600322
`600.5309
`6005323
`(100 344
`.. 428-"88
`6005']
`., 422-"58
`600-310
`(1005344
`6003335
`600.5323
`
`[54) NON-ADHESIVE OXJMETER SENSOR FOR
`SENSITIVE SKIN
`
`[75)
`
`Inventors: Don Ilannula. San Luis Obispo. (TA
`(US): Paul I}. Mannheimer. Damvflle.
`CA (US)
`
`Assignee:
`
`Nelleor Puritan Bennett Ine..
`[‘leasanton. CA (US)
`
`Notice:
`
`Subject to any disclaimer. the term ofthis
`patent is extended or adjusted under 35
`use. 1540:) by 0 days,
`
`Appl. No.: 101274.845
`
`Filed:
`
`Oct. 18, 2002
`
`Int. C1.
`(2006.01)
`.4610? 5/00
`600f344;600.t310: 600823
`LLS. CI.
`Field of Classification Search ...... .. 600809—310.
`600/322 323. 344
`Sec application file for complete search history.
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`3.696.131 A '°
`4.830.014 -
`4.953.552 r
`5.246.003 .
`5.478.824
`5.584.296
`5.758.644
`5.1191841
`5.830.136
`5.913.819
`
`ifiéié-iii
`
`l 0." 1972
`5! 1989
`9-" 1990
`9! 1993
`12! 1995
`1 2-" 1 996
`6! 1998
`8-' 1998
`|-' 1998
`6! 1999
`
`|
`
`264353
`
`Bonner. Jt.
`Goodman ct a].
`600-2347
`DcMarIo
`.. 6009344
`Delnnzor
`. 3510??
`Burns cl 3].
`. 6006479
`('ui et al.
`.
`. 600-"323
`Diab at a].
`. 600-323
`Delonzor et al.
`. 6005323
`Dcion‘zoret al.
`Taylor et til.
`............. ..
`(100-323
`
`..
`
`8,989,830
`
`The present invention provides non-adhesive oximeter sen—
`sors for patients with sensitive skin. Sensors ot‘tltc present
`invention include a light Cl‘l‘lillit’tg diode (LIED) and a pho-
`todetector. The LED and the photodetector may be covered
`by a reflective mask and a faraday shield. Sensors of the
`present invention have a non-adhesive laminated layer. The
`non-adhesive layer contacts. but does not stick to.
`the
`patient‘s skin. When the sensor is removed ll‘Dltt the patient.
`the non-adhesive layer does not tear or irritate the patient‘s
`skin lite non-adhesive layer preferably has a large static
`coeflicient of friction. Sensors of the present invention can
`also have hook—and—loop layers. The sensor can be attached
`to the patient‘s body by wrapping the sensor around the
`patient and engaging the hook layer to the loop layer.
`
`|||||||||||||||||||||||||||||||||l|||||||||||||||||||||||||||||||||||||||||
`U3007190986B1
`
`(12) United States Patent
`Hannula at at.
`
`[10} Patent No;
`(45) Date of Patent:
`
`US 7,190,986 B]
`Mar. 13, 2007
`
`6.018.675
`6.063.029 .
`(1.0373038 .-
`6.321.100 131*
`6.342.285 Bl *
`(1.354.989 Bl “
`6.479.015 Bl "’
`6.615.052 132*
`(1.671.532 131‘“
`6.731.963 BE "‘
`200250038082 Al ’3
`
`6-”2000
`1152001
`1-‘2002
`352002
`“52002
`932003
`12.52003
`5-2004
`3.52002
`
`.
`
`(bin at a].
`Saita et a1.
`Wang et a1.
`Parker
`Shepard el :11.
`Nut‘leshima
`Long et al
`Ryan et a1.
`Fudge cl :1].
`Finamv el ill.
`Chin
`
`.
`.
`
`OTHER PUBLIC ATIONS
`
`3M product information for {/32 inch I‘VC' Foam Tape 9777-1. from
`3M onlim: product catalog?“
`
`"‘ cited by examiner
`
`lirit: l". Winakur
`Primary firmniner
`[74) Armmqt-z Agent. or firm l-"letcher Yodcr PC
`
`(57)
`
`ABSTRACT
`
`'71 Claims, 2 Drawing Sheets
`
`0001
`
`Apple Inc.
