Peritoneal dialysis systems, devices, and methods

• US 10,688,235 B2
• Filed: 03/31/2017
• Issued: 06/23/2020
• 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:
  US15/476,927
• Publication Number:
  US 20170203026A1
• 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 dialysis treatment includes using a pump and a dialysate supply line to transport peritoneal dialysis fluid, the supply line having a proximal end into which peritoneal dialysis fluid is supplied and from which spend dialysate is withdrawn, and a distal end which is connected to a patient'"'"'s peritoneal access. The method further includes generating proximal and distal pressure signals using pressure detectors located at both the proximal and distal ends, respectively, of said supply line. During a drain cycle in which spent dialysate is pumped from the patient, the method includes, responsively to the proximal and distal pressure signals, detecting a characteristic of a pressure difference between the distal and proximal ends whose magnitude is determined by a predicted change in dialysate properties, and responsively to the characteristic, generating a signal indicating the change in dialysate properties.

Claims

1. A system for performing peritoneal dialysis, the system comprising:

a peritoneal catheter for infusing a fluid into an abdomen of a patient during a fill cycle and withdrawing the fluid from the abdomen of the patient during a drain cycle, the withdrawn fluid being a waste fluid;

a peritoneal fill line having a distal end and a proximal end opposite the distal end, the peritoneal catheter being connected at the distal end of the peritoneal fill line and the proximal end of the peritoneal fill line being connected to a fluid circuit switch;

the fluid circuit switch, wherein the fluid circuit switch selectively connects the peritoneal fill line at least to a source of the fluid and to a drain for receiving the waste fluid that has been withdrawn from the abdomen of the patient, wherein the fluid flows through the peritoneal fill line in a distal direction during the fill cycle in a proximal direction during the drain cycle;

a controller;

a distal pressure sensor at the distal end configured to apply a distal pressure signal to the controller, the distal pressure sensor being configured to permit measurement of pressure of the fluid flowing in the proximal direction and also in the distal direction; and

a proximal pressure sensor at the proximal end configured to apply a proximal pressure signal to the controller, the proximal pressure sensor being configured to permit measurement of pressure of the fluid flowing in the proximal direction and also in the distal direction, wherein

the controller is configured to detect a difference in pressures represented by the proximal pressure signal and the distal pressure signal during the fill cycle and during the drain cycle thereby to detect a condition where the difference in pressures exceeds a predefined threshold and to generate a first output based on the difference in pressures.

2. The system of claim 1, wherein

the controller is further configured to access data indicative of a target flow rate and to maintain the target flow rate based on the data and on at least one of the proximal pressure signal and the distal pressure signal.

3. The system of claim 2, wherein the first output triggers an alarm signal.

4. The system of claim 2, wherein

the controller is configured to regulate a rate of flow of fluid in said peritoneal fill line and further is configured to command a change of a flow rate of the fluid in said peritoneal fill line based on the first output.

5. The system of claim 4, wherein

the controller is configured to regulate a flow rate of fluid in said peritoneal fill line based on a difference in pressures represented by the proximal pressure signal and the distal pressure signal.

6. The system of claim 5, wherein

the controller is configured

to detect a pressure drop characteristic in response to a difference in pressures represented by the proximal pressure signal and the distal pressure signal, and

to generate a second output based on the flow rate of fluid in said peritoneal fill line and on said pressure drop characteristic.

7. The system of claim 6, wherein

the second output includes an audible or visible output on a user interface indicating a peritoneal fill line error condition.

8. The system of claim 7, wherein

the controller is configured to generate the second output when fluid is flowing from the proximal end to the distal end of said peritoneal fill line.

9. The system of claim 6, wherein

the second output includes an output on a user interface indicating a patient health condition.

10. The system of claim 9, wherein

the controller is configured to output the second output when fluid is flowing from the distal end to the proximal end of said peritoneal fill line.