CA2753046C - Medical monitoring device with flexible circuitry - Google Patents
Medical monitoring device with flexible circuitry Download PDFInfo
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- CA2753046C CA2753046C CA2753046A CA2753046A CA2753046C CA 2753046 C CA2753046 C CA 2753046C CA 2753046 A CA2753046 A CA 2753046A CA 2753046 A CA2753046 A CA 2753046A CA 2753046 C CA2753046 C CA 2753046C
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- patient
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- integrated circuit
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
- A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
- A61B5/14552—Details of sensors specially adapted therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
Abstract
Embodiments described herein may include systems and methods for monitoring physiological parameters of a patient.
Specifically, embodiments disclose the use of a flexible circuitry in a medical sensor that is small and lightweight and easily bendable, such that it may be comfortably affixed to a patient while also providing added electronic functions, such as digital conversion and wireless capability.
Specifically, embodiments disclose the use of a flexible circuitry in a medical sensor that is small and lightweight and easily bendable, such that it may be comfortably affixed to a patient while also providing added electronic functions, such as digital conversion and wireless capability.
Description
MEDICAL MONITORING DEVICE WITH FLEXIBLE CIRCUITRY
BACKGROUND
The present disclosure relates generally to medical devices and, more particularly, to medical monitoring devices.
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 should be understood that these statements are to be read in this light, and not as admissions of prior art.
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 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 modem 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.
Pulse oximeters typically utilize a non-invasive sensor that is placed on or against a patient's tissue that is well perfused with blood, such as a patient's finger, toe, forehead or earlobe. The sensor is usually small, lightweight, and flexible so that it may be easily and comfortably held against the patients tissue. The pulse oximeter sensor emits light and photoelectrically senses the absorption and/or scattering of the light after passage through the perfused tissue. The data collected by the sensor may then be used to calculate one or more of the above physiological characteristics based upon the absotption or scattering of the light. More specifically, the emitted light is typically selected to be of one or more wavelengths that are absorbed or scattered in an amount related to the presence of oxygenated versus de-oxygenated hemoglobin in the blood. The amount of light absorbed and/or scattered may then be used to estimate the amount of the oxygen in the tissue using various algorithms.
Due to the flexibility and small size of the pulse oximeter sensor, the amount of circuitry included in the sensor is usually rather limited. Accordingly, the sensor is usually coupled through a cable to a monitor that sends and receives electrical signals to the sensor and includes circuitry used for processing the received signals and performing other functions that are outside the limited capabilities of the sensor.
This conventional configuration, however, may have several disadvantages. For example, the cable may tend to pick up unwanted electrical noise, thereby reducing the signal-to-noise ratio of transmitted signal. For another example, the transmission of analog signals through the resistive cable may result in substantial power loss. For yet another example, the patient's comfort and mobility may be limited by the cable running between the sensor and the monitor. It may be desirable, therefore, to provide a medical sensor with improved processing functionality while maintaining the sensor's flexibility and comfort.
SUMMARY OF THE INVENTION
To address the foregoing issues, there is provided a sensor adapted for placement adjacent to tissue to be tested, comprising: at least one light emitter and at least one light detector capable of acquiring physiological data from a patient; a deformable integrated circuit comprising an analog-to-digital converter coupled to an output of the at least one light detector and configured to output a digital signal corresponding to the physiological data from the patient; and a flexible outer covering configured to be placed adjacent the tissue of the patient and to house the deformable integrated circuit and the emitter and the detector.
There is also provided a monitoring system, comprising: a sensor, comprising:
at least one light emitter and at least one light detector, configured to acquire physiological data from a patient; a deformable integrated circuit comprising an analog-to-digital converter coupled to an output of the at least one light detector and configured to output a digital signal corresponding to the physiological data from the patient; and a monitor configured to communicatively coupled to the sensor and configured to receive the digital signal and generate an output corresponding to the physiological data.
There is still further provided a method of generating physiological data, comprising: using a driving circuit disposed in a sensor to drive at least one light emitting diode disposed in the sensor and configured to emit a light signal into a tissue to be tested;
receiving a modified light signal through a light detector disposed in the sensor, the modified light signal corresponding to the light signal after it has been transmitted through or reflected from the tissue to be tested; generating a digital signal through an analog-to-digital converter disposed in the sensor, the digital signal corresponding to the modified light signal; and generating a physiological parameter by processing the digital signal; wherein at least one of the driving circuit and the analog-to-digital converter comprises a deformable integrated circuit.
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. 1 is a perspective view of a medical monitoring system with flexible, bandage-style sensors in accordance with an embodiment;
FIG. 2 is a perspective view of a partially assembled flexible, bandage-style sensor in accordance with an embodiment in which the sensor includes a display and a wireless device;
FIGS. 3A and 3B are perspective views of the back side of the bandage-style sensor of FIG. 2 in accordance with an embodiment;
FIG. 4A is a perspective view of a flexible clip-style sensor, in accordance with an embodiment;
FIG. 4B is a cross-sectional view of the flexible clip-style sensor of FIG. 4A
taken along line 4-4, in accordance with an embodiment; and 2a FIGS. 5-7 are block diagrams of the sensors of FIGS. 1-4 in accordance with various embodiments.
DETAILED DESCRIPTION
One or more 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.
The present disclosure is directed to an improved medical sensor that includes flexible circuitry. For the purposes of the present specification, the term "flexible circuit"
is intended to describe a deformable integrated circuit that may be flexed without damaging the circuit. By including flexible circuitry within the sensor, the processing capabilities of the sensor may be improved while maintaining the sensor's flexibility and comfort. The enhanced processing capabilities of the sensor may include amplification and filtering of signals received by the sensing components of the sensor and analog-to-digital conversion of the received signals. The digital signals may then be transmitted to the monitor with less power consumption and higher signal-to-noise ratio.
Certain other embodiments may additionally include circuitry that enables the sensor to wirelessly transmit the digital signals to the monitor, thereby eliminating the communications cable.
Further embodiments may include a sensor with circuitry that enables the sensor to calculate and/or display some physiological parameters.
Referring to the figures and turning initially to FIG. 1, a medical monitoring device is illustrated in accordance with an embodiment and is generally designated by the reference numeral 10. The device 10 may include a monitor 12 which may house hardware and software configured to compute various physiological parameters.
The monitor 12 may be configured to operate as a pulse oximeter or as a multi-parameter monitor, such as those available from Nellcor Puritan Bennett L.L.C. and/or Covidien.
The monitor 12 may include a display 14 to display the various physiological parameters.
For example, the display 14 may display the pulse rate and the concentration of a blood analyte, such as, percent oxygen saturation of hemoglobin, for example. The display 14 may show the physiological parameters and calculated values in any appropriate manner.
For example, the calculated values may be displayed numerically and/or as a waveform over time. Additionally, any notifications or alerts prompted by abnormal measurements, calculated values and/or other conditions may be displayed.
One or more flexible sensors 16, in accordance with various embodiments, may be communicatively coupled to the monitor 12. As shown in FIG. 1, the sensors 16 are flexible and, thus, may be attached to the tissue of a patient in a variety of ways. For example, the sensor 16 may be wrapped around a portion of a patient, such as a finger, toe, arm, leg, earlobe, etc. In other embodiments, the sensor may be held against the patients' forehead or torso, such that the sensor fits the contours of the tissue.
In some embodiments, the sensor 16 may be communicatively coupled to the monitor 12 via a cable 18. in other embodiments, however, the sensor 16 may communicate with the monitor 12 wirelessly. In the latter case, both the monitor 12 and the sensor 16 may include wireless devices that allow the monitor and the sensor to communicate as will be explained below in reference to FIG. 6. By eliminating the cable 18, the patient is no longer tethered to the monitor 12 and may move more freely without the risk of inadvertently jerking or damaging the cable 18. In this way, the sensor 16 may be less susceptible to movement or accidental removal, and the risk of the sensor 16 or the monitor 12 is reduced.
