Granted Patent B2

US 12,611,497 · App. 18/210,228 · Granted Apr 28, 2026

Inventors: Mauro Suffritti (Modena, IT); Mauro Gusella (Modena, IT)

Assignees: Vantive US Healthcare LLC; Vantive Health GmbH

A61M1/282A61M1/155A61M1/1656A61M1/1658A61M1/166A61M1/1668A61M1/287A61M1/1565A61M2205/3334A61M2205/3368A61M2205/36

Abstract

Claims (106)

1 . A peritoneal dialysis (“PD”) fluid circuit comprising:

a patient line extending between a first end configured to connect to a patient's abdomen and a second end;

a fluid recirculation loop comprising:

a delivery line connected to the second end of the patient line to supply fresh dialysis fluid towards the patient line; and

a withdrawal line connected to the second end of the patient line to withdraw spent dialysis fluid from the patient line;

a first pump arranged on the delivery line to supply the fresh dialysis fluid towards the patient line;

a second pump arranged on the withdrawal line to withdraw the spent dialysis fluid from the patient line,

wherein the fluid recirculation loop further comprises a recirculation portion extending from an outlet of the second pump up to an inlet of the first pump according to a fluid direction defined by the first pump and the second pump, the recirculation portion not including the second end of the patient line,

wherein the fluid direction is defined from the first pump towards the patient line, and from the patient line to the second pump, and from the second pump towards the recirculation portion, and

wherein the delivery line, the withdrawal line and the recirculation portion are fluidly connected to each other in series defining the fluid recirculation loop; and

a control unit operatively connected to the first pump and to the second pump, the control unit being configured to perform a peritoneal dialysis procedure comprising the step of:

commanding activation of the first pump at a first flow rate, and commanding activation of the second pump at a second flow rate different from the first flow rate,

wherein the first pump and the second pump are active simultaneously to provide the first flow rate and the second flow rate,

wherein the control unit is further configured to cause dialysis fluid to circulate in the fluid recirculation loop through the first pump and the second pump during the peritoneal dialysis procedure.

2 . The peritoneal dialysis (“PD”) fluid circuit of claim 1 , wherein a 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 with the patient in the patient line,

wherein, during the peritoneal dialysis procedure, the control unit is further configured to either:

calculate the exchange parameter value based on the difference between the first flow rate and the second flow rate; or

receive, as an input, a desired exchange parameter value representing a desired exchange flow rate of the dialysis fluid with the patient in the patient line; and

set a difference between the first flow rate and the second flow rate based on the desired exchange parameter value to obtain the desired exchange flow rate of the dialysis fluid in the patient line.

3 . The peritoneal dialysis (“PD”) fluid circuit of claim 1 , wherein, during the peritoneal dialysis procedure, the control unit is further configured to:

receive 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 first flow rate and the second flow rate representing an optimal operating condition for the first pump and for the second pump;

set the first flow rate of the first pump within a first range of 30% of the optimal first flow rate; and

set the second flow rate of the second pump within a second range of +30% of the optimal second flow rate;

cause the first flow rate to be in a range between 100 ml/min and 1500 ml/min; and

cause the second flow rate to be in a range between 100 ml/min and 1500 ml/min.

4 . The peritoneal dialysis (“PD”) fluid circuit of claim 1 , wherein, during the peritoneal dialysis procedure, the control unit is further configured to execute

a filling procedure to fill the patient's abdomen with the dialysis fluid through the patient line, during the filling procedure the first flow rate being higher than the second flow rate, and

a drainage procedure to remove the spent dialysis fluid from the patient's abdomen through the patient line, during the drainage procedure the first flow rate being lower than the second flow rate,

the control unit being configured to alternate the filling procedure and the drainage procedure.

5 . The peritoneal dialysis (“PD”) fluid circuit of claim 4 , wherein, during the peritoneal dialysis procedure, the control unit is further configured to interpose a dwell time between an end of the filling procedure and a subsequent start of the drainage procedure, the dwell time being comprised between 1 min and 360 min,

and wherein, during the peritoneal dialysis procedure, the control unit is further configured to interpose a waiting time between an end of the drainage procedure and a subsequent start of the filling procedure, the waiting time being less than 20 min.

6 . The peritoneal dialysis (“PD”) fluid circuit of claim 1 , wherein the first pump is a volumetric pump, the first pump being one of a reciprocating pump, a peristaltic pump, a membrane pump, a gear pump, and a piston pump,

wherein the second pump is a volumetric pump, the second pump being one of a reciprocating pump, a peristaltic pump, a membrane pump, a gear pump, and a piston pump, and

wherein the first pump and the second pump are of the same type.

7 . The peritoneal dialysis (“PD”) fluid circuit of claim 1 , further comprising a discharging line connected to the recirculation portion, wherein the discharging line extends from the recirculation portion to an outlet for draining the dialysis fluid, and

wherein the control unit is further configured to drain the dialysis fluid through the discharging line during a drainage procedure.

