`
`USOt}?I90986B1
`
`(12) United States Patent
`Hannuta et at.
`
`(10) Patent No.:
`(45; Date of Patent:
`
`US 7,190,986 B1
`Mar. 13, 2007
`
`(54) NON-ADHESIVE OXIMETER SENSOR FOR
`SENSITIVE SKIN
`
`(75)
`
`.
`.
`-
`Inventors: Don Ilannula. San Luis Obispo. (TA
`am‘ PM D‘ M‘"'"h""“”‘ I)‘‘“‘”“‘'‘
`CA (US)
`03> Assisnee: Nellwr Puritan Bennett
`I‘leas«'mt0n. CMUS)
`Subject to any disclaimer. the term of this
`patent is extended or adjusted under 35
`U.S.C. l54(b) by 0 days.
`
`( ‘V ) Notice:
`
`(21) Appl. No.: 101274.845
`
`(22)
`
`Fllcdi
`
`03- 13: 2002
`
`(51)
`
`Int. Cl.
`
`(2006.01)
`/l6IB 5/00
`600844; 600:’?-10: 600823
`(52) U.S. CI.
`Field of Classification Search '''''' H
`600;322 323‘ 344
`See application file for complete search history.
`
`(56)
`
`AB§']"RA(_'T
`,
`_
`_
`_
`‘
`T113 ]'1l't3St3l'II i.Il\«’t3fllll.‘tl'l ['Il'D\-"Idt35 |'lO1'1'€lCll'l€SI\?I‘r3 OXIIIIEIEF SEN.-
`sons for patients with sensitive skin. Sensors oftlie present
`invention include a light emitting diode ([.l*l|)} and a pho-
`todetector. The LED and the photodeteetor may be covered
`by a reflective mask and a faraday shield. Sensors of the
`References Cited
`present inverttiort have a 11011-adl1esive lziniinated layer. The
`I
`non-adlwsive layer etntlacls. but does not stick to.
`the
`U'S' PATENT DOCUMENTS
`patient's skin. When the sensor is renloved from the patient.
`3.695.131 A *
`[(1.-']t)72 Bonner, Jr_
`the non-adhesive layer does not tear or irritate the patient‘s
`4.830.014 A
`S.-' 1989 Goodmmi ct at.
`skin. The non-adliesive layer preferably has :1
`large static
`5905347
`4~953-552 A "‘
`9-4999 DCMHWO
`eoeflicient of friction. Sensors of the present invention can
`5°”-""344
`5345-0“ A ’°
`‘M993 Delv°"7°’
`‘E :
`313'": ell 3" '
`also have l1ook—and—loop layers. The sensor can be attached
`. 1;
`-
`u1ea..... r _
`,4_ ,_
`._
`-
`,,__ ,
`‘
`
`5.-1993 Diab et at. ................ .. sou.-323
`5.753.544 A *
`i” ll“ p"”‘"’" *1 b.”dy by ‘°”"pp“‘3 ll“ ”““"‘” "’f“”‘d 11“
`5_?97_s_,_H A ..,
`851998 Delonzor C‘ RI’
`50U___‘-H3
`patient and engaging the hook layer to the loop layer.
`5.830.136 A “’
`ll-"1998 De1on'zoI'et al.
`G00-""323
`5.913.819 A "'
`6.-‘I999 ”t'.1y1or et at.
`............. .. 600-'323
`
`liric F. Winal-aur
`Prfiimr_t' Emmfner
`(74) Arrormzj.-'. Agent‘. or Firm l-'letcher Ynder PC
`
`(57)
`
`264.-'53
`
`71 Claims. 2 Drawing Sheets
`
`0001
`°°°‘
`
`Apple Inc.
`APL1009
`
`U.S. Patent No. 8,886,269
`
`sun-322
`.. 600.-"309
`.
`600-""323
`.. 6005344
`-
`498 88
`‘
`.... .. soars
`422-"'58
`233..-iii
`sen-335
`.
`600 in
`
`
`
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`
`.
`
`6.018.673 .4 *4
`6.063.020 A "‘
`6.073.038 A *
`.
`=1.
