 is further shown to include a bidirectional transceiver 110 and a network stack for sending and receiving information to and from a personal digital assistant ("PDA") operated by the patient 12. The PDA can be any type of smart phone 120 or laptop / wireless keypad 122. The PDA includes a display area for displaying information to the patient 12. The PDA also includes input devices (buttons or selectors) for allowing the patient to enter and change data. The entered and changed data is delivered to the control unit 100 via the transceiver 110, and the control unit 100 uses the data to make changes to the operation of the PD machine 20, as discussed in detail herein.

[0061] exist Figure 1 In the illustrated embodiment of the medical fluid handling device or disposable cassette 70, a pump actuation chamber 72 is provided that matches the pump actuation area 26 to form an overall pumping chamber. The medical fluid handling device 70 in the illustrated embodiment includes a flexible membrane, diaphragm, or sheet 74 that can be sized to fit the pump actuation chamber 72, or can be sized to cover the entire side of the medical fluid handling device 70 (as shown), wherein a portion of the membrane 74 covers the pump actuation chamber 72, and wherein the portion can be at least substantially flat or pre-dome-shaped or pre-formed to fit into one or both of the pump actuation area 26 and the pump actuation chamber 72. The flexible membrane 74 (or a separate membrane) may also cover and be used to actuate medical fluid valves (not shown), such as: (i) a fluid valve positioned and arranged to selectively allow medical fluid to flow from the fluid source 40 through the supply line 42 and the supply channel 76 of the medical fluid handling device 70 to the pump actuation chamber 72; and (ii) a fluid valve positioned and arranged to selectively allow medical fluid to flow from the pump actuation chamber 72 through the patient channel 78 of the medical fluid handling device 70, through the patient line 16 and the patient transfer kit 18 to the peritoneal cavity of the patient 12. It should be understood that the medical fluid handling device 70 may have additional fluid valves, for example, additional fluid valves for additional pump actuation chambers 72 (operated in an alternating manner to provide more continuous flow) and additional fluid valves for multiple supply lines 42, fluid heater lines and / or drain lines, for simplicity. Figure 1 , these additional fluid valves are not shown.

[0062] The control unit 100 causes negative pressure from the source 34 to be applied to the flexible membrane 74 to draw the sheet against the wall of the pump actuation area 26, thereby correspondingly drawing fresh or spent PD fluid into the pump actuation chamber 72. To this end, the control unit causes valves 48, 52, and 56 to close and valve 50 to open. During filling of the pump actuation chamber 72, the pressure sensor 46 measures the negative pumping pressure, which is used as feedback in the pressure control routine to set the level of negative pneumatic pressure applied at the pump actuation area 26 via the negative pressure regulator 64.

[0063] The control unit 100 causes positive pressure from the source 30 to be applied to the flexible membrane 74 to push the sheet against the wall of the pump actuation chamber 72, thereby correspondingly pushing fresh or spent PD fluid from the pump actuation chamber 72. To this end, the control unit 100 causes valves 50, 52, and 56 to close and valve 48 to open. During the discharge of the pump actuation chamber 72, the pressure sensor 44 measures the positive pumping pressure, which is used as feedback in the pressure control routine to set the level of positive pneumatic pressure applied at the pump actuation area 26 via the positive pressure regulator 62.

[0064] It should be understood that the PD machine 20 may provide two pump actuation areas 26 and pump actuation chambers 72 that operate in an alternating manner (one filling while the other draining) so that the flow rate of fresh or used PD fluid is continuous for the most part. Figure 1 The PD machine 20 in FIG. 1 has been shown as a pneumatically operated PD machine, but the system 10 may alternatively employ different types of PD fluid pumping (and valve actuation), such as electromechanical pumping, including piston pumping or peristaltic pumping. Figure 2 An alternative pumping configuration is shown in which an electromechanical stepper motor pump 80 is employed. Figure 2 In the embodiment of the present invention, the control unit 100 is again employed, but here for controlling the stepper motor pump 80. The stepper motor pump 80 is a piston pump in one embodiment, wherein fresh and used PD fluid flows through the body of the pump. The stepper motor pump 80 is a peristaltic pump in an alternative embodiment, wherein fresh and used PD fluid flows through a tube actuated by a rotor driven by a stepper motor.