The sensor 16 may also include a display 20 that provides information regarding the physiological parameters of the patient, such as blood oxygenation and heart rate. In some embodiments, the sensor 16 may receive the displayed physiological parameters from the monitor 12. As such, the sensor 16 may transmit the raw physiological data to the monitor 12, and the monitor 12 may then calculate physiological parameters based the physiological data and transmit the physiological parameters back to the sensor 16 for display. In other embodiments, the sensor 16 may include flexible circuitry configured to calculate the physiological parameters based on the data gathered by the sensor 16. In this way, the senor 16 may be a stand-alone unit, capable of providing physiological data without the use of the monitor 12. The sensor 16 may, therefore, be used in situations in which a monitor 12 may not be readily available or convenient, such as during an emergency, patient transportation, or other situations where the patient is away from a medical facility. By displaying physiological parameters directly on the sensor 16, a medical service provider may devote greater attention to the patient while obtaining important information regarding the patient's health.
Additional details of the sensor 16 are provided with reference to FIGS. 2-7.
Specifically, FIGS. 2-4 illustrate various embodiments of sensor construction, while FIGS. 5-7 illustrate the electrical components that may be included in various embodiments. Turning first to FIG. 2, a perspective view of the sensor 16 is illustrated. As shown in FIG. 2, the circuitry of the sensor 16 may be housed within a flexible outer covering that may include a flexible top layer 23 and a flexible bottom layer 24. Both the top layer 23 and bottom layer 24 may include flexible polymers, such as silicon polymers, polyvinylchloride, and polyethylene. The polymers may be elastomeric to provide for flexibility of the sensor 16 such that it may conform to the tissue of a patient. In some embodiments, the top and bottom layers 23 and 24 may include cloth or a bandage material, such as gauze. The top layer 23 and bottom layer 24 may be held together by an adhesive. For convenience, FIG. 2 shows the top layer 23 as partially separated from the bottom layer 24 to provide a view of the internal circuitry within the sensor 16. In some embodiments, the top layer 23 may include a window 26 to enable viewing of a display 20. The window 26 may be an unfilled aperture within the top layer 23 or, alternatively, the window may include a clear polymer layer. In some embodiments, the top layer 23 and bottom layer 24 may also include complimentary fastening mechanisms 28, such as rows of buttons or strips of hook and loop type fasteners, which allow the sensor 16 to be wrapped around an extremity of the patient and held in position.
As is also shown in FIG. 2, the sensor 16 may also include one or more flexible circuits 30 held between the top layer 23 and the bottom layer 24. The flexible circuits 30 provide the added functionality of the sensor 16, which will be described further below in relation to FIGS. 5-7. In embodiments with more than one flexible circuit 30, the flexible circuits 30 may be physically and communicatively coupled to one another by a flexible circuit board 32, such as a "flex" circuit board made from a flexible polymer substrate, such as polyimide. The flexible circuit board 32 may be communicatively coupled to electrical leads from the cable 18 at an electrical interface 34.
In this way, signals from the monitor 12 may be routed to or from the emitter 38, detector 40, and other circuit components.
The flexible circuits 30 may include flexible semiconductors fabricated on a flexible polymer substrate according to any of several flexible semiconductor fabrication techniques. In some embodiments, for example, the flexible circuits 30 may include thin film transistors (TFTs), such as low-temperature polysilicon TFTs deposited on a flexible polymer substrate. In some embodiments, the TFTs may be deposited on the flexible polymer substrate by a method of chemical vapor deposition (CVD) or physical vapor deposition (PVD), such as sputtering. Furthermore, in some embodiments, the flexible circuits 30 may be inkjet printed on the polymer substrate at low temperature using a low-temperature liquid silicon, such as polysilane or cyclopentasilane.
The flexible circuits 30 may include some or all of the circuit components of the sensor 16, such as emitters, detectors, drivers, processors, batteries, etc, as will be described below. Among other things, the flexible circuits 30 may include the display 20 and the wireless device 22A. The display 20 may be any thin flexible display, such as a flexible organic light-emitting diode OLED display or a flexible electrophoretic display, for example. The wireless device 22A on the sensor 16 may include a flexible radio frequency antenna, such as a flexible microstrip antenna or flexible patch antenna, for example.
Sensors 16 in accordance with present embodiments may be either transmissive or reflective. In a transmissive sensor 16, emitted light signals pass completely through the patient's tissue before being received by the sensor 16. In a reflective sensor 16, the emitted light signals penetrate the patient's tissue only partially before being reflected back and received by the sensor 16. Embodiments of a transmissive sensor 16 and a reflective sensor 16 are illustrated in FIGS. 3A and 313, respectively.
Turning first to FIG. 3A, a bottom layer 24 of a transmissive sensor 16 is illustrated in accordance with embodiments, The bottom layer 24 of the sensor 16 is held adjacent to the tissue of a patient so that the sensor 16 may detect physiological data of the patient through an emitter 38 and a detector 40, both of which may be held in close proximity to the skin or tissue of the patient. The emitter 38 may include a red emitter and an infra-red emitter that are configured to transmit electromagnetic radiation through the tissue of a patient. In accordance with this embodiment, the red and infra-red emitters may include light emitting diodes (LEDs) that emit electromagnetic radiation in the respective region of the electromagnetic spectrum. The radiation emitted by the emitter 38 into the patient's tissue is detected by the detector 40 after the radiation has passed through or reflected from blood perfused tissue of the patient 42, and the detector 40 generates an electrical signal correlative to the amount of radiation detected.
To facilitate the transmission of light through the patient's tissue, the bottom layer 24 of the sensor 16 may include transparent windows 36 that expose the emitter 38 and detector 40 and allow light to pass through the tissue of a patient from the emitter 38 to the detector 40. The windows 36 may be unfilled apertures within the bottom layer 24 or, alternatively, the windows 36 may include a clear polymer layer. The bottom layer 24 may also include one or more adhesive layers 44 for attaching the sensor 16 to the skin of the patient and securing the emitter 38 and the detector 40.
Furthermore, the adhesive layers 44 may surround both the emitter 38 and the detector 40 to prevent the emitter 38 and the detector 40 from moving relative to the skin of the patient.
The emitter 38 may include any kind of light emitting diodes (LED) suitable for pulse oximetry, while the detector may include any suitable kind of photodiode. In some embodiments, the emitter 38 and the detector 40 may be flexible and may be formed directly on the flexible circuits 30 of the sensor 16. For example, the emitter 38 may include one or more organic light emitting diodes (OLEDs) formed on the plastic substrate of the flexible circuits 30. Additionally, the detector 40 may also include an organic diode configured to operate as a light-detecting photodiode. The emitter 38 and the detector 40 may be disposed on opposite sides of the tissue so that the detector 40 may detect light transmitted through the tissue by the emitter 38.
Turning now to FIG. 3B, a bottom layer 24 of a reflective sensor 16 is illustrated in accordance with embodiments. In this embodiment, as in FIG. 3A, the bottom layer 24 may also include one or more adhesive layers 44 that surround both the emitter 38 and the detector 40 and secure the emitter 38 and the detector 40 to the skin of the patient. In this embodiment, however, the sensor 16 may operate by reflecting light from the tissue of the patient, rather than transmitting light through the tissue. Accordingly, the emitter 38 and the detector 40 may be positioned close to one another to reduce the transmission path between the emitter 38 and the detector 40. In this embodiment, the sensor 16 may be disposed adjacent to any part of a patient's body that is conducive to measuring physiological parameters, such as the forehead, for example. Again, the flexibility of the flexible circuits 30 enables the sensor 16 to easily bend to fit the contour of the tissue to which it is attached.
Embodiments of the present invention may also include a clip-style sensor 16 configured to grasp the tissue of a patient. Turning to FIGS. 4A and 4B, an embodiment of a clip-style sensor 16 is illustrated, in accordance with embodiments.
Turning first to FIG. 4A, the sensor 16 may include a sensor body 46 with an upper clip portion 48 and a lower clip portion 50 coupled together by a hinge 52 that allows the upper clip portion 48 and a lower clip portion 50 to flex outward to receive a body part of the patient, such as a patient's finger. As shown in FIG. 4A, the sensor body 46 may be a single, continuous structure that includes a semi-rigid polymer injection molded around the flexible circuitry 30 and other circuit components of the sensor 16. In this embodiment, the hinge 52 may be a living hinge formed by a thinning of the semi-rigid polymer, and the flexible circuits 30 may pass through the hinge 52. Further, the resiliency of the hinge 52 may provide a compressive force that holds the upper clip portion 48 and the lower clip portion 50 in place against the patient's tissue. In alternative embodiments, the upper clip portion 48 and the lower clip portion 50 of the sensor body 46 may be separate pieces coupled together by the hinge 52, which may be spring loaded to provide the compressive force for holding the upper clip portion 48 and the lower clip portion 50 against the patient's tissue.
