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`(cid:143)(cid:117)(cid:148)(cid:165)(cid:189)(cid:117)(cid:157)(cid:127)(cid:189)(cid:162)(cid:131)(cid:157)(cid:130)(cid:174)(cid:165)(cid:117)(cid:174)(cid:130)(cid:189)(cid:159)(cid:174)(cid:143)(cid:130)(cid:165)(cid:189)(cid:149)(cid:147)(cid:140)(cid:143)(cid:174)(cid:15)(cid:117)(cid:174)(cid:174)(cid:130)(cid:157)(cid:177)(cid:117)(cid:174)(cid:148)(cid:157)(cid:140)(cid:189)(cid:159)(cid:165)(cid:140)(cid:117)(cid:157)(cid:148)(cid:125)(cid:189)(cid:154)(cid:117)(cid:174)(cid:130)(cid:186)
`(cid:167)(cid:147)(cid:117)(cid:149)(cid:169)(cid:189) (cid:159)(cid:157)(cid:189) (cid:174)(cid:143)(cid:130)(cid:189) (cid:143)(cid:130)(cid:117)(cid:127)(cid:31)(cid:189) (cid:107)(cid:143)(cid:130)(cid:189) (cid:125)(cid:149)(cid:177)(cid:169)(cid:174)(cid:130)(cid:165)(cid:169)(cid:189) (cid:174)(cid:143)(cid:177)(cid:169)(cid:189) (cid:174)(cid:165)(cid:117)(cid:157)(cid:169)(cid:154)(cid:148)(cid:174)(cid:189) (cid:117)(cid:189) (cid:154)(cid:159)(cid:165)(cid:130)(cid:189)
`(cid:147)(cid:157)(cid:174)(cid:130)(cid:157)(cid:169)(cid:130)(cid:189) (cid:149)(cid:148)(cid:140)(cid:143)(cid:174)(cid:189) (cid:169)(cid:147)(cid:140)(cid:157)(cid:117)(cid:149)(cid:31)(cid:189) (cid:107)(cid:159)(cid:189) (cid:165)(cid:130)(cid:127)(cid:177)(cid:125)(cid:130)(cid:189) (cid:174)(cid:143)(cid:130)(cid:189) (cid:117)(cid:154)(cid:159)(cid:177)(cid:157)(cid:174)(cid:189) (cid:159)(cid:137)(cid:189) (cid:169)(cid:148)(cid:140)(cid:157)(cid:117)(cid:149)(cid:189)
`(cid:169)(cid:143)(cid:177)(cid:157)(cid:174)(cid:148)(cid:157)(cid:140)(cid:189)(cid:121)(cid:130)(cid:174)(cid:180)(cid:130)(cid:130)(cid:157)(cid:189)(cid:174)(cid:143)(cid:130)(cid:154)(cid:11)(cid:189)(cid:174)(cid:143)(cid:130)(cid:189)(cid:125)(cid:149)(cid:177)(cid:169)(cid:174)(cid:130)(cid:165)(cid:169)(cid:189)(cid:117)(cid:149)(cid:169)(cid:159)(cid:189)(cid:154)(cid:117)(cid:183)(cid:189)(cid:121)(cid:130)(cid:189)(cid:169)(cid:130)(cid:162)(cid:117)(cid:187)
`(cid:165)(cid:117)(cid:174)(cid:130)(cid:127)(cid:189)(cid:121)(cid:183)(cid:189)(cid:117)(cid:127)(cid:127)(cid:148)(cid:174)(cid:148)(cid:159)(cid:157)(cid:117)(cid:151)(cid:189)(cid:159)(cid:162)(cid:117)(cid:164)(cid:177)(cid:130)(cid:189)(cid:2)(cid:149)(cid:148)(cid:140)(cid:143)(cid:174)(cid:16)(cid:169)(cid:143)(cid:148)(cid:130)(cid:149)(cid:127)(cid:148)(cid:157)(cid:140)(cid:4)(cid:189)(cid:121)(cid:177)(cid:154)(cid:162)(cid:169)(cid:30)(cid:189)
`
`(cid:40)(cid:42)(cid:189)(cid:70)(cid:149)(cid:120)(cid:153)(cid:171)(cid:12)(cid:189)(cid:47)(cid:189)(cid:73)(cid:167)(cid:116)(cid:181)(cid:144)(cid:158)(cid:141)(cid:189)(cid:102)(cid:142)(cid:133)(cid:173)(cid:171)(cid:189)
`
`(cid:2)(cid:1)(cid:1)(cid:3)(cid:4)
`
`MASIMO 2013
`Apple v. Masimo
`IPR2020-01526
`
`

`

`US. Patent
`
`Mar. 31, 1992
`
`Sheet 1 of 4
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`5,099,842
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`US. Patent
`
`Mar. 31, 1992
`
`Sheet 2 of 4
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`5,099,842
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`240
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`5,099,842 ‘
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`

