Functionally-closed, sterile blood processing solution system and method

A system useful in delivering a blood processing solution to blood present in a blood bag, the system comprising:

• a functionally-closed, sterile Y-type tube set comprising:
• a vented spike coupled to a first end of a first tube;
• a Y-shaped tube connector having a first and a second input and an output, wherein a second end of the first tube is coupled to the first input of the Y-shaped tube connector;
• an in-line microbiotic barrier filter coupled between the first and second ends of the first tube, wherein a flow path extends from the first end to the second end of the first tube that passes through the microbiotic barrier filter;
• a transfer bag coupled to a first end of a second tube, wherein a second end of the second tube is coupled to the second input of the Y-shaped tube connector;
• and
• a third tube coupled to the output of the Y-shaped tube connector, wherein a second end of the third tube is sealed;
• and
• indicia instructing a user to weld the third tube to a sealed blood bag tube using a sterile tubing welder and thereby maintain a functionally-closed, sterile flow path through which the blood processing solution can flow into the blood bag.

A method of delivering a blood processing solution to blood present in a blood bag, the method comprising:

• coupling a first end of a first tube to a vented spike and a second end of the first tube to a first input of a Y-shaped tube connector;
• coupling an in-line microbiotic barrier filter between the first and second ends of the first tube, wherein a flow path extends from the first end to the second end of the first tube that passes through the microbiotic barrier filter;
• coupling a first end of a second tube to a transfer bag and a second end of the second tube to a second input of the Y-shaped tube connector;
• coupling a first end of a third tube to an output of the Y-shaped tube connector;
• sealing a second end of the third tube;
• sealing a second end of a fourth tube that is coupled at a first end to the blood bag;
• and
• welding the third tube to the fourth tube using a sterile tubing welder, wherein a functionally-closed, sterile flow path through which the blood processing solution can flow into the blood bag is maintained.

A functionally-closed, sterile Y-type tube set comprising:

• a vented spike coupled to a first end of a first tube;
• a Y-shaped tube connector having a first and a second input and an output, wherein a second end of the first tube is coupled to the first input of the Y-shaped tube connector;
• an in-line microbiotic barrier filter coupled between the first and second ends of the first tube, wherein a flow path extends from the first end to the second end of the first tube that passes through the microbiotic barrier filter;
• a transfer bag coupled to a first end of a second tube, wherein a second end of the second tube is coupled to the second input of the Y-shaped tube connector;
• and
• a third tube coupled to the output of the Y-shaped tube connector, wherein a second end of the third tube is sealed.

A method for delivering a blood processing solution to blood present in a blood bag, the method comprising:

• obtaining a functionally-closed sterile Y-type tube set comprising an input tubing member coupled to an output tubing member and providing a sterile flow path extending from a vented spike at a distal end of the input tubing member through an inline microbiotic filter and to a distal end of the output tubing member which is closed by a seal;
• welding the output tubing member to a sealed input tubing member of the blood bag using a sterile tubing welder, wherein a functionally-closed, sterile flow path through which the blood processing solution can flow into the blood bag is maintained;
• and
• inserting the vented spike into a vial containing the blood processing solution to deliver the blood processing solution through the inline microbiotic filter and into the blood in the blood bag.