`.
`_
`-'_
`_
`‘J.
`._
`:
`342002 Ni:up:.hi:i1a1....
`5.354 939 Ht‘
`||:"2{li}2 Long et al.
`.
`6.479.015 Bl "‘
`.-'2
`'
`*
`4
`.
`.
`'7
`7*
`2'§~li"_i§§ 31» .3433? i3.’.3f;.§'L.‘l..
`5.731.953 B2*
`5.-"2004 Fin.-irovel at.
`-'
`.
`.
`‘K
`._
`.'
`'
`2001 00380“ M
`mm “H”
`OTHER PUBLICATIONS
`RM product information for './:2 inch PVC‘ Fozun Tape WT?-I_. from
`3M online product catalog.‘'‘
`* tiled by cumin“
`
`152000 (‘hin et at.
`5.-‘"2000 Sana et al.
`6.-‘Z000 Wang et al.
`
`.
`
`Apple Inc.
`APL1009
`U.S. Patent No. 8,886,269
`
`
`
`US. Patent
`
`Mar. 13,2007
`
`Sheet 1 of2
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`US 7,190,986 B1
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`0002
`0002
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`US. Patent
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`Mar. 13, 2007
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`Sheet 2 of2
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`US 7,190,986 B1
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`0003
`0003
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`US 7,190,986 B1
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`2
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`irritate the patient’s skin. Therefore. the non-adhesive layer
`protects sensitive skirt. In one embodiment. the non-adhe-
`sive layer is a polyvinyl chloride foam material. The non-
`adhesive layer preferably has a large static coefiiciertt 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. These layers may include 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.
`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 minimize 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. IA illustrates a plan view of an exemplary embodi-
`ment of a non-adhesive oxirneter sensor in accordance with
`
`the present invention:
`FIG. 1B illustrates a cross-sectional view ofthe sensor of
`FIG. IA taken along line IEISA -l{|5A;
`FIG. 1C illustrates a detailed view ofa portion of FIG. 1B
`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
`
`Oximeter sensor 101 shown in I"-‘IGS. IA. 13. and C is an
`embodiment of the present invention. A top down view of
`oximeter sensor 101 is shown in FIG. 1A. A cross sectional
`
`view of oximeter sensor 101 along a plane 105A is shown in
`FIG. 1B. The cross sectional view shows the laminated
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`NON-ADHESIVE OXIMETER SENSOR FOR
`SENSITIVE SKIN
`
`BACKGROUND OF THE INVENTION
`
`The present application relates to non-adhesive oximcter
`sensors. and more particularly to non—adhesive 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 more light-emitting-diodes (LEDS) to
`shine through an area of tissue containing large amounts of
`blood. The light source is niounted to well-perfused tissue,
`such as a lingertip. 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
`perfusing through the monitored tissue. The I..EIJs can emit
`either broad—speetrun1 visual light or narrow bandwidth light
`in the red or infrared wavelengths.
`‘the absorption of certain wavelengths is related to the
`oxygen saturation 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-
`tnent of the arterial oxygen content.
`One type of prior art oximeter sensor is the STAT-
`WRAPT“ sensor E542 by Epic Medical Equipment Services
`of Plano. Tex. The S’1'A'I‘-WRAE”-"‘ sensor has a non-adhe-
`sive foam outer layer that 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 coetlicient of
`friction of about 1.43.
`The STAT-WRAPT” sensor also has hook-and-loop layers
`that engage each other. The hook layer is a separate layer
`that is stitched to an end of the sensor.
`Other prior art oximeter sensors have an outer adhesive
`layer. The adhesive layer is a sticky material that bonds
`temporarily to the skin like a band-aid. The adltesive holds
`tlte oxitneter sensor on the skin of the patient so that it does
`not move or fall ofi. 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 oliprior-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.
`
`BRIEF SUMMARY OF THE lNV"}':ZN'l"l0N
`
`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 photodetector. The l..l:il) light shines light through a
`patient‘s tissue. The light from the LED is detected by the
`photodetector. The LED and photodetector may be covered
`by transparent windows. The LED and the photodetector
`ntay also be covered by a reflective mask and a Faraday
`electromagnetic shield.
