EXHIBIT 2122
`EXHIBIT 2122
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`(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2004/0054291 A1
`(43) Pub. Date: Mar. 18, 2004
`
`Schulz et al.
`
`US 20040054291A1
`
`PULSE OXIMETRY EAR SENSOR
`
`Publication Classification
`
`Int. Cl.7 ....................................................... A61B 5/00
`(51)
`(52) U.S.Cl.
`............................................ 600/500; 600/559
`
`(57)
`
`ABSTRACT
`
`An embodiment of an ear sensor assembly comprises an
`emitter pad and a detector pad. A clip is configured to
`removably retain each of the pads. The clip has an open
`position for placement on an ear tissue site and a closed
`position for securing the pads to opposite sides of the site.
`The assembly includes a sensor connector adapted to elec-
`trically communicate With a host instrument. A sensor cable
`has a first end terminating at the pads and a second end
`terminating at the sensor connector and provides electrical
`communications between the pads and the connector. In one
`embodiment, one or more silicone lenses or removable
`adhesive tabs aid in relieving patient discomfort and pres-
`sure necrosis.
`
`(54)
`
`(76)
`
`Inventors: Christian Schulz, Rancho Santa
`Margarita, CA (US); Massi E. Kiani,
`Laguna Niguel, CA (US); Eugene
`Mason, La Mirada, CA (US)
`
`Correspondence Address:
`KNOBBE MARTENS OLSON & BEAR LLP
`2040 MAIN STREET
`FOURTEENTH FLOOR
`IRVINE, CA 92614 (US)
`
`(21)
`
`Appl. No.:
`
`10/631,882
`
`(22)
`
`Filed:
`
`Jul. 31, 2003
`
`Related US. Application Data
`
`(60)
`
`Provisional application No. 60/412,281, filed on Sep.
`21, 2002. Provisional application No. 60/410,499,
`filed on Sep. 14, 2002.
`
`
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`Patent Application Publication Mar. 18, 2004 Sheet 1 0f 23
`
`US 2004/0054291 A1
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`
`
`[76: 1
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`Patent Application Publication Mar. 18, 2004 Sheet 2 0f 23
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`US 2004/0054291 A1
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`FIG:2
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`Patent Application Publication Mar. 18, 2004 Sheet 3 0f 23
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`US 2004/0054291 A1
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`‘300
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`Patent Application Publication Mar. 18, 2004 Sheet 4 0f 23
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`US 2004/0054291 A1
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`Patent Application Publication Mar. 18, 2004 Sheet 5 0f 23
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`US 2004/0054291 A1
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`Patent Application Publication Mar. 18, 2004 Sheet 6 0f 23
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`US 2004/0054291 A1
`
`629
`
`[76:
`FIG:
`
`624
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`Patent Application Publication Mar. 18, 2004 Sheet 7 0f 23
`
`US 2004/0054291 A1
`
`' 700.
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`Patent Application Publication Mar. 18, 2004 Sheet 8 0f 23
`
`US 2004/0054291 A1
`
`
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`£76:
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`Patent Application Publication Mar. 18, 2004 Sheet 9 0f 23
`
`US 2004/0054291 A1
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`Patent Application Publication Mar. 18, 2004 Sheet 10 0f 23
`
`US 2004/0054291 A1
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`

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`Patent Application Publication Mar. 18, 2004 Sheet 12 0f 23
`
`US 2004/0054291 A1
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`Patent Application Publication Mar. 18, 2004 Sheet 13 0f 23
`
`US 2004/0054291 A1
`
`
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`Patent Application Publication Mar. 18, 2004 Sheet 14 0f 23
`
`US 2004/0054291 A1
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`

`Patent Application Publication Mar. 18, 2004 Sheet 15 0f 23
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`Patent Application Publication Mar. 18, 2004 Sheet 16 0f 23
`
`US 2004/0054291 A1
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`Patent Application Publication Mar. 18, 2004 Sheet 17 0f 23
`
`US 2004/0054291 A1
`
`176*
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`Patent Application Publication Mar. 18, 2004 Sheet 18 0f 23
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`US 2004/0054291 A1
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`Patent Application Publication Mar. 18, 2004 Sheet 19 0f 23
`
`US 2004/0054291 A1
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`Patent Application Publication Mar. 18, 2004 Sheet 20 0f 23
`
`US 2004/0054291 A1
`
`[£4
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`Patent Application Publication Mar. 18, 2004 Sheet 21 0f 23
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`US 2004/0054291 A1
`
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`Patent Application Publication Mar. 18, 2004 Sheet 22 0f 23
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`US 2004/0054291 A1
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`Patent Application Publication Mar. 18, 2004 Sheet 23 0f 23
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`US 2004/0054291 A1
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`[76:
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`US 2004/0054291 A1
`
`Mar. 18, 2004
`
`PULSE OXIMETRY EAR SENSOR
`
`REFERENCE TO RELATED APPLICATIONS
`
`[0001] The present application claims the benefit of US.
