Shade element for a sensor

Abstract

A sensor includes a sensor body with a light emitter, a light detector to detect light emitted by the light detector, and a patient adhesive to couple the sensor body to skin of a patient. The sensor also includes a shade element that extends laterally relative to the sensor body to block ambient light from the light detector.

Description

SHADE ELEMENT FOR A SENSORCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 675,803, filed July 26, 2024, the entire content of which is incorporated herein by reference.TECHNICAL FIELD

[0001] The present disclosure generally relates to medical monitoring devices (e.g., sensors), and more particularly to a shade element for a sensor.BACKGROUND

[0002] Various medical monitoring devices may be used to monitor physiological characteristics of an individual. For example, various sensors may measure temperature, pressure, oxygen, and other physiological characteristics of the individual. One such sensor, a pulse oximetry sensor, may utilize wavelengths of light to measure oxygen saturation levels in arterial blood of the individual. Another such sensor, a regional oximetry sensor, may utilize wavelengths of light to measure oxygen saturation levels in tissue of the individual.

[0003] In certain cases, the pulse oximetry sensor and / or the regional oximetry sensor may include an adhesive to enable application or adherence (e.g., attachment) to skin of the individual. After the application to the skin, the pulse oximetry sensor may emit the wavelengths of light through the skin to measure the oxygen saturation levels in the arterial blood of the individual. Similarly, after the application to the skin, the regional oximetry sensor may emit the wavelengths of light through the skin to measure the oxygen saturation levels in the tissue of the individual.

[0004] This section is intended to introduce the reader to various aspects of art that may be related to various aspects of the present disclosure, which are described and / or claimed below. This discussion is believed to be helpful in providing the reader with background information to facilitate a better understanding of the various aspects of the present disclosure. Accordingly, it may be understood that these statements are to be read in this light, and not as admissions of prior art.SUMMARY

[0005] Certain embodiments commensurate in scope with the originally claimed subject matter are summarized below. These embodiments are not intended to limit the scope of the disclosure. Indeed, the present disclosure may encompass a variety of forms that may be similar to or different from the embodiments set forth below.

[0006] In certain embodiments, a sensor includes a sensor body with a light emitter, a light detector to detect light emitted by the light detector, and a patient adhesive to couple the sensor body to skin of a patient. The sensor also includes a shade element that extends laterally relative to the sensor body to block ambient light from the light detector.

[0007] In certain embodiments, a sensor includes a flexible circuit that supports a light emitter and a light detector. The sensor also includes a first layer having one side with a body adhesive to adhere to the flexible circuit and another side with a patient adhesive to adhere the sensor to skin of the patient. The sensor further includes a shade element that extends about a periphery of the first layer to block ambient light from the light detector.

[0008] Various refinements of the features noted above may exist in relation to various aspects of the present disclosure. Further features may also be incorporated in these various aspects as well. These refinements and additional features may exist individually or in any combination. For instance, various features discussed below in relation to one or more of the illustrated embodiments may be incorporated into any of the above-described aspects of the present disclosure alone or in any combination. The brief summary presented above is intended only to familiarize the reader with certain aspects and context of embodiments of the present disclosure without limitation to the claimed subject matter.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Advantages of the disclosed techniques may become apparent upon reading the following detailed description and upon reference to the drawings in which:

[0010] FIG. 1 is a perspective view of an embodiment of a medical monitoring system configured to monitor oxygen saturation, in accordance with an aspect of the present disclosure;

[0011] FIG. 2 is a block diagram of the medical monitoring system of FIG. 1, in accordance with an aspect of the present disclosure;

[0012] FIG. 3 is a perspective exploded view of an embodiment of a sensor with a shade element, which may be employed in the medical monitoring system of FIG. 1, in accordance with an aspect of the present disclosure;

[0013] FIG. 4 is a top view of an embodiment of the sensor prior to assembly of the shade element of FIG. 3, in accordance with an aspect of the present disclosure;

[0014] FIG. 5 is atop view of the sensor after assembly of the shade element of FIG. 3, in accordance with an aspect of the present disclosure;

[0015] FIG. 6 is a top view of a sensor with a shade element having different dimensions than the shade element of FIG. 3, in accordance with an aspect of the present disclosure;

[0016] FIG. 7 is a top view of a sensor with a shade element having a different shape than the shade element of FIG. 3, in accordance with an aspect of the present disclosure;

[0017] FIG. 8 is a top view of a sensor with a shade element extending along a portion of the sensor, in accordance with an aspect of the present disclosure;

[0018] FIG. 9 is a top view of a sensor with a shade element that includes one or more slits, in accordance with an aspect of the present disclosure; and

[0019] FIG. 10 is a perspective view of an embodiment of a sensor with a shade element, which may be employed in the medical monitoring system of FIG. 1, wherein a patient adhesive is applied to a portion of the shade element, in accordance with an aspect of the present disclosure.DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS

[0020] One or more specific embodiments will be described below. In an effort to provide a concise description of these embodiments, not all features of an actual implementation are described in the specification. It should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous implementation-specific decisions must be made to achieve the developers’ specific goals, such as compliance with system-related and business-related constraints, which may vary from one implementation to another. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure.

[0021] When introducing elements of various embodiments of the present disclosure, the articles “a,” “an,” and “the” are intended to mean that there are one or more of the elements. The terms “comprising,” “including,” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements. Additionally, it should be understood that references to “one embodiment” or “an embodiment” of the present disclosure are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features.

[0022] Various sensors may measure various physiological characteristics of the individual. For example, a pulse oximetry sensor may use wavelengths of light to measure oxygen saturation levels in arterial blood of an individual and a regional oximetry sensor may use wavelengths of light to measure oxygen saturation in tissue of the individual. The pulse oximetry sensor may include a light emitter that emits light at two wavelengths (e.g., red and infrared (IR)) into tissue of the individual and a light detector that detects the light after the light passes through the tissue of the individual. The regional oximetry sensor may include a light emitter that emits light at two or more wavelengths (e.g., red and infrared (IR)) into tissue of the individual and two light detectors that detect the light after the light passes through the tissue of the individual.

