US4689309A
Expired / Lapsed
US
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Test device, method of manufacturing same and method of determining a component in a sample
Assignee: Bayer Corp
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Filing: 1985-09-30
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Granted: 1987-08-25
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Expires: 2005-09-30
Abstract
Abstract A method of manufacturing the test device and method of determining the presence and relative concentration of a component in a test sample. The device includes a carrier matrix incorporated with a reactant system capable of interacting with a sample component to produce a detectable response. For home use, the reactant system produces a visibly detectable response. The carrier matrix of the device comprises a new and improved whole blood compatible, glucose-permeable strip or layer of a polymerizable silicone material. A reactant system is homogeneously mixed into the polymerizable carrier matrix prior to complete curing of the matrix, and the matrix then is cured to hold the reactant system homogeneously throughout the carrier matrix in a known concentration while maintaining matrix penetrability of the predetermined component after complete curing of the carrier matrix. The carrier matrix is formed from a dispersion of a polymerizable silicon-containing compound applied in an incompletely cured from in a liquid carrier containing a homogeneously mixed reactant system.
Inventors
- 👤 James E. Jones
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-09 14:31
CPC Classifications
A; A61; A61B; A61B5/00; A61B5/145; A61B5/14507; A61B5/14517; A61B5/14521; A61B5/14532; C; C12; C12Q; C12Q1/00; C12Q1/54; G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/52; G01N33/521; Y; Y10; Y10S; Y10S435/00; Y10S435/805; Y10T; Y10T436/00; Y10T436/14; Y10T436/142222; Y10T436/143333; Y10T436/144444
Claims Analysis
Total Claims: 44
Claim 1
Independent Claim
67 words
A test article for detecting the relative concentration of glucose in a test fluid comprising a matrix layer polymerized from a polymerizable compound dispersed in a carrier liquid and having homogeneously incorporated therein a reagent system capable of reaction with glucose in said test fluid to produce a detectable change in said matrix layer, and wherein said polymerizable compound is a glucose permeable, silicone water-based elastomer compound.
Claim 2
Dependent Claim
67 words
A test article for detecting the relative concentration of glucose in a test fluid comprising a matrix layer polymerized from a polymerizable compound dispersed in a carrier liquid and having homogeneously incorporated therein a reagent system capable of reaction with glucose in said test fluid to produce a detectable change in said matrix layer, and wherein said polymerizable compound is a glucose permeable, silicone water-based elastomer compound.
Claim 3
Dependent Claim
24 words
The test article of claim 1 wherein said matrix layer, when dried, is impermeable to hemoglobin and other coloring bodies found in whole blood.
Claim 4
Dependent Claim
56 words
The test article of claim 1 wherein the reagent system comprises a catalyst capable of causing a reaction with glucose to produce hydrogen peroxide; a substance having peroxidative activity. and a compound capable of reaction to a colored form or reaction to change color in the presence of hydrogen peroxide and a material having peroxidative activity.
Claim 5
Dependent Claim
15 words
The test article of claim 3 wherein said catalyst is glucose oxidase or glucose dehydrogenase.
Claim 6
Dependent Claim
16 words
The test article of claim 1 wherein the glucose permeable, silocone water-based compound comprises an organosiloxane.
Claim 7
Dependent Claim
13 words
The test article of claim 5 wherein the organosiloxane compound comprises a diorganosiloxane.
Claim 8
Dependent Claim
12 words
The test article of claim 6 wherein the diorganosiloxane comprises a dimethylsiloxane.
Claim 9
Dependent Claim
14 words
The test article of claim 6 wherein the diorganosiloxane compound comprises an endblocked diorganosiloxane.
Claim 10
Dependent Claim
18 words
The test article of claim 8 wherein the endblocked diorganosiloxane compound comprises a vinyl or hydroxy endblocked diorganosiloxane.
Claim 11
Dependent Claim
82 words
A reagent strip for sensing the presence of a chemical compound in a liquid, comprising: a silicone water-based polymerizable material permeable to a liquid chemical compound and including a reagent system incorporated homogeneously into the silicone water-based material, said reagent system including a catalyst capable of causing reaction of the chemical compound to produce H 2 O 2 , and a material capable of reaction with the H 2 O 2 to produce a detectable color change in said silicone water-based material.
Claim 12
Dependent Claim
82 words
A reagent strip for sensing the presence of a chemical compound in a liquid, comprising: a silicone water-based polymerizable material permeable to a liquid chemical compound and including a reagent system incorporated homogeneously into the silicone water-based material, said reagent system including a catalyst capable of causing reaction of the chemical compound to produce H 2 O 2 , and a material capable of reaction with the H 2 O 2 to produce a detectable color change in said silicone water-based material.
Claim 13
Dependent Claim
15 words
The reagent strip of claim 10 wherein said catalyst is glucose oxidase or glucose dehydrogenase.
Claim 14
Dependent Claim
17 words
The reagent strip of claim 10 wherein said silicone water-based polymerizable material is a silicone water-based elastomer.
