EXHIBIT 2123
`EXHIBIT 2123
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`United States Patent
`Willett et al.
`
`[19]
`
`[11] Patent Number:
`
`5,080,098
`
`[45] Date of Patent:
`
`Jan. 14, 1992
`
`lllllfllllllflllllllllllllllllllllllllll
`USOOSOSOO98A
`
`.
`
`.
`
`.
`
`.
`
`5/1981 Fritzlen et al.
`4,268,751
`7/1981 Zurcher .
`4,280,506
`8/1981
`Jobsis .
`4,281,645
`4,301,808 11/1981 Taus _
`4,305,401 12/1981 Reissmueller et al.
`4,321,930 3/1982 Jobsis et a1.
`.
`4,332,258
`6/1982 Arai et al.
`.
`4,334,544 6/1982 Hill et a1.
`4,338,950 7/1982 Barlow et a1.
`4,347,852
`9/1982 Tar .
`4,353,152 10/1982 O’Connor et al.
`4,380,240 4/1983 Jobsis et al.
`.
`4,409,983 10/1983 Albert ................................. 128/689
`4,494,550
`1/1985 Blazek et a1.
`.
`4,510,938 4/1985 Jobsis et a1.
`4,598,700 7/1986 Tamm .
`............... 128/633
`4,685,464
`8/1987 Goldberger et a1.
`4,799,491
`1/1987 Eckerle ............................... 128/640
`4,825,872
`5/1989 Tan et a1.
`.
`.
`4,830,014
`5/1989 Goodman et all
`4,915,116 4/1990 Hasebe et a1.
`....................... 128/666
`4,938,218
`7/1990 Goodman et al.
`.................. 128/664
`
`.
`
`.
`
`[54]
`
`[75]
`
`NON-INVASIVE SENSOR
`
`Inventors: Ronald P. Willett, Bloomington;
`Dennis K. Dawes; Hammond R.
`Roudedush, both of Indianapolis;
`Mark W. Baldwin, Speedway, all of
`Ind.
`
`{73]
`
`Assignee:
`
`Sentinel Monitoring, Inc.,
`Indianapolis, Ind.
`
`[21]
`
`App]. No.: 452,700
`
`[22]
`
`[51]
`[52]
`
`[5 8]
`
`[56]
`
`Dec. 18, 1989
`Filed:
`Int. Cl.5 ................................................ A61B 5/00
`US. Cl. .................................... 128/633; 128/665;
`128/666
`Field of Search ........................ 128/633, 665—667,
`128/689, 690
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`.
`
`3,359,975 12/1967 Sherman .
`3,602,213
`8/1971 Howell et al.
`3,698,382 10/1972 Howell
`.
`.
`3,704,708 12/1972 Iberall
`3,810,460
`5/1974 Van Nie .
`3,815,583
`6/1974 Scheidt
`.
`3,847,483 11/1974 Shaw et a1.
`3,908,636
`9/1975 Page .
`3,993,047 11/1976 Peek .
`4,013,067
`3/1977 Kresse et al.
`4,030,483
`6/1977 Stevens .
`4,038,976
`8/1977 Hardy et a1,
`4,086,915
`5/1978 Kofsky et a1,
`4,091,803
`5/1978 Pinder .
`4,109,643
`8/1978 Bond et al.
`4,129,124 12/1978 Thalmann .
`4,183,360
`1/1980 Carlson et a1.
`4,223,680 9/1980 Jobsis .
`4,259,963
`4/1981 Huch .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`FOREIGN PATENT DOCUMENTS
`
`............ 128/633
`0135840 4/1985 European Pat. Off.
`1128908 12/1984 U.S.S.R,
`.............................. 128/666
`
`Primary Examiner—Ruth S, Smith
`Attorney, Agent, or Firm—Marjama & Pincelli
`
`[57]
`
`ABSTRACT
`
`A sensor for placement against the tissue of a living
`subject for the purpose of measuring a physiological
`quantity. The sensor includes a rigid housing having a
`recess chamber formed therein. A light source and sen-
`sor is mounted in a flexible mounting pad secured to the
`housing. The flexible mounting pad allows the light
`source and sensor to move independently of each other
`and conforms to the adjacent tissue.
