United States Patent (19)
`Reber et al.
`
`54) NONINVASIVE APPARATUS HAVING A
`RETAINING MEMBERTO RETAINA
`REMOVABLE BIOSENSOR
`
`(75) Inventors: William L. Reber, Schaumburg,
`
`Jeffrey G. Toler, Algonquin, both of
`Ill; Cary D. Perttunen, Shelby
`Township, Mich.
`73 Assignee: Motorola, Inc., Schaumburg, Ill.
`
`21 Appl. No.: 08/833,566
`22 Filed:
`Apr. 7, 1997
`6
`51) Int. Cl. ........................................................ A61B 5/00
`52 U.S. Cl. .......................... 600/322; 600/316; 600/310;
`250/341.1
`58 Field of Search ..................................... 600/309, 322,
`600/346, 347,572, 573,578, 314, 316,
`575,583,584,562,310, 604/290,313;
`s
`s
`s
`s
`s
`s
`s
`436/95; 250/341.1; 422/99, 82.05
`
`56)
`
`References Cited
`
`2Y- - 2
`
`apoport et al. .
`
`U.S. PATENT DOCUMENTS
`3/1977 March.
`4,014,321
`4,655.225 4/1987 Dahne et al.
`3.
`181. Scott
`4,882,492 11/1989 Schlager.
`4,921,728 5/1990 Takiguchi et al..
`5,009.230 4/1991 Hutchinson.
`5,019,974 5/1991 Beckers .............................. 364/413.02
`5,028,787
`7/1991 Rosenthal et al..
`5,036,861
`8/1991 Sembrowich et al. .................. 600/573
`5,070,874 12/1991 Barnes et al..
`E. 13.
`R.W.. al. .
`5,086.229 2f1992 Rosenthal et al
`2 - a-Y-2
`5,110,833 5/1992 Mosbach.
`5,112,124 5/1992 Harjunmaa et al..
`5.1198.19 6/1992 Thomas et al. .
`5,137,023 8/1992 Mendelson et al..
`5,222,496
`6/1993 Clarke et al..
`5,233,997 8/1993 Klein et al..
`5,237,178 8/1993 Rosenthal et al..
`
`
`
`USOO596,1451A
`Patent Number:
`11
`(45) Date of Patent:
`
`5,961,451
`Oct. 5, 1999
`
`5.243,983 9/1993 Tarr et al..
`5,267,152 11/1993 Yang et al..
`5,297.548 3/1994 Pologe .................................... 600/322
`5,310,648 5/1994 Arnold et al..
`
`5,313,941
`
`5/1994 Braig et al. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 600/322
`
`5,321,265 6/1994 Block.
`536,1758 11
`2- Y- a-2
`f1994 Hall et al. .
`5,370,114 12/1994 Wong et al. .
`5,379,764
`1/1995 Barnes et al..
`5,383,452
`1/1995 Buchert.
`5,398,681 3/1995 Kupershmidt.
`5,424,545 6/1995 Block et al..
`5,433,197 7/1995 Stark.
`5.434,412 7/1995 Sodickson et al..
`5,438,201
`8/1995 Rosenthal et al..
`5,448,992 9/1995 Kupershmidt.
`5,458,140 10/1995 Eppstein et al. ........................ 600/573
`5,459,317 10/1995 Small et al..
`5,492,118 2/1996 Gratton et al..
`5,497,772 3/1996 Schulman et al. ...................... 600/347
`5,507,288 4/1996 Bocker et al. .......................... 600/322
`55.08.203 4/1996 Fuller et all
`436/149
`2- Y- a-2
`C. C. a.
`5,580,794 12/1996 Allen ...........
`... 436/169
`5,601,079 2/1997 Wong et al. .
`600/322
`5,617,851
`4/1997 Lipkovker ...
`... 600/573
`5,617,852 4/1997 MacGregor .
`... 600/322
`5,618,275 4/1997 Bock ........