`APL1009
`
`US. Patent No.
`
`Apple Inc.
`APL1009
`U.S. Patent No. 8,989,830
`
`FITBIT, Ex. 1009
`
`

`

`US. Patent
`
`Mar. 13,2007
`
`Sheet 1 of2
`
`US 7,190,986 B1
`
`\101
`
`MR
`
`105A
`
`0002
`
`FITBIT, Ex. 1009
`
`

`

`Mar. 13, 2007
`
`Sheet 2 of2
`
`US. Patent
`
`US 7,190,986 Bl
`
`0003
`
`FITBIT, Ex. 1009
`
`

`

`US 7,190,986 Bi
`
`1
`NON-ADHESIVE OXIMETER SENSOR FOR
`SENSITIVE SKIN
`
`BACKGROUND OF THE INVENTION
`
`2
`irritate the patient’s skin. Therefore. the non-adhesive layer
`protects sensitive skin. In one embodiment. the non-adhe-
`sive layer is a polyvinyl chloride foam material. The non-
`adhesive layer preferably has a large static coefiicient of
`friction to help keep the sensor motionless relative to the
`patient.
`Sensors of the present invention also include one or more
`laminated layers that hold the sensor unit on the patient‘s
`body. 'lhese layers may include hook and loop layers. 'Ihe
`sensor cart be attached to the patient’s body by wrapping the
`sensor around the patient and engaging the hook layer to the
`loop layer.
`Sensors of the present invention may include a strength-
`ening layer that lies between the other laminated layers.
`Furthermore. sensors of the present invention may include
`light-blocking features to minimiire or eliminate ambient
`light interference and LED light from reaching the photo-
`detector without passing through blood-perfused tissues
`(shunting).
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1A illustrates a plan view of an exemplary embodi-
`ment of a non-adhesive oxirneter sensor in accordance with
`the present invention:
`FIG. 13 illustrates a cross-sectional view ot‘thc sensor of
`FIG. 1A taken along line 105A IIISA;
`FIG. 1C illustrates a detailed view ofa portion of FIG. 13
`designated by the circle 1C: and
`FIG. 2 illustrates how an embodiment of the non-adhesive
`oximetcr sensor of the present invention can be placed on a
`patient‘s foot.
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`,
`
`The present application relates to non-adhesive oxirncter
`sensors. and tnore particularly to nonsadhesive oximeter
`sensors for patients with sensitive skin.
`Non-invasive monitoring ofa patient’s pulse is common
`in medical practice. One type of pulse oximeter monitor
`incorporates one or ntore light-emitting-diodes (LEDs) to
`shine through an area of tissue containing large amounts of
`blood. The light source is mounted to well-perfused tissue.
`such as a fingertip. Light is emitted and shines through the
`tissue. The amount of light passing through the tissue is
`measured using a photodetector.
`Changes between the light emitted by the light source and
`the light received by the photodetector are caused by
`changes in the optical absorption of the light by the blood
`perliising through the monitored tissue. The LEle can emit
`either broadsspectrum visual light or narrow bandwidth light
`in the red or infrared wavelengths.
`‘lhe absorption of certain wavelengths is related to the
`oxygen santration level of hemoglobin in the blood perfus-
`ing the tissue. The variations in light absorption caused by
`change in oxygen saturations make possible direct measure-
`ment of the arterial oxygen content.
`One type of prior art oximeter sensor is the STAT—
`It‘lIRAI'”M sensor E542 by Epic Medical Equipment Services
`of Plano. Tex. The S'I'A‘ILWRAPT-‘t‘ sensor has a non-adhe—
`sive foam outer layer Ihat contacts a patient's skin. The foam
`layer is a thick. bulky layer relative to the overall thickness
`of the sensor. The foam layer has a static coeflicient of
`friction of about 1.43.
`The STAT—WRAPTM sensor also has hook—and—Ioop layers
`that engage each other. The hook layer is a separate layer
`that is stitched to an end of the sensor.
`Other prior art oxinteter sensors have an outer adhesive
`layer. The adhesive layer is a sticky material that bonds
`temporarily to the skin like a band-aid. The adhesive holds
`the oximeter sensor on the skin of the patient so that it does
`not move or fall 011'. while measurements are being taken.