`
`15 Claims, 4 Drawing Sheets
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`US. Patent
`
`Jan. 14, 1992
`
`Sheet 1 of 4
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`5,080,098
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`16
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`7‘
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`14
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`3..
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`FIG. 2C————_——
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`FIGZB
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`US. Patent
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`Jan. 14, 1992
`
`Sheet 2 of 4
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`5,080,098
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`
`
`4e 42
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`34
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`I
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`17
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`US. Patent
`
`Jan. 14, 1992
`
`Sheet 3 of 4
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`5,080,098
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`US. Patent
`
`Jan. 14, 1992
`
`Sheet 4 of 4
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`5,080,098
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`62.47
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`1
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`5,080,098
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`2
`
`NON-INVASIVE SENSOR
`
`The present invention relates to an non-invasive sen-
`sor for use in determining various physiological mea-
`surements of a patient, for example, arterial oxygen
`saturation heart rate.
`
`BACKGROUND OF THE INVENTION
`
`The non-invasive measuring of certain physiological
`properties has long been practiced by physicians in the
`prior art. Such techniques include the transmitting of
`one or more wavelengths of radiation into perfused
`tissue and detecting the amount of light passing through
`or being reflected from the tissue, and using the signal
`obtained to determine various physiological measure-
`ments such as arterial oxygen saturation and heart rate.
`Examples of prior art devices are illustrated in US. Pat.
`Nos. 4,485,464; 4,086,915; and 3,847,483. The sensors
`used with such devices are either of the transmissive
`type,
`i.e., light being transmitted to a sensor on the
`opposite side of the tissue, or of the reflective type,
`wherein the radiation sensed is reflected off the tissue.
`A common problem for transmissive and reflectance
`type sensors is the amount of pressure applied by the
`sensor against the tissue. It is important the sensor be
`pressed firmly against the tissue to efficiently use the
`radiation being transmitted and minimize radiation leak-
`age problems with the sensor. However, too much pres—
`sure will cause blood to leave the tissue making it more
`difficult to obtain accurate measurements. Thus, a deli-
`cate balance is needed in order to optimize performance
`of the sensor. Additionally, patient comfort during pro-
`longed use of the sensor becomes important.
`A further problem with transmissive type sensors is
`that they require the light to pass through the tissue and
`are thus limited to contain parts of the body such as a
`digit or an ear. Further, since transmissive type sensors
`require the radiation detector to be located opposite the
`radiation source, proper sensor alignment is very criti-
`cal for optimal operation. Additionally, radiation leak-
`age at the radiation source and sensor can lead to signifi-
`cant measurement errors.
`
`With regard to reflective type sensors, it is also very
`important that the radiation emitting source be in rela—
`tively close proximity to the radiation detector. How-
`ever, this close proximity presents the risk of radiation
`leakage from the radiation source to the radiation detec-
`tor without passing through pulsatile tissue, and there—
`fore provide inaccurate readings. Conformance of-the
`radiation source and detector with the tissue is very
`important as improper sensor alignment may cause er-
`rors in measurement. Further,
`if insufficient confor-
`mance of the detector radiation source exists, the sensor
`may not operate at all.
`Applicants have invented a reflective type sensor
`which minimizes or avoids the many problems of the
`prior art.
`SUMMARY OF THE INVENTION
`
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`A sensor for placement against the tissue of a living
`subject for the purpose of measuring a physiological
`quantity. The sensor includes a rigid housing having a
`recess chamber formed therein. A light source and sen-
`sor are mounted in a flexible member pad secured to the
`housing. The flexible mounting pad allows the light
`source and sensor to move independently of each other
`and conforms to the adjacent tissue.
