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US6155992A Expired / Lapsed US ⏱️ 0.0 years remaining

Method and apparatus for obtaining interstitial fluid for diagnostic tests

Assignee: Abbott Laboratories
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Filing: 1997-12-02
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Granted: 2000-12-05
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Expires: 2017-12-02
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Abstract

Abstract A method and apparatus for obtaining a sample of interstitial fluid from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of (a) treating an area of the skin with vacuum or heat or both vacuum and heat to increase the availability of interstitial fluid at that area of the skin; (b) forming an opening in the treated area of the skin; and (c) extracting the sample of interstitial fluid from the opening in the skin, with the aid of vacuum and stretching of the skin. In another aspect of the invention, an apparatus for carrying out the method described previously is provided. Th apparatus comprises (a) a device for forming an unobstructed opening in the area of the skin from which the sample is to be extracted, preferably a lancing assembly; and (b) a vacuum pump. Preferably, the apparatus also includes a housing.

Inventors

  • 👤 Timothy P. Henning
  • 👤 Robert G. Hiltibran
  • 👤 David D. Cunningham
  • 👤 Eric B. Shain
  • 👤 Brian J. Tarkowski
  • 👤 Douglas F. Young

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-31 11:21
CPC Classifications
A; A61; A61B; A61B5/00; A61B5/145; A61B5/14507; A61B5/1451; A61B5/14514; A61B10/00; A61B10/0045; A61B5/14532; A61B2010/008; A61M; A61M37/00; A61M2037/0007

