Whole blood separation system

Patent metadata

Field	Value
Publication number	US-10300189-B2
Application number	US-201415122060-A
Country	US
Kind code	B2
Filing date	Apr 30, 2014
Priority date	Apr 30, 2014
Publication date	May 28, 2019
Grant date	May 28, 2019

Abstract

A system and method are provided for controlling fouling and complement protein activation during separation of plasma from whole blood using a spinning membrane separator. The separator includes a pair of relatively rotating surfaces spaced apart to define a gap therebetween, with at least one of the surfaces comprising a membrane that allows plasma to pass therethrough but substantially prevents the passage of red cells. In accordance with the method, the membrane material and membrane fabrication technique are selected so as that the resulting membrane both resists fouling and complement protein activation. In a specific embodiment, the membrane is has a smooth surface and substantially linear pores. The pores have a nominal diameter of less than 2 microns (so as to exclude platelets) and preferably a diameter of from 0.6 microns to 0.8 microns, as may be obtained by use of track-etching. In addition, the membrane material preferably is polycarbonate, as it has been determined that polycarbonate does not activate complement proteins.

First claim

The invention claimed is:

1. An automated whole blood separation system comprising a disposable fluid flow circuit and a durable controller configured to cooperate with and control flow through the disposable fluid flow circuit, the disposable fluid flow circuit comprising:
a whole blood fluid flow path with a whole blood inlet for connection to a source of whole blood;
a separator including outer housing and inner rotor mounted within the outer housing for rotation relative to the outer housing, a gap being defined between an outer surface of the rotor and an inner surface of the outer housing, at least one of the outer surface of the rotor or inner surface of the outer housing comprising a filter membrane configured to allow the passage of plasma therethrough while substantially blocking cellular components, the membrane consisting of polycarbonate and having a smooth surface and substantially linear pores with a nominal diameter of from 0.6 microns to 0.8 microns, the outer housing including an inlet in fluid communication with the whole blood fluid flow path, or a cell preservation solution fluid flow path, or the whole blood fluid flow path and the cell preservation solution fluid flow path, and in flow communication with the gap for directing whole blood, or cell preservation solution, or whole blood and cell preservation solution into the gap, the outer housing including an outlet communicating with the gap, and one of the outer housing and the rotor including an outlet communicating with the side of the membrane facing away from the gap; and
the outlet in the outer housing communicating with the gap being in flow
communication with an outlet fluid flow path for connection to a storage container.

2. A method controlling fouling and complement protein activation during spinning membrane filtration of plasma from whole blood comprising:
(a) providing a source of whole blood;
(b) providing a blood separation circuit comprising
a whole blood fluid flow path with a whole blood inlet for connection to a source of whole blood;
a separator including outer housing and inner rotor mounted within the outer housing for rotation relative to the outer housing, a gap being defined between an outer surface of the rotor and an inner surface of the outer housing, at least one of the outer surface of the rotor or inner surface of the outer housing comprising a filter membrane configured to allow the passage of plasma therethrough while substantially blocking cellular components, the membrane consisting of polycarbonate and having a smooth surface and substantially linear pores with a nominal diameter of from 0.6 microns to 0.8 microns, the outer housing including an inlet in fluid communication with the whole blood fluid flow path, or a cell preservation solution fluid flow path, or the whole blood fluid flow path and the cell preservation solution fluid flow path, and in flow communication with the gap for directing whole blood, or cell preservation solution, or whole blood and cell preservation solution into the gap, the outer housing including an outlet communicating with the gap, and one of the outer housing and the rotor including an outlet communicating with the side of the membrane facing away from the gap; and the outlet in the outer housing communicating with the gap being in flow communication with an outlet fluid flow path for connection to a storage container;
(c) flowing whole blood from the collected unit through the gap, to allow plasma to pass through the membrane and cellular components to be blocked;
(d) withdrawing concentrated red blood cells from the gap.

3. A disposable fluid flow circuit for separating whole blood into a plasma component and a concentrated red cell component, the circuit comprising:
a whole blood fluid flow path with a whole blood inlet for connection to a source of whole blood;
a separator including outer housing and inner rotor mounted within the housing for rotation relative to the outer housing, a gap being defined between an outer surface of the rotor and an inner surface of the outer housing, at least one of the outer surface of the rotor or inner surface of the housing comprising a filter membrane configured to allow the passage of plasma therethrough while substantially blocking cellular components, the membrane consisting of polycarbonate and having a smooth surface and substantially linear pores with a nominal diameter of from 0.6 microns to 0.8 microns, the outer housing including an inlet in fluid communication with the whole blood fluid flow path, or a cell preservation solution fluid flow path, or the whole blood fluid flow path and the cell preservation solution fluid flow path, and in flow communication with the gap for directing whole blood, cell preservation solution, or whole blood and cell preservation solution into the gap, the outer housing including an outlet communicating with the gap, and one of the outer housing and the rotor including an outlet communicating with the side of the membrane facing away from the gap; and
the outlet in the outer housing communicating with the gap being in flow communication with an outlet fluid flow path for connection to a storage container.

Assignees

• Fenwal Inc

Inventors

• Kusters Benjamin E
• Min Kyungyoon
• Wegener Christopher J
• Boggs Daniel R

Classifications

• A61M1/3633

  Blood component filters, e.g. leukocyte filters · CPC title

• B01D65/08

  Prevention of membrane fouling or of concentration polarisation · CPC title

• B01D2321/2033

  dynamically · CPC title

• B01D2315/02

  Rotation or turning · CPC title

• A61M2205/7563

  with means preventing clogging of filters · CPC title