[0023] It is presently recognized that, in addition to detecting the light (e.g., emitted by the light emitter and after the light passes through tissue of the individual), the light detector(s) may also detect ambient light (e.g., environmental light; other than the light emitted by the light emitter). Further, in some clinical settings, various items (e.g., clothing, towels, blankets) having various colors (e.g., blue, yellow) may be positioned over the patient and may cover the pulse oximetry sensor and / or the regional oximetry sensor. The ambient light and / or use of the various items that may cover the pulse oximetry sensor may cause error in measurements by the pulse oximetry sensor (e.g., the ambient light may be detected by the light detector; the various items may affect the light emitted by the light emitter and detected at the light detector). Similarly, the ambient light and / or use of the various items that may cover the regional oximetry sensor may cause error in measurements by the regional oximetry sensor (e.g., the ambient light may be detected by the light detectors; the various items may affect the light emitted by the light emitter and detected at the light detectors). In certain cases, the pulse oximetry sensor and / or the regional oximetry sensor may include an adhesive to enable application oradherence (e.g., attachment) to skin of the individual. It is presently recognized that it may be desirable to block interference due to ambient light and / or use of the various items that may cover the pulse oximetry sensor and / or the regional oximetry sensor, as well as to limit a surface area of the adhesive, such as to reduce skin irritation, facilitate removal, and so forth.

[0024] With the foregoing in mind, the present disclosure generally relates to a shade element for a sensor. The shade element may include a layer of material, such as a plastic material (e.g., polyethylene plastic). The shade element may have a black color, be opaque, be flexible, and / or a thickness between approximately 0.01 and 0.03 millimeters (mm), for example. Advantageously, the shade element may block ambient light from reaching the light detector, and further may block effects of various items (e.g., clothing, towels, blankets) that may be positioned over the sensor, thereby facilitating accuracy in measurements by the sensor. Also, at least a portion of the shade element may not adhere to skin of the individual, thereby facilitating the accuracy in measurements by the sensor without increasing a surface area of an adhesive on the skin of the individual (e.g., as compared to the sensor without the shade element). While certain embodiments and examples herein relate to a pulse oximetry sensor to facilitate discussion, it should be appreciated that the shade element may be utilized with any type of sensor, such as a regional oximetry sensor or any type of sensor (e.g., optical sensor) with at least one light emitter and / or at least one light detector.

[0025] With the foregoing in mind, FIG. 1 is a perspective view of an embodiment of a medical monitoring system 10 that includes a patient monitor 12 (referred to herein as “the monitor 12”) that may be used in conjunction with a medical sensor 14 (referred to herein as “the sensor 14”). In the illustrated example, the monitor 12 is a pulse oximetry monitor and the sensor 14 is a pulse oximetry sensor. In such cases, the monitor 12 may be configured to process photoplethysmography (PPG) signals (e.g., pulse oximetry signals) to calculate oxygen saturation (SpO2). It should be appreciated that the medical monitoring system 10 may be configured to obtain any of a variety of medical measurements and the techniques described herein may be adapted for use with any variety of monitors and sensors. By way of non-limiting example, in some embodiments, the monitor 12 may include a regional oximeter and the sensor 14 may include a regional oximetry sensor. In such cases, the monitor 12 may be configured to process near-infraredspectroscopy (NIRS) signals (e.g., regional oximetry signals) to calculate regional oxygen saturation (rSCh), and the sensor 14 may include two detectors. Additionally, it should be understood that the sensor 14 may be adapted for use at any of a variety of tissue locations, such as a foot, forehead, temple, earlobe, toe, heel, ankle, stomach, chest, back, neck, write, thigh, finger, or any other suitable measurement site (e.g., with pulsatile arterial flow). In certain embodiments, the medical monitoring system 10 may include multiple sensors 14 at multiple locations.

[0026] The sensor 14 includes a sensor body 16 that includes multiple layers, such as a flexible circuit between a first layer (e.g., light blocking layer; metallized tape; plastic tape) and a second layer (e.g., light blocking layer; metallized tape; plastic tape). The sensor body 16 may include or be coupled to a patient adhesive (e.g., first adhesive) that is utilized to couple (e.g., adhere) the sensor 14 to skin of a patient. As shown, the sensor 14 includes optical components in the form of one or more emitters 18 (collectively referred to herein as “the emitter 18” for convenience) and one or more detectors 20 (collectively referred to herein as “the detector 20” for convenience). The sensor 14 also includes or is coupled to a shade element 22 (e.g., umbrella, skirt) that extends outwardly from and / or surrounds the sensor body 16. The shade element 22 may be coupled to the sensor body 16, such as via a shade adhesive (e.g., second adhesive). However, at least a portion of a patient-facing side of the shade element 22 does not include any adhesive that contacts the skin of the patient (e.g., at least a portion of the patient-facing side of the shade element 22 does not directly adhere to the skin of the patient, although at least the portion of the patient-facing side of the shade element 22 may contact the skin of the patient when the sensor 14 is applied to the patient). The sensor 14 may be reusable, disposable, partially usable, or partially disposable.

[0027] The sensor 14 is communicatively coupled to the monitor 12. In the illustrated embodiment, the sensor 14 is coupled to the monitor 12 via a cable 24. The cable 24 may interface directly with the sensor 14 and may include multiple conductors (e.g., wires) to transmit signals and / or receive signals. Additionally or alternatively, the sensor 14 may communicate with the monitor 12 wirelessly (e.g., the sensor 14 and the monitor 12 include wireless transceivers configured to communicate via any suitable wireless protocol). For example, the sensor 14 may include a transceiver that enables wireless signals to be transmitted to and / or received from an external device (e.g., the monitor 12).

[0028] In operation, the monitor 12 may receive a signal from the sensor 14, and the monitor 12 may be configured to calculate or measure one or more physiological parameters based on the signal. In particular, the monitor 12 may include a processor configured to execute code (e.g., stored in a memory of the monitor 12 or received from another device) for filtering and processing the signal from the sensor 14 to calculate one or more physiological parameters, such as oxygen saturation. The monitor 12 may additionally or alternatively calculate any variety of physiological parameters, such as arterial blood oxygen saturation, regional or tissue oxygen saturation, pulse rate, respiration rate, blood pressure, blood pressure characteristic measure, autoregulation status, brain activity, or any other suitable physiological parameter.

