IP Library Granted Patent US 10,537,673
Granted Patent B2
US 10,537,673 · App. 15/666,604 · Granted Jan 21, 2020

Intersession adaptive peritoneal dialysis fluid removal for multiple session optimization

Inventors: Martin T. Gerber (Maple Grove, MN); Christopher M. Hobot (Rogers, MN)
Assignee: Medtronic, Inc.
A61M1/282A61M1/287A61M2205/18A61M2205/3303A61M2205/3324A61M2205/3368A61M2205/3379A61M2230/30G06F19/325G06F19/3418G06F19/3468
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Quick Facts
Patent No.
US 10,537,673
App. No.
15/666,604
Granted
Jan 21, 2020
Kind
B2
Abstract

The invention relates to systems and methods for optimizing a peritoneal dialysate therapy session based on one or more patient or system parameters obtained from a previous peritoneal dialysis therapy session. The systems and methods include various sensors, flow paths, and processors to adjust a peritoneal dialysis prescription for a subsequent therapy session based on data received during or after one or more previous therapy session. For example, a first peritoneal dialysis therapy session can provide data on patient or system parameters that can adjust the dialysis parameters used to deliver a subsequent peritoneal dialysis therapy session. The method can be computer implemented. The system can also include a peritoneal dialysate generation flow path.

Claims (52)

1. A computer implemented method, comprising the steps of:

receiving one or more patient parameters before the start of a current peritoneal dialysis session;

receiving a prior peritoneal dialysis prescription from a prior peritoneal dialysis session; and

storing the one or more patient parameters before the start of the current peritoneal dialysis session and the prior peritoneal dialysis prescription into a machine-readable storage medium for storing instructions, which when executed by a dialysis machine performs the steps of:

determining a new peritoneal dialysis prescription based on adjustments of the prior peritoneal dialysis prescription based on the one or more patient parameters before the start of the current peritoneal dialysis session; and

delivering the new peritoneal dialysis prescription for a current peritoneal dialysis therapy to a patient in need thereof, using the dialysis machine; and further comprising at least one of:

a) receiving an effluent pH from a first dialysis session; receiving an effluent pH from at least a second dialysis session; trending the effluent pH over the first and second dialysis sessions; and providing an alert if a trend of effluent pH changes by greater than a predetermined threshold;

b) receiving an effluent color and clarity from a first dialysis session; receiving an effluent color and clarity from at least a second dialysis session; trending the effluent color and clarity over the first and second dialysis sessions; and providing an alert if a trend of effluent color and clarity changes by greater than a predetermined threshold; and

c) receiving an intraperitoneal pressure from a first dialysis session; receiving an intraperitoneal pressure from at least a second dialysis session; trending the intraperitoneal pressure over the first and second dialysis sessions; and adjusting a dwell time if the intraperitoneal pressure changes by greater than a predetermined threshold between the first and second dialysis sessions.

2. The computer implemented method of claim 1 , wherein the one or more patient parameters comprise one or more of the following:

i) a patient weight loss;

ii) a patient blood pressure change;

iii) a fluid removal volume;

iv) a patient goal;

v) an effluent pH;

vi) an effluent color and clarity;

vii) an effluent temperature;

viii) a patient posture;

ix) an intersession history;

x) an intraperitoneal pressure; and

xi) a membrane transfer efficiency.

3. The computer implemented method of claim 2 , wherein the step of determining a new peritoneal dialysis prescription comprises the step of reducing an osmotic agent concentration, reducing a dwell time, and/or reducing a number of cycles if the patient blood pressure change exceeds a predetermined threshold.

4. The method of claim 1 , wherein the new peritoneal dialysis prescription includes at least one of:

i) a number of cycles;

ii) a dialysate temperature;

iii) a target fluid removal volume;

iv) a cycle volume;

v) a dwell time;

vi) an osmotic agent concentration; and

vii) a solute concentration.

5. The computer implemented method of claim 1 , wherein at least one patient parameter is received from an implantable or wearable sensor.

6. The computer implemented method of claim 1 , wherein the one or more patient parameters comprise at least an intersession history; wherein the intersession history includes one or more of a peritoneal dialysate composition, a target fluid removal volume and a fluid removal volume, a dwell time, a number of cycles, a cycle volume, a patient activity, and a patient well-being.

