US5077012A — Device for detecting disease markers

Claim 1

Independent Claim 67 words

An apparatus for testing biological fluids and/or particulate matter comprising a fluid container, a specimen test assembly moveably mounted in said fluid container, said specimen test assembly comprising piston means with a membrane provided with immobilized antibodies and cytology means including a cytology membrane for capturing a biological mass for quantitative analysis, said piston means membrane with immobilized antibodies capturing a predetermined antigen mass for qualitative analysis.

Claim 2

Independent Claim 67 words

An apparatus for testing biological fluids and/or particulate matter comprising a fluid container, a specimen test assembly moveably mounted in said fluid container, said specimen test assembly comprising piston means with a membrane provided with immobilized antibodies and cytology means including a cytology membrane for capturing a biological mass for quantitative analysis, said piston means membrane with immobilized antibodies capturing a predetermined antigen mass for qualitative analysis.

Claim 3

Independent Claim 81 words

An apparatus for testing biological fluids and/or particulate matter comprising a fluid container with removable cytology cup means, a specimen test assembly moveably mounted in said fluid container, said specimen test assembly comprising piston means, a membrane assembly mounted in said piston means, said membrane assembly including a membrane means provided with immobilized antibodies selected to capture a predetermined antigen mass and a housing means removably mounted to said membrane assembly, said housing means comprising a housing containing fluid filter means.

Claim 4

Independent Claim 81 words

An apparatus for testing biological fluids and/or particulate matter comprising a fluid container with removable cytology cup means, a specimen test assembly moveably mounted in said fluid container, said specimen test assembly comprising piston means, a membrane assembly mounted in said piston means, said membrane assembly including a membrane means provided with immobilized antibodies selected to capture a predetermined antigen mass and a housing means removably mounted to said membrane assembly, said housing means comprising a housing containing fluid filter means.

Claim 5

Dependent Claim 37 words

An apparatus for testing biological fluids and/or particulate matter as claimed in claim 2, wherein said fluid container comprises a syringe barrel and said cytology cup means is removably mounted to one end of said syringe barrel.

Claim 6

Dependent Claim 33 words

An apparatus for testing biological fluids and/or particulate matter as claimed in claim 3, wherein said cytology cup means is provided with fluid container holding means and housing means for a cytology membrane.

Claim 7

Dependent Claim 55 words

An apparatus for testing biological fluids as and/or particulate matter claimed in claim 4, wherein said cup housing means comprises an open ended barrel with a cap removably seated in an aperture defined by said cytology cup means with the open end of the barrel extending into a chamber defined by said cytology cup means.

Claim 8

Dependent Claim 53 words

An apparatus for testing biological fluids and/or particulate matter as claimed in claim 2, wherein said housing means comprises a cylindrical housing, a flange means mounted to said housing and extending outward from said cylindrical housing and end members covering both ends of said cylindrical housing, said end members allowing fluid flow therethrough.

Claim 9

Dependent Claim 24 words

An apparatus for testing biological fluids and/or particulate matter as claimed in claim 2 wherein said housing means holds beads provided with immobilized antibodies.

Claim 10

Dependent Claim 22 words

An apparatus for testing biological fluids and/or particulate matter as claimed in claim 2 wherein said housing means holds a filtration membrane.

Claim 11

Dependent Claim 33 words

An apparatus for testing biological fluids and/or particulate matter as claimed in claim 6, wherein said flange means comprises a saucer shaped member extending outward from the outer surface of said cylindrical barrel.

Claim 12

Dependent Claim 32 words

An apparatus for testing biological fluids and/or particulate matter as claimed in claim 9, wherein said saucer shaped member has a flat rim and defines fluid flow means allowing fluid flow therethrough.

Claim 13

Dependent Claim 65 words

An apparatus for testing biological fluids and/or particulate matter as claimed in claim 2, wherein said piston means comprises a piston barrel defining a chamber, a cap member mounted over one end of said piston barrel and an end support means formed on the other end of said piston barrel, said end support means defining an aperture therein allowing fluid flow into said barrel chamber.

Claim 14

Dependent Claim 30 words

An apparatus for testing biological fluids and/or particulate matter as claimed in claim 2, wherein a prelabelled antibody is added to a body fluid sample held in said fluid container.

Claim 15

Dependent Claim 34 words

An apparatus for testing biological fluids and/or particulate matter as claimed in claim 12, wherein buffer reagents are added to said body fluid sample along with said prelabelled antibody held in said fluid container.

