I lllll llllllll Ill lllll lllll lllll lllll lllll 111111111111111111111111111111111
`
`US006591125Bl
`
`(12) United States Patent
`Buse et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 6,591,125 Bl
`Jul. 8, 2003
`
`4,444,892 A
`4,450,842 A
`4,461,691 A
`4,469,110 A
`4,477,314 A
`4,483,924 A
`4,484,987 A
`4,522,690 A
`4,524,114 A
`4,526,661 A
`4,534,356 A
`4,538,616 A
`4,543,955 A
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`
`FOREIGN PATENT DOCUMENTS
`227 029 A3
`0 048 090 A2
`0 078 636 Al
`0 096 288 Al
`0 125 139 A2
`0 136 362 Al
`0 170 375 A2
`0 184 909 A2
`0 206 218 A2
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`
`29 03 216
`
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`12/1986
`8/1987
`
`DD
`DE
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`EP
`EP
`EP
`
`(54) SMALL VOLUME IN VITRO A NALYTE
`SENSOR WITH DIFFUSIBLE OR NON­
`LEACHABLE REDOX MEDIATOR
`
`(75)
`
`Inventors: John Bernard Buse, Chapel Hill, NC
`(US); A lan Charles Moses, Newton
`Centre, MA (US)
`
`(73) Assignee: TheraSense, Inc., Alameda, CA (US)
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 238 days.
`
`(21) Appl. No.: 09/604,614
`
`(22) Filed:
`
`Jun.27,2000
`
`(51)
`Int. Cl.7 .................................................. A61B 5/05
`(52) U.S. Cl. ........................ 600/347; 600/345; 600/365
`(58) Field of Search ................................. 600/300-301,
`600/345, 347, 365, 573; 436/95, 180, 174,
`183
`
`(56)
`
`References Cited
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`Abrufla, H. D. et al., "Rectifying Interfaces Using
`Two-Layer Films of Electrochemically Polymerized
`Vinylpyridine and Vinylbipyridine Complexes of Ruthe­
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`
`Primary Examiner-Robert L. Nasser
`Assistant Examiner-Patricia Mallari
`(74) Attorney, Agent, or Firm-Merchant & Gould P.C.
`(57)
`ABSTRACT
`A region of skin, other than the fingertips, is stimulated.
`After stimulation, an opening is created in the skin (e.g., by
`lancing the skin) to cause a flow of body fluid from the
`region. At least a portion of this body fluid is transported to
`a testing device where the concentration of analyte (e.g.,
`glucose) in the body fluid is then determined. It is found that
`the stimulation of the skin provides results that are generally
`closer to the results of measurements from the fingertips, the
`traditional site for obtaining body fluid for analyte testing.
`
`37 Claims, 30 Drawing Sheets
`
`AGAMATRIX, INC. EXHIBIT NO. 1024
`Page 1 of 71
`
`

`

`US 6,591,125 Bl
`Page 2
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`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
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`JP
`JP
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`JP
`JP
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`6/1992
`4/1996
`5/1998
`5/1975
`10/1981
`8/1985
`11/1988
`4/1979
`1/1980
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`0 245 073 A2
`0 278 647 A2
`0 286 084 A2
`
`10/1987
`11/1987
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`12/1990
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`
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`0 368 209 Al
`0 390 390 Al
`0 400 918 Al
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`Page 3 of 71
`
`

`

`US 6,591,125 Bl
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