[0065] Figure 2The control unit 100 is shown controlling valves 82, which are fluid valves, such as solenoid operated solenoid pinch valves or electric pinch valves. The control unit 100 is configured to selectively control the valves 82 to open flow (i) from a desired fluid source (such as a supply container 40, a heater container, or a patient) (ii) to a desired fluid destination (such as a patient or a drain container / house drain). The control unit 100 receives one or more inputs from one or more pressure sensors 84, such as a first pressure sensor positioned and arranged to sense the pressure of a common PD fluid source line and a second pressure sensor positioned and arranged to sense the pressure of a common PD fluid destination line. The control unit 100 receives one or more inputs from one or more temperature sensors 86, such as a first temperature sensor positioned and arranged to sense the temperature of the PD fluid located within the PD fluid heating container or to sense the temperature of the PD fluid downstream of an inline PD fluid heater. A second temperature sensor may be provided as a redundant or additional sensor for sensing the temperature of the PD fluid within the PD fluid heating vessel, or positioned to detect the PD fluid temperature upstream of an inline PD fluid heater.

[0066] Figure 2 It is further shown that one or more memories 104 can store an electromechanical pump algorithm operated by one or more processors 102 of the control unit 100, such as a proportional integral derivative ("PID") pump algorithm 88. Here, the control unit 100 can receive a command discharge pressure from the patient's PDA (smartphone 120 or laptop / wireless keypad 122) via the transceiver 110. The command discharge pressure (which can alternatively come from the PD machine 20) is used in the PID pump algorithm 88 together with the measured patient discharge pressure from the corresponding pressure sensor 84 to determine the pressure error. The PID algorithm 88 inputs the pressure error and outputs a corrected speed for the stepper motor pump 80 using different PID gain values, which can be in the form of a current, a pulse width modulation ("PWM") value, or a value associated with the stepper motor controller for obtaining a corrected pump speed. Over time, the actual pressure output by the pressure sensor 84 should meet the command pressure.

[0067] Figure 3The system 10 of the present disclosure is further schematically shown. The system 10 includes a PD machine 20 having a housing that holds: any one or more of any of the different types of pumps discussed herein; a pneumatic or direct fluid pressure sensor as discussed herein; one or more temperature sensors; a pneumatic or electromechanical actuated valve; a batch or inline PD fluid heater; an air or bubble trap for removing air from the PD fluid prior to delivering the PD fluid to the patient 12; a leak sensor for detecting PD fluid leaks; and / or one or more Hall effect sensors for detecting whether a fluid connection is made or whether a door of the PD machine 20 is properly closed.

[0068] exist Figure 3 , the PD fluid machine receives fresh PD fluid from one or more PD fluid sources 40. For a patient fill, the control unit 100 causes fresh PD fluid to be delivered from the PD fluid source 40 to the peritoneal cavity of the patient 12 via the patient line 16, the patient transfer set 18, and the peritoneal dialysis catheter 14, which is surgically attached to the patient 12 and extends from the patient transfer set 18 into the patient's peritoneal cavity. For a patient drain, the control unit 100 causes spent PD fluid to be delivered from the peritoneal cavity of the patient 12 back through the peritoneal dialysis catheter 14, through the patient transfer set 18, and through the patient line 16 to a drain container 60 or a house drain (such as a nearby toilet or bathtub).

