# Patent

## Title
Medical sensor and technique for using the same

## Abstract

According to various embodiments, a hat-based or headband sensor assembly may provide an output to indicate when a patient's body temperature changes. The sensor assembly may include sensors and other features to alert healthcare providers when a temperature is outside of a desired range. The sensor assembly may include a medical sensor, such as a pulse oximetry sensor, and a temperature sensor.

## Background
BACKGROUND
The present disclosure relates generally to medical devices and, more particularly, to sensors used for sensing physiological parameters of a patient.
In the field of medicine, doctors often desire to monitor certain physiological characteristics of their patients. Accordingly, a wide variety of devices have been developed for monitoring many such physiological characteristics. Such devices provide doctors and other healthcare personnel with the information they need to provide the best possible healthcare for their patients. As a result, such monitoring devices have become an indispensable part of modern medicine.
One technique for monitoring certain physiological characteristics of a patient is commonly referred to as pulse oximetry, and the devices built based upon pulse oximetry techniques are commonly referred to as pulse oximeters. Pulse oximetry may be used to measure various blood flow characteristics, such as the blood-oxygen saturation of hemoglobin in arterial blood, the volume of individual blood pulsations supplying the tissue, and/or the rate of blood pulsations corresponding to each heartbeat of a patient. In fact, the “pulse” in pulse oximetry refers to the time varying amount of arterial blood in the tissue during each cardiac cycle.
Pulse oximeters typically utilize a non-invasive sensor that transmits light through a patient's tissue and that photoelectrically detects the absorption and/or scattering of the transmitted light in such tissue. One or more of the above physiological characteristics may then be calculated based upon the amount of light absorbed or scattered. More specifically, the light passed through the tissue is typically selected to be of one or more wavelengths that may be absorbed or scattered by the blood in an amount correlative to the amount of the blood constituent present in the blood. The amount of light absorbed and/or scattered may then be used to estimate the amount of blood constituent in the tissue using various algorithms.
Pulse oximetry readings involve placement of a sensor on a patient's tissue, typically via a lightly adhesive sensor, a clip-style sensor, or a sensor that may be fitted into a wearable garment, such as a hat. In certain medical environments, placement of such sensors on the tissue may preclude the placement of other sensors for measuring parameters of interest.



BRIEF DESCRIPTION OF THE DRAWINGS
Advantages of the disclosure may become apparent upon reading the following detailed description and upon reference to the drawings in which:
FIG. 1A illustrates a perspective view of an exemplary hat structure for holding a pulse oximetry sensor on a patient's tissue;
FIG. 1B illustrates a perspective view of an exemplary pulse oximetry sensor body with an integrated temperature sensor that may be incorporated with the hat of FIG. 1A;
FIG. 1C illustrates a perspective view of the hat of FIG. 1A with the pulse oximetry sensor with an integrated temperature sensor of FIG. 1B;
FIG. 2A illustrates a perspective view of an exemplary hat pulse oximetry sensor with a temperature-sensitive film incorporated into the band of the hat;
FIG. 2B is a cross-sectional view of the exemplary hat pulse oximetry sensor of FIG. 2A;
FIG. 3A illustrates an exemplary hat pulse oximetry sensor with an integrated temperature display;
FIG. 3B is a cross-sectional view of the exemplary hat pulse oximetry sensor of FIG. 3A;
FIG. 4 illustrates an exemplary hat pulse oximetry sensor with an array of temperature sensors woven into the fabric of the hat;
FIG. 5 illustrates a perspective view of an exemplary headband-style sensor with a temperature sensor;
FIG. 6 illustrates an exemplary pulse oximetry system coupled to a multi-parameter patient monitor and a sensor; and
FIG. 7 is a block diagram of an exemplary pulse oximetry system.



DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS
One or more specific embodiments of the present disclosure 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.
Sensors for pulse oximetry or other applications utilizing spectrophotometry are provided therein that include temperature sensing capabilities. In an embodiment, a hat-based pulse oximetry sensor assembly for neonatal patients may include a temperature sensor. Such a sensor assembly may provide certain advantages for caregivers. In one embodiment, applying a hat-based sensor that is easy to pull on and off of a baby's head saves time for the caregiver. Because many medical parameters may be monitored in one neonatal patient, combining their sensing capabilities into one sensor assembly eliminates the time involved in applying multiple sensors to the patient. In another embodiment, the parents of an infant in the intensive care unit may prefer having fewer visible sensors on the infant. A hat-based sensor may effectively hide a pulse oximetry sensor as well as a temperature sensor.
In an embodiment, an oximetry sensor with an integral temperature transducer may be adapted for placement in a hat (for example, a neonatal stocking cap), a headband, or other wearable structure (i.e. a glove, a sock, a wristband) to apply the sensor on the body of the user. FIGS. 1A-1C illustrate an assembly drawing of an embodiment of a sensor assembly 10 including a wearable structure, which may be a hat 11, as shown in FIG. 1A. A reflectance-type pulse oximetry sensor 15, as shown in FIG. 1B, is adapted to be placed or adhered to the inside of a hat 11.
The sensor 15 includes a substrate 14 that may be made from any suitable material. In an embodiment, the substrate 14 is a foam or other conformable material. In one embodiment, the substrate 14 is black or dark in color to absorb stray light and minimize any shunting of light between sensor and patient skin. In one embodiment, the substrate 14 may include an adhesive material to secure the sensor directly to the tissue. In one embodiment, the sensor 15 may include an emitter 16 containing emitters for two or more wavelengths of lights and a detector 18 spaced apart from the emitter 16. The sensor 15 also includes a temperature sensor 12 adapted to provide an indication of the tissue temperature.
Also shown in FIG. 1B is a cable 20 for providing drive current to the temperature sensor 12, providing the temperature signal to a downstream medical device, providing drive current to the LED, and providing the detector signal to the medical device. In addition to providing the electrical connection to the downstream medical device, the cable may provide shielding to protect the small signals from the detector against external electrical interference. In addition, the sensor 15 may include suitable structures for providing electrical connections to the cable and/or downstream medical device, such as a flex circuit, a Faraday shield, and leads connecting the optical components and the temperature transducer of the sensor 15 to the electrical components.
The sensor assembly 10 is shown fully assembled in FIG. 1C. As shown, the sensor 15 is positioned on the interior of the hat 11 such that the emitter 16 and detector 18, as well as the temperature sensor 12, may come into contact with the skin when the sensor assembly 10 is applied to a patient. The sensor 15 may be attached (e.g., adhered or sewn into) to the inside band of a hat. In one embodiment, the hat may include indicators to position the sensor 15 on a particular location on the patient's forehead, for example to position the sensor 15 on the lower forehead region, above the eyebrow, with the sensor optics (emitter 16 and detector 18) located above and predominantly lateral to or centered over the iris. The location of the reflectance sensor 15 in the hat allows appropriate placement of the sensor in the desired forehead location by a user not skilled in sensor placement. FIG. 1C shows that the cable 20 is positioned through a hole in the top of the hat 11. In an embodiment, the cable 20 may be adhered or otherwise constrained in the hat 11 so that the cable generally is positioned away from the sensor 15 to avoid interfering with the patient's eyesight or bothering the patient.
In certain embodiments, it is envisioned that temperature data generated from the temperature sensor 12 may be further processed by a downstream monitor to be stored or to generate displays or other information related to the patient's temperature. However, as patients may not be familiar with the medical monitor icons and displays that may be used in conjunction with a sensor assembly 10, in certain embodiments it may be advantageous to provide a sensor assembly 10 with a temperature-sensitive signal that is easily identifiable by a patient. FIG. 2A illustrates a sensor assembly 10 that may be applied to a patient's head. The sensor assembly 10 includes a hat 11 and a medical sensor 34 (e.g., a pulse oximetry sensor) including an emitter 16, a detector 18, and a cable 20. The pulse oximetry sensor 34 is placed on the interior of the hat band 26. The sensor assembly 10 also includes a temperature-sensitive film 24 where the color of the film 24 is an indication of the patient's temperature. The temperature-sensitive film 24 may be viewed by the patient or the caregiver through a viewing window, depicted here as a buttonhole 22 formed in the knit fabric of the hat 11. As shown in FIG. 2B, the temperature-sensitive film 24 may be located on the interior of the hat band 26 at approximately the same latitude as the pulse oximetry sensor 34. In one embodiment, the temperature-sensitive film 24 may be Clinitemp thermometer, available from Liquid. Crystal Resources LLC (Glenview, Ill.), which includes a moving line along a temperature scale that allows a caregiver to view a temperature reading. In one embodiment, the sensor assembly 10 may also include a reference color strip that may be compared to the color of the temperature-sensitive film 24. When the color matches or is brighter than the color in the reference color strip, a patient or caregiver may be alerted to a change in temperature.
