Apparatus for use in artificial kidney system

• US 4,153,554 A
• Filed: 02/22/1977
• Issued: 05/08/1979
• Est. Priority Date: 02/22/1977
• Status: Expired due to Term

• Current Assignee: American Micro-Bionics Corporation
• Original Assignee: American Micro-Bionics Corporation
• Inventors: von der Heide, Jack, McLeod, Murray R., Edelman, Robert J.
• Primary Examiner(s): Hart, Charles N.
• Assistant Examiner(s): Sadowski, David R.
• Application Number:
  US05/770,789
• Time in Patent Office: 805 Days
• Field of Search: 210/321 B, 210/85, 210/321 HT, 210/87, 210/90, 210/96 M, 210/195 R, 210/194, 210/197, 210/22, 210/137, 210/135
• US Class Current: 210/96.2
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1605 Physical characteristics of the dialysate fluid
• CPC Class Codes: A61M 1/165 with a dialyser bypass on the dialysis fluid line
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/1664 with temperature control
• CPC Class Codes: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/169 using chemical substances
• CPC Class Codes: A61M 1/1692 Detection of blood traces in dialysate
• CPC Class Codes: A61M 2205/18 with alarm
• 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 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/50 with microprocessors or computers

Abstract

A machine is disclosed for use with an artificial kidney. The machine has three separately controllable pumps enabling delivery and return of a dialysate solution to an artificial kidney with precise control of various dialysate parameters such as temperature, pressure, conductivity, and flow rate.

The machine has redundant control and monitor circuits to assure safe operation. The monitor circuit is capable of causing the machine to stop dialysis if any one of various monitored parameters goes out of limits.

Claims

1. An apparatus for delivering a dialysate solution to an artifical kidney device comprising:

a hydraulics circuit, the hydraulics circuit having a water supply branch, a dialysate solution supply branch extending from the junction of the water supply branch and the dialysate concentrate supply branch to a port for supplying dialysate solution to an artifical kidney, and a return branch extending from a port through which dialysate solution returns from the artifical kidney to a drain line for passing used dialysate solution out of the hydraulics circuit;

a supply pump disposed in the water supply branch for pumping water into the dialysate solution supply branch at a controlled rate;

means for controllably heating water flowing in the water supply branch;

means downstream from the heating means for deaerating water flowing in the water supply branch;

a concentrate pump disposed in the dialysate concentrate supply branch for pumping dialysate concentrate into the dialysate solution supply branch at a controlled rate;

a return pump disposed in the return branch for drawing effluent dialysate solution from the artifical kidney and pumping the solution out through the drain line;

a first transducer for generating an electrical signal representative of the negative pressure in the return branch upstream from the return pump;

a second transducer for generating an electrical signal representative of arterial pressure in the artificial kidney;

a third transducer for generating an electrical signal representative of venous pressure in the artificial kidney; and

first electrical circuit means for controlling the speed of the return pump in response to the electrical signals from the first, second and third transducers in a combination representative of transmembrane pressure such that the speed of the return pump maintains a predetermined transmembrane pressure in the artifical kidney.

2. The apparatus of claim 1 further comprising:

a concentrate inlet line joining the dialysate concentrate supply branch upstream from the concentrate pump for drawing dialysate concentrate from a container;

a concentrate outlet line for returning unused dialysate concentrate to the container;

an interconnecting branch joining the concentrate outlet line to the dialysate concentrate supply line at a point in the dialysate concentrate supply line downstream from the concentrate pump; and

means for restricting the flow of dialysate concentrate through the interconnecting branch such that a predetermined fraction of the dialysate concentrate passing through the concentrate pump is injected into the water flowing from the water supply branch into the dialysate solution supply branch while the remaining dialysate concentrate passing through the concentrate pump is returned to the container through the concentrate outlet line.

3. The apparatus of claim 1 further comprising:

means for generating an electrical signal representative of the conductivity of the dialysate solution flowing in the dialysate solution supply branch;

electrical circuit means for controlling the speed of the concentrate pump in response to the electrical signal from the generating means to provide a flow of dialysate solution of a predetermined conductivity; and

means for manually adjusting the predetermined conductivity value within a defined range of compensate for ions in the water supply.

4. The apparatus of claim 1 further comprising:

a mixing chamber disposed in the dialysate solution supply branch for damping conductivity variations in the flowing dialysate solution;

a first conductivity cell disposed in the dialysate solution supply branch upstream from the mixing chamber;

second electrical circuit means for controlling the speed of the concentrate pump in response to a signal from the first conductivity cell to regulate the conductivity of the dialysate solution;

a second conductivity cell disposed in the dialysate solution supply branch downstream from the mixing chamber; and

third electrical circuit means for comparing a signal from the second conductivity cell to predetermined limits and initiating commands for selectively controlling the delivery or nondelivery of dialysate solution from the apparatus to the artifical kidney device in response to the comparisons made.

5. The apparatus of claim 4 wherein the mixing chamber includes an inlet at an upstream end of the chamber, an outlet at a downstream end of the chamber, a tubular member disposed within the chamber and having a plurality of orifices disposed along its length, an open end of the tubular member being in fluid communication with the inlet, whereby dialysate solution flows through the inlet into the tubular member and then through the orifices into the chamber and then out through the outlet.

