Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57.
The present disclosure relates to devices and methods for monitoring a patient’s physiological information. More specifically, the present disclosure relates to noninvasive measurement of the physiological information using multiple sources of data.
Hospitals, nursing homes, and other patient care facilities typically include patient monitoring devices in the facility. Patient monitoring devices can include sensors, processing equipment, and displays for obtaining and analyzing a medical patient’s physiological parameters such as blood oxygen saturation level, respiratory rate, pulse, and a myriad of other parameters, such as those monitored on commercially available patient monitors from Masimo Corporation of Irvine, California. Clinicians, including doctors, nurses, and other medical personnel, use the physiological parameters and trends of those parameters obtained from patient monitors to diagnose illnesses and to prescribe treatments. Clinicians also use the physiological parameters to monitor patients during various clinical situations to determine whether to increase the level of medical care given to patients.
Patient monitoring can be achieved through spectroscopic analysis using, for example, a pulse oximeter. A pulse oximeter generally includes one or more light sources transmitting optical radiation into or reflecting off through a portion of the body, for example a digit such as a finger, a hand, a foot, a nose, an earlobe, or a forehead. One or more photo detection devices detect the light after attenuation by tissue and fluids of the portion of the body, and output one or more detector signals responsive to the detected attenuated light. One or more signal processing devices process the detector signals and output a measurement indicative of a blood constituent of interest, such as oxygen saturation (SpO2), pulse rate, a plethysmograph waveform, perfusion index (PI), pleth variability index (PVI), methemoglobin (MetHb), carboxyhemoglobin (CoHb), total hemoglobin (tHb), glucose, and/or otherwise, and the oximeter may display on one or more monitors the foregoing parameters individually, in groups, in trends, as combinations, or as an overall wellness or other index. An example of such an oximeter is described in U.S. Application No. 09/323176, filed May 27, 1999, titled “Stereo Pulse Oximeter,” now U.S. Pat. No. 6,334,065, the disclosure of which is hereby incorporated by reference in its entirety.
In noninvasive devices and methods, a sensor is often adapted to position the portion of the body proximate the light source and light detector. Some noninvasive sensors can include a finger clip that includes a contoured bed conforming generally to the shape of a finger. An example of such a noninvasive sensor is described in U.S. Application No. 12/829352, filed Jul. 1, 2010, titled “Multi-Stream Data Collection System for Noninvasive Measurement of Blood Constituents,” now U.S. Pat. No. 9,277,880, the disclosure of which is hereby incorporated by reference in its entirety. Some noninvasive sensors can include one or more sensing components, such as the light source and/or the photodetectors on an adhesive tape, such as described in U.S. Application No. 13/041,803, filed May 7, 2011, titled “Reprocessing of a physiological sensor,” now U.S. Pat. No. 8,584,345, the disclosure of which is hereby incorporated by reference in its entirety.
Conventional physiological monitors, such as pulse oximeters, typically are restricted to measuring physiological information at a single patient site. Stereo pulse oximeter as described in U.S. Pat. No. 6,334,065, can receive data input from sensors placed at multiple measurement sites of a patient and output simultaneous or substantially simultaneous measurements at each of the measurement sites. However, a processor of the stereo pulse oximeter as described in U.S. Pat. No. 6,334,065 processes data input from sensors placed at each measurement site independent of data from sensors at the other measurement sites. Useful information can be obtained if raw or minimally processed sensor data from different measurement sites can be combined and fed into the processor to calculate a single measurement of a physiological parameter. Minimally processed sensor data can be demodulated, filtered, and/or otherwise processed to prepare the data for use by the signal processor to calculate measurements of physiological parameters. This disclosure describes embodiments of noninvasive methods and devices for processing data input from optical sensors located at multiple measurement sites to generate a single measurement of a physiological parameter. The parameter can be a measurement of blood constituent or analyte, such as oxygen saturation (Sp02), pulse rate, a plethysmograph waveform, perfusion index (PI), pleth variability index (PVI), methemoglobin (MetHb), carboxyhemoglobin (CoHb), total hemoglobin (tHb), glucose, and/or of many other physiologically relevant patient characteristics.
