CLAIM OF PRIORITYThis patent application is a continuation of and claims the benefit of priority under 35 U.S.C. § 120 to U.S. patent application Ser. No. 15/592,897, filed on May 11, 2017, which claims the benefit of priority of U.S. Provisional Patent Application Ser. No. 62/334,708, filed on 11 May 2016, each of which is hereby incorporated by reference herein in its entirety.
BACKGROUNDPulse oximetry provides a measure of the oxygenation in arterial blood. Regional oximetry, sometimes referred to as tissue oximetry can provide a measure of organ health associated with oxygenation of the organ tissue. These different measurements of oxygenation are determined using emitted light of different optical wavelengths and using different algorithms. For example, with pulse oximetry, arterial blood exhibits a pulsatile behavior which facilitates measurement of oxygen content. On the other hand, pulsatile behavior of a signal associated with the cerebellum does not facilitate measurement of oxygenation in the brain.
Clinical systems provide a measure of both pulse oximetry and regional oximetry using a variety of optical sensors that interface with a processor. A clinical system can be powered by metered line service and, in some instances, using multiple processors.
In field settings, however, the power demands to provide both pulse oximetry and regional oximetry have resulted in devices that are rather large and suffer poor battery life.
OVERVIEWThe present inventors have recognized, among other things, that a problem to be solved can include providing both pulse oximetry and regional oximetry in a compact package that enable simplified physiological measurements. The present subject matter can help provide a solution to this problem, such as by using multiple emitters and detectors affixed to various surfaces and activated in a coordinated manner to provide low noise measurement of both pulse oximetry and regional oximetry.
This overview is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The detailed description is included to provide further information about the present patent application.
BRIEF DESCRIPTION OF THE DRAWINGSIn the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.
FIG. 1 illustrates a digit probe, according to one example.
FIG. 2 illustrates a digit probe, according to one example.
FIG. 3 illustrates a block diagram of a device, according to one example.
FIG. 4 illustrates a digit probe, according to one example.
FIG. 5 illustrates a digit probe, according to one example.
FIGS. 6 and 7 illustrate a digit probe in a first and second configuration, according to one example.
FIG. 8 illustrates a patient fitted with two devices, according to one example.
FIG. 9 illustrates a flow chart, according to one example.
FIG. 10 illustrates a device, according to one example.
DETAILED DESCRIPTIONFIG. 1 illustrates device100A, sometimes referred to as a digit probe, according to one example. Device100A includes upper jaw16A coupled to lower jaw12A by a joint. The joint in this example includes an articulating hinge having a dynamic pivot axis. A curved feature on the sides of upper jaw16A and a corresponding feature on the lower jaw12A is adapted to mesh when the jaws are brought together. A spring or elastic element is fitted to the jaws and urges the jaws to a closed position.
Interior surface18A is disposed on an interior portion of upper jaw16A and interior surface14A is disposed on an interior portion of lower jaw12A. Interior surface18A and interior surface14A are configured to receive a digit, such as a finger or toe, in the example illustrated. Other configurations are also contemplated, including an embodiment suited for affixation at an ear lobe.
Optical elements20A and20B are fitted to interior surface18A and14A, respectively.Optical elements20A and20B can include any combination of an emitter and a detector. An emitter can include a fiber optic element or a light emitting diode (LED) suited for emission at a particular wavelength or selected wavelengths. An optical detector can include a photodetector having sensitivity at a particular wavelength and can include an electrical terminal for providing an electrical signal corresponding to detected light energy.
In this example,optical elements20A and20B include an emitter and a detector and are configured for determining pulse oximetry.
FIG. 2 illustrates a view of lower jaw12A of device100A. Lower jaw12A is shown in a closed configuration relative to upper jaw16A. Lower jaw12A is configured with a plurality of optical elements disposed near corners of the generally rectangular shape of contact surface10A of lower jaw12A. The plurality of optical elements includes optical element20C,optical element20D,optical element20E, andoptical element20F.
In this example, optical element20C,optical element20D,optical element20E, andoptical element20F includes at least one emitter and at least one detector and are configured for determining regional oximetry.
Port42 is an electrical connection accessible from an external surface ofdevice100A. Port42 can enable coupling of device100A with an auxiliary sensor or other device.Port42 can be referred to as a sensor port. In the example shown,port42 is affixed to lower jaw12A, however, in other examples,port42 is affixed to upper jaw16A.
Port42 can carry an analog signal, digital data, or power, and in oneexample port42 can be used to configure device100A for measuring regional oximetry (rSO2), pulse oximetry (SpO2), or any other compatible external sensor by plugging into the appropriate port.
