Blood fluid removal system performance monitoring

• US 10,406,268 B2
• Filed: 03/11/2016
• Issued: 09/10/2019
• Est. Priority Date: 04/29/2011
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin, Lyu, Suping, Pudil, Bryant
• Primary Examiner(s): Kim, John
• Application Number:
  US15/067,559
• Publication Number:
  US 20160206801A1
• Time in Patent Office: 1,278 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

Monitoring of the performance of a blood fluid removal medium of a blood fluid removal device includes monitoring of condition, such as fluid flow rate or concentration of blood waste product, downstream of the medium. Upstream monitoring of the condition may also be performed to enhance the ability to determine whether the blood fluid removal medium is performing within predetermined ranges.

Claims

1. A blood fluid removal system comprising:

a media housing defining a major chamber;

a blood fluid removal membrane disposed into the media housing and sealingly dividing the major chamber into first and second minor chambers;

a first inlet and a first outlet in fluid communication with the first minor chamber, wherein the system is configured such that blood enters the first minor chamber through the first inlet and exits the first minor chamber though the first outlet;

a second outlet in fluid communication with the second minor chamber, wherein the system is configured such that fluid removed from the blood exits the second minor chamber through the second outlet;

a first sensor configured to detect an indicator of a blood waste product at or downstream of the second outlet;

control electronics configured to acquire data from the sensor and configured to determine whether the membrane is functioning within predetermined parameters based on the acquired data; and

further comprising;

(i) a second inlet in communication with the second minor chamber, wherein dialysate is configured to flow through the second inlet and the second outlet; and

(ii) a dialysate flow controller operably coupled to the control electronics, wherein, if the membrane is determined not to be functioning within predetermined limits, the control electronics are configured to adjust one or more system parameters selected from the group of;

adjusting a dialysate flow rate via the dialysate flow controller, adjusting a blood flow rate via a blood flow control element, and adjusting a pressure differential between the first minor chamber and the second minor chamber.

2. The blood fluid removal system of claim 1, wherein the control electronics are further configured to acquire data from the sensor at a predetermined time after the system parameters are adjusted, and to determine whether the membrane is functioning within predetermined parameters based on the acquired data at the predetermined amount of time after the system parameters are adjusted.

3. The blood fluid removal system of claim 1, further comprising a second sensor configured to detect the indicator of a blood waste product at or upstream of the second inlet, wherein the control electronics are configured to acquire data from the second sensor, and wherein the control electronics are configured to compare data acquired from the first sensor to data acquired from the second sensor in determining whether the membrane is functioning within predetermined parameters.

4. The blood fluid removal system of claim 1, further comprising a second sensor configured to detect the indicator of a blood waste product at or upstream of the first inlet, wherein the control electronics are configured to acquire data from the second sensor, and wherein the control electronics are configured to compare data acquired from the first sensor to data acquired from the second sensor in determining whether the membrane is functioning within predetermined parameters.

5. The blood fluid removal system of claim 1, wherein the control electronics are configured to acquire data from the sensor at a first time and at a second time later than the first time, and wherein the control electronics are configured to compare data from the first sensor at the first time and second time in determining whether the membrane is functioning within predetermined parameters.

6. The blood fluid removal system of claim 1, wherein, if the membrane is determined not to be functioning within predetermined limits, the control electronics are further configured to determine whether the data from the first sensor is indicative of clotting, and to increase an amount of anticoagulants added to the blood or dialysate if the data from the sensor is indicative of clotting.

7. The blood fluid removal system of claim 1, wherein, if the membrane is determined not to be functioning within predetermined limits, the control electronics determine whether the data from the first sensor is indicative of protein deposition.

8. A method comprising:

monitoring rate of flow of blood, or an indicator thereof, entering the blood fluid removal system of claim 1;

determining whether the monitored flow rate or indicator is within a predetermined range; and

adjusting a system parameter of the blood fluid removal system or a blood fluid removal session parameter if the monitored flow rate or indicator is not within the predetermined range.

9. The method of claim 8, wherein the blood fluid removal system comprises a blood flow control element configured to control the rate of flow of blood through the system and wherein adjusting a system parameter comprises adjusting a parameter of a blood flow control element to adjust the rate of flow of blood through the system.

10. The method of claim 9, further comprising:

monitoring rate of flow of blood, or an indicator thereof, through the blood fluid removal system; and

determining whether the monitored flow rate or indicator is within a predetermined range.