`Provisional Application No. 60/412,281, filed Sep. 21, 2002,
`entitled, “Pulse Oximetry Ear Sensor” and US. Provisional
`Application No. 60/410,499, filed Sep. 14, 2002, entitled,
`“Pulse Oximetry Ear Sensor,” the disclosures of which are
`incorporated by reference herein.
`
`FIELD OF THE INVENTION
`
`[0002] The present invention relates to the field of medical
`devices. More specifically,
`the invention relates to pulse
`oximetry sensors.
`
`BACKGROUND OF THE INVENTION
`
`[0003] Pulse oximetry is a noninvasive procedure for
`measuring the oxygen saturation level of arterial blood, an
`important parameter in critical patient care applications.
`Pulse oximeters generally perform a spectral analysis of the
`pulsatile component of arterial blood in order to determine
`the relative concentration of oxygenated hemoglobin, the
`major oxygen carrying constituent of blood,
`to depleted
`hemoglobin. A pulse oximetry system includes of a sensor
`and a monitor. The sensor includes emitters generally having
`at least one red light emitting diode (LED) and at least one
`infrared LED that project light through blood vessels and
`capillaries underneath a tissue site, such as a fingernail bed.
`The sensor also has a detector typically consisting of a
`photodiode positioned opposite the LEDs so as to detect the
`emitted light as it emerges from the tissue site. Pulse
`oximeters have gained rapid acceptance in a wide variety of
`medical applications,
`including surgical wards,
`intensive
`care units, general wards and home care by providing early
`detection of decreases in the arterial oxygen supply and
`thereby, reducing the risk of accidental death and injury.
`
`SUMMARY OF THE INVENTION
`
`[0004] A pulse oximetry sensor may be attached to a
`variety of tissue sites including a finger, a foot, an ear, a
`forehead, and the like. An ear site has the advantage of
`providing a fast response to central changes in oxygenation
`or lack thereof. Conventional ear sensors, however, have the
`disadvantage of constricting the ear site because such
`designs use the monitoring site to secure sensor attachment.
`
`[0005] One aspect of a pulse oximetry ear sensor is an
`assembly configured to relieve patient discomfort and pres-
`sure necrosis. The assembly comprises an emitter pad and a
`detector pad, along with a clip configured to removably
`retain each of the pads. The clip has an open position for
`placement on an ear tissue site and a closed position for
`securing the pads to opposite sides of the site. The assembly
`includes a sensor connector adapted to electrically commu-
`nicate with a host instrument. A sensor cable has a first end
`
`terminating at the pads and a second end terminating at the
`sensor connector and provides electrical communications
`between the pads and the connector. In one embodiment, the
`assembly includes an attachment supplement configured to
`assist the clip in securing the pads to the ear tissue site.
`
`[0006] Another aspect of a pulse oximetry ear sensor are
`the steps of assembling a sensor with an attachment, posi-
`tioning the sensor against an ear tissue site with the attach-
`
`ment and supplementing the attachment so as to reduce
`pressure on said site. Afurther aspect of a pulse oximetry ear
`sensor is a sensing means for transmitting and receiving an
`optical signal to and from a tissue site, an attachment means
`for securing the sensing means to the site and a supplemental
`means for assisting the attachment means in securing the
`sensing means to the site.
