EXHIBIT 2125
`EXHIBIT 2125
`
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`

`5,817,008
`[11] Patent Number:
`[19]
`Unlted States Patent
`
`Rafert et al.
`[45] Date of Patent:
`Oct. 6, 1998
`
`U8005817008A
`
`[54] CONFORMAL PULSE OXIMETRY SENSOR
`AND MONITOR
`
`[75]
`
`Inventors: Stephen c_ Rafert, Kent; David R.
`Marble, Seattle, both of Wash.; Glenn
`W Pelikan Portland Ore
`. Alan
`'
`.
`’
`.
`’
`.
`g"
`Kahn> aneaPOhS> an.
`[73] Assigneei SPaCELabS Medical, 1116-, Redmond,
`Wash.
`
`.
`..
`,
`[21] Appl No . 741 735
`.
`.
`,
`[22]
`Filed'
`Oct 31 1996
`
`Int. C116 ........................................................ A61B 5/00
`[51]
`[52] US. Cl.
`............................................. 600/323; 600/344
`
`128/633
`128/633
`128/690
`
`4,266,554
`4,281,645
`4,305,401
`
`5/1981 Hamaguri ..
`
`8/1981 J6bsis ...................
`12/1981 Reissmueller etal.
`
`.........
`3/1982 Jébsis et al.
`.. 128/633
`4,321,930
`9/1982 Stnese ..................................... 128/640
`4,350,165
`4,353,372 10/1982 Ayer ........................................ 128/640
`4,370,984
`2/1983 Cartmell
`128/640
`
`......
`4,380,240
`4/1983 J6bsis et al.
`128/633
`9/1983 Wesselin et al.
`4,406,289
`128/670
`
`4,407,290 10/1983 Wilber ...g.................................. 128/633
`4,424,814
`1/1984 Secunda .................................. 128/663
`
`(List continued on next page.)
`FOREIGN PATENT DOCUMENTS
`671279
`10/1963 Canada .
`0 019 478
`11/1980 European Pat. OE. .
`2 039 364
`8/1980 United Kingdom .
`
`[58] Field of Search ..................................... 128/633, 664,
`128/665, 666; 356/41; 600/310, 322, 323,
`340 344 473 476
`’
`’
`’
`
`’f B h
`J
`.
`E
`P .
`”Wary xamlfler— en?” er
`?1 r
`Asststant Exammer—Eric F. Winakur
`Attorney, Agent, or Firm—Seed and Berry LLP
`
`[56]
`
`References Cited
`
`[57]
`
`ABSTRACT
`
`U.S. PATENT DOCUMENTS
`55
`d
`411/1365 miter........................................258/3239
`31277258
`
`2/1965 Phipps etal
`128/2 06
`3’170’459
`
`.........128/206 E
`8/1971 Gordy .......
`3,599,629
`8/1971 Howell et 31.
`.. 128/2.05 F
`3:602:213
`
`2/1972 shaw ................ 128/2 R
`3,638,640
`
`
`...........
`3,698,382 10/1972 Howell
`128/2 R
`12/1972 Herczfeld el; al.
`...................... 128/2 R
`3,704,706
`3,769,974
`11/1973 Smart et al.
`........................ 128/2.05 P
`3/1974 Vurek ’1"""""""" 356;“
`397999672
`
`3982794318: 14313;: gig; ’al””
`12892;;/41:
`
`3,943,918
`3/1976 Lewis
`'
`'
`"""1'28/2 1 A
`3:980:075
`9/1976 Heule iIIIIIIIII::::::::::::::..128/2.05 R
`........ 356/39
`3,998,550 12/1976 Konishi et 31.
`
`. 128/2.05 R
`4,013,067
`3/1977 Kresge et a1.
`
`.. 128/2.05 P
`4,038,976
`8/1977 Hardy et al.