`Sensors of the present invention have a laminated non-
`adhesive layer. The non—adhesive layer contacts. but does
`not stick to. die patiet1l's skin. When the sensor is removed
`from the patient. the non-adhesive layer does not tear or
`
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`layers of sensor 101. FIG. 1C illustrates an expanded view
`of a portion of the cross sectional view.
`Oximeter sensor 101 has one or more light emitting
`diodes (LIED) 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 photodetector 116.
`Photodetector 116 produces a signal
`in response to the
`detected light. The signal is decoded by an oximeter monitor
`(not shown} to calculate the patient‘s blood oxygen satura-
`tion. I.l‘£lJ 111 and photodetector 116 are connected to the
`oximeter monitor tlu-ough wires that feed through cable 122.
`Sensor 10] has a polyurethane window 118 below pho-
`todetector I16. Sensor ll}! also has a polyuretltane window
`below LED Ill. The polyurethane windows are transparent.
`Light from LED 111 can pass unobstructed through the
`polyurethane windows to photodetector 116.
`As shown i11 exploded view in FIG. 1C. photodetector
`116, is surrounded by a reflective mask 117'. 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 11'?’ 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
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`US 7,190,986 B1
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`111 toward the patiet1t‘s tissue. The reflective masks may
`comprise polyester or polypropylene with a reflective metal
`surface.
`
`Photodetector 116 is also covered with a Faraday shield
`I15. Faraday shield 115 protects photodetector .116 from
`electrotiiagltetic fields
`in the cnvirorlment. Shield 115
`reduces electromagnetic interference that may introduce
`noise into the output signal of photodetector 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 ll3 has. for example. small hooks 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 l1ook-and-
`loop layers remain attached to each other. until they are
`pulled apart. The end user can 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 \r'lil..Cl{()
`layers.
`In this
`embodiment. layer 114 comprises a VELCRO loop. and
`layer 113 comprises a VELCRO hook.
`Loop layer 114 ltas a first
`raised portion 114A that
`provides room for the thickness of photodctector .116. Loop
`114 also has a second raised portion that provides room for
`LED 111.
`Sensor 101 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. cotnprise
`polyvinyl chloride (PVC) foam. One type of PVC that may
`be used with the present invention is 3M—97"7?L PVC foam
`manufactured by 3M Co. Layer 112 may also comprise other
`types of soft. no11-adhesive material.
`Bottom layer 112 is an outer layer of the sensor that
`contacts the patient‘s skin. Layer 112 comprises a non-
`adhesive material
`that does not adhere or stick to the
`
`patient’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 eoeflicient of friction. A material with
`a large static coeflicient 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 coefficient
`of friction of a 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 Hat 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). Lift the free edge of the glass plate until the
`test samplejust starts to slip. Record angle at which slippage
`first occurred. This angle is the angle of repose. Then
`calculate the coefizicient of friction. which is the tangent of
`the angle of repose.
`’ll1e coellicient of friction of polyvinyl chloride (PVC)
`foam is greater than the prior art foam wrap assembly found
`
`4
`in the STAT-WRAPTM sensor. The 3M-9777L PVC foam
`measured using the above-described measuring technique
`resulted in a value of static coeflicient of friction of infinity
`with respect to glass. The 3M-97??L PVC foam actually
`stayed on the glass test plate even after achieving a 90
`degree angle of repose.
`The 3M-9Tr'7L 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 [or
`layer 112 in consideration of the preferred non-slip charac-
`teristics. Using skin as a reference material instead of glass.
`the 3M-97771. PVC foam exhibits a static coellicient of
`friction of greater than 5. such as 5.7.
`The 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 than PVC foam can be used for layer 112.
`The static coelficient of friction for layer 112 is preferably
`greater than 10. Most preferably.
`layer 112 has a static
`coeflicient of friction that is greater than 100.
`Layer 112 is preferably light
`in color to enhance the
`amplitude of the light signals received by photodetector 116.
`For example. layer 112 may be white. oil"-white. 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 Llil) light signals.
