Peritoneal dialysis loop

Abstract

A peritoneal dialysis fluid circuit includes: a patient line; a delivery line configured to supply fresh dialysis fluid to the patient line; an extraction line configured to extract the used dialysis fluid from the patient line; a first pump disposed on the delivery line and configured to supply fresh dialysis fluid to the patient line; and a second pump disposed on the extraction line and configured to extract the used dialysis fluid from the patient line. The fluid circuit also includes a control unit configured to perform a peritoneal dialysis procedure. A peritoneal dialysis procedure includes commanding activation of a first pump at a first flow rate and activation of a second pump at a second flow rate different than the first flow rate. The first and second pumps are simultaneously activated to provide a first flow rate and a second flow rate.

Description

Technical Field

[0001] The present disclosure relates generally to peritoneal dialysis circuits.

[0002] In particular, the present disclosure also relates to a peritoneal dialysis device including the circuit, and a process for performing peritoneal dialysis treatment. Background Art

[0003] Due to various reasons, a person's kidney system can fail. Kidney failure produces several physiological disorders. It is unable to maintain the balance of water and minerals and to discharge the daily metabolic load. Toxic end products of metabolism (such as urea, creatinine, uric acid and others) can accumulate in the patient's blood and tissues.

[0004] Dialysis is used to treat decreased kidney function, especially kidney failure. Dialysis removes waste products, toxins, and excess water from the body that are removed by normally functioning kidneys. Dialysis treatment to replace kidney function is vital for many people because it can mean the difference between life and death.

[0005] One type of renal failure therapy is hemodialysis ("HD"), which generally 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.

[0006] Hemofiltration ("HF") is an alternative renal replacement therapy that relies on the convective transport of toxins from the patient's blood. Hemofiltration is performed by adding replacement fluid, or substitution fluid, to the extracorporeal circuit during treatment. During hemofiltration treatment, the replacement fluid, as well as fluid accumulated by the patient between treatments, undergoes ultrafiltration, providing a convective transport mechanism that is particularly beneficial in removing medium and large molecules.

[0007] Hemodiafiltration ("HDF") is a treatment modality that combines convective and diffuse cleansing. HDF uses dialysis fluid flowing through the dialyzer (similar to standard hemodialysis) to provide diffuse cleansing. In addition, a replacement solution is provided directly to the extracorporeal circuit to provide convective cleansing.

[0008] Most HD, HF, and HDF treatments occur in centers. Today there is a trend toward home hemodialysis (HHD), in part because HHD can be performed daily, providing therapeutic benefits compared to the typically two to three times a week in-center hemodialysis treatments. Studies have shown that more frequent treatments remove more toxins and waste products and reduce interdialytic fluid overload compared to patients who receive less frequent but potentially longer treatments. Patients who receive more frequent treatments do not experience as many troughs (fluid and toxin fluctuations) as in-center patients because in-center patients have accumulated toxins for two or three days prior to treatment. In some areas, the nearest dialysis center to a patient's home can be miles away, making home treatment times consume a large portion of the day. Treatment at a center close to the patient's home can also consume a large portion of the patient's day. HHD can be performed at night or during the day when the patient is resting, working, or doing other things.

[0009] 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 cavity via a catheter. The dialysis fluid comes into contact with the peritoneum in the patient's peritoneal cavity. Waste, toxins, and excess water pass from the patient's bloodstream through the capillaries in the peritoneum and enter the dialysis fluid due to diffusion and osmosis (i.e., an osmotic gradient occurs across the membrane). The osmotic agent in the PD dialysis fluid provides the osmotic gradient. Used or spent dialysis fluid is discharged from the patient, removing waste, toxins, and excess water from the patient's body. Such a cycle is repeated, for example, multiple times.

[0010] 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 cavity. The patient then switches the fluid connection so that the patient's catheter is connected to a bag of fresh dialysis fluid to infuse the fresh dialysis fluid into the patient's body through the catheter. The patient then disconnects the catheter from the bag of fresh dialysis fluid, allowing the dialysis fluid to reside in the peritoneal cavity, where waste, toxins, and excess water are transferred. After the dwell period, the patient repeats this manual dialysis procedure, for example, four times a day. Manual peritoneal dialysis requires a lot of time and effort from the patient, which leaves a lot of room for improvement.

[0011] APD is similar to CAPD in that dialysis treatment includes a drain, fill, and dwell cycle. However, the APD machine cycles automatically, usually while the patient is sleeping. The APD machine frees the patient from having to manually perform treatment cycles and having to transport 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 dialysis fluid source, through a catheter, and then into the patient's peritoneal cavity. The APD machine also allows the dialysis fluid to remain in the peritoneal cavity and allows waste, toxins, and excess water to be transferred. The source can include multiple liters of dialysis fluid, including several solution bags.

[0012] The APD machine pumps used or spent dialysis fluid from the patient's peritoneal cavity through a catheter to a drain. As with the manual process, multiple drain, fill, and dwell cycles occur during dialysis. The "final fill" can occur at the end of an APD treatment. The final fill fluid can remain in the patient's peritoneal cavity until the next treatment begins, or it can be manually emptied at some time during the day.

[0013] In any of the above forms using an automatic machine, the automatic machine typically operates with a disposable kit which is discarded after a single use.

[0014] The circuit for peritoneal dialysis may include one or two pumps to supply fresh dialysis fluid to the abdomen of the patient and to extract the used dialysis fluid after a residence time. The amount of fluid supplied to the patient and the rate at which the fluid is supplied must be controlled and set within preset thresholds in order to ensure that the treatment is carried out according to the predetermined regulations. It is worth noting that during peritoneal dialysis treatment, the accuracy of determining the actual amount of fluid supplied to and extracted from the patient is of utmost importance. The flow rate during the supply and / or extraction of fluid should be very low to avoid pain and / or health risks to the patient: for example, the flow rate may be about 5 ml / min. Unfortunately, the lower the flow rate, the lower the accuracy of the sensors used to measure the flow rate and the amount of fluid supplied to and extracted from the patient's abdomen. In order to measure small flow rate values, peritoneal dialysis equipment should use very expensive sensors to ensure appropriate accuracy, or use more economical sensors to accept measurement errors.

[0015] However, especially for APD and CAPD devices, costs should be kept as low as possible while still ensuring adequate accuracy of fluid measurements.

[0016] Other devices for peritoneal dialysis are known from document WO 2007 / 143497 and document US 2011 / 184339. Purpose of the Invention

[0017] It is therefore an object of the present invention to at least partially address one or more disadvantages and / or limitations of previous solutions.

[0018] A first object of one or more of the described embodiments is to provide a peritoneal dialysis apparatus capable of improving flow rate measurement accuracy.

[0019] Another object of one or more of the described embodiments is to provide a peritoneal dialysis apparatus capable of ensuring accuracy in flow rate measurement while keeping manufacturing costs low.

[0020] Another object of one or more of the described embodiments is to provide a peritoneal dialysis apparatus capable of ensuring accuracy of flow rate measurement over a wide range of flow rates for supplying fluid to or withdrawing fluid from a patient.

[0021] Another object of one or more of the described embodiments is to provide a peritoneal dialysis apparatus that can use standard and commercially available positive displacement fluid pumps without compromising the accuracy of flow rate delivery.

[0022] Another object of one or more of the described embodiments is to provide a peritoneal dialysis apparatus that uses low-cost commercial components that operate at their optimal operating points and is reliable in ensuring accuracy in flow measurement.

[0023] Another object is to provide a peritoneal dialysis device capable of ensuring accuracy in flow rate delivery and measurement while avoiding extensive changes in the design of known devices in order to minimize redesign costs. Summary of the invention

[0024] A first aspect relates to a peritoneal dialysis fluid circuit (10), comprising: at least one patient line extending between a first end and a second end, the first end being configured to be connected to the abdomen of the patient; a delivery line connected to the second end of the at least one patient line and configured to supply fresh dialysis fluid to the at least one patient line; a draw line connected to the second end of the at least one patient line and configured to draw spent dialysis fluid from the at least one patient line; a first pump disposed on the delivery line and configured to supply fresh dialysis fluid to the patient line; a second pump disposed on the draw line and configured to draw spent dialysis fluid from the patient line; A control unit is operably connected to a first pump and a second pump, the control unit being configured to perform a peritoneal dialysis procedure, the peritoneal dialysis procedure comprising the steps of commanding the first pump to be activated at a first flow rate, and commanding the second pump to be activated at a second flow rate different from the first flow rate, and wherein the first pump and the second pump are activated simultaneously to deliver the first flow rate and the second flow rate. A second aspect relates to a method (process) of performing a peritoneal dialysis treatment via a peritoneal dialysis fluid circuit (10), the peritoneal dialysis fluid circuit (10) comprising: at least one patient line extending between a first end and a second end, the first end being configured to be connected to the abdomen of the patient; a delivery line connected to the second end of the at least one patient line and configured to supply fresh dialysis fluid to the at least one patient line; a draw line connected to the second end of the at least one patient line and configured to draw spent dialysis fluid from the at least one patient line; a first pump disposed on the delivery line and configured to supply fresh dialysis fluid to the patient line; a second pump disposed on the draw line and configured to draw spent dialysis fluid from the patient line; a control unit operably connected to the first pump and the second pump;

[0025] The method comprises performing (by the control unit) a peritoneal dialysis procedure, the peritoneal dialysis procedure comprising the following steps: The first pump is commanded to be activated at a first flow rate, and the second pump is commanded to be activated at a second flow rate different from the first flow rate, and wherein the first pump and the second pump are activated simultaneously to deliver the first flow rate and the second flow rate.

[0026] Another aspect relates to a peritoneal dialysis device (20) comprising a housing (22) carrying a fluid circuit (10), the fluid circuit (10) comprising: at least one patient line extending between a first end and a second end, the first end being configured to be connected to the abdomen of the patient; a delivery line connected to the second end of the at least one patient line and configured to supply fresh dialysis fluid to the at least one patient line; a draw line connected to the second end of the at least one patient line and configured to draw spent dialysis fluid from the at least one patient line; a first pump disposed on the delivery line and configured to supply fresh dialysis fluid to the patient line; a second pump disposed on the draw line and configured to draw spent dialysis fluid from the patient line; A control unit operatively connected to the first pump and the second pump, the control unit being configured to perform a peritoneal dialysis procedure, the peritoneal dialysis procedure comprising the following steps: The first pump is commanded to be activated at a first flow rate, and the second pump is commanded to be activated at a second flow rate different from the first flow rate, and wherein the first pump and the second pump are activated simultaneously to deliver the first flow rate and the second flow rate.

[0027] In particular, the fluid recirculation loop is defined inside the PD fluid circuit (10) and includes a delivery line (11) and an extraction line (12). In more detail, the fluid recirculation loop is a closed loop and optionally also includes a recirculation portion (13) extending upward from the outlet of the second pump (70b) to the inlet of the first pump (70a) according to a fluid direction (A) defined by the first pump (70a) and the second pump (70b); according to an embodiment of the present disclosure, the recirculation portion (13) does not include the second end (28b) of the patient line (28).

