Membrane separation devices, systems and methods employing same, and data management systems and methods
A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed.
1 . A single pass method for collection and separation of whole blood from a donor into blood components employing an automated blood collection system comprising a donor access device and a blood separation device employing rotating surfaces, the single pass method comprising:
a) preventing communication between the donor access device and the blood separation device by closing a first clamp upstream of an anticoagulant source and pump;
b) priming the system with anticoagulant while the first clamp remains closed;
performing a venipuncture on the donor with the donor access device;
c) flowing whole blood from the donor after opening the first clamp to allow communication between the donor access device and the blood separation device;
d) adding anticoagulant to the whole blood upstream of the blood separation device to obtain anticoagulated whole blood;
e) flowing anticoagulated whole blood through a leukoreduction filter by exerting a draw force on the anticoagulated whole blood with a draw line pump located downstream from the leukoreduction filter and then to the blood separation device wherein the leukoreduction filter is located upstream of the blood separation device;
f) separating the anticoagulated whole blood into substantially concentrated red blood cells and plasma;
g) flowing plasma from the blood separation device to a first collection container and substantially concentrated red blood cells from the blood separation device to a second collection container;
h) continuing steps c)-g) until a volume of red blood cells in the second collection container reaches a predetermined volume;
i) removing the donor access device from the donor upon the collection of the predetermined volume of red blood cells; and
j) rinsing the system with anticoagulant and exhausting the anticoagulant used for rinsing into the second collection container;
wherein the method is performed with only a single pass of the anticoagulated whole blood through the blood separation device and without reinfusion of blood components to the donor.
2 . The method of claim 1 further comprising employing a needle for blood withdrawal from a donor, the needle being of about 18-21 gauge.
3 . The method of claim 1 wherein the blood separation device employs an outer housing having an inner rotor mounted therein that is spaced from an inner surface of the housing by a gap having a radial dimension into which anticoagulated whole blood is flowed, further comprising creating separate fluid flow regions within the gap during the separation of the whole blood into substantially concentrated red blood cells and plasma without the use of seals.
4 . The method of claim 3 further comprising creating the separate fluid flow regions by providing one of an inner wall of the outer housing or an external surface of the inner rotor with a raised circumferential ridge that extends into the gap.
5 . The method of claim 4 further comprising providing the ridge with an axial dimension of at least the radial dimension of the gap to decrease mixing of fluids between the separate fluid flow regions.
6 . The method of claim 1 , wherein said preventing communication between the donor access device and the blood separation device and said priming the system with anticoagulant are executed before said performing the venipuncture on the donor with the donor access device.
7 . The method of claim 1 , further comprising leukoreducing the substantially concentrated red blood cells.
8 . The method of claim 1 , wherein the volume of red blood cells in the second collection container is determined by measuring the weight of the second collection container with a weight scale.
9 . The method of claim 1 , wherein the method is terminated by occluding a draw line from the donor access device.
10 . The method of claim 1 , wherein step h) includes automatically preventing communication between the donor access device and the blood separation device when the volume of red blood cells in the second collection container reaches the predetermined volume.
11 . The method of claim 1 , wherein the first clamp is automatically opened and closed by a controller.
12 . The method of claim 1 , wherein the draw line pump is the only pump on a draw line.