US6206841B1
Expired / Lapsed
US
⏱️ 0.0 years remaining
Method and apparatus for obtaining blood for diagnostic tests
Assignee: Abbott Laboratories
•
Filing: 2000-04-11
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Granted: 2001-03-27
•
Expires: 2020-04-11
Abstract
Abstract Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of:(a) forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted; and(b) extracting the sample of blood from the unobstructed opening in the skin, with the aid of a vacuum and a stretching of the skin.In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises:(a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted, preferably a lancing assembly; and(b) a vacuum pump.Preferably, the apparatus also includes a housing.In another aspect of this invention, an article is provided for an article capable of both collecting blood and detecting an analyte in that blood is provided. The article, which contains an appropriate detection element for determining the amount of analyte in the blood, can be used in conjunction with a meter that measures the signal generated by the detection element of the article. In one embodiment, the article is a multiple-layer element comprising:(a) a layer capable of receiving blood and transporting the blood received by means of chemically aided wicking;(b) a layer capable of detecting the presence of analyte or measuring the amount of analyte in blood; and(c) a layer that can be placed in contact with a meter, the meter-contactable layer overlying the blood-transporting layer, said layer (a) capable of transporting blood to said layer (b).
Inventors
- 👤 David D. Cunningham
- 👤 Timothy P. Henning
- 👤 Eric B. Shain
- 👤 Douglas F. Young
- 👤 Michael G. Lowery
- 👤 Thomas G. Schapira
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-02 15:19
CPC Classifications
A; A61; A61B; A61B5/00; A61B5/15; A61B5/151; A61B5/15186; A61B5/145; A61B5/14532; A61B5/1468; A61B5/1486; A61B5/150007; A61B5/150015; A61B5/150022; A61B5/150053; A61B5/150061; A61B5/150068; A61B5/150076; A61B5/150099; A61B5/150206; A61B5/150221; A61B5/150267; A61B5/150374; A61B5/150381; A61B5/150412; A61B5/150503; A61B5/150534; A61B5/150664; A61B5/15101; A61B5/15103; A61B5/15107; A61B5/15113; A61B5/15115; A61B5/15125; A61B5/15188; A61B5/1519; A61B5/15192; A61B5/15194; A61B5/157; A61B5/41; A61B5/411; A61B2562/00; A61B2562/02; A61B2562/0295; A61B5/150358
Claims Analysis
Total Claims: 12
Claim 1
Independent Claim
191 words
A method for performing a diagnostic test utilizing a sample of blood, said method comprising the steps of: (a) forming an unobstructed opening in an area of skin from which said sample is to be extracted; (b) extracting said sample from said unobstructed opening in said area of said skin, with the aid of vacuum and stretching of the skin; (c) providing a multiple-layer article comprising: (i) a layer capable of receiving blood and transporting the blood received by means of chemically aided wicking; (ii) a layer capable of detecting the presence of analyte or measuring the amount of analyte in blood; and (iii) a layer that can be placed in contact with a meter, the meter-contactable layer overlying the blood-transporting layer, said layer (i) capable of transporting blood to said layer (ii). (d) allowing said extracted sample to be received by said blood-transporting layer and allowing said blood to be transported by means of chemically aided wicking to said layer capable of detecting the presence of analyte or measuring the amount of analyte in blood; and (e) determining the presence of analyte or measuring the amount of analyte in blood.
Claim 2
Independent Claim
191 words
A method for performing a diagnostic test utilizing a sample of blood, said method comprising the steps of: (a) forming an unobstructed opening in an area of skin from which said sample is to be extracted; (b) extracting said sample from said unobstructed opening in said area of said skin, with the aid of vacuum and stretching of the skin; (c) providing a multiple-layer article comprising: (i) a layer capable of receiving blood and transporting the blood received by means of chemically aided wicking; (ii) a layer capable of detecting the presence of analyte or measuring the amount of analyte in blood; and (iii) a layer that can be placed in contact with a meter, the meter-contactable layer overlying the blood-transporting layer, said layer (i) capable of transporting blood to said layer (ii). (d) allowing said extracted sample to be received by said blood-transporting layer and allowing said blood to be transported by means of chemically aided wicking to said layer capable of detecting the presence of analyte or measuring the amount of analyte in blood; and (e) determining the presence of analyte or measuring the amount of analyte in blood.
Claim 3
Dependent Claim
19 words
The method of claim 1 , wherein no more than two microliters of blood are required for analyte determination.
Claim 4
Dependent Claim
19 words
The method of claim 1 , wherein no more than one microliter of blood is required for analyte determination.