Claim 15
Dependent Claim
87 words
An article for determining the relative concentration of glucose in a biological fluid comprising: a glucose-permeable polymerized layer formed from a layer of a dispersed, polymerizable silicone water-based elastomer in a removable carrier liquid, said silicone elastomer being substantially immiscible in said carrier liquid, and a portion of said carrier liquid being removed during polymerization of said silicone elastomer in dispersed, layered form; and a glucose reagent system incorporated into said layer of disperesed, polymerizable silicone water-based elastomer by mixing said reagent system into said carrier liquid.
Claim 16
Dependent Claim
87 words
An article for determining the relative concentration of glucose in a biological fluid comprising: a glucose-permeable polymerized layer formed from a layer of a dispersed, polymerizable silicone water-based elastomer in a removable carrier liquid, said silicone elastomer being substantially immiscible in said carrier liquid, and a portion of said carrier liquid being removed during polymerization of said silicone elastomer in dispersed, layered form; and a glucose reagent system incorporated into said layer of disperesed, polymerizable silicone water-based elastomer by mixing said reagent system into said carrier liquid.
Claim 17
Independent Claim
194 words
A method of manufacturing a test article for determining the presence of a predetermined chemical compound in a test fluid comprising: mixing a predetermined quantity of a reagent composition into an incompletely cured silicone polymerizable material dispersed in a removable carrier liquid to form a reagent containing matrix material; forming said reagent-containing matrix material into a layer on a support surface; and drying said layer and polymerizing said silicone polymerizable material on said support surface while removing said carrier liquid to form a dried matrix material layer permeable to a predetermined chemical compound and containing reagent composition capable of reaction with the predetermined chemical compound in a test fluid when the predetermined chemical compound penetrates into said dried matrix material layer; wherein a catalyst is added to the reagent containing matrix material, said catalyst capable of causing a reaction with the predetermined chemical compound in the test fluid to produce hydrogen peroxide; a substance having peroxidative activity is added to the reagent containing matrix material; and a compound capable of reaction to a colored form or reaction to change color in the presence of hydrogen peroxide is added to the regaent containing matrix material.
Claim 18
Independent Claim
194 words
A method of manufacturing a test article for determining the presence of a predetermined chemical compound in a test fluid comprising: mixing a predetermined quantity of a reagent composition into an incompletely cured silicone polymerizable material dispersed in a removable carrier liquid to form a reagent containing matrix material; forming said reagent-containing matrix material into a layer on a support surface; and drying said layer and polymerizing said silicone polymerizable material on said support surface while removing said carrier liquid to form a dried matrix material layer permeable to a predetermined chemical compound and containing reagent composition capable of reaction with the predetermined chemical compound in a test fluid when the predetermined chemical compound penetrates into said dried matrix material layer; wherein a catalyst is added to the reagent containing matrix material, said catalyst capable of causing a reaction with the predetermined chemical compound in the test fluid to produce hydrogen peroxide; a substance having peroxidative activity is added to the reagent containing matrix material; and a compound capable of reaction to a colored form or reaction to change color in the presence of hydrogen peroxide is added to the regaent containing matrix material.
Claim 19
Dependent Claim
36 words
The method of claim 14 wherein the test fluid comprises a biological fluid and the predetermined chemical compound comprises glucose, and said catalyst capable of causing a glucose reaction to form hydrogen peroxide is glucose oxidase.
Claim 20
Dependent Claim
23 words
The method of claim 14 wherein the predetermined chemical compound comprises an alcohol and said reagent system includes alcohol oxidase as a catalyst.
Claim 21
Dependent Claim
22 words
The method of claim 14 wherein the predetermined chemical compound comprises cholesterol and said reagent system includes cholesterol oxidase as a catalyst.
Claim 22
Dependent Claim
21 words
The method claim 14 wherein the predetermined chemical compound comprises uric acid and said reagent system includes urease as a catalyst.
Claim 23
Dependent Claim
14 words
The method of claim 14 wherein said catalyst is glucose oxidase or glucose dehydrogenase.
Claim 24
Dependent Claim
13 words
The method of claim 14 wherein the silicone polymerizable material comprises an organosiloxane.
Claim 25
Dependent Claim
12 words
The method of claim 20 wherein the organosiloxane material comprises a diorganosiloxane.
Claim 26
Dependent Claim
13 words
The method of claim 21 wherein the diorganosiloxane material comprises an endblocked diorganosiloxane.
Claim 27
Dependent Claim
16 words
The method of claim 21 wherein the diorganosiloxane material comprises a vinyl or hydroxy endblocked diorganosiloxane.
Claim 28
Dependent Claim
12 words
The method of claim 21 wherein the diorganosiloxane material comprises a dimethylsiloxane.
Claim 29
Independent Claim
155 words
A method of measuring the concentration of a predetermined chemical compound in a test fluid comprising: mixing a predetermined quantity of a reagent composition into an incompletely cured silicone polymerizable material dispersed in a removable carrier liquid to form a reagent-containing matrix material permeable to a predetermined chemical compound in a test fluid; forming said reagent-containing matrix material into a layer; and drying said layer and polymerizing said polymerizable material while removing said carrier liquid to form a dried matrix material layer permeable to said predetermined chemical compound and containing a reagent composition capable of reaction with said predetermined chemical compound when said predetermined chemical compound penetrates into said dried matrix material layer; contacting a surface of said dried matrix material layer with said test fluid to cause a visibly detectable color change in said matrix material layer; and determining the concentration of said predetermined chemical compound based upon the degree of said color change.
