Artificial kidney for frequent (daily) hemodialysis

• US 5,484,397 A
• Filed: 11/22/1993
• Issued: 01/16/1996
• Est. Priority Date: 08/21/1991
• Status: Expired due to Term

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Zbylut J. Twardowski
• Inventors: Twardowski, Zbylut J.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): RUHL, DENNIS WILLIAM
• Application Number:
  US08/155,993
• Time in Patent Office: 785 Days
• Field of Search: 604/4, 604/5, 604/6, 623/11, 623/12, 210/634, 210/646
• US Class Current: 604/5.01
• CPC Class Codes: A61M 1/1639 linked by membranes
• CPC Class Codes: A61M 1/1666 by dissolving solids
• CPC Class Codes: A61M 1/1674 using UV radiation sources for sterilising the dialysate
• CPC Class Codes: A61M 1/1682 both machine and membrane module, i.e. also the module blood side
• CPC Class Codes: A61M 1/1686 by heat
• CPC Class Codes: A61M 1/169 using chemical substances
• CPC Class Codes: A61M 1/3643 Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3644 Mode of operation
• CPC Class Codes: A61M 1/3646 Expelling the residual body fluid after use, e.g. back to the body
• CPC Class Codes: A61M 1/3647 with recirculation of the priming solution
• CPC Class Codes: A61M 1/3649 using dialysate as priming or rinsing liquid
• CPC Class Codes: A61M 1/365 through membranes, e.g. by inverted trans-membrane pressure [TMP]
• CPC Class Codes: B01D 2321/16 Use of chemical agents
• CPC Class Codes: B01D 65/022 Membrane sterilisation
• CPC Class Codes: Y10S 210/929 Hemoultrafiltrate volume measurement or control processes

Abstract

A hemodialyzer apparatus comprises a reusable dialyzer membrane as well as reusable blood flow path and dialysis flow path units. The apparatus automatically primes itself and makes dialysis solution from dry chemicals, concentrates, and fresh water which is provided to the apparatus. Also, after use, the apparatus automatically prepares cleaning and rinsing solution for the cleaning and rinsing of the dialyzer membrane as well as the dialyzate and blood flow path means, to provide a system which is so simplified in terms of automatic operation that it may be usable for daily dialysis at home.

Claims

1. A hemodialyzer apparatus, which comprises:

a dialyzer membrane having first and second sides;

a dialysate flow path positioned for passing dialysis solution across the first side of said membrane;

a blood flow path positioned for passing blood across the second side of said membrane for dialysis thereof;

a solution storage tank connected to said dialysate flow path;

venous and arterial connectors communicating with said blood flow path for alternative connection with a vascular system of a patient and with each other;

a water inlet conduit communicating with a water treatment system for processing water from said inlet conduit, to purify said water to a condition wherein said water is substantially purified water;

a first conduit communicating with said solution storage tank and extending from said water inlet conduit to receive purified water therefrom;

apparatus for providing desired amounts of dialysis solution solutes to said purified water to provide said dialysis solution containing said dialysis solution solutes in dispersed form in said solution storage tank, to thus provide a desired quantity of said dialysis solution in a first operating mode;

apparatus for providing desired amounts of antimicrobial and cleaning agent to said purified water to provide said antimicrobial and cleaning agent dispersed in said purified water in said solution storage tank, to provide a desired quantity of antimicrobial cleaning solution in a second operating mode; and

a valve and control system to selectively and automatically provide and control fluid flow throughout the apparatus.

2. The apparatus of claim 1 having conduit, connected between said dialysate flow path and said blood flow path, plus one way valve means to selectively permit one way flow of antimicrobial cleaning solution from said blood flow path to said dialysate flow path.

3. The apparatus of claim 1 which further comprises access means between patient'"'"'s blood supply and the blood flow path, said access means comprising a needleless system such as an arterioveneus shunt catheter or double lumen intravenous catheter.