In one embodiment, a wearable sensor assembly may include an integral digital display for displaying patient temperature readings. FIG. 3A shows an embodiment of a hat-based sensor assembly 10 for pulse oximetry or other medical monitoring that includes a temperature sensor 12 connected by lead 32 to an integral display 30. The display 30 may be any suitable display, such as an LCD screen. As shown in FIG. 3B, the medical sensor 34 and temperature sensor 12 are located on the inside of the hat band to directly contact the forehead tissue when the hat is put on a patient's head. Such an embodiment may allow healthcare workers to quickly spot changes in patient temperature. For example, a quick glance at a digital display may alert a healthcare worker to check the patient's status or take steps to address the patient's temperature.
FIG. 4 shows a hat-based sensor assembly 10 that includes an array of temperature sensors 38 that may located on or in the fabric of the hat 11. The temperature sensors 38 may be connected by leads 42 to cable 20, which may also carry signals to and from the an emitter 16 and detector 18 of medical sensor 34. In one embodiment, the temperature sensors 38 may be woven into the fabric of the hat 11.
FIG. 5 illustrates an embodiment of a headband-based sensor assembly 50 that includes a medical sensor 34 and a temperature sensor 12. The headband-based sensor assembly 50 may include a strap or band 52 that may be fitted around a patient's forehead tissue to contact the sensor 34 with the tissue. In certain embodiments, a temperature sensor 12 may send feedback to a downstream monitor through cable 20 relating to both the medical sensor and the temperature sensor 12
A sensor or sensor assembly, illustrated generically as a sensor assembly 10, may be used in conjunction with a pulse oximetry monitor 100, as illustrated in FIG. 6. It should be appreciated that the cable 20 of the sensor assembly 10 may be coupled to the monitor 100 or it may be coupled to a transmission device to facilitate wireless transmission between the sensor assembly 10 and the monitor 100. The monitor 100 may be any suitable pulse oximeter, such as those available from Nellcor Puritan Bennett LLC. Furthermore, to upgrade conventional pulse oximetry provided by the monitor 100 to provide additional functions, the monitor 100 may be coupled to a multi-parameter patient monitor 102 via a cable 104 connected to a sensor input port or via a cable 106 connected to a digital communication port.
FIG. 7 is a block diagram of an embodiment of a pulse oximeter 100 that may be configured to implement the embodiments of the present disclosure. Light from emitter 16 may pass into a blood perfused tissue, and may be scattered, and then detected by detector 18. A sensor assembly 10 containing an emitter 16 and a detector 18 may also contain an encoder 116 which may be capable of providing signals indicative of the wavelength(s) of light source 16 to allow the oximeter to select appropriate calibration coefficients for calculating oxygen saturation. The encoder 116 may, in an embodiment, be a resistor. In an embodiment, the sensor assembly 10 also includes a temperature sensor/transducer 12 and may be capable of carrying a signal from the temperature sensor 12 to a monitor 100.
In an embodiment, the sensor assembly 10 may be connected to a pulse oximetry monitor 100. The monitor 100 may include a microprocessor 122 coupled to an internal bus 124. Also connected to the bus may be a RAM memory 126 and a display 128. A time processing unit (TPU) 130 may provide timing control signals to light drive circuitry 132, which controls when the emitter 16 is activated, and if multiple light sources are used, the multiplexed timing for the different light sources. TPU 130 may also control the gating-in of signals from detector 18 through an amplifier 133 and a switching circuit 134. These signals are sampled at the proper time, depending at least in part upon which of multiple light sources is activated, if multiple light sources are used. The received signal from the detector 18 and the temperature sensor 12 may be passed through an amplifier 136, a low pass filter 138, and an analog-to-digital converter 140. The digital data may then be stored in a queued serial module (QSM) 142, for later downloading to RAM 126 as QSM 142 fills up. In an embodiment, there may be multiple parallel paths of separate amplifier, filter, and A/D converters for multiple light wavelengths or spectra received and/or the temperature data from the temperature sensor 12. In one embodiment, the signal from the temperature sensor 12 may have its own data path and may be processed separately from the signal from the detector 18.
In an embodiment, the monitor 100 may be configured to receive signals from the sensor assembly 10. In certain embodiments, the signals may be related to a temperature sensor 12 and may be processed by the monitor 100 to indicate the patient's temperature and/or whether it is too high or too low. The monitor 100 may be configured to provide an indication about the sensor condition, such as an audio alarm, visual alarm or a display message if the patient's temperature is outside of a predetermined range. Further, the monitor 100 may be configured to receive information about the temperature sensor 12 from a memory chip or other device, such as the encoder 116, which may be on the sensor assembly 10 or the cable 20. In an embodiment, such a device may include a code or other identification parameter that may allow the monitor 100 to select an appropriate software or hardware instruction for processing the signal. In an embodiment, a monitor 100 may run an algorithm or code for processing the signal provided by the temperature sensor 12. In one embodiment, when the encoder 116 indicates that the sensor assembly 10 is configured for neonates, the temperature range that is indicative of acceptable temperatures may be slightly narrower than in sensors designed for adult populations.
The temperature sensor 12 may include one or more temperature-sensing structures that contact the tissue of the patient. The temperature sensor 12 may be any suitable medical-grade temperature sensor, such as resistance-based temperature sensors and infrared temperature sensors available from Thermometrics (Plainville, Conn.).
