Extracorporeal blood treatment apparatus and method

• US 5,730,712 A
• Filed: 01/17/1995
• Issued: 03/24/1998
• Est. Priority Date: 01/17/1994
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Althin Medical, Inc.
• Inventors: Anderson, William W., Falkvall, Thore, Kelly, Thomas D.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): Cho, David J.
• Application Number:
  US08/374,485
• Time in Patent Office: 1,162 Days
• Field of Search: 604/4-6, 138/40, 138/44, 138/646, 138/321.6, 138/321.8, 138/321.62, 138/321.64, 138/321.67, 138/321.72, 138/321.71, 138/321.88, 138/321.89
• US Class Current: 604/5.01
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1613 Profiling or modelling of patient or predicted treatment evolution or outcome
• CPC Class Codes: A61M 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/3427 back through the membrane, e.g. by inverted trans-membrane pressure [TMP]
• CPC Class Codes: A61M 1/3607 Regulation parameters
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: B01D 2313/19 Specific flow restrictors
• CPC Class Codes: B01D 61/243 Dialysis
• CPC Class Codes: B01D 61/32 Controlling or regulating
• CPC Class Codes: B01D 63/02 Hollow fibre modules
• CPC Class Codes: B01D 63/04 comprising multiple hollow fibre assemblies

Abstract

Dialyzers and methods are disclosed for performing shortened extracorporeal blood treatments. A flow restriction is provided in a dialyzer serving to partially impede flow of dialysate through the dialysate compartment of the dialyzer. As a result, the pressure of the dialysate upstream of the flow restriction is sufficient to cause the pressure profile of the dialysate from the dialysate inlet to the dialysate outlet of the dialyzer to be non-linear, in contrast to prior-art dialyzers. This perturbation of the dialysate pressure profile permits a single dialyzer to be used to remove large amounts of blood water from a patient'"'"'s blood and re-infuse large amounts of liquid to the blood while still attaining a desired net ultrafiltration of the patient without the need for more than one dialyzer per treatment or for a separate replacement fluid.

Claims

1. A dialyzer comprising:

(a) a casing with a blood inlet, a blood outlet, a dialysate inlet, and a dialysate outlet;

(b) a hollow-fiber semipermeable membrane having a lumen, the fiber extending through the casing and being connected to the blood inlet and the blood outlet so as to conduct extracorporeal blood from the blood inlet through the lumen to the blood outlet while a dialysate flow is conducted from the dialysate inlet through the casing to the dialysate outlet, the dialysate flow exhibiting a pressure profile on the membrane from the dialysate inlet to the dialysate outlet; and

(c) the dialyzer including an impediment serving to restrict dialysate flow through the casing in a first region compared to a second region adjacent the first region, the restriction to dialysate flow in the first region serving to increase dialysate pressure on the membrane in the first region compared to the second region sufficiently to cause the pressure profile through the casing from the dialysate inlet to the dialysate outlet to be non-linear.

2. The dialyzer as recited in claim 1 wherein the casing is substantially cylindrical.

3. The dialyzer as recited in claim 2 wherein the impediment comprises an external annular constriction of the casing between the first region and the second region.

4. The dialyzer as recited in claim 2 wherein the impediment comprises an internal annular restriction in the casing between the first region and the second region.

5. The dialyzer as recited in claim 4 wherein the internal annular restriction is positionally adjustable in the casing so as to allow a change in size of the first region relative to the second region to be made.

6. The dialyzer as recited in claim 2 wherein the impediment comprises an inclusion body located in the first region of the casing.

7. The dialyzer as recited in claim 2 wherein the impediment comprises a reduced size of the casing in the first region so as to provide the dialysate with a space having a reduced cross-sectional area through which to flow compared to the second region.

8. The dialyzer as recited in claim 1 adapted for use as a hemodiafilter.

9. The dialysate circuit comprising a dialyzer as recited in claim 1.

13. The dialysate circuit comprising a dialyzer as recited in claim 9.

10. A dialyzer comprising:

(a) a casing;

(b) a bundle of hollow-fiber semipermeable membranes disposed in the casing, each hollow-fiber membrane having a lumen;

(c) a first inlet and a first outlet attached to the casing, the first inlet and outlet being connected to the fibers so as to conduct a first liquid in parallel through the lumina of the hollow-fiber membranes from the first inlet to the first outlet;

(d) a second inlet and a second outlet attached to the casing so as to conduct a second liquid though the casing from the second inlet to the second outlet, the second liquid exhibiting a pressure profile on the membranes during conduction of the second liquid from the second inlet to the second outlet; and

(e) flow-restricting means situated between the second inlet and the second outlet for imparting a restriction to flow of the second liquid through the casing sufficiently to cause the pressure profile to be non-linear from the second inlet to the second outlet.