`
`[0007] Yet another aspect of a pulse oximetry ear sensor is
`one or more silicone lenses that can be incorporated into a
`clip type oximetry sensor and can aid in relieving patient
`discomfort and pressure necrosis. In one embodiment, the
`lenses can provide grippy surfaces in contact with the
`patient’s skin, which helps to keep the sensor from slipping
`off the patient’s earlobe or other suitable tissue site. The
`silicone lenses can also provide pliable contact surfaces that
`accommodate the patient’s skin shape and help to relieve the
`earlobe or other suitable tissue site from undue pressure. In
`one embodiment, the clip type sensor includes windows for
`the optical components of an oximetry sensor that allow for
`transmission of optical energy to or from a tissue site. The
`silicone lenses each comprise a translucent silicone material
`covering the foregoing windows.
`
`[0008] For purposes of summarizing the invention, certain
`aspects, advantages and novel features of the invention have
`been described herein. Of course, it is to be understood that
`not necessarily all such aspects, advantages or features will
`be embodied in any particular embodiment of the invention.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0009] A general architecture that implements the various
`features of the invention will now be described with refer-
`
`ence to the drawings. The drawings and the associated
`descriptions are provided to illustrate embodiments of the
`invention and not
`to limit
`the scope of the invention.
`Throughout the drawings, reference numbers are re-used to
`indicate correspondence between referenced elements. In
`addition, the first digit of each reference number indicates
`the figure in which the element first appears.
`
`[0010] FIG. 1 is a perspective view of a pulse oximetry
`ear sensor attached to a patient, according to an embodiment
`of the invention;
`
`[0011] FIG. 2 is a perspective view of an ear sensor
`assembly;
`
`[0012] FIG. 3 is a perspective view of an ear sensor;
`
`[0013] FIG. 4 is an exploded perspective view of an ear
`sensor;
`
`[0014] FIGS. 5A-B are top and perspective views, respec-
`tively, of ear sensor pad assemblies;
`
`[0015] FIGS. 6A-B are top and perspective views, respec-
`tively of a pad base;
`
`[0016]
`
`FIG. 7 is a perspective view of a pad cover;
`
`[0017] FIGS. 8A-B are top views of a detector shield
`without and with a mounted detector, respectively;
`
`[0018]
`
`FIG. 9 is a top view of an ear sensor cable;
`
`[0019] FIGS. 10A-C are top enclosed, end enclosed, and
`bottom unenclosed views of a modular plug;
`
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`US 2004/0054291 A1
`
`Mar. 18, 2004
`
`[0020] FIGS. 11A-B are top views of a connector flex
`circuit, with and without an attached sensor cable, respec-
`tively;
`
`[0021] FIGS. 12A-C are exploded, front perspective and
`back perspective views, respectively, of a sensor clip;
`
`[0022] FIGS. 13A-D are top, perspective, side and front-
`end views, respectively, of a clip outer jaw;
`
`[0023] FIGS. 14A-E are perspective, top, side, bottom and
`front-end views, respectively, of a clip innerj aw;
`
`[0024] FIGS. 15A-D are side, back, sectional and back
`perspective views, respectively, of an ear hanger;
`
`[0025] FIGS. 16A-C are side views of an unformed,
`partially formed and fully formed ear hanger, respectively;
`
`[0026] FIGS. 17A-E are views of an adhesive tab and an
`associated tab carrier;
`
`[0027] FIGS. 17A-B are top and side views of a tab
`carrier;
`
`[0028] FIGS. 17C-D are top and side views of an adhesive
`tab; and
`
`[0029] FIG. 17E is a top view of a tab handle; and
`
`[0030] FIGS. 18A-F are top, front perspective, side, back,
`rear perspective and bottom perspective views, respectively,
`of an ear sensor boot.
`
`[0031] FIGS. 19A-D are assembled front perspective,
`exploded bottom, exploded top, and rear perspective views,
`respectively, of an ear sensor clip with one or more silicone
`lenses.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENT
`
`[0032] To facilitate a complete understanding of the inven-
`tion, the remainder of the detailed description describes the
`invention with reference to the drawings, wherein like
`reference numbers
`are referenced with like numerals
`
`throughout.
`
`[0033] FIG. 1 illustrates a pulse oximetry ear sensor
`assembly 100 attached to an ear monitoring site 10. The ear
`sensor assembly 100 includes an ear sensor 300, a replace-
`able clip 1200, an ear hanger 1500 and adhesive tabs 1710.