`
`4,052,977 10/1977 Kay .................. 128/2 V
`5/1978 KPfSkY (’1 al~
`~~~~~~ 128/2 L
`4,086,915
`
`313;: End? tml””””
`‘ 1251/55: 11:
`19235922:
`......
`,
`,
`on e a.
`
`4,121,573
`10/1978 Crovella et al.
`128/2.1 A
`
`
`9/1979 Nielsen ............... 356/39
`4,167,331
`9/1980 Jobsis ...................................... 128/633
`4,223,680
`
`An optoelectronic pulse oximetry sensor is described Which
`physically conforms to a body portion of a patient, such as
`a finger, and provides a firm pressing engagement between
`the sensor and the patient’s body portion. The sensor
`includes a flexible substrate, such as an elastic bandage-type
`material, Which is physically conformable and attachable/
`adherable to the patient’s body portion. The sensor also
`includes a light source assembly for transilluminating the
`patient’s body portion, and a llght detector assembly for
`measuring transmitted light. The dimensions of the light
`source and light detector assemblies are constructed to
`provide a high aspect ratio relative to the flexible substrate.
`When the sensor is conformably applied to the patient’s
`bOdY Portiom localized Pressure is exerted on the bOdY
`portion at the points of contact With the light source and light
`detector assemblies,
`thereby stressing the skin and the
`underlying blood-perfused tissue. The stress imparted to the
`skin and underlying tissues affects the distributions of blood
`in the tissues and provides improved accuracy and sensitiv-
`ity in arterial oxygen saturation measurement, especially in
`-
`-
`Clrcumsmnces 0f 10W perfusmn‘
`
`40 Claims, 3 Drawing Sheets
`
`\ 25 30
`
`58
`
`78
`
`.36 / ,2
`
`20
`
`44
`
`28
`
`70
`
`I4
`
`I6
`
`
`
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`5,817,008
`
`Page 2
`
`US. PATENT DOCUMENTS
`
`..
`
`. 128/664
`1/1985 Blazek eta].
`4,494,550
`. 128/633
`4/1985 Jobsisetal.
`4,510,938
`
`128/633
`11/1986 New, Jr. et al.
`4,621,643
`........................ 128/633
`3/1987 New, Jr. et al.
`4,653,498
`8/1987 Goldberger et a1.
`.................... 128/633
`4,685,464
`
`4,700,708 10/1987 New, Jr. et al.
`128/633
`....................... 128/667
`4,726,382
`2/1988 Boehmeretal.
`..................................... 128/633
`4,759,369
`7/1988 Taylor
`
`4,770,179
`9/1988 New, J1: et al.
`128/633
`................................ 128/633
`4,825,879
`5/1989 Tan et al.
`
`4,830,014
`...................... 128/665
`5/1989 Goodman et al.
`4,859,057
`8/1989 Taylor et al.
`............................. 356/41
`.
`$32223: 1323:?) 31°16: 311’ “
`332::
`7
`7
`m e a' "
`570357243
`7/1991 MPZ ~~~~~~~~~~~~
`128/633
`5,041,187
`8/1991 Hmk et al:
`.............................. 156/634
`5,069,213
`12/1991 Polczynskl
`.............................. 128/633
`590999842
`3/1992 Mannheimeretal-
`128/633
`
`............................. 128/633
`5,237,994
`8/1993 Goldberger
`5,335,659
`8/1994 Pologe .................................... 128/633
`5,427,093
`6/1995 Ogawa et al.
`.......................... 128/633
`
`
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`

`US. Patent
`
`Oct. 6, 1998
`
`Sheet 1 0f3
`
`5,817,008
`
`70
`
`
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`US. Patent
`
`Oct. 6, 1998
`
`Sheet 2 0f3
`
`5,817,008
`
`
`
`
`5939359593..
