Dialysis system having non-invasive fluid velocity sensing

• US 8,858,787 B2
• Filed: 10/22/2007
• Issued: 10/14/2014
• Est. Priority Date: 10/22/2007
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Muller, Matthew, Busby, Donald, Rohde, Justin, Jablonski, Mark
• Primary Examiner(s): BASS, DIRK R
• Application Number:
  US11/876,619
• Publication Number:
  US 20090101550A1
• Time in Patent Office: 2,549 Days
• US Class Current: 210/87
• CPC Class Codes: A61M 1/1524 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/154 with sensing means or components thereof
• CPC Class Codes: A61M 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: A61M 1/1565 Details of valves
• CPC Class Codes: A61M 1/16 with membranes
• 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 1/1645 with mechanically linked peristaltic dialysis fluid pumps one upstream, the other one downstream of the dialyser
• CPC Class Codes: A61M 1/1647 with flow rate measurement of the dialysis fluid, upstream and downstream of the dialyser
• CPC Class Codes: A61M 1/1658 Degasification
• CPC Class Codes: A61M 1/288 Priming priming in extracorporeal blood circuits A61M1/3643
• 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 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/3413 Diafiltration
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/3643 Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3644 Mode of operation
• CPC Class Codes: A61M 1/3649 : using dialysate as priming or rinsing liquid
• CPC Class Codes: A61M 1/365 : through membranes, e.g. by inverted trans-membrane pressure [TMP]
• CPC Class Codes: A61M 1/3656 : Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/3306 : Optical measuring means
• CPC Class Codes: A61M 2205/3313 : used specific wavelengths
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3368 : Temperature
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2230/20 : Blood composition characteristics
• CPC Class Codes: G01F 1/708 : Measuring the time taken to traverse a fixed distance

Abstract

A dialysis system includes a dialyzer; a blood pump coupled operably to a dialyzer; a dialysate inlet pump couple operably to a dialysate inlet of the dialyzer; a dialysate outlet pump coupled operably to a dialysate outlet of the dialyzer; a first non-invasive fluid velocity sensor positioned to sensor of inlet flowrate of dialysate pumped to the dialysate inlet by the dialysate inlet pump; and a second non-invasive fluid velocity sensor positioned to sense an outlet flowrate of dialysate pumped from the dialysate outlet by the dialysate outlet pump.

Claims

1. A dialysis system comprising:

a dialyzer;

a blood pump coupled operably to the dialyzer;

a dialysate inlet pump coupled operably to a dialysate inlet of the dialyzer;

a dialysate outlet pump coupled operably to a dialysate outlet of the dialyzer;

a first non-invasive fluid velocity sensor positioned to sense an inlet velocity of dialysate pumped to the dialyzer inlet by the dialysate inlet pump;

a second non-invasive fluid velocity sensor positioned to sense an outlet velocity of dialysate pumped from the dialyzer outlet by the dialysate outlet pump; and

a logic implementor programmed to;

(i) set a speed of the dialysate inlet pump and a speed of the dialysate outlet pump so that an ultrafiltration rate is achieved, (ii) multiply a cross-sectional area of the dialyzer inlet by the sensed fluid inlet velocity and by a sample time to determine a sample time inlet volume, (iii) multiply a cross-sectional area of the dialyzer outlet by the sensed fluid outlet velocity and by the sample time to determine a sample time outlet volume, (iv) integrate the determined sample time inlet and outlet volumes over a treatment period to determine a total amount of dialysate delivered to and from the dialyzer during the treatment, and (v) use the determined total amount of dialysate delivered to and from the dialyzer to adjust the ultrafiltration rate as treatment proceeds.

2. The dialysis system of claim 1, wherein the first and second non-invasive fluid velocity sensors are of a type selected from the group consisting of:

optical, laser and heat pulse.

3. The dialysis system of claim 1, which includes at least one of a heparin pump and a saline pump connected to a blood circuit, the blood circuit including the blood pump and a blood side of the dialyzer, and at least one of:

(i) an additional non-invasive fluid velocity sensor positioned to sense a velocity of heparin pumped by the heparin pump; and

(ii) an additional non-invasive fluid velocity sensor positioned to sense a velocity of saline pumped by the saline pump.

4. The dialysis system of claim 1, wherein the logic implementor is programmed to subtract an output of the first non-invasive fluid velocity sensor from an output of the second non-invasive fluid velocity sensor to determine an amount of ultrafiltration removal from a patient during the treatment.

