Apparatus for the treatment of blood in particular for hemodialysis and hemofiltration

• US 4,923,598 A
• Filed: 06/21/1988
• Issued: 05/08/1990
• Est. Priority Date: 06/23/1987
• Status: Expired due to Fees

• Current Assignee: Fresenius AG (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius AG (Fresenius SE & Co. KGaA)
• Inventors: Schal, Wilfried
• Primary Examiner(s): JONES, WILLIAM G
• Application Number:
  US07/209,678
• Time in Patent Office: 686 Days
• Field of Search: 210/87, 210/90, 210/137, 210/143, 210/321.65, 210/321.71, 210/929, 604/4, 604/5
• US Class Current: 210/87
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1605 Physical characteristics of the dialysate fluid
• 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 1/36 Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
• CPC Class Codes: A61M 1/3663 Flow rate transducers; Flow integrators
• CPC Class Codes: A61M 1/367 Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 PH measuring means
• 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 2205/50 with microprocessors or computers
• CPC Class Codes: B01D 61/22 Controlling or regulating
• CPC Class Codes: G01F 1/663 by measuring Doppler frequency shift
• CPC Class Codes: Y10S 210/929 Hemoultrafiltrate volume measurement or control processes

Abstract

The apparatus for hemodialysis and hemofiltration comprises an extracorporeal blood circuit comprising a dialyzer and/or filter arrangement. For determining the fluid withdrawal per unit time and the total amount of fluid withdrawn flow sensors in conjunction with an evaluating unit are inserted into the blood circuit upstream and downstream of the dialyzer or filter arrangement. The flow measurement is by the ultrasonic Doppler principle and for obtaining high accuracy the sensors comprise measuring inserts belonging to the blood tubing system and having special means for defined coupling-in and coupling-out and precise conduction of the ultrasonic waves. Apart from the measurement, means are provided for regulating the net fluid withdrawal.

Claims

1. An apparatus for the extracorporeal treatment of blood, comprising:

an extracorporeal blood circuit which is formed by a blood tubing system;

means for dialyzing, filtering or both located in said extracorporeal blood circuit;

a first ultrasonic flow sensor located in said extracorporeal blood circuit upstream of the dialyzing and filtering means, comprising;

a first dimensionally stable measuring insert inserted into the blood tubing system having a defined flow cross-section and lateral extensions for coupling-in said coupling-out and conducting of ultrasonic waves, each said extension having at one end a coupling face;

ultrasonic transducers with piezoelectric transducer elements having coupling pieces connected thereto and disposed such that each said coupling piece is in mechanical engagement with a corresponding coupling face;

a second ultrasonic flow sensor located in said extracorporeal blood circuit downstream of the dialyzing and filter means, comprising;

a second dimensionally stable measuring insert inserted into the blood tubing system having a defined flow cross-section and lateral extensions for coupling-in and coupling-out and conducting of ultrasonic waves, each said extension having at one end a coupling face;

second ultrasonic transducers with piezoelectric transducer elements having coupling pieces connected thereto and disposed such that each said coupling piece is in mechanical engagement with a corresponding coupling face;

evaluating means for performing predetermined evaluating operations based on signals generated by the first and second flow sensors connected to the first and second flow sensors; and

withdrawal control means for controlling the withdrawal of fluid from the extracorporeal blood circuit via the dialyzer or filter means, based on said evaluating operations.

2. The apparatus according to claim 1, wherein said evaluating means comprising:

means for determining the difference between the flow rate through said first flow sensor and said second flow sensor; and

means for displaying from said determining means the amount of fluid withdrawn from a patient per unit time.

3. The apparatus according to claim 1, wherein said evaluating means comprising:

means for determining the difference between the flow rate through said first flow sensor and said second flow sensor;

means for forming the time integral of the difference of the flow rates; and

means for displaying from said integral forming means the total amount of fluid withdrawn from a patient.