Together, the upper clip portion 48 and the lower clip portion 50 may be configured to flex outward about the hinge 52 to allow the finger of a patient to be inserted into the sensor 16 for testing, Furthermore, the sensor body 46 may also include grips 54 to facilitate the flexing of the sensor body 48 and the placement of the sensor 16 around the patient's finger. As will be shown, both the upper clip portion 48 and the lower clip portion 50 may house a variety of flexible electronic circuits and devices for measuring biological parameters.
FIG. 4B shows a side cross-sectional view of the clip-style embodiment of sensor assembly 16. As shown in FIG. 4B, the sensor 16 includes a emitter 38 and a detector 40 embedded in the sensor 16 on opposite sides of the sensor 16. In this embodiment, light signals may be emitted by emitter 38 into the bottom of patient's finger, transmitted through the patient's finger tissue, and received by detector 40. The detector 38 and the emitter 40 may each include or be adjacent to a transparent window which allows light to be transmitted from the emitter 40 to the detector 38, through the patient's finger tissue.
As in the sensor 16 described in relation to FIGS. 1-3, the sensor 16 may include a flexible circuit 30. The flexible circuit 30 may include electrical leads located on a surface of the flexible circuit 30 at an electrical interface 56. The flexible circuit leads may be electrically coupled at the electrical interface 56 to electrical leads from the cable 18 so that signals may be routed to or from the emitter 38, detector 40, and other circuit components.
In other embodiments, the clip-style sensor 16 may also include a wireless device so that signals may be routed to or from the emitter 38, detector 40, and other circuit components wirelessly, and the cable 18 may not be present. In some embodiments, the flexible circuit 30 may be one continuous flexible circuit 30 that extends from the electrical interface 56 through both the upper clip portion 48 and the lower clip portion 50, bending approximately 180 degrees at the joint 30. Moreover, as shown in FIG. 4B, the flexible circuit 30 may be folded on itself one or more times to increase the amount of circuitry that may be included in the sensor 16. In some embodiments, the flexible circuit 30 may include a thin insulative sheet (not shown) to prevent electrical shorting between the folded layers. In other embodiments, electrical insulation may be provided by a thin insulative sheet imposed between the folded layers. By including the flexible circuit 30 in the clip-style sensor 16, a relatively large amount of circuitry may be included within the sensor 16, thus enhancing the capabilities of the sensor as described below while maintaining the flexibility, small size, and comfort of the sensor 16.
Various other physical embodiments of the sensor 16 with flexible circuitry 30 may be possible. In fact, many techniques may be used for holding the sensor 16 against the skin of a patient, and the examples recited above should not be considered an exhaustive list of possible embodiments.
Turning now to FIGS. 5-7, the electrical features of various embodiments of the sensor 16 are described. Embodiments of the sensor 16 may include various levels of additional functionality, some of which will be described below. For example, FIG. 5 describes a sensor 16 electrically coupled by a cable to a monitor 12, wherein the sensor 16 includes, among other things, circuity for amplification, filtering, and digital conversion of the signals received by the detector 40. For another example, FIG. 6 describes a sensor 16 with circuitry that enables the sensor to communicate with the monitor 12 wirelessly. For yet another example, FIG. 7 describes a sensor 16 with a display 20 and circuitry for calculating and displaying some physiological parameters. It will be understood that an actual implementation described herein may include more or fewer components as needed for a specific application.
Turning first to FIG. 5, a block diagram of the monitoring device 10 with the sensor 16 is illustrated in accordance with an embodiment. As shown in FIG. 5, the monitor 12 may include one or more processors 62. The processor 62 may be configured to calculate physiological parameters using various algorithms programmed into the monitor 12 and based on signals received from the sensor 16. For example, the processor 62 may compute a percent oxygen saturation of hemoglobin and/or a pulse rate, among other useful physiological parameters.
The processor 62 may be connected to other component parts of the monitor 12, such as one or more read only memories (ROM) 64, one or more random access memories (RAM) 66, the display 20, and control inputs 70. The ROM 64 and the RAM
66 may be used in conjunction, or independently, to store the algorithms used by the processor 62 in computing physiological parameters. The ROM 64 and the RAM 66 may also be used in conjunction, or independently, to store signals received from the sensor 16 for use in the calculation of the aforementioned algorithms. The control inputs 70 may be provided to allow a user to interface with the monitor 12 and may include soft keys, dedicated function keys, a keyboard, and/or keypad type interfaces for providing parameters, data, and/or instructions to the monitor 12.
As described above in relation to FIGS. 3-4, the sensor 16 may include an emitter 38 and a detector 40. Additionally, the sensor 16 of FIG. 5 may also perform many of the functions traditionally performed by the monitor 12. For example, the sensor 16 may include a light drive 72 that provides signals to a red emitter 38A and an infra-red emitter 38B that cause the emitters 38A and 38B to produce the emitted light signals.
The light drive 72 may be driven by an analog signal from the monitor 12, which controls the timing and intensity of the light signals emitted by the emitters 38A and 38B.
The analog signal from the monitor 12 may then trigger the light drive 72 to generate an excitation signal that is transmitted to the emitters 38A and 38B. In accordance with an embodiment, the light drive 72 may be a simplified light drive circuit discussed in detail in U.S. Patent Application No. 12/343,799, entitled "LED Drive Circuit and Method for Using Same," by Ethan Peterson, which was filed December 24, 2008, and is incorporated herein by reference in its entirety for all purposes. The simplified light drive 72 described therein may include fewer circuit components as compared to light drive circuits typically found on pulse oximetry monitors.
For another example of added sensor 16 functionality, the sensor 16 may also include circuitry for converting the analog signal received from the detector 40 into a digital signal. Specifically, the sensor 16 may include an amplifier 74 that amplifies the electrical signal generated by the detector 40 and a filter 76 that reduces unwanted signals located outside the frequencies of interest. The amplified and filtered signal may then be provided to an analog-to-digital converter (ADC 78) that converts the analog signal into a digital format. The digital signal may then be provided to the monitor 12 for further processing, such as for the calculation of various physiological parameters.
By transmitting a digital signal from the sensor 16 to the monitor 12 rather than an analog signal, the electrical interference introduced by the cable 18 may be reduced.
Turning now to FIG. 6, a block diagram of another embodiment of the monitoring device 12 with the sensor 16 is illustrated. As shown in FIG. 6, the sensor 16 may include the emitter 38 and the detector 40, as well the additional circuitry such as the light drive 72, the amplifier 74, the filter 76, and the ADC 78, as discussed above in relation to FIG.
5. In this embodiment, however, the sensor 16 and the monitor 12 both include wireless devices 22A and 22B that enable the sensor 16 and the monitor 12 to communicate wirelessly. In this way, the communications cable 18 may be eliminated. The wireless device 22A on the sensor 16 may also include driver circuitry (not shown) that receives the digital signal from the ADC 78 and generates an excitation signal for driving an antenna (not shown). In an embodiment, the sensor 16 may transmit data via a wireless communication protocol such as, but not limited to, WiFi, Bluetooth or ZigBee.
In some embodiments, the monitor 12 may communicate with several sensors 16 at the same time. In such embodiments, the operator of the monitor 12 may choose to view physiological data from one or more sensors 16 at any time. To correlate a sensor 16 with a particular patient 42, each sensor 16 may provide a unique identifier that allows the health care provider to match sensor 16 readings with the patient 42 wearing the sensor 16. In various embodiments, for example, each sensor 16 may be tuned to a slightly different broadcast frequency, or each sensor 16 may periodically broadcast an identification sequence.
As is also shown in FIG. 6, the sensor 16 may also include a display 20 that may display various information about the sensor 16 and/or the patient 42. In embodiments, the display 20 may include a numerical display. As such, the display 20 may receive incoming data and convert the data into a format suitable for driving the display 20.
Furthermore, the display 20 may be configured to cycle through a set of display data, either on a timed basis or responsive to an input of the user.