5. The dialysis system of claim 4, wherein the outputs are totaled outputs or instantaneous outputs.

6. The dialysis system of claim 1, which includes a bypass line positioned to selectively enable the dialysate inlet pump to pump dialysate past both the non-invasive fluid velocity sensors to calibrate the sensors.

7. The dialysis system of claim 6, wherein the bypass line is positioned from a junction between the first non-invasive fluid velocity sensor and the dialysate inlet to a junction between the dialysate outlet and the second non-invasive fluid velocity sensor.

8. The dialysis system of claim 6, which includes a calibration mode in which the bypass line is opened to calibrate the first and second non-invasive fluid velocity sensors and a therapy mode in which the bypass line is closed.

9. The dialysis system of claim 1, wherein the dialysate inlet and dialysate outlet pumps are peristaltic pumps or membrane pumps.

10. A dialysis system comprising:

a dialysate inlet pump configured to pump dialysate to a dialyzer;

a dialysate outlet pump configured to pump dialysate from the dialyzer;

a dialysis instrument configured to actuate the dialysate inlet and outlet pumps, the instrument including a first non-invasive fluid velocity sensor and a second non-invasive fluid velocity sensor;

a disposable dialysate carrying unit operable with the dialysis instrument, the disposable unit including a to-dialyzer channel pathway, at least a portion of which having a known cross-sectional area defined by walls extending from a rigid base plate of the disposable unit, the to-dialyzer portion when placed in the dialysis instrument positioned to operate with the first non-invasive fluid velocity sensor,

the disposable unit further including a from-dialyzer channel pathway, at least a portion of which having a known cross-sectional area defined by walls extending from a rigid base plate of the disposable unit, the from-dialyzer portion when placed in the dialysis instrument positioned to operate with the second non-invasive fluid velocity sensor; and

a logic implementor programmed to (i) integrate a signal from the first non-invasive fluid velocity sensor to determine an amount of dialysate delivered to the dialyzer during a treatment, (ii) integrate a signal from the second non-invasive fluid velocity sensor to determine an amount of dialysate delivered from the dialyzer during the treatment, and (iii) use the determined amount of dialysate delivered to and from the dialyzer to determine an ultrafiltration rate as the treatment proceeds.

11. The dialysis system of claim 10, wherein the known cross-sectional areas are rectangular or square cross-sectional areas having a width D and length L that are from about less than a centimeter to about a few centimeters long.

12. The dialysis system of claim 10, wherein at least one of the known cross-sectional areas is further defined by a clear rigid plate covering the area to produce a fixed cross-sectional area.

13. The dialysis system of claim 12, wherein the disposable unit includes at least one of:

(i) a flexible sheet operable with at least one valve actuator of the instrument;

(ii) a flexible sheet operable with at least one of the dialysate inlet and outlet pumps;

(iii) peristaltic pump tubing operable with at least one of the inlet and outlet pumps; and

(iv) at least one supply bag.

14. The dialysis system of claim 10, wherein at least one of the known cross-sectional areas is formed via the instrument and the disposable unit, the instrument configured to apply negative pressure to a sheeting of the disposable unit at the known cross-sectional area of the disposable dialysate carrying unit.

15. The dialysis system of claim 10, wherein the to-dialyzer pathway is positioned upstream or downstream of the dialysate inlet pump.

16. The dialysis system of claim 10, wherein the from-dialyzer pathway is positioned upstream or downstream of the dialysate outlet pump.

17. The dialysis system of claim 10, wherein the logic implementer is programmed to subtract an output of the first non-invasive fluid velocity sensor from an output of the second non-invasive fluid velocity sensor to determine an amount of ultrafiltration removed from a patient during the treatment.

18. A dialysis system comprising:

a dialysate inlet pump configured to pump dialysate to a dialyzer;

a dialysate outlet pump configured to pump dialysate from the dialyzer;

a dialysis instrument configured to actuate the dialysate inlet and outlet pumps, the instrument including a first non-invasive fluid velocity sensor and a second non-invasive fluid velocity sensor;

a disposable dialysate carrying unit operable with the dialysis instrument, the disposable unit including a to-dialyzer pathway, at least a portion of the to-dialyzer pathway having a sensor area operable with the first non-invasive fluid velocity sensor when the unit is placed in the dialysis instrument, the to-dialyzer sensing area having an entrance length long enough to allow dialysate flow to be at least substantially laminar prior to reaching the first non-invasive fluid velocity sensor,