`
`
`
`
`22
`
`I6
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`US. Patent
`
`Oct. 6, 1998
`
`Sheet 3 0f3
`
`5,817,008
`
`80
`
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`5,817,008
`
`1
`CONFORMAL PULSE OXIMETRY SENSOR
`AND MONITOR
`
`TECHNICAL FIELD
`
`The present invention relates generally to pulse oximetry
`instruments, and more particularly,
`to an optoelectronic
`pulse oximetry sensor which is physically conformable to a
`body portion of a patient.
`BACKGROUND OF THE INVENTION
`
`Oximeters are well known in the art, and are used to
`measure the level of oxygen in a patient’s blood non-
`invasively. More precisely, oximeters measure the level of
`arterial oxygen saturation, which is the ratio of arterial blood
`oxyhemoglobin concentration to total hemoglobin concen-
`tration. Optoelectronic pulse oximeters are well known in
`the art and typically include a sensor having a light source,
`such as a light-emitting diode (LED), and a light sensor,
`such as a photodetector. The light source emits light which
`transilluminates—that
`is, shines through—the patient’s
`body portion, and light which is neither absorbed nor
`scattered away by the blood-perfused tissue is measured by
`the light sensor.
`Although broad-spectrum visual light may be employed,
`more typically light of two or more discrete wavelengths,
`such as red and infrared wavelengths, is used. The red light
`is primarily absorbed by the oxyhemoglobin, whereas the
`infrared light is primarily absorbed by all blood hemoglobin,
`independent of the oxyhemoglobin concentration. The
`absorption of the red and infrared light then varies as a
`function of the quantity of hemoglobin and the quantity of
`oxyhemoglobin in the lightpaths. Both the quantity of hemo-
`globin and the quantity of oxyhemoglobin vary as a function
`of the heartbeat cycle—namely, with the pulsatile distention
`of the arteries.
`
`the light sensor also
`The amount of light received at
`depends on effects other than light absorption by blood
`hemoglobin, such as the effects due to bone, skin
`pigmentation, etc. However, these other effects do not vary
`as a function of the heartbeat cycle. Also, the light absorbing
`effects due to venous blood hemoglobin do not vary with the
`heartbeat cycle nearly as much as the effects due to arterial
`blood hemoglobin, since the capillary bed essentially iso-
`lates the veins from the high blood pressure pulse. Thus, the
`light received by the light sensor has both an alternating
`component (associated primarily with the arterial blood
`hemoglobin) and a steady-state component (associated with
`other light absorbing and/or scattering effects of the patient’s
`body portion). As is well known in the art, determining the
`ratios of the alternating components to the steady-state
`components allows an accurate determination of arterial
`oxygen saturation, independent of the light absorbing and/or
`scattering effects associated with the steady-state compo-
`nent.
`
`Typically, the amplitude of the alternating component is
`of the order of 2%—3% of the total light received by the light
`sensor. In circumstances of low perfusion, such as when the
`patient’s body portion is particularly cold, or when a patient
`is in shock, experiencing declining blood pressure, etc., the
`amplitude of the alternating component can be of the order
`of only 1% of the total light received by the light sensor.
`Thus, any signal noise and/or other spurious effecting tend-
`ing to mimic the alternating component can detrimentally
`affect measurement accuracy. Accordingly, currently avail-
`able oximeters include hardware circuitry and a variety of
`signal processing software algorithms for performing noise
`reduction and other signal processing.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`2
`The effect of a patient’s blood oxygen content on the
`intensity of transmitted light is well known, and is described
`in US. Pat. Nos. 4,621,643, 4,653,498, 4,685,464, and
`4,700,708, which are incorporated herein by reference. Also
`well known in the art are pulse oximetry sensors that are
`placed on the patient’s body portion and substantially physi-
`cally conformed to that body portion. One example is US.
`Pat. No. 4,830,014 to Goodman et al., incorporated herein
`by reference. The sensor described in Goodman et al.
`includes an elongated flexible strip (much like an elastic
`bandage) to which an LED and a photodetector are attached.
