Separable hemodialysis system

• US 5,824,213 A
• Filed: 09/24/1997
• Issued: 10/20/1998
• Est. Priority Date: 09/07/1994
• Status: Expired due to Term

• Current Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Medisystems Technology Corporation
• Inventors: Utterberg, David S.
• Primary Examiner(s): KIM, SUN U
• Application Number:
  US08/937,121
• Time in Patent Office: 391 Days
• Field of Search: 210/134, 210/143, 210/241, 210/195.2, 210/321.71, 210/646, 210/929, 604/4, 604/5, 604/6, D24/186, D24/216, D24/107
• US Class Current: 210/241
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/3606 Arrangements for blood-volume reduction of extra-corporeal circuits
• 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 1/3649 using dialysate as priming or rinsing liquid
• CPC Class Codes: A61M 2209/082 Mounting brackets, arm supports for equipment
• CPC Class Codes: Y10S 210/929 Hemoultrafiltrate volume measurement or control processes

Abstract

A hemodialysis system comprises the following: a dialysate handling unit for providing dialysate to the patient. This unit comprises a hemodialysis solution pump and apparatus for monitoring hemodialysis solution safety such as a conductivity tester. Additionally a solution heater and appropriate conventional controls can be provided, as well as a proportioning system, an ultrafiltration measuring unit, and other known apparatus for handling dialysis solution. A blood handling unit is also provided, which comprises a membrane dialyzer and holder, a blood pump, blood flow tubing and safety equipment for monitoring blood flow as it is pumped through the arterial/venous blood conduit set tubing from the patient, through the membrane dialyzer, and back to the patient. A first conduit is present for conveying fresh dialysate from the dialysate handling unit to the blood handling unit (or directly to the membrane dialyzer). A second conduit is provided for conveying spent hemodialysis solution away from the blood handling unit. By this invention, the dialysate handling unit and the blood handling unit are separate from and movable relative to each other while the hemodialysis is being performed. Significant economic and functional advantages can be achieved.

Claims

1. A hemodialysis system which comprises:

a dialysate handling unit for providing hemodialysis solution to the patient, comprising a hemodialysis solution pump and a hemodialysis solution safety monitoring apparatus;

a blood handling unit which comprises a membrane dialyzer holder, a blood pump, and equipment for safely handling blood as it is pumped from the patient, through a membrane dialyzer and back to the patient, said blood handling unit being carried on a moveable stand, separate and spaced from said dialysate handling unit;

a first conduit for conveying fresh dialysate from said dialysate handling unit to a membrane dialyzer in the blood handling unit, and a second conduit for conveying spent hemodialysis solution away from said blood handling unit;

said dialysate handling unit and said blood handling unit being movably separate from each other and free of any mechanical connection preventing them from being moveable in all directions relative to each other while hemodialysis is being performed, the dialysate handling unit being free of blood-contacting components and the blood handling unit being free of dialysis solution processing components other than said membrane dialyzer, said blood handling unit being positioned closer to a patient treatment site than to said dialyzate handling unit.

2. The hemodialysis system of claim 1 in which said dialysate handling unit also comprises a proportioning system.

3. The hemodialysis system of claim 1 in which said blood handling unit also comprises a blood conduit connected through said blood pump and membrane dialyzer and which has at least one bubble trap in said blood conduit.

4. The hemodialysis system of claim 3 in which the portion of said blood conduit extending from said bubble trap to the patient is shorter than the first conduit.

5. The hemodialysis system of claim 4 in which said blood conduit portion has a length of about 1 to 3 feet, and the first conduit has a length of at least about 6 feet.

6. The hemodialysis system of claim 1 in which a membrane dialyzer is carried in said dialyzer holder, and said equipment for safely handling blood comprises a pair of blood lines each communicating between patient connecting access devices and said membrane dialyzer, said blood lines each being of less length than the first conduit.

7. The hemodialysis system of claim 1 in which said dialysate handling unit carries an electronic system for control of all system functions, and a cable communicating between said electronic system and said blood handling unit to provide power and control from said electronic system to the blood pump and any other electrically operated components of said blood handling unit.

8. The hemodialysis system of claim 1 in which said blood handling unit further comprises an electronic bubble detector.

9. The hemodialysis system of claim 1 in which said second conduit connects with said dialysate handling unit.

10. The hemodialysis system of claim 1 in which said blood pump comprises a rotor and a U-shaped track for receiving blood tubing which is part of said equipment for safely handling blood, said U-shaped track being in the form of an upright U.

11. The hemodialysis system of claim 1 in which a dialyzer having a blood inlet and outlet is mounted in the remainder of the blood handling unit with said blood outlet positioned higher than said blood inlet, the dialyzer being connected to blood lines so short that the dialyzer cannot be inverted after priming to dialyze in that inverted position.