[0069] As discussed herein, applying a constant negative pressure during patient draining may cause patient draining pain during periods of low flow rates or for reasons associated with the location of the peritoneal dialysis catheter 14. To alleviate draining pain, and allow the patient to generally control draining pressure, the present system 10 provides the patient with a wireless PDA (smartphone 120 or laptop / wireless keypad 122) as discussed herein, which communicates with the control unit 100 via the transceiver 110 and WIFI, Bluetooth or other wireless technology. Figure 3 As shown in , the smartphone 120 and the laptop / wireless keypad 122 each include or display a plurality of buttons or selectors. The buttons may be touch screen buttons formed by a touch screen cover placed on the display screen 132. Alternatively, the buttons may be electromechanical buttons, such as membrane switches. The buttons may include increment buttons, such as an upper button 124a and a lower button 124b. The buttons may include limit buttons, such as a minimum button 126a and a maximum button 126b. The buttons may further include a help button 128 and a send button 130, the help button 128 being used when the patient's discharge pain cannot be relieved, the patient pressing the send button 130 to send the commanded negative discharge pressure update.

[0070] Figure 3It is further shown that the user interface 108 of the PD machine 20 may show a display screen 132 and all associated user-expedited control buttons or selectors instead of or in addition to the display screen 132 on the smartphone 120 or laptop / wireless keypad 122. Figure 3 As shown in FIG. 1 , the display screen 132 at the user interface 108 includes an up button 124a, a down button 124b, a minimum button 126a, a maximum button 126b, a help button 128, a send button 130 (each of which is selectable by the patient, for example, via a touch screen associated with the user interface 108) and a display area 134 that shows a number corresponding to the discharge pressure level. In one embodiment, the display screen 132 at the user interface 108 is displayed together with the display screens 132 at the smartphone 120 and the laptop / wireless keypad 122. Changes made by the patient at the display screen 132 of any one of the user interface 108, the smartphone 120, or the laptop / wireless keypad 122 are reflected at the display screen 132 of the other of the user interface 108, the smartphone 120, or the laptop / wireless keypad 122. That is, the display screen 132 of the user interface 108 is updated to mirror the changes made at the display screen 132 of the smartphone 120 or the laptop / wireless keypad 122, and vice versa.

[0071] Reference now Figure 4 , showing a patient 12 in a reclining position, for example, during PD treatment. The patient is controlling his PDA (smartphone 120 or laptop / wireless keypad 122). The smartphone 120 and laptop / wireless keypad 122 are broken down so that increment buttons or selectors including an upper button 124a and a lower button 124b, limit buttons such as a minimum button 126a and a maximum button 126b, a help button 128, and a send button 130 are shown in more detail. The display screen 132 is shown having a display area 134 that shows numbers corresponding to the discharge pressure level. The example shown for the display area 134 shows numbers 1 to 10. In other embodiments, a smaller scale (such as 1 to 5) or a larger scale (such as 1 to 100) is provided.

[0072] Regarding the wireless keypad 122 version of the patient's PDA, the wireless keypad 122 can be a small keypad with few buttons and powered by one or more coin batteries. In one embodiment, the wireless keypad 122 is provided with a Bluetooth transceiver and a network stack. In one embodiment, the wireless keypad 122 communicates with the control unit 100 via Bluetooth, which uses less energy to save the battery life of the keypad. In various embodiments regarding the power-on and sleep modes of the wireless keypad 122 (also applicable to the smartphone 120): (i) pressing any button of the wireless keypad 122 will wake the keypad out of sleep; (ii) when awake, the keypad 122 receives the current stage of treatment (filling, staying or draining) from the PD machine 20; and (iii) if the current stage is not the draining stage, the keypad 122 can return to sleep. In various embodiments regarding a display 132 for a wireless keypad 122: (i) the wireless keypad 122 will have a small liquid crystal display ("LCD"), light emitting diode display ("LED"), or other type of character display; (ii) during powering of the wireless keypad 122, the display area 134 will briefly show the keypad's serial number (e.g., a few seconds), after which the display area 134 will display the current negative discharge pressure level (e.g., 1 to 10). The wireless keypad 122 can be configured to display the serial number when it is powered on, and the PD machine 20 provides a configuration screen to register the keypad 122 via its serial number. In one embodiment, only one keypad 122 is allowed to pair with the PD machine 20.

