Automated system and method for pre-surgical blood donation and fluid replacement

• US 6,808,503 B2
• Filed: 03/06/2001
• Issued: 10/26/2004
• Est. Priority Date: 03/06/2001
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Thom, Sandra, Farrell, Liam, Brown, Richard I., Vishnoi, Rohit
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): DEAK, LESLIE R
• Application Number:
  US09/800,024
• Publication Number:
  US 20020128582A1
• Time in Patent Office: 1,330 Days
• Field of Search: 604/4.01, 604/5.01, 604/6-1-, 604/6-9-, 604/65-67, 738/61, 210/739-746, 210/252, 210/258, 210/781, 210/782, 422/44
• US Class Current: 604/6.01
• CPC Class Codes: A61M 1/30 Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/302 having a reservoir for withdrawn untreated blood
• CPC Class Codes: A61M 1/303 having a reservoir for treated blood to be returned
• CPC Class Codes: A61M 1/308 Volume control, e.g. with open or flexible containers, by counting the number of pump revolutions, weighing
• CPC Class Codes: A61M 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3441 Substitution rate control as a function of the ultrafiltration rate
• CPC Class Codes: A61M 1/3451 the difference in weight between both ultra-filtrate and substitution reservoir being used as control signal
• CPC Class Codes: A61M 1/3622 with a cassette forming partially or totally the blood circuit
• CPC Class Codes: A61M 1/362227 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362261 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/3672 Means preventing coagulation
• CPC Class Codes: A61M 1/3675 Deactivation
• CPC Class Codes: A61M 1/3679 by absorption A61M1/3675 takes precedence
• CPC Class Codes: A61M 1/3687 Chemical treatment A61M1/3675 takes precedence
• CPC Class Codes: A61M 1/3692 Washing or rinsing blood or blood constituents
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 1/3696 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
• CPC Class Codes: A61M 2202/0429 : Red blood cells; Erythrocytes
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit

Abstract

Automated systems and methods for withdrawing and replacing fluids in a patient are disclosed. The system withdraws blood from a donor or patient, separates the blood into two or more components and collects the separated component. A replacement fluid capable of at least partially providing the biological function of the separated component is infused into the patient.

Claims

1. An automated system for withdrawing and replacing fluids in a patient comprising:

means for separating whole blood into at least plasma and another blood component;

a separation chamber in association with said means for separating;

means for withdrawing whole blood from a patient and introducing said whole blood into said separation chamber;

means in fluid communication with said separation chamber for collecting a selected amount of said other component, said collected component having at least one known biological function;

a flow control cassette for controlling fluid flow through said system, said cassette having preformed flow path segments therein separated by valve stations for controlling communication between said flow path segments and inlet and outlet ports for introducing and removing fluid from said cassette;

a container of a first replacement fluid comprising a volume replacement fluid, said container being in flow communication with an inlet port on said cassette;

a container of a second replacement fluid capable of at least partially providing said biological function of said collected component, said container being in flow communication with an inlet port on said cassette;

means for determining the effective amounts and flow rates of plasma and said first and second replacement fluids to be administered to said patient.

2. The system of claim 1 wherein said separating means comprises a rotatable centrifuge.

3. The system of claim 1 further comprising an operator-programmable system controller that includes said determining means.

4. The system of claim 3 comprising a weight scale for measuring the weight of said collected component and said determining means comprises an algorithm for determining the amount of said replacement fluid based on said weight.

5. The system of claim 1 wherein said means for withdrawing comprises a first tube defining a flow path between the patient and said separator.

6. The system of claim 5 wherein said means for withdrawing further comprises a pump associated with said first tube.

7. The system of claim 1 wherein said means for collecting one of said fractions comprises a plastic reservoir.

8. The system of claim 1 wherein said amount of said first and second replacement fluids is based at least in part on the amount of said component collected or patient data.

9. A method for withdrawing and replacing fluid from a patient comprising:

withdrawing whole blood from a patient;

separating said whole blood into at least plasma and another component having at least one known biological function;

collecting said other component;

providing a first replacement fluid and a second replacement fluid, wherein one of said replacement fluids is capable of at least partially providing said biological function of said collected component;

determining the effective amounts and flow rates of plasma and said first and second replacement fluids to be administered to said patient;

returning at least a part of said plasma to the patient; and

infusing said effective amounts of first and second replacement fluids to said patient.