An auxiliary sensor can include an external rSO2sensor or an SpO2probe suited for use with a particular tissue site (such as an ear probe or a forehead probe). In various examples, a processor internal to device100A (such asprocessor84 discussed elsewhere in conjunction withFIG. 3) or a manually operated switch coupled to device100A can be used to configure device100A to a configuration suitable for a particular selected physiological parameter measurement. Alternately, in an example, the device can also have a separate analog front end for each optical element. The figure illustrates a single port (here referenced as port42) and in some examples, more than one port is provide on an external surface.
FIG. 3 illustrates a block diagram ofdevice100F, according to one example.Device100F includesoptical module20J,processor84,memory86,interface88,communication module80, anddisplay30.Optical module20J,processor84,memory86,interface88,communication module80, anddisplay30 can each be located in upper jaw16A, for example, located in lower jaw12A, or some portion can be located in upper jaw16A and some portion can be located in lower jaw12A.
Optical module20J can include any number of separate optical elements, some examples of which are represented byoptical elements20A-20F in other portions of this document.Optical module20J can be configured for transmission through tissue or configured for reflectance measurement in which light reflected from the tissue site provides a measurement signal associated with a physiological parameter. The separate optical elements ofoptical module20J can include any combination of internal or external elements. For example,optical module20J can include an emitter and a detector affixed directly to a housing ofdevice100F oroptical module20J can include an auxiliary sensor having an emitter and a detector coupled by an electrical cord or an optical fiber.
Processor84 is coupled tooptical module20J.Processor84 is configured to provide a drive current to a portion ofoptical module20J and configured to receive an electrical signal corresponding to a detected light emission.Processor84, in various configurations, includes a driver circuit, a filter, an analog-to-digital converter, a digital-to-analog converter, an amplifier, a microprocessor, and other elements.
Processor84 is coupled tomemory86.Memory86 provides storage for data corresponding to a measured physiological parameter, calibration information, authentication information, patient information, communication parameters, and other data, and provides storage for instructions for execution byprocessor84.
Interface88 is coupled toprocessor84 and can include a graphical user interface by which a user can interact withdevice100F. For example,interface88 can include a touch-sensitive screen, any number of switches or controls, and can include a display or an indicator light to show device activity or readiness.
Communication module80 can include wired or wireless telemetry module. For example,communication module80 can include a radio frequency (RF) receiver, an RF transmitter, or an RF transceiver. Invarious examples module80 can include a Bluetooth or low power radio communication module. In various examples,communication module80 can include a wired port configured to electrically connect with a cable or connector.
Display30 can include an indicator light, visible display of characters, an LED emitter or other indicator to show a physiological measurement, the condition of the device, the state of the device, device activity, calibration information, device settings, patient identification information, communication channel information, paired devices in a communication network, synchronization status information, or other information.
FIG. 4 illustrates device100B having display30 coupled to upper jaw16B. In this example, lower jaw12B is coupled to contact surface10B. Contact surface10B includes elements that provide a region of contact on the tissue surface that has sufficient length to allow measurement of regional oximetry. In the example shown, contact surface10B provides spacing that allows measurement of light energy along multiple pathways through the tissue. Contact surface10B can be electrically or mechanically coupled to a corresponding feature of lower jaw12B. In the example shown,display30 illustrates two lines of numerical data and a heart icon that can be modulated to show device activity and measurement.
FIG. 5 illustrates a view of device100C, according to one example. Device100C includes an upper jaw16C jointly coupled tolower jaw12C. Upper jaw16C includes interior surface18B, here shown in dashed lines. In addition, interior surface18B is fitted withoptical elements20A and20B.Lower jaw12C includesinterior surface14B, here shown in dashed lines. In addition,interior surface14B is fitted withoptical elements20C and20D.
In the example shown,lower jaw12C includesnotches36 on opposing ends.Notches36 are configured to engage withcatch feature32 disposed on a side of contact surface10C. Contact surface10C andlower jaw12C are electrically coupled by a plurality ofelectrical contacts34A,34B, and34C at a mating surface. Contact surface10C includes a plurality ofoptical elements20E,20F,20G, and20H, some of which can include at least one emitter and at least one detector. In one example,electrical contacts34A,34B, and34C provides drive current to emitters and measured signal conduction from detectors of the plurality of optical elements.
In one example, an optical element is coupled by a translucent conduit. For example, the translucent conduit can include a resin, an epoxy, a light pipe, or a fiber optic element. For example, a translucent conduit can be configured to carry emitted light between a tissue site and an optical element in either a unidirectional manner or a bidirectional manner.
Catch feature32 includes an elastically mounted pawl that engages withnotch36 to retain contact surface10C in a fixed positon relative tolower jaw12C. In one example, an electrical connector on a cord can be used to provide an electrical connection between contact surface10C and lower jaw12c.