[0073] As with any type of PDA, the buttons 124a, 124b, 126a, 126b, 128, 130 and display screen 134 are provided in one embodiment as a mobile application that can be downloaded and played on the smartphone 120 or laptop / wireless keypad 122. The mobile application allows the smartphone 120 or laptop / wireless keypad 122 to transmit data to and receive data from the PD machine 20. In one embodiment, the mobile application is provided with tools that allow the patient 12 to register or pair with the PD machine 20, for example, via WIFI (e.g., for the smartphone 120 or laptop 122), Bluetooth (e.g., for the keypad 122), or other wireless technologies. Wireless communication between the mobile application on the patient's PDA and the control unit 100 of the PD machine 20 can be carried out in various ways, for example: (i) via infrastructure mode, in which the control unit 100 of the PD machine 20 and the mobile application of the PDA are each connected to a home router and communication is carried out through the home network; or (ii) via WIFI direct connection, in which the control unit 100 of the PD machine 20 provides a WIFI access point and the mobile application of the PDA connects to the WIFI access point in a peer-to-peer manner.

[0074] In one embodiment, the mobile application is provided with a tab for registering with the PD machine 20. After pressing the tab, the patient is allowed to enter a unique number into the control unit 100 of the PD machine 20 or scan a QR code using the mobile application to register. After registration, the version of the mobile application installed on the smartphone 120 or laptop / wireless keypad 122 communicates only with the patient's PD machine 20. The memory 104 of the control unit 100 can store a unique International Mobile Equipment Identity ("IMEI") identifier to authenticate the discharge pressure command from the smartphone 120 or laptop / wireless keypad 122 before entering it into the machine control area of ​​the control unit. The control unit 100 may also look for a secret code generated by the mobile application for authentication purposes. In one embodiment, only one mobile application can be registered with the PD machine 20.

[0075] Once registered, the mobile application automatically connects to the PD machine 20 when both (i) the smartphone 120 or laptop / wireless keypad 122 and (ii) the PD machine 20 are powered. The mobile application can be configured to receive and display at the display area 134 the maximum and minimum allowable discharge pressure values ​​configured in the PD machine 20. The mobile application can be configured to have a persistent memory that stores old maximum, minimum, and default discharge pressure values. The mobile application can be configured so that: when the mobile application is opened, it displays at the display area 134 the unique identification of the PD machine 20 to which it is paired together with the minimum and maximum negative pressure thresholds of the machine.

[0076] In one embodiment, the upper button 124a and the lower button 124b enable the patient 12 to increase and decrease, respectively, the negative pressure or suction level provided by the pump 26 / 72 (pneumatic) or the pump 80 (electromechanical) between a minimum allowable negative pressure and a maximum allowable negative pressure. The display area 134 of the smartphone 120 or laptop / wireless keypad 122 displays increasing negative pressure level numbers, for example, 1 to 10 in the illustrated embodiment, which is a relative scale, where 1 indicates the minimum allowable negative pressure, 10 indicates the maximum allowable negative pressure, and 2 to 9 range from minimum to maximum allowable negative pump pressure.

[0077] The up button 124a and the down button 124b increment the count one after the other in the selected direction, such as from 4 to 5 or from 9 to 8. Pressing the minimum button 126a goes directly to 1 from whatever level it is at. For example, if the patient 12 begins to experience a lot of discharge pain while the PD machine 20 is pumping at a high negative pressure level, the patient can press the minimum button 126a and then press the send button 130, which causes the pump 26 / 27 or pump 80 to modify its output so that the negative pressure is reduced from whatever level it is currently at to the minimum negative pressure level of 1. Pressing the maximum button 126b takes the level directly to 10. If the patient 12 instead feels well and wants to speed up the patient discharge phase by raising the negative pressure level, the patient can press the maximum button 126b and then press the send button 130, which causes the pump 26 / 27 or pump 80 to modify its output so that the negative pressure is raised from whatever level it is currently at to the maximum negative pressure level of 10. In one embodiment, negative pressure levels 1 through 10 are each within established safe patient pressure limits such that in no event can PD machine 20 supply too much negative pressure (potentially over-pressurizing patient 12) or too little negative pressure (resulting in ineffective patient expulsion).