`Some patients (e.g.. neonates) have sensitive skin that
`may tear or become irritated when adhesive material
`is
`applied to the skin and later removed. It would therefore be
`desirable to provide an oximeter sensor
`that
`remains
`attached to a patient's skin without using adhesive material.
`while avoiding the bulk ol‘prior—art non-adhesive sensors. It
`would further be desirable to accomplish these two features
`in a manner that the sensor can be sterilized and produced _
`economically.
`
`0004
`
`Oximeter sensor 101 shown in FIGS. IA. 13. and C is an
`embodiment of the present invention. A top down view of
`oximeter sensor 101 is shown in FIG. IA. A cross sectional
`- view of oximeter sensor 101 along a plane 105A is shown in
`FIG. 13. The cross sectional view shows the laminated
`layers of sensor 101. FIG. 1C illustrates an expanded view
`of a portion of the cross sectional view.
`(himetcr sensor [III has one or more light emitting
`diodes (LED) 111 and a photodetector 116 as shown in FIG.
`1. LED Ill emits light that shines through a patient‘s tissue.
`The light from LED III is sensed by pltotodet'cctor 116.
`Photodetector 116 produces a signal
`in response to the
`detected light. Tile signal is decoded by an oximeter monitor
`(not shown} to calculate the patient‘s blood oxygen satura—
`tion. LIED 111 and photodetector 116 are connected to the
`oximeter monitor through wires that feed through cable 122.
`Sensor 10] has a polyurethane window 118 below pho-
`todetector 116. Sensor 10! also has a polyurethane window
`below LIED Ill. The polyurethane windows are transparent.
`Light from LED 111 can pass unobstructed through the
`polyurethane windows to photodetector 116.
`As shown in exploded view in FIG. 1C. photodetector
`116. is surrounded by a reflective mask 11?. Reflective mask
`11'? reflects light from LEI) 111 (that has passed through
`patient tissue and exited near the photodetector) back toward
`photodetector 116 like a mirror.
`Reflective mask ll'i‘r increases the amount of LED light
`that the photodetector 116 receives from the patient‘s tissue.
`while assisting in blocking ambient light and LED light that
`may shunt through the laminated layers. LED 111 is also
`surrounded by a reflective mask that reflects light from LED
`
`BRIEF SUMMARY OF THE INVENTION
`
`invention provides non-adhesive oxitneter ..
`The present
`sensors for patients with sensitive or fragile skin. Sensors of
`the present invention include a light emitting diode (LED)
`and a photodettwtor. The l..l'.il) light shines light through a
`patient‘s tissue. The light from the LED is detecttxi by the
`photodetector. The LED and photodetcctor may be covered
`by transparent windows. The LED and the photodetector
`may also be covered by a reflective mask and a Faraday
`electromagnetic shield.
`Sensors of the present invention have a laminated none
`adhesive layer. The non—adhesive layer contacts. bttt does
`not stick to. the patient's skin. When the sensor is removed
`front the patient. the non-adhesive layer does not tear or
`
`0004
`
`FITBIT, Ex. 1009
`
`

`

`0005
`
`4
`in the STAT-WRAPTM sensor. The 3M-9777L PVC foam
`measured using the above-described measuring technique
`resulted in a value of static coefficient of friction of infinity
`with respect to glass. The 3M-9777L PVC foam actually
`stayed on the glass test plate even after achieving a 90
`degree angle of repose.
`The 3M~9777L PVC material almost exhibits slight adhe—
`sive properties. surface tension forces. or static cling forces.
`Therefore, PVC foam is a very good choice of material for
`layer 112 in consideration of the preferred non-slip charac-
`teristics. Using skin as a reference material instead of glass.
`the 3M-9777L PVC foam exhibits a static coellicient of
`friction of greater than 5. such as 5.7".
`'[he PVC material almost exhibits slight adhesive prop-
`erties. surface tension forces. or static cling forces. There-
`fore. PVC foam is a very good choice of material for layer
`112 in consideration of the preferred non-slip characteristics.
`Materials other titan PVC foam can be used for layer 112.