`The clip 1200 advantageously has a relatively low spring
`tension and the area of the ear sensor 300 that contacts the
`
`ear is relatively large compared with conventional ear sen-
`sors, allowing longer monitoring on the ear by reducing
`patient discomfort and pressure necrosis. To provide secure
`sensor attachment to the ear site 10, the ear sensor assembly
`100 optionally utilizes an ear hanger 1500 and adhesive tabs
`1710, individually or in combination, to supplement the clip
`1200. The ear hanger 1500 goes around the ear, much like
`sports glasses, and supports the weight of the ear sensor
`assembly 100. The adhesive tabs 1710 may be added to the
`ear sensor 300 to provide adhesive attachment to the tissue
`site 10. Further, a clasp (not shown) may be added to a
`sensor cable 900 (FIG. 2) and attached to patient clothing,
`for example, to provide strain relief and reduce the risk that
`accidental cable snags might pull the ear sensor 300 off of
`the ear.
`
`[0034] FIG. 2 further illustrates the ear sensor assembly
`100. Ear sensor pads 500 removably press-fit into the clip
`1200. The clip 1200 advantageously allows inexpensive
`replacement of a moving part upon wear or breakage. The
`ear hanger 1500 removably clamps to an ear sensor cable
`900. The ear hanger 1500 is advantageously constructed to
`be easily bent and shaped to comfortably fit various ear
`shapes and sizes, as described in further detail with respect
`to FIGS. 15-16, below. The ear hanger 1500 is provided to
`users either straight or preformed as shown in FIG. 16C.
`Additionally, FIG. 2 shows the ear sensor assembly includ-
`ing one or more integrated finger grips 620 as will be
`described in further detail with respect to FIG. 10 below.
`
`[0035] FIG. 3 illustrates the ear sensor 300 including the
`sensor pads 500,
`the sensor cable 900 and a modular
`connector 1000. The sensor pads 500 house the sensor
`optical components and include a detector pad 506 and an
`emitter pad 507. The sensor cable 900 provides a signal path
`between the sensor pads 500 and the modular connector
`1000. The modular connector 1000 provides pinouts for a
`patient cable (not shown), which is used to provide com-
`munication between the ear sensor 300 and a pulse oximeter
`(not shown).
`
`[0036] FIG. 4 illustrates pieces of the ear sensor 300. The
`sensor pads 500 advantageously include a common base 600
`and cover 700 for each of the detector pad 506 and the
`emitter pad 507. According to an embodiment used, the base
`600 and cover 700 reduces or even minimizes the number of
`
`unique parts for the ear sensor 300. The detector pad 506
`houses a shielded detector assembly 800. The emitter pad
`507 houses an emitter 400. The modular connector 1000
`includes a connector flex circuit 1100 installed onto a tab
`
`1010 and enclosed between a bottom cover 1020 and a top
`cover 1030 that clasp a bend relief 1040.
`
`[0037] FIGS. 5A-B further illustrate exemplary embodi-
`ments of the detector and emitter pads 500. As shown in
`FIG. 5A, both the detector (not visible) within the shielded
`detector assembly 800 and the emitter 400 are connected to
`the sensor cable 900 after the cable is inserted into the
`
`respective bases 600. As shown in FIG. 5B, the cover 700
`is secured in place onto the base 600 so as to enclose, and
`in an embodiment, seal the shielded detector assembly 800
`and emitter 400 in their respective housings.
`
`[0038] FIGS. 6A-B illustrate a base 600 having a bend
`relief 610, the integrated finger grip 620, a head 630 and a
`head extension 640. The base 600 has a cable end 601 and
`a head end 602. The bend relief 610 extends between the
`
`cable end 601 and the finger grip 620 and is configured to
`accept one end of the sensor cable 900 (FIG. 9). The bend
`relief 610 is adapted to reduce bending stress on the sensor
`cable 900 (FIG. 9). The finger grip 620 extends between the
`bend relief 610 and the head extension 640 and provides a
`finger pressing surface so as to open the clip 1200 (FIGS.
`12A-C). In one embodiment, the finger grip 620 provides a
`generally round, planar surface that may be comprised of a
`generally pliable material.