[0078] When the negative pressure value that the patient wishes to send to the PD machine 20 is displayed in the display area 134, the patient selects or presses the send button 130, which causes the PDA to wirelessly deliver the new commanded negative pressure value to the control unit 100 of the PD machine 20. Thus, the patient can increment the negative pressure values ​​as displayed at the display area 134 without sending those values ​​to the PD machine 20. Conversely, pressing the send button 130 causes the negative pressure value currently displayed at the display area 134 to be delivered to the PD machine 20, which correspondingly changes the pump pressure of the spent PD fluid removed from the patient. The smartphone 120 or laptop / wireless keypad 122 may optionally display a pop-up confirmation button after the patient presses the send button 130 to confirm that the patient wants to deliver the new negative pressure value to the PD machine 20.

[0079] The negative pressure value set as discussed above is transmitted to the PD cycler 20 wirelessly (as discussed herein) and continuously or according to some transmission frequency. The control unit 100 of the PD machine automatically converts the mobile application value into a corresponding negative pump pressure, for example, via one or more lookup tables stored in one or more memories 104. That is, the pressure level (e.g., 1 to 10) input by the patient is converted into a pressure value (e.g., in a pressure unit such as psig) at the control unit 100. In an alternative embodiment, the pressure level (e.g., 1 to 10) input by the patient is converted into a pump actuation value such as a variable orifice valve value (pneumatic) or a motor current value (electromechanical), which corresponds to the updated pressure value. In another alternative embodiment, any of the above alternatives is performed at the PDA (smartphone 120 or laptop / wireless keypad 122).

[0080] A patient using the system 10 can change the discharge pressure value during patient discharge based on the pain experienced, and change the discharge pressure value gradually or via larger steps as discussed above. However, in one embodiment, the patient cannot completely turn off the patient discharge. If the patient 12 still feels pain after the PD machine 20 is running at the minimum negative pressure level, the patient can press the help button 128, which causes the control unit 100 of the PD machine 20 to alert a remote caregiver or clinic. The caregiver or clinic in communication with the control unit 100 of the PD machine 20 over the network provides additional steps or procedures to reduce discharge pain.

[0081] The control unit 100 of the PD machine 20 is configured to end the patient drain in several ways. In one approach, the control unit looks for a specific effluent drain volume based on the amount of PD fluid filled by the previous patient, the expected ultrafiltration amount ("UF") obtained during the previous patient stay, and any residual PD fluid volume accumulated during the course of treatment. Here, the control unit 100 is not monitoring the patient drain time, so that if the patient reduces the negative drain pressure and slows the patient drain, the control unit 100 allows the patient drain to run until the target effluent drain volume has been removed. In another embodiment, the patient drain is time-based, so that if the patient reduces the negative drain pressure and slows the patient drain, the control unit 100 extends the patient drain time accordingly, so that the amount of effluent removed is the same as if the patient did not reduce the negative drain pressure and slow the patient drain. In a third embodiment (which can be combined with the first two embodiments), the control unit 100 looks for a characteristic increase or peak in the drain pressure that indicates that the patient is empty or almost empty, so that the drain should be stopped. In any of the above embodiments, to reduce patient expulsion time, it may be desirable to prompt the patient to increase expulsion pressure in the manner discussed herein (if the patient feels well) to accelerate the subsequent portion of the patient's expulsion.

[0082] Reference now Figure 5 , an embodiment of PD therapy using patient controlled negative drain pressure of the present disclosure is shown by method 150. Method 150 shows a PD therapy in which the patient is empty at the start of therapy, such that the first stage of therapy is a patient fill. Many PD therapies instead begin with the patient filling with spent PD fluid, such that the first stage of therapy is a patient drain. It should be understood that the patient drain control discussed herein and at steps from diamond 164 to diamond 174 of method 150 can be equally performed for an initial patient drain for starting PD therapy.

[0083] At oval 152, method 150 begins. At box 154, treatment setup is performed, such as fluid connection to PD fluid source 40 and placing a disposable kit (e.g., Figure 1 The medical fluid processing device 70 of the PD machine 20 is loaded into the PD machine 20. At box 156, an automatic data connection of the patient's PDA (smartphone 120 or laptop / wireless keypad 122) to the control unit 100 of the PD machine 20 is performed (assuming pairing or registration has already occurred).