`
`65
`
`DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a perspective view of a sensor assembly
`made in accordance with the present invention;
`FIG. 2 is a top plan view of the sensor head assembly
`outlined by line 2—2 of FIG. 1;
`FIG. 2A is a side elevational view of FIG. 2;
`FIG. 2B is a bottom plan view of the sensor head
`assembly of FIG. 2;
`FIG. 2C is an end elevational view of the sensor head
`assembly of FIG. 2, taken along the line 2C—2C of
`FIG. 2A;
`FIG. 3 is an enlarged cross-sectional view taken
`along line 3-3 of the sensor head assembly of FIG. 2C;
`FIG. 4 is an enlarged top cross-sectional view of the
`sensor head assembly of FIG. 3 taken along line 4—4;
`FIG. 5 is an enlarged partial view of the electrical
`circuitry of the sensor of FIG. 4;
`FIG. 6 is an enlarged partial cross-sectional view of
`the sensor head assembly of FIG. 2 partially broken
`away as applied against a substantially flat portion of
`the tissue;
`FIG. 7 is an enlarged partial cross-sectional view of
`the sensor head assembly partially broken away as ap-
`plied against the finger of a patient;
`FIG. 8 is a top plan view of an outer flexible housing
`which is secured to the sensor assembly of FIG. 2;
`FIG. 9 is a side cross-section view of the outer flexi-
`ble housing of FIG. 8 taken along line 9—9;
`FIG. 10 is a perspective view of the outer flexible
`housing of FIG. 8 as applied to the sensor head assem-
`bly of FIG. 2;
`FIG. 11 is a perspective view of sensor head assembly
`and outer flexible housing of FIG. 10 as applied to the
`finger of a patient;
`FIG. 12 is a top plan view ofa modified outer flexible
`housing for use with sensor head assembly of FIG. 2;
`FIG. 13 is an end view of the outer flexible housing of
`FIG. 12;
`FIG. 14 is a side cross-sectional view of the outer
`flexible housing of FIG. 12 taken along line 14—14;
`FIG. 15 is a perspective view of the sensor head
`assembly and outer flexible housing of FIG. 12 adjacent
`the forehead of a patient; and
`FIG. 16 is a view of the sensor head assembly of FIG.
`15 secured to the patient by an appropriate tape.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`Referring to FIG. 1, there is illustrated a sensor as—
`sembly 10 made in accordance with the present inven-
`tion. The sensor assembly 10 comprises a sensor head
`assembly 12, a connecting cord 14, and plug 16 at the
`terminal end of the cord 14 for connecting to an appro-
`priate device for processing the signal received by the
`sensor head assembly 12. In the particular embodiment,
`the sensor assembly 10 is designed to be used with a
`device for measuring arterial oxygen saturation such as
`described in Applicant’s co-pending application Serial
`No. 07/190,661, filed May 5, 1988, entitled Pulse Oxime-
`try, which is hereby incorporated by reference.
`Referring to FIGS. 2—7, there is illustrated in more
`detail the sensor head assembly 12. The sensor head
`assembly 12 which includes a rigid housing 17 having a
`rigid base support 18, and a rigid peripheral upstanding
`wall 20 which extends about the periphery of rigid base
`support 18 and forms a receiving recess chamber 22.
`The peripheral upstanding wall 20 terminates at
`its
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`5,080,098
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`3
`upper end in an upper rim portion 24. In the particular
`embodiment illustrated, rigid housing 17 is made out of
`a hard plastic material, and in particular, of a polypro-
`pylene plastic material. Peripheral upstanding wall 20 is
`provided with an opening 26 to allow cord 14 and with
`its internal electrical wires to extend within recess
`chamber 22. The sensor head assembly 12 further in—
`clude a radiation source 28 and sensing means 30 for
`detecting reflected radiation from the tissue that ema-
`nates from the radiation source 28. In the particular
`embodiment illustrated, the radiation source 28 com-
`prises two LEDs (light emitting diodes) which pro-
`duces light at two different wavelengths. In the particu-
`lar embodiment
`illustrated,
`light
`is produced in the
`infrared spectrum, and in the red spectrum. Applicants
`have found that wavelengths of 665 nm (nanometers)
`and 890 nm (nanometers) work quite satisfactorily for
`an oximetry sensor. However, it is to be understood that
`as many or as few radiation sources may be used, and at
`any desired frequency as may be required for the physi-
`ological property being measured.