`
`[0039] As shown in FIGS. 6A-B, the head 630 extends
`between the head end 602 and the head extension 640,
`opposite the head extension 640 from the finger grip 620.
`The head 630 has an open face 632 and an opposite,
`generally planar pad face 634. The pad face 634 provides a
`generally planar contact surface for a tissue site. Advanta-
`
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`the pad face 634 has a relatively large area to
`geously,
`minimize the force on a tissue site. In one embodiment, the
`area of the pad face 634 is in the range of about 0.225 sq. in.
`to about 0.325 sq. in. In a particular embodiment, the pad
`face 634 is generally rectangular. In a specific embodiment,
`the pad face 634 has dimensions of about 0.69 in. by about
`0.45 in. However, a skilled artisan will recognize from the
`disclosure herein that the pad face 634 may be sized to take
`into account a wide variety of parameters, including for
`example, tissue site size, component size, necrosis, patient
`comfort, combinations of the same or the like.
`
`[0040] Also shown in FIGS. 6A-B, the open face 632 is
`configured to accept an optical component. In one embodi-
`ment, the open face 632 has a raised wall 650 defining a
`component cavity 652 configured to accept and retain either
`an emitter 400 (FIG. 4) or a detector assembly 800 (FIG. 4).
`The open face 632 also defines a window 654 that provides
`an aperture for transmission of optical energy to or from a
`tissue site. In one embodiment, the window 654 is filled with
`a translucent silicone material as will be further described
`with reference to FIG. 19. The extension 640 extends
`
`between the finger grip 620 and the head 630 and provides
`a channel 642 for the sensor cable 900 (FIG. 9). In one
`embodiment, the open face 632 is closed and sealed with the
`pad cover 700 (FIG. 7). The base 600 has slots 660 disposed
`along the base edges. The slots 660 are configured to mate
`with corresponding clip tabs 1326 (FIGS. 13A-D), 1426
`(FIGS. 14A-E) so as to retain the pads 500 (FIGS. 5A-B)
`within the clip 1200 (FIGS. 12A-C), as described with
`respect to FIGS. 12A-C, below.
`
`[0041] FIG. 7 illustrates a pad cover 700 having a plat-
`form 710, a raised cap 720 and an extension 730. The cover
`700 can be configured to close and seal the base 600 (FIGS.
`6A-B), as described with respect to FIG. 5B. In particular,
`the platform 710 corresponds to the open face 632 and
`covers an optical component. The raised cap 720 accom-
`modates an optical component accordingly. The extension
`730 corresponds to the channel 642 (FIGS. 6A-B) and
`covers the sensor cable leads. Both the base 600 (FIGS.
`6A-B) and the cover 700 can be injection molded of a pliant
`material. In one embodiment, the material is a medical grade
`thermoplastic elastomer, such as AES Santoprene, #281-45.
`In a particular embodiment, the base 600 (FIGS. 6A-B) is
`constructed of a reflective material so as to advantageously
`reflect scattered light back into the tissue site, while the
`cover 700 is constructed of an absorbent material so as to
`
`block ambient light for noise reduction at the detector.
`
`[0042] FIGS. 8A-B illustrate the shielded detector assem-
`bly 800, having a shield 801 and a detector 802. The shield
`801 has a back shield 810, a front shield 820 having a grid
`822, a detector lead shield 830 and a cable lead shield 840.
`The detector 802 is placed on the shield 801 so that the front,
`light-receiving face (not visible) is proximate to and aligned
`with the grid 822. The sensor cable 900 is attached to the
`detector 802 so that the detector cable leads 910 are elec-
`
`trically connected to the detector leads 803 and the detector
`cable shield lead 920 is electrically connected to the cable
`lead shield 840. The shield 801 is then folded so that the
`
`back shield 810 is placed over the back face of the detector
`802, the sides of the front shield 820 are placed over the
`detector sides, the detector lead shield 830 is folded over the
`detector leads 803 and the cable lead shield 840 is folded
`over the cable leads 920.
