IP Library Granted Patent US 9,011,408
Granted Patent B2
US 9,011,408 · App. 13/756,712 · Granted Apr 21, 2015

Functionally-closed, sterile blood processing solution system and method

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Quick Facts
Patent No.
US 9,011,408
App. No.
13/756,712
Granted
Apr 21, 2015
Kind
B2
Abstract

Delivering a blood processing solution to blood in a blood bag includes coupling a first tube to a vented spike at one end and to a Y-shaped tube connector at a second end. An in-line microbiotic barrier filter is coupled to the first tube between its ends. A second tube is coupled to a transfer bag at one end and to the Y-shaped tube connector at its other end. A third tube is coupled to the output of the Y-shaped tube connector and sealed at its distal end. The blood bag includes a fourth tube that is sealed at a distal end. The third tube is welded 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.

Claims (41)

1. A method useful in 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;

providing instructions to seal a second end of a fourth tube that is coupled at a first end to the blood bag; and

providing instructions to weld the third tube to the fourth tube using a sterile tubing welder.

2. The method of claim 1 , wherein the coupling an in-line microbiotic barrier filter comprises coupling a 0.2 micron IV filter.

3. The method of claim 1 , wherein the blood in the blood bag is a red blood cell concentrate.

4. The method of claim 1 , further comprising inserting the vented spike into a vial containing the blood processing solution to deliver the blood processing solution to the blood in the blood bag to increase the intracellular content of ATP and 2,3-DPG of the blood in the blood bag.

5. The method of claim 1 , wherein the blood in the blood bag is a red blood cell concentrate, and further comprising delivering the blood processing solution to the blood in the blood bag to increase the intracellular content of ATP and 2,3-DPG of the blood in the blood bag.

6. The method of claim 1 , further comprising providing instructions indicating that one of a functionally-closed, sterile cell processor; a functionally-closed, sterile centrifuge; or both; be used in processing the blood.

7. The method of claim 1 , further comprising providing information indicating that the blood can be stored for use for more than 24 hours after delivering the blood processing solution into the blood bag.

8. 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.

9. The system of claim 8 , wherein the inline microbiotic filter is a 0.2 micron IV filter.

10. The system of claim 8 , wherein the blood in the blood bag is a red blood cell concentrate.

11. The system of claim 8 , further comprising delivering the blood processing solution to the blood in the blood bag to increase the intracellular content of ATP and 2,3-DPG of the blood in the blood bag.

12. The system of claim 8 , wherein the Y-type tube set is provided in a package comprising the indicia.

13. The system of claim 8 , wherein one of a pamphlet and a package insert comprises the indicia.

14. The system of claim 8 , wherein the indicia further indicates that one of a functionally-closed, sterile cell processor; a functionally-closed, sterile centrifuge; or both; should be used in the system.

15. The system of claim 8 , wherein the indicia further indicates that the blood can be stored for use for more than 24 hours after delivering the blood processing solution into the blood bag.

16. 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.

17. The method of claim 16 , wherein the coupling an in-line microbiotic barrier filter comprises coupling a 0.2 micron IV filter.

18. The method of claim 16 , wherein the blood in the blood bag is a red blood cell concentrate.

19. The method of claim 16 , further comprising delivering the blood processing solution to the blood in the blood bag to increase the intracellular content of ATP and 2,3-DPG of the blood in the blood bag.

20. The method of claim 16 , further comprising storing the treated blood greater than 24 hours for use thereafter.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 12, 2018
From: BIOMET BIOLOGICS, LLC
To: BIOMET, INC.
Reel/Frame 045914/0262 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 12, 2018
From: ZB MANUFACTURING, LLC
To: BIOMET MANUFACTURING, LLC
Reel/Frame 045914/0335 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 12, 2018
From: BIOMET, INC.
To: ZB MANUFACTURING, LLC
Reel/Frame 045914/0350 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 17, 2013
From: GRAY, ALAN
To: BIOMET BIOLOGICS, LLC
Reel/Frame 031799/0964 →