`... 604/290
`5,714,123 2/1998 Sohrab ...................................... 422/99
`5,728,352 3/1998 Poto et al. ........................... 422/82.05
`Primary Examiner Richard J. Apley
`ASSistant Examiner Justine R. Yu
`Ately Agent, or Firm Jeffrey G. Toler; James E.
`auger
`57
`ABSTRACT
`In accordance with a first aspect, a noninvasive apparatus
`comprises housing (42) having grasping region (44), and
`a noninvasive extraction device (10) to noninvasively
`extract a Sample from a hand of an end user at the grasping
`region (44). In accordance with a second aspect, a nonin
`vasive apparatus comprises a card-shaped housing which
`pp
`comp
`pe
`9.
`Supports the noninvasive extraction device 10. In accor
`dance with a third aspect, a retaining member (22) retains a
`removable biosensor (16) proximate to at least a portion of
`the noninvasive extraction device (10).
`9 Claims, 5 Drawing Sheets
`
`irm
`
`IPR2020-00910
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`
`

`

`U.S. Patent
`
`Oct. 5, 1999
`
`Sheet 1 of 5
`
`5,961,451
`
`
`
`
`
`0£
`
`|- – – – – – –\– – – – – /– – – –-j
`
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`

`

`U.S. Patent
`
`Oct. 5, 1999
`
`Sheet 2 of 5
`
`5,961,451
`
`
`
`ed
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`

`U.S. Patent
`
`Oct. 5, 1999
`
`Sheet 3 of 5
`
`5,961,451
`
`42
`
`
`
`FIC3
`
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`

`U.S. Patent
`
`Oct. 5, 1999
`
`Sheet 4 of 5
`
`5,961,451
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`INTERFACE A
`BIOSENSOR TO THE
`APPARATUS
`
`PERFORM A TEST
`
`100
`
`102
`
`
`
`STORE INFORMATION 104
`ASSOCIATED WITH
`THE TEST
`
`REMOVE THE
`BIOSENSOR FROW
`THE APPARATUS
`
`106
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`FIC.4
`
`
`
`COUPLE THE
`APPARATUS TO AN
`EXTERNAL DEVICE
`
`f0
`
`UPLOAD TEST
`INFORMATION TO
`THE EXTERNAL DEVICE
`
`ft2
`
`
`
`DOWNLOAD A
`PROGRAW FROM
`THE EXTERNAL
`DEVICE
`
`
`
`RECEIVE POWER
`FROM THE
`EXTERNAL DEVICE
`
`is
`
`UNCOUPLE THE
`APPARATUS FROM
`THE EXTERNAL DEVICE
`
`20
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`
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`U.S. Patent
`
`Oct. 5, 1999
`
`Sheet 5 of 5
`30
`
`5,961,451
`
`
`
`16
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`5,961,451
`
`1
`NONINVASIVE APPARATUS HAVING A
`RETAINING MEMBERTO RETAINA
`REMOVABLE BIOSENSOR
`
`2
`FIG. 2 is a view of a first embodiment of a noninvasive
`apparatus in accordance with the present invention;
`FIG.3 is a view of a second embodiment of a noninvasive
`apparatus in accordance with the present invention;
`FIG. 4 is a flow chart of a method of using a noninvasive
`apparatus in accordance with the present invention;
`FIG. 5 is a view of a first alternative configuration of the
`transducer and the biosensor for embodiments of the present
`invention;
`FIG. 6 is a view of a second alternative configuration of
`the transducer and the biosensor for embodiments of the
`present invention; and
`FIG. 7 is a view of a third alternative configuration of the
`transducer and the biosensor for embodiments of the present
`invention.
`
`DETAILED DESCRIPTION OF A PREFERRED
`EMBODIMENT
`FIG. 1 is a block diagram of a noninvasive apparatus in
`accordance with the present invention. The apparatus
`includes a noninvasive extraction device 10 to noninvasively
`extract a biological Sample from an end user. Examples of
`the biological Sample include, but are not limited to, blood
`from the end user and an interstitial fluid from the end user.