4. A hemodialyzer apparatus, which comprises:

a dialyzer membrane having first and second sides;

a dialysate flow path positioned for passing dialysis solution across the first side of said membrane;

a blood flow path positioned for passing blood across the second side of said membrane for dialysis thereof;

a solution storage tank connected to said dialysate flow path;

venous and arterial connectors communicating with said blood flow path, for alternative connection with a vascular system of a patient and with each other;

a water inlet conduit;

a first conduit communicating with said solution storage tank and extending from said water inlet conduit to receive water therefrom;

apparatus for providing desired amounts of dialysis solution solutes to said water in a manner providing water containing said dialysis solution solutes in dissolved form in said solution storage tank, to thus provide a desired quantity of said dialysis solution in a first operating mode;

apparatus for providing desired amounts of antimicrobial and cleaning agent to said water to provide said antimicrobial and cleaning agent dispersed in said water in said solution storage tank, to provide a desired quantity of antimicrobial cleaning solution in a second operating mode;

a second conduit connected between said dialysis flow path and said blood flow path, plus a one-way valve to selectively permit one-way flow of antimicrobial cleaning solution from said blood flow path to said dialyzate flow path for discard; and

valve and control means to selectively and automatically provide and control fluid flow throughout the apparatus.

5. The apparatus of claim 4 in which access to a patient'"'"'s blood supply takes place through a needleless system such as an arteriovenous shunt catheter or double lumen intravenous catheter.

6. The apparatus of claim 4 which further comprises a source of normal saline solution to the blood flow path to selectively permit flushing of the saline solution through said second conduit and the blood flow path in one mode of operation, and to flush saline through the blood flow path to at least one of the venous and arterial connectors in another mode of operation to maximize blood return to the patient.

7. The hemodialyzer apparatus of claim 4 which further comprises an ultrafiltration regulating system which automatically measures the volume of dialysis solution by monitoring of an overflow measuring container.

8. The apparatus of claim 4 which further comprises a conductivity detector positioned to measure the conductivity across said blood flow path.

9. The apparatus of claim 4 in which said water inlet conduit communicates with a water treatment means for processing said water from said inlet conduit, to purify said water to a condition wherein said water is substantially purified water, and said first conduit communicates with said water treatment means, to receive purified water therefrom.

10. The apparatus of claim 9 which further comprises a source of normal saline solution to the blood flow path to selectively permit flushing of the saline solution through said second conduit and the blood flow path in one mode of operation, and to flush saline through the blood flow path to at least one of the venous and arterial connectors in another mode of operation to maximize blood return to the patient.

11. The apparatus of claim 10 which further comprises a conductivity detector positioned to measure the conductivity across said blood flow path.

12. A hemodialyzer apparatus, which comprises:

a dialyzer membrane having first and second sides;

a dialysate flow path positioned for passing dialysis solution across the first side of said membrane;

a blood flow path positioned for passing blood across the second side of said membrane for dialysis thereof;

a solution storage tank connected to said dialysate flow path;

venous and arterial connectors communicating with said blood flow path for alternative connection with a vascular system of a patient and with each other;

a water inlet conduit;

a first conduit communicating with said tank and extending from said water inlet conduit to receive water therefrom;

apparatus for automatically providing desired amounts of dialysis solution solutes to said water in a manner providing water containing said dialysis solution solutes in dispersed form in said solution storage tank, to thus provide a desired quantity of said dialysis solution in a first operating mode;

apparatus for providing desired amounts of antimicrobial and cleaning agent to said water to provide said antimicrobial and cleaning agent dispersed in said water in said solution storage tank, to provide a desired quantity of antimicrobial cleaning solution in a second operating mode; and

valve and control means to selectively and automatically provide and control fluid flow throughout the apparatus.

13. The apparatus of claim 12 which further comprises a conductivity detector positioned to measure the conductivity across said blood flow path.

14. The hemodialyzer apparatus of claim 13 which further comprises an ultrafiltration regulating system which automatically measures the volume of said dialysis solution by monitoring of an overflow measuring container.