Claim 16

Dependent Claim 40 words

An apparatus for testing biological fluids and/or particulate matter as claimed in claim 5, wherein a cytology membrane is seated at the bottom of the barrel on t he barrel cap to capture cells at the end of the assay.

Claim 17

Dependent Claim 24 words

An apparatus for testing biological fluids and/or particulate matter as claimed in claim 2 wherein said housing means holds beads provided with immobilized antibodies.

Claim 18

Dependent Claim 28 words

An apparatus for testing biological fluids and/or particulate matter as claimed in claim 2 wherein said membrane is polycarbonate with a pore size of 2.0 um or less.

Claim 19

Dependent Claim 23 words

An apparatus for testing biological fluids and/or particulate matter as claimed in claim 2 wherein said membrane is coated with a hydrophilic surface.

Claim 20

Independent Claim 165 words

An apparatus for collecting biological fluids and holding samples taken from a biological fluid for testing comprising a tubular container open at both ends, a quantitative test storage unit removably secured to one of said tubular container ends, said quantitative test storage unit having an open end, a cytology membrane mounted in said storage unit and retaining means defined by said storage unit, a shuttle assembly slidably mounted in said tubular container, said shuttle assembly comprising a cylindrical hollow piston, defining a chamber, a cover means covering one end of said piston and fluid flow means formed in said piston and a qualitative sample container means removably secured to said piston, said qualitative sample container means comprising a clip on membrane assembly including a membrane containing immobilized antibodies and filter housing means mounted to said clip on membrane assembly, said filter housing means being adapted to be seated in said quantitative test storage unit after being slidably transported along said tubular container by said piston.

Claim 21

Independent Claim 165 words

An apparatus for collecting biological fluids and holding samples taken from a biological fluid for testing comprising a tubular container open at both ends, a quantitative test storage unit removably secured to one of said tubular container ends, said quantitative test storage unit having an open end, a cytology membrane mounted in said storage unit and retaining means defined by said storage unit, a shuttle assembly slidably mounted in said tubular container, said shuttle assembly comprising a cylindrical hollow piston, defining a chamber, a cover means covering one end of said piston and fluid flow means formed in said piston and a qualitative sample container means removably secured to said piston, said qualitative sample container means comprising a clip on membrane assembly including a membrane containing immobilized antibodies and filter housing means mounted to said clip on membrane assembly, said filter housing means being adapted to be seated in said quantitative test storage unit after being slidably transported along said tubular container by said piston.

Claim 22

Independent Claim 173 words

An apparatus for collecting biological fluids and holding a biological sample for testing comprising an open ended tubular container; a cytology cup means removably secured to one of said tubular container ends to form a closed container which can hold biological fluid, said cytology cup means comprising a body, cytology membrane holding means mounted to said body, a membrane held by said cytology membrane holding means and locking means secured to said body, said locking means being adapted to lock onto one end of said tubular container, a shuttle assembly slidably mounted in said tubular container, said shuttle assembly comprising a cylindrical hollow piston defining a chamber with fluid flow means and a testing means removably mounted to said piston, said testing means comprising a housing provided with means to allow fluid flow therethrough and sample holding membrane means removably mounted to said housing, said sample holding means capturing biological specimens from the biological fluid flowing through the testing means housing by the action of the shuttle assembly moving in the tubular container.

Claim 23

Independent Claim 173 words

An apparatus for collecting biological fluids and holding a biological sample for testing comprising an open ended tubular container; a cytology cup means removably secured to one of said tubular container ends to form a closed container which can hold biological fluid, said cytology cup means comprising a body, cytology membrane holding means mounted to said body, a membrane held by said cytology membrane holding means and locking means secured to said body, said locking means being adapted to lock onto one end of said tubular container, a shuttle assembly slidably mounted in said tubular container, said shuttle assembly comprising a cylindrical hollow piston defining a chamber with fluid flow means and a testing means removably mounted to said piston, said testing means comprising a housing provided with means to allow fluid flow therethrough and sample holding membrane means removably mounted to said housing, said sample holding means capturing biological specimens from the biological fluid flowing through the testing means housing by the action of the shuttle assembly moving in the tubular container.

