Peritoneal dialysis systems, devices, and methods

• US 9,861,733 B2
• Filed: 09/23/2012
• Issued: 01/09/2018
• Est. Priority Date: 03/23/2012
• Status: Active Grant

• Current Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Burbank, Jeffrey H., Brugger, James M., Treu, Dennis M., Wyeth, Mark T.
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US14/348,533
• Publication Number:
  US 20150005699A1
• Time in Patent Office: 1,934 Days
• CPC Class Codes: A61M 1/1524 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/154 with sensing means or components thereof
• CPC Class Codes: A61M 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: A61M 1/159 specially adapted for peritoneal dialysis
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/282 Operational modes
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 1/287 Dialysates therefor
• CPC Class Codes: A61M 1/288 Priming priming in extracorporeal blood circuits A61M1/3643
• CPC Class Codes: A61M 2205/705 Testing of filters for leaks

Abstract

An automated peritoneal dialysis system provides various features including prescription-driven dialysis fluid preparation, an integrated disposable fluid circuit, and sensor capabilities that allow accurate filing and draining control with high safety margins. Features include a peritoneal fluid circuit with a pressure sensor at either end and methods and devices for using the pressure signals. Other features and embodiments are disclosed.

Claims

1. A peritoneal dialysis system, comprising:

a fluid batch preparation component configured to prepare a batch of dialysate by diluting concentrated dialysate with a liquid;

a cycler component configured to perform cycler-assisted peritoneal dialysis treatment;

a controller configured to operate the fluid batch preparation component and the cycler component;

further comprising a flow path switching mechanism, the flow path switching mechanism being shared by the fluid batch preparation component and the cycler component and being adapted to define multiple flow paths interconnecting a patient-connectable port, one or more fluid component and water lines, and a drain line;

a pair of fluid property sensors interconnected by at least one of the multiple flow paths;

a peristaltic pump shared by the cycler component and the fluid batch preparation component, the controller being configured to calibrate said pump to generate calibration data and to use said calibration data to perform at least one of;

calculate a volume of fluid transferred to a patient;

calculate a volume of fluid transferred from a patient;

calculate a difference between a volume of fluid transferred to a patient and a volume of fluid transferred from the patient;

determine an amount of fluid being transferred to a patient to compare the amount with a predetermined amount and to regulate the pump so that the amount being transferred does not exceed the predetermined amount; and

calculate a difference between a volume of fluid transferred to a patient and a volume of fluid transferred from the patient to determine a net transfer amount and output an indication if the net transfer amount is outside a predefined range, the output being applied to a user interface, applied to a data store, or communicated to an external terminal.

2. The system of claim 1, wherein

the controller is configured to calibrate said pump by generating a fluid property perturbation using said flow path switching mechanism and measuring a transit time of the fluid property perturbation between said pair of fluid property sensors, said measuring including receiving successive signals from each of said pair of fluid property sensors as said fluid property perturbation passes said each of said pair of fluid property sensors,

said controller is further configured to control a total fluid transferred to said batch of dialysate responsively to data representing compensation factors respective to each of said multiple flow paths, and

the compensation factors compensate for factors that influence a ratio of pump cycles to volume displaced that differ for fluids flowing in different flow paths.

3. The system of claim 1, wherein

the controller is configured to calibrate said pump by generating a fluid property perturbation using said flow path switching mechanism and measuring a transit time of the fluid property perturbation between said pair of fluid property sensors, said measuring including receiving successive signals from each of said pair of fluid property sensors as said fluid property perturbation passes said each of said pair of fluid property sensors.

4. The system of claim 1, wherein the cycler component and the fluid batch preparation component share the drain line with said pair of fluid property sensors.

5. The system of claim 4, wherein

said pair of fluid property sensors are first and second fluid conductivity sensors,

the controller is configured to compare a fluid conductivity of a batch of fluid, prepared by said fluid batch preparation component, indicated by said first and second fluid conductivity sensors, to a predefined range and output a result of said comparing.

6. The system of claim 5, wherein

the controller is configured to compare fluid conductivity measurements by each of said first and second fluid conductivity sensors to each other and output a first indication responsively thereto,

said controller is further configured to compare at least one of the fluid conductivity measurements to a predetermined range and output a second indication responsively thereto, and

said controller is configured to control a treatment of said cycler component responsively to one or both of said first and second indications.

7. The system of claim 5, wherein

the first and second fluid conductivity sensors are arranged in series along said drain line and said controller is configured to calibrate said pump at least in part by generating a fluid conductivity perturbation in a flow through said drain line and measuring a time between successive detections of said perturbation by said first and second fluid conductivity sensors.

8. The system of claim 7, wherein

said controller is configured to generate said fluid conductivity perturbation by flowing a first fluid and a second fluid in said drain line,

one of said first fluid and said second fluid is water, and

the first fluid and the second fluid have different conductivities.

9. The system of claim 7, wherein

said controller is configured to generate said fluid conductivity perturbation by flowing a portion of the batch of dialysate in said drain line and flowing purified water in said drain line, in succession.

10. The system of claim 9, wherein

the controller is configured to control flow path selection actuators of the flow patch switching mechanism and said pump to transfer fluid from a concentrate container and a water source at a single pumping rate.

11. The system of claim 10, wherein

the controller is configured to control the flow path selection actuators and said pump such that between a time of pumping water and a time of pumping concentrate, a bolus of said concentrate is transferred to said drain line and then a quantity of said concentrate is transferred to a batch container.

12. The system of claim 1, wherein

the controller is further configured to operate the pump and control valves of the flow path switching mechanism to transfer fluid from the patient-connectable port to the drain line.