Chronic pH or electrolyte monitoring

• US 9,700,661 B2
• Filed: 03/20/2012
• Issued: 07/11/2017
• Est. Priority Date: 04/29/2011
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin, Lyu, Suping, Pudil, Bryant
• Primary Examiner(s): BASS, DIRK R
• Assistant Examiner(s): Brewster, Hayden
• Application Number:
  US13/424,525
• Publication Number:
  US 20120277552A1
• Time in Patent Office: 1,939 Days
• Field of Search: 210647, 210 962, 210143, 210645, 210646, 210739, 800309, 800377, 800381, 600309, 600377, 600381, 600300, 600483, 600485, 600508
• 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 blood pH or electrolyte levels and setting initial fluid parameters, such as dialysate fluid parameters or replacement fluid parameters, for a blood fluid removal session based the monitored data. 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 method for a blood fluid removal device, comprising the steps of:

(1) chronically monitoring a blood electrolyte concentration or blood pH of a patient via an implantable sensor device; and

(2) transmitting data regarding the monitored blood electrolyte concentration or blood pH to the blood fluid removal device selected from the group consisting of an ultrafiltration device, a hemofiltration device, a hemodiafiltration device, and a peritoneal dialysis device, or to control electronics configured to control the blood fluid removal device,

wherein the blood fluid removal device or control electronics determines an appropriate electrolyte concentration or buffer concentration of a fluid to be used in the blood fluid removal device based on the monitored blood electrolyte concentration or blood pH during a blood fluid removal session, and controls flow of a concentrate from one or more concentrate sources into the fluid to achieve the appropriate electrolyte concentration or buffer concentration.

2. The method of claim 1, further comprising

(i) determining whether the monitored blood electrolyte concentration or blood pH crosses a predetermined threshold;

and

(ii) alerting the patient if the blood electrolyte concentration or blood pH is determined to cross the threshold.

3. The method of claim 2, further comprising alerting a healthcare provider if the blood electrolyte concentration or blood pH is determined to cross the threshold.

4. The method of claim 1, wherein the fluid to be used in the blood fluid removal device comprises dialysate fluid.

5. The method of claim 1, wherein the fluid to be used in the blood fluid removal device comprises replacement fluid.

6. The method of claim 1, further comprising monitoring the blood electrolyte concentration or blood pH via an external sensor, and calibrating the implantable sensor based on data acquired from the external sensor.

7. The method of claim 6, wherein the monitoring via the external sensor occurs during a blood fluid removal session, and wherein the calibrating occurs during a blood fluid removal session.

10. The method of claim 1, wherein the flow of concentrate from the one or more concentrate sources is controlled by one or more pumps and one or more valves in fluid communication with the one or more concentrate sources.

11. The method of claim 1, wherein a patient for which a blood fluid removal session is indicated is identified prior to monitoring the blood electrolyte concentration or blood pH.

12. The method of claim 1, wherein the step of determining an appropriate electrolyte concentration is performed by an implanted transducer.

13. The method of claim 1, wherein the blood fluid removal device is an implantable blood fluid removal device.

14. The method of claim 1, wherein the blood fluid removal device is a wearable blood fluid removal device.

15. The method of claim 1, wherein the blood fluid removal device or control electronics determines an appropriate buffer concentration buffer is selected from the group consisting of bicarbonate, acetate, lactate, citrate, amino acid, and protein buffers.

16. The method of claim 1, wherein the electrolyte is selected from the group consisting of sodium, potassium, calcium, and chloride.

17. The method of claim 1, wherein the step of chronically monitoring blood electrolyte concentration comprises chronically monitoring multiple blood electrolyte concentrations, and wherein the step of determining an appropriate electrolyte concentration comprises determining an appropriate electrolyte concentration for each of the multiple electrolytes.

18. The method of claim 1, further comprising the step of initiating a blood fluid removal session;

and wherein the blood fluid removal device or control electronics determines an appropriate electrolyte concentration or buffer concentration of the fluid to be used in the blood fluid removal device based on the blood electrolyte concentration or blood pH during the blood fluid removal session.

19. The method of claim 1, wherein the blood fluid removal device or control electronics determines an appropriate dialysate flow rate based on the blood electrolyte concentration or blood pH.

20. The method of claim 1, wherein the blood fluid removal device or control electronics determines an appropriate blood flow rate based on the blood electrolyte concentration or blood pH.

21. The method of claim 1, wherein the data is transmitted wirelessly.

22. The method of claim 1, wherein the blood pH is monitored.

23. The method of claim 1, wherein at least a portion of the chronic monitoring of the blood electrolyte concentration or blood pH of the patient comprises monitoring prior to a blood removal session.

24. The method of claim 1, wherein the blood fluid removal device or control electronics determines an appropriate pH of the fluid to be used in treatment based on the blood electrolyte concentration or blood pH during a blood fluid removal session.

8. A method for a blood fluid removal device comprising:

chronically monitoring, via an implantable sensor, a blood electrolyte concentration or blood pH of a patient during a blood fluid removal session; and

initiating a blood fluid removal procedure for a patient in need thereof, wherein the procedure comprises use of a dialysate fluid and a dialysis membrane, as at least a part of a blood fluid removal medium, across which electrolytes may be exchanged between blood and dialysate fluid, and

transmitting data regarding the monitored blood electrolyte concentration or blood pH to the blood fluid removal device, containing the blood fluid removal medium, wherein the blood fluid removal device is selected from the group consisting of an ultrafiltration device, a hemofiltration device, a hemodiafiltration device, and a peritoneal dialysis device or to control electronics configured to control a blood fluid removal device,

wherein the blood fluid removal device or control electronics determines the appropriate electrolyte concentration or buffer concentration in the dialysate fluid based on a value of the monitored blood electrolyte concentration or blood pH during the blood fluid removal session, and the blood fluid removal device or control electronics controls flow of a concentrate from one or more concentrate sources into the dialysate fluid to achieve the appropriate electrolyte concentration or buffer concentration, and wherein the data is transmitted wirelessly.

9. A method for a blood fluid removal device comprising:

chronically monitoring, via an implantable sensor, a blood electrolyte concentration or blood pH of a patient during a blood fluid removal session; and

initiating a blood fluid removal procedure for a patient in need thereof, wherein the procedure comprises use of a dialysate fluid and a dialysis membrane, as at least a part of a blood fluid removal medium, across which electrolytes may be exchanged between blood and dialysate fluid,

wherein the rate of flow of the dialysate fluid or the blood is based on a value of the monitored blood electrolyte concentration or blood pH; and

transmitting data regarding the monitored blood electrolyte concentration or blood pH to the blood fluid removal device, containing the blood fluid removal medium, wherein the blood fluid removal device is selected from the group consisting of an ultrafiltration device, a hemofiltration device, a hemodiafiltration device, and a peritoneal dialysis device, or to control electronics configured to control the blood fluid removal device,

wherein the blood fluid removal device or control electronics determines an appropriate electrolyte concentration or buffer concentration in the dialysate fluid during the blood fluid removal session and controls flow of a concentrate from one or more concentrate sources into the dialysate fluid to achieve the appropriate electrolyte concentration or buffer concentration, and wherein the data is transmitted wirelessly.