ACNAA>
`
`20040242976A1
`
`as) United States
`a2) Patent Application Publication co) Pub. No.: US 2004/0242976 Al
`
` Abreu (43) Pub. Date: Dec. 2, 2004
`
`
`(54) APPARATUS AND METHOD FOR
`MEASURING BIOLOGIC PARAMETERS
`
`Publication Classification
`
`(76)
`
`Inventor: Marcio Marc Abreu, New Haven, CT
`US(US)
`Correspondence Address:
`JACOBSON HOLMAN PLLC
`400 SEVENTH STREETN.W.
`SUITE 600
`WASHINGTON, DC 20004 (US)
`(21) Appl. No.:
`10/786,623
`
`(22)
`
`Filed:
`
`Feb. 26, 2004
`
`Related U.S. Application Data
`
`(63) Continuation-in-part of application No. 10/420,295,
`filed on Apr. 22, 2003.
`(60) Provisional application No, 60/374,133, filed on Apr.
`22, 2002. Provisional application No. 60/449,800,
`filed on Feb. 26, 2003. Provisional application No.
`60/475,470, filed on Jun. 4, 2003. Provisional appli-
`cation No. 60/497,306, filed on Aug. 25, 2003.
`
`Uinte C07 cicccccccscssscssssssssssnssnssnstnsentn A61B 5/00
`(SL)
`UWS. Che cecececcecssesncsteeeeseeneasenesnenteseenseneane 600/315
`(52)
`ABSTRACT
`(57)
`Support structures for positioning sensors on a physiologic
`tunne!
`for measuring physical, chemical and biological
`parameters of the body and to produce an action according
`to the measured value of the parameters. The support
`structure includes a sensorfitted on the support structures
`using a special geometry for acquiring continuous and
`undisturbed data on the physiology of the body. Signals are
`transmittedto a remote station by wireless transmission such
`as by electromagnetic waves, radio waves, infrared, sound
`and the like or by being reported locally by audio or visual
`transmission. The physical and chemical parameters include
`brain function, metabolic function, hydrodynamic function,
`hydrationstatus, levels of chemical compoundsin the blood,
`aesk-the like, "Ths stipport stracmre cseipae prices. oly2
`eyeglasses, head mounted gear and the like, containing
`passive or active sensors positionedat the end ofthe tunnel
`with sensing systems positioned on and accessing a physi-
`ologic tunnel.
`
`0001
`
`Apple Inc.
`APL1053
`U.S. Patent No. 8,652,040
`
`Apple Inc.
`APL1053
`U.S. Patent No. 8,652,040
`
`0001
`
`

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`Patent Application Publication Dec. 2,2004 Sheet 1 of 95
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`Patent Application Publication Dec. 2,2004 Sheet 2 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 7 of 95
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`Patent Application Publication Dec. 2,2004 Sheet 8 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 9 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 10 of 95
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`Dec. 2, 2004 Sheet 12 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 14 of 95
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`Patent Application Publication Dec. 2,2004 Sheet 15 of 95
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`Patent Application Publication Dec. 2,2004 Sheet 16 of 95
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`Patent Application Publication Dec. 2,2004 Sheet 18 of 95
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`Patent Application Publication Dec. 2,2004 Sheet 19 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 20 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 21 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 23 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 24 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 25 of 95
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`Patent Application Publication Dec. 2,2004 Sheet 27 of 95
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`Patent Application Publication Dec. 2,2004 Sheet 28 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 29 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 30 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 31 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 32 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 33 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 34 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 35 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 36 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 37 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 38 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 39 of 95
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`Patent Application Publication Dec. 2,2004 Sheet 40 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 41 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 42 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 43 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 44 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 45 of 95
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`FIG. 32A
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`Patent Application Publication Dec. 2,2004 Sheet 46 of 95
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`FIG. 33A
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`Patent Application Publication Dec. 2, 2004 Sheet 47 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 48 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 49 of 95
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`Patent Application Publication Dec. 2,2004 Sheet 50 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 52 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 53 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 54 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 55 of 95
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`Patent Application Publication Dec. 2,2004 Sheet 57 of 95
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`FIG. 46A
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`Patent Application Publication Dec. 2, 2004 Sheet 58 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 59 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 61 of 95
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`FIG. 49
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`Patent Application Publication Dec. 2, 2004 Sheet 63 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 64 of 95
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`FIG. S2A
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`Patent Application Publication
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`Dec. 2, 2004 Sheet 65 of 95
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`FIG. 53
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`Patent Application Publication Dec. 2, 2004 Sheet 66 of 95
