Autologous Blood Processing System
Preparation of Autologous Blood Serum
Defects in articular cartilage can induce osteoarthritis by causing molecular changes in the synovial fluid. One of the major inducers of osteoarthritis is the general inflammatory cytokine Interleukin-1 (IL-1) which plays a key role in accelerating tissue destruction and the repair mechanisms.
In a healthy joint, IL-1 and Interleukin-1 receptor antagonist (IL-1Ra) are in balanced concentrations. In cases of osteoarthritis, there is not sufficient IL-1Ra produced to block the destructive effects of the increased IL-1. The result is inflammation, joint pain, and finally cartilage destruction. The following technique explains how to process autologous serum containing increased levels of anabolic and inhibitory cytokines for use at the point of care. Users of this device are encouraged to contact their Arthrex representatives if, in their professional judgment, they require a more comprehensive surgical technique.
Using aseptic technique, prepare the jugular vein for needle penetration. Attach the enclosed Butterfly Needle to the 60mL syringe and puncture the jugular vein.
Harvest ~50mL of whole blood into the 60mL syringe. Remove needle from the jugular and detach from the syringe.
Unscrew the red tethered cap and loosen the white tethered cap on the Arthrex IRAP II construct. Attach the syringe with blood to the red luer and inject blood into the Arthrex IRAP II device, holding the syringe and the Arthrex IRAP II device at an angle of approximately ~60°. The blood should flow against the side of the construct. (Take care not toinject above Max Fill Line.)
Remove syringe, recap and tighten both tethered male caps, and gently rock the blood in the Arthrex IRAP II device,
inverting at least 10 times.
Place the Arthrex IRAP II device horizontally on the middle rack in the incubator for approximately 24 hours at 37°C, not to exceed 24 hours.
After incubation, let the device stand for 20 minutes then place the Arthrex IRAP II device into a centrifuge for 10 minutes at 4000 rpm. Make sure to balance centrifuge with an appropriate counterweight.
Remove white tethered cap. Slowly draw the serum into a 20mL syringe using a spinal needle, being careful not to pull up red blood cells.
Attach a sterile 0.22μm filter between the 20mL syringe containing the serum and an empty, sterile 6mL syringe. Transfer 4mL of serum to the 6mL syringe, detach the 6mL syringe and cap. Two serum filtrations are recommended. Repeat until all the serum has been transferred through the sterile filter into the 6mL syringes. Individual doses may be used immediately or frozen at or less than -18°C for administration at a later date. Excess blood and/or serum should be disposed of appropriately.
Excess blood should be disposed of and the disposal documented according to applicable regulations. When using at site of treatment, a sterile filter should be placed on the syringe containing the autologous serum, prior to use.
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