`The LED and photodetector have a very small physical
`profile. The LED and photodetector are essentially inte-
`grated within the flexible strip so that they do not stress the
`skin by imparting localized pressure to the skin beneath the
`LED and light detector. The sensor described in Goodman et
`al. readily conforms to the body portion, such as a finger, on
`which it is placed or wrapped.
`The sensor described in Goodman et al. exhibits a number
`
`of disadvantages. In particular, the sensor would not work
`well unless firmly applied to the patient, and even then
`would provide a measured pulse amplitude which may be
`insufficient for accurate measurement of a patient’s pulse
`and blood oxygen level. In particular,
`the primary goal
`taught by Goodman et al., i.e., avoiding the application of
`localized stress to the skin (and hence stress,
`to blood-
`perfused tissue beneath the skin), actually impairs the ability
`of the sensor to provide accurate blood oxygen levels.
`SUMMARY OF THE INVENTION
`
`In accordance with the present invention, an improved
`optoelectronic pulse oximetry sensor is provided which
`substantially physically conforms to a body portion of a
`patient. The sensor is removably securable to the patient’s
`body portion by an adhesive coating, and includes at least
`one light source for transilluminating the body portion and
`a light detector for measuring light transmitted through the
`body portion. The sensor includes a flexible substrate having
`an inner surface and an outer surface—the inner surface
`
`disposed towards the body portion and the outer surface
`disposed away from the body portion. The light source and
`the light detector are mounted on the flexible substrate at
`spaced-apart locations. Significantly, the light source and the
`light detector project a substantial distance from the inner
`surface to provide firm localized pressure against the body
`portion, thereby stressing blood-perfused tissues beneath the
`skin.
`
`In one embodiment, the light source and light detector are
`each enclosed in a substantially rigid transparent housing.
`Each of the housings includes a flange portion securable
`between an inner layer and an outer layer forming the
`flexible substrate. In another embodiment, each of the light
`source and light detector includes a substantially rigid circuit
`board for holding a light source or a light detector and
`providing electrical connections thereto. A substantially
`elastomeric transparent cover is connected to the circuit
`board and covers the corresponding light source or light
`detector.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is an isometric view of an optoelectronic pulse
`oximetry sensor having a flexible substrate, a light source
`assembly, and a light detector assembly according to the
`present invention.
`FIG. 2 is an enlarged cross-sectional view of the sensor of
`FIG. 1, showing certain details of a preferred embodiment of
`the light source and light detector assemblies.
`
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`

`5,817,008
`
`3
`FIG. 3 is an isometric view of the sensor of FIG. 1, having
`the light source and light detector assemblies of FIG. 2,
`showing a portion of the flexible substrate pulled back to
`expose certain details of the inner construction.
`FIG. 4 is an enlarged cross-sectional view of the sensor of
`FIG. 1, showing an alternate embodiment of the light source
`and light detector assemblies.
`FIG. 5 is an isometric view showing the sensor of FIG. 1
`connected to a conventional pulse oximetry monitor.
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`An improved pulse oximetry sensor is described which
`substantially physically conforms to a body portion of a
`patient, such as a finger, while providing suflicient stress to
`the patient’s body portion to afford greater accuracy of
`measurement. In the following description, certain specific
`details are set forth in order to provide a thorough under-
`standing of the preferred embodiment of the present inven-
`tion. However, it will be obvious, to one skilled in the art,
`that the present invention may be practiced without these
`details. In other instances, well-known pulse oximetry sen-
`sor components are not discussed in detail in order not to
`unnecessarily obscure the invention.
