Peritoneal dialysis intracycle osmotic agent adjustment

Patent metadata

Field	Value
Publication number	US-10874790-B2
Application number	US-201715666631-A
Country	US
Kind code	B2
Filing date	Aug 2, 2017
Priority date	Aug 10, 2016
Publication date	Dec 29, 2020
Grant date	Dec 29, 2020

Abstract

The invention relates to systems and methods for making intracycle adjustments to an osmotic agent concentration of peritoneal dialysate inside the peritoneal cavity of a patient. The systems and methods include osmotic agent sources, flow paths, and processors to adjust the osmotic agent concentration of dialysate in the peritoneal cavity of the patient. The method can include infusing peritoneal dialysate containing an osmotic agent into the peritoneal cavity of a patient; monitoring one or more patient parameters; and adjusting the osmotic agent concentration of the peritoneal dialysate in the peritoneal cavity of the patient by infusing a concentrated osmotic agent solution or by infusing sterile fluid into the peritoneal cavity of the patient using an on-line peritoneal dialysis machine. The system can include a peritoneal dialysis cycler.

First claim

We claim:

1. A method for adjusting an osmotic agent concentration in a peritoneal cavity, comprising the steps of:
infusing peritoneal dialysate containing an osmotic agent into the peritoneal cavity of a patient;
monitoring one or more patient parameters; and
adjusting the osmotic agent concentration of the peritoneal dialysate in the peritoneal cavity of the patient by infusing a concentrated osmotic agent solution or by infusing sterile fluid into the peritoneal cavity of the patient using the on-line peritoneal dialysis machine; wherein
the method uses a system comprising:
a peritoneal dialysis cycler having either a combined effluent and infusion line or an infusion line and an effluent line, the peritoneal dialysis cycler further having an infusion pump;
a peritoneal dialysate generation flow path fluidly connected to the infusion line or combined effluent and infusion line; the peritoneal dialysate generation flow path having:
(i) a water source fluidly connected to the peritoneal dialysate generation flow path;
(ii) a concentrate source fluidly connected to the peritoneal dialysate generation flow path;
(iii) at least a first osmotic agent source fluidly connected to the peritoneal dialysate generation flow path;
(iv) an osmotic agent pump positioned on a fluid line between the first osmotic agent source and the peritoneal dialysate generation flow path;
(v) a sterilization module positioned in the peritoneal dialysate generation flow path downstream of the first osmotic agent source and the concentrate source; and
(vi) a processor in communication with the osmotic agent pump and the infusion pump; the processor configured to adjust an osmotic agent concentration of a peritoneal dialysate delivered to the peritoneal cavity of the patient during at least one peritoneal dialysis cycle based on the one or more patient parameters; wherein the processor is programmed to increase an osmotic agent concentration in a peritoneal dialysate inside the peritoneal cavity of the patient by infusing a more concentrated osmotic agent into the peritoneal cavity of the patient; or to decrease the osmotic agent concentration in the peritoneal dialysate inside the peritoneal cavity of the patient by diluting the peritoneal dialysate inside the peritoneal cavity of the patient; wherein the processor is programmed to increase or decrease the osmotic agent concentration in the peritoneal dialysate inside the peritoneal cavity of the patient after peritoneal dialysate is infused into the patient and before the peritoneal dialysate is drained from the patient.

2. The method of claim 1 , further comprising the step of infusing the concentrated osmotic agent solution into the patient mid-cycle.

3. The method of claim 2 , further comprising the step of draining a volume of peritoneal dialysate from the peritoneal cavity of the patient prior to the step of infusing the concentrated osmotic agent solution into the peritoneal cavity of the patient.

4. The method of claim 1 , further comprising the step of draining a volume of peritoneal dialysate from the peritoneal cavity of the patient prior to the step of infusing sterile fluid into the peritoneal cavity of the patient.

5. The method of claim 1 , further comprising the step of determining a change to the osmotic agent concentration based on one or more patient parameters prior to the step of adjusting the osmotic agent concentration.

