Methods for the selective separation of organic components...

Details Methods for the selective separation of organic components... Methods for the selective separation of organic components...

1996-12-20

2001-02-27

Drodge, Joseph W. (Department: 1723)

Liquid purification or separation

Processes

Liquid/liquid solvent or colloidal extraction or diffusing...

C210S502100, C210S660000, C210S663000, C210S690000, C423S331000, C424S693000, C604S004010

Reexamination Certificate

active

06193891

ABSTRACT:

TECHNICAL FIELD
The present invention pertains to improved methods for the selective separation of organic components from biological fluids. More particularly, the present invention pertains to methods for the selective separation of organic components from biological fluids which comprise the step of contacting the biological fluid with a synthetic hydrated alkaline earth silicate (i.e., SHAES), such as synthetic hydrated calcium silicate (i.e., SHCS) or synthetic hydrated magnesium silicate (i.e., SHMS). In a preferred embodiment, the present invention pertains to such methods where the biological fluid is a mammalian blood fluid (e.g., whole blood, blood plasma, blood serum, blood fraction, plasma fraction, serum fraction).
BACKGROUND
Throughout this application, various publications, patents, and published patent applications are referred to by an identifying citation. Corresponding complete citations are provided below under the heading “References.” The disclosures of the publications, patents, and published patent specifications referenced in this application are hereby incorporated by reference into the present disclosure to more fully describe the state of the art to which this invention pertains.
Blood is the fluid that circulates in the blood vessels of the body, that is, the fluid that is circulated through the heart, arteries, veins, and capillaries. The function of the blood and the circulation is to service the needs of other tissues: to transport oxygen and nutrients to the tissues, to transport carbon dioxide and various metabolic waste products away, to conduct hormones from one part of the body to another, and in general to maintain an appropriate environment in all tissue fluids for optimal survival and function of the cells. See, for example, Guyton, 1991.
Blood consists of a liquid component, plasma, and a solid component, cells and formed elements (e.g., erythrocytes, leukocytes, and platelets), suspended within it. Erythrocytes, or red blood cells account for about 99.9% of the cells suspended in human blood. They contain hemoglobin which is involved in the transport of oxygen and carbon dioxide. Leukocytes, or white blood cells, account for about 0.1% of the cells suspended in human blood. They play a role in the body's defense mechanism and repair mechanism, and may be classified as agranular or granular. Agranular leukocytes include monocytes and small, medium and large lymphocytes, with small lymphocytes accounting for about 20-25% of the leukocytes in human blood. T cells and B cells are important examples of lymphocytes. Three classes of granular leukocytes are known, neutrophils, eosinophils, and basophils, with basophils accounting for about 65-75% of the leukocytes in human blood. Platelets (i.e., thrombocytes) are not cells but small spindle-shaped or rodlike bodies about 3 microns in length which occur in large numbers in circulating blood. Platelets play a major role in clot formation.
Plasma is the liquid component of blood. It serves as the primary medium for the transport of materials among cellular, tissue, and organ systems and their various external environments, and it is essential for the maintenance of normal hemostasis. One of the most important functions of many of the major tissue and organ systems is to maintain specific components of plasma within acceptable physiological limits.
Plasma is the residual fluid of blood which remains after removal of suspended cells and formed elements. Serum is the fluid which is obtained after blood has been allowed to clot and the clot removed. Serum and plasma differ primarily in their content of fibrinogen and several components which are removed in the clotting process. Plasma may be effectively prevented from clotting by the addition of an anti-coagulant (e.g., sodium citrate, heparin) to permit handling or storage. Plasma constitutes about 4% of total body weight in humans. It is composed primarily of water (approximately 90%), with approximately 7% proteins, 0.9% inorganic salts, and smaller amounts of carbohydrates, lipids, and organic salts. See, for example, Carlson, 1991.
The protein portion of plasma and serum is a mixture of a large number different protein components. Standard methods, such as precipitation by various salts or organic compounds, electrophoresis, ultracentrifugation, ion-exchange chromatography, gel filtration, and immunoprecipitation with antibody-containing antisera, have been variously employed to identify and characterize at least 100 distinct protein components in human plasma. See, for example, Putnam, 1975-1987; Handin et al., 1995. Five major fractions of blood protein (as determined electrophoretically) are albumin, &agr;1-globulin, &agr;2-globulin, &bgr;-globulin, and &ggr;-globulin.
In human blood, approximately one-half of blood protein is albumin, a relatively small protein with molecular weight of 69,000. Albumin contributes greatly to the colloid osmotic pressure of plasma and thus plays a major role in the regulation of intravascular volume and the fluid exchange between the vascular system and extravascular system. Albumin also serves as a transport protein for various substances, including small ions such as calcium and iodine and organic compounds such as bilirubin.
In human blood, the &agr;1-globulin fraction contains proteins such as &agr;1-acid glycoprotein, &agr;1-antitrypsin, and &agr;1-lipoprotein. The &agr;2-globulin fraction contains proteins such as &agr;2-macroglobulin, haptoglobulin, ceruloplasmin, and group-specific complement. The &bgr;-globulin fraction contains proteins such as transferrin, hemopexin, &bgr;1-lipoprotein, &bgr;2-microglobulin, and complement components. The &ggr;-globulin fraction contains proteins such as immunoglobulins and C-reactive protein.
Immunoglobulins (which are antibodies found circulating in the blood) represent approximately one-sixth of the total human blood protein and largely constitute the &ggr;-globulin fraction. Of the different classes of immunoglobulins which can be distinguished, the principle ones are IgG, IgM, IgA, IgD, and IgE.
In addition to albumin and immunoglobulins, lipoproteins are another class of blood components and account for approximately 10% of total human blood protein. Lipoproteins are water soluble complexes comprising protein components (e.g., apolipoproteins) and lipid components (e.g., cholesterol, cholesteryl esters, phospholipids, and triglycerides). Lipoproteins are often conveniently considered to comprise a hydrophobic core (primarily of cholesteryl esters and triglycerides) surrounded by a relatively more hydrophilic shell (primarily apolipoproteins, phospholipids, and unesterified cholesterol) projecting its hydrophilic domains into the aqueous environment. Lipoproteins presumably serve as transport proteins for lipids, such as triacylglyercols, cholesterol (and cholesteryl esters), and other lipids (e.g., phospholipids). Lipoprotein remnants are the biological byproducts produced in the metabolism of lipoproteins.
Three classes of lipoproteins, &agr;1-lipoprotein, pre-&bgr;-lipoprotein, and &bgr;1-lipoprotein, can be distinguished in human blood, according to their electrophoretic behavior. However, lipoproteins are more conveniently characterized by their ultracentrifligation behavior in high-salt media, as described by their flotation constants (densities), as follows: chylomicra, less than 1.006; very low density (VLDL), 1.006-1019; low density (LDL), 1.019-1.063; high density (HDL), 1.063-1.21; very high density (VHDL), >1.21. Lipoproteins are often approximately spherical in shape, and range in diameter from about 0.1 micron (for chylomicra) to about 5 nanometers (for VHDL). Lipoproteins range in molecular weight from 200 kd to 10,000 kd and from 4 to 95% lipid (the higher the density the lower the lipid content). The very low- and low-density fractions appear in the &bgr;1-globulin fraction and the high-density and very high-density fractions appear in the &agr;1-globulin fraction. Chylomicra and VLDLs are rich in triglycerides (~90% and ~60% of the

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