Sensors with multiple photodetectors can be used in an optical sensor to also provide useful information about the patient’s physiological condition and/or the placement of the optical sensor. Each of the photodetectors can provide a respective output stream based on the detected optical radiation, or a sum of output streams can be provided from multiple photodetectors. An example of a sensor which employs multiple photodetectors is described in U.S. Pat. No. 9,277,880. Configurations of those multiple photodetectors can include a substantially linear geometry or substantially two-dimensional grid geometry. However, the anatomy at most measurement sites is three-dimensional and irregularly-shaped. The optical sensor with multiple detectors disclosed herein has an improved spatial configuration. The multiple photodetectors described herein can be placed on various locations on a three-dimensional contour of the measurement site on the patient. Use of multiple photodetectors in a spatial configuration can have several advantages. The multiple photodetectors can allow a caregiver or a patient to confirm or validate that the sensor is positioned correctly. This is because the multiple locations of the spatial configuration can provide, for example, topology information that indicates where the sensor has been positioned. This spatial configuration can also provide a diversity of light path lengths among at least some of the detectors and improve robustness of measurements of the physiological parameter(s). The optical sensor described herein can have multiple light emitters and/or multiple photodetectors.
A noninvasive physiological monitor can include at least two sensor interfaces each in communication with at least one sensor adapted to be positioned at one of at least two measurement sites of a patient, each of the interfaces having an output responsive to light transmitted through one of the at least two measurement sites. The system can also include a signal processor in communication with the at least two interface outputs, the signal processor configured to combine the interface outputs to generate a single measurement of physiological parameters. Data from the sensors located at multiple measurement sites can be fed into a single algorithm in the signal processor. The sensors can each include a plurality of light emitters configured to emit optical radiation onto a tissue of one of the at least two measurement sites.
A method of calculating a single measurement of physiological parameters can include transmitting light of at least first and second wavelengths through tissues of at least two measurement sites of a patient; detecting the light attenuated by the tissues of the at least two measurement sites; generating a signal output based on the light detected at each of the at least two measurement sites; and determining the single measurement of the physiological parameters by combining the signal outputs relating to the at least two measurement sites.
A noninvasive sensor capable of producing a signal responsive to light attenuated by tissue at a measurement site on a patient can include an optical source configured to emit optical radiation onto the tissue at the measurement site. The sensor can also include more than one photodetector configured to detect the optical radiation form the optical source after attenuation by the tissue of the patient and to output more than one respective signal stream responsive to the detected optical radiation. When the sensor is coupled to the measurement site, the photodetectors can be distributed throughout a sensor area in contact with the measurement site. The photodetectors can be arranged in a three-dimensional configuration conforming to a contour of the measurement site when the sensor is attached to the measurement site. The sensor can further include a housing for positioning the optical source and the more than one photodetectors with respect to the measurement site, or an adhesive tape portion for positioning the optical source and the more than one photodetectors with respect to the measurement site.
A method of measuring a physiological parameter using multiple photodetectors in one sensor can comprise transmitting light from a light source through tissue of a measurement site of a patient; detecting the light after the light has passed through the tissue of the measurement site; generating a data stream based on the light detected by each of a plurality of photodetectors, the plurality of photodetectors distributed throughout a sensor area in contact with the measurement site; and determining the physiological parameter from the data streams of the plurality of photodetectors.
A noninvasive physiological monitor can include at least two optical sensors, at least two sensor interfaces each in communication with one of the at least two sensors, and a signal processor. Each sensor can have a plurality of light emitters configured to emit optical radiation onto tissue of one of at least two measurement sites of a patient and a plurality of photodetectors configured to detect the optical radiation attenuated by the tissue of the one of at least two measurement sites, the plurality of photodetectors distributed throughout a sensor area in contact with the one of the at least two measurement sites. Each of the interfaces can have an output responsive to the optical radiation attenuated by the tissue of the one of at least two measurement sites. The signal processor can be in communication with the at least two interface outputs and configured to combine the interface outputs to generate a single measurement of physiological parameters.
