IP Library › Granted Patent US 11,491,267
Granted Patent B2
US 11,491,267 · App. 16/521,193 · Granted Nov 8, 2022

Method for tailoring dialysis treatment based on sensed potassium concentration in blood serum or dialysate

Inventors: Stephen Merchant (Oklahoma City, OK); Roland Levin (San Ramon, CA); Chris Chau (Mission, TX); Shakil Aslam (Lincoln, MA)
Assignee: FRESENIUS MEDICAL CARE HOLDINGS, INC.
A61M1/1603A61B5/0075A61B5/02055A61B5/02427A61M1/1609A61M1/1613A61M1/1635A61M1/1672A61M1/1694A61M1/1696A61M1/342A61M1/3424A61M1/3455A61M1/3607A61M1/3609G01J1/00G01N21/31G01N21/33G01N21/62G01N21/63G01N21/631G01N21/64G01N21/6402G01N21/7703G01N27/333G01N27/3335G01N33/0067G01Q30/04G06F3/14A61M2205/18A61M2205/33A61M2205/502A61M2230/04A61M2230/20
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Quick Facts
Patent No.
US 11,491,267
App. No.
16/521,193
Granted
Nov 8, 2022
Kind
B2
Abstract

A method of dialysis is provided that includes sensing the concentration of potassium in a patient's blood serum, in used dialysate resulting from treating the patient, or in both. The method involves generating a sensed value of the concentration of potassium, comparing the sensed value with one or more values stored in a memory, and generating a control signal based on the comparison. Supplemental potassium solution is infused into the treatment dialysate, based on the control signal. The comparison can be made to patient-historical data, population data, or both.

Claims (52)

1. A dialysis method comprising:

receiving patient parameters including a time-since-last-treatment value, by a control and computing unit that comprises a processor and a memory;

performing a dialysis treatment on a patient, the patient having blood including blood serum and the dialysis treatment comprising dialyzing the patient's blood with a treatment dialysate;

sensing a concentration of potassium in the patient's blood serum, the sensing comprising generating a sensed value of blood serum potassium concentration;

receiving with the control and computing unit the sensed value;

comparing, using the processor, the sensed value with one or more patient-historical data values stored in the memory, the patient-historical data pertaining to sensed blood serum potassium concentration values resulting from dialysis treatments performed on the patient under different patient parameters comprising at least one parameter based on a length of time since a last dialysis treatment was carried out on the patient;

generating, using the processor, a control signal based on the comparison and the received patient parameters;

sending the control signal to a potassium infusion circuit that is configured to receive the control signal; and

modifying the dialysis treatment by infusing potassium solution into treatment dialysate that is then used during the dialysis treatment, the infusion being based on the control signal received by the potassium infusion circuit.

2. The dialysis method of claim 1 , further comprising storing the sensed value of blood serum potassium concentration in the memory.

3. The dialysis method of claim 1 , further comprising:

comparing the sensed value of blood serum potassium concentration to blood serum potassium concentration values of a population of different patients obtained under different patient parameters;

generating the control signal based on the sensed value of blood serum potassium concentration and based on population data stored in the memory; and

supplying a concentrated solution of a potassium salt at a first rate and for a first period of time, into a dialysate circuit used for the dialysis treatment, based on the control signal.

4. The dialysis method of claim 1 , wherein the sensing the concentration of potassium comprises using an ion selective electrode pair to generate ion selective electrode measurements, and the method further comprises calculating the concentration of potassium in the patient's blood serum based on the ion selective electrode measurements.

5. The dialysis method of claim 1 , wherein the sensing the concentration of potassium comprises sensing fluorescent photo-induced electron transfer resulting from subjecting a portion of the patient's blood to fluorescent excitation radiation.

6. The dialysis method of claim 1 , wherein the sensing the concentration of potassium comprises:

flowing a portion of the patient's blood in a microfluidic channel on a microfluidic chip;

directing electromagnetic radiation through an optical fiber and toward the portion of the patient's blood in the microfluidic channel, to cause fluorescent emissions from the microfluidic channel;

directing the fluorescent emissions through a second optical fiber and toward a fluorescence detector; and

detecting the fluorescent emissions with the fluorescence detector.