10. The method of claim 9 wherein said collected component comprises concentrated red blood cells and said replacement fluid capable of at least partially providing said biological function comprises an intravenous oxygen carrier.

11. The method of claim 10 further comprising infusing an effective amount of the other of said first and second replacement fluids into the patient wherein said amount is based on the amount of said collected red blood cells.

12. The method of claim 11 wherein one of said replacement fluids is a solution selected from the group consisting of a crystalloid, colloid and albumin solution.

13. The method of claim 11 comprising combining said first and second replacement fluids prior to infusing said fluids into said patient.

14. The method of claim 11 comprising separately infusing said first and second replacement fluids into said patient.

15. The method of claim 10 comprising determining the effective amount of said replacement fluids by:

collecting concentrated red blood cells in a container;

determining the weight of said collected red cells;

automatically determining the amount of said oxygen carrier effective to provide oxygen transport comparable to that of said collected concentrated red blood cells; and

automatically infusing said effective amount of said oxygen carrier to the patient.

16. The method of claim 15 further comprising:

automatically determining the effective amount of said other of said first and second replacement fluids based on the weight of said collected red blood cells;

automatically infusing said effective amount of said other replacement fluid into said patient.

17. The method of claim 16 comprising infusing said other replacement fluid prior to infusing said oxygen carrier.

18. The method of claim 16 comprising automatically determining the effective amounts of said oxygen carrier and said other replacement fluid based on the amounts of said red blood cells collected and said plasma returned to the patient.

19. The method of claim 9 comprising determining the amount of said collected component by collecting said component in a container and weighing the same.

20. The method of claim 9 comprising providing a pump and tubing set for withdrawing, separating and collecting, and determining the amount of said collected component based at least in part on pump head revolution and the internal tubing diameter of said tubing.

21. An automated system for withdrawing and replacing fluids in a patient comprising:

means for separating whole blood into at least a plasma component and red blood cell component;

a separation chamber in association with said means for separating;

means for withdrawing whole blood from a patient and introducing said whole blood into said separation chamber;

a container in fluid communication with said separation chamber suitable for collecting and temporarily storing a selected amount of said red blood cells;

means for returning at least a part of said separated plasma to said patient;

a container including a replacement fluid for at least partially providing a biological function of red blood cells;

means for determining an effective amount of a replacement fluid to be administered to said patient; and

means for infusing said replacement fluid into the patient.

22. The system of claim 21 wherein said separating means comprises a rotatable centrifuge.

23. The system of claim 21 further comprising an operator-programmable system controller that includes said determining means.

24. The system of claim 23 comprising a weight scale for measuring the weight of said collected component and said determining means comprises an algorithm for determining the amount of said replacement fluid based on said weight of said collected component.

25. The system of claim 21 further comprising:

means for determining an effective amount of another replacement fluid; and

means for infusing said amount of said other replacement fluid into said patient, wherein said amount is based at least in part on the amount of said component collected or patient data and said other replacement fluid being capable of at least partially providing said biological function.

26. The system of claim 21 further comprising a flow control cassette for controlling fluid flow through said system, said cassette having preformed flow path segments therein separated by valve stations for controlling communications between said flow path segments.

27. The system of claim 21 further comprising a second replacement fluid.

28. The system of claim 27 wherein said first replacement fluid comprises an oxygen carrier and said second replacement fluid comprises a volume replacement fluid.

29. A method for withdrawing and replacing fluid from a patient comprising:

withdrawing whole blood from a patient;

separating said whole blood into at least a plasma component and red blood cell component;

collecting at least a portion of said red blood cell component;

returning at least a portion of the plasma component to the patient; and

infusing an effective amount of a replacement fluid to said patient, said replacement fluid being capable of at least partially providing said biological function of said red blood cells.

30. The method of claim 29 further comprising infusing an effective amount of a second replacement fluid into said patient wherein said amount is based on the amount of said collected component.

31. The method of claim 30 wherein said first replacement fluid is an oxygen carrier and said second replacement fluid is a volume replacement fluid.