[0084] At box 158, the control unit 100 calculates the time required for the pump 26 / 27 or pump 80 to perform a patient fill. At box 160, the control unit 100 causes the pump 26 / 27 or pump 80 to be actuated and operates any required valves in sequence to perform a patient fill. At box 160, the control unit 100 stops the pump 26 / 27 or pump 80 and operates any required valves in sequence to perform a patient stay. At diamond 164, the control unit 100 determines whether the patient stay has been completed. If not, the method 150 returns to box 162. If it is determined at diamond 164 that the patient stay has been completed, the control unit 100 proceeds to perform a patient drain according to the system 10 of the present disclosure.

[0085] At box 166, the control unit 100 initiates patient discharge by obtaining an initial negative discharge pressure and calculating or determining a corresponding level for actuating the pump 26 / 27 or pump 80. The control unit 100 for patient discharge is divided into parallel paths. In one path, at box 168, no patient command is received from the patient's PDA, causing the control unit 100 to continue patient discharge with the pump 26 / 27 or pump 80 actuated at the initially obtained level.

[0086] In the second path at box 170, the control unit 100 receives a wireless command from the patient's PDA (smartphone 120 or laptop / wireless keypad 122). At diamond 172, the control unit determines whether the wireless command is a command to change the negative patient drain pressure (e.g., as opposed to a help button command). If not, the control unit 100 performs any tasks associated with the wireless command, and the patient drain proceeds according to box 168 of the first path. If the command does involve a change in negative patient drain pressure as determined at diamond 172, the method proceeds to box 174.

[0087] At box 174, the control unit 100 updates the patient discharge by updating the negative discharge pressure according to the newly received command from the patient (up or down), and calculates or determines a new corresponding level for actuating pumps 26 / 27 or pump 80. The method 150 then returns to the point where the control unit 100 splits into parallel paths (one path to box 168 and the other path to box 170).

[0088] At diamond 176, the control unit 100 determines whether the current discharge has been completed (according to any one or more of the ways discussed above). If not, the method 150 returns to the point where the control unit 100 splits into parallel paths (one path to box 168 and the other path to box 170). If the current discharge has been completed (according to any one or more of the ways discussed above) as determined at diamond 176, the method 150 proceeds to diamond 178.

[0089] At diamond 178, the control unit 100 determines whether all treatment cycles for the current treatment have been completed. If not, the method 150 returns to box 158 to start the next patient fill. If all treatment cycles for the current treatment have been completed as determined at diamond 178, the method 150 ends at ellipse 180.

[0090] 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. Such changes and modifications are therefore intended to be covered by the appended claims. For example, while the system 10 and its associated methods have been discussed as providing negative discharge pressure control to a patient, the system 10 may alternatively provide positive fill pressure control to a patient.

Claims

1. A peritoneal dialysis ("PD") system comprising: PD fluid pump; a patient line for receiving spent PD fluid pumped by the PD fluid pump during a patient drain; a control unit configured to cause the PD fluid pump to pump the spent PD fluid through the patient line according to a first command pressure during the patient drain; as well as a personal digital assistant ("PDA") in wireless communication with the control unit, the PDA being configured to enable a patient while undergoing the patient drain to send commands to the control unit, the commands instructing the control unit to cause the PD fluid pump to pump the spent PD fluid according to a second command pressure during the patient drain.

2. The PD system according to claim 1, wherein: The second command pressure is less than the first command pressure, the second command pressure facilitating reduction of pain experienced by a patient during expulsion of the patient.

3. The PD system according to claim 1, wherein: The second command pressure is greater than the first command pressure, the second command pressure facilitating reducing a duration of expulsion of the patient.

4. The PD system according to claim 1, wherein: The PDA provides a set of relative pressure values ​​from which the patient can select for sending the command, and wherein the control unit is configured to convert the selected relative pressure value into the second command pressure.