In an embodiment, based at least in part upon the received signals corresponding to the light received by detector 18, microprocessor 122 may calculate the oxygen saturation using various algorithms. These algorithms may require coefficients, which may be empirically determined, and may correspond to the wavelengths of light used. The algorithms may be stored in a ROM 146 and accessed and operated according to microprocessor 122 instructions.
In an embodiment of a two-wavelength system, the particular set of coefficients chosen for any pair of wavelength spectra may be determined by a value indicated by the encoder 116 corresponding to a particular light source in a particular sensor assembly 10. In one embodiment, multiple resistor values may be assigned to select different sets of coefficients. In another embodiment, the same resistors are used to select from among the coefficients appropriate for an infrared source paired with either a near red source or far red source. The selection between whether the near red or far red set will be chosen can be selected with a control input from control inputs 154. Control inputs 154 may be, for instance, a switch on the pulse oximeter, a keyboard, or a port providing instructions from a remote host computer. Furthermore, any number of methods or algorithms may be used to determine a patient's pulse rate, oxygen saturation or any other desired physiological parameter.
The sensor assembly 10 includes an emitter 16 and a detector 18 that may be of any suitable type. For example, the emitter 16 may be one or more light emitting diodes adapted to transmit one or more wavelengths of light in the red to infrared range, and the detector 18 may one or more photodetectors selected to receive light in the range or ranges emitted from the emitter 16. Alternatively, an emitter 16 may also be a laser diode or a vertical cavity surface emitting laser (VCSEL). An emitter 16 and detector 18 may also include optical fiber sensing elements. An emitter 16 may include a broadband or “white light” source, in which case the detector could include any of a variety of elements for selecting specific wavelengths, such as reflective or refractive elements or interferometers. These kinds of emitters and/or detectors would typically be coupled to the rigid or rigidified sensor via fiber optics. Alternatively, a sensor assembly 10 may sense light detected from the tissue is at a different wavelength from the light emitted into the tissue. Such sensors may be adapted to sense fluorescence, phosphorescence, Raman scattering, Rayleigh scattering and multi-photon events or photoacoustic effects.
For pulse oximetry applications using either transmission or reflectance type sensors the oxygen saturation of the patient's arterial blood may be determined using two or more wavelengths of light, most commonly red and near infrared wavelengths. Similarly, in other applications, a tissue water fraction (or other body fluid related metric) or a concentration of one or more biochemical components in an aqueous environment may be measured using two or more wavelengths of light, most commonly near infrared wavelengths between about 1,000 nm to about 2,500 nm. 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.
The emitter 16 and the detector 18, and in some embodiments the temperature sensor 12, may be disposed on a sensor body, which may be made of any suitable material, such as plastic, foam, woven material, or paper. Alternatively, the emitter 16 and the detector 18 may be remotely located and optically coupled to the sensor assembly 10 using optical fibers. In the depicted embodiments, the sensor assembly 10 is coupled to a cable that is responsible for transmitting electrical and/or optical signals to and from the emitter 16 and detector 18 of the sensor assembly 10. The cable may be permanently coupled to the sensor assembly 10, or it may be removably coupled to the sensor assembly 10—the latter alternative being more useful and cost efficient in situations where the sensor assembly 10 is disposable.
The sensor assembly 10 may be a “transmission type” sensor. Transmission type sensors include an emitter 16 and detector 18 that are typically placed on opposing sides of the sensor site. If the sensor site is a fingertip, for example, the sensor assembly 10 is positioned over the patient's fingertip such that the emitter 16 and detector 18 lie on either side of the patient's nail bed. In other words, the sensor assembly 10 is positioned so that the emitter 16 is located on the patient's fingernail and the detector 18 is located 180° opposite the emitter 16 on the patient's finger pad. During operation, the emitter 16 shines one or more wavelengths of light through the patient's fingertip and the light received by the detector 18 is processed to determine various physiological characteristics of the patient. In each of the embodiments discussed herein, it should be understood that the locations of the emitter 16 and the detector 18 may be exchanged. For example, the detector 18 may be located at the top of the finger and the emitter 16 may be located underneath the finger. In either arrangement, the sensor assembly 10 will perform in substantially the same manner.
Reflectance type sensors also operate by emitting light into the tissue and detecting the light that is transmitted and scattered by the tissue. However, reflectance type sensors include an emitter 16 and detector 18 that are typically placed on the same side of the sensor site. For example, a reflectance type sensor may be placed on a patient's fingertip or forehead such that the emitter 16 and detector 18 lie side-by-side. Reflectance type sensors detect light photons that are scattered back to the detector 18. A sensor assembly 10 may also be a “transflectance” sensor, such as a sensor that may subtend a portion of a baby's heel.
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. Indeed, the disclosed embodiments may not only be applied to measurements of blood oxygen saturation, but these techniques may also be utilized for the measurement and/or analysis of other blood constituents. For example, using the same, different, or additional wavelengths, the present techniques may be utilized for the measurement and/or analysis of carboxyhemoglobin, met-hemoglobin, total hemoglobin, fractional hemoglobin, intravascular dyes, and/or water content. 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