In some embodiments, the display 20 may be configured to display data corresponding to the sensor 16, such as, for example, battery life and/or whether the sensor 16 is transmitting a wireless signal. Moreover, the display 20 may also be configured to display any useful data corresponding to a physiological parameter of a patient 42, such as, for example, a pulse rate and/or a blood-oxygen saturation level. In the embodiment shown in FIG. 6, the sensor 16 may not have processor circuitry suitable for generating the displayed physiological data. Therefore, the sensor 16 may receive physiological data through the wireless link provided by the wires devices 22A
and 22B.
As such, physiological data may be calculated by the processor 62 of the monitor 12 based on the digital signals received from the ADC 78 of the sensor 16, as discussed above. The physiological data may then be transmitted back to the sensor 16 via the wireless device 22B. The wireless device 22A may then route the physiological data to the display 20.
The same physiological data may also be displayed on the display 14 of the monitor 12.
Including a display 20 on the sensor 16 provides several advantages. For example, by displaying information regarding the battery life of the sensor 16, a caregiver may be alerted to replace or recharge the sensor 16. For another example, displaying information regarding the health of the patient in direct proximity to the patient, may enable the caregiver to devote greater attention to the patient while still monitoring physiological data provided by the sensor 16.
As is also shown in FIG. 6, the sensor 16 may include a power source 82, such as a battery for example. The power source 82 may serve to power several of the electrical components of the sensor 16 such as the light drive 72, the amplifier 74, the ADC 78, the wireless device 22A, and the display 20. The power source 82 may include any small, lightweight battery such as a "coin cell" or "button cell." In some embodiments, the power source 82 may include lithium ion batteries, such as nanowire batteries, i.e., high performance lithium ion batteries made from silicon nanowires. Furthermore, in some embodiments, the power source 82 may include one or more flexible thin-film batteries, which may be included in or coupled to the flexible circuitry 30. Furthermore, in some embodiments, the power source 82 may be rechargeable.
In some embodiments, the sensor 16 may be activated by coupling the power source 82 to the sensor circuitry 16. For example, an electrically insulative film (not shown) may be inserted between the power source 82 and an electrical contact coupling the power source 82 to the sensor circuitry, thus blocking the flow of current from the power source. In this way, removal of the electrically insulative film may activate the sensor 16.
Turning now to FIG. 7, a block diagram of another embodiment of a sensor 16 is illustrated. As discussed above, some or all of the circuit components shown in FIG. 7 may be included on one or more flexible circuits 30. As shown in FIG. 7, the sensor 16 may include several additional circuit components traditionally included in the monitor 12. For example, in addition to the signal processing and display capabilities discussed above, the sensor 16 may also include a processor 62. The processor 62 may be communicatively coupled to the light drive 72 for controlling the timing and intensity of the emitters 38A and 38B. Additionally, the processor 62 may be communicatively coupled to the ADC 78 for receiving the digital signal output of the ADC 78 and calculating physiological parameters based on the received digital signals. In some embodiments, the processor 62 may be a synchronous, i.e. clocked, circuit. In other embodiments, however, the processor 62 may be asynchronous, this reducing the power usage of the processor 62 and reducing the heat generated by the processor 62.
Other components of the sensor 16 may also be coupled to the processor 62, such as the display 20 and the wireless device 22. The display 20 may be a simplified display as discussed above in relation to FIG. 6. The wireless device 22A may allow the sensor 16 to transmit data wirelessly to a remote monitor 12. For example, the wireless device 22A may enable the sensor 16 to transmit digital signals received from the ADC
78 to the remote monitor, as discussed above in relation to FIG. 6. Additionally, the wireless device 22A may also enable the sensor 16 to transmit physiological parameters calculated by the sensor 16 to the remote monitor 12. The remote monitor 12 may use the data received from the sensor 16 to execute more advanced features that may not be included in the sensor 16. For example, the remote monitor 12 may calculate additional physiological data that may require more robust algorithms. For another example, the remote monitor 12 may store physiological data gathered over time by the sensor 16 in a long term memory. In this way, information pertaining to physiological trends over time may be stored and displayed by the monitor 12.
Furthermore, the processor(s) 62 may also be coupled to a memory such as read-only memory (ROM) 64 and/or a random access memory (RAM) 66. In certain embodiments, the ROM 64 may be used to store one or more pulse oximetry algorithms, which may be simplified pulse oximetry algorithms such that the computer code associated with those algorithms may be reduced and the circuit footprint of the ROM 64 on the flexible circuitry 30 may also be reduced. In other embodiments, the calculation algorithms may be hardwired into the processor 62, and the ROM 64 may be eliminated, thereby further reducing the circuit footprint of the sensor 16 circuitry on the flexible circuit 30. For example, the processor 62 may be an application specific integrated circuit (ASIC) or a programmable logic device (PLD). The RAM 66 may store intermediate values that are generated in the process of calculating patient parameters as well as certain software routines used in the operation of the sensor 16, such as measurement algorithms, light drive algorithms, and patient parameter calculation algorithms, for example.
From the embodiments describe above, it will be appreciated that several advantages may be achieved by including flexible circuitry within a medical sensor 16.
The use flexible circuitry enables the addition of several electronic components that would traditionally be included in a monitor coupled to a sensor rather than the sensor itself. For example, the use of flexible semiconductor circuitry may enable the sensor to amplify and filter analog signals generated by the detector 40 and convert the analog signals into a digital signal that may then be transmitted to the monitor 12 with less electromagnetic interference and higher signal-to-noise ratio. Additionally, the use of flexible semiconductor circuitry may enable the sensor 16 to communicate wirelessly with the monitor 12, thus increasing the mobility and comfort of the patient.
Furthermore, the use of flexible semiconductor circuitry may enable the sensor 16 to calculate and/or display physiological data detected by the sensor. Moreover, all of the benefits described above may be achieved while maintaining the comfort and flexibility of the sensor 16.
BACKGROUND
The present disclosure relates generally to medical devices and, more particularly, to medical monitoring devices.
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 should be understood that these statements are to be read in this light, and not as admissions of prior art.
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 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 modem 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.
Pulse oximeters typically utilize a non-invasive sensor that is placed on or against a patient's tissue that is well perfused with blood, such as a patient's finger, toe, forehead or earlobe. The sensor is usually small, lightweight, and flexible so that it may be easily and comfortably held against the patients tissue. The pulse oximeter sensor emits light and photoelectrically senses the absorption and/or scattering of the light after passage through the perfused tissue. The data collected by the sensor may then be used to calculate one or more of the above physiological characteristics based upon the absotption or scattering of the light. More specifically, the emitted light is typically selected to be of one or more wavelengths that are absorbed or scattered in an amount related to the presence of oxygenated versus de-oxygenated hemoglobin in the blood. The amount of light absorbed and/or scattered may then be used to estimate the amount of the oxygen in the tissue using various algorithms.
Due to the flexibility and small size of the pulse oximeter sensor, the amount of circuitry included in the sensor is usually rather limited. Accordingly, the sensor is usually coupled through a cable to a monitor that sends and receives electrical signals to the sensor and includes circuitry used for processing the received signals and performing other functions that are outside the limited capabilities of the sensor.
This conventional configuration, however, may have several disadvantages. For example, the cable may tend to pick up unwanted electrical noise, thereby reducing the signal-to-noise ratio of transmitted signal. For another example, the transmission of analog signals through the resistive cable may result in substantial power loss. For yet another example, the patient's comfort and mobility may be limited by the cable running between the sensor and the monitor. It may be desirable, therefore, to provide a medical sensor with improved processing functionality while maintaining the sensor's flexibility and comfort.
SUMMARY OF THE INVENTION
To address the foregoing issues, there is provided a sensor adapted for placement adjacent to tissue to be tested, comprising: at least one light emitter and at least one light detector capable of acquiring physiological data from a patient; a deformable integrated circuit comprising an analog-to-digital converter coupled to an output of the at least one light detector and configured to output a digital signal corresponding to the physiological data from the patient; and a flexible outer covering configured to be placed adjacent the tissue of the patient and to house the deformable integrated circuit and the emitter and the detector.
There is also provided a monitoring system, comprising: a sensor, comprising:
at least one light emitter and at least one light detector, configured to acquire physiological data from a patient; a deformable integrated circuit comprising an analog-to-digital converter coupled to an output of the at least one light detector and configured to output a digital signal corresponding to the physiological data from the patient; and a monitor configured to communicatively coupled to the sensor and configured to receive the digital signal and generate an output corresponding to the physiological data.