FIGS. 6 and 7 illustrate a digit probe in a first and second configuration, according to one example. Device10D represents a configuration suited for pulse oximetry in which upper jaw16C andlower jaw12D are in closed configuration havingoptical elements20A,20B,20C, and20D disposed on opposing regions ofdigit60. Interior surface18C and interior surface14C are in facing alignment. Upper jaw16C andlower jaw12D are jointly coupled bylink38.
Device100E represents a configuration suited for regional oximetry in which upper jaw16C andlower jaw12D are in an open configuration, as shown by the inverted reference character ‘B’ onlower jaw12D. In the open configuration,optical elements20A,20B,20C, and20D are disposed along a common contact surface anddevice100E is configured for regional oximetry. In various examples, one set of the optical elements are operated to provide a measure of regional oximetry and a second set (different from the first set) is operated to provide a measure of pulse oximetry. In the example illustrated,tissue62 is shown in contact with theoptical elements20A,20B,20C, and20D.Link38 provides freedom of movement to allow upper jaw16C andlower jaw12D to align as shown.
Consider an example in whichoptical elements20A and20C are emitters andoptical elements20B and20D are detectors in a configuration for reflectance measurement. In this configuration, light energy fromoptical element20A is emitted intotissue62 and detected by detector ofoptical element20B, alonglight pathway52A, as well as detector ofoptical element20D, alonglight pathway54A. In a similar manner, light energy from optical element20C is emitted intotissue62 and detected by detector ofoptical element20D, along light pathway52B, as well as detector ofoptical element20B, alonglight pathway54B. The multiple pathways allows calculation of regional oximetry using a sum and difference method that reduces the influence of noise and surface artifacts. For a transmittance mode of operation, a different set of optical elements can be activated.
FIG. 8 illustrates a patient fitted withdevice100E,device100D, anddevice100G. In this example,device100E provides a measure of regional oximetry attissue site62. Here,tissue site62 can represent cerebral oximetry. In addition,device100D is affixed tofinger62 in the manner of pulse oximetry.Device100G is affixed to a forearm location and can be configured to provide regional oximetry measurements suitable for monitoring for shock. In this example,device100D anddevice100E are structurally matched but in one instance, the jaws are in an open configuration and in the other instance, the jaws are in the closed configuration.
Device100E is fitted withRF antenna82A,device100D is fitted with RF antenna82C, anddevice100G is fitted withRF antenna82D.Antennas82A,82C, and82D can be internal to the device and represented as a component ofcommunication module80 described elsewhere in this document. In one example,antennas82A,82C, and82D are external to the device. Remote device70 is fitted withantenna82B. In various examples, remote device70 is body worn or is at a distance from the user. Remote device70, in one example provides synchronization to allowdevice100E,device100D, anddevice100G to operate without interfering with each other. For example, optical emissions from an emitter ofdevice100D can provide additional input that can alter the measured signal provided bydevice100D ordevice100G. In one example, synchronization includes controlling emissions in a manner that includes dead time between signal readings to avoid sensor crosstalk.
FIG. 9 illustrates a flow chart ofmethod900, according to one example. At910, the method includes controlling relative timing as to emitter operation of a first sensor and a second sensor. At920, the method includes generating a first measurement from the first sensor, and at930, the method includes generating a second measurement from the second sensor. In this manner, the devices can be operated without interference. For example, synchronization can be provide by a remote device, such as device70. In one example, synchronization is provided by one device operating as a master and establishing all other devices in the system as slaves.
In one example, a handshake protocol can determine classification of devices in a system. In one example, a master clock provides a timing signal to other elements to ensure precision LED timing to allow for signal processing and for noise and artifact reduction.
FIG. 10 illustratesdevice100F, according to one example.Device100F includes upper jaw16E (sometimes referred to as display-side jaw) coupled tolower jaw12E (sometimes referred to as non-display-side jaw). Upper jaw16E is coupled to display30 and includes opticalelement20N. Port48 is accessible on a back side of upper jaw16E and provides an electrical connection to enable certain device functions.
Lower jaw12E includesoptical element20K and is affixed to contact surface10D by catches32 andnotches36. Port46 is accessible on a back side oflower jaw12E and provides an electrical connection to enable certain device functions.
Contact surface10D is physically separable fromlower jaw12E and includes optical elements, some of which are denoted here asoptical element20L andoptical element20M. Contact surface10D can be electrically connected to a particular port ofdevice100F bylink44.
In one example, certain electronic components such, such as those shown inFIG. 3, are housed inlower jaw12E.