8 . The peritoneal dialysis (“PD”) fluid circuit of claim 1 , wherein the patient line comprises one of:

a dual lumen patient line combining in a single body a filling line connected to the delivery line to deliver the fresh dialysis fluid into the patient's abdomen, and a sucking line connected to the withdrawal line to remove the spent dialysis fluid from the patient's abdomen;

a filling line connected to the delivery line to deliver the fresh dialysis fluid into the patient's abdomen, and a sucking line connected to the withdrawal line to remove the spent dialysis fluid from the patient's abdomen, wherein the filling line is distinct from the sucking line; and

a single lumen line for alternatively sending and withdrawing the dialysis fluid into and from the patient's abdomen.

9 . The peritoneal dialysis (“PD”) fluid circuit of claim 1 , further comprising:

a dialysis fluid heater to heat the dialysis fluid, wherein the dialysis fluid heater is arranged in a recirculation portion of the fluid recirculation loop; and

an air trap to remove air bubbles from the dialysis fluid, the air trap being arranged on the recirculation portion of the fluid recirculation loop.

10 . The peritoneal dialysis (“PD”) fluid circuit of claim 1 , further comprising a preparation assembly to prepare the dialysis fluid according to a predefined recipe, the preparation assembly comprising one or more supply lines for connection to a respective fluid source containing the dialysis fluid or a solution for preparing the dialysis fluid, wherein the one or more supply lines are configured, during a filling procedure, to deliver fluid to the recirculation portion of the PD fluid circuit.

11 . The peritoneal dialysis (“PD”) fluid circuit of claim 10 , wherein the one or more supply lines comprise a first supply line and a second supply line respectively connected to a first fluid source and a second fluid source, and

wherein the preparation assembly is configured to deliver the solution of the first fluid source and the solution of the second fluid source to the fluid recirculation loop.

12 . The peritoneal dialysis (“PD”) fluid circuit of claim 10 , further comprising a supplying valve fluidly interposed between the one or more supply lines and the recirculation portion of the PD fluid circuit,

the supplying valve being fluidly interposed between the one or more supply lines and the fluid recirculation loop, and

the supplying valve being movable between an open position, wherein fluid is allowed to move from the one or more supply lines to the fluid recirculation loop, and a close position wherein fluid passage is prevented between the one or more supply lines and the fluid recirculation loop.

13 . The peritoneal dialysis (“PD”) fluid circuit of claim 12 , wherein:

during the filling procedure, the control unit is further configured to execute the peritoneal dialysis procedure comprising a step to control the supplying valve in the open position to allow fluid to move from the preparation assembly to the recirculation portion; and

during a drainage procedure, the control unit is further configured to execute the peritoneal dialysis procedure comprising a step to control the supplying valve in the close position.

14 . A peritoneal dialysis (“PD”) fluid circuit comprising:

a patient line extending between a first end, configured to connect to a patient's abdomen, and a second end;

a fluid recirculation loop comprising:

a delivery line connected to the second end of the patient line and configured to supply fresh dialysis fluid towards the patient line;

a withdrawal line connected to the second end of the patient line and configured to withdraw spent dialysis fluid from the patient line; and

a discharging line connected to a recirculation portion, wherein the discharging line extends from the recirculation portion to an outlet for draining dialysis fluid;

a first pump arranged on the delivery line and configured to supply the fresh dialysis fluid towards the patient line;

a second pump arranged on the withdrawal line and configured to withdraw the spent dialysis fluid from the patient line,

wherein the fluid recirculation loop further comprises the recirculation portion extending from an outlet of the second pump up to an inlet of the first pump according to a fluid direction defined by the first pump and the second pump, the recirculation portion not including the second end of the patient line, wherein the fluid direction is defined from the first pump towards the patient line, and from the patient line to the second pump, and from the second pump towards the recirculation portion,

wherein the delivery line, the withdrawal line and the recirculation portion are fluidly connected to each other in series defining the fluid recirculation loop; and

a control unit operatively connected to the first pump and the second pump, the control unit being configured to perform a peritoneal dialysis procedure comprising the step of:

commanding activation of the first pump at a first flow rate, and commanding activation of the second pump at a second flow rate different from the first flow rate, and circulating the dialysis fluid into the fluid recirculation loop through the first pump and the second pump, wherein the first pump and the second pump are active simultaneously to provide the first flow rate and the second flow rate,

wherein, during the peritoneal dialysis procedure, the control unit is further configured to:

receive 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 for the first pump and for the second pump;

set the first flow rate of the first pump within a first range of 30% of the optimal first flow rate; and

set the second flow rate of the second pump within a second range of +30% of the optimal second flow rate;

command the first flow rate in a range between 100 ml/min and 1500 ml/min; and

command the second flow rate in a range between 100 ml/min and 1500 ml/min.