There is still further provided a method of generating physiological data, comprising: using a driving circuit disposed in a sensor to drive at least one light emitting diode disposed in the sensor and configured to emit a light signal into a tissue to be tested;
receiving a modified light signal through a light detector disposed in the sensor, the modified light signal corresponding to the light signal after it has been transmitted through or reflected from the tissue to be tested; generating a digital signal through an analog-to-digital converter disposed in the sensor, the digital signal corresponding to the modified light signal; and generating a physiological parameter by processing the digital signal; wherein at least one of the driving circuit and the analog-to-digital converter comprises a deformable integrated circuit.
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. 1 is a perspective view of a medical monitoring system with flexible, bandage-style sensors in accordance with an embodiment;
FIG. 2 is a perspective view of a partially assembled flexible, bandage-style sensor in accordance with an embodiment in which the sensor includes a display and a wireless device;
FIGS. 3A and 3B are perspective views of the back side of the bandage-style sensor of FIG. 2 in accordance with an embodiment;
FIG. 4A is a perspective view of a flexible clip-style sensor, in accordance with an embodiment;
FIG. 4B is a cross-sectional view of the flexible clip-style sensor of FIG. 4A
taken along line 4-4, in accordance with an embodiment; and 2a FIGS. 5-7 are block diagrams of the sensors of FIGS. 1-4 in accordance with various embodiments.
DETAILED DESCRIPTION
One or more 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.
The present disclosure is directed to an improved medical sensor that includes flexible circuitry. For the purposes of the present specification, the term "flexible circuit"
is intended to describe a deformable integrated circuit that may be flexed without damaging the circuit. By including flexible circuitry within the sensor, the processing capabilities of the sensor may be improved while maintaining the sensor's flexibility and comfort. The enhanced processing capabilities of the sensor may include amplification and filtering of signals received by the sensing components of the sensor and analog-to-digital conversion of the received signals. The digital signals may then be transmitted to the monitor with less power consumption and higher signal-to-noise ratio.
Certain other embodiments may additionally include circuitry that enables the sensor to wirelessly transmit the digital signals to the monitor, thereby eliminating the communications cable.
Further embodiments may include a sensor with circuitry that enables the sensor to calculate and/or display some physiological parameters.
Referring to the figures and turning initially to FIG. 1, a medical monitoring device is illustrated in accordance with an embodiment and is generally designated by the reference numeral 10. The device 10 may include a monitor 12 which may house hardware and software configured to compute various physiological parameters.
The monitor 12 may be configured to operate as a pulse oximeter or as a multi-parameter monitor, such as those available from Nellcor Puritan Bennett L.L.C. and/or Covidien.
The monitor 12 may include a display 14 to display the various physiological parameters.
For example, the display 14 may display the pulse rate and the concentration of a blood analyte, such as, percent oxygen saturation of hemoglobin, for example. The display 14 may show the physiological parameters and calculated values in any appropriate manner.
For example, the calculated values may be displayed numerically and/or as a waveform over time. Additionally, any notifications or alerts prompted by abnormal measurements, calculated values and/or other conditions may be displayed.
One or more flexible sensors 16, in accordance with various embodiments, may be communicatively coupled to the monitor 12. As shown in FIG. 1, the sensors 16 are flexible and, thus, may be attached to the tissue of a patient in a variety of ways. For example, the sensor 16 may be wrapped around a portion of a patient, such as a finger, toe, arm, leg, earlobe, etc. In other embodiments, the sensor may be held against the patients' forehead or torso, such that the sensor fits the contours of the tissue.
In some embodiments, the sensor 16 may be communicatively coupled to the monitor 12 via a cable 18. in other embodiments, however, the sensor 16 may communicate with the monitor 12 wirelessly. In the latter case, both the monitor 12 and the sensor 16 may include wireless devices that allow the monitor and the sensor to communicate as will be explained below in reference to FIG. 6. By eliminating the cable 18, the patient is no longer tethered to the monitor 12 and may move more freely without the risk of inadvertently jerking or damaging the cable 18. In this way, the sensor 16 may be less susceptible to movement or accidental removal, and the risk of the sensor 16 or the monitor 12 is reduced.
The sensor 16 may also include a display 20 that provides information regarding the physiological parameters of the patient, such as blood oxygenation and heart rate. In some embodiments, the sensor 16 may receive the displayed physiological parameters from the monitor 12. As such, the sensor 16 may transmit the raw physiological data to the monitor 12, and the monitor 12 may then calculate physiological parameters based the physiological data and transmit the physiological parameters back to the sensor 16 for display. In other embodiments, the sensor 16 may include flexible circuitry configured to calculate the physiological parameters based on the data gathered by the sensor 16. In this way, the senor 16 may be a stand-alone unit, capable of providing physiological data without the use of the monitor 12. The sensor 16 may, therefore, be used in situations in which a monitor 12 may not be readily available or convenient, such as during an emergency, patient transportation, or other situations where the patient is away from a medical facility. By displaying physiological parameters directly on the sensor 16, a medical service provider may devote greater attention to the patient while obtaining important information regarding the patient's health.
Additional details of the sensor 16 are provided with reference to FIGS. 2-7.
Specifically, FIGS. 2-4 illustrate various embodiments of sensor construction, while FIGS. 5-7 illustrate the electrical components that may be included in various embodiments. Turning first to FIG. 2, a perspective view of the sensor 16 is illustrated. As shown in FIG. 2, the circuitry of the sensor 16 may be housed within a flexible outer covering that may include a flexible top layer 23 and a flexible bottom layer 24. Both the top layer 23 and bottom layer 24 may include flexible polymers, such as silicon polymers, polyvinylchloride, and polyethylene. The polymers may be elastomeric to provide for flexibility of the sensor 16 such that it may conform to the tissue of a patient. In some embodiments, the top and bottom layers 23 and 24 may include cloth or a bandage material, such as gauze. The top layer 23 and bottom layer 24 may be held together by an adhesive. For convenience, FIG. 2 shows the top layer 23 as partially separated from the bottom layer 24 to provide a view of the internal circuitry within the sensor 16. In some embodiments, the top layer 23 may include a window 26 to enable viewing of a display 20. The window 26 may be an unfilled aperture within the top layer 23 or, alternatively, the window may include a clear polymer layer. In some embodiments, the top layer 23 and bottom layer 24 may also include complimentary fastening mechanisms 28, such as rows of buttons or strips of hook and loop type fasteners, which allow the sensor 16 to be wrapped around an extremity of the patient and held in position.
As is also shown in FIG. 2, the sensor 16 may also include one or more flexible circuits 30 held between the top layer 23 and the bottom layer 24. The flexible circuits 30 provide the added functionality of the sensor 16, which will be described further below in relation to FIGS. 5-7. In embodiments with more than one flexible circuit 30, the flexible circuits 30 may be physically and communicatively coupled to one another by a flexible circuit board 32, such as a "flex" circuit board made from a flexible polymer substrate, such as polyimide. The flexible circuit board 32 may be communicatively coupled to electrical leads from the cable 18 at an electrical interface 34.
In this way, signals from the monitor 12 may be routed to or from the emitter 38, detector 40, and other circuit components.
The flexible circuits 30 may include flexible semiconductors fabricated on a flexible polymer substrate according to any of several flexible semiconductor fabrication techniques. In some embodiments, for example, the flexible circuits 30 may include thin film transistors (TFTs), such as low-temperature polysilicon TFTs deposited on a flexible polymer substrate. In some embodiments, the TFTs may be deposited on the flexible polymer substrate by a method of chemical vapor deposition (CVD) or physical vapor deposition (PVD), such as sputtering. Furthermore, in some embodiments, the flexible circuits 30 may be inkjet printed on the polymer substrate at low temperature using a low-temperature liquid silicon, such as polysilane or cyclopentasilane.
The flexible circuits 30 may include some or all of the circuit components of the sensor 16, such as emitters, detectors, drivers, processors, batteries, etc, as will be described below. Among other things, the flexible circuits 30 may include the display 20 and the wireless device 22A. The display 20 may be any thin flexible display, such as a flexible organic light-emitting diode OLED display or a flexible electrophoretic display, for example. The wireless device 22A on the sensor 16 may include a flexible radio frequency antenna, such as a flexible microstrip antenna or flexible patch antenna, for example.