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`FIG. S4A
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`Patent Application Publication Dec. 2,2004 Sheet 67 of 95
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`FIG. 54B
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`Patent Application Publication Dec. 2, 2004 Sheet 68 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 69 of 95
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`FIG. S6A
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`Patent Application Publication Dec. 2, 2004 Sheet 70 of 95
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`FIG. 58B
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`Patent Application Publication Dec. 2, 2004 Sheet 71 of 95
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`FIG. 60A
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`Patent Application Publication Dec. 2,2004 Sheet 72 of 95
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`Patent Application Publication Dec. 2, 2004 Sheet 73 of 95
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`FIG. 64A
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`Patent Application Publication Dec. 2,2004 Sheet 74 of 95
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`FIG. 65
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`Patent Application Publication Dec. 2, 2004 Sheet 75 of 95
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`FIG. 67C
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`Patent Application Publication Dec. 2, 2004 Sheet 76 of 95
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`FIG. 68A
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`Patent Application Publication Dec. 2, 2004 Sheet 77 of 95
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`FIG. 68B
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`Patent Application Publication Dec. 2, 2004 Sheet 78 of 95
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`FIG. 69A
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`

`

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`FIG. 69D
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`0080
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`0080
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`Patent Application Publication Dec. 2, 2004 Sheet 80 of 95
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`FIG. 70>
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`Patent Application Publication Dec. 2,2004 Sheet 81 of 95
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`FIG. 71B
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`1014
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`Patent Application Publication Dec. 2,2004 Sheet 82 of 95
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`FIG. 72
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`FIG. 73
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`1070
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`

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`Patent Application Publication Dec. 2,2004 Sheet 83 of 95
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`1514
`
`1506
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`
`0084
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`0084
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`Patent Application Publication Dec. 2, 2004 Sheet 84 of 95
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`75A
`
`FIG.
`
`time:
`
`temp
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`0085
`
`0085
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`Patent Application Publication Dec. 2, 2004 Sheet 85 of 95
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`FIG. 75B
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`Patent Application Publication Dec. 2, 2004 Sheet 86 of 95
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`FIG. 75D
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`Patent Application Publication Dec. 2, 2004 Sheet 87 of 95
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`FIG. 76A
`
`FIRST STEP: C. SCREEN
`
`FIG. 76B—~
`
`SECOND STEP:
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`1542a
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`

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`Patent Application Publication Dec. 2, 2004 Sheet 88 of 95
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`1596
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`1596
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`0089
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`0089
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`Patent Application Publication Dec. 2, 2004 Sheet 89 of 95
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`FIG. 77C
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`
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`
`FIG. 78
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`Patent Application Publication Dec. 2, 2004 Sheet 90 of 95
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`FIG. 79A
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`1744
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`Patent Application Publication Dec. 2, 2004 Sheet 91 of 95
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`FIG. 80
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`

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`FIG. 81C
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`
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`0094
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`0094
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`FIG. 83
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`

`Patent Application Publication Dec. 2,2004 Sheet 95 of 95
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`US 2004/0242976 Al
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`FIG. 85A
`
`1914
`
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`
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`0096
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`0096
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`APPARATUS AND METHOD FOR MEASURING
`BIOLOGIC PARAMETERS
`
`(0001] This application is a continuation-in-part of U.S.
`Ser. No, 10/420,295, filed Apr. 22, 2003, which claims the
`benefit of U.S. Provisional Application Ser. No. 60/374, 133,
`filed Apr. 22, 2002, and claims the benefit ofthe priority of
`No. 60/449,800, filed Feb. 26, 2003, No. 60/475,470, filed
`Jun. 4, 2003 and No, 60/497,306,filed Aug. 25, 2003, herein
`incorporated in their entirety by reference.