`Preferably, the noninvasive extraction device 10 extracts
`the Sample through the Skin of the end user by transdermal
`permeation. Alternatively, the noninvasive extraction device
`10 can extract the Sample through a buccal membrane by
`transbuccal permeation. Regardless of where the Sample is
`extracted, the noninvasive extraction device 10 extracts the
`Sample without penetrating the Skin or another portion of the
`end user's body.
`Preferably, the noninvasive extraction device 10 includes
`a signal generator 12 and a transducer 14. The Signal
`generator 12 drives the transducer 14 to produce acoustic
`preSSure waves. The acoustic pressure waves enhance and
`control the permeation of the Sample out of the end user's
`body.
`In accordance with the teachings in U.S. Pat. Nos. 4,767,
`402, 4,780,212, 4,948,587 which are hereby incorporated by
`reference into this disclosure, it is preferred that the trans
`ducer 14 includes an ultraSonic emitter. In this case, the
`ultraSonic emitter emits an ultrasonic Signal having a fre
`quency between 20 kHz and 10 MHz, with a preferred range
`being between 0.5 MHz and 1.5 MHz. Further, the intensity
`of the ultrasound Signal is Selected So as not to burn the end
`user. In general, the ultraSonic emitter can emit either a
`pulsed or a continuous ultraSonic Signal.
`The apparatus further comprises a biosensor 16 to Sense
`a characteristic, property, or parameter of the biological
`Sample. The Specific characteristic is dependent upon the
`biosensor 16 Selected in the apparatus. In a first preferred
`embodiment, the biosensor 16 includes a glucose Sensor to
`Sense a measure of glucose in the Sample. It is noted that the
`presence or a level of analytes other than glucose can be
`Sensed using different biosensors. In a Second preferred
`embodiment, the biosensor 16 includes a DNA sensor to
`Sense a DNA sequence in the Sample. In a third preferred
`embodiment, the biosensor 16 includes an HIV sensor.
`The biosensor 16 can include a molecular detection
`device having one or more Selective binding Sites and/or
`molecular receptors. In this case, the biosensor 16 preferably
`includes an imprinted matrix in accordance with U.S. Pat.
`No. 5,310,648 which is hereby incorporated by reference
`into the present disclosure. Alternatively, the biosensor 16
`
`1O
`
`15
`
`25
`
`TECHNICAL FIELD
`The present invention relates to methods and Systems to
`noninvasively extract biological Samples.
`BACKGROUND OF THE INVENTION
`Many diagnostic devices and methods perform an inva
`Sive test requiring a blood Sample to be extracted from an
`end user. For example, most commercially-available por
`table blood glucose meters require an end user to prick
`his/her finger with a lancet to perform a blood glucose level
`test. After pricking his/her finger, the end user deposits a
`drop of blood onto a test strip. The sample of blood on the
`test Strip is tested by the glucose meter to determine a
`glucose level. Since a typical end user with diabetes per
`forms the above-described invasive test four times a day, the
`need exists for a noninvasive apparatus to perform blood
`glucose level tests.
`HIV testing is another diagnostic procedure which uses an
`invasively-extracted Sample of blood. This procedure and
`other diagnostic procedures also would benefit from a non
`invasive apparatus designed therefor.
`SUMMARY OF THE INVENTION
`The present invention provides an apparatus comprising a
`noninvasive extraction device and a retaining member. The
`noninvasive extraction device is to noninvasively extract a
`biological Sample. The retaining member is to retain a
`removable biosensor proximate to at least a portion of the
`noninvasive extraction device. The retaining member covers
`a first portion of a surface of the removable biosensor while
`externally exposing a Second portion of the Surface of the
`removable biosensor for user contact. The removable bio
`Sensor is to Sense a characteristic of the biological Sample.