`In the particular
`embodiment illustrated, the sensing means 30 is a photo-
`diode and radiation source 28 is a set of two LEDs,
`sensing means 30 and radiation source 28 each being
`placed beneath an individual lens. Appropriate LEDs
`and photodiodes may be obtained from Optek, Inc. and
`Shin-Estsu.
`The radiation source 28 and the light sensing means
`30 are mounted within a flexible support pad 32 which
`is then mounted to the peripheral upstanding wall 20.
`Housing 17, pad 32 and cord 14 combine together to
`form closed chamber. In the particular embodiment
`illustrated, radiation source means 28 comprises a pair
`of LEDs 34 mounted in a generally cylindrical hollow
`clear plastic lens 36 and light sensing means 30 com-
`prises a photodiode 38 also mounted in a generally cy-
`lindrical hollow clear plastic lens 40. In the particular
`embodiment illustrated, the lenses 36 and 40 are of sub-
`stantially equal size and configuration. In the particular
`embodiment illustrated, flexible support pad 32 is pro-
`vided with a pair of openings 42, 32. Each opening 42,
`43 being substantially circular in shape and designed to
`mate and receive the outer surface of the respective lens
`to be placed therein. Each opening 42, 43 having a
`diameter of about 0.25 inches (6.35 mm). The lens 36, 40
`are secured within opening 42, 43 by the elastic nature
`of flexible pad 32. However, it is to be understood that
`lens 36, 40 may be secured to flexible support pad 32 in
`any desired manner. While substantial identically sized
`circular openings are preferred, various other sizes and
`shapes openings may be used as desired. Openings 42,
`43 are spaced apart a sufficient distance L to minimize
`or prevent radiation leakage passing across from the
`radiation source 28 to the sensor 30, but not too far
`apart so as to optimize sensing of the reflected radiation.
`In the particular embodiment illustrated, openings 42,
`43 are spaced a distance of about 0.375 inches (9.525
`mm). However, is to be understood that any suitable
`distance may be used keeping the foregoing objectives
`in mind. Each lens 36 and 40 has an upper contact sur-
`face 45, 47 for engagement with the surface of the tissue
`against which it is to be placed. The support pad 32 is
`secured to rigid base support 18 by a downwardly ex-
`tending outer wall integrally formed therewith. The
`pad 32 may be secured to rigid base support 18 in any
`desired manner, for example, by being adhesively af-
`fixed thereto or by the elastomeric tension of the sup-
`port pad on the rigid peripheral upstanding wall 20. The
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`support pad 32 is designed such that lenses 36 and 40
`can move independently of each other so as to allow the
`top contact surface 45, 47 of each lens 36, 40 to conform
`to the surface of the tissue against which it is placed.
`Additionally, the pad 32 is also designed such that ex-
`cessive force is not applied to the lenses 36, 40 so as to
`minimize the loss of blood in the adjacent tissue and
`provide comfort to the patient. In sensors which rely on'
`the radiation transmissivity of blood, it is important that
`the tissue against which the sensor is placed not be
`pressed too hard, as this will cause blood to leave the
`tissue, thus reducing the sensitivity of the sensor. How-
`ever, if an insufficient amount of pressure is placed, the
`risk of light leakage increases which can significantly
`affect the accuracy of the measurement being taken. It_
`is also very important that the contact surfaces 45, 47 of
`each lens 36, 40 be oriented in a direction substantially
`perpendicular toward the tissue. Accordingly, it is im-
`portant that the contact surfaces 45, 47 conform to the
`configuration of the adjacent tissue. The support pad 32
`is designed such that each lens 36, 40 can independently
`and freely move within recess chamber 22 and provide
`a maximum amount of pressure against the tissue. The
`recess chamber being sized to prevent bottoming of the
`lenses 36, 40 against rigid base support 18. In the partic-
`ular embodiment illustrated, the support pad 32 is de-
`signed to flex such that a force of about 0.120 lbs. to
`about 0.130 lbs. is applied against the tissue by the lens
`36, 40 when the rim portion 24 is firmly pressed against
`the tissue in the pad 32. The decreased flexibility of pad
`32 may be obtained by the appropriate selection of the
`material from which pad 32 is made, and providing an
`appropriate thickness t. Applicants have found that an
`appropriate elastomeric material from which the sup-
`port pad 32 may be made is polyvinyl chloride (PVC)
`with a thickness t of about 0.010 inches. In the particular
`embodiment illustrated,
`the polyvinyl chloride has a
`Shore A hardness of about 55.