[0029] Additionally, as illustrated in FIG. 1, the monitor 12 includes a display 26 configured to display one or more calculated physiological parameters, such as oxygen saturation. The display 26 may also display other information, such as instructions to charge the sensor 14, alarm indications, settings, and so forth. In certain embodiments, the display 26 may be a touch screen display. The monitor 12 may include various input components, such as the touch screen display, knobs, switches, keys and keypads, buttons, and so forth, to provide for operation and configuration of the monitor 12. The monitor 12 may also include one or more indicator lights and one or more speakers. The monitor 12 may also include additional slot(s) or wireless interfaces (e.g., channels) to connect to additional devices, such as additional sensors to monitor additional physiological parameters of the patient and / or to monitor physiological parameters of other patients at one time.

[0030] Furthermore, one or more functions of the monitor 12 disclosed herein may also be implemented directly in the sensor 14, or by any other suitable device. For example, in some embodiments, the sensor 14 may include one or more processing components configured to calculate physiological parameters, such as oxygen saturation. The sensor 14 may have varying levels of processing power, and may output data in various stages to the monitor 12. For example, in some embodiments, the data output to the monitor 12 may be analog signals, such as detected light signals (e.g., pulse oximetry signals or regional saturation signals), or processed signals (e.g., filtered pulse oximetry signals or filtered regional saturation signals; oxygen saturation values or regional oxygen saturation values).

[0031] Further, in some embodiments, the sensor 14 may include a battery to provide power to components of the sensor 14. For example, the sensor 14 may be configured to operate in a wireless mode and, at times, may not receive power from the monitor 12 while operating in the wireless mode. In some embodiments, the battery may be a rechargeable battery such as, for example, a lithium ion, a lithium polymer, a nickel-metal hydride, a nickel-cadmium battery, or any other suitable rechargeable battery. In other embodiments, any suitable power source may be utilized, such as, one or more capacitors or an energy harvesting power supply (e.g., a motion generated energy harvesting device, thermoelectric generated energy harvesting device, or any other suitable energy harvesting power supply).

[0032] Turning to FIG. 2, a simplified block diagram of the medical monitoring system 10 is illustrated in accordance with an embodiment. The emitter 18 includes two light emitting diodes (LEDs) that are configured to emit at least two wavelengths of light, e.g., a red LED 28 configured to emit wavelengths of light within the red spectrum and an infrared (IR) LED 30 configured to emit wavelengths of light within the infrared or near infrared spectrum. In one embodiment, the LEDs 28, 30 emit light in a range of about 600 nanometers (nm) to about 1000 nm. In one embodiment, the red LED 28 is configured to emit light between approximately 600 nm and 735 nm, and the IR LED 30 is configured to emit light between approximately 800 nm and 1000 nm. It should be noted that the emitter 18 may also transmit 3, 4, or 5 or more wavelengths of light in any suitable application.

[0033] As discussed in more detail herein, a light drive circuitry 32 of the monitor 12 may provide respective drive currents to the LEDs 28, 30 to cause the LEDs 28, 30 to emit respective wavelengths of light. It should be understood that, as used herein, the term "light" may refer to one or more of ultrasound, radio, microwave, millimeter wave, infrared, visible, ultraviolet, gamma ray or X-ray electromagnetic radiation, and may also include any wavelength within the radio, microwave, infrared, visible, ultraviolet, or X-ray spectra, and that any suitable wavelength of light may be appropriate for use with the present disclosure.

[0034] The emitter 18 emits light that passes through blood perfused tissue, and the detector 20 detects the light as reflected or transmitted by the tissue. The emitter 18 and the detector 20 may be arranged in a transmission configuration or a reflectanceconfiguration with respect to one another. In the transmission configuration, the light enters the detector 20 after passing through the tissue of the patient. In the reflectance configuration, the light is reflected by elements in the tissue of the patient to enter the detector 20. In any case, the detector 20 may generate a signal (e.g., PPG signal) indicative of an intensity of the light received at the detector 20, and the detector 20 may send the signal to the monitor 12.

[0035] In context of pulse oximetry, a signal representing light intensity versus time or a mathematical manipulation of this signal (e.g., a scaled version thereof, a log taken thereof, a scaled version of a log taken thereof) may be referred to as the PPG signal. Additionally, the term “PPG signal,” as used herein, may also refer to an absorption signal (e.g., representing an amount of light absorbed by the tissue) or any suitable mathematical manipulation thereof. The amount of light detected or absorbed may then be used to calculate any of a number of physiological parameters, including oxygen saturation (e.g., the saturation of oxygen in pulsatile blood, SpO2), an amount of a blood constituent (e.g., oxyhemoglobin), and / or a physiological rate (e.g., pulse rate or respiration rate; when each individual pulse or breath occurs). For SpO2, red and infrared (IR) wavelengths may be used because it has been observed that highly oxygenated blood will absorb relatively less Red light and more IR light than blood with a lower oxygen saturation. By comparing the intensities of two wavelengths at different points in the pulse cycle, it is possible to estimate the blood oxygen saturation of hemoglobin in arterial blood, such as from empirical data that may be indexed by values of a ratio, a lookup table, from curve fitting, or other interpolative techniques.

[0036] In context of regional oximetry, the detector 20 may include two detectors, such as a first detector (e.g., near detector; shallow detector) positioned closer to the emitter 18 and a second detector (e.g., far detector; deep detector) positioned further from the emitter 18 relative to the near detector (e.g., along a longitudinal axis of the sensor 14; the emitter 18 and the two detectors are stacked in a line along the longitudinal axis of the sensor 14). Optical density values are measured at the first detector and the second detector for each wavelength of light emitted by the emitter 18 (e.g., two, three, or four wavelengths of light emitter by the emitter 18 at different times or in sequence; one wavelength at a time). For example, in certain embodiments, the emitter 18 may emit two or four different wavelengths of light, such as two or four wavelengths of light selected from I-A=690nm, Xl=730 nm, X2=770 nm and X2+A=810 nm. With four different wavelengths of light, the wavelengths may be chosen to have a constant gap (A) between them, which, in this exemplary embodiment is 40 nm. Other possible wavelengths may be selected. For each wavelength introduced into the body of the patient, the optical density values of the reflected light are detected and measured by both the first detector and the second detector of the sensor 14. The detected optical densities are conveyed as electrical signals to the monitor 12, where they are processed by an algorithm (e.g., stored in the memory 42) executed by the processor 40 to generate useful physiological information related to rSCh (e.g., tissue blood oxygen saturation; cerebral tissue blood oxygen saturation).