`The present invention further provides an apparatus com
`prising a card-shaped housing having a grasping region, a
`40
`noninvasive extraction device to noninvasively extract a
`biological Sample from a portion of a hand grasping the
`card-shaped housing at the grasping region, and a retaining
`member to retain a removable biosensor proximate to at
`least a portion of the noninvasive extraction device. The
`retaining member is to cover a first portion of a Surface of
`the removable biosensor while exposing a Second portion of
`the surface of the removable biosensor for contact by the
`portion of the hand. The removable biosensor is to sense a
`characteristic of the biological Sample.
`The present invention Still further provides an apparatus
`comprising a housing and a noninvasive extraction device.
`The housing has a grasping region. The noninvasive extrac
`tion device is to noninvasively extract a biological Sample
`from a portion of a handgrasping the housing at the grasping
`region.
`The present invention yet still further provides an appa
`ratus having a noninvasive extraction device Supported by a
`card-shaped housing. The noninvasive extraction device is
`to noninvasively extract a biological Sample.
`BRIEF DESCRIPTION OF THE DRAWINGS
`The invention is pointed out with particularity in the
`appended claims. However, other features of the invention
`are described in the following detailed description in con
`junction with the accompanying drawings in which:
`FIG. 1 is a block diagram of a noninvasive apparatus in
`accordance with the present invention;
`
`35
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`5,961,451
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`3
`can include an imprinted film or memberin accordance with
`any of U.S. Pat. Nos. 5,110,833, 5,310,648, 5,372,719,
`5,453,199, 5,461,175, 5,541,342, and 5,587,273 which are
`hereby incorporated by reference into the present disclosure.
`As another alternative,
`the biosensor 16 can include
`biological molecular receptors each having a specific affinity
`to a corresponding molecular structure. For example, each
`biological molecular receptor can include a chain of a
`plurality of nucleotides which binds or hybridizes with a
`molecule having a complementary chain of nucleotides. In
`this case, each biological molecular receptor can include a
`DNAprobe for detecting a corresponding, complementary
`DNA sequencein the sample, or an RNA probefor detecting
`a corresponding, complementary RNA sequence in a
`sample. As another example, the biological molecular recep-
`tor can include an antigen for detecting a corresponding
`antibody in the sample.
`Regardless of its form, the biosensor 16 produces a signal
`such as an optical signal or an electrical signal in depen-
`dence upon the characteristic of the sample. The signal can
`indicate the presence of the characteristic in the sample, or
`a measure of the characteristic of the sample. If necessary,
`the biosensor 16 can include optical or electrical detection
`means for detecting the binding of sample molecules
`thereto.
`
`Preferably, the biosensor 16 is adjacent at least a portion
`of the noninvasive extraction device 10. In this case, it is
`further preferred that the biosensor 16 covers at least a
`portion of the noninvasive extraction device 10, such as at
`least a portion of the transducer 14. As a result, the sample
`is directly and immediately applied to the biosensor 16 after
`being noninvasively extracted from the end user.
`Alternatively, the apparatus can include a sample handling
`conduit to communicate the sample from the noninvasive
`extraction device 10 to the biosensor 16.
`
`The apparatus includes an interface 20 to communicate
`with the biosensor 16.
`In a preferred embodiment,
`the
`interface 20 includes a plurality of electrodes which either
`capacitively, inductively, or directly couple to the biosensor
`16. The biosensor 16 can be permanently integrated with the
`apparatus or can be removable. The apparatus can include a
`retaining member 22 which retains a removable biosensor.
`The retaining member22 retains the biosensor 16 proximate
`to at least a portion of the noninvasive extraction device 10.
`Optionally,
`the apparatus includes a display device 24
`responsive to the biosensor 20. The display device 24
`displays human-readable information associated with the
`characteristic of the biological sample. The information can
`include textual information and/or graphical information.
`The display device 24 can include a plurality of liquid
`crystal display (LCD) elements or a plurality of light-
`emitting display (LED) elements to display the information.
`The display elements can be arranged as an array of pixels
`or as segments in a segmented display (e.g. a seven-segment
`display).
