Peritoneal dialysis systems, devices, and methods

• US 10,610,630 B2
• Filed: 03/31/2017
• Issued: 04/07/2020
• Est. Priority Date: 03/23/2011
• 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:
  US15/476,714
• Publication Number:
  US 20170203027A1
• Time in Patent Office: 1,103 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 1/1562 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/1565 Details of valves
• CPC Class Codes: A61M 1/159 specially adapted for peritoneal dialysis
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• CPC Class Codes: A61M 1/1664 with temperature control
• CPC Class Codes: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/167 Flexible packaging for solid concentrates
• CPC Class Codes: A61M 1/1672 using membrane filters, e.g. for sterilising the dialysate
• CPC Class Codes: A61M 1/1674 using UV radiation sources for sterilising the dialysate
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/281 Instillation other than by gravity
• 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 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/123 : with incorporated reservoirs
• CPC Class Codes: A61M 2205/128 : with incorporated valves
• CPC Class Codes: A61M 2205/14 : Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/33 : Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3351 : Controlling upstream pump pressure
• CPC Class Codes: A61M 2205/3355 : Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus

Abstract

A method of performing a peritoneal dialysis treatment includes connecting a disposable unit to a source of water, the disposable unit including at least a first container holding a sterile concentrate containing an osmotic agent, a second container holding a sterile concentrate containing electrolytes, an empty sterile mixing container, and a tubing set with a pre-attached peritoneal fill/drain line. The method further includes receiving a prescription command by a controller, indicating at least the fill volume and desired final concentration of the osmotic agent to be used for a current fill cycle under said treatment, and using the controller, pumping a quantity of the concentrated osmotic agent that is at least sufficient to achieve the desired final concentration into the mixing container. The contents of the mixing container are mixed, further diluted or concentrated, and then flowed to a patient.

Claims

1. A system for performing a peritoneal dialysis treatment, comprising:

a disposable unit with at least

a first container holding a sterile concentrate containing an osmotic agent,

a second container holding a sterile concentrate containing electrolytes,

an empty sterile mixing container, and

a tubing set with branches having valve portions, the branches connecting the first container, the second container, and the sterile mixing container through a pumping tube segment;

a source of purified water;

a treatment component with a controller connected to a pump actuator and valve actuators, the treatment component being configured to engage the valve portions and the pump actuator being configured to engage the pumping tube segment;

the controller storing a prescription data indicating at least a fill volume and a desired final concentration of the osmotic agent in a mixture of the purified water and at least the concentrate containing the osmotic agent to be used for a current fill cycle of the peritoneal dialysis treatment;

the controller being configured to pump a quantity of the concentrate containing the osmotic agent that is at least sufficient to achieve the desired final concentration based on a capacity of the mixing container and the stored prescription data;

the controller further being configured to pump the purified water from the source of purified water into the mixing container and using the pump actuator, to mix contents of the mixing container; and

the controller further being configured to pump a quantity of the concentrate containing electrolytes into the mixing container; and

the controller further being configured to pump purified water from the source of purified water into the mixing container and, using the pump actuator, mixing the contents of the mixing container to achieve said desired final concentration.

2. The system of claim 1, wherein

the controller is configured to pump fluid from the mixing container to a patient to perform a peritoneal fill cycle of a cycler assisted peritoneal dialysis therapy.

3. The system of claim 2, wherein,

the controller is configured to pump spent dialysate from the patient before the fluid from the mixing container is pumped to the patient.

4. The system of claim 1, wherein the controller is configured to control the valve actuators and the pump actuator to pump a sample of fluid from the mixing container to a conductivity sensor and to sample a signal from the conductivity sensor.

5. The system of claim 1, wherein the controller is configured to control the valve actuators and the pump actuator to pump a sample of fluid from the mixing container to a conductivity sensor and to sample a conductivity signal from the conductivity sensor, and

the controller is configured to generate a command signal to permit or deny pumping of the fluid from the mixing container to a patient in response to the conductivity signal.

6. The system of claim 1, wherein

the sterile concentrate in the first container contains a predefined mixture containing electrolytes in addition to said osmotic agent, said predefined mixture serving as a marker for establishing a conductivity versus concentration characteristic that is monotonic within a range suitable for closed-loop control.

7. The system of claim 1, wherein

the controller is configured to control the pump actuator to pump the quantity of the concentrate containing the electrolytes from said second container that, in combination with the quantity of the concentrate containing the osmotic agent pumped from said first container, results, upon further dilution with the purified water, in the desired final concentration.

8. The system of claim 1, wherein the mixing container has two ports to permit the pump actuator to cause fluid to flow into and out of the mixing container to mix contents of the mixing container through the pumping tube segment by actuating selected ones of said valve actuators.

9. The system of claim 6, wherein the electrolytes and the osmotic agent in said first container are proportioned such that only concentrate from said first container is needed when the stored prescription data calls for a maximum desired concentration.