11. The method of claim 10, wherein adjusting a system parameter comprises adjusting a parameter configured to control rate of fluid removal from the blood.

12. The method of claim 11, wherein adjusting the parameter configured to control rate of fluid removal from the blood comprises adjusting the rate of flow of dialysate.

13. The method of claim 11, wherein adjusting the parameter configured to control rate of fluid removal from the blood comprises adjusting a pressure differential across a media configured to remove fluid from the blood.

14. The method of claim 11, wherein adjusting the session parameter comprises adjusting the length of time of the session.

15. A blood fluid removal system comprising:

a media housing defining a major chamber;

a blood fluid removal membrane disposed into the media housing and sealingly dividing the major chamber into first and second minor chambers;

a first inlet and a first outlet in fluid communication with the first minor chamber, wherein the system is configured such that blood enters the first minor chamber through the first inlet and exits the first minor chamber though the first outlet;

a second inlet and a second outlet in fluid communication with the second minor chamber, wherein the system is configured such that fluid removed from the blood exits the second minor chamber through the second outlet and such that dialysate flows through the second minor chamber from the second inlet to the second outlet;

one or more sensors configured to measure a pressure differential across the membrane;

control electronics configured to acquire data from the one or more sensors and configured to determine whether the membrane is functioning within a first predefined range of parameters based on the acquired data;

wherein, if the membrane is determined not to be functioning within the first predefined range of parameters, the control electronics determine whether the data from the one or more sensors is indicative of clotting or of protein deposition; and

a dialysate flow controller operably coupled to the control electronics, wherein, if the membrane is determined not to be functioning within predetermined limits, the control electronics are configured to adjust one or more system parameters from an original setting, wherein adjusting the one or more system parameters is selected from the group of;

adjusting a dialysate flow rate via the dialysate flow controller, adjusting a blood flow rate via a blood flow control element, and adjusting a pressure differential between the first minor chamber and the second minor chamber;

wherein, if the data from the one or more sensors is indicative of clotting;

the control electronics are further configured to increase an amount of anticoagulants added to the blood or dialysate.

16. The blood fluid removal system of claim 15, wherein the control electronics are further configured to acquire data from the one or more sensors and to determine whether the membrane is functioning within a first predefined range of parameters based on the acquired data at a predetermined amount of time after the dialysate flow rate is increased.

17. The blood fluid removal system of claim 15, wherein the control electronics configured (i) adjust the one or more system parameters back to the original setting at a predetermined time after the system parameters are adjusted, and (ii) to acquire data from the one or more sensors after the dialysate rate has been reduced and to determine whether the membrane is functioning within a first predefined range of parameters based on the acquired data after the one or more system parameters are adjusted back to the original setting.

18. The blood fluid removal system of claim 15, further comprising:

a computer-readable medium comprising instructions that, when implemented, cause the control electronics (i) to acquire data from the one or more sensors, (ii) determine whether the membrane is functioning within a first predefined range of parameters based on the acquired data; and

(iii) adjust the dialysate flow rate through the second minor chamber from an original dialysate flow rate, via control of the dialysate flow controller, if the membrane is determined to not be function within the first range.

19. A method for de-fouling a membrane of the blood fluid removal system of claim 15, the method carried out by the control electronics of the system and comprising:

acquiring data from the one or more sensors;

determining whether the membrane is functioning within a first predefined range of parameters based on the acquired data; and

adjusting one or more system parameters from an original setting if the membrane is determined to not be functioning within the first range, wherein the adjusting one or more system parameters is selected from the group consisting of;

adjusting a dialysate flow rate, via the dialysate flow controller, adjusting a blood flow rate via a blood flow control element, and adjusting a pressure differential between the first minor chamber and the second minor chamber.

20. The method of claim 19, further comprising:

acquiring data from the one or more sensors; and

determining whether the membrane is functioning within a first predefined range of parameters based on the acquired data at a predetermined amount of time after the one or more system parameters are adjusted.

21. The method of claim 19, further comprising:

adjusting the one or more system parameters back to the original setting at a predetermined time after the flow rate is increased;

acquiring data from the one or more sensors after the one or more system parameters are adjusted back to the original setting; and

determining whether the membrane is functioning within a first predefined range of parameters based on the acquired data after the one or more system parameters are adjusted back to the original setting.