Port42, port46, andport48 can each be configured for various applications. For example, contact surface10D can be coupled, viaconnector49 andlink44, to port42 (as shown inFIG. 10), or to port46, or toport48. These configurations enable various measurements, such as rSO2measurement or SpO2measurement. As another example, an electrical conductor coupled toport42 can be connected toconnector48 on the upper jaw16E. This configuration is suitable for pulse oximetry measurement. In one example, an electrical conductor coupled toport42 can be connected to an external sensor and suited for an application based on the external sensor. In another example,port42 can be left open in which case, no measurement is provided.
Any one or more ofport42, port46, andport48 can each be configured for connecting to an external device. For example, an external device can include a site-specific sensor such as a forehead sensor or an ear sensor. In addition, an external device can include a long-cabled wired connector, such as an rSO2sensor. Furthermore, any such port can be configured to communicate with, and electrically connect with, an external sensor, some examples of which can include: a pulse oximetry sensor, a disposable sensor, a reusable sensor, a flexible substrate sensor, a wrist-worn sensor, a capnography sensor, a regional oximetry sensor, a neonatal sensor, a pediatric sensor, and a veterinary sensor. In one example, a port of the present subject matter is configured to connect with a patient interface carrier (rSO2without cable) and a display (such as display30) is configured to automatically display relevant parameters. In one example, the display content can be configured for a particular visual configuration of data and information based on a control signal provided by the processor.
Various Notes & ExamplesA number of other configurations are also contemplated. For example, in embodiment includes a sensor device having a first leaf and a second leaf. Both the first leaf and the second leaf have an interior surface and an exterior surface. At least one surface is configured with an optical element. A joint couples the first leaf and the second leaf.
A sensor, according to one example, includes a first emitter and a second emitter wherein each emitter is configured to emit light directed to a tissue site. A first detector is configured to provide an electrical signal corresponding to light from the tissue site. The light from the tissue site corresponds to the emitted light from at least one of the first emitter and the second emitter. A processor is coupled to the first emitter, the second emitter, and the detector and wherein the processor is configured to execute instructions to determine regional oximetry corresponding to the tissue site and to determine pulse oximetry corresponding to arterial oxygenation of blood at the tissue site. A communication module is coupled to the processor. The communication module is configured to telemeter data between the processor and a remote device.
In one example, at least one of the first emitter, the second emitter, and the detector are disposed on an interior surface of a digit probe.
In one example, at least one of the first emitter, the second emitter, and the detector are disposed on an exterior surface of a digit probe.
In one example, at least one of the first emitter, the second emitter, and the detector are disposed on an interior surface of a digit probe.
The plurality of optical elements can include two emitters and one detector. This can include two light emitting diodes (LEDs) and one photodetector. The emitter, and the photodetector are selected to have a particular amplitude at a specified wavelength.
A first device can be in wireless communication with a second device or in wireless communication with a remote device. In one example, communication entails a wired connection. Wireless telemetry can allow for synchronization and for data processing and data compilation. In an example device having a wireless communication module, a battery provides a power supply.
In addition to measuring pulse oximetry and regional oximetry, other physiological parameters can also be measured using various examples of the present subject matter. For example, a device can be configured to measure carboxyhemoglobin, methemoglobin, total hemoglobin, pulse wave velocity, heart rate variability, pulse rate, respiration rate, and other parameters.
An optical element can include a surface mounted component. In one example, the optical elements are configured for transmittance measurement of oxygenation. In one example, reflectance measurement is performed.
In an example of an implementation having multiple devices on a single patient, the resulting data can be compiled at a single device, at multiple devices, or at a remote monitor in communication with the multiple devices. In one example, data is conveyed from one device to another device in a daisy-chain manner. Synchronization and communication enables selection of a measurement and communication time slot in a manner that reduces or eliminates interference from other nearby devices.
Handshaking and pairing routines can be implemented to ensure that data associated with one user does not interfere or contaminate data associated with a different user.
In one example, an application specific integrated circuit (ASIC) provides an interface between the optical module and the processor and allows for low power operation and functionality.
Each of these non-limiting examples can stand on its own, or can be combined in various permutations or combinations with one or more of the other examples.
The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.
In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.
In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.
Geometric terms, such as “parallel”, “perpendicular”, “round”, or “square”, are not intended to require absolute mathematical precision, unless the context indicates otherwise. Instead, such geometric terms allow for variations due to manufacturing or equivalent functions. For example, if an element is described as “round” or “generally round,” a component that is not precisely circular (e.g., one that is slightly oblong or is a many-sided polygon) is still encompassed by this description.
Method examples described herein can be machine or computer-implemented at least in part. Some examples can include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code may form portions of computer program products. Further, in an example, the code can be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media can include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.
The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.