Portable hemodialysis system

• US 4,083,777 A
• Filed: 09/07/1976
• Issued: 04/11/1978
• Est. Priority Date: 09/07/1976
• Status: Expired due to Term

• Current Assignee: Union Carbide Corporation (Dow, Inc.)
• Original Assignee: Union Carbide Corporation (Dow, Inc.)
• Inventors: Hutchisson, James Thomas
• Primary Examiner(s): Spear, Jr., Frank A.
• Assistant Examiner(s): Sadowski, David R.
• Application Number:
  US05/720,672
• Time in Patent Office: 581 Days
• Field of Search: 210/416 M, 210/22, 210/96 M, 210/195 R, 210/321 B, 210/85, 210/87
• US Class Current: 210/646
• CPC Class Codes: A61M 1/153 the cassette being adapted for heating or cooling the treating fluid, e.g. the dialysate or the treating gas
• CPC Class Codes: A61M 1/154 with sensing means or components thereof
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1605 Physical characteristics of the dialysate fluid
• CPC Class Codes: A61M 1/1649 with pulsatile dialysis fluid flow
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/1664 with temperature control
• CPC Class Codes: A61M 1/1692 Detection of blood traces in dialysate
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/3607 Regulation parameters
• CPC Class Codes: A61M 2205/103 rotating
• CPC Class Codes: A61M 2205/15 Detection of leaks
• 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 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3365 Rotational speed
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2230/65 Impedance, e.g. conductivity, capacity

Abstract

A portable hemodialysis system wherein blood and dialysate are pumped in the extracorporeal flow circuit by peristaltic compression of the blood and dialysate flow lines to provide high frequency pulsatile flows in the respective fluid lines. The pulsatile flows of blood and dialysate are passed through the dialyzer to reduce fluid film mass transfer resistance therein and enhance the dialyzing efficiency of the hemodialysis system.

Claims

1. In a hemodialysis apparatus for treatment of blood to remove waste impurities therefrom, including:

dialyzer means through which waste impurity containing blood and a dialysate solution are passed in indirect mass transfer dialyzing relationship for transfer of said waste impurities from said blood to said dialysate solution;

means for transferring waste impurity-containing blood from a patient to said dialyzer means including a flexible resiliant tubing pumping section through which blood is pumped and means for returning waste impurity-depleted blood to said patient forming a blood flow circuit;

peristaltic pump means with a rotatable pump head assembly including a base member positioned for rotation about a fixed axis with a plurality of circumferentially spaced apart rollers mounted thereon for independent rotation about respective axes parallel to the base member fixed axis;

means for anchoring the end segments of the flexible resiliant tubing pumping section such that the tubing is tensionally extended around the pump head assembly, being simultaneously engaged and compressed by at least two of said circumferentially spaced apart rollers with at least partial closure of the tubing at the points of compression, said rollers being mounted for longitudinal movement of the points of compression along the tubing during rotation of said pump head assembly to advance blood through said tubing;

means for supplying dialysate solution to said dialyzer means; and

means for discharging waste impurity-enriched dialysate solution from said dialyzer means the improvement wherein said peristaltic pump means comprises three rollers mounted on said base member, each having a diameter of between 0.25 and 0.75 inch and circumferentially spaced 120°

apart from the others with a radial distance between the roller axis and said base member fixed axis of from 0.50 to 1.25 inches;

said flexible resiliant tubing pumping section has a length, as measured longitudinally along the tubing between the anchored end segments thereof, of from 6.0 to 6.75 inches, a wall thickness of from 0.03 to 0.10 inch, and an internal diameter of from 0.18 to 0.25 inch; and

drive means coupled to said pump head assembly for rotation thereof at a speed in the range of from 50 to 400 rpm.

2. Apparatus according to claim 1 wherein the flexible resiliant tubing pumping section is formed of a silicone elastomer.

3. Apparatus according to claim 1 wherein said drive means are coupled to said pump head assembly for rotation thereof at a speed in the range of from 180 to 240 rpm.

4. Apparatus according to claim 1 wherein said dialyzer means is of the parallel flow hollow fiber type comprising a bundled array of said hollow fibers through which said waste impurity-containing blood is passed in countercurrent flow relationship with the dialysate solution flowing through said bundled array along the exterior surfaces of said hollow fibers.