`The static coefficient of friction for layer 112 is preferably
`"I greater than 10. Most preferably.
`layer 112 has a static
`coefficient of friction that is greater than 100.
`Layer 112 is preferably light
`in color to enhance the
`amplitude ofthe light signals received by photodetector 116.
`For example. layer 112 may be white. off-while. or cream
`colored. Altematively. layer 112 may be dark in color to
`decrease the amount of ambient and shunted light
`that
`reaches the photodetector. at an expense of the amount of
`detected LED light signals.
`Layer 112 is preferably a thin layer. as shown in the cross
`sectional views in FIG. 1. By selecting a narrow thickness
`for layer 112. sensor 11]] is less bulky. Because sensor 101
`is thin.
`it
`is more flexible. and it can be easily conformed
`around a patient's body part. FIG. 2 illustrates an example
`of how sensor 101 can be placed around a patient's foot.
`Sensor 11!] may include an additional laminated layer.
`The additional laminated layer is a strengthening film (not
`shown) that lies between laminated layers 114 and 112. In
`one embodiment. hook layer 113 is attached to the strength-
`. citingI film. in this embodiment. hook 113 is an integral part
`of one of the laminated layers that makes tip the body of
`sensor [1]]. Hook portion 113 is not attached to layer 112.
`The foam layer 112 is discontinued at point 1211 in FIG. 1,
`and hook portion 113 begins to the right of 127. In other
`embodiments. hook layer 113 is an integral part of bottom
`layer 112 or top layer 114.
`In one embodiment of the present invent ion. the inner side
`125 of layer 112 is covered with a laminated opaque film.
`The opaque film blocks ambient light that may interfere with
`photodetector 116. The opaque film may comprise polyeth—
`ylene. The Opaque film may be black or some other dark
`color that helps block ambient light and reduces shunted
`light. Dark in color is understood here to be ofa nature with
`little reflectance of the wavelengths of light sensed by the
`sensor’s photodetector.
`Non-adhesive layer 112 is preferably [orig enough to wrap
`the way around the patient‘s finger.
`toe. ear. or other
`all
`portion of [he body. Non-adhesive layer 112 is [he only
`portion ofsensor 101 that directly contacts the patient’s skin.
`This feature of the present invention eliminates damage to
`the patient‘s skin that can be caused by adhesive portions of
`a sensor.
`
`Once sensor 101 has been wrapped snuggly around the
`patient's finger. toe. or other body part. hook 113 is engaged
`with loop layer 114. Layer 114 is facing outward relative to
`the patient and does not contact the skin. Hook [13 engages
`with any portion of loop layer 114. The coiuiection between
`
`0005
`
`US 7,190,986 El
`
`3
`11] toward the patient‘s tissue. The reflective masks may
`comprise polyester or polypropylene with a reflective metal
`surface.
`Htotodetector 116 is also covered with a Faraday shield
`115. Faraday shield 115 protects photodeteetor .116 from
`electromagnetic fields
`in the environment. Shield 115
`reduces electromagnetic interference that may introduce
`noise into the output signal of pltotodetector 116.
`Sensor 10] has laminated layers including layer 112 and
`hook-and—loop layers 113 and 114 shown in FIG. 1. Loop
`layer 114 has. for example. small loops of threads. Hook
`layer 113 has. for example. small books that engage with the
`loops in loop layer 114.
`Hook layer 113 and loop layer 114 are used to attach
`sensor 101 to a patient. Hooks in hook layer 113 engage with
`the loops in loop layer 114. Once engaged. the hook-and-
`loop layers remain attached to each other. until they are
`pulled apart. The end user cart engage and disengage hook
`layer 113 from loop layer 114 multiple times in order to open
`or close the fastener. One portion of layer 114 cannot attach
`to another portion of layer 114.
`In one embodiment of the present invention. hook and
`loop layers 113 and 114 are VELCRU layers.
`In this
`embodiment. layer 114 comprises a VELCRO loop. and
`layer 113 comprises a VELCRO hook.
`Loop layer 114 has a first
`raised portion 114A that
`provides room for the thickness of photodetector .116. Loop
`114 also has a second raised portion that provides room for
`LED 111.