`FIG. 1 shows a preferred embodiment of an optoelec-
`tronic pulse oximetry sensor 10 made in accordance with the
`present invention. The sensor 10 includes a flexible substrate
`12, such as an elastic bandage-type material. The flexible
`substrate 12 is preferably constructed from a plurality of
`layers which are bonded or otherwise connected to one
`another. The flexible substrate 12 includes an inner surface
`
`14 and an outer surface 16. The designations of “inner” and
`“outer” correspond with the intended orientation of the
`flexible substrate 12 upon physical conformation with the
`patient’s body portion. The flexible substrate 12 preferably
`includes a conventional adhesive on the inner surface 14 to
`
`securely attach and conform the sensor 10 to the patient’s
`body portion. Alternatively, if the ends of the substrate 12
`overlap, a hook-and-loop type fastener of the type com-
`monly sold under the trademark Velcro® may be suitably
`employed.
`A light source assembly 18 and a light detector assembly
`20 are attached to the flexible substrate 12. The dimensions
`
`of the light source assembly 18 and light detector assembly
`20 are constructed to provide a high aspect ratio relative to
`the flexible substrate 12. In this way, the light source and
`light detector assemblies 18, 20 project a substantial dis-
`tance from the inner surface 14 of the flexible substrate 12.
`
`When the inner surface of the flexible substrate 12 is placed
`against the skin of the patient’s body portion,
`the light
`source and detector assemblies 18, 20 firmly press into the
`skin to apply substantial stress to the skin and the blood-
`perfused tissue beneath the skin. Consequently, the skin and
`the underlying tissue are displaced and deformed, thereby
`partially depleting the tissue of blood. As shown in the
`embodiments depicted in FIGS. 2 and 4, the source and
`detector assemblies 18, 20 project from the flexible substrate
`12 a distance that is not less than approximately the distance
`they extend along the substrate—i.e., having an aspect ratio
`relative to the flexible substrate of not less than approxi-
`mately 1:1.
`the light
`As in conventional pulse oximetry sensors,
`source assembly 18 may include two light-emitting diodes
`(LEDs) emitting light at red and infrared wavelengths, and
`the light detector assembly 20 may include a corresponding
`two or more photodetectors, although a single light detector
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`4
`is normally used to detect light at both wavelengths. Electric
`signals are carried to and from the light source and light
`detector assemblies 18, 20 by a multistrand electric cable 22,
`which terminates at an electrical connector 24 to which
`conventional optoelectronic oximeter control and processing
`circuitry is attached.
`The high aspect ratio of the light source and light detector
`assemblies 18, 20 provides a number of distinct advantages
`over prior art pulse oximetry sensors. Some conventional
`pulse oximetry sensors, including sensors like that described
`in Goodman et al., do not apply pressure to the patient’s
`body portion at the points of contact with the light source
`and/or light detector to achieve optimum performance. As
`mentioned above, when the sensor 10 is placed in substantial
`physical conformance with the patient’s body portion, the
`light source and light detector assemblies 18, 20 each project
`a substantial distance from the inner surface 14 of the
`
`flexible substrate 12 into firm pressing engagement with the
`patient’s body portion.
`By exerting pressure at the points of contact, localized
`stress is imparted to blood-perfused tissue beneath the light
`source and detector assemblies 18, 20. This localized stress
`forces some of the blood from the blood-perfused tissues
`adjoining the points of contact. Because a patient’s arterial
`blood is at a higher pressure than the venous blood, a greater
`quantity of venous blood will be removed. This removal of
`venous blood correspondingly decreases associated light
`attenuation effects and thereby increases the amount of light
`reaching the light detector assembly 20, from which the
`measurements of arterial blood oxygen saturation levels are
`determined. Also, because the venous blood has been largely
`depleted from the transilluminated body portion, any local-
`ized pulse effects in the veins (due to pulsatile distention of
`adjacent arteries) is minimized. This is particularly advan-
`tageous since arterial oxygen saturation is of primary clini-
`cal
`interest. When the patient’s heart beats,
`there is a
`momentary increase in the arterial pressure and a corre-
`sponding increase in arterial blood quantity, thereby causing
`a momentary decrease in the amount of light received at the
`light detector assembly 20, from which the patient’s pulse is
`determined.