6. The apparatus of claim 4 further comprising:

a bypass line extending from a connection point on the dialysate solution supply branch to a connection point on the return branch; and

electrically actuable valve means at the connection of the dialysate solution supply branch and the bypass line for automatically diverting the flow of dialysate solution from the dialysate solution supply branch to the return branch in order to bypass the artificail kidney, the valve means being responsive to a command from the third electrical circuit means indicating that the conductivity of the dialysate solution is out of limits;

wherein the return pump is controlled such that it runs in synchronization with the supply pump when dialysate solution is flowing through the bypass line or when dialysate solution is flowing out to an artificial kidney coincident with a STERILIZE or PURGE command, but is servo-controlled by the first electrical circuit mmeans when dialysate solution is flowing out to an artificial kidney coincident with a RUN command.

7. The apparatus of claim 6 further comprising means for manually controlling the speed of the supply pump to achieve a desired flow rate.

8. The apparatus of claim 1 further comprising means for selectively controlling a blood pump to start blood flowing into the artificial kidney in response to an enabling signal from an alarm circuit coincident with RUN and DIALYZE commands from a control panel.

9. The apparatus of claim 1 further comprising a control panel, the panel including at least one electronic readout device, means for setting various parameter limits, and a switch for selectively displaying any one of several parameter readings or parameter limit settings on the readout device.

10. The apparatus of claim 1, wherein the deaerating means comprises:

a float tank upstream from the supply pump for containing controlled volume of water;

means for pulling a partial vacuum on the float tank to remove air bubbles from the water;

a deaerator downstream from the supply pump for removing additional air bubbles from the water;

a line interconnecting the top of the deaerator to the top of the float tank to permit air flow from the deaerator to the float tank; and

a restriction disposed in the interconnecting line for maintaining a positive pressure in the deaerator.

11. The apparatus of claim 10 further comprising:

means disposed in the water supply branch upstream from the heating means for sensing water pressure;

a manually engageable STERILIZE command switch on a panel of the apparatus;

electrical circuit means operable when power is supplied to the apparatus for selectively permitting operation of the heating means and the pumps in response to the sensing means and STERILIZE command switch, such that the heating means and pumps are operable whenever the STERILIZE command switch is disengaged coincident with the sensing means detecting a water pressure above a predetermined minimum level, and such that the heating means is inoperable and the pumps are operable whenever the STERILIZE command switch is engaged regardless of the water pressure detected by the sensing means;

whereby, when the STERILIZE command switch is engaged, the combined suction of the supply pump and the means for pulling partial vacuum on the float tank enable cleansing fluid to be rapidly drawn into the water supply branch through an inlet line interconnecting the upstream end of the water supply branch and an unpressurized container of cleansing fluid.

12. A system for dialyzing the blood of a kidney-failure patient, comprising:

an artificial kidney including entry and return lines for the patient'"'"'s blood, a bottom portion including inlet means for receiving dialysate solution and a top portion for permitting dialysate solution to flow out in a fountain-like manner;

a device for developing a negative pressure on the dialysate solution flowing through the artificial kidney, the device including a tank for isolating the artificial kidney from the atmosphere, means for holding the artificial kidney in an upright position in the tank, a dialysate input line for supplying dialysate solution to the bottom of the artificial kidney, a standpipe in the tank having an open top for draining the dialysate solution thereby permitting the dialysate solution to form and maintain a reservoir of a predetermined height below the top of the artificial kidney in the tank, means for recirculating dialysate solution from the reservoir back through the artifical kidney, and vacuum seal means for permitting ingress and egress of the various fluid carrying lines through the walls of the tank; and

a dialysate delivery machine including means for controllably proportioning water and dialysate concentrate to provide dialysate solution, means in fluid communication with the recirculating means for delivering dialysate solution from the machine to the artificial kidney, means in fluid communication with the bottom of the standpipe for returning the overflow of dialysate solution from the standpipe to the machine, a return pump for drawing air and dialysate solution from the tank through the standpipe, the return pump being capable of developing a negative pressure in the tank, and means for regulating the negative pressure in the return line within defined limits thereby maintaining a desired value of negative pressure in the tank.

13. An apparatus for delivering a dialysate solution to an artificial kidney device comprising:

a hydraulics circuit, the hydraulics circuit having a water supply branch, a dialysate concentrate supply branch joined at one end to the water supply branch, a dialysate solution supply branch extending from the junction of the water supply branch and the dialysate concentrate supply branch to a port for supplying dialysate solution to an artificial kidney, and a return branch extending from a port through which dialysate solution returns from the artificial kidney to a drain line for passing used dialysate solution out of the hydraulics circuit;

a supply pump disposed in the water supply branch for pumping water into the dialysate solution supply branch at a controlled rate;

a concnetrate pump disposed in the dialysate concentrate supply branch for pumping dialysate concentrate into the dialysate solution supply branch at a controlled rate;

a return pump disposed in the return branch for drawing effluent dialysate from the artificial kidney and pumping the solution out through the drain line;

a mixing chamber disposed in the dialysate solution supply branch for damping conductivity variations in the flowing dialysate solution;

a first conductivity cell disposed in the dialysate solution supply branch upstream from the mixing chamber;

electrical circuit means for controlling the speed of the concentrate pump in response to a signal from the first conductivity cell to regulate the conductivity of the dialysate solution;

a second conductivity cell disposed in the dialysate solution supply branch downstream from the mixing chamber; and

electrical circuit means for comparing a signal from the second conductivity cell to predetermined limits and initiating commands for selectively controlling the delivery or nondelivery of dialysate solution from the apparatus to the artifical kidney device in response to the comparisons made.

14. The apparatus of claim 13 wherein the mixing chamber includes an inlet at an upstream end of the chamber, an outlet at a downstream end of the chamber, a tubular member disposed within the chamber and having a plurality of orifices disposed along its length, an open end of the tubular member being in fluid communication with the inlet, whereby dialysate solution flows through the inlet into the tubular member and then through the orifices into the chamber and then out through the outlet.