US6036659A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Collection device for biological samples and methods of use
Assignee: HealthPoint Diagnostix Inc
•
Filing: 1998-10-09
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Granted: 2000-03-14
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Expires: 2018-10-09
Abstract
Abstract A device for remote-site biological sample collection for laboratory analysis is described. The device can be made in several configurations which all include separate members for collecting and separating the biological sample into its desired components which are detected or measured. Methods of use for the device are also described.
Inventors
- 👤 Robert A. Ray
- 👤 Robert Stangarone
- 👤 Julie Peddicord
- 👤 Raul Sarzo
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-08 13:39
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/483; G01N33/487; G01N33/49; G01N33/491; B; B01; B01L; B01L3/00; B01L3/50; B01L3/502; B01L3/5023; B01L2200/00; B01L2200/02; B01L2200/026; B01L2300/00; B01L2300/06; B01L2300/0681; B01L2300/08; B01L2300/0809; B01L2300/0825; B01L2300/0861; B01L2300/0864; B01L2300/0887; B01L2400/00; B01L2400/04; B01L2400/0403; B01L2400/0406
Claims Analysis
Total Claims: 28
Claim 1
Independent Claim
99 words
A device for quantitative remote-site collection and drying of a liquid biological sample obtained from an individual for the purpose of mailing for recovery and laboratory analysis of an analyte contained in the biological sample, said device comprising: a separation member which selectively separates and retains an undesired component in the sample from a component of interest containing analyte; and a non-reactive collection member for collecting and drying the separated analyte-containing component of interest, wherein said dried collection member can be later at least partially removed from the device to recover the analyte-containing component for laboratory analysis of analyte.
Claim 2
Independent Claim
99 words
A device for quantitative remote-site collection and drying of a liquid biological sample obtained from an individual for the purpose of mailing for recovery and laboratory analysis of an analyte contained in the biological sample, said device comprising: a separation member which selectively separates and retains an undesired component in the sample from a component of interest containing analyte; and a non-reactive collection member for collecting and drying the separated analyte-containing component of interest, wherein said dried collection member can be later at least partially removed from the device to recover the analyte-containing component for laboratory analysis of analyte.
Claim 3
Dependent Claim
21 words
The device of claim 1 wherein the biological sample is whole blood and the component of interest is plasma or serum.
Claim 4
Dependent Claim
33 words
The device of claim 1 wherein the separation member is capable of separating and substantially permanently retaining cellular components in the biological sample without leaching of said cellular components into the collection member.
Claim 5
Dependent Claim
14 words
The device of claim 1 wherein the separation member is an absorbent filter material.
Claim 6
Dependent Claim
21 words
The device of claim 1 wherein the separation material is selected from glass fiber, glass fiber/cellulose mixtures, cellulose, or synthetic materials.
Claim 7
Dependent Claim
12 words
The device of claim 4 wherein the separation member is glass fiber.
Claim 8
Dependent Claim
35 words
The device of claim 1 wherein the collection member is made from a material selected from cellulose, polypropylene, nylon, polyester, modified polyester, polyethersulfone, nitrocellulose, high density polyethylene, or a composite of natural and synthetic fibers.
Claim 9
Dependent Claim
31 words
The device of claim 1 wherein at least one of said members is pre-treated with a reagent which facilitates the collection, separation, storage, transport, preservation, recovery, or analysis of the sample.
Claim 10
Dependent Claim
11 words
The device of claim 1 further comprising a substantially impermeable cover.
Claim 11
Dependent Claim
33 words
The device of claim 9 wherein said cover further comprises an aperture which is superimposed over the top face of a separation member when the cover is placed in position on the device.
Claim 12
Dependent Claim
28 words
The device of claim 1 further comprising a quantitation member in contact or fluid communication with the separation member for quantitatively delivering the sample to the separation member.
Claim 13
Dependent Claim
13 words
The device of claim 11 wherein the quantitation member is a capillary tube.
Claim 14
Dependent Claim
14 words
The device of claim 11, wherein the quantitation member is a non-absorbent screen material.
Claim 15
Dependent Claim
13 words
The device of claim 11, wherein the quantitation member is a track-etched membrane.
Claim 16
Dependent Claim
27 words
The device of claim 1 wherein the analyte is selected from bone alkaline phosphatase, cholesterol, triglyceride, high density lipoprotein, low density lipoprotein, fructosamine, and alanine amino transferase.