[0028] The first end (28a) of the patient line (28) is removably connected to a disposable patient line connected to a patient implanted catheter, or is directly connected to the patient implanted catheter.

[0029] The patient line (28) is generally non-disposable (sterilized after treatment) or at least partially non-disposable; the disposable portion is discarded after treatment and the non-disposable portion including the second end (28b) is sterilized after treatment.

[0030] The recirculation loop is a closed loop that allows fluid to recirculate. The PD fluid circuit (10) may of course include fluid lines that enter and / or leave the recirculation loop. The fluid lines may or may not be closed by respective valves (i.e., valves are present but closed, or there are no valves). Regardless of the presence or absence of open / closed fluid lines, the recirculation loop may allow fluid to recirculate within itself.

[0031] In a third aspect according to any of the preceding aspects, the difference between the first flow rate and the second flow rate defines an exchange parameter value representing an exchange flow rate of the dialysis fluid in the patient line (28) with the patient.

[0032] In a fourth aspect according to any of the preceding aspects, the peritoneal dialysis procedure comprises the step of calculating said exchange parameter value based on a difference between the first flow rate and the second flow rate.

[0033] In a fifth aspect according to any of the preceding aspects, a peritoneal dialysis procedure comprises the step of receiving as input a desired exchange parameter value representing an exchange flow rate of dialysis fluid with a patient in a patient line (28).

[0034] In a sixth aspect according to the preceding aspects, the peritoneal dialysis procedure comprises the step of setting a difference between a first flow rate and a second flow rate based on said desired exchange parameter value, in particular in order to obtain said desired exchange flow rate of the dialysis fluid in the patient line (28).

[0035] In a seventh aspect according to any of the preceding aspects, the peritoneal dialysis procedure (200) comprises the step of determining or receiving an optimal first flow rate and / or an optimal second flow rate, wherein the optimal first flow rate and / or the optimal second flow rate particularly represent optimal operating conditions of the first pump (70a) and the second pump (70b).

[0036] In other words, since the dialysis fluid flow rate generated in the patient line (28) (for filling with fresh fluid or extracting used fluid) is defined by the flow rate difference between the first pump (70a) and the second pump (70b), both pumps can be driven substantially at their operating set points, maintaining high efficiency, high reliability and minimizing noise.

[0037] In an eighth aspect according to the preceding aspects, the peritoneal dialysis procedure (200) comprises the following steps: setting the first flow rate of the first pump (70a) within a first range of ±30% of the optimal first flow rate, in particular the first range is ±20%; and / or setting the second flow rate of the second pump (70b) within a second range of ±30% of the optimal second flow rate, in particular the second range is ±20%.

[0038] In a ninth aspect according to any one of the previous two aspects, the optimal first flow rate is comprised between 100 ml / min and 1500 ml / min, and / or wherein the optimal second flow rate is comprised between 100 ml / min and 1500 ml / min.

[0039] In a tenth aspect according to any one of the previous three aspects, the peritoneal dialysis procedure comprises the following steps: - commanding a first flow rate in the range between 100 ml / min and 1500 ml / min, - Commanding the second flow rate to be in the range between 100 ml / min and 1500 ml / min.

[0040] In an eleventh aspect according to any of the preceding aspects, the peritoneal dialysis procedure comprises a filling procedure for filling the abdomen of the patient with dialysis fluid through at least one patient line (28), during which the first flow rate is higher than the second flow rate.

[0041] In a twelfth aspect according to any of the preceding aspects, the peritoneal dialysis procedure comprises a drain procedure for removing spent dialysis fluid from the abdomen of the patient through at least one patient line, during which the first flow rate is lower than the second flow rate.

[0042] In a thirteenth aspect according to any one of the two previous aspects, the peritoneal dialysis program comprises alternating filling programs and draining programs in one cycle. For example, 3 to 5 cycles may be provided to the patient (eg, for each night's treatment).

[0043] In a fourteenth aspect according to any of the preceding aspects, the peritoneal dialysis procedure comprises inserting a dwell time between the end of a filling procedure and the start of a subsequent draining procedure, said dwell time being comprised between 1 min and 360 min.

[0044] In a fifteenth aspect according to any of the preceding aspects, the peritoneal dialysis procedure comprises inserting a waiting time between the end of a drain procedure and the start of a subsequent fill procedure, said waiting time being comprised between 1 min and 20 min.

[0045] In a sixteenth aspect according to any of the preceding aspects, the first pump is a positive displacement pump, in particular, the first pump is one of a reciprocating pump, a peristaltic pump, a diaphragm pump or a gear pump, a piston pump.

[0046] In a seventeenth aspect according to any of the preceding aspects, the second pump is a positive displacement pump, in particular, the second pump is one of a reciprocating pump, a peristaltic pump, a diaphragm pump or a gear pump, a piston pump.

[0047] In an eighteenth aspect according to any of the preceding aspects, the first pump and the second pump comprise a rotating element movable by rotation, in particular, wherein the rotation of the first pump and the rotation of the second pump determine the first flow rate and the second flow rate, respectively.

[0048] In a nineteenth aspect according to any of the preceding aspects, the first pump and the second pump are of the same type.

[0049] In a twentieth aspect according to any of the preceding aspects, the fluid circuit (in detail, the fluid recirculation loop 130) includes a recirculation portion extending upward from the outlet of the second pump to the inlet of the first pump, in particular, extending upward from the second pump to the first pump along a fluid direction A defined by the first pump and the second pump.

[0050] It should be noted that the recirculation portion (13) does not include (is not in direct fluid communication with) the second end (28b) of the patient line (28).

[0051] In a twenty-first aspect according to any of the preceding aspects, the fluid direction (A) is defined as from the first pump (70a) toward the patient line (28), and from the patient line (28) to the second pump (70b), and in particular, from the second pump (70b) toward the recirculation portion (13).

[0052] In a 22nd aspect according to any of the preceding aspects, the recirculation portion comprises a waste container, and / or is connected to a discharge line.

[0053] In a 23rd aspect according to any of the preceding aspects, if the first flow rate is less than the second flow rate, the waste container fills and / or the drain line drains the dialysis fluid.

[0054] In a twenty-fourth aspect according to any of the preceding aspects, the transfer line, the extraction line and the recirculation portion are fluidly connected in series with each other, defining a portion (annular loop) of a fluid recirculation loop (130).

[0055] In a twenty-fifth aspect according to the preceding aspects, the peritoneal dialysis procedure includes circulating the dialysis fluid into the fluid recirculation loop (130) via the first pump (70a) and the second pump (70b).

[0056] In a twenty-sixth aspect according to any of the preceding aspects, the fluid circuit comprises a discharge line (14) connected to a recirculation portion (13), wherein the discharge line extends from the recirculation portion to an outlet (e.g., a free outlet) for discharging the fluid, in particular, the discharge line is connected to the recirculation portion via a three-way connector.

[0057] In a 27th aspect according to any of the preceding aspects, the first pump comprises an inlet and an outlet, the first pump being configured to move the dialysis fluid in a direction from the inlet to the outlet.

[0058] In a 28th aspect according to any of the preceding aspects, the second pump comprises an inlet and an outlet, the second pump being configured to move the dialysis fluid in a direction from the inlet to the outlet.

[0059] In a twenty-ninth aspect according to any one of the two previous aspects, the outlet of the first pump and the inlet of the second pump face the second end (28b) of the patient line (28).

[0060] In a 30th aspect according to any of the preceding aspects, at least one patient line comprises: a double lumen patient line comprising a filling line connected to the delivery line and configured to deliver dialysis fluid to the abdomen of the patient, and an aspiration line connected to the extraction line and configured to remove fluid from the abdomen of the patient, in particular the double lumen patient line combining the two into one; or - a fill line connected to the delivery line and configured to deliver dialysis fluid to the patient's abdomen, and an aspiration line connected to the extraction line and configured to remove fluid from the patient's abdomen, wherein the fill line is distinct from the aspiration line.

[0061] In a thirty-first aspect according to the preceding aspects, the patient line comprises a dual lumen patient line, and wherein the fluid circuit comprises a three-way connector comprising a first passage connected to one end of the delivery line, a second passage connected to a second end of the patient line, and a third passage connected to one end of the extraction line.

[0062] In a further dependent aspect according to any of the preceding aspects, at least one patient line comprises a single lumen line for alternately delivering dialysis fluid to and withdrawing dialysis fluid from the abdomen of the patient.

[0063] In a thirty-second aspect according to any of the preceding aspects, the fluid circuit (10) includes a first flow meter (81), the first flow meter (81) being configured to measure a current first flow rate provided by the first pump (70a), the first flow meter (81) being arranged in series with the first pump (70a) so that the same fluid flow rate flows through the first pump (70a) and the first flow meter (81), in particular, wherein the first flow meter (81) is arranged on the recirculation portion (13) upstream of the first pump (70a) or on the delivery pipeline (11).

[0064] According to another aspect of the foregoing aspect, when arranged on the delivery line (12), the first flow meter (81) is upstream of the second end (28b) of the patient line (28).

[0065] In another aspect according to the two previous aspects, when arranged on the recirculation section (13), the first flow meter (81) is downstream of the discharge line (14).

[0066] In a thirty-third aspect according to any of the preceding aspects, the fluid circuit (10) comprises a second flow meter (82), the second flow meter (82) being configured to measure a current second flow rate provided by the second pump (70b), the second flow meter (82) being arranged in series with the second pump (70b) so that the same fluid flow rate flows through the second pump (70b) and the second flow meter (82), in particular, wherein the second flow meter (82) is arranged on the recirculation portion (13) downstream of the second pump (70b) or on the extraction line (12).

[0067] According to another aspect of the foregoing aspect, when disposed on the delivery line (12), the second flow meter (82) is downstream of the second end (28b) of the patient line (28).

[0068] According to another aspect of the two previous aspects, when arranged on the recirculation section (13), the second flow meter (82) is upstream of the discharge line (14).

[0069] In a 34th aspect according to any of the preceding aspects, during a run state, a first flow rate of the first pump flows through a first flow meter.

[0070] In a 35th aspect according to any of the preceding aspects, during the run state, a second flow rate of the second pump flows through the second flow meter.

[0071] In a 36th aspect according to any of the preceding aspects, the peritoneal dialysis procedure comprises: - calculating / determining the current first flow rate measured by the first flow meter (81); - calculating / determining the current second flow rate measured by the second flow (82) meter; - calculating / determining a current exchange parameter value based on a difference between a current first flow rate and a current second flow rate, said current exchange parameter value representing a current exchange flow rate of the dialysis fluid with the patient; - comparing current exchange parameter values ​​with expected exchange parameter values; - Based on the comparison, in particular if the difference between the current exchange parameter value and the desired exchange parameter value exceeds a predetermined threshold, adjusting the flow rate of the first pump (70a) and / or the flow rate of the second pump (70b), in particular adjusting the flow rate difference between the first pump (70a) and the second pump (70b).

