Hemodialysis apparatus

• US 4,267,040 A
• Filed: 08/24/1979
• Issued: 05/12/1981
• Est. Priority Date: 09/02/1978
• Status: Expired due to Term

• Current Assignee: Dr Eduard Fresenius Chemisch-Pharmazeutische Industrie KG Apparatebau KG
• Original Assignee: Dr Eduard Fresenius Chemisch-Pharmazeutische Industrie KG Apparatebau KG
• Inventors: Schal, Wilfried
• Primary Examiner(s): Castel, Benoit
• Assistant Examiner(s): Sadowski, David R.
• Application Number:
  US06/069,387
• Time in Patent Office: 627 Days
• Field of Search: 210/96.2, 210/104, 210/137, 210/149, 210/188, 210/195.2, 210/257.2, 210/321 A, 210/321 B, 210/433 M, 210/416, 210/258, 137/99
• US Class Current: 210/104
• 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 1/1609 after use, i.e. downstream of dialyser
• CPC Class Codes: A61M 1/1639 linked by membranes
• CPC Class Codes: A61M 1/1692 Detection of blood traces in dialysate
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3379 Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/705 Testing of filters for leaks blood in dialysate A61M1/1692
• CPC Class Codes: Y10S 210/929 Hemoultrafiltrate volume measurement or control processes

Abstract

The ultra-filtration in a hemodialysis operation is controlled by a control apparatus which is connected to a balancing device (1) and to a dosing device (9) to form a closed loop control circuit for the metered supply of dialysis concentrate into the balancing device and for the metered supply of fresh dialysis solution into the dialyzer. The closed loop control circuit controls the alternating supply of fresh dialysis solution into one chamber of a balancing device and the withdrawal of used-up dialysis solution from the other chamber of the balancing device. The closed loop control circuit also controls a pump for the metered withdrawal of used-up dialysis solution out of the dialysis circulatory system. The dosing device operates as a proportionality device to produce fresh dialysis solution from water and dialysis concentrate whereby the concentrate is dosed and the dialysis solution is also dosed or metered.

Claims

1. A hemodialysis apparatus, comprising:

(a) dialyzer means, and dialysis solution supply means,

(b) balancing chamber means having a defined volume

(c) sealing means movably supported in said defined volume, said sealing means separating said defined volume into two chamber components each having respective inlet and outlet means said inlet and outlet means being operatively connected to said dialyzer means and to said dialysis solution supply means,

(d) controllable valve means operatively connected to said inlet and outlet means for controlling the inflow to and the outflow from said chamber components,

(e) control means operatively connected to said controllable valve means for supplying, in a first operational phase, fresh dialysis solution into one of said chamber components while discharging used dialysis solution from the other chamber component, and for transferring, in a second operational phase fresh dialysis solution from said one chamber component into said dialyzer while supplying used dialysis solution from the dialyzer into said other chamber component,

(f) sensor means operatively arranged for sensing end positions of said sealing means, said sensor means being operatively connected to said control means, for controlling the sequencing of said first and second operational phases and vice versa in response to said sealing means reaching its end positions,

(g) adjustable means (7) operatively connected to said dialyzer means for withdrawing measured quantities of ultrafiltrate from said dialyzer means, and indicator means connected to said withdrawing means for indicating the quantity of withdrawn ultrafiltrate,

(h) said dialysis solution supply means including mixing means connected to a source of water and a source of dialysis concentrate and having an output operatively connected to said one chamber component for filling the latter,

(i) dosing means operatively connected to said mixing means for supplying said dialysis concentrate to said mixing means, said control means being also operatively connected to said dosing means for controlling the dosing means also in response to said sealing means reaching its end positions,

(j) and means operatively connected to said hemodialysis apparatus for monitoring the concentration of said dialysis solution.

2. The apparatus of claim 1, wherein said sealing means comprise flexible membrane means dividing the balancing chamber means into said chamber components which are hermetically sealed from each other by the flexible membrane means, said flexible membrane means being passively displaceable so that one chamber component increases in its volume while the other chamber component correspondingly decreases in its volume and vice versa.

3. The apparatus of claim 1, wherein each of said chamber components comprises an energy storing element for filling said dialyzer in response to a counter pressure.

4. The apparatus of claim 1, wherein said two chamber components are duplicated and arranged to form a push-pull circulatory system for continuously flowing dialysis solution through said dialyzer means.

