Extracorporeal blood processing methods and apparatus

• US 6,200,287 B1
• Filed: 09/05/1997
• Issued: 03/13/2001
• Est. Priority Date: 09/05/1997
• Status: Expired due to Term

• Current Assignee: Terumo BCT, Inc. (Terumo Corporation)
• Original Assignee: Gambro, Inc. (DaVita Incorporated)
• Inventors: Bainbridge, Marlene, Keller, Muriel
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Bianco, Patricia
• Application Number:
  US08/924,519
• Time in Patent Office: 1,285 Days
• Field of Search: 604/4, 604/5, 604/6, 604/540, 422/44, 210/645, 210/767, 210/780-782, 128/898, 128/DIG.3, 128/FOR-100
• 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 1/303 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 1/36222 Details related to the interface between cassette and machine
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/362262 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362264 the filter being a blood filter
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• 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

Abstract

Improved extracorporeal blood processing methods and apparatus are disclosed. In one aspect of the invention, an extracorporeal method for the collection of platelets and red blood cells, and if desired plasma, is provided, wherein the collection of platelets and red blood cells may occur in differing time periods utilizing the same blood processing vessel. The flow of blood to the blood processing vessel and return of uncollected blood components may be provided via a single needle, wherein blood is removed and returned to a donor/patient during alternating blood removal and blood return submodes. Prior to red blood cell collection, a set-up phase may be carried out during which a predetermined hematocrit and AC ratio is established.

Claims

1. A method for extracorporeal collection of blood components from a donor/patient, comprising:

flowing blood into a blood processing vessel for continuous blood processing;

separating platelets from said blood within said blood processing vessel;

collecting at least a portion of said platelets in a platelet collection reservoir separate from said blood processing vessel;

separating red blood cells from said blood within said blood processing vessel;

collecting at least a portion of said separated red blood cells in a red blood cell collection reservoir separate from said blood processing vessel, wherein said platelet collection step is completed separate from said red blood cell collection step and wherein said platelet collection step and said red blood cell collection step each include a sub-step of removing uncollected blood components from said blood processing vessel for return of said uncollected blood components to said donor/patient.

2. A method as recited in claim 1, wherein said platelet collection step is completed prior to said red blood cell collection step.

3. A method as recited in claim 1, wherein prior to said red blood cell collection step, and separate from said platelet collection step, said method further comprises a red blood cell collection set-up phase including:

separating red blood cells from said blood within said blood processing vessel;

establishing an AC ratio in the blood processing vessel of between about 6 and 16 and a packing factor of at least about 11 within separated red blood cells within said blood processing vessel.

4. A method as recited in claim 3, wherein said packing factor is established to be about 13, and wherein said AC ratio is established to be about 8.

5. A method as recited in claim 3, said set-up phase further including:

flowing blood components out of said blood processing vessel, wherein substantially all of said blood components flowing out of the blood processing vessel are accumulated for infusion to a donor/patient.

6. A method as recited in claim 3, further comprising:

removing said blood from a donor/patient through a single needle;

returning uncollected components of said blood to said donor/patient through said single needle.

7. A method as recited in claim 6, wherein said removing and returning steps are alternately and repeatedly performed during corresponding blood component collection and blood component return modes, respectively.

8. A method as recited in claim 6, wherein during said platelet separation and collection steps, said method further comprises:

recirculating a portion of said uncollected blood components into said blood processing vessel; and

,

wherein during said red blood cell separation and collection steps, said method includes;

returning substantially all of said uncollected blood components to said donor/patient.

9. A method as recited in claim 3, wherein said blood is flowed into said blood processing vessel at a flow rate, and said establishing step comprises:

reducing said flow rate.

10. A method as recited in claim 3, wherein said blood processing vessel is rotated at an rpm rate, and wherein said establishing step comprises:

increasing said rpm rate.

11. A method as recited in claim 3, said establishing step including:

maintaining a predetermined anticoagulant infusion rate to said donor/patient.

12. A method as recited in claim 3, said establishing step including:

removing platelets and plasma together through a common port from said blood processing vessel.

13. A method as recited in claim 1, wherein during said platelet separation and collection steps said method further comprises:

separating plasma from said blood within said blood processing vessel;

collecting at least a portion of said separated plasma in a plasma collection reservoir.

14. A method as recited in claim 1, wherein during said red blood cell separation and collection steps said method further comprises:

separating plasma from said blood within said blood processing vessel;

collecting at least a portion of said separated plasma in a plasma collection reservoir.

15. A method as recited in claim 1, further comprising:

adding a storage solution to said red blood cells collected in said red blood cell collection reservoir.

16. A method as recited in claim 15, wherein said storage solution is added through an assembly having a sterile barrier filter.

17. A method as recited in claim 1, further comprising:

leukoreduction filtering of said red blood cells collected in said red blood cell collection reservoir.

18. A method for extracorporeal collection of blood components from a donor/patient comprising:

removing blood from a donor/patient through a single needle;

flowing said blood into a blood processing vessel for continuous blood processing;

separating platelets from said blood within said blood processing vessel;

collecting at least a portion of said platelets in a platelet collection reservoir separate from said blood processing vessel;

separating red blood cells from said blood within said blood processing vessel;

collecting at least a portion of said separated red blood cells in a red blood cell collection reservoir separate from said blood processing vessel, wherein said platelet collection step is completed separate from said red blood cell collection step and wherein said platelet collection step and said red blood cell collection step each include a sub-step of removing uncollected blood components from said blood processing vessel for return of said uncollected blood components to said donor/patient; and

returning said uncollected blood components of said blood to said donor/patient through said single needle.

19. A method as recited in claim 18, further comprising:

separating plasma from said blood within said blood processing vessel;

collecting at least a portion of said plasma in a plasma collection reservoir separate from said blood processing vessel, wherein said plasma collection step is completed at least partially contemporaneous with said platelet collection step.

20. A method as recited in claim 18, wherein prior to said red blood cell collection step, and separate from said platelet collection step, said method further comprises a red blood cell collection set-up phase including:

separating red blood cells from said blood within said blood processing vessel;

establishing a hematocrit of at least about 75% within said separated red blood cells within said blood processing vessel and an AC ratio within said blood at about 8.

21. A method as recited in claim 20, further comprising:

maintaining said hematocrit and AC ratio during said red blood cell collection step.