Peritoneal dialysis systems, devices, and methods

• US 10,688,234 B2
• Filed: 03/31/2017
• Issued: 06/23/2020
• 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:
  US15/476,015
• Publication Number:
  US 20170203024A1
• Time in Patent Office: 1,180 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 includes 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 also 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 pumping a quantity of the concentrated osmotic agent that is at least sufficient to achieve the desired final concentration into the mixing container. The contest of the mixing container are mixed, further diluted or concentrated, and then flowed to a patient.

Claims

1. A method of performing a peritoneal dialysis treatment with a peritoneal dialysis treatment system, the method comprising:

connecting a disposable unit to a source of water, said disposable unit including at least a first container holding a sterile first concentrate containing at least an osmotic agent, a second container holding a sterile second concentrate containing electrolytes, an empty sterile mixing container, and a tubing set with a pre-attached peritoneal fill/drain line;

receiving a prescription command by a controller of the peritoneal dialysis treatment system, the prescription command including at least a fill volume and a desired final concentration of the osmotic agent in a mixture of the water and at least the first concentrate to be used as a treatment fluid for a current fill cycle under said peritoneal dialysis treatment;

pumping a first volume of water from the source of water into the mixing container, wherein the first volume is based on at least the prescription command;

using the controller, pumping a quantity of the first concentrate into the mixing container, the quantity, based on an expected concentration of the first concentrate, being at least sufficient to achieve the desired final concentration based on the fill volume;

mixing all contents of the mixing container after said pumping the quantity of the first concentrate;

after said mixing, adding water or the first concentrate to the mixing container to generate the treatment fluid in the mixing container; and

flowing the treatment fluid from the mixing container to a patient.

2. The method of claim 1, further comprising:

after the mixing, detecting a concentration of the osmotic agent in the mixing container.

3. The method of claim 2, wherein said first concentrate contains both the osmotic agent and the electrolytes, said electrolytes in the first concentrate serving as a marker for establishing a conductivity versus concentration characteristic that is monotonic within a range suitable for closed-loop control.

4. The method of claim 3, further comprising:

before said mixing all contents of the mixing container, pumping into the mixing container a quantity of the second concentrate from said second container that, in combination with the quantity of the first concentrate pumped from said first container, will result, after mixing with the water, in the treatment fluid that has a desired final dialysis fluid formulation; and

detecting a total concentration of the electrolytes in the mixing container to verify the desired final dialysis fluid formulation.

5. The method of claim 4, wherein the electrolytes contained in the first concentrate are of the same chemical species as the electrolytes in the second concentrate held in said second container.

6. The method of claim 5, wherein

the detecting the concentration of the osmotic agent in the mixing container includes inferring said concentration of the osmotic agent from the total concentration of the electrolytes in the mixing container.

7. The method of claim 6, wherein the electrolytes and the osmotic agent in the first concentrate have been proportioned such that only the first concentrate is used when the prescription command calls for a maximum desired concentration of the osmotic agent in the treatment fluid.

8. The method of claim 7, wherein the disposable unit also includes a third container holding a buffer.

9. The method of claim 8, wherein pH of the osmotic agent held in said first container is less than 4.0 and pH of the electrolytes and the buffer held respectively in said second and third containers is such that pH of the desired final dialysis fluid formulation will be in a range of 6.0 to 8.0.

10. The method of claim 9, wherein the osmotic agent is, or includes, glucose.

11. The method of claim 10, wherein the osmotic agent has been prepared via sterile filtration.

12. The method of claim 11, further comprising:

providing a sterilizing-grade filter in the disposable unit.

13. The method of claim 12, further comprising:

passing the water from said source of water through said sterilizing-grade filter prior to flowing the water into said mixing container; and

confirming integrity of said sterilizing-grade filter prior to flowing the treatment fluid from the mixing container to the patient.

14. The method of claim 13, wherein

contents of said first container and of said second container pass through said sterilizing-grade filter prior to flowing into said mixing container.

15. The method of claim 14, wherein said volume of water is initially less than 100% of the fill volume.

16. The method of claim 15, wherein said peritoneal dialysis treatment includes multiple cycles of filling and draining the patient, and fill volumes and desired final concentrations of the osmotic agent vary from cycle to cycle.

17. The method of claim 7, wherein the maximum desired concentration is 4.25% for dextrose.