`the display device 24 is responsive to the
`Preferably,
`biosensor 20 via a processor 26. The processor 26 receives
`data associated with a characteristic, property, or parameter
`of the sample from the biosensor 20. The processor 26
`processes the data to determine the characteristic, property,
`or parameter of the sample. Thereafter, the processor 26
`drives the display device 24 to display information based
`upon the characteristic. For example, the display device 24
`can display a glucose level associated with the sample, a
`DNA or RNA sequence associated with the sample, or a
`positive/negative HIV indication associated with the sample.
`
`4
`Additionally, the processor 26 can direct the activation
`and deactivation of the noninvasive extraction device 10.
`
`the processor 26 can control parameters of the
`Further,
`noninvasive extraction device 10 such as the frequency,
`intensity, and duration of the signal emitted by the trans-
`ducer 14.
`
`The processor 26 can write the data and/or the processed
`information to a memory 30. Thereafter, the processor 26
`can read the data and/or the processed information for
`subsequent processing or for subsequent display by the
`display device 24. The memory 30 can also serve to store a
`program which directs the processor 26 in operating the
`noninvasive extraction device 10, applying signals to the
`biosensor 16, processing the data from the biosensor 16, and
`displaying the information. In general, the memory 30 can
`include a random-access memory and/or a read-only
`memory. Preferably, the memory 30 is nonvolatile to main-
`tain its contents in the absence of a powering signal.
`The various components of the apparatus are selectively
`powered by a power source 32.
`In response to a first
`user-initiated input received by a powerbutton 34, the power
`source 32 powers various components to activate the appa-
`ratus. In response to a second user-initiated input received
`by the power button 34, the power source 32 unpowers
`various components to deactivate the apparatus. The power
`source 32 can include battery-receiving terminals in contact
`with a battery. Alternatively,
`the power source 32 can
`include a solar cell. As another alternative, the power source
`32 can include a plastic battery.
`Optionally,
`the apparatus includes an interface 36 for
`interfacing with an external device 40. Via the interface 36,
`the external device 40 can powerthe various components of
`the apparatus and/or rechargethe battery in the power source
`32. Further, data can be communicated between the proces-
`sor 26 and the external device 40 via the interface 36. For
`
`example, the processor 26 can download a software program
`from the external device 40 to direct the operation of the
`apparatus. As another example, the processor 26 can com-
`municate sensed data or stored data to the external device
`40.
`The external device 40 can have various forms. Of
`
`particular interest is where the external device 40 includes a
`computer or a like processing apparatus. In this case, the
`external device 40 can include a desktop computer, a laptop
`computer, a palmtop computer, or a personal digital assis-
`tant. Alternatively,
`the external device 40 can include a
`communication device such as a two-way pager, a
`telephone, a cellular telephone, or a personal communication
`system (PCS) telephone. As another alternative, the external
`device 40 can include a basestation or other transceiver in
`
`a communication network such as a paging network, a
`wireless telephone network, a wireless data network, or a
`satellite network. Other electronic devices are also contem-
`
`plated for the external device 40.
`Dependent upon the external device 40, the interface 36
`can include any of: (i) a PCMCIAinterface for mating in a
`PCMCIAslot; (ii) a serial interface for mating with a serial
`port; (iii) a parallel interface for mating with a parallel port;
`(iv) a SCSI interface for mating with a SCSI port; (v) an
`infrared interface for communicating with an infrared port;
`(vi) a radio frequency transceiver for communicating with a
`radio frequency port; (vii) a telephone interface for mating
`with a telephone port; or (viii) an interface for mating with
`a data port in a wireless telephone. In general, the interface
`36 can include any plurality of connectors which mate with
`a plurality of connectors associated with the external device
`
`10
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`5
`40. Additionally, any signal standard can be used to com-
`municate signals between the apparatus and the external
`device 40.