7. The computer implemented method of claim 1 , wherein the one or more patient parameters comprise at least a patient well-being, wherein the patient well-being includes whether the patient experienced cramping during or after a previous dialysis session; and wherein the adjustments of the prior peritoneal dialysis prescription comprise increasing a solute concentration of at least one solute if the patient experienced cramping during or after the previous dialysis session.

8. The computer implemented method of claim 1 , wherein the one or more patient parameters comprise at least patient well-being; wherein the patient well-being includes whether the patient experienced edema during or after a previous dialysis session; and wherein the adjustments of the prior peritoneal dialysis prescription comprise increasing an osmotic agent concentration, increasing a dwell time, and/or increasing a number of cycles if the patient experienced edema during or after the previous dialysis session.

9. The computer implemented method of claim 1 , wherein the one or more patient parameters include a fluid removal volume; the new peritoneal dialysis prescription includes a target fluid removal volume; and the method further comprises the step of adjusting an osmotic agent concentration, a dwell time, a number of cycles, or combinations thereof, in response to a difference between the fluid removal volume and the target fluid removal volume.

10. The computer implemented method of claim 9 , wherein the step of determining a new peritoneal dialysis prescription comprises the step of increasing an osmotic agent concentration, increasing a dwell time, and/or increasing a number of cycles if the fluid removal volume is less than the target fluid removal volume; and

wherein the step of determining a new peritoneal dialysis prescription comprises the step of decreasing an osmotic agent concentration, decreasing a dwell time, and/or decreasing a number of cycles if the fluid removal volume is greater than the target fluid removal volume.

11. The computer implemented method of claim 1 , wherein the one or more patient parameters comprise at least a fluid removal volume; and wherein the fluid removal volume is determined by the patient weight loss.

12. The computer implemented method of claim 1 , wherein the step of delivering the new peritoneal prescription to a patient comprises:

controlling the movement of a fluid from a water source to an infusion line of an integrated cycler in a peritoneal dialysate generation flow path;

controlling the movement of a fluid from one or more concentrate sources to the peritoneal dialysate generation flow path to generate a peritoneal dialysate;

sterilizing the peritoneal dialysate with a sterilization module;

infusing the peritoneal dialysate into a patient with the integrated cycler; and

removing the peritoneal dialysate from the patient through an effluent line.

13. A system, comprising:

a peritoneal dialysate generation flow path having (i) a water source fluidly connectable to the peritoneal dialysate generation flow path; (ii) one or more water purification modules fluidly connectable to the peritoneal dialysate generation flow path; (iii) one or more concentrate sources fluidly connectable to the peritoneal dialysate generation flow path; the one or more concentrate sources containing one or more solutes and including at least an osmotic agent source and an ion concentrate source; (iv) at least one concentrate pump; the concentrate pump controlling the movement of fluid from the one or more concentrate sources to the peritoneal dialysate generation flow path; and (v) a sterilization module fluidly connectable to the peritoneal dialysate generation flow path;

an integrated cycler fluidly connected to the peritoneal dialysate generation flow path; the integrated cycler having at least an infusion line and an effluent line; and

a processor; the processor performing the method of claim 1 , and controlling the concentrate pump and integrated cycler based on the new peritoneal dialysis prescription.

14. The system of claim 13 , further comprising at least one pump positioned in the infusion line and effluent line; the pump in communication with the processor.

15. The system of claim 14 , the processor controlling the pump to infuse peritoneal dialysate from the infusion line into a peritoneal cavity of a patient based on the new peritoneal dialysis prescription.

16. The system of claim 13 , the processor comprising one or more input/output interfaces for receiving the one or more patient parameters.

17. The system of claim 13 , further comprising a peritoneal dialysate regeneration module fluidly connected to the effluent line and the peritoneal dialysate generation flow path.

Assignments (3)
SECURITY INTEREST Recorded Dec 1, 2025
From: MOZARC MEDICAL US LLC
To: ORBIMED ROYALTY & CREDIT OPPORTUNITIES V, LP
Reel/Frame 073800/0164 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 19, 2023
From: MEDTRONIC, INC.
To: MOZARC MEDICAL US LLC
Reel/Frame 063375/0659 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 2, 2017
From: GERBER, MARTIN T.; HOBOT, CHRISTOPHER M.
To: MEDTRONIC, INC.
Reel/Frame 043164/0683 →
Cited By (1)
US 12,465,675