[0037] As shown, the sensor 14 also includes an encoder 34. The encoder 34 may store information about the sensor 14, such as a type of sensor, calibration information, and so forth. In certain embodiments, the information about the sensor 14 may relate to and / or indicate a presence or an absence of the shade element 22 of FIG. 1. When accessed by the monitor 12, the information about the sensor 14 may enable the monitor 12 to calculate oxygen saturation and / or other physiological parameters using the signal generated by the detector 20. For example, the information about the sensor 14 may relate to and / or indicate the presence of the shade element 22 of FIG. 1 (e.g., the sensor 14 is a type of sensor that includes the shade element 22 of FIG. 1; first coefficients), and the monitor 12 may use the information to select and / or utilize an appropriate algorithm (e.g., first algorithm and / or with the first coefficients) to calculate the oxygen saturation and / or one or more other physiological parameters using the signal generated by the detector 20. However, the information about the sensor 14 may relate to and / or indicate absence of the shade element 22 of FIG. 1 (e.g., the sensor 14 is another type of sensor that is devoid of the shade element 22 of FIG. 1 ; second coefficients different from the first coefficients), and the monitor 12 may use the information to select and / or utilize an appropriate algorithm (e.g., second algorithm different from the first algorithm, and / or with the second coefficients) to calculate the oxygen saturation and / or other physiological parameters using the signal generated by the detector 20.

[0038] As shown, the monitor 12 includes one or more processors 40, a memory 42, and the display 26. The processor 40 may process the signal generated by the detector 20 and received from the sensor 14, such as by performing synchronized demodulation,amplification, and filtering of the signal. The processor 40 may process the signal to calculate one or more physiological parameters, such as the oxygen saturation, using various algorithms. Coefficients utilized in the algorithms may be accessed by the processor 40 from the encoder 34 or determined by the processor 40 based on the information about the sensor 14 from the encoder 34, for example. Further, the display 26 may present visual notifications based on the information about the sensor 14 from the encoder 34, such as visual notifications of the type of sensor 14, the presence or the absence of the shade element 22, and / or other aspects.

[0039] As shown, the monitor 12 includes a time processing unit (TPU) 44, which may be controlled by the processor 40 and is configured to provide timing control signals to the light drive circuitry 32 and optionally to other parts of the medical monitoring system 10. The light drive circuitry 32 may control when the red LED 28 and the IR LED 30 are illuminated and / or a drive current provided to the red LED 28 and the IR LED 30. It should be appreciated that one or more functions or components of the monitor 12 disclosed herein may also be implemented directly in the sensor 14, or by any other suitable device. As described herein, the sensor 14 includes various structural features, such as the shade element 22 of FIG. 1.

[0040] FIG. 3 is a perspective exploded view of an embodiment of the sensor 14, which may be employed in the medical monitoring system 10 of FIG. 1, in accordance with an aspect of the present disclosure. To facilitate discussion, the sensor 14 is described with reference to a longitudinal axis or direction 50, a lateral axis or direction 52, and / or a vertical axis or direction 54. Further, the sensor 14 is described with reference to a first side 56 (e.g., bottom side; patient-facing side) and a second side 58 (e.g., top side; opposite the first side 56, such as opposite the first side 56 along the vertical axis 54 at least when in a flat configuration, such as prior to application to a patient and / or when applied to certain locations on the patient).

[0041] The sensor 14 includes the sensor body 16, which in FIG. 4 includes a first layer 60 (e.g., a bottom layer), a second layer 62 (e.g., atop layer), and a flexible circuit 64 positioned between the first layer 60 and the second layer 62. The emitter 18 and the detector 20 of FIGS. 1 and 2 are supported on the flexible circuit 64. Thus, the emitter 18 emits light through a corresponding emitter opening 63 formed in the first layer 60, and the detector 20 detects the light through a corresponding detector opening 65 formed in thefirst layer 60. It should be appreciated that, when the sensor 14 is a regional oximetry sensor with two detectors 20, each of the two detectors 20 detects light through a respective corresponding detector opening 65 formed in the first layer 60. The flexible circuit 64 may be coupled to the first layer 60 and the second layer 62 via any suitable adhesive (e.g., body adhesive) between these layers. Further, the first layer 60 includes or is coated in a patient adhesive 66 (e.g., first adhesive; patient-contacting adhesive) on the first side 56 of the first layer 60 and that is utilized to couple (e.g., adhere) the sensor 14 to skin of the patient. In FIG. 3, the flexible circuit 64, the first layer 60, the second layer 62, the body adhesive, and / or the patient adhesive 66 may be considered to form the sensor body 16.

[0042] As shown in FIG. 3, the shade element 22 may be coupled to the sensor body 16, such as via a shade adhesive 68 (e.g., second adhesive; does not contact the patient). In certain embodiments, the shade adhesive 68 adheres to the first layer 60 (e.g., on the second side 58 of the first layer 60) and also to the shade element 22 to couple the shade element 22 to the first layer 60 of the sensor body 16. For example, in FIG. 3, the first layer 60 extends outwardly from the flexible circuit 64 and the second layer 62 (e.g., along the longitudinal axis 50 and / or the lateral axis 52) to provide a surface 80 (e.g., vertically- facing surface; exposed surface) about at least a portion of the flexible circuit 64 and the second layer 62. The shade adhesive 68 includes a respective shape (e.g., annular shape) and a respective size that enables placement of the shade adhesive 68 onto the surface 80 of the first layer 60 and about at least a portion of the flexible circuit 64 and the second layer 62. Further, in FIG. 3, the shade element 22 includes an opening 70 with a respective shape and a respective size that enables placement of the shade element 22 onto the surface 80 of the first layer 60 and about at least a portion of the flexible circuit 64 and the second layer 62 (e.g., with the shade adhesive 68 between the shade element 22 and the surface 80 of the first layer 60; the shade adhesive 68 may be applied to the surface 80, and then the shade element 22 may be applied to the shade adhesive 68; or the shade adhesive 68 may be applied to the shade element 22, and then the shade element 22 with the shade adhesive 68 may be applied to the surface 80). In this way, the opening 70 receives the flexible circuit 64 and the second layer 62 when the shade element 22 is coupled to the sensor body 16 via the shade adhesive 68 (e.g., the flexible circuit 64 and / orthe second layer 62 extend through the opening 70 when the shade element 22 is coupled to the sensor body 16 via the shade adhesive 68).

