Systems and methods for cellular separation
Methods and systems disclosed herein provide systems and methods for maintaining sterile conditions inside of a biological-fluid container during an entire process of delivery, incubation, centrifugation, and extraction of fluid. The methods and systems also provide systems and methods for localized extraction of a portion of a biological fluid.
1. A cap for a biological-fluid container, the cap comprising:
an injection port configured for injection of biological fluid through the injection port;
an extraction port configured for extraction of biological fluid through the extraction port;
an injection-port cap configured to attach to the injection port;
an extraction-port cap configured to attach to the extraction port, wherein at least one of the injection-port cap or the extraction-port cap is a vented cap; and a penetrable flexible seal configured for insertion and extraction of biological fluid through the flexible seal, wherein the flexible seal is present on the top of the cap for a biological-fluid container.
2. The cap of claim 1 , wherein the at least one vented cap is configured to release pressure from the biological-fluid container during insertion and extraction of biological fluid through the flexible seal via a needle.
3. The cap of claim 1 , wherein the injection port and extraction port each include a cannula configured to extend into the biological-fluid container.
4. The cap of claim 1 , wherein the injection port comprises a connection fitting configured to attach directly to a syringe or the injection-port cap, and wherein the extraction port comprises a connection fitting configured to attach directly to a syringe or the extraction-port cap.
5. The cap of claim 1 , wherein the penetrable flexible seal comprises a rubber stopper.
6. The cap of claim 1 , wherein the injection-port cap and the extraction-port cap are vented Luer caps.
7. The cap of claim 1 , further comprising a base configured to attach to the biological-fluid container.
8. The cap of claim 7 , wherein the base is attached to the biological-fluid container, and wherein the cap for a biological-fluid container provides a hermetic seal for the biological-fluid container.
9. The cap of claim 1 , wherein the injection-port cap is tethered to the injection port, and wherein the extraction-port cap is tethered to the extraction port.
10. The cap of claim 1 , wherein the injection port comprises threading to accommodate the injection-port cap, and wherein the extraction port comprises threading to accommodate the extraction-port cap.
11. The cap for a biological-fluid container of claim 1 , wherein the penetrable flexible seal is on the same plane on the cap for a biological-fluid container as the injection port and the extraction port.
12. A cellular-separation system comprising:
a biological-fluid container; and
a cap attached to the biological-fluid container, wherein the cap comprises:
an injection port configured for injection of biological fluid through the injection port;
an extraction port configured for extraction of biological fluid through the extraction port;
an injection-port cap configured to attach to the injection port;
an extraction-port cap configured to attach to the extraction port, wherein at least one of the injection-port cap or the extraction-port cap is a vented cap; and
a penetrable flexible seal configured for insertion and extraction of biological fluid through the flexible seal, wherein the flexible seal is present on the top of the cap for a biological-fluid container.
13. The cellular-separation system of claim 12 , wherein the biological-fluid container comprises a tubular body.
14. The cellular-separation system of claim 12 , further comprising a plurality of beads in the biological-fluid container.
15. The cellular-separation system of claim 14 , wherein the plurality of beads are suitable to activate Interleukin-I-Receptor Antagonist Protein.
16. The cellular-separation system of claim 12 , wherein the at least one vented cap is configured to release pressure from the biological-fluid container during insertion and extraction of biological fluid through the flexible seal via a needle.
17. The cellular-separation system of claim 12 , wherein the cap for a biological-fluid container hermetically seals the biological-fluid container.
18. The cellular-separation system of claim 12 , wherein the injection port and extraction port each include a cannula configured to extend into the biological-fluid container.
19. The cellular-separation system of claim 12 , wherein the penetrable flexible seal comprises a rubber stopper.
20. The cellular-separation system of claim 12 , wherein the injection-port cap and the extraction-port cap are both vented caps.
21. A method to isolate one or more fractions of a biological fluid, the method comprising:
injecting a biological fluid into a biological-fluid container through an injection port in a cap of the cellular-separation system of claim 12 , wherein the injection port is configured to attach to a vented cap;
incubating the biological fluid injected into the biological-fluid container;
centrifuging the biological-fluid container to form two or more fractions of the biological fluid; and
removing one or more fractions of the biological fluid from the biological-fluid container through the penetrable flexible seal in the cap, wherein during said removing the vented cap is attached to the injection port and releases pressure from the biological-fluid container.
22. The method of claim 21 , wherein the vented cap is attached to the injection port during said injecting, and wherein said injecting comprises injecting blood through the vented cap.
23. The method of claim 21 , wherein the biological fluid is blood, wherein the biological-fluid container has a plurality of beads to activate protein production in the blood, wherein incubating the biological-fluid container comprises incubating the biological-fluid container for a sufficient time and at a sufficient temperature to produce a therapeutically active protein in the blood, and wherein centrifuging the biological-fluid container to form two or more fractions of the biological fluid comprises centrifuging the biological-fluid container to form a serum containing the therapeutically active protein.