5. Apparatus according to claim 1 wherein said means for supplying dialysate solution to said dialyzer means comprises a dialysate solution supply container formed of flexible collapsible material with a volume of between 10 and 30 liters.

6. Apparatus according to claim 1 wherein said dialysate solution supply and discharge means comprise a dialysate solution flow circuit joined to said dialyzer means including a flexible resiliant tubing pumping section through which dialysate solution is pumped, with further peristaltic pump means coupled to said flexible resiliant tubing section in the dialysate solution flow circuit in the same manner as the peristaltic pump in the blood flow circuit.

7. Apparatus according to claim 6 wherein said further peristaltic pump means and said flexible resiliant tubing section in said dialysate solution flow circuit are dimensionally sized identically with said peristaltic pump means and said flexible resiliant tubing section in said blood flow circuit, with drive means coupled to the pump head assembly of said further peristaltic pump means for rotation thereof at a speed in the range of from 200 to 600 rpm, to induce pulsatile flow in the dialysate solution being advanced through the flexible resiliant tubing pumping section of the dialysate solution flow circuit and passed through said dialyzer means.

8. Apparatus according to claim 7 wherein said drive means are coupled to said pump head assembly of said further peristaltic pump means for rotation thereof at a speed of from 450 to 500 rpm.

9. Apparatus according to claim 1 wherein said dialysate solution supply and discharge means comprise a closed loop dialysate flow circuit joining said dialyzer means with a dialysate solution supply container, for batch recirculation of said dialysate solution through said dialyzer means.

10. Apparatus according to claim 9 comprising adsorbent filter means disposed in said dialysate solution flow circuit downstream from said dialyzer means for removal of waste impurities from said waste impurity-enriched dialysate solution discharged from said dialyzer means.

11. Apparatus according to claim 1 wherein said dialysate solution supply means comprise a dialysate solution flow circuit portion upstream of said dialyzer means in which are disposed:

means for heating said dialysate solution;

means for sensing the temperature of said dialysate solution positioned downstream from said heating means and for adjusting the rate of heating of said dialysate solution by said heating in response to said temperature sensing to maintain a predetermined dialysate solution temperature level; and

means for sensing the electrolytic conductivity of said dialysate solution.

12. Apparatus according to claim 11 wherein said dialysate solution supply and discharge means comprise a closed loop dialysate flow circuit joining said dialyzer means with a dialysate solution supply container, for batch recirculation of said dialysate solution through said dialyzer means and wherein means for detecting blood leakage are disposed in said dialysate solution flow circuit portion upstream of said dialyzer means.

13. Apparatus according to claim 11 comprising:

means for converting said dialysate solution temperature sensing into a transmittable signal;

means for transmitting said temperature sensing signal;

visual display means coupled with said temperature sensing means by said signal transmitting means for indication of said sensed dialysate solution temperature;

means for converting said dialysate solution electrolytic conductivity into a transmittal signal;

means for transmitting said electrolytic conductivity sensing signal; and

visual display means coupled with said electrolytic conductivity sensing means by said conductivity signal transmitting means for indication of said sensed dialysate solution electrolytic conductivity.

14. Apparatus according to claim 13 further comprising:

audio alarm means coupled with said temperature sensing signal transmitting means and with said conductivity sensing signal transmitting an audible alarm when the sensed dialysate solution temperature or conductivity exceeds a predetermined value; and

means responsive to said audio alarm means for deactivating said peristaltic pump means in said blood flow circuit upon the emission of said audible alarm.

15. In a hemodialysis apparatus for treatment of blood to remove waste impurities therefrom, including:

dialyzer means through which waste-impurity containing blood and a dialysate solution are passed in indirect mass transfer dialyzing relationship for transfer of said waste impurities from said blood to said dialysate solution;

means for transferring waste impurity-containing blood from a patient to said dialyzer means including a flexible resiliant tubing pumping section through which blood is pumped and means for returning waste impurity-depleted blood to said patient forming a blood flow circuit;

means for transferring dialysate solution to said dialyzer means and means for discharging waste impurity-enriched dialysate solution from said dialyzer means forming a dialysate solution flow circuit including a flexible resiliant tubing pumping section through which dialysate solution is pumped;

dual peristaltic pump means each with a rotatable pump head assembly including a base member positioned for rotation about a fixed axis with a plurality of circumferentially spaced apart rollers mounted thereon for independent rotation about respective axes parallel to the base member fixed axis;