A noninvasive physiological monitor can comprise at least one input in communication with first and second sensors adapted to be respectively positioned at first and second measurement sites of a patient, the at least one input configured to receive one or more signals responsive to light of at least a plurality of wavelengths attenuated by tissue at the first and second measurement sites of the patient, the one or more signals outputted by one or more optical detectors of the first and second sensors; and one or more signal processors configured to combine the one or more signals from the first and second sensors into combined sensor data and to generate a single measurement of a physiological parameter based on the combined sensor data. The first and second measurement sites can comprise different types of body tissues. The first measurement site can be on or around the patient’s head. The first measurement site can be the patient’s nose. The second measurement site can be a peripheral site of the patient. The second measurement site can be the patient’s finger. The first and/or second sensor can comprise a plurality of light emitters configured to emit optical radiation onto the tissue of the first and/or second measurement sites. The first and/or second sensor can comprise a plurality of light detectors configured to detect light attenuated by the tissue of the first and/or second measurement sites. The physiological parameter can comprise oxygen saturation, pulse rate, a plethysmograph waveform, perfusion index, pleth variability index, methemoglobin, carboxyhemoglobin, total hemoglobin, and/or glucose.
A method of calculating a single measurement of a physiological parameter can comprise using a first sensor including one or more light emitters, emitting light of at least first and second wavelengths into tissues of a first measurement site of a patient; using one or more electronic light detectors of the first sensor, detecting the light attenuated by the tissues of the first measurement site and outputting at least a first signal based on the light detected at the first measurement site; using a second sensor including one or more light emitters, emitting light of at least first and second wavelengths into tissues of a second measurement site of a patient, the second measurement site different from the first measurement site; using one or more electronic light detectors of the first sensor, detecting the light attenuated by the tissues of the second measurement site and outputting at least a second signal based on the light detected at the second measurement site; and using one or more signal processors, combining the at least a first signal and the at least a second signal into combined sensor data, and processing the combined sensor data to determine the single measurement of the physiological parameter. The first and second measurement sites can comprise different types of body tissues. The first measurement site can be on or around the patient’s head. The first measurement site can be the patient’s nose. The second measurement site can be a peripheral site of the patient. The second measurement site can be the patient’s finger. The first and/or second sensor can comprise a plurality of light emitters configured to emit optical radiation onto the tissue of the first and/or second measurement sites. The first and/or second sensor can comprise a plurality of light detectors configured to detect light attenuated by the tissue of the first and/or second measurement sites. The physiological parameter can comprise oxygen saturation, pulse rate, a plethysmograph waveform, perfusion index, pleth variability index, methemoglobin, carboxyhemoglobin, total hemoglobin, and/or glucose.
A noninvasive physiological monitor can comprise a first optical sensor having one or more light emitters configured to emit optical radiation onto tissue of a first measurement site of a patient and one or more of photodetectors configured to detect the optical radiation attenuated by the tissue of the first measurement site and to output a signal responsive to the light attenuation by the tissue of the first measurement site; a second optical sensor having one or more light emitters configured to emit optical radiation onto tissue of a second measurement site of the patient and one or more of photodetectors configured to detect the optical radiation attenuated by the tissue of the second measurement site and to output a signal responsive to the light attenuation by the tissue of the second measurement site; and one or more signal processors in communication with the first and second optical sensors, the signal processor configured to combine the signals responsive to the light attenuation by the tissues of the first and second measurement sites into combined sensor data, and to generate a single measurement of a physiological parameter from the combined sensor data. The one or more photodetectors can be distributed throughout a sensor area in contact with one of the first and second measurement sites. The first and second measurement sites can comprise different types of body tissues. The first measurement site can be on or around the patient’s head. The first measurement site can be the patient’s nose. The second measurement site can be a peripheral site of the patient. The second measurement site can be the patient’s finger. The physiological parameter can comprise oxygen saturation, pulse rate, a plethysmograph waveform, perfusion index, pleth variability index, methemoglobin, carboxyhemoglobin, total hemoglobin, and/or glucose.
