Artificial kidney and method for making same

• US 4,231,871 A
• Filed: 08/07/1978
• Issued: 11/04/1980
• Est. Priority Date: 06/10/1977
• Status: Expired due to Term

• Current Assignee: Cordis Dow Corp.
• Original Assignee: Cordis Dow Corp.
• Inventors: Murphy, William P. Jr., Mather, Frank W. III, Lipps, Bennie J.
• Primary Examiner(s): Spear, Jr., Frank A.
• Application Number:
  US05/931,229
• Time in Patent Office: 820 Days
• Field of Search: 210/321 A, 210/321 B, 210/321 R, 210/96 M, 210/90, 210/87
• US Class Current: 210/87
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00 ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 2205/125 with incorporated filters
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: B01D 63/02 Hollow fibre modules
• CPC Class Codes: B01D 63/021 Manufacturing thereof
• CPC Class Codes: B01D 63/0233 forming the bundle
• CPC Class Codes: B01D 63/032 More than two tube sheets for one bundle
• CPC Class Codes: Y02A 20/131 Reverse-osmosis

Abstract

An improved one-piece, integral hollow fiber artificial kidney and a semi-continuous method for making such kidneys and other apparatus of the hollow fiber separatory-type.

Claims

1. An improved hollow fiber artificial kidney comprising in a one-piece integral construction a jacket member having

(1) spaced apart end portions interconnected by curvilinear portions, said curvilinear portions having portions integral with an exterior surface thereof and at least one of said exterior surface portions extending outwardly from said curvilinear portions for at least a part of the length thereof, said curvilinear portions and said end portions encompassing an inlet blood chamber, a dialysate chamber and an outlet blood chamber, each said chamber being fluid-tight and separated from each other,

(2) a first tubesheet adjacent one end of said curvilinear portions separating said inlet blood chamber from said dialysate chamber,

(3) a second tubesheet adjacent the other end of said curvilinear portions separating said dialysate chamber from said outlet blood chamber,

(4) a multiplicity of hollow fibers embedded in each said first and second tubesheet and extending therebetween, said hollow fibers being semipermeable and the ends of said fibers being open and terminating substantially in the plane of the outer end surface of each said tubesheet thereby providing communications between the interiors of said blood chambers through the passageways in said fibers, said hollow fibers between said tubesheets being within said dialysate chamber,

(5) blood supply means including an integral blood port in communication with said inlet blood chamber for supplying blood thereto,

(6) blood return means including an integral blood port in communication with said outlet blood chamber for removing blood therefrom, and

(7) dialysate means including integral inlet and outlet ports in communication with said dialysate chamber for supplying fresh dialysate to and removing spent dialysate from said dialysate chamber.

2. An improved artificial kidney in accordance with claim 1 wherein at least a portion of said blood supply means consists of integral channel means located in at least one of said exterior surface portions of said jacket member.

3. An improved artificial kidney in accordance with claim 2 wherein at least one of said exterior surface (end and said side) portions is substantially flat.

4. An improved artificial kidney in accordance with claim 1 wherein said blood supply means includes associated means integral with said exterior surface portion for effecting at least one function selected from the functions of

assisting blood flow within said blood supply means, measuring the pressure, temperature and rate of flow of blood therein,

removing gases from said blood,

sampling at least one of the whole blood and the fluid portion of said blood therein,

analyzing and establishing components and acidity of blood therein,

adding materials to blood therein, and for flushing blood from said blood supply means, said artificial kidney and said blood return means.

5. An improved artificial kidney in accordance with claim 4 wherein said blood return means includes associated means integral with said outwardly extending exterior surface portion for effecting at least one function selected from the functions of

detecting bubbles in the blood therein, collecting bubbles in the blood therein, removing bubbles from the blood therein, filtering the blood therein, measuring the pressure, temperature and rate of flow of blood therein, sampling at least one of the whole blood and the fluid portion of said blood therein, analyzing and establishing components and acidity of blood therein, and controlling the pressure of blood therein.

6. An improved artificial kidney in accordance with claim 4 wherein said dialysate means includes associated means integral with said outwardly extending exterior surface portion for effecting at least one function selected from the functions of

detecting blood in said spent diasylate,

analyzing and establishing the components and acidity of dialysate therein, restoring said component concentrations to approximately the concentration of each said component in said fresh dialysate,

restoring said acidity to approximately its initial value, and removing metabolic wastes from said spent dialysate.

