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Whole blood separation method and devices using the same

Assignee: Diabetes Diagnostics Inc
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Filing: 1995-04-07
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Granted: 1998-03-10
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Expires: 2015-04-07
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Abstract

Abstract The present invention relates to a method and to a device for separating plasma from whole blood. The method and device utilize a permeable non-glass fiber matrix containing a polyol which is capable of clumping red blood cells. The matrix, in the absence of such a polyol, would otherwise be porous to red blood cells. The polyol-containing matrix has a first surface and a second surface such that a whole blood sample which is applied to the first surface flows directionally toward the second surface. Plasma separated from whole blood becomes available at the second surface of the matrix and can be tested for the presence of a particular analyte, such as glucose or fructosamine, as provided by multi-layer test devices of the present invention.

Inventors

  • 👤 Gebhard Neyer

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-08 14:15
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/5002; B; B01; B01D; B01D39/00; B01D39/14; B01D39/16; B01D39/1607; B01D39/1623; B01D39/18; B01D69/00; B01D69/10; B01D69/107; B01D69/1071; D; D04; D04H; D04H1/00; D04H1/40; D04H1/42; D04H1/4326; D04H1/435; D04H13/00; G01N33/52; G01N33/525; G01N33/526; G01N33/66; Y; Y10; Y10T; Y10T436/00; Y10T436/25; Y10T436/25375; Y10T436/255