Claim 5
Independent Claim
219 words
A method for performing a diagnostic test utilizing a sample of blood, said method comprising the steps of: (a) forming an unobstructed opening in an area of skin from which said sample is to be extracted; (b) extracting said sample from said unobstructed opening in said area of said skin, with the aid of vacuum and stretching of the skin; (c) providing a multiple-layer article comprising: (i) a covering layer having an opening therein; (ii) a layer, overlying the covering layer, capable of receiving blood through the opening in the covering layer and transporting blood by means of chemically aided wicking; (iii) a layer that can be placed in contact with a meter, the meter-contactable layer overlying the blood-transporting layer; and (iv) a layer capable of detecting the presence of analyte or measuring the amount of analyte in blood, which layer is disposed between the covering layer and the meter-contactable layer and is capable of receiving blood from the blood-transporting layer. (d) allowing said extracted sample to be received by said blood-transporting layer and allowing said blood to be transported by means of chemically aided wicking to said layer capable of detecting the presence of analyte or measuring the amount of analyte in blood; and (e) determining the presence of analyte or measuring the amount of analyte in blood.
Claim 6
Independent Claim
219 words
A method for performing a diagnostic test utilizing a sample of blood, said method comprising the steps of: (a) forming an unobstructed opening in an area of skin from which said sample is to be extracted; (b) extracting said sample from said unobstructed opening in said area of said skin, with the aid of vacuum and stretching of the skin; (c) providing a multiple-layer article comprising: (i) a covering layer having an opening therein; (ii) a layer, overlying the covering layer, capable of receiving blood through the opening in the covering layer and transporting blood by means of chemically aided wicking; (iii) a layer that can be placed in contact with a meter, the meter-contactable layer overlying the blood-transporting layer; and (iv) a layer capable of detecting the presence of analyte or measuring the amount of analyte in blood, which layer is disposed between the covering layer and the meter-contactable layer and is capable of receiving blood from the blood-transporting layer. (d) allowing said extracted sample to be received by said blood-transporting layer and allowing said blood to be transported by means of chemically aided wicking to said layer capable of detecting the presence of analyte or measuring the amount of analyte in blood; and (e) determining the presence of analyte or measuring the amount of analyte in blood.
Claim 7
Dependent Claim
19 words
The method of claim 4 , wherein no more than two microliters of blood are required for analyte determination.
Claim 8
Dependent Claim
19 words
The method of claim 4 , wherein no more than one microliter of blood is required for analyte determination.
Claim 9
Independent Claim
207 words
A method for performing a diagnostic test utilizing a sample of blood, said method comprising the steps of: (a) forming an unobstructed opening in an area of skin from which said sample is to be extracted; (b) extracting said sample from said unobstructed opening in said area of said skin, with the aid of vacuum and stretching of the skin; (c) providing a multiple-layer article comprising: (i) a covering layer; (ii) a layer, overlying said covering layer, that can be placed in contact with a meter; and (iii) a layer capable of detecting the presence of analyte or measures the amount of analyte in blood, which layer is disposed between said covering layer and said meter-contactable layer and is capable of receiving blood by means of capillary flow of blood between said covering layer and said meter-contactable layer, wherein said covering layer and said meter-contactable layer are spaced apart at a sufficient distance so that a capillary is formed between them; (d) allowing said extracted sample to be transported by means of capillary flow to said layer capable of detecting the presence of analyte or measuring the amount of analyte in blood; and (e) determining the presence of analyte or measuring the amount of analyte in blood.
Claim 10
Independent Claim
207 words
A method for performing a diagnostic test utilizing a sample of blood, said method comprising the steps of: (a) forming an unobstructed opening in an area of skin from which said sample is to be extracted; (b) extracting said sample from said unobstructed opening in said area of said skin, with the aid of vacuum and stretching of the skin; (c) providing a multiple-layer article comprising: (i) a covering layer; (ii) a layer, overlying said covering layer, that can be placed in contact with a meter; and (iii) a layer capable of detecting the presence of analyte or measures the amount of analyte in blood, which layer is disposed between said covering layer and said meter-contactable layer and is capable of receiving blood by means of capillary flow of blood between said covering layer and said meter-contactable layer, wherein said covering layer and said meter-contactable layer are spaced apart at a sufficient distance so that a capillary is formed between them; (d) allowing said extracted sample to be transported by means of capillary flow to said layer capable of detecting the presence of analyte or measuring the amount of analyte in blood; and (e) determining the presence of analyte or measuring the amount of analyte in blood.
Claim 11
Dependent Claim
19 words
The method of claim 7 , wherein no more than two microliters of blood are required for analyte determination.
Claim 12
Dependent Claim
19 words
The method of claim 7 , wherein no more than one microliter of blood is required for analyte determination.
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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) | 2004-03-26 | 2004-09-25 | 2005-03-27 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2008-03-26 | 2008-09-25 | 2009-03-27 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2012-03-26 | 2012-09-25 | 2013-03-27 | $7700.00 | Window Closed / Lapsed |