Hemodialysis system with modular dialysate manifold assembly

• US 4,079,007 A
• Filed: 09/07/1976
• Issued: 03/14/1978
• 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): Cross, E. Rollins
• Application Number:
  US05/720,673
• Time in Patent Office: 553 Days
• Field of Search: 210/85, 210/87, 210/94, 210/96 M, 210/186, 210/321 B
• US Class Current: 210/85
• 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 1/1664 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 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 PH measuring means
• CPC Class Codes: A61M 2205/3365 Rotational speed
• CPC Class Codes: A61M 2205/3368 Temperature

Abstract

A hemodialysis system comprising a modularized dialysate flow circuit manifold assembly. The manifold assembly is detachably secured in the hemodialysis system for ready replacement, whereby cross-contamination problems associated with multiple patient use of the system may be simply eliminated by the dedication of a manifold assembly to each patient.

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 supplying waste impurity-containing blood from a patient to said dialyzer means;

means for returning waste impurity-depleted blood to said patient; and

means for supplying dialysate solution to said dialyzer means and means for discharging waste impurity-enriched dialysate solution from said dialyzer means forming a dialysate flow circuit, the improvement wherein said dialysate flow circuit includes a modularized dialysate solution manifold assembly and tubing segments for flowing dialysate solution to and discharging dialysate solution from said manifold assembly, said manifold assembly comprising;

(a) a base support plate member with main flat top and bottom surfaces having spaced-apart dialysate solution inlet and outlet openings therein, with coupling means associated with said inlet and outlet openings on the main top surface of said base support plate member for detachably joining the manifold assembly with said dialysate solution tubing segments;

(b) means positioned on the main bottom surface of said base support plate member comprising a tubular passage having an inlet end communicating with said dialysate solution inlet opening for flow of dialysate solution therethrough to an outlet end of said tubular passage and means for heating said dialysate solution in said tubular passage to form warm dialysate solution;

(c) means for sensing the temperature of said warm dialysate solution positioned downstream from said heating means and for 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;

(d) a flow enclosure means positioned on the main bottom surface of said base support plate member containing a dialysate solution flow passage having an inlet joined to the outlet end of said tubular passage of (b) and having an outlet communicating with said dialysate solution outlet opening for flow of dialysate solution therethrough, with monitor sensing means positioned in said dialysate solution flow passage including;

means for detecting blood leakage into said dialysate solution, means for sensing the electrolytic conductivity of said dialysate solution, and means for sensing said dialysate solution temperature,

the apparatus being constructed such that said manifold assembly may readily be detached from said dialysate solution tubing segments and separably removed from the remainder of said hemodialysis apparatus.

2. Apparatus according to claim 1 wherein said dialysate solution temperature sensing means of (c) is positioned in said dialysate solution flow passage of (d).

3. Apparatus according to claim 1 wherein said means for heating said dialysate solution comprise an insulated resistance heating strip means wound around said tubular passage.

4. Apparatus according to claim 1 further comprising:

means for converting said temperature sensing of means (d) 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 sensed 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.

5. Apparatus according to claim 3 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.

6. Apparatus according to claim 1 wherein said means for supplying waste impurity-containing blood from a patient to said dialyzer means include a flexible resiliant tubing pumping section through which blood is pumped, with said blood supplying means and said means for returning waste impurity-depleted blood to said patient forming a blood flow circuit, further comprising:

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.

7. 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 assembly to advance fluid through said tubing;

the improvement wherein said dialysate flow circuit includes a modularized dialysate solution manifold assembly and tubing segments of said dialysate solution flow circuit for flowing dialysate solution to and discharging dialysate solution from said manifold assembly, said manifold assembly comprising;

(a) a base support plate member with main flat top and bottom surfaces having spaced-apart dialysate solution inlet and outlet openings therein, with coupling means associated with said inlet and outlet openings on the main top surface of said base support plate number for detachably joining the manifold assembly with said dialysate solution tubing segments;

(b) means positioned on the main bottom surface of said base support plate member comprising a tubular passage having an inlet end communicating with said dialysate solution inlet opening for flow of dialysate solution therethrough to an outlet end of said tubular passage and means for heating said dialysate solution in said tubular passage to form warm dialysate solution;

(c) means for sensing the temperature of said warm dialysate solution positioned downstream from said heating means and for 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;

(d) a flow enclosure means positioned on the main bottom surface of said base support plate member containing a dialysate solution flow passage having an inlet joined to the outlet end of said tubular passage of (b) and having an outlet communicating with said dialysate solution outlet opening for flow of dialysate solution therethrough, with monitor sensing means position in said dialysate solution flow passage including;

means for detecting blood leakage into said dialysate solution, means for sensing the electrolytic conductivity of said dialysate solution, and means for sensing said dialysate solution temperature,

wherein said dual peristaltic pump means, anchoring means, pump drive means, and said modularized dialysate solution manifold assembly are mounted for service in a unitary enclosure, and said modularized dialysate solution manifold assembly is detachably mounted in said unitary enclosure, whereby said manifold assembly may readily be detached from said dialysate solution tubing segments and separably removed from the remainder of said hemodialysis apparatus in said unitary enclosure.