`
`5,961,451
`
`6
`portion 70 is retained by the retaining member 22. The
`interface 20 includes a plurality of electrodes, a representa-
`tive one being indicated by reference numeral 72, which
`couple to the peripheral portion 70 when the biosensor 16 is
`The apparatus includes a housing 42 to house and/or
`inserted. The biosensor 16 covers at least a portion of the
`support the noninvasive extraction device 10, the biosensor
`transducer 14, and preferably all of the transducer 14, when
`16, the interface 20, the retaining member 22, the display
`inserted. Although illustrated to be rectangular, it is noted
`device 24,
`the processor 26,
`the memory 30,
`the power
`that the biosensor 16 can be alternatively shaped.
`source 32,
`the power button 34, and the interface 36.
`To use the apparatus, the end user inserts the biosensor 16
`Preferably, the housing 42 is sized to be handheld by the end
`through the slot 60 and depresses the power button 34 to
`user. It is further preferred that the housing 42 be sized and
`activate the apparatus. Thereafter, the end user contacts the
`shaped for carrying within a wallet, a purse, or a pocket of
`interior portion 68 of the biosensor 16 to perform a nonin-
`the end user. For these purposes, it is preferred that the
`vasive test or diagnostic. Preferably, the end user applies a
`housing 42 be card shaped. In this case, for example, the
`finger or a thumb to the biosensor 16. In these cases, the
`housing 42 can have the size of a credit card, a PCMCIA
`15
`
`card, a business card, a smart card, an index card, a trading apparatus can be supported by a membersuchasatable top
`card, or a playing card.
`or a wall. Alternatively, the apparatus is grasped by applying
`a thumb to the biosensor 16 and one or more fingers to an
`It is also preferred that the housing 42 be either rigid,
`opposite surface of the housing 42.
`semi-rigid, or resilient. The housing 42 can beresilient to
`deform over a portion of the end user’s body when in use,
`The noninvasive extraction device 10 facilitates the per-
`and to recover its shape after use.
`meation of the sample through the end user’s skin at the
`grasping region 44. Once extracted, the sample is immedi-
`Preferably, the housing 42 includes a grasping region 44
`ately and directly applied to a surface of the biosensor 16.
`for grasping by a hand of the end user. In this case, it is
`The processor 26 directs a plurality of conductance mea-
`preferred that the noninvasive extraction device 10 extracts
`surements to be taken for the biosensor 16. The conductance
`the biological sample from a portion of the hand which
`25
`measurements are taken betweenaplurality of pairs of the
`grasps the grasping region 44. For this purpose, the trans-
`electrodes 72. The processor 26 processes the conductance
`ducer 14 and the biosensor 16 can be located proximate to
`measurements to determine a characteristic (e.g. a glucose
`the grasping region 44. The portion of the hand from which
`level) associated with the sample. The characteristic is
`the sample is extracted can include the thumb, the fingers,
`displayed by the display device 24. For example, a numeri-
`the palm, or the back of the hand. In general, however, the
`cal indication or a graphical indication of the glucose level
`noninvasive extraction device 10 can extract the biological
`can be displayed by the display device 24. Thereafter, the
`sample from any portion of the end user’s body including
`biosensor 16 can be removed throughthe slot 60.
`but not limited to his/her arms, legs, and feet.
`FIG. 3 is a view of a second embodimentof a noninvasive
`FIG. 2 is a view ofa first embodiment of a noninvasive
`apparatus in accordance with the present invention. In this
`embodiment, the housing 42 includes a card-shaped sub-
`strate. The card-shaped substrate supports the noninvasive
`extraction device 10 and the biosensor 16. The transducer 14
`of the noninvasive extraction device 10 is sandwiched
`between the biosensor 16 and the substrate. Preferably, the
`card-shaped substrate is rigid, semi-rigid, or resilient.
`The biosensor 16 is permanently integrated with the
`apparatus. The biosensor 16 is permanently coupled to a
`plurality of electrodes, a representative one being indicated
`by reference numeral 80, which comprise the interface 20.
`The electrodes 80 are arranged as a grid across a bottom
`surface of the biosensor 16.