Sensors 16 in accordance with present embodiments may be either transmissive or reflective. In a transmissive sensor 16, emitted light signals pass completely through the patient's tissue before being received by the sensor 16. In a reflective sensor 16, the emitted light signals penetrate the patient's tissue only partially before being reflected back and received by the sensor 16. Embodiments of a transmissive sensor 16 and a reflective sensor 16 are illustrated in FIGS. 3A and 313, respectively.
Turning first to FIG. 3A, a bottom layer 24 of a transmissive sensor 16 is illustrated in accordance with embodiments, The bottom layer 24 of the sensor 16 is held adjacent to the tissue of a patient so that the sensor 16 may detect physiological data of the patient through an emitter 38 and a detector 40, both of which may be held in close proximity to the skin or tissue of the patient. The emitter 38 may include a red emitter and an infra-red emitter that are configured to transmit electromagnetic radiation through the tissue of a patient. In accordance with this embodiment, the red and infra-red emitters may include light emitting diodes (LEDs) that emit electromagnetic radiation in the respective region of the electromagnetic spectrum. The radiation emitted by the emitter 38 into the patient's tissue is detected by the detector 40 after the radiation has passed through or reflected from blood perfused tissue of the patient 42, and the detector 40 generates an electrical signal correlative to the amount of radiation detected.
To facilitate the transmission of light through the patient's tissue, the bottom layer 24 of the sensor 16 may include transparent windows 36 that expose the emitter 38 and detector 40 and allow light to pass through the tissue of a patient from the emitter 38 to the detector 40. The windows 36 may be unfilled apertures within the bottom layer 24 or, alternatively, the windows 36 may include a clear polymer layer. The bottom layer 24 may also include one or more adhesive layers 44 for attaching the sensor 16 to the skin of the patient and securing the emitter 38 and the detector 40.
Furthermore, the adhesive layers 44 may surround both the emitter 38 and the detector 40 to prevent the emitter 38 and the detector 40 from moving relative to the skin of the patient.
The emitter 38 may include any kind of light emitting diodes (LED) suitable for pulse oximetry, while the detector may include any suitable kind of photodiode. In some embodiments, the emitter 38 and the detector 40 may be flexible and may be formed directly on the flexible circuits 30 of the sensor 16. For example, the emitter 38 may include one or more organic light emitting diodes (OLEDs) formed on the plastic substrate of the flexible circuits 30. Additionally, the detector 40 may also include an organic diode configured to operate as a light-detecting photodiode. The emitter 38 and the detector 40 may be disposed on opposite sides of the tissue so that the detector 40 may detect light transmitted through the tissue by the emitter 38.
Turning now to FIG. 3B, a bottom layer 24 of a reflective sensor 16 is illustrated in accordance with embodiments. In this embodiment, as in FIG. 3A, the bottom layer 24 may also include one or more adhesive layers 44 that surround both the emitter 38 and the detector 40 and secure the emitter 38 and the detector 40 to the skin of the patient. In this embodiment, however, the sensor 16 may operate by reflecting light from the tissue of the patient, rather than transmitting light through the tissue. Accordingly, the emitter 38 and the detector 40 may be positioned close to one another to reduce the transmission path between the emitter 38 and the detector 40. In this embodiment, the sensor 16 may be disposed adjacent to any part of a patient's body that is conducive to measuring physiological parameters, such as the forehead, for example. Again, the flexibility of the flexible circuits 30 enables the sensor 16 to easily bend to fit the contour of the tissue to which it is attached.
Embodiments of the present invention may also include a clip-style sensor 16 configured to grasp the tissue of a patient. Turning to FIGS. 4A and 4B, an embodiment of a clip-style sensor 16 is illustrated, in accordance with embodiments.
Turning first to FIG. 4A, the sensor 16 may include a sensor body 46 with an upper clip portion 48 and a lower clip portion 50 coupled together by a hinge 52 that allows the upper clip portion 48 and a lower clip portion 50 to flex outward to receive a body part of the patient, such as a patient's finger. As shown in FIG. 4A, the sensor body 46 may be a single, continuous structure that includes a semi-rigid polymer injection molded around the flexible circuitry 30 and other circuit components of the sensor 16. In this embodiment, the hinge 52 may be a living hinge formed by a thinning of the semi-rigid polymer, and the flexible circuits 30 may pass through the hinge 52. Further, the resiliency of the hinge 52 may provide a compressive force that holds the upper clip portion 48 and the lower clip portion 50 in place against the patient's tissue. In alternative embodiments, the upper clip portion 48 and the lower clip portion 50 of the sensor body 46 may be separate pieces coupled together by the hinge 52, which may be spring loaded to provide the compressive force for holding the upper clip portion 48 and the lower clip portion 50 against the patient's tissue.
Together, the upper clip portion 48 and the lower clip portion 50 may be configured to flex outward about the hinge 52 to allow the finger of a patient to be inserted into the sensor 16 for testing, Furthermore, the sensor body 46 may also include grips 54 to facilitate the flexing of the sensor body 48 and the placement of the sensor 16 around the patient's finger. As will be shown, both the upper clip portion 48 and the lower clip portion 50 may house a variety of flexible electronic circuits and devices for measuring biological parameters.
FIG. 4B shows a side cross-sectional view of the clip-style embodiment of sensor assembly 16. As shown in FIG. 4B, the sensor 16 includes a emitter 38 and a detector 40 embedded in the sensor 16 on opposite sides of the sensor 16. In this embodiment, light signals may be emitted by emitter 38 into the bottom of patient's finger, transmitted through the patient's finger tissue, and received by detector 40. The detector 38 and the emitter 40 may each include or be adjacent to a transparent window which allows light to be transmitted from the emitter 40 to the detector 38, through the patient's finger tissue.
As in the sensor 16 described in relation to FIGS. 1-3, the sensor 16 may include a flexible circuit 30. The flexible circuit 30 may include electrical leads located on a surface of the flexible circuit 30 at an electrical interface 56. The flexible circuit leads may be electrically coupled at the electrical interface 56 to electrical leads from the cable 18 so that signals may be routed to or from the emitter 38, detector 40, and other circuit components.
In other embodiments, the clip-style sensor 16 may also include a wireless device so that signals may be routed to or from the emitter 38, detector 40, and other circuit components wirelessly, and the cable 18 may not be present. In some embodiments, the flexible circuit 30 may be one continuous flexible circuit 30 that extends from the electrical interface 56 through both the upper clip portion 48 and the lower clip portion 50, bending approximately 180 degrees at the joint 30. Moreover, as shown in FIG. 4B, the flexible circuit 30 may be folded on itself one or more times to increase the amount of circuitry that may be included in the sensor 16. In some embodiments, the flexible circuit 30 may include a thin insulative sheet (not shown) to prevent electrical shorting between the folded layers. In other embodiments, electrical insulation may be provided by a thin insulative sheet imposed between the folded layers. By including the flexible circuit 30 in the clip-style sensor 16, a relatively large amount of circuitry may be included within the sensor 16, thus enhancing the capabilities of the sensor as described below while maintaining the flexibility, small size, and comfort of the sensor 16.
Various other physical embodiments of the sensor 16 with flexible circuitry 30 may be possible. In fact, many techniques may be used for holding the sensor 16 against the skin of a patient, and the examples recited above should not be considered an exhaustive list of possible embodiments.
Turning now to FIGS. 5-7, the electrical features of various embodiments of the sensor 16 are described. Embodiments of the sensor 16 may include various levels of additional functionality, some of which will be described below. For example, FIG. 5 describes a sensor 16 electrically coupled by a cable to a monitor 12, wherein the sensor 16 includes, among other things, circuity for amplification, filtering, and digital conversion of the signals received by the detector 40. For another example, FIG. 6 describes a sensor 16 with circuitry that enables the sensor to communicate with the monitor 12 wirelessly. For yet another example, FIG. 7 describes a sensor 16 with a display 20 and circuitry for calculating and displaying some physiological parameters. It will be understood that an actual implementation described herein may include more or fewer components as needed for a specific application.
