Peritoneal dialysis systems, devices, and methods

• US 9,907,897 B2
• Filed: 03/23/2012
• Issued: 03/06/2018
• 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:
  US14/006,763
• Publication Number:
  US 20140018727A1
• Time in Patent Office: 2,174 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 method of performing a peritoneal dialysis treatment, comprising:

pumping peritoneal dialysis fluid with a pump into a dialysate supply line;

using a dialysate supply line, the dialysate supply line having a tubular body, a proximal end into which peritoneal dialysis fluid is supplied and from which spent peritoneal dialysis fluid is withdrawn, and a distal end which is connected to a patient'"'"'s peritoneal access;

generating a proximal pressure signal using a pressure detector located at the proximal end of said dialysate supply line;

generating a distal pressure signal using a pressure detector located at the distal end of said dialysate supply line;

continuously monitoring the distal pressure signal at least during a fill cycle of the peritoneal dialysis treatment and reducing a flow rate of the pump in response to the distal pressure signal exceeding a predefined threshold value of the patient'"'"'s peritoneal cavity;

determining presence of a kink in the tubular body of the dialysate supply line between the proximal end and the distal end of the dialysate supply line based on a pressure drop between the proximal pressure signal and the distal pressure signal; and

controlling the flow rate of the pump in response to the determination of the presence of the kink.

2. The method of claim 1, wherein peritoneal dialysis fluid is supplied at a variable rate which is adjusted by a controller responsively to both the distal and proximal pressure signals.

3. The method of claim 1, wherein the controlling includes calculating a height of a fluid column responsively to a difference in the proximal and distal pressures and supplying peritoneal dialysis fluid at a rate that is responsive to said height.

4. The method of claim 1, wherein the controlling includes

varying a rate of pumping of peritoneal dialysis fluid responsively to a difference between the proximal and distal pressure signals such that an input pressure of fluid at a point of entry into the peritoneum is maintained, the input pressure corresponding to a predefined pressure stored in a controller that controls the flow rate of the pump.

5. The method of claim 1, wherein the controlling is effective to limit a pressure difference determined by a controller between the proximal and distal pressure signals.

6. The method of claim 1, wherein the controlling includes generating a user interface output that is responsive to said determination of the presence of the kink.

7. The method according to claim 1, wherein the determining includes:

storing a historical record of the proximal and distal pressure signals; and

fitting the historical record to a curve that characterizes identifiable conditions.

8. The method according to claim 1, wherein

the determining the presence of the kink is performed directly from the pressure drop without calculating the flow rate through the tubular body of the dialysate supply line.

9. A method of performing a dialysis treatment, comprising:

using a pump and a dialysate supply line to transport peritoneal dialysis fluid, the dialysate supply line having a proximal end into which peritoneal dialysis fluid is supplied and from which spent peritoneal dialysis fluid is withdrawn, and a distal end which is connected to a patient'"'"'s peritoneal access;

during a drain cycle in which spent peritoneal dialysis fluid is pumped from the patient, generating proximal and distal pressure signals using pressure detectors located at both the proximal and distal ends, respectively, of said dialysate supply line;

responsively to the proximal and distal pressure signals, detecting a characteristic of a pressure difference between the distal and proximal ends whose magnitude is compared with a predicted change in peritoneal dialysis fluid properties; and

responsively to the characteristic, generating a signal indicating a change in at least peritoneal dialysis fluid viscosity.

10. The method of claim 9, further comprising generating a display indicating the change in the peritoneal dialysis fluid viscosity based on the generated signal.

11. The method of claim 9, further comprising recording in a non-volatile data store, an indicator of a potential pathology event including an identifier of the peritoneal dialysis fluid viscosity and an identifier of the patient.

12. The method of claim 11, further comprising transmitting a message to a care provider service, the message indicating the pathology event.

13. The method according to claim 9, further comprising:

storing a historical record of the proximal and distal pressure signals; and

fitting the historical record to a curve that characterizes fluid viscosity.

14. A method of performing a dialysis treatment, comprising:

using a pump and a dialysate supply line to transport peritoneal dialysis fluid, the dialysate supply line having a proximal end into which peritoneal dialysis fluid is supplied and from which spent peritoneal dialysis fluid is withdrawn, and a distal end which is connected to a patient'"'"'s peritoneal access;

during a drain cycle in which spent peritoneal dialysis fluid is pumped from the patient, generating first and second pressure signals using at least two pressure detectors located at least at a first location and a second location along a line conveying the dialysis fluid during the drain cycle, respectively;

responsively to the first and second pressure signals, detecting a characteristic of a pressure difference between the first and second locations whose magnitude is compared with a predicted change in peritoneal dialysis fluid properties; and

responsively to the characteristic, generating a signal indicating a change in at least peritoneal dialysis fluid viscosity.

15. The method according to claim 14, further comprising generating a display indicating the change in the peritoneal dialysis fluid viscosity based on the generated signal.

16. The method of claim 14, further comprising recording in a non-volatile data store, an indicator of a potential pathology event including an identifier of the peritoneal dialysis fluid viscosity and an identifier of the patient.

17. The method of claim 16, further comprising transmitting a message to a care provider service, the message indicating the pathology event.

18. The method according to claim 14, further comprising:

storing a historical record of the first and second pressure signals; and

fitting the historical record to a curve that characterizes fluid viscosity.

19. The method according to claim 14, wherein

the first location is on the proximal end of the dialysate supply line, and

the second location is on the distal end of the dialysate supply line.