Claim 17
Dependent Claim
24 words
The device of claim 1 wherein said device comprises a plurality of collection members in contact or fluid communication with a single separation member.
Claim 18
Dependent Claim
14 words
The device of claim 1 wherein said device comprises a plurality of separation members.
Claim 19
Dependent Claim
19 words
The device of claim 1, said device further comprising an overflow member to absorb excess volume of liquid sample.
Claim 20
Independent Claim
193 words
A method for quantitative remote-site collection of a biological sample and laboratory analysis of an analyte in the sample, said method comprising: providing a collection device to an individual or a health care professional, said device comprising a separation member which selectively separates and retains an undesired component in the sample from the component of interest containing the analyte, and a separable collection member for collecting the analyte-containing component of interest which has been separated from the undesired component, wherein said separation member and collection member are in contact or fluid communication with one another for delivering the analyte-containing component of interest from the separation member to the collection member; applying the biological sample in liquid form to the device so that the analyte-containing component of interest is quantitatively collected onto the collection member; drying said collection member having the analyte-containing component of interest collected thereon; transporting the collection member to a facility for analysis of the analyte; removing the collection member from the device; eluting the analyte from the collection member; determining presence, absence, or concentration of the analyte; and reporting results of the analysis to the individual or health care professional.
Claim 21
Independent Claim
193 words
A method for quantitative remote-site collection of a biological sample and laboratory analysis of an analyte in the sample, said method comprising: providing a collection device to an individual or a health care professional, said device comprising a separation member which selectively separates and retains an undesired component in the sample from the component of interest containing the analyte, and a separable collection member for collecting the analyte-containing component of interest which has been separated from the undesired component, wherein said separation member and collection member are in contact or fluid communication with one another for delivering the analyte-containing component of interest from the separation member to the collection member; applying the biological sample in liquid form to the device so that the analyte-containing component of interest is quantitatively collected onto the collection member; drying said collection member having the analyte-containing component of interest collected thereon; transporting the collection member to a facility for analysis of the analyte; removing the collection member from the device; eluting the analyte from the collection member; determining presence, absence, or concentration of the analyte; and reporting results of the analysis to the individual or health care professional.
Claim 22
Dependent Claim
20 words
The method of claim 19 wherein the drying step can be completed before the step of removing the collection member.
Claim 23
Dependent Claim
15 words
The method of claim 19 further comprising identifying the individual and sample by a code.
Claim 24
Dependent Claim
20 words
The method of claim 19 wherein the elution step is modified according to the particular component of interest being determined.
Claim 25
Dependent Claim
24 words
The method of claim 19 wherein the step of determining presence, absence, or concentration of the analyte is modified according to said particular component.
Claim 26
Dependent Claim
127 words
A kit for quantitative remote-site collecting of a biological sample from a patient for laboratory analysis of said sample, said kit comprising: a device for quantitative remote-site collection and drying of a liquid biological sample obtained from an individual for the purpose of mailing for recovery and laboratory analysis of an analyte contained in the biological sample; a separation member which selectively separates and retains an undesired component in the sample from a component of interest containing analyte; a non-reactive collection member for collecting and drying the separated analyte-containing component of interest, wherein said dried collection member can be later at least partially removed from the device to recover the analyte-containing component for laboratory analysis of analyte; and an information card for providing information about the patient.
Claim 27
Dependent Claim
127 words
A kit for quantitative remote-site collecting of a biological sample from a patient for laboratory analysis of said sample, said kit comprising: a device for quantitative remote-site collection and drying of a liquid biological sample obtained from an individual for the purpose of mailing for recovery and laboratory analysis of an analyte contained in the biological sample; a separation member which selectively separates and retains an undesired component in the sample from a component of interest containing analyte; a non-reactive collection member for collecting and drying the separated analyte-containing component of interest, wherein said dried collection member can be later at least partially removed from the device to recover the analyte-containing component for laboratory analysis of analyte; and an information card for providing information about the patient.
Claim 28
Dependent Claim
26 words
The kit of claim 24 wherein said kit further comprises a component selected from a lancet, antiseptic swab, and packaging means for transporting the collected sample.
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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) | 2003-03-14 | 2003-09-13 | 2004-03-14 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2007-03-14 | 2007-09-13 | 2008-03-14 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2011-03-14 | 2011-09-13 | 2012-03-14 | $7700.00 | Window Closed / Lapsed |