Systems and methods for removing undesired matter from blood cells

Abstract

Systems and methods of collecting blood cells, substantially free of undesired matter, use a first container, that forms a part of a blood collection system, to initially collect a quantity of blood cells. A filtration system is then attached to the first container. The filtration system includes a second container, a first fluid path that leads to the second container through a filtration device, and a second fluid path that leads to the second container bypassing the filtration device. The blood cells are conveyed from the first container through the first fluid path and filtration device and into the second container to separate the undesired matter from the blood cells. The blood cells, now substantially free of the undesired matter, are then conveyed from the second container through the second fluid path, bypassing the filtration device, and back into the first container. The filtration system is then detached from the blood collection system.

I claim: 
     
       1. A method of collecting blood cells, substantially free of undesired matter, comprising the steps of: collecting a quantity of blood cells in a first container that forms a part of a blood collection system,   opening communication between the first container and a separation system that includes a second container, a first fluid path leading into the second container that includes means for separating the undesired matter from the blood cells, and a second fluid path leading into the second container that bypasses the separation means,   conveying the blood cells from the first container through the first fluid path and separation means and into the second container, thereby separating the undesired matter from the blood cells, and   returning the blood cells, now substantially free of the undesired matter, from the second container through the second fluid path, bypassing the separation means, and back into the first container.   
     
     
       2. A method according to claim 1 wherein the step of opening communication with the separation system includes the step of attaching the filtration system to the blood collection system.   
     
     
       3. A method according to claim 2 wherein the step of attaching the separation system includes the step of employing a sterile connecting assembly that is associated with the separation and blood collection systems.   
     
     
       4. A method according to claim 1 wherein, during the step of conveying blood cells from the first container and into the second container, the first container is located above the second container to convey the blood cells by gravity flow.   
     
     
       5. A method according to claim 4 wherein, during the step of returning blood cells from the second container back to the first container, the second container is located above the first container to return the blood cells by gravity flow.   
     
     
       6. A method according to claim 1 and further including the step, accomplished prior to the step of returning blood cells from the second container back to the first container, of expelling air from the first container into the second container through the second fluid path.   
     
     
       7. A method according to claim 1 and further including the step of storing the blood cells in the first container substantially free of the undesired matter.   
     
     
       8. A method according to claim 1 wherein the blood cells comprise red blood cells and the undesired matter includes white blood cells.   
     
     
       9. A blood collection system comprising a blood collection assembly comprising a primary container for the collection of blood cells,   a separation assembly comprising a transfer container, a first fluid path communicating with the transfer container and having an inline separation means for separating undesired matter from blood cells, a second fluid path communicating with the transfer container and bypassing the first fluid path, and flow control means associated with the first and second fluid paths operable in a first mode for directing fluid between the primary and transfer containers through the first fluid path and separation means and in a second mode for directing fluid flow between the primary and transfer containers through the second fluid path bypassing the separation means, and   means establishing communication between the separation assembly and the blood collection assembly for conveying, when the flow control means is in its first mode, blood cells from the primary container through the first fluid path and separation means into the transfer container, thereby separating the undesired matter from the blood cells, and to return, when the flow control means is in its second mode, blood cells, now substantially free of the undesired matter, from the transfer container through the second fluid path, bypassing the separation means, and into the primary container.   
     
     
       10. A system according to claim 9 wherein the means for establishing communication includes connection means associated with the separation assembly and the blood collection assembly for attaching and detaching the collection and separation assemblies.   
     
     
       11. A blood collection system according to claim 9 and wherein the blood collection assembly and the separation assembly each comprises a separate closed system, and   wherein the means for establishing communication includes connection means associated with the separation assembly and the blood collection assembly for attaching and detaching the collection and separation assemblies in a manner that preserves the sterile integrity of the closed systems.   
     
     
       12. A blood collection system according to claim 9 wherein the first fluid path includes first and second opposite end portions, the first opposite end portion is connected to the transfer container, and the separation means is located in the first fluid path between the second opposite end portion and the transfer container,   wherein the second fluid path includes opposite end portions, one of the end portions communicates with the first fluid path between the second opposite end portion and the separation means, and the other one of the end portions communicates with the first fluid path between the separation means and the transfer container.   
     