[0072] In a 37th aspect according to any of the preceding aspects, the filling procedure comprises the following steps: - calculating a filling fluid amount of dialysis fluid delivered to the abdomen of the patient from the start of the filling procedure based on a difference between the first flow rate and the second flow rate, in particular based on a difference between a current first flow rate and a current second flow rate, and optionally further based on a dwell time of the filling procedure; - comparing the filling fluid amount with a (maximum) filling fluid amount threshold; - when the filling fluid amount exceeds a (maximum) filling fluid amount threshold, commanding the first pump (70a) And the second pump (70b) is stopped.

[0073] In a 38th aspect according to any of the preceding aspects, the discharge procedure comprises the following steps: - calculating a drain fluid amount of dialysis fluid removed from the abdomen of the patient from the start of the drain procedure based on a difference between the first flow rate and the second flow rate, in particular based on a difference between a current first flow rate and a current second flow rate, optionally further based on a dwell time of the drain procedure; - comparing the discharged fluid amount with a (maximum) discharged fluid amount threshold; - when the discharge fluid amount exceeds a (maximum) discharge fluid amount threshold, commanding the first pump (70a) And the second pump (70b) is stopped.

[0074] The discharge amount threshold value and the filling amount threshold value may be equal to each other.

[0075] Furthermore, different drain volume thresholds and fill volume thresholds may be used for different treatment cycles.

[0076] In a 39th aspect according to any of the preceding aspects, the fluid circuit comprises a dialysis fluid heater configured to heat the dialysis fluid, in particular wherein the dialysis fluid in-line heater is arranged in a recirculation part of the fluid circuit.

[0077] Preferably, the heater (56) is arranged in the fluid recirculation loop (130).

[0078] In a 40th aspect according to any of the preceding aspects, the fluid circuit comprises an air trap configured to remove air bubbles from the dialysis fluid, in particular the air trap is arranged on a recirculation part of the fluid circuit.

[0079] Preferably, the air trap (60) is arranged in the fluid recirculation loop (130) (eg, downstream of the heater (56)).

[0080] In a 41st aspect according to any of the preceding aspects, the fluid circuit defines a loop circuit for recirculating the dialysis fluid (fluid recirculation loop 130), the loop circuit comprising at least a delivery line and an extraction line fluidically connected to each other to define the loop circuit, the loop circuit also comprising in particular a recirculation portion.

[0081] In a 42nd aspect according to the preceding aspect, the annular circuit includes at least a first pump and a second pump.

[0082] In a 43rd aspect according to any of the preceding aspects, the loop circuit comprises a patient line.

[0083] In a 44th aspect according to any of the preceding aspects, the loop circuit comprises a fill line and an aspiration line of the patient line.

[0084] In a 45th aspect according to any of the preceding aspects, the loop circuit further comprises a dialysis fluid heater configured to heat the dialysis fluid.

[0085] In a 46th aspect according to any of the preceding aspects, the annular circuit further comprises an air trap configured to remove air bubbles from the dialysis fluid flow.

[0086] In a 47th aspect according to any of the preceding aspects, the fluid circuit comprises a drain line extending from an inlet connected to the circular circuit, and an outlet for spent dialysis fluid.

[0087] In a 48th aspect according to any of the preceding aspects, the delivery line is between the first pump and the second end of the patient line.

[0088] In a 49th aspect according to any of the preceding aspects, the extraction line is interposed between the second pump and the second end of the patient line.

[0089] In a fiftieth aspect according to any of the preceding aspects, the fluid circuit further comprises a preparation component configured to prepare dialysis fluid to be supplied to the patient according to a predetermined prescription.

[0090] In a fifty-first aspect according to the preceding aspects, the preparation assembly comprises one or more supply lines for connection to a respective fluid source, in particular a solution bag, containing a dialysis fluid or solution.

[0091] In a 52nd aspect according to any of the preceding aspects, the one or more supply lines are configured to deliver fluid to a recirculation portion (13) of the fluid circuit (10), in particular during a filling procedure.

[0092] In a fifty-third aspect according to any of the preceding aspects, the one or more supply lines include at least a first supply line and a second supply line, and the first supply line and the second supply line are respectively connected to or configured to be connected to a first fluid source (i.e., a first solution bag) and a second fluid source (i.e., a second solution bag).

[0093] In a fifty-fourth aspect according to any of the preceding aspects, the preparation assembly is configured to convey (and also in particular mix) the solution of the first solution bag and the solution of the second solution bag in a circular loop.

[0094] In a fifty-fifth aspect according to any of the preceding aspects, the preparation component, in particular one or more supply lines, is connected to a recirculation part of the fluid circuit.

[0095] In a fifty-sixth aspect according to any of the preceding aspects, one or more supply lines are connected to a ring loop of the fluid circuit.

[0096] In a fifty-seventh aspect according to any of the preceding aspects, the fluid circuit (10) comprises at least one supply valve (54a, 54b, 54c, 154) fluidly interposed between the preparation component (90), in particular between one or more supply lines, and the recirculation portion (13) of the fluid circuit (10).

[0097] In a fifty-eighth aspect according to any of the preceding aspects, at least one supply valve (54a, 54b, 54c, 154) is fluidly interposed between the preparation assembly (90), in particular between one or more supply lines, and the ring loop.

[0098] In aspect fifty-ninth according to any of the preceding aspects, at least one supply valve (54a, 54b, 54c, 154) is movable between an open position and a closed position, wherein the open position allows fluid to move from one or more supply lines to the recirculation portion (13) or the loop, and the closed position prevents fluid from passing between one or more supply lines and the recirculation portion (13) or the loop.

[0099] In a sixtieth aspect according to any of the preceding aspects, during a filling procedure, the peritoneal dialysis procedure (200) comprises a step performed by the control unit (100) for commanding at least one supply valve (54a, 54b, 54c, 154) to be in an open position to allow fluid to move from the preparation component (90) to the recirculation portion (13) or the annular loop of the fluid circuit (10).

[0100] In a sixty-first aspect according to any of the preceding aspects, the fluid circuit comprises a drain valve movable between an open position allowing fluid to be drained through the drain line and a closed position preventing fluid from passing through the drain line.

[0101] In a sixty-second aspect according to the preceding aspects, the peritoneal dialysis procedure comprises, during the drain procedure, a step performed by the control unit for commanding the drain valve to be in an open position.

[0102] In a sixty-third aspect according to any of the preceding aspects, during a filling procedure, the peritoneal dialysis procedure (200) comprises steps performed by the control unit (100) for commanding: - at least one supply valve (54a, 54b, 54c, 154) is in an open position; and - The discharge valve (54i) is in the closed position.

[0103] In a sixty-fourth aspect according to any of the preceding aspects, during an extraction procedure, the peritoneal dialysis procedure (200) comprises steps performed by the control unit (100) for commanding: - at least one supply valve (54a, 54b, 54c, 154) is in a closed position; and - The outlet valve (54i) is in the open position.

[0104] A sixty-fifth aspect relates to a peritoneal dialysis device (20) comprising a housing (22) carrying a fluid circuit (10) according to any one of the preceding aspects and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0105] Figure 1 is a perspective view of one embodiment of a peritoneal dialysis apparatus according to the present invention;

[0106] Figure 2 and Figure 3 is a schematic diagram of a fluid circuit of a peritoneal dialysis apparatus during a filling process according to an embodiment of the present invention;

[0107] Figure 4 is a schematic diagram of a fluid circuit of a peritoneal dialysis apparatus during a draining process according to an embodiment of the present invention;

[0108] Figure 5 is a schematic diagram of a fluid circuit of a peritoneal dialysis apparatus during a filling process according to another embodiment of the present invention;

[0109] Figure 6 is a schematic diagram of a fluid circuit of a peritoneal dialysis apparatus during a discharge process according to another embodiment of the present invention;

[0110] Figure 7 is a flow chart of the major steps of the peritoneal dialysis procedure.

[0111] It is worth noting that in Figure 2-Figure 6 In the diagram, the dark colored valves are open at least at some point in the sequence, while the empty valves are in the closed position. The arrows show the direction A of fresh or spent dialysis fluid. DETAILED DESCRIPTION

[0112] The following disclosure relates to a peritoneal dialysis apparatus 20 that includes a fluid circuit for performing peritoneal dialysis treatment on a patient. Figure 1 A representative embodiment of a peritoneal dialysis apparatus 20 including a fluid circuit 10 of the present invention is depicted.

[0113] In particular, peritoneal dialysis device 20 includes a housing 22 defining an interior volume that carries at least a portion of a fluid circuit 10 for conducting peritoneal dialysis treatment. Fluid circuit 10 may include PD fluid lines 24a, 24b, 24c extending outwardly from an aperture 26 defined or provided by housing 22. Aperture 26 may be fitted with a gasket or otherwise sealed so that dust, fluids, and other matter cannot enter housing 22 from the environment.

[0114] Figure 1 A patient line 28 is also shown extending from the housing 22 of the device 20 via a sealing aperture 26 (e.g., fitted with a gasket). The patient line 28 is typically longer than the PD fluid lines 24a-24c and can be wound or rolled up within the housing via a spool or hose reel 110 when the patient line 28 is not connected to a patient for treatment. The patient line 28 can also be coated with a non-stick or lubricious coating to prevent dust from accumulating on the patient line over time. The patient line 28 can be reusable or disposable.

[0115] The patient line 28 extends between a first end 28a and a second end 28b, with the first end 28a being configured to be connected to the abdomen of the patient.

[0116] The patient line 28 may include a dual lumen patient line that combines a fill line configured to deliver dialysis fluid to the patient's abdomen and an aspiration line configured to remove fluid from the patient's abdomen. The system 10 also includes a patient line connector 32b. The patient line connector 32b includes an internal lumen (e.g., a U-shaped lumen) that directs fresh dialysis fluid or used dialysis fluid from one PD fluid lumen of the dual lumen reusable patient line 28 to another PD fluid lumen. Alternatively, the patient line may include a fill line and an aspiration line that are distinct from each other, thereby defining two distinct lines. Patient lines that include a single lumen are also included in the described embodiments; the single lumen line is used to alternately deliver dialysis fluid to the patient's abdomen and to withdraw dialysis fluid from the patient's abdomen.

[0117] Cleaning box 240 is also Figure 1 It is shown in Figure 1 It is shown as being conveniently slidable into a slot 224 of a housing 222 of the circulator 20 .

[0118] The fluid circuit 10 also includes a delivery line 11 configured to deliver dialysis fluid to a patient line 28. The delivery line 11 is fluidically and directly connected to a second end 28b of the patient line 28b. In particular, the delivery line 11 can be connected to a fill line of the patient line 28 to deliver dialysis fluid to the abdomen of the patient. The delivery line 11 extends in a length direction between a first end 11a and a second end 11b. The second end 11b of the delivery line 11 is connected to a second end 28b of the patient line 28 so that fluid can flow from the delivery line 11 to the patient line 28 to supply dialysis fluid to the patient. In particular, the second end 11b of the delivery line 11 is connected to a fill line of the patient line 28.