`Sensor 181 also has a bottom laminated layer 112 as
`shown in FIG. 1. Layer 112 is a non-adhesive layer. Layer
`112 is preferably made of a material that has a soft. smooth.
`non-skid surface. layer 112 may. for example. comprise
`polyvinyl chloride (PVC) foam. One type of PVC that may
`be used with the present invention is 3M—9777L PVC foam
`manufactured by 3M Co. Layer 112 may also comprise other
`types of soft. non-adhesive material.
`Bottom iayer 112 is an outer layer of the sensor that
`contacts the patient‘s skin. Layer 112 comprises a non—
`adhesivc material
`that does not adhere or stick to the
`
`palienl’s skin. Because layer 112 comprises a soft. non-
`adhesive material.
`it does not tear or irritate sensitive or
`fragile skin when sensor 101 is removed from the patient,
`Layer 112 preferably comprises a material
`that has a
`relatively large static coeflicient of friction. A material with
`a large static coefficient of friction helps to keep sensor 101
`motionless relative to the skin as a patient moves. In sensors
`of the present invention.
`it
`is important to maximize the
`friction between the sensor and the skin. without the use of
`adhesives. Adhesives can damage fragile skin. and one .
`objective ofthe present invention is to keep the sensor on the
`patient without slippage. but without the use of an adhesive.
`According to the present invention. the static coemcient
`of friction ofa material is tested using the following pro-
`cedure. Attach a protractor to a vertical wall with the center ..
`in line with the edge of a table. Set up a stop block at the
`edge of the table to act as a pivot point for a glass plate. Place
`the glass plate flat on the table with one edge along the edge
`ofthe table, up against the stop block. Place a test sample of
`the material on the glass plate (or other reference materials.
`such as skirt). Lifl the free edge of the glass plate until the
`test sample just starts to slip. Record angle at which slippage
`first occurred. This angle is the angle of repose. Then
`calculate the coeflicient of friction. which is the tangent of
`the angle of repose.
`The coefficient of friction of polyvinyl chloride (PVC)
`foam is greater than the prior art foam wrap assembly fotmd
`
`FITBIT, Ex. 1009
`
`

`

`0006
`
`6
`4. The oximeter sensor of claim 1 wherein the first
`substrate predominantly has a thickness of less than 0.] inch.
`5. The oximeter sensor of claim 1 wherein:
`the substrate comprises polyvinyl chloride foam.
`6. The oxiurelcr sensor of claim I further comprising:
`a cable attached to the sensor; and
`a strap movany attached to the cable. wherein the strap
`can be attached to the patient.
`7. The oximctcr sensor of claim 1 fttrther comprising:
`reflective mask layers over one or both of the light
`emitting element and light detecting element.
`8. The oximeter sensor ofclaim I further comprising:
`faraday shields over one or both oflhe light emitting and
`light detecting elements.
`9. The oxirneter sensor of claim 1 further comprising:
`an opaque film that covers the inner surface of the first
`laminated layer.
`10. The oximeter sensor of claim 9 wherein:
`the opaque film is dark in color.
`I]. A method for faulting an oximcter sensor. the method
`comprising:
`providing a substrate having a surface that contacts a
`patient. the substrate comprising a non-adhesive mate-
`rial that has a static coefiicicnt of friction greater than
`5 with respect to the patient’s skirt. the non-adhesive
`material retaining the oxirneter sensor on the patient
`without the use ofan adhesive that contacts skin of the
`patient.
`the substrate having first and second recep—
`tacles: and
`placing a light emitting element in the first receptacle:
`placing a light detecting element in the second receptacle.
`12. The method of claim 11 further comprising:
`placing a first
`transparent polyurethane layer over the
`light emitting element: and
`placing a second transparent polyurethane layer over the
`light detecting element.
`13. The method of claim 11 further comprising:
`placing a first reflective layer over the light emitting
`element: and
`placing a second reflective layer over the light detecting
`element.
`14. The method of claim 11 further comprising:
`placing a hook layer and a loop layer on the substrate,
`wherein the loop layer is adapted to engage with the
`hook layer.
`15. The method of claim 11 wherein the substrate com-
`prises polyvinyl chloride foam.
`16. The method of claim 11 wherein the light emitting and
`light detecting elements include faraday shields.