`
`10
`
`20
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`35
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`40
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`45
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`50
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`55
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`60
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`The power button 34 is co-located with the transducer 14
`and the biosensor 16 to activate the apparatus when the
`biosensor 16 is depressed by the end user’s hand. Preferably,
`the powerbutton 34 is located beneath the biosensor 16 and
`the transducer 14.
`
`The card-shaped substrate can comprise a smart card
`having the display 24, the processor 26 and the power supply
`32 integrated therewith. The processor 26 communicates
`with the biosensor 16 via the electrodes 80.
`
`In use, the apparatus is either supported by a member or
`grasped by the end usersothat a finger or a thumbis applied
`to the biosensor 16. The end user applies a sufficient force
`to the biosensor 16 to generate a user-initiated activation
`signal for the power button 34. In response to the user-
`initiated activation signal, the noninvasive extraction device
`14 is activated to facilitate the permeation of the sample
`through the end user’s skin.
`Once extracted, the sample is immediately and directly
`applied to a surface of the biosensor 16. The processor 26
`directs a plurality of conductance or resistance measure-
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`apparatus in accordance with the present invention. In this
`embodiment, the housing 42 includes a card-shaped hous-
`ing. The housing 42 is shaped and sized in accordance with
`a PCMCIA(Personal Computer Memory Card International
`Association) form standard. The housing 42 has a length 50
`of 85.6 mm and a width 52 of 54.0 mm. The housing 42 has
`a thickness 54 dependent upon the PCMCIA type. For
`example, the thickness 54 is 3.3 mm for Type I, 5.0 mm for
`Type I, and 10.5 mm for Type II. Preferably, the housing
`42 is rigid or semi-rigid.
`The interface 36 comprises a PCMCIAbusconnector. In
`accordance with PCMCIA standards,
`the interface 36
`includes sixty-eight connectors which mate with sixty-eight
`pins in a mating connector associated with the external
`device 40. Typically, the external device 40 includes a socket
`into which the apparatus is inserted to mate the interface 36
`thereto. Signals are communicated via the interface 36 in
`accordance with PCMCIAsignal standards.
`The housing 42 has a face 56 at which the display device
`24 is viewable and at which the grasping region 44 is
`disposed. At least a portion of the noninvasive extraction
`device 10, including at least a portion of the transducer 14,
`is disposed at
`the grasping region 44 of the face 56.
`Additionally, the power button 34 is accessible at the face
`56.
`
`The housing 42 includes a slot 60 through which the
`biosensor 16 is inserted and removed. The biosensor 16 can
`
`be inserted into the slot 60 at an end 62 of the housing 42
`opposite to an end 64 having the interface 36. Alternatively,
`the slot 60 can receive the biosensor 16 at ends 66 adjacent
`to the end 64.
`
`Wheninserted, an interior portion 68 of the biosensor 16
`is exposed for contact with the end user while a peripheral
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`

`

`7
`ments to be taken for the biosensor 16. The conductance or
`resistance measurements are taken between a plurality of
`pairs of the electrodes 80. The processor 26 processes the
`measurements to determine a characteristic (e.g. a glucose
`level) associated with the sample. The characteristic is
`displayed by the display device 24. Thereafter, the apparatus
`can be either disposed or cleaned for a Subsequent use. The
`apparatus can be cleaned with a Swab and a cleaning Solution
`Such as alcohol. Alternatively, the apparatus can be cleaned
`electronically if the biosensor 16 is reversible.
`FIG. 4 is a flow chart of a method of using a noninvasive
`apparatus in accordance with the present invention. AS
`indicated by block 100, if the biosensor 16 is removable, the
`method optionally includes a step of interfacing the biosen
`Sor 16 to the remainder of the apparatus. The biosensor 16
`is Selected in dependence upon which test is to be performed
`by the apparatus.
`As indicated by block 102, the method includes a step of
`performing the test using the apparatus. The Step of per
`forming the test includes noninvasively extracting the
`Sample from the end user, optionally communicating the
`Sample to the biosensor 16, Sensing data associated with the
`Sample with the biosensor 16, processing the data to deter
`mine a characteristic of the Sample, and displaying an
`indication of the characteristic.