`
`FIELD OF THE INVENTION
`
`[0002] The present invention includes support and sensing
`structures positioned in a physiologic tunnel for measuring
`bodily functions and to manage abnormal conditions indi-
`cated by the measurements.
`
`BACKGROUNDOF THE INVENTION
`
`Interfering constituents and variables can introduce
`(0003]
`significant source of errors that prevent measured biologic
`parameters from being ofclinical value. In order to bypass
`said interfering constituents and achieve undisturbed sig-
`nals, invasive and semi-invasive techniques have been used.
`Such techniques have many drawbacks includingdifficulties
`in providing continuous monitoring for long periods of time.
`Non-invasive techniques also failed to deliver the clinical
`usefulness needed. The placement of a sensor on the skin
`characterized by the presence ofinterfering constituents do
`not allow obtaining clinically useful nor accurate signals due
`to the presence of said interfering constituents and back-
`ground noise which greatly exceedsthe signal related to the
`physiologic parameter being measured.
`
`[0004] The most precise, accurate, and clinically useful
`way of evaluating thermal status of the body in humans and
`animals is by measuring brain temperature. Brain tempera-
`lure measurement is the key and universal indicator of both
`disease and health equally, and is the only vital sign that
`cannotbe artificially changed by emotionalstates. The other
`vital signs (heart rate, blood pressure, and respiratory rate)
`all can be influenced andartificially changed by emotional
`states or voluntary effort.
`
`[0005] Body temperature is determined by the temperature
`of blood, which emits heat as far-infrared radiation. Adipose
`lissue (fat
`tissue) absorbs far-infrared and the body is
`virtually completely protected with a layer of adipose tissue
`adherent
`to the skin. Thus measurement of temperature
`using the skin did not achieve precision nor accuracy
`because previous techniques used sensors placed on skin
`characterized by the presence of adipose tissue.
`
`[0006] Because it appeared to be impossible with current
`technology to non-invasively measure brain temperature,
`allempts were made to determine internal body temperature,
`also referred to as core temperature. An invasive, artificial,
`inconvenient, and costly process is currently used to mea-
`sure internal (core) temperature consisting of inserting a
`catheter with a temperature sensor in the urinary canal,
`rectum or esophagus, But such methodology is not suitable
`for routine measurement,it is painful, and has potential fatal
`complications.
`
`[0007] Semi-invasive techniques have also being tried.
`Abreu disclosed in U.S. Pat. No. 6,120,460 apparatus and
`methods for measuring core temperature continuously using
`
`a contact lens in the eyelid pocket, but the contact lens is a
`semi-invasive device which requires prescription by a phy-
`sician and sometimesit is not easy to place the contact lens
`in the eye ofan infant or even in adults and many people are
`afraid of touching their eyes.
`
`[0008] There are several drawbacks and limitations in the
`prior art for continuous and/or core measurement of tem-
`perature.
`
`[0009] Measurement of temperature today is non-continu-
`ous, non-core and nurse dependent. Nurses have tostick a
`thermometer in the patient’s mouth, rectum or ear. To get
`core temperature nurses invasively place a tube inside the
`body which can cause infection and costly complications.
`
`[0010] Measurement of core temperature on a routine
`basis in the hospital and/or continuously is very difficult and
`risky because il requires an invasive procedure with inser-
`tion of tubes inside the body or by ingesting a thermometer
`pill. The thermometer pill can cause diarrhea, measure
`temperature of the fluid/food ingested and not body tem-
`perature, and have fatal complications if the pill obstructs
`ithe pancreasor liver ducts. Placement ofsensors on the skin
`do not provide clinically useful measurements because of
`the presence of many interfering constituents including fat
`tissue.
`
`It is not possible to acquire precise and clinically
`(0011)
`useful measurements of not only brain temperature, but also
`metabolic parameters, physical parameters, chemical param-
`elers, and the like by simply placing a sensor on the skin.