`
`The localized pressure exerted by the light source and
`detector assemblies 18, 20 partially depletes the tissue
`portions adjacent to the assemblies of blood. These tissue
`portions then become more and less depleted of blood as a
`function of the heartbeat cycle, thereby enhancing the alter-
`nating component of the light received at the light detector
`assembly 20. Also, a boundary region separating the blood-
`depleted tissue portions from the surrounding blood-
`perfused tissue portions changes position as a function of the
`heartbeat cycle and creates a shutter-like effect, which
`further enhances the alternating component of the light
`received at the light detector assembly 20. The enhanced
`amplitude of the alternating component provided by the
`sensor 10 affords improved reliability, accuracy, and sensi-
`tivity in arterial oxygen saturation measurement. This is
`especially advantageous when arteries are constricted, as
`when dealing with low perfusion states.
`FIG. 2 shows a cross-section of the sensor 10 of FIG. 1,
`and depicts a preferred embodiment of the light source and
`light detector assemblies 18, 20. Each of the light source and
`light detector assemblies 18, 20 includes a rigid transparent
`housing 26, 28, respectively, enclosing other components of
`the light source and light detector assemblies. The transpar-
`ent housings 26, 28 then provide the firm pressing engage-
`ment between the light source and light detector assemblies
`18, 20 and the patient’s body portion. The light source
`
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`5,817,008
`
`5
`assembly 18 includes a plurality of light sources, such as a
`red LED 30 and an infrared LED 32. The LEDs 30, 32 are
`mounted on a substantially rigid LED holder 34, which
`preferably includes a printed circuit board for making the
`appropriate electrical connections. The LEDs 30, 32 may be
`encased by a protective covering material 36, such as
`silicone, although the transparent housing 26 itself can
`provide sufficient protection. The light detector assembly 20
`includes a single photodetector 38 operable to detect light
`received from the red LED 30 and the infrared LED 32. The
`
`photodetector 38 is mounted on a substantially rigid photo-
`detector holder 42, which preferably includes a printed
`circuit board for making the appropriate electrical connec-
`tions. The photodetector 38 may be encased by protective
`covering 44, such as silicone, although the transparent
`housing 28 itself can provide sufficient protection.
`Each of the transparent housings 26, 28 includes a flange
`portion 46, 48, respectively, which extends between an inner
`layer 50 and an outer layer 52 of the flexible substrate 12.
`The flange portions 46, 48 are held between the inner and
`outer layers 50, 52 to secure the light source and light
`detector assemblies 18, 20 to the flexible substrate 12. The
`inner layer 50 includes first and second openings 54, 56
`through which a cover portion 58, 60 of the transparent
`housings 26, 28 extend, all respectively. The cover portions
`58, 60 are preferably rounded so as to minimize any shearing
`effects when applied to a patient’s skin. This shape also
`provides a smooth boundary transition from the blood-
`depleted tissue portions to the surrounding blood-perfused
`tissue portions, which enhances the mobility of the boundary
`region in response to the heartbeat cycle. Correspondingly,
`this enhances the amplitude of the alternating component of
`the light received at the light detector assembly 20. Also held
`between the inner and outer layers 50, 52 are the various
`electric wires 62, 64 connecting to the light source and light
`detector assemblies 18, 20, respectively. The electric wires
`62, 64 are gathered together at the multistrand electric cable
`22, which then emerges from the flexible substrate 12 at a
`position approximately midway between the light source
`and light detector assemblies 18, 20 (see also FIG. 1).
`FIG. 3 shows a portion of the inner layer 50 pulled away
`to show how the light source and light detector assemblies
`18, 20 are secured to the flexible substrate 12. In particular,
`the opening 54 in the inner layer 50 is placed over the cover
`portion 58 of the transparent housing 26 of the light source
`assembly 18. The inner and outer layers 50, 52, when
`bonded or otherwise attached, then hold in place the trans-
`parent housing 26 by virtue of the flange portion 46 held
`securely therebetween. Also shown is the routing of electric
`wires 62, 64 and the electric cable 22.