15 . The peritoneal dialysis (“PD”) fluid circuit of claim 14 , further comprising:

a first flow meter configured to measure a current first flow rate provided by the first pump, the first flow meter being arranged in series with the first pump so that a same fluid flow rate flows through the first pump and the first flow meter, wherein the first flow meter is arranged on the fluid recirculation loop upstream of the first pump; and

a second flow meter configured to measure a current second flow rate provided by the second pump, the second flow meter being arranged in series with the second pump so that a same fluid flow rate flows through the second pump and the second flow meter, wherein the second flow meter is arranged on the fluid recirculation loop downstream from the second pump or on the withdrawal line downstream from the second end of the patient line.

16 . The peritoneal dialysis (“PD”) fluid circuit of claim 15 , wherein, during the peritoneal dialysis procedure, the control unit is further configured to:

determine the current first flow rate measured by the first flow meter;

determine the current second flow rate measured by the second flow meter;

calculate 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; and

based on the comparison, when a difference between the current exchange parameter value and the desired exchange parameter value exceeds a predefined threshold, adjusting a difference in flow rate between the first pump and the second pump towards the desired exchange parameter value by changing the first flow rate of the first pump and/or the second flow rate of the second pump.

17 . The peritoneal dialysis (“PD”) fluid circuit of claim 15 , further comprising a discharging valve movable between an open position, wherein fluid is allowed to be discharged through the discharging line, and a close position wherein fluid passage through the discharging line is prevented,

and wherein:

during a drainage procedure, the control unit is further configured to execute the peritoneal dialysis procedure comprising a step to control the discharging valve in the open position; and

during a filling procedure, the control unit is further configured to execute the peritoneal dialysis procedure comprising a step to control the discharging valve in the close position.

18 . A peritoneal dialysis (“PD”) fluid circuit comprising:

a patient line extending between a first end configured to connect to a patient's abdomen and a second end;

a fluid recirculation loop comprising:

a delivery line connected to the second end of the patient line to supply fresh dialysis fluid towards the patient line; and

a withdrawal line connected to the second end of the patient line to withdraw spent dialysis fluid from the patient line;

a first pump arranged on the delivery line to supply the fresh dialysis fluid towards the patient line;

a second pump arranged on the withdrawal line to withdraw the spent dialysis fluid from the patient line;

a first flow meter configured to measure a current first flow rate provided by the first pump, the first flow meter being arranged in series with the first pump so that a same fluid flow rate flows through the first pump and the first flow meter, wherein the first flow meter is arranged on the fluid recirculation loop upstream of the first pump;

a second flow meter configured to measure a current second flow rate provided by the second pump, the second flow meter being arranged in series with the second pump so that a same fluid flow rate flows through the second pump and the second flow meter, wherein the second flow meter is arranged on the fluid recirculation loop downstream from the second pump or on the withdrawal line downstream from the second end of the patient line,

wherein the fluid recirculation loop further comprises a recirculation portion extending from an outlet of the second pump up to an inlet of the first pump according to a fluid direction defined by the first pump and the second pump, the recirculation portion not including the second end of the patient line,

wherein the fluid direction is defined from the first pump towards the patient line, and from the patient line to the second pump, and from the second pump towards the recirculation portion; and

a control unit operatively connected to the first pump and to the second pump, the control unit being configured to perform a peritoneal dialysis procedure comprising the step of:

commanding activation of the first pump at a first flow rate, and commanding activation of the second pump at a second flow rate different from the first flow rate, and wherein the first pump and the second pump are active simultaneously to provide the first flow rate and the second flow rate,

filling the patient's abdomen with dialysis fluid through the patient line, during a filling procedure, the first flow rate being higher than the second flow rate, and

removing the spent dialysis fluid from the patient's abdomen through the patient line, during a drainage procedure, the first flow rate being lower than the second flow rate, the control unit being configured to alternate the filling procedure and the drainage procedure,

wherein, during the peritoneal dialysis procedure, the control unit is further configured to:

determine the current first flow rate measured by the first flow meter;

determine the current second flow rate measured by the second flow meter;

calculate 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;

compare the current exchange parameter value with a desired exchange parameter value; and

based on the comparison, if when a difference between the current exchange parameter value and the desired exchange parameter value exceeds a predefined threshold, adjust a difference in flow rate between the first pump and the second pump towards the desired exchange parameter value by changing rhe first flow rate of the first pump and/or the second flow rate of the second pump.

19 . The peritoneal dialysis (“PD”) fluid circuit of claim 18 , wherein the delivery line, the withdrawal line and the recirculation portion are fluidly connected to each other in series defining the fluid recirculation loop,

and wherein the control unit is further configured to circulate the dialysis fluid into the fluid recirculation loop through the first pump and the second pump during the peritoneal dialysis procedure.

Assignments (5)

Priority Claims (1)

Continuity (1)

References Cited (15)