[0119] The delivery line 11 may be a reusable line arranged in the housing 22 of the device 20. In particular, the delivery line 11 may be made of a rigid or flexible material.

[0120] The fluid circuit 10 also includes an extraction line 12 configured to extract used dialysis fluid from a patient line 28. The extraction line 12 extends in a length direction between a first end 12a and a second end 12b. The second end 12b of the extraction line 12 is connected to a second end 28b of the patient line 28 so that fluid can flow from the patient line 28 to the extraction line 12 to remove the dialysis fluid from the patient. In particular, the second end 12b of the extraction line 12 is connected to an aspiration line of the patient line 28. The extraction line 12 may be a reusable line arranged within the housing 22 of the device 20. In particular, the extraction line 12 may be made of a rigid or flexible material.

[0121] It is noteworthy that the second end 12b of the extraction line 12, the second end 11b of the delivery line 11, and the second end 28b of the patient line 28 are interconnected, thereby defining a three-way connection.

[0122] The fluid circuit 10 also includes a first pump 70a, which is arranged on the delivery line 11 and is configured to supply fresh dialysis fluid to the patient line 28. The first pump 70a includes an inlet and an outlet, wherein the first pump 70a is configured to move the dialysis fluid in a direction from the inlet toward the outlet. The outlet of the first pump 70a is connected to the first end 11a of the delivery line 11 to move the dialysis fluid into the delivery line 11 and toward the patient line 28. Therefore, the delivery line 11 is between the outlet of the first pump 70a and the second end 28b of the patient line 28. It is worth noting that the outlet of the first pump 70a faces the second end 28b of the patient line 28.

[0123] The first pump 70a may be a positive displacement pump: in particular, the first pump may be one of a reciprocating pump, a peristaltic pump, a diaphragm pump or a gear pump, and a piston pump.

[0124] The first pump may include an element movable by rotation, such that the rotation of the first pump 70 a determines the flow rate of the dialysis fluid towards the patient line 28 .

[0125] The first pump 70a may be configured to operate at an optimal first flow rate range between 100 ml / min and 1500 ml / min. The optimal flow rate range of the first pump 70a may define an optimal efficiency operating condition of the first pump.

[0126] The fluid circuit 10 also includes a second pump 70b, which is arranged on the extraction line 12 and is configured to draw the dialysis fluid from the patient line 28 into the extraction line 12. The second pump 70b includes an inlet and an outlet, wherein the second pump 70b is configured to move the dialysis fluid in the direction from the inlet to the outlet. The inlet of the second pump 70b is connected to the first end 12a of the extraction line 12, so the extraction line 12 is between the second end 28b of the patient line 28 and the inlet of the second pump 70b. It is worth noting that the inlet of the second pump 70b faces the second end 28b of the patient line 28.

[0127] The second pump 70b may be a positive displacement pump: in particular, the second pump 70b may be one of a reciprocating pump, a peristaltic pump, a diaphragm pump or a gear pump and a piston pump. Optionally, the first pump 70a and the second pump 70b are of the same type, for example two gear pumps.

[0128] The second pump 70 b may include an element movable by rotation, such that the rotation of the second pump 70 b determines the flow rate of the dialysis fluid from the patient line 28 to the draw line 12 .

[0129] The second pump 70b may be configured to operate in an optimal second flow rate range between 100 ml / min and 1500 ml / min. The optimal second flow rate range of the second pump 70b may define an optimal efficiency operating condition of the second pump 70b.

[0130] When the mentioned pump is driven within its optimum flow rate, the accuracy of the pump is improved and the noise of the pump is reduced.

[0131] The fluid circuit 10 also includes a recirculation portion 13, which is inserted between the second pump 70b and the first pump 70a along the fluid direction A defined by the first pump and the second pump. In particular, the recirculation portion 13 extends upward from the outlet of the second pump 70b to the inlet of the first pump 70a. In particular, the fluid direction A is defined from the first pump 70a toward the patient line 28, and from the patient line 28 to the second pump 70b, and from the second pump 70b toward the recirculation portion 13.

[0132] The recirculation portion 13 may be a reusable line arranged within the housing 22 of the device 20. In particular, the recirculation portion 13 may be made of a rigid or flexible material.

[0133] The recirculation section 13 may include a waste container. For example, the recirculation section 13 may include an air trap 60 configured to remove air bubbles from the dialysis fluid flowing into the fluid circuit. According to the fluid direction A, the air trap 60 may be arranged upstream of the first pump 70a and downstream of the second pump 70b. The air trap may be provided with an upper level sensor 62a and / or a lower level sensor 62b to monitor the fluid level within the air trap 60. The upper level sensor 62a and / or the lower level sensor 62b may be operably connected to the control unit 100, so that the control unit may be configured to trigger an action or issue an alarm if the fluid level exceeds the upper level or the lower level.

[0134] The fluid circuit 10 may further include a fluid heater 56 configured to heat the dialysis fluid to a temperature compatible with the patient (eg, 37° C.). The fluid heater 56 may be disposed on the recirculation portion 13. For example, the fluid heater 56 may be disposed upstream of the air trap 60.

[0135] In one embodiment, the dialysis fluid heater 56 may be electrically actuated and, for example, be a resistive heater having a reusable heater body that receives heated PD fluid for treatment and sterilization. The heater 56 is capable of heating the PD fluid from room temperature or colder (e.g., if the PD fluid is stored in a cold environment) to body temperature (e.g., 37° C.) at a flow rate of at least 200 milliliters (ml) / minute (e.g., lower flow rates may also be achieved for children or infants). Alternatively, the device 20 includes an external heater configured to receive the fluid circuit to heat the dialysis fluid therein.

[0136] The fluid circuit 10 may include a temperature sensor 58a located near the fluid heater 56 (e.g., downstream of the heater) to provide feedback for temperature control. If desired, a second temperature sensor (not shown) may be provided upstream of the heater 56 to enable the incoming temperature of the fresh dialysis fluid to be factored into the heating algorithm or routine, that is, to provide a feed-forward control that stabilizes and speeds up the response of the overall heating control. The second sensor may also provide useful information for calculating disinfection dose values ​​(e.g., A0 values ​​used during disinfection).

[0137] A flow switch 80 outputting to the control unit 100 may be arranged on the recirculation portion 13 of the fluid circuit 10. The flow switch 80 is arranged to trip or output at a specified low flow rate, which indicates that one of the containers or bags 38a to 38c is empty, and this may also be used to ensure that fresh PD fluid flows through the inline heater 56 when the heater is energized for fluid heating.

[0138] The fluid circuit may further include a first flow meter 81 configured to measure a flow rate provided by the first pump 70a. The first flow meter 81 may be arranged in series with the first pump 70a so that the same fluid flow rate flows through the first pump 70a and the first flow meter 81. In particular, the first flow meter 81 may be arranged on the delivery line 11 between the first pump 70a and the second end 28b of the patient line 28. Alternatively, the first flow meter 81 may be arranged on the recirculation portion 13 upstream of the first pump 70a. The first flow meter 81 may be arranged upstream or downstream of the first pump 70a close to the first pump, for example at a maximum fluid distance from the first pump 70a, the maximum fluid distance being comprised between 1 cm and 5 cm.

[0139] The fluid circuit can further include a second flow meter 82 configured to measure the flow rate provided by the second pump 70b. The second flow meter 82 can be arranged in series with the second pump 70b so that the same fluid flow rate flows through the second pump 70b and the second flow meter 82. In particular, the second flow meter 82 can be arranged on the extraction line 12 between the second pump 70b and the second end 28b of the patient line 28. Optionally, the second flow meter 82 can be arranged on the recirculation portion 13 downstream of the second pump 70b. The second flow meter 82 can be arranged upstream or downstream of the second pump 70b close to the second pump 70b, for example at a maximum fluid distance from the second pump 70b, which is included between 1cm and 5cm.

[0140] Fluid circuit 10 may include conductivity sensor 74 for detecting the conductivity of fresh PD fluid to ensure that it is of the prescribed type (e.g., has a prescribed glucose or dextrose level). Conductivity sensor 74 may alternatively or additionally be used to detect the conductivity of fresh PD fluid to ensure that it has been properly mixed (e.g., if an online PD fluid source is instead connected to one of PD fluid lines 24a-24c). Conductivity sensor 74 may alternatively or additionally be used to detect the conductivity of used PD fluid to assess treatment effectiveness and / or to look for patient disease, such as peritonitis.

[0141] The conductivity sensor 74 may be arranged near the first pump 70a, upstream or downstream relative to the first pump 70. According to the embodiment of the drawings, the conductivity sensor 74 may be interposed between the first pump 70a and the patient line 28. In particular, the conductivity sensor 74 may be arranged downstream of the first pump 70a. Alternatively, the conductivity sensor 74 may be arranged upstream of the first pump 70a, in particular between the air trap 60 and the inlet of the first pump 70a.

[0142] The temperature sensor 58b may be positioned proximate to the conductivity sensor 74 so that the conductivity reading from the sensor may be temperature compensated.

[0143] The fluid circuit 10 defines a loop for recirculating the dialysis fluid. In particular, the delivery line 11, the extraction line 12 and the recirculation portion 13 together define a loop. The dialysis fluid flows in the loop along a fluid direction A. In particular, the dialysis fluid can be recirculated from the delivery line 11 to the extraction line 12 in the loop and enter the recirculation portion 13. In more detail, the dialysis fluid can be recirculated from the delivery line 11 in the loop, enter the filling line of the patient line 28, then return to the aspiration line of the patient line 28, reach the extraction line 12, and then enter the recirculation portion 13, thereby returning at the inlet of the first pump 70a.

[0144] The loop loop also includes a first pump 70a, a second pump 70b, and a second end 28b of at least one patient line 28. It is worth noting that the loop loop also includes the patient line 28. In addition, the loop loop may include a first flow meter 81 and a second flow meter 82. In addition, the loop loop may include a heater 56 and / or a temperature sensor 58a. The loop loop may also include an air trap 60. The loop loop may also include a conductivity sensor 74.

[0145] according to Figure 2-Figure 4 In the embodiment of the present invention, the loop circuit includes a first pump 70a, a second pump 70b, a delivery line 11, an extraction line 12, a recirculation portion 13, a heater 56, an air trap 60, and optional first and second flow meters 81 and 82.

[0146] according to Figure 5 In another embodiment, the loop includes a first pump 70a, a second pump 70b, a delivery line 11, an extraction line 12, a recirculation portion 13, and optionally a first flow meter 81 and a second flow meter 82. Figure 5 In this embodiment, the air collector 60 and the heater 56 are excluded from the circular loop.