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`US. Patent
`
`Mar. 31, 1992
`
`Sheet 4 of 4
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`5,099,842
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`1
`
`PERINATAL PULSE OXIMETRY PROBE
`
`PRIOR APPLICATION
`
`This application is a continuationvin-part of US. Pat.
`No. 4.938218 entitled “Improved Perinatal Pulse Oxim-
`etry Probe."
`
`BACKGROUND OF THE INVENTION
`The present invention relates to transflectance-type
`fetal pulse oximetry probes. “Transflectance” probes
`attach to a single physiological surface. Their light
`source and detector need not lie on opposite sides of the
`pulsatile tissue. “Transmission" probes, by contrast,
`monitor signals across pulsatile tissue, for example sig—
`nals passing from the dorsal to the volar surface of a
`finger. The invention relates to improvements for
`transllectance probes, especially to enhance the light
`signal
`in the presence of fetal hair or other light-
`attenuating materials when the probe is attached to the
`head.
`Application Ser. No. 264,196, here incorporated by
`reference, describes various embodiments of an im-
`
`5,099,842
`
`2
`high, a single bump would hold the probe too far above
`the fetal tissue.
`
`invention therefore uses clusters of
`The- present
`bumps over the source,
`the detector, or both. The
`bumps in the clusters are sufficiently pointed to pene-
`trate the substances. The action of these bumps is much
`like combing. Like the teeth of a comb, the bumps pene-
`trate a wad of hair or other material. When the probe,
`biased toward the head,
`is slid back. and forth,
`the
`“comb" also moves aside substances caught underneath
`its “teeth" (i.e., the bumps). As the probe slides back
`and forth the substances are forced away from the apex
`of the bumps. The spaces between the bumps receive
`the substances that are pushed aside.
`It is an object of the invention to provide a cluster of
`bumps on a fetal oximetry probe to part the fetal hair
`and penetrate other light-attenuating materials to pro-
`vide a relatively unobstructed light path between the
`probe and the skin, thus raising the optical signal level.
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`5
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`proved perinatal pulse oximetry probe. The function of 25
`the probe and the nature of pulse oximetry are discussed
`in that application and will not be repeated here. The
`application particularly refers to “curved surface por-
`tions"
`through which the optical signals pass. When
`brought into contact with the fetal tissue, these curved
`portions create a dimple in the tissue surface.
`The dimple helps prevent light from shunting be—
`tween the source and the detector without passing
`through blood-perfused tissue. It also improves the
`contact between the probe and the fetal tissue. Nonethe-
`less the oximetry readings, if made on the head, may be
`inaccurate or inconsistent due to low light levels, i.e.,
`poor signal-to-noise ratio. The optical signal levels may
`be attenuated by intra-uterine materials like blood, dead
`cells, mucous, vemix caseosa, or fetal hair. These mate-
`'rials and fetal hair collectively will be referred to as
`“substances."