12. A hemodialysis system which comprises:

a dialysate handling unit for providing dialysate to a patient, comprising a hemodialysis solution pump and hemodialysis solution safety monitoring apparatus;

a blood handling unit which comprises a membrane dialyzer holder carrying a membrane dialyzer, a blood pump, and equipment for safely handling blood as it is pumped from the patient, through a membrane dialyzer in the holder, and back to the patient, said blood pump comprising a rotor and a U-shaped track containing a portion of blood tubing as part of said equipment for safely handling blood, said U-shaped track being in a form of an upright U, one end of the blood tubing in said U-shaped track connecting directly to said membrane dialyzer, the other end of the blood tubing in said track being directly connected to a bubble trap, said bubble trap being also connected to a blood conduit which communicates with a connector for an access device to the patient, said blood handling unit being carried on a moveable stand, separate and spaced from said dialysate handling unit;

a first conduit for conveying fresh dialysate from said dialysate handling unit to a membrane dialyzer in the blood handling unit, and a second conduit for conveying spent dialysate away from the blood handling unit;

said dialysate handling unit and the blood handling unit being movably separate from each other and free of any mechanical connection preventing them from being moveable in all directions relative to each other while hemodialysis is being performed, the dialysate handling unit being free of blood-contacting components and the blood handling unit being free of dialysate solution processing components other than the membrane dialyzer, said blood conduit being shorter than said first conduit, said blood handling unit being positioned closer to a patient treatment site than to said dialyzate handling unit.

13. The hemodialysis system of claim 12 in which a pair of said blood conduits are present, each blood conduit having a length of about 1 to 3 feet, and the first conduit has a length of at least about 6 feet.

14. The hemodialysis system of claim 13 in which said membrane dialyzer has a blood inlet and outlet, and is mounted in the remainder of the blood handling unit with said blood outlet positioned higher than said blood inlet, the dialyzer being connected to blood lines so short that the dialyzer cannot be inverted after priming to dialyze while inverted.

15. The hemodialysis system of claim 12 in which said dialysate handling unit carries an electronic system for control of system functions, a cable communicating between said electronic system and said blood handling unit to provide power and control from said electronic system to the blood pump.

16. The hemodialysis system of claim 15 in which said blood handling unit further comprises a length of tubing;

means at one end of the tubing for connection with a blood access device; and

a bubble trap connected to the other end of said length of tubing, said length of tubing being from 1 to 3 feet in length.

17. A hemodialysis system which comprises:

a dialysate handling unit for providing hemodialysis solution to the patient, comprising a hemodialysis solution pump and hemodialysis solution safety monitoring equipment;

a blood handling unit which comprises a membrane dialyzer holder, a blood pump, and equipment for safely handling blood as it is pumped from the patient, through a membrane dialyzer, and back to the patient, said blood handling unit being carried on a moveable stand, separate and spaced from said dialysate handling unit;

a first conduit for conveying fresh dialysate from said dialysate handling unit to a membrane dialyzer in the blood handling unit, and a second conduit for conveying spent hemodialysis solution away from said blood handling unit;

said dialysate handling unit and said blood handling unit being movably separate from each other and free from any mechanical connection preventing them from being moveable in all directions relative to each other while hemodialysis is being performed, said dialysate handling unit carrying an electronic system for powering and controlling all system functions of blood handling and dialysate handling, and a cable communicating between said electronic system and said blood handling unit to provide power and control from said electronic system to the blood pump and any other electrically operated components of said blood handling unit, said blood handling unit being positioned closer to a patient treatment site than to said dialyzate handling unit.

18. The hemodialysis system of claim 17 in which said blood handling unit also comprises a blood conduit connected through said pump and membrane dialyzer and which has at least one bubble trap in said blood conduit, the portion of the said blood conduit extending from said bubble trap to the patient being shorter than the first conduit.

19. The hemodialysis system of claim 18 in which said blood handling unit further comprises an electronic bubble detector and in which said second conduit connects with said dialysate handling unit.

20. The hemodialysis system of claim 19 in which said blood pump comprises a rotor and a U-shaped track for receiving blood tubing which is part of said equipment for safely handling blood, said U-shaped track being in the form of an upright U.

21. The hemodialysis system of claim 20 in which a dialyzer having a blood inlet and outlet is mounted in the remainder of the blood handling unit with said blood outlet positioned higher than said blood inlet, the dialyzer being connected to blood lines so short that the dialyzer cannot be inverted after priming to dialyze in that inverted position.

22. A hemodialysis system which comprises:

a dialyzate handling unit for providing hemodialysis solution to the patient;

a blood handling unit which comprises a membrane dialyzer holder and equipment for safely handling blood as it passes from the patient, through a membrane dialyzer, and back to the patient, said blood handling unit being carried on a movable stand, separate from said dialyzate handling unit;

a first conduit for conveying fresh dialyzate from said dialyzate handling unit to a membrane dialyzer in the blood handling unit, and a second conduit for conveying spent hemodialysis solution away from said blood handling unit;

said dialyzate handling unit and said blood handling unit being spaced and movably separate from each other and free of any mechanical connection preventing them from being movable in all directions relative to each other while hemodialysis is being performed, the dialyzate handling unit being free of blood-contacting components and the blood handling unit being free of dialysis solution processing components other than said membrane dialyzer.

23. The hemodialysis system of claim 22 in which a blood conduit is connected to said membrane dialyzer, which blood conduit has at least one bubble trap in the blood conduit, and in which the portion of said blood conduit extending from said bubble trap to the patient is shorter than the first conduit.

24. The hemodialysis system of claim 23 in which said blood conduit portion has a length of about 1 to 3 feet and the first conduit has a length of at least about 6 feet.

25. The hemodialysis system of claim 22 in which said blood pump comprises a rotor and a U-shaped track for receiving blood tubing which is part of said equipment for safely handling blood, said U-shaped track being in the form of an upright U.

26. The hemodialysis system of claim 22 in which blood conduits are carried by said blood handling unit for communication between the blood handling unit and said patient for inflow and outflow of blood to and from said patient, each blood conduit being shorter than said first conduit.

27. The hemodialysis system of claim 26 in which said blood handling unit is positioned closer to a patient treatment site than to said dialyzate handling unit.