[0147] The fluid circuit 10 may further include a drain line 14 configured to drain spent dialysis fluid. The drain line 14 extends in length between an inlet 14a and an outlet, such that the dialysis fluid is drained in a direction from the inlet of the drain line 14 to the outlet.

[0148] Optionally, the exhaust line 14 may be connected to the recirculation portion 13, as shown in the drawings. In particular, the inlet of the exhaust line 14 may be arranged upstream of the first pump 70a and downstream of the second pump 70b. For example, the inlet of the exhaust line 14 may be arranged between the air trap 60 and the inlet of the first pump 70a.

[0149] Generally speaking, the inlet of the discharge line 14 is connected to the annular loop of the fluid circuit 10 .

[0150] A discharge line connector 34 may be provided at the outlet 14b of the discharge line 14, and the discharge line connector 34 may be releasably covered by a movable (e.g., rotatable or slidable) cover 34c. The discharge line connector 34 may receive a disposable discharge line 36 for treatment, which may lead to a discharge container or bag or to an indoor sewer. In an alternative embodiment, the discharge line 36 is reusable and connected to a sterilization loop.

[0151] The fluid circuit 10 also includes a preparation assembly 90 configured to prepare dialysis fluid to be supplied to the patient according to a predetermined prescription. The preparation assembly includes one or more supply lines 24a, 24b, 24c for connection to respective fluid sources (i.e., one or more solution bags 38a, 38b, 38c containing dialysis fluid or solution).

[0152] The distal ends 24d of the PD fluid lines 24a to 24c may be color coded and / or keyed to match the colored or keyed connectors of dedicated PD fluid containers or bags 38a to 38c. The containers or bags may contain, for example, dialysis fluids with different dextrose or glucose levels, such as 1.36% glucose dialysis fluid, 2.27% glucose dialysis fluid, 3.86% glucose dialysis fluid, and / or finally a bag of PD fluid of a different formulation, such as icodextrin (isodextrin).

[0153] It should be understood that any number of PD fluid lines and PD fluid containers or bags may be provided, including a single PD fluid line and PD fluid container or more than one PD fluid line and PD fluid container (such as two, three or four). In another optional embodiment, the PD fluid containers or bags 38a to 38c are replaced by an online PD fluid generation source, which is connected to the single PD fluid line and is in fluid communication with it. In another alternative embodiment, any device described herein is configured to operate with a pre-filled PD fluid container or bag 38a to 38c or an online PD fluid generation source. For example, the device described herein may be provided with additional ports so that the device can be docked or connected to an online PD fluid production equipment. Here, if the patient wants to travel or if the online source is being repaired, the PD can be released or disconnected from the online PD fluid generation source. A large number of peritoneal dialysis fluid bags are provided to the patient so that treatment can still be performed. The group of PD fluid containers or bags or online PD fluid generation sources generally at least partially defines a fluid preparation component

[0154] In particular, the supply lines 24a, 24b, 24c are connected to the recirculation portion 13 of the fluid loop so that the fluid solution delivered from the fluid sources 38a, 38b, 38c can enter the loop. In one embodiment, the supply lines 24a, 24b, 24c can be connected to the recirculation portion 13 upstream of the heater 56 and / or upstream of the air trap 60.

[0155] As depicted in the drawings, the preparation assembly includes a first supply line 24a and a second supply line 24b, which are connected or configured to be connected to a first fluid source 38a (i.e., a first solution bag 38a) and a second fluid source 38b (i.e., a second solution bag 38b), respectively. The preparation assembly is configured to convey and mix the solution of the first solution bag 38a and the solution of the second solution bag 38b in a circular loop.

[0156] The system 10 includes sterile connectors 30a-30c for connection to the distal ends 24d of the reusable PD fluid lines 24a-24c, respectively, during sterilization. A third sterile conduit or line 52h3 extends between the sterile connectors 30a and 30b for use during sterilization.

[0157] It is contemplated that any of the reusable or disposable PD fluid lines 24a-24c, reusable or disposable patient line 28, sterile connectors 30a-30c, patient line connector 32a, drain line connector 34, drain line 36, PD fluid containers or bags 38a-38c, and patient line filter assembly 40 may be made of any one or more plastics (e.g., polyvinyl chloride (“PVC”) or non-PVC materials such as polyethylene (“PE”), polyurethane (“PU”), polyetheretherketone (“PEEK”), or polycarbonate (“PC”)). Certain components, such as sterile connectors 30a-30c, may be made of, for example, stainless steel or titanium.

[0158] The fluid circuit 10 may include a first pressure sensor 78a located proximate to the patient line 28 (e.g., upstream) to enable monitoring and control of the positive fresh PD fluid fill pressure. A second pressure sensor 78b may be located proximate to the patient line 28 (e.g., downstream) to enable monitoring and control of the spent PD fluid drain pressure. The second pressure sensor 78b may include pressure sensors 78b1 and 78b2, one for control and the other for safety.

[0159] Optionally, the fluid circuit 10 may include a pressure sensor 78c upstream of the first pump 70a. Measuring the suction pressure of the first pump 70a can help the control unit 100 determine the pump capacity more accurately. For example, the output of some piston pumps depends on the inlet pressure. Another use of the pressure sensor 78c is to determine whether the currently used container or bag 38a to 38c is empty or nearly empty.

[0160] The fluid circuit 10 may include a plurality of valves configured to allow or prevent the passage of dialysis fluid.

[0161] At least one supply valve 54a, 54b, 54c, 154 may be fluidly interposed between the preparation assembly 90, in particular between one or more supply lines 24a, 24b, 24c, and the recirculation portion 13. In particular, at least one supply valve 154 is fluidly interposed between the preparation assembly 90 (in particular one or more supply lines) and the ring loop.

[0162] In one embodiment, at least one supply valve includes a main valve 154 fluidly interposed between the second supply line 24b and the recirculation loop 13 and between the third supply line 24c and the recirculation loop. In particular, the second supply line 24b and the third supply line 24c may converge in a common line leading to the main valve 154, such that the main valve 154 is fluidly interposed between the common line and the recirculation portion 13. Thus, when arranged in the open position, the main valve 154 allows the substance contained in the second and third bags 38b, 38c to be delivered to the recirculation portion 13 in the fluid circuit (particularly the annular circuit).

[0163] Furthermore, according to an embodiment not shown in the drawings, the main valve 154 may also be fluidly interposed between the first supply line 24 a and the recirculation loop 13 .

[0164] The at least one supply valve may further include a first valve 54a, a second valve 54b, and a third valve 54c, respectively, disposed on the first supply line 24a, the second supply line 24b, and the third supply line 24c. The second valve 54b and the third valve 54c may be disposed upstream of the main valve 154 according to the direction of the fluid from the bags 38b, 38c to the recirculation portion 13. The three-way valve 154 may switch between the supply lines 52a2, 52a3 and the sterilization connector line 52a4 in any valve opening and switching arrangement.

[0165] In one embodiment, the first valve 54a can be arranged directly on the recirculation portion 13, ie on the loop. In this case, the first valve 54a can be arranged downstream of the connection point between the first supply line 24a and the recirculation portion 13.

[0166] In addition, the fourth valve 54d can be arranged on the recirculation portion 13 of the fluid circuit upstream of the connection point between the first supply line 24a and the recirculation portion 13. Therefore, the connection point between the first supply line 24a and the recirculation portion 13 can be fluidly interposed between the first valve 54a and the fourth valve 54d. The fourth valve 54d can be fluidly interposed between the connection point and the second pump 70b. Therefore, the second flow meter 82 can be interposed between the fourth valve 54d and the second pump 70b.

[0167] In addition to the first valve 54a, or in place of the first valve 54a, the at least one supply valve may include another valve 54a1 disposed on the first supply line 24a and between the recirculation portion 13 and the first bag 38a. The other valve 54a1 is movable between an open position, in which fluid is allowed to flow from the first bag 38a to at least a section of the recirculation portion 13, and a closed position, in which fluid is blocked from flowing from the first bag 38a to the recirculation portion 13.

[0168] The fluid circuit 10 may further include a fifth valve 54e disposed downstream of the air trap 60 and downstream of the heater 56. The fifth valve 54e may be disposed between the outlet of the air trap 60 and the inlet of the first pump 70a to selectively allow and prevent the dialysis fluid from being delivered to the first pump 70a. When the fifth valve 54e is in a closed position, the fluid is prevented from flowing to the first pump 70a. Conversely, when the fifth valve 54e is in an open position, the fluid is allowed to flow to the first pump 70a. It is noteworthy that the first flow meter 81 may be disposed between the fifth valve 54e and the first pump 70a.

[0169] The fluid circuit 10 may further include a sixth valve 54f disposed on the delivery line 11 downstream of the first pump 70a. The sixth valve 54f may be interposed between the outlet of the first pump 70a and the second end 28b of the patient line 28. Thus, the sixth valve 54f may be configured to selectively allow and prevent fluid from flowing from the first pump 70a to the patient line 28, particularly to the filling line of the patient line 28.

[0170] The fluid circuit 10 may further include an auxiliary valve, not shown in the drawings, disposed on the extraction line 12 upstream of the second pump 70b. The auxiliary valve may be interposed between the inlet of the second pump 70b and the second end 28b of the patient line 28. Thus, the auxiliary valve may be configured to selectively allow and prevent fluid from flowing from the patient line 28 to the second pump 70b, in particular, from the suction line of the patient line 28 to the second pump 70b.

[0171] The air trap 60 may include a ventilation line 52v connected to the top of the air trap 60 and configured to extract air or gas from the air trap 60. The ventilation line 52v may be connected to the exhaust line 14 so that the air or gas can be exhausted from the fluid circuit. In one embodiment, the ventilation line 52v may be provided with one or more intersections with the loop (particularly with the recirculation portion 13 of the fluid circuit 10), marked by X. When the ventilation line 52v intersects the loop, additional valves may be provided, for example, a seventh valve 54g, an eighth valve 54h, and a ninth valve 54h2 may be provided in the fluid circuit, wherein the seventh valve 54g is between the air trap 60 and the first intersection X with the annular loop, the eighth valve 54h is between the first intersection and the ventilation line and the second intersection of the annular loop, and the ninth valve 54h2 may be arranged between the second intersection and the outlet of the exhaust line or between the second intersection and the exhaust line 14. Alternatively, the vent line 52v may extend between the air trap 60 and the outlet (ie, at the exhaust line 14) without passing through the loop. Alternatively, the exhaust line 52v may extend between the air trap 60 and a free end configured to exhaust gas to the atmosphere.

[0172] The fluid circuit 10 further includes a discharge valve 54i disposed on the discharge line 14 and movable between an open position, in which the fluid is allowed to pass through the discharge line 14, and a closed position, in which the fluid is blocked from passing through the discharge line 14. The control unit 100 may be configured to selectively command the discharge valve 54i to be in the closed position and the open position.