`
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`SUMMARY OF THE INVENTION
`
`The purpose of the present invention is to improve
`the accuracy and consistency of the readings, especially
`in the presence of substances, by increasing the optical
`signal levels.
`Various methods may be used to increase signal lev-
`els by intensifying the emitted light from the probe and
`increasing the sensitivity of the detector. However,
`substances like hair may significantly lessen the amount
`of light passing between the probe and the skin and
`consequently decrease the signal-to-noise ratio.
`To overcome this problem, the invention reduces the
`amount of substances between the probe and the fetal
`tissue. In the probe of the prior application, the curved
`surface portions or bumps improve the signal. The apex
`of the bump pushes aside the substances and comes to
`rest on the scalp (or close to it). The clusters in the
`present invention more effectively penetrate the sub—
`stances on the head.
`The clusters “scrub" aside the substances better than
`does the single bump of the prior invention. Clusters
`also are more effective when used over larger surface
`areas of the source and detector. A single bump, if too
`flat, would not effectively pan the fetal hair and pene-
`trate the other light-attenuating materials. But if too
`
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`In all drawings, like parts are designated by like refer-
`ence numbers.
`FIG. 1(a) is a cross-sectional view of an embodiment
`of the probe of the present invention.
`FIG. 1(b) is a top view of the probe of FIG. 1(a).
`FIG. 1(a) is a second cross-sectional view of the em-
`bodiment of FIGS. 1(a) and 1(b).
`FIG. 2(a) is a top view of a cluster of bumps.
`FIG. 2(b) is cross-sectional view of a cluster of
`bumps.
`FIG. 3(a) is a cross-sectional View of an alternative
`embodiment of the probe of the present
`invention,
`showing opaque bumps.
`FIG. 3(b) is a top view of the probe of FIG. 3(a),
`showing opaque bumps.
`FIG. 4 is a cross-sectional view of an alternative
`embodiment of the cluster of bumps, using optical f1-
`bers.
`FIG. 5(a) is a cross-sectional view of an alternative
`embodiment of the probe of the present invention.
`FIG. 5(b) is a cross-sectional view of another alterna-
`tive embodiment of the probe of the present invention.
`DETAILED DESCRIPTION OF THE
`EMBODIMENTS
`
`invention are
`
`Several embodiments of the present
`described and shown in the drawings.
`FIG. 1(a) shows a perinatal pulse oximetry probe 200
`that includes light source 110, detector 120, and cord
`14-0. The probe can be made of acrylonitrile-co—butadi-
`ene-co-styrene (ABS) plastic or any bio—compatible
`flexible or inflexible material. Source 110 and detector
`120 are covered by light-transmissive bumps 100.
`Opaque surface 130 covers the probe 200. FIG. 1(b)
`shows the clusters 220 of bumps 100. Cord 140 connects
`probe 200 to a power source.
`FIGS. 2a-b is an enlarged view of clusters 220 of
`bumps 100. These clusters cover source 110 and detec-
`tor 120 of FIGS. la-b. The bumps 100 are separated by
`spaces 150. The spaces are non-raised areas of the
`probe‘s surface.
`In FIG. 2(a) the distance 160 is identified as measured
`between the centers of any two adjacent bumps 100. In
`one embodiment this distance is 0.053 inches. Measure-
`ments 230 and 240 are the length and width, respec-
`tively, ofthe clusters. The size and shape of the source
`and detector can vary. In the preferred embodiment the
`
`

`

`3
`source is covered by seven bumps and is 0.15 in-
`ehesXO.l7 inches; the detector is covered by thirteen
`bumps and is 0.165 inchesX0.30 inches.
`As is conventional in pulse oximetry, source 110 pro-
`vides light oftwo different wavelengths (red and infra-
`red). To further intensify the signal, this particular em-
`bodiment uses a light source having three light-emitting
`diodes or “LEDs” (two red LEDs 112, one infrared
`LED 114) that each generate the necessary red and
`infra-red wavelengths (660 and 900 nanometers, respec-
`tively).