[0043] However, it should be appreciated that the shade adhesive 68 may additionally or alternatively adhere to the second layer 62 (e.g., on the second side 58 of the second layer 62) and also to the shade element 22 to couple the shade element 22 to the second layer 62 of the sensor body 16. In some such cases, the shade element 22 may not include the opening 70, but instead may be a solid sheet of material that extends over and covers the sensor body 16 (e.g., an entirety of the sensor body 16; a portion of the sensor body 16). Indeed, multiple variations and configurations to couple the shade element 22 to the sensor body 16 are envisioned, such as that the shade adhesive 68 may additionally or alternatively adhere to the flexible circuit 64 (e.g., on the second side 58 of the flexible circuit 64) and also to the shade element 22 to couple the shade element 22 to the flexible circuit 64 of the sensor body 16. In some such cases, the shade element 22 may not include the opening 70, but instead may be a solid sheet of material that operates as the second layer (e.g., replaces the second layer 62) to extend over and cover the flexible circuit 64 (e.g., an entirety of the flexible circuit 64; a portion of the flexible circuit 64).

[0044] In certain embodiments, the shade element 22 may be incorporated into the sensor 14 at manufacturing, and thus, may be provided as part of the sensor 14. In some such cases, the shade element 22 may be incorporated into the sensor 14 such that the shade element 22 is not intended to be removable from the sensor 14 (e.g., by an operator, such as a clinician and / or the patient; prior to and / or during use in a clinical setting; not removable without damaging the sensor 14; removal causes damage to the sensor 14).

[0045] However, in certain embodiments, the shade element 22 may be designed to be attachable and / or removable (e.g., by the operator prior to and / or during use in the clinical setting; removable without damaging the sensor 14; removal does not cause damage to the sensor 14). For example, the sensor 14 may be operable with the sensor body 16 coupled to the patient. In certain cases, the operator may access the shade element 22 and the shade adhesive 68 (e.g., in separate packaging; as an optional component in a kit), and the operator may apply (e.g., adhere; attach) the shade element 22 with the shade adhesive 68 to the sensor body 16 (e.g., align and apply force to adhere together; according to preference of the operator; in bright light settings). Additionally or alternatively, the shade element 22, the shade adhesive 68, and the sensor body 16 may be formed from materials(e.g., removable adhesive) that enable separation of the shade element 22 from the sensor body 16. In certain embodiments, the shade element 22 may include a perforated edge 72 to facilitate separation of the shade element 22 from the sensor body 166 for removal of the shade element 22 (e.g., according to preference of the operator; in low-light settings).

[0046] The shade element 22 may include a layer of material, such as a plastic material (e.g., polyethylene plastic). The shade element 22 may have certain properties, such as a black color, be opaque, be flexible, and / or have a thickness between approximately 0.01 and 0.03 mm, for example. In certain embodiments, the first layer 60 and / or the second layer 62 may include a plastic material (e.g., polyethylene plastic). The first layer 60 and / or the second layer 62 may include a same material or different material as the shade element 22, and / or may include same properties or different properties as the shade element 22.

[0047] The patient adhesive 66, the shade adhesive 68, and the body adhesive may include any of a variety of adhesive materials. For example, the patient adhesive 66 may include a silicone -based adhesive, such as a silicone gel or a silicone pressure sensitive adhesive. The patient adhesive 66 facilitates adherence to the patient (e.g., to skin of the patient) where the patient adhesive 66 is in contact with the patient. The patient adhesive 66 may minimize disruption of the skin (e.g., by removing only minimal skin protein) during removal. Further, the silicone of the patient adhesive 66 may provide comfort to the patient. The patient adhesive 66 and the shade adhesive 68 may be different from one another (e.g., different types of adhesives, such as with different chemical formulations and / or different material properties). For example, the patient adhesive 66 may include the silicone -based adhesive, while the shade adhesive 68 may not include any silicone- based adhesive.

[0048] FIG. 4 is a top view of an embodiment of the sensor 14 prior to assembly of the shade element 22, in accordance with an aspect of the present disclosure. FIG. 5 is a top view of the sensor 14 after assembly of the shade element 22, in accordance with an aspect of the present disclosure. As shown in FIG. 4, the sensor 14 includes the sensor body 16 with the first layer 60 and the second layer 62 (with the flexible circuit 64 of FIG. 3 therebetween). The sensor body 16 also includes the emitter 18 and the detector 20, which emit and detect light, respectively. The emitter 18 emits the light through the corresponding emitter opening 63 formed in the first layer 60, and the detector 20 detectsthe light through the corresponding detector opening 65 formed in the first layer 60. As noted herein, it should be appreciated that, when the sensor 14 is a regional oximetry sensor with two detectors 20, each of the two detectors 20 detects the light through a respective corresponding detector opening 65 formed in the first layer 60. For example, to facilitate understanding of the regional oximetry sensor with two detectors 20 discussed herein, FIG. 4 includes one example of an additional detector 20’ and an additional corresponding opening 65’.

[0049] The first layer 60 surrounds (e.g., at least partially surrounds) and extends outwardly from (e.g., along the longitudinal axis 50 and / or the lateral axis 52) the second layer 62 (and the flexible circuit 64 of FIG. 3). In this way, at least a portion of the second side 58 of the first layer 60 may be exposed to provide the surface 80, as shown in FIG. 4, to couple to the shade element 22, as shown in FIG. 5. For example, as shown in FIG. 4, the surface 80 may be provided on opposite lateral sides of the sensor body 16, as well as at a distal end 82 (e.g., distal end portion furthest from the cable 24 of FIG. 1) of the sensor body 16. Thus, the shade adhesive 68 of FIG. 3 may adhere to the surface 80 as well as to the shade element 22 to thereby couple the sensor body 16 to the shade element 22, as shown in FIG. 5.

[0050] In FIGS. 3-5, the shade adhesive 68 includes a portion that overlays or adheres to the second layer 62 at a proximal end 84 (e.g., proximal end portion closest to the cable 24 of FIG. 1) of the sensor body 16, and thus, the shade element 22 covers the second layer 62 at the proximal end 84 of the sensor body 16. However, as noted herein, various configurations are envisioned and the shade element 22 may not cover the second layer 62 at the proximal end 84 of the sensor body 16 and / or may not cover any portion of the second layer 62 (e.g., the shade adhesive 68 of FIG. 3 and / or the shade element 22 may be open at the proximal end 84 of the sensor body 16).