`17. An oximeter sensor comprising:
`a light emining element;
`a light detecting element:
`a substrate on which the light emitting eletnent and the
`light detecting element are disposed.
`the substrate
`comprising a non-adhesive patient—contacting surface,
`the patient—contacting surface having a static coefficient
`of friction greater than 10 with respect to glass.
`18. The oximcter sensor of claim 17 further comprising:
`a hook portion and a loop portion coupled to the substrate.
`the hook portion being releasany coupleable to the
`loop portion to facilitate attaching the sensor to a
`patient.
`19. The oximeter sensor of claim 17 wherein the substrate
`55 predominantly has a thickness less than 0.1 inch.
`20. The oximeter sensor of claim 17 wherein:
`the substrate comprises polyvinyl chloride foam.
`
`1;
`
`US 7,190,986 Bl
`
`hook 113 and loop 114 keeps sensor 101 firmly attached to
`the patient so that it does not fall 00' or move.
`The laminated layers of sensor 10] are preferably thin
`layers. Non-adhesive layer 112 is preferably a thin. non-
`bulky layer. Because sensor 101 comprises thin laminated
`layers, sensor 101 has a low profile and can function much
`like a second skin. The laminated layers of sensor 101. when
`combined. are preferably less than 0.1 inches thick. and
`more preferably less than 0.75 inches thick.
`Sensor 101 is also easily conformable to the shape of a
`patient’s body part. because the laminated layers that make
`up sensor 101 are thin and flexible. Sensor 10] may be a
`single patient use {disposable} sensor.
`Sensor 10]. by virtue of the choice of materials used in the
`preferred embodiment and the simplicity of the lamination
`style construction. can be sterilized ttsing conventional
`Ethylene Oxide (130) methods and can be produced eco-
`nornically.
`Sensor 101 can also have a portion 12] around the end of
`cable 122. Portion 121 includes loop material that wraps all
`the way around the circumference of cable 122 as shown in
`FIG. 1. Loop portion 121 provides additional area that book
`113 can attach to.
`Referring again to FIG. 2. a strap 130 is attached to cable
`122. Strap 130 includes hook-and-loop layers that engage
`each other. Strap 130 can be wrapped around a portion of the
`patient's body (cg. the patient’s ankle as shown in FIG. 2)
`to further secure sensor 101 to the patient. Strap 130 may be
`movabiy attached to cable 122 so that strap 130 can slide up
`and down the cable. ‘Ihis feature allows strap 130 to be
`placed at a position along cable 122 where it can be
`conveniently marched to the patient.
`While the present invention has been described herein
`with reference to particular embodiments thereof. a latitude
`of modification. various changes. and substitutions are
`intended in the present invention. In sortie instances. features
`of the invention can be employed without a corresponding
`use ofother features. without departing from the scope of the
`invention as set forth. Therefore. many modifications may
`be made to adapt a particular configuration or method
`diaclosed. without departing from the essential scope and
`spirit of the present invention. It is intended that the inven—
`tion not be limited to the particular embodiment disclosed.
`but that the invention will include all embodiments and
`equivalents falling within the scope of the claims.
`What is claimed is:
`1. An oximeter sensor comprising:
`a light emitting element:
`a light detecting element:
`a substrate adapted to support the. light emitting clement
`and the light detecting element. the substrate compris-
`ing a non-adhesive patient-contacting surface.
`the
`patient contacting-surface having a static coellicicnt of
`friction greater than 5 with respect to a patient‘s skirt.
`2. The oximeter sensor of claim 1 wherein:
`the substrate includes first and second receptacles, the
`light emitting clement residing in the first receptacle,
`and the light detecting element residing in the second
`receptacle: and comprising:
`transparent polyurethane layer that covers the first
`receptacle and the second-receptacle.
`3. The oximeter sensor of claim 1 comprising:
`a hook portion and a loop portion coupled to the substrate.
`the hook portion being releasany coupleable to the
`loop portion to facilitate attaching the sensor to a
`patient.