`
`[0043] FIG. 9 illustrates a sensor cable 900 having a
`sensor end 901, a connector end 902, a cable midsection
`904, a detector cable 905 and a emitter cable 906. Both the
`detector cable 905 and emitter cable 906 extend between the
`sensor end 901 and the connector end 902. The detector
`
`cable 905 and emitter cable 906 are joined throughout the
`cable midsection 904. The detector cable 905 and emitter
`
`cable 906 are separated at a Y—section 980 proximate the
`sensor end 901. A binder 990, such as a shrink-wrap insu-
`lator or an over mold section, binds the cable 900 between
`the Y—section 980 and the midsection 904 to prevent the
`Y—section 980 from extending into the midsection 904 by
`inadvertent separation of the detector cable 905 and emitter
`cable 906. The detector cable 905 has detector cable leads
`910 and a detector cable shield 930 that has a shield lead 920
`formed from the shield 930 at both the sensor end 901 and
`the connector end 902. The emitter cable 906 has emitter
`cable leads 960 and an emitter cable shield 980 that has a
`shield lead 970 formed from the shield 980 at the connector
`end 902. An insulator 972 on the emitter cable shield lead
`
`970 prevents electrical contact with the detector cable shield
`lead 920.
`
`[0044] FIGS. 10A-C illustrate the cable connector 1000
`having a tab 1010, a lower shell 1020, an upper shell 1030
`and a bend relief 1040. As shown in FIG. 10A, the tab 1010
`supports a flexible circuit assembly 1100, which provides
`connector pinouts and connections to the sensor cable 900,
`as described with respect to FIGS. 11A-B, below. The lower
`shell 1020 and upper shell 1030 are mating halves of the
`connector body, which provides a grip for connecting to a
`patient cable, protects the flexible circuit connections and
`retains the bend relief 1040. The bend relief 1040 prevents
`the sensor cable 900 from bending a sharp angles at the
`boundary of the connector body 1020, 1030. As shown in
`FIG. 10C, the tab 1010 has a catch 1014 that provides a
`locking mechanism for a patient cable connector, such as
`described in US. Pat. No. 6,152,754 entitled “Circuit Board
`Based Cable Connector,” assigned to Masimo Corporation,
`Irvine, Calif. and incorporated by reference herein. The tab
`1010 also has apertures 1012 that accept corresponding
`posts 1032 of the upper shell 1030. The posts 1032 fit into
`corresponding standoffs (not shown) of the lower shell 1020
`so that the tab is held in position between the lower shell
`1020 and upper shell 1030.
`
`[0045] FIGS. 11A-B illustrate a self-shielding flexible
`circuit assembly 1100 having a printed circuit 1110, a top
`shield 1130 and a bottom shield 1150. As shown in FIG.
`
`11A, the printed circuit 1110 has pinouts 1112, lead pads
`1114, apertures 1116 and an information element 1118. The
`pinouts 1112 are electrically connected to corresponding
`ones of the lead pads 1114 and provide the connection to a
`mating patient cable connector. The apertures 1116 align
`with upper shell posts 1032 (FIG. 10C). The information
`element 1118 provides sensor information, such as sensor
`type, to a compatible pulse oximeter instrument connected
`to the ear sensor 300 (FIG. 3) via a patient cable (not
`shown). An information element is described in US. Pat.
`No. 6,011,986 entitled “Manual And Automatic Probe Cali-
`bration,” assigned to Masimo Corporation, Irvine, Calif. and
`incorporated by referenced herein.
`
`the sensor cable 900 is
`[0046] As shown in FIG. 1B,
`integrated with the flexible circuit assembly 1100 with the
`cable leads 910, 920, 960, 970 attached and electrically
`
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`EXHIBIT 2122 — PAGE 28
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`US 2004/0054291 A1
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`Mar. 18, 2004
`
`connected to corresponding ones of the lead pads 1114, such
`as with a soldered connection. After the sensor cable 900 is
`
`attached to the printed circuit 1110, the top shield 1130 is
`folded over the printed circuit traces 1112, 1114 and the
`bottom shield 1150 is wrapped around the printed circuit
`1110 and folded over the bottom of the printed circuit 1110.
`In this manner, the connections, in particular the detector
`leads 910, are EMI shielded and physically protected. The
`top shield 1130 and bottom shield 1150 are folded so that top
`shield apertures 1136 and bottom shield apertures 1156 align
`with the printed circuit apertures 1116. The folded flexible
`circuit assembly 1100 is attached to the tab 1010 (FIGS.
