Peritoneal dialysis systems, devices, and methods

• US 10,046,100 B2
• Filed: 01/07/2017
• Issued: 08/14/2018
• Est. Priority Date: 03/23/2011
• Status: Active Grant

• Current Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Original Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Inventors: Burbank, Jeffrey H., Brugger, James M., Treu, Dennis M., Wyeth, Mark T.
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US15/400,978
• Publication Number:
  US 20170182237A1
• Time in Patent Office: 584 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

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 disposable unit, comprising:

a manifold unit with a first and a second array of ports and containing a mechanism for selectively interconnecting the first array of ports with the second array of ports to define respective fluid paths, the interconnecting being completed through a pumping portion;

a water inlet port of the first array of ports of the manifold unit being fluidly connected to a source of purified water through a water inlet tube;

a respective port of the first array of ports of the manifold unit being connected to a first container holding at least a sterile, concentrated osmotic agent;

one port of each of the first and second arrays of ports being connected to respective ports of an empty sterile mixing container, the empty sterile mixing container having a capacity sufficient for at least a single automated peritoneal dialysis treatment cycle; and

at least a port of the second array of ports of the manifold unit being connected to a tubing set that includes a pre-attached peritoneal fill/drain line.

2. The unit of claim 1, wherein said first container contains a mixture of a sterile osmotic agent and electrolytes in a predefined concentration ratio effective to permit a concentration of said osmotic agent to be determined whereby the electrolytes function as a marker to establish a conductivity versus concentration characteristic that is monotonic within a range of concentrations suitable for closed-loop control.

3. The unit of claim 2, wherein a fluid path that connects to the source of purified water includes an inline sterilizing filter.

4. The unit of claim 2, further comprising:

a first removable seal closing the water inlet tube connected to the water inlet port;

a second removable seal closing the pre-attached peritoneal fill/drain line; and

a third removable seal closing a waste drain line fluidly connected to at least one of the first and second arrays of ports, wherein

said peritoneal dialysis disposable unit is a closed, sterile system, which is accessible to the outside environment only when at least one of said first, second, and third removable seals is opened.

5. The unit of claim 4, further comprising an air line connecting a pressure pod on the peritoneal fill/drain line with a pressure transducer.

6. The unit of claim 4, wherein the pumping portion includes a pumping tube segment.

7. The unit of claim 2, further comprising an air line connecting a pressure pod on the peritoneal fill/drain line with a pressure transducer.

8. The unit of claim 2, wherein the pumping portion includes a pumping tube segment.

9. The unit of claim 2, wherein the pumping portion includes only one pumping tube segment.

10. The unit of claim 1, wherein a fluid path that connects to the source of purified water includes an inline sterilizing filter.

11. The unit of claim 10, further comprising:

a first removable seal closing the water inlet tube connected to the water inlet port;

a second removable seal closing the pre-attached peritoneal fill/drain line; and

a third removable seal closing a waste drain line fluidly connected to at least one of the first and second arrays of ports, wherein

said peritoneal dialysis disposable unit is a closed, sterile system, which is accessible to the outside environment only when at least one of said first, second, and third removable seals is opened.

12. The unit of claim 10, further comprising an air line connecting a pressure pod on the peritoneal fill/drain line with a pressure transducer.

13. The unit of claim 10, wherein the pumping portion includes a pumping tube segment.

14. The unit of claim 10, wherein the pumping portion includes only one pumping tube segment.

15. The unit of claim 1, further comprising:

a first removable seal closing the water inlet tube connected to the water inlet port;

a second removable seal closing the pre-attached peritoneal fill/drain line; and

a third removable seal closing a waste drain line fluidly connected to at least one of the first and second arrays of ports, wherein

said peritoneal dialysis disposable unit is a closed, sterile system, which is accessible to the outside environment only when at least one of said first, second, and third removable seals is opened.

16. The unit of claim 15, wherein the pumping portion includes only one pumping tube segment.

17. The unit of claim 1, further comprising an air line connecting a pressure pod on the peritoneal fill/drain line with a pressure transducer.