`
`,
`
`-
`
`__
`
`0006
`
`FITBIT, Ex. 1009
`
`

`

`8
`35. An oximeter sensor comprising:
`a light emitting element:
`a light detecting element:
`a substrate having a strap-like configuration configured
`encircle a portion of a patient and to attach to itself. the
`substrate being adapted to support the light emitting
`element and the light detecting element, the substrate
`comprising a non-adhesive patient-contacting surface.
`the patient contacting-surface having a static coefficient
`of friction greater than 5 with respect to the patient's
`skirt.
`36. The oximeter sensor of claim 35 wherein:
`the substrate includes first and second receptacles, the
`light emitting element residing in the first receptacle.
`and the light detecting element residing in the second
`receptacle: and comprising:
`a transparent layer that covers the first receptacle and the
`second receptacle.
`37. The oximeter sensor of claim 35 comprising:
`a hook portion and a loop portion coupled to Lhe substrate.
`the hook portion being releasath cuupleable to the
`loop portion to facilitate attaching the sensor to a
`patient.
`38. The oximeter sensor ofclaim 35 wherein the substrate
`predominantly has a thickness of less titan 0.1 inch.
`39. The oxirneter sensor of claim 35 wherein the substrate
`comprises polyvinyl chloride foam.
`4“. The oxitneter sensor of claim 35 comprising:
`a cable attached to the sensor; and
`a strap movath attached to the cable. wherein the strap is
`configured to be attachable to the patient.
`41. The oximeter sensor of claim 35 comprising:
`reflective mask layers over one or both of the light
`emitting element and light detecting element.
`42. The oximeter sensor of claim 35 comprising:
`faraday shields over one or both of the light emitting and
`light detecting elements.
`43. The oximeter sensor of claim 35 comprising:
`an opaque film that covers the inner surface of the first
`laminated layer.
`44. The oximeter sensor of claim 43 wherein:
`the opaque film is dark in color.
`45. A method for forming an oximeter sensor. the method
`comprtsmg:
`providing a substrate having a predominant thickness of
`less than 0.1 inch and having a surface that contacts a
`patient‘ the substrate comprising a non-adhesive mate-
`rial that has a static coefficient of friction greater than
`5 with respect to the patient’s skin. the non—adhesive
`material retaining the oximeter sensor on the patient
`without the use of an adhesive that contacts skin of the
`patient.
`the substrate having first and second recep-
`tacles: and
`
`element.
`
`'
`
`__
`
`0007
`
`US 7,190,986 El
`
`7
`21. The oximeter sensor of claim 17 wherein:
`tlte patient contacting surface has a static coeflicieru of
`friction greater than 100 with respect to glass.
`22. The oximeter sensor of claim 1'? wherein the substrate
`
`comprises at least two layers laminated together.
`23. The oxirnetcr sensor of claim 1'? wherein the substrate
`cotnprises at least three layers laminated together, wherein at
`least one of the at least three layers cotnprises a strength-
`ening layer.
`24. A method for forming an oximeter sensor. the method
`comprising:
`providing a substrate having a surface that contacts a
`patient. the substrate comprising a non-adhesive mate-
`rial that has a static coefiicient of friction greater than
`10 with respect
`to glass.
`the non-adhesive material
`retaining the oxinteter sensor on the patient without the
`use of an adhesive that contacts skin of the patient. the
`substrate having first and second receptacles: and
`placing a light emitting element in the first receptacle;
`placing a light detecting element in the second receptacle.
`25. The method of claim 24 further comprising:
`placing a first transparent polyurethane layer over the
`light emitting element: and
`placing a second transparent polyurethane layer over the
`light detecting element.
`26. The method of claim 24 further comprising:
`placing a first reflective layer over the light emitting
`element: and
`placing a second reflective layer over the light detecting
`element.
`
`27, The method of claim 24 further comprising:
`placing a hook layer and a loop layer on the substrate.
`wherein the loop layer is adapted to engage with the
`hook layer.
`28. The method of claim 24 wherein the substrate com—
`prises polyvinyl chloride foam,
`29. The method of claim 24 wherein the non-adhesive
`material has a static coeflicient of friction greater than 100
`with respect to glass.
`30. Au oximeter sensor comprising:
`a light emitting element:
`a light detecting element:
`a substrate being strap-like in shape and configured to
`encircle a portion of a patient. the substrate adapted to
`support the light emitting element and the light detect-
`ing element. the substrate comprising a non-adhesive
`polyvinyl chloride material having a patient~contacting
`surface the substrate having a thickness of less than 0.]
