Electrolyte and pH monitoring for fluid removal processes

• US 10,179,198 B2
• Filed: 08/18/2015
• Issued: 01/15/2019
• Est. Priority Date: 04/29/2011
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin, Burnes, John, Lyu, Suping, Manda, VenKatesh R., Pudil, Bryant
• Primary Examiner(s): Kim, John
• Application Number:
  US14/828,979
• Publication Number:
  US 20150352269A1
• Time in Patent Office: 1,246 Days
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/6866 Extracorporeal blood circuits, e.g. dialysis circuits
• CPC Class Codes: A61M 1/00 Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems catheters A61M25/00; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; devices for taking samples of blood A61B5/15; filters implantable into blood vessels A61F2/01
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00 ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1603 Regulation parameters
• CPC Class Codes: A61M 1/1605 Physical characteristics of the dialysate fluid
• CPC Class Codes: A61M 1/1607 : before use, i.e. upstream of dialyser
• CPC Class Codes: A61M 1/1613 : Profiling or modelling of patient or predicted treatment evolution or outcome
• CPC Class Codes: A61M 1/28 : Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/34 : Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3403 : Regulation parameters
• CPC Class Codes: A61M 1/342 : Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3607 : Regulation parameters
• CPC Class Codes: A61M 1/3609 : Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/361 : before treatment
• CPC Class Codes: A61M 1/3612 : after treatment
• CPC Class Codes: A61M 2205/04 : implanted
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/33 : Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 : Using a biosensor
• CPC Class Codes: A61M 2205/3306 : Optical measuring means
• CPC Class Codes: A61M 2205/3313 : used specific wavelengths
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3375 : Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3523 : using telemetric means
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/60 : with identification means
• CPC Class Codes: A61M 2205/70 : with testing or calibration facilities
• CPC Class Codes: A61M 2230/00 : Measuring parameters of the user
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/20 : Blood composition characteristics
• CPC Class Codes: A61M 2230/207 : hematocrit
• CPC Class Codes: A61M 2230/208 : pH-value
• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity
• CPC Class Codes: B01D 2321/12 : Use of permeate
• CPC Class Codes: B01D 2321/40 : Automatic control of cleaning processes
• CPC Class Codes: B01D 61/00 : Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor separation of gases or vapours by diffusion B01D53/22
• CPC Class Codes: B01D 61/32 : Controlling or regulating
• CPC Class Codes: B01D 65/02 : Membrane cleaning or sterilisation ; Membrane regeneration
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 50/70 : for mining of medical data, e.g. analysing previous cases of other patients
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

Abstract

Methods include monitoring indicators of blood pH or blood electrolyte levels during a blood fluid removal session and adjusting concentrations of pH buffers or electrolytes in dialysate or replacement fluid used during the session based on the monitored indicators. Blood fluid removal systems may employ sensors that monitor blood pH or electrolyte levels to adjust the fluid parameters during a blood fluid removal session.

Claims

1. A system comprising:

a blood fluid removal device comprising;

(i) an inlet for receiving blood from a patient,

(ii) an outlet for returning blood from the patient,

(iii) a medium for removing fluid and contaminants from the blood, the medium being positioned between the inlet and the outlet, and

(iv) a fluid line for carrying fluid to the medium;

a concentrate source for housing a concentrate solution comprising concentrated electrolyte or pH buffer;

a concentrate flow control element for controlling the rate that the concentrate solution enters the fluid line;

a first sensor configured to monitor an indicator of electrolyte concentration or pH in dialysate in the fluid line before the dialysate enters the medium;

a second sensor configured to monitor an indicator of electrolyte concentration or pH in the dialysate in the fluid line after the dialysate exits the medium; and

control electronics in operable communication with the first sensor and the concentrate flow control element,

wherein the control electronics are configured, via the concentrate flow control element, to adjust the rate at which the concentrate solution enters the fluid line based on a rate of change of blood electrolyte level or blood pH based on data obtained from the first sensor and the second sensor.