5. The PD system according to claim 1, wherein: The PDA provides a set of relative pressure values ​​from which the patient can select for sending the command, and wherein the control unit is configured to convert the selected relative pressure value into a pump actuation value corresponding to the second command pressure.

6. The PD system according to claim 1, wherein: The PDA provides a set of relative pressure values ​​from which the patient can select for sending the command, and wherein the PDA is configured to convert the selected relative pressure value into the second command pressure.

7. The PD system according to claim 1, wherein: The PDA provides a set of relative pressure values ​​from which the patient can select for sending the command, and wherein the PDA is configured to convert the selected relative pressure value into a pump actuation value corresponding to the second command pressure.

8. The PD system according to claim 1, wherein: The PDA provides a set of relative pressure values ​​from which the patient can select for sending the command, and wherein the PDA provides at least one of an upper increment selector or a lower increment selector for incrementing through the set of relative pressure values.

9. The PD system according to claim 8, wherein: The PDA further provides a display for displaying increasing relative pressure values.

10. The PD system according to claim 8, wherein: The PDA further provides a selector for causing the incremental relative pressure value desired by the patient or a converted value of the incremental relative pressure value to be delivered to the control unit.

11. The PD system according to claim 8, wherein: The PDA further provides a selector for moving through the set of relative pressure values ​​to a minimum relative pressure value.

12. The PD system according to claim 8, wherein: The PDA further provides a selector for moving through the set of relative pressure values ​​to a maximum relative pressure value.

13. The PD system according to claim 1, wherein: The PD fluid pump is either pneumatically operated or electromechanically operated.

14. The PD system according to claim 1, wherein: The PDA is configured to register with the control unit such that, after registration, the PDA and the control unit automatically communicate wirelessly when powered.

15. The PD system according to claim 14, wherein: The PDA is configured to register with the control unit via a serial number or a QR code from the PDA, which is input into the control unit.

16. The PD system according to claim 1, wherein: The PDA runs a mobile application configured to enable the patient, while experiencing the patient discharge, to send the commands to the control unit.

17. The PD system according to claim 1, wherein: The command is a first command, wherein the control unit is further configured to communicate with a patient clinic via a network, and wherein the PDA further provides a selector, the selector being configured such that a second command is generated when the selector is selected, the second command requesting the control unit to contact the patient clinic.

18. The PD system according to claim 1, wherein: The PD fluid pump and the control unit are part of a PD machine, and wherein the PDA is remote from the PD machine.

19. A peritoneal dialysis ("PD") system comprising: PD fluid pump; a patient line for receiving PD fluid pumped by the PD fluid pump during a PD therapy procedure; a control unit configured to cause the PD fluid pump to pump the PD fluid through the patient line according to a first command pressure during the PD therapy procedure; as well as a personal digital assistant ("PDA") in wireless communication with the control unit, the PDA being configured to enable a patient, while undergoing the PD therapy procedure, to send commands to the control unit, the commands instructing the control unit to cause the PD fluid pump to pump PD fluid according to a second command pressure during the PD therapy procedure.

20. The PD system according to claim 19, wherein: The PD fluid is spent PD fluid and the PD treatment procedure is patient drained.

21. A peritoneal dialysis ("PD") machine comprising: PD fluid pump; a patient line for receiving spent PD fluid pumped by the PD fluid pump during a patient drain; a control unit configured to cause the PD fluid pump to pump the spent PD fluid through the patient line according to a first command pressure during the patient drain; as well as a user interface in communication with the control unit, the user interface being configured to enable a patient while undergoing the patient drain to send commands to the control unit, the user interface commands instructing the control unit to cause the PD fluid pump to pump the spent PD fluid according to a second command pressure during the patient drain.

22. A PD system, the PD system using the PD machine according to claim 21, wherein: The PD system includes a personal digital assistant ("PDA") that wirelessly communicates with the control unit, and the PDA is also configured to enable the patient to send commands to the control unit while experiencing the patient discharge, the PDA commands instructing the control unit to cause the PD fluid pump to pump the used PD fluid according to a second command pressure during the patient discharge.

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