Claim 24

Independent Claim 170 words

An apparatus for collecting biological fluids and holding a biological sample for quantitative and qualitative testing comprising a container having open ends; a cytology cup removably secured to one end of said container, said cytology cup being provided with a stop rib and a cytology membrane, a piston assembly slidably mounted in said open ended container, said piston assembly comprising a hollow piston body with an internal surface defining a chamber, fluid flow means formed in said piston body providing fluid communication with said chamber, a cap member covering one end of said piston, said cap member being provided with locking means allowing it to be locked on to said container, fluid sample ligand capture means removably secured to said piston body, said ligand capture means comprising a cylindrical housing with one end defining an aperture allowing body fluid flow therethrough to contact a membrane with immobilized ligands, said ligand capture means being adapted to visually indicate the presence of specific biological components on designated areas of a membrane surface.

Claim 25

Independent Claim 170 words

An apparatus for collecting biological fluids and holding a biological sample for quantitative and qualitative testing comprising a container having open ends; a cytology cup removably secured to one end of said container, said cytology cup being provided with a stop rib and a cytology membrane, a piston assembly slidably mounted in said open ended container, said piston assembly comprising a hollow piston body with an internal surface defining a chamber, fluid flow means formed in said piston body providing fluid communication with said chamber, a cap member covering one end of said piston, said cap member being provided with locking means allowing it to be locked on to said container, fluid sample ligand capture means removably secured to said piston body, said ligand capture means comprising a cylindrical housing with one end defining an aperture allowing body fluid flow therethrough to contact a membrane with immobilized ligands, said ligand capture means being adapted to visually indicate the presence of specific biological components on designated areas of a membrane surface.

Claim 26

Dependent Claim 74 words

An apparatus for collecting biological fluid and removing a biological sample from the fluid for quantitative and qualitative testing as claimed in claim 20 wherein said fluid sample ligand capture means includes a filter housing mounted to said cylindrical housing and filter means seated in said filter housing to filter out predetermined sized biological components carried by the biological fluid and prevent said predetermined sized components from contacting the biological sample capture means membrane.

Claim 27

Dependent Claim 13 words

An apparatus as claimed in claim 20 wherein said biological fluid is urine.

Claim 28

Dependent Claim 13 words

An apparatus as claimed in claim 20 wherein said biological fluid is blood.

Claim 29

Dependent Claim 27 words

An apparatus as claimed in claim 20 wherein said biological fluid sample capture means comprises a polycarbonate membrane with a pore size of 2.0 um of less.

Claim 30

Independent Claim 119 words

An apparatus for testing biological fluids and particulate matter comprising a fluid container with removable cytology cup means, a specimen test assembly moveably mounted in said fluid container, said specimen test assembly comprising piston means, a membrane assembly mounted in said piston means, said membrane assembly comprising a cup shaped housing with a funnel shaped end wall defining an aperture therein and seat means surrounding said aperture, a membrane means is mounted to said housing and seated on said seat means covering said aperture, said membrane means being provided with immobilized antibodies selected to capture a predetermined antigen mass and a housing means removably mounted to said membrane assembly, said housing means comprising a housing containing fluid filter means.

Claim 31

Independent Claim 119 words

An apparatus for testing biological fluids and particulate matter comprising a fluid container with removable cytology cup means, a specimen test assembly moveably mounted in said fluid container, said specimen test assembly comprising piston means, a membrane assembly mounted in said piston means, said membrane assembly comprising a cup shaped housing with a funnel shaped end wall defining an aperture therein and seat means surrounding said aperture, a membrane means is mounted to said housing and seated on said seat means covering said aperture, said membrane means being provided with immobilized antibodies selected to capture a predetermined antigen mass and a housing means removably mounted to said membrane assembly, said housing means comprising a housing containing fluid filter means.

Claim 32

Dependent Claim 77 words

An apparatus for testing biological fluids and/or particulate matter as claimed in claim 25, wherein said membrane means comprises a curved spring loaded plastic clip member defining a channel and constructed to engage said cup shaped housing, a membrane provided with immobilized antibodies is mounted on said spring loaded plastic clip member and an "O" ring is mounted on said spring loaded plastic clip member in said channel holding said membrane means on said cup shaped housing.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1994-12-30	1995-07-01	1995-12-31	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	1998-12-30	1999-07-01	1999-12-31	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2002-12-30	2003-07-01	2003-12-31	$7700.00	Window Closed / Lapsed

Device for detecting disease markers

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