     
       13. A system according to claim 12 wherein the flow control means includes a first flow control mechanism in the first fluid path between the separation means and the transfer container and a second flow control mechanism in the second fluid path between the opposite ends thereof.   
     
     
       14. A system according to claim 13 wherein the second flow control mechanism is located adjacent the one end portion of the second fluid path that communicates with the first fluid path between the second end portion thereof and the separation means.   
     
     
       15. An assembly usable in association with a primary blood collection and storage container for removing undesired matter from blood cells, the assembly comprising a transfer container,   a first fluid path communicating with the transfer container and having an inline separation means for separating undesired matter from blood cells,   a second fluid path communicating with the transfer container and bypassing the first fluid path,   flow control means associated with the first and second fluid paths operable in a first mode for directing fluid into the transfer container through the first fluid path and separation means and in a second mode for directing fluid from the transfer container through the second fluid path bypassing the separation means, and   means establishing communication between the separation assembly and the primary container for conveying, when the flow control means is in its first mode, blood cells from the primary container through the first fluid path and separation means into the transfer container, thereby separating the undesired matter from the blood cells, and to return, when the flow control means is in its second mode, blood cells, now substantially free of the undesired matter, from the transfer container through the second fluid path, bypassing the separation means, and into the primary container.   
     
     
       16. An assembly according to claim 15 wherein the transfer container is free of fluid prior to use.   
     
     
       17. An assembly according to claim 15 wherein the first fluid path includes first and second opposite end portions, the first opposite end portion is connected to the transfer container, and the separation means is located in the first fluid path between the second opposite end portion and the transfer container,   wherein the second fluid path includes opposite end portions, one of the end portions communicates with the first fluid path between the second opposite end portion and the separation means, and the other one of the end portions communicates with the first fluid path between the separation means and the transfer container.   
     
     
       18. A system according to claim 17 wherein the flow control means includes a first flow control mechanism in the first fluid path between the separation means and the transfer container and a second flow control mechanism in the second fluid path between the opposite ends thereof.   
     
     
       19. A system according to claim 18 wherein the second flow control mechanism is located adjacent the one end portion of the second fluid path that communicates with the first fluid path between the second end portion thereof and the separation means.   
     
     
       20. A blood collection system according to claim 15 and wherein the assembly comprises a sterile, closed system, and   wherein the means for establishing communication includes connection means for attaching and detaching the assembly to the primary container in a manner that preserves the sterile integrity of the system. .Iadd.   
     
     
       21.  An assembly for removing undesired matter from blood cells comprising a filter body having an inlet and an outlet,   filtration medium in the filter body for removing undesired matter from blood cells,   an inlet fluid path communicating with the inlet of the filter body and including means for attaching a first container holding a quantity of blood cells for conveying blood cells from the first container to the filtration medium for the removal of undesired matter,   an outlet fluid path communicating with the outlet of the filter body for conveying blood cells from the filtration medium substantially free of undesired matter, the outlet fluid path including a second container for receiving blood cells substantially free of undesired matter, and   a bypass path having opposite ends, one end being attached to the inlet fluid path between the first container and the inlet of the filter body and the opposite end being attached to the outlet fluid path between the second container and the outlet of the filter body for venting air without transferring liquid between the inlet fluid path and the outlet fluid path, bypassing the filtration medium in the filter body..Iaddend..Iadd.22. An assembly according to claim 21   and further including flow control means in the bypass path operable to open and close the bypass path..Iaddend..Iadd.23. An assembly for removing undesired matter from blood cells comprising   a filter body having an interior and inlet and an outlet,   filtration medium in the body interior for removing undesired matter from blood cells,   inlet tubing communicating with the inlet of the filter body and including means for attaching a first container holding a quantity of blood cells for conveying blood cells from the first container to the filtration medium for the removal of undesired matter,   outlet tubing communicating with the outlet of the filter body for conveying blood cells from the filtration medium substantially free of undesired matter, the outlet tubing including a second container for receiving blood cells substantially free of undesired matter, and   a length of tubing extending outside the filter body with one end attached to the inlet tubing between the filter inlet and the first container and the opposite end attached to the outlet tubing between the filter outlet and the second container for conveying air without transferring liquid between the inlet tubing and the outlet tubing in a path that bypasses the interior of the filter body..Iaddend..Iadd.24. An assembly according to claim 23   and further including flow control means in the length of tubing operable to open and close the length of tubing..Iaddend.