4. The apparatus according to claim 1, further comprising:

infusion control means connected to said blood circuit for controlling the infusion into said blood circuit of an infusion solution; and

second evaluating means for performing predetermined evaluating operations for automatic control of said infusion control means.

5. The apparatus according to claim 4, further comprising:

display means connected to said infusion control means for indicating and limit-value monitoring of the supply rate of the infusion solution.

6. The apparatus according to claim 1, wherein said dialyzing and filtering means includes a first chamber through which blood flows and a second chamber through which dialysis fluid or withdrawal of filtrate flows, the first and second chambers separated by a semipermeable membrane across which a transmembrane pressure differential is maintained, said apparatus further comprising:

pressure control means connected to the evaluating means for automatic setting of the transmembrane pressure.

7. The apparatus according to claim 6, further comprising:

a drive-motor actuated throttle connected to the pressure control means and located downstream of the filtering and dialyzing means for controlling fluid flow through the blood circuit.

8. The apparatus according to claim 7, further comprising:

display means connected to said pressure control means for indicating and limit-value monitoring the transmembrane pressure.

9. The apparatus according to claim 8, wherein said display means is adapted to display and limit-value monitor the position of the drive motor actuating the throttle.

10. The apparatus according to claim 1, further comprising:

automatic periodic calibration means connected to the evaluating means, comprising;

calibration control means;

a plurality of valves for isolating the dialyzing and filtering means from the blood circuit controlled by said calibration means;

said evaluating means for determining the difference of measurement between signals issuing from said first flow sensor and said second flow sensor and for determining therefrom a zero point correction, the evaluating means further comprising;

means for storing said difference of measurement signals and the zero point correction corresponding to the magnitude of said difference of measurement signals.

11. The apparatus according to claim 1, wherein the longitudinal axes of the lateral extensions of the measuring inserts form an angle in the range 10-60 degrees with the longitudinal axis of the measuring inserts.

12. The apparatus according to claim 1, wherein the longitudinal axes of the lateral extensions of the measuring inserts form an angle of 30 degrees with the longitudinal axis of the measuring inserts.

13. The apparatus according to claim 1, wherein that portion of the each coupling piece in contact with the corresponding coupling face is a rubber-elastic material.

14. The apparatus according to claim 1, wherein each said measuring insert comprises:

a fixed part for receiving and containing the transducers; and

an element resiliently mounted with respect to said fixed part for affixing the fixed part to the measuring insert.

15. The apparatus according to claim 1, wherein said evaluating means further includes means for determining the flow rate through said blood circuitry employing the Doppler effect.

16. The apparatus for the extracorporeal treatment of blood, comprising:

an extracorporeal blood circuit which is formed by a blood tubing system;

means for dialyzing, filtering or both located in said extracorporeal blood circuit;

a first ultrasonic flow sensor located in said extracorporeal blood circuit upstream of the dialyzing and filtering means, comprising;

a first dimensionally stable measuring insert inserted into the blood tubing system having a defined flow cross-section and lateral extensions for coupling-in and coupling-out and conducting of ultrasonic waves, each said extension having at one end a coupling face;

first ultrasonic transducers with piezoelectric transducer element having coupling pieces connected thereto and disposed such that each said coupling piece is in mechanical engagement with a corresponding coupling face;

a second ultrasonic flow sensor located in said extracorporeal blood circuit downstream of the dialyzing and filter means, comprising;

a second dimensionally stable measuring insert inserted into the blood tubing system having a defined flow cross-section and lateral extensions for coupling-in and coupling-out and conducting of ultrasonic waves, each said extension having at one end a coupling face;

second ultrasonic transducers with piezoelectric transducer elements having coupling pieces connected thereto and disposed such that each said coupling piece is in mechanical engagement with a corresponding coupling face;

first evaluating means connected to the first and second flow sensors, comprising;

means for determining the difference between the flow rate through said first flow sensor and said second flow sensor;

means for forming the time integral of the difference of the flow rates;

means for displaying from said determining means the amount of fluid withdrawn from a patient per unit time and the total amount of fluid withdrawn from a patient;

withdrawal control means for controlling the withdrawal of fluid from the extracorporeal blood circuit via the dialyzer or filter means, based on said evaluating operations;

infusion control means connected to said blood circuit for controlling the infusion into said blood circuit of an infusion solution; and

second evaluating means for performing predetermined evaluating operations for automatic control of said infusion control means.