6. The method of claim 5 , wherein the patient parameters are selected from the group of: blood pressure; and interperitoneal pressure.

7. The method of claim 6 , further comprising the steps of determining an intraperitoneal pressure at a first time and at least a second time, and wherein the step of determining a change to the osmotic agent concentration comprises determining a change to the osmotic agent concentration based on a change in intraperitoneal pressure.

8. The method of claim 1 , wherein the step of adjusting the osmotic agent concentration comprises selectively flowing fluid from an osmotic agent source into the peritoneal cavity of the patient.

9. The method of claim 8 , wherein the osmotic agent source contains glucose, dextrose, icodextrin, or combinations thereof.

10. The method of claim 1 , wherein the step of adjusting the osmotic agent concentration comprises selectively flowing fluid from an osmotic agent source into the peritoneal cavity of the patient at a set time after infusing the peritoneal dialysate into the peritoneal cavity of the patient.

11. The method of claim 1 , wherein the peritoneal dialysate comprises multiple osmotic agents.

12. The method of claim 11 , wherein the peritoneal dialysate comprises icodextrin and either glucose or dextrose.

13. The method of claim 1 , further comprising the steps of draining the peritoneal dialysate from the patient; and infusing a second peritoneal dialysate into the patient;
wherein the second peritoneal dialysate comprises an osmotic agent different from the first peritoneal dialysate.

14. The method of claim 1 , further comprising the steps of:
receiving one or more dialysis results from at least one prior dialysis session into a machine readable storage medium; and receiving a dialysis prescription from the prior dialysis session into a machine readable storage medium;
wherein the one or more dialysis results includes a volume of ultrafiltrate removed and a rate of ultrafiltration and wherein the dialysis prescription comprises an adjustment made to the osmotic agent concentration in the peritoneal cavity of the patient during the prior dialysis session.

15. The method of claim 14 , wherein the step of adjusting the osmotic agent concentration comprises determining a change to the osmotic agent concentration based on the dialysis results from the prior dialysis session and the dialysis prescription from the prior dialysis session.

16. The method of claim 1 , wherein the step of infusing a concentrated osmotic agent solution or sterile fluid is performed at a set time after infusing the peritoneal dialysate into the peritoneal cavity of the patient.

17. The method of claim 1 , wherein the steps of monitoring the one or more patient parameters, and adjusting the osmotic agent concentration of the peritoneal dialysate are performed by a processor.

18. The method of claim 1 , wherein the patient parameters are monitored while the peritoneal dialysate is inside the patient during a cycle.

19. A system comprising:
a peritoneal dialysis cycler having either a combined effluent and infusion line or an infusion line and an effluent line, the peritoneal dialysis cycler further having an infusion pump;
a peritoneal dialysate generation flow path fluidly connected to the infusion line or combined effluent and infusion line; the peritoneal dialysate generation flow path having:
(i) a water source fluidly connected to the peritoneal dialysate generation flow path;
(ii) a concentrate source fluidly connected to the peritoneal dialysate generation flow path;
(iii) at least a first osmotic agent source fluidly connected to the peritoneal dialysate generation flow path;
(iv) an osmotic agent pump positioned on a fluid line between the first osmotic agent source and the peritoneal dialysate generation flow path;
(v) a sterilization module positioned in the peritoneal dialysate generation flow path downstream of the first osmotic agent source and the concentrate source; and
(vi) a processor in communication with the osmotic agent pump and the infusion pump; the processor configured to adjust an osmoti

Assignees

• Medtronic Inc

Inventors

• Gerber Martin T
• Hobot Christopher M

Classifications

• A61K31/718

  Starch or degraded starch, e.g. amylose, amylopectin · CPC title

• A61M2230/30

  Blood pressure (A61M2230/04 takes precedence) · CPC title

• A61M2202/0486

  Glucose · CPC title

• A61M1/287 Primary

  Dialysates therefor · CPC title

• A61K31/7004

  Monosaccharides having only carbon, hydrogen and oxygen atoms · CPC title