For purposes of summarizing the disclosure, certain aspects, advantages and novel features of the inventions have been described herein. It is to be understood that not necessarily all such advantages can be achieved in accordance with any particular embodiment of the inventions disclosed herein. Thus, the inventions disclosed herein can be embodied or carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as can be taught or suggested herein.
Various embodiments will be described hereinafter with reference to the accompanying drawings. These embodiments are illustrated and described by example only, and are not intended to limit the scope of the disclosure. In the drawings, similar elements have similar reference numerals.
Although certain embodiments and examples are described below, those of skill in the art will appreciate that the disclosure extends beyond the specifically disclosed embodiments and/or uses and obvious modifications and equivalents thereof. Thus, it is intended that the scope of the disclosure herein disclosed should not be limited by any particular embodiments described below.
As shown in
Each sensor 110, 120 can provide a stream of data to a signal processor 130. For example, as shown in
The unprocessed or minimally processed streams of data from the first and second sensors 110, 120 can be combined by the signal processor 130 into combined sensor data. The combined sensor data can include a plurality of features of the signals from the first and second sensors 110, 120, such as amplitude, phase, DC value, or others. The measurement site and/or body tissue information can be provided to the signal processor 130 as independent features. The signal processor 130 can produce a single measurement 132 of a physiological parameter based on the combined sensor data. The plurality of features of the signals can be mapped onto empirical data, which can provide estimates of physiological parameter measurements. The additional independent features of the measurement site and/or body tissue information can provide more combinations of features and improve the estimation of the physiological parameters. The combinations of features can be linear and/or can include high-ordered combinations. The signal processor 130 can analyze from the combined sensor data various features, such as a ratiometric value, such as ratios of attenuated light of one wavelength to attenuated light of another wavelength, and/or combinations of features, including non-normalized features, data from bulk absorption and/or peripheral absorption signals, or others.
The single measurement 132 can be displayed on a display 140 of the monitor 10. The measured physiological parameter can include one or more of oxygen saturation (Sp02), pulse rate, a plethysmograph waveform, perfusion index (PI), pleth variability index (PVI), methemoglobin (MetHb), carboxyhemoglobin (CoHb), total hemoglobin (tHb), glucose, and/or of many other physiologically relevant patient characteristics. The signal processor 130 can also optionally process the combined data from the first and second sensors 110, 120 using a single algorithm. The single measurement 132 can provide caregivers with the patient’s systematic status of the physiological information. The single measurement 132 from the combined sensor data may be more informative of the well-being of the patient than measurements from a single patient site. Combining streams of data from multiple patient sites can also reduce errors and/or noise associated with a particular sensor to provide a more robust reading of the physiological parameter.
The signal processor 130 of the monitor 10 can process streams of data from the sensors into combined sensor data to generate a single measurement, and/or to independently generate measurements for each of the measurement sites.
With continued reference to
The signal of the detected light from the plurality of emitters 1110 and the signal of the detected light from the plurality of emitters 1210 can be fed into the signal processor 130 such that the signal processor 130 can combine the two signals to process data from all the emitters 1110, 1210 into combined sensor data. For example, the signal processor 130 can process raw or minimally processed data from twelve to sixteen light emitters to generate a single measurement of physiological parameters. Having data from twelve to sixteen emitters can advantageously allow the processor to produce a more robust measurement. The signal processor 130 can additionally and/or alternatively process the output 116 of the first sensor interface 114 independently of the output 126 of the second sensor interface 124 to produce two measurements of the physiological parameter respectively. The signal processor 130 can determine a final measurement of the physiological parameter based on one or more of the single measurement, or the two measurements from the signals of the first and second sensors respectively. The final measurement can be an average or weighted average of those measurements, or others. The signal processor can also compare the single measurement from the combined data with the measurements from the individual sensors to obtain additional information about the patient.