`As indicated by block 104, the method optionally includes
`a step of Storing information associated with the Sample to
`the memory 30. The information can include the data
`asSociated with the Sample and/or the characteristic of the
`Sample. Preferably, this step further includes Storing a time
`and a date associated with the test.
`As indicated by block 106, the method optionally includes
`a step of removing the biosensor 16 from the remainder of
`the apparatus. The biosensor 16 can be disposed after a
`Single use, or cleaned for a Subsequent use.
`Flow of the method can return back to block 100 to
`perform one or more Subsequent tests. For example, in a
`glucose meter embodiment of the apparatus, an end user
`may perform three or four glucose tests over the course of
`a day.
`Thereafter, flow of the method proceeds to block 110
`which indicates a step of coupling the apparatus to the
`external device 40. The Step of coupling can include cou
`pling the interface 36 and the external device 40 by a
`wireline connection. For example, the Step of coupling can
`include inserting the PCMCIA card embodiment of FIG. 2
`into a PCMCIA Socket associated with the external device
`40. Alternatively, the Step of coupling can include coupling
`the interface 36 and the external device 40 by a wireless link.
`The wireleSS link can include an infrared link or a radio
`frequency link.
`As indicated by block 112, the method optionally includes
`a step of uploading the test information from the apparatus
`to the external device 40. The test information is retrieved
`from the memory 30 by the processor 26, and communicated
`to the interface 36. A Signal representative of the test
`information is communicated from the interface 36 to the
`external device 40.
`As indicated by block 114, the method optionally includes
`a step of downloading a program from the external device 40
`to the apparatus. The program directs the operation of the
`apparatus in performing Subsequent tests. The interface 36
`receives a signal representative of the program from the
`external device 40. The interface 36 communicates the
`program to the processor 26. The processor 26 Stores the
`program in the memory 30.
`
`15
`
`25
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`5,961,451
`
`8
`As indicated by block 116, the method optionally includes
`a Step of powering the apparatus while the apparatus is
`linked to the external device 40. This step can include
`recharging the power Source 32 by a current received via the
`interface 36.
`As indicated by block 120, the method optionally includes
`a step of uncoupling the apparatus from the external device
`40. The Step of uncoupling can include uncoupling a wire
`line connection between the interface 36 and the external
`device 40. For example, the PCMCIA card embodiment of
`FIG. 2 can be removed from a PCMCIA Socket associated
`with the external device 40.
`Flow of the method is directed back to block 100 to
`perform one or more Subsequent tests. The Subsequent tests
`can be performed in accordance with the program down
`loaded in the step indicated by block 114. The programma
`bility of the apparatus advantageously allows a plurality of
`different tests to be performed using a single apparatus. The
`test is performed by downloading the program and inserting
`a specific biosensor therefor.
`FIG. 5 is a view of a first alternative configuration of the
`transducer 14 and the biosensor 16 for embodiments of the
`present invention. In this configuration, the biosensor 16 is
`adjacent a side 130 of the transducer 14. Preferably, the
`biosensor 16 and the transducer 14 are oriented to be
`Substantially coplanar.
`One approach to using this configuration includes the end
`user rolling or Sliding his/her finger or thumb from the
`transducer 14 to the biosensor 16. In this approach, the
`transducer 14 promotes the noninvasive extraction of the
`Sample, and the Sample is deposited onto the biosensor 16
`thereafter.
`FIG. 6 is a view of a second alternative configuration of
`the transducer 14 and the biosensor 16 for embodiments of
`the present invention. In this configuration, the biosensor 16
`masks at least a portion of the transducer 14. In particular,
`the biosensor 16 masks all of the transducer 14 but a
`plurality of holes. A representative one of the holes is
`indicated by reference numeral 132. The holes provide paths
`for directly exposing portions of the end user's body to the
`noninvasive extraction device 10. For example, the holes
`provide paths for directly applying ul