`Layer 112 is preferably a I11in layer. as shown in the cross
`sectional views in FIG. 1. By selecting a narrow thickness
`for layer 112. sensor 101 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 10] may include an additional laminated layer.
`The additional laminated layer is a strcngtheiling lilnt (not
`shown} that lies between laminated layers 114 and 112. In
`one embodiment. hook layer 113 is attached to the strength-
`ening film. in this etnbodiment. hook 113 is an integral part
`of one of the laminated layers that makes up the body of
`sensor 101. Hook portion 113 is not attached to layer 112.
`The foam layer 112 is discontinued at point 127 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 itmer 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 long enough to wrap
`all the way around the patient‘s finger.
`toe. ear, or other
`portion of the body. Non-adhesive layer 112 is the only
`portion ofscnsor 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.
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`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 113 engages
`with any portion of loop layer 114. The connection between
`0005
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`US 7,190,986 B1
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`hook 113 and loop 114 keeps sensor 101 firmly attached to
`tl1e patient so that it does not fall oil" 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 tl1an 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 llexible. Sensor 10] Inay 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 sterilixed using conventional
`Ethylene Oxide (1-30) methods and can be produced eco-
`nomically.
`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 hook
`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 [e.g.. the patient’s ankle as shown in FIG. 2]
`to further secure sensor 101 to the patient. Strap 130 may be
`movably attached to cable 122 so that strap 130 can slide up
`and down the cable. This feature allows strap 130 to be
`placed at a position along cable 122 where it can be
`conveniently attached 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 some instances. features
`of the invention can be employed without a corresponding
`use of other 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
`disclosed. 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 element
`and the light detecting element. the substrate compris-
`ing a non-adhesive patient-contacting surface.
`the
`patient contacting-surface having a static coeliicient of
`friction greater than 5 with respect to a patient‘s skin.
`2. The oximeter sensor of claim 1 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 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 releasably coupleable to the
`loop ponion to facilitate attaching the sensor to a
`patient.
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`4. The oximeter sensor of claim 1 wherein the first
`substrate predominantly has a thickness of less than 0.1 inch
`5. The oximeter sensor of claim 1 wherein:
`
`the substrate comprises polyvinyl chloride foam.
`6. The oximctcr sensor of claim I further comprising:
`a cable attached to the sensor; and
`a strap movably attached to the cable. wherein the strap
`can be attached to the patient.
`7. The oximeter sensor of claim 1 fitrther 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 of the liglu emitting and
`light detecting elements.
`9. The oximeter sensor of claim 1 further comprising:
`an opaque film that covers the inner surface of the first
`laminated layer.
`II). The oximeter sensor of claim 9 wherein:
`
`the opaque film is dark in color.
`11. 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
`5 with respect to the patient’s skin. the non-adhesive
`material retaining the oximeter 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 ligln 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 foarn.
`16. The method of claim 11 wherein the light emitting and
`light detecting elements include faraday shields.
`]";'. An oximeter sensor eornprising:
`a light emitting element;
`a light detecting element:
`a substrate on which the light emitting element and the
`light detecting element are disposed.
`the substrate
`comprising a non-adhesive patient-contacting surface,
`the patient—eontacting surface having a static coefiicient
`of friction greater than 10 with respect to glass.
`18. The oximeter sensor of claim 1’? further comprising:
`a hook portion and a loop portion coupled to the substrate.
`the hook portion being releasably coupleable to the
`loop portion to facilitate attaching the sensor to a
`patient.
`19. The oximeter sensor of claim 1'? wherein the substrate
`predominantly has a thickness less than 0.1 inch.
`2!}. The oximeter sensor of claim 17 wherein:
`
`the substrate comprises polyvinyl chloride foam.
`
`0006
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`US 7,190,986 B1
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`21. The oximeter sensor of claim 17 wherein:
`
`the patient contacting surface has a static coeficient of
`friction greater than 100 with respect to glass.
`22. The oximeter sensor ofclairn 1'? wherein the substrate
`
`comprises at least two layers Iamirtatcd together.
`23. The oximeter sensor of claim 1'? 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.