`One key elementis the presence of fat tissue. Fat varies from
`person to person, fal varies with aging, fat content varies
`from time to time in the same person,fat attenuates a signal
`coming from a blood vessel, fat absorbs heat, fal prevents
`delivery of undisturbed far-infrared radiation, fat increases
`ihe distance traveled by the element being measured inside
`the body and an external sensor placed on the surface ofthe
`skin.
`
`[0012] There is a need to identify a method and apparatus
`that can non-invasively, conveniently and continuously
`monitor brain temperature in a painless, simple, external and
`safe manner with sensors placed on the skin.
`
`[0013] There is further a need to identify a method and
`apparatus that can conveniently, non-invasively, safely and
`precisely monitor biological parameters including metabolic
`parameters, physical parameters, chemical parameters, and
`the like.
`
`Thereis a need to identify an apparatus and method
`{0014]
`capable of measuring biological parameters by positioning a
`sensor on a physiologic tunnel for the acquisition of undis-
`turbed and continuous biological signals.
`
`SUMMARY OF THE INVENTION
`
`(0015] The present invention provides methods, apparatus
`and systems that effectively address the needs of the prior
`art.
`
`In general, the invention provides a set of sensing
`(0016]
`systems and reporting means which may be used individu-
`ally or in combination, which are designed to access a
`physiologic tunnel
`to measure biological, physical and
`chemical parameters. Anatomically and physiologically
`speaking, the tunnel discovered by the present invention is
`
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`an anatomic path which conveys undisturbed physiologic
`signals to the exterior. The tunnel consists of a direct and
`undisturbed connection between the source of the function
`(signal) within the body and an external pointat the end of
`the tunnel located on the skin. A physiologic tunnel conveys
`continuous and integral data on the physiology of the body.
`An undisturbed signal from within the body is delivered to
`an external point at the end of the tunnel. Asensor placed on
`the skin at
`the end of the tunnel allows optimal signal
`acquisition without interfering constituents and sources of
`CIror.
`
`Included in the present invention are support struc-
`(0017]
`tures for positioning a sensor on the skin at the end of the
`tunnel. The present invention discloses devices directed al
`measuring brain temperature, brain function, metabolic
`function, hydrodynamic function, hydration status, hemo-
`dynamic function, body chemistry and the like. The com-
`ponents include devices and methodsfor evaluating biologi-
`cal parameters using patches, clips, eyeglasses, head
`mounted gear and the like with sensing systems adapted to
`access physiologic tunnels to provide precise and clinically
`useful information about the physiologic status of the wearer
`and for enhancingthe safety and performanceofsaid wearer,
`and helping to enhance and preserve the life of said wearer
`by providing adequate reporting means and alert means
`relating to the biological parameter being monitored. Other
`components provide for producing direct or indirect actions,
`acting on another device, or adjusting another device or
`article of manufacture based on the biological parameter
`measured.
`
`[0018] The search for a better way to measure biological
`parameters has resulted in long and careful research, which
`included the discovery of a Brain Temperature Tunnel (BTT)
`and other physiologic tunnels in humans and animals. The
`present invention wasthefirst to recognize the physiologic
`tunnel in the body. The present invention wasyet the first to
`recognize the end ofthe tunnel on the skin surface in which
`an optimal signal is acquired and measurements can be done
`without the presence ofinterfering constituents and back-
`ground noise that exceeds the signal being measured. The
`present invention was also the first
`to recognize and pre-
`cisely map the special geometry and location of the tunnel
`including the main entry point. The present invention was
`yet
`first
`to recognize the precise positioning of sensing
`systems al the main entry point for optimal signal acquisi-
`tion. Careful studies have been undertaken including soft-
`ware development for characterizing infrared radiation to
`precisely determine the different aspects ofthe tunnel. This
`research has determined that
`the measurement of brain
`(core) temperature and other body parameters can be accom-
`plished in a non-invasive and continuous manner in humans
`and animals with sensors positioned in a confined area ofthe
`skin at the end ofa physiologic tunnel.