means for anchoring the end segments of the flexible resiliant tubing pumping sections in said blood flow circuit and said dialysate solution flow circuit such that the tubing in each circuit is tensionally extended around the pump head assembly of one of said peristaltic pump means and is simultaneously engaged and compressed by at least two of said circumferentially spaced apart rollers of the peristaltic pump means for said circuit with at least partial closure of the tubing at the points of compression, the rollers of each peristaltic pump means being mounted for longitudinal movement of the points of compression along the associated tubing during rotation of said pump head assembly to advance fluid through said tubing;

the improvement wherein each of said peristaltic pump means comprises three rollers mounted on said base member, each having a diameter between 0.25 and 0.75 inch and circumferentially spaced 120°

apart from the others with a radial distance between the roller axis and said base member fixed axis of from 0.50 to 1.25 inches, said flexible resiliant tubing pumping sections in the blood and dialysate flow circuits each have a length, as measured longitudinally along the tubing between the anchored end segments thereof, of from 6.0 to 6.75 inches, a wall thickness of from 0.03 to 0.10 inch, and an internal diameter of from 0.18 to 0.25 inch;

drive means coupled to the pump head assembly of the peristaltic pump means in the blood flow circuit for rotation thereof at a speed in the range of from 50 to 400 rpm; and

drive means coupled to the pump head assembly of the peristaltic pump means in the dialysate solution flow circuit for rotation thereof at a speed in the range of from 200 to 600 rpm.

16. Apparatus according to claim 15 wherein said dialysate solution flow circuit has associated therewith means for heating said dialysate solution;

means for sensing the temperature of said dialysate solution and adjusting the rate of heating of said dialysate solution by said heating means in response to said temperature sensing to maintain a predetermined dialysate solution temperature level;

means for converting said dialysate solution temperature sensing into a transmittable signal;

means for transmitting said temperature sensing signal;

visual display means coupled with said temperature sensing means by said signal transmitting means for indication of said sensed dialysate solution temperature;

means for sensing the electrolytic conductivity of said dialysate solution;

means for converting said dialysate solution electrolytic conductivity into a transmittable signal;

means for transmitting said electrolytic conductivity sensing signal; and

visual display means coupled with said electrolytic conductivity sensing means by said conductivity signal transmitting means for indication of said sensed dialysate solution electrolytic conductivity;

audio alarm means coupled with said temperature sensing signal transmitting means and with said conductivity sensing signal transmitting means and arranged for emitting an audible alarm when the sensed dialysate solution temperature or conductivity exceeds a predetermined value; and

means for detecting blood leakage into said dialysate solution flow circuit, wherein said dual peristaltic pump means, anchoring means, pump drive means, and said means associated with said dialysate solution flow circuit are mounted for service in a unitary enclosure.

17. In a method of hemodialysis for treatment of blood to remove waste impurities therefrom in a dialyzer means joined to a patient by a closed loop blood flow circuit and to a dialysate solution source by a dialysate flow circuit, including the steps of:

withdrawing waste impurity-containing blood from said patient;

peristaltically pumping said withdrawn waste impurity-containing blood upstream of said dialyzer means, whereby blood is advanced through said blood flow circuit;

passing said waste impurity-containing blood and said dialysate solution through said dialyzer means in indirect mass transfer dialyzing relationship for transfer of said waste impurities from said blood to said dialysate solution;

discharging waste impurity-enriched dialysate solution from said dialyzer means; and

returning waste impurity-depleted blood from said dialyzer means through said blood flow circuit to said patient, the improvement of producing a pulsatile flow in said waste impurity-containing blood withdrawn from said patient by said peristaltic pumping having a frequency of between 150 and 1200 cycles/minute whereby said pulsatile flow of blood is passed through said dialyzer means to reduce blood film mass transfer resistance therein.

18. A method according to claim 17 wherein said pulsatile blood flow has a frequency of between 300 and 600 cycles/minute.

19. A method according to claim 17 wherein said waste impurity-enriched dialysate solution discharged from said dialyzer means is returned to said dialysate solution source, for batch recirculation through said dialyzer means.

20. A method according to claim 17 comprising peristaltically pumping dialysate solution in said dialysate flow circuit to produce a pulsatile flow of said dialysate solution therein having a frequency of between 400 and 1200 cycles/minutes.