`
`The support pad 32 is also designed to minimize radi-
`ation leakage from the radiation source 28 to the radia-
`tion sensing means 30. This is accomplished by provid-
`ing pad 32 adjacent each opening 42, 43 with a down-
`wardly extending annular skirt 49 adjacent to the out-
`side surface of the lens 36, 40. Preferably, the pad 32 is
`made out of a dark non-transparent color, black in this
`embodiment. Referring back to FIG. 3, immediately
`adjacent to end openings 42, 43 is a substantially annular
`ridge 46 integrally formed in the pad 32 so that the
`contact surfaces 45, 47 is slightly raised above the adja—
`cent top surface 48 of the support pad 32. Applicants
`have found that the ridge 46 is raised above the top
`surface 48 a distance D which is generally in the range
`of about 0.005 inches (0.127 mm). The top surface 48 is
`raised’slightly above the outer rim 50 of the pad which
`comes into contact with the peripherally upstanding
`wall 20. Top surface 48 is raised only a slight distance
`D1 above the periphery 50 so as to provide a further
`degree of flexibility to the central area of the support
`pad 32. In the particular embodiment illustrated, top
`surface 48 extends a distance D1 above the periphery
`50.
`
`Referring to FIGS. 6, and 7, there is illustrated a
`portion of the sensor head assembly 12 as pressed
`against the forehead and finger, respectively, of an indi-
`vidual. As can be seen,
`the contact surfaces 45, 47
`contacts the surface of the tissue, thus, as radiation is
`emitted from radiation source 28,
`radiation sensing
`means 30 will produce an electrical impulse in response
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`5
`thereto. Flexible electrical circuitry is provided for
`connecting radiation source 28 and light sensing means
`30 for providing appropriate power to radiation source
`28 and transmitting a signal from the sensor means 30.
`In the particular embodiment
`illustrated,
`radiation
`source 28 and light sensing means 30 are appropriately
`connected by contacts 52, 54, respectively, placed at the
`back of lens 36, 40 (See FIG. 5) which are appropriately
`connected to wires 56, 58, which extend into cord 14
`which in turn, are appropriately connected to the plug
`16 in a manner as is customarily done in the prior art.
`The contacts 52, 54 and skirts 49 are preferably de—
`signed to stop any undesirable radiation from entering
`or escaping from each lens 36, 40, thus allowing light to
`leave or enter by the contact surface 44 of each lens.
`Suitable flexible circuits may be obtained from Nitto-
`Denko of America.