`24. A method for forming an oximeter sensor. the method
`comprising:
`providing a substrate having a surface that contacts a
`patient. the substrate cornprisirtg a non-adhesive mate-
`rial that has a static coelficient of friction greater than
`10 with respect
`to glass.
`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 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 t.:t:IrI1prisi11g:
`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 tl1e light detecting
`element.
`
`27. The method of clai111 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 tl1e non-adhesive
`
`material has a static coeflicient of friction greater than 100
`with respect to glass.
`3|}. An 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 eiernent mid the light detect-
`ing element. the substrate comprising a non-adhesive
`polyvinyl chloride material having a patienbcontacting
`surface. the substrate having a thickness of less than 0.1
`inch and being adapted to attach to itsel ffor secttrement
`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 30 wherein the patient
`contacting surface has a static coellicient of friction greater
`than 10 with respect to glass.
`33. The oximeter sensor of claim 30 wherein the patient
`contacting surtace has a static cocllicient of friction greater
`than 100 with respect to glass.
`34. The oximeter 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.
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`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 coeflicient
`of friction greater than 5 with respect to the patient's
`skin.
`36. The oximeter sensor of claim 35 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:
`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 the substrate.
`the hook portion being releasably eoupleable 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 than 0.1 inch.
`39. The oximeter sensor of claim 35 wherein the substrate
`
`comprises polyvinyl chloride foam.
`4!}. The oximeter sensor of claim 35 comprising:
`a cable attached to the sensor; and
`a strap movably 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 cotnprising:
`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
`comprising:
`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 cocfiicient 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 ofan adhesive that contacts skin of the
`
`patient. the substrate having first and second recep-
`tacles: and
`
`placing a light emitting element in the lirsl receptacle:
`placing a light detecting element i11 the second receptacle.
`46. The method of claim 45 comprising:
`placing a first transparent layer over the light emitting
`ele111e11t: 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
`element.
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`US 7,190,986 B1
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`48. The method of claitn 45 comprising:
`placing a hook layer and a loop layer on tl1e substrate.
`wherein the loop layer is adapted to engage with the
`hook layer.
`49. The method of claim 45 wherein the substrate com-
`prises polyvinyl chloride foam.
`50. The method ofclaim 45 wherein the light emitting and
`light detecting elements include faraday shields.
`51. An oximeter sensor comprising:
`a light emitting element:
`a light detecting element;
`a substrate on which t.he light emitting element and the
`light detecting element are disposed the substrate hav-
`ing a strap—like configuration configured encircle a
`portion ofa patient and to attach to itself. the substrate
`comprising a non-adhesive patient-contacting surface.
`the patient-contacting sttrface having a static coeflicient
`of friction greater than 10 with respect to glass.
`52. The oximeter sensor of claim 51 comprising:
`a hook layer and a loop layer coupled to the substrate. the
`hook layer being configured to engage the loop layer to
`facilitate attaching the strap-like substrate to itself.
`53. The oxirneter sensor of claim 51 wherein the substrate
`
`predominantly has a thickness less than 0.1 inch.
`54. The oximeter sensor of claim 51 wherein the substrate
`
`comprises polyvinyl chloride foam.
`55. The oximeter sensor of claim 51 wherein the patient
`contacting surface has a static coeflicient of friction greater
`than 100 with respect to glass.
`56. The oximeter sensor of claim 51 wherein the substrate
`
`comprises at least two layers laminated together.
`57. The oximeter sensor of claim 51 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.
`58. A method for fonning an oximeter sensor, the method
`comprising:
`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 coeilicient of friction greater than
`10 with respect
`to glass.
`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 receptacles: and
`placing a light entitting element in the lirst receptacle:
`placing a light detecting element in the second receptacle.
`59. The method of claim 58 comprising:
`placing a first transparent layer over the light emitting
`element: and
`
`placing a second transparent layer over the light detecting
`element.
`
`60. The method of claim 58 comprising:
`placing a first reflective layer over the light emitting
`element: and
`placing a second reflective layer over the light detecting
`element.
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`61. The method of claitn 58 comprising:
`placing a hook layer and a loop layer on the substrate