11. The dialyzer as recited in claim 10 further comprising a partition in the casing between a first portion of the bundle and a second portion of the bundle, said flow-restriction means comprising an opening through the partition for passage therethrough of the second liquid as the second liquid passes to the second portion of the bundle after contacting the first portion of the bundle.

12. The dialyzer as recited in claim 11 adapted for use as a hemodiafilter.

14. A dialyzer comprising:

(a) a casing defining a dialyzer volume, and including a partition dividing the dialyzer volume into first and second portions, the partition defining at least one opening allowing liquid to flow therethrough from the first portion to the second portion;

(b) first and second groups of hollow-fiber semipermeable membranes, the first group extending through the first portion and the second group extending through the second portion, each of the fibers of each said group having a lumen;

(c) a blood inlet and a blood outlet attached to the casing so as to conduct extracorporeal blood from the blood inlet to the blood outlet through the lumina of the fibers of the first and second group;

(d) a dialysate inlet and a dialysate outlet attached to the casing so as to conduct dialysate from the dialysate inlet to the first portion, through the opening to the second portion, then to the dialysate outlet, the dialysate exhibiting a pressure profile on the membranes as the dialysate is conducted from the dialysate inlet to the dialysate outlet; and

(e) the opening serving to restrict dialysate flow therethrough from the first portion to the second portion so as to increase dialysate pressure in the first region compared to the second region sufficiently to cause the pressure profile to be non-linear from the dialysate inlet to the dialysate outlet.

15. The dialyzer as recited in claim 14 adapted for use as a hemodiafilter.

16. The dialysate circuit comprising a dialyzer as recited in claim 14.

17. A dialyzer, comprising;

(a) a casing defining a dialysate compartment and having a blood inlet and a blood outlet, the dialysate compartment being operable to conduct dialysate entering the dialysate compartment;

(b) a semipermeable membrane configured as plural hollow fibers each having a lumen, the hollow fibers extending through the dialysate compartment so as to be operable to conduct extracorporeal blood through the lumina of the hollow fibers from the blood inlet to the blood outlet;

(c) the dialysate compartment having a first region and a second region, the first and second regions having a pressure barrier therebetween that is operable to cause, as dialysate enters the dialysate compartment, the first region to exhibit a pressure profile that is different from a pressure profile exhibited by the second region.

18. The dialyzer of claim 17, wherein the pressure profile in the first region is non-linear with the pressure profile in the second region.

19. The dialyzer of claim 17, wherein the pressure barrier comprises a partition substantially separating the first region from the second region.

20. The dialyzer of claim 19, wherein the partition defines an aperture for passage of dialysate between the first and second regions.

21. The dialyzer of claim 17, wherein the pressure barrier comprises a restriction in the casing between the first and second regions.

22. A dialyzer comprising:

(a) a casing with a blood inlet, a blood outlet, a dialysate inlet and a dialysate outlet;

(b) first and second groups of hollow-fiber semipermeable membranes, the first group representing a first region in the casing and the second group representing a second region in the casing, each of the fibers of the first and second groups having a lumen, the first and second groups connected to the blood inlet and the blood outlet so as to conduct extracorporeal blood from the blood inlet through the lumina of the fibers of the first and second groups to the blood outlet while dialysate is conducted though the casing, the dialysate flow exhibiting a pressure profile on the first and second groups from the first region to the second region; and

(c) the dialyzer including a pressure barrier between the first region and the second region, the pressure barrier serving to restrict dialysate flow through the casing in the first region compared to the second region, the restriction to dialysate flow in the first region serving to increase dialysate pressure on the membrane in the first region compared to the second region sufficiently to cause the pressure profile through the casing from the dialysate inlet to the dialysate outlet to be non-linear.

23. The dialyzer as recited in claim 22 wherein the pressure barrier is operable, whenever dialysate is being conducted through the casing, to create a pressure profile in the first region that is different from the pressure profile in the second region.