[0051] With reference to FIG. 5, the shade element 22 surrounds (e.g., at least partially surrounds) and extends outwardly from (e.g., along the longitudinal axis 50 and / or the lateral axis 52) the sensor body 16. In this way, the shade element 22 blocks ambient light from reaching the detector 20, for example. Further, should the operator place various items over the sensor 14, the shade element 22 also blocks interference or errors due to effects on light absorption and transmission due to the various items. The shade element 22 may have any suitable size and / or shape to provide these advantages, as well as toaccount for patient comfort (e.g., fit comfortably on a target patient and / or a target location of the patient). For example, the shade element 22 may be sized based on an estimated (e.g., average or median) size of the target patient, such as adult or child, and / or based on features of the target location on the patient, such as a forehead or a foot. Indeed, a first sensor 14 designed for use on a forehead of an adult patient may include a respective shade element 22 with a first size and / or a first shape that is sufficient to block the ambient light, while also providing a comfortable fit. However, a second sensor 14 designed for use on a foot of a pediatric patient may include a respective shade element 22 with a second size and / or a second shape that is sufficient to block the ambient light, while also providing a comfortable fit. Further, a third sensor 14 designed for use on a foot of a pediatric patient may include a respective shade element 22 with a third size and / or a third shape that is sufficient to block the ambient light, while also providing a comfortable fit according to preference of the operator, for example.

[0052] In this way, various combinations of sensor bodies 16 (e.g., of same sizes and shapes) and shade elements 22 (e.g., of different sizes and / or shapes) may be manufactured and made available (e.g., provided as a kit and / or a set; the operator may select a particular sensor with a particular shade element from the kit and / or the set). Further, as described herein, the shade element 22 may be attached and / or removable from the sensor body 16 by the operator. Thus, it should also be appreciated that various shade elements 22 (e.g., of different sizes and / or shapes) may be manufactured and made available for selection and attachment in the clinical setting (e.g., according to preference of the operator; to the sensor bodies 16 of same sizes and shapes; to the sensor bodies of different sizes and shapes; the operator may mix and match the various shade elements 22 and the sensor bodies 16).

[0053] In FIG. 5, the shade element 22 has a rectangular shape with a width 90 (e.g., maximum width) and a length 92 (e.g., maximum length). The width 90 and / or the length 92 may have any suitable dimension that is sufficient to block the ambient light, as well as to provide a comfortable fit. For example, the width 90 may be greater than a respective width of the sensor body 16, such as approximately 1 to 5 times or 2 to 4 times the respective width of the sensor body 16 and / or approximately 10 to 50 mm or 20 to 40 mm. In certain embodiments, the width 90 causes the shade element 22 to extend about 5 to 20, 5 to 15, or 8 to 12 mm from each opposite lateral side of the sensor body 16. Additionallyor alternatively, the length 92 may be greater than a respective length of the sensor body 16, the length 92 may be greater than a distance between the emitter 18 and the detector 20 along the longitudinal axis 50, and / or the length 92 may be approximately 40 to 100 mm or 50 to 80 mm. Additionally or alternatively, the shade element 22 may extend about (e.g., circumferentially surround) at least a portion of a periphery of the sensor body 16, such as at least 50 percent, 75 percent, 90 percent, or an entirety of the periphery of the sensor body 16. Further, as noted herein, the shade element 22 (e.g., without the opening 70) may cover at least a portion of the sensor body 16, such as at least 50 percent, 75 percent, 90 percent, or an entirety of the sensor body 16.

[0054] In FIG. 5, the shade element 22 has the rectangular shape, the width 90 is uniform across the shade element 22, and the length 92 is uniform across the shade element 22. However, it should be appreciated that the shade element 22 may have any of a variety of shapes (e.g., edges, outlines, periphery, in the top view), including ornamental shapes (e.g., a geometric shape, an animal shape, a symbol shape), with varied width 90 and / or varied length across the shade element 22, and / or with curved and / or linear edges. Indeed, because the shade element 22 does not adhere to the skin of the patient, the shade element 22 size and / or shape may be selected to block the ambient light, for comfort of the patient, as well as for other reasons (e.g., to convey information, such as via a recognizable shape that indicates sensor type and / or manufacturer; to guide application to the skin of the patient via asymmetrical shape features; for ornamental or aesthetic purposes; and so forth) without considering whether such size and / or shape would impact adhesive contact area to the skin of the patient (e.g., whether such size and / or shape would result in unnecessarily larger adhesive contact area to the skin of the patient). In FIGS. 3-5, the shade element 22 does not adhere to the skin of the patient (e.g., does not directly adhere to the skin of the patient), as the shade element 22 is only indirectly adhered to the patient via adherence to the shade adhesive 68, which contacts and adheres to the sensor body 16, which contacts and adheres to the skin of the patient. Thus, the shade element 22 may contact the skin of the patient and may move (e.g., lift, slide, bend) relative to the skin of the patient, even while the sensor body 16 is adhered to the patient and does not move relative to the skin of the patient. For example, the operator could lift a portion of the shade element 22 to visually observe the skin of the patient under the shade element 22 and / or to visually observe an interface between the sensor body 16 and the skin of thepatient, without disturbing adherence of the sensor 14 to the skin of the patient. It should also be appreciated that the shade element 22 does not adhere to itself (e.g., does not adhere via adhesive or any other fastener, such as a hook and loop fastener) and / or is not designed to wrap around a portion of the patient to adhere to itself (e.g., to hold the sensor 14 onto the patient). Indeed, other than the shade adhesive 68 that may be applied along the first side 56 of the shade element 22 between the shade element 22 and the first layer 60, a remainder of the first side of the shade element 22 and an entirety of the second side 58 of the shade element 22 may be devoid of adhesive or any other fastener.