[0173] The device 20 may include a leak detection disc 83 located at the bottom of the housing 22, and a corresponding leak detection sensor 85 that outputs to the control unit 100. The leak detection disc 83 may be made of any material and angled or funneled to have an angle or funnel shape that collects any type of fluid (fresh or used PD fluid, sterilizing fluid, flushing fluid, RO or distilled water) that falls from the reusable tubing of the device 20 due to a wrong connection, broken material, or other reasons. In one embodiment, the leak detection sensor 85 does not directly contact the leaking fluid and may be any type of sensor used for a liquid level sensor (e.g., ultrasonic, inductive, capacitive, and / or optical sensor). The leak detection sensor 85 may alternatively directly contact the leaking material (e.g., via an electrical contact closure sensor). Combinations of different types of sensors 85 and multiple sensors 85 may be provided as desired. When a fluid leak signal is received from the leak detection sensor 85, the control unit 100 issues an alarm.

[0174] A filter pack 40 may be provided on patient line 28 to provide a final stage of filtration of the PD fluid prior to delivery to the patient.

[0175] As shown in the drawings, a section of the recirculation portion 13 between the first valve 54a and the heater 56 is referred to as 52a1. In addition, a section of the recirculation portion 13 between the heater 56 and the air trap 60 is referred to as 52b.

[0176] A section of the recirculation portion 13 between the air trap 60 and the first pump 70a is referred to as 52c. In addition, a section of the ventilation line 52v between the valve 54h and the valve 54h2 is referred to as 52g. In addition, a section of the ventilation line 52v between the valve 54h2 and the exhaust line 14 is referred to as 52h2. A section of the preparation assembly 90 between the second valve 54b and the main valve 154 is referred to as 52a2. A section of the preparation assembly 90 between the third valve 54c and the main valve 154 is referred to as 52a3.

[0177] Figure 5 Shows Figures 2 to 4 Another embodiment of a PD fluid circuit 10 is shown.

[0178] System 10a includes many of the same components as system 10, which are generally numbered the same and include all of the structures, functions, and alternatives discussed above for the previous system. For example, system 10a includes circulator 20 and control unit 100, which has one or more processors 102, one or more memories 104, video controller 106, and user interface 108. The system 10a includes an in-line dialysis fluid heater 56, reusable lines or tubing 52a and 52b, an air trap 60 operative with respective upper and lower level sensors 62a and 62b, an air trap valve 54d, a vent valve 54e positioned along a vent line 52e, a reusable line or tubing 52c, dialysis fluid pumps 70a and 70b, temperature sensors 58a and 58b, a reusable line or tubing 52d, pressure sensors 78a, 78b1, 78b2, and 78c, reusable patient tubing or lines 52f and 52g, a hose reel 110, a dual lumen reusable patient line 28, a reusable drain tubing or line 52i extending to a drain line connector 34 and having a drain line valve 54i, and reusable recirculating sterile tubing or lines 52r1 and 52r2 operative with sterile valves 54r1 and 54r2, respectively. A third recirculation or sterilization conduit or line 52r3 extends between sterilization connectors 30a and 30b for use during sterilization. A fourth recirculation or sterilization conduit or line 52r4 extends between sterilization connectors 30c and 30e for use during sterilization.

[0179] One major difference from system 10 is that system 10a also includes a fourth PD fluid container or bag 38e connected to distal end 24d of reusable PD fluid line 24e. Fourth PD fluid container or bag 38e may contain the same or a different type of PD fluid as PD fluid containers or bags 38a-38c. In one embodiment, reusable PD fluid lines 24a-24c and 24e extend from aperture 26 defined or provided by housing 22 of cycler 20 (see FIG. 1 ). Figure 1 ).

[0180] Thus, system 10a includes four sterile connectors 30a-30c and 30e for connecting to distal ends 24d of reusable PD fluid lines 24a-24c and 24e, respectively, during sterilization.

[0181] The three-way valve 154a in the illustrated embodiment allows the control unit 100 to select between (i) 2.27% glucose dialysis fluid from container or bag 38b or 38e and (ii) icodextrin from container or bag 38c. In the illustrated embodiment, icodextrin from container or bag 38c is connected to the normally closed port of the three-way valve 154a.

[0182] Figure 5 The fluid circuit of PD includes an acid source, such as a citric acid container or bag 66. The citric acid container or bag 66 is selectively fluidly connected to the second three-way valve 154b via a citric acid valve 54m located along the citric acid line 52m. In one embodiment, the citric acid line 52m is connected to the normally closed port of the second three-way valve 154b to provide a redundant valve between the citric acid container or bag 66 and the PD fluid circuit during treatment.

[0183] As previously described, the device 20 includes a control unit 100. The control unit 100 may be contained within the interior volume of the housing 22. The control unit 100 may have one or more processors 102 and one or more memories 104, which may receive, store and process signals or outputs from the pressure sensors 78a and 78b, the temperature sensors 58a and 58b, the conductivity sensor 74, the first flow meter 81, and the second flow meter 82.

[0184] The control unit 100 is also operably connected to the first pump 70a and the second pump 70b. The control unit can be configured to command the start and stop of the first pump 70a and the second pump 70b, and control their speeds and / or control them based on the desired flow rate. It is worth noting that the control unit 100 is configured to independently control the first pump 70a and the second pump 70b, so that the first pump can be commanded to be at a first flow rate or first speed, and the second pump can be commanded to be at a second flow rate or second speed different from the first flow rate / speed. The control unit 100 can change the first flow rate and the second flow rate.

[0185] As previously described, the control unit 100 is also operably connected to the valves 54a to 54h2, the auxiliary valves, the main valve 154, and the drain valve 54i of the fluid circuit. The control unit 100 can be configured to open and close the valves (i.e., define different configurations of the fluid circuit according to a predetermined program). For example, the control unit 100 can be configured to command the valves of the fluid circuit to deliver dialysis fluid to the patient's abdomen, or to aspirate spent dialysis fluid from the patient's abdomen after a dwell time.

[0186] The control unit 100 is also operatively connected to the conductivity sensor 74 to monitor the fluid conductivity. The control unit 100 can also control the supply valve between the fluid preparation assembly 90 and the circular circuit to change the conductivity of the dialysis fluid.

[0187] The device 20 may also include a video controller 106 operatively connected to the control unit 100 connected to a user interface 108, which may include a display screen operated using a touch screen and / or one or more electromechanical buttons (such as membrane switches). The user interface 108 may also include one or more speakers for outputting alarms, warnings and / or voice guidance commands. The user interface 108 may be connected to a display such as a touch screen. Figure 1 The device 20 shown is provided together with, and / or may be, a remote user interface that operates in conjunction with the control unit 100. The control unit 100 may also include a transceiver (not shown) and a wired or wireless connection to a network (e.g., the Internet) for sending treatment data and receiving prescription instructions to a doctor or clinician's server that interfaces with the doctor or clinician's computer.

[0188] It is worth noting that in Figure 2-Figure 4 In the diagram, the dark valves are open at least at some point in the sequence, while the empty valves are in a closed position. The arrows show one embodiment of the direction of flow of fresh or used dialysis fluid. Peritoneal dialysis procedure

[0189] The following invention relates to a peritoneal dialysis procedure 200 for performing peritoneal dialysis treatment on a patient. The peritoneal dialysis procedure 200 is performed by the control unit 100 , in particular, all steps described hereafter or in the claims / aspects are performed by the control unit 100 .

[0190] The peritoneal dialysis procedure 200 includes the steps of commanding the activation 201 of the first pump 70a at a first flow rate and the activation 202 of the second pump 70b at a second flow rate different from the first flow rate. It is noteworthy that during the peritoneal dialysis procedure and thus during peritoneal treatment, the first pump 70a and the second pump 70b are activated simultaneously to deliver the first flow rate and the second flow rate. In particular, during peritoneal treatment, both the first pump 70a and the second pump 70b rotating elements rotate.

[0191] The first flow rate may be in the range between 100 ml / min and 1500 ml / min. Similarly, the second flow rate may be in the range between 100 ml / min and 1500 ml / min. It is noteworthy that these two ranges are different and may not even include some of the desired flow rates required at the patient line 28 to fill the patient or to empty the patient, i.e., low flow rates in the range of 15 to 100 ml / min. The first flow rate and the second flow rate may correspond to conditions where the first pump 70a and the second pump 70b operate near optimal conditions, such as operating near optimal conditions in terms of efficiency, or where the current flow rate provided by the pump substantially corresponds to the optimal condition of the commanded flow rate (e.g., 500 / 600 ml / min).

[0192] The peritoneal dialysis procedure 200 may include the step of determining or receiving an optimal first flow rate and / or an optimal second flow rate. The optimal first flow rate and / or the optimal second flow rate may specifically represent an optimal operating range for the first pump 70a and the second pump 70b.

[0193] Based on the structure of the fluid circuit 10 described above, the difference between the first flow rate and the second flow rate defines an exchange parameter value representing the exchange flow rate of the dialysis fluid with the patient. In other words, the difference between the first flow rate and the second flow rate determines a filling procedure 203, in which the abdomen of the patient is filled with dialysis fluid through the patient line 28, or a draining procedure 204, in which the spent dialysis fluid is withdrawn from the abdomen of the patient through the patient line 28.

[0194] like Figure 2-Figure 3 and Figure 5 As shown, during the filling process, the first flow rate is greater than the second flow rate. Figure 4As shown, the first flow rate is less than the second flow rate. Therefore, it should be noted that the current flow rate for filling the patient's abdomen is not determined by the rotation speed of a single pump, but by the flow rate / speed difference between the first pump 70a and the second pump 70b. For example, when the first pump 70a is set to 220ml / min and the second pump is set to 200ml / min, the patient's abdomen is filled at a flow rate of 20ml / min. On the contrary, when the first pump 70a is set to 200ml / min and the second pump is set to 220ml / min, the patient's abdomen is emptied at a flow rate of 20ml / min. Patient filling can be achieved using the flow rate in the patient line that changes during the filling step. A higher flow rate (e.g., 350ml / min) can be used at the beginning of the filling phase, and then a lower flow rate (e.g., 20ml / min) can be used after, for example, 5 minutes or 2 liters of infusion. A lower infusion rate can be lower than 50ml / min. In low filling mode, a flow rate lower than 15ml / min can be used.

[0195] As already mentioned, each dwell is followed by a complete drain, after which the peritoneal cavity is refilled with fresh dialysis fluid. The outflow of the drain fluid can be biphasic, with a "fast phase" with a flow rate of about 350 ml / min, and a "slow phase" with a significantly lower flow rate of only 30 to 40 ml / min (or lower). The separation between the fast outflow phase and the slow outflow phase is called the transition point or breakpoint, and usually occurs after 5 minutes of a 2-liter dwell.

[0196] The peritoneal dialysis procedure 200 may then include the step of determining an operating time, e.g., between 30 seconds and 20 minutes, to fill the patient's abdomen with a predetermined amount of dialysis fluid. Similarly, the peritoneal dialysis procedure 200 may include the step of determining an operating time, e.g., between 30 seconds and 20 minutes, to remove a predetermined amount of spent dialysis fluid from the patient's abdomen.