18. The unit of claim 17, wherein the pumping portion includes a pumping tube segment.

19. The unit of claim 1, wherein the pumping portion includes a pumping tube segment.

20. The unit of claim 19, wherein the pumping portion includes only one pumping tube segment.

21. The unit of claim 1, wherein the pumping portion includes only one pumping tube segment.

22. A peritoneal dialysis system, comprising:

a peritoneal dialysis disposable unit, including

a manifold unit with a first and a second array of ports and containing a mechanism for selectively interconnecting the first array of ports with the second array of ports to define respective flow paths, the interconnecting being completed through a pumping portion,

a water inlet port of the first array of ports of the manifold unit being fluidly connected to a source of purified water through a water inlet tube;

a respective port of the first array of ports of the manifold unit being connected to a first container holding at least a sterile, concentrated osmotic agent;

one port of each of the first and second arrays of ports being connected to respective ports of an empty sterile mixing container, the empty sterile mixing container having a capacity sufficient for at least a single automated peritoneal dialysis treatment cycle; and

at least a port of the second array of ports of the manifold unit being connected to a tubing set that includes a pre-attached peritoneal fill/drain line; and

a controller configured to control an actuator mechanism adapted to flow fluid through the disposable unit, the controller being programmed to calculate respective flow characteristics of respective flow paths connecting the mixing container to the source of purified water, the first container, and an electrolyte container at a first time and later use the calculated flow characteristics to control quantities of fluid flowed from the source of purified water, the first container, and the electrolyte container to the mixing container.

23. The peritoneal dialysis system according to claim 22, wherein said first container contains a mixture of a sterile osmotic agent and electrolytes in a predefined concentration ratio effective to permit a concentration of said osmotic agent to be determined whereby the electrolytes function as a marker to establish a conductivity versus concentration characteristic that is monotonic within a range of concentrations suitable for closed-loop control.

24. The peritoneal dialysis system according to claim 22, wherein a fluid path that connects to the source of purified water includes an inline sterilizing filter.

25. The peritoneal dialysis system according to claim 22, wherein the disposable unit further comprises:

a first removable seal closing the water inlet tube connected to the water inlet port;

a second removable seal closing the pre-attached peritoneal fill/drain line; and

a third removable seal closing a waste drain line fluidly connected to at least one of the first and second arrays of ports, wherein

said peritoneal dialysis disposable unit is a closed, sterile system, which is accessible to the outside environment only when at least one of said first, second, and third removable seals is opened.

26. The peritoneal dialysis system according to claim 22, wherein the disposable unit further comprises:

an air line connecting a pressure pod on the peritoneal fill/drain line with a pressure transducer.

27. The peritoneal dialysis system according to claim 22, wherein the pumping portion includes only one pumping tube segment.

28. The peritoneal dialysis system of claim 22, further comprising:

one or more flow rate sensors configured to measure a flow rate through at least one flow path of the respective flow paths,

wherein the controller is programmed to calculate the respective flow characteristics of the respective flow paths by commanding the actuator mechanism to flow fluid through said disposable unit and recording sensor signals from the one or more flow rate sensors indicating flow rates of said fluid through the at least one flow path.

29. The peritoneal dialysis system of claim 28, wherein the controller is further programmed to detect connection of said disposable unit to the source of purified water and to calculate said respective flow characteristic responsively to a detection of the connection of said disposable unit.

30. The peritoneal dialysis system of claim 28, wherein

the one or more flow rate sensors include a flow sensor connected to a pump outlet, and

the controller is programmed to calculate said respective flow characteristics by pumping fluid while simultaneously measuring flow rate using the flow sensor.

31. The peritoneal dialysis system of claim 22, wherein the controller is further programmed to detect connection of said disposable unit to the source of purified water and to calculate said respective flow characteristic responsively to a detection of the connection of said disposable unit to the source of purified water.

32. The peritoneal dialysis system of claim 31, wherein the controller is programmed to calculate said respective flow characteristics by pumping fluid while simultaneously measuring flow rate using a flow sensor connected to a pump outlet.

33. The peritoneal dialysis system of claim 22, wherein the controller is programmed to calculate said respective flow characteristics by pumping fluid while simultaneously measuring flow rate using a flow sensor connected to a pump outlet.