IP Library Granted Patent US 9,907,897
Granted Patent B2
US 9,907,897 · App. 14/006,763 · Granted Mar 6, 2018

Peritoneal dialysis systems, devices, and methods

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Quick Facts
Patent No.
US 9,907,897
App. No.
14/006,763
Granted
Mar 6, 2018
Kind
B2
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 (44)

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body, a proximal end into which peritoneal dialysis fluid is supplied and from which spent peritoneal dialysis fluid is withdrawn, and a distal end which is connected to a patient's peritoneal access;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.

Assignments (4)
RELEASE OF SECURITY INTEREST Recorded Feb 21, 2019
From: CAPITAL ONE, NATIONAL ASSOCIATION (AS SUCCESSOR BY MERGER TO HEALTHCARE FINANCIAL SOLUTIONS, LLC)
To: NXSTAGE MEDICAL, INC.
Reel/Frame 048407/0865 →
ASSIGNMENT OF INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Nov 16, 2015
From: GENERAL ELECTRIC CAPITAL CORPORATION, AS RETIRING AGENT
To: HEALTHCARE FINANCIAL SOLUTIONS, LLC, AS SUCCESSOR AGENT
Reel/Frame 037112/0376 →
SECURITY INTEREST Recorded Jun 10, 2014
From: NXSTAGE MEDICAL, INC.
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS ADMINISTRATIVE AGENT
Reel/Frame 033123/0836 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 27, 2013
From: BURBANK, JEFFREY H.; BRUGGER, JAMES M.; TREU, DENNIS M.; WYETH, MARK T.
To: NXSTAGE MEDICAL, INC.
Reel/Frame 031294/0415 →