Claims Analysis

Total Claims: 35
Claim 1
Independent Claim 111 words
A process for separating plasma from a whole blood sample, comprising: (a) applying the whole blood sample to a first surface of a permeable non-glass fiber matrix containing (1) a C 3 to C 20 polyhydroxy alcohol capable of clumping red blood cells and (2) a polycationic polymer, said matrix being porous to red blood cells in the absence of said polyhydroxy alcohol; (b) flowing said whole blood sample under conditions which allow said sample to flow vertically toward a second surface of said matrix, said first and second surfaces being on opposite sides of said matrix; and (c) receiving plasma separated from said whole blood sample at said second surface.
Claim 2
Dependent Claim 111 words
A process for separating plasma from a whole blood sample, comprising: (a) applying the whole blood sample to a first surface of a permeable non-glass fiber matrix containing (1) a C 3 to C 20 polyhydroxy alcohol capable of clumping red blood cells and (2) a polycationic polymer, said matrix being porous to red blood cells in the absence of said polyhydroxy alcohol; (b) flowing said whole blood sample under conditions which allow said sample to flow vertically toward a second surface of said matrix, said first and second surfaces being on opposite sides of said matrix; and (c) receiving plasma separated from said whole blood sample at said second surface.
Claim 3
Dependent Claim 12 words
The process of claim 1, wherein the polycationic polymer is hexadimethrine bromide.
Claim 4
Dependent Claim 15 words
The process of claim 1, wherein said matrix is supported by a permeable filter material.
Claim 5
Dependent Claim 30 words
The process of claim 3, wherein the permeable filter material is a reagent layer containing at least one chemical reagent for determining the presence of an analyte in the plasma.
Claim 6
Dependent Claim 13 words
The process of claim 4, wherein said chemical reagent provides a color determination.
Claim 7
Dependent Claim 16 words
The process of claim 4, wherein determining the presence of an analyte is a quantitative determination.
Claim 8
Dependent Claim 30 words
The process of claim 3, wherein the permeable filter material is selected from the group consisting of a nylon, a cellulose acetate, a polysulfone, a synthetic fiber, and a polycarbonate.
Claim 9
Dependent Claim 14 words
The process of claim 1, wherein the polyhydroxy alcohol is impregnated in the matrix.
Claim 10
Dependent Claim 24 words
The process of claim 1, wherein the matrix is selected from the group consisting of a polyester, a nylon, a rayon, and a cotton.
Claim 11
Dependent Claim 13 words
The process of claim 1, wherein the matrix is a non-woven, non-absorbent polyester.
Claim 12
Dependent Claim 12 words
The process of claim 10, wherein the polyester is a poly(paraphenylene terephthalate).
Claim 13
Dependent Claim 17 words
The process of claim 1, wherein the polyhydroxy alcohol is present in a concentration of about 10%.
Claim 14
Independent Claim 101 words
A device for separating plasma from a whole blood sample, comprising a permeable non-glass fiber matrix containing (1) a C 3 to C 20 polyhydroxy alcohol capable of clumping red blood cells and (2) a polycationic polymer, said matrix being porous to red blood cells in the absence of said polyhydroxy alcohol, said matrix further having a first surface and a second surface which are on opposite sides of said matrix, wherein the whole blood sample vertically flows from said first surface toward said second surface and wherein plasma separated from a whole blood sample becomes available at said second surface.
Claim 15
Independent Claim 101 words
A device for separating plasma from a whole blood sample, comprising a permeable non-glass fiber matrix containing (1) a C 3 to C 20 polyhydroxy alcohol capable of clumping red blood cells and (2) a polycationic polymer, said matrix being porous to red blood cells in the absence of said polyhydroxy alcohol, said matrix further having a first surface and a second surface which are on opposite sides of said matrix, wherein the whole blood sample vertically flows from said first surface toward said second surface and wherein plasma separated from a whole blood sample becomes available at said second surface.
Claim 16
Dependent Claim 12 words
The device of claim 13, wherein the polycationic polymer is hexadimethrine bromide.
Claim 17
Dependent Claim 15 words
The device of claim 13, wherein the matrix is supported by a permeable filter material.
Claim 18
Dependent Claim 30 words
The device of claim 15, wherein the permeable filter material is a reagent layer containing at least one chemical reagent for determining the presence of an analyte in the plasma.
Claim 19
Dependent Claim 30 words
The device of claim 15, wherein the permeable filter material is selected from the group consisting of a nylon, a cellulose acetate, a polysulfone, a synthetic fiber, and a polycarbonate.
Claim 20
Dependent Claim 14 words
The device of claim 13, wherein the polyhydroxy alcohol is impregnated in the matrix.
Claim 21
Dependent Claim 24 words
The device of claim 13, wherein the matrix is selected from the group consisting of a polyester, a nylon, a rayon, and a cotton.
Claim 22
Dependent Claim 13 words
The device of claim 13, wherein the matrix is a non-woven, non-absorbent polyester.
Claim 23
Dependent Claim 12 words
The device of claim 20, wherein the polyester is a poly(paraphenylene terephthalate).
Claim 24
Dependent Claim 17 words
The device of claim 13, wherein the polyhydroxy alcohol is present in a concentration of about 10%.
Claim 25
Independent Claim 95 words
A device for separating plasma from a whole blood sample, comprising: (a) a non-woven, non-absorbent polyester matrix impregnated with mannitol and hexadimethrine bromide, said matrix being porous to red blood cells in the absence of said mannitol and said matrix further having a first surface and a second surface which are on opposite sides of said matrix, wherein the whole blood sample vertically flows from said first surface toward said second surface and wherein plasma separated from the whole blood sample becomes available at said second surface; and (b) a nylon membrane supporting said matrix.
Claim 26
Independent Claim 95 words
A device for separating plasma from a whole blood sample, comprising: (a) a non-woven, non-absorbent polyester matrix impregnated with mannitol and hexadimethrine bromide, said matrix being porous to red blood cells in the absence of said mannitol and said matrix further having a first surface and a second surface which are on opposite sides of said matrix, wherein the whole blood sample vertically flows from said first surface toward said second surface and wherein plasma separated from the whole blood sample becomes available at said second surface; and (b) a nylon membrane supporting said matrix.
Claim 27
Dependent Claim 15 words
The device of claim 23, wherein mannitol is present in a concentration of about 10%.
Claim 28
Dependent Claim 99 words
A process for separating plasma from a whole blood sample, comprising: (a) applying the whole blood sample to a first surface of a permeable non-glass fiber matrix containing (1) a C 3 to C 20 polyhydroxy alcohol capable of clumping red blood cells and (2) a polycationic polymer, said matrix being porous to red blood cells in the absence of said polyhydroxy alcohol; (b) flowing said whole blood sample under conditions which allow said sample to flow directionally toward a second surface of said matrix; and (c) receiving plasma separated from said whole blood sample at said second surface.
Claim 29
Dependent Claim 99 words
A process for separating plasma from a whole blood sample, comprising: (a) applying the whole blood sample to a first surface of a permeable non-glass fiber matrix containing (1) a C 3 to C 20 polyhydroxy alcohol capable of clumping red blood cells and (2) a polycationic polymer, said matrix being porous to red blood cells in the absence of said polyhydroxy alcohol; (b) flowing said whole blood sample under conditions which allow said sample to flow directionally toward a second surface of said matrix; and (c) receiving plasma separated from said whole blood sample at said second surface.
Claim 30
Dependent Claim 20 words
The process of claim 25, wherein the polyhydroxy alcohol is mannitol and further wherein the polycationic polymer is hexadimethrine bromide.
Claim 31
Dependent Claim 17 words
The process of claim 25, wherein the polyhydroxy alcohol is present in a concentration of about 10%.
Claim 32
Independent Claim 97 words
A device for separating plasma from a whole blood sample, comprising a permeable non-glass fiber matrix containing (1) a C 3 to C 20 polyhydroxy alcohol capable of clumping red blood cells and (2) a polycationic polymer, said matrix being porous to red blood cells in the absence of said polyhydroxy alcohol, said matrix further having a first surface and a second surface, wherein the whole blood sample is applied to said first surface and flows directionally toward said second surface and further wherein plasma separated from a whole blood sample becomes available at said second surface.
Claim 33
Independent Claim 97 words
A device for separating plasma from a whole blood sample, comprising a permeable non-glass fiber matrix containing (1) a C 3 to C 20 polyhydroxy alcohol capable of clumping red blood cells and (2) a polycationic polymer, said matrix being porous to red blood cells in the absence of said polyhydroxy alcohol, said matrix further having a first surface and a second surface, wherein the whole blood sample is applied to said first surface and flows directionally toward said second surface and further wherein plasma separated from a whole blood sample becomes available at said second surface.
Claim 34
Dependent Claim 20 words
The device of claim 28, wherein the polyhydroxy alcohol is mannitol and further wherein the polycationic polymer is hexadimethrine bromide.
Claim 35
Dependent Claim 17 words
The process of claim 28, wherein the polyhydroxy alcohol is present in a concentration of about 10%.

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Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2001-03-09 2001-09-08 2002-03-10 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2005-03-09 2005-09-08 2006-03-10 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2009-03-09 2009-09-08 2010-03-10 $7700.00 Window Closed / Lapsed

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