`10A-C) with an adhesive, such as PSA, and mounted within
`the connector shells 1020, 1030 (FIG. 10B), as described
`above.
`
`[0047] FIGS. 12A-C illustrate a removable sensor clip
`1200. As shown in FIG. 12A, the removable clip 1200 has
`an outer jaw 1300, an inner jaw 1400, a hinge pin 1201, and
`a hinge spring 1202. The outer jaw 1300 has an outer hinge
`support 1310, and the inner jaw 1400 has an inner hinge
`support 1410. The clip 1200 is assembled with the hinge
`supports 1310, 1410 aligned, the spring 1202 between the
`hinge supports 1310, 1410, and the pin 1201 inserted
`through the hinge supports 1310, 1410 and the spring 1202
`so as to rotatably attach the jaws 1300, 1400 at
`their
`respective hinge supports 1310, 1410. The spring 1202 urges
`the jaws to a closed position in which the sensor pads 500
`(FIGS. 5A-B) are held against an earlobe or other suitable
`tissue site.
`
`[0048] The spring 1202 is advantageously designed so that
`the force the jaws 1300, 1400 exert on a tissue site is
`relatively small. In an embodiment, the ear sensor assembly
`300 (FIG. 3) utilizes various attachment mechanisms to
`supplement or supplant the jaw force in maintaining sensor
`attachment to the tissue site, including an ear hanger 1500
`(FIGS. 15A-D), ear boot 1800 (FIGS. 18A-F), adhesive tabs
`1710 (FIG. 17C), and/or silicone lenses (FIGS. 19A-D)
`described below. In a preferred embodiment, the force of the
`jaws 1300, 1400 on a tissue site is in the range of about 90
`g to about 140 g. In a more preferred embodiment, the jaw
`force is in the range of about 115 g to about 130 g. In a most
`preferred embodiment, the jaw force is about 116 g. How-
`ever, an artisan will recognize from the disclosure herein that
`a wide number of ranges can be implemented for the jaw
`force. For example a clip used on trauma or other potentially
`active patients or diflicult tissue sites may use more or less
`force.
`
`[0049] As shown in FIGS. 12B-C, the assembled clip 1200
`has opposing head holders 1322, 1422 that removably retain
`the head portions 630 (FIGS. 6A-B) of the sensor pads 500
`(FIGS. 5A-B). The assembled clip 1200 also has opposing
`grip holders 1332, 1432 that removably retain the finger
`grips 620 (FIGS. 6A-B). The finger grips 620 (FIGS. 6A-B)
`are squeezed so as to move the jaws 1300, 1400 to an open
`position in which the pads 500 (FIGS. 5A-B) are separated
`for positioning the ear sensor 300 (FIG. 3) on a tissue site
`or for removal of the ear sensor 300 (FIG. 3) from a tissue
`site. End slots 1382, 1482 removably retain the pad bend
`reliefs 610 (FIGS. 6A-B). A jaw stop 1390 advantageously
`prevents the jaws 1300, 1400 from closing to the extent that
`the pad faces 634 (FIGS. 6A-B) touch. In this manner,
`adhesive tabs 1710 (FIG. 17C) can be applied to the pad
`faces 634 (FIGS. 6A-B) to assist in holding the ear sensor
`
`300 (FIG. 3) to an ear tissue site, without having the
`adhesive tabs 1710 (FIG. 17C) adhere to each other.
`[0050] FIGS. 13A-D illustrate a clip outer jaw 1300 hav-
`ing a back end 1301, a front end 1303, a top side 1306 and
`a bottom side 1308. The outer jaw 1300 has a pair of hinge
`supports 1310, a head holder 1320 proximate the front end
`1303, a grip holder 1330 extending from the back end 1301,
`a middle 1350 between and adjoining both the head holder
`1320 and grip holder 1330, a bend relief holder 1380 at the
`back end 1301 and adjoining the grip holder 1330, and a jaw
`stop 1390. The hinge supports 1310 each extend from the
`bottom side 1308 at the grip holder 1330, generally perpen-
`dicular to the plane of the head holder 1320 and generally
`