`Referring to FIGS. 8 through 11 and FIGS. 12-15,
`there is illustrated outer flexible housings 60 and 62
`which are designed to be used with sensor head assem-
`bly 12 and placed against tissue of an individual. Outer
`flexible housings 60, 62 each have an outer peripheral
`wall 69 which conforms to the outer surface of upstand-
`ing wall 20 and pad 32 and forms an opening 65 for
`receiving sensor head assembly 12. Outer flexible hous-
`ings 60, 62 are preferably made of an elastomeric mate-
`rial which serves to provide flexibility so as to conform
`to the shape of the tissue and provide comfort to the
`patient. Outer flexible housings 60, 62 also provide
`means for allowing easy adaptation of the sensor head
`assembly 12 to different parts of the body. However,
`outer flexible housings 60, 62 are secured to sensor head
`assembly 12 in any desired manner. The outer flexible
`housing 60 of FIG. 8 is designed to be used with the
`fingers and outer flexible housing 62 of FIG. 12 is de-
`signed to be placed against the forehead or other alter-
`native anatomical site of an individual. The outer flexi-
`ble housings 60 and 62, fits around the rigid base 18 and,
`each having an outwardly extending surface 67 which
`has a configuration designed to conform to the anatomi-
`cal site which it is to be placed against and minimizes
`any potential external light leakage that might reach
`radiation sensing means 30. Outer flexible housings 60,
`62 also provide means whereby the sensor head assem—
`bly can be easily secured to the patient. In particular,
`outer flexible housings 60, 62 provides means for allow-
`ing a strip of adhesive tape to secure the sensor head
`assembly 12 against the tissue. FIG. 9 is a cross sectional
`view of sensor 60 illustrating opening 63 in which the
`wire cord is received. FIG. 10 illustrates the sensor
`head assembly 12 with the outer flexible housing 60
`assembled thereto. Referring to FIG. 11, there is illus-
`trated the light sensor assembly 12 and outer flexible
`housing 60 as placed against the finger of a patient and
`secured by an adhesive tape 64 having a generally T-
`shaped configuration. As can be seen, the adhesive tape
`64 is simply secured to the back of the rigid base support
`18 and the 12 is provided for use with a single one of the
`outer flexible housings 60, 62. However,
`if desired,
`outer flexible housings 60, 62 may be provided for inter-
`changeably with a single head assembly 12. FIGS. 13
`and 14 illustrate an end view and cross sectional view,
`respectively, of housing 62.
`Referring to FIG. 15,
`there is illustrated a single
`sensor head assembly 12 having the outer flexible hous-
`ing 62 adjacent the forehead of a patient, and FIG. 16
`illustrates the sensor head assembly of FIG. 15 secured
`to the forehead of an individual by an adhesive tape 66.
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`5,080,098
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`6
`In the particular embodiment illustrated, adhesive tape
`66 has a configuration designed to receive therethrough
`a portion of the head assembly, It is of course, under—
`stood that the configuration of tape 64, 66 may take any
`desired configuration.
`In order to more fully understand the operation and
`use of the sensor, applicants will describe in detail the
`placement and use of the sensor. First,
`the operator
`selects the appropriate sensor head assembly 12 to be
`used having the desired flexible outer housing. For
`example, if the sensor is to be placed against the finger,
`the sensor head assembly 12 having outer flexible hous-
`ing 60 as illustrated in FIG. 8 would be selected, or if
`the sensor is to be placed against a substantially flat
`portion of the body, such as the forehead the sensor
`head assembly 12 having outer flexible housing 62
`would be selected. The sensor head assembly 12 is
`placed against the appropriate portion of the body, at
`which time the contact surface 45, 47 of each of the
`lenses 36, 40 initially contact the tissue. The sensor head
`assembly 10 is pressed against the individual and is lim-
`ited in its movement by the peripheral upstanding wall
`20 of rigid base 18. As the rigid base 18 is pressed
`against the tissue, the lenses are free to independently
`move and redirect its contact surface 45, 47 so as to
`properly conform to the adjacent tissue and deflect
`within the pad 32 a sufficient amount so that the appro-
`priate amount of force is exerted against the tissue. Each
`lens 36, 40 accomplishes this independently of the other.
`Thereafter, the sensor head assembly 12 is simply se-
`cured by an appropriate strip of adhesive tape as illus-
`trated in FIGS. 11 and 15. Thereafter, the apparatus
`used with sensor assembly 10 is operated, as is well
`known and described in the prior art. For example, as
`described in applicants co-pending application previ-
`ously discussed. After obtaining the appropriate mea-
`surements, the sensor is simply removed by removing
`the strip of adhesive tape used to secure the sensor to
`the patient.
`It is to be understood that various other changes and
`modifications can be made without departing from the
`spirit and scope of the present invention.
