IP Library Patent Application 16148383
Patent Application
App. No. 16/148,383

PATIENT BUN ESTIMATOR FOR SORBENT HEMODIALYSIS

Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US None
App. No.
16/148,383
Abstract

The invention relates to systems and methods for estimating a patient urea level at any arbitrary time during dialysis treatment. The systems and methods use either one or more urea sensors or any two of a pH sensor, ammonia sensor, and ammonium sensor to determine an amount of urea removed by a dialysate regeneration system. The systems and methods use the amount of urea removed by the dialysate regeneration system to estimate the patient urea level.

Claims (151)

1 . A dialysis system, comprising:

a dialysate flow path fluidly connectable to a dialyzer; the dialysate flow path having a dialysate regeneration system comprising urease;

either a urea sensor or at least two sensors selected from: ammonia sensors, ammonium sensors, and pH sensors; and

a processor; the processor in communication with the urea sensor, ammonia sensor, ammonium sensor, and/or pH sensor; the processor programmed to determine an amount of urea removed by the dialysate regeneration system;

the processor further programmed to estimate a patient urea level from either one or more lookup tables or a mathematical model based on the amount of urea removed by the dialysate regeneration system;

the mathematical model using solutions to a formula:

dM

P

,

i

dt

=

G

P

,

i

-

(

Ind

)

J

i

(

V

P

,

M

P

,

i

,

C

Di

,

i

)

+

R

P

,

i

,

wherein M p,i is a mass of a species “i” in a patient, G p,i is a generation rate of the of the species “i” in the patient, J i is a total mass transfer rate of species “i” from the patient into a dialysate, C Di,i is a concentration of species “i” in a regenerated dialysate when the regenerated dialysate enters the dialyzer, R P,i is a production rate of species “i” due to chemical reactions, and Ind is a binary indicator variable for dialysis therapy with Ind=0 if dialysis is not occurring, and Ind=1 if dialysis is occurring.

2 . The dialysis system of claim 1 , wherein the mathematical model uses a formula:

CBi

Urea

tCrit

=

(

QDi

D

Urea

)

(

CDo

Urea

-

CDi

Urea

)

+

CDi

Urea

;

wherein CBi Urea tCrit is the patient urea level at time t; QDi is a dialysate flow rate exiting the dialyzer; D Urea is a dialysance of urea; CDo Urea is a urea concentration in a dialysate exiting the dialyzer; and CDi Urea is a urea concentration in the dialysate entering the dialyzer.

3 . The dialysis system of claim 1 , wherein the dialysate regeneration system comprises one or more sorbent cartridges.

4 . The dialysis system of claim 1 , wherein the sensors comprise a first urea sensor located upstream of the dialysate regeneration system and an optional second urea sensor located downstream of the dialysate regeneration system.

5 . The dialysis system of claim 1 , wherein the sensors comprise at least two of an ammonia sensor, an ammonium sensor, and a pH sensor located downstream of the urease and upstream of an ammonium and/or ammonia exchange material.

6 . The dialysis system of claim 5 , wherein the sensors are part of a combined pH, ammonium, and/or ammonia sensor.

7 . The dialysis system of claim 1 , the processor further programmed to estimate a urea reduction ratio based on a urea level of the patient at a beginning of a dialysis session and a urea level of a patient at an end of the dialysis session.

8 . The dialysis system of claim 1 , the processor further programmed to estimate a urea reduction ratio at an arbitrary time during treatment.

9 . The dialysis system of claim 1 , wherein the dialysis system has a single urea sensor upstream of the dialysate regeneration system.

10 . The dialysis system of claim 9 , the processor programmed to estimate the patient urea level at a beginning of a dialysis session.

11 . A method, comprising:

a) initiating a dialysis session for a patient using a dialysis system having a dialysate regeneration system comprising urease in a dialysate flow path;

b) determining an amount of urea removed by the dialysate regeneration system based on data received from either one or more urea sensors or at least two sensors selected from: ammonia sensors, ammonium sensors, and pH sensors;

c) estimating a patient urea level from a mathematical model or a lookup table based on the amount of urea removed by the dialysate regeneration system;

the mathematical model using solutions to a formula:

dM

P

,

i

dt

=

G

P

,

i

-

(

Ind

)

J

i

(

V

P

,

M

P

,

i

,

C

Di

,

i

)

+

R

P

,

i

,

wherein M p,i is a mass of a species “i” in the patient, G p,i is a generation rate of the of the species “i” in the patient, J i is a total mass transfer rate of species “i” from the patient into a dialysate, C Di,i is a concentration of species “i” in a regenerated dialysate when the regenerated dialysate enters a dialyzer, R P,i is a production rate of species “i” due to chemical reactions, and Ind is a binary indicator variable for dialysis therapy with Ind=0 if dialysis is not occurring, and Ind=1 if dialysis is occurring.

12 . The method of claim 11 , wherein the mathematical model uses a formula:

CBi

Urea

tCrit

=

(

QDi

D

Urea

)

(

CDo

Urea

-

CDi

Urea

)

+

CDi

Urea

;

wherein CBi Urea tCrit is the patient urea level at time t; QDi is a dialysate flow rate exiting the dialyzer; D Urea is a dialysance of urea; CDo Urea is a urea concentration in a dialysate exiting the dialyzer; and CDi Urea is a urea concentration in the dialysate entering the dialyzer.

13 . The method of claim 11 , wherein the sensors comprise a first urea sensor located upstream of the dialysate regeneration system and a second urea sensor located downstream of the dialysate regeneration system.

14 . The method of claim 11 , wherein the sensors comprise at least two of an ammonia sensor, an ammonium sensor, and a pH sensor located downstream of the urease and upstream of an ammonium and/or ammonia exchange material.

15 . The method of claim 11 , wherein the method is performed by a dialysis system.

16 . The method of claim 11 , wherein the patient urea level is estimated at a beginning of the dialysis session.

17 . The method of claim 11 , wherein the patient urea level is estimated at an end of the dialysis session.

18 . The method of claim 11 , wherein the patient urea level is estimated at an arbitrary time during treatment.

19 . The method of claim 11 , wherein the patient urea level is estimated at a beginning of the dialysis session and at an end of the dialysis session.

20 . The method of claim 19 , further comprising the step of estimating a urea reduction ratio and/or a dialysis adequacy based on calculations using the patient urea level at a beginning of a dialysis session and the patient urea level at the end of the dialysis session.

Assignments (2)
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 Oct 1, 2018
From: MAZACK, MICHAEL J. M.; GERBER, MARTIN T.; HOBOT, CHRISTOPHER M.
To: MEDTRONIC, INC.
Reel/Frame 047020/0732 →