`FIG. 4 is a cross-sectional view like that of FIG. 2, but
`showing an alternate embodiment of the light source and
`light detector assemblies 18, 20.
`In this alternate
`embodiment,
`the flexible substrate 12 may be suitably
`constructed from a single layer, or from two layers carrying
`the electric wires 62, 64 and a portion of the electric cable
`22 therebetween. If the flexible substrate 12 is of a single
`layer construction, the electric wires 62, 64 would preferably
`pass through the flexible substrate 12 and be gathered
`together at the electric cable 22 proximate to (or attached to)
`the outer surface 16 of the flexible substrate 12.
`
`The light source assembly 18 includes a flexible support
`pad 66, such as a soft foam pad, which is bonded by glue or
`other suitable means to the inner surface 14 of the flexible
`
`substrate 12. A substantially rigid LED holder, such as a
`printed circuit board 68, is mounted on the support pad 66.
`The printed circuit board 68 provides the appropriate elec-
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`6
`trical connections between the electric wires 62 and the
`LEDs 30, 32 which are mounted on the printed circuit board.
`The electric wires 62 preferably pass from the printed circuit
`board 68 through the flexible support pad 66. The LEDs 30,
`32 are mounted on the printed circuit board 68 and enclosed
`by a rounded soft protective cover, such as a silicone cap 70.
`When the sensor 10 is placed in physical conformance with
`the patient’s body portion, the silicone cap 70 is pressed into
`firm engagement with the patient’s body portion to exert
`localized pressure thereon. This localized pressure stresses
`the skin, and hence the underlying blood-perfused tissues,
`and the consequent compression of the skin and underlying
`tissue partially depletes the underlying tissue of blood.
`The light detector assembly 20 is similarly constructed. A
`flexible support pad 72, such as a soft foam pad, is attached
`to the inner surface 14 of the flexible substrate 12. The
`electric wires 64 pass through the support pad 72 and
`connect to a substantially rigid photodetector holder, such as
`a printed circuit board 74. The printed circuit board 74
`provides the appropriate electrical connections to the pho-
`todetector 38 which is mounted on the printed circuit board.
`The photodetector 38 is enclosed by a rounded protective
`cover, such as a silicone cap 76, which exerts localized
`pressure on the patient’s body portion when the sensor 10 is
`placed in physical conformance therewith.
`The sensor 10 of FIG. 1 is shown in FIG. 5 connected to
`a conventional pulse oximetry monitor 80. As is well known
`in the art, the monitor 80 is housed in a case 82 and has
`conventional internal circuitry (not shown) to provide appro-
`priate drive signals to the LEDs 30, 32 (see FIGS. 2 and 4)
`through a connector 84. The case 82 also houses conven-
`tional circuitry (not shown) for receiving the output signal of
`the photodetector 38 (see FIGS. 2 and 4) via the connector
`84 and for determining the percentage of oxygen saturation
`in blood-perfused tissues in a body part to which the sensor
`10 is attached. The circuitry then displays the oxygen
`saturation percent in a display window 86 in a conventional
`manner.
`
`It will be appreciated that, although the various embodi-
`ments of the invention have been described above for
`
`purposes of illustration, a number of modifications may be
`made without deviating from the spirit and scope of the
`invention. For example, the light source and light detector
`assemblies 18, 20 may be constructed in any of a wide
`variety of ways and in a variety of shapes, but all having a
`high aspect ratio relative to the flexible substrate 12 sufli-
`cient
`to provide the attendant
`localized pressure on a
`patient’s body portion to achieve the advantages described
`above. Those skilled in the art will understand that the
`
`advantages described above may be obtained by adapting
`only one of the light source and light detector assemblies 18,
`20 to provide the requisite localized pressure on the patient’s
`body portion. Additionally, any of a wide variety of suitable
`means may be employed for attaching and/or adhering the
`flexible substrate 12 to the patient’s body portion. Similarly,
`any of a wide variety of means for securing the light source
`and light detector assemblies 18, 20 to the flexible substrate
`12 may be employed. Indeed, numerous variations are well
`within the scope of this invention. Accordingly, the inven-
`tion is not limited except as by the appended claims.