the disposable unit further including a from-dialyzer pathway, at least a portion of the from-dialyzer pathway having a sensor area operable with the second non-invasive fluid velocity sensor when the unit is placed in the dialysis instrument, the from-dialyzer sensing area having an entrance length long enough to allow dialysate flow to be at least substantially laminar prior to reaching the second non-invasive fluid velocity sensor; and

a logic implementor programmed to (i) integrate a signal from the first non-invasive fluid velocity sensor to determine an amount of dialysate delivered to the dialyzer during a treatment, (ii) integrate a signal from the second non-invasive fluid velocity sensor to determine an amount of dialysate delivered from the dialyzer during the treatment, and (iii) use the determined total amount of dialysate delivered to and from the dialyzer to determine an ultrafiltration rate as the treatment proceeds.

19. The dialysis system of claim 18, wherein at least one of the sensor areas is configured to produce dialysate flow having a Reynolds number of less than one-thousand.

20. The dialysis system of claim 18, wherein at least one of the entrance lengths prior to the respective sensing areas is equal to or greater than 0.02*a hydraulic diameter of a laminar flow portion*a Reynolds number of dialysate flow through the laminar flow portion.

21. A dialysis system comprising:

a dialyzer;

a blood pump coupled operably to the dialyzer;

a dialysate inlet pump coupled operably to a dialysate inlet of the dialyzer;

a dialysate outlet pump coupled operably to a dialysate outlet of the dialyzer;

a first non-invasive fluid velocity sensor positioned to sense an inlet velocity of dialysate pumped to the dialyzer inlet by the dialysate inlet pump;

a second non-invasive fluid velocity sensor positioned to sense an outlet velocity of dialysate pumped from the dialyzer outlet by the dialysate outlet pump; and

a logic implementor programmed to;

(i) subtract a sensed inlet velocity signal from a sensed outlet velocity signal to determine an instantaneous ultrafiltration velocity, (ii) multiply the determined instantaneous ultrafiltration velocity by a cross-sectional area of the dialyzer inlet to determine an instantaneous ultrafiltration rate, (iii) multiply the determined instantaneous ultrafiltration rate by a sample volume to determine an instantaneous ultrafiltration volume, and (iv) integrate the determined instantaneous volume to determine a total amount of ultrafiltration.

22. A dialysis system comprising:

a dialysis instrument including

a blood pump,

a dialysate inlet pump,

a dialysate outlet pump, and

a fluid velocity sensor including an emitter and a receiver;

a dialyzer arranged (i) to receive blood pumped by the blood pump, (ii) to receive fresh dialysate pumped by the dialysate inlet pump and (iii) such that used dialysate is pumped from the dialyzer by the dialysate outlet pump;

a disposable cassette including a to-dialyzer dialysate pathway carrying dialysate pumped by the dialysate inlet pump and a from-dialyzer dialysate pathway carrying used dialysate pumped by the dialysate outlet pump, one of the to-dialyzer dialysate pathway and the from-dialyzer dialysate pathway including a sensing area so positioned and arranged such that when the disposable cassette is mounted to the instrument, the sensing area is coupled operably to both the emitter and the receiver of the fluid velocity sensor; and

a logic implementor programmed to;

(i) receive a sensed velocity signal from the fluid velocity sensor, (ii) multiply the sensed velocity by a cross-sectional area of the sensing area to determine an instantaneous ultrafiltration rate, (iii) multiply the determined instantaneous ultrafiltration rate by a sample volume to determine an instantaneous ultrafiltration volume, and (iv) integrate the determined instantaneous volume to determine a total amount of ultrafiltration.

23. The dialysis system of claim 22, wherein the fluid velocity sensor is non-invasive.

24. The dialysis system of claim 22, wherein the emitter and receiver of the fluid velocity sensor are located on a same side of the disposable cassette.

25. The dialysis system of claim 22, wherein the emitter and receiver of the fluid velocity sensor are located on opposite sides of the disposable cassette.

26. The dialysis system of claim 22, wherein the fluid velocity sensor is a first fluid velocity sensor, and which includes a second fluid velocity sensor, the other of the to-dialyzer pathway and the from-dialyzer pathway including a second sensing area so positioned and arranged such that when the disposable cassette is mounted to the instrument, the second sensing area is coupled operably to the second fluid velocity sensor.

27. The dialysis system of claim 22, wherein the fluid velocity sensor is an optical, laser or heat pulse sensor.