Blood separation and concentration system
View Patent ↗This invention provides an apparatus and methods to consistently separate and concentrate selected blood components. The system includes, e.g., a computerized fluid handling system to transfer blood components between a centrifugal blood separation disc, containers and a concentrator.
1. A method for producing concentrated blood components, the method comprising:
a) separating blood using centripetal force in a separation disk that rotates about a rotational axis;
b) detecting one or more red blood cell (RBC) interfaces with a first RBC detector at one or more levels of a separation disc, which RBC interface levels are predetermined to provide a desired composition of one or more separated components including buffy coat;
c) initiating collection of the buffy coat in response to the detecting;
d) collecting the separated components from an outlet port proximate to a rotational axis of the separation disc until RBCs are detected with a second RBC detector in the collection stream;
e) transferring the separated components through a conduit to a concentrator; and,
f) concentrating the separated components, which concentration comprises ultrafiltration;
thereby producing concentrated blood components.
2. The method of claim 1 , further comprising collecting a platelet poor blood plasma from the outlet port before the RBC interface is detected.
3. The method of claim 2 , wherein thrombin is produced from prothrombin present in the platelet poor blood plasma.
4. The method of claim 1 , further comprising isolating one or more growth factors, one or more compliment cascade proteins, or one or more coagulation factors from the concentrated blood components.
5. The method of claim 1 , further comprising contacting the concentrated blood components with thrombin to prepare a fibrin gel, a wound sealant or a bone graft substitute.
6. The method of claim 1 , wherein collecting the separated components comprises repeating cycles of collecting not more than about 10% of a separation disc volume and pausing collection for a time period.
7. The method of claim 1 , further comprising pausing separation or concentration processes and sampling of blood components before completion of processing.
8. The method of claim 1 , further comprising loading blood or blood components into the rotating separation disc.
9. The method of claim 8 , further comprising determining a total blood volume (V b ) loaded onto the separation disc, monitoring a separated component volume (V sc ), calculating an expected separated component volume (V sce ), and ending collection of separated components when the separated component volume (V sc ) equals the expected separated component volume (V sce ).
10. The method of claim 9 , further comprising calculating the expected separated component volume (V sce ) as the total blood volume (V b ) multiplied by a separation factor.
11. The method of claim 1 , further comprising determining a separated component volume (V sc ), calculating an expected concentrated component volume (W cce ), monitoring a concentrated component volume (V cc ), and ending concentration of separated components when the concentrated component volume (V cc ) equals the expected concentrated component volume (V cce ).
12. The method of claim 11 , further comprising calculating the expected concentrated component volume (V cce ) as the separated component volume (V sc ) multiplied by a concentration factor.
13. The method of claim 11 , wherein the concentrated component volume (V cc ) is calculated as the separated component volume (V sc ) minus a concentrator filtrate volume (V f ).
14. The method of claim 1 , wherein detecting in a), collecting in b), transferring in c) and concentrating in d) are performed by a single bench top instrument.
15. The method of claim 1 , further comprising monitoring detection in a), directing collection in b), directing transfer in c) and/or directing concentrating in d) with a control system.
16. A method for producing concentrated blood components, the method comprising:
providing a separation disk configured to receive whole blood through an inlet port and discharge lower density components of the whole blood through an outlet port;
rotating the separation disk about an axis causing the whole blood to be separated by centripetal force;
detecting, with a first red blood cell (RBC) detector, an interface level of the RBC;
initiating collection of the lower density components in response to the first RBC detector detecting an interface level that satisfies a predetermined level;
detecting, with a second RBC detector, a presence of RBC discharged through the outlet port; and
terminating the collecting of the lower density components in response to the second RBC detecting RBC discharged through the outlet port.
17. The method of claim 16 , further comprising transferring the lower density components from the outlet port to a concentrator.
18. The method of claim 17 , further comprising concentrating the lower density components by ultrafiltration.
19. The method of claim 16 , further comprising collecting a platelet poor blood plasma from the outlet port before the terminating of the collecting.
20. The method of claim 16 , further comprising determining a total blood volume (V b ) loaded onto the separation disc, monitoring a separated component volume (V sc ), calculating an expected separated component volume (V sce ), and ending collection of separated components when the separated component volume (V sc ) equals the expected separated component volume (V sce ).