[0055] FIG. 6 is a top view of an embodiment of the sensor 14 with the shade element 22, wherein a respective width 90 (e.g., second width) of the shade element 22 is greater than a respective width 90 (e.g., first width) of the shade element 22 of FIG. 5, in accordance with an aspect of the present disclosure. As noted herein, the width 90 may have any suitable dimension that is sufficient to block the ambient light, as well as to provide comfort to the patient. Thus, even in the case of the sensor body 16 with a same size and shape as in FIGS. 5 and 6, the shade element 22 may include a different size and / or shape as shown in FIGS. 5 and 6. For example, the sensor body 16 with the shade element 22 with the respective width 90 as shown in FIG. 5 and the sensor body 16 with the shade element 22 with the respective width 90 as shown in FIG. 6 may be sold as part of a kit and / or a set. Variable options for the size of the shade element 22 may enable the operator to select a preferred sensor 14 that includes a preferred sensor body 16 with a preferred shade element 22 (e.g., preferred combination), such as based on patient size, patient tolerance, light conditions, space needed for other sensors on the patient, and so forth. It should be appreciated that the shade element 22 may additionally or alternatively vary in the length 92.

[0056] FIG. 7 is a top view of an embodiment of the sensor 14 with the shade element 22, wherein the shade element 22 includes a respective width 90 (e.g., non-uniform width), in accordance with an aspect of the present disclosure. In particular, the shade element 22 includes the respective width 90 that is non-uniform across the shade element 22. In FIG. 7, the respective width 90 of the shade element 22 is greatest proximate to the detector 20 (e.g., greatest at and / or proximate to the detector 20 along the longitudinal axis 50; greater than other locations along the longitudinal axis 50), such as to block the ambient light from reaching the detector 20. Additionally, as shown in FIGS. 3 and 5-7, edges (e.g.,periphery, outer edges) of the shade element 22 may be straight and / or curved, such as to facilitate manufacturing and / or clinical use, for example. It should be appreciated that the shade element 22 may additionally or alternatively include the respective width 90 greatest proximate to the emitter 18 and / or may additionally or alternatively include a respective length 92 that is non-uniform.

[0057] FIG. 8 is a top view of an embodiment of the sensor 14 with the shade element 22, wherein the shade element 22 includes a respective length 92 that extends only along a portion of the respective length of the sensor body 16, in accordance with an aspect of the present disclosure. For example, the shade element 22 may extend along less than 25 percent, 33 percent, 50 percent, 75 percent, or 90 percent of the respective length of the sensor body 16. In FIG. 8, the shade element 22 includes the respective length 92 that is positioned and extends proximate to the detector 20 (e.g., at and / or proximate to the detector 20 along the longitudinal axis 50), such as to block the ambient light from reaching the detector 20. It should be appreciated that the shade element 22 may additionally or alternatively include the respective length 92 that is positioned and extends proximate to the emitter 18.

[0058] FIG. 9 is a top view of an embodiment of the sensor 14 with the shade element 22, wherein the shade element 22 includes one or more slits 100, in accordance with an aspect of the present disclosure. In particular, the shade element 22 includes the one or more slits 100 to facilitate bending of the shade element 22 along the width 90 and / or the length 92 of the shade element 22 to facilitate comfort for the patient, for example. As shown, the one or more slits 100 may extend along the lateral axis 52 and may be spaced apart along the longitudinal axis 50. It should be appreciated that the one or more slits 100 may include any number of slits 100 (e.g., 1, 2, 3, 4, 5, 6, or more) that extend in any direction and / or have any spacing across the shade element 22 to provide flexibility to the shade element 22. FIG. 9 also illustrates the sensor body 16 with a respective example size and / or a respective example shape to emphasize that that sensor body 16 described herein may have any suitable size and any suitable shape, and further, that the shade element 22 may be modified and / or adapted to the sensor body 16 having any suitable size and any suitable shape.

[0059] FIG. 10 is a perspective view of an embodiment of the sensor 14 with the shade element 22, wherein the patient adhesive 66 is applied to a portion of the shade element22, in accordance with an aspect of the present disclosure. As shown, the patient adhesive 66 is applied to the first side 56 of the portion of the shade element 22 that provides (e.g., forms, operates as) the first layer 60 between the flexible circuit 64 and the skin of the patient. In particular, the patient adhesive 66 is only applied to the first side 56 of the portion of the shade element 22 that provides the first layer 60, which may be the portion of the shade element 22 having the size, the shape, and / or the location of the first layer 60 relative to the sensor body 16 as shown in FIGS. 3 and 4. Additionally or alternatively, the portion of the shade element 22 that provides the first layer 60 may include or be an inner portion of the shade element 22 that overlaps with the flexible circuit 64 and / or is positioned between the flexible circuit 64 and the skin of the patient when the sensor 14 is applied to the patient.

[0060] Further, a remainder of the shade element 22 does not have any adhesive and does not adhere to the skin of the patient, and therefore provides (e.g., forms, operates as) the shade element 22 to block ambient light, as described herein. In particular, the remainder of the shade element 22 that does not have an adhesive and does not adhere to the skin of the patient may include or be an outer portion of the shade element 22 that is outside of the inner portion of the shade element 22 and / or that does not overlap with the flexible circuit 64 and / or is not positioned between the flexible circuit 64 and the skin of the patient when the sensor 14 is applied to the patient. Thus, instead of the shade element 22 and the first layer 60 being two separate components (e.g., pieces) that are adhered together via the shade adhesive 68 as shown at least in FIGS. 3-5, the shade element 22 and the first layer 60 are integrated as one component (e.g., one piece) in FIG. 10. Accordingly, the sensor 14 of FIG. 10 may be manufactured and / or assembled via respective processes.

[0061] In FIG. 10, the shade element 22 (e.g., the inner portion; the first layer 60) may include the corresponding emitter opening 63 of FIG. 3 and the corresponding detector opening 65 of FIG. 3 (or, in the case of a regional oximetry sensor with two detectors, two corresponding detector openings 65). Further, in FIG. 10, the shade element 22 may be coupled to the flexible circuit 64 via any suitable adhesive (e.g., body adhesive) on the second side 58 of the shade element 22, and the flexible circuit 64 may be coupled to the second layer 62 via any suitable adhesive (e.g., body adhesive). In FIG. 10, the flexible circuit 64, the first layer 60, the second layer 62, the body adhesive, and / or the patient adhesive 66 may be considered to form the sensor body 16. In some instances, in FIG. 10,the flexible circuit 64, the second layer 62, and the body adhesive therebetween may be considered to form the sensor body 16, and the shade element 22 with the patient adhesive 66 at the inner portion of the shade element 22 (e.g., to provide the first layer 60) may be considered to form a laminated shade element 110 (e.g., laminated layer between the patient adhesive 66 and the body adhesive along the flexible circuit 64).