`The red wavelength especially is attenuated by
`darkly pigmented hair. The thickness of the hair also
`attenuates the signal. Such interference can cause too
`great a variation in the ratio of red to infra-red signals.
`The applicants have observed red-to-infrared transmis‘
`sion ratios of 1:4 for lightly pigmented hair, and as little
`as 1:150 for darker pigments. Using clusters of bumps to
`provide a relatively less obstructed path makes the ratio
`more consistent.
`In FIG. 2(b) measurement 170 is the height of each
`bump 100 (its radius, if hemispheriCal). One embodi-
`ment has bumps with a radius of curvature of 0.024
`inches and an overall height of 0.033 inches. Curve 180
`is the arc, or radius of curvature, of each bump 100. The
`bumps can be non-hemispheric, for example parabolic,
`conical, or domed. The bumps are shown as uniform,
`but their individual dimensions and shapes may vary.
`Bumps with smaller aspect ratios (width to height)
`more effectively push the hair aside and penetrate the
`light-attenuating materials than do bumps with larger
`aspect ratios.
`As shown in FIG. 2(a), the size and placement of
`light-transmissive bumps 100 in cluster 220 allow for
`spaces between bumps 100 to receive the displaced
`substances.
`An alternative embodiment involves the use of spher-
`ical bumps that are undercut below opaque cover 130.
`Most of the sphere would protrude above the surface of
`the probe. This arrangement would better trap the sub-
`stances beneath the “shelf’ formed by each sphere‘s
`equator.
`The light-transmissive bumps can be constructed in
`various ways. In the preferred embodiment, the bump
`cluster is cast in transparent UV-curable epoxy (Hysol
`UV6000, for example) in an aluminum or Teflon mold.
`The same epoxy is then used to bond the cluster to the
`source and detector. Other methods, including injection
`molding and transfer molding directly onto the opto-
`electronic substrate, are possible as well.
`FIG. 3(a) shows a perinatal pulse oximetry probe 210
`that includes light source 110, detector 120, and cord
`1‘0. Light-transmissive bumps 100 are bordered by
`opaque bumps 190. The opaque bumps may be of one
`piece with opaque surface 130, as shown, or separate
`pieces attached to surface 130. The opaque bumps may
`be shaped and sized differently from the light-transmis-
`sive bumps. FIG. 3(b), a top view, shows light-transmis-
`sive bumps 100 encircled by opaque bumps 190.
`Alternatively, opaque bumps 190 can be placed be
`tween light-transmissive bumps 100 without enclosing
`them.
`In one embodiment,
`the two facing rows of
`opaque bumps are staggered such that lines 250 drawn
`through their centers are diagonal to the edges 260 of
`the source and detector.
`The opaque bumps reduce the amount of light shunt-
`ing between the source and detector, that is, diffusing
`sideways and bypassing the blood-perfused fetal tissue.
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`5,099,842
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`4
`Shunting distorts the calibration of the pulse oxrmetrv
`measurements.
`Another alternative embodiment would use optical
`fibers, which pass light through a defined core. Manv
`short fibers could be arranged vertically on the surface
`of the probe, with small spaces between them. The
`spaces would receive the substances pushed aside by the
`tips of the fibers, the equivalent of the bumps in the
`preferred embodiment. These “light combs“ would
`have the advantage of being both transmitter and bar.
`rier: they would pass the light signal in a confined path
`and thus reduce shunting. In one variation of this em-
`bodiment the optical fibers would extend outside the
`patient‘s body to an external light source and detector.
`as in the prior application.
`FIG. 4 shows that alternative embodiment, with clus-
`ter 200 comprised of optical fibers 330. These fibers
`consist of an optical core 300 and cladding 310. The
`fibers are surrounded by an opaque matrix 320 which
`further reduces shunting.