`
`(0019] The key function and critical factor for life pres-
`ervation and human performanceis brain temperature. Brain
`tissue is the tissue in the body most susceptible to thermal
`damage, by both high and low temperature. Brain tempera-
`ture is the most clinically relevant parameter to determine
`the thermal status of the body and the human brain is
`responsible for 18 to 20%of the heat producedin the body,
`which is an extraordinary fact considering that the brain
`represents only 2% ofthe body weight. The great amount of
`thermal energy generated in the brain ts kept in a confined
`
`space and the scalp, skull, fat and CSF(cerebral spinal fluid)
`form an insulating layer. The recognition of the BTTby the
`present invention bypasses the insulating barriers and pro-
`vides a direct connection to inside the brain physiology and
`physics.
`a
`[0020] Anatomically and physiologically speaking,
`Brain ‘Temperature Tunnel consists of a continuous,direct,
`and undisturbed connection between the heat source within
`the brain and an external point at the end ofthe tunnel. The
`physical and physiological events at one end of the tunnel
`inside the brain are reproduced at the opposite end on the
`skin. A BTT enables the integral and direct heat transfer
`through the tunnel! without interference by heat absorbing
`elements,i.e., elements that can absorb far-infrared radiation
`transmitted as heat by blood within the brain. There are six
`characteristics needed to define aBIT. These characteristics
`are:
`
`1) area without heat absorbing elements,i.e.,
`[0021]
`the area must not contain adipose tissue (fal tissue).
`This is a key and needed characteristic for defining
`a temperature tunnel,
`
`2) area must have a terminal branch of a
`[0022]
`vessel in order to deliver the integral amountofheat,
`[0023]
`3) terminal branch hasto be a direct branch of
`a blood vessel from the brain,
`
`terminal branch has to be superficially
`4)
`[0024]
`located to avoid heat absorption by deep structures
`such as muscles,
`
`5) area must have a thin and negligible inter-
`[0025]
`face between a sensor and the source of thermal
`energy to achieve high heat How, and
`
`6) area must not have thermoregulatory arte-
`[0026]
`riovenous shunts.
`
`[6027] Allsix characteristics are present on the skin on the
`medial canthal area adjacent to the medial corner of the eye
`above the medial canthal tendon and in the medial third of
`ihe upper eyelid. In more detail the end of BTTarea on the
`skin measures about 11 mm in diameter measured from the
`medial corner of the eye at the medial canthal tendon and
`extends superiorly for about 6 mm and then extends into the
`upper eyelid in a horn like projection for another 22 mm.
`
`[0028] The BTT area is the only area in the body without
`adipose tissue, which is in addition supplied by a terminal
`branch, which has a superficial blood vessel coming from
`the brain vasculature, and which has a thin interface and no
`thermoregulatory shunts. The BTTarea is supplied by a
`terminal branch of the superior ophthalmic vein which is a
`direct connection to the cavernous sinus, said cavernous
`sinus being an endothelium-lined system of venous channels
`inside the brain which collects and stores thermal energy.
`The blood vessel supplying the BTT area is void of ther-
`moregulatory arteriovenous shunts and it ends on the skin
`adjacent to the medial corner ofthe eye and in the superior
`aspectof the medial canthal area right at the beginning ofthe
`upper eyelid. The blood vessels deliver undisturbed heat to
`the skin on the medial canthal area and upper eyelid as can
`be seen in the color as well as black and white photos of
`infrared images shown in FIGS. 1 and 2. The undisturbed
`thermal radiation from the brain is delivered to the surface
`of the skin al the end of the tunnel. The heat is delivered to
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`
`an area ofskin without fat located at the end of the tunnel.
`The blood vessel delivering heat is located just below the
`skin and thus there is no absorption of infrared radiation by
`deep structures.
`
`Ifthe blood vessel is located deep,other tissues and
`(0029]
`chemical substances would absorb the heat, and that can
`invalidate the clinical usefulness of the measurement. There
`is direct heat transfer and the skin in the BTT area is the
`thinnest skin in the body and is void of thermoregulatory
`arteriovenous shunts. A very important aspect for optimal
`measurement of temperature is no interference by fat tissue
`and direct heat transfer.