7. The dialysis method of claim 1 , wherein the sensing the concentration of potassium comprises:

sensing electrocardiogram signals corresponding to a heartbeat of the patient, from an electrocardiogram lead connected to the patient;

determining the amplitude of a T wave component of a first heartbeat signal of the electrocardiogram signals;

determining a negative slope of the T wave component;

computing a ratio of the negative slope to the amplitude; and

correlating the ratio to a predetermined blood serum potassium concentration value stored in the memory.

8. A dialysis method comprising:

receiving patient parameters including a time-since-last-treatment value, by a control and computing unit that comprises a processor and a memory;

performing a dialysis treatment on a patient, the patient having blood including blood serum and the dialysis treatment comprising dialyzing the patient's blood with a treatment dialysate to form used dialysate;

sensing a concentration of potassium in the used dialysate formed by the dialysis treatment, the sensing comprising generating a sensed value of potassium concentration in the used dialysate;

receiving, with the control and computing unit, the sensed value;

comparing, using the processor, the sensed value with one or more patient-historical data values stored in the memory, the patient-historical data pertaining to sensed used dialysate potassium concentration values resulting from dialysis treatments performed on the patient under different patient parameters comprising at least one parameter based on a length of time since a last dialysis treatment was carried out on the patient;

generating, using the processor, a control signal based on the comparison and the received patient parameters;

sending the control signal to a potassium infusion circuit that is configured to receive the control signal; and

modifying the dialysis treatment by infusing potassium solution into fresh treatment dialysate that is then used during the dialysis treatment, the infusing being based on the control signal received by the potassium infusion circuit.

9. The dialysis method of claim 8 , further comprising comparing, using the processor, the sensed value of potassium concentration in the used dialysate to potassium concentration values that are stored in the memory, for used dialysate resulting from dialysis treatments previously conducted on a population of different patients obtained under different patient parameters, wherein

the generating the control signal, using the processor, is also based on the comparison of the sensed value of potassium concentration in the used dialysate to the potassium concentration values that are stored in the memory, for used dialysate resulting from the dialysis treatments previously conducted on the population of different patients obtained under different patient parameters.

10. The dialysis method of claim 9 , further comprising:

supplying a concentrated solution of a potassium salt at a first rate and for a first period of time, into a dialysate circuit used for the dialysis treatment.

11. The dialysis method of claim 8 , further comprising computing, with the control and computing unit, a blood serum potassium concentration value based on the sensed value of potassium concentration in the used dialysate.

12. The dialysis method of claim 8 , wherein the sensing the concentration of potassium comprises using an ion selective electrode pair to generate ion selective electrode measurements, and the method further comprises calculating the concentration of potassium in the used dialysate formed by the dialysis treatment, based on the ion selective electrode measurements.

13. The dialysis method of claim 8 , wherein the sensing the concentration of potassium comprises using an ion selective electrode pair to generate ion selective electrode measurements, and the method further comprises calculating the concentration of potassium in the patient's blood serum, based on the ion selective electrode measurements.

14. The dialysis method of claim 8 , wherein the sensing the concentration of potassium comprises sensing transmission of ultraviolet light directed through the used dialysate.

15. The dialysis method of claim 8 , wherein the sensing the concentration of potassium comprises sensing transmission of near-infrared radiation directed through the used dialysate.

16. The dialysis method of claim 8 , wherein the sensing the concentration of potassium comprises:

flowing a portion of the used dialysate in a microfluidic channel on a microfluidic chip;

directing electromagnetic radiation through an optical fiber and toward the portion of the used dialysate in the microfluidic channel, to cause fluorescent emissions from the microfluidic channel;

directing the fluorescent emissions through a second optical fiber and toward a fluorescence detector; and

detecting the fluorescent emissions with the fluorescence detector.

17. The dialysis method of claim 8 , wherein the patient has a peritoneum, the dialysis treatment comprises a peritoneal dialysis treatment, and the used dialysate comprises a used peritoneal dialysis solution that has dwelled in the patient's peritoneum.

18. The dialysis method of claim 8 , further comprising inputting the patient parameters including a time-since-last-treatment value, into the control and computing unit.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 27, 2019
From: MERCHANT, STEPHEN; LEVIN, ROLAND; CHAU, CHRIS; ASLAM, SHAKIL
To: FRESENIUS MEDICAL CARE HOLDINGS, INC.
Reel/Frame 050513/0750 →
Continuity (3)
Provisional Application 62711163 · Jul 27, 2018
Provisional Application 62711204 · Jul 27, 2018
Related Publication 20200030515A1 · Jan 30, 2020