Turning first to FIG. 5, a block diagram of the monitoring device 10 with the sensor 16 is illustrated in accordance with an embodiment. As shown in FIG. 5, the monitor 12 may include one or more processors 62. The processor 62 may be configured to calculate physiological parameters using various algorithms programmed into the monitor 12 and based on signals received from the sensor 16. For example, the processor 62 may compute a percent oxygen saturation of hemoglobin and/or a pulse rate, among other useful physiological parameters.
The processor 62 may be connected to other component parts of the monitor 12, such as one or more read only memories (ROM) 64, one or more random access memories (RAM) 66, the display 20, and control inputs 70. The ROM 64 and the RAM
66 may be used in conjunction, or independently, to store the algorithms used by the processor 62 in computing physiological parameters. The ROM 64 and the RAM 66 may also be used in conjunction, or independently, to store signals received from the sensor 16 for use in the calculation of the aforementioned algorithms. The control inputs 70 may be provided to allow a user to interface with the monitor 12 and may include soft keys, dedicated function keys, a keyboard, and/or keypad type interfaces for providing parameters, data, and/or instructions to the monitor 12.
As described above in relation to FIGS. 3-4, the sensor 16 may include an emitter 38 and a detector 40. Additionally, the sensor 16 of FIG. 5 may also perform many of the functions traditionally performed by the monitor 12. For example, the sensor 16 may include a light drive 72 that provides signals to a red emitter 38A and an infra-red emitter 38B that cause the emitters 38A and 38B to produce the emitted light signals.
The light drive 72 may be driven by an analog signal from the monitor 12, which controls the timing and intensity of the light signals emitted by the emitters 38A and 38B.
The analog signal from the monitor 12 may then trigger the light drive 72 to generate an excitation signal that is transmitted to the emitters 38A and 38B. In accordance with an embodiment, the light drive 72 may be a simplified light drive circuit discussed in detail in U.S. Patent Application No. 12/343,799, entitled "LED Drive Circuit and Method for Using Same," by Ethan Peterson, which was filed December 24, 2008, and is incorporated herein by reference in its entirety for all purposes. The simplified light drive 72 described therein may include fewer circuit components as compared to light drive circuits typically found on pulse oximetry monitors.
For another example of added sensor 16 functionality, the sensor 16 may also include circuitry for converting the analog signal received from the detector 40 into a digital signal. Specifically, the sensor 16 may include an amplifier 74 that amplifies the electrical signal generated by the detector 40 and a filter 76 that reduces unwanted signals located outside the frequencies of interest. The amplified and filtered signal may then be provided to an analog-to-digital converter (ADC 78) that converts the analog signal into a digital format. The digital signal may then be provided to the monitor 12 for further processing, such as for the calculation of various physiological parameters.
By transmitting a digital signal from the sensor 16 to the monitor 12 rather than an analog signal, the electrical interference introduced by the cable 18 may be reduced.
Turning now to FIG. 6, a block diagram of another embodiment of the monitoring device 12 with the sensor 16 is illustrated. As shown in FIG. 6, the sensor 16 may include the emitter 38 and the detector 40, as well the additional circuitry such as the light drive 72, the amplifier 74, the filter 76, and the ADC 78, as discussed above in relation to FIG.
5. In this embodiment, however, the sensor 16 and the monitor 12 both include wireless devices 22A and 22B that enable the sensor 16 and the monitor 12 to communicate wirelessly. In this way, the communications cable 18 may be eliminated. The wireless device 22A on the sensor 16 may also include driver circuitry (not shown) that receives the digital signal from the ADC 78 and generates an excitation signal for driving an antenna (not shown). In an embodiment, the sensor 16 may transmit data via a wireless communication protocol such as, but not limited to, WiFi, Bluetooth or ZigBee.
In some embodiments, the monitor 12 may communicate with several sensors 16 at the same time. In such embodiments, the operator of the monitor 12 may choose to view physiological data from one or more sensors 16 at any time. To correlate a sensor 16 with a particular patient 42, each sensor 16 may provide a unique identifier that allows the health care provider to match sensor 16 readings with the patient 42 wearing the sensor 16. In various embodiments, for example, each sensor 16 may be tuned to a slightly different broadcast frequency, or each sensor 16 may periodically broadcast an identification sequence.
As is also shown in FIG. 6, the sensor 16 may also include a display 20 that may display various information about the sensor 16 and/or the patient 42. In embodiments, the display 20 may include a numerical display. As such, the display 20 may receive incoming data and convert the data into a format suitable for driving the display 20.
Furthermore, the display 20 may be configured to cycle through a set of display data, either on a timed basis or responsive to an input of the user.
In some embodiments, the display 20 may be configured to display data corresponding to the sensor 16, such as, for example, battery life and/or whether the sensor 16 is transmitting a wireless signal. Moreover, the display 20 may also be configured to display any useful data corresponding to a physiological parameter of a patient 42, such as, for example, a pulse rate and/or a blood-oxygen saturation level. In the embodiment shown in FIG. 6, the sensor 16 may not have processor circuitry suitable for generating the displayed physiological data. Therefore, the sensor 16 may receive physiological data through the wireless link provided by the wires devices 22A
and 22B.
As such, physiological data may be calculated by the processor 62 of the monitor 12 based on the digital signals received from the ADC 78 of the sensor 16, as discussed above. The physiological data may then be transmitted back to the sensor 16 via the wireless device 22B. The wireless device 22A may then route the physiological data to the display 20.
The same physiological data may also be displayed on the display 14 of the monitor 12.
Including a display 20 on the sensor 16 provides several advantages. For example, by displaying information regarding the battery life of the sensor 16, a caregiver may be alerted to replace or recharge the sensor 16. For another example, displaying information regarding the health of the patient in direct proximity to the patient, may enable the caregiver to devote greater attention to the patient while still monitoring physiological data provided by the sensor 16.
As is also shown in FIG. 6, the sensor 16 may include a power source 82, such as a battery for example. The power source 82 may serve to power several of the electrical components of the sensor 16 such as the light drive 72, the amplifier 74, the ADC 78, the wireless device 22A, and the display 20. The power source 82 may include any small, lightweight battery such as a "coin cell" or "button cell." In some embodiments, the power source 82 may include lithium ion batteries, such as nanowire batteries, i.e., high performance lithium ion batteries made from silicon nanowires. Furthermore, in some embodiments, the power source 82 may include one or more flexible thin-film batteries, which may be included in or coupled to the flexible circuitry 30. Furthermore, in some embodiments, the power source 82 may be rechargeable.
In some embodiments, the sensor 16 may be activated by coupling the power source 82 to the sensor circuitry 16. For example, an electrically insulative film (not shown) may be inserted between the power source 82 and an electrical contact coupling the power source 82 to the sensor circuitry, thus blocking the flow of current from the power source. In this way, removal of the electrically insulative film may activate the sensor 16.
Turning now to FIG. 7, a block diagram of another embodiment of a sensor 16 is illustrated. As discussed above, some or all of the circuit components shown in FIG. 7 may be included on one or more flexible circuits 30. As shown in FIG. 7, the sensor 16 may include several additional circuit components traditionally included in the monitor 12. For example, in addition to the signal processing and display capabilities discussed above, the sensor 16 may also include a processor 62. The processor 62 may be communicatively coupled to the light drive 72 for controlling the timing and intensity of the emitters 38A and 38B. Additionally, the processor 62 may be communicatively coupled to the ADC 78 for receiving the digital signal output of the ADC 78 and calculating physiological parameters based on the received digital signals. In some embodiments, the processor 62 may be a synchronous, i.e. clocked, circuit. In other embodiments, however, the processor 62 may be asynchronous, this reducing the power usage of the processor 62 and reducing the heat generated by the processor 62.
Other components of the sensor 16 may also be coupled to the processor 62, such as the display 20 and the wireless device 22. The display 20 may be a simplified display as discussed above in relation to FIG. 6. The wireless device 22A may allow the sensor 16 to transmit data wirelessly to a remote monitor 12. For example, the wireless device 22A may enable the sensor 16 to transmit digital signals received from the ADC
78 to the remote monitor, as discussed above in relation to FIG. 6. Additionally, the wireless device 22A may also enable the sensor 16 to transmit physiological parameters calculated by the sensor 16 to the remote monitor 12. The remote monitor 12 may use the data received from the sensor 16 to execute more advanced features that may not be included in the sensor 16. For example, the remote monitor 12 may calculate additional physiological data that may require more robust algorithms. For another example, the remote monitor 12 may store physiological data gathered over time by the sensor 16 in a long term memory. In this way, information pertaining to physiological trends over time may be stored and displayed by the monitor 12.