`
`tissue in this particular and
`[0030] The absence of fat
`unique area in the body at the end ofthe tunnel allows the
`undisturbed acquisition of the signal. The combination of
`those six elements allows the undisturbed and integral
`emission ofinfrared radiation from the brain in the form of
`direct heat transfer at the BTTarea location, which can be
`seen in the infrared image photographs (FIGS. 1 to 8) The
`BTT and physiologic tunnels are also referred in this
`description as the “Target Area”.
`
`(0031] From a physical standpoint, the BTTis the equiva-
`lent of a Brain Thermal Energy tunnel with high total radiant
`power and high heat flow. The temperature of the brain is
`determinedby the balance between thermal energy produced
`due to metabolic rate plus the thermal energy delivered by
`the arterial supply to the brain minusthe heat that is removed
`by cerebral blood flow. Convection of heat between tissue
`and capillaries is high and the temperature of the cerebral
`venousblood ts in equilibrium with cerebral tissue. Accord-
`ingly, parenchymal temperature and thermal energy of the
`brain can be evaluated by measuring the temperature and
`thermal energy of the cerebral venous blood. The superior
`ophthalmic vein has a direct and undisturbed connection to
`the cavernous sinus and carries cerebral venous blood with
`a thermal energy capacity of 3.6 JamI-'. (° C.)"? at hemat-
`ocrit of 45%. Cerebral
`thermodynamic response, thermal
`energy, and brain temperature can be evaluated by placing a
`sensor to capture thermal energy conveyed by the cerebral
`venous blood at the end of the BTT.
`
`[0032] The research concerning BTT and physiologic tun-
`nels involved various activities and studies including: 1)
`In-vitro histologic analysis of mucosal and superficial body
`areas; 2) In-vivo studies with temperature evaluation of
`external areas in humans and animals; 3) In-vivo functional
`angiographic evaluation of heat source; 4) Morphologic
`studies of the histomorphometric features of the BTT area;
`5) In-vivo evaluation of temperature in the BTT area using:
`thermocouples, thermistors, and far-infrared; 6) Comparison
`of the BTTarea measurements with the internal eye anatomy
`and current standard most used (oral) for temperature mea-
`surement; 7) Cold and heat challenge to determine tempera-
`ture stability of BTT; and 8) Infrared imaging and isotherm
`determination. Software for evaluating geometry of tunnel
`was also developed and used. Simultaneous measurement of
`a reference temperature and temperature in the BTT area
`were done using pre-equally calibrated thermistors. A spe-
`cifie circuit with multiple channels was designed for the
`experiments and data collection.
`
`[0033] The measurement of temperature in the BTT area
`showed almost
`identical
`temperature signal between the
`BTT area and the internal conjunctival anatomy of the eye,
`
`which is a continuation of the central nervous system.
`Measurement of the temperature in the internal conjunctival
`anatomy of eye as usedin the experiment was described by
`Abreu in U.S. Pat. Nos. 6,120,460 and 6,312,393. The
`averaged temperature levels for BTTand internal eye were
`within 0.1° C. (0.18° F.) with an average normothermia
`value equivalent of 37.1° C. (98.8° F.) for the BTT and 37°
`C. (98.6° F.)
`for the internal eye. Comparison with the
`standard most used, oral temperature, was also performed.
`The temperature voltage signal of the BTT area showed an
`average higher temperature level
`in the BTT area of an
`equivalent of 0.3° C. (0.5° F.) when compared to oral.
`[0034] Subjects underwent cold challenge and heat chal-
`lenge through exercising and heat room. The lowering and
`rising of temperature in the BTT area was proportional to the
`lowering and rising in the oral cavity. However, the rate of
`temperature change was faster in the BTT area than for oral
`by about 1.2 minutes, and temperature at the BTT site was
`0.5° C. (0.9° F) higher on few occasions. Subjects of
`different race, gender, and age were evaluated to determine
`the precise location of the BTT area across a different
`population and identify any anatomicvariation. The location
`