[0062] While the disclosure may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail herein. However, it should be understood that the embodiments provided herein are not intended to be limited to the particular forms disclosed. Rather, the various embodiments may cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure as defined by the following appended claims. It should be appreciated that any features shown or described herein, such as with reference to FIGS. 1-10, may be combined in any suitable manner. For example, the laminated shade element 110 of FIG. 10 may include perforations similar to the perforations 72 of FIG. 3 and located between the inner portion (e.g., the first layer 60) and the outer portion (e.g., the shade element 22) to facilitate removal of the outer portion from the inner portion in the clinical setting. Further, the laminated shade element 110 of FIG. 10 may have any suitable size and / or any suitable shape, and / or may be utilized with any of a variety of sensors 14 (e.g., as part of a kit or a set). Further, any sensor 14 described herein or shown in FIGS. 1-10 may be a pulse oximetry sensor (e.g., with one detector 20) or a regional oximetry sensor (e.g., with two detectors 20, 20’, as shown in FIG. 4).

[0063] The following examples are illustrative of the techniques described herein.

[0064] Example 1. A sensor, comprising: a sensor body, comprising: a light emitter; a light detector to detect light emitted by the light detector; and a patient adhesive to couple the sensor body to skin of a patient; and a shade element that extends laterally relative to the sensor body to block ambient light from the light detector.

[0065] Example 2. The sensor of Example 1, wherein the shade element comprises an opaque plastic material.

[0066] Example 3. The sensor of Example 2, wherein the shade element comprises a black color.

[0067] Example 4. The sensor of Example 1, comprising a shade adhesive to couple the shade element to the sensor body.

[0068] Example 5. The sensor of Example 1, wherein the shade element does not adhere to the skin of the patient and does not adhere to itself while the sensor is applied to the patient.

[0069] Example 6. The sensor of Example 1, wherein the shade element is movable relative to the skin of the patient while the sensor is adhered to the skin of the patient.

[0070] Example 7. The sensor of Example 1, wherein the shade element comprises at least one of a width that varies across the shade element or a length that varies across the shade element.

[0071] Example 8. The sensor of Example 1, wherein the shade element comprises one or more slits to facilitate bending of the shade element.

[0072] Example 9. The sensor of Example 1, wherein the shade element comprises a perforated edge to facilitate separation of the shade element from the sensor body.

[0073] Example 10. The sensor of Example 1, comprising an additional shade element, wherein the shade element comprises first dimensions, the additional shade element comprises second dimensions, and the shade element is removable from the sensor body to enable the additional shade element to couple to the sensor body.

[0074] Example 11. The sensor of Example 1, wherein the sensor body comprises: a first layer; a second layer; and a flexible circuit with the light emitter and the light detector, wherein at least a portion of the flexible circuit with the light emitter and the light detector is positioned between the first layer and the second layer, and the patient adhesive is applied to the first layer.

[0075] Example 12. A sensor, comprising: a flexible circuit that supports a light emitter and a light detector; a first layer comprising one side with a body adhesive to adhere to the flexible circuit and another side with a patient adhesive to adhere the sensor to skin of a patient; and a shade element that extends about a periphery of the first layer to block ambient light from the light detector.

[0076] Example 13. The sensor of Example 12, comprising a shade adhesive to couple the shade element to a surface of the first layer.

[0077] Example 14. The sensor of Example 13, wherein the first layer extends outwardly from the flexible circuit to expose the surface at the periphery of the first layer.

[0078] Example 15. The sensor of Example 12, wherein the shade element comprises an opaque material and does not adhere to the skin of the patient while the sensor is applied to the patient.

Claims

CLAIMSWhat is claimed is:

1. A sensor (14), comprising: a sensor body (16), comprising: a light emitter (18); a light detector (20) to detect light emitted by the light emitter (18); and a patient adhesive (66) to couple the sensor body (16) to skin of a patient; and a shade element (22) that extends laterally relative to the sensor body (16) to block ambient light from the light detector (20).

2. The sensor (14) of claim 1, wherein the shade element (22) comprises an opaque plastic material.

3. The sensor (14) of any of claims 1 to 2, wherein the shade element (22) comprises a black color.

4. The sensor (14) of any of claims 1 to 3, comprising a shade adhesive (68) to couple the shade element (22) to the sensor body (16).

5. The sensor (14) of any of claims 1 to 4, wherein the shade element (22) does not adhere to the skin of the patient and does not adhere to itself while the sensor (14) is applied to the patient.

6. The sensor (14) of any of claims 1 to 5, wherein the shade element (22) is movable relative to the skin of the patient while the sensor (14) is adhered to the skin of the patient.

7. The sensor (14) of any of claims 1 to 6, wherein the shade element (22) comprises at least one of a width (90) that varies across the shade element (22) or a length (92) that varies across the shade element (22).

8. The sensor (14) of any of claims 1 to 7, wherein the shade element (22) comprises one or more slits (100) to facilitate bending of the shade element (22).

9. The sensor (14) of any of claims 1 to 8, wherein the shade element (22) comprises a perforated edge (72) to facilitate separation of the shade element (22) from the sensor body (16).

10. The sensor (14) of any of claims 1 to 9, comprising an additional shade element (22), wherein the shade element (22) comprises first dimensions, the additional shade element (22) comprises second dimensions, and the shade element (22) is removable from the sensor body (16) to enable the additional shade element (22) to couple to the sensor body (16).

11. The sensor (14) of any of claims 1 to 10, wherein the sensor body (16) comprises: a first layer (60); a second layer (62); and a flexible circuit (64) with the light emitter (18) and the light detector (20), wherein at least a portion of the flexible circuit (64) with the light emitter (18) and the light detector (20) is positioned between the first layer (60) and the second layer (62), and the patient adhesive (66) is applied to the first layer (60).

12. The sensor (14) of claim 11, wherein the shade element (22) extends about a periphery of the first layer (60) to block ambient light from the light detector (20).

13. The sensor (14) of claim 12, comprising a shade adhesive (66) to couple the shade element (22) to a surface (80) of the first layer (60).

14. The sensor (14) of claim 13, wherein the first layer (60) extends outwardly from the flexible circuit (64) to expose the surface (80) at the periphery of the first layer (60).

15. The sensor (14) of any of claims 1 to 14, wherein the sensor (14) comprises an oximetry sensor.

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