`We claim:
`
`1. A sensor for placement against the tissue of a living
`subject for the purpose of measuring a physiological
`quantity, said sensor comprising:
`a rigid housing having a rigid peripheral upstanding
`wall which forms a recess chamber, said upstand-
`ing peripheral wall terminating in an upper rim
`designed for providing a force against the tissue of
`a patient and limiting the amount of movement of
`said housing;
`light source means for exposing said tissue to a source
`of light having at least one predetermined wave-
`length;
`light sensing means for sensing light reflected from
`said tissue which has been exposed to said light
`source means;
`
`flexible support means secured to said housing and
`placed against said upper rim for independently
`supporting said light source means and light sens-
`ing means within said recess chamber and for
`placement against the tissue of a patient, said light
`source means and light
`sensing means being
`mounted in said flexible support means such that
`said light sensing means and light source means
`move independently from each other and conform
`to the tissue of the patient.
`
`IPR2017—003 15
`
`CONDITIONAL MOTION TO AMEND
`
`VALENCELL, INC.
`EXHIBIT 2123 — PAGE 9
`
`IPR2017-00315
`CONDITIONAL MOTION TO AMEND
`
`VALENCELL, INC.
`EXHIBIT 2123 - PAGE 9
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`

`

`7
`
`5,080,098
`
`8
`9. A sensor according to claim 1 wherein said light
`sensor means and light sensing means are spaced apart a
`distance of about 0.375 inches.
`10. A sensor according to claim 1 wherein said flexi-
`ble support means is designed such that when said sen—
`sor is placed against the tissue of the living subject, the
`force exerted on the tissue by said light source means
`and light sensing means is in the range of about 0.120 lbs
`to 0.130 lbs.
`11. A sensor according to claim 1 further comprising
`an outer flexible housing secured to said rigid housing
`for adaption of said sensor to tissue of said patient.
`12. A sensor according to claim 1 wherein said light
`source means and light sensing means are designed so
`that said physiological quantity being monitored is arte-
`rial blood oxygen saturation.
`,
`13. A sensor according to claim 12 wherein said light
`source means includes a first light source which emits
`light at 890 nm and a second light source which emits
`light at 665 nm.
`14. A sensor according to claim 12 wherein said light
`sensing means comprises a photodiode.
`15. A sensor according to claim 1 wherein said light
`source means and said light sensing means are designed
`so that said physiological quantity being monitored is
`heart rate.
`I
`I
`I
`I
`I
`
`5
`
`10
`
`2. A sensor according to claim 1 wherein said flexible
`support means comprises a flexible support pad made of
`an elastomeric material, said support pad having a pair
`of openings therethrough, one of said openings receiv-
`ing and holding said light source means and the other
`opening receiving and holding said light sensing means.
`3. A sensor according to claim 2 wherein said pad is
`made of polyvinyl chloride.
`4. A sensor according to claim 1 further comprising
`an outer housing for placement adjacent the outer pe-
`riphery of said upstanding wall.
`5. A sensor according to claim 4 wherein said outer
`housing has a configuration shaped so as to conform to
`the tissue against which the sensor is placed.
`6. A sensor according to claim 1 further comprising
`flexible electrical circuitry means for providing appro-
`priate power to said light source means and for trans- 20
`mitting a signal from said light sensing means.
`7. A sensor according to claim 1 wherein said flexible
`support means is secured to the top of said upper rim.
`
`15
`
`8. A sensor according to claim 1 wherein said light 25
`source means and light source sensing means each have
`a lens for contacting the tissue of the patient.
`
`30
`
`35
`
`45
`
`50
`
`55
`
`65
`
`IPR2017—003 15
`
`CONDITIONAL MOTION TO AMEND
`
`' VALENCELL, INC.
`EXHIBIT 2123 — PAGE 10
`
`IPR2017-00315
`CONDITIONAL MOTION TO AMEND
`
`VALENCELL, INC.
`EXHIBIT 2123 - PAGE 10
`
`