`inch and being adapted to attach to itsel ffor securernent
`to the patient.
`wherein the substrate comprises at least two layers lami-
`nated together.
`31. The oximeter sensor of claim 30 wherein the patient
`contacting surface has a static coeflicient of friction greater
`than 5 with respect to a patient's skin.
`32. The oximeter sensor of claim 3|] wherein the patient
`contacting surface has a static coeflicient of li-iction greater
`than 10 with respect to glass.
`33. The oximeter sensor of claim 30 wherein the patient
`contacting surface has a static coeflicient of friction greater
`than 100 with respect to glass.
`34. The oxirneter sensor of claim 30 wherein the substrate
`comprises at least three layers laminated together. wherein at
`least one of the at least three layers comprises a strength-
`ening layer.
`
`placing a light etnitling element in the first receptacle:
`placing a light detecting element in the second receptacle.
`46. The method ofclaim 45 comprising:
`placing a first
`transparent
`layer over the light emitting
`element: and
`
`placing a second transparent layer over the light detecting
`element.
`
`47. The method of claim 45 comprising:
`placing a first reflective layer over the light emitting
`element: and
`placing a second reflective layer over the light detecting
`
`FITBIT, Ex. 1009
`
`

`

`US 7,190,986 El
`
`10
`61. The method of claitn 58 comprising:
`placing a hook layer and a loop layer on the substrate.
`wherein the loop layer is adapted to engage with the
`hook layer,
`62. The method of claim 58 wherein the substrate com—
`prises polyvinyl chloride loam.
`63. The method of claim 58 wherein the non-adhesive
`material has a static ooefiieient of friction greater than 100
`with respect to glass.
`64. An oximetcr sensor comprising:
`a light emitting element:
`a light detecting element:
`a substrate having a coefficient of friction greater than 10
`with respect to glass. the substrate being adapted to
`support the light emitting element and the light detect-
`ing element. the substrate comprising a non-adhesive
`material having a patient-contacting surface. the sub-
`strate having a thickness of less than 0.] inch and being
`adapted to attach to itself for securement to the patient.
`65. The oximeter sensor of claim 64 comprising:
`a hook portion and a loop portion cottpled to the substrate.
`the hook portion being releasany coupleable to the
`loop portion to facilitate attachment of the substrate to
`itself for securement to the patient.
`66. The oxirneter sensor of claim 64 wherein the substrate
`comprises at least two layers laminated together.
`67. The oximetcr sensor ul‘claim 64 wherein the substrate
`comprises at least three layers laminated together. wherein at
`least one of the at least three layers comprises a strength-
`ening layer.
`68. An oximeter sensor comprising:
`a light entitling element:
`a light detecting element:
`a substrate having a coefficient of friction greater than 5
`with respect to a patient‘s skirt
`the substrate being
`adapted to support the light emitting element and the
`light detecting element.
`the substrate comprising a
`non-adhesive material having a patient-contacting sur-
`face. the substrate having a thickness of less than 0.]
`inch and being adapted to attach to itself for securement
`to the patient.
`69. The oximeter sensor of claim 68 comprising:
`a hook portion and a loop portion coupled to the substrate.
`the hook portion being releasany coupleable to the
`loop portion to facilitate attachment of the substrate to
`itself for securement to the patient.
`70. The oximeter sensor of claim 68 wherein the substrate
`comprises at least two layers laminated together.
`71. The oximetcr sensor ol‘claim 68 wherein the substrate
`comprises at least three layers laminated together. wherein at
`least one of the at least three layers comprises a strength-
`
`ening layer.
`
`9
`48. The method of claim 45 comprising:
`placing a hook layer and a loop layer on the substrate.
`wherein the loop layer is adapted to engage with the
`hook layer.
`49. The method of claim 45 wherein the substrate corn-
`prises polyvinyl chloride foam.
`50. The method ofclaim 45 wherein the light emitting and
`light detecting elements include faraday shields.
`51. An oximetcr sensor comprising:
`a light emitting element:
`a light detecting element;
`a substrate on which the light