Claim 30
Independent Claim
155 words
A method of measuring the concentration of a predetermined chemical compound in a test fluid comprising: mixing a predetermined quantity of a reagent composition into an incompletely cured silicone polymerizable material dispersed in a removable carrier liquid to form a reagent-containing matrix material permeable to a predetermined chemical compound in a test fluid; forming said reagent-containing matrix material into a layer; and drying said layer and polymerizing said polymerizable material while removing said carrier liquid to form a dried matrix material layer permeable to said predetermined chemical compound and containing a reagent composition capable of reaction with said predetermined chemical compound when said predetermined chemical compound penetrates into said dried matrix material layer; contacting a surface of said dried matrix material layer with said test fluid to cause a visibly detectable color change in said matrix material layer; and determining the concentration of said predetermined chemical compound based upon the degree of said color change.
Claim 31
Dependent Claim
12 words
The method of claim 25 wherein said test fluid is whole blood.
Claim 32
Dependent Claim
37 words
The method of claim 26 further including wiping or washing the test fluid contacted surface to remove any substantial amount of hemoglobin and other coloring bodies found in said whole blood prior to determining the color change.
Claim 33
Independent Claim
157 words
A method of manufacturing a test device including a continuous layer of a silicone containing polymer permeable to a predetermined chemical compound while screening out hemoglobin and other coloring bodies found in whole blood comprising: dispersing a polymerizable silicone containing compound in removable carrier liquid to form an incompletely cured polymerizable layer forming composition, said silicone containing compound being substantially immiscible in said carrier liquid; adding a reagent composition to said polymerizable layer forming a composition capable of interaction with a predetermined chemical compound to produce a detectable color change in said polymerizable layer; applying said incompletely cured polymerizable layer forming composition containing said reagent composition onto a support surface; and polymerizing said silicone containing compound while in layer form and removing at least a portion of the carrier liquid during polymerization of the silicone containing compound in dispersed, layered form, to form a cured, continuous polymerized silicone containing compound layer permeable to said predetermined chemical compound.
Claim 34
Independent Claim
157 words
A method of manufacturing a test device including a continuous layer of a silicone containing polymer permeable to a predetermined chemical compound while screening out hemoglobin and other coloring bodies found in whole blood comprising: dispersing a polymerizable silicone containing compound in removable carrier liquid to form an incompletely cured polymerizable layer forming composition, said silicone containing compound being substantially immiscible in said carrier liquid; adding a reagent composition to said polymerizable layer forming a composition capable of interaction with a predetermined chemical compound to produce a detectable color change in said polymerizable layer; applying said incompletely cured polymerizable layer forming composition containing said reagent composition onto a support surface; and polymerizing said silicone containing compound while in layer form and removing at least a portion of the carrier liquid during polymerization of the silicone containing compound in dispersed, layered form, to form a cured, continuous polymerized silicone containing compound layer permeable to said predetermined chemical compound.
Claim 35
Dependent Claim
17 words
The method of claim 28 including stripping the polymerized silicone containing compound layer from said support surface.
Claim 36
Dependent Claim
16 words
The method of claim 28 wherein said support surface comprises a continuous sheet of polyethylene terephthalate.
Claim 37
Dependent Claim
37 words
The method of claim 28 including adding a polymerization initiator to said incompletely cured polymerizable layer forming composition and heating said polymerizable layer forming composition to temperature above above ambient to remove the carrier liquid during polymerization.
Claim 38
Dependent Claim
35 words
The method of claim 28 including adding an emulsifying agent to said incompletely cured membrane composition and emulsifying said polymerizable layer forming composition prior to applying said incompletely cured polymerizable layer onto the support layer.
Claim 39
Dependent Claim
28 words
The method of claim 28 wherein the carrier liquid comprises at least 5% by weight of the incompletely cured polymerizable layer forming composition prior to completion of polymerization.
Claim 40
Dependent Claim
14 words
The method of claim 28 wherein the polymerizable silicone containing compound is an organosiloxane.
Claim 41
Dependent Claim
12 words
The method of claim 34 wherein the organosiloxane compound is a diorganosiloxane.
Claim 42
Dependent Claim
11 words
The method of claim 35 wherein the diorganosiloxane is a dimethylpolysiloxane.
Claim 43
Dependent Claim
13 words
The method of claim 35 wherein the diorganosiloxane compound is an endblocked diorganosiloxane.
Claim 44
Dependent Claim
17 words
The method of claim 37 wherein the endblocked diorganosiloxane compound is a vinyl or hydroxy endblocked diorganopolysiloxane.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1990-08-24 | 1991-02-23 | 1991-08-25 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1994-08-24 | 1995-02-23 | 1995-08-25 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1998-08-24 | 1999-02-23 | 1999-08-25 | $7700.00 | Window Closed / Lapsed |