`We claim:
`
`1. An optoelectronic sensor removably securable to a
`body portion of a patient, comprising:
`an elastic substrate having an inner surface for disposition
`towards the body portion and an outer surface for
`disposition away from the body portion;
`a light source assembly mounted on the elastic substrate;
`and
`
`IPR2017—003 15
`
`CONDITIONAL MOTION TO AMEND
`
`VALENCELL, INC.
`EXHIBIT 2125 — PAGE 9
`
`IPR2017-00315
`CONDITIONAL MOTION TO AMEND
`
`VALENCELL, INC.
`EXHIBIT 2125 - PAGE 9
`
`

`

`5,817,008
`
`7
`a light detector assembly mounted on the elastic substrate;
`wherein at least one of the light source and light detector
`assemblies projects away from the inner surface of the
`elastic substrate, and wherein the elastic substrate is
`adapted to press the one of the light source and light
`detector assemblies into firm pressing engagement with
`the body portion to exert a localized pressure thereon.
`2. The sensor of claim 1 wherein the light source assembly
`comprises a light source and a substantially rigid transparent
`housing enclosing the light source.
`3. The sensor of claim 2 wherein the substrate comprises
`inner and outer substrate layers, and wherein the transparent
`housing comprises a hollow body portion having a trans-
`parent cover portion at one end and a flange at the other end,
`the flange being positioned between the inner and outer
`substrate layers with the cover portion projecting through a
`hole in the inner substrate layer.
`4. The sensor of claim 1 wherein the light detector
`assembly comprises a light detector and a substantially rigid
`transparent housing enclosing the light detector.
`5. The sensor of claim 4 wherein the substrate comprises
`inner and outer substrate layers, and wherein the transparent
`housing comprises a hollow body portion having a trans-
`parent cover portion at one end and a flange at the other end,
`the flange being positioned between the inner and outer
`substrate layers with the cover portion projecting through a
`hole in the inner substrate layer.
`6. The sensor of claim 1 wherein the light source assembly
`comprises:
`a light source;
`a substantially rigid circuit board for holding the light
`source and providing electrical connections thereto;
`and
`
`a substantially elastomeric transparent cover connected to
`the circuit board and covering the light source.
`7. The sensor of claim 6 wherein the light source assembly
`further includes an elastomeric layer attached to the flexible
`substrate on a first side and attached to the circuit board on
`a second side.
`
`8. The sensor of claim 1 wherein the light detector
`assembly comprises:
`a light detector;
`a substantially rigid circuit board for holding the light
`detector and providing electrical connections thereto;
`and
`
`a substantially elastomeric transparent cover connected to
`the circuit board and covering the light detector.
`9. The sensor of claim 8 wherein the light detector
`assembly further includes an elastomeric layer attached to
`the elastic substrate on a first side and attached to the circuit
`board on a second side.
`10. The sensor of claim 1 wherein the elastic substrate
`includes:
`
`an outer layer providing the outer surface;
`an inner layer attached to the outer layer and providing the
`inner surface, the inner layer having an opening; and
`wherein the light source assembly is attached to the elastic
`substrate at a location between the inner and outer
`
`layers and extends through the opening in the inner
`layer.
`11. The sensor of claim 10 wherein the light source
`assembly includes a substantially rigid transparent housing
`enclosing the light source and having a flange portion and a
`cover portion, the flange portion being held between the
`outer and inner layers to attach the light source assembly to
`
`8
`the elastic substrate, and the cover portion projecting
`through the