Turning to
As shown in
For a tape type of sensor, the light source 3010 and the detectors 3020 can be arranged on a flat or substantially tape such that when the sensor 300 is taped to the measurement site, such as the fingertip 12, the light source 3010 can be spaced away from the plurality of photodetectors 3020 and the photodetectors 3020 can be at various locations of the fingertip 12. As shown in
The measurements 332 can provide the caregiver with the physiological information of the entire tissue bed of the patient covered by the contact area 3050. The three-dimensional geometry of the distribution of the detectors 3020 on the fingertip 12 can provide a diversity of light paths among at least some of the photodetectors and improve robustness of the physiological parameter measurements. The signals from the multiple photodetectors 3020 can also inform the caregiver whether the sensor is positioned correctly. This is because the randomly-spaced photodetectors 3020 can provide, for example, topology information, which can indicate where the sensor has been positioned and/or whether the sensor has been positioned correctly.
In
As shown in
The first and second sensors 510, 520 can each have a plurality of light emitters 5110, 5210 and a plurality of photodetectors 5120, 5220. The number and/or spatial configuration of light emitters 5110, 5210 and/or photodetectors 5120, 5220 in each of the first and second sensors 510, 520 can be the same or different. When the first sensor 510 is attached to the first measurement site 11, the plurality of detectors 5120 can be distributed in a spatial configuration conforming to a shape of the patient anatomy at the first measurement site 11. When the second sensor 520 is attached to the second measurement site 12, the photodetectors 5220 can be distributed in a spatial configuration to a shape of the patient anatomy at the second measurement site 12. An example of the spatial configuration of the photodetectors 3020 is shown in
The photodetectors 5120, 5220 can detect light emitted by at least some or all of the light emitters 5110, 5210 and can each generate a signal responsive to the detected light. Signals 512 from the photodetectors 5120 and signals 522 from the photodetectors 5220 can be provided to a signal processor 530 for processing into measurements of physiological parameters. The signal processor 530 can combine all the signals 512, 522 representing respective streams of data from the photodetectors based on light from at least some of the light emitters at each measurement site into combined sensor data. The signal processor 530 can generate a single measurement of the physiological parameter based on the combined sensor data. The signal processor 530 can also independently process the signals 512, 522 to generate measurements of the physiological parameter for each of the measurement sites.
The physiological monitor 50 can combine the advantages of the physiological monitors 10 and 30 of
Although this disclosure has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the disclosure and obvious modifications and equivalents thereof. In addition, while a number of variations of the disclosure have been shown and described in detail, other modifications, which are within the scope of this disclosure, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the disclosure. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed.
Features, materials, characteristics, or groups described in conjunction with a particular aspect, embodiment, or example are to be understood to be applicable to any other aspect, embodiment or example described in this section or elsewhere in this specification unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The protection is not restricted to the details of any foregoing embodiments. The protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.
Furthermore, certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations, one or more features from a claimed combination can, in some cases, be excised from the combination, and the combination may be claimed as a subcombination or variation of a subcombination.
Moreover, while operations may be depicted in the drawings or described in the specification in a particular order, such operations need not be performed in the particular order shown or in sequential order, or that all operations be performed, to achieve desirable results. Other operations that are not depicted or described can be incorporated in the example methods and processes. For example, one or more additional operations can be performed before, after, simultaneously, or between any of the described operations. Further, the operations may be rearranged or reordered in other implementations. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the processes illustrated and/or disclosed may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be removed, others may be added. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure. Also, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products.
For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure may be embodied or carried out in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.
Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, and/or steps are included or are to be performed in any particular embodiment.
Language of degree used herein, such as the terms “approximately,” “about,” “generally,” and “substantially” as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, “generally,” and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount.
The scope of the present disclosure is not intended to be limited by the specific disclosures of preferred embodiments in this section or elsewhere in this specification, and may be defined by claims as presented in this section or elsewhere in this specification or as presented in the future. The language of the claims is to be interpreted broadly based on the language employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive.
Number | Date | Country | |
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62429458 | Dec 2016 | US |
Number | Date | Country | |
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Parent | 15824983 | Nov 2017 | US |
Child | 18048365 | US |