IP Library Granted Patent US 11,135,348
Granted Patent B2
US 11,135,348 · App. 15/820,672 · Granted Oct 5, 2021

Peritoneal dialysis systems, devices, and methods

Inventors: Jeffrey H. Burbank (Boxford, MA); James M. Brugger (Newburyport, MA); Dennis M. Treu (Castle Rock, CO); Mark T. Wyeth (Andover, MA)
Assignee: NxStage Medical, Inc.
A61M1/282A61M1/166A61M1/167A61M1/1656A61M1/1664A61M1/1668A61M1/1672A61M1/1674A61M1/28A61M1/281A61M1/285A61M1/287A61M1/288A61M2025/0002A61M2205/12A61M2205/123A61M2205/128A61M2205/14A61M2205/18A61M2205/33A61M2205/3331A61M2205/3334A61M2205/3351A61M2205/3355A61M2205/52A61M2230/005
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Quick Facts
Patent No.
US 11,135,348
App. No.
15/820,672
Granted
Oct 5, 2021
Kind
B2
Abstract

An automated peritoneal dialysis system provides both cycler-assisted peritoneal dialysis treatment and also continuous ambulatory peritoneal dialysis (CAPD). The system includes a fluid preparation and treatment device with a concentrate dilution components connected to a source of purified water and medicament concentrate. The treatment device has at least one mixing container connected via a pump and valves to the sources, the valves and the pump mixing and diluting the concentrate to form a medicament. An auxiliary port is provided for attaching a CAPD container and for receiving medicament. A controller is programmed to control the fluid preparation and treatment device to implement one or more cycler-assisted peritoneal dialysis treatment cycles using medicament from the mixing container and also to control the preparation of additional dialysate at the end of the cycler-assisted peritoneal dialysis treatment cycles to dispense additional dialysate through the auxiliary port for use in CAPD.

Claims (48)

1. A method of providing dialysate for continuous ambulatory peritoneal dialysis (CAPD) of a patient, comprising:

providing a device configured for preparing a first batch of dialysate for at least one dialysis treatment session of the patient, the device having a mixed batch container configured to receive purified water and concentrated dialysate to prepare said first batch of dialysate for use in a cycler-assisted peritoneal dialysis treatment;

pumping the purified water and the concentrated dialysate into the mixed batch container;

preparing said first batch of dialysate using said device and the purified water and the concentrated dialysate in the mixed batch container;

performing the cycler-assisted peritoneal dialysis treatment using said device, the performing including

conveying a first amount of dialysate of the first batch from said mixed batch container to a peritoneum of the patient with a pumping portion of said device,

extracting said dialysate of the first batch from the peritoneum, and

measuring net fluid gain or loss between the dialysate conveyed to the peritoneum and the dialysate extracted from the peritoneum during said extracting; and

preparing a second batch of dialysate for CAPD using said device, the preparing the second batch including

connecting a CAPD container to a predefined connector, and

filling said CAPD container by conveying a second amount of dialysate of the first batch from said mixed batch container to said CAPD container while the patient is still undergoing the cycler-assisted peritoneal dialysis treatment.

2. The method of claim 1 , further comprising:

performing a CAPD treatment using said CAPD container.

3. The method according to claim 1 , wherein

the pumping of the purified water and of the concentrated dialysate into the mixed batch container is performed with a peristaltic pump rotating in a first direction,

the conveying of the first amount of the dialysate of the first batch to the peritoneum is performed with said peristaltic pump rotating in said first direction, and

the extracting said dialysate of the first batch from the peritoneum is performed with said peristaltic pump rotating in said first direction.

4. The method according to claim 1 , wherein preparing said first batch of dialysate includes:

mixing contents of the mixed batch container at a first rate, and

subsequent to the mixing at the first rate, mixing the contents of the mixed batch container at a second rate different than the first rate.

5. The method according to claim 1 , further comprising:

calibration of the pumping portion, wherein

the pumping portion includes a peristaltic pump, and

the calibration maps a number of rotations of the peristaltic pump to a quantity of fluid transported.

6. The method according to claim 5 , wherein the calibration includes

measuring a transit time of a fluid property perturbation between spaced fluid property sensors to thereby determine the quantity of the fluid transported.

7. The method according to claim 5 , wherein

the peristaltic pump rotates only in a single direction during the conveying of the first amount of the dialysate to the peritoneum and during the extracting of said dialysate from the peritoneum.

8. A method of providing dialysate for continuous ambulatory peritoneal dialysis (CAPD) of a patient, comprising:

providing a device configured for preparing a first batch of dialysate for at least one dialysis treatment session of the patient, the device having a mixed batch container configured to receive purified water and concentrated dialysate to prepare the first batch of dialysate for use in a cycler-assisted peritoneal dialysis treatment;

pumping the purified water and the concentrated dialysate into the mixed batch container;

preparing the first batch of dialysate using the device and the purified water and the concentrated dialysate in the mixed batch container;

performing the cycler-assisted peritoneal dialysis treatment using the device, the performing including

conveying a first amount of dialysate of the first batch from the mixed batch container to a peritoneum of the patient with a pumping portion of the device, the pumping portion including a peristaltic pump,

extracting the dialysate of the first batch from the peritoneum, and

measuring net fluid gain or loss between the dialysate conveyed to the peritoneum and the dialysate extracted from the peritoneum during the extracting; and

preparing a second batch of dialysate for CAPD using the device, the preparing the second batch including

connecting a CAPD container to a predefined connector, and

filling the CAPD container by conveying a second amount of dialysate of the first batch from the mixed batch container to the CAPD container, wherein

the peristaltic pump rotates only in a first direction during the conveying of the first amount of the dialysate to the peritoneum and also during the extracting of said dialysate from the peritoneum.

9. The method according to claim 8 , wherein preparing said first batch of dialysate includes

mixing contents of the mixed batch container at a first rate, and

subsequent to the mixing at the first rate, mixing the contents of the mixed batch container at a second rate different than the first rate.

10. The method according to claim 8 , further comprising:

calibration of the pumping portion, wherein

the calibration includes mapping a number of rotations in the first direction of the peristaltic pump to a quantity of fluid transported.

11. The method according to claim 10 , wherein the calibration includes

measuring a transit time of a fluid property perturbation between spaced fluid property sensors to thereby determine the quantity of the fluid transported.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 23, 2018
From: BURBANK, JEFFREY H.; BRUGGER, JAMES M.; TREU, DENNIS M.; WYETH, MARK T.
To: NXSTAGE MEDICAL, INC.
Reel/Frame 045886/0504 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 24, 2017
From: BURBANK, JEFFREY H.; BRUGGER, JAMES M.; TREU, DENNIS M.; WYETH, MARK T.
To: NXSTAGE MEDICAL, INC.
Reel/Frame 044205/0975 →