Cardiovascular monitoring for fluid removal processes

• US 9,061,099 B2
• Filed: 03/20/2012
• Issued: 06/23/2015
• 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, VenKatesh, Manda R., Pudil, Bryant
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US13/424,490
• Publication Number:
  US 20120277650A1
• Time in Patent Office: 1,190 Days
• Field of Search: 604/5.01, 604/5.04, 604/6.09, 604/6.11, 604/4.01, 210/645, 210/646
• US Class Current: 1/1
• 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

A method includes initiating a blood fluid removal session for a patient in need thereof; monitoring a cardiovascular parameter of the patient; determining whether the indicator of the cardiovascular state crosses a predetermined threshold; and altering a parameter of the blood fluid removal session if the indicator is determined have crossed the threshold.

Claims

1. A method carried out by a blood fluid removal device or system, comprising:

initiating a blood fluid removal session for a patient in need thereof;

monitoring a cardiovascular parameter and at least one additional physiological parameter of the patient with at least one sensor;

determining whether an indicator of the cardiovascular parameter or physiological parameter crosses a predetermined threshold; and

altering a parameter of the blood fluid removal session if the indicator is determined to have crossed the threshold,

wherein the blood fluid removal device comprises control electronics, wherein the control electronics are configured to control one or more flow control elements to adjust a pH or electrolyte concentration of a replacement fluid based on the data from the at least one sensor; and

wherein altering a parameter of the blood fluid removal session comprises setting or adjusting the pH and electrolyte concentration of the replacement fluid based at least on the cardiovascular or physiological parameter of the patient wherein the step of altering the parameter of the blood fluid removal session is carried out by the blood fluid removal device.

2. The method of claim 1, wherein the predetermined threshold is based on measurements of the cardiovascular parameter obtained prior to initiating the blood fluid removal session.

3. The method of claim 1, further comprising monitoring the cardiovascular parameter of the patient prior to initiating the blood fluid removal session, and setting an initial prescription for the blood fluid removal session based on the cardiovascular parameter monitored prior to initiating the blood fluid removal session.

4. The method of claim 3, wherein setting the initial prescription for the blood fluid removal session comprises setting a fluid removal prescription or setting a dialysate composition prescription.

5. The method of claim 4, wherein monitoring the cardiovascular parameter of the patient prior to initiating the blood fluid removal session comprises chronically monitoring the cardiovascular parameter.

6. The method of claim 5, further comprising (i) determining whether the cardiovascular parameter crosses a predetermined threshold, and (ii) scheduling the blood fluid removal session or providing an alert if the parameter crosses the threshold.

7. The method of claim 1, wherein monitoring the cardiovascular parameter comprises monitoring one or more of heart rate, heart rhythm or blood pressure.

8. The method of claim 1, wherein altering the parameter of the blood fluid removal session comprises altering the rate of removal of fluid from the patient'"'"'s blood.

9. The method of claim 1, wherein altering the parameter of the blood fluid removal session comprises altering a concentration of a component of a fluid selected from dialysate or replacement fluid.

10. A method carried out by a blood fluid removal device or system, comprising:

receiving data regarding a monitored cardiovascular parameter and at least one additional physiological parameter to a blood fluid removal device or system;

wherein

the blood fluid removal device comprises control electronics, wherein the control electronics are configured to control one or more flow control elements to adjust a pH or electrolyte concentration of a replacement fluid based on the data from the at least one sensor; and

setting a parameter for a blood fluid removal session based on the received data regarding the monitored cardiovascular or physiological parameter, wherein the parameter for the blood fluid removal session is set by control electronics of a blood fluid removal device or system,

wherein setting the parameter for the blood fluid removal session comprises setting or adjusting the pH and electrolyte concentration of a replacement fluid based at least on the monitored physiological parameter, and wherein setting the parameter for the blood fluid removal session is carried out by the blood fluid removal device.

11. The method of claim 10, wherein the cardiovascular and at least one physiological parameter of the patient are used in setting an initial prescription for the blood fluid removal session, wherein setting an initial prescription for the blood fluid removal session comprises setting a fluid volume removal prescription.

12. The method of claim 10, wherein setting an initial prescription for the blood fluid removal session comprises setting a dialysate composition or a replacement fluid composition.

13. The method of claim 10, wherein the cardiovascular parameter comprises one or more of heart rate, heart rhythm and blood pressure.

14. A system comprising:

a blood fluid removal device comprising

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

(ii) an outlet for returning blood to 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 control element for controlling the rate at which fluid is removed from the blood by the medium;

a sensor for monitoring a cardiovascular parameter and at least one additional physiological parameter of the patient; and

control electronics in operable communication with the sensor and the control element, wherein the control electronics are configured, via the control element, to adjust the rate at which the fluid is removed from the blood,

and wherein the pH and electrolyte concentration of a replacement fluid can be set or adjusted based at least on a cardiovascular or physiological parameter of the patient by the blood fluid removal device.

15. The system of claim 14, wherein the blood fluid removal device further comprises a fluid source for carrying a system fluid, the system fluid selected from dialysate and replacement fluid, wherein if the fluid is dialysate the fluid source carries the fluid to the medium, and wherein if the fluid is replacement fluid the fluid source carries the fluid to the blood after the blood exits the medium;

wherein the system further comprises

a concentrate source for housing a concentrate solution comprising a concentrated component for the system fluid; and

a concentrate flow control element for controlling the rate at which the concentrate solution enters the fluid source;

wherein the sensor is operably coupled to the control electronics and the control electronics are further configured, via the concentrate flow control element, to adjust the rate at which the concentrate solution enters the fluid source based on data obtained from the sensor.

16. The system of claim 14, wherein the control electronics are housed within the blood fluid removal device.

19. The system of claim 16, further comprising a non-transitory computer readable medium, wherein the computer readable medium comprises instructions that cause the control electronics to control the concentrate flow control element to adjust the rate at which the concentrate solution enters the fluid source based on data obtained from the sensor.

17. A system comprising:

a blood fluid removal device comprising

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

(ii) an outlet for returning blood to 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 source for carrying a fluid, the fluid selected from dialysate and replacement fluid, wherein if the fluid is dialysate the fluid source carries the fluid to the medium, and wherein if the fluid is replacement fluid the fluid source carries the fluid to the blood after the blood exits the medium;

a concentrate source for housing a concentrate solution comprising a concentrated component for the fluid;

a concentrate flow control element for controlling the rate at which the concentrate solution enters the fluid source;

a sensor for monitoring a cardiovascular parameter and at least one additional physiological parameter of the patient; and

control electronics in operable communication with the 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 source based on data obtained from the sensor, and wherein the pH and electrolyte concentration of a replacement fluid can be set or adjusted based at least on the physiological parameter of the patient by the blood fluid removal device.

18. The system of claim 17, wherein control electronics are housed within the blood fluid removal device.