7. An improved artificial kidney in accordance with claim 1 wherein at least a portion of said blood return means consists of integral channel means located in at least one of said exterior surface portions of said jacket member.

8. An improved artificial kidney in accordance with claim 7 wherein at least one of said exterior surface portions is substantially flat.

9. An improved artificial kidney in accordance with claim 1 wherein said blood return means includes associated means integral with said outwardly extending exterior surface portion for effecting at least one function selected from the functions of

detecting bubbles in the blood therein,

collecting bubbles in the blood therein,

removing bubbles from the blood therein,

filtering the blood therein,

measuring the pressure, temperature, and rate of flow of blood therein,

sampling at least one of the whole blood and the fluid portion of said blood therein,

analyzing and establishing components and acidity of blood therein, and

controlling the pressure of blood therein.

10. An improved artificial kidney in accordance with claim 9 wherein said dialysate means includes associated means integral with said outwardly extending exterior surface portion for effecting at least one function selected from the functions of

detecting blood in said spent dialysate,

analyzing and establishing the components and acidity of dialysate therein, restoring said component concentrations to approximately the concentration of each said component in said fresh dialysate,

restoring said acidity to approximately its initial value, and removing metabolic wastes from said spent dialysate.

11. An improved artificial kidney in accordance with claim 1 wherein at least a portion of said dialysate means consists of dialysate channel means located in at least one of said exterior surface portions of said jacket members.

12. An improved artificial kidney in accordance with claim 11 wherein at least one of said exterior surface portions is substantially flat.

13. An improved artificial kidney in accordance with claim 1 wherein said dialysate means includes associated means integral with said outwardly extending exterior surface portion for effecting at least one function selected from the functions of

detecting blood in said spent dialysate,

analyzing and establishing the components and acidity of said spent dialysate therein,

restoring said component concentrations to approximately the concentration of each said component in said fresh dialysate,

restoring said acidity to approximately its initial value, and removing metabolic wastes from said spent dialysate.

14. An improved artificial kidney comprising in a one-piece integral construction a jacket member having

(1) end portions spaced apart and interconnected by curvilinear portions, said curvilinear portions and said end portions encompassing an inlet blood chamber, a dialysate chamber and an outlet blood chamber, each said chamber being fluid-tight and separated from each other, and at least one portion extending outwardly from an exterior surface of said curvilinear portions,

(2) a first tubesheet adjacent one end of said curvilinear portions separating said inlet blood chamber from said dialysate chamber.

(3) a second tubesheet adjacent the other end of said curvilinear portions separating said dialysate chamber from said outlet blood chamber,

(4) a multiplicity of hollow fibers embedded in each said first and second tubesheet and extending therebetween,

said hollow fibers having a degree of porosity and the ends of each said fiber being open and terminating substantially in the plane of the outer end surface of each said tubesheet thereby providing communication between the interiors of said blood chambers through the passageways in said fibers, said hollow fibers between said tubesheets being within said dialysate chamber,

(5) blood supply means associated with said inlet blood chamber for supplying blood thereto, said blood supply means including associated means integral with said jacket member for effecting at least one function selected from the functions of assisting blood flow within said blood supply means, measuring the pressure, temperature and rate of fluid motion of said blood therein, removing gases from said blood, sampling at least one of the whole blood and the fluid portion of said blood therein, analyzing and establishing components and acidity of blood therein, adding materials to blood therein, and for flushing blood from said blood supply means, and artificial kidney and said blood return means,

(6) blood return means associated with said outlet blood chamber for removing blood therefrom, said blood return means including associated means integral with said jacket member for effecting at least one function selected from the functions of detecting bubbles in the blood therein, collecting bubbles in the blood therein, removing bubbles from the blood therein, filtering the blood therein, measuring the pressure, temperature and rate of flow of blood therein, sampling at least one of the whole blood and the fluid portion of said blood therein, analyzing and establishing components and acidity of blood therein, and controlling the pressure of blood therein, and

(7) dialysate means associated with said dialysate chamber for supplying dialysate fluid to and removing dialysate from said dialysate chamber.

15. An artificial kidney in accordance with claim 14 wherein said dialysate means includes associated means integral with said jacket member for effecting at least one function selected from the functions of

detecting blood in said spent dialysate,

analyzing and establishing the components and acidity of said spent dialysate therein,

adjusting said component concentrations to approximately the concentration of each said component in said fresh dialysate,

restoring said acidity to approximately its initial value, and removing metabolic wastes from said spent dialysate.