[0197] The peritoneal dialysis procedure may further comprise the step of calculating an exchange parameter value based on the first flow rate and the second flow rate difference value.In addition, the exchange parameter value may be calculated based on the operation time of the peritoneal dialysis procedure, in particular the operation time of the filling procedure and the draining procedure.

[0198] The peritoneal dialysis procedure may further or alternatively include the step of receiving as input a desired value of an exchange parameter representing an exchange flow rate of the dialysis fluid with the patient, and then setting a difference between the first flow rate and the second flow rate based on the desired exchange parameter value received as input so as to obtain the desired exchange parameter value.

[0199] In an embodiment including the first flow meter 81 and the second flow meter 82 , the first flow rate delivered by the first pump passes through the first flow meter 81 , while the second flow rate delivered by the second pump 70 b passes through the second flow meter 82 .

[0200] During a peritoneal dialysis procedure, the first flow meter 81 and the second flow meter 82 may be configured to measure the current flow rates in the delivery line 11 and the extraction line 12, respectively. Thus, a peritoneal dialysis procedure may include calculating the current first flow rate measured by the first flow meter, and / or calculating the current second flow rate measured by the second flow meter.

[0201] The peritoneal dialysis procedure may then include calculating an exchange parameter value, i.e., a current exchange parameter value, based on the difference between the current first flow rate and the current second flow rate measured by the first flow meter 81 and the second flow meter 82. In other words, the first flow meter 81 and the second flow meter 82 allow checking of the current flow rate determined by the first pump 70a and the second pump 70b. If the difference between the current first flow rate and the desired first flow rate exceeds a predetermined threshold, the control unit may be configured to command adjustment of the first pump 70a until the difference between the current first flow rate and the desired first flow rate is below a predetermined threshold. Similarly, if the difference between the current second flow rate and the desired second flow rate exceeds a predetermined threshold, the control unit 100 may be configured to command adjustment of the second pump 70b until the difference between the current second flow rate and the desired second flow rate is below a predetermined threshold.

[0202] In addition, the peritoneal dialysis program 200 may include adjusting the first pump 70a and / or the second pump 70b based on an actual exchange parameter value, i.e., an exchange parameter value calculated according to a difference between a current first flow rate and a current second flow rate measured by the first flow meter 81 and the second flow meter 82. For example, if the exchange parameter value is too low or too high, the peritoneal dialysis program may adjust the first pump and / or the second pump so as to change the flow rate difference of the first pump and the second pump. For example, if the actual exchange parameter value used to fill the patient with dialysis fluid is lower than the desired exchange parameter value, the control unit 100 may command the first pump 70a to increase the first flow rate, or may command the second pump 70b to decrease the second flow rate, or may command both an increase in the first flow rate and a decrease in the second flow rate.

[0203] Furthermore, the filling procedure 203 may include the steps of calculating a filling fluid amount of the dialysis fluid currently present in the abdomen of the patient based on the exchange parameter value, comparing the filling fluid amount with a maximum fluid amount threshold, and commanding the first pump and the second pump to stop when the filling fluid amount exceeds the maximum fluid amount threshold. The maximum fluid amount threshold may represent the maximum amount of dialysis fluid that the abdomen of the patient can receive during the filling procedure.

[0204] Similarly, the drain procedure 204 may include the steps of calculating a drain fluid volume of the dialysis fluid currently present in the abdomen of the patient based on the exchange parameter value, comparing the drain fluid volume to a minimum fluid volume threshold, and then commanding the first pump and the second pump to stop when the drain fluid volume becomes below the minimum fluid volume threshold.

[0205] Of note, a peritoneal dialysis procedure may include a dwell time inserted between the end of a fill procedure and the beginning of a subsequent drain procedure, and the dwell time may be between 1 min and 360 min.

[0206] Similarly, a peritoneal dialysis procedure may include a waiting time inserted between the end of a drain procedure and the start of a subsequent fill procedure, and the waiting time may be between 1 min and 20 min.

[0207] A peritoneal dialysis procedure may include the steps of performing a fill procedure and a drain procedure in subsequent cycles.

[0208] During the filling procedure 203, the peritoneal dialysis procedure may include steps performed by the control unit 100 for commanding one or more supply valves 54a, 54b, 54c, 154 to allow the dialysis fluid to enter the recirculation portion of the fluid circuit. For example, the filling procedure 203 may include moving the first valve 54a to an open position so that the container or bag 38a is in fluid communication with the annular circuit, in particular, in fluid communication with the recirculation portion 13 of the fluid circuit. Alternatively, the filling procedure may include moving the second valve 54b to an open position so that the container or bag 38b is in fluid communication with the annular circuit, in particular, in fluid communication with the recirculation portion 13 of the fluid circuit. Alternatively, the filling procedure may include moving the third valve 54c to an open position so that the container or bag 38c is in fluid communication with the annular circuit, in particular, in fluid communication with the recirculation portion 13 of the fluid circuit. In one embodiment, the filling procedure may include moving the first valve 54a, the second valve 54b, and the third valve 54c to an open position so that the container or bag 38a, 38b, 38c is in fluid communication with the annular circuit, in particular, in fluid communication with the recirculation portion 13 of the fluid circuit. In another embodiment, the filling procedure may include moving the second valve 54b and the third valve 54c to an open position to place the container or bag 38b, 38c in fluid communication with the loop circuit, and in particular with the recirculation portion 13 of the fluid circuit.

[0209] In another embodiment, the filling procedure may include moving the main valve 154 to an open position so that the containers or bags 38b, 38c and optionally the first container are in fluid communication with the annular circuit, in particular with the recirculation portion 13 of the fluid circuit. Due to the speed / flow rate difference between the first pump 70a and the second pump 70b, the step of moving one or more of the supply valves 54a, 54b, 54c, 154 to an open position during the filling procedure 203 causes the dialysis fluid to be drawn into the annular circuit. It is worth noting that during the filling process, the discharge valve 54i remains in a closed position, in particular, the control unit 100 commands the discharge valve 54i to be in a closed position. During the discharge procedure 204, the peritoneal dialysis procedure may include a step performed by the control unit for commanding the discharge valve 54i to be in an open position. During the discharge procedure 204, the first flow rate delivered by the first pump 70a is lower than the second flow rate of the second pump 70b, and this difference causes an overpressure of the fluid downstream of the second pump 70b and upstream of the first pump, i.e., in the recirculation portion 13. When the discharge valve 54 i is in the open position, the overpressure in the recirculation section causes the dialysis fluid to be discharged through the discharge line 14 .

[0210] Similarly, the difference between the first flow rate and the second flow rate during the drain procedure 204 determines the step of aspirating the dialysis fluid from the abdomen of the patient through the patient line 28, in particular through the aspiration line of the patient line 28. In this way, the spent dialysis fluid is aspirated from the patient and discharged through the drain line. During the drain procedure, the peritoneal dialysis procedure includes the step of fluidly disconnecting the annular circuit from the preparation assembly 90, in particular, the peritoneal dialysis procedure includes moving one or more of the supply valves 54a, 54b, 54c, 154 to the closed position to fluidly separate the annular circuit from the preparation assembly 90. Thus, during the drain procedure, the dialysis fluid circulates in the annular circuit while being discharged through the drain line 14.

[0211] It is worth noting that during the filling procedure and the draining procedure, the first pump 70a and the second pump 70b are operated simultaneously at different flow rates.

Claims

1. A peritoneal dialysis ("PD") fluid circuit (10), comprising: at least one patient line (28) extending between a first end (28a) and a second end (28b), the first end (28a) being configured to be connected to the abdomen of a patient; A fluid recirculation loop (130) comprising: A delivery line (11) connected to the first two ends (28b) and is configured to supply at least one patient line (28) The dialysis fluid should be fresh; and an extraction line (12) connected to said first The two ends (28b) are configured to draw water from the at least one patient line (28). Retrieving used dialysis fluid; a first pump (70a) arranged on the delivery line (11) and configured to supply fresh dialysis fluid to the at least one patient line (28); a second pump (70b) arranged on the extraction line (12) and configured to extract spent dialysis fluid from the at least one patient line (28); A control unit (100) operably connected to the first pump (70a) and the second pump (70b), the control unit (100) being configured to perform a peritoneal dialysis procedure (200), the peritoneal dialysis procedure (200) comprising the following steps: The first pump (70a) is commanded to be activated at a first flow rate, and the second pump (70b) is commanded to be activated at a second flow rate different from the first flow rate, and wherein the first pump (70a) and the second pump (70b) are activated simultaneously to provide the first flow rate and the second flow rate.

2. The peritoneal dialysis ("PD") fluid circuit (10) of claim 1, wherein: The difference between the first flow rate and the second flow rate defines an exchange parameter value representing an exchange flow rate of dialysis fluid with the patient in the patient line (28), and wherein the peritoneal dialysis procedure (200) comprises the following steps: Calculating the exchange parameter value based on the difference between the first flow rate and the second flow rate; or comprising the following steps: receiving as input a desired exchange parameter value representing a desired exchange flow rate of dialysis fluid with the patient in the patient line (28); A difference between the first flow rate and the second flow rate is set based on the desired exchange parameter value to obtain the desired exchange flow rate of the dialysis fluid in the patient line (28).

3. A peritoneal dialysis ("PD") fluid circuit (10) according to any one of the preceding claims 1 to 2, wherein: The peritoneal dialysis procedure (200) comprises the following steps: Determining or receiving an optimal first flow rate comprised between 100 ml / min and 1500 ml / min and an optimal second flow rate comprised between 100 ml / min and 1500 ml / min, the optimal first flow rate and the optimal second flow rate representing an optimal operating condition of the first pump (70a) and an optimal operating condition of the second pump (70b); setting the first flow rate of the first pump (70a) within a first range of ±30% of the optimal first flow rate, in particular, the first range is ±20%; and Setting the second flow rate of the second pump (70b) within a second range of ±30% of the optimal second flow rate, in particular, the second range is ±20%; commanding the first flow rate to be within a range between 100 ml / min and 1500 ml / min; The second flow rate is commanded within a range between 100 ml / min and 1500 ml / min.

4. A peritoneal dialysis ("PD") fluid circuit (10) according to any one of the preceding claims 1 to 3, wherein: The peritoneal dialysis procedure (200) includes: a filling procedure for filling the abdomen of the patient with dialysis fluid through the at least one patient line (28), during which the first flow rate is higher than the second flow rate, and a drain procedure for removing spent dialysis fluid from the abdomen of the patient through the at least one patient line (28), during which the first flow rate is lower than the second flow rate, The control unit (100) is configured to perform the filling procedure and the draining procedure alternately.