## Claims

1. An apparatus comprising:
a stocking cap capable of being applied to a patient's head;
a substrate disposed adjacent the stocking cap;
a pulse oximetry sensor disposed on the substrate, wherein the pulse oximetry sensor comprises a light emitter and a light detector;
a cable disposed on the substrate, wherein the cable extends from the substrate through an open portion of the stocking cap configured to be proximate to a top of the stocking cap when the stocking cap is applied to the patient; and
an array of temperature sensors woven into the stocking cap, wherein each of the array of temperature sensors is capable of providing a feedback related to a temperature of the patient.

2. The apparatus, as set forth in claim 1, wherein the feedback comprises an electrical signal.

3. The apparatus, as set forth in claim 1, wherein each of the array of temperature sensors comprises a transducer.

4. The apparatus, as set forth in claim 1, wherein each of the array of temperature sensors comprises a colorimetric film.

5. The apparatus, as set forth in claim 1, wherein each of the array of temperature sensors is disposed on the substrate.

6. The apparatus of claim 1, wherein the stocking cap comprises a stocking cap capable of being placed on the head of a neonate.

7. The apparatus, as set forth in claim 1, wherein the cable is electrically connected to the pulse oximetry sensor and the temperature sensor.

8. The apparatus, as set forth in claim 1, comprising a digital LCD display disposed on the stocking cap configured to display the temperature of the patient.

9. A pulse oximetry system comprising:
a pulse oximetry monitor; and
a sensor assembly capable of being operatively coupled to the pulse oximetry monitor, the sensor assembly comprising:
a stocking cap capable of being applied to a patient's head;
a substrate disposed on the stocking cap;
a pulse oximetry sensor disposed on the substrate, wherein the pulse oximetry sensor comprises a light emitter and a light detector;
a cable disposed on the substrate, wherein the cable extends from the substrate generally through the stocking cap and configured to be generally proximate to a top of the stocking cap when the stocking cap is applied to the patient; and
an array of temperature sensors woven into the stocking cap, wherein each of the array of temperature sensors is capable of providing a feedback to the pulse oximetry monitor.

10. The system, as set forth in claim 9, wherein each of the array of temperature sensors comprises a transducer.

11. The system, as set forth in claim 9, wherein each of the array of temperature sensors comprises a colorimetric film.

12. The system, as set forth in claim 9, wherein each of the array of temperature sensors is disposed on the substrate.

13. The system, as set forth in claim 9, wherein the stocking cap comprises a stocking cap capable of being placed on the head of a neonate.

14. A sensor comprising:
a structure capable of being applied to a patient's head;
a substrate disposed on the structure;
a pulse oximetry sensor disposed on the substrate, wherein the pulse oximetry sensor comprises a light emitter and a light detector;
an array of temperature sensors woven into the structure, wherein each of the array of temperature sensors is capable of providing a feedback related to a temperature of the patient; and
a cable disposed on the substrate, wherein the cable is electrically connected to the pulse oximetry sensor and each of the array of temperature sensors.

15. The sensor, as set forth in claim 14, wherein each of the array of temperature sensors comprises a transducer.

16. The sensor, as set forth in claim 14, wherein each of the array of temperature sensors comprises a colorimetric film.

17. The sensor, as set forth in claim 14, wherein each of the array of temperature sensors is disposed on the substrate.

18. The sensor, as set forth in claim 14, wherein the structure comprises a stocking cap.

19. The sensor, as set forth in claim 14, wherein the structure comprises a headband.