Claims Analysis

Total Claims: 35
Claim 1
Independent Claim 85 words
A method for obtaining a sample of interstitial fluid for a diagnostic test, said method comprising the steps of: (a) treating an area of the skin with vacuum or heat or both vacuum and heat to increase the availability of interstitial fluid at that area of the skin; (b) forming an unobstructed opening in the treated area of the skin; and (c) extracting the sample of interstitial fluid from the unobstructed opening in the skin, with the aid of vacuum and stretching of the skin.
Claim 2
Independent Claim 85 words
A method for obtaining a sample of interstitial fluid for a diagnostic test, said method comprising the steps of: (a) treating an area of the skin with vacuum or heat or both vacuum and heat to increase the availability of interstitial fluid at that area of the skin; (b) forming an unobstructed opening in the treated area of the skin; and (c) extracting the sample of interstitial fluid from the unobstructed opening in the skin, with the aid of vacuum and stretching of the skin.
Claim 3
Dependent Claim 22 words
The method of claim 1, wherein said diagnostic test is a test to determine the concentration of glucose in a biological fluid.
Claim 4
Dependent Claim 49 words
The method of claim 1, further comprising the step of increasing the availability of interstitial fluid to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.
Claim 5
Dependent Claim 50 words
The method of claim 3, wherein a vacuum is used to increase the availability of interstitial fluid to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.
Claim 6
Dependent Claim 49 words
The method of claim 4, wherein stretching is used to increase the availability of interstitial fluid to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.
Claim 7
Dependent Claim 49 words
The method of claim 3, wherein heat is used to increase the availability of interstitial fluid to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.
Claim 8
Dependent Claim 49 words
The method of claim 4, wherein heat is used to increase the availability of interstitial fluid to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.
Claim 9
Dependent Claim 29 words
The method of claim 1, wherein said opening in said area of said skin from which the sample is to be extracted is formed by a rotating opening-forming device.
Claim 10
Dependent Claim 13 words
The method of claim 8, wherein said rotating opening-forming device is a drill.
Claim 11
Dependent Claim 13 words
The method of claim 8, wherein said rotating opening-forming device is a lancet.
Claim 12
Dependent Claim 17 words
The method of claim 1, wherein said extracted sample is analyzed by means of a glucose detector.
Claim 13
Dependent Claim 13 words
The method of claim 11, wherein said glucose detector employs an optical meter.
Claim 14
Dependent Claim 13 words
The method of claim 11, wherein said glucose detector employs an electrochemical meter.
Claim 15
Dependent Claim 21 words
The method of claim 8, wherein said rotating drill penetrates said skin to a depth of no more than 1.0 mm.
Claim 16
Dependent Claim 27 words
The method of claim 1, wherein said opening in said area of said skin from which the sample is to be extracted is formed by a laser.
Claim 17
Dependent Claim 21 words
The method of claim 1, wherein said interstitial fluid is obtained from a part of the body other than a finger.
Claim 18
Dependent Claim 29 words
The method of claim 1, wherein said interstitial fluid is obtained at a pain level lower than that experienced when a finger is pierced by a standard finger lancet.
Claim 19
Independent Claim 170 words
An apparatus suitable for obtaining a sample of interstitial fluid for analysis in a diagnostic test, said apparatus comprising: (a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted; (b) a vacuum pump for extracting said sample from said unobstructed opening in said area of said skin; and (c) a nosepiece having an end that contacts said area of said skin, said end being equipped with a seal, said seal surrounding an opening in said nosepiece, said opening allowing communication between said area of said skin and an interstitial fluid extraction chamber in said nosepiece, said seal preventing air from leaking into said interstitial fluid extraction chamber, so that said vacuum pump can provide sufficient suction action for increasing availability of interstitial fluid to said area of said skin from which said sample is to be obtained, for stretching said skin, and for extracting said sample of interstitial fluid from said unobstructed opening in said area of said skin.
Claim 20
Independent Claim 170 words
An apparatus suitable for obtaining a sample of interstitial fluid for analysis in a diagnostic test, said apparatus comprising: (a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted; (b) a vacuum pump for extracting said sample from said unobstructed opening in said area of said skin; and (c) a nosepiece having an end that contacts said area of said skin, said end being equipped with a seal, said seal surrounding an opening in said nosepiece, said opening allowing communication between said area of said skin and an interstitial fluid extraction chamber in said nosepiece, said seal preventing air from leaking into said interstitial fluid extraction chamber, so that said vacuum pump can provide sufficient suction action for increasing availability of interstitial fluid to said area of said skin from which said sample is to be obtained, for stretching said skin, and for extracting said sample of interstitial fluid from said unobstructed opening in said area of said skin.
Claim 21
Dependent Claim 9 words
The apparatus of claim 18, further including a housing.
Claim 22
Dependent Claim 17 words
The apparatus of claim 19, wherein said device for forming said unobstructed opening comprises a lancing assembly.
Claim 23
Dependent Claim 16 words
The apparatus of claim 18, wherein said device for forming said unobstructed opening is a laser.
Claim 24
Dependent Claim 17 words
The apparatus of claim 18, wherein said device for forming said unobstructed opening is a lancing assembly.
Claim 25
Dependent Claim 16 words
The apparatus of claim 22, wherein said lancing assembly comprises a lancet capable of being rotated.
Claim 26
Dependent Claim 22 words
The apparatus of claim 23, wherein said lancet is capable of being retracted after it forms said unobstructed opening in said skin.
Claim 27
Dependent Claim 16 words
The apparatus of claim 22, wherein said lancing assembly comprises a drill capable of being rotated.
Claim 28
Dependent Claim 22 words
The apparatus of claim 25, wherein said drill is capable of being retracted after it forms said unobstructed opening in said skin.
Claim 29
Dependent Claim 10 words
The apparatus of claim 18, further comprising a heating element.
Claim 30
Dependent Claim 10 words
The apparatus of claim 18, further comprising a glucose detector.
Claim 31
Dependent Claim 14 words
The apparatus of claim 28, wherein said glucose detector can utilize an electrochemical meter.
Claim 32
Dependent Claim 14 words
The apparatus of claim 28, wherein said glucose detector can utilize an optical meter.
Claim 33
Dependent Claim 27 words
The apparatus of claim 18, wherein said vacuum is applied through said opening in said nosepiece, said opening having an area up to 5 cm 2 .
Claim 34
Independent Claim 88 words
A method for obtaining a sample of interstitial fluid for a diagnostic test, said method comprising the steps of: (1) first treating an area of the skin with vacuum or heat or both vacuum and heat to increase the availability of interstitial fluid at that area of the skin; (2) then forming an unobstructed opening in the treated area of the skin; and (3) then extracting the sample of interstitial fluid from the unobstructed opening in the skin, with the aid of vacuum and stretching of the skin.
Claim 35
Independent Claim 88 words
A method for obtaining a sample of interstitial fluid for a diagnostic test, said method comprising the steps of: (1) first treating an area of the skin with vacuum or heat or both vacuum and heat to increase the availability of interstitial fluid at that area of the skin; (2) then forming an unobstructed opening in the treated area of the skin; and (3) then extracting the sample of interstitial fluid from the unobstructed opening in the skin, with the aid of vacuum and stretching of the skin.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2003-12-05 2004-06-05 2004-12-05 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2007-12-05 2008-06-05 2008-12-05 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2011-12-05 2012-06-05 2012-12-05 $7700.00 Window Closed / Lapsed

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