5. The peritoneal dialysis ("PD") fluid circuit (10) of claim 4, wherein: The peritoneal dialysis procedure (200) comprises inserting a dwell time between the end of the filling procedure and the subsequent start of the draining procedure, the dwell time being comprised between 1 minute and 360 minutes, And wherein the peritoneal dialysis procedure (200) comprises inserting a waiting time between the end of the drain procedure and the subsequent start of the fill procedure, the waiting time being comprised between 0 minutes and 20 minutes.

6. A peritoneal dialysis ("PD") fluid circuit (10) according to any one of the preceding claims 1 to 5, wherein: The first pump (70a) is a positive displacement pump, in particular, the first pump (70a) is one of a reciprocating pump, a peristaltic pump, a diaphragm pump, a gear pump and a piston pump, and wherein the second pump (70b) is a volumetric pump, in particular, the second pump (70b) is one of a reciprocating pump, a peristaltic pump, a diaphragm pump, a gear pump and a piston pump, wherein the first pump (70a) and the second pump (70b) are rotary pumps, the rotation of the first pump (70a) and the rotation of the second pump (70b) respectively determine the first flow rate and the second flow rate, Optionally, wherein the first pump (70a) and the second pump (70b) are of the same type.

7. A peritoneal dialysis ("PD") fluid circuit (10) according to any one of the preceding claims 1 to 6, wherein: The fluid recirculation loop (130) further includes a recirculation portion (13) extending upward from an outlet of the second pump (70b) to an inlet of the first pump (70a) according to a fluid direction (A) defined by the first pump (70a) and the second pump (70b), the recirculation portion (13) excluding the second end (28b) of the patient line (28), Wherein the fluid direction (A) is defined as from the first pump (70a) towards the patient line (28), and from the patient line (28) to the second pump (70b), and from the second pump (70b) towards the recirculation portion (13).

8. The peritoneal dialysis ("PD") fluid circuit (10) of claim 7, wherein: The delivery line (11), the extraction line (12) and the recirculation portion (13) are fluidically connected in series with each other to define the fluid recirculation loop (130), And wherein the peritoneal dialysis procedure includes circulating the dialysis fluid into the fluid recirculation loop (130) via the first pump (70a) and the second pump (70b).

9. A peritoneal dialysis ("PD") fluid circuit (10) according to any one of the preceding claims 7 to 8, wherein: The fluid circuit (10) comprises a discharge line (14) connected to the recirculation section (13), wherein the discharge line (14) extends from the recirculation section (13) to an outlet for discharging the dialysis fluid, in particular, the discharge line (14) is connected to the recirculation section via a three-way connector, The draining procedure comprises draining the dialysis fluid through the drain line (14).

10. A peritoneal dialysis ("PD") fluid circuit (10) according to any one of the preceding claims 1 to 9, wherein: The at least one patient line (28) comprises: a double lumen patient line (28) which integrates a fill line connected to the delivery line (11) and configured to deliver dialysis fluid to the patient's abdomen and an aspiration line connected to the extraction line (12) and configured to remove fluid from the patient's abdomen; or a fill line connected to the delivery line (11) and configured to deliver dialysis fluid to the abdomen of the patient, and an aspiration line connected to the extraction line (12) and configured to remove fluid from the abdomen of the patient, wherein the fill line is different from the aspiration line; or A single lumen line is provided for alternately delivering dialysis fluid to and withdrawing dialysis fluid from the abdomen of the patient.

11. A peritoneal dialysis ("PD") fluid circuit (10) according to any one of the preceding claims 1 to 10, wherein: The fluid circuit (10) comprises a first flow meter (81), wherein the first flow meter (81) The first flow meter (81) is configured to measure a current first flow rate provided by the first pump (70a), the first flow meter (81) being arranged in series with the first pump (70a) so that the same fluid flow rate flows through the first pump (70a) and the first flow meter (81), wherein the first flow meter (81) is arranged in the fluid recirculation loop (130) upstream of the first pump (70a) or on the delivery line (11) downstream of the first pump (70a) and upstream of the second end (28b) of the patient line (28); and The fluid circuit (10) includes a second flow meter (82), wherein the second flow meter (82) The second flow meter (82) is configured to measure a current second flow rate provided by the second pump (70b), the second flow meter (82) being arranged in series with the second pump (70b) so that the same fluid flow rate flows through the second pump (70b) and the second flow meter (82), wherein the second flow meter (82) is arranged in the fluid recirculation loop (130) downstream of the second pump (70b) On the extraction line (12), or arranged on the extraction line (12) downstream of the second end (28b) of the patient line (28).

12. The peritoneal dialysis ("PD") fluid circuit (10) of claim 11, wherein: The peritoneal dialysis procedure (200) includes: determining the current first flow rate measured by the first flow meter (81); determining the current second flow rate measured by the second flow meter (82); calculating a current exchange parameter value based on a difference between the current first flow rate and the current second flow rate, the current exchange parameter value representing a current exchange flow rate of the dialysis fluid with the patient; comparing the current exchange parameter value with a desired exchange parameter value; Based on the comparison, in particular, if the difference between the current exchange parameter value and the desired exchange parameter value exceeds a predetermined threshold, adjusting the flow rate difference between the first pump (70a) and the second pump (70b) towards the desired exchange parameter value, In particular, by adjusting the flow rate of the first pump (70a) and / or the flow rate of the second pump (70b).

13. A peritoneal dialysis ("PD") fluid circuit (10) according to any one of the preceding claims 1 to 12, wherein: The fluid circuit (10) comprises a dialysis fluid heater (56) configured to heat the dialysis fluid, wherein the dialysis fluid inline heater (56) is arranged in the fluid recirculation loop (130), and in particular in the recirculation portion (13) of the fluid recirculation loop, And wherein the fluid circuit (10) comprises an air trap (60) configured to remove air bubbles from the dialysis fluid, the air trap (60) being arranged on the fluid recirculation loop (130), and in particular on the recirculation portion (13) of the fluid recirculation loop.

14. A peritoneal dialysis ("PD") fluid circuit (10) according to any one of the preceding claims 1 to 13, wherein: The fluid circuit (10) further comprises a preparation assembly (90) configured to prepare a dialysis fluid to be supplied to the patient according to a predetermined prescription, the preparation assembly (90) comprising one or more supply lines for connection to a respective fluid source, in particular a solution bag, containing the dialysis fluid or a solution for preparing the dialysis fluid, wherein the one or more supply lines are configured to deliver fluid to the fluid recirculation loop (130), in particular to the recirculation portion (13) of the fluid circuit (10) during the filling procedure, Optionally, the one or more supply lines include at least a first supply line (24a) and a second supply line (24b), wherein the first supply line (24a) and the second supply line (24b) are respectively connected to a first fluid source (38a) and a second fluid source (38b) or are configured to be connected to the first fluid source (38a) and the second fluid source (38b), The preparation assembly (90) is configured to transport the solution of the first solution bag (38a) and the solution of the second solution bag (38b) in the fluid recirculation loop (130).

15. The peritoneal dialysis ("PD") fluid circuit (10) of claim 14, wherein: The fluid circuit (10) comprises at least one supply valve (54a, 54b, 54c, 154) which is fluidly interposed between the preparation assembly (90), in particular between the one or more supply lines, and the fluid recirculation loop (130), optionally between the recirculation portion (13) of the fluid circuit (10), The at least one supply valve (54a, 54b, 54c, 154) is fluidly interposed between the preparation assembly (90), in particular between the one or more supply lines, and the fluid recirculation loop (130), The at least one supply valve (54a, 54b, 54c, 154) is capable of moving between an open position and a closed position, wherein the open position allows fluid to move from the one or more supply pipelines to the recirculation portion (13) or to the fluid recirculation loop (130), and the closed position prevents the passage of fluid between the one or more supply pipelines and the fluid recirculation loop (130).

16. The peritoneal dialysis ("PD") fluid circuit (10) of claim 15, wherein: During the filling procedure, the peritoneal dialysis procedure (200) comprises steps performed by the control unit (100) for commanding the at least one supply valve (54a, 54b, 54c, 154) to be in the open position to allow fluid to flow from the preparation assembly (90). moving to the fluid recirculation loop (130), in particular to the recirculation section (13); During the draining procedure, the peritoneal dialysis procedure (200) comprises steps executed by the control unit (100) for commanding the at least one supply valve (54a, 54b, 54c, 154) to be in the closed position.

17. A peritoneal dialysis ("PD") fluid circuit (10) according to any one of the preceding claims 1 to 16, wherein: The fluid circuit (10) includes a discharge valve (54i) movable between an open position allowing fluid to be discharged through the discharge line (14) and a closed position preventing fluid from passing through the discharge line (14), And among them: During the discharge procedure, the peritoneal dialysis procedure (200) comprises steps performed by the control unit (100) for commanding the discharge valve (54i) to be in the open position; During the filling procedure, the peritoneal dialysis procedure (200) comprises steps executed by the control unit (100) for commanding the outlet valve (54i) to be in the closed position.

18. A peritoneal dialysis ("PD") fluid circuit (10) comprising: at least one patient line (28) extending between a first end (28a) and a second end (28b), the first end being configured to be connected to the abdomen of a patient; A fluid recirculation loop (130) comprising: a delivery line (11) connected to the second end (28b) of the at least one patient line (28) and configured to supply fresh dialysis fluid to the at least one patient line (28); an extraction line (12) connected to the second end (28b) of the at least one patient line (28) and configured to extract spent dialysis fluid from the at least one patient line (28); and a recirculation portion (13) extending upwardly from an outlet of the second pump (70b) to an inlet of the first pump (70a) according to a fluid direction (A) defined by the first pump (70a) and the second pump (70b), the recirculation portion (13) excluding the second end (28b) of the patient line (28), wherein the fluid direction (A) is defined from the first pump (70a) toward the patient line (28), and from the patient line (28) to the second pump (70b), and from the second pump (70b) toward the recirculation portion (13); wherein the delivery line (11), the extraction line (12) and the recirculation portion (13) are fluidly connected in series with each other to define the fluid recirculation loop (130); a discharge line (14) connected to the recirculation section (13), wherein the discharge line (14) extends from the recirculation section (13) to an outlet for discharging the dialysis fluid; a first pump (70a) arranged on the delivery line (11) and configured to supply fresh dialysis fluid to the at least one patient line (28); a second pump (70b) arranged on the extraction line (12) and configured to extract spent dialysis fluid from the at least one patient line (28); A control unit (100) operably connected to the first pump (70a) and the second pump (70b), the control unit (100) being configured to perform a peritoneal dialysis procedure (200), the peritoneal dialysis procedure (200) comprising the following steps: The first pump (70a) is commanded to be activated at a first flow rate, and the second pump (70b) is commanded to be activated at a second flow rate different from the first flow rate, and the dialysis fluid is circulated into the fluid recirculation loop (130) by the first pump (70a) and the second pump (70b), wherein the first pump (70a) and the second pump (70b) are activated simultaneously to provide the first flow rate and the second flow rate.

Images