Furthermore, the processor(s) 62 may also be coupled to a memory such as read-only memory (ROM) 64 and/or a random access memory (RAM) 66. In certain embodiments, the ROM 64 may be used to store one or more pulse oximetry algorithms, which may be simplified pulse oximetry algorithms such that the computer code associated with those algorithms may be reduced and the circuit footprint of the ROM 64 on the flexible circuitry 30 may also be reduced. In other embodiments, the calculation algorithms may be hardwired into the processor 62, and the ROM 64 may be eliminated, thereby further reducing the circuit footprint of the sensor 16 circuitry on the flexible circuit 30. For example, the processor 62 may be an application specific integrated circuit (ASIC) or a programmable logic device (PLD). The RAM 66 may store intermediate values that are generated in the process of calculating patient parameters as well as certain software routines used in the operation of the sensor 16, such as measurement algorithms, light drive algorithms, and patient parameter calculation algorithms, for example.
From the embodiments describe above, it will be appreciated that several advantages may be achieved by including flexible circuitry within a medical sensor 16.
The use flexible circuitry enables the addition of several electronic components that would traditionally be included in a monitor coupled to a sensor rather than the sensor itself. For example, the use of flexible semiconductor circuitry may enable the sensor to amplify and filter analog signals generated by the detector 40 and convert the analog signals into a digital signal that may then be transmitted to the monitor 12 with less electromagnetic interference and higher signal-to-noise ratio. Additionally, the use of flexible semiconductor circuitry may enable the sensor 16 to communicate wirelessly with the monitor 12, thus increasing the mobility and comfort of the patient.
Furthermore, the use of flexible semiconductor circuitry may enable the sensor 16 to calculate and/or display physiological data detected by the sensor. Moreover, all of the benefits described above may be achieved while maintaining the comfort and flexibility of the sensor 16.
Claims (20)
1. A sensor adapted for placement adjacent to tissue to be tested, comprising:
at least one light emitter and at least one light detector capable of acquiring physiological data from a patient;
a deformable integrated circuit comprising an analog-to-digital converter coupled to an output of the at least one light detector and configured to output a digital signal corresponding to the physiological data from the patient; and a flexible outer covering configured to be placed adjacent the tissue of the patient and to house the deformable integrated circuit and the emitter and the detector.
at least one light emitter and at least one light detector capable of acquiring physiological data from a patient;
a deformable integrated circuit comprising an analog-to-digital converter coupled to an output of the at least one light detector and configured to output a digital signal corresponding to the physiological data from the patient; and a flexible outer covering configured to be placed adjacent the tissue of the patient and to house the deformable integrated circuit and the emitter and the detector.
2. The sensor of claim 1, wherein the deformable integrated circuit comprises thin film transistors disposed on a flexible polymer substrate.
3. The sensor of claim 1 or 2, wherein the deformable integrated circuit comprises low-temperature polycrystalline silicon.
4. The sensor of claim 1, 2 or 3, wherein the flexible outer covering is configured to be wrapped around a body part of the patient.
5. The sensor of claim 1, 2 or 3, wherein the flexible outer covering comprises a clip configured to grasp an extremity of the patient.
6. The sensor of any one of claims 1 to 5, wherein the at least one light emitter comprises at least one flexible, organic light emitting diode.
7. The sensor of any one of claims 1 to 6, wherein the deformable integrated circuit comprises a wireless device coupled to an output of the analog-to-digital converter and configured to wirelessly transmit the digital signal to a monitor.
8. The sensor of any one of claims 1 to 7, wherein the deformable integrated circuit comprises an amplifier coupled to an output of the at least one light detector and a filter coupled to an output of the amplifier, wherein an output of the filter is coupled to an input of the analog-to-digital converter.
9. The sensor of any one of claims 1 to 8, wherein the deformable integrated circuit comprises a drive circuit coupled to an input of the at least one light emitter and configured to provide an electrical signal to the at least one light emitter that causes the at least one light emitter to emit at least one light signal into a tissue of the patient.
10. The sensor of any one of claims 1 to 9, wherein the deformable integrated circuit comprises a display configured to display an output corresponding to at least one of the physiological data and a state of the sensor.
11. The sensor of claim 1, wherein the deformable integrated circuit comprises a processor configured to receive the digital signal and generate an output corresponding to the physiological data.
12. A monitoring system, comprising:
a sensor, comprising:
at least one light emitter and at least one light detector, configured to acquire physiological data from a patient;
a deformable integrated circuit comprising an analog-to-digital converter coupled to an output of the at least one light detector and configured to output a digital signal corresponding to the physiological data from the patient; and a monitor configured to communicatively coupled to the sensor and configured to receive the digital signal and generate an output corresponding to the physiological data.
a sensor, comprising:
at least one light emitter and at least one light detector, configured to acquire physiological data from a patient;
a deformable integrated circuit comprising an analog-to-digital converter coupled to an output of the at least one light detector and configured to output a digital signal corresponding to the physiological data from the patient; and a monitor configured to communicatively coupled to the sensor and configured to receive the digital signal and generate an output corresponding to the physiological data.
13. The monitoring system of claim 12, wherein the output corresponding to the physiological data is transmitted from the monitor to the sensor; and wherein the sensor comprises a display configured to display the output.
14. The monitoring system of claim 12 or 13, wherein the deformable integrated circuit of the sensor comprises a flexible wireless transmitter configured to transmit the digital signal to the monitor.
15. The monitoring system of claim 12, 13 or 14, wherein the deformable integrated circuit of the sensor comprises thin film transistors comprising low-temperature, polycrystalline silicon disposed on a flexible polymer substrate.
16. A method of generating physiological data, comprising:
using a driving circuit disposed in a sensor to drive at least one light emitting diode disposed in the sensor and configured to emit a light signal into a tissue to be tested;
receiving a modified light signal through a light detector disposed in the sensor, the modified light signal corresponding to the light signal after it has been transmitted through or reflected from the tissue to be tested;
generating a digital signal through an analog-to-digital converter disposed in the sensor, the digital signal corresponding to the modified light signal; and generating a physiological parameter by processing the digital signal;
wherein at least one of the driving circuit and the analog-to-digital converter comprises a deformable integrated circuit.
using a driving circuit disposed in a sensor to drive at least one light emitting diode disposed in the sensor and configured to emit a light signal into a tissue to be tested;
receiving a modified light signal through a light detector disposed in the sensor, the modified light signal corresponding to the light signal after it has been transmitted through or reflected from the tissue to be tested;
generating a digital signal through an analog-to-digital converter disposed in the sensor, the digital signal corresponding to the modified light signal; and generating a physiological parameter by processing the digital signal;
wherein at least one of the driving circuit and the analog-to-digital converter comprises a deformable integrated circuit.
17. The method of claim 16, wherein generating a physiological parameter comprises sending the digital signal to a flexible processor disposed on the sensor.
18. The method of claim 16 or 17, comprising wirelessly transmitting the digital signal via a flexible wireless transmitter to at least one of a monitor, a display, and other device.
19. The method of claim 18, comprising wirelessly transmitting the physiological parameter from the at least one of the monitor, the display, and other device to the sensor and displaying the physiological parameter on a flexible display disposed on an outer surface of the sensor.
20. The method of claim 16, 17, 18 or 19, wherein driving the light emitting diodes comprises sequentially activating a red light emitting diode and an infrared light emitting diode.
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| PCT/US2010/025360 WO2010107563A1 (en) | 2009-03-16 | 2010-02-25 | Medical monitoring device with flexible circuitry |
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2009
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2010
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- 2010-02-25 CA CA2753046A patent/CA2753046C/en not_active Expired - Fee Related
- 2010-02-25 EP EP10706103A patent/EP2408348A1/en not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| US20100234706A1 (en) | 2010-09-16 |
| WO2010107563A1 (en) | 2010-09-23 |
| CA2753046A1 (en) | 2010-09-23 |
| US8452366B2 (en) | 2013-05-28 |
| EP2408348A1 (en) | 2012-01-25 |
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