Extracorporeal blood processing methods and apparatus

• US 6,773,413 B2
• Filed: 12/04/2000
• Issued: 08/10/2004
• Est. Priority Date: 09/05/1997
• Status: Expired due to Term

• Current Assignee: Terumo BCT, Inc. (Terumo Corporation)
• Original Assignee: Gamero Incorporated
• Inventors: Bainbridge, Marlene, Keller, Muriel
• Primary Examiner(s): BIANCO, PATRICIA
• Application Number:
  US09/729,578
• Publication Number:
  US 20010000185A1
• Time in Patent Office: 1,345 Days
• Field of Search: 604/4.01, 604/5.01, 604/6-1-, 604/6.1, 604/6.11, 604/540, 422/44, 210/645, 210/646, 210/767, 210/780-82, 128/DIG.3, 128/898, 494/11, 494/23, 494/24, 494/27, 494/28, 494/35-37, 494/43, 494/49, 494/56, 494/85
• 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

An extracorporeal blood processing method includes a set-up phase establishing certain conditions in blood being processed prior to separation of the blood into components. Also, a blood processing method contemporaneously extracts selected multiple blood components from a blood processing vessel. Blood is separated into components in the blood processing vessel in a centrifugal field. Further, an extracorporeal blood processing method establishes a packing factor in the blood processing vessel prior to collecting red blood cells.

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;

separating red blood cells from said blood within said blood processing vessel continuously with said step or separating platelets;

removing a collectable quantity of said platelets and a collectable quantity of said red blood cells from said blood processing vessel separately and contemporaneously;

collecting collectable quantity of red blood cells in a red blood cell collection reservoir separate from said blood processing vessel, and

collecting said collectable quantity of said platelets in a platelet collection reservoir separate from said blood processing vessel,

wherein said platelet separation step is completed continuously with said red blood cell separation and collection steps.

2. A method as recited in claim 1, wherein said method further comprises establishing an AC ratio of between about 6 and 16.

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

continuously separating plasma from said blood within said blood processing vessel;

continuously removing a collectable quantity of said separated plasma through a plasma port from said blood processing vessel.

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

establishing a blood component interface between separating blood components within said blood processing vessel, said interface including a red blood cell component disposed in a radially outwardmost disposition, a buffy coat component including a platelet component adjacent said red blood cell component, and a plasma component disposed in a radially inwardmost disposition adjacent said buffy coat component.

15. A method as recited in claim 14, wherein said blood processing vessel further comprises:

a red blood cell outlet port for continuously removing said red blood cell component from said blood processing vessel.

16. A method as recited in claim 15, wherein said blood processing vessel further comprises a platelet outlet port for continuously removing said platelet component from said blood processing vessel.

17. A method as recited in claim 16, wherein said blood processing vessel further comprises:

a plasma outlet port for continuously removing said plasma component from said blood processing vessel.

3. 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;

separating red blood cells from said blood within said blood processing vessel continuously with said step of separating platelets;

performing a red blood cell collection set-up phase including;

establishing a packing factor of at least about 11 within separated red blood cells within said blood processing vessel; and

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 separation step is completed continuously with said red blood cell separation and collection steps.

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

5. A method as recited in claim 3, wherein an AC ratio is established to be between about 6 and 16.

6. A method as recited in claim 3, wherein an AC ratio is established to be about 8.

7. A method as recited in claim 3, said setup phase further including:

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

8. A method as recited in claim 7, wherein, said set-up phase of said method further comprises:

returning substantially all of said separated blood components to said donor/patient for at least two volumes of said blood processing vessel.

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 of said set-up phase 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 of said set-up phase comprises:

increasing said rpm rate.

11. A method as recited in claim 3, said establishing step of said set-up phase further comprises:

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

12. A method as recited in claim 3, said establishing step of said set-up phase further comprises:

continuously removing platelets through a platelet port from said blood processing vessel.

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

continuously flowing said blood into a blood processing vessel;

continuously separating platelets from said blood within said blood processing vessel by flowing said platelets in a first circumferential direction;

continuously flowing at least a portion of said platelets out of sai blood processing vessel through a platelet outlet line;

continuously separating red blood cells from said blood within said blood processing vessel by flowing said red blood cells in a second circumferential direction opposite to said first circumferential direction;

continuously flowing at least a portion of said separated red blood cells out of said blood processing vessel through a red blood cell outlet line wherein said platelet separation and flowing steps are completed contemporaneously with said red blood cell separation and flowing steps;

collecting red blood cells in a red blood cell collection reservoir.

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

continuously separating plasma from said blood within said blood processing vessel;

continuously flowing said collectable quantity of said plasma out of said blood processing vessel through a plasma outlet line, wherein said plasma separation and flowing steps are completed at least partially contemporaneous with said platelet separation and flowing steps.

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

establishing a hematocrit of at least about 75% within said separated 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, said method further comprising:

maintaining said hematocrit and AC ratio during said red blood cell separation, flowing and collection steps.