17. The apparatus according to claim 16, further comprising:

display means connected to said infusion control means for indicating and limit-value monitoring of the supply rate of the infusion solution.

18. The apparatus according to claim 16, further comprising:

automatic periodic calibration means connected to the evaluating means, comprising;

calibration control means;

a plurality of valves for isolating the dialyzing and filtering means from the blood circuit controlled by said calibration means;

said evaluating means for determining the difference of measurement between signals issuing from the first flow sensor and said second flow sensor and for determining therefrom a zero point correction, the evaluating means further comprising;

means for storing said difference of measurement signals and the zero point correction corresponding to the magnitude of said difference of measurement signals.

19. An apparatus for the extracorporeal treatment of blood, comprising:

an extracorporeal blood circuit which is formed by a blood tubing system;

means for dialyzing, filtering or both located in said extracorporeal blood circuit including a first chamber through which blood flows and a second chamber through which dialysis fluid or withdrawal of filtrate flows, the first and second chambers separated by a semipermeable membrane across which a transmembrane pressure differential is maintained;

a first ultrasonic flow sensor located in said extracorporeal blood circuit upstream of the dialyzing and filtering means, comprising;

a first dimensionally stable measuring insert inserted into the blood tubing system having a defined flow cross-section and lateral extensions for coupling-in and coupling-out and conducting of ultrasonic waves, each said extension having at one end a coupling face;

second ultrasonic transducers with piezoelectric transducer elements having coupling pieces connected thereto and disposed such that each said coupling piece is in mechanical engagement with a corresponding coupling face;

a second ultrasonic flow sensor located in said extracorporeal blood circuit downstream of the dialyzing and filter means, comprising;

a second dimensionally stable measuring insert inserted into the blood tubing system having a defined flow cross-section and lateral extensions for coupling-in and coupling-out and conducting of ultrasonic waves, each said extension having at one end a coupling face;

second ultrasonic transducers with piezoelectric transducer elements having coupling pieces connected thereto and disposed such that each said coupling piece is in mechanical engagement with a corresponding coupling face;

first evaluating means connected to the first and second flow sensors, comprising;

means for determining the difference between the flow rate through said first flow sensor and said second flow sensor;

means for forming the time integral of the difference of the flow rates;

means for displaying from said determining means the amount of fluid withdrawn from a patient per unit time and the total amount of fluid withdrawn from a patient;

withdrawal control means for controlling the withdrawal of fluid from the extracorporeal blood circuit via the dialyzer or filter means, based on said evaluating operations;

pressure control means connected to the first evaluating means for automatic setting of the transmembrane pressure; and

a drive-motor actuated throttle connected to the pressure control means and located downstream of the filtering and dialyzing means for controlling fluid flow through the blood circuit.

20. The apparatus according to claim 19, further comprising:

display means connected to said pressure control means for indicating and limit-value monitoring the transmembrane pressure.

21. The apparatus according to claim 20, wherein said display means is adapted to display and limit-value monitor the position of the drive motor actuating the throttle.

22. The apparatus according to claim 19, further comprising:

automatic periodic calibration means connected to the evaluating means, comprising;

calibration control means;

a plurality of valves for isolating the dialyzing and filtering means from the blood circuit controlled by said calibration means;

said evaluating means for determining the difference of measurement between signals issuing from the first flow sensor and said second flow sensor and for determining therefrom a zero point correction, the evaluating means further comprising;

means for storing said difference of measurement signals and the zero point correction corresponding to the magnitude of said difference of measurement signals.