`The probe can be attached to the fetal tissue by any
`practical means including suction, compression, adhe~
`sives, or clips.
`FIGS. Sa—b show another alternative embodiment
`where either only the light source 110 or the detector
`120 is covered by light transmissive bumps 100. FIG. 5a
`shows the probe 500 with only detector 120 havmg
`light transmissive bumps 100 as a cover, while FIG. 5b
`shows the probe 510 with only light source 110 havmg
`light transmissive bumps 100 as a cover.
`The invention, an improved perinatal pulse oxtmetrv
`probe as illustrated above, is defined by the claims that
`follow.
`We claim:
`1. A transflectance-type pulse oximetry probe com-
`prising:
`a light source and a light detector mounted wtthm a
`probe, the light source operating at a plurality or
`wavelengths;
`means for transmitting electrical signals to and from
`the probe;
`and a cluster of light-transmisswe bumps covering the
`light source and arranged so that
`light at eacn
`wavelength may be transmitted through all of the
`bumps.
`2. The probe of claim 1 wherein the light-transmisswe
`bumps have rounded surfaces.
`3. The probe of claim 1 wherein the light-transmisswe
`bumps are sufficiently high to penetrate light-attenuat-
`ing materials.
`4. The probe of claim 1 wherein the light-transmisswe
`bumps have an aspect ratio sufficient to penetrate light-
`attenuating materials.
`5. A transllectance-type pulse oximetry probe com-
`prising:
`: light source and a light detector mounted Within a
`probe;
`means for transmitting electrical signals to and from
`the probe; and
`a cluster of light-transmissive bumps covering the
`- light detector.
`6. A transflectance-type pulse oximetry probe com-
`prising:
`a light source and a light detector mounted Within a
`probe;
`means for transmitting electrical signals to and from
`the probe;
`
`

`

`5,099,842
`
`5
`a first cluster of light-transmissive bumps covering
`the light source; and
`a second cluster of light-transmissive bumps covering
`the light detector.
`7. The probe of claim 6 wherein the surface of the
`probe has one or more opaque bumps between the clus»
`ters.
`
`6
`wherein the cluster of light-transmissive bumps
`comprises optical fibers.
`10. The probe of claim 9 wherein the optical fibers
`are surrounded by opaque material.
`11. A method for displacing hair and other light-
`attenuating materials from the paths of optical signals in
`a transflectance-type pulse oximetry probe, the probe
`comprising a light source and a light detector mounted
`within the probe and further comprising means for
`transmitting electrical signals to and from the probe, the
`method comprising the steps of (a) providing a cluster
`of light-transmissive bumps covering one or the other of
`the light source and the light detector; and (b) position-
`ing the probe by sliding it back and forth over the tissue
`such that the hair and other light-attenuating materials
`are displaced between the bumps.
`12. The method of claim 11 wherein the cluster of
`light-transmissive bumps covers the light source, and
`wherein the method further comprises the steps of pro-
`viding a second cluster of light-transmissive bumps
`covering the light detector, whereby the probe is posi-
`tioned by sliding it back and forth over the tissue such
`that the hair and other light-attenuating materials are
`displaced between the bumps of the second cluster.
`C
`C
`t
`t
`t
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`8. A transtlectance-type pulse oximetry probe com-
`prising:
`a light scurce and a light detector mounted within a
`probe;
`means for transmitting electrical signals to and from
`the probe;
`3 cluster of light-transmissive bumps covering one or
`the other of the light source and light detector; and
`a plurality of opaque bumps surrounding the cluster
`of light-transmissive bumps.
`9. A transflectance-type pulse oximetry probe com-
`prising:
`a light source and a light detector mounted within a
`probe;
`means for transmitting electrical signals to and from
`the probe; and
`_
`a cluster of light-transmissive bumps covering one or
`the other of the light source and light detector, and
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