2. The system of claim 1, wherein the data obtained from the first sensor and the second sensor is used to predict blood electrolyte concentration or blood pH.

3. The system of claim 1, wherein the control electronics are configured, via the concentrate flow control element, to adjust the rate at which the concentrate solution enters the fluid line based on a comparison of the data received from the first sensor and the data received from the second sensor.

4. The system of claim 1, further comprising a dialysate regeneration system, wherein the first sensor is configured to monitor the indicator of electrolyte concentration or pH in the dialysate in the fluid line after the dialysate exits the regeneration system, and wherein the second sensor is configured to monitor the indicator of electrolyte concentration or pH in the dialysate in the fluid line before the dialysate enters the regeneration system.

5. The system of claim 4, wherein the concentrate solution enters the fluid line after the dialysate exits the dialysate regeneration system.

6. The system of claim 1, wherein the first sensor is configured to monitor the indicator of electrolyte concentration or pH in the dialysate in the fluid line after the concentrate solution enters the fluid line.

7. The system of claim 1, further comprising a third sensor configured to monitor the indicator in the blood after the blood exits the medium.

8. The system of claim 1, wherein the control electronics are configured to adjust a rate at which dialysate enters the medium or the rate at which blood enters the medium based on data obtained from the first sensor and the second sensor.

9. The system of claim 1, wherein the control electronics, or components thereof, are housed within a housing of the blood fluid removal device.

10. A method carried out by the system of claim 1, comprising:

initiating a blood fluid removal procedure, wherein the procedure comprises use of a dialysate with an initial pH buffer composition or electrolyte composition;

monitoring an indicator of pH or electrolyte concentration in the dialysate during the blood fluid removal session; and

adjusting the pH buffer composition or the electrolyte composition of the dialysate based on a value of the monitored indicator.

11. The method of claim 10, wherein the indicator of pH or electrolyte concentration in the dialysate is monitored after the dialysate exits a blood fluid removal medium and wherein the indicator of pH or electrolyte concentration in the dialysate is monitored before the dialysate enters the blood fluid removal medium.

12. The method of claim 11, wherein the pH buffer composition or electrolyte composition of the dialysate is adjusted based on a blood electrolyte concentration or blood pH, based on the indicator of pH or electrolyte concentration in the dialysate after the dialysate exits a blood fluid removal medium and the indicator of pH or electrolyte concentration in the dialysate before the dialysate enters the blood fluid removal medium.

13. The method of claim 12, wherein adjusting the pH buffer composition or electrolyte composition comprises adding a concentrate electrolyte solution or concentrated buffer solution to the dialysate.

14. The method of claim 10, further comprising:

determining whether a value of the monitored indicator crosses a threshold; and

providing an alert if the value of the monitored indicator crosses the threshold.

15. The method of claim 11, further comprising deriving a blood electrolyte concentration or blood pH from the monitored indicator before the dialysate enters the medium and after the dialysate exits the medium.

16. The method of claim 11, further comprising monitoring the indicator in blood after the blood exits the blood fluid removal medium.

17. The method of claim 11, further comprising adjusting a rate at which dialysate enters the blood fluid removal medium or a rate at which blood enters the blood fluid removal medium based on the monitored indicator.

18. The method of claim 11, wherein the dialysate is regenerated with a dialysate regeneration system, and wherein the indicator of pH or electrolyte concentration in the dialysate is monitored after the dialysate exits the blood fluid removal medium but before the dialysate enters the dialysate regeneration system;

and wherein the indicator of pH or electrolyte concentration in the dialysate is monitored after the dialysate exits the dialysate regeneration system but before the dialysate enters the blood fluid removal medium.

19. The method of claim 18, wherein adjusting the pH buffer composition or electrolyte composition comprises adding a concentrated electrolyte solution or concentrated buffer solution to the dialysate after the dialysate has been regenerated.

20. The method of claim 19, wherein the pH or electrolyte concentration in the dialysate is monitored after the concentrated electrolyte solution or concentrated buffer solution has been added to the dialysate.