5. The apparatus of claim 4, wherein said end position sensor means are pressure responsive sensor means, operatively arranged for providing a control signal for controlling the push-pull operation of said push-pull circulatory system.

6. The apparatus of claim 1, further comprising temperature control means operatively arranged for maintaining the temperature of the dialysis solution.

7. The apparatus of claim 6, wherein said temperature control means maintain a uniform temperature for the fresh dialysis solution and for the used dialysis solution upstream of the other chamber component between said dialyzer means and said other chamber component.

8. The apparatus of claim 6, wherein said temperature control means comprise first temperature sensor means (T₁) at the inlet means of said one chamber component, second temperature sensor means (T₃) at the outlet of said dialyzer means, heating means (H₁) operatively arranged to heat the fresh dialysis solution, closed loop control means (28) operatively connected to said heating means (H₁) and to said first and second temperature sensing means for controlling the temperature of the fresh dialysis solution so that the temperature difference (T₃ -T₁) is as small as possible, and second heating means (H₂), further temperature sensing means (T₂) and further control means (27) operatively arranged to maintain the temperature of the fresh dialysis solution at the body temperature of a patient.

9. The apparatus of claim 6, wherein said temperature control means comprise first temperature sensor means (T₁) at the inlet of said one chamber component, said first temperature sensor means producing a first temperature-output signal, second temperature sensor means (T₃) at the outlet of said dialyzer means, said second temperature sensor producing a second temperature output signal computer circuit means operatively connected to receive said output signals of said first and second temperature sensor means and to receive a signal (Q_D) corresponding to the dialysis solution flow in grams per minute to calculate a correction value Δ

m which is equal to;

space="preserve" listing-type="equation">Δ

m=a·

Q.sub.D (T.sub.3 -T.sub.1)β

wherein a is a constant and wherein β

is the cubic expansion coefficient of the dialysis solution and T₃ -T₁ is the temperature difference, said computer circuit means being operatively connected to said adjustable means (7) for controlling the quantity of withdrawn ultrafiltrate.

10. The apparatus of claim 1, further comprising a supply system for providing degassed dialysis solution, said supply system comprising a flow circuit including pump means (54), air separator means (56), pressure maintaining valve means (61), flow impedance means (55) arranged in sequence in the mentioned order in the throughflow direction, supply conduit means for feeding not yet degassed, fresh dialysis solution into the supply system, said supply conduit means being operatively connected to the junction between said pressure maintaining valve means and said flow impedance means, further conduit means operatively connecting said air separator means (56) to said balancing chamber means, and wherein said flow impedance means (55) has a value such that at the inlet of said pump means (54) a high negative pressure is maintained, said pressure maintaining valve means being so adjusted that in said further conduit means a positive pressure relative to atmospheric pressure is maintained.

11. The apparatus of claim 1 or 10, further comprising air separator means (47) operatively connected to the output of said dialyzer means (4), filling level sensor means (49) operatively connected to said air separator means (47), valve means (48) operatively connected to an outlet of said air separator means (47) and air discharge conduit means (68) operatively connected to said air separator means through said valve means (48), said valve means (48) being operatively responsive to said filling level sensor means (49).

12. The apparatus of claim 11 as dependent on claim 10, wherein said air discharge conduit means (68) are operatively connected to an inlet of said pump means (54).

13. The apparatus of claim 10, further comprising heater means (58) operatively connected to said flow circuit of elements (54, 55 56, 61), temperature sensor means (59), temperature control means (60) operatively connected to said heater means (58) and to said temperature sensor means for controlling the temperature of the degassed, fresh dialysis solution.

14. The apparatus of claim 11, wherein said filling level sensor means (49) comprise timer means for producing a control signal when the filling level in said air separator means has remained at a too low level in excess of a predetermined length of time, said apparatus comprising further valve means (69) connecting said air separator means (47) to a discharge conduit (57) of the system, said further valve means (69) being operatively responsive to said control signal from said timer means whereby the outlet of the dialyzer (4) is operatively connected to said discharge conduit (57), said apparatus comprising additional valve means operatively interposed at said inlet and outlet means of said balancing chamber components, said additional valve means being so controlled in response to said timer control signal that fresh dialysis solution may be supplied to the inlet of said dialyzer means.